Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015, 67547-68010 [2014-26183]
Download as PDF
<![CDATA[
Vol. 79
Thursday,
No. 219
November 13, 2014
Book 2 of 2 Books
Pages 67547–68092
Part II
Department of Health and Human Services
ebenthall on DSK5SPTVN1PROD with $$_JOB
Centers for Medicare & Medicaid Services
42 CFR Parts 403, 405, 410, et al.
Medicare Program; Revisions to Payment Policies Under the Physician Fee
Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for
the Center for Medicare and Medicaid Innovation Models & Other
Revisions to Part B for CY 2015; Final Rule
VerDate Sep 11 2014
22:30 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00001
Fmt 4717
Sfmt 4717
E:\FR\FM\BOOK2.TXT
BOOK2
67548
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 403, 405, 410, 411, 412,
413, 414, 425, 489, 495, and 498
[CMS–1612–FC]
RIN 0938–AS12
Medicare Program; Revisions to
Payment Policies Under the Physician
Fee Schedule, Clinical Laboratory Fee
Schedule, Access to Identifiable Data
for the Center for Medicare and
Medicaid Innovation Models & Other
Revisions to Part B for CY 2015
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule with comment period.
AGENCY:
This major final rule with
comment period addresses changes to
the physician fee schedule, and other
Medicare Part B payment policies to
ensure that our payment systems are
updated to reflect changes in medical
practice and the relative value of
services, as well as changes in the
statute. See the Table of Contents for a
listing of the specific issues addressed
in this rule.
DATES: Effective date: The provisions of
this final rule are effective on January 1,
2015, with the exception of
amendments to parts 412, 413, and 495
which are effective October 31, 2014.
Comment date: To be assured
consideration, comments must be
received at one of the addresses
provided below, no later than 5 p.m. on
December 30, 2014.
Compliance date: The compliance
date for new data collection
requirements in § 403.904(c)(8) is
January 1, 2016.
ADDRESSES: In commenting, please refer
to file code CMS–1612–FC. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to www.regulations.gov. Follow the
instructions for ‘‘submitting a
comment.’’
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–1612–FC, P.O. Box 8013,
Baltimore, MD 21244–8013.
ebenthall on DSK5SPTVN1PROD with $$_JOB
SUMMARY:
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–1612–FC,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments before the close
of the comment period to either of the
following addresses:
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue SW.,
Washington, DC 20201.
(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
federal government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address,
please call telephone number (410) 786–
7195 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses
indicated as appropriate for hand or
courier delivery may be delayed and
received after the comment period.
FOR FURTHER INFORMATION CONTACT:
Donta Henson, (410) 786–1947 for any
physician payment issues not identified
below.
Gail Addis, (410) 786–4522, for issues
related to the refinement panel.
Chava Sheffield, (410) 786–2298, for
issues related to practice expense
methodology, impacts, the sustainable
growth rate, conscious sedation, or
conversion factors.
Kathy Kersell, (410) 786–2033, for
issues related to direct practice expense
inputs.
Jessica Bruton, (410) 786–5991, for
issues related to potentially misvalued
services or work RVUs.
Craig Dobyski, (410) 786–4584, for
issues related to geographic practice
cost indices or malpractice RVUs.
PO 00000
Frm 00002
Fmt 4701
Sfmt 4700
Ken Marsalek, (410) 786–4502, for
issues related to telehealth services.
Pam West, (410) 786–2302, for issues
related to conditions for therapists in
private practice or therapy caps.
Ann Marshall, (410) 786–3059, for
issues related to chronic care
management.
Marianne Myers, (410) 786–5962, for
issues related to ambulance extender
provisions.
Amy Gruber, (410) 786–1542, for
issues related to changes in geographic
area designations for ambulance
payment.
Anne Tayloe-Hauswald, (410) 786–
4546, for issues related to clinical lab
fee schedule.
Corinne Axelrod, (410) 786–5620, for
issues related to Rural Health Clinics or
Federally Qualified Health Centers.
Renee Mentnech, (410) 786–6692, for
issues related to access to identifiable
data for the Centers for Medicare &
Medicaid models.
Marie Casey, (410) 786–7861 or Karen
Reinhardt, (410) 786–0189, for issues
related to local coverage determination
process for clinical diagnostic laboratory
tests.
Frederick Grabau, (410) 786–0206, for
issues related to private contracting/optout.
David Walczak, (410) 786–4475, for
issues related to payment policy for
substitute physician billing
arrangements (locum tenens).
Melissa Heesters, (410) 786–0618, for
issues related to reports of payments or
other transfers of value to covered
recipients.
Alesia Hovatter, (410) 786–6861, for
issues related to physician compare.
Christine Estella, (410) 786–0485, for
issues related to the physician quality
reporting system.
Alexandra Mugge, (410) 786–4457, for
issues related to EHR incentive program.
Patrice Holtz, (410) 786–5663, for
issues related to comprehensive primary
care initiative.
Terri Postma, (410) 786–4169, for
issues related to Medicare Shared
Savings Program.
Kimberly Spalding Bush, (410) 786–
3232, for issues related to value-based
modifier and improvements to
physician feedback.
Elizabeth Holland, (410) 786–1309,
Medicare EHR Incentive Program
(Medicare payment adjustments and
hardship exceptions).
Elisabeth Myers (CMS), (410) 786–
4751, Medicare EHR Incentive Program
(Medicare payment adjustments and
hardship exceptions).
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://
www.regulations.gov. Follow the search
instructions on that Web site to view
public comments.
Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
ebenthall on DSK5SPTVN1PROD with $$_JOB
Table of Contents
I. Executive Summary and Background
A. Executive Summary
B. Background
C. Health Information Technology
II. Provisions of the Final Rule With
Comment Period for PFS
A. Resource-Based Practice Expense (PE)
Relative Value Units (RVUs)
B. Potentially Misvalued Services Under
the Physician Fee Schedule
C. Malpractice Relative Value Units (RVUs)
D. Geographic Practice Cost Indices
(GPCIs)
E. Medicare Telehealth Services
F. Valuing New, Revised and Potentially
Misvalued Codes
G. Establishing RVUs for CY 2015
H. Chronic Care Management (CCM)
I. Therapy Caps for CY 2015
J. Definition of Colorectal Cancer Screening
Tests
K. Payment of Secondary Interpretation of
Images
L. Conditions Regarding Permissible
Practice Types for Therapists in Private
Practice
M. Payments for Practitioners Managing
Patients on Home Dialysis
N. Sustainable Growth Rate
III. Other Provisions of the Final Rule With
Comment Period Regulation
A. Ambulance Extender Provisions
B. Changes in Geographic Area
Delineations for Ambulance Payment
C. Clinical Laboratory Fee Schedule
D. Removal of Employment Requirements
for Services Furnished ‘‘Incident to’’
Rural Health Clinic (RHC) and Federally
Qualified Health Center (FQHC) Visits
E. Access to Identifiable Data for the Center
for Medicare and Medicaid Innovation
Models
F. Local Coverage Determination Process
for Clinical Diagnostic Laboratory Tests
G. Private Contracting/Opt-Out
H. Solicitation of Comments on the
Payment Policy for Substitute Physician
Billing Arrangements
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
I. Reports of Payments or Other Transfers
of Value to Covered Recipients
J. Physician Compare Web Site
K. Physician Payment, Efficiency, and
Quality Improvements—Physician
Quality Reporting System
L. Electronic Health Record (EHR)
Incentive Program
M. Medicare Shared Savings Program
N. Value-Based Payment Modifier and
Physician Feedback Program
O. Establishment of the Federally Qualified
Health Center Prospective Payment
System (FQHC PPS)
P. Physician Self-Referral Prohibition:
Annual Update to the List of CPT/
HCPCS Codes
Q. Interim Final Revisions to the Electronic
Health Record (EHR) Incentive Program
IV. Collection of Information Requirements
V. Response to Comments
VI. Waiver of Proposed Rulemaking and
Waiver of Delay in Effective Date
VII. Regulatory Impact Analysis
Regulations Text
Acronyms
In addition, because of the many
organizations and terms to which we
refer by acronym in this final rule with
comment period, we are listing these
acronyms and their corresponding terms
in alphabetical order below:
AAA Abdominal aortic aneurysms
ACO Accountable care organization
AMA American Medical Association
ASC Ambulatory surgical center
ATA American Telehealth Association
ATRA American Taxpayer Relief Act (Pub.
L. 112–240)
BBA Balanced Budget Act of 1997 (Pub. L.
105–33)
BBRA [Medicare, Medicaid and State Child
Health Insurance Program] Balanced
Budget Refinement Act of 1999 (Pub. L.
106–113)
CAD Coronary artery disease
CAH Critical access hospital
CBSA Core-Based Statistical Area
CCM Chronic care management
CEHRT Certified EHR technology
CF Conversion factor
CG–CAHPS Clinician and Group Consumer
Assessment of Healthcare Providers and
Systems
CLFS Clinical Laboratory Fee Schedule
CNM Certified nurse-midwife
CP Clinical psychologist
CPC Comprehensive Primary Care
CPEP Clinical Practice Expert Panel
CPT [Physicians] Current Procedural
Terminology (CPT codes, descriptions and
other data only are copyright 2014
American Medical Association. All rights
reserved.)
CQM Clinical quality measure
CSW Clinical social worker
CT Computed tomography
CY Calendar year
DFAR Defense Federal Acquisition
Regulations
DHS Designated health services
DM Diabetes mellitus
DSMT Diabetes self-management training
eCQM Electronic clinical quality measures
PO 00000
Frm 00003
Fmt 4701
Sfmt 4700
67549
EHR Electronic health record
E/M Evaluation and management
EP Eligible professional
eRx Electronic prescribing
ESRD End-stage renal disease
FAR Federal Acquisition Regulations
FFS Fee-for-service
FQHC Federally qualified health center
FR Federal Register
GAF Geographic adjustment factor
GAO Government Accountability Office
GPCI Geographic practice cost index
GPO Group purchasing organization
GPRO Group practice reporting option
GTR Genetic Testing Registry
HCPCS Healthcare Common Procedure
Coding System
HHS [Department of] Health and Human
Services
HOPD Hospital outpatient department
HPSA Health professional shortage area
IDTF Independent diagnostic testing facility
IPPS Inpatient Prospective Payment System
IQR Inpatient Quality Reporting
ISO Insurance service office
IWPUT Intensity of work per unit of time
LCD Local coverage determination
MA Medicare Advantage
MAC Medicare Administrative Contractor
MAP Measure Applications Partnership
MAPCP Multi-payer Advanced Primary
Care Practice
MAV Measure application validity
[process]
MCP Monthly capitation payment
MedPAC Medicare Payment Advisory
Commission
MEI Medicare Economic Index
MFP Multi-Factor Productivity
MIPPA Medicare Improvements for Patients
and Providers Act (Pub. L. 110–275)
MMA Medicare Prescription Drug,
Improvement and Modernization Act of
2003 (Pub. L. 108–173, enacted on
December 8, 2003)
MP Malpractice
MPPR Multiple procedure payment
reduction
MRA Magnetic resonance angiography
MRI Magnetic resonance imaging
MSA Metropolitan Statistical Areas
MSPB Medicare Spending per Beneficiary
MSSP Medicare Shared Savings Program
MU Meaningful use
NCD National coverage determination
NCQDIS National Coalition of Quality
Diagnostic Imaging Services
NP Nurse practitioner
NPI National Provider Identifier
NPP Nonphysician practitioner
NQS National Quality Strategy
OACT CMS’s Office of the Actuary
OBRA ’89 Omnibus Budget Reconciliation
Act of 1989 (Pub. L. 101–239)
OBRA ’90 Omnibus Budget Reconciliation
Act of 1990 (Pub. L. 101–508)
OES Occupational Employment Statistics
OMB Office of Management and Budget
OPPS Outpatient prospective payment
system
OT Occupational therapy
PA Physician assistant
PAMA Protecting Access to Medicare Act of
2014 (Pub. L. 113–93)
PC Professional component
PCIP Primary Care Incentive Payment
E:\FR\FM\13NOR2.SGM
13NOR2
67550
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
PE Practice expense
PE/HR Practice expense per hour
PEAC Practice Expense Advisory
Committee
PECOS Provider Enrollment, Chain, and
Ownership System
PFS Physician Fee Schedule
PLI Professional Liability Insurance
PMA Premarket approval
PQRS Physician Quality Reporting System
PPIS Physician Practice Expense
Information Survey
PT Physical therapy
PY Performance year
QCDR Qualified clinical data registry
QRUR Quality and Resources Use Report
RBRVS Resource-based relative value scale
RFA Regulatory Flexibility Act
RHC Rural health clinic
RIA Regulatory impact analysis
RUC American Medical Association/
Specialty Society Relative (Value) Update
Committee
RUCA Rural Urban Commuting Area
RVU Relative value unit
SBA Small Business Administration
SGR Sustainable growth rate
SIM State Innovation Model
SLP Speech-language pathology
SMS Socioeconomic Monitoring System
SNF Skilled nursing facility
TAP Technical Advisory Panel
TC Technical component
TIN Tax identification number
UAF Update adjustment factor
UPIN Unique Physician Identification
Number
USPSTF United States Preventive Services
Task Force
VBP Value-based purchasing
VM Value-Based Payment Modifier
ebenthall on DSK5SPTVN1PROD with $$_JOB
Addenda Available Only Through the
Internet on the CMS Web Site
The PFS Addenda along with other
supporting documents and tables
referenced in this final rule with
comment period are available through
the Internet on the CMS Web site at
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-Notices.html. Click on the
link on the left side of the screen titled,
‘‘PFS Federal Regulations Notices’’ for a
chronological list of PFS Federal
Register and other related documents.
For the CY 2015 PFS final rule with
comment period, refer to item CMS–
1612–FC. Readers who experience any
problems accessing any of the Addenda
or other documents referenced in this
rule and posted on the CMS Web site
identified above should contact
donta.henson1@cms.hhs.gov.
CPT (Current Procedural Terminology)
Copyright Notice
Throughout this final rule with
comment period, we use CPT codes and
descriptions to refer to a variety of
services. We note that CPT codes and
descriptions are copyright 2013
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
American Medical Association. All
Rights Reserved. CPT is a registered
trademark of the American Medical
Association (AMA). Applicable Federal
Acquisition Regulations (FAR) and
Defense Federal Acquisition Regulations
(DFAR) apply.
I. Executive Summary and Background
A. Executive Summary
1. Purpose
This major final rule with comment
period revises payment polices under
the Medicare Physician Fee Schedule
(PFS) and makes other policy changes
related to Medicare Part B payment.
These changes are applicable to services
furnished in CY 2015.
2. Summary of the Major Provisions
The Social Security Act (the Act)
requires us to establish payments under
the PFS based on national uniform
relative value units (RVUs) that account
for the relative resources used in
furnishing a service. The Act requires
that RVUs be established for three
categories of resources: Work, practice
expense (PE); and malpractice (MP)
expense; and, that we establish by
regulation each year’s payment amounts
for all physicians’ services,
incorporating geographic adjustments to
reflect the variations in the costs of
furnishing services in different
geographic areas. In this major final rule
with comment period, we establish
RVUs for CY 2015 for the PFS, and other
Medicare Part B payment policies, to
ensure that our payment systems are
updated to reflect changes in medical
practice and the relative value of
services, as well as changes in the
statute. In addition, this final rule with
comment period includes discussions
and proposals regarding:
• Misvalued PFS Codes.
• Telehealth Services.
• Chronic Care Management Services.
• Establishing Values for New,
Revised, and Misvalued Codes.
• Updating the Ambulance Fee
Schedule regulations.
• Changes in Geographic Area
Delineations for Ambulance Payment.
• Updating the—
++ Physician Compare Web site.
++ Physician Quality Reporting
System.
++ Medicare Shared Savings
Program.
++ Electronic Health Record (EHR)
Incentive Program.
• Value-Based Payment Modifier and
the Physician Feedback Program.
3. Summary of Costs and Benefits
The Act requires that annual
adjustments to PFS RVUs may not cause
PO 00000
Frm 00004
Fmt 4701
Sfmt 4700
annual estimated expenditures to differ
by more than $20 million from what
they would have been had the
adjustments not been made. If
adjustments to RVUs would cause
expenditures to change by more than
$20 million, we must make adjustments
to preserve budget neutrality. These
adjustments can affect the distribution
of Medicare expenditures across
specialties. In addition, several
proposed changes would affect the
specialty distribution of Medicare
expenditures. When considering the
combined impact of work, PE, and MP
RVU changes, the projected payment
impacts are small for most specialties;
however, the impact would be larger for
a few specialties.
We have determined that this final
rule with comment period is
economically significant. For a detailed
discussion of the economic impacts, see
section VII. of this final rule with
comment period.
B. Background
Since January 1, 1992, Medicare has
paid for physicians’ services under
section 1848 of the Act, ‘‘Payment for
Physicians’ Services.’’ The system relies
on national relative values that are
established for work, PE, and MP, which
are adjusted for geographic cost
variations. These values are multiplied
by a conversion factor (CF) to convert
the RVUs into payment rates. The
concepts and methodology underlying
the PFS were enacted as part of the
Omnibus Budget Reconciliation Act of
1989 (Pub. L. 101–239, enacted on
December 19, 1989) (OBRA ’89), and the
Omnibus Budget Reconciliation Act of
1990 (Pub. L. 101–508, enacted on
November 5, 1990) (OBRA ’90). The
final rule published on November 25,
1991 (56 FR 59502) set forth the first fee
schedule used for payment for
physicians’ services.
We note that throughout this final
rule with comment period, unless
otherwise noted, the term ‘‘practitioner’’
is used to describe both physicians and
nonphysician practitioners (NPPs) who
are permitted to bill Medicare under the
PFS for services furnished to Medicare
beneficiaries.
1. Development of the Relative Values
a. Work RVUs
The work RVUs established for the
initial fee schedule, which was
implemented on January 1, 1992, were
developed with extensive input from
the physician community. A research
team at the Harvard School of Public
Health developed the original work
RVUs for most codes under a
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
cooperative agreement with the
Department of Health and Human
Services (HHS). In constructing the
code-specific vignettes used in
determining the original physician work
RVUs, Harvard worked with panels of
experts, both inside and outside the
federal government, and obtained input
from numerous physician specialty
groups.
As specified in section 1848(c)(1)(A)
of the Act, the work component of
physicians’ services means the portion
of the resources used in furnishing the
service that reflects physician time and
intensity. We establish work RVUs for
new, revised and potentially misvalued
codes based on our review of
information that generally includes, but
is not limited to, recommendations
received from the American Medical
Association/Specialty Society Relative
Value Update Committee (RUC), the
Health Care Professionals Advisory
Committee (HCPAC), the Medicare
Payment Advisory Commission
(MedPAC), and other public
commenters; medical literature and
comparative databases; as well as a
comparison of the work for other codes
within the Medicare PFS, and
consultation with other physicians and
health care professionals within CMS
and the federal government. We also
assess the methodology and data used to
develop the recommendations
submitted to us by the RUC and other
public commenters, and the rationale
for their recommendations.
ebenthall on DSK5SPTVN1PROD with $$_JOB
b. Practice Expense RVUs
Initially, only the work RVUs were
resource-based, and the PE and MP
RVUs were based on average allowable
charges. Section 121 of the Social
Security Act Amendments of 1994 (Pub.
L. 103–432, enacted on October 31,
1994), amended section 1848(c)(2)(C)(ii)
of the Act and required us to develop
resource-based PE RVUs for each
physicians’ service beginning in 1998.
We were required to consider general
categories of expenses (such as office
rent and wages of personnel, but
excluding malpractice expenses)
comprising PEs. The PE RVUs continue
to represent the portion of these
resources involved in furnishing PFS
services.
Originally, the resource-based method
was to be used beginning in 1998, but
section 4505(a) of the Balanced Budget
Act of 1997 (Pub. L. 105–33, enacted on
August 5, 1997) (BBA) delayed
implementation of the resource-based
PE RVU system until January 1, 1999. In
addition, section 4505(b) of the BBA
provided for a 4-year transition period
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
from the charge-based PE RVUs to the
resource-based PE RVUs.
We established the resource-based PE
RVUs for each physicians’ service in a
final rule, published on November 2,
1998 (63 FR 58814), effective for
services furnished in CY 1999. Based on
the requirement to transition to a
resource-based system for PE over a 4year period, payment rates were not
fully based upon resource-based PE
RVUs until CY 2002. This resourcebased system was based on two
significant sources of actual PE data:
The Clinical Practice Expert Panel
(CPEP) data and the AMA’s
Socioeconomic Monitoring System
(SMS) data. (These data sources are
described in greater detail in the CY
2012 final rule with comment period (76
FR 73033).)
Separate PE RVUs are established for
services furnished in facility settings,
such as a hospital outpatient
department (HOPD) or an ambulatory
surgical center (ASC), and in nonfacility
settings, such as a physician’s office.
The nonfacility RVUs reflect all of the
direct and indirect PEs involved in
furnishing a service described by a
particular HCPCS code. The difference,
if any, in these PE RVUs generally
results in a higher payment in the
nonfacility setting because in the facility
settings some costs are borne by the
facility. Medicare’s payment to the
facility (such as the outpatient
prospective payment system (OPPS)
payment to the HOPD) would reflect
costs typically incurred by the facility.
Thus, payment associated with those
facility resources is not made under the
PFS.
Section 212 of the Balanced Budget
Refinement Act of 1999 (Pub. L. 106–
113, enacted on November 29, 1999)
(BBRA) directed the Secretary of Health
and Human Services (the Secretary) to
establish a process under which we
accept and use, to the maximum extent
practicable and consistent with sound
data practices, data collected or
developed by entities and organizations
to supplement the data we normally
collect in determining the PE
component. On May 3, 2000, we
published the interim final rule (65 FR
25664) that set forth the criteria for the
submission of these supplemental PE
survey data. The criteria were modified
in response to comments received, and
published in the Federal Register (65
FR 65376) as part of a November 1, 2000
final rule. The PFS final rules published
in 2001 and 2003, respectively, (66 FR
55246 and 68 FR 63196) extended the
period during which we would accept
these supplemental data through March
1, 2005.
PO 00000
Frm 00005
Fmt 4701
Sfmt 4700
67551
In the CY 2007 PFS final rule with
comment period (71 FR 69624), we
revised the methodology for calculating
direct PE RVUs from the top-down to
the bottom-up methodology beginning
in CY 2007. We adopted a 4-year
transition to the new PE RVUs. This
transition was completed for CY 2010.
In the CY 2010 PFS final rule with
comment period, we updated the
practice expense per hour (PE/HR) data
that are used in the calculation of PE
RVUs for most specialties (74 FR
61749). In CY 2010, we began a 4-year
transition to the new PE RVUs using the
updated PE/HR data, which was
completed for CY 2013.
c. Malpractice RVUs
Section 4505(f) of the BBA amended
section 1848(c) of the Act to require that
we implement resource-based MP RVUs
for services furnished on or after CY
2000. The resource-based MP RVUs
were implemented in the PFS final rule
with comment period published
November 2, 1999 (64 FR 59380). The
MP RVUs are based on commercial and
physician-owned insurers’ malpractice
insurance premium data from all the
states, the District of Columbia, and
Puerto Rico. For more information on
MP RVUs, see section II.C. of this final
rule with comment period.
d. Refinements to the RVUs
Section 1848(c)(2)(B)(i) of the Act
requires that we review RVUs no less
often than every 5 years. Prior to CY
2013, we conducted periodic reviews of
work RVUs and PE RVUs
independently. We completed five-year
reviews of work RVUs that were
effective for calendar years 1997, 2002,
2007, and 2012.
Although refinements to the direct PE
inputs initially relied heavily on input
from the RUC Practice Expense
Advisory Committee (PEAC), the shifts
to the bottom-up PE methodology in CY
2007 and to the use of the updated PE/
HR data in CY 2010 have resulted in
significant refinements to the PE RVUs
in recent years.
In the CY 2012 PFS final rule with
comment period (76 FR 73057), we
finalized a proposal to consolidate
reviews of work and PE RVUs under
section 1848(c)(2)(B) of the Act and
reviews of potentially misvalued codes
under section 1848(c)(2)(K) of the Act
into one annual process.
With regard to MP RVUs, we
completed five-year reviews of MP that
were effective in CY 2005 and CY 2010.
This final rule with comment period
establishes a five-year review for CY
2015.
E:\FR\FM\13NOR2.SGM
13NOR2
67552
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
In addition to the five-year reviews,
beginning for CY 2009, CMS, and the
RUC have identified and reviewed a
number of potentially misvalued codes
on an annual basis based on various
identification screens. This annual
review of work and PE RVUs for
potentially misvalued codes was
supplemented by the amendments to
section 1848 of the Act, as enacted by
section 3134 of the Affordable Care Act,
which requires the agency to
periodically identify, review and adjust
values for potentially misvalued codes.
e. Application of Budget Neutrality To
Adjustments of RVUs
As described in section VI.C. of this
final rule with comment period, in
accordance with section
1848(c)(2)(B)(ii)(II) of the Act, if
revisions to the RVUs caused
expenditures for the year to change by
more than $20 million, we make
adjustments to ensure that expenditures
did not increase or decrease by more
than $20 million.
ebenthall on DSK5SPTVN1PROD with $$_JOB
2. Calculation of Payments Based on
RVUs
To calculate the payment for each
physicians’ service, the components of
the fee schedule (work, PE, and MP
RVUs) are adjusted by geographic
practice cost indices (GPCIs) to reflect
the variations in the costs of furnishing
the services. The GPCIs reflect the
relative costs of physician work, PE, and
MP in an area compared to the national
average costs for each component. (See
section II.D. of this final rule with
comment period for more information
about GPCIs.)
RVUs are converted to dollar amounts
through the application of a CF, which
is calculated based on a statutory
formula by CMS’s Office of the Actuary
(OACT). The CF for a given year is
calculated using (a) the productivityadjusted increase in the Medicare
Economic Index (MEI) and (b) the
Update Adjustment Factor (UAF),
which is calculated by taking into
account the Medicare Sustainable
Growth Rate (SGR), an annual growth
rate intended to control growth in
aggregate Medicare expenditures for
physicians’ services, and the allowed
and actual expenditures for physicians’
services. The formula for calculating the
Medicare fee schedule payment amount
for a given service and fee schedule area
can be expressed as:
Payment = [(RVU work × GPCI work) +
(RVU PE × GPCI PE) + (RVU MP ×
GPCI MP)] × CF.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
3. Separate Fee Schedule Methodology
for Anesthesia Services
Section 1848(b)(2)(B) of the Act
specifies that the fee schedule amounts
for anesthesia services are to be based
on a uniform relative value guide, with
appropriate adjustment of an anesthesia
conversion factor, in a manner to assure
that fee schedule amounts for anesthesia
services are consistent with those for
other services of comparable value.
Therefore, there is a separate fee
schedule methodology for anesthesia
services. Specifically, we establish a
separate conversion factor for anesthesia
services and we utilize the uniform
relative value guide, or base units, as
well as time units, to calculate the fee
schedule amounts for anesthesia
services. Since anesthesia services are
not valued using RVUs, a separate
methodology for locality adjustments is
also necessary. This involves an
adjustment to the national anesthesia CF
for each payment locality.
4. Most Recent Changes to the Fee
Schedule
The CY 2014 PFS final rule with
comment period (78 FR 74230)
implemented changes to the PFS and
other Medicare Part B payment policies.
It also finalized many of the CY 2013
interim final RVUs and established
interim final RVUs for new and revised
codes for CY 2014 to ensure that our
payment system is updated to reflect
changes in medical practice, coding
changes, and the relative values of
services. It also implemented section
635 of the American Taxpayer Relief
Act of 2012 (Pub. L. 112–240, enacted
on January 2, 2013) (ATRA), which
revised the equipment utilization rate
assumption for advanced imaging
services furnished on or after January 1,
2014.
Also, in the CY 2014 PFS final rule
with comment period, we announced
the following for CY 2014: the total PFS
update of ¥20.1 percent; the initial
estimate for the SGR of ¥16.7 percent;
and a CF of $27.2006. These figures
were calculated based on the statutory
provisions in effect on November 27,
2013, when the CY 2014 PFS final rule
with comment period was issued.
The Pathway for SGR Reform Act of
2013 (Pub. L. 113–67, enacted on
December 26, 2013) established a 0.5
percent update to the PFS CF through
March 31, 2014 and the Protecting
Access to Medicare Act of 2014 (Pub. L.
113–93, enacted on April 1, 2014)
(PAMA) extended this 0.5 percent
update through December 31, 2014. As
a result, the CF for CY 2014 that was
published in the CY 2014 final rule with
PO 00000
Frm 00006
Fmt 4701
Sfmt 4700
comment period (78 FR 74230) was
revised to $35.8228 for services
furnished on or after January 1, 2014
and on or before December 31, 2014.
The PAMA provides for a 0.0 percent
update to the PFS for services furnished
on or after January 1, 2015 and on or
before March 31, 2015.
The Pathway for SGR Reform Act
extended through March 31, 2014
several provisions of Medicare law that
would have otherwise expired on
December 31, 2013. The PAMA
extended these same provisions further
through March 31, 2015. A list of these
provisions follows.
• The 1.0 floor on the work geographic
practice cost index
• The exceptions process for outpatient
therapy caps
• The manual medical review process
for therapy services
• The application of the therapy caps
and related provisions to services
furnished in HOPDs
In addition, section 220 of the PAMA
included several provisions affecting the
valuation process for services under the
PFS. Section 220(a) of the PAMA
amended section 1848(c)(2) of the Act to
add a new subparagraph (M). The new
subparagraph (M) provides that the
Secretary may collect or obtain
information from any eligible
professional or any other source on the
resources directly or indirectly related
to furnishing services for which
payment is made under the PFS, and
that such information may be used in
the determination of relative values for
services under the PFS. Such
information may include the time
involved in furnishing services; the
amounts, types and prices of practice
expense inputs; overhead and
accounting information for practices of
physicians and other suppliers, and any
other elements that would improve the
valuation of services under the PFS.
This information may be collected or
obtained through surveys of physicians
or other suppliers, providers of services,
manufacturers, and vendors; surgical
logs, billing systems, or other practice or
facility records; EHRs; and any other
mechanism determined appropriate by
the Secretary. If we use this information,
we are required to disclose the source
and use of the information in
rulemaking, and to make available
aggregated information that does not
disclose individual eligible
professionals, group practices, or
information obtained pursuant to a
nondisclosure agreement. Beginning
with fiscal year 2014, the Secretary may
compensate eligible professionals for
submission of data.
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
Section 220(c) of the PAMA amended
section 1848(c)(2)(K)(ii) of the Act to
expand the categories of services that
the Secretary is directed to examine for
the purpose of identifying potentially
misvalued codes. The nine new
categories are as follows:
• Codes that account for the majority
of spending under the PFS.
• Codes for services that have
experienced a substantial change in the
hospital length of stay or procedure
time.
• Codes for which there may be a
change in the typical site of service
since the code was last valued.
• Codes for which there is a
significant difference in payment for the
same service between different sites of
service.
• Codes for which there may be
anomalies in relative values within a
family of codes.
• Codes for services where there may
be efficiencies when a service is
furnished at the same time as other
services.
• Codes with high intra-service work
per unit of time.
• Codes with high PE RVUs.
• Codes with high cost supplies.
(See section II.B. of this final rule with
comment period for more information
about misvalued codes.).
Section 220(i) of the PAMA also
requires the Secretary to make publicly
available the information we considered
when establishing the multiple
procedure payment reduction (MPPR)
policy for the professional component of
advanced imaging procedures. The
policy reduces the amount paid for the
professional component when two
advanced imaging procedures are
furnished in the same session. The
policy was effective for individual
physicians on January 1, 2012 and for
physicians in the same group practice
on January 1, 2013.
In addition, section 220 of the PAMA
includes other provisions regarding
valuation of services under the PFS that
take effect in future years. Section
220(d) of the PAMA establishes an
annual target from CY 2017 through CY
2020 for reductions in PFS expenditures
resulting from adjustments to relative
values of misvalued services. The target
is calculated as 0.5 percent of the
estimated amount of expenditures under
the fee schedule for the year. If the net
reduction in expenditures for the year is
equal to or greater than the target for the
year, the funds shall be redistributed in
a budget-neutral manner within the
PFS. The amount by which such
reduced expenditures exceed the target
for the year shall be treated as a
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
reduction in expenditures for the
subsequent year, for purposes of
determining whether the target has or
has not been met. The legislation
includes an exemption from budget
neutrality of reduced expenditures if the
target is not met. Other provisions of
section 220 of the PAMA include a 2year phase-in for reductions in RVUs of
at least 20 percent for potentially
misvalued codes that do not involve
coding changes, and certain adjustments
to the fee schedule areas in California.
These provisions will be addressed as
we implement them in future
rulemaking.
On March 5, 2014, we submitted to
MedPAC an estimate of the SGR and CF
applicable to Medicare payments for
physicians’ services for CY 2015, as
required by section 1848(d)(1)(E) of the
Act. The actual values used to compute
physician payments for CY 2015 will be
based on later data and are scheduled to
be published by November 1, 2014, as
part of the CY 2015 PFS final rule with
comment period.
C. Health Information Technology
The Department of Health and Human
Services (HHS) believes all patients,
their families, and their health care
providers should have consistent and
timely access to patient health
information in a standardized format
that can be securely exchanged between
the patient, providers, and others
involved in the patient’s care. (HHS
August 2013 Statement, ‘‘Principles and
Strategies for Accelerating Health
Information Exchange,’’ see https://
www.healthit.gov/sites/default/files/
acceleratinghieprinciples_strategy.pdf)
HHS is committed to accelerating health
information exchange (HIE) through the
use of safe, interoperable health
information technology (health IT),
including electronic health records
(EHRs), across the broader care
continuum through a number of
initiatives: (1) Alignment of incentives
and payment adjustments to encourage
provider adoption and optimization of
health IT and HIE services through
Medicare and Medicaid payment
policies; (2) adoption of common
standards and certification requirements
for interoperable HIT; (3) support for
privacy and security of patient
information across all HIE-focused
initiatives; and (4) governance of health
information. These initiatives are
designed to encourage HIE among
health care providers, including
professionals and hospitals eligible for
the Medicare and Medicaid EHR
Incentive Programs and those who are
not eligible for the EHR Incentive
Programs, and are designed to improve
PO 00000
Frm 00007
Fmt 4701
Sfmt 4700
67553
care delivery and coordination across
the entire care continuum. For example,
the Transition of Care Measure #2 in
Stage 2 of the Medicare and Medicaid
EHR Incentive Programs requires HIE to
share summary records for more than 10
percent of care transitions. In addition,
to increase flexibility in the Office of the
National Coordinator for Health
Information Technology’s (ONC)
regulatory certification structure, ONC
expressed in the 2014 Edition Release 2
final rule (79 FR 54472–73) an intent to
propose future changes to the ONC HIT
Certification Program that would permit
more efficient certification of health IT
for other health care settings, such as
long-term and post-acute care and
behavioral health settings.
We believe that health IT that
incorporates usability features and has
been certified to interoperable standards
can effectively and efficiently help all
providers improve internal care delivery
practices, support management of
patient care across the continuum, and
support the reporting of electronically
specified clinical quality measures
(eCQMs).
II. Provisions of the Proposed Rule for
PFS
A. Resource-Based Practice Expense
(PE) Relative Value Units (RVUs)
1. Overview
Practice expense (PE) is the portion of
the resources used in furnishing a
service that reflects the general
categories of physician and practitioner
expenses, such as office rent and
personnel wages, but excluding
malpractice expenses, as specified in
section 1848(c)(1)(B) of the Act. As
required by section 1848(c)(2)(C)(ii) of
the Act, we use a resource-based system
for determining PE RVUs for each
physician’s service. We develop PE
RVUs by considering the direct and
indirect practice resources involved in
furnishing each service. Direct expense
categories include clinical labor,
medical supplies, and medical
equipment. Indirect expenses include
administrative labor, office expense, and
all other expenses. The sections that
follow provide more detailed
information about the methodology for
translating the resources involved in
furnishing each service into servicespecific PE RVUs. We refer readers to
the CY 2010 PFS final rule with
comment period (74 FR 61743 through
61748) for a more detailed explanation
of the PE methodology.
E:\FR\FM\13NOR2.SGM
13NOR2
67554
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
2. Practice Expense Methodology
ebenthall on DSK5SPTVN1PROD with $$_JOB
a. Direct Practice Expense
We determine the direct PE for a
specific service by adding the costs of
the direct resources (that is, the clinical
staff, medical supplies, and medical
equipment) typically involved with
furnishing that service. The costs of the
resources are calculated using the
refined direct PE inputs assigned to
each CPT code in our PE database,
which are generally based on our review
of recommendations received from the
RUC and those provided in response to
public comment periods. For a detailed
explanation of the direct PE
methodology, including examples, we
refer readers to the Five-Year Review of
Work Relative Value Units under the
PFS and Proposed Changes to the
Practice Expense Methodology proposed
notice (71 FR 37242) and the CY 2007
PFS final rule with comment period (71
FR 69629).
b. Indirect Practice Expense Per Hour
Data
We use survey data on indirect PEs
incurred per hour worked in developing
the indirect portion of the PE RVUs.
Prior to CY 2010, we primarily used the
practice expense per hour (PE/HR) by
specialty that was obtained from the
AMA’s Socioeconomic Monitoring
Surveys (SMS). The AMA administered
a new survey in CY 2007 and CY 2008,
the Physician Practice Expense
Information Survey (PPIS). The PPIS is
a multispecialty, nationally
representative, PE survey of both
physicians and nonphysician
practitioners (NPPs) paid under the PFS
using a survey instrument and methods
highly consistent with those used for
the SMS and the supplemental surveys.
The PPIS gathered information from
3,656 respondents across 51 physician
specialty and health care professional
groups. We believe the PPIS is the most
comprehensive source of PE survey
information available. We used the PPIS
data to update the PE/HR data for the
CY 2010 PFS for almost all of the
Medicare-recognized specialties that
participated in the survey.
When we began using the PPIS data
in CY 2010, we did not change the PE
RVU methodology itself or the manner
in which the PE/HR data are used in
that methodology. We only updated the
PE/HR data based on the new survey.
Furthermore, as we explained in the CY
2010 PFS final rule with comment
period (74 FR 61751), because of the
magnitude of payment reductions for
some specialties resulting from the use
of the PPIS data, we transitioned its use
over a 4-year period from the previous
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PE RVUs to the PE RVUs developed
using the new PPIS data. As provided in
the CY 2010 PFS final rule with
comment period (74 FR 61751), the
transition to the PPIS data was complete
for CY 2013. Therefore, PE RVUs from
CY 2013 forward are developed based
entirely on the PPIS data, except as
noted in this section.
Section 1848(c)(2)(H)(i) of the Act
requires us to use the medical oncology
supplemental survey data submitted in
2003 for oncology drug administration
services. Therefore, the PE/HR for
medical oncology, hematology, and
hematology/oncology reflects the
continued use of these supplemental
survey data.
Supplemental survey data on
independent labs from the College of
American Pathologists were
implemented for payments beginning in
CY 2005. Supplemental survey data
from the National Coalition of Quality
Diagnostic Imaging Services (NCQDIS),
representing independent diagnostic
testing facilities (IDTFs), were blended
with supplementary survey data from
the American College of Radiology
(ACR) and implemented for payments
beginning in CY 2007. Neither IDTFs,
nor independent labs, participated in
the PPIS. Therefore, we continue to use
the PE/HR that was developed from
their supplemental survey data.
Consistent with our past practice, the
previous indirect PE/HR values from the
supplemental surveys for these
specialties were updated to CY 2006
using the MEI to put them on a
comparable basis with the PPIS data.
We also do not use the PPIS data for
reproductive endocrinology and spine
surgery since these specialties currently
are not separately recognized by
Medicare, nor do we have a method to
blend the PPIS data with Medicarerecognized specialty data.
Previously, we established PE/HR
values for various specialties without
SMS or supplemental survey data by
crosswalking them to other similar
specialties to estimate a proxy PE/HR.
For specialties that were part of the PPIS
for which we previously used a
crosswalked PE/HR, we instead used the
PPIS-based PE/HR. We continue
previous crosswalks for specialties that
did not participate in the PPIS.
However, beginning in CY 2010 we
changed the PE/HR crosswalk for
portable x-ray suppliers from radiology
to IDTF, a more appropriate crosswalk
because these specialties are more
similar to each other for work time.
For registered dietician services, the
resource-based PE RVUs have been
calculated in accordance with the final
policy that crosswalks the specialty to
PO 00000
Frm 00008
Fmt 4701
Sfmt 4700
the ‘‘All Physicians’’ PE/HR data, as
adopted in the CY 2010 PFS final rule
with comment period (74 FR 61752) and
discussed in more detail in the CY 2011
PFS final rule with comment period (75
FR 73183).
c. Allocation of PE to Services
To establish PE RVUs for specific
services, it is necessary to establish the
direct and indirect PE associated with
each service.
(1) Direct Costs
The relative relationship between the
direct cost portions of the PE RVUs for
any two services is determined by the
relative relationship between the sum of
the direct cost resources (that is, the
clinical staff, medical supplies, and
medical equipment) typically involved
with furnishing each of the services.
The costs of these resources are
calculated from the refined direct PE
inputs in our PE database. For example,
if one service has a direct cost sum of
$400 from our PE database and another
service has a direct cost sum of $200,
the direct portion of the PE RVUs of the
first service would be twice as much as
the direct portion of the PE RVUs for the
second service.
(2) Indirect Costs
Section II.A.2.b. of this final rule with
comment period describes the current
data sources for specialty-specific
indirect costs used in our PE
calculations. We allocated the indirect
costs to the code level on the basis of
the direct costs specifically associated
with a code and the greater of either the
clinical labor costs or the physician
work RVUs. We also incorporated the
survey data described earlier in the PE/
HR discussion. The general approach to
developing the indirect portion of the
PE RVUs is as follows:
• For a given service, we use the
direct portion of the PE RVUs calculated
as previously described and the average
percentage that direct costs represent of
total costs (based on survey data) across
the specialties that furnish the service to
determine an initial indirect allocator.
In other words, the initial indirect
allocator is calculated so that the direct
costs equal the average percentage of
direct costs of those specialties
furnishing the service. For example, if
the direct portion of the PE RVUs for a
given service is 2.00 and direct costs, on
average, represented 25 percent of total
costs for the specialties that furnished
the service, the initial indirect allocator
would be calculated so that it equals 75
percent of the total PE RVUs. Thus, in
this example, the initial indirect
allocator would equal 6.00, resulting in
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
a total PE RVUs of 8.00 (2.00 is 25
percent of 8.00 and 6.00 is 75 percent
of 8.00).
• Next, we add the greater of the work
RVUs or clinical labor portion of the
direct portion of the PE RVUs to this
initial indirect allocator. In our
example, if this service had work RVUs
of 4.00 and the clinical labor portion of
the direct PE RVUs was 1.50, we would
add 4.00 (since the 4.00 work RVUs are
greater than the 1.50 clinical labor
portion) to the initial indirect allocator
of 6.00 to get an indirect allocator of
10.00. In the absence of any further use
of the survey data, the relative
relationship between the indirect cost
portions of the PE RVUs for any two
services would be determined by the
relative relationship between these
indirect cost allocators. For example, if
one service had an indirect cost
allocator of 10.00 and another service
had an indirect cost allocator of 5.00,
the indirect portion of the PE RVUs of
the first service would be twice as great
as the indirect portion of the PE RVUs
for the second service.
• Next, we incorporate the specialtyspecific indirect PE/HR data into the
calculation. In our example, if, based on
the survey data, the average indirect
cost of the specialties furnishing the
first service with an allocator of 10.00
was half of the average indirect cost of
the specialties furnishing the second
service with an indirect allocator of
5.00, the indirect portion of the PE
RVUs of the first service would be equal
to that of the second service.
ebenthall on DSK5SPTVN1PROD with $$_JOB
d. Facility and Nonfacility Costs
For procedures that can be furnished
in a physician’s office, as well as in a
hospital or other facility setting, we
establish two PE RVUs: Facility and
nonfacility. The methodology for
calculating PE RVUs is the same for
both the facility and nonfacility RVUs,
but is applied independently to yield
two separate PE RVUs. Because in
calculating the PE RVUs for services
furnished in a facility, we do not
include resources that would generally
not be provided by physicians when
furnishing the service in a facility, the
facility PE RVUs are generally lower
than the nonfacility PE RVUs. Medicare
makes a separate payment to the facility
for its costs of furnishing a service.
e. Services With Technical Components
(TCs) and Professional Components
(PCs)
Diagnostic services are generally
comprised of two components: A
professional component (PC); and a
technical component (TC). The PC and
TC may be furnished independently or
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
by different providers, or they may be
furnished together as a ‘‘global’’ service.
When services have separately billable
PC and TC components, the payment for
the global service equals the sum of the
payment for the TC and PC. To achieve
this we use a weighted average of the
ratio of indirect to direct costs across all
the specialties that furnish the global
service, TCs, and PCs; that is, we apply
the same weighted average indirect
percentage factor to allocate indirect
expenses to the global service, PCs, and
TCs for a service. (The direct PE RVUs
for the TC and PC sum to the global.)
f. PE RVU Methodology
For a more detailed description of the
PE RVU methodology, we refer readers
to the CY 2010 PFS final rule with
comment period (74 FR 61745 through
61746).
(1) Setup File
First, we create a setup file for the PE
methodology. The setup file contains
the direct cost inputs, the utilization for
each procedure code at the specialty
and facility/nonfacility place of service
level, and the specialty-specific PE/HR
data calculated from the surveys.
(2) Calculate the Direct Cost PE RVUs
Sum the costs of each direct input.
Step 1: Sum the direct costs of the
inputs for each service. Apply a scaling
adjustment to the direct inputs.
Step 2: Calculate the aggregate pool of
direct PE costs for the current year. This
is the product of the current aggregate
PE (direct and indirect) RVUs, the CF,
and the average direct PE percentage
from the survey data used for
calculating the PE/HR by specialty.
Step 3: Calculate the aggregate pool of
direct PE costs for use in ratesetting.
This is the product of the aggregated
direct costs for all services from Step 1
and the utilization data for that service.
Step 4: Using the results of Step 2 and
Step 3, calculate a direct PE scaling
adjustment to ensure that the aggregate
pool of direct PE costs calculated in
Step 3 does not vary from the aggregate
pool of direct PE costs for the current
year. Apply the scaling factor to the
direct costs for each service (as
calculated in Step 1).
Step 5: Convert the results of Step 4
to an RVU scale for each service. To do
this, divide the results of Step 4 by the
CF. Note that the actual value of the CF
used in this calculation does not
influence the final direct cost PE RVUs,
as long as the same CF is used in Step
2 and Step 5. Different CFs will result
in different direct PE scaling factors, but
this has no effect on the final direct cost
PE RVUs since changes in the CFs and
PO 00000
Frm 00009
Fmt 4701
Sfmt 4700
67555
changes in the associated direct scaling
factors offset one another.
(3) Create the Indirect Cost PE RVUs
Create indirect allocators.
Step 6: Based on the survey data,
calculate direct and indirect PE
percentages for each physician
specialty.
Step 7: Calculate direct and indirect
PE percentages at the service level by
taking a weighted average of the results
of Step 6 for the specialties that furnish
the service. Note that for services with
TCs and PCs, the direct and indirect
percentages for a given service do not
vary by the PC, TC, and global service.
Step 8: Calculate the service level
allocators for the indirect PEs based on
the percentages calculated in Step 7.
The indirect PEs are allocated based on
the three components: The direct PE
RVUs; the clinical PE RVUs; and the
work RVUs.
For most services the indirect
allocator is: Indirect PE percentage *
(direct PE RVUs/direct percentage) +
work RVUs.
There are two situations where this
formula is modified:
• If the service is a global service (that
is, a service with global, professional,
and technical components), then the
indirect PE allocator is: Indirect
percentage (direct PE RVUs/direct
percentage) + clinical labor PE RVUs +
work RVUs.
• If the clinical labor PE RVUs exceed
the work RVUs (and the service is not
a global service), then the indirect
allocator is: Indirect PE percentage
(direct PE RVUs/direct percentage) +
clinical labor PE RVUs.
(Note: For global services, the indirect PE
allocator is based on both the work RVUs and
the clinical labor PE RVUs. We do this to
recognize that, for the PC service, indirect
PEs will be allocated using the work RVUs,
and for the TC service, indirect PEs will be
allocated using the direct PE RVUs and the
clinical labor PE RVUs. This also allows the
global component RVUs to equal the sum of
the PC and TC RVUs.)
For presentation purposes in the
examples in Table 1, the formulas were
divided into two parts for each service.
• The first part does not vary by
service and is the indirect percentage
(direct PE RVUs/direct percentage).
• The second part is either the work
RVU, clinical labor PE RVU, or both
depending on whether the service is a
global service and whether the clinical
PE RVUs exceed the work RVUs (as
described earlier in this step).
Apply a scaling adjustment to the
indirect allocators.
Step 9: Calculate the current aggregate
pool of indirect PE RVUs by multiplying
E:\FR\FM\13NOR2.SGM
13NOR2
67556
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
the current aggregate pool of PE RVUs
by the average indirect PE percentage
from the survey data.
Step 10: Calculate an aggregate pool of
indirect PE RVUs for all PFS services by
adding the product of the indirect PE
allocators for a service from Step 8 and
the utilization data for that service.
Step 11: Using the results of Step 9
and Step 10, calculate an indirect PE
adjustment so that the aggregate indirect
allocation does not exceed the available
aggregate indirect PE RVUs and apply it
to indirect allocators calculated in Step
8.
Calculate the indirect practice cost
index.
Step 12: Using the results of Step 11,
calculate aggregate pools of specialtyspecific adjusted indirect PE allocators
for all PFS services for a specialty by
adding the product of the adjusted
indirect PE allocator for each service
and the utilization data for that service.
Step 13: Using the specialty-specific
indirect PE/HR data, calculate specialtyspecific aggregate pools of indirect PE
for all PFS services for that specialty by
adding the product of the indirect PE/
HR for the specialty, the work time for
the service, and the specialty’s
utilization for the service across all
services furnished by the specialty.
Step 14: Using the results of Step 12
and Step 13, calculate the specialtyspecific indirect PE scaling factors.
Step 15: Using the results of Step 14,
calculate an indirect practice cost index
at the specialty level by dividing each
specialty-specific indirect scaling factor
by the average indirect scaling factor for
the entire PFS.
Step 16: Calculate the indirect
practice cost index at the service level
to ensure the capture of all indirect
costs. Calculate a weighted average of
the practice cost index values for the
specialties that furnish the service.
(Note: For services with TCs and PCs,
we calculate the indirect practice cost
index across the global service, PCs, and
TCs. Under this method, the indirect
practice cost index for a given service
(for example, echocardiogram) does not
vary by the PC, TC, and global service.)
Step 17: Apply the service level
indirect practice cost index calculated
in Step 16 to the service level adjusted
indirect allocators calculated in Step 11
to get the indirect PE RVUs.
(4) Calculate the Final PE RVUs
Step 18: Add the direct PE RVUs from
Step 6 to the indirect PE RVUs from
Step 17 and apply the final PE budget
neutrality (BN) adjustment. The final PE
BN adjustment is calculated by
comparing the results of Step 18 to the
current pool of PE RVUs. This final BN
adjustment is required to redistribute
RVUs from step 18 to all PE RVUs in the
PFS, and because certain specialties are
excluded from the PE RVU calculation
for ratesetting purposes, but we note
that all specialties are included for
purposes of calculating the final BN
adjustment. (See ‘‘Specialties excluded
from ratesetting calculation’’ later in
this section.)
(5) Setup File Information
• Specialties excluded from
ratesetting calculation: For the purposes
of calculating the PE RVUs, we exclude
certain specialties, such as certain
nonphysician practitioners paid at a
percentage of the PFS and low-volume
specialties, from the calculation. These
specialties are included for the purposes
of calculating the BN adjustment. They
are displayed in Table 1.
TABLE 1—SPECIALTIES EXCLUDED FROM RATESETTING CALCULATION
ebenthall on DSK5SPTVN1PROD with $$_JOB
Specialty
code
49 .............
50 .............
51 .............
52 .............
53 .............
54 .............
55 .............
56 .............
57 .............
58 .............
59 .............
60 .............
61 .............
73 .............
74 .............
87 .............
88 .............
89 .............
96 .............
97 .............
A0 ............
A1 ............
A2 ............
A3 ............
A4 ............
A5 ............
A6 ............
A7 ............
B2 ............
B3 ............
Specialty description
Ambulatory surgical center.
Nurse practitioner.
Medical supply company with certified orthotist.
Medical supply company with certified prosthetist.
Medical supply company with certified prosthetist-orthotist.
Medical supply company not included in 51, 52, or 53.
Individual certified orthotist.
Individual certified prosthetist.
Individual certified prosthetist-orthotist.
Medical supply company with registered pharmacist.
Ambulance service supplier, e.g., private ambulance companies, funeral homes, etc.
Public health or welfare agencies.
Voluntary health or charitable agencies.
Mass immunization roster biller.
Radiation therapy centers.
All other suppliers (e.g., drug and department stores).
Unknown supplier/provider specialty.
Certified clinical nurse specialist.
Optician.
Physician assistant.
Hospital.
SNF.
Intermediate care nursing facility.
Nursing facility, other.
HHA.
Pharmacy.
Medical supply company with respiratory therapist.
Department store.
Pedorthic personnel.
Medical supply company with pedorthic personnel.
• Crosswalk certain low volume
physician specialties: Crosswalk the
utilization of certain specialties with
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
relatively low PFS utilization to the
associated specialties.
PO 00000
Frm 00010
Fmt 4701
Sfmt 4700
• Physical therapy utilization:
Crosswalk the utilization associated
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
with all physical therapy services to the
specialty of physical therapy.
• Identify professional and technical
services not identified under the usual
TC and 26 modifiers: Flag the services
that are PC and TC services, but do not
use TC and 26 modifiers (for example,
electrocardiograms). This flag associates
the PC and TC with the associated
global code for use in creating the
indirect PE RVUs. For example, the
professional service, CPT code 93010
(Electrocardiogram, routine ECG with at
least 12 leads; interpretation and report
only), is associated with the global
service, CPT code 93000
(Electrocardiogram, routine ECG with at
least 12 leads; with interpretation and
report).
• Payment modifiers: Payment
modifiers are accounted for in the
creation of the file consistent with
current payment policy as implemented
in claims processing. For example,
services billed with the assistant at
surgery modifier are paid 16 percent of
the PFS amount for that service;
therefore, the utilization file is modified
to only account for 16 percent of any
service that contains the assistant at
67557
surgery modifier. Similarly, for those
services to which volume adjustments
are made to account for the payment
modifiers, time adjustments are applied
as well. For time adjustments to surgical
services, the intraoperative portion in
the work time file is used; where it is
not present, the intraoperative
percentage from the payment files used
by contractors to process Medicare
claims is used instead. Where neither is
available, we use the payment
adjustment ratio to adjust the time
accordingly. Table 2 details the manner
in which the modifiers are applied.
TABLE 2—APPLICATION OF PAYMENT MODIFIERS TO UTILIZATION FILES
Modifier
Description
Volume adjustment
80,81,82 ...............
AS ........................
16% ........................................................................................
14% (85% * 16%) ..................................................................
Intraoperative portion.
Intraoperative portion.
or LT and RT ..
.........................
.........................
.........................
.........................
Assistant at Surgery ..............
Assistant at Surgery—Physician Assistant.
Bilateral Surgery ....................
Multiple Procedure ................
Reduced Services .................
Discontinued Procedure ........
Intraoperative Care only ........
150% of work time.
Intraoperative portion.
50%.
50%.
Preoperative + Intraoperative
portion.
55 .........................
Postoperative Care only ........
62 .........................
66 .........................
Co-surgeons ..........................
Team Surgeons .....................
150% ......................................................................................
50% ........................................................................................
50% ........................................................................................
50% ........................................................................................
Preoperative + Intraoperative Percentages on the payment
files used by Medicare contractors to process Medicare
claims.
Postoperative Percentage on the payment files used by
Medicare contractors to process Medicare claims.
62.5% .....................................................................................
33% ........................................................................................
50
51
52
53
54
ebenthall on DSK5SPTVN1PROD with $$_JOB
We also make adjustments to volume
and time that correspond to other
payment rules, including special
multiple procedure endoscopy rules and
multiple procedure payment reductions
(MPPR). We note that section
1848(c)(2)(B)(v) of the Act exempts
certain reduced payments for multiple
imaging procedures and multiple
therapy services from the BN
calculation under section
1848(c)(2)(B)(ii)(II) of the Act. These
MPPRs are not included in the
development of the RVUs.
For anesthesia services, we do not
apply adjustments to volume since the
average allowed charge is used when
simulating RVUs, and therefore,
includes all adjustments. A time
adjustment of 33 percent is made only
for medical direction of two to four
cases since that is the only situation
where time units are duplicative.
• Work RVUs: The setup file contains
the work RVUs from this final rule with
comment period.
(6) Equipment Cost Per Minute
The equipment cost per minute is
calculated as:
(1/(minutes per year * usage)) * price *
((interest rate/(1¥(1/((1 + interest
rate)∧ life of equipment)))) +
maintenance)
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Where:
minutes per year = maximum minutes per
year if usage were continuous (that is,
usage = 1); generally 150,000 minutes.
usage = variable, see discussion below.
price = price of the particular piece of
equipment.
life of equipment = useful life of the
particular piece of equipment.
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion below.
Usage: We currently use an
equipment utilization rate assumption
of 50 percent for most equipment, with
the exception of expensive diagnostic
imaging equipment, for which we use a
90 percent assumption as required by
Section 1848(b)(4)(C) of the Act.
Maintenance: This factor for
maintenance was proposed and
finalized during rulemaking for CY 1998
PFS (62 FR 33164). Several stakeholders
have suggested that this maintenance
factor assumption should be variable.
We solicited comments regarding
reliable data on maintenance costs that
vary for particular equipment items. We
received several comments about
variable maintenance costs, which we
will consider in future rulemaking. We
note, however, that we do not believe
that high-level summary data from
informal surveys constitutes reliable
data. Rather than assertions that a
PO 00000
Frm 00011
Fmt 4701
Sfmt 4700
Time adjustment
Postoperative portion.
50%.
33%.
particular maintenance rate is typical,
multiple invoices containing equipment
prices that are accompanied by
maintenance contracts would provide
support for a maintenance cost other
than our currently assumed 5 percent.
We continue to seek reliable data about
variable maintenance costs, as we
consider adjustments to our
methodology to accommodate variable
maintenance costs.
Per-use Equipment Costs: Several
stakeholders have also suggested that
our PE methodology should incorporate
usage fees and other per-use equipment
costs as direct costs. We also solicited
comment on adjusting our cost formula
to include equipment costs that do not
vary based on the equipment time. We
received a comment that addressed how
to incorporate usage fees and other peruse equipment costs into our
methodology, and received several
comments that addressed how we
should reclassify the anomalous supply
inputs removed from the direct PE
database. We will consider these
comments in future rulemaking,
including the way these anomalous
supply inputs fit in to any future
proposals related to per-use costs.
Interest Rate: In the CY 2013 final rule
with comment period (77 FR 68902), we
updated the interest rates used in
E:\FR\FM\13NOR2.SGM
13NOR2
67558
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
developing an equipment cost per
minute calculation. The interest rate
was based on the Small Business
Administration (SBA) maximum
interest rates for different categories of
loan size (equipment cost) and maturity
(useful life). The interest rates are listed
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
in Table 3. (See 77 FR 68902 for a
thorough discussion of this issue.)
PO 00000
TABLE 3—SBA MAXIMUM INTEREST
RATES
Price
<$25K .....................
$25K to $50K ..........
>$50K .....................
<$25K .....................
$25K to $50K ..........
>$50K .....................
Frm 00012
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
Useful life
<7
<7
<7
7+
7+
7+
Years
Years
Years
Years
Years
Years
Interest
rate
(%)
7.50
6.50
5.50
8.00
7.00
6.00
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Step 5 ..............
Step 1 ..............
Step 1 ..............
Step 1 ..............
Step 1 ..............
Steps 2–4 ........
Steps 2–4 ........
Steps 2–4 ........
Steps 2–4 ........
Steps 2–4 ........
Step 5 ..............
Step 5 ..............
Step
Frm 00013
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
=Ind Alloc * Ind
Adj.
..........................
Steps 9–11 ......
Step 18 ............
(27) Final PE RVU .....................
=((14)+(26)) *
Other Adj)
=(24)*(25)
..............................
..............................
..............................
See 20
=(19)+(21)
See 18
..............................
=(11)+(12)+(13)
..............................
..............................
..............................
..............................
=(8)/(10)
=(7)/(10)
..............................
..............................
..............................
=(1)+(2)+(3)
..............................
=(1)*(5)
=(2)*(5)
=(3)*(5)
=(6)+(7)+(8)
..............................
=(6)/(10)
Formula
1.01
0.73
1.07
0.68
0.3813
0.97
1.79
0.27
0.97
0.25
0.75
((14)/
(16)*(17)
0.82
(15)
................
0.05
13.32
2.98
0.17
16.48
0.5898
7.86
1.76
0.10
9.72
35.82
0.22
13.04
11.59
0.75
15.41
0.3813
33.75
40.42
1.41
33.75
0.17
0.83
((14)/
(16)*(17)
6.67
(15)
0.01
0.12
77.52
7.34
0.58
85.45
0.5898
45.72
4.33
0.34
50.40
35.82
1.28
33533
CABG,
arterial,
single
facility
0.54
0.32
0.99
0.32
0.3813
0.31
0.84
0.22
0.22
0.29
0.71
((14)/
(16)*(17)
0.53
(15+11)
0.11
0.01
5.74
0.53
6.92
13.19
0.5898
3.39
0.31
4.08
7.78
35.82
0.09
71020
Chest xray nonfacility
0.46
0.24
0.99
0.24
0.3813
0.09
0.62
0.22
................
0.29
0.71
((14)/
(16)*(17)
0.53
(11)
0.11
0.01
5.74
0.53
6.92
13.19
0.5898
3.39
0.31
4.08
7.78
35.82
0.09
71020–
TC Chest
x-ray,
nonfacility
Note: PE RVUs in Table 5, row 27, may not match Addendum B due to rounding.
* The direct adj = [current pe rvus * CF * avg dir pct]/[sum direct inputs] = [step2]/[step3].
** The indirect adj = [current pe rvus * avg ind pct]/[sum of ind allocators] = [step9]/[step10].
Note: The use of any particular conversion factor (CF) in Table 5 to illustrate the PE Calculation has no effect on the resulting RVUs.
Note: The Other Adjustment includes an adjustment for the equipment utilization change.
Step 17 ............
= Adj.Ind Alloc *
PCI.
=(Adj Dir + Adj
Ind) * Other
Adj.
See Footnote**
Steps 9–11 ......
Steps 12–16 ....
..........................
..........................
Step 8 ..............
Step 8 ..............
(25) Ind. Practice Cost Index
(IPCI).
(26) Adjusted Indirect ................
..........................
See Step 8 ......
Step 8 ..............
Step 8 ..............
Step 5 ..............
Setup File ........
Steps 6,7 .........
Steps 6,7 .........
Step 8 ..............
Step 5 ..............
(13) Adj. equipment cost converted.
(14) Adj. direct cost converted ..
(15) Work RVU ..........................
(16) Dir_pct ................................
(17) Ind_pct ................................
(18) Ind. Alloc. Formula (1st
part).
(19) Ind. Alloc.(1st part) .............
(20) Ind. Alloc. Formula (2nd
part).
(21) Ind. Alloc.(2nd part) ............
(22) Indirect Allocator (1st +
2nd).
(23) Indirect Adjustment (Ind.
Adj.).
(24) Adjusted Indirect Allocator
AMA .................
AMA .................
AMA .................
..........................
See footnote* ...
=Labor * Dir Adj
=Eqp * Dir Adj
=Sup * Dir Adj
..........................
PFS ..................
=(Lab * Dir
Adj)/CF.
=(Sup * Dir
Adj)/CF.
=(Eqp * Dir
Adj)/CF.
..........................
PFS ..................
Surveys ............
Surveys ............
See Step 8 ......
Source
99213 Office visit,
est nonfacility
0.08
0.08
0.99
0.08
0.3813
0.22
0.22
................
0.22
0.29
0.71
((14)/
(16)*(17)
................
(15)
................
................
................
................
................
................
0.5898
................
................
................
................
35.82
................
71020–26
Chest xray, nonfacility
TABLE 4—CALCULATION OF PE RVUS UNDER METHODOLOGY FOR SELECTED CODES
(12) Adj. supply cost converted
(1) Labor cost (Lab) ...................
(2) Supply cost (Sup) .................
(3) Equipment cost (Eqp) ..........
(4) Direct cost (Dir) ....................
(5) Direct adjustment (Dir. Adj.)
(6) Adjusted Labor .....................
(7) Adjusted Supplies ................
(8) Adjusted Equipment .............
(9) Adjusted Direct .....................
(10) Conversion Factor (CF) .....
(11) Adj. labor cost converted- ..
Factor (CF) (2nd part)
ebenthall on DSK5SPTVN1PROD with $$_JOB
0.29
0.18
0.91
0.20
0.3813
0.25
0.51
0.11
0.17
0.29
0.71
((14)/
(16)*(17)
0.26
(15+11)
................
0.02
5.10
1.19
0.09
6.38
0.5898
3.01
0.70
0.05
3.77
35.82
0.08
93000
ECG,
Complete,
nonfacility
0.23
0.12
0.91
0.13
0.3813
0.08
0.34
0.11
................
0.29
0.71
((14)/
(16)*(17)
0.26
(11)
................
0.02
5.10
1.19
0.09
6.38
0.5898
3.01
0.70
0.05
3.77
35.82
0.08
93005
ECG,
Tracing
nonfacility
0.06
0.06
0.91
0.06
0.3813
0.17
0.17
................
0.17
0.29
0.71
((14)/
(16)*(17)
................
(15)
................
................
................
................
................
................
0.5898
................
................
................
................
35.82
................
93010
ECG,
Report
non-facility
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
67559
67560
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
3. Changes to Direct PE Inputs for
Specific Services
In this section, we discuss other CY
2015 revisions related to direct PE
inputs for specific services. The final
direct PE inputs are included in the
final rule CY 2015 direct PE input
database, which is available on the CMS
Web site under downloads for the CY
2015 PFS final rule with comment
period at https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-Notices.html.
a. RUC Recommendation for Monitoring
Time following Moderate Sedation
We received a recommendation from
the RUC regarding appropriate clinical
labor minutes for post-procedure
moderate sedation monitoring and postprocedure monitoring. The RUC
recommended 15 minutes of RN time
for one hour of monitoring following
moderate sedation and 15 minutes of
RN time per hour for post-procedure
monitoring (unrelated to moderate
sedation). For 17 procedures listed in
Table 5, the recommended clinical labor
minutes differed from the clinical labor
minutes in the direct PE database. We
proposed to accept, without refinement,
the RUC recommendation to adjust
these clinical labor minutes as indicated
in Table 5 as ‘‘Change to Clinical Labor
Time.’’
TABLE 5—CODES WITH CHANGES TO POST-PROCEDURE CLINICAL LABOR MONITORING TIME
Current
monitoring
time
(min)
CPT Code
32553
35471
35475
35476
36147
37191
47525
49411
50593
50200
31625
31626
31628
31629
31634
31645
31646
...........................................................................................................................................
...........................................................................................................................................
...........................................................................................................................................
...........................................................................................................................................
...........................................................................................................................................
...........................................................................................................................................
...........................................................................................................................................
...........................................................................................................................................
...........................................................................................................................................
...........................................................................................................................................
...........................................................................................................................................
...........................................................................................................................................
...........................................................................................................................................
...........................................................................................................................................
...........................................................................................................................................
...........................................................................................................................................
...........................................................................................................................................
ebenthall on DSK5SPTVN1PROD with $$_JOB
Comment: We received two comments
supporting our proposal to accept the
RUC recommendation, without
refinement, to adjust the clinical labor
minutes as indicated in Table 5. One
commenter noted that the RUC
recommendation was a more accurate
reflection of the monitoring time,
particularly for codes 50593 (Ablation,
renal tumor(s), unilateral, percutaneous,
cryotherapy) and 50200 (Renal biopsy;
percutaneous, by trocar or needle), than
the current time.
Response: We appreciate commenters’
support for our proposal. After
consideration of comments received, we
are finalizing our proposal to accept,
without refinement, the RUC
recommendation to adjust the clinical
labor minutes as indicated in Table 5 as
‘‘Change to Clinical Labor Time.’’
b. RUC Recommendation for Standard
Moderate Sedation Package
We received a RUC recommendation
to modify PE inputs included in the
standard moderate sedation package.
Specifically, the RUC indicated that
several specialty societies have pointed
to the need for a stretcher during
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
procedures for which moderate sedation
is inherent in the procedure. Although
the RUC did not recommend that we
make changes to PE inputs for codes at
this time, the RUC indicated that its
future recommendations would include
the stretcher as a direct input for
procedures including moderate
sedation.
The RUC recommended three
scenarios that it would use in the future
to allocate the equipment time for the
stretcher based on the procedure time
and whether the stretcher would be
available for other patients to use during
a portion of the procedure. Although we
appreciate the RUC’s attention to the
differences in the time required for the
stretcher based on the time for the
procedure, we believe that one of the
purposes of standard PE input packages
is to reduce the complexity associated
with assigning appropriate PE inputs to
individual procedures while, at the
same time, maintaining relativity
between procedures. Since we generally
allocate inexpensive equipment items to
the entire service period when they are
likely to be unavailable for another use
during the full service period, we
PO 00000
Frm 00014
Fmt 4701
Sfmt 4700
30
21
60
60
18
60
6
30
30
15
20
25
25
25
25
10
10
RUC recommended
total post-procedure monitoring time
(min)
60
60
30
30
30
30
15
60
60
60
15
15
15
15
15
15
15
Change to
clinical labor
time
(min)
30
39
¥30
¥30
12
¥30
9
30
30
45
¥5
¥10
¥10
¥10
¥10
5
5
believe it is preferable to treat the
stretcher consistently across services.
Therefore, we proposed to modify the
standard moderate sedation input
package to include a stretcher for the
same length of time as the other
equipment items in the moderate
sedation package. The revised moderate
sedation input package will be applied
to relevant codes as we review them
through future notice and comment
rulemaking. In seeking comments on the
proposal, we stated that it would be
useful to hear stakeholders’ views and
the reasoning behind them on this issue,
especially from those who think that the
stretcher, as expressed through the
allocation of equipment minutes, should
be allocated with more granularity than
the equipment costs that are allocated to
other similar items.
Comment: We received comments
supporting our proposal to add the
stretcher to the moderate sedation
package, including support to include
the stretcher for the same length of time
as the other equipment items included
in the moderate sedation package since
it is used by the patient for the duration
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
of their recovery and not available to
other patients during that time.
Response: We appreciate the
commenters’ support for our proposal.
After consideration of comments
received, we are finalizing our proposal
to add the stretcher to the moderate
sedation package for the same length of
time as the other equipment items in the
moderate sedation package. We note
that we will not apply this change
retroactively, but will make the change
to the moderate sedation package for
codes being finalized for 2015, as well
as interim final codes for 2015. For a
detailed discussion of the specific codes
impacted by this change, we refer
readers to sections II.F. of this final rule
with comment period.
c. RUC Recommendation for Migration
From Film to Digital Practice Expense
Inputs
The RUC provided a recommendation
regarding the PE inputs for digital
imaging services. Specifically, the RUC
recommended that we remove a list of
supply and equipment items associated
with film technology since these items
are no longer a typical resource input;
these items are detailed in Table 6. The
RUC also recommended that the Picture
Archiving and Communication System
(PACS) equipment be included for these
imaging services since these items are
now typically used in furnishing
imaging services. We received a
description of the PACS system as part
of the recommendation, which included
both items that appear to be direct PE
items and items for which indirect PE
RVUs are allocated in the PE
methodology. As we have previously
indicated, items which are not clinical
labor, medical supplies, or medical
equipment, or are not individually
allocable to a particular patient for a
particular procedure, are not categorized
as direct costs in the PE methodology.
Since we did not receive any invoices
for the PACS system prior to the
proposed rule, we were unable to
determine the appropriate pricing to use
for the inputs. We proposed to accept
the RUC recommendation to remove the
film supply and equipment items, and
to allocate minutes for a desktop
computer (ED021) as a proxy for the
PACS workstation as a direct expense.
Specifically, for the 31 services that
already contain ED021 (computer,
desktop, w-monitor), we proposed to
retain the time that is currently
included in the direct PE input
database. For the remaining services
that are valued in the nonfacility setting,
we proposed to allocate the full clinical
labor intraservice time to ED021, except
for codes without clinical labor, in
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
which case we proposed to allocate the
intraservice work time to ED021. For
services valued only in the facility
setting, we proposed to allocate the
post-service clinical labor time to
ED021, since the film supply and/or
equipment inputs were previously
associated with the post-service period.
TABLE 6—RUC-RECOMMENDED SUPPLY AND EQUIPMENT ITEMS REMOVED FOR DIGITAL IMAGING SERVICES
CMS
Code
Description
SK013
SK014
SK015
SK016
SK022
SK025
SK028
SK033
SK034
SK035
SK037
SK038
computer media, dvd.
computer media, floppy disk 1.44mb.
computer media, optical disk 128mb.
computer media, optical disk 2.6gb.
film, 8inx10in (ultrasound, MRI).
film, dry, radiographic, 8in x 10in.
film, fluoroscopic 14 x 17.
film, x-ray 10in x 12in.
film, x-ray 14in x 17in.
film, x-ray 14in x 36in.
film, x-ray 8in x 10in.
film, x-ray 8in x 10in (X-omat,
Radiomat).
video tape, VHS.
x-ray developer solution.
x-ray digitalization separator sheet.
x-ray envelope.
x-ray fixer solution.
x-ray ID card (flashcard).
x-ray marking pencil.
film, x-ray, laser print.
cleaner, x-ray cassette-screen.
computer workstation, 3D reconstruction CT–MR.
computer workstation, MRA post
processing.
film processor, PET imaging.
film processor, dry, laser.
film processor, wet.
film processor, x-omat (M6B).
densitometer, film.
film
alternator
(motorized
film
viewbox).
x-ray view box, 4 panel.
SK086
SK089
SK090
SK091
SK092
SK093
SK094
SK098
SM009
ED014
ED016
ED023
ED024
ED025
ED027
ER018
ER029
ER067
We note that the RUC exempted
certain procedures from its
recommendation because (a) the
dominant specialty indicated that
digital technology is not yet typical or
(b) the procedure only contained a
single input associated with film
technology, and it was determined that
the sharing of images, but not actual
imaging, may be involved in the service.
However, we do not believe that the
most appropriate approach in
establishing relative values for services
that involve imaging is to exempt
services from the transition from film to
digital PE inputs based on information
reported by individual specialties.
Although we understand that the
migration from film technology to
digital technology may progress at
PO 00000
Frm 00015
Fmt 4701
Sfmt 4700
67561
different paces for particular specialties,
we do not have information to suggest
that the migration is not occurring for
all procedures that require the storage of
images. Just as it was appropriate to use
film inputs as a proxy for some services
for which digital inputs were typical
pending these changes in the direct PE
input database, we believe it is
appropriate to use digital inputs as a
proxy for the services that may still use
film, pending their migration to digital
technology. In addition, since the RUC
conducted its collection of information
from the specialties over several years,
we believe the migration process from
film to digital inputs has likely
continued over the time period during
which the information was gathered,
and that the digital PE inputs will
reflect typical use of technology for
most if not all of these services before
the change to digital inputs would take
effect beginning January 1, 2015.
We noted that we believed that, for
the sake of relativity, we should remove
the equipment and supply inputs noted
below from all procedures in the direct
PE database, including those listed in
Table 7. We sought comment on
whether the computer workstation,
which we proposed to use as a proxy for
the PACS workstation, is the
appropriate input for the services listed
in Table 7, or whether an alternative
input is a more appropriate reflection of
direct PE costs.
TABLE 7—CODES CONTAINING FILM
INPUTS BUT EXCLUDED FROM THE
RUC RECOMMENDATION
HCPCS
21077
28293
61580
61581
61582
61583
61584
61585
61586
64517
64681
70310
77326
77327
77328
91010
91020
91034
91035
91037
91038
91040
91120
91122
91132
91133
92521
E:\FR\FM\13NOR2.SGM
Short descriptor
Prepare face/oral prosthesis.
Correction of bunion.
Craniofacial approach skull.
Craniofacial approach skull.
Craniofacial approach skull.
Craniofacial approach skull.
Orbitocranial approach/skull.
Orbitocranial approach/skull.
Resect nasopharynx skull.
N block inj hypogas plxs.
Injection treatment of nerve.
X-ray exam of teeth.
Brachytx isodose calc simp.
Brachytx isodose calc interm.
Brachytx isodose plan compl.
Esophagus motility study.
Gastric motility studies.
Gastroesophageal reflux test.
G-esoph reflx tst w/electrod.
Esoph imped function test.
Esoph imped funct test > 1hr.
Esoph balloon distension tst.
Rectal sensation test.
Anal pressure record.
Electrogastrography.
Electrogastrography w/test.
Evaluation of speech fluency.
13NOR2
67562
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 7—CODES CONTAINING FILM
INPUTS BUT EXCLUDED FROM THE
RUC RECOMMENDATION—Continued
HCPCS
ebenthall on DSK5SPTVN1PROD with $$_JOB
92523
92524
92601
92603
92611
92612
92614
92616
95800
95801
95803
95805
95806
95807
95808
95810
95811
95812
95813
95829
95950
95953
95954
95955
95956
95957
96904
G0270
G0271
Short descriptor
Speech sound lang comprehend.
Behavioral qualit analys voice.
Cochlear implt f/up exam <7.
Cochlear implt f/up exam 7/>.
Motion fluoroscopy/swallow.
Endoscopy swallow tst (fees).
Laryngoscopic sensory test.
Fees w/laryngeal sense test.
Slp stdy unattended.
Slp stdy unatnd w/anal.
Actigraphy testing.
Multiple sleep latency test.
Sleep study unatt&resp efft.
Sleep study attended.
Polysom any age 1–3> param.
Polysom 6/> yrs 4/> param.
Polysom 6/>yrs cpap 4/> parm.
Eeg 41–60 minutes.
Eeg over 1 hour.
Surgery electrocorticogram.
Ambulatory eeg monitoring.
Eeg monitoring/computer.
Eeg monitoring/giving drugs.
Eeg during surgery.
Eeg monitor technol attended.
Eeg digital analysis.
Whole body photography.
Mnt subs tx for change dx.
Group mnt 2 or more 30 mins.
Finally, we noted that the RUC
recommendation also indicated that,
given the labor-intensive nature of
reviewing all clinical labor tasks
associated with film technology, these
times would be addressed as these
codes are reviewed. We agreed with the
RUC that reviewing and adjusting the
times for each code would be difficult
and labor-intensive since the direct PE
input database does not allow for a
comprehensive adjustment of the
clinical labor time based on changes in
particular clinical labor tasks. To make
broad adjustments such as this across
codes, the PE database would need to
contain the time associated with
individual clinical labor tasks rather
than reflecting only the sum of times for
the pre-service period, service period,
and post-service period, as it does now.
We recognized this situation presents a
challenge in implementing RUC
recommendations such as this one, and
makes it difficult to understand the
basis of both the RUC’s recommended
clinical labor times and our refinements
of those recommendations. Therefore,
we stated that we were considering
revising the direct PE input database to
include task-level clinical labor time
information for every code in the
database. As an example, we referred
readers to the supporting data files for
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
the direct PE inputs, which include
public use files that display clinical
labor times as allocated to each
individual clinical labor task for a
sample of procedures. We displayed this
information as we attempt to increase
the transparency of the direct PE
database. We stated that we hoped that
this modification would enable us to
more accurately allocate equipment
minutes to clinical labor tasks in a more
consistent and efficient manner. Given
the number of procedures and the
volume of information involved, we
sought comments on the feasibility of
this approach. We note that we did not
propose to make any changes to PE
inputs for CY 2015 based on this
modification to the design of the direct
PE input database.
As discussed in section II.G. of this
final rule with comment period, some of
the RUC recommendations for 2015
included film items as practice expense
inputs. For existing codes, the database
from the proposed rule already included
the PACS workstation proxy. However,
for new services, as with the current
items in the database, we have replaced
the film items with the PACS
workstation proxy. The codes affected
by this change are listed in Table 8.
TABLE 8—CODES AFFECTED BY
REMOVAL OF FILM INPUTS
HCPCS
22510
22511
22513
22514
62302
62303
62304
62305
71275
72191
72240
72255
72265
72270
74174
74175
74230
76942
93312
93314
93320
93321
93325
93880
93882
93886
93888
93895
93925
93926
93930
93931
93970
93971
PO 00000
Short descriptor
Perq cervicothoracic inject.
Perq lumbosacral injection.
Perq vertebral augmentation.
Perq vertebral augmentation.
Myelography lumbar injection.
Myelography lumbar injection.
Myelography lumbar injection.
Myelography lumbar injection.
Ct angiography chest.
Ct angiograph pelv w/o&w/dye.
Myelography neck spine.
Myelography thoracic spine.
Myelography l-s spine.
Myelogphy 2/> spine regions.
Ct angio abd&pelv w/o&w/dye.
Ct angio abdom w/o & w/dye.
Cine/vid x-ray throat/esoph.
Echo guide for biopsy.
Echo transesophageal.
Echo transesophageal.
Doppler echo exam heart.
Doppler echo exam heart.
Doppler color flow add-on.
Extracranial bilat study.
Extracranial uni/ltd study.
Intracranial complete study.
Intracranial limited study.
Carotid intima atheroma eval.
Lower extremity study.
Lower extremity study.
Upper extremity study.
Upper extremity study.
Extremity study.
Extremity study.
Frm 00016
Fmt 4701
Sfmt 4700
TABLE 8—CODES AFFECTED BY
REMOVAL OF FILM INPUTS—Continued
HCPCS
93975
93976
93978
93979
Short descriptor
Vascular
Vascular
Vascular
Vascular
study.
study.
study.
study.
Comment: We received many
comments on our proposal to remove
the equipment and supply inputs
associated with film technology from
the direct PE database. In general,
commenters supported our proposal to
remove the film inputs from the direct
PE database. Some commenters
supported our use of the desktop
computer as a proxy for the PACS
workstation, but other commenters
opposed using this item as a proxy.
Commenters opposed to using the
desktop computer as the proxy item
stated that the PACS workstation was
significantly more expensive and
included greater functionality than a
desktop computer. Some commenters
opposed our proposal to maintain the
current equipment time allocated to the
computer desktop for the 31 services
that already included this equipment
item, suggesting that it was incorrect to
eliminate the film inputs without
proportionately increasing the proxy
time for ED021. Some commenters
requested a delay in implementation
until stakeholders provide invoices or
otherwise work with CMS to identify
prices for the PACS items. Some
commenters suggested CMS should
develop a means to allocate digital
technology costs to individual services,
even if it is difficult to do so. Another
commenter explained that it is difficult
for stakeholders to obtain invoices that
display prices for individual items, such
as the PACS workstation, since the price
of the particular items is often bundled
with other related equipment and
services. Many commenters urged CMS
to work with stakeholders to obtain
invoices, while other commenters
requested that CMS accept the RUC
recommendation regarding the PACS
workstation.
Response: We appreciate commenters’
support for our proposal to incorporate
the transition from film to digital
imaging technology into the direct PE
input database. With regard to the
pricing of the PACS workstation, as
with all inputs, we would prefer to use
actual paid invoices to establish the
input price. However, in the absence of
invoices demonstrating the actual cost,
we believe that use of a proxy to price
the appropriate inputs, in this case the
PACS workstation, is preferable to
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
continuing to use inputs that we know
are no longer typical. We made the
proposal to use the computer, desktop,
w-monitor (ED021), priced at $2,501, as
a proxy based on our assessment of
similar resource costs between the item
and the PACS workstation. Although
some commenters stated that the item
was not an appropriate proxy, these
commenters did not provide any
evidence to indicate that the resource
costs are not similar or to suggest a more
appropriate proxy. Nor were any paid
invoices submitted. Absent such
information, we continue to believe that
using the proxy item is the best
approach to incorporate the direct PE
cost of the digital imaging technology.
With regard to the 31 services that
already included the desktop computer
as an equipment input, we will include
the desktop computer as a proxy for the
PACS workstation using the same
methodology as for the services that did
not previously contain the desktop
computer. To clearly differentiate the
desktop computer proxy from the
desktop computer currently included in
these services, and to facilitate accurate
replacement of this input when we do
receive pricing information, we will
create a new equipment item called
‘‘desktop computer (proxy for PACS
workstation),’’ which will be allocated
to each procedure using the
methodology described above.
Comment: Some commenters opposed
our removal of the film inputs from
services that were not included in the
RUC recommendation, but did not
provide a rationale for their opposition.
Response: For the reasons we
explained in making the proposal and
reiterate above, we continue to believe
that it is appropriate to remove these
items from the direct PE database.
Comment: Some commenters
provided specific suggestions regarding
the use of digital inputs should CMS
decide to move forward with the
proposal. Commenters requested that for
portable x-ray services, CMS include a
flat plate receptor/image capture plate to
capture the image, specialized software
to process the image, and multiple high
definition monitors used by the
interpreting radiologist. Commenters
provided an invoice for the image
capture plate at a price of $25,600
indicating that this item replaces the
film as the media to record the image.
Response: We appreciate that
commenters provided us with an
invoice for the image capture plate.
However, services furnished by portable
x-ray providers are reported using the
same procedure codes as services
provided using fixed machines. Since
the typical x-ray service is furnished
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
using fixed equipment, we are not
including the image capture plate that is
associated with portable equipment as
an input for the imaging procedure
codes. We also do not believe that high
definition monitors used by the
interpreting radiologist are
appropriately included in the technical
component of imaging procedures;
rather, these are indirect costs
associated with the professional
component of the service. Therefore, we
are not including the high definition
monitors as an input for these services.
Finally, to determine whether the
software is appropriately categorized as
a direct PE input, we need more
information about the functionality of
the software, and whether it is used in
furnishing the typical x-ray service
(including services furnished using
fixed machinery). Until we have
information that supports the inclusion
of this item as a direct cost, we will not
include the software for x-ray services.
Comment: Commenters were
supportive of the increased
transparency with regard to the direct
PE inputs, but several commenters
suggested that there may be more
feasible approaches to break out the
individual clinical labor tasks
associated with each portion of the
service (pre-service period, service
period, and post-service period). The
RUC suggested that we post all PE
worksheets and supporting materials in
code-order on our Web site. Other
commenters did not suggest a specific
alternative approach to providing detail
for the individual clinical labor tasks.
Response: We appreciate the RUC’s
suggestion regarding the posting of the
PE worksheets, but we do not believe
that this would enable us to accomplish
a comprehensive cross-code analysis
and refinement to clinical labor times
within the direct PE input database to
increase consistency for identical
clinical labor tasks between codes.
Since we did not receive other
suggestions from commenters on an
approach to break out the individual
clinical labor tasks associated with each
service period to enable us to conduct
the necessary analysis, we will pursue
the approach described in the proposed
rule. We will consider the comments
submitted and continue to work with
interested stakeholders regarding the
best approaches to displaying the
supporting files. We note that public use
files continue to be available in the
same format as in previous years, but
that additional public use files now
display the clinical labor tasks for each
service period, providing greater
transparency and enabling comparisons
across codes. We note that we have
PO 00000
Frm 00017
Fmt 4701
Sfmt 4700
67563
refined the file structure based on
comments, and we continue to seek
input on whether there are additional or
alternative ways to display this
information to enhance its clarity, and
note that there are challenges inherent
in the display of this information in a
two-dimensional format. We refer
readers to the public use files available
on the CMS Web site under downloads
for the CY 2015 PFS final rule with
comment period at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html
d. Inputs for Digital Mammography
Services
Mammography services are currently
reported and paid using both CPT codes
and G-codes. To meet the requirements
of the Medicare, Medicaid, and SCHIP
Benefits Improvement and Protection
Act of 2000 (BIPA), we established Gcodes for use beginning in CY 2002 to
pay for mammography services using
new digital technologies (G0202
screening mammography digital; G0204
diagnostic mammography digital; G0206
diagnostic mammography digital). We
continued to use the CPT codes for
mammography services furnished using
film technology (77055 (Mammography;
unilateral); 77056 (Mammography;
bilateral); 77057 (Screening
mammography, bilateral (2-view film
study of each breast)). As we discussed
previously in this section, the RUC has
recommended that all imaging codes,
including mammography, be valued
using digital rather than film inputs
because the use of film is no longer
typical. A review of Medicare claims
data shows that the mammography CPT
codes are billed extremely infrequently,
and that the G-codes are billed for the
vast majority of mammography claims,
confirming the RUC’s conclusion that
the typical service uses digital
technology. As such, we stated that we
do not believe there is a reason to
continue the separate CPT codes and Gcodes for mammography services since
both sets of codes would have the same
values when priced based upon the
typical digital technology. Accordingly,
we proposed to delete the
mammography G-codes beginning for
CY 2015 and to pay all mammography
using the CPT codes.
We indicated that, although we
believed that the CPT codes should now
be used to report all mammography
services, we had concerns about
whether the current values for the CPT
codes accurately reflect the resource
inputs associated with furnishing the
services. Because the CPT codes have
not been recently reviewed and
E:\FR\FM\13NOR2.SGM
13NOR2
67564
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
significant technological changes have
occurred since the current values were
established, we did not believe it would
be appropriate to retain the current
values for the CPT codes. Therefore, we
proposed to value the CPT codes using
the RVUs previously established for the
G-codes. We believed these values
would be most appropriate since they
were established to reflect the use of
digital technology, which is now
typical.
As discussed in section II.B of this
final rule with comment period, we
proposed these CPT codes as potentially
misvalued and requested that the RUC
and other interested stakeholders review
these services in terms of appropriate
work RVUs, work time assumptions,
and direct PE inputs. However, as
discussed in section II.B. of this final
rule with comment period, we will
continue to maintain separate payment
rates for film and digital mammography
while we consider revaluation of all
mammography services. For CY 2015,
we will therefore maintain both the Gcodes and CPT codes; we will continue
using the 2014 RVUs from each of the
following codes to price them for 2015:
G0202, G0204, G0206, 77055, 77056,
and 77057. 2015. We also note that we
will continue to pay for film
mammography services at the 2014 rates
until we revalue the mammography
services.
We refer readers to section II.B. of this
final rule with comment period, where
we address comments received on this
proposal.
e. Radiation Treatment Vault
In previous rulemaking (77 FR 68922,
78 FR 74346), we indicated that we
included the radiation treatment vault
as a direct PE input for several recently
reviewed radiation treatment codes for
the sake of consistency with its previous
inclusion as a direct PE input for some
other radiation treatment services, but
that we intended to review the radiation
treatment vault input and address
whether or not it should be included in
the direct PE input database for all
services in future rulemaking.
Specifically, we questioned whether it
was consistent with the principles
underlying the PE methodology to
include the radiation treatment vault as
a direct cost given that it appears to be
more similar to building infrastructure
costs than to medical equipment costs.
In response to this discussion, we
received comments and invoices from
stakeholders who indicated that the
vault should be classified as a direct
cost. However, upon review of the
information received, we believed that
the specific structural components
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
required to house the linear accelerator
are similar in concept to components
required to house other medical
equipment such as expensive imaging
equipment. In general, the electrical,
plumbing, and other building
specifications are often unique to the
intended functionality of a given
building, including costs that are
attributable to the specific medical
equipment housed in the building, but
those building characteristics do not
represent direct medical equipment
costs in our established PE
methodology. Therefore, we believed
that the special building requirements
indicated for the radiation treatment
vault to house a linear accelerator do
not represent a direct cost in our PE
methodology, and that the vault
construction is instead accounted for in
the indirect PE methodology, just as the
building and infrastructure costs are
treated for other PFS services including
those with specialized infrastructure
costs to accommodate specific
equipment. Therefore, we proposed to
remove the radiation treatment vault as
a direct PE input from the radiation
treatment procedures listed in Table 9,
because we believed that the vault is
not, itself, medical equipment; and
therefore, it is accounted for in the
indirect PE methodology.
TABLE 9—HCPCS CODES AFFECTED
BY PROPOSED REMOVAL OF RADIATION TREATMENT VAULT
HCPCS
77373
77402
77403
77404
77406
77407
77408
77409
77411
77412
77413
77414
77416
77418
Short descriptor
Sbrt delivery.
Radiation treatment delivery.
Radiation treatment delivery.
Radiation treatment delivery.
Radiation treatment delivery.
Radiation treatment delivery.
Radiation treatment delivery.
Radiation treatment delivery.
Radiation treatment delivery.
Radiation treatment delivery.
Radiation treatment delivery.
Radiation treatment delivery.
Radiation treatment delivery.
Radiation tx delivery imrt.
Comment: We received many
comments regarding our proposal to
remove the radiation treatment vault as
a direct cost from the radiation
treatment delivery codes. Although one
commenter supported the proposal,
most commenters opposed the proposal.
In general, commenters reiterated their
rationale for inclusion of the vault as a
direct practice expense input, asserting
that the vault is necessary for the
functioning of the equipment, serves a
unique medical need, cannot be
separated from the treatment delivered
PO 00000
Frm 00018
Fmt 4701
Sfmt 4700
by the linear accelerator, and cannot be
repurposed for another use.
Commenters also stated that the Internal
Revenue Code treats the vault as
medical equipment that is separately
depreciable from the building itself. For
the most part, commenters objected to
the removal of the vault given the
context of declining Medicare payment
for radiation oncology services over the
past few years, or in conjunction with
the revised radiation treatment code set.
Specifically, several commenters
suggested that stakeholders cannot
provide meaningful comment about the
impact of the vault proposal in the
context of other pending changes. Some
commenters requested a phase-in of any
decrease in payment so that providers of
radiation therapy services have an
opportunity to adjust their practice
costs. Several commenters also
suggested that the change in payment
could exacerbate problems in access to
oncology services for Medicare patients.
Response: We appreciate commenters’
concerns regarding the proposal to
remove the vault as a direct practice
expense input. We understand the
essential nature of the vault in the
provision of radiation therapy services
and its uniqueness to a particular piece
of medical equipment but are not
convinced that either of these factors
leads to the conclusion that the vault
should be considered medical
equipment for purposes of the PE
methodology under the PFS. We
appreciate the information commenters
provided regarding the IRS treatment of
the vault under tax laws, but the
purposes and goals of the tax code and
the PFS PE methodology are different,
and, as such, attempts to draw parallels
between the two are not necessarily
instructive or relevant. We are not
finalizing our proposal at this time, but
intend to further study the issues raised
by the vault and how it relates to our PE
methodology.
Comment: A commenter noted that
removing the vault as a direct cost also
reduces the amount of indirect PE
allocated for these procedures, and that
this proposal does not shift the vault
from direct PE to indirect PE, but rather
drops the cost of the vault entirely.
Another commenter stated that since the
pool of indirect PE RVUs associated
with radiation oncology services is
fixed, the issue in question is how the
indirect costs involved in furnishing
treatment services compare to the
indirect costs in providing other
radiation oncology services.
Response: We understand the
concerns of commenters regarding the
importance of ensuring that the costs
related to the vault are included in the
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
PE methodology. We want to point out,
however, that within the established PE
methodology, the allocation of indirect
PE to individual codes has significant
impact on the PE RVUs that determine
Medicare payment for individual
services. In other words, we believe it is
important for stakeholders to recognize
that practice expense costs not included
in the direct PE input database
contribute to the development of PE
RVUs through the data used to allocate
indirect PE RVUs. We also want to point
out that the pool of indirect PE RVUs is
not fixed at the specialty level. Rather,
the pool of indirect costs under the
entire PFS is maintained from year to
year, as delineated in step 11 of the PE
methodology above. Therefore, changes
in the allocation of indirect PE for
particular PFS services based on
changes in either direct PE inputs, work
RVUs, work time, or utilization data,
impacts the amount of indirect PE
allocated to all other PFS services, not
just those furnished by specialties that
furnish that service.
After continued review of the issues
pertaining to the vault in the context of
the comments, we believe that these
issues require further study. Therefore,
at this time, we will continue to include
the vault as a direct PE input for the
services listed in Table 9.
f. Clinical Labor Input Errors
Subsequent to the publication of the
CY 2014 PFS final rule with comment
period, it came to our attention that, due
to a clerical error, the clinical labor type
for CPT code 77293 (Respiratory Motion
Management Simulation (list separately
in addition to code for primary
procedure)) was entered as L052A
(Audiologist) instead of L152A (Medical
Physicist), which has a higher cost per
minute. We proposed a correction to the
clinical labor type for this service.
Comment: Commenters appreciated
our proposal to correct this error.
Response: We appreciate commenters’
support for our proposal, and are
finalizing the assignment of clinical
labor type L152A to code 77293 as
proposed. The CY 2015 Direct Practice
Expense Input database reflects this
correction.
In conducting a routine data review of
the database, we also discovered that,
due to a clerical error, the RN time
allocated to CPT codes 33620 (Apply r&l
pulm art bands), 33621 (Transthor cath
for stent), and 33622 (Redo compl
cardiac anomaly) was entered in the
nonfacility setting, rather than in the
facility setting where the code is valued.
When a service is not valued in a
particular setting, any inputs included
in that setting are not included in the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
calculation of the PE RVUs for that
service. Therefore, we proposed to move
the RN time allocated to these
procedures to the facility setting. The PE
RVUs listed in Addendum B reflect
these technical corrections.
We did not receive any comments on
this proposal; therefore, we are
finalizing our proposal to move the RN
time allocated to these procedures to the
facility setting. The CY 2015 Direct
Practice Expense Input database reflects
this correction.
g. Work Time
Subsequent to the publication of the
CY PFS 2014 final rule with comment
period, several inconsistencies in the
work time file came to our attention.
First, for some services, the total work
time, which is used in our PE
methodology, did not equal the sum of
the component parts (pre-service, intraservice, post-service, and times
associated with global period visits).
The times in the CY 2015 work time file
reflect our corrected values for total
work time. Second, for a subset of
services, the values in the prepositioning time, pre-evaluation time,
and pre-scrub-dress-wait time, were
inadvertently transposed. We note that
this error had no impact on calculation
of the total times, but has been corrected
in the CY 2015 work time file. Third,
minor discrepancies for a series of
interim final codes were identified
between the work time file and the way
we addressed these codes in the
preamble text. Therefore, we have made
adjustments to the work time file to
reflect the decisions indicated in the
preamble text. The work time file is
available on the CMS Web site under
the supporting data files for the CY 2015
PFS final rule with comment period at
https://www.cms.gov/
PhysicianFeeSched/. Note that for
comparison purposes, the CY 2014 work
time file is located at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-Notices-Items/CMS-1600FC.html.
Comment: A commenter supported
our proposal to correct the work times
associated with the procedures affected
by this proposal.
Response: We appreciate the
commenter’s support for our proposal.
After consideration of the comment
received, we are finalizing our proposal
to adjust the work time file as proposed.
The work time file is available on the
CMS Web site under the supporting data
files for the CY 2015 PFS final rule with
comment period at https://www.cms.gov/
PhysicianFeeSched/
PO 00000
Frm 00019
Fmt 4701
Sfmt 4700
67565
h. Updates to Price for Existing Direct
Inputs.
In the CY 2011 PFS final rule with
comment period (75 FR 73205), we
finalized a process to act on public
requests to update equipment and
supply price and equipment useful life
inputs through annual rulemaking
beginning with the CY 2012 PFS
proposed rule. During 2013, we received
a request to update the price of SD216
(catheter, balloon, esophageal or rectal
(graded distention test)) from $217 to
$237.50. We also received a request to
update the price of SL196 (kit, HER–2/
neu DNA Probe) from $105 to $144.50.
We received invoices that documented
updated pricing for each of these supply
items. We proposed to increase the price
associated with these supply items.
We continue to believe it is important
to maintain a periodic and transparent
process to update the price of items to
reflect typical market prices in our
ratesetting methodology, and we
continue to study the best way to
improve our current process. We remind
stakeholders that we have difficulty
obtaining accurate pricing information.
The goal of the current transparent
process is to offer the opportunity for
the community to both request supply
price updates by providing us copies of
paid invoices, and to object to proposed
changes in price inputs for particular
items by providing additional
information about prices available to the
practitioner community. We remind
stakeholders that PFS payment rates are
developed within a budget neutral,
relative value system, and any increases
in price inputs for particular supply
items result in corresponding decreases
to the relative values of all other direct
PE inputs.
We also received a RUC
recommendation to update the prices
associated with two supply items.
Specifically, the RUC recommended
that we increase the price of SA042
(pack, cleaning and disinfecting,
endoscope) from $15.52 to $17.06 to
reflect the addition of supply item SJ009
(basin, irrigation) to the pack, and
increase the price of SA019 (kit, IV
starter) from $1.37 to $1.60 to reflect the
addition of supply item SA044
(underpad 2 ft. x 3 ft. (Chux)) to the kit.
We proposed to update the prices for
both of these items based on these
recommendations.
Comment: We received several
comments regarding our concern about
obtaining accurate pricing information
for equipment and supply items
included in the direct PE database. The
RUC indicated that it would continue to
work with specialty societies to obtain
E:\FR\FM\13NOR2.SGM
13NOR2
67566
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
paid invoices. A commenter suggested
that a sample of paid invoices be
obtained from practices and submitted
with the PE materials to the RUC, or
directly to CMS. Another commenter
expressed concern regarding CMS’s
assertion that invoices are difficult to
obtain, given that the RUC process
collects lists of resources required to
furnish services in the physician office
using a standardized process that is
typically accompanied by invoices.
Another commenter stated that CMS
used only the lowest-cost invoice for a
particular equipment item since the
other invoices included ‘‘soft costs,’’
and that CMS should establish an
approach that would allow invoices to
be used even if they contain ‘‘soft
costs.’’
Response: We appreciate the RUC’s
assistance in obtaining paid invoices
from the specialty societies. These
invoices are helpful in pricing inputs.
We disagree that we use the lowest-cost
invoice because it had the lowest cost;
rather, we often use the lowest-cost
invoice because we do not have a
method to use invoices that include
costs that are not included as part of the
equipment costs, so called ‘‘soft costs,’’
within the PE methodology. We do not
believe it would serve accuracy or
relativity to include as part of the
pricing inputs ‘‘soft costs’’ that increase
the price of particular supply or
equipment items. We would welcome
further input on potential approaches
for ‘‘backing out’’ these costs.
Comment: One commenter disagreed
with CMS’s position that the RUC PE
Subcommittee’s review results in biased
or inaccurate resource input costs
because the prices are largely
maintained in the direct PE input
database by CMS.
Response: Although we did not raise
this point in the CY 2015 PFS proposed
rule, we refer readers to our discussion
in previous rulemaking (for example,
the CY 2011 PFS final rule with
comment period at 75 FR 73250 and the
CY 2014 PFS final rule with comment
period at 78 FR 74246) regarding issues
associated with obtaining appropriate
prices for medical equipment and
supply items included in the direct PE
database. We note that the RUC
provides recommendations regarding
the use of particular items in furnishing
a service, but does not provide CMS
with recommendations regarding the
prices of direct PE item. Without
assigning a price, the input cannot be
factored in to our PE RVU methodology.
Our price information is almost
exclusively anecdotal, and generally
updated only through voluntary
submission of a small number of
invoices from the same practitioners
that furnish and are paid for the services
that use the particular inputs. Therefore,
we continue to believe there is potential
for bias in the information we receive.
Comment: In its comment, the RUC
suggested that an annual CMS review of
paid invoices for high-cost supplies
would be appropriate. A commenter
referenced comments made on the CY
2014 PFS final rule with comment
period, and expressed agreement with
those commenters that the provision of
pricing information is sensitive because
of issues involving proprietary pricing
information and price negotiations for
individual practitioners. This
commenter also agreed with CMS that
such information would be less
sensitive if it confirmed inputs
contained in the direct PE database.
However, the commenter noted that
requiring paid invoices from this point
forward only partially addresses the
concern since many existing inputs are
not based on paid invoices; specifically,
societies working on inputs for new,
revised, or potentially misvalued
services are disadvantaged in
comparison to many existing inputs due
to fee schedule relativity. The
commenter suggested that CMS may
need to undertake a comprehensive
review of all direct PE inputs and obtain
paid invoices to systematically address
its concerns.
Response: We share commenters’
concerns that codes that are being
reviewed may be disadvantaged relative
to codes that contain input prices that
may not be based on paid invoices; and
note that we rely on the public process
to ensure continued relativity within the
direct PE inputs. We encourage
interested stakeholders to review
updates to prices, as well as prices for
new items, to ensure that they appear
reasonable and current, and to provide
us with updated pricing information,
particularly regarding high cost supplies
that have a greater impact on relativity.
We refer readers to section II.F. of this
final rule with comment period, in
which we detail price updates, as well
as establish new prices, for inputs
included in new, revised, and
potentially misvalued codes.
Comment: We received some
comments in support of our proposal to
update the price for SL196 (kit, HER–2/
neu DNA Probe).
Response: We appreciate the
commenters’ support for our proposal to
update the price for SL196. After
publication of our proposal, we
obtained new information suggesting
that further study of the price of this
item is necessary before proceeding to
update the input price. Therefore, we
are not finalizing our proposal to update
the price for SL196, and will consider
this matter in future rulemaking.
Comment: We did not receive any
comments regarding our proposal to
update the price for of SD216 (catheter,
balloon, esophageal or rectal (graded
distention test)).
Response: We are finalizing the price
updates for SD216.
Comment: We received comments in
support of the price update to SA019
(kit, IV starter) and SA042 (pack,
cleaning and disinfecting, endoscope).
Response: We appreciate the
commenters’ support for our proposal to
update the price for SA019 and SA042.
After consideration of comments
received, we are finalizing the price
updates for SA019 and SA042.
i. New Standard Supply Package for
Contrast Imaging
The RUC recommended creating a
new direct PE input standard supply
package ‘‘Imaging w/contrast, standard
package’’ for contrast enhanced imaging,
with a price of $6.82. This price reflects
the combined prices of the medical
supplies included in the package; these
items are listed in Table 10. We
proposed to accept this
recommendation, but sought comment
on whether all of the items included in
the package are used in the typical case.
The CY 2015 direct PE database reflects
this change and is available on the CMS
Web site under the supporting data files
for the CY 2015 PFS proposed rule at
https://www.cms.gov/PhysicianFee
Sched/.
TABLE 10—STANDARD CONTRAST IMAGING SUPPLY PACKAGE
Medical supply description
SCMS
supply
code
Unit
Kit, IV starter .................................................................................................................
Gloves, non-sterile ........................................................................................................
SA019
SB022
Kit ................
Pair ..............
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00020
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
Quantity
13NOR2
Price
1
1
$1.60
0.084
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
67567
TABLE 10—STANDARD CONTRAST IMAGING SUPPLY PACKAGE—Continued
Medical supply description
SCMS
supply
code
Angiocatheter 14g–24g .................................................................................................
Heparin lock ..................................................................................................................
IV tubing (extension) .....................................................................................................
Needle, 18–27g .............................................................................................................
Syringe 20ml .................................................................................................................
Sodium chloride 0.9% inj. bacteriostatic (30ml uou) .....................................................
Swab-pad, alcohol .........................................................................................................
SC001
SC012
SC019
SC029
SC053
SH068
SJ053
Total .......................................................................................................................
Unit
Item
Item
Foot
Item
Item
Item
Item
Quantity
Price
.............
.............
.............
.............
.............
.............
.............
1
1
*3
1
1
1
1
.....................
........................
1.505
0.917
1.590
0.089
0.558
0.700
0.013
7.06
ebenthall on DSK5SPTVN1PROD with $$_JOB
* The price for SC019 (IV tubing, (extension)) is $0.53 per foot.
Comment: Commenters supported our
proposal to create the standard supply
package for contrast imaging. Some
commenters expressed concern that the
proposed supply package did not
include the full range of supplies
typically used when performing contrast
imaging. One commenter stated that, for
echocardiography labs that utilize
contrast-enhanced ultrasound,
additional items are typically part of the
contrast imaging supply package,
including 2x2 gauze pads, a stopcock,
and tape. Another commenter suggested
that a power injector should also be
included in the standard contrast
imaging supply package. Commenters
also noted that CMS provided limited
information regarding how the prices
were assigned to the supply items, and
pointed to discrepancies between the
direct PE database files and the prices
quoted in the table.
Response: We appreciate commenters’
support for our proposal. We note that
the RUC recommendation for the
standard contrast imaging supply
package also noted that the inputs for
CTA and MRA studies would include
the standard contrast imaging supply
pack in addition to a stop cock (SC050)
and additional tubing. While we
acknowledge a commenter’s suggestion
that additional items may be used when
echocardiography labs conduct contrastenhanced ultrasound studies, we do not
have information to suggest that these
items are used for other imaging studies,
such as CT and MRI contrast-enhanced
studies. We would welcome more
information on whether these items
should be included in the newly created
standard contrast imaging kit, as well as
whether the power injector is used
whenever the other inputs in the
standard contrast imaging supply
package are used, or whether they are
used only in certain instances. We note
that the reason for the discrepancy in
the price for the IV starter kit is that we
proposed to update the price at the same
time that we proposed to create a new
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
contrast imaging kit. Since we are
finalizing the price update for SA019
(kit, IV starter), we are also finalizing a
revised price for the new standard
contrast imaging package of $7.06.
Finally, we disagree with the
commenter’s suggestion that CMS
provided limited information about the
pricing for the items included in the kit,
as these items are existing inputs in the
direct PE database, and the codes
associated with these items were listed
in the table in the proposed rule. After
consideration of comments received, we
are finalizing our proposal to create a
standard contrast imaging supply pack,
with a revised price of $7.06.
j. Direct PE Inputs for Stereotactic
Radiosurgery (SRS) Services (CPT Codes
77372 and 77373)
In the CY 2014 PFS final rule with
comment period (78 FR 74245), we
summarized comments received about
whether CPT codes 77372 and 77373
would accurately reflect the resources
used in furnishing the typical SRS
delivery if there were no coding
distinction between robotic and nonrobotic delivery methods. Until now,
SRS services furnished using robotic
methods were billed using contractorpriced G-codes G0339 (Image-guided
robotic linear accelerator based
stereotactic radiosurgery, complete
course of therapy in one session or first
session of fractionated treatment), and
G0340 (Image-guided robotic linear
accelerator-based stereotactic
radiosurgery, delivery including
collimator changes and custom
plugging, fractionated treatment, all
lesions, per session, second through
fifth sessions, maximum five sessions
per course of treatment). We indicated
that we would consider deleting these
codes in future rulemaking.
Most commenters responded that the
CPT codes accurately described both
services, and the RUC stated that the
direct PE inputs for the CPT codes
accurately accounted for the resource
PO 00000
Frm 00021
Fmt 4701
Sfmt 4700
costs of the described services. One
commenter objected to the deletion of
the G-codes but did not include any
information to suggest that the CPT
codes did not describe the services or
that the direct PE inputs for the CPT
codes were inaccurate. Based on a
review of the comments received, we
had no indication that the direct PE
inputs included in the CPT codes would
not reflect the typical resource inputs
involved in furnishing an SRS service.
Therefore, in the CY 2014 proposed rule
we proposed to recognize only the CPT
codes for SRS services, and to delete the
G-codes used to report robotic delivery
of SRS.
Comment: We received several
comments regarding our proposal to
delete the SRS G-codes. Some
commenters supported our proposal,
but most opposed our proposal on the
grounds that the direct PE inputs
included in the CPT codes do not reflect
the typical resource inputs used in
furnishing robotic SRS services. Some
commenters urged CMS to delay this
policy change and continue to
contractor price the G-codes until a
more appropriate solution can be found.
Response: After consideration of the
comments regarding the appropriate
inputs to use in pricing the SRS
services, we have concluded that at this
time, we lack sufficient information to
make a determination about the
appropriateness of deleting the G-codes
and paying for all SRS/SBRT services
using the CPT codes. Therefore, we will
not delete the G-codes for 2015, but will
instead work with stakeholders to
identify an alternate approach and
reconsider this issue in future
rulemaking.
k. Inclusion of Capnograph for Pediatric
Polysomnography Services
We proposed to include equipment
item EQ358, Sleep capnograph,
polysomnography (pediatric), for CPT
codes 95782 (Polysomnography;
younger than 6 years, sleep staging with
E:\FR\FM\13NOR2.SGM
13NOR2
67568
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
4 or more additional parameters of
sleep, attended by a technologist) and
95783 (Polysomnography; younger than
6 years, sleep staging with 4 or more
additional parameters of sleep, with
initiation of continuous positive airway
pressure therapy or bi-level ventilation,
attended by a technologist). Based upon
our understanding that capnography is
a required element of sleep studies for
patients younger than 6 years, we
proposed to allocate this equipment
item to 95782 for 602 minutes, and
95783 for 647 minutes. Based on the
invoice we received for this equipment
item, we proposed to price EQ358 at
$4,534.23.
Comment: We received two comments
in support of our proposal to include
the capnograph in CPT codes 95782 and
95783.
Response: We appreciate commenters’
support for our proposal. After
consideration of comments received, we
are finalizing our proposal to include
the capnograph in CPT codes 95782 and
95783.
4. Using OPPS and ASC Rates in
Developing PE RVUs
Accurate and reliable pricing
information for both individual items
and indirect PEs is critical to establish
accurate PE RVUs for PFS services. As
we have addressed in previous
rulemaking, we have serious concerns
regarding the accuracy of some of the
information we use in developing PE
RVUs. In particular, as discussed in the
CY 2014 PFS final rule with comment
period, we have several longstanding
concerns regarding the accuracy of
direct PE inputs, including both items
and procedure time assumptions, and
prices of individual supplies and
equipment (78 FR 74248–74250). In
addition to the concerns regarding the
inputs used in valuing particular
procedures, we also noted that the
allocation of indirect PE is based on
information collected several years ago
(as described above) and will likely
need to be updated in the coming years.
To mitigate the impact of some of
these potentially problematic data used
in developing values for individual
services, in rulemaking for the CY 2014
PFS, we proposed to limit the
nonfacility PE RVUs for individual
codes so that the total nonfacility PFS
payment amount would not exceed the
total combined amount that Medicare
would pay for the same code in the
facility setting. In developing the
proposal, we sought a reliable means for
Medicare to set upper payment limits
for office-based procedures and believed
OPPS and ASC payment rates would
provide an appropriate comparison
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
because these rates are based on
relatively more reliable cost information
in settings with cost structures that
generally would be expected to be
higher than in the office setting.
We received many comments
regarding our proposal, the vast majority
of which urged us to withdraw the
proposal. Some commenters questioned
the validity of our assumption that
facilities’ costs for providing all services
are necessarily higher than the costs of
physician offices or other nonfacility
settings. Other commenters expressed
serious concerns with the asymmetrical
comparisons between PFS payment
amounts and OPPS/ASC payment
amounts. Finally, many commenters
suggested revisions to technical aspects
of our proposed policy.
In considering all the comments,
however, we were persuaded that the
comparison of OPPS (or ASC) payment
amounts to PFS payment amounts for
particular procedures is not the most
appropriate or effective approach to
ensuring that PFS payment rates are
based on accurate cost assumptions.
Commenters noted several flaws with
the approach. First, unlike PFS
payments, OPPS and ASC payments for
individual services are grouped into
rates that reflect the costs of a range of
services. Second, commenters suggested
that since the ASC rates reflect the
OPPS relative weights to determine
payment rates under the ASC payment
system, and are not based on cost
information collected from ASCs, the
ASC rates should not be used in the
proposed policy. For these and other
reasons raised by commenters, we did
not propose a similar policy for the CY
2015 PFS. If we consider using OPPS or
ASC payment rates in developing PFS
PE RVUs in future rulemaking, we
would consider all of the comments
received regarding the technical
application of the previous proposal.
After thorough consideration of the
comments regarding the CY 2014
proposal, we continue to believe that
there are various possibilities for
leveraging the use of available hospital
cost data in the PE RVU methodology to
ensure that the relative costs for PFS
services are developed using data that is
auditable and comprehensively and
regularly updated. Although some
commenters questioned the premise that
the hospital cost data are more accurate
than the information used to establish
PE RVUs, we continue to believe that
the routinely updated, auditable
resource cost information submitted
contemporaneously by a wide array of
providers across the country is a valid
reflection of ‘‘relative’’ resources and
could be useful to supplement the
PO 00000
Frm 00022
Fmt 4701
Sfmt 4700
resource cost information developed
under our current methodology based
upon a typical case that are developed
with information from a small number
of representative practitioners for a
small percentage of codes in any
particular year.
Section 220(a)(1) of the PAMA added
a new subparagraph (M) under section
1848(c)(2) of the Act that gives us
authority to collect information on
resources used to furnish services from
eligible professionals (including
physicians, non-physician practitioners,
PTs, OTs, SLPs and qualified
audiologists), and other sources. It also
authorizes us to pay eligible
professionals for submitting solicited
information. We will be exploring ways
of collecting better and updated
resource data from physician practices,
including those that are provider-based,
and other non-facility entities paid
through the PFS. We believe such efforts
will be challenging given the wide
variety of practices, and that any effort
will likely impose some burden on
eligible professionals paid through the
PFS regardless of the scope and manner
of data collection. Currently, through
one of the validation contracts
discussed in section II.B. of this final
rule with comment period, we have
been gathering time data directly from
physician practices. Through this
project, we have learned much about the
challenges for both CMS and the eligible
professionals of collecting data directly
from practices. Our own experience has
shown that is difficult to obtain invoices
for supply and equipment items that we
can use in pricing direct PE inputs.
Many specialty societies also have
noted the challenges in obtaining recent
invoices for medical supplies and
equipment (78 FR 74249). Further, PE
calculations rely heavily on information
from the Physician Practice Expense
Information Survey (PPIS) survey,
which, as discussed earlier, was
conducted in 2007 and 2008. When we
implemented the results of the survey,
many in the community expressed
serious concerns over the accuracy of
this or other PE surveys as a way of
gathering data on PE inputs from the
diversity of providers paid under the
PFS.
In addition to data collection, section
1848(c)(2)(M) of the Act as added by
section 220(a) of the PAMA provides
authority to develop and use alternative
approaches to establish PE relative
values, including the use of data from
other suppliers and providers of
services. We are exploring the best
approaches for exercising this authority,
including with respect to use of hospital
outpatient cost data. We understand that
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
many stakeholders will have concerns
regarding the possibility of using
hospital outpatient cost data in
developing PE RVUs under the PFS, and
we want to be sure we are aware of
these prior to considering or developing
any future proposal relying on those
data.
Therefore, in the CY 2015 PFS
proposed rule (79 FR 40333), we sought
comment on the possible uses of the
Medicare hospital outpatient cost data
(not the APC payment amount) in
potential revisions of the PFS PE
methodology. This could be as a means
to validate or, perhaps, in setting the
relative resource cost assumptions
within the PFS PE methodology. We
noted that the resulting PFS payment
amounts would not necessarily conform
to OPPS payment amounts since OPPS
payments are grouped into APCs, while
PFS payments would continue to be
valued individually and would remain
subject to the relativity inherent in
establishing PE RVUs, budget neutrality
adjustments, and PFS updates. We
expressed particular interest in
comments that compare such
possibilities to other broad-based,
auditable, mechanisms for data
collection, including any we might
consider under the authority provided
under section 220(a) of the PAMA. We
urged commenters to consider a wide
range of options for gathering and using
the data, including using the data to
validate or set resource assumptions for
only a subset of PFS services, or as a
base amount to be adjusted by code or
specialty-level recommended
adjustments, or other potential uses. We
appreciate the many thoughtful
comments that we received on whether
and how to use the OPPS cost data in
establishing PE relative values. We will
consider these as we continue to think
about mechanisms to improve the
accuracy of PE values.
In addition to soliciting comments as
noted above, in the CY 2015 proposed
rule we stated that we continue to seek
a better understanding regarding the
growing trend toward hospital
acquisition of physicians’ offices and
how the subsequent treatment of those
locations as off-campus provider-based
outpatient departments affects payments
under PFS and beneficiary cost-sharing.
MedPAC continues to question the
appropriateness of increased Medicare
payment and beneficiary cost-sharing
when physicians’ offices become
hospital outpatient departments, and to
recommend that Medicare pay selected
hospital outpatient services at PFS rates
(MedPAC March 2012 and June 2013
Report to Congress). We noted that we
also remain concerned about the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
validity of the resource data as more
physician practices become providerbased. Our survey data reflects the PE
costs for particular PFS specialties,
including a proportion of practices that
may have become provider-based since
the survey was conducted. Additionally,
as the proportion of provider-based
offices varies among physician
specialties, so do the relative accuracy
of the PE survey data. Our current PE
methodology primarily distinguishes
between the resources involved in
furnishing services in two sites of
service: The non-facility setting and the
facility setting. In principle, when
services are furnished in the non-facility
setting, the costs associated with
furnishing services include all direct
and indirect PEs associated with the
work and the PE of the service. In
contrast, when services are furnished in
the facility setting, some costs that
would be PEs in the office setting are
incurred by the facility. Medicare makes
a separate payment to the facility to
account for some portion of these costs,
and we adjust PEs accordingly under
the PFS. As more physician practices
become hospital-based, it is difficult to
know which PE costs typically are
actually incurred by the physician,
which are incurred by the hospital, and
whether our bifurcated site-of service
differential adequately accounts for the
typical resource costs given these
relationships. We also have discussed
this issue as it relates to accurate
valuation of visits within the
postoperative period of 10- and 90-day
global codes in section II.B.4 of this
final rule with comment period.
To understand how this trend is
affecting Medicare, including the
accuracy of payments made through the
PFS, we need to develop data to assess
the extent to which this shift toward
hospital-based physician practices is
occurring. To that end, during CY 2014
rulemaking we sought comment
regarding the best method for collecting
information that would allow us to
analyze the frequency, type, and
payment for services furnished in offcampus provider-based hospital
departments (78 FR 74427). We received
many thoughtful comments. However,
the commenters did not present a
consensus opinion regarding the options
we presented in last year’s rule. Based
on our analysis of the comments, we
stated that we believed the most
efficient and equitable means of
gathering this important information
across two different payment systems
would be to create a HCPCS modifier to
be reported with every code for
physicians’ and hospital services
PO 00000
Frm 00023
Fmt 4701
Sfmt 4700
67569
furnished in an off-campus providerbased department of a hospital.
We proposed that the modifier would
be reported on both the CMS–1500
claim form for physicians’ services and
the UB–04 (CMS form 1450) for hospital
outpatient claims. (We note that the
requirements for a determination that a
facility or an organization has providerbased status are specified in § 413.65,
and we define a hospital campus to be
the physical area immediately adjacent
to the provider’s main buildings, other
areas and structures that are not strictly
contiguous to the main buildings but are
located within 250 yards of the main
buildings, and any other areas
determined on an individual case basis,
by the CMS regional office.)
Therefore, we proposed to collect this
information on the type and frequency
of services furnished in off-campus
provider-based departments in
accordance with our authority under
section 1848(c)(2)(M) of the Act (as
added by section 220(a) of the PAMA)
beginning January 1, 2015. The
collection of this information would
allow us to begin to assess the accuracy
of the PE data, including both the
service-level direct PE inputs and the
specialty-level indirect PE information
that we currently use to value PFS
services. Furthermore, this information
would be critical in order to develop
proposed improvements to our PE data
or methodology that would
appropriately account for the different
resource costs among traditional office,
facility, and off-campus provider-based
settings. We also sought additional
comment on whether a code modifier is
the best mechanism for collecting this
service-level information.
Comment: Many commenters agreed
on the need to collect information on
the frequency, type, and payment of
services furnished in off-campus
provider-based departments of
hospitals, however, several commenters
expressed concern that the HCPCS
modifier would create additional
administrative burden for providers.
Many of these commenters stated that
the new modifier would require
significant changes to hospitals’ billing
systems, including a separate charge
master for outpatient off-campus PBDs
and training for staff on how to use the
new modifier. Several commenters
thought that education and training
would be required for physician offices
to attach a modifier to services
furnished in an off-campus providerbased department. These same
commenters suggested that a new place
of service (POS) code would be more
appropriate for physician billing.
Several commenters suggested that CMS
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67570
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
should re-propose a detailed data
collection methodology, test it with
providers, make adjustments, and allow
additional time for implementation.
Response: While we understand
commenters’ concerns about the
additional administrative burden of
reporting a new HCPCS modifier, we
have weighed the burden of reporting
the modifier for each service against the
benefit of having data that will allow us
to obtain and assess accurate
information on the type and frequency
of outpatient hospital services furnished
in off-campus provider-based
departments, and we do not believe that
the modifier is excessively burdensome
for providers to report. When billing for
hospital services, providers must know
where services are furnished in order to
accurately complete value code 78 of an
outpatient claim or item 32 for service
location on the practitioner claim.
However, as discussed later in this
section, we agree that a POS code on the
professional claim allows for the same
type of data collection as a modifier and
would be less burdensome than the
modifier for practitioners. We discuss
the timeframe for implementation later
in this section.
Comment: Some commenters who
were concerned about the
administrative burden of the new
HCPCS modifier suggested several
alternative methods for CMS to collect
data on services furnished in off-campus
provider-based departments. Several of
these commenters recommended that
CMS consider establishing of a new POS
code for professional claims, or for both
professional and hospital claims,
because they believed this approach
would be less administratively
burdensome than attaching a modifier to
each service reported on the claim that
was furnished in an off-campus
provider-based department. Some
commenters preferred identifying
services furnished in provider-based
departments on the Medicare cost report
(CMS–2552–10). Some commenters
suggested using provider numbers and
addresses to identify off-campus PBDs,
or changing the provider enrollment
process to be able to track this data. Yet
other commenters suggested creating a
new bill type to track off-campus PBD
services.
Commenters generally recommended
that CMS choose the least
administratively burdensome approach
that would ensure accurate data
collection, but did not necessarily agree
on what approach would optimally
achieve that result. Some commenters
believed that a HCPCS modifier would
more clearly identify specific services
furnished at off-campus PBDs, and
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
would provide better information about
the type and level of care furnished.
Some commenters believed that a
HCPCS modifier would be the least
administratively burdensome approach
because hospitals and physicians
already report a number of claims-based
modifiers. However, other commenters
stated that additional modifiers would
increase administrative burden because
this approach would increase the
modifiers that would need to be
considered when billing.
Response: With respect to creating a
new POS code to obtain data on services
furnished in off-campus PBDs of a
hospital, we note that POS codes are
only reported on professional claims
and are not included on institutional
claims. Therefore, a POS code could not
be easily implemented for hospital
claims. However, POS codes are already
required to be reported on every
professional claim, and POS 22 is
currently used when physicians’
services are furnished in an outpatient
hospital department. (More information
on existing POS codes is available on
the CMS Web site at https://
www.cms.gov/Medicare/Coding/placeof-service-codes/Place_of_Service_
Code_Set.html).
Though we considered proposing a
new POS code for professional claims to
collect data on services furnished in the
off-campus hospital setting, we note that
previous GAO and OIG reports (October
2004 A–05–04–0025, January 2005 A–
06–04–00046, July 2010 A–01–09–
00503, September 2011 A–01–10–
00516) have noted frequent inaccuracies
in the reporting of POS codes.
Additionally, at the time the proposed
rule was developed, we had concerns
that using a POS code to report this
information might not give us the
reliable data we are looking to collect,
especially if such data were to be crosswalked with hospital claims for the
same service, since the hospital claim
would have a modifier, not a POS code.
However, we have been persuaded by
public comments suggesting that use of
a POS code on professional claims
would be less administratively
burdensome than use of a modifier, and
would be more familiar to those
involved in practitioner billing.
Specifically, since a POS code is already
required on every professional claim,
we believe that creating a new POS code
to distinguish outpatient hospital
services that are furnished on the
hospital campus versus in an offcampus provider-based department
would require less staff training and
education than would the use of a
modifier on the professional claim.
Additionally, professional claims only
PO 00000
Frm 00024
Fmt 4701
Sfmt 4700
have space for four modifiers; while a
very small percentage of professional
claims have four modifiers, required use
of an additional modifier for every
professional claim could lead to more
occurrences where there would not be
space for all applicable payment
modifiers for a specific service. Unlike
institutional claims, we note that a new
professional claim is required whenever
the place of service changes. That is,
even if the same practitioner treats the
same patient on the same day in the
office and the hospital, the services
furnished in the office setting must be
submitted on one claim with POS 11
(Office), while those furnished in the
outpatient hospital department would
be submitted on a separate claim with
POS 22 (Outpatient Hospital). Likewise,
if a new POS code were to be created
for off-campus outpatient providerbased hospital department, a separate
claim for services furnished in that
setting would be required relative to a
claim for outpatient services furnished
on the hospital’s main campus by the
same practitioner to the same patient on
the same day. Based on public
comments and after further consultation
with Medicare billing experts, we
believe that use of the POS code on
professional claims would be no less
accurate than use of a modifier on
professional claims in identifying
services furnished in off-campus PBDs.
In addition, we believe that the POS
code would be less administratively
burdensome for practitioners billing
using the professional claim since a POS
code is already required for every
professional claim.
With respect to adding new fields to
existing claim forms or creating a new
bill type, we do not believe that this
data collection warrants these measures.
We believe that those changes would
create greater administrative burden
than the proposed HCPCS modifier and
POS codes, especially since providers
are already accustomed to using
modifiers and POS codes. Revisions to
the claim form to add new fields or an
additional bill type would create
significant administrative burden to
revise claims processing systems and
educate providers that is not necessary
given the availability of a modifier and
POS codes. Though providers may not
be familiar with this new modifier or
any new POS code; since these types of
codes already exist generally for
hospital and professional claims,
providers and suppliers should already
have an understanding of these types of
codes and how to apply them. Finally,
we do not believe that expansions to the
claim form or use of a new bill type
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
would provide us with detailed
information on exactly which services
were furnished in an off-campus PBD
versus those furnished on the main
campus when those services are
furnished on the same day.
We also do not believe that we could
accurately determine which services are
furnished at off-campus provider-base
departments (PBDs) using currently
available NPI and facility address data.
Hospitals are required to report the
nine-digit ZIP code indicating where a
service was furnished for purposes of
paying properly for physician and
anesthesia services paid off the PFS
when that ZIP code differs from the
master address for the hospital on file in
CMS claims systems in value code 78
(pub 100–04, transmittal 1681, February
13, 2009). However, the billing ZIP code
for the hospital main campus could be
broad enough to incorporate on and offcampus provider-based departments.
Further, a ZIP code reported in value
code 78 does not allow CMS to
distinguish between services furnished
in different locations on the same date.
Therefore, we do not believe that a
comparison of the ZIP code captured in
value code 78 and the main campus ZIP
code is sufficiently precise.
Finally, while we considered the
suggestion that CMS use currently
reported Medicare hospital cost report
(CMS–2552–10) data to identify services
furnished at off-campus PBDs, we note
that though aggregate data on services
furnished in different settings must be
reported through the appropriate cost
center, we would not be able to obtain
the service-specific level of detail that
we would be able to obtain from claims
data.
We will take under consideration the
suggestion that CMS create a way for
hospitals to report their acquisition of
physician offices as off-campus PBDs
through the enrollment process,
although this information, as currently
reported, would not allow us to know
exactly which services are furnished in
off-campus provider based departments
and which services are furnished on the
hospital’s main campus when a hospital
provides both on the same day.
Comment: Commenters noted that the
proposed modifier would not allow
CMS to know the precise location of the
off-campus provider-based department
for billed services or when services are
furnished at different off-campus
provider-based locations in the same
day.
Response: We agree that neither the
proposed modifier nor a POS code
provides details on the specific
provider-based location for each
furnished service. However, we believe
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
that collecting information on the type
and frequency of services furnished at
all off-campus locations will assist CMS
in better understanding the distribution
of services between on and off-campus
locations.
Comment: MedPAC believed there
may be some value in collecting data on
services furnished in off-campus
provider-based departments to validate
the accuracy of site-of-service reporting
when the physician’s office is offcampus but bills as an outpatient
department. MedPAC indicated that any
data collection effort should not prevent
the development of policies to align
payment rates across settings. MedPAC
encouraged CMS to seek legislative
authority to set equal payment rates
across settings for evaluation and
management office visits and other
select services.
Response: We thank MedPAC for its
support of our data collection efforts to
learn more about the frequency and
types of services that are being
furnished in off-campus PBDs.
Comment: Many commenters
suggested that providers would not be
able to accurately apply the new
modifier by the January 1, 2015
implementation timeline and
recommended a one-year delay before
providers would be required to apply
the modifier to services furnished at offcampus PBDs. Some commenters
requested only a six-month delay in
implementation. Commenters indicated
that significant revisions to internal
billing processes would require
additional time to implement.
Response: Though we believe that the
January 1st effective date that applies to
most policies adopted in the final rules
with comment period for both the PFS
and the OPPS would provide sufficient
lead time, we understand commenters’
concerns with the proposed timeline for
implementation given that the new
reporting requirements may require
changes to billing systems as well as
education and training for staff. With
respect to the POS code for professional
claims, we will request two new POS
codes to replace POS code 22 (Hospital
Outpatient) through the POS Workgroup
and expect that it will take some time
for these new codes to be established.
Once the revised POS codes are ready
and integrated into CMS claims systems,
practitioners would be required to use
them, as applicable. More information
on the availability of the new POS codes
will be forthcoming in subregulatory
guidance, but we do not expect the new
codes to be available prior to July 1,
2015. There will be no voluntary
reporting period of the POS codes for
applicable professional claims because
PO 00000
Frm 00025
Fmt 4701
Sfmt 4700
67571
each professional claim requires a POS
code in order to be accepted by
Medicare. However, we do not view this
to be problematic because we intend to
give prior notice on the POS coding
changes and, as many public
commenters noted, because
practitioners are already accustomed to
using a POS on every claim they submit.
We also are finalizing our proposal to
create a HCPCs modifier for hospital
services furnished in an off-campus PBD
setting; but we are adopting a voluntary
reporting period for the new HCPCS
modifier for one year. That is, reporting
the new HCPCS modifier for services
furnished at an off-campus PBD will not
be mandatory until January 1, 2016, in
order to allow providers time to make
systems changes, test these changes, and
train staff on use of the new modifier
before reporting is required. We
welcome early reporting of the modifier
and believe a full year of preparation
should provide hospitals with sufficient
time to modify their systems for
accurate reporting.
Comment: Many commenters
expressed concern that this data
collection would eventually lead to
equalizing payment for similar services
furnished in the non-facility setting and
the off-campus PBD setting. Several
commenters noted that the trend of
hospitals acquiring physician practices
is due to efforts to better integrate care
delivery, and suggested that CMS weigh
the benefits of care integration when
deciding payment changes. Some
commenters suggested that CMS should
use the data to equalize payment for
similar services between these two
settings. These commenters suggest that
there is little difference in costs and care
between the two settings that would
warrant the difference in payment.
Several of these commenters highlighted
beneficiary cost sharing as one reason
for site-neutral payment, noting that the
total payment amount for hospital
outpatient services is generally higher
than the total payment amount for those
same services when furnished in a
physician’s office.
Response: We appreciate the
comments received. At this time, we are
only finalizing a data collection in this
final rule with comment period. We did
not propose, and therefore, are not
finalizing any adjustment to payments
furnished in the off-campus PBD setting.
Comment: Several commenters noted
that the CMS proposal would not
provide additional information on how
a physician practice billed prior to
becoming an off-campus PBD, which
would be important for analyzing the
impact of this trend.
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67572
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
Response: We agree that, in analyzing
the impact of this trend, it is important
to understand physician billing patterns
that were in place prior to becoming an
off-campus PBD, and we will continue
to evaluate ways to analyze claims data
to gather this information. We believe
that collecting data using the additional
modifier and POS code as finalized in
this rule will be an important tool in
furthering this analysis.
Comment: Some commenters
suggested that the term ‘‘off-campus’’
needs to be better defined. Commenters
asked how billing would occur for
hospitals with multiple campuses since
the CMS definition of campus
references main buildings and does not
include remote locations. One
commenter also asked whether the
modifier is intended to cover services
furnished in free-standing emergency
departments.
Response: For purposes of the
modifier and the POS codes we are
finalizing in this final rule with
comment period, we define a ‘‘campus’’
using the definition at § 413.65(a)(2) to
be the physical area immediately
adjacent to the provider’s main
buildings, other areas and structures
that are not strictly contiguous to the
main buildings but are located within
250 yards of the main buildings, and
any other areas determined on an
individual case basis, by the CMS
regional office, to be part of the
provider’s campus. We agree with
commenters that our intent is to capture
data on outpatient services furnished off
of the hospital’s main campus and off of
any of the hospital’s other campuses.
The term ‘‘remote location of a hospital’’
is defined in our regulations at section
413.65(a)(2). Under the regulation, a
‘‘remote location’’ includes a hospital
campus other than the main hospital
campus. Specifically, a remote location
is ‘‘a facility or an organization that is
either created by, or acquired by, a
hospital that is a main provider for the
purposes of furnishing inpatient
hospital services under the name,
ownership, and financial and
administrative control of the main
provider . . . .’’ Therefore, we agree
with the commenters that the new
HCPCS modifier and the POS code for
off-campus PBDs should not be reported
for services furnished in remote
locations of a hospital. The term
‘‘remote location’’ does not include
‘‘satellite’’ locations of a hospital.
However, since a satellite facility is one
that provides inpatient services in a
building also used by another hospital,
or in one or more entire buildings
located on the same campus as
buildings used by another hospital, the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
new HCPCS modifier and the POS code
for off-campus hospital PBDs should not
be reported for services furnished in
satellite facilities. Satellite facilities are
described in our regulations at
§ 412.22(h). Accordingly, reporting of
the modifier and the POS code that
identifies an off-campus hospital PBD
would be required for outpatient
services furnished in PBDs that are
located beyond 250 yards from the main
campus of the hospital, excluding
services furnished in a remote location
or satellite facility of the hospital.
We also appreciate the comment on
emergency departments. We do not
intend for hospitals to report the new
modifier for services furnished in
emergency departments. We note that
there is already a POS code for the
emergency department, POS 23
(emergency room-hospital), and this
would continue to be used on
professional claims for services
furnished in emergency departments.
That is, the new POS code for offcampus hospital PBDs that will be
created for purposes of this data
collection would not apply to
emergency department services.
Hospitals and practitioners that have
questions about which departments are
considered to be ‘‘off-campus PBDs’’
should review additional guidance that
CMS releases on this policy and work
with the appropriate CMS regional
office if individual, specific questions
remain.
Comment: Several commenters asked
for clarification on when to report the
modifier for services furnished both on
and off-campus on the same day.
Commenters provided several scenarios
of visits and diagnostic services
furnished on the same day.
Response: The location where the
service is actually furnished would
dictate the use of the modifier and the
POS codes, regardless of where the
order for services is initiated. We expect
the modifier and the POS code for offcampus PBDs to be reported in locations
in which the hospital expends resources
to furnish the service in an off-campus
PBD setting. For example, hospitals
would not report the modifier for a
diagnostic test that is ordered by a
practitioner who is located in an offcampus PBD when the service is
actually furnished on the main campus
of the hospital. This issue does not
impact use of the POS codes since
practitioners submit a different claim for
each POS where they furnish services
for a specific beneficiary.
Comment: A few commenters asked
for clarification on whether their entity
constitutes a provider-based
department.
PO 00000
Frm 00026
Fmt 4701
Sfmt 4700
Response: Provider-based
departments are departments of the
hospital that meet the criteria in
§ 413.65.
Comment: A commenter
recommended that CMS publish the
data it acquires through adoption of this
modifier.
Response: Data collected through the
new HCPCS modifier would be part of
the Medicare Limited Data Set and
would be available to the public for
purchase along with the rest of the
Limited Data Set. Similarly, professional
claims data with revised POS coding
would be available as a standard
analytic file for purchase.
In summary, after consideration of the
comments received, we are finalizing
our proposal with modifications. For
professional claims, instead of finalizing
a HCPCS modifier, in response to
comments, we will be deleting current
POS code 22 (outpatient hospital
department) and establishing two new
POS codes—one to identify outpatient
services furnished in on-campus, remote
or satellite locations of a hospital, and
another to identify services furnished in
an off-campus hospital PBD setting that
is not a remote location of a hospital, a
satellite location of a hospital or a
hospital emergency department. We will
maintain the separate POS code 23
(emergency room-hospital) to identify
services furnished in an emergency
department of the hospital. These new
POS codes will be required to be
reported as soon as they become
available, however advance notice of the
availability of these codes will be shared
publicly as soon as practicable.
For hospital claims, we are creating a
HCPCS modifier that is to be reported
with every code for outpatient hospital
services furnished in an off-campus PBD
of a hospital. This code will not be
required to be reported for remote
locations of a hospital defined at
§ 412.65, satellite facilities of a hospital
defined at § 412.22(h) or for services
furnished in an emergency department.
This 2-digit modifier will be added to
the HCPCS annual file as of January 1,
2015, with the label ‘‘PO,’’ the short
descriptor ‘‘Serv/proc off-campus pbd,’’
and the long descriptor ‘‘Services,
procedures and/or surgeries furnished at
off-campus provider-based outpatient
departments.’’ Reporting of this new
modifier will be voluntary for 1 year
(CY 2015), with reporting required
beginning on January 1, 2016.
Additional instruction and provider
education will be forthcoming in
subregulatory guidance.
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
B. Potentially Misvalued Services Under
the Physician Fee Schedule
1. Valuing Services Under the PFS
Section 1848(c) of the Act requires the
Secretary to determine relative values
for physicians’ services based on three
components: Work, PE, and malpractice.
Section 1848(c)(1)(A) of the Act defines
the work component to mean, ‘‘the
portion of the resources used in
furnishing the service that reflects
physician time and intensity in
furnishing the service.’’ In addition,
section 1848(c)(2)(C)(i) of the Act
specifies that ‘‘the Secretary shall
determine a number of work relative
value units (RVUs) for the service based
on the relative resources incorporating
physician time and intensity required in
furnishing the service.’’
Section 1848(c)(1)(B) of the Act
defines the PE component as ‘‘the
portion of the resources used in
furnishing the service that reflects the
general categories of expenses (such as
office rent and wages of personnel, but
excluding malpractice expenses)
comprising practice expenses.’’ Section
1848(c)(2)(C)(ii) of the Act requires that
PE RVUs be determined based upon the
relative PE resources involved in
furnishing the service. (See section II.A.
of this final rule with comment period
for more detail on the PE component.)
Section 1848(c)(1)(C) of the Act
defines the MP component as ‘‘the
portion of the resources used in
furnishing the service that reflects
malpractice expenses in furnishing the
service.’’ Section 1848(c)(2)(C)(iii) of the
Act specifies that MP expense RVUs
shall be determined based on the
relative MP expense resources involved
in furnishing the service. (See section
II.C. of this final rule with comment
period for more detail on the MP
component.)
2. Identifying, Reviewing, and
Validating the RVUs of Potentially
Misvalued Services
ebenthall on DSK5SPTVN1PROD with $$_JOB
a. Background
Section 1848(c)(2)(B) of the Act
directs the Secretary to conduct a
periodic review, not less often than
every 5 years, of the RVUs established
under the PFS. Section 1848(c)(2)(K) of
the Act requires the Secretary to
periodically identify potentially
misvalued services using certain criteria
and to review and make appropriate
adjustments to the relative values for
those services. Section 1848(c)(2)(L) of
the Act also requires the Secretary to
develop a process to validate the RVUs
of certain potentially misvalued codes
under the PFS, using the same criteria
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
used to identify potentially misvalued
codes, and to make appropriate
adjustments.
As discussed in section I.B. of this
final rule with comment period, each
year we develop appropriate
adjustments to the RVUs taking into
account recommendations provided by
the American Medical Association/
Specialty Society Relative Value Scale
Update Committee (RUC), the Medicare
Payment Advisory Commission
(MedPAC), and others. For many years,
the RUC has provided us with
recommendations on the appropriate
relative values for new, revised, and
potentially misvalued PFS services. We
review these recommendations on a
code-by-code basis and consider these
recommendations in conjunction with
analyses of other data, such as claims
data, to inform the decision-making
process as authorized by the law. We
may also consider analyses of work
time, work RVUs, or direct PE inputs
using other data sources, such as
Department of Veteran Affairs (VA),
National Surgical Quality Improvement
Program (NSQIP), the Society for
Thoracic Surgeons (STS), and the
Physician Quality Reporting Initiative
(PQRI) databases. In addition to
considering the most recently available
data, we also assess the results of
physician surveys and specialty
recommendations submitted to us by
the RUC. We also consider information
provided by other stakeholders. We
conduct a review to assess the
appropriate RVUs in the context of
contemporary medical practice. We note
that section 1848(c)(2)(A)(ii) of the Act
authorizes the use of extrapolation and
other techniques to determine the RVUs
for physicians’ services for which
specific data are not available, in
addition to taking into account the
results of consultations with
organizations representing physicians.
In accordance with section 1848(c) of
the Act, we determine and make
appropriate adjustments to the RVUs.
In its March 2006 Report to the
Congress, MedPAC discussed the
importance of appropriately valuing
physicians’ services, noting that
‘‘misvalued services can distort the
price signals for physicians’ services as
well as for other health care services
that physicians order, such as hospital
services.’’ In that same report MedPAC
postulated that physicians’ services
under the PFS can become misvalued
over time. MedPAC stated, ‘‘When a
new service is added to the physician
fee schedule, it may be assigned a
relatively high value because of the
time, technical skill, and psychological
stress that are often required to furnish
PO 00000
Frm 00027
Fmt 4701
Sfmt 4700
67573
that service. Over time, the work
required for certain services would be
expected to decline as physicians
become more familiar with the service
and more efficient in furnishing it.’’ We
believe services can also become
overvalued when PE declines. This can
happen when the costs of equipment
and supplies fall, or when equipment is
used more frequently than is estimated
in the PE methodology, reducing its cost
per use. Likewise, services can become
undervalued when physician work
increases or PE rises.
As MedPAC noted in its March 2009
Report to Congress, in the intervening
years since MedPAC made its initial
recommendations, ‘‘CMS and the RUC
have taken several steps to improve the
review process.’’ Also, since that time
the Congress added section
1848(c)(2)(K)(ii) to the Act, which
augments our efforts. It directs the
Secretary to specifically examine, as
determined appropriate, potentially
misvalued services in the following
seven categories:
• Codes and families of codes for
which there has been the fastest growth;
• Codes and families of codes that
have experienced substantial changes in
PEs;
• Codes that are recently established
for new technologies or services;
• Multiple codes that are frequently
billed in conjunction with furnishing a
single service;
• Codes with low relative values,
particularly those that are often billed
multiple times for a single treatment;
• Codes which have not been subject
to review since the implementation of
the RBRVS (the so-called ‘Harvardvalued codes’); and
• Other codes determined to be
appropriate by the Secretary.
Section 220(c) of the Protecting
Access to Medicare Act of 2014 (PAMA)
further expanded the categories of codes
that the Secretary is directed to examine
by adding nine additional categories.
These are:
• Codes that account for the majority
of spending under the PFS;
• Codes for services that have
experienced a substantial change in the
hospital length of stay or procedure
time;
• Codes for which there may be a
change in the typical site of service
since the code was last valued;
• Codes for which there is a
significant difference in payment for the
same service between different sites of
service;
• Codes for which there may be
anomalies in relative values within a
family of codes;
E:\FR\FM\13NOR2.SGM
13NOR2
67574
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
• Codes for services where there may
be efficiencies when a service is
furnished at the same time as other
services;
• Codes with high intra-service work
per unit of time;
• Codes with high PE RVUs; and
• Codes with high cost supplies.
Section 1848(c)(2)(K)(iii) of the Act
also specifies that the Secretary may use
existing processes to receive
recommendations on the review and
appropriate adjustment of potentially
misvalued services. In addition, the
Secretary may conduct surveys, other
data collection activities, studies, or
other analyses, as the Secretary
determines to be appropriate, to
facilitate the review and appropriate
adjustment of potentially misvalued
services. This section of the Act also
authorizes the use of analytic
contractors to identify and analyze
potentially misvalued codes, conduct
surveys or collect data, and make
recommendations on the review and
appropriate adjustment of potentially
misvalued services. Additionally, this
section provides that the Secretary may
coordinate the review and adjustment of
any RVU with the periodic review
described in section 1848(c)(2)(B) of the
Act. Section 1848(c)(2)(K)(iii)(V) of the
Act specifies that the Secretary may
make appropriate coding revisions
(including using existing processes for
consideration of coding changes) that
may include consolidation of individual
services into bundled codes for payment
under the physician fee schedule.
b. Progress in Identifying and Reviewing
Potentially Misvalued Codes
To fulfill our statutory mandate, we
have identified and reviewed numerous
potentially misvalued codes as specified
in section 1848(c)(2)(K)(ii) of the Act,
and we plan to continue our work
examining potentially misvalued codes
as authorized by statute over the coming
years. As part of our current process, we
identify potentially misvalued codes for
review, and request recommendations
from the RUC and other public
commenters on revised work RVUs and
direct PE inputs for those codes. The
RUC, through its own processes, also
identifies potentially misvalued codes
for review. Through our public
nomination process for potentially
misvalued codes established in the CY
2012 PFS final rule with comment
period, other individuals and
stakeholder groups submit nominations
for review of potentially misvalued
codes as well.
Since CY 2009, as a part of the annual
potentially misvalued code review and
Five-Year Review process, we have
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
reviewed over 1,250 potentially
misvalued codes to refine work RVUs
and direct PE inputs. We have assigned
appropriate work RVUs and direct PE
inputs for these services as a result of
these reviews. A more detailed
discussion of the extensive prior
reviews of potentially misvalued codes
is included in the CY 2012 PFS final
rule with comment period (76 FR 73052
through 73055). In the CY 2012 final
rule with comment period, we finalized
our policy to consolidate the review of
physician work and PE at the same time
(76 FR 73055 through 73958), and
established a process for the annual
public nomination of potentially
misvalued services.
In the CY 2013 final rule with
comment period, we built upon the
work we began in CY 2009 to review
potentially misvalued codes that have
not been reviewed since the
implementation of the PFS (so-called
‘‘Harvard-valued codes’’). In CY 2009,
we requested recommendations from
the RUC to aid in our review of Harvardvalued codes that had not yet been
reviewed, focusing first on high-volume,
low intensity codes (73 FR 38589). In
the fourth Five-Year Review, we
requested recommendations from the
RUC to aid in our review of Harvardvalued codes with annual utilization of
greater than 30,000 (76 FR 32410). In the
CY 2013 final rule with comment
period, we identified Harvard-valued
services with annual allowed charges
that total at least $10,000,000 as
potentially misvalued. In addition to the
Harvard-valued codes, in the CY 2013
final rule with comment period we
finalized for review a list of potentially
misvalued codes that have stand-alone
PE (codes with physician work and no
listed work time, and codes with no
physician work that have listed work
time).
In the CY 2014 final rule with
comment period, we finalized for
review a list of potentially misvalued
services. We included on the list for
review ultrasound guidance codes that
had longer procedure times than the
typical procedure with which the code
is billed to Medicare. We also finalized
our proposal to replace missing postoperative hospital E/M visit information
and work time for approximately 100
global surgery codes. For CY 2014, we
also considered a proposal to limit PFS
payments for services furnished in a
nonfacility setting when the nonfacility
PFS payment for a given service exceeds
the combined Medicare Part B payment
for the same service when it is furnished
in a facility (separate payments being
made to the practitioner under the PFS
and to the facility under the OPPS).
PO 00000
Frm 00028
Fmt 4701
Sfmt 4700
Based upon extensive public comment,
we did not finalize this proposal. We
address our current consideration of the
potential use of OPPS data in
establishing RVUs for PFS services, as
well as comments received, in section
II.B. of this final rule with comment
period.
c. Validating RVUs of Potentially
Misvalued Codes
Section 1848(c)(2)(L) of the Act
requires the Secretary to establish a
formal process to validate RVUs under
the PFS. The Act specifies that the
validation process may include
validation of work elements (such as
time, mental effort and professional
judgment, technical skill and physical
effort, and stress due to risk) involved
with furnishing a service and may
include validation of the pre-, post-, and
intra-service components of work. The
Secretary is directed, as part of the
validation, to validate a sampling of the
work RVUs of codes identified through
any of the 16 categories of potentially
misvalued codes specified in section
1848(c)(2)(K)(ii)of the Act. Furthermore,
the Secretary may conduct the
validation using methods similar to
those used to review potentially
misvalued codes, including conducting
surveys, other data collection activities,
studies, or other analyses as the
Secretary determines appropriate to
facilitate the validation of RVUs of
services.
In the CY 2011 PFS proposed rule (75
FR 40068) and CY 2012 PFS proposed
rule (76 FR 42790), we solicited public
comments on possible approaches,
methodologies, and data sources that we
should consider for a validation process.
We provided a summary of the
comments along with our responses in
the CY 2011 PFS final rule with
comment period (75 FR 73217) and the
CY 2012 PFS final rule with comment
period (76 FR 73054 through 73055).
We contracted with two outside
entities to develop validation models for
RVUs. Given the central role of time in
establishing work RVUs and the
concerns that have been raised about the
current time values used in rate setting,
we contracted with the Urban Institute
to collect time data from several
practices for services selected by the
contractor in consultation with CMS.
These data will be used to develop time
estimates. The Urban Institute will use
a variety of approaches to develop
objective time estimates, depending on
the type of service. Objective time
estimates will be compared to the
current time values used in the fee
schedule. The project team will then
convene groups of physicians from a
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
range of specialties to review the new
time data and their potential
implications for work and the ratio of
work to time. The Urban Institute has
prepared an interim report,
Development of a Model for the
Valuation of Work Relative Value Units,
which discusses the challenges
encountered in collecting objective time
data and offers some thoughts on how
these can be overcome. This interim
report is available on the CMS Web site
at https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
PhysicianFeeSched/Downloads/RVUsValidation-UrbanInterimReport.pdf.
Collection of time data under this
project has just begun. A final report
will be available once the project is
complete.
The second contract is with the RAND
Corporation, which is using available
data to build a validation model to
predict work RVUs and the individual
components of work RVUs, time, and
intensity. The model design was
informed by the statistical
methodologies and approach used to
develop the initial work RVUs and to
identify potentially misvalued
procedures under current CMS and RUC
processes. RAND will use a
representative set of CMS-provided
codes to test the model. RAND
consulted with a technical expert panel
on model design issues and the test
results. We anticipate a report from this
project by the end of the year and will
make the report available on the CMS
Web site.
Descriptions of both projects are
available on the CMS Web site at
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
PhysicianFeeSched/Downloads/RVUsValidation-Model.pdf.
We acknowledge comments received
regarding the Urban Institute and RAND
projects, but note that we did not solicit
comments on these projects because we
made no proposals related to them. Any
changes to payment policies under the
PFS that we might make after
considering these reports would be
issued in a proposed rule and subjected
to public comment before they would be
finalized and implemented.
ebenthall on DSK5SPTVN1PROD with $$_JOB
3. CY 2015 Identification and Review of
Potentially Misvalued Services
a. Public Nomination of Potentially
Misvalued Codes
In the CY 2012 PFS final rule with
comment period, we finalized a process
for the public to nominate potentially
misvalued codes (76 FR 73058). The
public and stakeholders may nominate
potentially misvalued codes for review
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
by submitting the code with supporting
documentation during the 60-day public
comment period following the release of
the annual PFS final rule with comment
period. Supporting documentation for
codes nominated for the annual review
of potentially misvalued codes may
include the following:
• Documentation in the peer
reviewed medical literature or other
reliable data that there have been
changes in physician work due to one
or more of the following: Technique;
knowledge and technology; patient
population; site-of-service; length of
hospital stay; and work time.
• An anomalous relationship between
the code being proposed for review and
other codes.
• Evidence that technology has
changed physician work, that is,
diffusion of technology.
• Analysis of other data on time and
effort measures, such as operating room
logs or national and other representative
databases.
• Evidence that incorrect
assumptions were made in the previous
valuation of the service, such as a
misleading vignette, survey, or flawed
crosswalk assumptions in a previous
evaluation.
• Prices for certain high cost supplies
or other direct PE inputs that are used
to determine PE RVUs are inaccurate
and do not reflect current information.
• Analyses of work time, work RVU,
or direct PE inputs using other data
sources (for example, VA NSQIP, STS
National Database, and the PQRS
databases).
• National surveys of work time and
intensity from professional and
management societies and
organizations, such as hospital
associations.
After we receive the nominated codes
during the 60-day comment period
following the release of the annual PFS
final rule with comment period, we
evaluate the supporting documentation
and assess whether the nominated codes
appear to be potentially misvalued
codes appropriate for review under the
annual process. In the following year’s
PFS proposed rule, we publish the list
of nominated codes and indicate
whether we are proposing each
nominated code as a potentially
misvalued code.
During the comment period to the CY
2014 final rule with comment period,
we received nominations and
supporting documentation for four
codes to be considered as potentially
misvalued codes. Although we
evaluated the supporting documentation
for two of the nominated codes to
ascertain whether the submitted
PO 00000
Frm 00029
Fmt 4701
Sfmt 4700
67575
information demonstrated that the code
should be proposed as potentially
misvalued, we did not identify the other
two codes until after the publication of
the proposed rule. We apologize for this
oversight and will address the
nomination of CPT codes 92227 and
92228 in the proposed rule for CY 2016.
We proposed CPT code 41530
(submucosal ablation of the tongue base,
radiofrequency, 1 or more sites, per
session) as potentially misvalued based
on public nomination due to a
significant decrease in two of the direct
PE inputs.
Comment: The commenter that
nominated this code as potentially
misvalued thanked CMS for proposing
this code as potentially misvalued, but
indicated that the RUC had made
recommendations for this code for CY
2015 and further review was no longer
necessary. Another commenter
suggested that this code should be
removed from the list of potentially
misvalued codes since it saves Medicare
millions of dollars per year.
Response: The RUC only provided us
with recommendations for PE inputs for
CPT code 41530. Under our usual
process, we value work and PE at the
same time and would expect to receive
RUC recommendations on both before
we revalue this service. We disagree
with the commenter’s statement that
codes that may save money for the
Medicare program should not be
considered as potentially misvalued.
Our aim, consistent with our statutory
directive, is to value all services
appropriately under the PFS to reflect
the relative resources involved in
furnishing them. After consideration of
public comments, we are finalizing CPT
code 41530 as potentially misvalued.
We did not propose CPT code 99174
(instrument-based ocular screening (for
example, photoscreening, automatedrefraction), bilateral) as potentially
misvalued, because it is a non-covered
service, and we only consider
nominations of active codes that are
covered by Medicare at the time of the
nomination (see 76 FR 73059).
Comment: Commenters did not
disagree with CMS not proposing this
code as potentially misvalued, but did
raise a variety of comments about the
code that were unrelated to our
proposal.
Response: We continue to believe that
our policy to limit the designation of
potentially misvalued to those codes
that are covered by Medicare is
appropriate, so that we focus our
limited resources on those services that
have an impact on the Medicare
program and its beneficiaries. Therefore,
we are not including CPT code 99174 on
E:\FR\FM\13NOR2.SGM
13NOR2
67576
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
our final list of potentially misvalued
codes for CY 2015.
b. Potentially Misvalued Codes
(1) Review of High Expenditure Services
Across Specialties With Medicare
Allowed Charges of $10,000,000 or
More
We proposed 68 codes listed in Table
11 as potentially misvalued codes under
the newly established statutory
category, ‘‘codes that account for the
majority of spending under the
physician fee schedule.’’ To develop
this list, we identified the top 20 codes
by specialty (using the specialties used
in Table 11) in terms of allowed charges.
We excluded those codes that we have
reviewed since CY 2009, those codes
with fewer than $10 million in allowed
charges, and E/M services. E/M services
were excluded for the same reason that
we excluded them in a similar review
for CY 2012. The reason was explained
in the CY 2012 final rule with comment
period (76 FR 73062 through 73065).
We stated that we believed that a
review of the codes in Table 11 is
warranted to assess changes in
physician work and to update direct PE
inputs since these codes have not been
reviewed since CY 2009 or earlier.
Furthermore, since these codes have
significant impact on PFS payment at
the specialty level, a review of the
relativity of the codes is essential to
ensure that the work and PE RVUs are
appropriately relative within the
specialty and across specialties, as
discussed previously. For these reasons,
we proposed the codes listed in Table
11 as potentially misvalued.
TABLE 11—POTENTIALLY MISVALUED
CODES IDENTIFIED THROUGH THE
HIGH EXPENDITURE BY SPECIALTY
SCREEN
ebenthall on DSK5SPTVN1PROD with $$_JOB
HCPCS
11100
11101
11730
11750
14060
17110
31575
31579
36215
36475
36478
36870
51720
51728
51798
52000
55700
65855
66821
67228
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
Short descriptor
Biopsy skin lesion.
Biopsy skin add-on.
Removal of nail plate.
Removal of nail bed.
Tis trnfr e/n/e/l 10 sq cm/.
Destruct b9 lesion 1–14.
Diagnostic laryngoscopy.
Diagnostic laryngoscopy.
Place catheter in artery.
Endovenous rf 1st vein.
Endovenous laser 1st vein.
Percut thrombect av fistula.
Treatment of bladder lesion.
Cystometrogram w/vp.
Us urine capacity measure.
Cystoscopy.
Biopsy of prostate.
Laser surgery of eye.
After cataract laser surgery.
Treatment of retinal lesion.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
TABLE 11—POTENTIALLY MISVALUED
CODES IDENTIFIED THROUGH THE
HIGH EXPENDITURE BY SPECIALTY
SCREEN—Continued
HCPCS
68761 ..
71010 ..
71020 ..
71260 ..
73560 ..
73562 ..
73564 ..
74183 ..
75978 ..
76536 ..
76700 ..
76770 ..
76775 ..
77263 ..
77334 ..
78452 ..
88185 ..
91110 ..
92136 ..
92250 ..
92557 ..
93280 ..
93306 ..
93351 ..
93978 ..
94010 ..
95004 ..
95165 ..
95957 ..
96101 ..
96118 ..
96372 ..
96375 ..
96401 ..
96409 ..
97032 ..
97035 ..
97110 ..
97112 ..
97113 ..
97116 ..
97140 ..
97530 ..
G0283
Short descriptor
Close tear duct opening.
Chest x-ray 1 view frontal.
Chest x-ray 2vw frontal&latl.
Ct thorax w/dye.
X-ray exam of knee 1 or 2.
X-ray exam of knee 3.
X-ray exam knee 4 or more.
Mri abdomen w/o & w/dye.
Repair venous blockage.
Us exam of head and neck.
Us exam abdom complete.
Us exam abdo back wall comp.
Us exam abdo back wall lim.
Radiation therapy planning.
Radiation treatment aid(s).
Ht muscle image spect mult.
Flowcytometry/tc add-on.
Gi tract capsule endoscopy.
Ophthalmic biometry.
Eye exam with photos.
Comprehensive hearing test.
Pm device progr eval dual.
Tte w/doppler complete.
Stress tte complete.
Vascular study.
Breathing capacity test.
Percut allergy skin tests.
Antigen therapy services.
Eeg digital analysis.
Psycho testing by psych/phys.
Neuropsych tst by psych/phys.
Ther/proph/diag inj sc/im.
Tx/pro/dx inj new drug addon.
Chemo anti-neopl sq/im.
Chemo iv push sngl drug.
Electrical stimulation.
Ultrasound therapy.
Therapeutic exercises.
Neuromuscular reeducation.
Aquatic therapy/exercises.
Gait training therapy.
Manual therapy 1/> regions.
Therapeutic activities.
Elec stim other than wound.
Comment: Many commenters
disagreed with the high expenditure
screen in principle, stating that the
frequency with which a service is
furnished (and therefore the total
expenditures) is not an indication that
the service is misvalued. Specifically,
commenters explained that many of the
services are highly utilized because of
the nature of the Medicare beneficiary
population, and not because there is
abuse or overutilization. Commenters
asserted that the current misvalued code
screens can produce a redundant list of
potentially misvalued codes while
failing to identify codes that are being
incorrectly reported. Another
commenter urged CMS to work with the
RUC to ensure that the code lists
identified by the misvalued code
screens are accurate. A commenter
PO 00000
Frm 00030
Fmt 4701
Sfmt 4700
asked CMS to provide justification for
including codes with charges greater
than $10 million on the potentially
misvalued codes list. Some commenters
urged us to reconsider including
particular families of codes that were
reviewed prior to 2009; others asked
that CMS exclude all codes that have
been reviewed in the last 10 years; and
still others requested that we exclude
codes that were bundled several years
ago. A commenter stated that the
emphasis on codes with spending of
more than $10 million demonstrates an
agenda to cut spending rather than to
ensure appropriate payment, and
expressed concern that CMS was simply
nominating high value services.
Commenters recommended that CMS
not finalize its proposed list of
potentially misvalued codes, and
instead develop a more targeted list of
codes that are likely to be misvalued
(not just potentially misvalued).
Commenters wanted CMS to exempt
codes when there have not been
fundamental changes in the way the
services are furnished or there is no
indication that their values are
inaccurate, so that specialty societies do
not have to go through the work of
reviewing them.
Several commenters questioned the
statutory authority for CMS’s proposal.
One commenter questioned CMS’s
authority under the relevant statute to
select potentially misvalued codes by
specialty. The commenter stated that
identifying the top 20 codes by specialty
in terms of allowed charges does not
appear to align with a direct reading of
the relevant statutory authority, which
allows CMS to identify codes that
account for the majority of spending
under the PFS, but does not provide for
the identification of codes by specialty.
The commenter said that a more direct
interpretation of the statutory authority
would be to select codes based on
allowed charges irrespective of
specialty, and then to narrow the
universe of codes based upon the top
codes in terms of allowed charges.
Another commenter believed the
proposed screen did not comport with
the statutory selection criteria because
the majority or near majority of
spending under the PFS is for
evaluation and management (E/M)
codes, which CMS excluded from
review. The commenter said that if CMS
believes that E/M services should not be
reviewed—a position the commenter
said they would certainly understand—
then such a determination is sufficient
to meet the statutory mandate to review
codes accounting for the majority of PFS
spending, and it would then be
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
appropriate for CMS and the RUC to
focus efforts on other categories of
potentially misvalued codes. The
commenter urged CMS at the very least
to develop a more targeted list of
potentially misvalued services in the
category of codes accounting for the
majority of PFS spending, and to
include codes that are likely to be
misvalued, not just potentially
misvalued.
Response: Potentially misvalued code
screens are intended to identify codes
that are possibly misvalued. By
definition, these screens do not assert
that codes are certainly or even likely
misvalued. As we discussed in the CY
2012 PFS final rule with comment
period (76 FR 73056), the screens serve
to focus our limited resources on
categories of codes where there is a high
risk of significant payment distortions.
One goal is to avoid perpetuating
payment for the services at a rate that
does not appropriately reflect the
relative resources involved in furnishing
the service. In implementing this
statutory provision, we consider
whether the codes meeting the
screening criteria have a significant
impact on payment for all PFS services
due to the budget neutral nature of the
PFS. That is, if codes meeting the
screening criteria are indeed misvalued,
they would be inappropriately
impacting the relative values of all PFS
services. Addressing included codes
therefore indirectly addresses other
codes that do not meet the screening
criteria but are themselves misvalued
because high expenditure codes are
misvalued. We agree with the
commenters that high program
expenditures and high utilization have
varying causes and do not necessarily
reflect misvalued codes. However, we
continue to believe that the high
expenditure screen is nevertheless an
appropriate means of focusing our
reviews, ensuring appropriate relativity
among PFS services, and identifying
services that are either over or
undervalued. The high expenditure
screen is likely to identify misvalued
codes, both directly and indirectly.
Regarding screening for codes by
specialty, as we discussed above, the
included codes have significant impact
on PFS payment at the specialty level,
therefore a review of the relativity of the
codes is essential to ensure that the
work and PE RVUs are appropriately
relative within the specialty and across
specialties. We mentioned in the CY
2012 final rule with comment period
how stakeholders have noted that many
of the services previously identified
under the potentially misvalued codes
initiative were concentrated in certain
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
specialties. To develop a robust and
representative list of codes for review,
we examine the highest PFS
expenditure services by specialty and
we identify those codes that have not
been recently reviewed (76 FR 73060).
Although we understand commenters’
concerns that the screens can produce
redundant results, we note that we
exempted codes that have been
reviewed since 2009 for this very
reason. We believe that the practice of
medicine can change significantly over
a 10-year period, and disagree with
commenters’ suggestions that no
changes would occur over a 10-year
period that would significantly affect a
procedure’s valuation.
Regarding the exclusion of E/M
services, we refer the commenters to the
extensive discussion in the CY 2012
PFS final rule with comment period (76
FR 73060 through 73065). It is true that
E/M services account for significant
volume under the PFS, but there are
significant issues with reviewing these
codes as discussed in the CY 2012 final
rule with comment period, and as a
result we did not propose to include
these codes as potentially misvalued.
Comment: Some commenters
suggested other screens that could be
used to identify misvalued codes. In
addition, even though our proposal only
relates to identifying potentially
misvalued codes, some commenters
commented on our mechanisms for revaluing misvalued codes.
Response: The only screen for which
we made a proposal and sought
comments was the high expenditure
screen. However, we will consider the
suggestions for other screens as we
develop proposals in future years.
Similarly, our proposal only related to
identifying potentially misvalued codes
and not how to re-value them if they
were finalized as potentially misvalued.
Comment: Several commenters
requested that CMS postpone the review
of potentially misvalued codes until the
revised process we proposed for
reviewing new, revised, and potentially
misvalued codes is in place.
Response: Although we believe that
the revised process for reviewing new,
revised, and potentially misvalued
codes will improve the transparency of
the PFS code review process, we do not
believe it is appropriate to postpone the
review of all potentially misvalued
codes until the new process is
implemented. We note that the codes
identified in this rule as potentially
misvalued would be revalued under the
new process, which will be phased in
starting for CY 2016 and will apply for
all codes revalued for CY 2017.
PO 00000
Frm 00031
Fmt 4701
Sfmt 4700
67577
Comment: Commenters raised several
codes that they believed should not be
included in the high expenditure screen
for a variety of reasons, for example if
the code is related to other codes that
were recently reviewed and the
utilization for the identified service is
expected to change significantly as a
result of coding changes in the family.
Commenters also suggested that codes
that have been referred to the CPT
Editorial Panel should be excluded from
the potentially misvalued codes list.
Response: We acknowledge
commenters’ suggestion that we exclude
particular codes from the screen, but
since we are not finalizing a particular
list of codes for this screen in this final
rule we are not addressing these at this
time. We note that we do not agree with
commenters that codes that have been
referred to CPT by the RUC should be
excluded from the potentially
misvalued list; rather, we believe that
only when these codes are either
deleted or revised, and/or we receive
new RUC recommendations for revaluing these codes, would it be
appropriate to remove these services
from the list.
Comment: A commenter suggested
that CMS’s high expenditure screen may
not account for the fact that many
radiology codes have already gone
through numerous five-year reviews;
have well-established RVUs that are
included on the RUC’s multispecialty
point of comparison (MPC) list; have
been included in new, bundled codes;
or have PE RVUs that were affected by
changes in clinical labor times or
equipment utilization assumption
changes. The commenter also suggested
that the screens do not account for the
value that patients receive in terms of
better, timelier diagnoses and avoidance
of invasive procedures.
Response: We acknowledge that
certain types of procedures have been
identified through multiple screens;
however, we continue to believe that it
is appropriate to include most codes
that are identified via these screens and
not to exclude codes simply because
many other procedures furnished by
that specialty have already been
reviewed. We further note that the
presence of codes on the MPC list makes
the case for their review more
compelling, given their importance in
ensuring overall relativity throughout
the PFS. With respect to changes in PE
RVUs, we note that cross-cutting
policies that affect large numbers of
codes are aimed at ensuring overall
relativity but do not address the inputs
associated with each procedure affected
by the change. Finally, a code’s status as
potentially misvalued does not imply
E:\FR\FM\13NOR2.SGM
13NOR2
67578
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
that the service itself is not of inherent
value; rather, that its valuation may be
inaccurate in either direction.
After considering the comments
received, as well as the other proposals
we are finalizing, we believe it is
appropriate to finalize the high
expenditure screen as a tool to identify
potentially misvalued codes. However,
given the resources required over the
next several years to revalue the services
with global periods, we believe it is best
to concentrate our efforts on these
valuations. Therefore, we are not
finalizing the codes identified through
the high expenditure screen as
potentially misvalued at this time. Also,
we are not responding to comments at
this time regarding whether particular
codes should or should not be included
in the high expenditure code screen and
identified as potentially misvalued
codes. We will re-run the high
expenditure screen at a future date, and
will propose at that time the specific set
of codes to be reviewed that meet the
high expenditure criteria.
(2) Epidural Injection and Fluoroscopic
Guidance—CPT Codes 62310, 62311,
62318, 62319, 77001, 77002 and 77003
For CY 2014, we established interim
final rates for four epidural injection
procedures, CPT codes 62310
(Injection(s), of diagnostic or therapeutic
substance(s) (including anesthetic,
antispasmodic, opioid, steroid, other
solution), not including neurolytic
substances, including needle or catheter
placement, includes contrast for
localization when performed, epidural
or subarachnoid; cervical or thoracic),
62311 (Injection(s), of diagnostic or
therapeutic substance(s) (including
anesthetic, antispasmodic, opioid,
steroid, other solution), not including
neurolytic substances, including needle
or catheter placement, includes contrast
for localization when performed,
epidural or subarachnoid; lumbar or
sacral (caudal)), 62318 (Injection(s),
including indwelling catheter
placement, continuous infusion or
intermittent bolus, of diagnostic or
therapeutic substance(s) (including
anesthetic, antispasmodic, opioid,
steroid, other solution), not including
neurolytic substances, includes contrast
for localization when performed,
epidural or subarachnoid; cervical or
thoracic) and 62319 (Injection(s),
including indwelling catheter
placement, continuous infusion or
intermittent bolus, of diagnostic or
therapeutic substance(s) (including
anesthetic, antispasmodic, opioid,
steroid, other solution), not including
neurolytic substances, includes contrast
for localization when performed,
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
epidural or subarachnoid; lumbar or
sacral (caudal)). These interim final
values resulted in CY 2014 payment
reductions from the CY 2013 rates for all
four procedures.
In the CY 2014 final rule with
comment period (78 FR 74340), we
described in detail our interim valuation
of these codes. We indicated we
established interim final work RVUs for
these codes that were less than those
recommended by the RUC because we
did not believe that the RUCrecommended work RVUs accounted for
the substantial decrease in time it takes
to furnish these services as reflected in
the RUC survey data for these four
codes. Since the RUC provided no
indication that the intensity of the
procedures had changed, we indicated
that we believed the work RVUs should
reflect the reduction in time. We also
established interim final direct PE
inputs for these four codes based on the
RUC-recommended inputs without any
refinement. These recommendations
included the removal of the
radiographic-fluoroscopy room for CPT
codes 62310, 62311, and 62318 and a
portable C-arm for CPT code 62319.
In response to the comments we
received objecting to the CY 2014
interim final values for these codes, we
looked at other injection procedures.
Other injection procedures, including
some that commenters recommended
we use to value these epidural injection
codes, include the work and practice
expenses of image guidance in the
injection code. In the proposed rule, we
detailed many of these procedures,
which include the image guidance in
the injection CPT code. Since our
analysis of the Medicare data and
comments received on the CY 2014 final
rule with comment period indicated
that these services are typically
furnished with imaging guidance, we
believe it would be appropriate for the
codes to be bundled and the inputs for
image guidance to be included in the
valuation of the epidural injection codes
as it is for transforaminal and
paravertebral codes. We stated that we
did not believe the epidural injection
codes can be appropriately valued
without considering the image
guidance, and that bundling image
guidance will help assure relativity with
other injection codes that include the
image guidance. To determine how to
appropriately value resources for the
combined codes, we indicated that we
believed more information is needed.
Accordingly, we proposed to include
CPT codes 62310, 62311, 62318, and
62319 on the potentially misvalued
code list so that we can obtain
information to value them with the
PO 00000
Frm 00032
Fmt 4701
Sfmt 4700
image guidance included. In the
meantime, we proposed to use the CY
2013 input values for CPT codes 62310,
62311, 62318 and 62319 to value these
codes for CY 2015. Specifically, we
proposed to use the CY 2013 work RVUs
and work times.
Because it was clear that inputs that
are specifically related to image
guidance, such as the radiographic
fluoroscopic room, are included in these
proposed direct PE inputs for the
epidural injection codes, we believed
allowing separate reporting of the image
guidance codes would overestimate the
resources used in furnishing the overall
service. To avoid this situation, we also
proposed to prohibit the billing of image
guidance codes in conjunction with
these four epidural injection codes. We
stated that we believed our two-tiered
proposal to utilize CY 2013 input values
for this family while prohibiting
separate billing of imaging guidance
best ensures that appropriate
reimbursements continue to be made for
these services, while we gather
additional data and input on the best
way to value them through codes that
include both the injection and the image
guidance.
Comment: The commenters did not
object to identifying these codes as
potentially misvalued and generally
agreed with our proposal to revert to the
2013 inputs for CY 2015.
Response: We appreciate support for
our proposal.
Comment: Several commenters agreed
that it would be appropriate to bundle
the image guidance with the epidural
procedures. Other commenters
suggested that we create both a bundled
code and a stand-alone epidural
injection code.
Response: We appreciate commenters’
support for our proposal to bundle
image guidance with the epidural
procedures. As part of the review
process, consideration can be given to
how to best implement bundled codes.
Comment: Other commenters
expressed concern that the bundling
approach CMS proposed to use until
these codes are reviewed did not
incorporate the work or time for
fluoroscopy. Some requested that we
add the payment for fluoroscopic
guidance to the epidural injection
codes, as we have done in the past for
facet joint injections and other services.
Commenters requested that we continue
to allow the image guidance codes to be
separately billed until these services are
revalued. Another commenter suggested
that it may be premature to prohibit
separate billing for image guidance, as
there is considerable variation on the
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
use of fluoroscopic guidance between
codes within this family.
Response: We understand
commenters’ concerns about our
proposal to prohibit separate billing for
image guidance, and note that these
concerns are part of the reason we are
referring these codes to the RUC as
potentially misvalued. However, given
that significant resources are allocated
to fluoroscopic guidance within the
current injection codes, we do not
believe it is appropriate to continue to
allow the image guidance to be
separately billed while we evaluate
these epidural injection codes as
potentially misvalued services.
After considering comments received,
we are finalizing CPT codes 62310,
62311, 62318, and 62319 as potentially
misvalued, finalizing the proposed
RVUs for these services, and prohibiting
separate billing of image guidance in
conjunction with these services.
ebenthall on DSK5SPTVN1PROD with $$_JOB
(3) Neurostimulator Implantation (CPT
Codes 64553 and 64555)
We proposed CPT codes 64553
(Percutaneous implantation of
neurostimulator electrode array; cranial
nerve) and 64555 (Percutaneous
implantation of neurostimulator
electrode array; peripheral nerve
(excludes sacral nerve)) as potentially
misvalued after stakeholders questioned
whether the codes included the
appropriate direct PE inputs when
furnished in the nonfacility setting.
Comment: A commenter encouraged
CMS to include these codes on the
potentially misvalued code list to
ensure that they are adequately
reimbursed in the nonfacility setting,
while another commenter disagreed that
the work for CPT codes 64553 and
64555 needed to be reviewed.
Response: In general, when a code is
proposed as potentially misvalued,
unless we receive information that
clearly demonstrates it is not potentially
misvalued, we finalize the code as
potentially misvalued. When we finalize
a code as potentially misvalued, we
then review the inputs for the code. As
a result of such review, inputs can be
adjusted either upward or downward.
We appreciate the support for our
proposal expressed by some
commenters. Since the commenter
opposing the addition of these codes to
the potentially misvalued code list did
not provide justification for its assertion
that the work RVUs for CPT codes
64553 and 64555 did not need to be
reviewed, after consideration of
comments received, we are finalizing
CPT codes 64553 and 64555 as
potentially misvalued.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
(4) Mammography (CPT Codes 77055,
77056, and 77057, and HCPCS Codes
G0202, G0204, and G0206)
Medicare currently pays for
mammography services through both
CPT codes, (77055 (mammography;
unilateral), 77056 (mammography;
bilateral) and 77057 (screening
mammography, bilateral (2-view film
study of each breast)) and HCPCS Gcodes, (G0202 (screening
mammography, producing direct digital
image, bilateral, all views), G0204
(diagnostic mammography, producing
direct digital image, bilateral, all views),
and G0206 (diagnostic mammography,
producing direct digital image,
unilateral, all views)). The CPT codes
were designed to be used for
mammography regardless of whether
film or digital technology is used.
However, for Medicare purposes, the
HCPCS G-codes were created to describe
mammograms using digital technology
in response to special payment rules for
digital mammography included in the
Medicare Benefit Improvements and
Protection Act of 2000 (BIPA).
The RUC recommended that CMS
update the direct PE inputs for all
imaging codes to reflect the migration
from film-to-digital storage technologies
since digital storage is now typically
used in imaging services. Review of the
Medicare data with regard to the
application of this policy to
mammography confirmed that virtually
all mammography is now digital. As a
result, we proposed that CPT codes
77055, 77056, and 77057 be used to
report mammography regardless of
whether film or digital technology is
used, and to delete the HCPCS G-codes
G0202, G0204, and G0206. We proposed
to establish values for the CPT codes by
crosswalking the values established for
the digital mammography G-codes for
CY 2015. (See section II.B. of this final
rule with comment period for more
discussion of this policy.) In addition,
since the G-code values have not been
evaluated since they were created in CY
2002 we proposed to include CPT codes
77055, 77056, and 77057 on the list of
potentially misvalued codes.
Comment: With regard to whether the
mammography codes should be
included on the potentially misvalued
codes list, commenters had differing
opinions. One commenter stated that
the work RVUs for digital
mammography are the same as those for
analog mammography, and maintained
that the BIPA-directed payment for
digital mammography of 1.5 times the
TC of the analog mammography codes
appropriately captures the practice
expense resources required for digital
PO 00000
Frm 00033
Fmt 4701
Sfmt 4700
67579
mammography. Another commenter
stated that digital mammography rates
resulted from a statutory construct and
do not reflect the actual costs of the
digital resources necessary to furnish
the services. One commenter noted that
moving from the non-resource-based
values to resource-based values will
result in a significant reduction to the
valuation of these services, and that this
reduction will result from the resourcebased PE methodology, not from the
RUC review. Another commenter
indicated that the RUC should not
survey these codes, but requested that if
the RUC does survey these codes, they
should not do so until after CMS
finalizes the new breast tomosynthesis
codes (3D mammography) and film-todigital transition. Another commenter
indicated that CMS needed to consider
that three-dimensional (3D)
mammography codes involve additional
resources over the two-dimensional (2D)
mammography codes. A commenter
suggested that this proposal fails to take
into account the increasing use of
tomography.
Response: The commenters’
disagreement about whether these codes
are misvalued would suggest that a
review is warranted. Given that more
than a decade has passed since these
services were reviewed, we continue to
believe that it is appropriate to review
the work RVUs for these services. By
including these codes on the potentially
misvalued code list, we will have
information to determine whether the
current values are still appropriate.
Finally, we anticipate that the survey
results for the mammography codes will
reflect the equipment that is typically
used. We note that until these services
are reviewed, we do not have adequate
information to respond to the suggestion
that the valuation for these services will
be significantly reduced. However, we
do acknowledge that the PE
methodology is not intended to account
for the actual costs in furnishing a
service; rather, it is required to account
for the relative resources in furnishing
that service. We also note that there are
new CPT codes for reporting
mammography using tomosynthesis and
we have RUC recommendations for
these codes. We believe it is most
appropriate to value the mammography
code family together, and receipt of RUC
recommendations on the other
mammography codes will assist us in
our review. Accordingly, we are
including all mammography codes
except those newly created for
tomosynthesis on the potentially
misvalued code list.
Comment: Although commenters
agreed with our assessment that digital
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67580
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
technology has replaced analog
mammography as typical, not all agreed
that it was appropriate to delete G-codes
and use the CPT codes. One commenter
supported the deletion of the G-codes.
Other commenters suggested that
deletion of the G-codes was
unnecessary. Another commenter stated
that the coding system frequently
reflects differences in approach and
technique, and that the equipment for
analog and digital mammography are
different enough to warrant separate
reporting so we should not delete the Gcodes. Some who supported
continuation of the G-codes asked us to
delay implementation as they were
concerned that other payers would not
have time to update their requirements
by January 1, 2015. Another commenter
applauded CMS’s decision to delete the
G-codes.
Response: In further consideration of
this proposal, we discovered that while
the CPT codes for diagnostic
mammography apply to mammography,
whether film or digital technology is
used, the descriptor for the screening
mammography CPT code specifically
refers to film. In light of this and that
fact that we anticipate revaluing these
codes when we have the benefit of RUC
recommendations for all codes in the
family, we believe it is appropriate to
continue to recognize both the CPT
codes and the G-codes for
mammography for CY 2015, as we
consider appropriate valuations now
that digital mammography is typical.
Therefore, we are not finalizing our
proposal to delete the G-codes. We are,
however, making a change in the
descriptors to make clear that the
G0202, G0204, and G0206 are specific to
2–D mammography. These codes are to
be reported with either G0279 or CPT
code 77063 when mammography is
furnished using 3–D mammography.
Comment: A commenter requested
that CMS ensure reimbursement rates
remain adequate to protect access for
Medicare beneficiaries. Another
commenter suggested that these changes
could result in barriers to access for
Medicare beneficiaries.
Response: We are strongly supportive
of access to mammography for Medicare
beneficiaries. As stated elsewhere in
this final rule with comment period, we
believe that accurate valuation
incentivizes appropriate utilization of
services.
After consideration of public
comments, we are modifying our
proposal as follows: We will include
CPT codes 77055, 77056, and 77057 on
the potentially misvalued codes list; we
will continue to recognize G0202,
G0204 and G0206 but will modify the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
descriptors so that they are specific to
2–D digital mammography, and instead
of using the digital values we will
continue to use the CY 2014 work and
PE RVUs to value the mammography
CPT codes. We expect that the CPT
Editorial Panel will consider the
descriptor for screening mammography,
CPT code 77057, in light of the
prevailing use of digital mammography.
(5) Abdominal Aortic Aneurysm
Ultrasound Screening (G0389)
When Medicare began paying for
abdominal aortic aneurysm (AAA)
ultrasound screening, HCPCS code
G0389 (Ultrasound, B-scan and/or real
time with image documentation; for
abdominal aortic aneurysm (AAA)
screening) in CY 2007, we set the RVUs
at the same level as CPT code 76775
(Ultrasound, retroperitoneal (e.g., renal,
aorta, nodes), B-scan and/or real time
with image documentation; limited). We
noted in the CY 2007 final rule with
comment period that CPT code 76775
was used to report the service when
furnished as a diagnostic test and that
we believed the service reflected by
G0389 used equivalent resources and
work intensity to those contained in
CPT code 76775 (71 FR 69664 through
69665).
In the CY 2014 proposed rule, we
proposed to replace the ultrasound
room included as a direct PE input for
CPT code 76775 with a portable
ultrasound unit based upon a RUC
recommendation. Since the RVUs for
G0389 were crosswalked from CPT code
76775, the proposed PE RVUs for G0389
in the CY 2014 proposed rule were
reduced as a result of this change.
However, we did not discuss the
applicability of this change to G0389 in
the preamble to the proposed rule, and
did not receive any comments on G0389
in response to the proposed rule. We
finalized the change to CPT code 76775
in the CY 2014 final rule with comment
period and as a result, the PE RVUs for
G0389 were also reduced.
We proposed G0389 as potentially
misvalued in response to a stakeholder
suggestion that the reduction in the
RVUs for G0389 did not accurately
reflect the resources involved in
furnishing the service. We sought
recommendations from the public and
other stakeholders, including the RUC,
regarding the appropriate work RVU,
time, direct PE input, and malpractice
risk factors that reflect the typical
resources involved in furnishing the
service.
Until we receive the information
needed to re-value this service, we
proposed to value this code using the
same work and PE RVUs we used for CY
PO 00000
Frm 00034
Fmt 4701
Sfmt 4700
2013. We proposed MP RVUs based on
the five-year review update process as
described in section II.C of this final
rule with comment period. We stated
that we believe this valuation would
ameliorate the effect of the CY 2014
reduction that resulted from the RVUs
for G0389 being tied to those for another
code while we assess appropriate
valuation through our usual
methodologies. Accordingly, we
proposed a work RVU of 0.58 for G0389
and proposed to assign the 2013 PE
RVUs until this procedure is reviewed.
Comment: Many commenters
supported our proposal to include this
service on the potentially misvalued
codes list. Some commenters agreed that
the crosswalk used to set rates for this
service does not appear to be
appropriate at this time, whether due to
changes in the way the service is
provided, or because the specialty mix
has shifted, and suggested that it would
be appropriate to establish a Category I
CPT code for this service. Another
commenter suggested that CMS consider
crosswalking G0389 to CPT code 93979
(Duplex scan of aorta, inferior vena
cava, iliac vasculature, or bypass grafts;
unilateral or limited study). One
commenter believed it was unnecessary
to survey this code, but recommended
that we instead maintain the general
ultrasound room as a direct PE input
and 2013 PE RVUs.
Response: We appreciate commenters’
support for our proposal to include
G0389 on the potentially misvalued
codes list and are finalizing this
proposal. We are finalizing this code as
potentially misvalued in large part
because we are unsure of the correct
valuation. Therefore, we believe it is
most appropriate to retain the 2013
inputs until we receive new
recommendations, rather than making
another change or retaining these inputs
indefinitely as commenters suggested.
After consideration of comments
received, we are finalizing our proposal
to add G0389 to the potentially
misvalued codes list, and to maintain
the 2013 work and PE RVUs while we
complete our review of the code. The
MP RVUs will be calculated as
discussion in section II.C. of this rule.
(6) Prostate Biopsy Codes—(HCPCS
Codes G0416, G0417, G0418, and
G0419)
For CY 2014, we modified the code
descriptors of G0416 through G0419 so
that these codes could be used for any
method of prostate needle biopsy
services, rather than only for prostate
saturation biopsies. The CY 2014
descriptions are:
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
• G0416 (Surgical pathology, gross
and microscopic examination for
prostate needle biopsies, any method;
10–20 specimens).
• G0417 (Surgical pathology, gross
and microscopic examination for
prostate needle biopsies, any method;
21–40 specimens).
• G0418 (Surgical pathology, gross
and microscopic examination for
prostate needle biopsies, any method;
41–60 specimens).
• G0419 (Surgical pathology, gross
and microscopic examination for
prostate needle biopsies, any method;
greater than 60 specimens).
Subsequently, we have discussed
prostate biopsies with stakeholders, and
reviewed medical literature and
Medicare claims data in considering
how best to code and value prostate
biopsy pathology services. After
considering these discussions and
information, we believed it would be
appropriate to use only one code to
report prostate biopsy pathology
services. Therefore, we proposed to
revise the descriptor for G0416 to define
the service regardless of the number of
specimens, and to delete codes G0417,
G0418, and G0419. We believe that
using G0416 to report all prostate biopsy
pathology services, regardless of the
number of specimens, would simplify
the coding and mitigate overutilization
incentives. Given the infrequency with
which G0417, G0418, and G0419 are
used, we did not believe that this was
a significant change.
Based on our review of medical
literature and examination of Medicare
claims data, we indicated that we
believe that the typical number of
specimens evaluated for prostate
biopsies is between 10 and 12. Since
G0416 currently is used for between 10
and 12 specimens, we proposed to use
the existing values for G0416 for CY
2015, since the RVUs for this service
were established based on similar
assumptions.
In addition, we proposed G0416 as a
potentially misvalued code for CY 2015
and sought public comment on the
appropriate work RVUs, work time, and
direct PE inputs.
Comment: One commenter supported
the elimination of the G-codes as a
means of simplifying coding
requirements, but other commenters
opposed our proposal to consolidate the
coding into G0416, disagreeing that this
would help establish ‘‘straightforward
coding and maintain accurate payment’’
as suggested in the proposed rule. Some
commenters suggested that we retain the
current codes so that biopsy procedures
requiring more than 10 specimens can
be reimbursed accurately, and indicated
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
that consolidating the coding would
further confuse physicians and their
staff who have not yet adapted to the CY
2014 coding changes for these G-codes.
Other commenters asserted that these
changes threaten to undermine access to
high quality pathology services.
Commenters also stated that the
decision to furnish more extensive
pathological analysis is not at the
discretion of the pathologist, and the
pathologist should not be penalized
when he or she receives more cores to
analyze.
With respect to our proposing G0416
as potentially misvalued, commenters
stated that the recent change to these
codes has already been confusing and
suggests that there is not a clear
understanding of what these codes
represent, thus making an assessment of
their valuation difficult. Commenters
further stated that it is unreasonable to
consider this a misvalued code when
the payment is already 30 percent below
what they think it should be, and that
CMS has failed to provide justification
for why it is potentially misvalued.
The RUC and others suggested that it
would be most accurate to utilize CPT
code 88305 (Level IV—surgical
pathology, gross and microscopic
examination) for the reporting of
prostate biopsies and to allow the
reporting of multiple units. Given the
additional granularity and scrutiny
given to CPT code 88305 in the CY 2014
final rule, the commenters indicated
that they believe that the agency’s intent
to establish straightforward coding and
accurate payment for these services
would be realized with this approach.
Response: Given that the typical
analysis of prostate biopsy specimens
differs significantly from the typical
analyses reported using CPT code
88305, as regards the number of blocks
used to process the specimen and thus
the amount of work involved, we
believe that by distinguishing prostate
biopsies from other types of biopsies
results in more accurate pricing for
prostate biopsies. Since CPT code 88305
was revalued with the understanding
that prostate biopsies are billed
separately, we believe that allowing CPT
code 88305 to be reported in multiple
units for prostate biopsies would
account for significantly more resources
than is appropriate. With respect to the
concern about higher numbers of
specimens, we note that our claims data
on the G-codes shows that the vast
majority of the claims used G0416,
rather than any of the G-codes for
greater numbers of specimens.
After consideration of comments
received, we are finalizing our proposal
to include G0416 on the potentially
PO 00000
Frm 00035
Fmt 4701
Sfmt 4700
67581
misvalued codes list, to modify the
descriptor to reflect all prostate
biopsies, and to maintain the current
value until we receive and review
information and recommendations from
the RUC. We are also finalizing our
proposal to delete codes G0417, G0418,
and G0419.
(7) Obesity Behavioral Group
Counseling—GXXX2 and GXXX3
Pursuant to section 1861(ddd) of the
Act, we added coverage for a new
preventive benefit, Intensive Behavioral
Therapy for Obesity, effective November
29, 2011, and created HCPCS code
G0447 (Face-to-face behavioral
counseling for obesity, 15 minutes) for
reporting and payment of individual
behavioral counseling for obesity.
Coverage requirements specific to this
service are delineated in the Medicare
National Coverage Determinations
Manual, Pub. 100–03, Chapter 1,
Section 210, available at https://
www.cms.gov/manuals/downloads/
ncd103c1_Part4.pdf.
It was brought to our attention that
behavioral counseling for obesity is
sometimes furnished in group sessions,
and questions were raised about
whether group sessions could be billed
using HCPCS code G0447. To improve
payment accuracy, we proposed to
create two new HCPCS codes for the
reporting and payment of group
behavioral counseling for obesity.
Specifically, we proposed to create
GXXX2 (Face-to-face behavioral
counseling for obesity, group (2–4), 30
minutes) and GXXX3 (Face-to-face
behavioral counseling for obesity, group
(5–10), 30 minutes). We indicated that
the coverage requirements for these
services would remain in place, as
described in the National Coverage
Determination for Intensive Behavioral
Therapy for Obesity cited above. The
practitioner furnishing these services
would report the relevant group code for
each beneficiary participating in a group
therapy session.
Since we believed that the face-to-face
behavioral counseling for obesity
services described by GXXX2 and
GXXX3 would require similar per
minute work and intensity as HCPCS
code G0447, we proposed work RVUs of
0.23 and 0.10 for HCPCS codes GXXX2
and GXXX3, with work times of 8
minutes and 3 minutes respectively.
Since the services described by GXXX2
and GXXX3 would be billed per
beneficiary receiving the service, the
work RVUs and work time that we
proposed for these codes were based
upon the assumed typical number of
beneficiaries per session, 4 and 9,
respectively. Accordingly, we proposed
E:\FR\FM\13NOR2.SGM
13NOR2
67582
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
a work RVU of 0.23 with a work time
of 8 minutes for GXXX2 and a work
RVU of 0.10 with a work time of 3
minutes for GXXX3. We proposed to use
the direct PE inputs for GXXX2 and
GXXX3 currently included for G0447
prorated to account for the differences
in time and number of beneficiaries, and
to crosswalk the malpractice risk factor
from HCPCS code G0447 to both HCPCS
codes GXXX2 and GXXX3, as we
believe the same specialty mix will
furnish these services. We requested
public comment on the proposed values
for HCPCS codes GXXX2 and GXXX3.
Comment: Commenters generally
supported our proposal to establish a
separate payment mechanism for
obesity behavioral group counseling
services, but raised several concerns
regarding the coding structure and
valuation of these services. Commenters
stated that the work times were
inaccurate, requested that the service be
valued based on a smaller number of
typical group participants, and
questioned the need for two G-codes
when group counseling services under
the PFS are generally billed with a
single G-code. A commenter also stated
that the lower payment for larger groups
will create disincentives for furnishing
this service except when there is a full
10-person group, which could limit
access. Commenters suggested that CMS
only finalize a single G-code for group
counseling for intensive behavioral
therapy for obesity, and crosswalk the
work RVU and work time for this
service from the Medical Nutrition
Therapy (MNT) group code.
Response: We appreciate commenters’
support for our proposal to provide new
codes for group obesity counseling
services. After reviewing the comments,
we agree that it is reasonable to create
a single code for group obesity
counseling and crosswalk the work RVU
and work time from the MNT group
code. The individual code for intensive
obesity behavioral therapy and the
individual MNT code are valued the
same, so in the absence of evidence that
group composition is different, we
believe it makes sense to use the same
values. Therefore, we will crosswalk the
work RVU of 0.25 and the work time of
10 minutes to a single new G-code for
group obesity counseling, G0473 (Faceto-face behavioral counseling for
obesity, group (2–10), 30 minutes).
4. Improving the Valuation and Coding
of the Global Package
a. Overview
Since the inception of the PFS, we
have valued and paid for certain
services, such as surgery, as part of
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
global packages that include the
procedure and the services typically
furnished in the periods immediately
before and after the procedure (56 FR
59502). For each of these codes (usually
referred to as global surgery codes), we
establish a single PFS payment that
includes payment for particular services
that we assume to be typically furnished
during the established global period.
There are three primary categories of
global packages that are labeled based
on the number of post-operative days
included in the global period: 0-day; 10day; and 90-day. The 0-day global codes
include the surgical procedure and the
pre-operative and post-operative
physicians’ services on the day of the
procedure, including visits related to
the service. The 10-day global codes
include these services and, in addition,
visits related to the procedure during
the 10 days following the procedure.
The 90-day global codes include the
same services as the 0-day global codes
plus the pre-operative services
furnished one day prior to the
procedure and post-operative services
during the 90 days immediately
following the day of the procedure.
Section 40.1 of the Claims Processing
Manual (Pub. 100–04, Chapter 12
Physician/Nonphysician Practitioners)
defines the global surgical package to
include the following services when
furnished during the global period:
• Preoperative Visits—Preoperative
visits after the decision is made to
operate beginning with the day before
the day of surgery for major procedures
and the day of surgery for minor
procedures;
• Intra-operative Services—Intraoperative services that are normally a
usual and necessary part of a surgical
procedure;
• Complications Following Surgery—
All additional medical or surgical
services required of the surgeon during
the postoperative period of the surgery
because of complications that do not
require additional trips to the operating
room;
• Postoperative Visits—Follow-up
visits during the postoperative period of
the surgery that are related to recovery
from the surgery;
• Postsurgical Pain Management—By
the surgeon;
• Supplies—Except for those
identified as exclusions; and
• Miscellaneous Services—Items such
as dressing changes; local incisional
care; removal of operative pack; removal
of cutaneous sutures and staples, lines,
wires, tubes, drains, casts, and splints;
insertion, irrigation and removal of
urinary catheters, routine peripheral
intravenous lines, nasogastric and rectal
PO 00000
Frm 00036
Fmt 4701
Sfmt 4700
tubes; and changes and removal of
tracheostomy tubes.
b. Concerns With the 10- and 90-Day
Global Packages
CMS supports bundled payments as a
mechanism to incentivize high-quality,
efficient care. Although on the surface,
the PFS global codes appear to function
as bundled payments similar to those
Medicare uses to make single payments
for multiple services to hospitals under
the inpatient and outpatient prospective
payment systems, the practical reality is
that these global codes function
significantly differently than other
bundled payments. First, the global
surgical codes were established several
decades ago when surgical follow-up
care was far more homogenous than
today. Today, there is more diversity in
the kind of procedures covered by
global periods, the settings in which the
procedures and the follow-up care are
furnished, the health care delivery
system and business arrangements used
by Medicare practitioners, and the care
needs of Medicare beneficiaries. Despite
these changes, the basic structures of the
global surgery packages are the same as
the packages that existed prior to the
creation of the resource-based relative
value system in 1992. Another
significant difference between this and
other typical models of bundled
payments is that the payment rates for
the global surgery packages are not
updated regularly based on any
reporting of the actual costs of patient
care. For example, the hospital inpatient
and outpatient prospective payment
systems (the IPPS and OPPS,
respectively) derive payment rates from
hospital cost and charge data reported
through annual Medicare hospital cost
reports and the most recent year of
claims data available for an inpatient
stay or primary outpatient service.
Because payment rates are based on
consistently updated data, over time,
payment rates adjust to reflect the
average resource costs of current
practice. Similarly, many of the new
demonstration and innovation models
track costs and make adjustments to
payments. Another significant
difference is that payment for the PFS
global packages relies on valuing the
combined services together. This means
that there are no separate PFS values
established for the procedures or the
follow-up care, making it difficult to
estimate the costs of the individual
global code component services.
In the following paragraphs, we
address a series of concerns regarding
the accuracy of payment for 10- and 90day global codes, including: The
fundamental difficulties in establishing
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
appropriate relative values for these
packages, the potential inaccuracies in
the current information used to price
global codes, the limitations on
appropriate pricing in the future, the
potential for global packages to create
unwarranted payment differentials
among specialties, the possibility that
the current codes are incompatible with
current medical practice, and the
potential for these codes to present
obstacles to the adoption of new
payment models.
Concerns such as these commonly
arise when developing payment
mechanisms, for example fee-for-service
payment rates, single payments for
multiple services, or payment for
episodes of care over a period of time.
However, in the case of the postoperative portion of the 10- and 90-day
global codes, we believe that together
with certain unique aspects of PFS rate
setting methodology, these concerns
create substantial barriers to accurate
valuation of these services relative to
other PFS services.
(1) Fundamental Limitations in the
Appropriate Valuation of the Global
Packages With Post-Operative Days
In general, we face many challenges
in valuing PFS services as accurately as
possible. However, the unique nature of
global surgery packages with 10- and 90day post-operative periods presents
additional challenges distinct from
those presented in valuing other PFS
services. Our valuation methodology for
PFS services generally relies on
assumptions regarding the resources
involved in furnishing the ‘‘typical
case’’ for each individual service unlike
other payment systems that rely on
actual data on the costs of furnishing
services. Consistent with this valuation
methodology, the RVUs for a global
code should reflect the typical number
and level of E/M services furnished in
connection with the procedure.
However, it is much easier to maintain
relativity among services that are valued
on this basis when each of the services
is described by codes of similar unit
sizes. In other words, because codes
with long post-operative periods
include such a large number of services,
any variations between the ‘‘typical’’
resource costs used to value the service
and the actual resource costs associated
with particular services are multiplied.
The effects of this problem can be twofold, skewing the accuracy of both the
RVUs for individual global codes and
the Medicare payment made to
individual practitioners. The RVUs of
the individual global service codes are
skewed whenever there is any
inaccuracy in the assumption of the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
typical number or kind of services in the
post-operative periods. This inaccuracy
has a greater impact than inaccuracies
in assumptions for non-global codes
because it affects a greater number of
service units over a period of time than
for individually priced services.
Furthermore, in contrast to prospective
payment systems, such inaccuracies
under the PFS are not corrected over
time through a ratesetting process that
makes year-to-year adjustments based
on data on actual costs. For example, if
a 90-day global code is valued based on
an assumption or survey response that
ten post-operative visits is typical, but
practitioners reporting the code in fact
typically only furnish six visits, then the
resource assumptions are overestimated
by the value of the four visits multiplied
by the number of the times the
procedure code is reported. In contrast,
when our assumptions are incorrect
about the typical resources involved in
furnishing a PFS code that describes a
single service, any inaccuracy in the
RVUs is limited to the difference
between the resource costs assumed for
the typical service and the actual
resource costs in furnishing one
individual service. Such a variation
between the assumptions used in
calculating payment rates and the actual
resource costs could be corrected if the
payments for packaged services were
updated regularly using data on actual
services furnished. Medicare’s
prospective payment systems have more
mechanisms in place than the PFS does
to adjust over time for such variation To
make adjustments to the RVUs to
account for inaccurate assumptions
under the current PFS methodology, the
global surgery code would need to be
identified as potentially misvalued,
survey data would have to reflect an
accurate account of the number and
level of typical post-operative visits, and
we (with or without a corresponding
recommendation from the RUC or
others) would have to implement a
change in RVUs based on the change in
the number and level of visits to reflect
the typical service.
These amplified inaccuracies may
also occur whenever Medicare pays an
individual practitioner reporting a 10or 90-day global code. Practitioners may
furnish a wide range of post-operative
services to individual Medicare
beneficiaries, depending on individual
patient needs, changes in medical
practice, and dynamic business models.
Due to the way the 10- and 90-day
global codes are constructed, the
number and level of services included
for purposes of calculating the payment
for these services may vary greatly from
PO 00000
Frm 00037
Fmt 4701
Sfmt 4700
67583
the number and level of services that are
actually furnished in any particular
case. In contrast, the variation between
the ‘‘typical’’ and the actual resource
cost for the practitioner reporting an
individually valued PFS service is
constrained because the practitioner is
only reporting and being paid for a
specific service furnished on a
particular date.
For most PFS services, any difference
between the ‘‘typical’’ case on which
RVUs are based and the actual case for
a particular service is limited to the
variation between the resources
assumed to be involved in furnishing
the typical case and the actual resources
involved in furnishing the single
specific service. When the global
surgical package includes more or a
higher level of E/M services than are
actually furnished in the typical postoperative period, the Medicare payment
is based on an overestimate of the
quantity or kind of services furnished,
not merely an overestimation of the
resources involved in furnishing an
individual service. The converse is true
if the RVUs for the global surgical
package are based on fewer or a lower
level of services than are typically
furnished for a particular code.
(2) Questions Regarding Accuracy of
Current Assumptions
In previous rulemaking (77 FR 68911
through 68913), we acknowledged
evidence suggesting that the values
included in the post-operative period
for global codes may not reflect the
typical number and level of postoperative E/M visits actually furnished.
In 2005, the OIG examined whether
global surgical packages are
appropriately valued. In its report on
eye and ocular surgeries, ‘‘National
Review of Evaluation and Management
Services Included in Eye and Ocular
Adnexa Global Surgery Fees for
Calendar Year 2005’’ (A–05–07–00077),
the OIG reviewed a sample of 300 eye
and ocular surgeries, and counted the
actual number of face-to-face services
recorded in the patients’ medical
records to establish whether and, if so,
how many post-operative E/M services
were furnished by the surgeons. For
about two-thirds of the claims sampled
by the OIG, surgeons furnished fewer E/
M services in the post-operative period
than were included in the global
surgical package payment for each
procedure. A small percentage of the
surgeons furnished more E/M services
than were included in the global
surgical package payment. The OIG
identified the number of face-to-face
services recorded in the medical record,
but did not review the medical necessity
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67584
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
of the surgeries or the related E/M
services. The OIG concluded that the
RVUs for these global surgical packages
are too high because they include a
higher number of E/M services than
typically are furnished within the global
period for the reviewed procedures.
Following that report, the OIG
continued to investigate E/M services
furnished during global surgical
periods. In May 2012, the OIG
published a report entitled
‘‘Musculoskeletal Global Surgery Fees
Often Did Not Reflect the Number of
Evaluation and Management Services
Provided’’ (A–05–09–00053). For this
investigation, the OIG sampled 300
musculoskeletal global surgeries and
again found that, for the majority of
sampled surgeries, physicians furnished
fewer E/M services than were included
as part of the global period payment for
that service. Once again, a small
percentage of surgeons furnished more
E/M services than were included in the
global surgical package payment. The
OIG concluded that the RVUs for these
global surgical packages are too high
because they include a higher number of
E/M services than typically are
furnished within the global period for
the reviewed procedures.
In both reports, the OIG
recommended that we adjust the
number of E/M services identified with
the studied global surgical payments to
reflect the number of E/M services that
are actually being furnished. However,
since it is not necessary under our
current global surgery payment policy
for a surgeon to report the individual E/
M services actually furnished during the
global surgical period, we do not have
objective data upon which to assess
whether the RVUs for global period
surgical services reflect the typical
number or level of E/M services that are
furnished. In the CY 2013 PFS proposed
rule (77 FR 44738), we previously
sought public comments on collecting
these data. As summarized in the CY
2013 PFS final rule (77 FR 68913) we
did not discover a consensus among
stakeholders regarding either the most
appropriate means to gather the data, or
the need for, or the appropriateness of
using such data in valuing these
services. In response to our comment
solicitation, some commenters urged us
to accept the RUC survey data as
accurate in spite of the OIG reports and
other concerns that have been expressed
regarding whether the visits included in
the global periods reflected the typical
case. Others suggested that we should
conduct new surveys using the RUC
approach or that we should mine
hospital data to identify the typical
number of visits furnished. Some
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
comments suggested eliminating the 10and 90-day global codes.
(3) Limitations on Appropriate Future
Valuations of 10- and 90-Day Global
Codes
Historically, our attempts to adjust
RVUs for global services based on
changes in the typical resource costs
(especially with regard to site of service
assumptions or changes to the number
of post-surgery visits) have been
difficult and controversial. At least in
part, this is because the relationship
between the work RVUs for the 10- and
90-day global codes (which includes the
work RVU associated with the
procedure itself) and the number of
included post-operative visits in the
existing values is not always clear.
Some services with global periods have
been valued by adding the work RVU of
the surgical procedure and all pre- and
post-operative E/M services included in
the global period. However, in other
cases, as many stakeholders have noted,
the total work RVUs for surgical
procedures and post-operative visits in
global periods are estimated as a single
value without any explicit correlation to
the time and intensity values for the
individual service components.
Although we would welcome more
objective information to improve our
determination of the ‘‘typical’’ case, we
believe that even if we engaged in the
collection of better data on the number
and level of E/M services typically
furnished during the global periods for
global surgery services, the valuation of
individual codes with post-operative
periods would not be straightforward.
Furthermore, we believe it would be
important to frequently update the data
on the number and level of visits
furnished during the post-operative
periods in order to account for any
changes in the patient population,
medical practice, or business
arrangements. Practitioners paid
through the PFS do not report such data.
(4) Unwarranted Payment Disparities
Subsequent to our last comment
solicitation regarding the valuation of
the post-operative periods (77 FR 68911
through 68913), some stakeholders have
raised concerns that global surgery
packages contribute to unwarranted
payment disparities between
practitioners who do and do not furnish
these services. These stakeholders have
addressed several ways the 10- and 90day global packages may contribute to
unwarranted payment disparities.
The stakeholders noted that, through
the global surgery packages, Medicare
pays practitioners who furnish E/M
services during post-surgery periods
PO 00000
Frm 00038
Fmt 4701
Sfmt 4700
regardless of whether the services are
actually furnished, while practitioners
who do not furnish global procedures
with post-operative visits are only paid
for E/M services that are actually
furnished. In some cases, it is possible
that the practitioner furnishing the
global surgery procedure may not
furnish any post-operative visits.
Although we have policies to address
the situation when post-operative care is
transferred from one practitioner to
another, the beneficiary might simply
choose to seek care from another
practitioner without a formal transfer of
care. The other practitioner would then
bill Medicare separately for E/M
services for which payment was
included in the global payment to the
original practitioner. Those services
would not have been separately billable
if furnished by the original practitioner.
These circumstances can lead to
unwarranted payment differences,
allowing some practitioners to receive
payment for fewer services than
reflected in the Medicare payment.
Practitioners who do not furnish global
surgery services bill and are paid only
for each individual service furnished.
When global surgery values are based on
inaccurate assumptions about the
typical services furnished in the postoperative periods, these payment
disparities can contribute to differences
in aggregate RVUs across specialties.
Since the RVUs are intended to reflect
differences in the relative resource costs
involved in furnishing a service, any
disparity between assumed and actual
costs results not only in paying some
practitioners for some services that are
not furnished, it also skews relativity
between specialties.
Stakeholders have also pointed out
that payment disparities can arise
because E/M services reflected in global
periods generally include higher PE
values than the same services when
billed separately. The difference in PE
values between separately billed visits
and those included in global packages
result primarily from two factors that
are both inherent in the PFS pricing
methodology.
First, there is a different mix of PE
inputs (clinical labor/supplies/
equipment) included in the direct PE
inputs for a global period E/M service
and a separately billed E/M service. For
example, the clinical labor inputs for
separately reportable E/M codes
includes a staff blend listed as ‘‘RN/
LPN/MTA’’ (L037D) and priced at $0.37
per minute. Instead of this input, some
codes with post-operative visits include
the staff type ‘‘RN’’ (L051A) priced at a
higher rate of $0.51 per minute. For
these codes, the higher resource cost
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
may accurately reflect the typical
resource costs associated with those
particular visits. However, the different
direct PE inputs may drive unwarranted
payment disparities among specialties
who report global surgery codes with
post-operative periods and those that do
not. The only way to correct these
potential discrepancies under the
current system, which result from the
specialty-based differences in resource
costs, would be to include standard
direct PE inputs for these services
regardless of whether or not the
standard inputs are typical for the
specialties furnishing the services.
Second, the indirect PE allocated to
the E/M visits included in global
surgery codes is higher than that
allocated to separately furnished E/M
visits. This occurs because the range of
specialties furnishing a particular global
service is generally not as broad as the
range of specialties that report separate
individual E/M services. Since the
specialty mix for a service is a key factor
in determining the allocation of indirect
PE to each code, a higher amount of
indirect PE can be allocated to the E/M
services that are valued as part of the
global surgery codes than to the
individual E/M codes. Practitioners who
use E/M codes to report visits separately
are paid based on PE RVUs that reflect
the amount of indirect PE allocated
across a wide range of specialties, which
has the tendency to lower the amount of
indirect PE. For practitioners who are
paid for visits primarily through postoperative periods, indirect PE is
generally allocated with greater
specificity. Two significant steps would
be required to alleviate the impact of
this disparity. First, we would have to
identify the exact mathematical
relationship between the work RVU and
the number and level of post-operative
visits for each global code; and second,
we would have to propose a significant
alteration of the PE methodology in
order to allocate indirect PE that does
not correlate to the specialties reporting
the code in the Medicare claims data.
Furthermore, stakeholders have
pointed out that the PE RVUs for codes
with 10- or 90-day post-operative
periods reflect the assumption that all
outpatient visits occur in the higherpaid non-facility office setting, when
many of these visits are likely to be
furnished in provider-based
departments, which would be paid at
the lower, PFS facility rate if they were
billable separately. As we note
elsewhere in this final rule with
comment period, we do not have data
on the volume of physicians’ services
furnished in provider-based
departments, but public information
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
suggests that it is not insignificant and
that it is growing. When these services
are paid as part of a global package,
there is no adjustment made based on
the site of service. Therefore, even
though the PFS payment for services
furnished in post-operative global
periods might include clinical labor,
disposable supply, and medical
equipment costs (and additional
indirect PE allocation) that are incurred
by the facility and not the practitioner
reporting the service, the RVUs for
global codes reflect all of these costs
associated with the visits.
(5) Incompatibility of Current Packages
With Current Practice and Unreliability
of RVUs for Use in New Payment
Models
In addition to these issues, the 10and 90-day global periods reflect a longestablished but no longer exclusive
model of post-operative care that
assumes the same practitioner who
furnishes the procedure typically
furnishes the follow-up visits related to
that procedure. In many cases, we
believe that models of post-operative
care are increasingly heterogeneous,
particularly given the overall shift of
patient care to larger practices or teambased environments.
We believe that RVUs used to
establish PFS payments are likely to
serve as critical building blocks to
developing, testing, and implementing a
number of new payment models,
including those that focus on bundled
payments to practitioners or payments
for episodes of care. Therefore, we
believe it is critical for us to ensure that
the PFS RVUs accurately reflect the
resource costs for individual PFS
services instead of reflecting potentially
skewed assumptions regarding the
number of services furnished over a
long period of time in the ‘‘typical’’
case. To the extent that the 10- and 90day global periods reflect inaccurate
assumptions regarding resource costs
associated with individual PFS services,
we believe they are likely to be obstacles
to a wide range of potential
improvements to PFS payments,
including the potential incorporation of
payment bundling designed to foster
efficiency and quality care for Medicare
beneficiaries.
c. Proposed Transformation of 10- and
90-Day Global Packages Into 0-Day
Global Packages
Although we have marginally
addressed some of the concerns noted
above with global packages in previous
rulemaking, we do not believe that we
have made significant progress in
addressing the fundamental issues with
PO 00000
Frm 00039
Fmt 4701
Sfmt 4700
67585
the 10- and 90-day post-operative global
packages. In the context of the
misvalued code initiative, we believe it
is critical for the RVUs used to develop
PFS payment rates reflect the most
accurate resource costs associated with
PFS services. Based on the issues
discussed above, we do not believe we
can effectively address the issues
inherent in establishing values for the
10- and 90-day global packages under
our existing methodologies and with
available data. As such, we do not
believe that maintaining the postoperative 10-and 90-day global periods
is compatible with our continued
interest in using more objective data in
the valuation of PFS services and
accurately valuing services relative to
each other. Because the typical number
and level of post-operative visits during
global periods may vary greatly across
Medicare practitioners and
beneficiaries, we believe that continued
valuation and payment of these face-toface services as a multi-day package
may skew relativity and create
unwarranted payment disparities within
PFS fee-for-service payment. We also
believe that the resource based
valuation of individual physicians’
services will continue to serve as a
critical foundation for Medicare
payment to physicians, whether through
the current PFS or in any number of
new payment models. Therefore, we
believe it is critical that the RVUs under
the PFS be based as closely and
accurately as possible on the actual
resources involved in furnishing the
typical occurrence of specific services.
To address the issues discussed
above, we proposed to retain global
bundles for surgical services, but to
refine bundles by transforming over
several years all 10- and 90-day global
codes to 0-day global codes. Medically
reasonable and necessary visits would
be billed separately during the pre- and
post-operative periods outside of the
day of the surgical procedure. We
propose to make this transition for
current 10-day global codes in CY 2017
and for the current 90-day global codes
in CY 2018, pending the availability of
data on which to base updated values
for the global codes.
We believe that transforming all 10and 90-day global codes to 0-day global
codes would:
• Increase the accuracy of PFS
payment by setting payment rates for
individual services based more closely
upon the typical resources used in
furnishing the procedures;
• Avoid potentially duplicative or
unwarranted payments when a
beneficiary receives post-operative care
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67586
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
from a different practitioner during the
global period;
• Eliminate disparities between the
payment for E/M services in global
periods and those furnished
individually;
• Maintain the same-day packaging of
pre- and post-operative physicians’
services in the 0-day global; and
• Facilitate availability of more
accurate data for new payment models
and quality research.
As we transition these codes, we
would need to establish RVUs that
reflect the change in the global period
for all the codes currently valued as 10and 90-day global surgery services. We
sought assistance from stakeholders on
various aspects of this task. Prior to
implementing these changes, we intend
to gather objective data on the number
of E/M and other services furnished
during the current post-operative
periods and use those data to inform
both the valuation of particular services
and the overall budget neutrality
adjustments required to implement this
proposal. We sought comment on the
most efficient means of acquiring
accurate data regarding the number of
visits and other services actually being
furnished by the practitioner during the
current post-operative periods. For all
the reasons stated above, we do not
believe that survey data reflecting
assumptions of the ‘‘typical case’’ meets
the standards required to measure the
resource costs of the wide range of
services furnished during the postoperative periods. We acknowledge that
collecting information on these services
through claims submission may be the
best approach, and we would propose
such a collection through future
rulemaking. However, we are also
interested in alternatives. For example,
we sought information on the extent to
which individual practitioners or
practices may currently maintain their
own data on services furnished during
the post-operative period, and how we
might collect and objectively evaluate
that data.
We also sought comment on the best
means to ensure that allowing separate
payment of E/M visits during postoperative periods does not incentivize
otherwise unnecessary office visits
during post-operative periods. If we
adopt this proposal, we intend to
monitor any changes in the utilization
of E/M visits following its
implementation but we also solicited
comment on potential payment policies
that will mitigate such a change in
behavior.
In developing this proposal, we
considered several alternatives to the
transformation of all global codes to 0-
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
day global codes. First, we again
considered the possibility of gathering
data and using the data to revalue the
10- and 90-day global codes. While this
option would have maintained the
status quo in terms of reporting services,
it would have required much of the
same effort as this proposal without
alleviating many of the problems
associated with the 10- and 90-day
global periods. For example, collecting
accurate data would allow for more
accurate estimates of the number and
kind of visits included in the postoperative periods at the time of the
survey. However, this alternative
approach would only mitigate part of
the potential for unwarranted payment
disparities. For example, the values for
the visits in the global codes would
continue to include different amounts of
PE RVUs than separately reportable
visits and would continue to provide
incentives to some practitioners to
minimize patient visits. Additionally, it
would not address the changes in
practice patterns that we believe have
been occurring whereby the physician
furnishing the procedure is not
necessarily the same physician
providing the post-procedure follow up.
This alternative option would also
rest extensively on the effectiveness of
using the new data to revalue the codes
accurately. Given the unclear
relationship between the assigned work
RVUs and the post-operative visits
across all of these services,
incorporating objective data on the
number of visits to adjust work RVUs
would still necessitate extensive review
of individual codes or families of codes
by CMS and stakeholders, including the
RUC. We believe the investment of
resources for such an effort would be
better made to solve a broader range of
problems.
We also considered other
possibilities, such as altering our PE
methodology to ensure that the PE
inputs and indirect PE for visits in the
global period were valued the same as
separately reportable E/M codes or
requiring reporting of the visits for all
10- and 90-day global services while
maintaining the 10- and 90-day global
period payment rates. However, we
believe this option would require all of
the same effort by practitioners, CMS,
and other stakeholders without
alleviating most of the problems
addressed in the preceding paragraphs.
We also considered maintaining the
status quo and identifying each of the
10- and 90-day global codes as
potentially misvalued through our
potentially misvalued code process for
review as 10- and 90-day globals.
Inappropriate valuations of these
PO 00000
Frm 00040
Fmt 4701
Sfmt 4700
services has a major effect on the fee
schedule due to the percentage of PFS
dollars paid through 10- and 90-day
global codes (3 percent and 11 percent,
respectively), and thus, valuing them
appropriately is critical to appropriate
valuation and relativity throughout the
PFS. Through the individual review
approach, we could review the
appropriateness of the global period and
the accurate number of visits for each
service. Yet revaluing all 3,000 global
surgery codes through the potentially
misvalued codes approach would not
address many of the problems identified
above. Unless such an effort was
combined with changes in the PE
methodology, it would only partially
address the valuation and accuracy
issues and would leave all the other
issues unresolved. Moreover, the
valuation and accuracy issues that could
be addressed through this approach
would rapidly be out of date as medical
practice continues to change. Therefore,
such an approach would be only
partially effective and would impede
our ability to address other potentially
misvalued codes.
We sought stakeholder input on an
accurate and efficient means to revalue
or adjust the work RVUs for the current
10- and 90-day global codes to reflect
the typical resources involved in
furnishing the services including both
the pre- and post-operative care on the
day of the procedure. We believe that
collecting data on the number and level
of post-operative visits furnished by the
practitioner reporting current 10- and
90-day global codes will be important to
ensuring work RVU relativity across
these services. We also believe that
these data will be important to
determine the relationship between
current work RVUs and current number
of post-operative visits, within
categories of codes and code families.
However, we believe that once we
collect those data, there is a wide range
of possible approaches to the
revaluation of the large number of
individual global services, some of
which may deviate from current
processes like those undertaken by the
RUC. To date, the potentially misvalued
code initiative has focused on several
hundred, generally high-volume codes
per year. This proposal requires
revaluing a larger number of codes over
a shorter period of time and includes
many services with relatively low
volume in the Medicare population.
Given these circumstances, it does not
seem practical to survey time and
intensity information on each of these
procedures. Absent any new survey data
regarding the procedures themselves,
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
we believe that data regarding the
number and level of post-service office
visits can be used in conjunction with
other methods of valuation, such as:
• Using the current potentially
misvalued code process to identify and
value the relatively small number of
codes that represent the majority of the
volume of services that are currently
reported with codes with post-operative
periods, and then adjusting the
aggregate RVUs to account for the
number of visits and using magnitude
estimation to value the remaining
services in the family.
• Valuing one code within a family
through the current valuation process
and then using magnitude estimation to
value the remaining services in the
family.
• Surveying a sample of codes across
all procedures to create an index that
could be used to value the remaining
codes.
Although we believe these are
plausible options for the revaluation of
these services, we believed there may be
others. Therefore, we sought input on
the best approach to achieve this
proposed transition from 10- and 90day, to 0-day global periods, including
the timing of the changes, the means for
revaluation, and the most effective and
least burdensome means to collect
objective, representative data regarding
the actual number of visits currently
furnished in the post-operative global
periods. We also solicited comment on
whether the effective date for the
transition to 0-day global periods should
be staggered across families of codes or
other categories. For example, while we
proposed to transition 10-day global
periods in 2017 and 90-day global
periods in 2018, we solicited comment
on whether we should consider
implementing the transition more or
less quickly and over one or several
years. We also solicited comment
regarding the appropriate valuation of
new, revised, or potentially misvalued
10- or 90-day global codes before
implementation of this proposal.
We received many comments
regarding the proposed transition to 0day global packages. Many commenters
expressed support or opposition to the
proposal. Some commenters offered
direct responses to the topics for which
we specifically sought comment, while
others raised questions regarding how
the transition would be implemented. In
the following paragraphs, we summarize
and respond to these comments.
Comment: Several commenters
supported the proposal, including
commenters representing several
medical specialty societies and several
health systems. Many of these
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
commenters agreed with the reasons
presented in the proposal. These
commenters agreed that the current
structure of the global surgery codes
prevents CMS from accurately valuing
and paying for these services, even if
CMS had necessary visit data available.
Many commenters agreed that the
current arrangement may lead to
unwarranted payment disparities and
that the current packages have not
evolved with changes in practice and
because of this, likely provide
unreliable building blocks for new
payment methodologies.
In agreeing with the proposal,
MedPAC stated that it ‘‘is essential that
the individual services that make up a
bundle have accurate values and that
there is a mechanism to ensure that the
services that are part of the bundle are
not paid separately (unbundling).
Otherwise, the payment rate for the
entire bundle will be inaccurate.’’
MedPAC urged CMS to finalize this
proposal and plan to use the more
accurate valuations to create more
accurate bundles in the future.
Response: We appreciate the
commenters’ support for the proposal,
and agree that there are many reasons
why the current construction of the
global surgery packages is difficult to
reconcile with accurate valuation of
individual services within the current
payment construct of the PFS. We agree
that achieving the agency’s goal of
greater bundling requires accurate
valuation of component services in a
surgical procedure.
Comment: Some commenters,
including several of those representing
specialty societies, urged CMS to
postpone finalization of the proposal
pending the report of stakeholder efforts
to conduct a comprehensive analysis of
the effect it would have on the provision
of surgical care, surgical patients, and
the surgeons who care for them.
Response: We share stakeholders’
concerns regarding the potential impact
of the change on Medicare beneficiaries
and practitioners. However, based upon
our analysis and the information that
stakeholders have provided, we believe
delaying the proposal to further study
the problems is not warranted given the
significant concerns that have been
raised with the current construction of
the global surgery packages. Instead, as
we articulated in making the proposal,
we anticipate that further analysis by
stakeholders will contribute to
implementing the transition in a manner
that accurately values and pays for PFS
services. We believe that accurate
valuation of services furnished to
Medicare beneficiaries is
overwhelmingly in the best interest of
PO 00000
Frm 00041
Fmt 4701
Sfmt 4700
67587
both beneficiaries and those who care
for them.
Comment: We received several
comments from commenters who
opposed our proposal, and in general
these commenters shared the concerns
of those who urged a delay in finalizing
or implementing the proposal. In
addition, some commenters who
opposed the proposal disputed our
contention that the global periods
contribute to unwarranted payment
disparities, saying that the increased
direct and indirect PE and MP RVUs for
E/M services furnished in the global
surgical post-operative periods
accurately account for the increased PE
and MP costs of practitioners who
furnish these services relative to
practitioners who typically furnish
separately reportable E/M services.
Response: Just as we do not agree that
we should delay addressing significant
problems with valuations while we
further study the issues, we do not
believe these same issues raised by
commenters opposing the proposal are
impediments to implementation. The
issues relating to valuation of global
period E/M services using our PE
methodology are just one of several
important considerations that led us to
propose transforming 10- and 90-day
global services to 0-day global packages.
We continue to believe the proposed
transformation to 0-day global packages
is a simple and immediate step to
improve the valuation of the various
services included in surgical care.
However, Medicare remains committed
to bundled payment as a mechanism for
delivery system reform and we will
continue to explore the best way to
bundle surgical services, including
alternatives to the 0-day global surgical
bundle.
Comment: Many commenters who
opposed the proposal addressed
valuation problems that would exist if
the proposal were implemented. Some
stated that, were CMS to finalize the
proposal to pay for post-surgical E/Ms
using the same codes, the PE and MP
RVUs for the services would be
artificially reduced because the data
from other specialties would be
incorporated. These commenters
suggested CMS should consider how to
maintain the current differences in
payment for these services even if the
proposal were finalized. Some
commenters suggested that CMS would
need to account for the additional
practice expense and malpractice costs
for post-operative surgical visits.
Response: We develop and establish
work, PE, and MP RVUs for specific
services to reflect the relative resource
costs involved in furnishing the typical
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67588
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
PFS service. In developing the proposal,
we noted that by including a significant
number of E/Ms in the global periods for
surgical services, the PFS ratesetting
methodology distinguishes these
services from other E/Ms for purposes of
developing PE and MP RVUs,
potentially to the advantage of
particular specialties with higher PE
and MP RVUs. In contrast, the work
RVUs for individual, separately billed
E/M services furnished, for example, by
primary care practitioners are valued
more generally as individual services,
and values are not maintained
separately from the work RVUs for E/Ms
furnished by other practitioners.
Therefore, we do not agree with
commenters that Medicare should
establish higher PE and MP values for
E/M services furnished in the postsurgical period than for other E/M
services.
Comment: Several commenters
suggested that CMS should not use the
OIG reports to generalize its concerns
about the provision of surgical care,
because the OIG reports represent only
a small sample of observations of
specific procedures and specialties.
Other commenters suggested that the
OIG methodology might be flawed
because, since CMS does not require
documentation of post-operative visits,
many practitioners may not document
such visits in the medical record.
Response: We do not have any reason
to believe that the OIG findings on the
global surgical service packages
furnished by particular specialties that
the OIG reviewed are not generalizable
to other global surgery services. Nor did
the commenters provide any evidence
that the OIG conclusions are likely to be
less accurate than the survey estimates
that CMS uses to value the services.
Finally, having an incorrect number of
postoperative visits is only one of the
many valuation problems that have been
identified for global surgical packages.
Additionally, we find the suggestion
that physicians do not document
medical visits that are occurring in the
post-surgical period to be concerning.
As a general matter, Medicare does not
require documentation to support a
billed service beyond information that
the physician would normally maintain
in the patient’s medical record. Even in
the absence of billing Medicare or
another insurer, we believe that
physicians and other practitioners
following standard medical practice
would document what occurred during
a patient encounter in order to ensure
the patient’s medical history is accurate
and up-to-date, and to facilitate
continuity in the patient’s medical care.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Comment: One commenter asserted
that the 90-day global period was
created to prevent two behaviors
referred to as ‘‘fee-splitting’’ and
‘‘itinerant surgery.’’ According to the
commenter, these terms refer to the
practice where a surgeon would provide
only the surgery and leave postoperative
care to other practitioners. The
commenter believes these practices are
inconsistent with professional
standards, and that it is medically
necessary and expected by patients that
surgeons will evaluate their patients on
a daily basis in the hospital and as
needed on an outpatient basis during
the recovery period.
Response: We do not believe that the
global surgical package was designed to
ensure or allocate appropriate postoperative care among practitioners.
Under Medicare’s current global surgery
policy, practitioners can agree on the
transfer of care during the global period
and, in such cases, modifiers are used
in order to split the payment between
the procedure and the post-operative
care. We do not agree that global
surgical packages obligate the surgeon to
furnish some or all of the post-operative
care. Global surgical packages are
valued based on the typical service, and
we would not expect every surgery to
require the same number of follow-up
visits. However, we would expect that
over a large number of services, the
central tendency would reflect the
number of visits we included as typical
for purposes of valuing the global
package; and as discussed above, we
have not found that this is necessarily
the case. Even if Medicare maintains the
10- and 90-day global surgery packages,
there would be no assurance that the
surgeon, and not another practitioner,
would furnish all or a certain amount of
post-operative care (whether by the
patient’s choice of practitioner or
otherwise). The global payment
includes payment for post-operative
care with the payment for the surgery,
which makes it difficult to know
whether or by whom the post-operative
care was actually furnished unless there
is an official transfer of care. We are
confident that the surgical community
will continue to furnish appropriate
care for Medicare beneficiaries
irrespective of changes in the structure
of payment for surgical services.
Comment: Several commenters stated
that if Medicare adopts a policy to pay
for post-operative care using E/M codes
rather than through a global package,
Medicare will likely pay a higher level
of E/M visits when they are separately
billed than it does currently, as the
existing global packages tend to include
PO 00000
Frm 00042
Fmt 4701
Sfmt 4700
more lower level E/M services than
those that are generally reported.
Response: We acknowledge that the
visits assumed in the global packages
are generally valued as lower-level visits
than are most commonly furnished, as
reflected in Medicare utilization data for
separately reportable E/Ms. However,
this disparity is only pertinent to the
proposal if the global packages are
inaccurately valued or, if, under the
proposed policy, practitioners who
furnish these services are likely to
inaccurately report the level of E/M
service that is actually being furnished.
If the former is true, then we believe this
supports the proposal to revalue these
services. As with every service, we
expect physicians to bill the most
appropriate E/M codes that reflect the
care that is furnished, including for
post-operative care.
Comment: One commenter expressed
concern that the proposal to require
separate billing for postoperative
surgical care provides a basis for the
eventual denial of payment to one or
more of the postoperative care
providers, based on the notion that care
furnished by other specialties is
duplicative of or replaces care furnished
by the surgeon. This commenter stated
that multiple providers with differing
expertise and training are essential to
achieve optimal patient outcomes and
expressed concern that this proposal
will provide disincentives to optimal
patient care.
Response: As we stated in the
proposal, we believe that there are
various models for postoperative care
that can often include multiple
providers, and this is another important
reason why we believe the services with
longer global periods should be
transformed to 0-day packages to
accommodate heterogeneous models of
care that optimize patient outcomes.
Comment: One commenter
recommended that CMS establish Gcodes for three levels of post-operative
visits furnished by the original surgeon
or another surgeon with the same board
certification, as well as a second set of
three level G-codes for postoperative
visits furnished by another provider.
The commenter also suggested that CMS
should develop methods to fairly
measure the duration of E/M times
through which a large sample of
surgeons might report the number and
intensity of post-operative visits. The
commenter also recommended that CMS
track E/M services furnished to surgical
patients within the global period by a
physician other than the operating
surgeon, for the same or similar
diagnosis, in order to begin to
understand what portion of
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
postoperative visits are being billed
outside of the global period.
The RUC informed CMS that it has
identified several large hospital-based
physician group practices that internally
use CPT code 99024 to report each
bundled post-operative visit, and
therefore data is already being captured
for some Medicare providers. The RUC
also suggested that CMS may have
denied-claims data available for CPT
code 99024 via the Medicare claims
processing system. The RUC
recommends that CMS work with it to
explore the availability, usefulness, and
appropriateness of these data from
group practices and the CMS deniedclaims dataset, in order to gather
existing, objective data to validate the
actual number of post-operative visits
for 10-day and 90-day procedures. The
RUC also suggested that CMS should
consider reviewing Medicare Part A
claims data to determine the length of
stay for surgical services furnished in
the inpatient acute care hospital setting.
MedPAC stated that data collection
could take several years, would be
burdensome for CMS and providers, and
may be inaccurate since providers
would have little incentive to report
each visit. Furthermore, MedPAC
suggested that such data collection
would be unnecessary since the current
ratesetting methodology already
assumes particular numbers of visits.
MedPAC suggested that CMS should
reduce the RVUs for the 10- and 90-day
global services based on the same
assumptions currently used to pay for
these services.
Several other commenters agreed with
the approach advocated by MedPAC
(often referred to as ‘‘reverse-building
block’’) to revaluing the services. These
commenters stated that since CMS has
increased RVUs for these services
proportionate to the number of E/M
services assumed to be included in the
postoperative period, for the sake of
relativity, the RVUs attributed to the
visits can be fairly removed in order to
value the new 0-day global codes. Many
of these commenters acknowledged that
this approach would result in negative
or other anomalous values for many of
these codes, but asserted that codes with
anomalous values might then be
individually reviewed. MedPAC
suggested that if specialty societies or
the RUC believe that the new values for
specific global codes are inaccurate,
they could present evidence that the
codes are misvalued to CMS,
presumably through the potentially
misvalued code public nomination
process. MedPAC further states that for
codes without accurate post-operative
assumptions, CMS could calculate
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
interim RVUs for these codes based on
the average percent reduction for other
global codes in the same family.
Many other commenters were against
the reverse-building block approach to
revaluation. These commenters stated
that backing out the bundled E/M
services would be highly inappropriate
and methodologically unsound since
the services were not necessarily valued
using a building-block methodology.
Many of these commenters, including
the RUC, stated that the amount of postoperative work included in the codes
can only be appropriately surveyed,
vetted, and valued by the RUC.
Response: We appreciate the concerns
of commenters regarding the difficulty
of revaluing the global surgery codes as
0-day global packages. As we stated in
making the proposal, we believe that
such stakeholder input and
participation in any revaluation will be
critical to the accuracy of the resulting
values. We will consider all of these
comments as we consider mechanisms
for revaluations and as we propose new
values for specific services. We believe
that the challenges involved in
revaluation, such as those articulated by
commenters, reinforce our
understanding that the current
construction of the 10- and 90-day
global packages are not a sustainable,
long-term approach to the accurate
valuation of surgical care. As noted
above, we will continue to explore
appropriate ways of bundling global
surgical services.
Comment: In general, commenters
supporting the proposal also supported
CMS’s proposed timeframe to transition
10-day global codes and 90-day global
codes to 0-day global surgical packages
by 2017 and 2018, respectively. In
contrast, most commenters objecting to,
or articulating reservations about, the
proposal urged CMS to slow its
implementation. Some of these
commenters suggested that the process
used to establish the current values for
these CPT codes is ideal and stated that
it would take many years to value the
many individual services using the
same methodologies.
The RUC stated that there are over
4,200 services within the PFS with a 10day or 90-day global period, so the
scope of the proposal is very large and
the transition should be staggered over
many years. However, the RUC also
pointed out that most of these services
have relatively low utilization, as only
268 of them (or 6 percent of 10- or 90day global surgery services) were
performed more than 10,000 times
annually based on 2013 Medicare
claims data.
PO 00000
Frm 00043
Fmt 4701
Sfmt 4700
67589
Response: We appreciate the concerns
of the commenters. We agree with those
commenters who urged us to move
quickly to value services as accurately
as possible. We note that most
comments suggesting a delay in
revaluation were based on a common
underlying view that code-level review
of the full set of services by the RUC
based on practitioner surveys is the only
appropriate way to value the services.
As we stated in making the proposal,
we do not believe that surveying
practitioners who furnish each of these
services is a practical or necessarily
advisable approach to appropriate
valuation. Regardless of when the
proposal is implemented, it seems likely
that the number of codes to be revalued
is much larger than the number of codes
that should or can be surveyed. Through
its normal process, the RUC routinely
makes annual recommendations
regarding several hundred codes, and
we acknowledge that thousands of
services cannot be valued using the
typical RUC process in one year. On the
other hand we believe that there are
other options for revaluing some of the
global surgery codes as 0-day global
packages, particularly those of low
volume, and we have indicated a
willingness to work with the RUC to
determine appropriate mechanisms for
revaluations. Therefore, although we
agree that revaluing such a high number
of codes is a significant undertaking, we
do not believe that that the required
revaluations would represent an undue
burden between the present and the
proposed implementation dates. We
also note that in order to focus efforts on
revaluing the global surgery packages,
we are not asking the RUC to review the
nearly 100 services we proposed as
potentially misvalued this year under
the high expenditure screen. We
continue to remain interested in other
potential data sources for accurately
valuing PFS services, especially the vast
majority of 10- and 90-day global codes
for which there is not significant
volume. We also urge stakeholders to
engage with us to help us understand
why alternative approaches to the
revaluation of the 10- and 90-day global
services would require the kind of delay
that was urged based on the assumption
that the RUC survey approach would be
used for all those services.
Additionally, we request
stakeholders, including the CPT
Editorial Panel and the RUC, to consider
the utility of establishing and
maintaining separate coding and
national Medicare RVUs for the many
procedures that have little to no
utilization in the Medicare population.
For example, there are over 1,000 10-
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67590
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
and 90-day global codes with fewer than
100 annual services in the Medicare
database. Although we recognize that
some portion of these services may be
utilized more extensively by nonMedicare payers, it is also likely that
many of these codes may reasonably be
consolidated. We request that
appropriate coding for surgical services
be considered as part of revaluing global
surgery.
Comment: Many commenters
expressed concerns that requiring
beneficiary coinsurance for each followup visit could dissuade beneficiaries
from returning for necessary follow-up
care and, therefore, adversely affect
surgical outcomes. Many of these
commenters acknowledged that overall
patient liability for the total amount of
care could be reduced, depending on
revaluation, but stated that paying
separate coinsurance for follow-up care
can cause patients to perceive the net
payments as larger, given the frequency
of payment required. These commenters
stated that the magnitude of these
problems might be directly
proportionate to how sick the patient is.
Response: We understand the
concerns of the commenters, but do not
agree that Medicare beneficiaries are
unlikely to appreciate the difference
between frequency of payment and
overall financial liability. We also note
that the significant majority of patient
encounters with Medicare practitioners
generate some degree of beneficiary
liability. While liability could prompt
the proportion of beneficiaries without
secondary insurance to forgo medically
reasonable and necessary care for the
treatment of illness or injury, we have
no reason to conclude that this would
be the case specifically for postoperative care. We do acknowledge that
surgeons may need to explain the
importance of follow-up care so that
patients understand and appreciate how
compliance with follow-up care can
improve the overall quality of care and
outcomes. As noted above, while our
proposal is to move to 0-day global
packages as a simple, immediate
adjustment, the agency remains
committed to bundling as a key
component of payment system delivery
reform, and we will consider beneficiary
impact as we further consider the
appropriate size and construction of a
surgical bundle.
Comment: Several commenters
expressed concerns that the proposal
would result in disjointed or inadequate
care and/or disrupt surgical registry
data. These commenters suggested that
neither patients nor alternate providers
are as qualified to determine whether or
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
not a postoperative visit by the surgeon
is necessary.
Response: As discussed above, we do
not agree that patients who require the
post-operative care of a surgeon are
likely to forgo such care if Medicare
changes how we pay the surgeon for
furnishing that care. Although several
commenters expressed these and similar
kinds of concerns, none explained how
the proposed change in payment would
change post operative care. We continue
to believe that surgeons will continue to
furnish appropriate post operative care
to Medicare beneficiaries, and we do not
agree that concerns about increased
patient liability or disjointed care are
warranted.
Comment: Several commenters
expressed concerns over other Medicare
payment policies related to surgical
procedures. Some commenters stated
that the current multiple procedure
payment reduction policies that apply
to all 0-, 10-, and 90-day global codes
are only appropriate for 10-day and 90day globals due to the overlap in
resource costs during the post-operative
period. Other commenters noted that
potential reductions in payment to
surgeons to account for the reduced
post-operative period would negatively
impact practitioners who assist at
surgery despite the fact that their
professional work and responsibilities
have not changed.
Response: We appreciate the issues
raised by these commenters. Again, we
seek continued input from the
stakeholder community regarding these
and other issues that need to be
considered in order to implement the
transition. In the case of the MPPR, we
note there are several hundred 0-day
global codes where these payment
policies currently apply. We are
especially interested in understanding
why stakeholders do not believe the
policies effective for the current 0-day
global codes would not similarly be
appropriate for the current 10-and 90day codes that will be revalued as 0-day
global codes.
Comment: Many of the commenters
who opposed or expressed concern
about the proposal urged CMS to
consider the extent to which this
proposal would increase the
administrative burden on CMS, MACs,
and providers. Other commenters urged
CMS to consider that post-operative
visits would be subject to the same
documentation requirements and other
scrutiny as other separately-reportable
PFS services. One commenter
representing other payers opposed the
proposal due to concerns about
predicting the usage of post-operative
services.
PO 00000
Frm 00044
Fmt 4701
Sfmt 4700
Response: We considered the
administrative burden on both CMS and
practitioners who furnish these services
in making the proposal. In both cases,
we note the administrative burden
would be no greater than the burden
associated with the vast majority of
other services paid through the
Medicare PFS. We do not believe that
the burden of separately reporting postoperative follow-up visits is particularly
or unduly burdensome, given that most
office visits paid through the PFS are
separately reported under current
Medicare policies. In comparison to the
number of separately reported visits and
other PFS services, the number of visits
that likely occur in post-operative
periods is relatively small. We do not
agree that there are inherent reasons that
medically necessary post-operative
visits should be exempt from the same
documentation and other requirements
applicable to other PFS services. We
appreciate that changes in Medicare
policy may affect other insurers who
choose to base their payments on the
PFS; however, it is our obligation to set
our policies based upon the needs of
Medicare and its beneficiaries.
Comment: A few commenters urged
CMS to consider the possibility that
there could be confusion among
practitioners and payers if some payers
continue to base payment on the 10- or
90-day post-operative periods.
Response: We believe that payment
policies that are appropriate for
Medicare may not always be optimal for
all payers. However, we seek continued
input and analysis from other payers as
we engage stakeholders in developing
our implementation strategy for the
transition of 10- and 90-day global
services to 0-day global services.
Comment: Several commenters urged
CMS to consult with stakeholders as we
develop appropriate plans for the global
period transition. These commenters
cautioned that the structural
reorganization of these services is
challenging due to the large set of
services that will be impacted and could
potentially disrupt well-established
payment for certain providers.
Response: We appreciate these
recommendations and agree that we
should continue to consult with
stakeholders regarding the
implementation of this proposal.
After consideration of all the
comments received regarding this
proposal, we are finalizing the proposal
to transition and revalue all 10- and 90day global surgery services with 0-day
global periods, beginning with the 10day global services in CY 2017 and
following with the 90-day global
services in CY 2018. We note that as we
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
develop implementation details,
including revaluations, we will take into
consideration all of the comments we
received to our global surgery proposal.
We will provide additional details
during the CY 2016 rulemaking. We are
finalizing a transformation to 0-day
global codes because we believe this is
the most straightforward way to
improve the accuracy of valuation for
the various components of global
surgical packages, including pre- and
post-operative visits and performance of
the surgical procedure. However, we
remain committed to delivery system
reform and ensuring Medicare makes
appropriate payment for bundles of
services whether our payment covers a
period of 0, 10 or 90 days. As we begin
revaluation of services as 0-day globals,
we will actively assess whether there is
a better construction of a bundled
payment for surgical services.
We also actively seek the analysis and
perspective of all affected stakeholders
regarding the best means to revalue
these services as 0-day global codes. We
urge all stakeholders to engage with us
regarding potential means of making the
transition as seamless as possible, both
for patient care and provider impact. We
are considering a wide range of
approaches to all details of
implementation from revaluation to
communication and transition, and we
are hopeful that sufficient agreement
can be reached among stakeholders on
important issues such as revaluation of
the global services and appropriate
coding for post-operative care. We
remain committed to collecting
objective data regarding the number of
visits typically furnished during postoperative periods and will explore the
extant source options presented by
commenters as we consider other
options as well.
5. Valuing Services That Include
Moderate Sedation as an Inherent Part
of Furnishing the Procedure
The CPT manual includes more than
300 diagnostic and therapeutic
procedures, listed in Appendix G, for
which CPT has determined that
moderate sedation is an inherent part of
furnishing the procedure and, therefore,
only the single procedure code is
appropriately reported when furnishing
the service and the moderate sedation.
The work of moderate sedation has been
included in the work RVUs for these
diagnostic and therapeutic procedures
based upon their inclusion in Appendix
G. Similarly, the direct PE inputs for
these services include those inputs
associated with furnishing a typical
moderate sedation service. To the extent
that moderate sedation is typically
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
furnished as part of the diagnostic or
therapeutic service, the inclusion of
moderate sedation in the valuation of
the procedure is appropriate.
In the CY 2014 PFS proposed rule (79
FR 40349), we noted that it appeared
that practice patterns for endoscopic
procedures were changing, with
anesthesia increasingly being separately
reported for these procedures. For
example, one study showed that while
the use of a separate anesthesia
professional for colonoscopies and
upper endoscopies was just 13.5 percent
in 2003, the rate more than doubled to
30.2 percent in 2009. An analysis of
Medicare claims data showed that a
similar pattern is occurring in the
Medicare program. We found that, for
certain types of procedures such as
digestive surgical procedures, a separate
anesthesia service is furnished 53
percent of the time. For some of these
digestive surgical procedures, the claims
analysis showed that this rate was as
high as 80 percent.
Our data clearly indicated that
moderate sedation was no longer typical
for all of the procedures listed in CPT’s
Appendix G, and, in fact, the data
suggested that the percent of cases in
which it is used is declining. For many
of these procedures in Appendix G,
moderate sedation continued to be
furnished. The trend away from the use
of moderate sedation toward a
separately billed anesthesia service was
not universal. We found that it differed
by the class of procedures, sometimes at
the procedure code level, and continued
to evolve over time. Due to the changing
nature of medical practice in this area,
we noted that we were considering
establishing a uniform approach to
valuation for all Appendix G services
for which moderate sedation is no
longer inherent, rather than addressing
this issue at the procedure level as
individual procedures are revalued.
We sought public comment on
approaches to address the appropriate
valuation of these services. Specifically,
we were interested in approaches to
valuing Appendix G codes that would
allow Medicare to pay accurately for
moderate sedation when it is furnished
while avoiding potential duplicative
payments when separate anesthesia is
furnished and billed. To the extent that
Appendix G procedure values are
adjusted to no longer include moderate
sedation, we requested suggestions as to
how moderate sedation should be
reported and valued, and how to remove
from existing valuations the RVUs and
inputs related to moderate sedation.
We noted that in the CY 2014 PFS
final rule with comment period, we
established values for many upper
PO 00000
Frm 00045
Fmt 4701
Sfmt 4700
67591
gastrointestinal procedures, 58 of which
were included in Appendix G. For those
interim final values, we included the
inputs related to moderate sedation. We
stated that we did not expect to change
existing policies for valuing moderate
sedation as inherent in these procedures
until we have the opportunity to assess
and respond to the comments on the
proposed rule on the overall valuation
of Appendix G codes.
We received many helpful suggestions
in response to our comment solicitation.
At this time, we are not making any
changes to how we value Appendix G
codes for which moderate sedation is an
inherent part of the procedure. We
intend to address this topic in future
notice and comment rulemaking, taking
into account the comments we received.
In section II.G. of this CY 2015 PFS final
rule with comment period, we address
interim final values and establish CY
2015 inputs for the lower
gastrointestinal procedures, many of
which are also listed in Appendix G.
C. Malpractice Relative Value Units
(RVUs)
1. Overview
Section 1848(c) of the Act requires
that each service paid under the PFS be
comprised of three components: Work;
PE; and malpractice (MP) expense. As
required by section 1848(c) of the Act,
beginning in CY 2000, MP RVUs are
resource based. Malpractice RVUs for
new codes after 1991 were extrapolated
from similar existing codes or as a
percentage of the corresponding work
RVU. Section 1848(c)(2)(B)(i) of the Act
also requires that we review, and if
necessary adjust, RVUs no less often
than every 5 years. For CY 2015, we are
proposing to implement the third
comprehensive review and update of
MP RVUs. For details about prior
updates, see the CY 2010 final rule with
comment period (74 FR 33537).
2. Methodology for the Proposed
Revision of Resource-Based Malpractice
RVUs
The proposed MP RVUs were
calculated by a CMS contractor based on
updated MP premium data obtained
from state insurance rate filings. The
methodology used in calculating the
proposed CY 2015 review and update of
resource-based MP RVUs largely
paralleled the process used in the CY
2010 update. The calculation required
using information on specialty-specific
MP premiums linked to a specific
service based upon the relative risk
factors of the various specialties that
furnish a particular service. Because MP
premiums vary by state and specialty,
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67592
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
the MP premium information were
weighted geographically and by
specialty. Accordingly, the proposed
MP RVUs were based upon three data
sources: CY 2011 and CY 2012 MP
premium data; CY 2013 Medicare
payment and utilization data; and CY
2015 proposed work RVUs and
geographic practice cost indices (GPCIs).
Similar to the previous update, we
calculated the proposed MP RVUs using
specialty-specific MP premium data
because they represent the actual
expense incurred by practitioners to
obtain MP insurance. We obtained and
used MP premium data from state
departments of insurance rate filings,
primarily for physicians and surgeons.
When the state insurance departments
did not provide data, we used state rate
filing data from the Perr and Knight
database, which derives its data from
state insurance departments. We used
information obtained from MP
insurance rate filings with effective
dates in 2011 and 2012. These were the
most current data available during our
data collection process.
We collected MP insurance premium
data from all 50 States, the District of
Columbia, and Puerto Rico. Rate filings
were not available in American Samoa,
Guam, or the Virgin Islands. Premiums
were for $1 million/$3 million, mature,
claims-made policies (policies covering
claims made, rather than those covering
services furnished, during the policy
term). A $1 million/$3 million liability
limit policy means that the most that
would be paid on any claim is $1
million and the most that the policy
would pay for claims over the timeframe
of the policy is $3 million. We made
adjustments to the premium data to
reflect mandatory surcharges for patient
compensation funds (funds to pay for
any claim beyond the statutory amount,
thereby limiting an individual
physician’s liability in cases of a large
suit) in states where participation in
such funds is mandatory. We attempted
to collect premium data representing at
least 50 percent of the medical MP
premiums paid.
We included premium information for
all physician and NPP specialties, and
all risk classifications available in the
collected rate filings. Most insurance
companies provided crosswalks from
insurance service office (ISO) codes to
named specialties. We matched these
crosswalks to Medicare primary
specialty designations (specialty codes).
We also used information we obtained
regarding surgical and nonsurgical
classes. Some companies provided
additional surgical subclasses; for
example, distinguishing family practice
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
physicians who furnish obstetric
services from those who do not.
Although we collected premium data
from all states and the District of
Columbia, not all specialties had
premium data in the rate filings from all
states. Additionally, for some
specialties, MP premiums were not
available from the rate filings in any
state. Therefore, for specialties for
which there was not premium data for
at least 35 states, and specialties for
which there was not distinct premium
data in the rate filings, we crosswalked
the specialty to a similar specialty,
conceptually or by available premium
data, for which we did have sufficient
and reliable data. Additionally, we
crosswalked three specialties—
physician assistant, registered dietitian
and optometry—for which we had data
from at least 35 states to a similar
specialty type because the available data
contained such extreme variations in
premium amounts that we found it to be
unreliable. The range in premium
amounts for registered dietitians is $85
to $20,813 (24,259 percent), for
physician assistants is $614 to $35,404
(5,665 percent), and for optometry is
$189 to $10,798 (5,614 percent). We
crosswalked these specialties to allergy
and immunology, the specialty with the
lowest premiums for which we had
sufficient and reliable data.
Our proposed methodology for
updating the MP RVUs conceptually
followed the specialty-weighted
approach, used in the CY 2010 update.
The specialty-weighted approach bases
the MP RVUs for a given service upon
a weighted average of the risk factors of
all specialties furnishing the service.
This approach ensures that all
specialties furnishing a given service are
accounted for in the calculation of the
MP RVUs. We also continued to use the
risk factor of the dominant specialty for
rarely billed services (that is, when CY
2013 claims data reflected allowed
services of less than 100).
We proposed minor refinements for
updating the CY 2015 MP RVUs as
compared to the previous update. These
refinements included calculating a
combined national average surgical
premium and risk factor for
neurosurgery and neurology and
updating the list of invasive cardiology
service HCPCS codes (for example,
cardiac catheterization and angioplasty)
to be classified as surgery for purposes
of assigning service level risk factors.
Additionally, we proposed to classify
injection procedures used in
conjunction with cardiac catheterization
as surgery (for purposes of assigning a
service specific risk factor). To calculate
the risk factor for TC services we
PO 00000
Frm 00046
Fmt 4701
Sfmt 4700
proposed to use the mean umbrella nonphysician MP premiums obtained from
Radiology Business Management
Association (RBMA) survey data, used
for the previous MP RVU update in
2010, and adjusted the premium data to
reflect the change in non-surgical
premiums for all specialties since the
previous MP RVU update.
As discussed in the CY 2015 proposed
rule (79 FR 40354 through 40355), we
did not include an adjustment under the
anesthesia fee schedule to reflect
updated MP premium information and
stated that we intend to propose an
anesthesia adjustment for MP in the CY
2016 PFS proposed rule. We also
requested comments on how to reflect
updated MP premium amounts under
the anesthesiology fee schedule.
We posted our contractors report,
‘‘Report on the CY 2105 Update of
Malpractice RVUs’’ on the CMS Web
site. The report on MP RVUs for the CY
2015 proposed rule and the proposed
MP premium amounts and specialty risk
factors are accessible from the CMS Web
site under the supporting documents
section of the CY 2015 PFS proposed
rule at https://www.cms.gov/
PhysicianFeeSched/. A more detailed
explanation of our proposed MP RVU
update can be found in the CY 2015 PFS
proposed rule (79 FR 40349 through
40355).
3. Response to Public Comments
We received over 70 industry
comments on the CY 2015 proposed MP
RVU update. A summary of the
comments we received on the proposed
MP RVU update and our responses are
discussed below.
Comment: Two commenters
supported our proposal to combine the
surgical premium data for neurosurgery
and neurology for establishing the
surgical risk factor for neurosurgery.
Response: We agree with the
commenters and will finalize our
approach for determining the surgical
premium for neurosurgery as proposed.
We will combine surgical premiums for
neurology and neurosurgery to calculate
a national average surgical premium and
risk factor for neurosurgery.
Comment: Three commenters
requested that we phase in the
reduction for ophthalmology and
optometry services over 2 years. The
commenters stated that the reduction is
due in part to an error we made in
calculating the MP RVUs for
ophthalmology and optometry codes
under the previous MP RVU update in
CY 2010. The commenters stated that an
immediate implementation of the
correction would result in significant
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
payment reductions for
ophthalmologists.
Response: We note that for the CY
2015 MP RVU update we did not correct
the mistake that was made in CY 2010.
For the CY 2015 MP update we
recalculated the MP RVUs based upon
the most recently available data for all
services, including ophthalmic services.
Accordingly, the proposed MP RVU
update reflects the use of updated MP
premium data and risk factors by
specialty and is not affected in any way
by the CY 2010 MP RVUs. In doing so,
even though the proposed CY 2015
ophthalmology non-surgical risk factor
was 14 percent greater than the CY 2010
non-surgical risk factor and the
proposed surgical risk factor was 17
percent greater, the proposed MP RVUs
for most services with significant
ophthalmology volume decreased
because the CY 2010 error resulted in
MP RVUs that were higher than they
should have been. That is, the reduction
in MP RVUs for ophthalmology and
optometry are solely due to
overpayments made due to a mistake
during the previous MP RVU update
rather than a proposed change in
methodology or the use of updated
premium data. We do not believe that a
previous error is sufficient justification
for not fully implementing updated MP
RVUs based on more recent premium
data. Therefore, we will implement the
updated MP RVUs for ophthalmology
and optometry services as proposed.
Comment: We received comments
regarding the application of our
specialty weighted approach for
calculating service level risk factors for
surgical services. For instance, the same
commenters that requested a 2-year
phase in of the reduction to
ophthalmology services also requested
that we exclude optometry from
calculating the risk factor for
ophthalmic surgery. One commenter
stated that ‘‘MP RVUs for cataract and
other ophthalmic surgeries are deflated
because CMS assumes that optometry is
providing the surgical portion of the
procedure.’’ The commenter also stated
that optometrists are involved only
during the pre- or post-procedure
periods of ophthalmic surgery. Another
specialty society stated that it appears
that CMS’s methodology for calculating
service level risk factors for surgical
services ‘‘may include the allowed
services for surgical assistance possibly
discounted to reflect the assistant role
under payment policy.’’ The commenter
also stated that ‘‘specialties that assist at
the procedure do not perform it, and the
assistant’s associated MP risk factor has
no bearing on the MP cost for the
surgeon.’’
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Response: The commenter is correct
to say that we calculated service level
risk factors based on the mix of all
practitioners billing for a given service
and that the specialty weighted
approach is applied to both surgical and
non-surgical services . That is, we apply
the risk factor(s) of all specialties
involved with furnishing the surgical
procedure to calculate service level risk
factors and MP RVUs. For assistants at
surgery, we discount the utilization to
reflect his or her role in furnishing the
surgical procedure. Although we agree
that MP cost for the surgeon may not be
affected by the surgical assistant’s MP
cost, we do not agree with the
suggestion that assistants at surgery
should be excluded from our specialty
weighted approach for determining
service level MP risk factors and MP
RVUs for surgical services. We believe
it is appropriate to apply the specialty
risk factor(s) of all practitioners
participating in and receiving a payment
for the surgical procedure for purposes
of determining a service level risk factor
and thus the payment for that service.
If we were to exclude the risk factors of
some specialties that bill a specific code
from the calculation of the service level
risk factor, the resulting MP RVU would
not reflect all utilization. Similarly, we
also disagree with the suggestion that
pre- and post- utilization should be
removed from determining MP RVUs for
ophthalmic surgical services. The
resources associated with pre- and postoperative periods for ophthalmic
surgery are included in the total RVUs
for the global surgical package.
Accordingly, if we did not include the
portion of utilization attributed to preand post-operative visits in the
calculation of service level risk factors,
the MP RVUs for global surgery would
overstate the MP costs.
We note that in both of these cases by
using the discounted utilization file the
weighted average that we use reflects
only the proportion of the utilization by
these practitioners and only at the
payment rate made. Including specialty
utilization for all practitioners involved
in furnishing the global service reflects
the MP risk for the entire global service.
Comment: We received two comments
regarding how risk factors are assigned
to existing services without Medicare
utilization. The commenters stated that
we crosswalk to the risk factor of an
analogous source code with Medicare
utilization for new codes but assign the
average risk factor for all physicians to
existing services without Medicare
utilization. The commenters contend
that ‘‘it is inappropriate for a service to
have fluctuating MP risk factors simply
due to whether it is reported in
PO 00000
Frm 00047
Fmt 4701
Sfmt 4700
67593
Medicare claims data for a given year.’’
The commenters requested that we
crosswalk existing services without
Medicare utilization to a recommended
source code.
Response: We used the most recently
available Medicare claims data (that is,
from CY 2013) to determine the service
level risk factors, either based on the
risk factors of the actual mix of
practitioners furnishing the service, or
in the case of low volume services, the
risk factor of the dominant specialty. We
disagree with the commenters’
suggestion to assign the risk factor of a
recommended specialty to an existing
service without Medicare utilization as
indicated by our most recently available
claims data. In the absence of Medicare
utilization we continue to believe that
the most appropriate risk factor is the
weighted average risk factor for all
service codes. The proposed weighted
average risk factor for all service codes
was 2.11. Using the weighted average
risk factor for all services effectively
neutralizes the impact of updated MP
premiums and risk factors for any
specific specialty (or mix of specialties).
Comment: The AMA and the RUC and
other commenters agreed with the
majority of our proposed claims based
dominant specialty designations for
codes with less than 100 allowed
services; however, the commenters
disagreed with our proposed dominant
specialty for some services. The
commenters believe that some claims
have been miscoded, resulting in
erroneous specialty designations. One
commenter stated that using the
dominant specialty from the claims data
resulted in unjustifiably low MP RVUs
for congenital heart surgery. The
commenter stated that congenital heart
surgery can only be done by a heart
surgeon and requested that we override
the dominant specialty in our claims
data and use the RUCs recommended
specialty.
Response: As discussed in the
previous response, we proposed to use
CY 2013 claims data to determine the
service level MP risk factors, either
based on the mix of practitioners
furnishing the service, or in the case of
low volume services, assigning the risk
factor of the dominant specialty. We
continue to believe that use of actual
claims data to determine the dominant
specialty is preferable to using a
‘‘recommended’’ specialty. However, we
recognize that anomalies in the claims
data can occur that would affect the
dominant specialty for low volume
services, and therefore resulting in the
need for a subjective review of some
services in place of a complete reliance
on claims data. To that end, we
E:\FR\FM\13NOR2.SGM
13NOR2
67594
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
reviewed the commenter’s
recommendations for overriding the
dominant specialty from our claims data
with a recommended specialty. After
careful consideration of the comments,
we will override the dominant specialty
from Medicare claims data when the
dominant specialty from our claims data
is inconsistent with a specialty that
could be reasonably expected to furnish
the service. For example, our claims
data indicates that pulmonary disease is
the dominant specialty for HCPCS code
33622 (Reconstruction of complex
cardiac anomaly), however as the
commenter mentioned, this service is
furnished by heart surgeons. A complete
listing of low volume services for which
we will override the claims based
dominant specialty with the
recommended specialty to assign a
service level risk factor is illustrated in
Table 12.
TABLE 12—LOW VOLUME SERVICE CODES WHERE ASSIGNED SPECIALTY USED RATHER THAN CLAIMS BASED DOMINANT
SPECIALTY
HCPCS Code
Short descriptor
Claims based dominant specialty
Assigned specialty
.............................................
.............................................
.............................................
.............................................
.............................................
.............................................
.............................................
.............................................
.............................................
.............................................
.............................................
.............................................
.............................................
.............................................
.............................................
.............................................
.............................................
.............................................
.............................................
.............................................
Reinforce radius ...........................
Toe joint transfer ..........................
Diagnostic incision larynx .............
Apply r&l pulm art bands ..............
Transthor cath for stent ................
Redo compl cardiac anomaly .......
Repair of heart defects .................
Major vessel shunt .......................
Revision of infusion pump ............
Fuse esophagus & intestine .........
Surgical opening esophagus ........
Rpr hern preemie reduc ...............
Measure ureter pressure ..............
Reconstruct urethra/penis ............
Repair penis .................................
Remove cranial cavity fluid ..........
Excision of skull/sutures ...............
Incision of brain tissue ..................
X-ray measurement of pelvis .......
Dynamic fine wire emg .................
Otolaryngology ..............................
Pulmonary Disease ......................
Cardiology .....................................
Anesthesiology .............................
Cardiology .....................................
Pulmonary Disease ......................
Cardiology .....................................
General Surgery ...........................
General Practice ...........................
Gastroenterology ..........................
General Practice ...........................
General Practice ...........................
Internal Medicine ..........................
Pediatric Medicine ........................
Gastroenterology ..........................
Family Practice .............................
Family Practice .............................
Cardiology .....................................
Thoracic Surgery ..........................
Cardiology .....................................
96420 .............................................
99170 .............................................
99461 .............................................
Chemo ia push technique ............
Anogenital exam child w imag .....
Init nb em per day non-fac ...........
Urology .........................................
Ophthalmology ..............................
Cardiac Electrophysiology ............
Orthopedic Surgery.
Orthopedic Surgery.
Otolaryngology.
Cardiac Surgery.
Cardiac Surgery.
Cardiac Surgery.
Cardiac Surgery.
Cardiac Surgery.
General Surgery.
Thoracic Surgery.
General Surgery.
General Surgery.
Urology.
Urology.
Urology.
Neurosurgery.
Neurosurgery.
Neurosurgery.
Diagnostic Radiology.
Physical
Therapist/Independent
Practice.
Hematology Oncology.
Pediatric Medicine.
Pediatric Medicine.
ebenthall on DSK5SPTVN1PROD with $$_JOB
25490
26556
31320
33620
33621
33622
33697
33766
36261
43341
43350
49491
50686
54352
54380
61000
61558
61567
74710
96003
Comment: Some commenters
requested that we crosswalk
gynecological oncology to general
surgery, instead of crosswalking to
obstetrics/gynecology because
gynecological oncology is more akin to
general surgery procedures than
obstetrics/gynecology. One specialty
society stated that gynecological
oncologists are predominantly cancer
surgeons with MP risk similar to general
surgery.
Response: We agree with the
commenters and will crosswalk
gynecological oncology to the general
surgery premium data and risk factor.
Comment: One commenter requested
that we crosswalk clinical laboratory to
pathology instead of the risk factor used
for TC services because clinical
laboratories and pathologists render
essentially identical medical procedures
that are paid on the Medicare PFS.
Response: We believe that the MP risk
for clinical laboratories is more akin to
the MP risk of radiation therapy centers,
mammography screening centers and
IDTFs, for which we assigned the TC
risk factor, than to the MP risks for
pathologists. The commenters did not
provide sufficient rationale to support
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
that MP risk for clinical laboratories is
similar to the MP risk of pathologists.
Therefore, we will crosswalk clinical
laboratory to the TC risk factor as
proposed.
Comment: One commenter
encouraged us to crosswalk the
interventional pain management
specialty to a specialty that more closely
reflects the risks and services associated
with interventional pain management,
such as interventional radiology or a
comparable surgical subspecialty.
Response: We believe that the MP risk
associated with interventional pain
management is conceptually similar to
the MP risk for anesthesiology more so
than to the MP risk for interventional
radiology. Given that the commenters
did not provide sufficient rationale to
support that MP risk for interventional
pain management is similar to
interventional radiology or to a
comparable surgical specialty, we will
crosswalk interventional pain
management to anesthesiology as
proposed.
Comment: We received contrasting
comments on our proposal to crosswalk
NPPs to the premium and risk factor
calculated for allergy/immunology. For
PO 00000
Frm 00048
Fmt 4701
Sfmt 4700
instance, one commenter acknowledged
the difficulty in identifying
comprehensive, accurate premium data
across the majority of states, especially
for NPPs. To that end, the commenter
supported our decision to crosswalk the
MP premiums of NPPs to the lowest
physician risk factor, allergy/
immunology. Another commenter,
specifically supported crosswalking
registered dieticians to the risk factor
calculated for allergy/immunology.
In contrast, the AMA and other
commenters did not support
crosswalking NPPs with insufficient or
unreliable premium data to the
premium amounts and risk factor used
for allergy/immunology. The
commenters stated that allergy/
immunology premiums overstate NPP
premiums and requested that we use the
generally lower MP survey data from the
Physician Practice Information Survey
(PPIS) for NPPs instead of crosswalking
NPPs to the lowest physician specialty
(allergy/immunology) or use some other
measure of central tendency within the
existing collected premium data to
determine accurate MP premium risk
factors for NPPs. Another commenter
suggested that we work with the AMA
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
to obtain the necessary data to ensure
the process for reviewing and updating
MP rates is accurate for all providers.
Response: As discussed previously in
this section, the resource-based MP
RVUs are based on verifiable MP
premium data. We do not believe it
would be appropriate to base the MP
RVUs for nonphysician specialties on
survey data and use premium data for
all other specialties. Therefore, we do
not agree with the commenters that
suggested using survey data for NPPs
and will finalize the specialty
crosswalks for NPPs as proposed.
However, in light of the commenter’s
suggestions, we will explore ways to
enhance our MP premium data
collection efforts to obtain better
premium data for NPPs for future
updates. We will also explore other
potential measures of central tendency
for determining the ‘‘indexed’’ specialty
as an alternative to using the premium
values of the lowest specialty.
Comment: We received two comments
regarding the data and or methodology
used to calculate the TC and PC of
diagnostic services. One specialty group
noted that the proposed MP RVUs for
the TC of some diagnostic services
increased while the MP RVUs for the PC
decreased. Specifically, the commenter
questioned why the MP RVUs for the PC
of diagnostic cardiac catheterization as
described by HCPCS codes 93451
through 93461 decreased by 6 to 12
percent while the TC portion for these
codes increased by 20 to 33 percent. The
commenter encouraged us to review the
reasons for this shift to TC MP RVUs.
Additionally, the RBMA submitted
updated MP premium information
collected from IDTFs in 2014. The
RBMA requested that we use the
recently obtained data reflecting the
median ‘‘50th percentile’’ premium data
for ‘‘umbrella non-physician MP
liability’’ for calculating CY 2015 MP
RVUs for TC services.
Response: To calculate the risk factor
for TC services we used the mean
umbrella non-physician MP premiums
obtained from the RBMA survey data
(used for the previous MP RVU update
in 2010) and adjusted the data to reflect
the change in non-surgical premiums for
all specialties since the previous MP
RVU update, for example, $9,374
deflated by ¥20.41 percent = $7,455.
However, given that the premiums of
the lowest physician specialty (allergy/
immunology) decreased by more than
20 percent, the proposed CY 2015 risk
factor for TC services increased from the
previous update in CY 2010 from 0.86
to 0.91, resulting in minor increases in
MP RVUs for TC services. However,
given that the MP RVUs for TC services
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
are generally low, any increase to the
MP RVUs could result in a significant
percentage increase. For example, the
proposed CY 2015 MP RVU for HCPCS
code 93455 increased from 0.04 to 0.05
yielding a 25 percent increase.
Therefore, a minor increase in MP RVUs
for a TC service could result in a
significant percentage change.
We believe that using the updated
RBMA premium data without further
study is problematic because the
updated data reflects only the median
umbrella non-physician MP premium,
rather than the mean as was used for the
2010 MP RVU update and the proposed
2015 MP RVU update.
We believe further study is necessary
to reconcile comments on the use of
updated RBMA premium data for TC
services (which would result in an
increase MP RVU for TC services) and
our current methodology for calculating
the risk factor for PC services relative to
the global service and TC service.
Therefore, we will finalize the TC
premium data as proposed and maintain
our current methodology for calculating
the PC risk factor. We will consider the
request to use the updated premium
information from RBMA and
alternatives to our current methodology
for calculating the PC risk factor as part
of our further study and would propose
any changes through future rulemaking.
Comment: Several commenters
supported our proposal to classify
cardiac catheterization and angioplasty
services as surgical procedures for the
purpose of establishing service level risk
factors. The commenters also agreed
with our proposal to apply the surgical
risk factor to injection procedures used
in conjunction with cardiac
catheterization. The same commenters
identified additional cardiac
catheterization and angioplasty services
that were not included on the proposed
list of invasive cardiology services.
Specifically, the commenters requested
that we consider adding HCPCS codes
92961, 92986, 92987, 92990, 92992,
92993, 92997, and 92998 to the list of
invasive cardiology procedures
classified as surgery for purposes of
assigning service level risk factors
because the MP risk for these services is
similar to surgery.
Response: We agree that the MP risk
associated with the cardiac
catheterization and angioplasty services
mentioned by the commenters are more
akin to surgical procedures than most
non-surgical services. Therefore, we will
add cardiac catheterization and
angioplasty services as described by
HCPCS codes 92961, 92986, 92987,
92990, 92997, and 92998 to the list of
services outside of the surgical HCPCS
PO 00000
Frm 00049
Fmt 4701
Sfmt 4700
67595
code range to be considered surgery for
purposes of assigning service level MP
risk factors. We note that HCPCS codes
92992 and 92993 are contractor-priced
codes, wherein the Medicare claims
processing contractors establish RVUs
and payment amounts for these services.
Therefore, we are not adding HCPCS
codes 92992 and 92993.
Comment: One commenter stated that
several injection codes were not
included in the list of services outside
of the surgical HCPCS code range
considered surgery. The commenter
requested that we add injection services
as described by HCPCS codes 93565,
93566, 93567, and 93568 to the services
considered as surgery.
Response: The commenter is
mistaken. As discussed in the CY 2015
proposed rule (79 FR 40353 through
40354), we included the injection
procedure codes mentioned by the
commenter on the list of services
outside of the surgical HCPCS code
range to be considered surgery for
purposes of assigning service level MP
risk factors.
Comment: One commenter questioned
why the MP RVUs decrease for cardiac
catheterization services as described by
HCPCS codes 93530, 93531 and 93580.
The commenter stated that our proposal
to assign the surgical risk factor to
invasive cardiology services outside of
the surgical HCPCS code range should
result in an increase in MP RVUs.
Response: Cardiac catheterizations as
described by HCPCS codes 93530,
93531 and 93580 are currently on the
list of invasive cardiology services
classified as surgery for purposes of
assigning service level risk factors.
Therefore, the MP RVUs for HCPCS
codes 93530, 93531, 93580 were
calculated in the last update using the
surgical risk factor applicable to the
specialty(s) furnishing these services. As
discussed previously in this section, the
service level risk factors reflect the
average risk factor (weighted by allowed
services) of the specialties furnishing a
given service. Changes in the specialty
mix since the previous MP RVU update
in 2010 resulted in a decrease in MP
RVUs for HCPCS codes 93530, 93531,
and 93580. That is, the percentage of
allowed services attributed to cardiology
decreased for these service codes while
the percentage of allowed services
furnished by other specialties with risk
factors lower than cardiology, such as
internal medicine and pediatric
medicine, increased.
Comment: Many commenters
requested an explanation as to why the
MP RVUs decreased for 4 out of the 6
newly bundled image guided breast
biopsy procedures. The commenters
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67596
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
stated that given that the MP RVUs
assigned to breast biopsy codes are
being reduced, CMS is not appropriately
capturing the risk a physician assumes
when performing a procedure to
diagnose cancer. Several commenters
also explained that the misdiagnosis of
breast cancer is a leading source of MP
litigation and that reduction in payment
for breast biopsies will have an impact
on patient care.
Response: For the image guided breast
biopsy procedures as described by
HCPCS codes 19081 through 19086, we
used the risk factors from source codes
as recommended by the RUC. The
source codes for breast biopsy codes
19081, 19082, 19083, 19084, 19085 and
19086 are HCPCS codes 32553, 64480,
32551, 64480, 36565, and 76812,
respectively. Given that the proposed
risk factors for HCPCS codes 32553,
64480, and 32551 decreased from 2014
to 2015, the corresponding
‘‘destination’’ service codes, that is
HCPCS codes 19081, 19082, 19083, and
19084 also decreased.
Comment: Several commenters
recommended that we implement an
annual collection and review of MP
premium data and rescale the MP RVUs
each year, as we do with the PE RVUs.
The commenters also stated that an
annual update would provide additional
transparency and allow stakeholders to
identify potential problems and or
improvements to MP RVUs more
frequently.
Response: We appreciate the
comments from stakeholders regarding
the frequency that we currently review
changes in MP premium data. As
discussed in the CY 2015 PFS proposed
rule (79 FR 40349 through 40355), there
are two main aspects to the update of
MP RVUs, recalculation of specialty risk
factors based upon updated premium
data and recalculation of service level
RVUs based upon the mix of
practitioners providing the service. We
will consider the recommendation from
stakeholders to conduct annual MP RVU
updates to reflect corrections and
changes in the mix of practitioners
providing services. We will also
consider the appropriate frequency for
collecting new MP premium data. After
reviewing these issues, we would
address potential changes regarding the
frequency of MP RVU updates in a
future proposed rule.
Comment: One commenter urged us
to calculate risk factors for all
specialties approved by the American
Board Medical Specialties (ABMS) since
2010. The commenter stated that by
using the approved ABMS specialties,
all specialties and subspecialties will be
represented, including the recently
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
approved sub-specialty of Female Pelvic
Medicine and Reconstructive Surgery.
Response: We calculate service level
risk factors based on the mix of
specialties that furnish a given service
as indicated by our claims data.
Medicare claims data reflects the service
volume by Medicare primary specialty
designations. Therefore, we can only
use MP risk factors by Medicare primary
specialty codes.
Comment: We received two comments
regarding our discussion of how to
reflect updated MP premium data under
the anesthesiology fee schedule. One
commenter supported our decision to
delay the anesthesia MP update and
requested to work with us on
developing an appropriate method for
updating the MP component associated
with anesthesia fee schedule services.
Another commenter suggested using
mean anesthesia MP premiums per
provider over a 4- or 5-year period
prorated by Medicare utilization to yield
the MP expense for anesthesia services.
The commenter stated that the
calculation of premiums over a longer
period of time renders the average more
accurate and less volatile than a
calculation over a 1-year period.
Response: We appreciate the
comments on our potential approach for
updating the MP resource costs for
anesthesia fee schedule services. We
will consider the commenter’s
suggestions to use multi-year average
premiums as we develop a method for
updating MP payments for services paid
on the anesthesia fee schedule.
4. Result of Evaluation of Comments
After consideration of the public
comments received on the CY 2015 MP
RVU update, we are finalizing the CY
2015 MP RVU update as proposed with
minor modifications. We are
crosswalking gynecological oncology to
the risk factor for general surgery
(instead of the risk factor for obstetrics
gynecology). We are also adding HCPCS
codes 92961, 92986, 92987, 92990,
92997, and 92998 to the list of services
outside of the surgical HCPCS code
range considered as surgery for
purposes of assigning service level risk
factors. Additionally, for determining
the risk factor for low volume services,
we are overriding the dominant
specialty from our claims data with the
recommended specialty for the low
volume service codes listed in Table 12.
For all other low volume services, we
are finalizing our proposal to use the
risk factor of the dominant specialty
from our Medicare claims data. The MP
premium amounts, specialty risk
factors, and a complete list of service
codes outside the surgical HCPCS code
PO 00000
Frm 00050
Fmt 4701
Sfmt 4700
range considered surgery for the
purpose of assigning service level risk
factors, may be found on the CMS Web
site under the supporting documents
section of the CY 2015 PFS final rule
with comment period.
Additional information on the CY
2015 update may be found in our
contractor’s report, ‘‘Final Report on the
CY 2105 Update of Malpractice RVUs,’’
which is available on the CMS Web site.
It is also located under the supporting
documents section of the CY 2015 PFS
final rule with comment period located
at https://www.cms.gov/
PhysicianFeeSched/.
D. Geographic Practice Cost Indices
(GPCIs)
1. Background
Section 1848(e)(1)(A) of the Act
requires us to develop separate
Geographic Practice Cost Indices
(GPCIs) to measure relative cost
differences among localities compared
to the national average for each of the
three fee schedule components (that is,
work, PE, and MP). Although the statute
requires that the PE and MP GPCIs
reflect the full relative cost differences,
section 1848(e)(1)(A)(iii) of the Act
requires that the work GPCIs reflect only
one-quarter of the relative cost
differences compared to the national
average. In addition, section
1848(e)(1)(G) of the Act sets a
permanent 1.5 work GPCI floor for
services furnished in Alaska beginning
January 1, 2009, and section
1848(e)(1)(I) of the Act sets a permanent
1.0 PE GPCI floor for services furnished
in frontier states (as defined in section
1848(e)(1)(I) of the Act) beginning
January 1, 2011. Additionally, section
1848(e)(1)(E) of the Act provided for a
1.0 floor for the work GPCIs, which was
set to expire on March 31, 2014.
However, section 102 of the PAMA
extended application of the 1.0 floor to
the work GPCI through March 31, 2015.
Section 1848(e)(1)(C) of the Act
requires us to review and, if necessary,
adjust the GPCIs at least every 3 years.
Section 1848(e)(1)(C) of the Act requires
that ‘‘if more than 1 year has elapsed
since the date of the last previous
adjustment, the adjustment to be
applied in the first year of the next
adjustment shall be 1/2 of the
adjustment that otherwise would be
made.’’ We completed a review and
finalized updated GPCIs in the CY 2014
PFS final rule with comment period (78
FR 74390). Since the last GPCI update
had been implemented over 2 years
prior, CY 2011 and CY 2012, we phased
in 1/2 of the latest GPCI adjustment in
CY 2014. We also revised the cost share
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
weights that correspond to all three
GPCIs in the CY 2014 PFS final rule
with comment period. We calculated a
corresponding geographic adjustment
factor (GAF) for each PFS locality. The
GAFs are a weighted composite of each
area’s work, PE and MP GPCIs using the
national GPCI cost share weights.
Although the GAFs are not used in
computing the fee schedule payment for
a specific service, we provide them
because they are useful in comparing
overall areas costs and payments. The
actual effect on payment for any actual
service will deviate from the GAF to the
extent that the proportions of work, PE
and MP RVUs for the service differ from
those of the GAF.
As previously noted, section 102 of
the PAMA extended the 1.0 work GPCI
floor through March 31, 2015.
Therefore, the CY 2015 work GPCIs and
summarized GAFs were revised to
reflect the 1.0 work floor. Additionally,
as required by sections 1848(e)(1)(G)
and 1848(e)(1)(I) of the Act, the 1.5 work
GPCI floor for Alaska and the 1.0 PE
GPCI floor for frontier states are
permanent, and therefore, applicable in
CY 2015.
Comment: A few commenters
requested that we extend the 1.0 work
GPCI floor beyond March 31, 2015.
Response: As discussed in section
II.D.1, the 1.0 work GPCI floor is
established by statute and expires on
March 31, 2015. We do not have
authority to extend the 1.0 work GPCI
floor beyond March 31, 2015.
As discussed in the CY 2014 PFS final
rule with comment period (78 FR
74380) the updated GPCIs were
calculated by a contractor to CMS. We
used updated Bureau of Labor and
Statistics Occupational Employment
Statistics (BLS OES) data (2009 through
2011) as a replacement for 2006 through
2008 data for purposes of calculating the
work GPCI and the employee
compensation component and
purchased services component of the PE
GPCI. We also used updated U.S.
Census Bureau American Community
Survey (ACS) data (2008 through 2010)
as a replacement for 2006 through 2008
data for calculating the office rent
component of the PE GPCI. To calculate
the MP GPCI we used updated
malpractice premium data (2011 and
2012) from state departments of
insurance as a replacement for 2006
through 2007 premium data. We also
noted that we do not adjust the medical
equipment, supplies and other
miscellaneous expenses component of
the PE GPCI because we continue to
believe there is a national market for
these items such that there is not a
significant geographic variation in
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
relative costs. Additionally, we updated
the GPCI cost share weights consistent
with the modifications made to the
2006-based MEI cost share weights in
the CY 2014 final rule with comment
period. As discussed in the CY 2014
final rule with comment period, use of
the revised GPCI cost share weights
changed the weighting of the
subcomponents within the PE GPCI
(employee wages, office rent, purchased
services, and medical equipment and
supplies). For a detailed explanation of
how the GPCI update was developed,
see the CY 2014 final rule with
comment period (78 FR 74380 through
74391).
2. Proposed Changes to the GPCI Values
for the Virgin Islands Payment Locality
As discussed in the CY 2015 proposed
rule (79 FR 40355 through 40356) the
current methodology for calculating
locality level GPCIs relies on the
acquisition of county level data (when
available). Where data for a specific
county are not available, we assign the
data from a similar county within the
same payment locality. The Virgin
Islands have county level equivalents
identified as districts. Specifically, the
Virgin Islands are divided into 3
districts: Saint Croix; Saint Thomas; and
Saint John. These districts are, in turn,
subdivided into 20 sub-districts.
Although the Virgin Islands are divided
into these county equivalents, county
level data for the Virgin Islands are not
represented in the BLS OES wage data.
Additionally, the ACS, which is used to
calculate the rent component of the PE
GPCI, is not conducted in the Virgin
Islands, and we have not been able to
obtain malpractice insurance premium
data for the Virgin Islands payment
locality. Given the absence of county
level wage and rent data and the
insufficient malpractice premium data
by specialty type, we have historically
set the three GPCI values for the Virgin
Islands payment locality at 1.0.
For CY 2015, we explored using the
available data from the Virgin Islands to
more accurately reflect the geographic
cost differences for the Virgin Islands
payment locality as compared to other
PFS localities. Although county level
data for the Virgin Islands are not
represented in the BLS OES wage data,
aggregate territory level BLS OES wage
data are available. We believe that using
aggregate territory level data is a better
reflection of the relative cost differences
of operating a medical practice in the
Virgin Islands payment locality as
compared to other PFS localities than
the current approach of assigning a
value of 1.0. At our request, our
contractor calculated the work GPCI,
PO 00000
Frm 00051
Fmt 4701
Sfmt 4700
67597
and the employee wage component and
purchased services component of the PE
GPCI, for the Virgin Islands payment
locality using aggregated 2009 through
2011 BLS OES data.
As discussed in this section, the ACS
is not conducted in the Virgin Islands
and we have not been able to obtain
malpractice premium data for the Virgin
Islands payment locality. Therefore, we
assigned a value of 1.0 for the rent index
of the PE GPCI and to the MP GPCI.
Using aggregate territory-level BLS
OES wage data resulted in a ¥2.3
percent decrease in the work GPCI, a
¥4.48 percent decrease in the PE GPCI
and a ¥3.2 percent decrease to the GAF
for the Virgin Islands payment locality.
However, with the application of the 1.0
work GPCI floor, there is no change to
the work GPCI and the overall impact of
using actual BLS OES wage data on the
Virgin Islands payment locality is only
reflected by the change in PE GPCI
(¥4.48 percent) resulting in a ¥2.00
percent decrease to the GAF. As
mentioned previously in this section,
since we have not been able to obtain
malpractice premium data for the Virgin
Islands payment locality we maintained
the MP GPCI at 1.0. As such, we did not
propose any changes to the MP GPCI.
We requested comments on our
proposal to use aggregate territory-level
BLS OES wage data to calculate the
work GPCI and the employee wage
component and purchased services
component of the PE GPCI for the Virgin
Islands payment locality beginning for
CY 2015, and for future GPCI updates.
However, we did not receive any
specific comments on this proposal. As
discussed above, we believe that using
aggregate territory level BLS OES wage
data is a better reflection of the relative
cost differences of operating a medical
practice in the Virgin Islands payment
locality as compared to other PFS
localities than the current approach of
assigning a value of 1.0. Therefore, we
will finalize the changes to the GPCI
values for the Virgin Islands payment
locality as proposed. See Addenda D
and E for the CY 2015 GPCIs and
summarized GAFs. Additional
information on the changes to GPCI
values for the Virgin Islands payment
locality may be found in our
contractor’s report, ‘‘Revised Final
Report on the CY 2014 Update of the
Geographic Practice Cost Index for the
Medicare Physician Fee Schedule,’’
which is available on the CMS Web site.
It is located under the supporting
documents section of the CY 2015 PFS
final rule with comment period located
at https://www.cms.gov/
PhysicianFeeSched/.
E:\FR\FM\13NOR2.SGM
13NOR2
67598
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
3. Additional Comments
We received several comments on
topics that are not within the scope of
proposals in the CY 2015 PFS proposed
rule. These comments are briefly
discussed below.
Comment: Many commenters
continued to request an increase in the
GPCI values for the Puerto Rico
payment locality. The commenters
stated that the cost of practicing
medicine in Puerto Rico continues to
rise. The commenters believe that
commercial rent and utility costs, and
the cost of obtaining medical equipment
and supplies are higher in Puerto Rico
than many states and territories.
Commenters contend that the data used
to calculate GPCIs do not accurately
reflect the cost of operating a medical
practice in Puerto Rico.
Response: Aside from proposing to
use territory-wide wage data for the
Virgin Islands payment locality, we
finalized the methodology and values
for the 7th GPCI update in the CY 2014
PFS final rule with comment period. We
did not propose any changes to the
GPCIs for the Puerto Rico payment
locality, and the commenters on the CY
2015 PFS proposed rule raised the same
issues they raised in response to the
proposed GPCI update that we finalized
in CY 2014. In the CY 2014 PFS final
rule with comment period (78 FR 74380
through 74391), we summarized these
comments and responded to these
issues.
Comment: A few commenters stated
that GPCIs for rural areas are too low
which leads to reduced numbers of rural
practitioners and reduced access to care.
Two commenters stated that the PE
GPCI does not account for differences in
practice costs for x-rays and imaging
studies. The same commenters and
another commenter also requested that
we replace the current method for
calculating the work GPCIs with one
that reflects the labor market for
physicians and other health
professionals as recommended by
MedPAC. Another commenter raised
questions about state patient
compensation fund surcharges for
malpractice insurance and the
implications of those for the MP GPCI
values. Additionally, we received a
comment about the physician fee
schedule payment localities.
Response: As noted in this section, we
finalized the 7th GPCI update in the CY
2014 PFS final rule with comment
period and, other than the proposal
relating to the use of territory-wide wage
data for the Virgin Islands payment
locality, we did not propose any further
changes in the CY 2015 PFS proposed
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
rule. We will consider these points
raised by commenters when we develop
a proposal for the 8th GPCI update.
E. Medicare Telehealth Services
1. Billing and Payment for Telehealth
Services
Several conditions must be met in
order for Medicare payments to be made
for telehealth services under the PFS.
Specifically, the service must be on the
list of Medicare telehealth services and
meet all of the following additional
requirements for coverage:
• The service must be furnished via
an interactive telecommunications
system.
• The practitioner furnishing the
service must meet the telehealth
requirements, as well as the usual
Medicare requirements.
• The service must be furnished to an
eligible telehealth individual.
• The individual receiving the
services must be in an eligible
originating site.
When all of these conditions are met,
Medicare pays an originating site fee to
the originating site and provides
separate payment to the distant site
practitioner furnishing the service.
Section 1834(m)(4)(F)(i) of the Act
defines Medicare telehealth services to
include consultations, office visits,
office psychiatry services, and any
additional service specified by the
Secretary, when furnished via a
telecommunications system. We first
implemented this statutory provision,
which was effective October 1, 2001, in
the CY 2002 PFS final rule with
comment period (66 FR 55246). We
established a process for annual updates
to the list of Medicare telehealth
services as required by section
1834(m)(4)(F)(ii) of the Act in the CY
2003 PFS final rule with comment
period (67 FR 79988).
As specified at § 410.78(b), we
generally require that a telehealth
service be furnished via an interactive
telecommunications system. Under
§ 410.78(a)(3), an interactive
telecommunications system is defined
as multimedia communications
equipment that includes, at a minimum,
audio and video equipment permitting
two-way, real-time interactive
communication between the patient and
distant site physician or practitioner.
Telephones, facsimile machines, and
electronic mail systems do not meet the
definition of an interactive
telecommunications system. An
interactive telecommunications system
is generally required as a condition of
payment; however, section 1834(m)(1)
of the Act allows the use of
PO 00000
Frm 00052
Fmt 4701
Sfmt 4700
asynchronous ‘‘store-and-forward’’
technology when the originating site is
part of a federal telemedicine
demonstration program in Alaska or
Hawaii. As specified in regulations at
§ 410.78(a)(1), store-and-forward means
the asynchronous transmission of
medical information from an originating
site to be reviewed at a later time by the
practitioner at the distant site.
Medicare telehealth services may be
furnished to an eligible telehealth
individual notwithstanding the fact that
the practitioner furnishing the
telehealth service is not at the same
location as the beneficiary. An eligible
telehealth individual means an
individual enrolled under Part B who
receives a telehealth service furnished at
an originating site.
Practitioners furnishing Medicare
telehealth services are reminded that
these services are subject to the same
non-discrimination laws as other
services, including the effective
communication requirements for
persons with disabilities of section 504
of the Rehabilitation Act and language
access for persons with limited English
proficiency, as required under Title VI
of the Civil Rights Act of 1964. For more
information, see https://www.hhs.gov/
ocr/civilrights/resources/specialtopics/
hospitalcommunication.
Practitioners furnishing Medicare
telehealth services submit claims for
telehealth services to the Medicare
Administrative Contractors that process
claims for the service area where their
distant site is located. Section
1834(m)(2)(A) of the Act requires that a
practitioner who furnishes a telehealth
service to an eligible telehealth
individual be paid an amount equal to
the amount that the practitioner would
have been paid if the service had been
furnished without the use of a
telecommunications system.
Originating sites, which can be one of
several types of sites specified in the
statute where an eligible telehealth
individual is located at the time the
service is being furnished via a
telecommunications system, are paid a
fee under the PFS for each Medicare
telehealth service. The statute specifies
both the types of entities that can serve
as originating sites and the geographic
qualifications for originating sites. With
regard to geographic qualifications,
§ 410.78(b)(4) limits originating sites to
those located in rural health
professional shortage areas (HPSAs) or
in a county that is not included in a
metropolitan statistical areas (MSAs).
Historically, we have defined rural
HPSAs to be those located outside of
MSAs. Effective January 1, 2014, we
modified the regulations regarding
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
originating sites to define rural HPSAs
as those located in rural census tracts as
determined by the Office of Rural
Health Policy (ORHP) of the Health
Resources and Services Administration
(HRSA) (78 FR 74811). Defining ‘‘rural’’
to include geographic areas located in
rural census tracts within MSAs allows
for broader inclusion of sites within
HPSAs as telehealth originating sites.
Adopting the more precise definition of
‘‘rural’’ for this purpose expands access
to health care services for Medicare
beneficiaries located in rural areas.
HRSA has developed a Web site tool to
provide assistance to potential
originating sites to determine their
geographic status. To access this tool,
see the CMS Web site at www.cms.gov/
telehealth/.
An entity participating in a federal
telemedicine demonstration project that
has been approved by, or received
funding from, the Secretary as of
December 31, 2000 is eligible to be an
originating site regardless of its
geographic location.
Effective January 1, 2014, we also
changed our policy so that geographic
eligibility for an originating site would
be established and maintained on an
annual basis, consistent with other
telehealth payment policies (78 FR
74400). Geographic eligibility for
Medicare telehealth originating sites for
each calendar year is now based upon
the status of the area as of December 31
of the prior calendar year.
For a detailed history of telehealth
payment policy, see 78 FR 74399.
2. Adding Services to the List of
Medicare Telehealth Services
As noted previously, in the December
31, 2002 Federal Register (67 FR
79988), we established a process for
adding services to or deleting services
from the list of Medicare telehealth
services. This process provides the
public with an ongoing opportunity to
submit requests for adding services.
Under this process, we assign any
qualifying request to make additions to
the list of telehealth services to one of
two categories. Revisions to criteria that
we use to review requests in the second
category were finalized in the November
28, 2011 Federal Register (76 FR
73102). The two categories are:
• Category 1: Services that are similar
to professional consultations, office
visits, and office psychiatry services that
are currently on the list of telehealth
services. In reviewing these requests, we
look for similarities between the
requested and existing telehealth
services for the roles of, and interactions
among, the beneficiary, the physician
(or other practitioner) at the distant site
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
and, if necessary, the telepresenter, a
practitioner with the beneficiary in the
originating site. We also look for
similarities in the telecommunications
system used to deliver the proposed
service; for example, the use of
interactive audio and video equipment.
• Category 2: Services that are not
similar to the current list of telehealth
services. Our review of these requests
includes an assessment of whether the
service is accurately described by the
corresponding code when furnished via
telehealth and whether the use of a
telecommunications system to deliver
the service produces demonstrated
clinical benefit to the patient. In
reviewing these requests, we look for
evidence indicating that the use of a
telecommunications system in
furnishing the candidate telehealth
service produces clinical benefit to the
patient. Submitted evidence should
include both a description of relevant
clinical studies that demonstrate the
service furnished by telehealth to a
Medicare beneficiary improves the
diagnosis or treatment of an illness or
injury or improves the functioning of a
malformed body part, including dates
and findings, and a list and copies of
published peer reviewed articles
relevant to the service when furnished
via telehealth. Our evidentiary standard
of clinical benefit does not include
minor or incidental benefits.
Some examples of clinical benefit
include the following:
• Ability to diagnose a medical
condition in a patient population
without access to clinically appropriate
in-person diagnostic services.
• Treatment option for a patient
population without access to clinically
appropriate in-person treatment options.
• Reduced rate of complications.
• Decreased rate of subsequent
diagnostic or therapeutic interventions
(for example, due to reduced rate of
recurrence of the disease process).
• Decreased number of future
hospitalizations or physician visits.
• More rapid beneficial resolution of
the disease process treatment.
• Decreased pain, bleeding, or other
quantifiable symptom.
• Reduced recovery time.
For the list of covered telehealth
services, see the CMS Web site at
www.cms.gov/teleheath/. Requests to
add services to the list of Medicare
telehealth services must be submitted
and received no later than December 31
of each calendar year to be considered
for the next rulemaking cycle. For
example, qualifying requests submitted
before the end of CY 2014 will be
considered for the CY 2016 proposed
rule. Each request to add a service to the
PO 00000
Frm 00053
Fmt 4701
Sfmt 4700
67599
list of Medicare telehealth services must
include any supporting documentation
the requester wishes us to consider as
we review the request. Because we use
the annual PFS rulemaking process as a
vehicle for making changes to the list of
Medicare telehealth services, requestors
should be advised that any information
submitted is subject to public disclosure
for this purpose. For more information
on submitting a request for an addition
to the list of Medicare telehealth
services, including where to mail these
requests, see the CMS Web site at
www.cms.gov/telehealth/.
3. Submitted Requests to the List of
Telehealth Services for CY 2015
Under our existing policy, we add
services to the telehealth list on a
category 1 basis when we determine that
they are similar to services on the
existing telehealth list with respect to
the roles of, and interactions among, the
beneficiary, physician (or other
practitioner) at the distant site and, if
necessary, the telepresenter. As we
stated in the CY 2012 final rule with
comment period (76 FR 73098), we
believe that the category 1 criteria not
only streamline our review process for
publicly requested services that fall into
this category, the criteria also expedite
our ability to identify codes for the
telehealth list that resemble those
services already on this list.
a. Submitted Requests
We received several requests in CY
2013 to add various services as
Medicare telehealth services effective
for CY 2015. The following presents a
discussion of these requests, and our
proposals for additions to the CY 2015
telehealth list. Of the requests received,
we find that the following services are
sufficiently similar to psychiatric
diagnostic procedures or office/
outpatient visits currently on the
telehealth list to qualify on a category
one basis. Therefore, we propose to add
the following services to the telehealth
list on a category 1 basis for CY 2015:
• CPT codes 90845 (Psychoanalysis);
90846 (family psychotherapy (without
the patient present); and 90847 (family
psychotherapy (conjoint psychotherapy)
(with patient present);
• CPT codes 99354 (prolonged service
in the office or other outpatient setting
requiring direct patient contact beyond
the usual service; first hour (list
separately in addition to code for office
or other outpatient evaluation and
management service); and, 99355
(prolonged service in the office or other
outpatient setting requiring direct
patient contact beyond the usual
service; each additional 30 minutes (list
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67600
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
separately in addition to code for
prolonged service); and,
• HCPCS codes G0438 (annual
wellness visit; includes a personalized
prevention plan of service (pps), initial
visit; and, G0439 (annual wellness visit,
includes a personalized prevention plan
of service (pps), subsequent visit).
We also received requests to add
services to the telehealth list that do not
meet our criteria for being on the
Medicare telehealth list. We did not
propose to add the following procedures
for the reasons noted:
• CPT codes 92250 (fundus
photography with interpretation and
report); 93010 (electrocardiogram,
routine ECG with at least 12 leads;
interpretation and report only), 93307
(echocardiography, transthoracic, realtime with image documentation (2d),
includes m-mode recording, when
performed, complete, without spectral
or color Doppler echocardiography;
93308 (echocardiography, transthoracic,
real-time with image documentation
(2d), includes m-mode recording, when
performed, follow-up or limited study);
93320 (Doppler echocardiography,
pulsed wave and/or continuous wave
with spectral display (list separately in
addition to codes for echocardiographic
imaging); complete); 93321 (Doppler
echocardiography, pulsed wave and/or
continuous wave with spectral display
(list separately in addition to codes for
echocardiographic imaging); follow-up
or limited study (list separately in
addition to codes for echocardiographic
imaging); and 93325 (Doppler
echocardiography color flow velocity
mapping (list separately in addition to
codes for echocardiography). These
services include a technical component
(TC) and a professional component (PC).
By definition, the TC portion of these
services needs to be furnished in the
same location as the patient and thus
cannot be furnished via telehealth. The
PC portion of these services could be
(and typically would be) furnished
without the patient being present in the
same location. (Note: For services that
have a TC and a PC, there is sometimes
an entirely different code that is used
when only the PC portion of the service
is being furnished, and other times the
same CPT code is used with a –26
modifier to indicate that only the PC is
being billed.) For example, the
interpretation by a physician of an
actual electrocardiogram or
electroencephalogram tracing that has
been transmitted electronically, can be
furnished without the patient being
present in the same location as the
physician. Given the nature of these
services, it is not necessary to consider
including the PC of these services for
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
addition to the telehealth list. When
these PC services are furnished
remotely, they do not meet the
definition of Medicare telehealth
services under section 1834(m) of the
Act. Rather, these remote services are
considered physicians’ services in the
same way as services that are furnished
in-person without the use of
telecommunications technology; they
are paid under the same conditions as
in-person physicians’ services (with no
requirements regarding permissible
originating sites), and should be
reported in the same way as other
physicians’ services (that is, without the
–GT or –GQ modifiers).
• CPT codes 96103 (psychological
testing (includes psychodiagnostic
assessment of emotionality, intellectual
abilities, personality and
psychopathology, eg, MMPI),
administered by a computer, with
qualified health care professional
interpretation and report); and, 96120
(neuropsychological testing (eg,
Wisconsin Card Sorting Test),
administered by a computer, with
qualified health care professional
interpretation and report). These
services involve testing by computer,
can be furnished remotely without the
patient being present, and are payable in
the same way as other physicians’
services. These remote services are not
Medicare telehealth services as defined
under the Act; therefore, we need not
consider them for addition to the
telehealth list, and the restrictions that
apply to telehealth services do not apply
to these services.
• CPT codes 90887 (interpretation or
explanation of results of psychiatric,
other medical examinations and
procedures, or other accumulated data
to family or other responsible persons,
or advising them how to assist patient);
99090 (analysis of clinical data stored in
computers (eg, ECGs, blood pressures,
hematologic data); 99091 (collection and
interpretation of physiologic data (eg,
ECG, blood pressure, glucose
monitoring) digitally stored and/or
transmitted by the patient and/or
caregiver to the physician or other
qualified health care professional,
qualified by education, training,
licensure/regulation (when applicable)
requiring a minimum of 30 minutes of
time); 99358 (prolonged evaluation and
management service before and/or after
direct patient care; first hour); and
99359 (prolonged evaluation and
management service before and/or after
direct patient care; each additional 30
minutes (list separately in addition to
code for prolonged service). These
services are not separately payable by
Medicare. It would be inappropriate to
PO 00000
Frm 00054
Fmt 4701
Sfmt 4700
include services as telehealth services
when Medicare does not otherwise
make a separate payment for them.
• CPT codes 96101 (psychological
testing (includes psychodiagnostic
assessment of emotionality, intellectual
abilities, personality and
psychopathology, eg, MMPI, Rorschach,
WAIS), per hour of the psychologist’s or
physician’s time, both face-to-face time
administering tests to the patient and
time interpreting these test results and
preparing the report); 96102
(psychological testing (includes
psychodiagnostic assessment of
emotionality, intellectual abilities,
personality and psychopathology, eg,
MMPI and WAIS), with qualified health
care professional interpretation and
report, administered by technician, per
hour of technician time, face-to-face);
96118 (neuropsychological testing (eg,
Halstead-Reitan Neuropsychological
Battery, Wechsler Memory Scales and
Wisconsin Card Sorting Test), per hour
of the psychologist’s or physician’s
time, both face-to-face time
administering tests to the patient and
time interpreting these test results and
preparing the report); and, 96119
(neuropsychological testing (eg,
Halstead-Reitan Neuropsychological
Battery, Wechsler Memory Scales and
Wisconsin Card Sorting Test), with
qualified health care professional
interpretation and report, administered
by technician, per hour of technician
time, face-to-face). These services are
not similar to other services on the
telehealth list, as they require close
observation of how a patient responds.
The requestor did not submit evidence
supporting the clinical benefit of
furnishing these services on a category
2 basis. As such, we did not propose to
add these services to the list of
telehealth services.
• CPT codes 57452 (colposcopy of the
cervix including upper/adjacent vagina;
57454 colposcopy of the cervix
including upper/adjacent vagina; with
biopsy(s) of the cervix and endocervical
curettage); and, 57460 (colposcopy of
the cervix including upper/adjacent
vagina; with loop electrode biopsy(s) of
the cervix). These services are not
similar to other services on the
telehealth service list. Therefore, it
would not be appropriate to add them
on a category 1 basis. The requestor did
not submit evidence supporting the
clinical benefit of furnishing these
services on a category 2 basis. As such,
we did not propose to add these services
to the list of telehealth services.
• HCPCS code M0064 (brief office
visit for the sole purpose of monitoring
or changing drug prescriptions used in
the treatment of mental psychoneurotic
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
and personality disorders) is being
deleted for CY 2015. This code was
created specifically to describe a service
that is not subject to the statutory
outpatient mental health limitation,
which limited payment amounts for
certain mental health services. Section
102 of the Medicare Improvements for
Patients and Providers Act (Pub. L. 110–
275, enacted on July 15, 2008) (MIPPA)
required that the limitation on payment
for outpatient mental health treatment
to 62.5 percent of incurred expenses, in
effect since the inception of the
Medicare program, be reduced over four
years. This limitation on payment for
mental health treatment created a higher
share of beneficiary coinsurance for
these services than for most other
Medicare services paid under the PFS.
Effective January 1, 2014, 100 percent of
expenses incurred for mental health
treatment services are considered as
incurred for purposes of Medicare,
resulting in the same beneficiary cost
sharing for these services as for other
PFS services. Since the statute was
amended to phase out the limitation,
and the phase-out was complete
effective January 1, 2014, Medicare no
longer has a need to distinguish services
subject to the mental health limitation
from those that are not. Accordingly, the
appropriate CPT code can now be used
to bill Medicare for the services that
would have otherwise been reported
using M0064 and M0064 will be
eliminated as a telehealth service,
effective January 1, 2015.
• Urgent Dermatologic Problems and
Wound Care—The American
Telemedicine Association (ATA) cited
several studies to support adding
dermatology services to the telehealth
list. However, the request did not
include specific codes. Since we did not
have specific codes to consider for this
request, we cannot evaluate whether the
services are appropriate for addition to
the Medicare telehealth services list. We
note that some of the services that the
requester had in mind may be billed
under the telehealth office visit codes or
the telehealth consultation G-codes.
In summary, we proposed to add the
following codes to the telehealth list on
a category 1 basis:
• Psychotherapy services CPT codes
90845, 90846 and 90847.
• Prolonged service office CPT codes
99354 and 99355.
• Annual wellness visit HCPCS codes
G0438 and G0439.
3. Modifying § 410.78 Regarding List of
Telehealth Services
As discussed in section II.E.2. of this
final rule with comment period, under
the statute, we created an annual
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
process for considering the addition of
services to the Medicare telehealth list.
Under this process, we propose services
to be added to the list in the proposed
rule in response to public nominations
or our own initiative and seek public
comments on our proposals. After
consideration of public comments, we
finalize additions to the list in the final
rule. We have also revised § 410.78(b)
each year to include the description of
the added services. Because the list of
Medicare telehealth services has grown
quite lengthy, and given the other
mechanisms by which we can make the
public aware of the list of Medicare
telehealth services for each year, we
proposed to revise § 410.78(b) by
deleting the description of the
individual services for which Medicare
payment can be made when furnished
via telehealth. Under this proposal, we
would continue our current policy to
address requests to add to the list of
telehealth services through the PFS
rulemaking process so that the public
would have the opportunity to comment
on additions to the list. We also
proposed to revise § 410.78(f) to indicate
that a list of Medicare telehealth codes
and descriptors is available on the CMS
Web site.
The following is a summary of the
comments we received regarding the
proposed addition of services to the list
of Medicare telehealth services.
Comment: All commenters supported
one or more of our proposals to add
psychotherapy services (CPT codes
90845, 90846 and 90847); prolonged
service office (CPT codes 99354 and
99355); and annual wellness visit
(HCPCS codes G0438 and G0439) to the
list of Medicare telehealth services for
CY 2015.
Response: We appreciate the
commenters’ support for the proposed
additions to the list of Medicare
telehealth services. After consideration
of the public comments received, we are
finalizing our CY 2015 proposal to add
these services to the list of telehealth
services for CY 2015 on a category 1
basis.
Comment: Commenters also agreed
with our rationale for rejecting other
requested additions to the telehealth
list. However, one commenter disagreed
with our decision not to propose adding
dermatology services, including those
furnished using store-and-forward
technology, to the list of telehealth
services. Another commenter objected
to our proposal not to add psychological
testing services to the telehealth services
list.
Response: As we noted in the
proposed rule, the request to add
dermatology services did not include
PO 00000
Frm 00055
Fmt 4701
Sfmt 4700
67601
specific codes. Without specific codes to
consider, we cannot evaluate whether
the services are appropriate for addition
to the Medicare telehealth services list.
We note that some of the services that
the requester had in mind may be billed
under the telehealth office visit codes or
the telehealth consultation G–codes.
Concerning payment for services
furnished using store-and-forward
technology, we note that the statute at
section 1861(m) of the Act includes
store-and-forward technology as a
telecommunication system for
telehealth services only in the case of
federal telemedicine demonstration
programs in Alaska and Hawaii (see
§ 410.78(d)).
Concerning psychological testing
services, we noted that remote services
(CPT codes 96103 and 96120) are not
Medicare telehealth services as defined
under the Act and thus can be furnished
when beneficiary is not in the same
place as the practitioner. It would also
be counter-productive to add these
codes to the telehealth list because, if
we did, the telehealth originating site,
geographic, and other restrictions would
apply to these services.
CPT codes 90887, 90991, 93358 and
99359 are not separately payable by
Medicare. It would be inappropriate to
include services as telehealth services
when Medicare does not otherwise
make a separate payment for them.
Finally, CPT codes 96101, 96102,
96118 and 96119 are not similar to other
services on the telehealth list, as they
require close observation of how a
patient responds. The requestor did not
submit evidence supporting the clinical
benefit of furnishing these services on a
category 2 basis. As such, we did not
propose to add these services to the list
of telehealth services.
We received other public comments
on matters related to Medicare
telehealth services that were not the
subject of proposals in the CY 2015 PFS
proposed rule. Because we did not make
any proposals regarding these matters,
we generally do not summarize or
respond to such comments in the final
rule. However, we are summarizing and
responding to the following comments
to acknowledge the interests and
concerns of the commenters, and a
mechanism to address some of those
concerns.
Many commenters supported the
overall expansion of telehealth by:
• Removing geographic restrictions to
include both rural and urban areas.
• Revising permissible originating
sites to include a patient’s home,
domiciliary care and first responder
vehicles.
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67602
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
• Adopting a broader definition of
telehealth technologies to include
services provide via mobile technology,
including emails, phone calls, and storeand-forward technologies.
• Adding physical and occupational
therapists as practitioners who can
remotely furnish telehealth services.
• Adding more services to the
telehealth list, including services under
category 2.
• Prioritizing coverage of services that
include care coordination with the
patient’s medical home and/or existing
treating physicians.
• Considering the use of telehealth
technology for the purpose of furnishing
direct supervision of services furnished
by on-site practitioners.
• Using demonstration projects under
CMS’s Center for Medicare and
Medicaid Innovation (CMMI) to collect
clinical evidence on the effect of
expanding telehealth and to address
how telemedicine can be integrated into
new payment and delivery models.
Response: We appreciate the
commenters’ suggestions. As some
commenters noted, we do not have
authority to implement many of these
revisions under the current statute. The
CMS Innovation Center is responsible
for developing and testing new payment
and service delivery models to lower
costs and improve quality for Medicare,
Medicaid, and CHIP beneficiaries. As
part of that authority, the CMS
Innovation Center can consider
potential new payment and service
delivery models to test changes to
Medicare’s telehealth payment policies.
In summary, after consideration of the
comments we received, we are
finalizing our proposal to add
psychotherapy services CPT codes
90845, 90846 and 90847; prolonged
service office CPT codes 99354 and
99355; and annual wellness visit HCPCS
codes G0438 and G0439 to the list of
Medicare telehealth services.
In addition, we are finalizing our
proposal to change our regulation at
§ 410.78(b) by deleting the description
of the individual services for which
Medicare payment can be made when
furnished via telehealth. We will
continue our current policy to address
requests to add services to the list of
Medicare telehealth services through the
PFS rulemaking process so that the
public has the opportunity to comment
on additions to the list. We are also
finalizing our proposal to revise
§ 410.78(f) to indicate that a list of
Medicare telehealth codes and
descriptors is available on the CMS Web
site.
We remind all interested stakeholders
that we are currently soliciting public
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
requests to add services to the list of
Medicare telehealth services. To be
considered during PFS rulemaking for
CY 2016, these requests must be
submitted and received by December 31,
2014. Each request to add a service to
the list of Medicare telehealth services
must include any supporting
documentation the requester wishes us
to consider as we review the request.
For more information on submitting a
request for an addition to the list of
Medicare telehealth services, including
where to mail these requests, we refer
readers to the CMS Web site at
www.cms.gov/telehealth/.
5. Telehealth Originating Site Facility
Fee Payment Amount Update
Section 1834(m)(2)(B) of the Act
establishes the Medicare telehealth
originating site facility fee for telehealth
services furnished from October 1, 2001,
through December 31 2002, at $20.00.
For telehealth services furnished on or
after January 1 of each subsequent
calendar year, the telehealth originating
site facility fee is increased by the
percentage increase in the MEI as
defined in section 1842(i)(3) of the Act.
The MEI increase for 2015 is 0.8
percent. Therefore, for CY 2015, the
payment amount for HCPCS code Q3014
(Telehealth originating site facility fee)
is 80 percent of the lesser of the actual
charge or $24.83. The Medicare
telehealth originating site facility fee
and MEI increase by the applicable time
period is shown in Table 13.
TABLE 13—THE MEDICARE TELEHEALTH ORIGINATING SITE FACILITY
FEE AND MEI INCREASE BY THE APPLICABLE TIME PERIOD
Facility
fee
MEI
increase
$20.00 ...
N/A
20.60 ...
3.0
21.20 ...
2.9
21.86 ...
3.1
22.47 ...
2.8
22.94 ...
2.1
23.35 ...
1.8
23.72 ...
1.6
24.00 ...
1.2
24.10 ...
0.4
24.24 ...
0.6
PO 00000
Frm 00056
Fmt 4701
Period
10/01/2001–12/31/
2002
01/01/2003–12/31/
2003
01/01/2004–12/31/
2004
01/01/2005–12/31/
2005
01/01/2006–12/31/
2006
01/01/2007–12/31/
2007
01/01/2008–12/31/
2008
01/01/2009–12/31/
2009
01/01/2010–12/31/
2010
01/01/2011–12/31/
2011
01/01/2012–12/31/
2012
Sfmt 4700
TABLE 13—THE MEDICARE TELEHEALTH ORIGINATING SITE FACILITY
FEE AND MEI INCREASE BY THE APPLICABLE TIME PERIOD—Continued
Facility
fee
MEI
increase
24.43 ...
0.8
24.63 ...
0.8
24.83 ...
0.8
Period
01/01/2013–12/31/
2013
01/01/2014–12/31/
2014
01/01/2015–12/31/
2015
F. Valuing New, Revised and Potentially
Misvalued Codes
Establishing valuations for newly
created and revised CPT codes is a
routine part of maintaining the PFS.
Since inception of the PFS, it has also
been a priority to revalue services
regularly to assure that the payment
rates reflect the changing trends in the
practice of medicine and current prices
for inputs used in the PE calculations.
Initially, this was accomplished
primarily through the five-year review
process, which resulted in revised RVUs
for CY 1997, CY 2002, CY 2007, and CY
2012. Under the five-year review
process, revisions in RVUs were
proposed in a proposed rule and
finalized in a final rule. In addition to
the five-year reviews, in each year
beginning with CY 2009, CMS and the
RUC have identified a number of
potentially misvalued codes using
various identification screens, such as
codes with high growth rates, codes that
are frequently billed together, and high
expenditure codes. Section 3134 of the
Affordable Care Act codified the
misvalued code initiative in section
1848(c)(2)(K) of the Act.
In the CY 2012 rulemaking process,
we proposed and finalized
consolidation of the five-year review
and the potentially misvalued code
activities into an annual review of
potentially misvalued codes to avoid
redundancies in these efforts and better
accomplish our goal of assuring regular
assessment of code values. Under the
consolidated process, we issue interim
final RVUs for all revaluations and new
codes in the PFS final rule with
comment period, and make payment
based upon those values during the
calendar year covered by the final rule.
(Changes in the PFS methodology that
may affect valuations of a variety of
codes are issued as proposals in the
proposed rule.) We consider and
respond to any public comments on the
interim final values in the final rule
with comment period for the subsequent
year. When consolidating these
processes, we indicated that it was
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
appropriate to establish interim values
for new, revised, and potentially
misvalued codes because of the
incongruity between the PFS
rulemaking cycle and the release of
codes by the AMA CPT Editorial Panel
and the RUC review process. We stated
that if we did not establish interim final
values for revalued codes in the final
rule with comment period, ‘‘a delay in
implementing revised values for codes
that have been identified as misvalued
would perpetuate payment for the
services at a rate that does not
appropriately reflect the relative
resources involved in furnishing the
service and would continue
unwarranted distortion in the payment
for other services across the PFS.’’ We
also reiterated that if we did not
establish interim final values for new
and revised codes, we would either
have to delay the use of new and revised
codes for one year, or permit each
Medicare contractor to establish its own
payment rate for these codes. We stated,
‘‘We believe it would be contrary to the
public interest to delay adopting values
for new and revised codes for the initial
year, especially since we have an
opportunity to receive significant input
from the medical community [through
the RUC] before adopting the values,
and the alternatives could produce
undesirable levels of uncertainty and
inconsistency in payment for a year.’’
ebenthall on DSK5SPTVN1PROD with $$_JOB
1. Current Process for Valuing New,
Revised, and Potentially Misvalued
Codes
Under the process finalized in the CY
2012 PFS final rule with comment
period, in each year’s proposed rule, we
propose specific codes and/or groups of
codes that we believe may be
appropriate to consider under our
potentially misvalued code initiative.
As part of our process for developing
the list of proposed potentially
misvalued codes, we consider public
nominations for potentially misvalued
codes under a process also established
in the CY 2012 PFS final rule with
comment period. If appropriate, we
include such codes in our proposed
potentially misvalued code list. In the
proposed rule, we solicit comments on
the proposed potentially misvalued
codes. We then respond to comments
and establish a final list of potentially
misvalued codes in the final rule for
that year. These potentially misvalued
codes are reviewed and revalued, if
appropriate, in subsequent years. In
addition, the RUC regularly identifies
potentially misvalued codes using
screens that have previously been
identified by CMS, such as codes
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
performed together more than 75
percent of the time.
Generally, the first step in revaluing
codes that have been identified as
potentially misvalued is for the RUC to
review these codes through its standard
process, which includes active
involvement of national specialty
societies for the specialties that
ordinarily use the codes. Frequently, the
RUC’s discussion of potentially
misvalued codes will lead the CPT
Editorial Panel to make adjustments to
the codes involved, such as bundling of
codes, creation of new codes or
revisions of code descriptors. The AMA
has estimated that 75 percent of all
annual CPT coding changes result from
the potentially misvalued code
initiative.
The RUC provides CMS with
recommendations for the work values
and direct PE inputs for the codes we
have identified as potentially misvalued
codes or, in the case of a coding
revision, for the new or revised codes
that will replace these potentially
misvalued codes. (This process is also
applied to codes that the RUC identifies
using code screens that we have
identified, and to new or revised codes
that are issued for reasons unrelated to
the potentially misvalued code process.)
Generally, we receive the RUC
recommendations concurrently for all
codes in the same family as the
potentially misvalued code(s). We
believe it is important to evaluate and
establish appropriate work and MP
RVUs and direct PE inputs for an entire
code family at the same time to avoid
rank order anomalies and to maintain
appropriate relativity among codes. We
generally receive the RUC
recommendations for the code or
replacement code(s) within a year or
two following the identification of the
code as potentially misvalued.
We consider the RUC
recommendations along with other
information that we have, including
information submitted by other
stakeholders, and establish interim final
RVUs for the potentially misvalued
codes, new codes, and any other codes
for which there are coding changes in
the final rule with comment period for
a year. There is a 60-day period for the
public to comment on those interim
final values after we issue the final rule.
For services furnished during the
calendar year following the publication
of interim final rates, we pay for
services based upon the interim final
values established in the final rule. In
the final rule with comment period for
the subsequent year, we consider and
respond to public comments received
on the interim final values, and make
PO 00000
Frm 00057
Fmt 4701
Sfmt 4700
67603
any appropriate adjustments to values
based on those comments. We then
typically finalize the values for the
codes.
As we discussed in the CY 2012 PFS
final rule with comment period, we
adopted this consolidated review
process to combine all coding
revaluations into one annual process
allowing for appropriate consideration
of relativity in and across code families.
In addition, this process assures that we
have the benefit of the RUC
recommendations for all codes being
valued.
2. Concerns With Current Process
Some stakeholders who have
experienced reductions in payments as
the result of interim final valuations
have objected to the process by which
we revise or establish values for new,
revised, and potentially misvalued
codes. Some have stated that they did
not receive notice of the possible
reductions before they occurred.
Generally, stakeholders are aware that
we are considering changes in the
payment rates for particular services
either because CPT has made changes to
codes or because we have identified the
codes as potentially misvalued. As the
RUC considers the appropriate value for
a service, representatives of the
specialties that use the codes are
involved in the process. The RUC
usually surveys physicians or other
practitioners who furnish the services
described by the codes regarding the
time it takes to furnish the services, and
representatives of the specialty(ies) also
participate in the RUC meetings where
recommendations for work RVUs and
direct PE inputs are considered.
Through this process, representatives of
the affected specialties are generally
aware of the RUC recommendations.
Some stakeholders have stated that
even when they are aware that the RUC
has made recommendations, they have
no opportunity to respond to the RUC
recommendations before we consider
them in adopting interim final values
because the RUC actions and
recommendations are not public. Some
stakeholders have also said that the
individuals who participate in the RUC
review process are not able to share the
recommendations because they have
signed a confidentiality agreement. We
note, however, that at least one specialty
society has raised funds via its Web site
to fight a ‘‘pending cut’’ based upon its
knowledge of RUC recommendations for
specific codes prior to CMS action on
the recommendation. Additionally,
some stakeholders have pointed out that
some types of suppliers that are paid
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67604
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
under the PFS are not permitted to
participate in the RUC process at all.
We recognize that some stakeholders,
including those practitioners
represented by societies that are not
participants in the RUC process, may
not be aware of the specifics of the RUC
recommendations before we consider
them in establishing interim final values
for new, revised, and potentially
misvalued codes. We note that, as
described above, before we review a
service as a potentially misvalued code,
we go through notice and comment
rulemaking to identify it as a potentially
misvalued code. Thus, the public has
notice and an opportunity to comment
on whether we should review the values
for a code before we finalize the code as
potentially misvalued and begin the
valuation process. As a result, all
stakeholders should be aware that a
particular code is being considered as
potentially misvalued and that we may
establish revised interim final values in
a subsequent final rule with comment
period. As noted above, there may be
some codes for which we receive RUC
recommendations based upon their
identification by the RUC through code
screens that we establish. These codes
are not specifically identified by CMS
through notice and comment
rulemaking as potentially misvalued
codes. We recognize that if stakeholders
are not monitoring RUC activities or
evaluating Medicare claims data, they
may be unaware that these codes are
being reviewed and could be revalued
on an interim final basis in a final rule
with comment period for a year.
In recent years, we have increased our
scrutiny of the RUC recommendations
and have increasingly found cause to
modify the values recommended by the
RUC in establishing interim final values
under the PFS. Sometimes we also find
it appropriate, on an interim final basis,
to refine how the CPT codes are to be
used for Medicare services or to create
G-codes for reporting certain services to
Medicare. Some stakeholders have
objected to such interim final decisions
because they do not learn of the CMS
action until the final rule with comment
period is issued. Stakeholders said that
they do not have an opportunity to
meaningfully comment and for CMS to
address their comments before the
coding or valuation decision takes
effect.
We received comments on the CY
2014 PFS final rule with comment
period suggesting that the existing
process for review and adoption of
interim final values for new, revised,
and misvalued codes violates section
1871(a)(2) of the Act, which prescribes
the rulemaking requirements for the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
agency in establishing payment rates. In
response to those commenters, we note
that the process we use to establish
interim final rates is in full accordance
with the statute and we do not find this
a persuasive reason to consider
modifying the process that we use to
establish PFS rates.
Our recent revaluation of the four
epidural injection codes provides an
example of the concerns that have been
expressed with the existing process. In
the CY 2014 PFS final rule with
comment period, we established interim
final values for four epidural injection
codes, which resulted in payment
reductions for the services when
furnished in the office setting of
between 35 percent and 56 percent. (In
the facility setting, the reductions
ranged from 17 percent to 33 percent.)
One of these codes had been identified
as a potentially misvalued code 2 years
earlier. The affected specialties had
been involved in the RUC process and
were generally aware that the family of
codes would be revalued on an interim
basis in an upcoming rule. They were
also aware that the RUC had made
significant changes to the direct PE
inputs, including removal of the
radiographic-fluoroscopy room, which
explains, in large part, the reduction to
values in the office setting. The societies
representing the affected specialty were
also aware of significant reductions in
the RUC-recommended ‘‘time’’ to
furnish the procedures based on the
most recent survey of practitioners who
furnish the services, which resulted in
reductions in both the work and PE
portion of the values. Although the
specialties were aware of the changes
that the RUC was recommending to
direct PE inputs, they were not
specifically aware of how those changes
would affect the values and payment
rate. In addition, we decreased the work
RVUs for these procedures because we
found the RUC-recommended work
RVUs did not adequately reflect the
RUC-recommended decreases in time.
This decision is consistent with our
general practice when the best available
information shows that the time
involved in furnishing the service has
decreased, and in the absence of
information suggesting an increase in
work intensity. Since the interim final
values for these codes were issued in
the CY 2014 PFS final rule with
comment period, we have received
numerous comments that will be useful
to us as we consider finalizing values
for these codes. If we had followed a
process that involved proposing values
for these codes in a proposed rule, we
would have been able to consider the
PO 00000
Frm 00058
Fmt 4701
Sfmt 4700
additional information contained in
these comments prior to making
payments for the services based upon
revised values. (See section II.B.3.b.(2)
of this final rule with comment period
for a discussion of proposed valuation
of these epidural injection codes for CY
2015.)
3. Alternatives to the Current Process
In the proposed rule, we noted that
given our heightened review of the RUC
recommendations and the increased
concerns expressed by some
stakeholders, we believed that an
assessment of our process for valuing
these codes was warranted. To that end,
we considered potential alternatives to
address the timing and rulemaking
issues associated with establishing
values for new, revised and potentially
misvalued codes (as well as for codes
within the same families as these
codes). Specifically, we explored three
alternatives to our current approach:
• Propose work and MP RVUs and
direct PE inputs for all new, revised and
potentially misvalued codes in a
proposed rule.
• Propose changes in work and MP
RVUs and direct PE inputs in the
proposed rule for new, revised, and
potentially misvalued codes for which
we receive RUC recommendations in
time; continue to establish interim final
values in the final rule for other new,
revised, and potentially misvalued
codes.
• Increase our efforts to make
available more information about the
specific issues being considered in the
course of developing values for new,
revised and potentially misvalued codes
to increase transparency, but without
making changes to the existing process
for establishing values.
In the proposed rule we discussed
each of these alternatives as follows.
(a) Propose work and MP RVUs and
direct PE inputs for new, revised, and
potentially misvalued codes in the
proposed rule:
Under this approach, we stated that
we would evaluate the RUC
recommendations for all new, revised,
and potentially misvalued codes, and
include proposed work and MP RVUs
and direct PE inputs for the codes in the
first available PFS proposed rule. We
would receive and consider public
comments on those proposals and
establish final values in the final rule.
The primary obstacle to this approach
relates to the current timing of the CPT
coding changes and RUC activities.
Under the current calendar, all CPT
coding changes and most RUC
recommendations are not available to us
in time to include proposed values for
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
all codes in the proposed rule for that
year.
Therefore, we stated that if we were
to adopt this proposal, which would
require us to propose changes in inputs
before we revalue codes based upon
those values, we would need a
mechanism to pay for services for which
the existing codes would no longer be
available, or for which there would be
changes for a given year.
As we noted in the CY 2012 PFS final
rule with comment period, the RUC
recommendations are an essential
element that we consider when valuing
codes. Likewise, we recognize the
significant contribution that the CPT
Editorial Panel makes to the success of
the potentially misvalued code initiative
through its consideration and adoption
of coding changes. Although we have
increased our scrutiny of the RUC
recommendations in recent years and
accepted fewer of the recommendations
without making our own refinements,
the CPT codes and the RUC
recommendations continue to play a
major role in our valuations. For many
codes, the surveys conducted by
specialty societies as part of the RUC
process are the best data that we have
regarding the time and intensity of
work. The RUC determines the criteria
and the methodology for those surveys.
It also reviews the survey results. This
process allows for development of
survey data that are more reliable and
comparable across specialties and
services than would be possible without
having the RUC at the center of the
survey vetting process. In addition, the
debate and discussion of the services at
the RUC meetings in which CMS staff
participate provides a good
understanding of what the service
entails and how it compares to other
services in the family, and to services
furnished by other specialties. The
debate among the specialties is also an
important part of this process. Although
we increasingly consider data and
information from many other sources,
and we intend to expand the scope of
those data and sources, the RUC
recommendations remain a vital part of
our valuation process.
Thus, if we were to adopt this
approach, we would need to address
how to make payment for the services
for which new or revised codes take
effect for the following year but for
which we did not receive RUC
recommendations in time to include
proposed work values and PE inputs in
the proposed rule. Because the annual
coding changes are effective on January
1st of each year, we would need a
mechanism for practitioners to report
services and be paid appropriately
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
during the interval between the date the
code takes effect and the time that we
receive RUC recommendations and
complete rulemaking to establish values
for the new and revised codes. One
option would be to establish G-codes
with identical descriptors to the
predecessors of the new and revised
codes and, to the fullest extent possible,
carry over the existing values for those
codes. This would effectively preserve
the status quo for one year.
The primary advantage of this
approach would be that the RVUs for all
services under the PFS would be
established using a full notice and
comment procedure, including
consideration of the RUC
recommendations, before they take
effect. In addition to having the benefit
of the RUC recommendations, this
would provide the public the
opportunity to comment on a specific
proposal prior to it being implemented.
This would be a far more transparent
process, and would assure that we have
the full benefit of stakeholder comments
before establishing values.
One drawback to such a process is
that the use of G-codes for a significant
number of codes may create an
administrative burden for CMS and for
practitioners. Presumably, practitioners
would need to use the G-codes to report
certain services for purposes of
Medicare, but would use the new or
revised CPT codes to report the same
services to private insurers. The number
of G-codes needed each year would
depend on the number of CPT code
changes for which we do not receive the
RUC recommendations in time to
formulate a proposal to be included in
the proposed rule for the year. To the
extent that we receive the RUC
recommendations for all new and
revised codes in time to develop
proposed values for inclusion in the
proposed rule, there would be no need
to use G-codes for this purpose.
Another drawback is that we would
need to delay for at least one year the
revision of values for any misvalued
codes for which we do not receive RUC
recommendations in time to include a
proposal in the proposed rule. For a
select set of codes, we would be
continuing to use the RVUs for the
codes for an additional year even
though we know they do not reflect the
most accurate resources. Since the PFS
is a budget neutral system, misvalued
services affect payments for all services
across the fee schedule. On the other
hand, if we were to take this approach,
we would have the full benefit of public
comments received on the proposed
values for potentially misvalued
PO 00000
Frm 00059
Fmt 4701
Sfmt 4700
67605
services before implementing any
revisions.
(b) Propose changes in work and MP
RVUs and PE inputs in the proposed
rule for new, revised, and potentially
misvalued codes for which we receive
RUC recommendations in time;
continue to establish interim final
values in the final rule for other new,
revised, and potentially misvalued
codes:
This alternative approach would
allow for notice and comment
rulemaking before we adopt values for
some new, revised and potentially
misvalued codes (those for which we
receive RUC recommendations in time
to include a proposal in the proposed
rule), while others would be valued on
an interim final basis (those for which
we do not receive the RUC
recommendations in time). Under this
approach, we would establish values in
a year for all new, revised, and
potentially misvalued codes, and there
would be no need to provide for a
mechanism to continue payment for
outdated codes pending receipt of the
RUC recommendations and completion
of a rulemaking cycle. For codes for
which we do not receive the RUC
recommendations in time to include a
proposal in the proposed rule for a year,
there would be no change from the
existing valuation process.
This would be a balanced approach
that recognizes the benefits of a full
opportunity for notice and comment
rulemaking before establishing rates
when timing allows, and the importance
of establishing appropriate values for
the current version of CPT codes and for
potentially misvalued codes when the
timing of the RUC recommendations
does not allow for a full notice and
comment procedure.
However, this alternative would go
only part of the way toward addressing
concerns expressed by some
stakeholders. For those codes for which
the RUC recommendations are not
received in time for us to include a
proposal in the proposed rule, Medicare
payment for one year would still be
based on inputs established without the
benefit of full public notice and
comment. Another concern with this
approach is that it could lead to the
valuation of codes within the same
family at different times depending on
when we receive RUC recommendations
for each code within a family. As
discussed previously, we believe it is
important to value an entire code family
together to make adjustments to account
appropriately for relativity within the
family and between the family and other
families. If we receive RUC
recommendations in time to propose
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67606
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
values for some, but not for all, codes
within a family, we would respond to
comments in the final rule to establish
final values for some of the codes while
adopting interim final values for other
codes within the same family. The
differences in the treatment of codes
within the same family could limit our
ability to value codes within the same
family with appropriate relativity.
Moreover, under this alternative, the
main determinant of how a code would
be handled would be the timing of our
receipt of the RUC recommendation for
the code. Although this approach would
offer stakeholders the opportunity to
comment on specific proposals in the
proposed rule, the adoption of changes
for a separate group of codes in the final
rule could significantly change the
proposed values simply due to the
budget neutrality adjustments due to
additional codes being valued in the
final rule.
(c) Increase our efforts to make
available more information about the
specific issues being considered in the
course of developing values for new,
revised and potentially misvalued codes
in order to increase transparency, but
without a change to the existing process
for establishing values:
The main concern with continuing
our current approach is that
stakeholders have expressed the desire
to have adequate and timely information
to permit the provision of relevant
feedback to CMS for our consideration
prior to establishing a payment rate for
new, revised, and potentially misvalued
codes. We could address some aspects
of this issue by increasing the
transparency of the current process.
Specifically, we could make more
information available on the CMS Web
site before interim final values are
established for codes. Examples of such
information include an up-to-date list of
all codes that have been identified as
potentially misvalued, a list of all codes
for which RUC recommendations have
been received, and the RUC
recommendations for all codes for
which we have received them.
Although the posting of this
information would significantly
increase transparency for all
stakeholders, it still would not allow for
full notice and comment rulemaking
procedures before values are established
for payment purposes. Nor would it
provide the public with advance
information about whether or how we
will make refinements to the RUC
recommendations or coding decisions in
the final rule with comment period.
Thus, stakeholders would not have an
opportunity to provide input on our
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
potential modifications before interim
final values are adopted.
4. Proposal To Modify the Process for
Establishing Values for New, Revised,
and Potentially Misvalued Codes
After considering the current process,
including its strengths and weaknesses,
and the alternatives to the current
process described previously, we
proposed to modify our process to make
all changes in the work and MP RVUs
and the direct PE inputs for new,
revised and potentially misvalued
services under the PFS by proposing the
changes in the proposed rule, beginning
with the PFS proposed rule for CY 2016.
We proposed to include proposed
values for all new, revised and
potentially misvalued codes for which
we have complete RUC
recommendations by January 15th of the
preceding year. We also proposed to
delay revaluing the code for one year (or
until we receive RUC recommendations
for the code before January 15th of a
year) and include proposed values in
the following year’s rule if the RUC
recommendation was not received in
time for inclusion in the proposed rule.
Thus, we would include proposed
values prior to using the new code (in
the case of new or revised codes) or
revising the value (in the case of
potentially misvalued codes). Due to the
complexities involved in code changes
and rate setting, there could be some
circumstances where, even when we
receive the RUC recommendations by
January 15th of a year, we are not able
to propose values in that year’s
proposed rule. For example, we might
not have recommendations for the
whole family or we might need
additional information to appropriately
value these codes. In situations where it
would not be appropriate or possible to
propose values for certain new, revised,
or potentially misvalued codes, we
would treat them in the same way as
those for which we did not receive
recommendations before January 15th.
For new, revised, and potentially
misvalued codes for which we do not
receive RUC recommendations before
January 15th of a year, we proposed to
adopt coding policies and payment rates
that conform, to the extent possible, to
the policies and rates in place for the
previous year. We would adopt these
conforming policies on an interim basis
pending our consideration of the RUC
recommendations and the completion of
notice and comment rulemaking to
establish values for the codes. For codes
for which there is no change in the CPT
code, it is a simple matter to continue
the current valuation. For services for
which there are CPT coding changes, it
PO 00000
Frm 00060
Fmt 4701
Sfmt 4700
is more complicated to maintain the
current payment rates until the codes
can be valued through the notice and
comment rulemaking process. Since the
changes in CPT codes are effective on
January 1st of a year, and we would not
have established values for the new or
revised codes (or other codes within the
code family), it would not be practical
for Medicare to use those CPT codes.
For codes that were revised or deleted
as part of the annual CPT coding
changes, when the changes could affect
the value of a code and we have not had
an opportunity to consider the relevant
RUC recommendations prior to the
proposed rule, we propose to create Gcodes to describe the predecessor codes
to these codes. If CPT codes are revised
in a manner that would not affect the
resource inputs used to value the
service (for example, a grammatical
changes to CPT code descriptors), we
could use these revised codes and
continue to pay at the rate developed
through the use of the same resource
inputs. For example, if a single CPT
code was separated into two codes and
we did not receive RUC
recommendations for the two codes
before January 15th of the year, we
would assign each of those new codes
an ‘‘I’’ status indicator (which denotes
that the codes are ‘‘not valid for
Medicare purposes’’), and those codes
could not be used for Medicare payment
during the year. Instead, we would
create a G-code with the same
description as the single predecessor
CPT code and continue to use the same
inputs as the predecessor CPT code for
that G-code during the year.
For new codes that describe wholly
new services, as opposed to new or
revised codes that are created as part of
a coding revision of a family or that
describe services are already on the PFS,
we would make every effort to work
with the RUC to ensure that we receive
recommendations in time to include
proposed values in the proposed rule.
However, if we do not receive timely
recommendations from the RUC for
such a code and we determine that it is
in the public interest for Medicare to
use a new code during the code’s initial
year, we would establish values for the
code’s initial year. As we do under our
current policy, if we receive the RUC
recommendations in time to consider
them for the final rule, we propose to
establish values for the initial year on an
interim final basis subject to comment
in the final rule. In the event we do not
receive RUC recommendations in time
to consider them for the final rule, or in
other situations where it would not be
appropriate to establish interim final
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
values (for example, because of a lack of
necessary information about the work or
the price of the PE inputs involved), we
would contractor price the code for the
initial year.
We specifically sought comments on
the following topics:
• Is this proposal preferable to the
present process? Is another one of the
alternatives better?
• If we were to implement this
proposal, is it better to move forward
with the changes, or is more time
needed to make the transition such that
implementation should be delayed
beyond CY 2016? What factors should
we consider in selecting an
implementation date?
• Are there alternatives other than the
use of G-codes that would allow us to
address the annual CPT changes
through notice and comment rather than
interim final rulemaking?
Comment: The vast majority of
commenters support a process, such as
the one we proposed, that would result
in having an opportunity for public
comment on specific CMS proposals to
change rates prior to payments being
made based upon those rates.
Commenters supporting a more
transparent process include most
medical organizations. MedPAC
supported including proposals for rate
changes in the proposed rule, but
disagreed with preserving existing rates
when RUC recommendations were not
received in time to value in the
proposed rule stating that this
perpetuates paying at rates that we
know are misvalued. As an alternative,
MedPAC suggested that for codes for
which we received RUC
recommendations after the deadline for
the proposed rule, we establish interim
final values using the existing process.
MedPAC also encouraged us to work
with the CPT Editorial Panel and the
RUC to better disseminate information
about coding and payment
recommendations that might be used for
interim values as far in advance as
possible. Several commenters who do
not currently participate in the
development of RUC recommendations
suggested that we require the RUC to
make its operations more transparent.
Most of the commenters that supported
the proposal also suggested making at
least some modifications to the
proposal. Some commenters indicated
there was no need for a change from the
current process. Another commenter
stated ‘‘CMS’s proposal is overly
complex, potentially burdensome, and
goes well beyond the principal request
of the medical specialty societies and
Congress—that is, for CMS to publish
reimbursement changes for misvalued
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
codes in the proposed rule, as opposed
to waiting until the final rule.’’
Response: We appreciate the many
comments in support of our proposal to
be more transparent in our ratesetting
process by including proposed changes
in inputs for new, revised, and
potentially misvalued codes in the PFS
proposed rules each year. We received
only minimal comments on the other
alternatives we presented, and only one
comment suggesting that the current
process was ideal and should be
maintained. Thus, we are finalizing the
proposal, with the modifications
discussed below, to change our process
for establishing values for new, revised,
and potentially misvalued codes each
year by proposing values for them in the
proposed rule. We note that the CPT
Editorial Panel and the RUC have made
significant efforts in recent years to
make their processes more transparent,
such as making minutes of meetings
publicly available. We encourage them
to continue these efforts and also to
consider ways that all physicians,
practitioners and other suppliers paid
under the PFS are aware of issues that
are being considered by the RUC, and
have an opportunity to provide input.
With regard to comments suggesting
that we propose values for some codes
in the proposed rule and establish
values for others as interim final in the
final rule with comment period, as we
discussed in making the proposal, we
believe this type of system has several
flaws. Most significantly, since the PFS
is a budget neutral system, proposals are
more meaningful when they can be
considered in relation to all codes being
revalued in a year in order to allow
public comment on the entire fee
schedule at one time. Additionally, we
believe it is difficult to justify the
presence or absence of an opportunity
for public comment in advance of our
adopting and using new values and
inputs for services when the outcome
essentially depends upon when we
receive RUC recommendations.
Comment: Commenters expressed
mixed opinions on when the new
process should begin. The AMA, the
RUC, and most medical specialties
opposed the proposed CY 2016
implementation and asked that it be
delayed until CY 2017. Commenters
supporting a delay suggested that much
work had already been done for the CY
2016 coding cycle in anticipation that
these codes could be used for CY 2016,
and stated it seems unfair to now delay
valuing these codes because the process
is being changed. These commenters
also suggested that by delaying until CY
2017, the CPT Editorial Panel and the
RUC would have time to adjust their
PO 00000
Frm 00061
Fmt 4701
Sfmt 4700
67607
agendas and workload so as to provide
more recommendations in time for the
proposed rule. By contrast, several
commenters, including those with major
code revisions for CY 2015, such as
codes for radiation therapy and upper
gastrointestinal procedures, suggested
that we should implement the new
process immediately, and thus, delay
implementation of the new code sets
and values so that they could be issued
as proposals in the CY 2016 proposed
rule. Although each of the commenters
took some unique positions in
supporting a delay, they emphasized the
importance of the opportunity to
comment on our specific proposals for
valuation as a major consideration for
the delay. A few other commenters also
suggested that the benefit of the
opportunity for public comment prior to
changing values warrants immediate
implementation. Some commenters
supported a CY 2016 implementation
date as we proposed. A small group of
commenters suggested an interim
approach under which, for CY 2016, we
would publish ‘‘some, but not all,
values’’ in the proposed rule and use the
interim final approach for others.
Response: After reviewing the
comments, we understand that the
implementation of a new process such
as this one will affect stakeholders in
differing ways. As we consider the most
appropriate time frame for
implementation, we believe that
flexibility in implementation offers the
optimal solution. Accordingly, we are
delaying the adoption of two new codes
sets (radiation therapy and lower
gastrointestinal endoscopies) until CY
2016 as requested by affected
stakeholders so that those most affected
by these significant changes have the
opportunity to comment on our
proposals for valuing these codes sets
before they are implemented. (See
section II.G.3 of this final rule.)
Similarly, as requested by the AMA
and most other medical specialty
societies, we are delaying the complete
implementation of this process so that
those who have requested new codes
and modifications in existing codes
with the expectation that they would be
valued under the PFS for CY 2016 will
not be negatively affected by timing of
this change. We note that the AMA has
been working to develop timeframes
that would allow a much higher
percentage of codes to be addressed in
the proposed rule, and has shared with
us some plans to achieve this goal. We
appreciate AMA’s efforts and are
confident that with the finalization of
this process, the CPT Editorial Panel
and the RUC will be able to adjust their
timelines and processes so that most, if
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67608
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
not all, of the annual coding changes
and valuation recommendations can be
addressed in the proposed rule prior to
the effective date of the coding changes.
This delay in implementation will
provide additional time for these bodies
to adjust their agendas and the timing of
their recommendations to CMS to more
appropriately align with the new
process. As suggested by some
commenters, we will use CY 2016 as a
transition year. In the PFS proposed rule
for CY 2016, we will propose values for
the new, revised and potentially
misvalued codes for which we receive
the RUC recommendations in time for
inclusion in the CY 2016 proposed rule.
We will also include proposals for the
two code sets delayed from CY 2015 in
the CY 2016 proposed rule, as discussed
above. For those new, revised, and
potentially misvalued codes for which
we do not receive RUC
recommendations in time for inclusion
in the proposed rule, we anticipate
establishing interim final values for
them for CY 2016, consistent with the
current process. Beginning with
valuations for CY 2017, the new process
will be applicable to all codes. In other
words, beginning with rulemaking for
CY 2017, we will propose values for the
vast majority of new, revised, and
potentially misvalued codes and
consider public comments before
establishing final values for the codes;
use G-codes as necessary in order to
facilitate continued payment for certain
services for which we do not receive
RUC recommendations in time to
propose values; and adopt interim final
values in the case of wholly new
services for which there are no
predecessor codes or values and for
which we do not receive RUC
recommendations in time to propose
values. Consistent with this policy, we
are finalizing our proposed regulatory
change to § 414.24 with the addition of
the phrase ‘‘For valuations for calendar
year 2017 and beyond,’’ to paragraph (b)
to reflect the implementation for all CY
2017 valuations.’’
Comment: Commenters also
addressed the January 15th deadline for
valuations to be considered for the
proposed rule. The AMA recommended
a deadline of 30 days after the RUC’s
January meeting to allow time to submit
complete recommendations for the
proposed rule. Many others supported
this, with some commenters suggesting
a variety of dates between January 31st
and April. Commenters suggested using
an April deadline so that we could
include the recommendations from the
April RUC meeting in the proposed rule.
Response: In proposing a deadline for
inclusion in the proposed rule, we
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
attempted to strike a balance that allows
CMS adequate time for CMS to do a
thorough job in vetting
recommendations and formulating
proposals, and allows the RUC as much
time as possible to complete its
activities. Review of RUC
recommendations and application of the
PFS methodology to particular codes
requires significant time to complete.
With new statutory requirements being
implemented in CY 2017, such as those
requiring multi-year transitions of
certain changes in values and
modification to PFS payments if
specified targets are not met, we believe
we will need more time to complete the
process of formulating proposals. We
believe that we need to establish a
consistent deadline for receipt of RUC
recommendations in order to allow all
stakeholders and CMS to plan
appropriately. To balance competing
priorities, we are finalizing a deadline of
February 10th. Our ability to complete
our work in this more limited time will
depend in large part on the volume of
recommendations handled at the last
RUC meeting and when we receive
those recommendations. We are seeking
the RUC’s assistance in minimizing the
recommendations that we receive after
the beginning of the year.
Comment: The majority of
commenters opposed the use of Gcodes, primarily citing the
administrative burden of having to use
a separate set of codes for Medicare
claims. One commenter called the Gcode proposal ‘‘unworkable.’’ In
addition, MedPAC objected to the
principal of attempting to maintain rates
that are known to be misvalued. Those
supporting the use of G-codes generally
recognized the administrative burden,
but believed the importance of the
opportunity for public comment on
proposed values before they take effect
outweighed the administrative
inconvenience. Commenters urged us to
minimize the use of G-codes.
Response: We recognize the
commenters’ concerns with the use of
G-codes. We agree that it is preferable to
use CPT codes whenever possible.
Under our finalized process, the use of
G-codes for the purpose of holding over
current coding and payment policies
should not be necessary, generally, as
long as we receive RUC
recommendations for all new, revised
and potentially misvalued codes before
February 10th of the prior year.
However, we need to preserve our
ability to establish a proxy for current
coding and values in situations where
we receive the RUC recommendations
too late or, for some other reason,
encounter serious difficulty developing
PO 00000
Frm 00062
Fmt 4701
Sfmt 4700
proposed values for revised code sets. In
the proposed rule, we sought input as to
ways to achieve this without using Gcodes. The only suggestion offered by
commenters was to value such codes on
an interim final basis. As we discuss
above, we believe the program and its
stakeholders are better served by
delaying revaluations for one year while
we used the notice and comment
process to obtain public comments in
advance. The comments on this
proposal were overall overwhelming
supportive of this point of view.
Accordingly, we are not foreclosing the
possibility of using G-codes for this
purpose when warranted by the
circumstances. However, we are
cognizant of the difficulties created by
the use of G-codes and will seek to
minimize their use. We also note that
the RUC and stakeholders can assist us
in minimizing the use of G-codes by
taking steps to insure that we receive
RUC recommendations as early as
possible.
5. Refinement Panel
As discussed in the 1993 PFS final
rule with comment period (57 FR
55938), we adopted a refinement panel
process to assist us in reviewing the
public comments on CPT codes with
interim final work RVUs for a year and
in developing final work values for the
subsequent year. We decided the panel
would be comprised of a multispecialty
group of physicians who would review
and discuss the work involved in each
procedure under review, and then each
panel member would individually rate
the work of the procedure. We believed
establishing the panel with a
multispecialty group would balance the
interests of the specialty societies who
commented on the work RVUs with the
budgetary and redistributive effects that
could occur if we accepted extensive
increases in work RVUs across a broad
range of services.
Following enactment of section
1848(c)(2)(K) of the Act, which required
the Secretary periodically to review
potentially misvalued codes and make
appropriate adjustments to the RVUs,
we reassessed the refinement panel
process. As detailed in the CY 2011 PFS
final rule with comment period (75 FR
73306), we continued using the
established refinement panel process
with some modifications.
As we considered making changes to
the process for valuing codes, we
reassessed the role that the refinement
panel process plays in the code
valuation process. We noted that the
current refinement panel process is tied
to interim final values. It provides an
opportunity for stakeholders to provide
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
new clinical information that was not
available at the time of the RUC
valuation that might affect work RVU
values that are adopted in the interim
final value process. We noted that if our
proposal to modify the valuation
process for new, revised, and potentially
misvalued codes is adopted, there
would no longer be interim final values
except for very few codes that describe
totally new services. Thus, we proposed
eliminating the refinement panel
process.
We also noted that by using the
proposed process for new, revised, and
potentially misvalued codes, we
believed the consideration of additional
clinical information and any other
issues associated with the CMS
proposed values could be addressed
through the notice and comment
process. Similarly, prior to CY 2012
when we consolidated the five-year
valuation, changes made as part of the
five-year review process were addressed
in the proposed rule and those codes
were generally not subject to the
refinement process. The notice and
comment process would provide
stakeholders with complete information
on the basis and rationale for our
proposed inputs and any relating coding
policies. We also noted that an
increasing number of requests for
refinement do not include new clinical
information that would justify a change
in the work RVUs and that was not
available at the time of the RUC
meeting, in accordance with the current
criteria for refinement. Thus, we did not
believe the elimination of the
refinement panel process would
negatively affect the code valuation
process. We believe the proposed
process, which includes a full notice
and comment procedure before values
are used for purposes of payment, offers
stakeholders a better mechanism for
providing any additional data for our
consideration and discussing any
concerns with our proposed values than
the current refinement process
Comment: We received many
comments on our proposal to eliminate
the refinement panel, but most
addressed problems with the existing
refinement process and suggested
improvements and alternatives rather
than reasons not to eliminate the
refinement panel. Concerns with the
refinement panel process included that
CMS imposed too high a standard for
referring codes to refinement and that
CMS decreasingly changed values based
upon the refinement panel results. Some
noted that organizations with limited
resources are disadvantaged compared
to those with significant resources to
overturn any CMS interim final values
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
without a refinement process. In
addition, some commenters stated that
elimination of the refinement panel runs
contrary to the transparency that CMS is
trying to achieve. Many discussed their
previous understanding that the
refinement panel was essentially an
appeals process for interim final values.
Commenters supported ‘‘a fair,
objective, and consistently applied
appeals process that would be open to
any commenting organization.’’
Commenters expressed concern that the
elimination of the refinement panel
without a replacement mechanism
‘‘indicates that CMS will no longer seek
the independent advice of contractor
medical officers and practicing
physicians and will solely rely on
Agency staff to determine if the
comment is persuasive in modifying a
proposed value. The lack of any
perceived organized appeal process will
likely lead to a fragmented lobbying
effort, rather than an objective review
process.’’
MedPAC suggested that we use a
panel with membership limited to those
without a financial stake in the process,
such as contractor medical directors,
experts in medical economics and
technology diffusion, private payer
representatives, and a mix of physicians
and other health professionals not
directly affected by the RVUs in
question. It also suggested user fees to
provide the resources needed or such a
refinement panel.
Response: We acknowledge the
commenters’ concerns and believe that
some of the dissatisfaction with the
current refinement panel mechanism
stems from the expectation that it
constitutes an appeals process. We do
not agree. We believe the purpose of the
refinement panel is to give us additional
information to consider in exercising
our responsibility to establish
appropriate RVUs for Medicare services.
Like many of the commenters, we
believe the refinement panel is not
achieving its purpose. Rather than
providing us with additional
information to assist us in establishing
work RVUs, most often the refinement
panel discussion reiterates the issues
raised and information discussed at the
RUC. Since we had access to this
information at the time interim final
values were established, it seems
unlikely that a repeat discussion of the
same issues would lead us to change
valuations based upon information that
already had been carefully considered.
We remain concerned about the amount
of resources devoted to refinement
panel activities as compared to the
benefit received. However, in light of
the significant concerns raised by
PO 00000
Frm 00063
Fmt 4701
Sfmt 4700
67609
commenters, we are not finalizing our
proposal to eliminate the refinement
panel. We will use the refinement panel
for consideration of interim final rates
for CY 2015 under the existing rules. We
will also explore ways to address the
many concerns that we and stakeholders
have about the refinement panel process
and whether the change in process
eliminates the need for a refinement
panel.
We are also finalizing our proposed
change to the regulation at § 414.24 with
the addition of the phrase ‘‘For
valuations for calendar year 2017 and
beyond,’’ to paragraph (b) to reflect
implementation of the revised process
for all valuations beginning with those
for CY 2017.
G. Establishing RVUs for CY 2015
1. Methodology
We conducted a review of each code
identified in this section and reviewed
the current work RVU, if one exists, the
RUC-recommended work RVUs,
intensity, and time to furnish the
preservice, intraservice, and postservice
activities, as well as other components
of the service that contribute to the
value. Our review generally includes,
but is not limited to, a review of
information provided by the RUC,
Health Care Professionals Advisory
Committee (HCPAC), and other public
commenters, medical literature, and
comparative databases, as well as a
comparison with other codes within the
Medicare PFS, consultation with other
physicians and health care professionals
within CMS and the federal
government. We also assessed the
methodology and data used to develop
the recommendations submitted to us
by the RUC and other public
commenters and the rationale for the
recommendations. In the CY 2011 PFS
final rule with comment period (75 FR
73328 through 73329), we discussed a
variety of methodologies and
approaches used to develop work RVUs,
including survey data, building blocks,
crosswalk to key reference or similar
codes, and magnitude estimation. More
information on these issues is available
in that rule. When referring to a survey,
unless otherwise noted, we mean the
surveys conducted by specialty societies
as part of the formal RUC process. The
building block methodology is used to
construct, or deconstruct, the work RVU
for a CPT code based on component
pieces of the code. Components used in
the building block approach may
include preservice, intraservice, or
postservice time and post-procedure
visits. When referring to a bundled CPT
code, the components could be the CPT
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67610
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
codes that make up the bundled code.
Magnitude estimation refers to a
methodology for valuing physician work
that determines the appropriate work
RVU for a service by gauging the total
amount of physician work for that
service relative to the physician work
for similar service across the PFS
without explicitly valuing the
components of that work.
The PFS incorporates cross-specialty
and cross-organ system relativity.
Valuing services requires an assessment
of relative value and takes into account
the clinical intensity and time required
to furnish a service. In selecting which
methodological approach will best
determine the appropriate value for a
service, we consider the current and
recommended work and time values, as
well as the intensity of the service, all
relative to other services.
Several years ago, to aid in the
development of preservice time
recommendations for new and revised
CPT codes, the RUC created
standardized preservice time packages.
The packages include preservice
evaluation time, preservice positioning
time, and preservice scrub, dress and
wait time. Currently there are six
preservice time packages for services
typically furnished in the facility
setting, reflecting the different
combinations of straightforward or
difficult procedure, straightforward or
difficult patient, and without or with
sedation/anesthesia. Currently, there are
three preservice time packages for
services typically furnished in the
nonfacility setting, reflecting procedures
without and with sedation/anesthesia
care. We have developed several
standard building block methodologies
to appropriately value services when
they have common billing patterns. In
cases where a service is typically
furnished to a beneficiary on the same
day as an evaluation and management
(E/M) service, we believe that there is
overlap between the two services in
some of the activities furnished during
the preservice evaluation and
postservice time. We believe that at least
one-third of the physician time in both
the preservice evaluation and
postservice period is duplicative of
work furnished during the E/M visit.
Accordingly, in cases where we believe
that the RUC has not adequately
accounted for the overlapping activities
in the recommended work RVU and/or
times, we adjust the work RVU and/or
times to account for the overlap. The
work RVU for a service is the product
of the time involved in furnishing the
service times the intensity of the work.
Preservice evaluation time and
postservice time both have a long-
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
established intensity of work per unit of
time (IWPUT) of 0.0224, which means
that 1 minute of preservice evaluation or
postservice time equates to 0.0224 of a
work RVU. Therefore, in many cases
when we remove 2 minutes of
preservice time and 2 minutes of
postservice time from a procedure to
account for the overlap with the same
day E/M service, we also remove a work
RVU of 0.09 (4 minutes × 0.0224
IWPUT) if we do not believe the overlap
in time has already been accounted for
in the work RVU. The RUC has
recognized this valuation policy and, in
many cases, addresses the overlap in
time and work when a service is
typically provided on the same day as
an E/M service. The RVUs and other
payment information for all CY 2015
payable codes are available in
Addendum B. The RVUs and other
payment information for all codes
subject to public comment are available
in Addendum C. Both addenda are
available on the CMS Web site under
downloads for the CY 2015 PFS final
rule with comment period at https://
www.cms.gov/physicianfeesched/
downloads/. The time values for all CY
2015 codes are listed in a file called ‘‘CY
2015 PFS Physician Time,’’ available on
the CMS Web site under downloads for
the CY 2015 PFS final rule with
comment period at https://www.cms.gov/
physicianfeesched/downloads/.
2. Addressing CY 2014 Interim Final
RVUs
In this section, we are responding to
the public comments received on
specific interim final values established
in the CY 2014 PFS final rule with
comment period and discussing the
final values that we are establishing for
CY 2015. The final CY 2015 work, PE,
and MP RVUs are in Addendum B of a
file called ‘‘CY 2015 PFS Addenda,’’
available on the CMS Web site under
downloads for the CY 2015 PFS final
rule with comment period at https://
www.cms.gov/physicianfeesched/PFSFederal-Regulation-Notices.html/. The
direct PE inputs are listed in a file
called ‘‘CY 2015 PFS Direct PE Inputs,’’
available on the CMS Web site under
downloads for the CY 2015 PFS final
rule with comment period at https://
www.cms.gov/physicianfeesched/PFSFederal-Regulation-Notices.html/.
a. Finalizing CY 2014 Interim Final
Work RVUs for CY 2015
(i) Refinement Panel
(1) Refinement Panel Process
As discussed in the 1993 PFS final
rule with comment period (57 FR
55938), we adopted a refinement panel
PO 00000
Frm 00064
Fmt 4701
Sfmt 4700
process soon after implementing the fee
schedule to assist us in reviewing the
public comments on CPT codes with
interim final work RVUs and in
developing final work values for the
subsequent year. We decided the panel
would be comprised of a multispecialty
group of physicians who would review
and discuss the work involved in each
procedure under review, and then each
panel member would individually rate
the work of the procedure. We believed
a multispecialty group would balance
the interests of the specialty societies
who commented on the work RVUs
with the budgetary and redistributive
effects that could occur if we accepted
extensive increases in work RVUs across
a broad range of services. Depending on
the number and range of codes that are
subject to refinement in a given year, we
establish refinement panels with
representatives from four groups:
Clinicians representing the specialty
identified with the procedures in
question; physicians with practices in
related specialties; primary care
physicians; and contractor medical
directors (CMDs). Typical panels have
included 8 to 10 physicians across the
four groups.
Following the addition of section
1848(c)(2)(K) to the Act, which requires
the Secretary periodically to review
potentially misvalued codes and make
appropriate adjustments to the RVUs,
we reassessed the refinement panel
process. As detailed in the CY 2011 PFS
final rule with comment period (75 FR
73306), we believed that the refinement
panel process might provide an
opportunity to review and discuss the
proposed and interim final work RVUs
with a clinically diverse group of
experts, who could provide informed
recommendations following the
discussion. Therefore, we indicated that
we would continue the refinement
process, but with administrative
modification and clarification. We also
noted that we would continue using the
established panel composition that
includes representatives from the four
groups—clinicians representing the
specialty identified with the procedures
in question, physicians with practices in
related specialties, primary care
physicians, and CMDs.
At that time, we made a change in
how we calculated refinement panel
results. The basis of the refinement
panel process is that, following
discussion of the information but
without an attempt to reach a
consensus, each member of the panel
submits an independent rating to CMS.
Historically, the refinement panel’s
recommendation to change a work value
or to retain the interim final value had
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
hinged solely on the outcome of a
statistical test on the ratings (an F-test of
panel ratings among the groups of
participants). Over time, we found the
statistical test used to evaluate the RVU
ratings of individual panel members
became less reliable as the physicians in
each group tended to select a previously
discussed value, rather than developing
a unique value, thereby reducing the
observed variability needed to conduct
a robust statistical test. In addition,
reliance on values developed using the
F-test also occasionally resulted in rank
order anomalies among services (that is,
a more complex procedure is assigned
lower RVUs than a less complex
procedure). As a result, we eliminated
the use of the statistical F-test and
replaced it with the median work value
of the individual panel members’
ratings. We stated that this approach
would simplify the refinement process
administratively, while providing a
result that reflects the summary opinion
of the panel members based on a
commonly used measure of central
tendency that is not significantly
affected by outlier values. We also
clarified that we have the final authority
to set the work RVUs, including making
adjustments to the work RVUs resulting
from the refinement process, and that
we will make such adjustments if
warranted by policy concerns (75 FR
73307).
We remind readers that the
refinement panels are not intended to
review the work RVUs for every code for
which we did not accept the RUCrecommended work RVUs. Rather,
refinement panels are designed for
situations where there is new clinical
information available that might provide
a reason for a change in work values and
where a multispecialty panel of
physicians might provide input that
would assist us in establishing work
RVUs. To facilitate the selection of
services for the refinement panels,
commenters seeking consideration by a
refinement panel should specifically
state in their public comments that they
are requesting refinement panel review.
Furthermore, we have asked
commenters requesting refinement
panel review to submit any new clinical
information concerning the work
required to furnish a service so that we
can consider whether the new
information warrants referral to the
refinement panel (57 FR 55917).
We note that most of the information
presented during the last several
refinement panel discussions has been
duplicative of the information provided
to the RUC during its development of
recommendations and considered by
CMS in establishing values. As detailed
above, we consider information and
recommendations from the RUC when
assigning proposed and interim final
RVUs to services. Thus, if the only
information that a commenter has to
present is information already
considered by the RUC, referral to a
refinement panel is not appropriate. We
request that commenters seeking
refinement panel review of work RVUs
submit supporting information that has
not already been considered by the RUC
in developing recommendations or by
CMS in assigning proposed and interim
final work RVUs. We can make best use
of our resources, as well as those of the
specialties and physician volunteers
involved, by avoiding duplicative
consideration of information by the
RUC, CMS, and a refinement panel. To
achieve this goal, CMS will continue to
critically evaluate the need to refer
codes to refinement panels in future
years, specifically considering any new
information provided by commenters.
(2) CY 2014 Interim Final Work RVUs
Considered by the Refinement Panel
We referred to the CY 2014
refinement panel 19 CPT codes with CY
2014 interim final work values for
which we received a request for
refinement that met the requirements
described above. For these 19 CPT
67611
codes, all commenters requested
increased work RVUs. For ease of
discussion, we will be referring to these
services as ‘‘refinement codes.’’
Consistent with the process described
above, we convened a multi-specialty
panel of physicians to assist us in the
review of the information submitted to
support increased work RVUs. The
panel was moderated by our physician
advisors, and consisted of the following
voting members:
• One to two clinicians representing
the commenting organization.
• One to two primary care clinicians
nominated by the American Academy of
Family Physicians and the American
College of Physicians.
• Four Contractor Medical Directors
(CMDs).
• One to two clinicians with practices
in related specialties, who were
expected to have knowledge of the
services under review.
The panel process was designed to
capture each participant’s independent
judgment and his or her clinical
experience which informed and drove
the discussion of the refinement code
during the refinement panel
proceedings. Following the discussion,
each voting participant rated the work
of the refinement code(s) and submitted
those ratings to CMS directly and
confidentially. We note that not all
voting participants voted for every CPT
code. There was no attempt to achieve
consensus among the panel members.
As finalized in the CY 2011 PFS final
rule with comment period (75 FR
73307), we calculated the median value
for each service based upon the
individual ratings that were submitted
to CMS by panel participants.
Table 14 presents information on the
work RVUs for the refinement codes,
including the refinement panel ratings
and the final CY 2015 work RVUs. In
section II.G.2.a.ii., we discuss the CY
2015 work RVUs assigned each of the
individual refinement codes.
TABLE 14—CODES REVIEWED BY THE 2014 MULTI-SPECIALTY REFINEMENT PANEL
HCPCS
Code
19081 .......
ebenthall on DSK5SPTVN1PROD with $$_JOB
19082 .......
19083 .......
19084 .......
19085 .......
19086 .......
VerDate Sep<11>2014
CY 2014
interim final
work RVU
Descriptor
Biopsy of breast
guidance.
Biopsy of breast
guidance.
Biopsy of breast
guidance.
Biopsy of breast
guidance.
Biopsy of breast
ance.
Biopsy of breast
ance.
20:15 Nov 12, 2014
RUC
recommended
work RVU
Refinement
panel median
rating
CY 2015 work
RVU
accessed through the skin with stereotactic
3.29
3.29
3.40
3.29
accessed through the skin with stereotactic
1.65
1.65
1.78
1.65
accessed through the skin with ultrasound
3.10
3.10
3.10
3.10
accessed through the skin with ultrasound
1.55
1.55
1.55
1.55
accessed through the skin with MRI guid-
3.64
3.64
3.64
3.64
accessed through the skin with MRI guid-
1.82
1.82
1.82
1.82
Jkt 235001
PO 00000
Frm 00065
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
67612
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 14—CODES REVIEWED BY THE 2014 MULTI-SPECIALTY REFINEMENT PANEL—Continued
CY 2014
interim final
work RVU
HCPCS
Code
Descriptor
19281 .......
Placement of breast localization devices accessed through
the skin with mammographic guidance.
Placement of breast localization devices accessed through
the skin with mammographic guidance.
Placement of breast localization devices accessed through
the skin with stereotactic guidance.
Placement of breast localization devices accessed through
the skin with stereotactic guidance.
Placement of breast localization devices accessed through
the skin with ultrasound guidance.
Placement of breast localization devices accessed through
the skin with ultrasound guidance.
Placement of breast localization devices accessed through
the skin with MRI guidance.
Placement of breast localization devices accessed through
the skin with MRI guidance.
Injection of dilated esophageal veins using an endoscope ......
Tying of esophageal veins using an endoscope ......................
Dilation of esophagus using an endoscope ..............................
Balloon dilation of esophagus, stomach, and/or upper small
bowel using an endoscope.
Control of bleeding of esophagus, stomach, and/or upper
small bowel using an endoscope.
19282 .......
19283 .......
19284 .......
19285 .......
19286 .......
19287 .......
19288 .......
43204
43205
43213
43233
.......
.......
.......
.......
43255 .......
ebenthall on DSK5SPTVN1PROD with $$_JOB
(ii) Code-Specific Issues
For each code with an interim final
work value, Table 15 lists the CY 2014
interim final work RVU and the CY
2015 work RVU and indicates whether
we are finalizing the CY 2015 work
RVU. For codes without a work RVU,
the table includes a PFS procedure
status indicator. A list of the PFS
procedure status indicators can be
found in Addendum A. If the CY 2015
Action column indicates that the CY
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
RUC
recommended
work RVU
Refinement
panel median
rating
CY 2015 work
RVU
2.00
2.00
2.00
2.00
1.00
1.00
1.00
1.00
2.00
2.00
2.00
2.00
1.00
1.00
1.00
1.00
1.70
1.70
1.70
1.70
0.85
0.85
0.85
0.85
2.55
3.02
3.02
2.55
1.28
1.51
1.51
1.28
2.40
2.51
4.73
4.05
2.89
3.00
5.00
4.45
2.77
2.88
5.00
4.26
2.40
2.51
4.73
4.26
3.66
4.20
4.20
3.66
2015 values are interim final, we will
accept public comments on these values
during the public comment period for
this final rule with comment period. A
comprehensive list of all values for
which public comments are being
solicited is contained in Addendum C to
the CY 2015 PFS final rule with
comment period. A comprehensive list
of all CY 2015 RVUs is in Addendum B
to this final rule with comment period.
All Addenda to PFS final rule are
PO 00000
Frm 00066
Fmt 4701
Sfmt 4700
available on the CMS Web site under
downloads at https://www.cms.gov/
physicianfeesched/
PFSFederalRegulationNotices.html/.
The time values for all codes are listed
in a file called ‘‘CY 2015 PFS Work
Time,’’ available on the CMS Web site
under downloads for the CY 2015 PFS
final rule with comment period at
https://www.cms.gov/physicianfeesched/
downloads/.
BILLING CODE 4120–01–P
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
67613
TABLE 15: CY 2015 Actions on Codes with CY 2014 Interim Final RVUs
HCPCS
Code
CY2014
Interim
Final
Work
RVU
Long Descriptor
CY
2015
Work
RVU
CY 2015 Action
3.00
3.00
Finalize
Destruction (eg, laser surgery, electrosurgery, cryosurgery,
chemosurgery, surgical curettement), premalignant lesions
(eg, actinic keratoses); first lesion
0.61
0.61
Finalize
17003
Destruction (eg, laser surgery, electrosurgery, cryosurgery,
chemosurgery, surgical curettement), premalignant lesions
(eg, actinic keratoses); second through 14lesions, each
(list separately in addition to code for first lesion)
0.04
0.04
Finalize
17004
Destruction (eg, laser surgery, electrosurgery, cryosurgery,
chemosurgery, surgical curettement), premalignant lesions
(eg, actinic keratoses), 15 or more lesions
1.37
1.37
Finalize
17311
Mohs micrographic technique, including removal of all
gross tumor, surgical excision of tissue specimens,
mapping, color coding of specimens, microscopic
examination of specimens by the surgeon, and
histopathologic preparation including routine stain( s) (eg,
hematoxylin and eosin, toluidine blue), head, neck, hands,
feet, genitalia, or any location with surgery directly
involving muscle, cartilage, bone, tendon, major nerves, or
vessels; first stage, up to 5 tissue blocks
6.20
6.20
Finalize
17312
Mohs micrographic technique, including removal of all
gross tumor, surgical excision of tissue specimens,
mapping, color coding of specimens, microscopic
examination of specimens by the surgeon, and
histopathologic preparation including routine stain( s) (eg,
hematoxylin and eosin, toluidine blue), head, neck, hands,
feet, genitalia, or any location with surgery directly
involving muscle, cartilage, bone, tendon, major nerves, or
vessels; each additional stage after the first stage, up to 5
tissue blocks (list separately in addition to code for
primary procedure)
3.30
3.30
Finalize
17313
Mohs micrographic technique, including removal of all
gross tumor, surgical excision of tissue specimens,
mapping, color coding of specimens, microscopic
examination of specimens by the surgeon, and
histopathologic preparation including routine stain( s) (eg,
hematoxylin and eosin, toluidine blue), of the trunk, arms,
or legs; first stage, up to 5 tissue blocks
5.56
5.56
Finalize
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00067
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.000</GPH>
Image-guided fluid collection drainage by catheter (eg,
abscess, hematoma, seroma, lymphocele, cyst), soft tissue
(eg, extremity, abdominal wall, neck), percutaneous
17000
ebenthall on DSK5SPTVN1PROD with $$_JOB
10030
67614
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCS
Code
17314
17315
19081
CY2014
Interim
Final
Work
RVU
Mohs micrographic technique, including removal of all
gross tumor, surgical excision of tissue specimens,
mapping, color coding of specimens, microscopic
examination of specimens by the surgeon, and
histopathologic preparation including routine stain( s) (eg,
hematoxylin and eosin, toluidine blue), of the trunk, arms,
or legs; each additional stage after the first stage, up to 5
tissue blocks (list separately in addition to code for
primary procedure)
Mohs micrographic technique, including removal of all
gross tumor, surgical excision of tissue specimens,
mapping, color coding of specimens, microscopic
examination of specimens by the surgeon, and
histopathologic preparation including routine stain(s) (eg,
hematoxylin and eosin, toluidine blue), each additional
block after the first 5 tissue blocks, any stage (list
separately in addition to code for primary procedure)
Biopsy, breast, with placement of breast localization
device(s) (eg, clip, metallic pellet), when performed, and
imaging of the biopsy specimen, when performed,
percutaneous; first lesion, including stereotactic guidance
3.06
3.06
Finalize
0.87
0.87
Finalize
3.29
Long Descriptor
CY
2015
Work
RVU
3.29
Finalize
CY 2015 Action
1.65
1.65
Finalize
3.10
3.10
Finalize
1.55
1.55
Finalize
19085
Biopsy, breast, with placement of breast localization
device(s) (eg, clip, metallic pellet), when performed, and
imaging of the biopsy specimen, when performed,
percutaneous; first lesion, including magnetic resonance
guidance
3.64
3.64
Finalize
19086
Biopsy, breast, with placement of breast localization
device(s) (eg, clip, metallic pellet), when performed, and
imaging of the biopsy specimen, when performed,
percutaneous; each additional lesion, including magnetic
resonance guidance (list separately in addition to code for
primary procedure)
1.82
1.82
Finalize
19082
19083
ebenthall on DSK5SPTVN1PROD with $$_JOB
19084
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00068
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.001</GPH>
Biopsy, breast, with placement of breast localization
device(s) (eg, clip, metallic pellet), when performed, and
imaging of the biopsy specimen, when performed,
percutaneous; each additional lesion, including stereotactic
guidance (list separately in addition to code for primary
procedure)
Biopsy, breast, with placement of breast localization
device(s) (eg, clip, metallic pellet), when performed, and
imaging of the biopsy specimen, when performed,
percutaneous; first lesion, including ultrasound guidance
Biopsy, breast, with placement of breast localization
device(s) (eg, clip, metallic pellet), when performed, and
imaging of the biopsy specimen, when performed,
percutaneous; each additional lesion, including ultrasound
guidance (list separately in addition to code for primary
procedure)
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCS
Code
CY2014
Interim
Final
Work
Long Descriptor
CY
2015
Work
CY 2015 Action
RVU
RVU
Placement of breast localization device(s) (eg, clip,
metallic pellet, wire/needle, radioactive seeds),
percutaneous; first lesion, including mammographic
guidance
2.00
2.00
Finalize
19282
Placement ofbreast localization device(s) (eg, clip,
metallic pellet, wire/needle, radioactive seeds),
percutaneous; each additional lesion, including
mammographic guidance (list separately in addition to
code for primary procedure)
1.00
1.00
Finalize
19283
Placement of breast localization device(s) (eg, clip,
metallic pellet, wire/needle, radioactive seeds),
percutaneous; first lesion, including stereotactic guidance
2.00
2.00
Finalize
19284
Placement of breast localization device(s) (eg, clip,
metallic pellet, wire/needle, radioactive seeds),
percutaneous; each additional lesion, including stereotactic
guidance (list separately in addition to code for primary
procedure)
1.00
1.00
Finalize
19285
Placement of breast localization device(s) (eg, clip,
metallic pellet, wire/needle, radioactive seeds),
percutaneous; first lesion, including ultrasound guidance
1.70
1.70
Finalize
19286
Placement of breast localization device(s) (eg, clip,
metallic pellet, wire/needle, radioactive seeds),
percutaneous; each additional lesion, including ultrasound
guidance (list separately in addition to code for primary
procedure)
0.85
0.85
Finalize
19287
Placement of breast localization device(s) (eg clip,
metallic pellet, wire/needle, radioactive seeds),
percutaneous; first lesion, including magnetic resonance
guidance
2.55
2.55
Finalize
19288
Placement of breast localization device(s) (eg clip,
metallic pellet, wire/needle, radioactive seeds),
percutaneous; each additional lesion, including magnetic
resonance guidance (list separately in addition to code for
primary procedure)
1.28
1.28
Finalize
23333
Removal offoreign body, shoulder; deep (subfascial or
intramuscular)
6.00
6.00
Finalize
23334
Removal of prosthesis, includes debridement and
synovectomy when performed; humeral or glenoid
component
15.50
15.50
Finalize
23335
Removal of prosthesis, includes debridement and
synovectomy when performed; humeral and glenoid
components (eg, total shoulder)
19.00
19.00
Finalize
23600
Closed treatment of proximal humeral (surgical or
anatomical neck) fracture; without manipulation
3.00
3.00
Finalize
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00069
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.002</GPH>
19281
ebenthall on DSK5SPTVN1PROD with $$_JOB
67615
67616
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCS
Code
CY2014
Interim
Final
Work
RVU
Long Descriptor
CY
2015
Work
RVU
CY 2015 Action
24160
Removal of prosthesis, includes debridement and
synovectomy when performed; humeral and ulnar
components
18.63
18.63
Finalize
24164
Removal of prosthesis, includes debridement and
synovectomy when performed; radial head
10.00
10.00
Finalize
27130
Arthroplasty, acetabular and proximal femoral prosthetic
replacement (total hip arthroplasty), with or without
autograft or allograft
20.72
20.72
Finalize
27236
Open treatment of femoral fracture, proximal end, neck,
internal fixation or prosthetic replacement
17.61
17.61
Finalize
27446
Arthroplasty, knee, condyle and plateau; medial or lateral
compartment
17.48
17.48
Finalize
27447
Arthroplasty, knee, condyle and plateau; medial and lateral
compartments with or without patella resurfacing (total
knee arthroplasty)
20.72
20.72
Finalize
28470
Closed treatment of metatarsal fracture; without
manipulation, each
2.03
2.03
Finalize
29075
Application, cast; elbow to finger (short arm)
0.77
0.77
Finalize
29581
Application of multi-layer compression system; leg (below
knee), including ankle and foot
0.25
0.25
Finalize
29582
Application of multi-layer compression system; thigh and
leg, including ankle and foot, when performed
0.35
0.35
Finalize
29583
Application of multi-layer compression system; upper arm
and forearm
0.25
0.25
Finalize
29584
Application of multi-layer compression system; upper
arm, forearm, hand, and fingers
0.35
0.35
Finalize
29824
Arthroscopy, shoulder, surgical; distal claviculectomy
including distal articular surface (mumford procedure)
8.98
8.98
Finalize
3.00
3.00
Finalize
2.60
2.60
Finalize
29826
31237
Arthroscopy, shoulder, surgical; decompression of
subacromial space with partial acromioplasty, with
coracoacromialligament (ie, arch) release, when
performed (list separately in addition to code for primary
procedure)
Nasal/sinus endoscopy, surgical; with biopsy,
polypectomy or debridement (separate procedure)
2.74
2.74
Finalize
Nasal/sinus endoscopy, surgical; with
dacryocystorhinostomy
9.04
9.04
Finalize
31240
Nasal/sinus endoscopy, surgical; with concha bullosa
resection
2.61
2.61
Finalize
33282
Implantation of patient-activated cardiac event recorder
3.50
3.50
Finalize
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00070
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.003</GPH>
Nasal/sinus endoscopy, surgical; with control of nasal
hemorrhage
31239
ebenthall on DSK5SPTVN1PROD with $$_JOB
31238
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCS
Code
CY2014
Interim
Final
Work
RVU
Long Descriptor
CY
2015
Work
RVU
CY 2015 Action
Removal of an implantable, patient-activated cardiac event
recorder
3.00
3.00
Finalize
33366
Transcatheter aortic valve replacement (tavr/tavi) with
prosthetic valve; transapical exposure (eg, left
thoracotomy)
35.88
35.88
Finalize
34841
Endovascular repair of visceral aorta (eg, aneurysm,
pseudoaneurysm, dissection, penetrating ulcer, intramural
hematoma, or traumatic disruption) by deployment of a
fenestrated visceral aortic endograft and all associated
radiological supervision and interpretation, including
target zone angioplasty, when performed; including one
visceral artery endoprosthesis (superior mesenteric, celiac
or renal artery)
c
c
Finalize
34842
Endovascular repair of visceral aorta (eg, aneurysm,
pseudoaneurysm, dissection, penetrating ulcer, intramural
hematoma, or traumatic disruption) by deployment of a
fenestrated visceral aortic endograft and all associated
radiological supervision and interpretation, including
target zone angioplasty, when performed; including two
visceral artery endoprostheses (superior mesenteric, celiac
and/or renal artery[s])
c
c
Finalize
34843
Endovascular repair of visceral aorta (eg, aneurysm,
pseudoaneurysm, dissection, penetrating ulcer, intramural
hematoma, or traumatic disruption) by deployment of a
fenestrated visceral aortic endograft and all associated
radiological supervision and interpretation, including
target zone angioplasty, when performed; including three
visceral artery endoprostheses (superior mesenteric, celiac
and/or renal artery[s])
c
c
Finalize
34844
Endovascular repair of visceral aorta (eg, aneurysm,
pseudoaneurysm, dissection, penetrating ulcer, intramural
hematoma, or traumatic disruption) by deployment of a
fenestrated visceral aortic endograft and all associated
radiological supervision and interpretation, including
target zone angioplasty, when performed; including four or
more visceral artery endoprostheses (superior mesenteric,
celiac and/or renal artery[ s])
c
c
Finalize
34845
Endovascular repair of visceral aorta and infrarenal
abdominal aorta (eg, aneurysm, pseudoaneurysm,
dissection, penetrating ulcer, intramural hematoma, or
traumatic disruption) with a fenestrated visceral aortic
endograft and concomitant unibody or modular infrarenal
aortic endograft and all associated radiological supervision
and interpretation, including target zone angioplasty, when
performed; including one visceral artery endoprosthesis
(superior mesenteric, celiac or renal artery)
c
c
Finalize
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00071
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.004</GPH>
33284
ebenthall on DSK5SPTVN1PROD with $$_JOB
67617
67618
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
CY2014
Interim
Final
Work
RVU
CY
2015
Work
RVU
34846
Endovascular repair of visceral aorta and infrarenal
abdominal aorta (eg, aneurysm, pseudoaneurysm,
dissection, penetrating ulcer, intramural hematoma, or
traumatic disruption) with a fenestrated visceral aortic
endograft and concomitant unibody or modular infrarenal
aortic endograft and all associated radiological supervision
and interpretation, including target zone angioplasty, when
performed; including two visceral artery endoprostheses
(superior mesenteric, celiac and/or renal artery[s])
c
c
Finalize
34847
Endovascular repair of visceral aorta and infrarenal
abdominal aorta (eg, aneurysm, pseudoaneurysm,
dissection, penetrating ulcer, intramural hematoma, or
traumatic disruption) with a fenestrated visceral aortic
endograft and concomitant unibody or modular infrarenal
aortic endograft and all associated radiological supervision
and interpretation, including target zone angioplasty, when
performed; including three visceral artery endoprostheses
(superior mesenteric, celiac and/or renal artery[s])
c
c
Finalize
34848
Endovascular repair of visceral aorta and infrarenal
abdominal aorta (eg, aneurysm, pseudoaneurysm,
dissection, penetrating ulcer, intramural hematoma, or
traumatic disruption) with a fenestrated visceral aortic
endograft and concomitant unibody or modular infrarenal
aortic endograft and all associated radiological supervision
and interpretation, including target zone angioplasty, when
performed; including four or more visceral artery
endoprostheses (superior mesenteric, celiac and/or renal
artery[s])
c
c
Finalize
35301
Thromboendarterectomy, including patch graft, if
performed; carotid, vertebral, subclavian, by neck incision
21.16
21.16
Finalize
36245
Selective catheter placement, arterial system; each first
order abdominal, pelvic, or lower extremity artery branch,
within a vascular family
4.90
4.90
Finalize
37217
Transcatheter placement of intravascular stent(s),
intrathoracic common carotid artery or innominate artery
by retrograde treatment, open ipsilateral cervical carotid
artery exposure, including angioplasty, when performed,
and radiological supervision and interpretation
20.38
20.38
Finalize
37236
Transcatheter placement of an intravascular stent(s)
(except lower extremity artery(s) for occlusive disease,
cervical carotid, extracranial vertebral or intrathoracic
carotid, intracranial, or coronary), open or percutaneous,
including radiological supervision and interpretation and
including all angioplasty within the same vessel, when
performed; initial artery
9.00
9.00
Finalize
VerDate Sep<11>2014
Long Descriptor
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00072
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
CY 2015 Action
ER13NO14.005</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
HCPCS
Code
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCS
Code
CY2014
Interim
Final
Work
RVU
Long Descriptor
CY
2015
Work
RVU
CY 2015 Action
Transcatheter placement of an intravascular stent(s)
(except lower extremity artery(s) for occlusive disease,
cervical carotid, extracranial vertebral or intrathoracic
carotid, intracranial, or coronary), open or percutaneous,
including radiological supervision and interpretation and
including all angioplasty within the same vessel, when
performed; each additional artery (list separately in
addition to code for primary procedure)
4.25
4.25
Finalize
37238
Transcatheter placement of an intravascular stent(s), open
or percutaneous, including radiological supervision and
interpretation and including angioplasty within the same
vessel, when performed; initial vein
6.29
6.29
Finalize
37239
Transcatheter placement of an intravascular stent(s), open
or percutaneous, including radiological supervision and
interpretation and including angioplasty within the same
vessel, when performed; each additional vein (list
separately in addition to code for primary procedure)
2.97
2.97
Finalize
37241
Vascular embolization or occlusion, inclusive of all
radiological supervision and interpretation, intraprocedural
roadmapping, and imaging guidance necessary to
complete the intervention; venous, other than hemorrhage
(eg, congenital or acquired venous malformations, venous
and capillary hemangiomas, varices, varicoceles)
9.00
9.00
Finalize
37242
Vascular embolization or occlusion, inclusive of all
radiological supervision and interpretation, intraprocedural
roadmapping, and imaging guidance necessary to
complete the intervention; arterial, other than hemorrhage
or tumor (eg, congenital or acquired arterial
malformations, arteriovenous malformations,
arteriovenous fistulas, aneurysms, pseudoaneurysms)
10.05
10.05
Finalize
37243
Vascular embolization or occlusion, inclusive of all
radiological supervision and interpretation, intraprocedural
roadmapping, and imaging guidance necessary to
complete the intervention; for tumors, organ ischemia, or
infarction
11.99
11.99
Finalize
37244
Vascular embolization or occlusion, inclusive of all
radiological supervision and interpretation, intraprocedural
roadmapping, and imaging guidance necessary to
complete the intervention; for arterial or venous
hemorrhage or lymphatic extravasation
14.00
14.00
Finalize
43191
Esophagoscopy, rigid, transoral; diagnostic, including
collection of specimen(s) by brushing or washing when
performed (separate procedure)
2.00
2.49
Finalize
43192
Esophagoscopy, rigid, transoral; with directed submucosal
injection(s), any substance
2.45
2.79
Finalize
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00073
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.006</GPH>
37237
ebenthall on DSK5SPTVN1PROD with $$_JOB
67619
67620
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCS
Code
CY2014
Interim
Final
Work
RVU
Long Descriptor
CY
2015
Work
RVU
CY 2015 Action
3.00
2.79
Finalize
Esophagoscopy, rigid, transoral; with removal of foreign
body(s)
3.00
3.51
Finalize
43195
Esophagoscopy, rigid, transoral; with balloon dilation (less
than 30 nun diameter)
3.00
3.07
Finalize
43196
Esophagoscopy, rigid, transoral; with insertion of guide
wire followed by dilation over guide wire
3.30
3.31
Finalize
43197
Esophagoscopy, flexible, transnasal; diagnostic, including
collection of specimen(s) by brushing or washing, when
performed (separate procedure)
1.48
1.52
Finalize
43198
Esophagoscopy, flexible, transnasal; with biopsy, single or
multiple
1.78
1.82
Finalize
43200
Esophagoscopy, flexible, transoral; diagnostic, including
collection of specimen(s) by brushing or washing, when
performed (separate procedure)
1.50
1.52
Finalize
43201
Esophagoscopy, flexible, transoral; with directed
submucosal injection(s), any substance
1.80
1.82
Finalize
43202
Esophagoscopy, flexible, transoral; with biopsy, single or
multiple
1.80
1.82
Finalize
43204
Esophagoscopy, flexible, transoral; with injection sclerosis
ofesophagealvarices
2.40
2.43
Finalize
43205
Esophagoscopy, flexible, transoral; with band ligation of
esophageal varices
2.51
2.54
Finalize
43206
Esophagoscopy, flexible, transoral; with optical
endomicroscopy
2.39
2.39
Finalize
43211
Esophagoscopy, flexible, transoral; with endoscopic
mucosal resection
4.21
4.30
Finalize
43212
Esophagoscopy, flexible, transoral; with placement of
endoscopic stent (includes pre- and post-dilation and guide
wire passage, when performed)
3.38
3.50
Finalize
43213
Esophagoscopy, flexible, transoral; with dilation of
esophagus, by balloon or dilator, retrograde (includes
fluoroscopic guidance, when performed)
4.73
4.73
Finalize
43214
Esophagoscopy, flexible, transoral; with dilation of
esophagus with balloon (30 nun diameter or larger)
(includes fluoroscopic guidance, when performed)
3.38
3.50
Finalize
43215
Esophagoscopy, flexible, transoral; with removal of
foreign body(s)
2.51
2.54
Finalize
43216
Esophagoscopy, flexible, transoral; with removal of
tumor(s), polyp(s), or other lesion(s) by hot biopsy forceps
2.40
2.40
Finalize
43217
Esophagoscopy, flexible, transoral; with removal of
tumor(s), polyp(s), or other lesion(s) by snare technique
2.90
2.90
Finalize
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00074
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.007</GPH>
Esophagoscopy, rigid, transoral; with biopsy, single or
multiple
43194
ebenthall on DSK5SPTVN1PROD with $$_JOB
43193
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCS
Code
CY2014
Interim
Final
Work
RVU
Long Descriptor
CY
2015
Work
RVU
CY 2015 Action
43220
Esophagoscopy, flexible, transoral; with transendoscopic
balloon dilation (less than 30 mm diameter)
2.10
2.10
Finalize
43226
Esophagoscopy, flexible, transoral; with insertion of guide
wire followed by passage of dilator(s) over guide wire
2.34
2.34
Finalize
2.99
2.99
Finalize
3.54
3.59
Finalize
2.90
2.90
Finalize
43227
43229
43231
Esophagoscopy, flexible, transoral; with control of
bleeding, any method
Esophagoscopy, flexible, transoral; with ablation of
tumor(s), polyp(s), or other lesion(s) (includes pre- and
post-dilation and guide wire passage, when performed)
Esophagoscopy, flexible, transoral; with endoscopic
ultrasound examination
Esophagoscopy, flexible, transoral; with transendoscopic
ultrasound-guided intramural or transmural fine needle
aspiration/biopsy(s)
3.54
3.59
Finalize
43233
Esophagogastroduodenoscopy, flexible, transoral; with
dilation of esophagus with balloon (30 mm diameter or
larger) (includes fluoroscopic guidance, when performed)
4.05
4.17
Finalize
43235
Esophagogastroduodenoscopy, flexible, transoral;
diagnostic, including collection ofspecimen(s) by
brushing or washing, when performed (separate
procedure)
2.17
2.19
Finalize
43236
Esophagogastroduodenoscopy, flexible, transoral; with
directed submucosal injection(s), any substance
2.47
2.49
Finalize
43237
Esophagogastroduodenoscopy, flexible, transoral; with
endoscopic ultrasound examination limited to the
esophagus, stomach or duodenum, and adjacent structures
3.57
3.57
Finalize
43238
Esophagogastroduodenoscopy, flexible, transoral; with
transendoscopic ultrasound-guided intramural or
transmural fine needle aspirationlbiopsy(s), (includes
endoscopic ultrasound examination limited to the
esophagus, stomach or duodenum, and adjacent structures)
4.11
4.26
Finalize
43239
Esophagogastroduodenoscopy, flexible, transoral; with
biopsy, single or multiple
2.47
2.49
Finalize
43240
Esophagogastroduodenoscopy, flexible, transoral; with
transmural drainage of pseudocyst (includes placement of
transmural drainage catheter[s]/stent[s], when performed,
and endoscopic ultrasound, when performed)
7.25
7.25
Finalize
43241
Esophagogastroduodenoscopy, flexible, transoral; with
insertion of intraluminal tube or catheter
2.59
2.59
Finalize
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00075
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.008</GPH>
43232
ebenthall on DSK5SPTVN1PROD with $$_JOB
67621
67622
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCS
Code
CY2014
Interim
Final
Work
RVU
Long Descriptor
CY
2015
Work
RVU
CY 2015 Action
43242
Esophagogastroduodenoscopy, flexible, transoral; with
transendoscopic ultrasound-guided intramural or
transmural fine needle aspiration/biopsy(s) (includes
endoscopic ultrasound examination of the esophagus,
stomach, and either the duodenum or a surgically altered
stomach where the jejunum is examined distal to the
anastomosis)
4.68
4.83
Finalize
43243
Esophagogastroduodenoscopy, flexible, transoral; with
injection sclerosis of esophageal/gastric varices
4.37
4.37
Finalize
43244
Esophagogastroduodenoscopy, flexible, transoral; with
band ligation of esophageal/gastric varices
4.50
4.50
Finalize
43245
Esophagogastroduodenoscopy, flexible, transoral; with
dilation of gastric/duodenal stricture(s) (eg, balloon,
bougie)
3.18
3.18
Finalize
43246
Esophagogastroduodenoscopy, flexible, transoral; with
directed placement of percutaneous gastrostomy tube
3.66
3.66
Finalize
43247
Esophagogastroduodenoscopy, flexible, transoral; with
removal offoreign body(s)
3.18
3.21
Finalize
43248
Esophagogastroduodenoscopy, flexible, transoral; with
insertion of guide wire followed by passage of dilator(s)
through esophagus over guide wire
3.01
3.01
Finalize
43249
Esophagogastroduodenoscopy, flexible, transoral; with
transendoscopic balloon dilation of esophagus (less than
30 mm diameter)
2.77
2.77
Finalize
43250
Esophagogastroduodenoscopy, flexible, transoral; with
removal oftumor(s), polyp(s), or other lesion(s) by hot
biopsy forceps
3.07
3.07
Finalize
43251
Esophagogastroduodenoscopy, flexible, transoral; with
removal oftumor(s), polyp(s), or other lesion(s) by snare
technique
3.57
3.57
Finalize
43253
ebenthall on DSK5SPTVN1PROD with $$_JOB
43254
43255
VerDate Sep<11>2014
Esophagogastroduodenoscopy, flexible, transoral; with
optical endomicroscopy
Esophagogastroduodenoscopy, flexible, transoral; with
transendoscopic ultrasound-guided transmural injection of
diagnostic or therapeutic substance(s) (eg, anesthetic,
neurolytic agent) or fiducial marker(s) (includes
endoscopic ultrasound examination of the esophagus,
stomach, and either the duodenum or a surgically altered
stomach where the jejunum is examined distal to the
anastomosis)
Esophagogastroduodenoscopy, flexible, transoral; with
endoscopic mucosal resection
3.06
3.06
Finalize
4.68
4.83
Finalize
4.88
4.97
Finalize
Esophagogastroduodenoscopy, flexible, transoral; with
control of bleeding, any method
3.66
3.66
Finalize
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00076
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.009</GPH>
43252
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCS
Code
43257
CY2014
Interim
Final
Work
RVU
Long Descriptor
Esophagogastroduodenoscopy, flexible, transoral; with
delivery of thermal energy to the muscle oflower
esophageal sphincter and/or gastric cardia, for treatment of
gastroesophageal reflux disease
Esophagogastroduodenoscopy, flexible, transoral; with
endoscopic ultrasound examination, including the
esophagus, stomach, and either the duodenum or a
surgically altered stomach where the jejunum is examined
distal to the anastomosis
CY
2015
Work
RVU
CY 2015 Action
4.25
Finalize
4.14
4.14
Finalize
43260
Endoscopic retrograde cholangiopancreatography (ercp);
diagnostic, including collection ofspecimen(s) by
brushing or washing, when performed (separate
procedure)
5.95
5.95
Finalize
43261
Endoscopic retrograde cholangiopancreatography (ercp);
with biopsy, single or multiple
6.25
6.25
Finalize
43262
Endoscopic retrograde cholangiopancreatography (ercp);
with sphincterotomy/papillotomy
6.60
6.60
Finalize
43263
Endoscopic retrograde cholangiopancreatography (ercp);
with pressure measurement of sphincter of oddi
6.60
6.60
Finalize
43264
Endoscopic retrograde cholangiopancreatography (ercp);
with removal of calculi/debris from biliary/pancreatic
duct(s)
6.73
6.73
Finalize
43265
Endoscopic retrograde cholangiopancreatography (ercp);
with destruction of calculi, any method (eg, mechanical,
electrohydraulic, lithotripsy)
8.03
8.03
Finalize
43266
Esophagogastroduodenoscopy, flexible, transoral; with
placement of endoscopic stent (includes pre- and postdilation and guide wire passage, when performed)
4.05
4.17
Finalize
43270
Esophagogastroduodenoscopy, flexible, transoral; with
ablation oftumor(s), polyp(s), or other lesion(s) (includes
pre- and post-dilation and guide wire passage, when
performed)
4.21
4.26
Finalize
43273
Endoscopic cannulation of papilla with direct visualization
of pancreatic/common bile duct(s) (list separately in
addition to code(s) for primary procedure)
2.24
2.24
Finalize
8.48
8.58
Finalize
6.96
6.96
Finalize
43274
43275
VerDate Sep<11>2014
Endoscopic retrograde cholangiopancreatography (ercp);
with placement of endoscopic stent into biliary or
pancreatic duct, including pre- and post-dilation and guide
wire passage, when performed, including sphincterotomy,
when performed, each stent
Endoscopic retrograde cholangiopancreatography (ercp);
with removal of foreign body(s) or stent(s) from
biliary/pancreatic duct( s)
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00077
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.010</GPH>
4.11
43259
ebenthall on DSK5SPTVN1PROD with $$_JOB
67623
67624
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
CY2014
Interim
Final
Work
RVU
CY
2015
Work
RVU
43276
Endoscopic retrograde cholangiopancreatography (ercp);
with removal and exchange ofstent(s), biliary or
pancreatic duct, including pre- and post-dilation and guide
wire passage, when performed, including sphincterotomy,
when performed, each stent exchanged
8.84
8.94
Finalize
43277
Endoscopic retrograde cholangiopancreatography (ercp);
with trans-endoscopic balloon dilation of
biliary/pancreatic duct(s) or of ampulla (sphincteroplasty),
including sphincterotomy, when performed, each duct
7.00
7.00
Finalize
43278
Endoscopic retrograde cholangiopancreatography (ercp);
with ablation oftumor(s), polyp(s), or other lesion(s),
including pre- and post-dilation and guide wire passage,
when performed
7.99
8.02
Finalize
43450
Dilation of esophagus, by unguided sound or bougie,
single or multiple passes
1.38
1.38
Finalize
43453
Dilation of esophagus, over guide wire
1.51
1.51
Finalize
49405
Image-guided fluid collection drainage by catheter (eg,
abscess, hematoma, seroma, lymphocele, cyst); visceral
(eg, kidney, liver, spleen, lung/mediastinum),
percutaneous
4.25
4.25
Finalize
49406
Image-guided fluid collection drainage by catheter (eg,
abscess, hematoma, seroma, lymphocele, cyst); peritoneal
or retroperitoneal, percutaneous
4.25
4.25
Finalize
49407
Image-guided fluid collection drainage by catheter (eg,
abscess, hematoma, seroma, lymphocele, cyst); peritoneal
or retroperitoneal, transvaginal or transrectal
4.50
4.50
Finalize
50360
Renal allotransplantation, implantation of graft; without
recipient nephrectomy
39.88
39.88
Finalize
52332
Cystourethroscopy, with insertion of indwelling ureteral
stent (eg, gibbons or double-j type)
2.82
2.82
Finalize
52356
Cystourethroscopy, with ureteroscopy and/or pyeloscopy;
with lithotripsy including insertion of indwelling ureteral
stent (eg, gibbons or double-j type)
8.00
8.00
Finalize
62310
Injection(s), of diagnostic or therapeutic substance(s)
(including anesthetic, antispasmodic, opioid, steroid, other
solution), not including neurolytic substances, including
needle or catheter placement, includes contrast for
localization when performed, epidural or subarachnoid;
cervical or thoracic
1.18
See II.G.3.a
62311
Injection(s), of diagnostic or therapeutic substance(s)
(including anesthetic, antispasmodic, opioid, steroid, other
solution), not including neurolytic substances, including
needle or catheter placement, includes contrast for
localization when performed, epidural or subarachnoid;
lumbar or sacral (caudal)
1.17
See II.G.3.a
VerDate Sep<11>2014
Long Descriptor
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00078
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
CY 2015 Action
ER13NO14.011</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
HCPCS
Code
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCS
Code
CY2014
Interim
Final
Work
RVU
Long Descriptor
CY
2015
Work
RVU
CY 2015 Action
Injection(s), including indwelling catheter placement,
continuous infusion or intermittent bolus, of diagnostic or
therapeutic substance(s) (including anesthetic,
antispasmodic, opioid, steroid, other solution), not
including neurolytic substances, includes contrast for
localization when performed, epidural or subarachnoid;
cervical or thoracic
1.54
See II.G.3.a
62319
Injection(s), including indwelling catheter placement,
continuous infusion or intermittent bolus, of diagnostic or
therapeutic substance(s) (including anesthetic,
antispasmodic, opioid, steroid, other solution), not
including neurolytic substances, includes contrast for
localization when performed, epidural or subarachnoid;
lumbar or sacral (caudal)
1.50
See II.G.3.a
63047
Laminectomy, facetectomy and foraminotomy (unilateral
or bilateral with decompression of spinal cord, cauda
equina and/or nerve root[ s], [eg, spinal or lateral recess
stenosis]), single vertebral segment; lumbar
15.37
15.37
Finalize
63048
Laminectomy, facetectomy and foraminotomy (unilateral
or bilateral with decompression of spinal cord, cauda
equina and/or nerve root[ s], [eg, spinal or lateral recess
stenosis]), single vertebral segment; each additional
segment, cervical, thoracic, or lumbar (list separately in
addition to code for primary procedure)
3.47
3.47
Finalize
64616
Chemodenervation ofmuscle(s); neck muscle(s),
excluding muscles of the larynx, unilateral (eg, for cervical
dystonia, spasmodic torticollis)
1.53
1.53
Finalize
64617
Chemodenervation ofmuscle(s); larynx, unilateral,
percutaneous (eg, for spasmodic dysphonia), includes
guidance by needle electromyography, when performed
1.90
1.90
Finalize
64642
Chemodenervation of one extremity; 1-4 muscle( s)
1.65
1.65
Finalize
64643
Chemodenervation of one extremity; each additional
extremity, 1-4 muscle( s) (list separately in addition to code
for primary procedure)
1.22
1.22
Finalize
64644
Chemodenervation of one extremity; 5 or more muscles
1.82
1.82
Finalize
64645
Chemodenervation of one extremity; each additional
extremity, 5 or more muscles (list separately in addition to
code for primary procedure)
1.39
1.39
Finalize
64646
Chemodenervation of trunk muscle(s); 1-5 muscle(s)
1.80
1.80
Finalize
64647
Chemodenervation of trunk muscle(s); 6 or more muscles
2.11
2.11
Finalize
66183
Insertion of anterior segment aqueous drainage device,
without extraocular reservoir, external approach
13.20
13.20
Finalize
67914
Repair of ectropion; suture
3.75
3.75
Finalize
67915
Repair of ectropion; thermocauterization
2.03
2.03
Finalize
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00079
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.012</GPH>
62318
ebenthall on DSK5SPTVN1PROD with $$_JOB
67625
67626
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCS
Code
CY2014
Interim
Final
Work
RVU
Long Descriptor
CY
2015
Work
RVU
CY 2015 Action
Repair of ectropion; excision tarsal wedge
5.48
5.48
Finalize
67917
Repair of ectropion; extensive (eg, tarsal strip operations)
5.93
5.93
Finalize
67921
Repair of entropion; suture
3.47
3.47
Finalize
67922
Repair of entropion; thermocauterization
2.03
2.03
Finalize
67923
Repair of entropion; excision tarsal wedge
5.48
5.48
Finalize
67924
Repair of entropion; extensive (eg, tarsal strip or
capsulopalpebral fascia repairs operation)
5.93
5.93
Finalize
69210
Removal impacted cerumen requiring instrumentation,
unilateral
0.61
0.61
Finalize
70450
Computed tomography, head or brain; without contrast
material
0.85
0.85
Finalize
70460
Computed tomography, head or brain; with contrast
material(s)
1.13
1.13
Finalize
70551
Magnetic resonance (eg, proton) imaging, brain (including
brain stem); without contrast material
1.48
1.48
Finalize
70552
Magnetic resonance (eg, proton) imaging, brain (including
brain stem); with contrast material(s)
1.78
1.78
Finalize
70553
Magnetic resonance (eg, proton) imaging, brain (including
brain stem); without contrast material, followed by
contrast material(s) and further sequences
2.29
2.29
Finalize
72141
Magnetic resonance (eg, proton) imaging, spinal canal and
contents, cervical; without contrast material
1.48
1.48
Finalize
72142
Magnetic resonance (eg, proton) imaging, spinal canal and
contents, cervical; with contrast material(s)
1.78
1.78
Finalize
72146
Magnetic resonance (eg, proton) imaging, spinal canal and
contents, thoracic; without contrast material
1.48
1.48
Finalize
72147
Magnetic resonance (eg, proton) imaging, spinal canal and
contents, thoracic; with contrast material(s)
1.78
1.78
Finalize
72148
Magnetic resonance (eg, proton) imaging, spinal canal and
contents, lumbar; without contrast material
1.48
1.48
Finalize
1.78
1.78
Finalize
2.29
2.29
Finalize
2.29
2.29
Finalize
2.29
2.29
Finalize
72149
72156
72157
ebenthall on DSK5SPTVN1PROD with $$_JOB
72158
VerDate Sep<11>2014
Magnetic resonance (eg, proton) imaging, spinal canal and
contents, lumbar; with contrast material(s)
Magnetic resonance (eg, proton) imaging, spinal canal and
contents, without contrast material, followed by contrast
material(s) and further sequences; cervical
Magnetic resonance (eg, proton) imaging, spinal canal and
contents, without contrast material, followed by contrast
material( s) and further sequences; thoracic
Magnetic resonance (eg, proton) imaging, spinal canal and
contents, without contrast material, followed by contrast
material(s) and further sequences; lumbar
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00080
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.013</GPH>
67916
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCS
Code
CY2014
Interim
Final
Work
RVU
Long Descriptor
CY
2015
Work
RVU
CY 2015 Action
72191
Computed tomographic angiography, pelvis, with contrast
material(s), including noncontrast images, if performed,
and image postprocessing
1.81
1.81
Finalize
7589626
Transcatheter therapy, infusion, other than for
thrombolysis, radiological supervision and interpretation
1.31
1.31
Finalize
75896TC
Transcatheter therapy, infusion, other than for
thrombolysis, radiological supervision and interpretation
Angiography through existing catheter for follow-up study
for transcatheter therapy, embolization or infusion, other
than for thrombolysis
c
c
Finalize
1.65
1.65
Finalize
c
c
Finalize
0.38
0.38
Finalize
0.54
0.54
Finalize
0.60
0.60
Finalize
0.70
0.70
Finalize
7589826
75898TC
77001
77002
77003
77280
Angiography through existing catheter for follow-up study
for transcatheter therapy, embolization or infusion, other
than for thrombolysis
Fluoroscopic guidance for central venous access device
placement, replacement (catheter only or complete), or
removal (includes fluoroscopic guidance for vascular
access and catheter manipulation, any necessary contrast
injections through access site or catheter with related
venography radiologic supervision and interpretation, and
radiographic documentation of final catheter position) (list
separately in addition to code for primary procedure)
Fluoroscopic guidance for needle placement (eg, biopsy,
aspiration, injection, localization device)
Fluoroscopic guidance and localization of needle or
catheter tip for spine or paraspinous diagnostic or
therapeutic injection procedures (epidural or
subarachnoid)
Therapeutic radiology simulation-aided field setting;
simple
Therapeutic radiology simulation-aided field setting;
intermediate
1.05
1.05
Finalize
77290
Therapeutic radiology simulation-aided field setting;
complex
1.56
1.56
Finalize
77293
Respiratory motion management simulation (list
separately in addition to code for primary procedure)
2.00
2.00
Finalize
77295
3-dimensional radiotherapy plan, including dose-volume
histograms
4.29
4.29
Finalize
81161
Dmd (dystrophin) (eg, duchenne/becker muscular
dystrophy) deletion analysis, and duplication analysis, if
performed
X
X
Finalize
0.56
0.56
Finalize
1.20
1.20
Finalize
88112
88120
VerDate Sep<11>2014
Cytopathology, selective cellular enhancement technique
with interpretation (eg, liquid based slide preparation
method), except cervical or vaginal
Cytopathology, in situ hybridization (eg, fish), urinary
tract specimen with morphometric analysis, 3-5 molecular
probes, each specimen; manual
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00081
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.014</GPH>
77285
ebenthall on DSK5SPTVN1PROD with $$_JOB
67627
67628
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
CY2014
Interim
Final
Work
RVU
CY
2015
Work
RVU
88121
Cytopathology, in situ hybridization (eg, fish), urinary
tract specimen with morphometric analysis, 3-5 molecular
probes, each specimen; using computer-assisted
technology
1.00
1.00
88342
Immunohistochemistry or immunocytochemistry, per
specimen; initial single antibody stain procedure
I
See II.G.3.b
I
See II.G.3.b
1.20
See II.G.3.b
1.30
See II. G.3.b
See II.G3.b
HCPCS
Code
88343
88365
88367
Long Descriptor
Immunohistochemistry or immunocytochemistry, each
separately identifiable antibody per block, cytologic
preparation, or hematologic smear; each additional
separately identifiable antibody per slide (list separately in
addition to code for primary procedure)
In situ hybridization (eg, fish), per specimen; initial single
probe stain procedure
Morphometric analysis, in situ hybridization (quantitative
or semi-quantitative), using computer-assisted technology,
per specimen; initial single probe stain procedure
CY 2015 Action
Finalize
88368
Morphometric analysis, in situ hybridization (quantitative
or semi-quantitative), manual, per specimen; initial single
probe stain procedure
1.40
88375
Optical endomicroscopic image(s), interpretation and
report, real-time or referred, each endoscopic session
I
0.91
Finalize
90785
Interactive complexity (list separately in addition to the
code for primary procedure)
0.33
0.33
Finalize
90791
Psychiatric diagnostic evaluation
3.00
3.00
Finalize
Psychiatric diagnostic evaluation with medical services
3.25
3.25
Finalize
1.50
1.50
Finalize
90792
1.50
1.50
Finalize
2.00
2.00
Finalize
1.90
1.90
Finalize
3.00
3.00
Finalize
90838
Psychotherapy, 60 minutes with patient and/or family
member when performed with an evaluation and
management service (list separately in addition to the code
for primary procedure)
2.50
2.50
Finalize
90839
Psychotherapy for crisis; first 60 minutes
3.13
3.13
Finalize
90832
90833
90834
90836
ebenthall on DSK5SPTVN1PROD with $$_JOB
90837
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00082
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.015</GPH>
Psychotherapy, 30 minutes with patient and/or family
member
Psychotherapy, 30 minutes with patient and/or family
member when performed with an evaluation and
management service (list separately in addition to the code
for primary procedure)
Psychotherapy, 45 minutes with patient and/or family
member
Psychotherapy, 45 minutes with patient and/or family
member when performed with an evaluation and
management service (list separately in addition to the code
for primary procedure)
Psychotherapy, 60 minutes with patient and/or family
member
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCS
Code
CY2014
Interim
Final
Work
RVU
Long Descriptor
CY
2015
Work
RVU
CY 2015 Action
90840
Psychotherapy for crisis; each additional 30 minutes (list
separately in addition to code for primary service)
1.50
1.50
Finalize
90845
Psychoanalysis
2.10
2.10
Finalize
90846
Family psychotherapy (without the patient present)
2.40
2.40
Finalize
90847
Family psychotherapy (conjoint psychotherapy) (with
patient present)
2.50
2.50
Finalize
90853
Group psychotherapy (other than of a multiple-family
group)
0.59
0.59
Finalize
90863
Pharmacologic management, including prescription and
review of medication, when performed with
psychotherapy services (list separately in addition to the
code for primary procedure)
I
I
Finalize
92521
Evaluation of speech fluency (eg, stuttering, cluttering)
1.75
1.75
Finalize
92522
Evaluation of speech sound production (eg, articulation,
phonological process, apraxia, dysarthria);
1.50
1.50
Finalize
92523
Evaluation of speech sound production (eg, articulation,
phonological process, apraxia, dysarthria); with evaluation
of language comprehension and expression (eg, receptive
and expressive language)
3.00
3.00
Finalize
92524
Behavioral and qualitative analysis of voice and resonance
1.50
1.50
Finalize
93000
Electrocardiogram, routine ecg with at least 12 leads; with
interpretation and report
0.17
0.17
Finalize
93010
Electrocardiogram, routine ecg with at least 12leads;
interpretation and report only
0.17
0.17
Finalize
12.56
12.56
Finalize
14.00
14.00
Finalize
93582
93583
93880
Percutaneous transcatheter closure of patent ductus
arteriosus
Percutaneous transcatheter septal reduction therapy (eg,
alcohol septal ablation) including temporary pacemaker
insertion when performed
Duplex scan of extracranial arteries; complete bilateral
study
0.60
See II.G.3.b
See II.G.3.b
Duplex scan of extracranial arteries; unilateral or limited
study
0.40
95816
Electroencephalogram (eeg); including recording awake
and drowsy
1.08
1.08
Finalize
95819
Electroencephalogram (eeg); including recording awake
and asleep
1.08
1.08
Finalize
95822
Electroencephalogram (eeg); recording in coma or sleep
only
1.08
1.08
Finalize
95928
Central motor evoked potential study (transcranial motor
stimulation); upper limbs
1.50
1.50
Finalize
95929
Central motor evoked potential study (transcranial motor
stimulation); lower limbs
1.50
1.50
Finalize
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00083
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.016</GPH>
93882
ebenthall on DSK5SPTVN1PROD with $$_JOB
67629
67630
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCS
Code
CY2014
Interim
Final
Work
Long Descriptor
CY
2015
Work
CY 2015 Action
RVU
RVU
Intravenous infusion, for therapy, prophylaxis, or
diagnosis (specify substance or drug); initial, up to 1 hour
0.21
0.21
Finalize
96366
Intravenous infusion, for therapy, prophylaxis, or
diagnosis (specify substance or drug); each additional hour
(list separately in addition to code for primary procedure)
0.18
0.18
Finalize
0.19
0.19
Finalize
0.17
0.17
Finalize
0.28
0.28
Finalize
0.19
0.19
Finalize
0.21
0.21
Finalize
c
c
Finalize
0.46
0.46
Finalize
0.71
0.71
Finalize
0.96
0.96
Finalize
B
B
Finalize
B
B
Finalize
B
B
Finalize
96367
96368
96413
96415
96417
97610
98940
98941
98942
99446
ebenthall on DSK5SPTVN1PROD with $$_JOB
99447
99448
VerDate Sep<11>2014
Intravenous infusion, for therapy, prophylaxis, or
diagnosis (specify substance or drug); additional
sequential infusion of a new drug/substance, up to 1 hour
(list separately in addition to code for primary procedure)
Intravenous infusion, for therapy, prophylaxis, or
diagnosis (specify substance or drug); concurrent infusion
(list separately in addition to code for primary procedure)
Chemotherapy administration, intravenous infusion
technique; up to 1 hour, single or initial substance/drug
Chemotherapy administration, intravenous infusion
technique; each additional hour (list separately in addition
to code for primary procedure)
Chemotherapy administration, intravenous infusion
technique; each additional sequential infusion (different
substance/drug), up to 1 hour (list separately in addition to
code for primary procedure)
Low frequency, non-contact, non-thermal ultrasound,
including topical application(s), when performed, wound
assessment, and instruction(s) for ongoing care, per day
Chiropractic manipulative treatment (cmt); spinal, 1-2
regions
Chiropractic manipulative treatment (cmt); spinal, 3-4
regions
Chiropractic manipulative treatment (cmt); spinal, 5
regions
Interprofessional telephone/internet assessment and
management service provided by a consultative physician
including a verbal and written report to the patient's
treating/requesting physician or other qualified health care
professional; 5-10 minutes of medical consultative
discussion and review
Interprofessional telephone/internet assessment and
management service provided by a consultative physician
including a verbal and written report to the patient's
treating/requesting physician or other qualified health care
professional; 11-20 minutes of medical consultative
discussion and review
Interprofessional telephone/internet assessment and
management service provided by a consultative physician
including a verbal and written report to the patient's
treating/requesting physician or other qualified health care
professional; 21-30 minutes of medical consultative
discussion and review
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00084
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.017</GPH>
96365
BILLING CODE 4120–01–C
In the following section, we discuss
each code for which we received a
comment on the CY 2014 interim final
work value or work time during the
comment period for the CY 2014 final
rule with comment period or for which
we are modifying the CY 2014 interim
final work RVU, work time or procedure
status indicator for CY 2015. If a code
in Table 15 is not discussed in this
section, we did not receive any
comments on that code and are
finalizing the interim final work RVU
and time without modification for CY
2015.
(1) Mohs Surgery (CPT Codes 17311 and
17313)
ebenthall on DSK5SPTVN1PROD with $$_JOB
As detailed in the CY 2014 PFS final
rule with comment period, we
maintained the CY 2013 work RVUs for
CPT codes 17311 and 17313 codes,
based upon the RUC-recommended
work RVUs.
Comment: We received a comment
that was supportive of the interim final
work RVU.
Response: We thank the commenter
for their support and are finalizing the
CY 2014 interim final values for CY
2015.
(2) Breast Biopsy (CPT Codes 19081,
19082, 19083, 19084, 19085, 19086,
19281, 19282, 19283, 19284, 19285,
19286, 19287, and 19288)
For CY 2014, the CPT Editorial Panel
created 14 new codes, CPT codes 19081
through 19288, to describe breast biopsy
and placement of breast localization
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
devices, and the RUC recommended
work RVUs for each of these codes. In
the 2014 final rule with comment
period, we established interim final
values for all of these codes as
recommended by the RUC except for
CPT code 19287 and its add-on CPT
code, 19288, which are used for
magnetic resonance (MR) guidance. We
expressed concern that for CPT code
19287 the RUC-recommended work
RVUs were too high in relation to those
of other marker placement codes, and
refined it to a lower value. Since we had
adopted the RUC recommendation that
all the add-on codes in this family have
work RVUs equal to 50 percent of the
base code’s work RVU, our refinement
of CPT code 19287 resulted in a
refinement of CPT code 19288 also. We
also changed the intraservice time of
CPT code 19286, an add-on code, from
19 minutes to 15 minutes since we
believed the intraservice time of an addon code should not be higher than its
base code and the base code for CPT
code 19286, has an intraservice time of
15 minutes.
Comment: Several commenters
disagreed with the new CPT coding
structure for breast biopsy and
placement of breast localization devices
because, unlike the predecessor
structure, it fails to distinguish between
the two types of biopsy devices—
standard core needle and vacuum
assisted. One commenter suggested that
the payment should be higher when
services are vacuum assisted, and
suggested that CMS create a modifier to
report when these services are furnished
PO 00000
Frm 00085
Fmt 4701
Sfmt 4700
67631
using a vacuum assisted biopsy or create
a series of G-codes that distinguish
between standard core needle biopsy
and vacuum assisted biopsy.
Response: We prefer to use the CPT
coding structure unless a programmatic
need suggests that an alternative coding
structure is preferable. In this case, we
believe that we can pay appropriately
for these services using the new CPT
coding structure. To the extent that the
commenters think the CPT coding
system is not ideal for these services, we
believe the CPT Editorial Panel is the
appropriate forum for this concern. The
commenters are mistaken regarding how
the inputs for these codes were
determined as they are based upon the
typical service being vacuum assisted.
Comment: Several commenters
disagreed with the interim final work
RVUs we established for CPT codes
19287 and 19288, stating that the higher
RUC-recommended RVUs were more
appropriate and would maintain
relativity within the family. The
commenters stated that these services
have longer intraservice time than other
codes in the marker placement family,
are of high intensity, produce high
patient and family anxiety, and have
higher malpractice costs. One
commenter requested that the entire
breast biopsy code family be referred to
refinement. Other commenters
requested refinement panel review of
selected codes within this family.
Response: Based upon this request,
we referred this family of codes to the
CY 2014 multi-specialty refinement
panel for further review. Prior to CY
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.018</GPH>
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
67632
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
2014, breast biopsies and marker
placements were billed using a single
code. In addition, the appropriate image
guidance code was separately billed.
Prior to CY 2014, there were individual
guidance codes for the different types of
guidance including MR and stereotactic
guidance.
For CY 2013, the MR guidance code,
CPT code 77032, had a lower work RVU
than the stereotactic guidance code, CPT
code 77031. Combining the values for
the marker placement or biopsy codes
with the guidance codes should not, in
our view, result in a change in the rank
order of the guidance. Accordingly, we
do not believe the bundled code that
includes MR guidance should now be
valued significantly higher than one that
includes the stereotactic guidance. Also,
the refinement panel discussions did
not provide new clinical information.
Therefore, we continue to believe the
CY 2014 interim final values are
appropriate for CPT codes 19287 and
19288, and are finalizing them for CY
2015.
Comment: Commenters stated that the
RUC-recommended intraservice time of
19 minutes for CPT code 19286, which
is an add-on code, was incorrect and
that the code should have the same
intraservice time as its base code (15
minutes) rather than the 14 minutes
assigned by CMS. The commenter said
that this was consistent with the other
base code/add-on relationships across
the family.
Response: We agree and are finalizing
the intraservice time for CPT code
19286 at 15 minutes.
Comment: In response to our request
for confirmation that a post procedure
mammogram is typically furnished with
a breast marker placement procedure,
commenters agreed that it was.
However, they disagreed with our
assertion that if it was typical it should
be bundled with the appropriate breast
marker procedures. Commenters said
that it should be a separately reportable
service because it requires additional
work not captured by the codes in this
family.
Response: We thank commenters for
their feedback. We are not bundling post
procedure mammograms with the
appropriate breast marker codes at this
time, but will consider whether as a
services that typically occur together
they should be bundled.
(3) Hip and Knee Replacement (CPT
Codes 27130, 27446 and 27447)
In the CY 2014 final rule with
comment period we established interim
final values for three CPT codes for hip
and knee replacements that had
previously been identified as potentially
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
misvalued codes under the CMS high
expenditure procedural code screen. For
CY 2014, we established the RUCrecommended work value of 17.48 as
interim final work RVUs for CPT code
27446. As we explained in the CY 2014
final rule with comment period, we
established interim final work RVUs for
CPT codes 27130 and 27447 that varied
from those recommended by the RUC
based upon information that we
received from the relevant specialty
societies. We noted that the information
presented by the specialty societies and
the RUC raised concerns regarding the
appropriate valuation of these services,
especially related to the use of the best
data source for determining the
intraservice time involved in furnishing
PFS services. Specifically, there was
significant variation between the time
values estimated through a survey
versus those collected through specialty
databases. We characterized our
concerns saying, ‘‘The divergent
recommendations from the specialty
societies and the RUC regarding the
accuracy of the estimates of time for
these services, including both the source
of time estimates for the procedure itself
as well as the inpatient and outpatient
visits included in the global periods for
these codes, lead us to take a cautious
approach in valuing these services.’’
With regard to the specific valuations,
we agreed with the RUC’s
recommendation to value CPT codes
27130 and 27447 equally. We explained
that we modified the RUCrecommended work RVUs for these two
codes to reflect the visits in the global
period as recommended by the specialty
societies, resulting in a 1.12 work RVU
increase from the RUC-recommended
value for each code. Accordingly, we
assigned CPT codes 27130 and 27447 an
interim final work RVU of 20.72. We
sought public comment regarding, not
only the appropriate work RVUs for
these services, but also the most
appropriate reconciliation for the
conflicting information regarding time
values for these services as presented to
us by the physician community. We also
sought public comment on the use of
specialty databases as compared to
surveys for determining time values,
potential sources of objective data
regarding procedure times, and levels of
visits furnished during the global
periods for the services described by
these codes.
Comment: The RUC submitted
comments explaining how it reached its
recommendations for these codes and
that it followed its process consistently
in developing its recommendations on
these codes. All those who commented
specifically on the interim final work
PO 00000
Frm 00086
Fmt 4701
Sfmt 4700
RVUs for these codes objected to the
interim final work RVUs—some citing
potential access problems. Commenters
suggested that we use more reliable time
data. Commenters suggested that
valuation should be based on actual
time data, which demonstrates that the
time for this code has not changed since
the last valuation; and thus the work
RVUs should not decrease from the CY
2013 values. Among the commenters’
suggestions were using data from the
Function and Outcomes Research for
Comparative Effectiveness in Total Joint
Replacement (FORCE–TJR), which
includes data on more than 15,000 total
lower extremity joint arthroplasty
procedures, including time in/time out
data for at least half of the procedures,
and working with the specialty societies
to explore the best data collection
methods. A commenter suggested
restoring the CY 2013 work RVUs until
additional time data are available.
Another commenter suggested valuing
these services utilizing a reverse
building block methodology resulting in
work RVU of 21.18 for CPT codes 27130
and 22.11 for CPT code 27447. A
commenter stated that the hip and knee
replacement codes should be valued
differently since they are clinically
different procedures. Two commenters
expressed concern regarding the use of
a final rule to establish interim values
for established hip and knee procedures
due to the lack of opportunity it
provides stakeholders to analyze and
comment on reductions prior to
implementation.
Response: In the CY 2014 final rule
with comment period, we noted
concerns about the time data used in
valuing these services and requested
additional input from stakeholders
regarding using other sources of data
beyond the surveys typically used by
the RUC. We do not believe that we
received the kind of information and the
level of detail about the other types of
data suggested by commenters that we
would need to be able to use routinely
in valuing procedures. We will continue
to explore the use of other data on time.
As we discuss in section II.B. we have
engaged contractors to assist us in
exploring alternative data sources to use
in determining the times associated
with particular services. At this time,
we are not convinced that data from
another source would result in an
improved value for these services. Nor
did we find the reasons given for
modifying the interim final work values
established in CY 2014. The interim
final values are based upon the best data
we have available and preserve
appropriate relativity with other codes.
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
Accordingly, we are finalizing the
interim final values for these
procedures.
ebenthall on DSK5SPTVN1PROD with $$_JOB
(4) Transcatheter Placement
Intravascular Stent (CPT Code 37236,
37237, 37238, and 37239)
For CY 2014, we established the RUCrecommended work RVUs for newly
created CPT codes 37236, 37237, and
37238 as the interim final values. We
disagreed with the RUC-recommended
work RVU for CPT code 37239, which
is the add-on code to CPT code 37238,
for the placement of an intravascular
stent in each additional vein. As we
described in the CY 2014 final rule with
comment period we believe that the
work for placement of an additional
stent in a vein should bear the same
relationship to the work of placing an
initial stent in the vein as the placement
of an additional stent in an artery to the
placement of the initial stent in an
artery.
Comment: Many commenters
indicated that our valuation of CPT code
37239 was inappropriate. They
indicated that instead we should use the
RUC’s recommended work RVU of 3.34
for this code since the procedure is
more intense and requires more
physician work than would result from
the comparison made by CMS. One
commenter requested that CPT code
37239 be referred to the refinement
panel.
Response: After re-review, we
continue to believe that the ratio of the
work of the placement of the initial
stent to the placement of additional
stents is the same whether the stents are
placed in an artery or a vein, and
accordingly the appropriate ratio is
found in the RUC-recommended work
RVUs of CPT codes 37236 and 37237,
the comparable codes for the arteries.
For that reason, we are finalizing our CY
2014 interim final values. Additionally,
we did not refer these codes for
refinement panel review because the
criteria for refinement panel review
were not met.
(5) Embolization and Occlusion
Procedures (CPT Codes 37242 and
37243)
For CY 2014, we established interim
final work RVUs for these two codes
based upon the survey’s 25th percentile.
As we discussed in the CY 2014 interim
final rule with comment period, we
believed that the RUC-recommended
work RVU for CPT code 37242 did not
adequately take into account the
substantial decrease in intraservice
time. We indicated that we believed that
the survey’s 25th percentile work RVU
of 10.05 was more consistent with the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
decreases in intraservice time since its
last valuation and more appropriately
reflected the work of the procedure.
Similarly, we did not believe that the
RUC-recommended work RVU for CPT
code 37243 adequately considered the
substantial decrease in intraservice time
for the procedure; and we also use the
survey’s 25th percentile for CPT code
37243.
Comment: Many commenters
disagreed with our interim final
valuation of 37242, including one who
recommended a work RVU of 11.98.
One commenter also believed the work
RVU assigned to CPT code 37243 was
inappropriate and recommended
instead a work RVU of 14.00.
Commenters requested that the family of
codes be referred for refinement.
Response: After consideration of the
comments, we continue to believe that
work RVUs should reflect the decreases
in intraservice time that have occurred
since the last valuation. As a result, we
continue to believe that our CY 2014
interim final values are most
appropriate and are finalizing them for
CY 2015. Additionally, we did not refer
these codes for refinement panel review
because the criteria for refinement panel
review were not met.
(6) Rigid Transoral Esophagoscopy (CPT
Codes 43191, 43192, 43193, 43194,
43195 and 43196)
We established CY 2014 interim final
work RVUs for the rigid transoral
esophagoscopy codes using a ratio of 1
RVU per 10 minutes of intraservice
time, resulting in a RVU of 2.00 for CPT
code 43191, 3.00 for CPT code 43193,
3.00 for CPT code 43194, 3.00 for CPT
code 43195, and 3.30 for CPT code
43196. As we detailed in the CY 2014
final rule with comment period, the
surveys showed that this ratio was
reflected for about half of the rigid
transoral esophagoscopy codes.
Additionally, we noted that this ratio
was further supported by the
relationship between the CY 2013 work
value of 1.59 RVUs for CPT code 43200
(Esophagoscopy, rigid or flexible;
diagnostic, with or without collection of
specimen(s) by brushing or washing
(separate procedure)) and its
intraservice time of 15 minutes. For CPT
code 43192, the 1 work RVU per 10
minutes ratio resulted in a value that
was less than the survey low, and thus
did not appear to be appropriate for this
procedure. Therefore, we established a
CY 2014 interim final work RVU for
CPT code 43192 of 2.45 based upon the
survey low.
Comment: Multiple commenters
objected to the interim final work RVUs
assigned to CPT codes 43191–43196,
PO 00000
Frm 00087
Fmt 4701
Sfmt 4700
67633
and expressed dissatisfaction with
CMS’s explanation for the valuations.
The commenters specifically noted that
CMS did not account for the difference
in intensity between flexible and rigid
scopes now that there are separate codes
for these procedures. The commenters
also suggested that the reduction in time
in the RUC recommendations for codes
43191, 43193, 43195, and 43196 was
also based on data from procedures with
flexible scopes. The commenters also
stated that our valuation of services
based upon 1 work RVU per 10 minutes
of intraservice time was inappropriate
and was based on the survey low, which
is an anomalous outlier. The
commenters suggested the following
work RVUs based upon the RUC
recommended values: 2.78 For CPT
code 43191, 3.21 for CPT code 43192,
3.36 for CPT code 43193, 3.99 for CPT
code 43194, 3.21 for CPT code 43195
and 3.36 or CPT code 43196. Finally,
the commenters asked that all these
codes be referred to a refinement panel
for reconsideration.
Response: After consideration of the
comments, we agree that modification of
the CY 2014 interim final values is
appropriate. Based upon the
information provided in comments and
further investigation, we believe that
greater intensity is involved in
furnishing rigid than flexible transoral
esophagoscopy. Accordingly, rather
than assigning 1 work RVU per 10
minutes of intraservice time as we did
for the CY 2014 interim final, we are
assigning a final work RVU to the base
code, CPT code 41391, of 2.49. This
work RVU is based on increasing the
work RVU of the previous comparable
code (1.59) to reflect the percentage
increase in time for the CY 2014 code.
For the remaining rigid esophagoscopy
codes, we developed RVUs by starting
with the RVUs for the corresponding
flexible esophagoscopy codes, and
increasing those values by adding the
difference between the base flexible
esophagoscopy and the base rigid
esophagoscopy codes to arrive at final
RVUs. We are establishing a final work
RVU of 2.79 to CPT code 43192, 2.79 to
CPT code 43193, 3.51 to CPT code
43194, 3.07 to CPT code 43195, and 3.31
to CPT code 43196. These codes were
not referred to refinement because the
request did not meet the criteria for
referral.
(7) Flexible Transnasal Esophagoscopy
(CPT Codes 43197 and 43198)
We established CY 2014 interim final
work RVUs of 1.48 for CPT code 43197
and 1.78 for CPT code 43198. As
detailed in the CY 2014 final rule with
comment period, we removed 2 minutes
E:\FR\FM\13NOR2.SGM
13NOR2
67634
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
of the pre-scrub, dress and wait
preservice time from the calculation of
the work RVUs that we established for
CY 2014 for CPT codes 43200 and 43202
because we believed that unlike the
transoral codes, which they correspond
to, the transnasal services are not
typically furnished with moderate
sedation.
Comment: Multiple commenters
objected to the work RVUs for these
codes and in particular to CMS basing
its valuation on the fact that these codes
typically do not involve moderate
sedation. Although the commenters
agreed that these codes typically do not
involve moderate sedation, they said
that procedures involving local/topical
anesthesia often take more work than
those involving general sedation due to
the difficulties of furnishing services to
a conscious and often anxious patient.
Some also noted that it ignores the time
necessary to apply local/topical
anesthesia and wait for it to take effect.
A commenter urged CMS to establish
values based upon the RUC
recommendations. Commenters
requested that these codes be referred
for refinement.
Response: After consideration of the
comments, we agree that the work RVUs
for these codes should not be reduced
because moderate sedation is not
typically used. Accordingly, we agree
with the RUC recommendation to assign
the same work RVUs to these codes as
to CPT code 43200 (Esophagoscopy,
flexible, transoral; diagnostic, including
collection of specimen(s) by brushing or
washing when performed) and 43202
(Esophagoscopy, flexible, transoral; with
biopsy, single or multiple) the
comparable transoral codes. We are
finalizing work RVUs of 1.52 and 1.82
for CPT codes 43197 and 43198,
respectively. We did not refer these
codes to refinement because the request
did not meet the criteria for refinement
panel review.
(8) Flexible Transoral Esophagoscopy,
(CPT Codes 43200, 43202, 43204, 43205,
43211, 43212, 43213, 43214, 43215,
43227, 43229, 43231, and 43232)
We established CY 2014 interim final
work RVUs for the flexible transoral
esophagoscopy family, which are
detailed in Table 15. As we described in
the CY 2014 final rule with comment
period, to establish work values for
these codes we used a variety of
methodologies as did the RUC. The
methodologies used by CMS And the
RUC include basing values on the
surveys (either medians or 25th
percentiles), crosswalking values to
other codes, using the building block
methodology, and valuing a family of
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
codes based on the incremental
differences in the work RVUs between
the codes being valued and another
family of codes. As we did for the rigid
transoral esophagoscopy codes, in
addition to the methodologies used by
the RUC, we also reduced the work
RVUs for particular codes in direct
proportion to the reduction in times that
were recommended by the RUC. Using
these methodologies, we assigned the
RUC-recommended work RVUs for five
codes in this family; for the other eight
codes we used these same
methodologies but because of different
values for a base code or variation in the
crosswalk selected we obtained different
values.
Comment: Commenters objected to
the interim final RVUs we assigned for
CPT code 43200, the base code for
flexible transoral esophagoscopy,
because they did not believe the work
RVU for the code should be less than
they were as of CY 2013 when there was
a single code to report both flexible and
rigid esophagoscopy services.
Commenters also disagreed with the
way we used standard methodologies to
value many of these codes, including
using the ratio of 1 work RVU per 10
minutes of intraservice time to CPT
code 43200. Commenters requested that
we accept the RUC values for all the
flexible transoral esophagoscopy codes
and asked that we refer all these codes
to the refinement panel.
Response: Although refinement was
requested for all of the flexible transoral
esophagoscopy codes, we found that the
codes (CPT codes 43204, 43205 and
43233) met the refinement criteria, and
those were referred to the refinement
panel. After consideration of the
comments and the refinement panel
results, we are revising the work RVUs
for many of the codes in this family.
For CPT code 43200, which is the
base code for flexible transoral
esophagoscopy, we agree with
commenters that another methodology
is preferable to applying the work RVU
ratio of 1 RVU per 10 minutes of
intraservice time. In revaluing this
service, we subtracted 0.07 to account
for the 3 minute decrease in postservice
time since the last valuation from the
CY 2013 work RVU for the predecessor
base code, which resulted in a work
RVU of 1.52. We are finalizing this work
RVU.
The CY 2014 interim final work RVUs
for CPT codes 43201, 43202, 43204,
43205 and 43215 were all based upon
methodologies using the work RVU of
the base code, 43200. As we are
establishing a final value for CPT code
43200 that is higher than the CY 2014
interim final value, we are also
PO 00000
Frm 00088
Fmt 4701
Sfmt 4700
adjusting the work RVUs for the other
codes based upon the new work RVU
for CPT code 43200. We are finalizing
a work RVU of 1.82 for 43201, 1.82 for
43202, 2.43 for 43204, 2.54 for 43205,
and 2.54 for 43215.
CPT codes 43204 and 43205 were
considered by the refinement panel. The
refinement panel median for each of
these codes was 2.77 and 2.88,
respectively. The refinement panel
discussion reiterated the information
presented to the RUC and in the
comments in response to the CY 2014
final rule with comment period, such as
that the typical patient for these codes
are sicker and thus the work is more
intense. Because we do not agree with
commenters’ contention that higher
work RVUs are warranted since these
codes involve the sicker patients or that
our methodology for calculating the
interim final RVUs was inappropriate,
we are establishing final values
determined using these methodologies.
However, due to the change in the base
code, CPT code 43200, as discussed in
the previous paragraph the final values
for these codes are higher than the
interim final values.
In the CY 2014 final rule with
comment period, we assigned an
interim final work RVU of 4.21 to CPT
code 43211 by using a comparable
esophagogastroduodenoscopy (EGD)
code and subtracting the difference in
work between the base esophagoscopy
and base EGD codes. After consideration
of the comments that indicated the
interim final work RVU of 4.21 was too
low, we believe this code should instead
be crosswalked to CPT code 31636
(Bronchoscopy bronch stents), which
we believe is a comparable service with
comparable intensity. It has the same
intraservice time and slightly higher
total time. As a result we are finalizing
a work RVU of 4.30.
As we noted in the CY 2014 final rule
with comment period, we crosswalked
the interim final work RVU for CPT
43212 to that of CPT code 43214. Since
we are increasing the work RVU for CPT
code 43214, we are also increasing the
work RVU for CPT code 43212, which
is consistent with comments that we
had undervalued this procedure.
As we detailed in the CY 2014 final
rule with comment period, we based the
work RVU of 4.73 for CPT code 43213
on the value of CPT code 43220,
increased proportionately to reflect the
longer intraservice time of CPT code
43213. The refinement panel median
was 5.00 for this code. No new
information was presented at the
refinement panel. We continue to
believe that 4.73 is the appropriate work
RVU and are finalizing it.
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
Based upon the information presented
by commenters about the typical patient
and the advanced skills required for the
procedure, we are changing our method
of valuing CPT code 43214. We believe
it should be crosswalked to CPT 52214
(cystoscopy), which we believe is
similar in intensity. This results in a
final work RVU of 3.50 as compared to
an interim final of 3.38. This refinement
also supports the belief made by
commenters that the work of CPT code
43214 is greater than the interim final
work RVU. Therefore, we are finalizing
a work RVU of 3.50 for CPT code 43214.
For CPT code 43227, we modified the
CY 2013 work RVU to reflect the
percentage decrease in intraservice time
of 36 minutes to 30 minutes in the RUC
recommendation to establish a CY 2014
interim final value of 2.99. The
commenters stated that the survey
validates the RUC recommendation of
3.26 and that the drop in intraservice
time that upon which we based our
change in the work RVU was
inappropriate since the intraservice time
had not really changed. They contend
that the change was from moving the
time for moderate sedation from
intraservice to preservice. We disagree.
We have no information from the RUC
that leads us to believe that when the
pre-service packages were developed
several years ago and moderate sedation
was explicitly recognized as a preservice item that the RUC also intended
CMS to assume that the intraservice
times were no longer correct. We believe
that our proposed valuation
methodology is correct and thus are
finalizing a work RUV of 2.99.
Commenters, disagreeing with our
crosswalk of CPT code 43229 to CPT
code 43232, stated that the two codes
were not comparable. We disagree. We
continue to believe this crosswalk is
appropriate as the times and intensities
are quite similar. We note that the RUC
also bases crosswalks on the
comparability of time and intensity of
codes and not on the clinical similarity
of work. Thus, we will continue this
crosswalk. However, as discussed
below, we are refining the interim final
value of CPT code 43232 to 3.59 and
thus are finalizing the work RVU of 3.59
for CPT code 43229.
For CPT code 43231, we added the
work of an endobronchial ultrasound
(EBUS) to the work of the base
esophagoscopy code to arrive at our
interim final value. The commenters
disagreed with our approach, stating
that the EBUS code is an add-on code
and as such does not have pre- and
postservice work. We agree that pre- and
postservice work is not included in the
EBUS code nor should it be for the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
ultrasound portion of the examination
of esophagus. Therefore, we are
finalizing a work RVU of 2.90.
For CPT code 43232, the commenters
stated our interim final value is too low
and that the work involved in this code
is appropriately reflected in the RUC
recommendation. They objected to our
basing the work RVU for 43232 on the
difference between the RUCrecommended values for this code and
CPT code 43231. We learned from the
comments that the typical patient for
this service has advanced cancer and
agree that our interim final value may
not represent the full extent of the work
involved in this procedure. Therefore,
we are crosswalking this code to CPT
code 36595 (Mechanical removal of
pericatheter obstructive material (eg,
fibrin sheath) from central venous
device via separate venous access),
which has identical intraservice time,
slightly less total time, and a slightly
higher intensity and are finalizing a
work RVU of 3.59.
(10) Esophagogastroduodenoscopy
(EGD) (CPT Codes 43233, 43235, 43236,
43237, 43238, 43239, 43242, 43244,
43246, 43247, 43249, 43253, 43254,
43255, 43257, 43259, 43266, and 43270.
We established interim final work
RVUs for various EGD codes in the CY
2014 final rule with comment period. In
this section, we discuss the 18 EGD
codes on which we received comments
disagreeing with or making
recommendations for changes in our
interim final values. As we detailed in
the CY 2014 final rule with comment
period, we valued many of these codes
by adding the additional work of an
EGD to the comparable esophagoscopy
(ESO) code. We determined the
additional work of an EGD by
subtracting the work RVU of CPT code
43200, the base ESO code, from the
work of CPT code 43235, the base EGD
code. For example, CPT code 43233 is
an identical procedure to CPT code
43214 except that it uses EGD rather
than ESO. We valued it by adding the
additional work of EGD to the work
RVU of CPT code 43214, resulting in an
interim final work RVU of 4.05. We
valued the additional work the same
way the RUC did in its
recommendations. The following EGD
codes were valued in the same way
using the code in parentheses as the
corresponding ESO code: 43233 (43214),
43236 (43201), 43237 (43231), 43238
(43232), 43247 (43215), 43254 (43211),
43255 (43227), 43266 (43212), and
43270 (43229). In valuing CPT codes
43235, we agreed with the RUC
recommended work RVU difference
between this EGD base code and the
PO 00000
Frm 00089
Fmt 4701
Sfmt 4700
67635
esophagoscopy base code, CPT 43200
but applied the difference to our CY
2014 RVU values. In a similar fashion,
in valuing CPT code 43242 we agreed
with the RUC recommended
methodology of which took the
increment between CPT code 43238 and
CPT code 43237 but we applied the
difference to our CY 2014 values. In
order to value other EGD codes, we
crosswalked the services to similar
procedures; specifically for CY 2014 we
crosswalked CPT codes 43239 to 43236,
43246 to 43255, 43253 to 43242 and
43257 to 43238. We valued CPT codes
43244 and 43249 through acceptance of
the RUC work RVU recommendation.
Lastly, we valued CPT code 43259 by
adjusting the CY 2013 work RVU to
account for the CY 2014 RUC
recommended reduction in total time.
Comment: For all codes, commenters
objected to our work RVUs and said that
our reductions from the RUC
recommendations were based on a
decrease in intraservice time that did
not reflect a change in the time required
to furnish the procedures but rather
only a change in which part of the
procedure the RUC includes the
moderate sedation time. Commenters
disagree with our valuing CPT code
43233 based on the value of CPT code
43214, saying that CPT code 43233 is
more intense due to the risk of
perforation, and that the achalasia
patients are at high risk and poor
candidates for surgery. Commenters
disagreed with our methodology for
valuing CPT code 43235, and suggested
that we use the RUC crosswalk to CPT
code 31579, contending that the slight
reductions in pre- and post-service
times are consistent with the slight drop
in the RUC-recommended RVU. For
CPT code 43237, commenters also noted
a rank order anomaly because the
interim final work RVU for this code is
the same as for CPT code 43251.
Commenters said that the robust survey
data on CPT code 43238 should override
CMS decisions. With regard to CPT code
43239, commenters suggest that the
survey is wrong and further point to the
fact that our valuation results in the
same value for CPT code 43239 as the
base EGD code, which they state is not
appropriate due to the additional work
in CPT code 43239. Commenters
disagreed with our value for CPT code
43242 stating that we inappropriately
valued CPT code 43259, which we used
in calculating the work RVUs for CPT
code 43242. Commenters objected to our
value of CPT code 43246 because they
disagree with the work RVU for the code
that it is crosswalked to, CPT code
43255. Commenters urged us to modify
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67636
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
our work RVU for CPT code 43247 to
equal the RUC recommendation. For
CPT code 43253, commenters did not
disagree with the valuation approach,
but disagreed with the valuation we had
assigned to the base code, CPT code
43259, which affected the valuation of
CPT code 43253. Comments indicated
that they did not understand how the
value of CPT code 43254 was derived.
Commenters indicated that they
disagreed with the reduction in the
work in CPT code 43255 due to a
decrease in time. They also cited that
this was an emergency procedure in
unstable patients and that it was more
difficult to control bleeding in the
stomach than in the esophagus. For CPT
code 43257, commenters disagreed with
our crosswalk to CPT code 43238
indicating that CPT code 43257 was
more intense than CPT code 43238.
Commenters acknowledged that
reduced times should result in reduced
work, but disagreed with our
proportional reduction approach.
Commenters agreed with our approach
to valuing CPT code 43266, but
disagreed with the valuation of the CPT
code 43212, that we used as the base.
With regard to CPT code 43270,
commenters disagreed with using CPT
code 43229 as the base.
Response: For each of these codes,
commenters were concerned that we did
not accept the RUC-recommended
values. Their common reasoning for
urging us to accept the RUCrecommended values was that moderate
sedation time had been removed from
intraservice time and that these
intraservice time changes should not
result in a change in the RUCrecommended RVU. However, for CPT
codes 43233, 43236, 43237, 43238,
43247, 43254, 43255, 43266, and 43270,
we used the standard methodology
described above for valuing EGD codes
and did not base our values on the time
change. Thus, any refinements to the
RUC recommendations for the EGD
codes are solely due to refinements in
the ESO codes. We discussed our
valuations of these codes in the
previous section. Since we have
finalized most of the ESO codes at
higher levels than the CY 2014 interim
final values, we are making
corresponding increases in the EGD
codes. Therefore, we are finalizing these
codes at the following work RVUs:
43233 at 4.17, 43235 at 2.19, 43236 at
2.49, 43237 at 3.57, 43238 at 4.26, 43247
at 3.21, 43254 at 4.97, 43255 at 3.66,
43266 at 4.17, and 43270 at 4.26.
CPT code 43233 was referred to the
refinement panel and received a median
work RVU of 4.26. As outlined above,
we are finalizing a work RVU of 4.17 for
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
CPT code 43233 at 4.17, which is higher
than our interim value of 4.05, but
consistent with our valuation of the
other EGD codes. We do not believe that
the comments provided at the
refinement panel justify adoption of the
higher median value.
The interim final work value of CPT
code 43239 was crosswalked to the
work RVU of CPT code 43236. Since we
increased the final work RVU from the
interim final for this code, the final
work RUV of CPT code 43239 increases
to 2.49.
(11) Endoscopic Retrograde
Cholangiopancreatography (ERCP) (CPT
Codes 43263, 43274, 43276, 43277 and
43278)
In the CY 2014 final rule with
comment period we established interim
final work RVUs for several ERCP codes
due to coding revisions. For all those
codes not discussed in this section, we
are finalizing the interim final work
RVUs. For CPT code 43263, we
established an interim final work RVU
based upon a crosswalk to CPT code
43262. As we detailed in the CY 2014
final rule with comment period, we
valued CPT codes 43274, 43276, and
43278 using the same formula that the
RUC used in determining its
recommendations, but substituting our
interim final work RVUs for codes used
in the formula for the RUCrecommended values. CPT code 43277
was valued using the survey 25th
percentile.
Comment: Commenters objected to
our valuation of CPT 43263 based upon
a crosswalk to CPT code 43262, saying
that CPT 43263 is more intense and has
greater risks than CPT code 43262.
Commenters also indicated that we
underestimated the intensity of CPT
code 43276 indicating that CPT code
43276 typically involves replacing
stents that are overgrown with
cancerous tissues. They also said that
we underestimated the intensity of CPT
coded 43274 and 43277. Commenters
further took issue with our valuing CPT
code 43277 based upon the survey when
most codes in this family were valued
based upon the incremental formula.
Commenters stated that CPT code 43278
is valued incorrectly because we did not
correctly value CPT code 43229, which
is used in the formula we used to value
CPT code 43278.
Response: After consideration of the
comments, we continue to believe that
CPT code 43263 is the appropriate
crosswalk for CPT code 43262 and we
are finalizing a work RVU of 6.60 for
that code. With regard to CPT code
43274, we continue to believe the
formula described in the CY 2014 final
PO 00000
Frm 00090
Fmt 4701
Sfmt 4700
rule with comment period is the
appropriate methodology. We are
finalizing a work RVU of 8.58 for CPT
code 43274 using the final values for the
codes used in the formula and thus
increasing the work RVU from the
interim final value of 8.48. Similarly, we
are finalizing a work RVU of 8.94 for
CPT code 43276 based upon the formula
described in the CY 2014 final rule with
comment period adjusted for changes in
the final work RVUs for values used in
the formula. For CPT code 43277, we
continue to believe the survey 25th
percentile is appropriate. This valuation
is supported by a drop in the
intraservice time from the code it
replaces. Thus, we are finalizing the
interim final work RVU of 7.00. For CPT
code 43278, we continue to believe use
of the RUC formula for this code is most
appropriate, and we are adjusting the
work RVU to reflect final work RVUs for
values used in the formula. The final
work RVU for CPT code 43278 is 8.
(12) Spinal Injections (CPT Codes
62310, 62311, 62318 and 62319)
We proposed new work RVUs for
these codes in the PFS proposed rule.
(79 FR 40338–40339). See section II.B.3
for a discussion of the valuation of these
codes, and a summary of public
comments and our responses.
(13) Laminectomy (CPT Codes 63045,
63046, 63047 and 63048)
We established interim final work
RVUs for CPT codes 63047 and 63048
for CY 2014. As we indicated in the CY
2014 final rule with comment period,
we had identified CPT code 63047 as
potentially misvalued through the high
expenditure procedure code screen and
the RUC included a recommendation for
CPT code 63048. We noted that, to
appropriately value these codes, we
need to consider the other two codes in
this family: CPT codes 63045
(Laminectomy, facetectomy and
foraminotomy (unilateral or bilateral
with decompression of spinal cord,
cauda equina and/or nerve root[s], [eg,
spinal or lateral recess stenosis]), single
vertebral segment; cervical) and 63046
(Laminectomy, facetectomy and
foraminotomy (unilateral or bilateral
with decompression of spinal cord,
cauda equina and/or nerve root[s], [eg,
spinal or lateral recess stenosis]), single
vertebral segment; thoracic). Although
we did not receive recommendations for
CPT codes 63045 and 63046, we
established CY 2014 interim final work
RVUs for CPT codes 63047 and 63048
of 15.37 and 3.47, respectively, based
upon the RUC recommendations. We
noted that we expected to review these
values in concert with the RUC
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
recommendations for CPT codes 63045
and 63046 when we received them.
Comment: Commenters questioned
our determination that CPT codes
63047, 63048, 63045 and 63046
constituted a family, noting that CPT
codes 63045 and 63046 require different
work. Commenters questioned the value
of resurveying this set of codes as a
family since CPT codes 63045 and
63046 constitute a small percentage of
the total volume of these codes. The
survey of CPT codes 63047 and 63048
did not reveal significant change in the
values of the codes, and the work
involved in resurveying would be
burdensome for those involved. One
commenter urged us to withdraw our
request to survey these codes.
Response: We continue to believe that
it is appropriate to value a family of
codes together in order to maintain
relativity. We also continue to believe
that CPT codes 63045 and 63046 are
indeed in the same family as CPT codes
63047 and 63048 due to similarity of
service. We have received new RUC
recommendations for CPT code 63045
and 63046, but did not receive them in
time to include in this rule. As a result,
we will finalize the interim work values
for CPT codes 63047 and 63048 for CY
2015.
(14) Chemodenervation of Muscles (CPT
Codes 64616, 64617, 64642, 64643,
64644, and 64645)
We assigned refined interim final
work RVU values of 1.53 to CPT code
64616 and 1.90 to CPT code 64617. As
detailed in the CY 2014 final rule with
comment period, we refined the RUCrecommended work RVUs of 1.79 for
CPT code 64616 and 2.06 for CPT code
64617 to reflect the deletion of an
outpatient visit that was included in the
predecessor code, CPT code 64613
(chemodenervation of muscle(s); neck
muscle(s) (eg, for spasmodic torticollis,
spasmodic dysphonia)). We also
explained that since CPT code 64617,
chemodenervation of the larynx,
includes EMG guidance when furnished
we determined the interim final work
RVU by adding the work RVU for CPT
code 95874 (Needle electromyography
for guidance in conjunction with
chemodenervation (List separately in
addition to code for primary procedure))
to the CY 2013 work RVU for CPT
64616.
For CY 2014, we assigned interim
final work RVUs for CPT code 64643
and CPT code 64645 of 1.22 and 1.39,
respectively. As we explained in the CY
2014 final rule with comment period,
we refined the RUC-recommended work
RVUs for these add-on codes by
subtracting the RVUs to account for 19
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
minutes of pre-service time and the
decrease in time for furnishing the addon service. Additionally, we based the
global period for these codes on the
predecessor code, CPT code 64614
(chemodenervation of muscle(s);
extremity and/or trunk muscle(s) (eg, for
dystonia, cerebral palsy, multiple
sclerosis)), which was deleted for CY
2014. Therefore, we assigned 10-day
global periods to the services.
Comment: Most commenters
disagreed with the CY 2014 interim
final work RVU valuations for CPT
codes 64616, 64643, and 64645. One
commenter stated that the work RVU for
the predecessor code, CPT code 64614,
did not take into account the full level
of intensity, time, and work that it takes
to perform the service. This commenter
also disagreed with the times for this
service. Several commenters disagreed
with the valuation of CPT code 64616
saying that we ignored the RUC
recommendation which was based on
survey data and RUC deliberations and
asked that we value the code based
upon the RUC recommendation. Several
commenters disagreed with the
valuations for CPT codes 64643 and
64645 saying that CMS did not explain
our valuation, ignored the fact that the
RUC discounted the add-on codes based
on the pre- and post-service time and
did not articulate any basis for our
valuation decision. Several commenters
requested refinement of the codes in the
chemodenervation family.
Response: After consideration of the
comments we are finalizing the interim
final work RVUs and time for these
codes. We continue to believe that our
valuations for this family take into
account the full level of intensity, time,
and work that are required to furnish
these services. Additionally, we
disagree with commenters that we did
not explain our valuation of CPT codes
64643 and 64645. In the CY 2014 final
rule with comment period, we detail
and thoroughly explain the
methodology utilized to value CPT
codes 64643 and 64645. Additionally,
the request for refinement panel review
was not granted as the criteria for
refinement were not met.
(15) Impacted Cerumen (CPT Code
69210)
After it was identified as a potentially
misvalued code pursuant to the CMS
high expenditure screen, CPT code
69210, which describes removal of
impacted cerumen, was revised from
being applicable to ‘‘1 or both ears’’ to
a unilateral code effective January 1,
2014. For Medicare purposes we limited
the code to billing once whether it was
furnished unilaterally or bilaterally
PO 00000
Frm 00091
Fmt 4701
Sfmt 4700
67637
because we believed the procedure
would typically be furnished in both
ears as the physiologic processes that
create cerumen impaction likely would
affect both ears. Similarly, we continued
the CY 2013 value as our interim final
CY 2014 value since for Medicare
purposes the service was unchanged.
Comment: Commenters requested that
we allow CPT code 69210 to be billed
twice when it is furnished bilaterally,
consistent with code descriptor.
Commenters stated that our assumption
regarding the physiologic processes that
create cerumen was flawed and
requested we provide a clinical
rationale and/or literature to support
our claim. Lastly, the commenters
requested guidance from the agency as
to how best deal with this CPT code;
specifically, if it should be sent to CPT
for clarification or if not, that we
provide further guidance as to how this
procedure should be billed using the
new code.
Response: We continue to believe that
the procedure will be furnished in both
ears as the physiologic processes that
create cerumen impaction likely would
affect both ears. As a result, we will
continue to allow only one unit of CPT
69210 to be billed when furnished
bilaterally and are finalizing our CY
2014 interim final work RVU for this
service.
(16) Magnetic Resonance Imaging (MRI)
Brain (CPT Codes 77001, 77002, and
77003)
As detailed in the CY 2014 final rule
with comment period, we agreed with
the RUC-recommended values for CPT
codes 77001, 77002 and 77003 but were
concerned that the recommended
intraservice times for all three codes
was generally higher than the procedure
codes with which they were typically
billed. We sought additional public
comment and input from the RUC and
other stakeholders regarding the
appropriate relationship between the
intraservice time associated with
fluoroscopic guidance and the
intraservice time of the procedure codes
with which they are typically billed.
Comment: Some commenters
disagreed with the concern expressed by
CMS that the intraservice time for codes
77001, 77002 and 77003 is higher than
the codes alongside which they are
typically billed, as the commenters
believed that the combinations being
used to support this concern were not
appropriate, and they requested
additional examples to support its
concern. The commenters believed that
the concerns CMS expressed are
unfounded and that we should assign
work RVUs of 0.38, 0.54, and 0.60 for
E:\FR\FM\13NOR2.SGM
13NOR2
67638
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
CPT code 77001, 77002, and 77003,
respectively.
Response: We continue to have
concerns regarding the appropriate
relationship between the intraservice
time associated with fluoroscopic
guidance and the intraservice time of
the procedure codes with which they
are typically billed and will continue to
study this issue. We are finalizing the
CY 2014 interim final values for CY
2015.
ebenthall on DSK5SPTVN1PROD with $$_JOB
(17) Immunohistochemistry (CPT Codes
88342 and 88343 and HCPCS Codes
G0461 and G0462)
These codes were revised for CY
2015. For discussion of valuation for CY
2015, see section II.G.3.b.
(18) Optical Endomicroscopy (Code
88375)
As detailed in the CY 2014 final rule
with comment period, we believed that
the typical optical endomicroscopy case
would involve only the endoscopist,
and CPT codes 43206 and 43253 were
valued to reflect this. Accordingly, we
believed a separate payment for CPT
code 88375 would result in double
payment for a portion of the overall
optical endomicroscopy service.
Therefore, we assigned a PFS procedure
status of I (Not valid for Medicare
purposes. Medicare uses another code
for the reporting of and the payment for
these services) to CPT code 88375.
Comment: Multiple commenters
objected to CMS’s decision to assign a
PFS status indicator of ‘‘I’’ to code
88375, stating that the code already
includes distinctions that would
prevent a physician from billing the
code when it would double count work.
The commenters urge CMS to assign
CPT code 88375 a Medicare status of A
(Active Code), and to immediately
publish RVUs associated with the
service.
Response: In our re-review of this
procedure and consideration of the
information provided by commenters,
we believe the coding is adequate to
avoid double payment for a portion of
the service. Accordingly, we assigned a
Medicare status indicator of A (Active).
To value this service, we based the
RVUs on those assigned to CPT code
88329, adjusted for the difference in
intraservice time between the two
codes. We are assigning a final work
RVU of 0.91 for CPT code 88375 for CY
2015.
(19) Speech Language (CPT Codes
92521, 92522, 92523 and 92524)
In CY 2014, we assigned CY 2014
interim final work RVUs of 1.75 and
1.50 for CPT codes 92521 and 92522,
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
respectively, as the HCPAC
recommended. For CPT code 92523, we
disagreed with the HCPACrecommended work RVU of 3.36. We
believed that the appropriate value for
60 minutes of work for the speech
evaluation codes was reflected in CPT
code 92522, for which the HCPAC
recommended 1.50 RVUs. Because the
intraservice time for CPT code 92523
was twice that for CPT code 92522, we
assigned a work RVU of 3.0 to CPT code
92523. Similarly, since CPT codes
92524 and 92522 had identical
intraservice time recommendations and
similar descriptions of work we
believed that the work RVU for CPT
code 92524 should be the same as the
work RVU for CPT code 95922.
Therefore, we assigned a work RVU of
1.50 to CPT code 92524.
Comment: Commenters disagreed
with the interim final work RVUs
assigned to CPT codes 92523 and 92524,
saying they based on inaccurate
assumptions. Commenters stated that
survey respondents appropriately took
time and effort into account when
valuing CPT code 92523 but had
difficulty using a time-based reference
code to value the RVU of an untimed
code like CPT code 92523. Commenters
noted that the HCPAC acknowledged
that the work of the second hour
involved in CPT code 92523 is indeed
more intense than the first hour.
Additionally, commenters stated that
the work RVU reduction of CPT code
92524 was arbitrary because it was
based solely on intraservice time and
failed to recognize the more difficult
aspects of performing the service
compared to that of CPT code 92522.
Commenters requested reconsideration
of CPT codes 92523 and 92524 through
refinement panel review.
Response: We believe that our interim
final work RVU is most appropriate for
these services. In the HCPAC
recommendation for CPT code 92523
the affected specialty society stated that
its survey results were faulty for this
CPT code because those surveyed did
not consider all the work necessary to
perform the service. The commenters
did not provide any information that
demonstrates that our valuations fail to
fully account for the intensity, work,
and time required to perform these
services. Therefore, we are finalizing
our CY 2014 interim final values for CY
2015. We did not refer these codes to
refinement because the request did not
meet the criteria for refinement.
(20) Percutaneous Transcatheter Closure
(CPT Code 93582)
As detailed in the CY 2014 final rule
with comment period, we reviewed new
PO 00000
Frm 00092
Fmt 4701
Sfmt 4700
CPT code 93582. Although the RUC
compared this code to CPT code 92941
(percutaneous transluminal
revascularization of acute total/subtotal
occlusion during acute myocardial
infarction, coronary artery or coronary),
which has a work RVU of 12.56 and 70
minutes of intraservice time, it
recommended a work RVU of 14.00, the
survey’s 25th percentile. We agreed
with the RUC that CPT code 92941 is an
appropriate comparison code and
believed that due to the similarity in
intensity and time that the codes should
be valued with the same work RVU.
Therefore, we assigned an interim final
work RVU of 12.56 to CPT code 93582.
Comment: One commenter disagreed
with the work RVU valuation of CPT
code 93582 because they believed it did
not accurately reflect the intensity of the
procedure, particularly in treating
infants. The commenter stated that the
RUC concluded that a 55 percent work
differential exists between performing
this service on a child versus an adult—
a fact that they stated supports the
higher work RVU recommended by the
RUC. As a result, the commenter
suggests we assign the RUCrecommended work RVU to CPT code
93582. A commenter requested referral
to the refinement panel.
Response: We continue to believe that
CPT code 92941 is an appropriate
comparison code to CPT code 93582
due to similarity in intensity and time
and, as a result, the codes should be
valued with the same work RVU.
Therefore, we are finalizing our CY 2014
interim final work RVU of 12.56 to CPT
code 93582 for CY 2015. We did not
refer this code to refinement because the
request did not meet the criteria for
refinement.
(21) Duplex Scans (CPT Codes 93925,
93926, 93880 and 93882)
For CY 2014 we maintained the CY
2013 RVUs for CPT codes 93880 and
93882. We were concerned that the
RUC-recommended values for CPT
codes 93880 and 93882, as well as our
final values for CPT codes 93925
(Duplex scan of lower extremity arteries
or arterial bypass grafts; complete
bilateral study) and 93926 (Duplex scan
of lower extremity arteries or arterial
bypass grafts; unilateral or limited
study), did not maintain the appropriate
relativity within the family and referred
the entire family to the RUC to assess
relativity among the codes and then
recommend appropriate work RVUs. We
also requested that the RUC consider
CPT codes 93886 (Transcranial Doppler
study of the intracranial arteries;
complete study) and 93888
(Transcranial Doppler study of the
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
intracranial arteries; limited study) in
conjunction with the duplex scan codes
to assess the relativity between and
among the codes.
Comment: One commenter questioned
why we did not include all duplex scan
codes we determined to be part of the
family in our original request to the
RUC. Another commenter opposed our
valuation approach and stated that we
should not redefine the codes in this
family and that we should reject the
RUC recommendations.
Response: The valuations for CPT
codes 93880, 93882, 93925, 93926,
93886 and 93888 are included in this
year’s valuations in section II.G.3.b
(22) Interprofessional Telephone/
Internet Consultative Services (CPT
Codes 99446, 99447, 99448 and 99449)
In CY 2014 we assigned CPT codes
99446, 99447, 99448, and 99449 a PFS
procedure status indicator of B
(Bundled code. Payments for covered
services are always bundled into
payment for other services, which are
not specified. If RVUs are shown, they
are not used for Medicare payment). If
these services are covered, payment for
them is subsumed by the payment for
the services to which they are bundled
(for example, a telephone call from a
hospital nurse regarding care of a
patient) because Medicare pays for
telephone consultations regarding
beneficiary services as a part of other
services furnished to the beneficiary.
Comment: A commenter expressed
concern that the services covered by
codes 99446–99449 were bundled
together, and that no RVUs were
published for these codes. The
commenter observed that CMS
compares the services to contact
between nurses and patients in
justifying its decision to bundle the
services in with other work, and stated
that this comparison is inappropriate to
use regarding consultation between
physicians. The commenter also stated
that these services are vital in providing
specific specialty expertise in areas
where timely face-to-face service is not
a viable option. The commenter urged
that the status of these services be
changed to ‘‘Active,’’ or at least ‘‘Noncovered,’’ and that the RUCrecommended values for these services
be published.
Response: Medicare pays for
telephone consultations regarding
beneficiary services as part of other
services furnished to a beneficiary. As a
result, we continue to believe that CPT
codes 99446- 99449 are bundled; and
we are finalizing the PFS procedure
status indicator of B for these codes for
CY 2015.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
b. Finalizing CY 2014 Interim Direct PE
Inputs
i. Background and Methodology
In this section, we address interim
final direct PE inputs as presented in
the CY 2014 PFS final rule with
comment period and displayed in the
final CY 2014 direct PE database
available on the CMS Web site under
the downloads at https://www.cms.gov/
PhysicianFeeSched/PFSFRN/
list.asp#TopOfPage.
On an annual basis, the RUC provides
CMS with recommendations regarding
PE inputs for new, revised, and
potentially misvalued codes. We review
the RUC-recommended direct PE inputs
on a code-by-code basis. When we
determine that the RUC
recommendations appropriately
estimate the direct PE inputs (clinical
labor, disposable supplies, and medical
equipment) required for the typical
service and reflect our payment policies,
we use those direct PE inputs to value
a service. If not, we refine the PE inputs
to better reflect our estimate of the PE
resources required for the service. We
also confirm whether CPT codes should
have facility and/or nonfacility direct
PE inputs and refine the inputs
accordingly.
In the CY 2014 PFS final rule with
comment period (78 FR 74242), we
addressed the general nature of some of
our common refinements to the RUCrecommended direct PE inputs, as well
as the reasons for refinements to
particular inputs. In the following
sections, we respond to the comments
we received regarding common
refinements we made based on
established principles or policies.
Following those discussions, we
summarize and respond to comments
received regarding other refinements to
particular codes.
We note that the interim final direct
PE inputs for CY 2014 that are being
finalized for CY 2015 are displayed in
the final CY 2015 direct PE input
database, available on the CMS Web site
under the downloads for the CY 2015
PFS final rule at www.cms.gov/
PhysicianFeeSched/. The inputs
displayed there have also been used in
developing the CY 2015 PE RVUs as
displayed in Addendum B of this final
rule with comment period.
Comment: Commenters indicated that
it would be helpful to have additional
information about the specific rationale
used in developing refinements, and
specifically requested that CMS provide
more information regarding how CMS
makes the determination of whether an
item is typical.
PO 00000
Frm 00093
Fmt 4701
Sfmt 4700
67639
Response: We continually seek ways
to increase opportunity for public
comment. In response to comments
received, we have provided more
detailed explanations about refinements
made for the CY 2015 interim final
direct PE inputs. We recognize that we
make assumptions about what is typical,
and note that we welcome objective data
that provides information about the
typical case. We prefer that this
information be submitted through the
notice and comment rulemaking
process. We also refer interested
stakeholders to section II.F. of this final
rule with comment period, in which we
provide extensive discussion of the
changes to the process that we are
finalizing for valuing new, revised, and
potentially misvalued codes.
ii. Common Refinements
(1) Equipment Time
Prior to CY 2010, the RUC did not
generally provide CMS with
recommendations regarding equipment
time inputs. In CY 2010, in the interest
of ensuring the greatest possible degree
of accuracy in allocating equipment
minutes, we requested that the RUC
provide equipment times along with the
other direct PE recommendations, and
we provided the RUC with general
guidelines regarding appropriate
equipment time inputs. We continue to
appreciate the RUC’s willingness to
provide us with these additional inputs
as part of its PE recommendations.
In general, the equipment time inputs
correspond to the service period portion
of the clinical labor times. We have
clarified this principle, indicating that
we consider equipment time as the
times within the intra-service period
when a clinician is using the piece of
equipment plus any additional time that
the piece of equipment is not available
for use for another patient due to its use
during the designated procedure. For
services in which we allocate cleaning
time to portable equipment items,
because the equipment does not need to
be cleaned in the room that contains the
remaining equipment items, we do not
include that time for the remaining
equipment items as they are available
for use for other patients during that
time. In addition, when a piece of
equipment is typically used during any
additional visits included in the global
period for a service, the equipment time
would also reflect that use.
We believe that certain highly
technical pieces of equipment and
equipment rooms are less likely to be
used during all of the pre-service or
post-service tasks performed by clinical
labor staff on the day of the procedure
E:\FR\FM\13NOR2.SGM
13NOR2
67640
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
assumptions regarding high-cost
equipment, including how many
procedures are furnished in a day, how
often the equipment is being used, and
other such information.
Comment: A commenter stated that
CMS should publish, on a quarterly
basis, refinements to the equipment
times, rather than waiting until the final
rule to publish these changes.
Response: We appreciate the
commenter’s concern about our making
available timely information about
refinements to practice expense inputs.
We note that since we do not review
and make refinements to practice
expense inputs on a quarterly basis, we
do not have information to publish on
a quarterly basis. Rather, we have
reviewed and refined practice expense
recommendations from the RUC on an
annual basis for the subset of codes for
which recommendations have been
provided to us. Because we have
received many requests from
stakeholders to publish our refinements
as proposals in the proposed rule rather
than in the final rule, we are finalizing
a change in the process in which
changes to RVUs and direct PE inputs
will be included in the proposed rule
rather than first appearing in the final
rule with comment period. We refer
readers to section II.F. of this final rule
with comment period for further
information about this change. We
believe that this process will address
commenters’ concerns about having an
opportunity to review these changes
prior to the publishing of the final rule.
Comment: Several commenters asked
that CMS identify what constitutes a
highly technical piece of equipment.
Response: As we have previously
indicated, during our review of all
recommended direct PE inputs, we
consider such items as the degree of
specificity of a piece of equipment,
(the clinical labor service period) and
are typically available for other patients
even when one member of clinical staff
may be occupied with a pre-service or
post-service task related to the
procedure.
Some commenters have repeatedly
objected to our rationale for refinement
of equipment minutes on this basis. We
acknowledge the comments we received
reiterating those objections to this
rationale and refer readers to our
extensive discussion in response to
those objections in the CY 2012 PFS
final rule with comment period (76 FR
73182). In the following paragraphs, we
address new comments on this policy.
Comment: A commenter indicated
that CMS removed minutes assigned to
vascular ultrasound rooms for activities
that CMS does not believe take place in
the room, but CMS did not provide
factual support for this assumption. The
commenter further stated that CMS did
not articulate the connection between
the relevant data that the Administrative
Procedures Act (APA) requires CMS to
consider and the conclusion that CMS
reached. The commenter indicated that
they conducted a survey of a significant
number of providers, in which most
providers indicated that they performed
these pre-service tasks in the room.
Response: We note that we would
welcome comments that include vetted
survey results, especially where the data
are included. Statements regarding the
existence of data to support
commenters’ assertions do not provide
us with information to support
conclusions based on the data. We
acknowledge that we make assumptions
about we believe to be typical. If there
are data that support or refute these
assumptions, we would be interested in
reviewing that information. We would
be most interested in reviewing survey
data that address multiple points of our
which may influence whether the
equipment item is likely to be stored in
the same room in which the clinical
staff greets and gowns, obtains vitals, or
provides education to a patient prior to
the procedure itself. We would expect
that items that are highly specific to
particular procedures would be moved
between rooms for those procedures. We
also consider the level of portability
(including the level of difficulty
involved in cleaning the equipment
item) to determine whether an item
could be easily transferred between
rooms before or after a given procedure.
Items that are portable would also be
expected to be moved between rooms.
We also examine the prices for the
particular equipment items to determine
whether the equipment is likely to be
located in the same room used for all
the tasks undertaken by clinical staff
prior to and following the procedure.
We believe that highly expensive
equipment would not be kept in a
location that does not allow for its
maximum utilization. For each service,
on a case-by-case basis, we look at the
description provided in the RUC
recommendation and consider the
overlap of the equipment item’s level of
specificity, portability, and cost; and,
consistent with the review of other
recommended direct PE inputs, we
make the determination of whether the
recommended equipment items are
highly technical. We note that it is not
practical to ensure that all of the
existing equipment time in the database
is allocated accordingly, but as we
review any recommendations received
from the RUC, we make this
determination. To provide stakeholders
with examples of the types of
equipment items that are and are not
considered highly technical, we have
listed several items below and indicated
whether they are highly technical.
TABLE 16—CLASSIFICATION OF HIGHLY TECHNICAL EQUIPMENT
Highly technical
Not highly technical
CMS code
room, CT ........................................................
accelerator, 6–18 MV .....................................
gamma camera system, single-dual head
SPECT CT.
ebenthall on DSK5SPTVN1PROD with $$_JOB
Item
EL007 ..........
ER010 .........
ER097 .........
(2) Standard Tasks and Minutes for
Clinical Labor Tasks
In general, the pre-service, service
period, and post-service clinical labor
minutes associated with clinical labor
inputs in the direct PE input database
reflect the sum of particular tasks
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Price
$1,284,000.00
1,832,941.00
600,272.00
Item
CMS code
Light, exam .......................
Table, exam ......................
Chair, medical recliner ......
EQ168 .........
EF023 ..........
EF009 ..........
described in the information that
accompanies the recommended direct
PE inputs, commonly called the ‘‘PE
worksheets.’’ For most of these
described tasks, there are a standardized
number of minutes, depending on the
type of procedure, its typical setting, its
global period, and the other procedures
PO 00000
Frm 00094
Fmt 4701
Sfmt 4700
Price
$1,630.12
1,338.17
829.03
with which it is typically reported. The
RUC sometimes recommends a number
of minutes either greater than or less
than the time typically allotted for
certain tasks. In those cases, CMS staff
reviews the deviations from the
standards to determine their
appropriateness. When we do not accept
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
the RUC-recommended exceptions, we
refine the interim final direct PE inputs
to match the standard times for those
tasks. In addition, in cases when a
service is typically billed with an E/M,
we remove the pre-service clinical labor
tasks to avoid duplicative inputs and to
reflect the resource costs of furnishing
the typical service.
In general, clinical labor tasks fall into
one of the categories on the PE
worksheets. In cases where tasks cannot
be attributed to an existing category, the
tasks are labeled ‘‘other clinical
activity.’’ In these instances, CMS staff
reviews these tasks to determine
whether they are similar to tasks
delineated for other services under the
PFS. For those tasks that do not meet
this criterion, we do not accept those
clinical labor tasks as direct inputs.
(3) Equipment Minutes for Film
Equipment Inputs
In section II.A. of this final rule with
comment period, we finalize our
proposal to accept the RUC
recommendation to remove inputs
associated with film technology that are
associated with imaging services. We
acknowledge comments received
regarding the minutes allocated to
equipment items associated with film
technology; we will not address those
comments below, because subsequent to
the publication of the CY 2014 final rule
with comment period, as discussed in
section II.A. of this final rule with
comment period, we finalized our
proposal to remove these inputs from
the Direct PE database, and thus the
comments are no longer relevant.
(4) Standard Inputs for Moderate
Sedation
In establishing interim final direct PE
inputs for services that contain the
standard moderate sedation input
package, we refined the RUC’s
recommendation by removing the
stretcher (EF018) and adjusting the
standard moderate sedation equipment
inputs to conform to the standard
moderate sedation equipment times.
These procedures are listed in Table 17.
Comment: Commenters objected to
our refinement of the standard moderate
sedation equipment input times to
conform to the moderate sedation
equipment standard times, since it
decreased the time allocated to these
equipment items.
Response: We note that for moderate
sedation procedures, the equipment
time is tied to the RN time rather than
to the entire service period. Specifically,
this time includes 2 minutes for sedate/
apply anesthesia, 100 percent of
physician intraservice time, and 60
minutes of post-procedure time for
every 15 minutes of RN monitoring
time. The times included in Table 17
reflect this standard. We note that for all
procedures in Table 17 the times
allocated to the equipment items that
were interim final for 2014 were already
consistent with the moderate sedation
standard equipment times, with the
exception of CPT code 37238, which
was mistakenly allocated 257 minutes,
when the correct time is actually 242
minutes.
Comment: Commenters indicated that
for office endoscopic procedures, the
stretcher is typically used throughout
the entire procedure, as well as during
post-procedure monitoring. Other
67641
commenters indicated that the stretcher
is required during the moderate
sedation recovery time. The commenters
requested that we include the stretcher
for those procedures, and that we
reduce the increased time allocated to
the power table.
Response: In section II.A. of this final
rule with comment period, we finalized
our proposal to modify the standard
moderate sedation input package to
include a stretcher for the same length
of time as the other equipment items in
the moderate sedation package. We
indicated that the revised package
would be applied to relevant codes as
we review them through future notice
and comment rulemaking. We have
therefore refined those inputs to
incorporate the stretcher for these codes
listed in Table 17. Since we are
incorporating the stretcher, we have
removed the power table for procedures
in which a power table was previously
included. We will hold these
procedures as interim final for CY 2015
due to the insertion of the stretcher and
removal of the power table.
We are therefore finalizing the PE
inputs for the procedures containing the
standard moderate sedation inputs, with
the additional refinements of including
the stretcher for all of these procedures,
removing the power table for the codes
noted in Table 17 as containing a power
table, and adjusting the equipment time
for CPT code 37238. We note that these
changes are displayed in the final CY
2015 direct PE input database, available
on the CMS Web site under the
downloads for the CY 2015 PFS final
rule at www.cms.gov/
PhysicianFeeSched/.
TABLE 17—CPT CODES WITH STRETCHER ADDED
ebenthall on DSK5SPTVN1PROD with $$_JOB
CPT Code
10030
36245
37236
37238
37241
37242
37243
37244
43200
43201
43202
43206
43213
43215
43216
43217
43220
43226
43227
43229
43231
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
VerDate Sep<11>2014
Moderate
sedation
Short descriptor
Guide cathet fluid drainage ...................................................................................................
Ins cath abd/l-ext art 1st ........................................................................................................
Open/perq place stent 1st .....................................................................................................
Open/perq place stent same .................................................................................................
Vasc embolize/occlude venous .............................................................................................
Vasc embolize/occlude artery ...............................................................................................
Vasc embolize/occlude organ ...............................................................................................
Vasc embolize/occlude bleed ................................................................................................
Esophagoscopy flexible brush ...............................................................................................
Esoph scope w/submucous inj ..............................................................................................
Esophagoscopy flex biopsy ...................................................................................................
Esoph optical endomicroscopy ..............................................................................................
Esophagoscopy retro balloon ................................................................................................
Esophagoscopy flex remove fb .............................................................................................
Esophagoscopy lesion removal .............................................................................................
Esophagoscopy snare les remv ............................................................................................
Esophagoscopy balloon <30mm ...........................................................................................
Esoph endoscopy dilation .....................................................................................................
Esophagoscopy control bleed ...............................................................................................
Esophagoscopy lesion ablate ................................................................................................
Esophagoscop ultrasound exam ...........................................................................................
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00095
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
152
167
332
242
272
342
362
332
77
80
82
92
107
82
84
92
82
87
92
107
107
Contained
power table?
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
67642
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 17—CPT CODES WITH STRETCHER ADDED—Continued
CPT Code
43232
43235
43236
43239
43245
43247
43248
43249
43250
43251
43252
43255
43270
43450
43453
49405
49406
49407
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
Esophagoscopy w/us needle bx ............................................................................................
Egd diagnostic brush wash ...................................................................................................
Uppr gi scope w/submuc inj ..................................................................................................
Egd biopsy single/multiple .....................................................................................................
Egd dilate stricture .................................................................................................................
Egd remove foreign body ......................................................................................................
Egd guide wire insertion ........................................................................................................
Esoph egd dilation <30 mm ..................................................................................................
Egd cautery tumor polyp .......................................................................................................
Egd remove lesion snare ......................................................................................................
Egd optical endomicroscopy .................................................................................................
Egd control bleeding any .......................................................................................................
Egd lesion ablation ................................................................................................................
Dilate esophagus 1/mult pass ...............................................................................................
Dilate esophagus ...................................................................................................................
Image cath fluid colxn visc ....................................................................................................
Image cath fluid peri/retro .....................................................................................................
Image cath fluid trns/vgnl ......................................................................................................
ebenthall on DSK5SPTVN1PROD with $$_JOB
(5) Recommended PE Inputs Not Used
in the Calculation of Practice Expense
Relative Value Units
In preparing the Direct Practice
Expense Input database for CY 2014, we
noted that in some cases, there were
recommended inputs in the database
that were not used in the calculation of
the PE RVUs. In cases where inputs are
included for a particular service in a
particular setting, but that service is not
priced in that setting, the inputs are not
used. In the documentation files for the
CY 2014 final rule, we stated, ‘‘In
previous years, we have displayed
recommended inputs even when these
inputs are not used in the calculation of
the practice expense relative value
units. We note that we are no longer
displaying such inputs in these public
use files since they are not used in the
calculation of the practice expense
relative value units that appear in the
final rule.’’
Comment: Some commenters objected
to our removing practice expense inputs
for services that were not reviewed for
CY 2014.
Response: As indicated in the
documentation files, the inputs removed
were not used in the calculation of the
PE RVUs. Therefore, their removal has
no impact on the PE RVUs for these
services or the payment for services. We
remind readers that, from our
perspective, the sole purpose of the
Direct PE database is to establish PE
RVUs. We believe it is more transparent
for these inputs to not appear in the
Direct Practice Expense Input database
when they do not contribute to the PE
RVU calculation for the relevant
services.
VerDate Sep<11>2014
Moderate
sedation
Short descriptor
20:15 Nov 12, 2014
Jkt 235001
iii. Code-Specific Direct PE Inputs
We note that we received many
comments objecting to refinements
made based on ‘‘CMS clinical review’’
(including our determination that
certain recommended PE inputs were
duplicative of others already included
with the service), statutory
requirements, or established principles
and policies under the PFS. We note
that for many of our refinements, the
specialty societies that represent the
practitioners who furnish the service
objected to most of these refinements for
the general reasons described above or
for the reasons we respond to in the
‘‘background and methodology’’ portion
of this section, or stated that they
supported the RUC recommended PE
inputs. Below, we respond to comments
in which commenters address specific
CPT/HCPCS codes and explain their
objections to our refinements by
providing us with new information
supporting the inclusion of the items
and/or times requested. When
discussing these refinements, rather
than listing all refinements made for
each service, we discuss only the
specific refinements for which
commenters provided supporting
information. We indicate the presence
of other refinements by noting ‘‘among
other refinements’’ after delineating the
specific refinements for a particular
service or group of services. For those
comments that stated that an item was
‘‘necessary for the service’’ and
provided no additional rationale or
information, we conducted further
review to determine whether the inputs
as refined were appropriate and
concluded that the inputs as refined
were indeed appropriate. We also note
that in many cases, commenters
PO 00000
Frm 00096
Fmt 4701
Sfmt 4700
122
77
82
77
85
92
82
82
82
82
92
92
107
77
87
162
162
167
Contained
power table?
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
objected to our indication that items
were duplicative, stating that they did
not know where the duplication existed.
In future rulemaking, we do not intend
to respond to comments where the
commenters dispute the duplicative
nature of inputs unless commenters
specifically explain why the relevant
items are not duplicative with the
identical items included in a room, kit,
pack, or tray. We expect that
commenters will review the
components of the room, kit, pack, or
tray included for that procedure prior to
commenting that the item is not
duplicative. Finally, we note that in
some cases we made proposals related
to comments received in response to the
CY 2014 final rule with comment
period. In cases where we have
addressed the concerns of commenters
in the proposed rule, we do not respond
to comments here as well.
(1) Cross-Family Comments
Comment: We received comments
regarding refinements to equipment
times for many procedures for which
commenters indicated that the
equipment time for the procedure
should include the time that the
equipment is unavailable for other
patients, including while preparing
equipment, positioning the patient,
assisting the physician, and cleaning the
room. Commenters also requested that
we indicate which clinical labor tasks
should be included in calculating the
equipment time for highly technical
equipment.
Response: As stated above, we agree
with commenters that the equipment
time should include the times within
the intra-service period when a clinician
is using the piece of equipment plus any
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
additional time the piece of equipment
is not available for use for another
patient due to its use during the
designated procedure. We believe that
some of these commenters are
suggesting that we should allocate the
full number of clinical labor minutes
included in the service period to the
equipment items. However, as we have
explained, the clinical labor service
period includes minutes based on some
clinical labor tasks associated with preand post-service activities that we do
not believe typically preclude
equipment items from being used in
furnishing services to other patients
because these activities typically occur
in other rooms. The equipment times
allocated to the CPT codes in Table 18
already include the full intraservice
time the equipment is typically used in
furnishing the service, plus additional
minutes to reflect time that the
equipment is unavailable for use in
furnishing services to other patients. In
response to commenters request for
clarification, Table 19 lists the standard
clinical labor tasks to be included in the
calculation of time allocated to highly
technical equipment. We note that in
some cases, some specialized
intraservice clinical labor tasks are also
67643
included in the equipment time
calculations; we have not detailed every
possible case in this table.
times for several procedures, in which
commenters indicated that CMS
reduced the clinical labor minutes
inappropriately for tasks related to film
TABLE 18—EQUIPMENT INPUTS THAT inputs, since the recommended minutes
INCLUDE APPROPRIATE CLINICAL were based on the PEAC surveyed
LABOR TASKS ABOUT WHICH COM- times. Tasks included ‘‘Process images,
complete data sheet, present images and
MENTS WERE RECEIVED
data to the interpreting physician’’ and
‘‘Retrieve prior appropriate imaging
Equipment
CPT Code
Items
exams.’’
Response: The surveyed times
70551 ........................................ EL008
referenced by the commenters refer to
70552 ........................................ EL008
the clinical labor tasks associated with
70553 ........................................ EL008
film technology. In reviewing the times
93880 ........................................ EL016
associated with these clinical labor
93882 ........................................ EL016
tasks, we noted that it would be
consistent with our policy finalized in
TABLE 19—CLINICAL LABOR TASKS IN- this rule to adjust the times associated
CLUDED IN CALCULATION OF EQUIP- with clinical labor tasks for all interim
MENT TIME FOR HIGHLY TECHNICAL final codes to be consistent with the
EQUIPMENT
RUC recommendations regarding
clinical labor tasks for digital
Clinical Labor Task
technology. We are making the
Prepare room, equipment, supplies
associated changes and holding these
Prepare and position patient
Assist physician in performing procedure and/or
direct PE inputs interim final for 2015.
Acquire images
These clinical labor tasks associated
Clean room/equipment by physician staff
with film and digital inputs are
Technologist QC’s images in PACS, checking for all
presented side-by-side, along with the
images, reformats, and dose page
range of typical times, in Table 20. The
Comment: We received comments
specific interim final codes and their
regarding refinements to clinical labor
time changes are listed in Table 21.
TABLE 20—CLINICAL LABOR TASKS ASSOCIATED WITH DIGITAL TECHNOLOGY
Service period
Clinical labor task: film inputs
Typical
minutes
Clinical labor task: digital inputs
Pre-Service ............
Retrieve prior appropriate imaging exams and
hang for MD review, verify orders, review the
chart to incorporate relevant clinical information and confirm contrast protocol with interpreting MD/Retrieve Prior Image for Comparison.
Process Images, complete data sheet, present
images and data to the interpreting physician/Process films, hang films and review
study with interpreting MD prior to patient
discharge.
4 to 7 .....
Availability of prior images confirmed ................
Patient clinical information and questionnaire
reviewed by technologist, order from physician confirmed and exam protocoled by radiologist.
2
2
4 to 20 ...
Technologist QC’s images in PACS, checking
for all images, reformats, and dose page.
Review examination with interpreting MD .........
Exam documents scanned into PACS. Exam
completed in RIS system to generate billing
process and to populate images into Radiologist work queue.
2
2
1
Service Period:
Post-Service.
Typical
minutes
TABLE 21—INTERIM FINAL CODES WITH ADJUSTED CLINICAL LABOR TIMES DUE TO FILM-TO-DIGITAL MIGRATION
ebenthall on DSK5SPTVN1PROD with $$_JOB
CPT code
19081
19082
19083
19084
19085
19086
19281
19282
19283
19284
19285
19286
19287
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
VerDate Sep<11>2014
20:15 Nov 12, 2014
Total film
task time
(2014)
CMS code
Jkt 235001
L043A
L043A
L051B
L051B
L047A
L047A
L043A
L043A
L043A
L043A
L051B
L051B
L047A
PO 00000
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
Frm 00097
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
Total digital
task time
8
5
8
5
8
5
8
5
8
5
8
5
8
13NOR2
9
5
9
*5
9
*5
9
*5
9
*5
9
*5
9
Time change
1
0
1
0
1
0
1
0
1
0
1
0
1
67644
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 21—INTERIM FINAL CODES WITH ADJUSTED CLINICAL LABOR TIMES DUE TO FILM-TO-DIGITAL MIGRATION—
Continued
CPT code
19288
19281
19282
70450
70460
70470
70551
70552
70553
72141
72142
72156
72146
72147
72157
72148
72149
72158
74174
Total film
task time
(2014)
CMS code
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
L047A
L043A
L043A
L046A
L046A
L046A
L047A
L047A
L047A
L047A
L047A
L047A
L047A
L047A
L047A
L047A
L047A
L047A
L046A
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
Total digital
task time
5
5
5
10
11
13
6
8
8
14
16
18
14
16
18
14
16
18
27
*5
5
5
9
9
9
9
9
9
9
9
9
9
9
9
9
9
9
9
Time change
0
0
0
¥1
¥2
¥4
2
0
0
¥5
¥7
¥9
¥5
¥7
¥9
¥5
¥7
¥9
¥22
* Add-on codes are allocated fewer minutes for these activities.
(2) Code-Specific Comments
ebenthall on DSK5SPTVN1PROD with $$_JOB
(a) Destruction of Premalignant Lesions
(CPT Codes 17000, 17003, 17004)
In establishing interim final direct PE
inputs for CY 2014, CMS accepted the
RUC’s recommendations for supply item
LMX 4% anesthetic cream (SH092).
Comment: Commenters indicated that
the quantity of cream units in CPT code
17003 created a rank order anomaly
with CPT codes 17000 and 17004, and
that the inclusion of 3 grams was
incorrect. Instead, 1 gram should have
been included in CPT code 17003.
Response: We agree with the
commenters that the quantity of SH092
in 17003 should be 1 gram. However,
we also note that CPT code 17000
should also contain a quantity of 1 gram
in order to avoid the rank order
anomaly. After consideration of the
comments received, we are finalizing
the CY 2014 interim final direct PE
inputs for CPT codes 17000, 17003, and
17004, with the additional refinement of
changing the quantity of SH092 to 1 for
CPT codes 17000 and 17003.
(b) Breast Biopsy (CPT Codes 19081,
19082, 19083, 19084, 19085, 19086,
19281, 19282, 19283, 19284, 19285,
19286, 19287, and 19288)
In establishing interim final direct PE
inputs for CY 2014, CMS refined the
RUC’s recommendations for CPT codes
19085, 19086, 19287, and 19288 by
removing several new PE inputs,
including items called ‘‘20MM
handpiece—MR,’’ ‘‘vacuum line
assembly,’’ ‘‘introducer localization set
(trocar),’’ and ‘‘tissue filter,’’ since we
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
concluded that these items served
redundant clinical purposes with other
biopsy supplies already included in the
PE inputs for these codes. We also
removed three new equipment items,
described as ‘‘breast biopsy software,’’
‘‘breast biopsy device (coil),’’ and
‘‘lateral grid,’’ because we determined
that these items served clinical
functions to items already included in
the MR room.
Comment: Commenters indicated that
the vacuum assisted breast biopsy
requires an assisted biopsy needle
system, and tubing must be run from the
biopsy device to the biopsy control unit.
Commenters also discussed supply
items ‘‘introducer localization set
(trocar)’’ and ‘‘tissue filter,’’ stating that
the trocar is used to target the biopsy on
the correct lesion, and the tissue filter
is necessary to remove the collected
core samples from the collection
chamber. Commenters described the
importance of the ‘‘breast biopsy device
(coil), ’’ which is used to move one
breast out of the way and the ‘‘breast
biopsy software,’’ which is required to
make the necessary calculations to
target and biopsy the lesions. Finally,
commenters stated that the lateral grid
is necessary to place the trocar correctly.
Response: The equipment item
‘‘breast biopsy device w-system
(Mammotome)’’ (EQ074) is described as
‘‘an all-in-one platform designed for use
under ultrasound, MRI, stereotactic and
3D image guidance’’ and is used with
supply item ‘‘Mammotome probe’’
(SD094). Therefore, the supply items
‘‘20 MM handpiece,’’ ‘‘vacuum line
PO 00000
Frm 00098
Fmt 4701
Sfmt 4700
assembly,’’ ‘‘tissue filter,’’ and ‘‘trocar,’’
are duplicative of items already
included in this procedure. We do note
that we have used the invoice to create
a price for equipment item ‘‘Breast
biopsy device (coil)’’ (EQ371) at a price
of $12,238. After consideration of the
comments received, we are finalizing
the CY 2014 interim final direct PE
inputs for CPT codes 19085, 19086,
19287, and 19288 as established with
the additional refinement of
incorporating the equipment item
‘‘Breast biopsy device (coil)’’ (EQ371).
Comment: A commenter noted that
the new breast biopsy codes do not
distinguish between the type of biopsy
device used for the procedure, and that
the cost of using the vacuum-assisted
biopsy device (including a Mammotome
probe, a Mammotome probe guide, and
tubing and vacuum for the Mammotome
device) is nearly eight times the cost of
the equipment and supplies required to
perform a standard (mechanical) core
needle biopsy. The commenter noted
that vacuum-assisted biopsy devices are
predominantly used in stereotactic and
MRI-guided breast biopsy procedures
and 50 percent of the time in
ultrasound-guided breast biopsy
procedures.
Response: For a discussion about the
change in coding, we refer readers to
section II.F. of this final rule with
comment period, where we finalize the
work RVUs for interim final 2014 codes.
With regard to the direct PE inputs for
these services, we note that we include
direct PE inputs based on the typical
case, and since, as the commenter
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
points out, the vacuum-assisted biopsy
devices are typically used, we include
these items as direct PE inputs.
In reviewing the breast biopsy codes,
we noted that we inadvertently
included supply and equipment items
related to breast biopsies in CPT codes
19283, 19284, 19285, 19286, 19087, and
19088, which are procedures that
describe the placement of a localization
device, not a biopsy. We will therefore
remove the items listed in Table 22,
which are currently included as direct
PE inputs for these procedures. After
consideration of the comments received,
we are finalizing the CY 2014 interim
final direct PE inputs for CPT codes
19081, 19082, 19083, 19084, 19085,
19086, 19281, 19282, 19283, 19284,
19285, 19286, 19287, and 19288 as
established, with the additional
refinements noted above.
TABLE 22—SUPPLY AND EQUIPMENT
ITEMS INADVERTENTLY INCLUDED IN
LOCALIZATION DEVICE PLACEMENT
BREAST BIOPSY CODES
CPT
ebenthall on DSK5SPTVN1PROD with $$_JOB
19283
19284
19285
19286
19087
19088
..........
..........
..........
..........
..........
..........
SD034
SC022
EQ074
X
X
..............
..............
X
X
..............
..............
..............
..............
X
X
X
X
X
X
X
X
(c) Nasal/Sinus Endoscopy (CPT Codes
31237, 31238)
In establishing interim final direct PE
inputs for CY 2014, CMS refined the
RUC’s recommendations for CPT codes
31237 and 31238 by refining the nurse
blend (L037D) clinical labor time
associated with task ‘‘Monitor pt.
following service/check tubes, monitors,
drains’’ from 15 minutes to 5 minutes.
Comment: Commenters stated that
CMS should maintain consistency in the
direct PE inputs across services by
allocating the standard 15 minutes for
every hour of post-procedure
monitoring time. Commenters indicated
that monitoring after these procedures is
critical, since the risk of recurrent
bleeding is high and patients may
become lightheaded.
Response: There are two types of postprocedure monitoring time; a standard
15 minutes per hour of post-procedure
monitoring time for moderate sedation,
and a standard 15 minutes per hour of
post-procedure monitoring time
unrelated to moderate sedation. We
understand the commenter’s position to
mean that there is 60 minutes of postprocedure monitoring required for these
services (in accordance with the 15
minutes of RN time per 60 minutes of
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
monitoring). Because these procedures
previously included 5 minutes of postprocedure monitoring time, we do not
have a reason to believe that the
monitoring time would have increased
by 55 minutes. Should commenters
believe this is the case, we invite
commenters to provide information to
justify this change. In cases where the
specialty society is recommending postprocedure monitoring unrelated to
moderate sedation, it is important that
the recommendation clearly indicates
the reason for the monitoring and the
relationship between the clinical staff
time and the monitoring time. After
consideration of the comments received,
we are finalizing the CY 2014 interim
final direct PE inputs for CPT codes
31237 and 31238 as established.
(d) Implantation and Removal of Patient
Activated Cardiac Event Recorder (CPT
Codes 33282 and 33284)
In the CY 2013 final rule with
comment period, in response to
nomination of CPT codes 33282 and
33284 as potentially misvalued codes,
we indicated that we did not consider
the absence of pricing in a particular
setting as an indicator of potentially
misvalued codes. However, we
requested that the RUC review these
codes, including the work RVUs, for
appropriate nonfacility and facility
inputs.
Comment: A commenter expressed
disappointment that CMS did not price
these services in the nonfacility setting
but did not provide further information
about this decision.
Response: We received
recommendations from the RUC for CPT
codes 33282 and 33284 that did not
include nonfacility inputs. Stakeholders
who are interested in providing
information about the direct PE inputs
used in furnishing these services are
welcome to submit this information to
us; information about the level of
information we seek is available to
stakeholders in the sample PE
worksheet available on the CMS Web
site under downloads at https://
www.cms.gov/PhysicianFeeSched/
PFSFRN/list.asp#TopOfPage. We
encourage commenters to submit the
best data available on the appropriate
inputs for these services.
(e) Transcatheter Placement of
Intravascular Stent (CPT Codes 37236,
37237)
In establishing interim final direct PE
inputs for CY 2014, CMS refined the
RUC’s recommendations for CPT codes
37236 and 37237 by including supply
item ‘‘catheter, balloon, PTA’’ (SD152)
as a proxy for ‘‘balloon expandable’’
PO 00000
Frm 00099
Fmt 4701
Sfmt 4700
67645
because we believed that was an
appropriate proxy. The invoices
provided with the recommendation did
not indicate the items on the PE
worksheet with which they were
associated.
Comment: The specialty society
representing practitioners who furnish
these services indicated that the item
‘‘balloon expandable’’ actually referred
to a ‘‘balloon implantable stent,’’ and
that the invoices provided were
associated with that item.
Response: We acknowledge the
specialty society’s clarification of the
RUC recommendation. We will add item
‘‘balloon implantable stent’’ at a price of
$1,500, and remove the proxy item
SD152. We note that when line items on
the invoices provided are not clearly
labeled, it is often difficult for us to
determine how to relate the items on the
PE spreadsheet with the items on the
invoices. For specialty societies to
ensure that the requested items are
considered for inclusion in the relevant
procedure codes, it is important that
invoices accompany the RUC
recommendations and the line items
associated with items on the PE
spreadsheet are clearly labeled.
After consideration of the comments
received, we are finalizing the CY 2014
interim final direct PE inputs for CPT
codes 37236 and 37237 as established
with the additional refinement of
including ‘‘balloon implantable stent’’
and removing ‘‘catheter, balloon, PTA’’
(SD152).
(f) Esophagoscopy (CPT Codes 43197
and 43198)
In establishing interim final direct PE
inputs for CY 2014, CMS refined the
RUC’s recommendations for CPT codes
43197 and 43198 to remove the
Medical/Technical Assistant (L026A)
time associated with clinical labor task
‘‘Clean Surgical Instrument Package,’’
since no surgical instrument package is
included in the service, and to remove
the endoscopic biopsy forceps (SD066)
from CPT code 43198, among other
refinements.
Comment: Commenters acknowledged
that the procedure did not contain a
surgical instrument package, but stated
that the time was still necessary for
cleaning equipment, such as the nasal
speculum, bayonette forceps, and
biopsy forceps.
Response: In general, as a matter of
relativity throughout the PFS, the time
allocated for the standard clinical labor
task ‘‘Clean room/equipment following
procedure’’ encompasses time for
cleaning all equipment items. The only
exceptions to this rule are for equipment
items that are tied to specific clinical
E:\FR\FM\13NOR2.SGM
13NOR2
67646
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
labor tasks, such as cleaning the surgical
instrument pack or cleaning a scope. We
do not believe it would serve relativity
to separately break out time to clean
various different types of equipment.
For the biopsy forceps, we indicated
in the final rule with comment period
that the information included with the
RUC recommendation suggested that the
biopsy forceps was reusable (as
suggested by the cleaning time
mentioned in this comment). As such,
we have created a new equipment item
based on the invoice provided with the
recommendation and assigned 46
minutes to this equipment item.
However, since we did not receive a
paid invoice with this item, we will
price it at $0 until we receive a paid
invoice.
After consideration of the comments
received, we are finalizing the CY 2014
interim final direct PE inputs for CPT
codes 43197 and 43198 as established,
with the additional refinement of
including 46 minutes for the reusable
biopsy forceps.
ebenthall on DSK5SPTVN1PROD with $$_JOB
(g) Esophagoscopy/Esophagoscopy
Gastroscopy Duodenoscopy (EGD) (CPT
Codes 43200, 43201. 43202, 43206,
43215, 43216, 43217, 43220, 43226,
43227, 43231, 43232, 43235, 43236,
43239, 43245, 43247, 43248, 43248,
43250, 43251, 43252, 43255, 43270)
In establishing interim final direct PE
inputs for CY 2014, CMS refined the
RUC’s recommendations for CPT codes
43200, 43201. 43202, 43206, 43215,
43216, 43217, 43220, 43226, 43227,
43231, 43232, 43235, 43236, 43239,
43245, 43247, 43248, 43248, 43250,
43251, 43252, 43255, and 43270 by
refining the quantity of item ‘‘canister,
suction’’ (SD009) from 2 to 1.
Comment: Commenters indicated
that, for patient safety reasons, one
suction canister is needed for the
mouth, and another for the scope for
patient safety reasons. Other
stakeholders, specifically, several
specialty societies with whom we met
during the comment period, informed
us that one suction canister is sufficient
and typical for these services.
Response: We are persuaded by the
information provided by the medical
specialty societies during the comment
period who indicated that one suction
canister is typical.
In establishing interim final direct PE
inputs for CY 2014, CMS refined the
RUC’s recommendations for CPT codes
43201 by removing needle,
micropigmentation (tattoo) (SC079), as
the needle required for this procedure
needs to go through an endoscope, and
no invoice was provided for this item.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Comment: Commenters indicated that
the tattoo needle was required to mark
the site for injection.
Response: We did not receive an
invoice for the tattoo needle and have
no information about this item. We are
also unable to include this item in the
PE calculations without a method to
price it. We do not believe that we have
a reasonable proxy at this time. If we
receive invoices for this item, we will be
able to include it in the direct PE input
database.
In establishing interim final direct PE
inputs for CY 2014, CMS refined the
RUC’s recommendations for CPT codes
43201, 43220, 43226, and 43231 by
removing supply item ‘‘cup, biopsyspecimen non-sterile 4oz’’ (SL035).
Comment: Commenters indicated that
the endoscopy base code, 43200, is
included in all of these procedures.
Since the biopsy cup is included in the
endoscopy base code, it should be
included for these codes as well.
Response: We agree with commenters
that it is appropriate to include this
supply item for these procedures. We
will include the supply item ‘‘cup,
biopsy-specimen non-sterile 4oz’’ in the
direct PE inputs for these procedures.
In establishing interim final direct PE
inputs for CY 2014, CMS refined the
RUC’s recommendations for CPT code
43220 by substituting supply item
‘‘SD019’’ as a proxy for ‘‘SD025.’’
Comment: Commenters requested that
we include ‘‘endoscopic balloon,
dilation’’ (SD287) rather than a proxy, as
this supply item is now included in the
database.
Response: After receiving clarification
regarding this request, we agree with
commenters that SD287 is an
appropriate supply input for this
procedure. Therefore, we will include
SD287 for CPT code 43220.
In establishing interim final direct PE
inputs for CY 2014, CMS refined the
RUC’s recommendations for CPT codes
43220, 43249, and 43270 by removing
supply item ‘‘guidewire, STIFF’’
(SD090), among other refinements.
Comment: Commenters indicated that
the guidewire is required to safely
straddle tumors for which there is
impaired visibility and an inability to
pass the scope through.
Response: We agree with commenters
that it would be appropriate to include
supply item ‘‘guidewire—STIFF’’ in
these procedures. We will include the
supply item ‘‘guidewire—STIFF’’ in the
direct PE inputs for these procedures.
After consideration of the comments
received, we are finalizing the CY 2014
interim final direct PE inputs for codes
43200, 43201. 43202, 43206, 43215,
43216, 43217, 43220, 43226, 43227,
PO 00000
Frm 00100
Fmt 4701
Sfmt 4700
43231, 43232, 43235, 43236, 43239,
43245, 43247, 43248, 43248, 43250,
43251, 43252, 43255, and 43270 as
established, with the additional
refinements of including the supply
items noted above.
(h) Dilation of Esophagus (CPT Codes
43450, 43453)
In establishing interim final direct PE
inputs for CY 2014, CMS refined the
RUC’s recommendations for CPT codes
43450 and 43453 by removing
equipment item ‘‘endoscope disinfector,
rigid or fiberoptic, w-cart’’ (ES005), and
not creating a new item ‘‘mobile stand,
vital signs monitor,’’ and other
refinements.
Comment: Commenters stated that the
endoscope disinfector is a necessary
part of all endoscopic procedures for
sanitary and safety reasons, and that it
should be restored for all
gastrointestinal endoscopy codes.
Commenters also noted that the mobile
stand is the standard method of
monitoring that must be moved along
with the patient.
Response: Since these are nonendoscopic dilation codes, there is no
scope to clean, and thus the endoscope
disinfector is unnecessary. The standard
inputs for moderate sedation as
recommended by the RUC were
included in this procedure; the mobile
stand overlaps with the standard
moderate sedation input items. After
consideration of the comments received,
we are finalizing the CY 2014 interim
final direct PE inputs for codes CPT
codes 43450 and 43453 as established.
(i) Spinal Injections (CPT Codes 62310,
62311, 62318, 62319)
In establishing interim final direct PE
inputs for CY 2014, CMS accepted the
RUC recommendations for CPT codes
62310, 62311, 62318, and 62319. Based
on comments received, we made a
proposal to maintain the CY 2014 direct
PE inputs for CY 2015 while the codes
are reexamined for bundling. We are
finalizing this proposal, so while we
acknowledge comments received on
these codes, we will not respond to
these comments as the interim final
inputs to which the comments relate
will not be used for 2015.
(j) Percutaneous Implantation of
Neurostimulator (CPT Code 63650)
In establishing interim final direct PE
inputs for CY 2014, CMS refined the
RUC’s recommendations for CPT code
time by removing the time associated
with clinical labor task ‘‘Clean Surgical
Instrument Package’’ and removing
supply item ‘‘pack, cleaning, surgical
instruments’’ (SA043) since no surgical
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
instrument package is included in the
service.
Comment: Commenters indicated that
clinical staff time is critical for the
safety and efficiency of the procedure,
and that the surgical instrument
cleaning package is necessary to ensure
proper adherence of the electrodes.
Response: In general, as a matter of
relativity throughout the PFS, the time
allocated for the standard clinical labor
task ‘‘Clean room/equipment following
procedure’’ encompasses time for
cleaning all equipment items. The only
exceptions to this rule are for equipment
items which are tied to specific clinical
labor tasks, such as cleaning the surgical
instrument pack or cleaning a scope. We
do not believe it would serve relativity
to separately break out time to clean
various different types of equipment.
After consideration of the comments
received, we are finalizing the CY 2014
interim final direct PE inputs for CPT
code 63650 as established.
ebenthall on DSK5SPTVN1PROD with $$_JOB
(k) Chemodenervation (CPT Codes
64616, 64642, 64644, 64646, 64647)
In establishing interim final direct PE
inputs for CY 2014, CMS refined the
RUC’s recommendations for CPT codes
64616, 64642, 64644, 64646, and 64647
by reducing the minutes allocated to
‘‘table, exam’’ (EF023) and removing the
time associated with clinical labor task
‘‘Complete botox log,’’ as well as
reducing the L037D time for clinical
labor ‘‘assist physician performing
procedure’’ for CPT code 64616, among
other refinements.
Comment: One commenter opposed
our adjusting the minutes allocated to
the exam table. Commenters stated that
the reference code, 64615, included
three minutes of clinical labor time for
‘‘complete botox log,’’ and requested
that they be included since they are in
the reference code. One commenter
asked whether CMS planned to remove
the minutes from the reference code as
well. Other commenters indicated that
as with most injections, it is necessary
to document various elements of
information for safety purposes.
Response: Upon reviewing the time
allocated to the exam table, we noted
that our standard equipment policy is to
allocate the entire service period for
equipment that is not highly technical.
Therefore, we will allocate minutes for
the entire service period for the exam
table, as follows: 28 minutes for 64616,
44 minutes for 64642, 49 minutes for
64644, 44 minutes for 64646, and 49
minutes for 64647. We appreciate
commenters pointing out the three
minutes of time inadvertently allocated
for ‘‘complete botox log’’ in the
reference code, 64615, and will consider
this issue in future rulemaking. We note
that one of the benefits of having
information stored in the direct PE
database at the clinical labor task level
is that it allows us to make comparisons
of codes under review to existing codes
in the PE database. This will help us
ensure greater consistency in our
refinements. As commenters point out,
various injections are documented in
logs, rather than medical records. The
use of a different location for
documentation is not a reason to
allocate additional clinical labor time
for a particular service.
Comment: One commenter supported
our adjustment of ‘‘assist physician’’
time from 7 minutes to 5 minutes.
Another commenter disagreed with the
refinement and requested that CMS
explain how physician time was
calculated, while a different commenter
stated that the ‘‘assist physician’’ time
should be 28 minutes.
Response: Upon reviewing the work
time and the time allocated for assist
physician, we determined that 7
minutes is actually appropriate for the
assist physician task.
After consideration of the comments
received, we are finalizing the CY 2014
interim final direct PE inputs for CPT
codes 64616, 64642, 64644, 64646, and
64647 as established, with the
additional refinement of adjusting the
minutes for the exam table as indicated
above and adding 2 minutes of clinical
labor for the ‘‘assist physician’’ task for
64616.
(l) MRI Brain (CPT Codes 70551, 70552,
70553)
In establishing interim final direct PE
inputs for CY 2014, CMS refined the
RUC’s recommendations for CPT codes
70551, 70552, and 70553 by adjusting
the time for clinical labor task ‘‘assist
physician in performing procedure/
acquire images,’’ removing 2 minutes of
clinical labor time for clinical labor task
‘‘escort patient from exam room due to
67647
magnetic sensitivity,’’ removing supply
items ‘‘gauze,sterile 2in x 2in’’ (SG053),
‘‘tape, phix strips (for nasal catheter)’’
(SG089), ‘‘povidone swabsticks (3 pack
uou’’ (SJ043), and ‘‘swab-pad, alcohol’’
(SJ 053) from CPT codes 70552 and
70553, among other refinements.
Comment: Commenters indicated that
the times associated with clinical labor
task ‘‘assist physician in performing
procedure/acquire images’’ reflected the
PEAC surveyed times, and they had no
reason to believe that the time had
decreased since the PEAC review.
Response: As indicated in the PFS CY
2014 final rule with comment period (78
FR 74345), the procedure time for these
services was last reviewed in 2002. We
noted that we believe there should be no
significant difference between the time
to acquire images for an MRI of the
brain and an MRI of the spine, and that,
rather than rely on very old survey data,
it would be appropriate to crosswalk the
time associated with the MRI of the
spine to the MRI of the brain. We
continue to believe that this time is
more accurate than that of the survey
data.
Comment: Commenters noted that the
clinical labor task ‘‘escort patient from
exam room due to magnetic sensitivity’’
is a necessary activity for patient safety.
Response: Upon review of this
clinical labor task, we noted that this
task was included in the PE worksheets
from when these codes were previously
reviewed in 2002. Therefore, since this
activity does not reflect a newly added
clinical labor task, we agree with
commenters that it would be
appropriate to include 2 minutes for this
clinical labor task.
Comment: Commenters stated that the
supplies removed from CPT codes
70552 and 70553 were necessary
supplies for the service, and that the
specialty society incorrectly included
supply item ‘‘tape, phix strips (for nasal
catheter)’’ (SG089), when the correct
supply item was ‘‘tape, surgical paper
1in (Micropore)’’ (SG079).
Response: We note that these supplies
were removed because they were
already contained in the supply item
‘‘kit, IV starter’’ (SA019). Table 23
shows the items contained in the IV
starter kit and the corresponding supply
items removed due to redundancy.
TABLE 23—ITEMS REMOVED FOR REDUNDANCY AND PARALLEL ITEMS INCLUDED IN IV STARTER KIT
Corresponding items removed for redundancy
Items in IV starter kit
1 tourniquet .................................................................................................................................................
1 PVP ointment ..........................................................................................................................................
1 PVP prep pad ..........................................................................................................................................
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00101
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
povidone swabsticks (3 pack uou)
swab-pad, alcohol
13NOR2
67648
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 23—ITEMS REMOVED FOR REDUNDANCY AND PARALLEL ITEMS INCLUDED IN IV STARTER KIT—Continued
Corresponding items removed for redundancy
Items in IV starter kit
2
1
1
1
1
gauze sponges ........................................................................................................................................
bandage (1″x3″) ......................................................................................................................................
sm roll surgical tape ................................................................................................................................
pr gloves ..................................................................................................................................................
underpad 2ft x 3ft (Chux) ........................................................................................................................
After consideration of the comments
received, we are finalizing the CY 2014
interim final direct PE inputs for CPT
codes 70551, 70552, and 70553, with
the additional refinement of including 2
minutes of clinical labor time as noted
above.
ebenthall on DSK5SPTVN1PROD with $$_JOB
(m) MRI Spine (CPT Codes 72141,
72142, 72146, 72147, 72149, 72156,
72157, 72158)
In establishing interim final direct PE
inputs for CY 2014, CMS refined the
RUC’s recommendations for CPT codes
72141, 72142, 72146, 72147, 72149,
72156, 72157, and 72158 by removing 2
minutes of clinical labor time for
clinical labor task ‘‘escort patient from
exam room due to magnetic sensitivity,’’
and other refinements.
Comment: Commenters noted that the
clinical labor task ‘‘escort patient from
exam room due to magnetic sensitivity’’
is a necessary activity for patient safety.
Response: Upon review of this
clinical labor task, we noted that this
task was included in the PE worksheets
from when these codes were previously
reviewed in 2002. Therefore, since this
activity does not reflect a newly added
clinical labor task, we agree with
commenters that it would be
appropriate to include 2 minutes for this
clinical labor task.
Comment: A commenter noted that
CMS did not include a contrast imaging
pack, which includes supplies
necessary for contrast enhanced studies.
Response: In section II.B. of this final
rule with comment period, we finalized
our policy to add a contrast imaging
pack to be used for imaging services
with contrast. Therefore, we will
include the contrast supply pack (CMS
code SA114) for CPT codes 72142,
74147, 72149, 72156, 72157, and 72158.
After consideration of the comments
received, we are finalizing the CY 2014
interim final direct PE inputs for CPT
codes 72141, 72142, 72146, 72147,
72149, 72156, 72157, and 72158, with
the additional refinement of including 2
minutes of clinical labor time and
including the supply pack for the
services noted above.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
(n) Selective Catheter Placement (CPT
Code 75726)
In establishing interim final direct PE
inputs for CY 2014, when reviewing
CPT code 36245, which was identified
through a misvalued code screen of
codes reported together more than 75
percent of the time, we noted that it was
frequently billed with 75726. We then
noted that these two services had
identical time for ‘‘assist physician in
performing procedure,’’ and since the
time for 36245 was reduced from 73 to
45 minutes, refined the clinical labor
time for 75726 to correspond to this
change.
Comment: Commenters indicated that
the 73 minutes reflected the PEAC
surveyed times, and that these activities
are imaging-related, and in addition to
the time and activities inherent in the
accompanying surgical base code.
Response: As indicated elsewhere in
this section, we note that the PEAC
survey data are very old, and that
refinements based on more updated
information are appropriate. We
continue to believe that it is appropriate
for the intraservice times for 36245 and
75726 to continue to correspond to one
another, as they are frequently furnished
together. After consideration of the
comments received, we are finalizing
the CY 2014 interim final direct PE
inputs for CPT code 75726 as
established.
(o) Radiation Treatment Delivery (CPT
Codes 77373, 77422, 77423)
In establishing interim final direct PE
inputs for CY 2014, CMS refined the
RUC’s recommendations for CPT code
77373 by refining the equipment time
for ‘‘pulse oximeter w-printer’’ (EQ211)
and ‘‘SRS system, SBRT, six systems,
average’’ (ER083) to conform to
established equipment policies.
Comment: Commenters stated that the
times should be maintained at 104
minutes, rather than being reduced to 86
minutes, and indicated the clinical labor
task lines that should be included in the
calculations.
Response: Upon reviewing the
equipment times associated with this
procedure, we agree with commenters
that the time allocated for the
PO 00000
Frm 00102
Fmt 4701
Sfmt 4700
gauze, sterile 2in x 2in
tape, surgical paper 1in
equipment should include the time
associated with the indicated clinical
labor tasks for these equipment items.
After consideration of the comments
received, we are finalizing the CY 2014
interim final direct PE inputs for CPT
code 77373 as established, with the
additional refinement of adjusting the
equipment times to 104 minutes as
noted above.
For CY 2014, we also eliminated
several anomalous supply inputs
included in the direct PE database,
which affected 77422 and 77423, among
other services.
Comment: Commenters indicated that
upon reviewing the inputs for these
services, they noted that the Record and
Verify System and the laser targeting
system were missing in both of these
services, despite being in the original
2005 recommendation.
Response: We appreciate the
commenters’ attention to detail.
However, as indicated elsewhere, we do
not believe that the record and verify
system is medical equipment used in
furnishing the technical component of
the service. We refer readers to our
discussion of this issue in the PFS 2014
Final rule with Comment period (78 FR
74317). Further, since these codes have
not been reviewed in many years, we do
not know if the laser targeting system
continues to be an appropriate input for
these services. Therefore, we request
that the RUC examine the inputs for
these services to ensure their accuracy.
(p) Hyperthermia (CPT Code 77600)
In establishing interim final direct PE
inputs for CY 2014, CMS refined the
RUC’s recommendations for CPT code
77600 by refining the time allocated to
equipment item ‘‘hyperthermia system,
ultrasound, external’’ (ER035) and
removing the time associated with
clinical labor task ‘‘clean scope,’’ among
other refinements.
Comment: Commenters indicated that
the appropriate lines were not used to
calculate the recommended equipment
times, including cleaning the scope and
check dressing.
Response: Upon reviewing the
comments, we re-examined the
equipment time calculation and
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
continue to believe that the time
allocated to this equipment item is
appropriate. We note that there is no
scope used in this procedure, so time to
clean the scope is unnecessary. After
consideration of the comments received,
we are finalizing the CY 2014 interim
final direct PE inputs for CPT code
77600 as established.
(q) High Dose Rate Brachytherapy (CPT
Codes 77785, 77586, 77787)
In establishing interim final direct PE
inputs for CY 2014, CMS refined the
RUC’s recommendations for CPT codes
77785, 77786, and 77787 to remove
‘‘Emergency service container—safety
kit,’’ as we consider it an indirect PE.
Comment: Commenters noted that the
emergency container is a safety device
used when a source must be retrieved
manually. Commenters indicated that it
is a mobile item and that the service
cannot be provided unless it is in the
room, and thus it is a direct PE, since
it is directly assumed by a physician in
the course of providing the service.
Commenters asked that we reclassify
this item as a direct input.
Response: In our clinical review, we
reviewed the work vignettes for these
procedures, which did not include the
use of the ‘‘emergency service
container—safety kit’’ as a part of the
procedure. Although we acknowledge
that the emergency service container
safety kit needs to be readily available
during the procedure, we note that
‘‘standby’’ equipment, or items that are
not used in the typical case, are
considered indirect costs. For further
discussion of this issue, we refer readers
to our discussion of ‘‘standby’’
equipment in the CY 2001 PFS
proposed rule (65 FR 44187).
When reviewing the interim final
direct PE inputs for these services, we
noted that the specialty societies
conducted a survey of the technicians,
which revealed higher procedure times
than the current procedure times.
However, since the RUC indicated that
they did not have ‘‘compelling
evidence,’’ the specialty society did not
request the higher procedure times. We
believe that if the specialty society
believes that the code is undervalued
relative to the expert panel value, and
there is no indication that the survey
was flawed, the specialty society should
recommend the use of the surveyed
procedure times. In doing so, the
specialty society would give CMS the
opportunity to consider the information
provided alongside the RUC
recommended times. We believe that
surveys of technicians have the
potential to be more accurate, rather
than less accurate, than those of
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
physicians, as the technicians do not
have incentives to increase the surveyed
time. We suggest that rather than
attempting to insert items that are not
standard in the PE methodology, that
specialty societies make a strong, datadriven case, for why the survey times
are correct.
Comment: A commenter noted that
there have been significant reductions to
these CPT codes over the last several
years, and urged CMS to phase in the
reductions over time should the
reductions be deemed appropriate after
review of the methodology and data.
Response: We note that reductions to
CPT codes are made on the basis that
they are potentially misvalued. We do
not typically transition such reductions.
However, the Protecting Access to
Medicare Act (PAMA) requires that
beginning in 2017, CMS transition codelevel reductions of greater than or equal
to 20 percent in a given year; therefore,
beginning in 2017, such reductions will
be transitioned.
After consideration of the comments
received, we are finalizing the CY 2014
interim final direct PE inputs for CPT
codes 77785, 77786, and 77787 as
established.
(r) Cytopathology (CPT Code 88112)
In establishing interim final direct PE
inputs for CY 2014, CMS refined the
RUC’s recommendations for CPT code
88112 by removing the clinical labor
time associated with several clinical
labor tasks, including ‘‘Order, restock,
and distribute specimen containers with
requisition forms,’’ ‘‘Perform screening
function (where applicable),’’ ‘‘Confirm
patient ID, organize work, verify and
review history,’’ and ‘‘Enter screening
diagnosis in laboratory information
system, complete workload recording
logs, manage any relevant utilization
review/quality assurance activities and
regulatory compliance documentation
and assemble and deliver slides with
paperwork to pathologist.’’
Comment: Commenters pointed out
that CPT code 88112 was inadvertently
listed in Table 28 in the CY 2014 final
rule with comment period as being
unrefined by CMS. Commenters also
opposed the reductions in clinical labor
time, and noted that the PE
subcommittee thoroughly reviewed
these inputs.
Response: We apologize for the
inadvertent inclusion of CPT code
88112 in Table 28 of the CY 2014 final
rule with comment period. We reexamined the clinical labor tasks in
light of the comments received and
noted that the clinical labor task ‘‘Order,
restock, and distribute specimen
containers with requisition forms’’ is
PO 00000
Frm 00103
Fmt 4701
Sfmt 4700
67649
not a clinical labor task associated with
furnishing a service to a particular
patient, and is therefore allocated in the
indirect practice expense. Clinical labor
task ‘‘Perform screening function (where
applicable)’’ is not a task completed in
the typical service, and is therefore not
included. Further, clinical labor task
‘‘Confirm patient ID, organize work,
verify and review history’’ is subsumed
within clinical labor task ‘‘Remove slide
from coverslipper; confirm patient ID,
organize work, send slides to cytotech
for screening’’; including both would
therefore be duplicative. Clinical labor
task ‘‘Enter screening diagnosis in
laboratory information system, complete
workload recording logs, manage any
relevant utilization review/quality
assurance activities and regulatory
compliance documentation and
assemble and deliver slides with
paperwork to pathologist’’ involves
quality assurance activities. We refer
readers to the CY 2014 PFS final rule
with comment period (78 FR 74308) for
a discussion regarding quality assurance
activities. After consideration of the
comments received, we are finalizing
the CY 2014 interim final direct PE
inputs for CPT code 88112.
Comment: One commenter noted that
the refinements to the PE inputs for CPT
code 88112 resulted in a rank-order
anomaly, as CPT code 88108 has higher
PE RVUs than CPT code 88112, while
CPT code 88108 is a less complex
service than CPT code 88112.
Specifically, commenters stated that it is
illogical for a cytology specimen
processing technique that involves an
additional step that requires materially
more resources to have an RVU that is
less than an associated technique that
requires fewer resources, and expressed
concerns about the potential for
misreporting.
Response: We appreciate this
commenter bringing this rank order
anomaly to our attention. As indicated
in section II.B. of this final rule with
comment period, we are referring this
code to the RUC as potentially
misvalued based on the information
received from the commenter.
(s) Duplex Scans (CPT Codes 93880 and
93882)
In establishing interim final direct PE
inputs for CY 2014, CMS refined the
RUC’s recommendations for CPT codes
93880 and 93882 by removing the
equipment time allocated for equipment
items ‘‘video SVHS VCR (medical
grade)’’ (ED034) and ‘‘video printer,
color (Sony medical grade)’’ (ED036),
and refining the equipment time for
‘‘computer desktop, w-monitor’’
E:\FR\FM\13NOR2.SGM
13NOR2
67650
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
(ED021) from 68 to 51 minutes, among
other refinements.
Comment: Commenters indicated that
these items are not redundant and asked
that CMS explain which items
encompass ED034 and ED036.
Commenters also stated that the desktop
computer is used for the entire
intraservice period. Commenters also
stated that the refinements were
expressed as a final decision effective
January 1, 2014.
Response: The equipment item
‘‘room, vascular ultrasound’’ (EL016)
contains ‘‘room, ultrasound general’’
(EL015), which contains both ‘‘video
SVHS VCR (medical grade)’’ and
‘‘digital printer (Sony UPD21).’’ We also
note that the RUC has reviewed these
codes again for 2015; we refer readers to
section II.F. of this rule for further
discussion, including the new interim
final inputs established for 2015. We
further note that contrary to the
commenters’ assertion, the refinements
made were indeed effective January 1,
2014, but were not final decisions;
rather, they were interim final for 2014
and subject to public comment.
(t) Electroencephalogram (CPT Codes
95816, 95819, 95822)
ebenthall on DSK5SPTVN1PROD with $$_JOB
In establishing interim final direct PE
inputs for CY 2014, CMS refined the
RUC’s recommendations for CPT codes
95816, 95819, and 95822 by refining the
equipment time allocated to equipment
item ‘‘EEG, digital, testing system
(computer hardware, software &
camera)’’ (EQ330), among other
refinements.
Comment: Commenters indicated that
various staff activities are performed on
the computer and requested that we
restore the time previously removed.
Response: Upon reviewing comments
regarding the equipment time, we agree
with commenters that we should
allocate the entire service period for
EQ330, since it is not highly technical
equipment. After consideration of the
comments received, we are finalizing
the CY 2014 interim final direct PE
inputs for CPT codes 95816, 95819, and
95822 as established, with the
additional refinement of assigning the
intraservice time to EQ330.
(u) Anogenital Examination With
Colposcopic Magnification in
Childhood for Suspected Trauma (CPT
Code 99170)
In establishing interim final direct PE
inputs for CY 2014, CMS refined the
RUC’s recommendations for CPT codes,
we accepted the RUC’s recommendation
to include a new clinical labor type
called ‘‘child life specialist.’’
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Comment: One commenter supported
the inclusion of clinical labor staff time
for the child life specialist.
Response: We appreciate the
commenter’s support for this decision.
After consideration of the comments
received, we are finalizing the CY 2014
interim final direct PE inputs for CPT
code 99170 as established.
(v) Immunohistochemistry (HCPCS
Codes G0461 and G0462)
In establishing interim final direct PE
inputs for CY 2014, CMS refined the
RUC’s recommendations for CPT codes
88342 and 88343 by creating G-codes
G0461 and G0462 and refining the
inputs for these services. We
acknowledge comments regarding the
refinements CMS made to these inputs,
as well as comments indicating that the
direct practice expense inputs for these
procedures implied that the reporting
would be different than the reporting
implied by the code descriptors. We
note that the RUC has subsequently
reviewed CPT codes 88342 and 88343
again and we present the interim final
values for 2015 in this final rule with
comment period. Therefore, we will not
address specific comments regarding
G0461 and G0462 except, as discussed
below, as they pertain to errors
identified with regard to the pricing of
supplies.
Comment: Commenters alerted us to
an error in the calculation of the supply
price for SL483 and SL486. Commenters
pointed out that the price for SL483 is
$22.56/ml, rather than the .00256/ml
that was listed in the database, and
based on the unit of measure established
in the direct PE inputs database for
SL486, which costs $65.63 for 250 tests,
the per test quantity should be 1, rather
than 0.004.
Response: We agree with commenters
that these prices were calculated
incorrectly and have made the
adjustments to the direct PE database.
c. Finalizing CY 2014 Interim
Malpractice Crosswalks for CY 2015
In accordance with our malpractice
methodology, we adjusted the
malpractice RVUs for the CY 2014 new/
revised/potentially misvalued codes for
the difference in work RVUs (or, if
greater, the clinical labor portion of the
PE RVUs) between the source codes and
the new/revised codes to reflect the
specific risk-of-service for the new/
revised codes. The interim final
malpractice crosswalks were listed in
Table 30 of the CY 2014 PFS final rule
with comment period.
We received only one comment on
our CY 2014 interim final cross walks.
As detailed in the CY 2014 final rule
PO 00000
Frm 00104
Fmt 4701
Sfmt 4700
with comment period, we assigned
malpractice crosswalk of CPT code
31575 (Laryngoscopy, flexible
fiberoptic; diagnostic) to CPT codes
43191–43195 and CPT code 31638
(Bronchoscopy, rigid or flexible,
including fluoroscopic guidance, when
performed; with revision of tracheal or
bronchial stent inserted at previous
session (includes tracheal/bronchial
dilation as required)) to CPT code
43196.
Comment: A commenter said that the
established PLI crosswalk, CPT code
31575, for CPT code 43191–43196 is not
appropriate because the latter services
have a life-threatening risk to patients
and the same is not true for CPT code
31575. The commenter recommends
instead that we utilize the RUC
recommended crosswalk of
bronchoscopy, rigid or flexible codes
(CPT codes 31622 (Bronchoscopy, rigid
or flexible, including fluoroscopic
guidance, when performed; diagnostic,
with cell washing, when performed
(separate procedure)) for CPT code
43191, 31625 (Bronchoscopy, rigid or
flexible, including fluoroscopic
guidance, when performed; with
bronchial or endobronchial biopsy(s),
single or multiple sites) for CPT code
43192, 43193, and 43195, and 31638
(Bronchoscopy, rigid or flexible,
including fluoroscopic guidance, when
performed; with revision of tracheal or
bronchial stent inserted at previous
session (includes tracheal/bronchial
dilation as required)) for CPT codes
43194 and 43196.
Response: We continue to believe that
our assigned CY 2014 malpractice
crosswalks best define the malpractice
risk associated with CPT codes 43191–
43196. Therefore, we are finalizing our
CY 2014 interim final crosswalks.
We received no comments on the CY
2014 interim final malpractice
crosswalks and are finalizing them
without modification for CY 2015.
The malpractice RVUs for these
services are reflected in Addendum B of
this CY 2014 PFS final rule with
comment period. Since we are finalizing
a five-year review of MP RVUs in this
final rule with comment period, the MP
RVUs assigned to this codes will also be
affected by the updates due to this
review. For details on the review, see
section II.C.
d. Other New, Revised or Potentially
Misvalued Codes with CY 2014 Interim
Final RVUs Not Specifically Discussed
in the CY 2015 Final Rule With
Comment Period
For all other new, revised, or
potentially misvalued codes with CY
2014 interim final RVUs that are not
E:\FR\FM\13NOR2.SGM
13NOR2
67651
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
specifically discussed in this CY 2015
PFS final rule with comment period, we
are finalizing for CY 2015, without
modification, the CY 2014 interim final
or CY 2014 proposed work RVUs,
malpractice crosswalks, and direct PE
inputs. Unless otherwise indicated, we
agreed with the time values
recommended by the RUC or HCPAC for
all codes addressed in this section. The
time values for all codes are listed in a
file called ‘‘CY 2014 PFS Work Time,’’
available on the CMS Web site under
downloads for the CY 2015 PFS final
rule with comment period at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-Notices.html.
3. Establishing CY 2015 RVUs
a. Finalizing CY 2015 Proposed RVUs
In the CY 2015 proposed rule, we
proposed CY 2015 work values for
several codes. Table 24 contains a list of
these codes and the final CY 2015 work
RVUs. For more information on these
codes and the establishment of the
values, see section II.Bof this final rule
with comment period.
TABLE 24—CY 2015 FINAL WORK RVUS FOR CODES WITH PROPOSED WORK RVUS
HCPCS
code
Long descriptor
CY 2014
WRVU
Proposed
CY 2015
work
RVU
CY 2015
work RVU
G0389 ..
Ultrasound, B-scan and/or real time with image documentation; for abdominal aortic aneurysm (AAA) screening.
Surgical pathology, gross and microscopic examination for prostate needle biopsies, any
method;.
Face-to-face behavioral counseling for obesity, group (2–10), 30 minutes .........................
Injection(s), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed,
epidural or subarachnoid; cervical or thoracic.
Injection(s), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed,
epidural or subarachnoid; lumbar or sacral (caudal).
Injection(s), including indwelling catheter placement, continuous infusion or intermittent
bolus, of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic,
opioid, steroid, other solution), not including neurolytic substances, includes contrast
for localization when performed, epidural or subarachnoid; cervical or thoracic).
Injection(s), including indwelling catheter placement, continuous infusion or intermittent
bolus, of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic,
opioid, steroid, other solution), not including neurolytic substances, includes contrast
for localization when performed, epidural or subarachnoid; lumbar or sacral (caudal).
mammography; unilateral, .....................................................................................................
mammography; bilateral ........................................................................................................
screening mammography, bilateral (2-view film study of each breast) ................................
Chronic care management services, at least 20 minutes of clinical staff time directed by
a physician or other qualified health care professional, per calendar month, with the
following required elements: multiple (two or more) chronic conditions expected to last
at least 12 months, or until the death of the patient; chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline; comprehensive care plan established, implemented, revised, or monitored.
0.58
0.58
0.58
3.09
3.09
3.09
(1)
1.18
N/A
1.91
0.25
1.91
1.17
1.54
1.54
1.54
2.04
2.04
1.50
1.87
1.87
.70
.87
.70
New
.70
.87
.70
.61
.70
.87
.70
.61
G0416 ..
G0473 ..
62310 ...
62311 ...
62318 ...
62319 ...
77055
77056
77057
99490
...
...
...
...
1 New.
b. Establishing CY 2015 Interim Final
Work RVUs
Table 25 contains the CY 2015 interim
final work RVUs for all codes for which
we received RUC recommendations for
CY 2015 and G-codes with interim final
values for CY 2015. These values are
subject to public comment. The column
labeled ‘‘CMS Time Refinement’’
indicates whether CMS refined the time
values recommended by the RUC or
HCPAC.
This section discusses codes for
which the interim final work RVU or
time values assigned for CY 2015 vary
from those recommended by the RUC or
for which we do not have RUC
recommendations.
TABLE 25—CY 2015 INTERIM FINAL WORK RVUS FOR NEW/REVISED OR POTENTIALLY MISVALUED CODES
ebenthall on DSK5SPTVN1PROD with $$_JOB
11980 ....
Long descriptor
CY 2014
WRVU
RUC/
HCPAC
recommended
work RVU
CY 2015
work RVU
Subcutaneous hormone pellet implantation (implantation of estradiol
and/or testosterone pellets beneath the skin).
Arthrocentesis, aspiration and/or injection, small joint or bursa (eg, fingers, toes); with ultrasound guidance, with permanent recording and
reporting.
1.48
1.10
1.10
No
( 1)
0.89
0.89
No
HCPCS
Code
20604 ....
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00105
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
CMS time
refinement
67652
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 25—CY 2015 INTERIM FINAL WORK RVUS FOR NEW/REVISED OR POTENTIALLY MISVALUED CODES—Continued
20606 ....
Long descriptor
CY 2014
WRVU
RUC/
HCPAC
recommended
work RVU
CY 2015
work RVU
Arthrocentesis, aspiration and/or injection, intermediate joint or bursa
(eg, temporomandibular, acromioclavicular, wrist, elbow or ankle,
olecranon bursa); with ultrasound guidance, with permanent recording
and reporting.
Arthrocentesis, aspiration and/or injection, major joint or bursa (eg,
shoulder, hip, knee, subacromial bursa); with ultrasound guidance,
with permanent recording and reporting.
Ablation therapy for reduction or eradication of 1 or more bone tumors
(eg, metastasis) including adjacent soft tissue when involved by tumor
extension, percutaneous, including imaging guidance when performed; cryoablation.
Open treatment of rib fracture(s) with internal fixation, includes
thoracoscopic visualization when performed, unilateral; 1–3 ribs.
Open treatment of rib fracture(s) with internal fixation, includes
thoracoscopic visualization when performed, unilateral; 4–6 ribs.
Open treatment of rib fracture(s) with internal fixation, includes
thoracoscopic visualization when performed, unilateral; 7 or more ribs.
Percutaneous vertebroplasty (bone biopsy included when performed), 1
vertebral body, unilateral or bilateral injection, inclusive of all imaging
guidance; cervicothoracic.
Percutaneous vertebroplasty (bone biopsy included when performed), 1
vertebral body, unilateral or bilateral injection, inclusive of all imaging
guidance; lumbosacral.
Percutaneous vertebroplasty (bone biopsy included when performed), 1
vertebral body, unilateral or bilateral injection, inclusive of all imaging
guidance; each additional cervicothoracic or lumbosacral vertebral
body (list separately in addition to code for primary procedure).
Percutaneous vertebral augmentation, including cavity creation (fracture
reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral
cannulation, inclusive of all imaging guidance; thoracic.
Percutaneous vertebral augmentation, including cavity creation (fracture
reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral
cannulation, inclusive of all imaging guidance; lumbar.
Percutaneous vertebral augmentation, including cavity creation (fracture
reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral
cannulation, inclusive of all imaging guidance; each additional thoracic
or lumbar vertebral body (list separately in addition to code for primary procedure).
Total disc arthroplasty (artificial disc), anterior approach, including
discectomy with end plate preparation (includes osteophytectomy for
nerve root or spinal cord decompression and microdissection); single
interspace, cervical.
Total disc arthroplasty (artificial disc), anterior approach, including
discectomy with end plate preparation (includes osteophytectomy for
nerve root or spinal cord decompression and microdissection); second
level, cervical (list separately in addition to code for primary procedure).
Arthrodesis, sacroiliac joint, percutaneous or minimally invasive (indirect
visualization), with image guidance, includes obtaining bone graft
when performed, and placement of transfixing device.
Strapping; thorax ........................................................................................
Strapping; shoulder (eg, velpeau) ..............................................................
Strapping; elbow or wrist ...........................................................................
Strapping; hand or finger ...........................................................................
Strapping; hip .............................................................................................
Strapping; knee ..........................................................................................
Endobronchial ultrasound (ebus) during bronchoscopic diagnostic or
therapeutic intervention(s) (list separately in addition to code for primary procedure[s]).
Repositioning of previously implanted transvenous pacemaker or
implantable defibrillator (right atrial or right ventricular) electrode.
Insertion of a single transvenous electrode, permanent pacemaker or
implantable defibrillator.
Insertion of 2 transvenous electrodes, permanent pacemaker or
implantable defibrillator.
( 1)
1.00
1.00
No
( 1)
1.10
1.10
No
( 1)
7.13
7.13
No
( 1)
19.55
10.79
Yes
( 1)
25.00
13.00
Yes
( 1)
35.00
17.61
Yes
( 1)
8.15
8.15
No
( 1)
8.05
7.58
No
( 1)
4.00
4.00
No
(1)
8.90
8.90
No
(1)
8.24
8.24
No
( 1)
4.00
4.00
No
24.05
24.05
24.05
No
( 1)
8.40
8.40
No
( 1)
9.03
9.03
No
0.65
0.71
0.55
0.51
0.54
0.57
1.40
0.39
0.39
0.39
0.39
0.39
0.39
1.50
0.39
0.39
0.39
0.39
0.39
0.39
1.40
No
No
No
No
No
No
No
4.92
4.92
4.92
No
5.87
5.87
5.87
No
5.84
5.84
5.84
No
HCPCS
Code
20611 ....
20983 ....
21811 ....
21812 ....
21813 ....
22510 ....
22511 ....
22512 ....
22513 ....
22514 ....
22515 ....
22856 ....
22858 ....
27279 ....
ebenthall on DSK5SPTVN1PROD with $$_JOB
29200
29240
29260
29280
29520
29530
31620
....
....
....
....
....
....
....
33215 ....
33216 ....
33217 ....
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00106
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
CMS time
refinement
67653
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 25—CY 2015 INTERIM FINAL WORK RVUS FOR NEW/REVISED OR POTENTIALLY MISVALUED CODES—Continued
33218 ....
Long descriptor
CY 2014
WRVU
RUC/
HCPAC
recommended
work RVU
CY 2015
work RVU
Repair of single transvenous electrode, permanent pacemaker or
implantable defibrillator.
Repair of 2 transvenous electrodes for permanent pacemaker or
implantable defibrillator.
Relocation of skin pocket for implantable defibrillator ...............................
Insertion of pacing electrode, cardiac venous system, for left ventricular
pacing, with attachment to previously placed pacemaker or
implantable defibrillator pulse generator (including revision of pocket,
removal, insertion, and/or replacement of existing generator).
Insertion of pacing electrode, cardiac venous system, for left ventricular
pacing, at time of insertion of implantable defibrillator or pacemaker
pulse generator (eg, for upgrade to dual chamber system) (list separately in addition to code for primary procedure).
Insertion of implantable defibrillator pulse generator only; with existing
single lead.
Removal of implantable defibrillator pulse generator only ........................
Removal of single or dual chamber implantable defibrillator electrode(s);
by thoracotomy.
Removal of single or dual chamber implantable defibrillator electrode(s);
by transvenous extraction.
Insertion or replacement of permanent implantable defibrillator system,
with transvenous lead(s), single or dual chamber.
Removal of implantable defibrillator pulse generator with replacement of
implantable defibrillator pulse generator; single lead system.
Removal of implantable defibrillator pulse generator with replacement of
implantable defibrillator pulse generator; dual lead system.
Insertion or replacement of permanent subcutaneous implantable
defibrillator system, with subcutaneous electrode, including
defibrillation threshold evaluation, induction of arrhythmia, evaluation
of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters, when performed.
Insertion of subcutaneous implantable defibrillator electrode ...................
Removal of subcutaneous implantable defibrillator electrode ...................
Repositioning of previously implanted subcutaneous implantable
defibrillator electrode.
Transcatheter mitral valve repair, percutaneous approach, including
transseptal puncture when performed; initial prosthesis.
Transcatheter mitral valve repair, percutaneous approach, including
transseptal puncture when performed; additional prosthesis(es) during
same session (list separately in addition to code for primary procedure).
Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; initiation, veno-venous.
Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; initiation, veno-arterial.
Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; daily management, each day, venoarterial.
Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; insertion of peripheral (arterial and/
or venous) cannula(e), percutaneous, birth through 5 years of age (includes fluoroscopic guidance, when performed).
Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; insertion of peripheral (arterial and/
or venous) cannula(e), percutaneous, 6 years and older (includes
fluoroscopic guidance, when performed).
Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; insertion of peripheral (arterial and/
or venous) cannula(e), open, birth through 5 years of age.
Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; insertion of peripheral (arterial and/
or venous) cannula(e), open, 6 years and older.
Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; insertion of central cannula(e) by
sternotomy or thoracotomy, birth through 5 years of age.
Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; insertion of central cannula(e) by
sternotomy or thoracotomy, 6 years and older.
6.07
6.07
6.07
No
6.15
6.15
6.15
No
6.55
9.04
6.55
9.04
6.55
9.04
No
No
8.33
8.33
8.33
No
6.05
6.05
6.05
No
3.29
23.57
3.29
23.57
3.29
23.57
No
No
13.99
13.99
13.99
No
15.17
15.17
15.17
No
6.06
6.06
6.06
No
6.33
6.33
6.33
No
( 1)
9.10
9.10
No
(1)
(1)
( 1)
7.50
5.42
6.50
7.50
5.42
6.50
No
No
No
( 1)
32.25
32.25
No
( 1)
7.93
7.93
No
(1)
6.00
6.00
No
( 1)
6.63
6.63
No
( 1)
4.60
4.60
No
( 1)
8.15
8.15
No
( 1)
8.43
8.15
No
( 1)
9.83
9.11
No
(1)
9.43
9.11
No
(1)
16.00
16.00
No
( 1)
16.00
16.00
No
HCPCS
Code
33220 ....
33223 ....
33224 ....
33225 ....
33240 ....
33241 ....
33243 ....
33244 ....
33249 ....
33262 ....
33263 ....
33270 ....
33271 ....
33272 ....
33273 ....
33418 ....
33419 ....
33946 ....
33947 ....
33949 ....
33951 ....
33952 ....
33953 ....
ebenthall on DSK5SPTVN1PROD with $$_JOB
33954 ....
33955 ....
33956 ....
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00107
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
CMS time
refinement
67654
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 25—CY 2015 INTERIM FINAL WORK RVUS FOR NEW/REVISED OR POTENTIALLY MISVALUED CODES—Continued
33957 ....
Long descriptor
CY 2014
WRVU
RUC/
HCPAC
recommended
work RVU
CY 2015
work RVU
Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; reposition peripheral (arterial and/or
venous) cannula(e), percutaneous, birth through 5 years of age (includes fluoroscopic guidance, when performed).
Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; reposition peripheral (arterial and/or
venous) cannula(e), percutaneous, 6 years and older (includes
fluoroscopic guidance, when performed).
Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; reposition peripheral (arterial and/or
venous) cannula(e), open, birth through 5 years of age (includes
fluoroscopic guidance, when performed).
Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; reposition peripheral (arterial and/or
venous) cannula(e), open, 6 years and older (includes fluoroscopic
guidance, when performed).
Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; reposition of central cannula(e) by
sternotomy or thoracotomy, birth through 5 years of age (includes
fluoroscopic guidance, when performed).
Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; reposition central cannula(e) by
sternotomy or thoracotomy, 6 years and older (includes fluoroscopic
guidance, when performed).
Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; removal of peripheral (arterial and/or
venous) cannula(e), percutaneous, birth through 5 years of age.
Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; removal of peripheral (arterial and/or
venous) cannula(e), percutaneous, 6 years and older.
Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; removal of peripheral (arterial and/or
venous) cannula(e), open, birth through 5 years of age.
Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; removal of peripheral (arterial and/or
venous) cannula(e), open, 6 years and older.
Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; removal of central cannula(e) by
sternotomy or thoracotomy, birth through 5 years of age.
Extracorporeal membrane oxygenation (ecmo)/extracorporeal life support (ecls) provided by physician; removal of central cannula(e) by
sternotomy or thoracotomy, 6 years and older.
Arterial exposure with creation of graft conduit (eg, chimney graft) to facilitate arterial perfusion for ecmo/ecls (list separately in addition to
code for primary procedure).
Insertion of left heart vent by thoracic incision (eg, sternotomy,
thoracotomy) for ecmo/ecls.
Removal of left heart vent by thoracic incision (eg, sternotomy,
thoracotomy) for ecmo/ecls.
Physician planning of a patient-specific fenestrated visceral aortic
endograft requiring a minimum of 90 minutes of physician time.
Endovascular repair of visceral aorta (eg, aneurysm, pseudoaneurysm,
dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) by deployment of a fenestrated visceral aortic endograft and
all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including one visceral artery
endoprosthesis (superior mesenteric, celiac or renal artery).
Endovascular repair of visceral aorta (eg, aneurysm, pseudoaneurysm,
dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) by deployment of a fenestrated visceral aortic endograft and
all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including two visceral artery
endoprostheses (superior mesenteric, celiac and/or renal artery[s]).
( 1)
4.00
3.51
No
( 1)
4.05
3.51
No
( 1)
4.69
4.47
No
( 1)
4.73
4.47
No
(1)
9.00
9.00
No
( 1)
9.50
9.50
No
(1)
3.51
3.51
No
( 1)
4.50
4.50
No
(1)
6.00
5.22
No
( 1)
6.38
5.46
No
( 1)
9.89
9.89
No
( 1)
10.00
10.00
No
( 1)
4.04
4.04
No
( 1)
15.00
15.00
No
( 1)
9.50
9.50
No
(1)
C
B
N/A
C
C
C
N/A
C
C
C
N/A
HCPCS
Code
33958 ....
33959 ....
33962 ....
33963 ....
33964 ....
33965 ....
33966 ....
33969 ....
33984 ....
33985 ....
33986 ....
33987 ....
33988 ....
33989 ....
34839 ....
34841 ....
ebenthall on DSK5SPTVN1PROD with $$_JOB
34842 ....
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00108
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
CMS time
refinement
67655
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 25—CY 2015 INTERIM FINAL WORK RVUS FOR NEW/REVISED OR POTENTIALLY MISVALUED CODES—Continued
34843 ....
Long descriptor
CY 2014
WRVU
RUC/
HCPAC
recommended
work RVU
CY 2015
work RVU
Endovascular repair of visceral aorta (eg, aneurysm, pseudoaneurysm,
dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) by deployment of a fenestrated visceral aortic endograft and
all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including three visceral artery
endoprostheses (superior mesenteric, celiac and/or renal artery[s]).
Endovascular repair of visceral aorta (eg, aneurysm, pseudoaneurysm,
dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) by deployment of a fenestrated visceral aortic endograft and
all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including four or more visceral
artery endoprostheses (superior mesenteric, celiac and/or renal
artery[s]).
Endovascular repair of visceral aorta and infrarenal abdominal aorta (eg,
aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural
hematoma, or traumatic disruption) with a fenestrated visceral aortic
endograft and concomitant unibody or modular infrarenal aortic
endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including one
visceral artery endoprosthesis (superior mesenteric, celiac or renal artery).
Endovascular repair of visceral aorta and infrarenal abdominal aorta (eg,
aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural
hematoma, or traumatic disruption) with a fenestrated visceral aortic
endograft and concomitant unibody or modular infrarenal aortic
endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including two
visceral artery endoprostheses (superior mesenteric, celiac and/or
renal artery[s]).
Endovascular repair of visceral aorta and infrarenal abdominal aorta (eg,
aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural
hematoma, or traumatic disruption) with a fenestrated visceral aortic
endograft and concomitant unibody or modular infrarenal aortic
endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including
three visceral artery endoprostheses (superior mesenteric, celiac and/
or renal artery[s]).
Endovascular repair of visceral aorta and infrarenal abdominal aorta (eg,
aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural
hematoma, or traumatic disruption) with a fenestrated visceral aortic
endograft and concomitant unibody or modular infrarenal aortic
endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including four
or more visceral artery endoprostheses (superior mesenteric, celiac
and/or renal artery[s]).
Endovenous ablation therapy of incompetent vein, extremity, inclusive of
all imaging guidance and monitoring, percutaneous, radiofrequency;
first vein treated.
Endovenous ablation therapy of incompetent vein, extremity, inclusive of
all imaging guidance and monitoring, percutaneous, radiofrequency;
second and subsequent veins treated in a single extremity, each
through separate access sites (list separately in addition to code for
primary procedure).
Endovenous ablation therapy of incompetent vein, extremity, inclusive of
all imaging guidance and monitoring, percutaneous, laser; first vein
treated.
Endovenous ablation therapy of incompetent vein, extremity, inclusive of
all imaging guidance and monitoring, percutaneous, laser; second and
subsequent veins treated in a single extremity, each through separate
access sites (list separately in addition to code for primary procedure).
Arteriovenous anastomosis, open; by upper arm cephalic vein transposition.
Arteriovenous anastomosis, open; by upper arm basilic vein transposition.
Arteriovenous anastomosis, open; by forearm vein transposition .............
Arteriovenous anastomosis, open; direct, any site (eg, cimino type) (separate procedure).
C
C
C
N/A
C
C
C
N/A
C
C
C
N/A
C
C
C
N/A
C
C
C
N/A
C
C
C
N/A
6.72
5.30
5.30
No
3.38
2.65
2.65
No
6.72
5.30
5.30
No
3.38
2.65
2.65
No
11.89
13.00
12.39
No
13.29
15.00
13.29
No
14.47
12.11
13.99
11.90
13.07
11.90
No
No
HCPCS
Code
34844 ....
34845 ....
34846 ....
34847 ....
34848 ....
36475 ....
36476 ....
36478 ....
ebenthall on DSK5SPTVN1PROD with $$_JOB
36479 ....
36818 ....
36819 ....
36820 ....
36821 ....
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00109
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
CMS time
refinement
67656
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 25—CY 2015 INTERIM FINAL WORK RVUS FOR NEW/REVISED OR POTENTIALLY MISVALUED CODES—Continued
36825 ....
Long descriptor
CY 2014
WRVU
RUC/
HCPAC
recommended
work RVU
CY 2015
work RVU
Creation of arteriovenous fistula by other than direct arteriovenous anastomosis (separate procedure); autogenous graft.
Creation of arteriovenous fistula by other than direct arteriovenous anastomosis (separate procedure); nonautogenous graft (eg, biological collagen, thermoplastic graft).
Thrombectomy, open, arteriovenous fistula without revision, autogenous
or nonautogenous dialysis graft (separate procedure).
Revision, open, arteriovenous fistula; without thrombectomy, autogenous
or nonautogenous dialysis graft (separate procedure).
Revision, open, arteriovenous fistula; with thrombectomy, autogenous or
nonautogenous dialysis graft (separate procedure).
Transcatheter placement of intravascular stent(s), intrathoracic common
carotid artery or innominate artery, open or percutaneous antegrade
approach, including angioplasty, when performed, and radiological supervision and interpretation.
Esophagoscopy, rigid, transoral with diverticulectomy of hypopharynx or
cervical esophagus (eg, zenker’s diverticulum), with cricopharyngeal
myotomy, includes use of telescope or operating microscope and repair, when performed.
Ileoscopy, through stoma; with transendoscopic balloon dilation .............
Ileoscopy, through stoma; with placement of endoscopic stent (includes
pre- and post-dilation and guide wire passage, when performed).
Colonoscopy through stoma; with ablation of tumor(s), polyp(s), or other
lesion(s) (includes pre- and post-dilation and guide wire passage,
when performed).
Colonoscopy through stoma; with endoscopic stent placement (including
pre- and post-dilation and guide wire passage, when performed).
Colonoscopy through stoma; with endoscopic mucosal resection ............
Colonoscopy through stoma; with directed submucosal injection(s), any
substance.
Colonoscopy through stoma; with transendoscopic balloon dilation .........
Colonoscopy through stoma; with endoscopic ultrasound examination,
limited to the sigmoid, descending, transverse, or ascending colon
and cecum and adjacent structures.
Colonoscopy through stoma; with transendoscopic ultrasound guided intramural or transmural fine needle aspiration/biopsy(s), includes
endoscopic ultrasound examination limited to the sigmoid, descending, transverse, or ascending colon and cecum and adjacent structures.
Colonoscopy through stoma; with decompression (for pathologic distention) (eg, volvulus, megacolon), including placement of decompression
tube, when performed.
Sigmoidoscopy, flexible; with ablation of tumor(s), polyp(s), or other lesion(s) (includes pre- and post-dilation and guide wire passage, when
performed).
Sigmoidoscopy, flexible; with placement of endoscopic stent (includes
pre- and post-dilation and guide wire passage, when performed).
Sigmoidoscopy, flexible; with endoscopic mucosal resection ...................
Sigmoidoscopy, flexible; with band ligation(s) (eg, hemorrhoids) .............
Colonoscopy, flexible; with ablation of tumor(s), polyp(s), or other lesion(s) (includes pre- and post-dilation and guide wire passage, when
performed).
Colonoscopy, flexible; with endoscopic stent placement (includes preand post-dilation and guide wire passage, when performed).
Colonoscopy, flexible; with endoscopic mucosal resection .......................
Colonoscopy, flexible; with decompression (for pathologic distention)
(eg, volvulus, megacolon), including placement of decompression
tube, when performed.
Colonoscopy, flexible; with band ligation(s) (eg, hemorrhoids) .................
Unlisted procedure, colon ..........................................................................
Anoscopy; diagnostic, with high-resolution magnification (hra) (eg, colposcope, operating microscope) and chemical agent enhancement, including collection of specimen(s) by brushing or washing, when performed.
Anoscopy; with high-resolution magnification (hra) (eg, colposcope, operating microscope) and chemical agent enhancement, with biopsy,
single or multiple.
Ablation, 1 or more liver tumor(s), percutaneous, cryoablation ................
14.17
15.93
14.17
No
12.03
11.90
12.03
No
8.04
11.00
11.00
Yes
10.53
13.50
13.50
Yes
11.98
14.50
14.50
Yes
( 1)
15.00
15.00
No
( 1)
9.03
9.03
No
(1)
( 1)
1.48
3.11
I
I
N/A
N/A
( 1)
4.44
I
N/A
( 1)
4.96
I
N/A
(1)
( 1)
5.81
3.13
I
I
N/A
N/A
(1)
( 1)
3.33
4.41
I
I
N/A
N/A
( 1)
5.06
I
N/A
(1)
4.24
I
N/A
( 1)
2.97
I
N/A
(1)
2.98
I
N/A
( 1)
( 1)
( 1)
3.83
1.78
4.98
I
I
I
N/A
N/A
N/A
( 1)
5.50
I
N/A
(1)
( 1)
6.35
4.78
I
I
N/A
N/A
(1)
( 1)
( 1)
4.30
None
1.60
....................
I
I
N/A
N/A
N/A
( 1)
2.20
I
N/A
( 1)
9.13
9.13
No
HCPCS
Code
36830 ....
36831 ....
36832 ....
36833 ....
37218 ....
43180 ....
44381 ....
44384 ....
44401 ....
44402 ....
44403 ....
44404 ....
44405 ....
44406 ....
44407 ....
44408 ....
45346 ....
45347 ....
45349 ....
45350 ....
45388 ....
45389 ....
ebenthall on DSK5SPTVN1PROD with $$_JOB
45390 ....
45393 ....
45398 ....
45399 ....
46601 ....
46607 ....
47383 ....
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00110
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
CMS time
refinement
67657
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 25—CY 2015 INTERIM FINAL WORK RVUS FOR NEW/REVISED OR POTENTIALLY MISVALUED CODES—Continued
52441 ....
Long descriptor
CY 2014
WRVU
RUC/
HCPAC
recommended
work RVU
CY 2015
work RVU
Cystourethroscopy, with insertion of permanent adjustable transprostatic
implant; single implant.
Cystourethroscopy, with insertion of permanent adjustable transprostatic
implant; each additional permanent adjustable transprostatic implant
(list separately in addition to code for primary procedure).
Prostatectomy, retropubic radical, with or without nerve sparing; .............
Prostatectomy, retropubic radical, with or without nerve sparing; with
lymph node biopsy(s) (limited pelvic lymphadenectomy).
Prostatectomy, retropubic radical, with or without nerve sparing; with bilateral pelvic lymphadenectomy, including external iliac, hypogastric,
and obturator nodes.
Laparoscopy, surgical, supracervical hysterectomy, for uterus 250 g or
less;.
Laparoscopy, surgical, supracervical hysterectomy, for uterus 250 g or
less; with removal of tube(s) and/or ovary(s).
Laparoscopy, surgical, supracervical hysterectomy, for uterus greater
than 250 g;.
Laparoscopy, surgical, supracervical hysterectomy, for uterus greater
than 250 g; with removal of tube(s) and/or ovary(s).
Laparoscopy, surgical, with total hysterectomy, for uterus 250 g or less;
Laparoscopy, surgical, with total hysterectomy, for uterus 250 g or less;
with removal of tube(s) and/or ovary(s).
Laparoscopy, surgical, with total hysterectomy, for uterus greater than
250 g;.
Laparoscopy, surgical, with total hysterectomy, for uterus greater than
250 g; with removal of tube(s) and/or ovary(s).
Injection procedure for myelography and/or computed tomography, lumbar (other than c1–c2 and posterior fossa).
Myelography via lumbar injection, including radiological supervision and
interpretation; cervical.
Myelography via lumbar injection, including radiological supervision and
interpretation; thoracic.
Myelography via lumbar injection, including radiological supervision and
interpretation; lumbosacral.
Myelography via lumbar injection, including radiological supervision and
interpretation; 2 or more regions (eg, lumbar/thoracic, cervical/thoracic, lumbar/cervical, lumbar/thoracic/cervical).
Transversus abdominis plane (tap) block (abdominal plane block, rectus
sheath block) unilateral; by injection(s) (includes imaging guidance,
when performed).
Transversus abdominis plane (tap) block (abdominal plane block, rectus
sheath block) unilateral; by continuous infusion(s) (includes imaging
guidance, when performed).
Transversus abdominis plane (tap) block (abdominal plane block, rectus
sheath block) bilateral; by injections (includes imaging guidance, when
performed).
Transversus abdominis plane (tap) block (abdominal plane block, rectus
sheath block) bilateral; by continuous infusions (includes imaging
guidance, when performed).
Percutaneous implantation of neurostimulator electrode array; sacral
nerve (transforaminal placement) including image guidance, if performed.
Aqueous shunt to extraocular equatorial plate reservoir, external approach; without graft.
Aqueous shunt to extraocular equatorial plate reservoir, external approach; with graft.
Revision of aqueous shunt to extraocular equatorial plate reservoir; without graft.
Revision of aqueous shunt to extraocular equatorial plate reservoir; with
graft.
Vitrectomy, mechanical, pars plana approach; ..........................................
Vitrectomy, mechanical, pars plana approach; with focal endolaser
photocoagulation.
Vitrectomy, mechanical, pars plana approach; with endolaser panretinal
photocoagulation.
Vitrectomy, mechanical, pars plana approach; with removal of preretinal
cellular membrane (eg, macular pucker).
( 1)
4.50
4.50
No
( 1)
1.20
1.20
No
24.63
26.49
21.36
24.16
21.36
21.36
No
No
30.67
29.07
25.18
No
14.70
12.29
12.29
No
16.56
14.16
14.16
No
16.87
14.39
14.39
No
18.37
15.60
15.60
No
15.88
17.69
13.36
15.00
13.36
15.00
No
No
20.09
17.71
17.71
No
23.11
20.79
20.79
No
1.54
1.54
1.54
No
(1)
2.29
2.29
No
( 1)
2.29
2.29
No
( 1)
2.25
2.25
No
( 1)
2.35
2.35
No
( 1)
1.27
1.27
No
( 1)
1.48
1.48
No
( 1)
1.60
1.60
No
(1)
1.80
1.80
No
7.15
5.44
5.44
No
( 1)
14.00
14.00
No
16.30
15.00
15.00
No
( 1)
9.58
9.58
No
9.58
10.58
10.58
No
13.32
16.74
12.13
13.20
12.13
13.20
No
No
19.61
14.50
14.50
No
19.25
16.33
16.33
No
HCPCS
Code
52442 ....
55840 ....
55842 ....
55845 ....
58541 ....
58542 ....
58543 ....
58544 ....
58570 ....
58571 ....
58572 ....
58573 ....
62284 ....
62302 ....
62303 ....
62304 ....
62305 ....
64486 ....
64487 ....
64488 ....
64489 ....
64561 ....
66179 ....
66180 ....
66184 ....
ebenthall on DSK5SPTVN1PROD with $$_JOB
66185 ....
67036 ....
67039 ....
67040 ....
67041 ....
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00111
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
CMS time
refinement
67658
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 25—CY 2015 INTERIM FINAL WORK RVUS FOR NEW/REVISED OR POTENTIALLY MISVALUED CODES—Continued
67042 ....
Long descriptor
CY 2014
WRVU
RUC/
HCPAC
recommended
work RVU
CY 2015
work RVU
Vitrectomy, mechanical, pars plana approach; with removal of internal
limiting membrane of retina (eg, for repair of macular hole, diabetic
macular edema), includes, if performed, intraocular tamponade (ie,
air, gas or silicone oil).
Vitrectomy, mechanical, pars plana approach; with removal of subretinal
membrane (eg, choroidal neovascularization), includes, if performed,
intraocular tamponade (ie, air, gas or silicone oil) and laser
photocoagulation.
Scleral reinforcement (separate procedure); with graft .............................
Computed tomography, maxillofacial area; without contrast material .......
Computed tomography, maxillofacial area; with contrast material(s) ........
Computed tomography, maxillofacial area; without contrast material, followed by contrast material(s) and further sections.
Computed tomographic angiography, head, with contrast material(s), including noncontrast images, if performed, and image postprocessing.
Computed tomographic angiography, neck, with contrast material(s), including noncontrast images, if performed, and image postprocessing.
Computed tomographic angiography, chest (noncoronary), with contrast
material(s), including noncontrast images, if performed, and image
postprocessing.
Computed tomographic angiography, pelvis, with contrast material(s), including noncontrast images, if performed, and image postprocessing.
Myelography, cervical, radiological supervision and interpretation ...........
Myelography, thoracic, radiological supervision and interpretation ...........
Myelography, lumbosacral, radiological supervision and interpretation ....
Myelography, 2 or more regions (eg, lumbar/thoracic, cervical/thoracic,
lumbar/cervical, lumbar/thoracic/cervical), radiological supervision and
interpretation.
Computed tomographic angiography, abdomen and pelvis, with contrast
material(s), including noncontrast images, if performed, and image
postprocessing.
Computed tomographic angiography, abdomen, with contrast material(s), including noncontrast images, if performed, and image
postprocessing.
Swallowing function, with cineradiography/videoradiography ....................
Ultrasound, breast, unilateral, real time with image documentation, including axilla when performed; complete.
Ultrasound, breast, unilateral, real time with image documentation, including axilla when performed; limited.
Ultrasound, abdominal, real time with image documentation; complete ...
Ultrasound, abdominal, real time with image documentation; limited (eg,
single organ, quadrant, follow-up).
Ultrasound, retroperitoneal (eg, renal, aorta, nodes), real time with
image documentation; complete.
Ultrasound, retroperitoneal (eg, renal, aorta, nodes), real time with
image documentation; limited.
Ultrasound, pelvic (nonobstetric), real time with image documentation;
complete.
Ultrasound, pelvic (nonobstetric), real time with image documentation;
limited or follow-up (eg, for follicles).
Ultrasonic guidance for pericardiocentesis, imaging supervision and interpretation.
Ultrasonic guidance for endomyocardial biopsy, imaging supervision and
interpretation.
Ultrasonic guidance for needle placement (eg, biopsy, aspiration, injection, localization device), imaging supervision and interpretation.
Ultrasonic guidance for aspiration of ova, imaging supervision and interpretation.
Digital breast tomosynthesis; unilateral .....................................................
Digital breast tomosynthesis; bilateral .......................................................
Screening digital breast tomosynthesis, bilateral (list separately in addition to code for primary procedure).
Dual-energy x-ray absorptiometry (dxa), bone density study, 1 or more
sites; axial skeleton (eg, hips, pelvis, spine).
Dual-energy x-ray absorptiometry (dxa), bone density study, 1 or more
sites; axial skeleton (eg, hips, pelvis, spine), including vertebral fracture assessment.
22.38
16.33
16.33
No
23.24
17.40
17.40
No
10.17
1.14
1.30
1.42
10.17
0.85
1.17
1.30
8.38
0.85
1.13
1.27
No
No
No
No
1.75
1.75
1.75
No
1.75
1.75
1.75
No
1.92
1.82
1.82
No
1.81
1.81
1.81
No
0.91
0.91
0.83
1.33
0.91
0.91
0.83
1.33
0.91
0.91
0.83
1.33
No
No
No
No
2.20
2.20
2.20
No
1.90
1.82
1.82
No
0.53
(1)
0.53
0.73
0.53
0.73
No
No
( 1)
0.68
0.68
No
0.81
0.59
0.81
0.59
0.81
0.59
No
No
0.74
0.74
0.74
No
0.58
0.58
0.58
No
0.69
0.69
0.69
No
0.38
0.50
0.50
No
0.67
0.67
0.67
No
C
0.85
0.85
No
0.67
0.67
0.67
No
0.38
0.92
0.92
No
(1 )
( 1)
( 1)
0.70
0.90
0.60
I
I
0.60
N/A
N/A
No
0.20
0.20
0.20
No
( 1)
0.30
0.30
No
HCPCS
Code
67043 ....
67255
70486
70487
70488
....
....
....
....
70496 ....
70498 ....
71275 ....
72191 ....
72240
72255
72265
72270
....
....
....
....
74174 ....
74175 ....
74230 ....
76641 ....
76642 ....
76700 ....
76705 ....
76770 ....
76775 ....
76856 ....
76857 ....
76930 ....
76932 ....
76942 ....
ebenthall on DSK5SPTVN1PROD with $$_JOB
76948 ....
77061 ....
77062 ....
77063 ....
77080 ....
77085 ....
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00112
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
CMS time
refinement
67659
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 25—CY 2015 INTERIM FINAL WORK RVUS FOR NEW/REVISED OR POTENTIALLY MISVALUED CODES—Continued
77086 ....
Long descriptor
CY 2014
WRVU
RUC/
HCPAC
recommended
work RVU
CY 2015
work RVU
Vertebral fracture assessment via dual-energy x-ray absorptiometry
(dxa).
Basic radiation dosimetry calculation, central axis depth dose calculation, tdf, nsd, gap calculation, off axis factor, tissue inhomogeneity
factors, calculation of non-ionizing radiation surface and depth dose,
as required during course of treatment, only when prescribed by the
treating physician.
Teletherapy isodose plan; simple (1 or 2 unmodified ports directed to a
single area of interest), includes basic dosimetry calculation(s).
Teletherapy isodose plan; complex (multiple treatment areas, tangential
ports, the use of wedges, blocking, rotational beam, or special beam
considerations), includes basic dosimetry calculation(s).
Brachytherapy isodose plan; simple (calculation[s] made from 1 to 4
sources, or remote afterloading brachytherapy, 1 channel), includes
basic dosimetry calculation(s).
Brachytherapy isodose plan; intermediate (calculation[s] made from 5 to
10 sources, or remote afterloading brachytherapy, 2–12 channels), includes basic dosimetry calculation(s).
Brachytherapy isodose plan; complex (calculation[s] made from over 10
sources, or remote afterloading brachytherapy, over 12 channels), includes basic dosimetry calculation(s).
Intensity modulated radiation treatment delivery (imrt), includes guidance
and tracking, when performed; simple.
Intensity modulated radiation treatment delivery (imrt), includes guidance
and tracking, when performed; complex.
Guidance for localization of target volume for delivery of radiation treatment delivery, includes intrafraction tracking, when performed.
Radiation treatment delivery, >1 mev; simple ...........................................
Radiation treatment delivery, >1 mev; intermediate ..................................
Radiation treatment delivery, >1 mev; complex ........................................
Immunohistochemistry or immunocytochemistry, per specimen; each additional single antibody stain procedure (list separately in addition to
code for primary procedure).
Immunohistochemistry or immunocytochemistry, per specimen; initial
single antibody stain procedure.
Immunohistochemistry or immunocytochemistry, per specimen; each
multiplex antibody stain procedure.
Morphometric analysis; nerve ....................................................................
In situ hybridization (eg, fish), per specimen; each additional single
probe stain procedure (list separately in addition to code for primary
procedure).
In situ hybridization (eg, fish), per specimen; initial single probe stain
procedure.
In situ hybridization (eg, fish), per specimen; each multiplex probe stain
procedure.
Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), using computer-assisted technology, per specimen; initial single probe stain procedure.
Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), manual, per specimen; initial single probe stain procedure.
Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), manual, per specimen; each additional single probe stain procedure (list separately in addition to code for primary procedure).
Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), using computer-assisted technology, per specimen; each additional single probe stain procedure (list separately in addition to
code for primary procedure).
Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), using computer-assisted technology, per specimen; each
multiplex probe stain procedure.
Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), manual, per specimen; each multiplex probe stain procedure.
Microdissection (ie, sample preparation of microscopically identified target); laser capture.
Microdissection (ie, sample preparation of microscopically identified target); manual.
Liver elastography, mechanically induced shear wave (eg, vibration),
without imaging, with interpretation and report.
( 1)
0.17
0.17
No
0.62
0.62
0.62
No
( 1)
1.40
1.40
No
( 1)
2.90
2.90
No
( 1)
1.50
1.40
No
( 1)
1.83
1.83
No
( 1)
2.90
2.90
No
(1)
....................
I
N/A
( 1)
....................
I
N/A
(1)
0.58
I
N/A
0.00
0.00
0.00
( 1)
....................
....................
....................
0.65
I
I
I
0.42
N/A
N/A
N/A
No
I
0.70
0.70
No
( 1)
0.77
0.77
No
3.02
( 1)
2.80
0.88
2.80
0.53
No
No
1.20
0.88
0.88
No
(1)
1.24
1.24
No
1.30
0.86
0.73
No
1.40
0.88
0.88
No
( 1)
0.88
0.53
No
( 1)
0.86
0.43
No
( 1)
1.04
0.93
No
( 1)
1.40
1.40
No
1.56
1.14
1.14
No
1.18
0.53
0.53
No
( 1)
0.30
0.30
No
HCPCS
Code
77300 ....
77306 ....
77307 ....
77316 ....
77317 ....
77318 ....
77385 ....
77386 ....
77387 ....
77402
77407
77412
88341
....
....
....
....
88342 ....
88344 ....
88356 ....
88364 ....
88365 ....
88366 ....
88367 ....
88368 ....
88369 ....
88373 ....
ebenthall on DSK5SPTVN1PROD with $$_JOB
88374 ....
88377 ....
88380 ....
88381 ....
91200 ....
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00113
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
CMS time
refinement
67660
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 25—CY 2015 INTERIM FINAL WORK RVUS FOR NEW/REVISED OR POTENTIALLY MISVALUED CODES—Continued
92145 ....
Long descriptor
CY 2014
WRVU
RUC/
HCPAC
recommended
work RVU
CY 2015
work RVU
Corneal hysteresis determination, by air impulse stimulation, unilateral
or bilateral, with interpretation and report.
Basic vestibular evaluation, includes spontaneous nystagmus test with
eccentric gaze fixation nystagmus, with recording, positional nystagmus test, minimum of 4 positions, with recording, optokinetic nystagmus test, bidirectional foveal and peripheral stimulation, with recording, and oscillating tracking test, with recording.
Spontaneous nystagmus test, including gaze and fixation nystagmus,
with recording.
Positional nystagmus test, minimum of 4 positions, with recording ..........
Caloric vestibular test, each irrigation (binaural, bithermal stimulation
constitutes 4 tests), with recording.
Optokinetic nystagmus test, bidirectional, foveal or peripheral stimulation, with recording.
Oscillating tracking test, with recording .....................................................
Programming device evaluation (in person) with iterative adjustment of
the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report
by a physician or other qualified health care professional; implantable
subcutaneous lead defibrillator system.
Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter;
implantable subcutaneous lead defibrillator system.
Programming device evaluation (in person) with iterative adjustment of
the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report
by a physician or other qualified health care professional; single lead
transvenous implantable defibrillator system.
Programming device evaluation (in person) with iterative adjustment of
the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report
by a physician or other qualified health care professional; dual lead
transvenous implantable defibrillator system.
Programming device evaluation (in person) with iterative adjustment of
the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report
by a physician or other qualified health care professional; multiple
lead transvenous implantable defibrillator system.
Peri-procedural device evaluation (in person) and programming of device system parameters before or after a surgery, procedure, or test
with analysis, review and report by a physician or other qualified
health care professional; single, dual, or multiple lead implantable
defibrillator system.
Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter;
single, dual, or multiple lead transvenous implantable defibrillator system, including analysis of heart rhythm derived data elements.
Echocardiography, transesophageal, real-time with image documentation (2d) (with or without m-mode recording); including probe placement, image acquisition, interpretation and report.
Echocardiography, transesophageal, real-time with image documentation (2d) (with or without m-mode recording); placement of
transesophageal probe only.
Echocardiography, transesophageal, real-time with image documentation (2d) (with or without m-mode recording); image acquisition, interpretation and report only.
Transesophageal echocardiography for congenital cardiac anomalies; including probe placement, image acquisition, interpretation and report.
Transesophageal echocardiography for congenital cardiac anomalies;
placement of transesophageal probe only.
Transesophageal echocardiography for congenital cardiac anomalies;
image acquisition, interpretation and report only.
(1)
0.17
0.17
No
1.50
1.50
1.50
No
0.40
0.40
0.40
No
0.33
0.10
0.48
0.35
0.48
0.10
No
No
0.26
0.27
0.27
No
0.23
(1)
0.27
0.85
0.27
0.85
No
No
( 1)
0.74
0.74
No
0.85
0.85
0.85
No
1.15
1.15
1.15
No
1.25
1.25
1.25
No
0.45
0.45
0.45
No
0.92
0.92
0.92
No
2.20
3.18
2.55
No
0.95
1.00
0.51
No
1.25
2.80
2.10
Yes
C
3.29
2.94
No
0.95
1.50
0.85
No
C
3.00
2.09
Yes
HCPCS
Code
92540 ....
92541 ....
92542 ....
92543 ....
92544 ....
92545 ....
93260 ....
93261 ....
93282 ....
93283 ....
93284 ....
93287 ....
93289 ....
93312 ....
93313 ....
ebenthall on DSK5SPTVN1PROD with $$_JOB
93314 ....
93315 ....
93316 ....
93317 ....
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00114
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
CMS time
refinement
67661
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 25—CY 2015 INTERIM FINAL WORK RVUS FOR NEW/REVISED OR POTENTIALLY MISVALUED CODES—Continued
93318 ....
Long descriptor
CY 2014
WRVU
RUC/
HCPAC
recommended
work RVU
CY 2015
work RVU
Echocardiography, transesophageal (tee) for monitoring purposes, including probe placement, real time 2-dimensional image acquisition
and interpretation leading to ongoing (continuous) assessment of (dynamically changing) cardiac pumping function and to therapeutic
measures on an immediate time basis.
Doppler echocardiography, pulsed wave and/or continuous wave with
spectral display (list separately in addition to codes for echocardiographic imaging); complete.
Doppler echocardiography, pulsed wave and/or continuous wave with
spectral display (list separately in addition to codes for echocardiographic imaging); follow-up or limited study (list separately in addition
to codes for echocardiographic imaging).
Doppler echocardiography color flow velocity mapping (list separately in
addition to codes for echocardiography).
Echocardiography, transesophageal (tee) for guidance of a transcatheter
intracardiac or great vessel(s) structural intervention(s) (eg, tavr,
transcathether pulmonary valve replacement, mitral valve repair,
paravalvular regurgitation repair, left atrial appendage occlusion/closure, ventricular septal defect closure) (peri- and intra-procedural),
real-time image acquisition and documentation, guidance with quantitative measurements, probe manipulation, interpretation, and report,
including diagnostic transesophageal echocardiography and, when
performed, administration of ultrasound contrast, doppler, color flow,
and 3d.
Electrophysiologic evaluation of subcutaneous implantable defibrillator
(includes defibrillation threshold evaluation, induction of arrhythmia,
evaluation of sensing for arrhythmia termination, and programming or
reprogramming of sensing or therapeutic parameters).
Duplex scan of extracranial arteries; complete bilateral study ..................
Duplex scan of extracranial arteries; unilateral or limited study ................
Transcranial doppler study of the intracranial arteries; complete study ....
Transcranial doppler study of the intracranial arteries; limited study ........
Quantitative carotid intima media thickness and carotid atheroma evaluation, bilateral.
Duplex scan of lower extremity arteries or arterial bypass grafts; complete bilateral study.
Duplex scan of lower extremity arteries or arterial bypass grafts; unilateral or limited study.
Duplex scan of upper extremity arteries or arterial bypass grafts; complete bilateral study.
Duplex scan of upper extremity arteries or arterial bypass grafts; unilateral or limited study.
Duplex scan of extremity veins including responses to compression and
other maneuvers; complete bilateral study.
Duplex scan of extremity veins including responses to compression and
other maneuvers; unilateral or limited study.
Duplex scan of arterial inflow and venous outflow of abdominal, pelvic,
scrotal contents and/or retroperitoneal organs; complete study.
Duplex scan of arterial inflow and venous outflow of abdominal, pelvic,
scrotal contents and/or retroperitoneal organs; limited study.
Duplex scan of aorta, inferior vena cava, iliac vasculature, or bypass
grafts; complete study.
Duplex scan of aorta, inferior vena cava, iliac vasculature, or bypass
grafts; unilateral or limited study.
Duplex scan of hemodialysis access (including arterial inflow, body of
access and venous outflow).
Electronic analysis of implanted neurostimulator pulse generator system
(eg, rate, pulse amplitude, pulse duration, configuration of wave form,
battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple spinal cord,
or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular)
neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming.
C
2.40
2.40
No
0.38
0.38
0.38
No
0.15
0.15
0.15
No
0.07
0.07
0.07
No
( 1)
4.66
4.66
No
( 1)
3.65
3.29
No
0.60
0.40
0.94
0.62
( 1)
0.80
0.50
1.00
0.70
0.55
0.80
0.50
0.91
0.50
N
No
No
No
No
No
0.80
0.80
0.80
No
0.50
0.60
0.50
No
0.46
0.80
0.80
No
0.31
0.50
0.50
No
0.70
0.70
0.70
No
0.45
0.45
0.45
No
1.80
1.30
1.16
No
1.21
1.00
0.80
No
0.65
0.97
0.80
No
0.44
0.70
0.50
No
0.25
0.60
0.50
No
0.78
0.78
0.78
No
HCPCS
Code
93320 ....
93321 ....
93325 ....
93355 ....
93644 ....
93880
93882
93886
93888
93895
....
....
....
....
....
93925 ....
93926 ....
93930 ....
93931 ....
93970 ....
93971 ....
93975 ....
93976 ....
93978 ....
93979 ....
93990 ....
ebenthall on DSK5SPTVN1PROD with $$_JOB
95971 ....
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00115
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
CMS time
refinement
67662
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 25—CY 2015 INTERIM FINAL WORK RVUS FOR NEW/REVISED OR POTENTIALLY MISVALUED CODES—Continued
95972 ....
Long descriptor
CY 2014
WRVU
RUC/
HCPAC
recommended
work RVU
CY 2015
work RVU
Electronic analysis of implanted neurostimulator pulse generator system
(eg, rate, pulse amplitude, pulse duration, configuration of wave form,
battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex spinal
cord, or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular)
(except cranial nerve) neurostimulator pulse generator/transmitter,
with intraoperative or subsequent programming, up to 1 hour.
Electronic analysis of implanted neurostimulator pulse generator system
(eg, rate, pulse amplitude, pulse duration, configuration of wave form,
battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex spinal
cord, or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular)
(except cranial nerve) neurostimulator pulse generator/transmitter,
with intraoperative or subsequent programming, each additional 30
minutes after first hour (list separately in addition to code for primary
procedure).
Negative pressure wound therapy (eg, vacuum assisted drainage collection), utilizing durable medical equipment (dme), including topical application(s), wound assessment, and instruction(s) for ongoing care,
per session; total wound(s) surface area less than or equal to 50
square centimeters.
Negative pressure wound therapy (eg, vacuum assisted drainage collection), utilizing durable medical equipment (dme), including topical application(s), wound assessment, and instruction(s) for ongoing care,
per session; total wound(s) surface area greater than 50 square centimeters.
Negative pressure wound therapy, (eg, vacuum assisted drainage collection), utilizing disposable, non-durable medical equipment including
provision of exudate management collection system, topical application(s), wound assessment, and instructions for ongoing care, per
session; total wound(s) surface area less than or equal to 50 square
centimeters.
Negative pressure wound therapy, (eg, vacuum assisted drainage collection), utilizing disposable, non-durable medical equipment including
provision of exudate management collection system, topical application(s), wound assessment, and instructions for ongoing care, per
session; total wound(s) surface area greater than 50 square centimeters.
Low frequency, non-contact, non-thermal ultrasound, including topical
application(s), when performed, wound assessment, and instruction(s)
for ongoing care, per day.
Physician or other qualified health care professional attendance and supervision of hyperbaric oxygen therapy, per session.
Initiation of selective head or total body hypothermia in the critically ill
neonate, includes appropriate patient selection by review of clinical,
imaging and laboratory data, confirmation of esophageal temperature
probe location, evaluation of amplitude eeg, supervision of controlled
hypothermia, and assessment of patient tolerance of cooling.
Application of topical fluoride varnish by a physician or other qualified
health care professional.
Complex chronic care management services, with the following required
elements: multiple (two or more) chronic conditions expected to last at
least 12 months, or until the death of the patient; chronic conditions
place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline; establishment or substantial revision of a comprehensive care plan; moderate or high complexity medical decision making; 60 minutes of clinical staff time directed by a
physician or other qualified health care professional, per calendar
month.
Advance care planning including the explanation and discussion of advance directives such as standard forms (with completion of such
forms, when performed), by the physician or other qualified health
care professional; first 30 minutes, face-to-face with the patient, family
member(s), and/or surrogate.
1.50
0.90
0.80
No
0.92
NA
0.49
No
0.55
0.55
0.55
No
0.60
0.60
0.60
No
( 1)
0.41
C
( 1)
0.46
C
Yes
C
0.35
0.35
No
2.34
2.11
2.11
No
( 1)
4.50
4.50
No
( 1)
0.20
N
N/A
1.00
1.00
B
N/A
( 1)
1.50
I
N/A
HCPCS
Code
95973 ....
97605 ....
97606 ....
97607 ....
97608 ....
97610 ....
99183 ....
99184 ....
99188 ....
ebenthall on DSK5SPTVN1PROD with $$_JOB
99487 ....
99497 ....
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00116
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
CMS time
refinement
67663
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 25—CY 2015 INTERIM FINAL WORK RVUS FOR NEW/REVISED OR POTENTIALLY MISVALUED CODES—Continued
99498 ....
Long descriptor
CY 2014
WRVU
RUC/
HCPAC
recommended
work RVU
CY 2015
work RVU
Advance care planning including the explanation and discussion of advance directives such as standard forms (with completion of such
forms, when performed), by the physician or other qualified health
care professional; each additional 30 minutes (list separately in addition to code for primary procedure).
Diagnostic digital breast tomosynthesis, unilateral or bilateral (list separately in addition to G0204 or G0206).
( 1)
1.40
I
N/A
( 1)
N/A
0.60
N/A
HCPCS
Code
G0279 ...
CMS time
refinement
1 New.
i. Code Specific Issues
ebenthall on DSK5SPTVN1PROD with $$_JOB
(1) Internal Fixation of Rib Fracture
(CPT Codes 21811, 21812 and 21813)
For CY 2015, the CPT Editorial Panel
deleted CPT code 21810 (Treatment of
rib fracture requiring external fixation
(flail chest)) and replaced it with three
CPT codes 21811, 21812 and 21813, to
report internal fixation of rib fracture.
The RUC recommended valuing these
three codes as 90-day global services.
For the reasons we articulate in section
II.B.4 of this final rule with comment
period about the difficulties in
accurately valuing codes as 90-day
global services, we believe that the
valuation of these codes should be as 0day global services. In addition, we
believe this is particularly appropriate
for these codes because the number of
RUC-recommended inpatient and
outpatient visits included in the
postservice time seems higher than
would likely occur. The vignette for
CPT code 21811 describes an elderly
patient who falls and experiences three
rib fractures that require internal
fixation. The seven visits included in
the postservice time for this code seem
high since the vignette does not describe
a very ill patient. The vignettes for CPT
codes 21812 and 21813 describe
patients experiencing significant rib
fractures in car accidents that require
internal fixation. We believe that in
these scenarios, injuries beyond rib
fractures are likely, and as a result, we
believe it is likely that multiple
practitioners would be involved in
providing post-operative care. If other
practitioners would furnish care in the
post-surgery period, we believe the ten
and thirteen postservice visits included
in CPT codes 21812 and 21813 would
likely not occur. By valuing these codes
as 0-day globals, we do not need to
address these issues because the
surgeon will be able to bill separately
for the postoperative services that are
furnished after the day of the procedure.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
To value these services as 0-day
global codes, we subtracted the work
RVUs related to the postoperative
services from the total work RVU. We
are establishing CY 2015 interim work
RVUs of 10.79 for CPT code 21811, of
13.00 for CPT code 21812, and of 17.61
for CPT code 21813. We also refined the
RUC recommended time by subtracting
the time associated with the
postoperative visits. By removing the
work and time associated with visits in
the postoperative period, the remaining
work and time reflect the work and time
of services furnished on the day of
surgery.
(2) Percutaneous Vertebroplasty and
Augmentation (CPT Codes 22510,
22511, 22512, 22513, 22514 and 22515)
For CY 2015, the CPT Editorial Panel
replaced the eight existing percutaneous
vertebroplasty with six new codes, CPT
codes 22510–22515, which include the
percutaneous vertebroplasty and the
image guidance together. We are
establishing the RUC-recommended
work values as interim final for CY 2015
for all of the codes in this family except
CPT code 22511.
Unlike other codes in this family for
which the RUC-recommended work
RVU was based on the 25th percentile
in the survey, the RUC established its
recommended work value for CPT code
22511 by crosswalking this service to
CPT code 39400 (Mediastinoscopy,
includes biopsy(ies), when performed),
which has a work RVU of 8.05. Because
the level of work performed by a
physician in the two services differs, we
do not agree that this crosswalk is
appropriate. Instead, we believe a more
appropriate analogy is found in the
difference between the work values for
the predecessor codes for CPT codes
22510 and 22511, CPT codes 22520
(Percutaneous vertebroplasty (bone
biopsy included when performed), 1
vertebral body, unilateral or bilateral
injection; thoracic) and 22521
(Percutaneous vertebroplasty (bone
PO 00000
Frm 00117
Fmt 4701
Sfmt 4700
biopsy included when performed), 1
vertebral body, unilateral or bilateral
injection; thoracic; lumbar).
Accordingly, we are applying the
difference in the current work RVUs for
CPT codes 22520 and 22521 to the work
RVU that we are establishing for CPT
code 22510. We believe this increment
establishes the appropriate rank order in
this family and thus are assigning an
interim final work RVU of 7.58 for CPT
code 22511, which is 0.57 work RVUs
lower than the CY 2015 work RVU for
CPT code 22510.
(3) Endobronchial Ultrasound (EBUS)
(CPT Code 31620)
For CY 2015, the RUC reviewed CPT
code 31620 because it was identified
through the High Volume Growth
Services, which are those services for
which Medicare utilization increased by
at least 100 percent from 2006 to 2011.
CPT code 31620 is an add-on code to
CPT code 31629 (Bronchoscopy, rigid or
flexible, including fluoroscopic
guidance, when performed; with
transbronchial needle aspiration
biopsy(s), trachea, main stem and/or
lobar bronchus(i)).
Medicare data show that 82 percent of
the time when EBUS is billed it is billed
with CPT code 31629. Given this
relationship, we believe that CPT code
31620 should be bundled with CPT
code 31629. The specialty societies
maintain that EBUS is distinct from
bronchoscopy with biopsy because the
intraservice work of EBUS occurs
between the two components of the base
code, bronchoscopy and biopsy.
However, based upon the discussion at
the RUC meeting, we believe that the
biopsy actually occurs during the EBUS
and the biopsy is actually performed
through the EBUS scope. Thus, we do
not believe the EBUS code descriptor
accurately describes the service nor is it
possible to accurately value this service
when the descriptor is inaccurate.
Therefore, for CY 2015 we are
maintaining the CY 2014 work RVU for
E:\FR\FM\13NOR2.SGM
13NOR2
67664
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
CPT code 31620. We understand that
the RUC will review this code for CY
2016.
(4) Extracorporeal Membrane
Oxygenation (ECMO)/Extracorporeal
Life Support (ECLS) (CPT Codes 33946,
33947, 33948, 33949, 33951–33959,
33962–33966, 33969, 33984–33989)
In the CY 2014 PFS final rule with
comment period, CPT codes 33960
(Prolonged extracorporeal circulation
for cardiopulmonary insufficiency;
initial day) and 33961 (Prolonged
extracorporeal circulation for
cardiopulmonary insufficiency; each
subsequent day) were identified as
potentially misvalued codes.
Specifically, the services were originally
valued when they were primarily
provided to premature neonates; but the
services are now typically used in
treating adults with severe influenza,
pneumonia, and respiratory distress
syndrome. For CY 2015, CPT codes
33960 and 33961 were deleted and
replaced with 25 new codes to describe
this treatment. We are assigning the
RUC-recommended work values as
interim final for CY 2015 for all of the
codes in this family except CPT codes
33952, 33953, 33954, 33957, 33958 and
33959, 33962, 33969, and 33984.
We accepted the RUC-recommended
work RVU of 8.15 for CPT code 33951,
which describes an ECMO peripheral
cannula(e) insertion for individuals up
to 5 years of age. The RUC
recommended a work RVU of 8.43 for
CPT code 33952, which describes the
same procedure for individuals 6 years
and older. We do not believe this
difference in the age of the patient
increases the work of the service from
the younger patient. The fact that the
RUC-recommended intraservice time is
identical for both codes supports our
view that the work RVU should be the
same for both codes. Therefore, for CY
2015, we are establishing an interim
final work RVUs of 8.15 for CPT code
33952, the same as we established for
CPT 33951 based upon the RUCrecommendation for the younger
patient.
The RUC recommended work RVUs of
9.83 and 9.43 for CPT codes 33953 and
33954, respectively. For the same
reasons discussed above, we are
establishing the same work values for
the code for treatment of patients from
birth through 5 years of age and the
code for treatment of patients 6 years
and older. To determine the value for
these codes, we adjusted the work RVU
of the equivalent percutaneous codes,
CPT code 33951 (Extracorporeal
membrane oxygenation (ECMO)/
extracorporeal life support (ECLS)
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
provided by physician; insertion of
peripheral (arterial and/or venous)
cannula(e), percutaneous, birth through
5 years of age (includes fluoroscopic
guidance, when performed)) and CPT
code 33952 (Extracorporeal membrane
oxygenation (ECMO)/extracorporeal life
support (ECLS) provided by physician;
insertion of peripheral (arterial and/or
venous) cannula(e), percutaneous, 6
years and older (includes fluoroscopic
guidance, when performed)), to reflect
the greater work of the open procedure
codes, CPT codes 33953 (Extracorporeal
membrane oxygenation (ECMO)/
extracorporeal life support (ECLS)
provided by physician; insertion of
peripheral (arterial and/or venous)
cannula(e), open birth, through 5 years
of age) and 33954 (Extracorporeal
membrane oxygenation (ECMO)/
extracorporeal life support (ECLS)
provided by physician; insertion of
peripheral (arterial and/or venous)
cannula(e), open, 6 years and older). To
measure the difference in work between
these two sets of codes we applied the
0.96 RVU differential between the
percutaneous arterial CPT code 33620
(Application of right and left pulmonary
artery bands (for example, hybrid
approach stage 1)) and the open arterial
CPT code 36625 (Arterial
catheterization or cannulation for
sampling, monitoring or transfusion
(separate procedure); cutdown) codes.
This measure allows us to establish the
difference in work between the sets of
codes based upon the difference in
intensity. Accordingly, we are assigning
an interim final work RVU to CPT codes
33953 and 33954 of 9.11.
Unlike other codes in this family for
which the RUC-recommended work
value was based upon the 25th
percentile of the survey, for CPT codes
33957 and 33958 the RUC
recommended a work RVU of 4.00 and
4.05, respectively, based upon the
survey median. We believe that, like
other services in this family, these codes
should be valued based upon the 25th
percentile values of the survey because
those values best describe the work
involved in these procedures and results
in the appropriate relativity amongst the
codes in the family. Therefore, for CY
2015 we are assigning an interim final
work RVU of 3.51 for CPT codes 33957
and 33958.
We believe the RUC-recommended
work RVUs of 4.69 and 4.73 for CPT
codes 33959 and 33962 respectively,
overstate the work involved in the
services. As we discussed above for CPT
codes 33953 and 33954, we believe the
differential between the percutaneous
arterial and open arterial CPT codes
more appropriately reflects the work
PO 00000
Frm 00118
Fmt 4701
Sfmt 4700
involved in these services. Accordingly
we are establishing a CY 2015 interim
final work RVU of 4.47 for CPT codes
33959 and 33962.
After researching comparable codes,
we believe the RUC-recommended work
RVUs of 6.00 and 6.38 for CPT codes
33969 and 33984, respectively,
overstates the work involved in the
procedures. For the same reasons and
following the same valuation
methodology utilized above, we added
the differential between the
percutaneous arterial and arterial
cutdown codes, 0.96 RVU, to the CY
2015 interim final work RVU of 4.50 for
CPT code 33966, which is the
percutaneous counterpart of CPT code
33984. This results in a work RVU of
5.46 for CPT code 33984. Because CPT
code 33969 has 2 minutes less
intraservice time than CPT code 33984
(Extracorporeal membrane oxygenation
(ECMO)/extracorporeal life support
(ECLS) provided by physician; removal
of peripheral (arterial and/or venous)
cannula(e), open, 6 years and older), we
adjusted the work RVU of CPT code
33984 for the decrease in time to get a
work RVU of 5.22 for CPT code 33969
(Extracorporeal membrane oxygenation
(ECMO)/extracorporeal life support
(ECLS) provided by physician; removal
of peripheral (arterial and/or venous)
cannula(e), open, birth through 5 years
of age). Therefore, for CY 2015 we are
establishing an interim final work RVU
of 5.46 to CPT code 33984 and 5.22 to
CPT code 33969.
(5) Fenestrated Endovascular Repair
(FEVAR) Endograft Planning (CPT Code
34839)
For CY 2015, CPT code 34839 was
created to report the planning that
occurs prior to the work included in the
global period for a FEVAR. The RUC
recommended that we contractor price
this service as the RUC survey response
rate was too low to provide the basis for
an appropriate valuation. In general, we
prefer that planning be bundled with
the underlying service, and we have no
reason to believe bundling is not
appropriate in this case. Accordingly,
we are assigning a PFS procedure status
indicator of B (Bundled Code) to CPT
code 34839.
(6) AV Anastomosis (CPT Codes 36818,
36819, 36820, 36821, 36825, 36830,
36831, 36832, and 36833)
In the CY 2013 PFS final rule with
comment period, the AV anastomosis
family of services were determined to be
potentially misvalued due to rank order
anomalies, including CPT codes 36818–
36821 and CPT codes 36825–36830. The
RUC recommendations that we received
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
in response also included CPT codes
36831–36833. We are assigning the
RUC-recommended work RVUs as CY
2015 interim final values for CPT codes
36821, 36831, 36832 and 36833. For
CPT code 36831, 36832, and 36833, we
are refining to remove the additional 10
minutes of preservice evaluation time.
The RUC added 10 minutes of
additional pre-service time to these
codes for determining the best source of
access. These three codes are revision/
repair codes and as such do not need
the additional time to determine the
access source. For CPT code 36818, the
RUC recommended an approximately 12
percent increase in work RVU but a total
time increase of approximately 4.2
percent. We are assigning a CY 2015
interim final work RVU of 12.39, which
reflects a 4.2 percent increase from the
current value based upon the increase in
total time.
For CPT code 36819, the RUCrecommended intraservice and total
times are only minimally different than
the current times. Even though the
intraservice and total times decreased
minimally, the RUC increased the work
RVU. We believe that the small decrease
in total time, 2 percent, suggest that the
current work RUV is appropriate.
Therefore, we are assigning a CY 2015
interim final work RVU of 13.29, which
is the current work value.
The RUC recommended a work value
of 13.99 for CPT code 36820. The RUC
recommended that the postservice time
of CPT code 36820 be reduced by
removing visits. Specifically, a CPT
code 99231 and one-half of a CPT code
99238 were removed from the service,
which would equal 1.40 RVU. We do
not believe that this reduction was
accounted for in the RUC-recommended
work RVU. To account for this
reduction in visits, we are establishing
a CY 2015 interim final work RVU of
13.07 for CPT 36820 which reflects a
1.40 work RVU reduction in the current
work RVU.
For CPT code 36825, the RUCrecommended intraservice and total
times are only minimally different than
the current times. However, the RUC
increased the work RVU. We do not
believe the work RVU should be
increased without corresponding time
changes. Therefore, we believe the
appropriate CY 2015 interim final work
RVU is the current work value of 14.17.
For CPT code 36830, the RUCrecommended intraservice and total
times are only minimally different than
the current times. However, the RUC
decreased the work RVU. We do not
believe the work RVU should be
decreased without corresponding time
changes. Therefore, we are establishing
a CY 2015 interim final work RVU of
12.03, which is equal to the current
work RVU.
Furthermore, we refined the total time
values as follows: 238 minutes for CPT
code 36831, 266 minutes for CPT code
36832, and 296 minutes for CPT code
36833.
(7) Illeoscopy, Pouchoscopy,
Colonoscopy through Stoma, Flexible
Sigmoidoscopy and Colonoscopy (CPT
Codes 44380, 44381, 44382, 44383,
44384, 44385, 44386, 44388, 44389,
44390, 44391, 44392, 44393, 44394,
44397, 44401, 44402, 44403, 44404,
44405, 44406, 44407, 44408, 44799,
45330, 45331, 45332, 45333, 45334,
45335, 45337, 45338, 45346, 45340,
45341, 45342, 45345, 45347, 45349,
45350, 45378, 45379, 45380, 45381,
45382, 45383, 45388, 45384, 45385,
45386, 45387, 45389, 45390, 45391,
45392, 45393, 45398, 45399, 0226T,
46601, 0227T, and 46607 and HCPCS
Codes G6018, G6019, G6020, G6021,
G6022, G6023, G6024, G6025, G6027,
G6028)
CPT revised the lower gastrointestinal
endoscopy code set for CY 2015
following identification of some of the
codes as potentially misvalued and the
affected specialty society’s contention
that this code set did not allow for
accurate reporting of services based
upon the current practice. The RUC
subsequently provided
recommendations to CMS for valuing
these services. In comments on the
proposed rule, stakeholders noted our
proposal to begin including proposed
values for new, revised and potentially
misvalued codes in the proposed rule.
67665
Commenters suggested that, rather than
implementing this new process in CY
2016, we should implement it
immediately and thus defer the
valuation of the new GI code set until
CY 2016. They indicated that the
opportunity to comment prior to
implementation of the new values was
important for these codes, many of
which have high utilization. In addition,
in this final rule with comment period
we discuss the need to modify how
moderate sedation is reported and
valued. Since the valuation of most
codes in this code set includes moderate
sedation, stakeholders suggested that we
revalue these codes in conjunction with
any changes in reporting and valuation
of moderate sedation.
We agree with the commenters. In
light of the substantial nature of this
code revision and its relationship to the
policies on moderate sedation, we are
delaying revaluation of these codes until
CY 2016 when we will be able to
include proposals in the proposed rule
for their valuation, along with
consideration of policies for moderate
sedation. Accordingly for CY 2015, we
are maintaining the inputs for the lower
gastrointestinal endoscopy codes at the
CY 2014 levels. (Note: Due to budget
neutrality adjustments and other
system-wide changes, the payment rates
may change.) Since the code set is
changing for CY 2015, including the
deletion of some of the CY 2014 codes,
we are creating G-codes as necessary to
allow practitioners to report services to
CMS in the same way in CY 2015 that
they did in CY 2014 and to maintain
payment under the PFS based on the
same inputs. All payment policies
applicable to the CY 2014 CPT codes
will apply to the replacement G-codes.
The new and revised CY 2015 CPT
codes for lower gastrointestinal
endoscopy that will not be recognized
by Medicare for CY 2015 are denoted
with an ‘‘I’’ (Not valid for Medicare
purposes) in Table 26. The chart below
lists the G-codes that we are creating
and the CY 2014 CPT codes that they
are replacing.
TABLE 26—LOWER GASTROINTESTINAL ENDOSCOPY G-CODES REPLACING CY 2015 CPT CODES
ebenthall on DSK5SPTVN1PROD with $$_JOB
CY 2014
CPT code 1
CY 2015
HCPCS
code
44383 ........
44393 ........
G6018 ......
G6019 ......
44397 ........
44799 ........
45339 ........
G6020 ......
G6021 ......
G6022 ......
VerDate Sep<11>2014
Long descriptor
Ileoscopy, through stoma; with transendoscopic stent placement (includes predilation).
Colonoscopy through stoma; with ablation of tumor(s), polp(s), or other lesion(s) not amenable to removal by hot biopsy forceps, bipolar cautery or snare technique.
Colonoscopy through stoma; with transendoscopic stent placement (includes predilation).
Unlisted procedure, intestine.
Sigmoidoscopy, flexible; with ablation of tumor(s), polyp(s), or other lesions(s)not amenable to removal by hot biopsy
forceps, bipolar cautery or snare technique.
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00119
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
67666
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 26—LOWER GASTROINTESTINAL ENDOSCOPY G-CODES REPLACING CY 2015 CPT CODES—Continued
CY 2014
CPT code 1
CY 2015
HCPCS
code
45345 ........
45383 ........
G6023 ......
G6024 ......
45387 ........
0226T ........
G6025 ......
G6027 ......
0227T ........
G6028 ......
Long descriptor
Sigmoidoscopy, flexible; with transenoscopic stent placement (includes predilation).
Colonoscopy, flexible, proximal to splenic flexure; with ablation of tumor(s), polyp(s), or other lesion(s) not amenable
to removal by hot biopsy forceps, bipolar cautery or snare technique.
Colonoscopy, flexible, proximal to splenic flexure; with transendoscopic stent placement (includes predilation).
Anoscopy, high resolution (HRA) (with magnification and chemical agent enhancement); diagnostic, including collection of specimen(s) by brushing or washing when performed.
Anoscopy, high resolution (HRA) (with magnification and chemical agent enhancement); with biopsy(ies).
1 This
chart only contains CY 2014 codes for which a HCPCS code is being used for CY 2015. Addendum B contains a complete list of CPT
and HCPCS codes being recognized by Medicare under the PFS for CY 20115.
(8) Prostatectomy (CPT Codes 55842 and
55845)
In the CY 2014 PFS final rule with
comment period, we finalized CPT
codes 55842 and 55845 as potentially
misvalued codes. For CY 2015, the RUC
provided recommendations for these
services of 29.07 and 24.16,
respectively. We disagreed with the
RUC-recommended crosswalk for CPT
code 55842. To value CPT code 55842,
we are crosswalking it to CPT code
55840 (Prostatectomy, retropubic
radical, with or without nerve sparing)
due to their identical times. Therefore,
we are establishing an interim final
work RVU of 21.36.
For CPT code 55845, we are
establishing a work RVU of 25.18 based
upon the 25th percentile of the survey.
This work RVU results in an 18 percent
decrease from the current work RVU,
which we believe reflects the changes
since the last valuation, based upon a 20
percent decrease in intraservice time
and the 29 percent decrease in total
time.
ebenthall on DSK5SPTVN1PROD with $$_JOB
(9) Aqueous Shunt (CPT Code 66179,
66180, 66184, 66185, and 67255)
After identifying CPT code 66180
through the Harvard-Valued Annual
Allowed Charges Greater than $10
million screen, the RUC recommended
work RVUs for the aqueous shunt family
for CY 2015. We are establishing the
RUC-recommended work RVUs as
interim final for all codes in this family
except CPT code 67255. The RUC
recommended maintaining the CY 2014
work RVU of 10.17 for CPT 67255.
However, we believe maintaining this
value would be inconsistent with the
RUC-recommended decreases in total
time for the service. As a result, we
reduced the work RVU by the same
percentage that the RUC recommended
a reduction in total time, which results
in a CY 2015 interim final work RVU of
8.38 for CPT code 67255.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
(10) Computed Tomography (CT)—
Maxillofacial (CPT Codes 70486, 70487
and 70488)
The RUC’s Relativity Assessment
Workgroup identified CPT code 70486
for review through the CMS/Other
Source—Utilization over 250,000
screen. The involved specialty societies
expanded the survey to include CPT
codes 70487 and 70488, all of which
involve maxillofacial CTs. We are
establishing the RUC-recommended
work RVU of 0.85 as the CY 2015
interim final value for CPT code 70486,
which is without contrast material. The
RUC established this recommendation
by crosswalking this code to the
equivalent code in the CT for the head
or brain, CPT code 70450 (Computed
tomography, head or brain without
contrast). We agree with that method
and in order to maintain rank order
within and across CT families, we
crosswalked CPT code 70487, which is
with contrast material(s), to the CPT
code 70460, which is the equivalent
code in the head or brain family and
CPT code 70488, which is without
contrast materials followed by contrast
material(s) and further sections to CPT
code 70470, which is the equivalent
code in the head or brain family.
Therefore, for CY 2015 we are
establishing interim final work RVUs of
1.13 for CPT code 70487 and 1.27 for
CPT code 70488.
(11) Breast Ultrasound (CPT Codes
76641 and 76642)
For CY 2015, the CPT Editorial Panel
replaced CPT code 76645 (Ultrasound,
breast(s) (unilateral or bilateral), real
time with image documentation) with
two codes, CPT codes 76641
(Ultrasound, breast, unilateral, real time
with image documentation, including
axilla when performed; complete) and
76642 (Ultrasound, breast, unilateral,
real time with image documentation,
including axilla when performed;
limited). The difference between the
new codes is that one is for complete
PO 00000
Frm 00120
Fmt 4701
Sfmt 4700
breast ultrasound procedures and the
other is for limited. We are assigning the
RUC-recommended work RVUs of 0.73
and 0.68 to CPT codes 76641 and 76642,
respectively, as interim final. One
difference between the predecessor code
and the new ones is that while the
predecessor code was used to report
unilateral or bilateral breast
ultrasounds, the new codes are
unilateral ones. To appropriately adjust
payment when bilateral procedures are
furnished under the PFS, payments are
adjusted to 150 percent of the unilateral
payment when a service has a bilateral
payment indicator assigned. We are
assigning a bilateral payment indicator
to these codes.
(12) Radiation Therapy Codes (CPT
Codes 76950, 77014, 77421, 77387,
77401, 77402, 77403, 77404, 77406,
77407, 77408, 77409, 77411, 77412,
77413, 77414, 77416, 77418, 77385,
77386, 0073T, and 0197T and HCPCS
Codes G6001, G6002, G6003, G6004,
G6005, G6006, G6007, G6008, G6009,
G6010, G6011, G6012, G6013, G6014,
G6015, G6016 and G6017)
CPT revised the radiation therapy
code set for CY 2015 following
identification of some of the codes as
potentially misvalued and the affected
specialty society’s contention that the
provision of radiation therapy could not
be accurately reported under the
existing code set. The RUC subsequently
provided recommendations to CMS for
valuing these services. Some
stakeholders approached CMS with
concerns about these codes being
revalued as interim final in the final
rule with comment period, noting that
these codes account for the vast majority
of Medicare payment for radiation
therapy centers. They noted our
proposal to begin including proposals to
value new, revised and potentially
misvalued codes in the proposed rule,
and suggested that these code valuations
should be delayed to CY 2016 so that
they could be addressed under this new
process. This would provide affected
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
stakeholders the opportunity to
comment prior to the valuations being
effective. They also noted that since
they do not participate in the RUC, they
did not have the opportunity to provide
input to the recommendations nor will
they have information about the RUC
recommendations until CMS makes this
information available in the final rule
with comment period.
In response to comments and in light
of the substantial nature of this code
revision, we are delaying revaluation of
these codes until CY 2016. The coding
changes for CY 2015 involve significant
changes in how radiation therapy
services and associated image guidance
are reported. There is substantial work
to be done to assure the new valuations
for these codes accurately reflect the
coding changes. Accordingly we are
delaying the use of the revised radiation
therapy code set until CY 2016 when we
will be able to include proposals in the
proposed rule for their valuation. We
are maintaining the inputs for radiation
therapy codes at the CY 2014 levels.
(Note: Due to budget neutrality
adjustments and other system-wide
changes, the payment rates may
change.) Since the code set has changed
and some of the CY 2014 codes are
being deleted, we are creating G-codes
as necessary to allow practitioners to
continue to report services to CMS in
CY 2015 as they did in CY 2014 and for
payments to be made in the same way.
All payment policies applicable to the
CY 2014 CPT codes will apply to the
replacement G-codes. The new and
revised CY 2015 CPT codes that will not
be recognized by Medicare for CY 2015
are denoted with an ‘‘I’’ (Not valid for
Medicare purposes) on Table 27. The
chart below lists the G-codes that we are
creating and the CY 2014 CPT codes
that they are replacing.
Additionally, we would like to note
that changes to the prefatory text modify
the services that are appropriately billed
with CPT code 77401, which is used to
report superficial radiation therapy.
67667
This change effectively means that CPT
code 77401 is now bundled with many
other procedures supporting superficial
radiation therapy. However, the RUC
did not review superficial radiation
therapy procedures, and therefore, did
not assess whether changes in its
valuation were appropriate in light of
this bundling. Stakeholders have
suggested to us that the change to the
prefatory text prohibits them from
billing for codes that were previously
frequently billed in addition to this code
and as a result there will be a significant
reduction in their payments.’’ We are
interested in information on whether
the new code set combined with
modifications in prefatory text allows
for appropriate reporting of the services
associated with superficial radiation
and whether the payment continues to
reflect the relative resources required to
furnish superficial radiation therapy
services.
TABLE 27—RADIATION THERAPY G-CODES REPLACING CY 2015 CPT CODES
CY 2015
HCPCS
code
76950 ........
77421 ........
77402 ........
G6001 ......
G6002 ......
G6003 ......
77403 ........
G6004 ......
77404 ........
G6005 ......
77406 ........
G6006 ......
77407 ........
G6007 ......
77408 ........
G6008 ......
77409 ........
G6009 ......
77411 ........
G6010 ......
77412 ........
G6011 ......
77413 ........
G6012 ......
77414 ........
G6013 ......
77416 ........
G6014 ......
77418 ........
G6015 ......
0073T ........
G6016 ......
0197T ........
ebenthall on DSK5SPTVN1PROD with $$_JOB
CY 2014
CPT code 2
G6017 ......
VerDate Sep<11>2014
Long descriptor
Ultrasonic guidance for placement of radiation therapy fields.
Stereoscopic X-ray guidance for localization of target volume for the delivery of radiation therapy.
Radiation treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks:
up to 5MeV.
Radiation treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks:
6–10MeV.
Radiation treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks:
11–19MeV.
Radiation treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks:
20 MeV or greater.
Radiation treatment delivery, 2 separate treatment areas, 3 or more ports on a single treatment area, use of multiple
blocks; up to 5MeV.
Radiation treatment delivery, 2 separate treatment areas, 3 or more ports on a single treatment area, use of multiple
blocks; 6–10MeV.
Radiation treatment delivery, 2 separate treatment areas, 3 or more ports on a single treatment area, use of multiple
blocks; 11–19MeV.
Radiation treatment delivery, 2 separate treatment areas, 3 or more ports on a single treatment area, use of multiple
blocks; 20 MeV or greater.
Radiation treatment delivery, 3 or more separate treatment areas, custom blocking, tangential ports, wedges, rotational beam, compensators, electron beam; up to 5MeV.
Radiation treatment delivery, 3 or more separate treatment areas, custom blocking, tangential ports, wedges, rotational beam, compensators, electron beam; 6–10MeV.
Radiation treatment delivery, 3 or more separate treatment areas, custom blocking, tangential ports, wedges, rotational beam, compensators, electron beam; 11–19MeV.
Radiation treatment delivery, 3 or more separate treatment areas, custom blocking, tangential ports, wedges, rotational beam, compensators, electron beam; 20MeV or greater.
Intensity modulated treatment delivery, single or multiple fields/arcs, via narrow spatially and temporally modulated
beams, binary, dynamic MLC, per treatment session.
Compensator-based beam modulation treatment delivery of inverse planned treatment using 3 or more high resolution (milled or cast) compensator, convergent beam modulated fields, per treatment session.
Intra-fraction localization and tracking of target or patient motion during delivery of radiation therapy (eg, 3D positional tracking, gating, 3D surface tracking), each fraction of treatment.
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00121
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67668
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
(13) Breast Tomosynthesis (CPT codes
77061, 77062, and 77063)
For CY 2015, the CPT Editorial Panel
created three codes to describe digital
breast tomosynthesis services: 77061
(Digital breast tomosynthesis;
unilateral), 77062 (Digital breast
tomosynthesis; bilateral) and 77063
(Screening digital breast tomosynthesis,
bilateral (List separately in addition to
code for primary procedure) and we
received RUC recommendations for
these codes. Currently, these services
are reported to Medicare using G0202,
G0204, and G0206, which describe the
equivalent procedures using any digital
technology (2–D or 3–D). In addition,
film mammography is reported to
Medicare using CPT codes 77055, 77056
and 77057).
In the proposed rule, based upon our
belief that digital mammography is now
typical, we proposed to replace the Gcodes that currently describe all digital
mammography services under Medicare
with the CPT codes, to value the CPT
codes for CY 2015 based upon the
current G-code values, and to include
the CPT codes on the potentially
misvalued code list since the resources
involved in furnishing these services
had not been evaluated in more than a
decade. Having reassessed the proposal
in light of the new codes and RUC
recommendations for tomosynthesis and
the comments received upon our
proposal, we are finalizing a modified
proposal. For a discussion of our
proposal, a summary of the comments
we received, and our policy for CY
2015, see section II.B.4.
With regard to screening
mammography, the CPT coding system
now has an add-on CPT code for
tomosynthesis. This coding scheme is
consistent with the FDA requiring a 2–
D mammography when tomosynthesis is
used for screening purposes.
Accordingly, we will recognize CPT
code 77063 to be reported, when
tomosynthesis is used in addition to 2–
D mammography. Since CPT code
77063 is an add-on code, and does not
have an equivalent CY 2014 code, we
believe it is appropriate to value it on
an interim final basis in advance of
receiving the RUC recommendations for
other mammography services. We are
assigning it a CY 2015 interim final
work RVU of 0.60 as recommended by
the RUC.
Whenever feasible, it is our strong
preference to value entire families
2 This chart only contains CY 2014 codes for
which a HCPCS code is being used for CY 2015.
Addendum B contains a complete list of CPT and
HCPCS codes being recognized by Medicare under
the PFS for CY 2015.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
together in order to avoid rank order
anomalies. In this final rule with
comment period, we are including the
codes for digital mammography on the
potentially misvalued code list, which
currently includes tomosynthesis as
well as 2–D mammography.
Accordingly, we will wait to value the
new diagnostic mammography
tomosynthesis codes until we have
received recommendations from the
RUC for all mammography services. In
the interim, we are assigning a PFS
indicator of ‘‘I’’ to 77061 and 77062.
Those furnishing diagnostic
mammography using tomosynthesis will
continue to report G0204 and G0206 as
appropriate. In addition, we are creating
a new code, G–2079 (Diagnostic digital
breast tomosynthesis, unilateral or
bilateral (List separately in addition to
G0204 or G0206)) as an add-on code that
should be reported in addition to the
relevant 2–D diagnostic mammography
G-code to recognize the additional
resources involved in furnishing
diagnostic breast tomosynthesis. We
will assign it the same inputs as CPT
code 77063 because we believe it
describes a similar service.
(14) Isodose Calculation with Isodose
Planning Bundle (CPT Code 77316)
For CY 2015, the CPT Editorial Panel
replaced six CPT codes (77305, 77310,
77315, 77326, 77327, and 77328) with
five new CPT codes to bundle basic
dosimetry calculation(s) with
teletherapy and brachytherapy isodose
planning. We are establishing the RUCrecommended work RVUs for CY 2015
for all of the codes in this family except
CPT code 77316. We disagree with the
RUC-recommended crosswalk for this
service because we do not believe it is
an appropriate match in work. The RUC
crosswalked CPT code 77318 to CPT
code 77307, both of which are complex
isodose planning codes in the same
family. We believe that the RUC should
have crosswalked CPT code 77316, a
simple isodose planning code, to the
corresponding simple isodose planning
code in the same family, CPT code
77306. Therefore, for CY 2015 we are
establishing an interim final work RVU
of 1.40 for CPT code 77316.
(15) Immunohistochemistry (CPT codes
88341, 88342, and 88344; HCPCS codes
G0461 and G0462)
In the CY 2014 PFS final rule with
comment period (78 FR 74341), we
assigned a status indicator of I (Not
valid for Medicare purposes) to CPT
codes 88341, 88342, and 88343 and
instead created two G-codes, G0461 and
G0462, to report immunohistochemistry
services. We did this in part to avoid
PO 00000
Frm 00122
Fmt 4701
Sfmt 4700
creating incentives for overutilization.
For CY 2015, the CPT coding was
revised with the creation of two new
CPT codes, 88341 and 88344, the
revision of CPT code 88342 and the
deletion of CPT code 88343. We believe
that the revised coding structure
addresses the concerns that we had with
the CY 2014 coding regarding the
creation of incentives and
overutilization. Accordingly, we are
deleting the G-codes and assigning
interim final values for these CPT codes
for CY 2015. We are establishing the
RUC-recommended work RVUs as
interim final for CY 2015 for CPT codes
88342 and 88344.
In the past for similar procedures in
this family, the RUC recommended a
work RVU for the add-on code that was
60 percent of the base code. For
example, the RUC-recommended work
RVU for CPT code 88334 (Pathology
consultation during surgery; cytologic
examination (for example, touch prep,
squash prep), each additional site (List
separately in addition to code for
primary procedure)) is 60 percent of the
work RVU of the base CPT code 88333
(Pathology consultation during surgery;
cytologic examination (for example,
touch prep, squash prep), initial site).
Similarly, the RUC-recommended work
RVU for CPT code 88177
(Cytopathology, evaluation of fine
needle aspirate; immediate
cytohistologic study to determine
adequacy for diagnosis, each separate
additional evaluation episode, same site
(List separately in addition to code for
primary procedure)) is 60 percent of the
recommended value for the base CPT
code 88172 (Cytopathology, evaluation
of fine needle aspirate; immediate
cytohistologic study to determine
adequacy for diagnosis, first evaluation
episode, each site). We believe that the
relative resources involved in furnishing
an add-on service in this family would
be reflected appropriately using the
same 60 percent metric. To value CPT
code 88341, we calculated 60 percent of
the work RVU of the base CPT code
88342, which has a work RVU of 0.70;
resulting in a work RVU of 0.42 for CPT
code 88341.
(16) Morphometric Analysis In Situ
Hybridization for Gene
Rearrangement(s) (CPT Codes 88364,
88365, 88366, 88368, 88369, 88373, and
88374 and 88377)
For CY 2014, the in situ hybridization
procedures, CPT codes 88365, 88367
and 88368, were revised to specify
‘‘each separately identifiable probe per
block;’’ three new add-on codes (CPT
codes 88364, 88373, 88369) were
created to specify ‘‘each additional
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
separately identifiable probe per slide;’’
and three new codes were created to
specify ‘‘each multiplex probe stain
procedure.’’ We are establishing the
RUC-recommended work RVUs as
interim final for CY 2015 for CPT codes
88365, 88366, 88368, and 88377.
CPT code 88367 is the computer
assisted version of morphometric
analysis, analogous to 88368 which is
the manual version. We have accepted
the RUC recommended work RVU of
0.88 for 88368 which has 30 minutes of
intraservice time. CPT code 88367 only
has 25 minutes of intraservice time and
we do not believe that the RUC
recommended work RVU of 0.86
adequately reflects that change in time.
We believe that the ratio of the
intraservice times (25/30) applied to the
work RVU (0.88) adequately reflects the
difference in work. Therefore, we are
assigning an interim final work RVU to
CPT code 88367 of 0.73.
Similarly, CPT code 88374 is the
computer assisted version of CPT code
88377 but with a drop in intraservice
time from 45 minutes to 30 minutes. We
believe applying this ratio to the work
RUV of 88377 more accurately reflects
the work. Therefore, we are assigning an
interim final work RVU to CPT code
88374 of 0.93.
As discussed in the previous section,
some of the add-on codes in this family
had RUC-recommended work RVUs that
were 60 percent of the work RVU of the
base procedure and we applied that
reduction to 88341. We believe this
accurately reflects the resources used in
furnishing these add-on codes.
Accordingly, we used this methodology
to establish interim final work RVUs of
0.53 for code 88364 (60 percent of the
work RVU of CPT code 88365); 0.53 for
CPT code 88369 (60 percent of the work
RVU of CPT code 88368); and 0.43 for
CPT code 88373 (60 percent of the work
RVU of CPT code 88367).
(17) Electro-oculography (EOG VNG)
CPT Codes 92270, 92540, 92541, 92542,
92544, 92543, and 92545)
After the RUC identified CPT code
92543 as potentially misvalued through
the CMS-Other Source—Utilization over
250,000 screen, CPT revised the
parentheticals for this code for CY 2015.
We received RUC recommendations for
CY 2015 for this code and other codes
in the family. We are assigning the RUCrecommended work values for CPT
codes 92270, 92540, 92541, 92542,
92544, and 92545. For CPT code 92543,
however, we have been informed by the
RUC that survey respondents may not
have understood the revised code
description for CPT code 92543, and
thus the survey data may be unreliable.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
As a result, we believe the most accurate
information upon which to base work
RVUs for CPT code 92543 is its existing
work RVU. Therefore, we are
establishing a work RVU of 0.10 for CPT
code 92543 as interim final for CY 2015.
(18) Interventional Transesophageal
Echocardiography (TEE) (CPT Codes
93312, 93313, 93314, 93315, 93316,
93317, 93318, 93355, and 93644)
For CY 2015, CPT code 93355 was
created to describe transesophageal
echocardiography during interventional
cardiac procedures. The RUC provided
recommendations for CPT code 93355,
and for CPT codes 93312–93318 in
order to ensure intra-family relativity.
We are establishing the RUCrecommended work RVU of 2.40 as
interim final for CY 2015 for CPT code
93318 and 4.66 for CPT code 93355.
The RUC based the work RVU for CPT
code 93312 upon a crosswalk to CPT
code 43247
(Esophagogastroduodenoscopy, flexible,
transoral; with removal of foreign body).
This code has significant differences
from CPT code 93312. We have been
unable to identify a CPT code with 30
minutes of intraservice time and 60
minutes of total time with a work RVU
higher than 2.55. We believe this service
is more similar to CPT code 75573
(Computed tomography, heart, with
contrast material, for evaluation of
cardiac structure and morphology in the
setting of congenital heart disease
(including 3D image postprocessing,
assessment of LV cardiac function, RV
structure and function and evaluation of
venous structures, if performed) since it
has similar work, time and the same
global period. Based upon this
crosswalk, we are assigning CPT code
93312 a CY 2015 interim final work
RVU of 2.55.
Due to CPT descriptor for CPT code
93315, we believe that the appropriate
work for this service is reflected in the
combined work of CPT codes 93316 and
93317, resulting in a CY 2015 interim
final work RVU of 2.94.
For CPT codes 93313, 93314, 93316
and 93317, we are assigning CY 2015
interim final work RVUs based upon the
25th percentile values from the survey:
0.51 for CPT code 93313, 2.10 for CPT
code 93314, 2.94 for CPT code 93315,
0.85 for CPT code 93316, 2.09 for CPT
code 93317, and 4.66 for CPT code
93355. Each of these codes had a
significant drop in intraservice time
since the last valuation and RUC
recommendations for higher work
RVUs. As we have stated in the absence
of information showing a change in
intensity, we believe meaningful
changes in time should be reflected in
PO 00000
Frm 00123
Fmt 4701
Sfmt 4700
67669
the work RVUs. For these codes, we
believe the 25th percentile survey
values better describe the work and time
involved in these procedures than the
RUC recommendations and also help
maintain appropriate relativity in the
family. Additionally, we are refining the
preservice and intraservice times for
CPT codes 93314 and 93317 to 10 and
20 minutes, respectively, to maintain
relativity among the interim final work
RVUs and times.
(19) Subcutaneous Implantable
Defibrillator Procedures (CPT Codes
33270, 33271, 33272, 33272, 93260,
93261 and 93644)
For CY 2015, the CPT Editorial Panel
added the word ‘‘implantable’’ to the
descriptors for several codes in this
family and created several new codes,
CPT codes 33270, 33271, 33272, 33272,
93260, 93261 and 93644. We received
RUC recommendations for the new and
revised codes. We are establishing the
RUC-recommended work RVUs for all of
the codes in this family except CPT
code 93644. This code has an
intraservice time of 20 minutes and a
total time of 84 minutes. We disagree
with the RUC-recommended crosswalk
for CPT code 93644 which has an
intraservice time of 29 minutes and a
total time of 115 minutes and believe
that a crosswalk to CPT code 32551
would be better as that code’s
intraservice time is 20 minutes and the
total time is 83 minutes. Therefore, we
are establishing a CY 2015 interim final
work RVU of 3.29 for CPT code 93644.
(20) Duplex Scans (CPT Codes 93886,
93888, 93926, 93975, 93976, 93977,
93978, and 93979)
In the CY 2013 PFS final rule with
comment period, we requested that the
RUC assess the relativity among the
entire family of duplex scans codes and
recommend appropriate work RVUs.
CMS also requested that the RUC
consider CPT codes 93886, Transcranial
Doppler study of the intracranial
arteries; complete study, and 93888,
Transcranial Doppler study of the
intracranial arteries; limited study, in
conjunction with the duplex scan codes
in order to assess the relativity between
and among those codes. The RUC
reviewed this entire family of codes and
provided recommendations for CY 2015.
For CY 2015, we are establishing the
RUC-recommended work RVUs as
interim final for all of the codes in the
family except CPT codes 93886, 93888,
93926, 93975, 93976, 93977, 93978, and
93979.
For several codes in this family with
10 minutes of intraservice time, the RUC
recommended 0.50 work RVUs. We
E:\FR\FM\13NOR2.SGM
13NOR2
67670
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
believe that this relationship between
intraservice time and work RVU
accurately reflects the time and
intensity involved, and should be used
for the majority of the codes in the
family. As a result, for CPT codes 93926,
93979, and 93888, which all have 10
minutes of intraservice time, we are
assigning an interim final work RVU of
0.50.
For several codes in this family with
15 minutes of intraservice time, the RUC
recommended work RVUs based upon
the survey 25th percentile. We find this
to appropriately reflect the work
involved. Accordingly, for CPT codes
93975, 93976, and 93978, which all
have 15 minutes of intraservice time, we
are disagreeing with the RUC work RVU
recommendations and assigning the
25th percentile of the survey as CY 2015
interim final values. Therefore, for CY
2015 we are establishing the following
interim final work RVUs: 1.16 for CPT
code 93975, 0.80 for CPT code 93976,
0.80 for CPT code 93978 and 0.50 for
CPT code 93979. Lastly, we believe that
the RUC recommendation for CPT code
93886 overvalues the work involved.
We accepted the RUC recommendation
for CPT code 93880 of 0.80 with an
intraservice time of 15 minutes. CPT
code 93886 has an intraservice time of
17 minutes. Applying the work RVU to
time ratio of CPT code 93880 to the
intraservice time of CPT code 93886
(results in our interim final value of 0.91
for CPT code 93886.
ebenthall on DSK5SPTVN1PROD with $$_JOB
(21) Carotid Intima-Media Thickness
Ultrasound (CPT Code 93895)
For CY 2015, a new code, CPT code
93895, describes the work of using
carotid ultrasound to measure
atherosclerosis and quantify the intimamedia thickness. After review of this
code, we determined that it is used only
for screening and therefore, we are
assigning a PFS procedure status
indicator of N (Noncovered service) to
CPT code 93895.
(22) Doppler Flow Testing (CPT Code
93990)
For CY 2015, the RUC provided a
recommendation for CPT code 93990
which had been identified through the
High Volume Growth Services where
Medicare utilization increased by at
least 100 percent from 2006 to 2011.
The RUC recommended a work RVU of
0.60 for this service. Due to the
similarity of this service to duplex
scans, we are establishing RVUs for CPT
code 93990 that are consistent with
duplex scans with 10 minutes of
intraservice time; which we discussed
above in section E.4.18. We assigned it
an interim final work RVU of 0.50.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
(23) Electronic analysis of implanted
neurostimulator (CPT Codes 95971 and
95972)
For CY 2015, the RUC reviewed CPT
codes 95971 and 95972 because they
were identified by the High Volume
Growth Services screen which identifies
services in which Medicare utilization
increased by at least 100 percent from
2006 to 2011 screen. It is unclear to us
why CPT code 95973, the add-on code
to CPT code 95972, was not also
surveyed. We are valuing CPT code
95971 based upon the RUC
recommended work RVU of 0.78.
For CPT code 95972, we do not
believe that the RUC recommended
change in work RVU from 1.50 to 0.90
reflects the much more significant
change in intraservice time from 60
minutes to 23 minutes. Therefore, we
used a building block methodology to
develop a work RUV of 0.80.
Even though the RUC did not survey
95973, we believe we should review it
as part of this family. Not having a
survey or RUC recommendations, we
believe that the percent decrease in the
work RVU from the base code 95972
should apply to this code. Therefore, we
are establishing an interim final work
RVU of 0.49 for CPT code 95973.
We note that the descriptor for CPT
code 95972 was changed from ‘‘. . .
first hour’’ to ‘‘. . .up to one hour.’’ We
note that for Medicare purposes this
code should only be billed when a
majority of an hour is completed. We
would also note that the add-on code
should only be reported after a full 60
minutes of service is furnished.
The lack of a survey for CPT code
95973 along with the confusing
descriptor language and intraservice
time suggest the need for this family to
be returned to CPT for clarification of
the descriptor and then to the RUC for
resurvey.
(24) Negative Pressure Wound Therapy
(CPT Codes 97607, and 97608, and
HCPCS codes G0456 and G0457)
Prior to CY 2013, the codes used to
report negative pressure wound therapy
were CPT codes 97605 and 97606, both
of which were typically reported in
conjunction with durable medical
equipment that was paid separately. In
the CY 2013 final rule with comment
period, we created two HCPCS codes to
provide a payment mechanism for
negative pressure wound therapy
services furnished to beneficiaries using
equipment that is not paid for as
durable medical equipment: G0456
(Negative pressure wound therapy, (for
example, vacuum assisted drainage
collection) using a mechanically-
PO 00000
Frm 00124
Fmt 4701
Sfmt 4700
powered device, not durable medical
equipment, including provision of
cartridge and dressing(s), topical
application(s), wound assessment, and
instructions for ongoing care, per
session; total wound(s) surface area less
than or equal to 50 square centimeters)
and G0457 (Negative pressure wound
therapy, (for example, vacuum assisted
drainage collection) using a
mechanically-powered device, not
durable medical equipment, including
provision of cartridge and dressing(s),
topical application(s), wound
assessment, and instructions for ongoing
care, per session; total wound(s) surface
area greater than 50 sq cm).
For CY 2015, two new codes, CPT
codes 97607 and 97608, were created to
describe negative pressure wound
therapy with the use of a disposable
system. In addition, CPT codes 97605
and 97606 were revised to specify the
use of durable medical equipment.
Based upon these the revised coding
scheme for negative pressure wound
therapy, we are deleting the G-codes.
We are contractor pricing these codes
for CY 2015. CPT codes 97607 and
97608 will be designated ‘‘Sometimes
Therapy’’ on our Therapy Code List,
which is consistent with the G-codes.
The Therapy Code List is available at
https://www.cms.gov/Medicare/Billing/
TherapyServices/?redirect=/
therapyservices.’’
(25) Application of Topical Fluoride
Varnish (CPT Code 99188)
CPT Code 99188 is a new code for CY
2015 that describes the application of
topical fluoride varnish to teeth. Since
this code describes a service that
involves the care of teeth, it is excluded
from coverage under Medicare by
section 1862(a)(12) of the Act, which
provides ‘‘items and services in
connection with the care, treatment,
filling, removal, or replacement of teeth,
or structures directly supporting the
teeth are excluded from coverage.’’
Accordingly, we are assigning a PFS
procedure status indicator of N
(Noncovered service) to CPT code
99188.
(26) Advance Care Planning (CPT codes
99497 and 99498)
For CY 2015, the CPT Editorial Panel
created two new codes describing
advance care planning services: CPT
code 99497 (Advance care planning
including the explanation and
discussion of advance directives such as
standard forms (with completion of
such forms, when performed), by the
physician or other qualified health
professional; first 30 minutes, face-toface with the patient, family member(s)
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
and/or surrogate); and an add-CPT code
99498 (Advance care planning
including the explanation and
discussion of advance directives such as
standard forms (with completion of
such forms, when performed), by the
physician or other qualified health
professional; each additional 30 minutes
(List separately in addition to code for
primary procedure)). For CY 2015, we
are assigning a PFS status indicator of
‘‘I’’ (Not valid for Medicare purposes.
Medicare uses another code for the
reporting and payment of these
services.) to CPT codes 99497 and 99498
for CY 2015. However, we will consider
whether to pay for CPT codes 99497 and
99498 after we have had the opportunity
to go through notice and comment
rulemaking.
c. Establishing Interim Final Direct PE
RVUs for CY 2015
ebenthall on DSK5SPTVN1PROD with $$_JOB
The RUC provides CMS with
recommendations regarding direct PE
inputs, including clinical labor,
disposable supplies, and medical
equipment, for new, revised, and
potentially misvalued codes. We review
the RUC-recommended direct PE inputs
on a code-by-code basis, including the
recommended facility PE inputs and/or
nonfacility PE inputs. This review is
informed by both our clinical
assessment of the typical resource
requirements for furnishing the service
and our intention to maintain the
principles of accuracy and relativity in
the database. We determine whether we
agree with the RUC’s recommended
direct PE inputs for a service or, if we
disagree, we refine the PE inputs to
represent inputs that better reflect our
estimate of the PE resources required to
furnish the service in the facility and/
or nonfacility settings. We also confirm
that CPT codes should have facility and/
or nonfacility direct PE inputs and make
changes based on our clinical judgment
and any PFS payment policies that
would apply to the code.
We have accepted for CY 2015, as
interim final and without refinement,
the direct PE inputs based on the
recommendations submitted by the RUC
for the codes listed in Table 28. For the
remainder of the RUC’s direct PE
recommendations, we have accepted the
PE recommendations submitted by the
RUC as interim final, but with
refinements. These codes and the
refinements to their direct PE inputs are
listed in Table 31.
We note that the final CY 2015 PFS
direct PE input database reflects the
refined direct PE inputs that we are
adopting on an interim final basis for
20:15 Nov 12, 2014
Jkt 235001
TABLE 28—CY 2015 INTERIM FINAL
CODES WITH DIRECT PE INPUT
RECOMMENDATIONS
ACCEPTED
WITHOUT REFINEMENT
HCPCS
i. Background and Methodology
VerDate Sep<11>2014
CY 2015. That database is available
under downloads for the CY 2015 PFS
final rule with comment period on the
CMS Web site at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html. We
also note that the PE RVUs displayed in
Addenda B and C reflect the interim
final values and policies described in
this section. All PE RVUs adopted on an
interim final basis for CY 2015 are
included in Addendum C and are open
for comment in this final rule with
comment period.
11980
22512
22515
22856
27280
31620
33270
33271
33272
33273
33951
33952
33953
33954
33955
33956
33957
33958
33959
33962
33963
33964
33969
33984
33985
33986
33988
33989
36818
36819
36820
36821
36825
36830
36831
36832
36833
37218
43180
52441
55840
55842
55845
58541
58542
58543
58544
58570
58571
58572
58573
PO 00000
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
Frm 00125
Short Descriptor
Implant hormone pellet(s)
Vertebroplasty addl inject
Perq vertebral augmentation
Cerv artific diskectomy
Fusion of sacroiliac joint
Endobronchial us add-on
Ins/rep subq defibrillator
Insj subq impltbl dfb elctrd
Rmvl of subq defibrillator
Repos prev impltbl subq dfb
Ecmo/ecls insj prph cannula
Ecmo/ecls insj prph cannula
Ecmo/ecls insj prph cannula
Ecmo/ecls insj prph cannula
Ecmo/ecls insj ctr cannula
Ecmo/ecls insj ctr cannula
Ecmo/ecls repos perph cnula
Ecmo/ecls repos perph cnula
Ecmo/ecls repos perph cnula
Ecmo/ecls repos perph cnula
Ecmo/ecls repos perph cnula
Ecmo/ecls repos perph cnula
Ecmo/ecls rmvl perph cannula
Ecmo/ecls rmvl prph cannula
Ecmo/ecls rmvl ctr cannula
Ecmo/ecls rmvl ctr cannula
Insertion of left heart vent
Removal of left heart vent
Av fuse uppr arm cephalic
Av fuse uppr arm basilic
Av fusion/forearm vein
Av fusion direct any site
Artery-vein autograft
Artery-vein nonautograft
Open thrombect av fistula
Av fistula revision open
Av fistula revision
Stent placemt ante carotid
Esophagoscopy rigid trnso
Cystourethro w/implant
Extensive prostate surgery
Extensive prostate surgery
Extensive prostate surgery
Lsh uterus 250 g or less
Lsh w/t/o ut 250 g or less
Lsh uterus above 250 g
Lsh w/t/o uterus above 250 g
Tlh uterus 250 g or less
Tlh w/t/o 250 g or less
Tlh uterus over 250 g
Tlh w/t/o uterus over 250 g
Fmt 4701
Sfmt 4700
67671
TABLE 28—CY 2015 INTERIM FINAL
CODES WITH DIRECT PE INPUT
RECOMMENDATIONS
ACCEPTED
WITHOUT REFINEMENT—Continued
HCPCS
64486
64487
64488
64489
66179
66180
66184
66185
67036
67039
67040
67041
67042
67043
67255
70496
70498
76770
76775
76856
76857
77080
77316
77317
77318
88348
88356
91200
92145
92541
92542
92544
92545
93260
93261
93644
97610
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
Short Descriptor
Tap block unil by injection
Tap block uni by infusion
Tap block bi injection
Tap block bi by infusion
Aqueous shunt eye w/o graft
Aqueous shunt eye w/graft
Revision of aqueous shunt
Revise aqueous shunt eye
Removal of inner eye fluid
Laser treatment of retina
Laser treatment of retina
Vit for macular pucker
Vit for macular hole
Vit for membrane dissect
Reinforce/graft eye wall
Ct angiography head
Ct angiography neck
Us exam abdo back wall comp
Us exam abdo back wall lim
Us exam pelvic complete
Us exam pelvic limited
Dxa bone density axial
Brachytx isodose plan simple
Brachytx isodose intermed
Brachytx isodose complex
Electron microscopy
Analysis nerve
Liver elastography
Corneal hysteresis deter
Spontaneous nystagmus test
Positional nystagmus test
Optokinetic nystagmus test
Oscillating tracking test
Prgrmg dev eval impltbl sys
Interrogate subq defib
Electrophysiology evaluation
Low frequency non-thermal us
ii. Common Refinements
Table 31 details our refinements of
the RUC’s direct PE recommendations at
the code-specific level. In this section,
we discuss the general nature of some
common refinements and the reasons
for particular refinements.
(a) Changes in Physician Time
Some direct PE inputs are directly
affected by revisions in work time
described in section II.E.3.a. of this final
rule with comment period. We note that
for many codes, changes in the
intraservice portions of the work time
and changes in the number or level of
postoperative visits included in the
global periods result in corresponding
changes to direct PE inputs. We also
note that, for a significant number of
services, especially diagnostic tests, the
procedure time assumptions used in
determining direct PE inputs are
distinct from, and therefore not
dependent on, work intraservice time
assumptions. For these services, we do
not make refinements to the direct PE
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67672
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
inputs based on changes to estimated
work intraservice times.
Changes in Intraservice Work Time in
the Nonfacility Setting. For most codes
valued in the nonfacility setting, a
portion of the clinical labor time
allocated to the intraservice period
reflects minutes assigned for assisting
the practitioner with the procedure. To
the extent that we are refining the times
associated with the intraservice portion
of such procedures, we have adjusted
the corresponding intraservice clinical
labor minutes in the nonfacility setting.
For equipment associated with the
intraservice period in the nonfacility
setting, we generally allocate time based
on the typical number of minutes a
piece of equipment is being used, and
therefore, not available for use with
another patient during that period. In
general, we allocate these minutes based
on the description of typical clinical
labor activities. To the extent that we
are making changes in the clinical labor
times associated with the intraservice
portion of procedures, we have adjusted
the corresponding equipment minutes
associated with the codes.
Changes in the Number or Level of
Postoperative Office Visits in the Global
Period. For codes valued with
postservice office visits during a global
period, most of the clinical labor time
allocated to the postservice period
reflects a standard number of minutes
allocated for each of those visits. To the
extent that we are refining the number
or level of postoperative visits, we have
modified the clinical staff time in the
postservice period to reflect the change.
We note that until the global periods are
transitioned, consistent with other
policies finalized in this rule, we will
make these refinements. For codes
valued with postservice office visits
during a global period, we allocate
standard equipment for each of those
visits. To the extent that we are making
a change in the number or level of
postoperative visits associated with a
code, we have adjusted the
corresponding equipment minutes. For
codes valued with postservice office
visits during a global period, a certain
number of supply items are allocated for
each of those office visits. To the extent
that we are making a change in the
number of postoperative visits, we have
adjusted the corresponding supply item
quantities associated with the codes. We
note that many supply items associated
with postservice office visits are
allocated for each office visit (for
example, a minimum multi-specialty
visit pack (SA048) in the CY 2015 direct
PE input database). For these supply
items, the quantities in the direct PE
input database should reflect the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
number of office visits associated with
the code’s global period. However, some
supply items are associated with
postservice office visits but are only
allocated once during the global period
because they are typically used during
only one of the postservice office visits
(for example, pack, post-op incision care
(suture) (SA054) in the direct PE input
database). For these supply items, the
quantities in the direct PE input
database reflect that single quantity.
These refinements are reflected in the
final CY 2015 PFS direct PE input
database and detailed in Table 31.
(b) Equipment Minutes
In general, the equipment time inputs
reflect the sum of the times within the
intraservice period when a clinician is
using the piece of equipment, plus any
additional time the piece of equipment
is not available for use for another
patient due to its use during the
designated procedure. In cases where
equipment times included time for
clinical labor activities in the preservice period, we have refined these
times to remove the minutes associated
with these tasks, since the pre-service
period ends ‘‘when patient enters office/
facility for surgery/procedure.’’
Although some services include
equipment that is typically unavailable
during the entire clinical labor service
period, certain highly technical pieces
of equipment and equipment rooms are
less likely to be used by a clinician for
all tasks associated with a service, and
therefore, are typically available for
other patients during the preservice and
postservice components of the service
period. We adjust those equipment
times accordingly. We refer interested
stakeholders to our extensive discussion
of these policies in the CY 2012 PFS
final rule with comment period (76 FR
73182–73183) and in section II.G.2.b. of
this final rule with comment period. We
are refining the CY 2015 RUC direct PE
recommendations to conform to these
equipment time policies. These
refinements are reflected in the final CY
2015 PFS direct PE input database and
detailed in Table 31.
(c) Moderate Sedation Inputs
In the CY 2012 PFS final rule (76 FR
73043–73049), we finalized a standard
package of direct PE inputs for services
where moderate sedation is considered
inherent in the procedure. In section
II.A. of this final rule with comment
period, we finalized a refinement to the
standard package to include a stretcher
for the same length of time as the other
equipment items in the standard
package. We are refining the CY 2015
RUC direct PE recommendations to
PO 00000
Frm 00126
Fmt 4701
Sfmt 4700
conform to these policies. This includes
the removal of a power table where it
was included during the intraservice
period, as the stretcher takes the place
of the table. These refinements are
reflected in the final CY 2015 PFS direct
PE input database and detailed in Table
31.
(d) Standard Minutes for Clinical Labor
Tasks
In general, the preservice, intraservice
period, and postservice clinical labor
minutes associated with clinical labor
inputs in the direct PE input database
reflect the sum of particular tasks
described in the information that
accompanies the recommended direct
PE inputs on ‘‘PE worksheets.’’ For most
of these described tasks, there are a
standardized number of minutes,
depending on the type of procedure, its
typical setting, its global period, and the
other procedures with which it is
typically reported. At times, the RUC
recommends a number of minutes either
greater than or less than the time
typically allotted for certain tasks. In
those cases, CMS reviews the deviations
from the standards to assess whether
they are clinically appropriate. Where
the RUC-recommended exceptions are
not accepted, we refine the interim final
direct PE inputs to match the standard
times for those tasks. In addition, in
cases when a service is typically billed
with an E/M or other evaluation service,
we remove the preservice clinical labor
tasks so that the inputs are not
duplicative and reflect the resource
costs of furnishing the typical service.
In some cases the RUC
recommendations include additional
minutes described by a category called
‘‘other clinical activity,’’ or through the
addition of clinical labor tasks that are
different from those previously included
as standard. In these instances, CMS
reviews the tasks as described in the
recommendation to determine whether
they are already incorporated into the
total number of minutes based on the
standard tasks. Additionally, CMS
reviews these tasks in the context of the
kinds of tasks delineated for other
services under the PFS. For those tasks
that are duplicative or not separately
incorporated for other services, we do
not accept those additional clinical
labor tasks as direct inputs. For
example, as we have previously
discussed (78 FR 74308), we believe that
quality assurance documentation tasks
for services across the PFS are already
accounted for in the overall estimate of
clinical labor time. We do not believe
that it would serve the relativity of the
direct PE input database were additional
minutes added for each clinical task that
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
could be discretely described for every
code. These refinements are reflected in
the final CY 2015 PFS direct PE input
database and detailed in Table 31.
(e) New Supply and Equipment Items
The RUC generally recommends the
use of supply and equipment items that
already exist in the direct PE input
database for new, revised, and
potentially misvalued codes. Some
recommendations include supply or
equipment items that are not currently
in the direct PE input database. In these
cases, the RUC has historically
recommended a new item be created
and has facilitated CMS’s pricing of that
item by working with the specialty
societies to provide sales invoices to us.
We received invoices for several new
supply and equipment items for CY
2015. We have accepted the majority of
these items and added them to the
direct PE input database. Tables 29 and
30 detail the invoices received for new
and existing items in the direct PE
database. As discussed in section II.A.
of this final rule with comment period,
we encourage stakeholders to review the
prices associated with these new and
existing items to determine whether
these prices appear reasonable. Where
prices appear unreasonable, we
encourage stakeholders to provide
invoices that provide more accurate
pricing for these items in the direct PE
database. We remind stakeholders that
due to the budget neutral nature of the
PFS, increased prices for any items in
the direct PE database decrease the pool
of PE RVUs available to all other PFS
services. Tables 29 and 30 also include
the number of invoices received as well
as the number of nonfacility allowed
services for procedures that use these
equipment items. In cases where large
numbers of allowed services exist, we
question pricing the item based upon a
single invoice. We are concerned that
the single invoice may not be reflective
of typical costs for these items and
67673
encourage stakeholders to provide
additional invoices.
In some cases we cannot adequately
price a newly recommended item due to
inadequate information. In some cases,
no supporting information regarding the
price of the item has been included in
the recommendation to create a new
item. In other cases, the supporting
information does not demonstrate that
the item has been purchased at the
listed price (for example, price quotes
instead of paid invoices). In cases where
the information provided allowed us to
identify clinically appropriate proxy
items, we have used existing items as
proxies for the newly recommended
items. In other cases, we have included
the item in the direct PE input database
without an associated price. Although
including the item without an
associated price means that the item
does not contribute to the calculation of
the PE RVU for particular services, it
facilitates our ability to incorporate a
price once we are able to do so.
TABLE 29—INVOICES RECEIVED FOR NEW DIRECT PE INPUTS
Non-facility allowed
services for HCPCS
codes using this item (or
projected services for
new CPT codes*)
Item name
CMS code
Average price
20604, 20606, 20611 ..
ebenthall on DSK5SPTVN1PROD with $$_JOB
CPT/HCPCS codes
No. of
invoices
ultrasound transmission gel, sterile ................
(single use) .....................................................
10g IVAS drill ..................................................
10g cannulae ..................................................
foam underwrap ..............................................
SJ089
$1.71 ................
1
748248*
SD292
SD293
SG097
139.33 ..............
86.11 ................
0.0043 per inch
1
1
1
99*
99*
415513
SG098
0.018 per inch ..
1
415513
SM029
0.20 ..................
1
415513
EQ361
160,260.06 .......
6
107
ER099
13,379.57 .........
6
107
SC102
SD294
SD291
SC101
SA116
ED051
SL495
SL496
ED048
EQ366
EQ365
EP115
EQ363
EQ364
SL500
SA117
145.82 ..............
28.68 ................
775.00 ..............
12.81 ................
23.69 ................
11,570.00 .........
3.61 per test .....
4.27 per test .....
774.89 ..............
22,540.08 .........
1,714.00 ...........
13,119.00 .........
18,139.00 .........
9,585.14 ...........
0.10 per ul ........
4.00 ..................
5
4
10
4
1
12
1
1
1
1
1
2
1
1
1
1
107
107
12*
46851*
802*
297529*
917673*
51591*
641
641
641
19134
19134
19134
3376*
1380597
SL507
SL497
20.15 ................
8.57 per test .....
1
2
8440
8440
22512 ...........................
22512 ...........................
29200, 29240, 29260,
29280, 29520,
29530, 29540, 29550.
29200, 29240, 29260,
rigid strapping tape (15 yards) .......................
29280, 29520,
29530, 29540, 29550.
29200, 29240, 29260,
skin prep barrier wipes ...................................
29280, 29520,
29530, 29540, 29550.
31620 ........................... Flexible dual-channeled EBUS bronchoscope, with radial probe.
31620 ........................... Video system, Ultrasound (processor, digital
capture, monitor, printer, cart).
31620 ........................... EBUS, single use aspiration needle, 21 g .....
31620 ........................... Balloon for Bronchosopy Fiberscope .............
52441, 52442 ............... Urolift Implant and implantation device ..........
64486, 64488 ............... ultrasound needle ...........................................
64487, 64489 ............... continuous peripehral nerve block tray ..........
77063 ........................... multimodality software ....................................
88341 ........................... Anti CD45 Monoclonal Antibody ....................
88344 ........................... 34 Beta E12 ....................................................
88348 ........................... Digital Printer ..................................................
88348 ........................... Carbon Coater ................................................
88348 ........................... Diamond Milling Tool ......................................
88356, 88348 ............... Electron Microscopy Tissue processor ..........
88356, 88348 ............... Block face milling machine .............................
88356, 88348 ............... Glass Knife Breaker .......................................
88364 ........................... CMV DNA Probe Cocktail ..............................
88341, 88342, 88344,
Universal Detection Kit ...................................
88364, 88365,
88367, 88368,
88369, 88373.
88365 ........................... EBER positive control slide ............................
88365 ........................... (EBER) DNA Probe Cocktail ..........................
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00127
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
67674
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 29—INVOICES RECEIVED FOR NEW DIRECT PE INPUTS—Continued
Non-facility allowed
services for HCPCS
codes using this item (or
projected services for
new CPT codes*)
CPT/HCPCS codes
Item name
CMS code
Average price
No. of
invoices
88365, 88366, 88367,
88368, 88374, 88377.
88367, 88368 ...............
88369, 88373 ...............
88380, 88381 ...............
91200 ...........................
92145 ...........................
92541, 92542, 92544,
92545.
93702 ...........................
VP–2000 Processor ........................................
EP116
30,800.00 .........
1
228243
Kappa Probe Cocktails ...................................
Lambda Probe Cocktail ..................................
Surface Decontaminant (DNA Away) .............
Fibroscan ........................................................
Ocular Response Analyzer .............................
VNG Recording System .................................
SL498
SL499
SL494
ER101
EQ360
EQ367
0.10 per ul ........
0.10 per ul ........
0.07 per ml .......
124,950.00 .......
12,000.00 .........
29,607.50 .........
1
1
1
1
3
2
36634
24423*
6649
87*
Unknown
101139
BIS monitoring system (bioimpedance spectroscopy).
electrode, BIS (bioimpedance spectroscopy)
Beck Youth Inventory, Second Edition (BYI–
II); Combination Inventory Booklet.
MIST Therapy System ....................................
MIST Therapy Cart .........................................
kit, low frequency ultrasound wound therapy
(MIST).
CavityShield 5% Varnish .25mL .....................
HBOT air break breathing apparatus demand
system (hoses, masks, penetrator and demand valve).
EQ359
3,316.93 ...........
1
Unknown
SD290
SK119
28.33 ................
1.96 per booklet
1
1
Unknown
Unknown
EQ372
EQ368
SA119
28,000.00 .........
1,250.00 ...........
63.33 ................
2
1
3
2*
2*
2*
SH106
EQ362
0.91 ..................
986.00 ..............
1
1
Unknown
153044*
93702 ...........................
96127 ...........................
97610 ...........................
97610 ...........................
97610 ...........................
99188 ...........................
G0277 ..........................
TABLE 30—INVOICES RECEIVED FOR EXISTING DIRECT PE INPUTS
CPT/HCPCS
codes
20983,
47383.
20983,
47383.
20983,
47383.
31627 ..........
31627 ..........
64561 ..........
88348 ..........
ebenthall on DSK5SPTVN1PROD with $$_JOB
88348,
88356.
G0277 ..........
Item name
CMS code
Current price
Updated price
% Change
cryosurgery system (for tumor
ablation).
gas, argon ..........
EQ302
missing ......................
$37,500.00 ................
....................
2
22 *
SD227
$0.25 per cubic foot ..
0.32 per cubic foot ....
28
1
22 *
gas, helium .........
SD079
0.25 per cubic foot ....
0.57 per cubic foot ....
128
1
22 *
system, navigational bronchoscopy
(superDimension).
kit, locatable
guide, ext.
working channel, w-b-scope
adapter.
kit, percutaneous
neuro test stimulation.
camera, digital
system, for
electron microscopy.
microtome, ultra
EQ326
137,800.00 ................
189,327.66 ................
37
4
37
SA097
995.00 .......................
1,063.67 ....................
7
3
37
SA022
305.00 .......................
420.00 .......................
38
1
8229
ED006
41,000.00 ..................
82,000.00 ..................
100
1
641
ER043
25,950.00 ..................
34,379.00 ..................
32
1
19134
HBOT
(hyperbaric oxygen therapy)
monochamber,
incl. gurney
and integrated
grounding assembly.
EQ131
125,000.00 ................
127,017.98 ................
2
1
153044 *
* New procedure—Projected volume.
VerDate Sep<11>2014
Non-facility allowed services
for HCPCS
codes using
this item
No. of
invoices
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00128
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
(f) Recommended Items That Are Not
Direct PE Inputs
In some cases, the recommended
direct PE inputs included items that are
not clinical labor, disposable supplies,
or medical equipment resources. We
have addressed these kinds of
recommendations in previous
rulemaking and in sections II.G.2.b. and
II.B.4.a. of this final rule with comment
period. Refinements to adjust for these
recommended inputs are reflected in the
final CY 2015 PFS direct PE input
database and detailed in Table 31.
(g) Film-to-Digital Migration
As discussed in section II.A.3 of this
final rule with comment period, we are
finalizing our policy to remove
equipment and supply inputs associated
with film technology from the direct PE
database. Since the recommendations
we received for 2015 were prepared
before the transition occurred, in some
cases, the RUC recommendations
included film inputs. Where
recommendations included these
inputs, we have removed these inputs
and replaced them with ‘‘PACS
workstation proxy’’ as described in
section II.A.3 of this final rule with
comment period. Since the film-todigital transition results from our
acceptance of a RUC recommendation,
we do not consider the removal of these
items to be refinements of RUC
recommendations, and therefore do not
include them in Table 31.
(h) Pre-Service and Post-Service Tasks
for Add-On Codes
In general, we believe that certain preservice and post-service tasks are not
repeated for services reported using
add-on codes. In some cases, we also
believe that the time for certain
equipment items are not duplicated for
add-on codes. In these cases, we
removed the time associated with those
tasks and/or equipment items from
those codes. These refinements appear
in Table 31.
ebenthall on DSK5SPTVN1PROD with $$_JOB
iii. Code-Specific Refinements
(a) Rib Fractures (CPT Codes 21811,
21812, and 21813)
For the newly created rib fracture
codes, which are frequently furnished as
emergency surgeries, the RUC did not
include time for the standard preservice activities ‘‘Provide pre-service
education/obtain consent’’ and ‘‘Followup phone calls & prescriptions.’’
However, the RUC recommendation
included time for pre-service activities
‘‘Complete pre-service diagnostic &
referral forms,’’ ‘‘Coordinate pre-surgery
services’’, and ‘‘Schedule space and
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
equipment in facility.’’ Since these
codes would typically be provided as
emergency surgeries, we question
whether these tasks would typically be
performed.
We reviewed other emergency
procedures in the PFS to determine
whether pre-service clinical labor
activities were typically included in the
PE worksheets. We found that the
recommendations for these procedures
were inconsistent. Therefore, we will
not remove the time allocated for these
clinical labor activities at this time.
However, we believe that for emergency
procedures, none of the pre-service
tasks listed above would typically be
performed. We seek comment to clarify
this issue, and plan to consider this
issue in future rulemaking.
As discussed earlier in this section of
this final rule with comment period, we
have valued CPT codes 21811, 21812,
and 21813 as 0-day globals. We have
therefore removed direct PE inputs
associated with the postoperative visits.
(b) Percutaneous Vertebroplasty and
Augmentation (CPT Codes 22510,
22511, 22512, 22513, 22514, and 22515)
The RUC recommendation regarding
add-on CPT code 22512 (Percutaneous
vertebroplasty (bone biopsy included
when performed), 1 vertebral body,
unilateral or bilateral injection,
inclusive of all imaging guidance, each
additional cervicothoracic or
lumbosacral vertebral body)) included
new supply item ‘‘10g IVAS drill.’’ We
note that the recommendations for the
base codes did not contain this supply
item, and the vertebroplasty kit does not
appear to contain this drill either. We
do not understand why the drill would
be required for the add-on code when it
is not required for the base code.
Therefore, we will not include supply
item ‘‘10g IVAS drill’’ in CPT code
22512 at this time.
(c) Endobronchial Ultrasound (EBUS)
(CPT Code 31620)
As indicated earlier in this section of
this final rule with comment period, we
are maintaining the CY 2014 work RVU
for CPT code 31620 in light of our
concerns regarding coding structure. As
such, we are maintaining the CY 2014
direct PE inputs for 31620 as well.
(d) Breast Tomosynthesis (CPT Codes
77061, 77062, and 77063)
For CY 2015, the CPT Editorial Panel
created three codes to describe digital
breast tomosynthesis services:
77061(Digital breast tomosynthesis;
unilateral), 77062 (Digital breast
tomosynthesis; bilateral) and 77063
(Screening digital breast tomosynthesis,
PO 00000
Frm 00129
Fmt 4701
Sfmt 4700
67675
bilateral (List separately in addition to
code for primary procedure)). For these
newly created codes, the RUC
recommended creating a new
equipment item, ‘‘room, breast
tomosynthesis’’, at a price of $667,669,
as well as a list of items contained in the
room. We believe that several of the
items included in the room are not
appropriately characterized as direct
costs. We also believe that the creation
of rooms sometimes causes confusion
when items in the room are also
included as stand-alone PE inputs, as
specialty societies do not consider the
items included in the room when
preparing the PE worksheets. Further,
we believe that the prices for the rooms
sometimes result in less transparency,
as prices for items within the room tend
to remain static over time. Therefore, we
are not creating this new equipment
item, but will instead include the
individual equipment items that we
believe are appropriately characterized
as direct costs.
The price for the digital breast
tomosynthesis unit indicated on the
invoice received by the RUC was
$498,412. We received many invoices
for this equipment item with an average
price of $381,380. Therefore, we will
create a new equipment item ‘‘DBT
unit’’, at a price of $381,380.
The RUC also recommended
including a new equipment item,
‘‘PACS cache’’, for these procedures. We
do not believe that digital storage
constitutes a direct cost, as it is not
individually allocable to an individual
patient for a particular service. .
Therefore, we will not add this new
equipment item to the direct PE
database.
(e) Radiation Treatment (CPT Codes
77385, 77386, 77387, 77402, 77407,
77412)
For CY 2015, the CPT Editorial Panel
revised the set of codes that describe
radiation treatment delivery services.
These revisions included the addition
and deletion of several codes and the
development of new guidelines and
coding instructions. Due to the
significant code restructuring and
potential for changes in payment, some
specialty societies representing
providers of radiation treatment services
have requested that we delay
implementation of the new code set. We
believe that given the large scale of the
changes in this code set restructuring, in
the context of our upcoming revised
process for valuing new, revised, and
potentially misvalued codes, it is
prudent to propose the values for the
revised code set in the CY 2016 rule
E:\FR\FM\13NOR2.SGM
13NOR2
67676
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
with opportunity for public comment
prior to establishing payment rates.
(f) Immunohistochemistry (CPT Codes
88341, 88342, and 88344)
The RUC recommended including
supply item ‘‘UltraView Universal DAB
Detection Kit’’ (SL488) for CPT codes
88341, 88342, and 88344, which is
priced at $10.49 per kit, and ‘‘UltraView
Universal Alkaline Phosphatase Red
Detection Kit’’, which is priced at
$20.64. We noted that for other similar
services, CPT codes 88364, 88365,
88367, 88368, 88369, and 88373, the
RUC recommended including supply
item ‘‘Universal Detection Kit’’ (SA117),
which is priced at $4.00 per kit. After
reviewing information about these two
kits, we believe that functions provided
by SL488 and SL489 are also provided
by SA117. The recommendations did
not explain why the more expensive kit
was necessary for 88341, 88342, and
88344 when the less expensive kit was
sufficient for CPT codes 88364, 88365,
88367, 88368, 88369, and 88373. Absent
any rationale for the use of the more
expensive kit, we are including SA117
for 88341, 88342, and 88344 in place of
SL488.
ebenthall on DSK5SPTVN1PROD with $$_JOB
(g) Electron Microscopy (CPT Code
88348)
The RUC recommended including a
new supply item, ‘‘diamond milling
tool’’, for use with CPT code 88348.
However, upon reviewing the invoice,
we believe that ‘‘diamond milling tool’’
is more appropriately characterized as
equipment. We have therefore created
an equipment item for this tool, as listed
in Table 29.
(h) Morphometric Analysis (CPT Codes
88364, 88365, 88366, 88367, 88373,
88374, 88377, 88368, and 88369)
The CPT Editorial Panel revised the in
situ hybridization codes (88365, 88367,
and 88368) and created three new addon codes for reporting each additional
separately identifiable probe per slide.
The RUC reviewed CPT codes 88365,
88367, and 88368, among other services
in this family, in October 2013 and
recommended direct inputs for these
procedures, including supply item ‘‘kit,
FISH paraffin pretreatment’’ (SL195),
with quantities of 1 unit for CPT code
88365, 0.75 units for CPT code 88367,
and 1 unit for CPT code 88368.
After the CY 2014 PFS final rule with
comment period was published, the
specialty societies determined that
additional clarification was necessary,
and requested that the CPT Editorial
Panel review the entire family again.
The CPT editorial panel added three
new codes for ‘‘each multiplex probe
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
stain procedure.’’ The specialty societies
then resurveyed these procedures. The
RUC reviewed the entire family at the
April 2014 meeting and recommended
supply item SL195 with a quantity of 2
units for CPT code 88365, 1.4 units for
CPT code 88367, and 2 units for CPT
code 88368. These quantities are double
what the RUC recommended to us in
October 2013, which was 1 unit for CPT
code 88365, 0.75 units for CPT code
88367, and one unit for CPT code
88368. Without an explanation for this
significant change, we are including
SL195 with the following quantities: 1
unit for CPT code 88365, 0.75 units for
CPT code 88367, and 1 unit for CPT
code 88368. Similarly, for add-on
services CPT codes 88364, 88366,
88369, 88373, 88374, and 88377, more
than one unit of SL195 was included.
We believe that the unit of the kit
should be consistent between the base
code and the add-on code. We will
therefore include 1 unit of SL195 for
CPT codes 88364, 88366, 88369, and
88377, and 0.75 units for CPT codes
88373 and 88374. We are also interested
in learning more about why a partial kit
would be used in furnishing the typical
service.
CPT codes 88374 and 88377, which
are add-on codes, contain more than one
unit of supply item ‘‘kit, HER–2/neu
DNA Probe’’ (SL196). Because these
codes describe a service that includes a
single specimen with one stain, we do
not understand why more than one kit
would be required. We have therefore
included a unit of 1 for SL196 in CPT
codes 88374 and 88377.
We also believe that the units of
positive control slides and negative
control slides should be consistent
throughout this entire family. We note
that CPT codes 88367, 88373, and 88374
included a recommended 0.2 units of
positive and/or negative control slide;
supply items SL118 and SL119 for CPT
code 88367, supply items SL120 and
SL121 for CPT code 88373, and supply
items SL184 and SL185 for CPT code
88374.) However, for CPT codes 88368,
88369, and 88377, the recommendation
included 0.5 units of the positive and/
or negative control slide (supply item
SL112 for CPT codes 88368 and 88369,
and supply items SL184 and SL185 for
CPT code 88377). No rationale was
provided for why a greater quantity of
the control slide would be required.
Therefore, we will include 0.2 units of
positive and/or negative control slides,
as appropriate, to maintain consistency
throughout this family of codes.
As with the positive and negative
control slides, we believe that the
number of units of supply item SL498
(‘‘Kappa probe cocktails’’) and SL499
PO 00000
Frm 00130
Fmt 4701
Sfmt 4700
(Lambda probe cocktails’’) should be
consistent across procedures. The
recommendations for CPT codes 88367
and 88373 contain 28 ul of SL498 for
88367 and 27 ul of SL499 for 88373.
Therefore, to maintain consistency, we
refined the units of SL498 for CPT code
88368 and SL499 for CPT code 88369 to
28 ul.
The RUC recommended a quantity of
1.6 for SL497 ‘‘(EBER) DNA Probe
Cocktail’’ for CPT code 88365. Since
this procedure describes a single stain,
and the stain needs to be added to the
positive control slide and the specimen
slide, we believe that a quantity of 2 is
more appropriate. We have therefore
included 2 units of SL497 for CPT code
88365.
The RUC recommendation also
included a new equipment item ‘‘VP–
2000 processor’’ (EP116). Among the
purposes of this equipment item is to
reduce the amount of technician time
needed to complete the clinical labor
task. However, in the recommendations
we received, rather than the clinical
labor time for these codes decreasing
with the addition of this new equipment
item, the RUC recommended increased
clinical labor times associated with this
task for CPT codes 88365, 88366, 88368,
and 88377 increased. We are unable to
reconcile as typical the new equipment
item, which is intended to reduce
technician time, with the increased
technician time for this same clinical
labor task. Therefore, we will not
allocate time for equipment item ‘‘VP–
2000 processor’’ (EP116) in CPT codes
88365, 88366, 88368, and 88377.
(h) Microdissection (CPT Codes 88380
and 88381)
In reviewing the RUC
recommendations for CPT code 88380,
the work vignette indicated that the
microdissection is performed by the
pathologist. However, the PE worksheet
also included several subtasks of
‘‘Microdissect each stained slide
sequentially while reviewing H and E
stained slide’’ that are performed by the
cytotechnologist. Since we do not
believe that both the pathologist and the
cytotechnologist are completing these
tasks, we have refined out the lines
associated with the specific tasks we
believe are completed by the
pathologist. Table 31 details our
refinements to the clinical labor tasks.
(j) Interventional Transesophageal
Echocardiography (TEE) (CPT Codes
93312 and 93314)
CPT code 93314 describes a service in
which the acquisition and interpretation
of images is furnished by a different
practitioner than the placement of the
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
probe. CPT code 93312 includes all
services encompassed by CPT code
93314 and included a recommendation
for 30 minutes of assist physician time.
We do not believe that CPT code 93314
should have more clinical labor than
CPT code 93312, which is the more
extensive code. We have therefore
refined this time to 30 minutes, which
is the same as the time allocated to
93312. We also note that the time
allocated to equipment item ‘‘room,
ultrasound, vascular’’ (EL016) was
affected by this refinement.
ebenthall on DSK5SPTVN1PROD with $$_JOB
(k) Hyperbaric Oxygen Therapy (HBOT)
(HCPCS Code G0277)
We received a RUC recommendation
for CPT code 99183 (Physician or other
qualified health care professional
attendance and supervision of
hyperbaric oxygen therapy, per session),
which included significant increases to
the direct PE inputs, which assumes a
treatment time of 120 minutes.
Currently, CPT code 99183 is used for
both the professional attendance and
supervision and the actual treatment
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
delivery. Stakeholders have pointed out
that although we include the PE inputs
for treatment delivery in this code, the
descriptor describes only attendance
and supervision. We note that under the
OPPS, the treatment is reported using
separate treatment code C1300
(Hyperbaric oxygen under pressure, full
body chamber, per 30 minute interval).
After considering this issue, we believe
the OPPS approach would also be
appropriate for the PFS. We are
therefore creating a G-code to report the
treatment delivery and to maintain
consistency with the OPPS coding. We
will use the same descriptor as
previously used for OPPS code C1300
for a timed 30-minute code, which can
then be used across settings. To value
this G-code, we used the RUC
recommended direct PE inputs for
99183 and adjusted them to align with
the 30 minute treatment interval.
In reviewing the recommended direct
PE inputs, we observed that the quantity
of oxygen increased significantly
relative to the previous value. To better
understand this change, we reviewed
PO 00000
Frm 00131
Fmt 4701
Sfmt 4700
67677
the instruction manual for the most
commonly used HBOT chamber, which
provide guidance regarding the quantity
of Oxygen used. Based on our review,
we determined that 12,000, rather than
47,000, was the typical number of units.
Therefore, in aligning the direct PE
inputs as described above, we first
adjusted the units of oxygen to 12,000
for the recommended 120 minute time,
and subsequently adjusted it to align
with the 30 minute G-code.
(l) EOG VNG (CPT code 92543)
As described earlier in this section of
this final rule with comment period, we
are maintaining the CY 2014 work RVU
for CPT code 92543 due to possible
confusion among survey respondents.
Similarly, we are also maintaining the
CY 2014 direct PE inputs for 92543.
These refinements, as well as other
applicable standard and common
refinements for these codes, are
reflected in the final CY 2015 PFS direct
PE input database and detailed in Table
31.
BILLING CODE 4120–01–P
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67678
VerDate Sep<11>2014
HCPCS
Code
HCPCSCode
Description
Input
Code
Jkt 235001
3
0
Typically billed with an ElM
service
$-1.11
3
0
Typically billed with an ElM
service
$-1.11
3
0
Typically billed with an ElM
service
$-1.11
3
0
Typically billed with an ElM
service
$-1.11
3
0
Typically billed with an E/M
service
$-1.11
Drain/inj
joint/bursa w/us
3
0
Typically billed with an ElM
service
$-1.11
Standard equipment and time
for moderate sedation
Standard equipment and time
for moderate sedation
Refined equipment time to
conform to established
policies for highly technical
equipment.
Standard equipment and time
for moderate sedation
$0.68
Standard equipment and time
for moderate sedation
Refmed equipment time to
conform to established
$-0.01
F
L037D
RN/LPN/MTA
NF
RN/LPN/MTA
F
L037D
RNILPN/MTA
NF
RN/LPN/MTA
F
L037D
RN/LPN/MTA
NF
stretcher
NF
60
193
EF027
20611
RN/LPN/MTA
EF018
Drain/inj
joint/bursa w/us
E:\FR\FM\13NOR2.SGM
13NOR2
CMS
Refinement
(minor
qty)
L037D
20606
Drain/inj
joint/bursa w/us
Fmt 4701
Sfmt 4725
Conduct phone
calls/call in
prescriptions
Conduct phone
calls/call in
prescriptions
Conduct phone
calls/call in
prescriptions
Conduct phone
calls/call in
prescriptions
Conduct phone
calls/call in
prescriptions
Conduct phone
calls/call in
prescriptions
RUC
Recommendation or
current value
(minor qty)
L037D
20604
PO 00000
Frm 00132
NF/F/PO
Labor Activity
(where applicable)
L037D
table, instrument,
mobile
room, CT
NF
134
193
NF
134
133
ECG, 3-channel
(with Sp02,
NIBP, temp,
resp)
IV infusion
pump
light, exam
NF
194
193
NF
194
193
NF
194
133
EL007
20983
Ablate bone
tumor(s) perq
EQOll
EQ032
EQ168
ER13NO14.019</GPH>
Input Code
Description
Comment
Direct
Costs
Change
$0.08
$-4.87
$-0.01
$-0.26
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
TABLE 31: CY 2015 INTERIM FINAL CODES WITH DIRECT PE INPUT RECOMMENDATIONS
ACCEPTED WITH REFINEMENTS
ebenthall on DSK5SPTVN1PROD with $$_JOB
VerDate Sep<11>2014
Input
Code
Input Code
Description
NF/F/PO
Labor Activity
(where applicable)
RUC
Recommendation or
current value
(min or qty)
CMS
Refinement
(min or
qty)
Direct
Costs
Change
policies for non-highly
technical equipment.
134
133
12
0
PO
72
0
table, power
PO
72
0
PO
2
0
SA0 52
PO
1
E:\FR\FM\13NOR2.SGM
L037D
pack, minimum
multi-specialty
visit
pack, post-op
incision care
(staple)
RN/LPN/MTA
F
EF014
light, surgical
EF031
SA048
PO 00000
Frm 00133
Fmt 4701
21812
13NOR2
Treatment of rib
fracture
RN/LPN/MTA
F
light, surgical
EF031
SA048
Optx of rib fx
w/fixj scope
NF
EF014
21811
cryosurgery
system (for
tumor ablation)
L037D
Jkt 235001
EQ302
SA0 52
L037D
21813
Treatment of rib
fracture
Discharge day
management
99238 --12
minutes
Refmed equipment time to
conform to established
policies for highly technical
equipment.
Post-operative visits removed;
see preamble text.
$-0.10
$-4.44
Post-operative visits removed;
see preamble text.
Post-operative visits removed;
see preamble text.
Post-operative visits removed;
see preamble text.
$-0.72
0
Post-operative visits removed;
see preamble text.
$-5.06
12
0
Post-operative visits removed;
see preamble text.
$-4.44
PO
99
0
$-0.99
table, power
PO
99
0
pack, minimum
multi-specialty
visit
pack, post-op
incision care
(staple)
RNILPN/MTA
PO
3
0
Post-operative visits removed;
see preamble text.
Post-operative visits removed;
see preamble text.
Post-operative visits removed;
see preamble text.
PO
1
0
Post-operative visits removed;
see preamble text.
$-5.06
12
0
Post-operative visits removed;
see preamble text.
$-4.44
F
Discharge day
management
99238 --12
minutes
Discharge day
management
99238 --12
minutes
$-1.18
$-2.29
$-1.62
$-3.43
67679
ER13NO14.020</GPH>
Comment
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCSCode
Description
Sfmt 4725
20:15 Nov 12, 2014
HCPCS
Code
ebenthall on DSK5SPTVN1PROD with $$_JOB
67680
VerDate Sep<11>2014
HCPCSCode
Description
Input Code
Description
NF/F/PO
Labor Activity
(where applicable)
RUC
Recommendation or
current value
(min or qty)
CMS
Refinement
(min or
qty)
Comment
Frm 00134
Fmt 4701
22513
Perq vertebral
augmentation
table, power
PO
99
0
pack, minimum
multi-specialty
visit
pack, post-op
incision care
(staple)
pack, post-op
incision care
(suture & staple)
PO
3
0
PO
1
0
Post-operative visits removed;
see preamble text.
$-5.06
NF
1
0
No justification provided for
use of staple and suture pack.
Suture pack sufficient in the
typical procedure.
No justification provided for
use of staple and suture pack.
Suture pack sufficient in the
typical procedure.
No justification provided for
use of staple and suture pack.
Suture pack sufficient in the
typical procedure.
No justification provided for
use of staple and suture pack.
Suture pack sufficient in the
typical procedure.
Aligned clinical1abor
discharge day management
time with the work time
discharge day code.
Typically billed with an ElM
or other evaluation service
$-6.11
Perq vertebral
augmentation
27279
Strapping of
shoulder
Typically billed with an ElM
or other evaluation service
$-0.69
NF
0
1
pack, post-op
incision care
(suture & staple)
NF
1
0
SA0 54
pack, post-op
incision care
(suture)
NF
0
1
RNILPN/MTA
F
12
6
L023A
Physical Therapy
Aide
NF
3
0
L023A
Physical Therapy
Aide
NF
3
0
Arthrodesis
sacroiliac joint
Strapping of
chest
pack, post-op
incision care
(suture)
L037D
22514
SA0 54
SA0 53
29240
13NOR2
0
SA0 53
Sfmt 4725
E:\FR\FM\13NOR2.SGM
99
SA048
PO 00000
PO
EF031
Jkt 235001
light, surgical
SA0 52
Discharge day
management
99238 --12
minutes
Greet patient and
provide gowning
Greet patient and
provide gowning
Post-operative visits removed;
see preamble text.
Post-operative visits removed;
see preamble text.
Post-operative visits removed;
see preamble text.
Direct
Costs
Change
EF014
29200
ER13NO14.021</GPH>
Input
Code
$-0.99
$-1.62
$-3.43
$4.91
$-6.11
$4.91
$-2.22
$-0.69
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
HCPCS
Code
ebenthall on DSK5SPTVN1PROD with $$_JOB
VerDate Sep<11>2014
29260
Strapping of
elbow or wrist
29280
Strapping of
hand or fmger
PO 00000
29520
Strapping of hip
Frm 00135
29530
Strapping of
knee
29540
29550
Input
Code
Input Code
Description
NFIF/PO
Labor Activity
(where applicable)
CMS
Refinement
(min or
qty)
0
Jkt 235001
Fmt 4701
Physical Therapy
Aide
NF
Greet patient and
provide gowning
L023A
Physical Therapy
Aide
NF
Greet patient and
provide gowning
3
L023A
Physical Therapy
Aide
NF
Greet patient and
provide gowning
L023A
Physical Therapy
Aide
NF
Strapping of
ankle and/or ft
L023A
Physical Therapy
Aide
Strapping of
toes
L023A
EF027
Direct
Costs
Change
E:\FR\FM\13NOR2.SGM
Typically billed with an ElM
or other evaluation service
$-0.69
0
Typically billed with an ElM
or other evaluation service
$-0.69
3
0
Typically billed with an ElM
or other evaluation service
$-0.69
Greet patient and
provide gowning
3
0
Typically billed with an ElM
or other evaluation service
$-0.69
NF
Greet patient and
provide gowning
3
0
Typically billed with an ElM
or other evaluation service
$-0.69
Physical Therapy
Aide
NF
Greet patient and
provide gowning
3
0
Typically billed with an ElM
or other evaluation service
$-0.69
table, instrument,
mobile
ECG, 3-channel
(with Sp02,
NIBP, temp,
resp)
IV infusion
pump
RN/Respiratory
Therapist
NF
45
30
$-0.02
NF
45
30
Standard equipment and time
for moderate sedation
Standard equipment and time
for moderate sedation
NF
45
30
$-0.09
2
0
Standard equipment and time
for moderate sedation
Add-on code; no additional
time required to prepare and
position patient
L037D
Sfmt 4725
L023A
Comment
RNILPN/MTA
F
12
0
$-4.44
L037D
RNILPN/MTA
F
0
15
Aligned clinical labor
discharge day management
time with the work time
discharge day code.
Aligned clinical labor
discharge day management
time with the work time
discharge day code.
EQOll
31627
Navigational
bronchoscopy
EQ032
L047C
13NOR2
33418
Repairtcat
mitral valve
NF
Prepare and
position pt/
monitor pt/ set up
IV
Discharge day
management
99238 --12
minutes
Discharge day
management
99239 -- 15
minutes
$-0.21
$-0.94
$5.55
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCSCode
Description
20:15 Nov 12, 2014
HCPCS
Code
RUC
Recommendation or
current value
(min or qty)
3
67681
ER13NO14.022</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
67682
VerDate Sep<11>2014
Jkt 235001
PO 00000
HCPCSCode
Description
33965
Ecmo/ecls rmvl
perph cannula
33966
Ecmo/ecls rmvl
prph cannula
36475
Endovenous rf
1st vein
Input
Code
NFIF/PO
Labor Activity
(where applicable)
Schedule space
and equipment in
facility
Schedule space
and equipment in
facility
Fmt 4701
F
L051A
RN
F
EF019
stretcher chair
NF
room,
ultrasound,
general
radio frequency
generator
(vascular)
Vascular
Technologist
NF
L054A
Vascular
Technologist
NF
EF019
stretcher chair
EL015
room,
ultrasound,
general
laser,
en dovascular
ablation (ELVS)
Vascular
Technologist
EQ215
L054A
36476
Sfmt 4725
E:\FR\FM\13NOR2.SGM
RN
EL015
Frm 00136
L051A
36478
Endovenous rf
vein add-on
Endovenous
laser 1st vein
13NOR2
EQ160
36479
Endovenous
laser vein addon
L054A
ER13NO14.023</GPH>
Input Code
Description
CMS
Refinement
(min or
qty)
5
0
Comment
Direct
Costs
Change
Standard inputs for procedures
with 90 day global periods
$2.55
5
Standard inputs for procedures
with 90 day global periods
$2.55
30
31
$0.01
NF
32
30
NF
32
30
Review
examination with
interpreting MD
1
0
Technologist QCs
images US
machine,
checking for all
images, reformats,
and dose page
1
0
Refmed equipment time to
conform to clinical labor time.
Refmed equipment time to
conform to changes in clinical
labor time.
Refmed equipment time to
conform to changes in clinical
labor time.
Add-on code; no additional
time required for clinical labor
tasks associated with digital
imaging
Add-on code; no additional
time required for clinical labor
tasks associated with digital
imaging
NF
30
31
Refined equipment time to
conform to clinical labor
time.
$0.01
NF
32
30
$-2.80
NF
32
30
1
0
Refined equipment time to
conform to changes in clinical
labor time.
Refined equipment time to
conform to changes in clinical
labor time.
Add-on code; no additional
time required for clinical labor
tasks associated with digital
imaging
NF
Review
examination with
interpreting MD
$-2.80
$-0.19
$-0.54
$-0.54
$-0.33
$-0.54
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
HCPCS
Code
RUC
Recommendation or
current value
(min or qty)
0
ebenthall on DSK5SPTVN1PROD with $$_JOB
VerDate Sep<11>2014
HCPCSCode
Description
Input
Code
Input Code
Description
NF/F/PO
Labor Activity
(where applicable)
Technologist QCs
images US
machine,
checking for all
images, reformats,
and dose page
CMS
Refinement
(min or
qty)
1
0
Add-on code; no additional
time required for clinical labor
tasks associated with digital
imaging
$-0.54
Standard equipment and time
for moderate sedation
Standard equipment and time
for moderate sedation
Standard equipment and time
for moderate sedation
$-0.39
Vascular
Technologist
NF
EF018
stretcher
NF
240
166
EF027
table, instrument,
mobile
ECG, 3-channel
(with Sp02,
NIBP, temp,
resp)
IV infusion
pump
light, exam
NF
104
166
NF
164
166
NF
164
166
NF
164
106
EF027
table, instrument,
mobile
NF
0
25
EF031
table, power
NF
0
25
EQ170
light, fiberoptic
headlight wsource
NF
0
25
ES018
fiberscope,
flexible,
cystoscopy
NF
0
25
Jkt 235001
L054A
PO 00000
Frm 00137
EQOll
Fmt 4701
47383
Perq abltj lvr
cryoablation
EQ032
Sfmt 4725
EQ168
E:\FR\FM\13NOR2.SGM
13NOR2
52442
Cystourethro
w/addl implant
Comment
Standard equipment and time
for moderate sedation
Refined equipment time to
conform to established
policies for non-highly
technical equipment.
No equipment times were
included; aligned equipment
time with assist physician
time.
No equipment times were
included; aligned equipment
time with assist physician
time.
No equipment times were
included; aligned equipment
time with assist physician
time.
No equipment times were
included; aligned equipment
time with assist physician
time.
Direct
Costs
Change
$0.09
$0.03
$0.01
$-0.25
$0.04
$0.41
$0.20
$1.07
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
HCPCS
Code
RUC
Recommendation or
current value
(min or qty)
67683
ER13NO14.024</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
67684
VerDate Sep<11>2014
Assist physician
in performing
procedure
L041B
Radiologic
Technologist
NF
Assist physician
in performing
procedure
stretcher
NF
L037D
RNILPN/MTA
NF
L041B
62302
62303
Radiologic
Technologist
NF
stretcher
NF
Myelography
lumbar
injection
Myelography
lumbar
injection
L037D
RNILPN/MTA
NF
13NOR2
62304
ER13NO14.025</GPH>
NF/F/PO
Labor Activity
(where applicable)
Myelography
lumbar
injection
Comment
Direct
Costs
Change
No equipment times were
included; aligned equipment
time with assist physician
time.
$3.22
48
Refined equipment time to
conform to established
policies for non-highly
technical equipment.
$-0.06
26
13
$-4.81
0
13
60
64
Assist physician
in performing
procedure
25
13
Assist physician
in performing
procedure
0
12
60
59
25
13
All clinical labor activities
were assgined to L037D.
Reassigned imaging tasks to
L041B.
All clinical labor activities
were assgined to L037D.
Reassigned imaging tasks to
L041B.
Refmed equipment time to
conform to established
policies for non-highly
technical equipment.
All clinica1labor activities
were assgined to L037D.
Reassigned imaging tasks to
L041B.
All clinical labor activities
were assgined to L037D.
Reassigned imaging tasks to
L041B.
Refined equipment time to
conform to established
policies for non-highly
technical equipment.
All clinical labor activities
were assgined to L037D.
Reassigned imaging tasks to
L041B.
Assist physician
in performing
procedure
$5.33
$0.02
$-4.44
$4.92
$-0.01
$-4.44
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
NF
Input Code
Description
CMS
Refinement
(min or
qty)
25
Injection for
myelogram
Sfmt 4725
E:\FR\FM\13NOR2.SGM
RNILPN/MTA
EF018
62284
Frm 00138
Fmt 4701
60
Input
Code
ES031
Jkt 235001
PO 00000
NF
EF018
20:15 Nov 12, 2014
video system,
endoscopy
(processor,
digital capture,
monitor, printer,
cart)
stretcher
L037D
HCPCSCode
Description
NF
EF018
HCPCS
Code
RUC
Recommendation or
current value
(min or qty)
0
ebenthall on DSK5SPTVN1PROD with $$_JOB
VerDate Sep<11>2014
HCPCSCode
Description
Input Code
Description
Assist physician
in performing
procedure
RUC
Recommendation or
current value
(min or qty)
CMS
Refinement
(min or
qty)
0
12
60
NF/F/PO
Labor Activity
(where applicable)
64
PO 00000
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
L037D
RN/LPN/MTA
NF
Assist physician
in performing
procedure
30
15
Radiologic
Technologist
NF
Assist physician
in performing
procedure
0
15
percutaneous
neuro test
stimulator
NF
0
65
drape, sterile, for
Mayo stand
NF
1
0
SG074
steri-strip (6 strip
uou)
NF
1
0
SJ043
Frm 00139
NF
SB012
Implant
neuroelectrodes
stretcher
EQ202
64561
NF
L041B
62305
Myelography
lumbar
injection
Radiologic
Technologist
EF018
Jkt 235001
L041B
povidone
swabsticks (3
pack uou)
Radiologic
Technologist
NF
I
0
3
2
L041B
70486
Ct maxillofacial
w/o dye
NF
Patient clinical
information and
questionnaire
reviewed by
technologist,
order from
physician
confirmed and
exam protocoled
by radiologist
Comment
All clinical labor activities
were assgined to L037D.
Reassigned imaging tasks to
L041B.
Refmed equipment time to
conform to established
policies for non-highly
technical equipment.
All clinical labor activities
were assgined to L037D.
Reassigned imaging tasks to
L041B.
All clinical labor activities
were assgined to L037D.
Reassigned imaging tasks to
L041B.
Neuro test stimulator is
required to complete
Percutaneous implanation of
neurostimulator
Duplicative; Item included in
percutaneous neuro test
stimulation kit (SA022).
Duplicative; Item included in
percutaneous neuro test
stimulation kit (SA022).
Duplicative; Item included in
percutaneous neuro test
stimulation kit (SA022).
Standard times for clinical
labor tasks associated with
digital imaging
Direct
Costs
Change
$4.92
$0.02
$-5.55
$6.15
$0.17
$-1.69
$-1.12
$-0.41
$-0.41
67685
ER13NO14.026</GPH>
Input
Code
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
HCPCS
Code
ebenthall on DSK5SPTVN1PROD with $$_JOB
Input
Code
Input Code
Description
NFIF/PO
Labor Activity
(where applicable)
RUC
Recommendation or
current value
(min or qty)
3
CMS
Refinement
(min or
qty)
2
3
2
3
2
3
2
3
2
Frm 00140
Fmt 4701
E:\FR\FM\13NOR2.SGM
CT Technologist
NF
L046A
CT Technologist
NF
room,
ultrasound,
general
NF
30
27
room,
ultrasound,
general
NF
28
20
Ct maxillofacial
w/o & w/dye
74174
Ct angio
abd&pelv
w/o&w/dye
Ultrasound
breast complete
76642
13NOR2
NF
EL015
Sfmt 4725
Radiologic
Technologist
L046A
PO 00000
NF
Ct maxillofacial
w/dye
76641
ER13NO14.027</GPH>
CT Technologist
L041B
70488
NF
L046A
70487
Radiologic
Technologist
EL015
Jkt 235001
L041B
Ultrasound
breast limited
Patient clinical
information and
questionnaire
reviewed by
technologist,
order from
physician
confirmed and
exam protocoled
by radiologist
SVC Provide preservice
education/obtain
consent
Patient clinical
information and
questionnaire
reviewed by
technologist,
order from
physician
confirmed and
exam protocoled
by radiologist
SVC Provide preservice
education/obtain
consent
Availability of
prior images
confirmed
Comment
Direct
Costs
Change
Standard times for clinical
labor tasks associated with
digital imaging
$-0.41
CT Angiography only requires
2 minutes for this task;
maintain consistency within
family
Standard times for clinical
labor tasks associated with
digital imaging
$-0.46
CT Angiography only requires
2 minutes for this task;
maintain consistency within
family
Standard times for clinical
labor tasks associated with
digital imaging
Refmed equipment time to
conform to established
policies for highly technical
equipment.
Refmed equipment time to
conform to established
policies for highly technical
equipment.
$-0.41
$-0.46
$-0.46
$-4.21
$-11.21
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
HCPCSCode
Description
67686
VerDate Sep<11>2014
HCPCS
Code
ebenthall on DSK5SPTVN1PROD with $$_JOB
VerDate Sep<11>2014
HCPCSCode
Description
Input
Code
Input Code
Description
Labor Activity
(where applicable)
PO 00000
Frm 00141
77061
77062
Fmt 4701
Sfmt 4725
77063
E:\FR\FM\13NOR2.SGM
77085
Echo guide for
biopsy
Breast
tomosynthesis
uni
Breast
tomosynthesis
bi
NF
Acquire images
L051B
RN/Diagnostic
Medical
Sonographer
Mammography
Technologist
NF
L043A
Mammography
Technologist
NF
Mammography
Technologist
NF
Availability of
prior images
confirmed
Availability of
prior images
confirmed
Availability of
prior images
confirmed
Federally
Mandated MQSA
Activities
Allocated To
Each
Mammogram
ER019
76942
CT Technologist
L043A
Jkt 235001
L046A
densitometry
unit, fan beam,
DXA(wcomputer
hardward&
software)
Radiologic
Technologist
NF
densitometry
unit, fan beam,
DXA(wcomputer
hardward&
software)
NF
L043A
Breast
tomosynthesis
bi
Dxa bone
density study
L041B
13NOR2
ER019
77086
Fracture
assessment via
dxa
NF
NF
Technologist QCs
images in PACS,
checking all
images, reformats,
and dose page
3
2
3
2
3
2
4
0
38
NF/F/PO
CMS
Refinement
(min or
qty)
10
34
Refmed equipment time to
conform to changes in clinical
labor time.
$-1.29
6
2
Standard times for clinical
labor tasks associated with
digital imaging
$-1.64
21
19
Refmed equipment time to
conform to changes in clinical
labor time.
$-0.64
Comment
Limited study takes less time
to complete than complete
study; used ratio of ultrasound
abdomen complete and limited
to adjust 15 to 10 minutes.
Standard times for clinical
labor tasks associated with
digital imaging
Standard times for clinical
labor tasks associated with
digital imaging
Standard times for clinical
labor tasks associated with
digital imaging
Add-on code; no additional
time required for this task.
Direct
Costs
Change
$-2.30
$-0.51
$-0.43
$-0.43
$-1.72
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
HCPCS
Code
RUC
Recommendation or
current value
(min or qty)
15
67687
ER13NO14.028</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
Input
Code
Input Code
Description
NFIF/PO
Labor Activity
(where applicable)
CMS
Refinement
(min or
qty)
2
PO 00000
Frm 00142
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.029</GPH>
0
computer
system, record
and verify
NF
5
0
computer
system, record
and verify
NF
5
0
microscope,
compound
NF
21
13
Freezer
NF
1
0
SA117
Universal
Detection Kit
NF
0
2
SL488
88342
5
EPllO
88341
NF
EP024
77307
computer
system, record
and verify
EDOll
77306
NF
EDOll
77300
Radiologic
Technologist
EDOll
Jkt 235001
L041B
UltraView
Universal DAB
Detection Kit
NF
2
0
EPllO
Freezer
NF
1
0
Radiation
therapy dose
plan
Telethx isodose
plan simple
Telethx isodose
plan cplx
Immunohisto
antibody slide
Immunohisto
antibody stain
Technologist QCs
images in PACS,
checking all
images, reformats,
and dose page
RUC
Recommendation or
current value
(min or qty)
4
Comment
Direct
Costs
Change
Standard times for clinical
labor tasks associated with
digital imaging
$-0.82
Item was not previously
included for this service;
rationale for change not
provided. See 78 FR 74317 for
further discussion.
Item was not previously
included for this service;
rationale for change not
provided. See 78 FR 74317 for
further discussion.
Item was not previously
included for this service;
rationale for change not
provided. See 78 FR 74317 for
further discussion.
Decreased physician work for
88341 to 60% of 88342; same
adjustment was made for
equipment used by physician.
Indirect Practice Expense. Not
individually allocable to a
particular patient for a
particular service
Maintain consistency in the
type of universal detection kit
with remaining code-sets
within this family.
Maintain consistency in the
type of universal detection kit
with remaining code-sets
within this family.
Indirect Practice Expense. Not
individually allocable to a
particular patient for a
$-3.10
$-3.10
$-3.10
$-0.30
$-0.02
$8.00
$-20.97
$-0.02
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
HCPCSCode
Description
67688
VerDate Sep<11>2014
HCPCS
Code
ebenthall on DSK5SPTVN1PROD with $$_JOB
VerDate Sep<11>2014
HCPCSCode
Description
Input
Code
Input Code
Description
NF/F/PO
Labor Activity
(where applicable)
CMS
Refinement
(min or
qty)
Comment
Direct
Costs
Change
particular service
Universal
Detection Kit
NF
0
2
PO 00000
SL488
UltraView
Universal DAB
Detection Kit
NF
2
0
EPllO
Freezer
NF
1
0
EP112
Benchmark
ULTRA
automated slide
preparation
system
Universal
Detection Kit
NF
33
30
NF
0
4
Frm 00143
Jkt 235001
SA117
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
SA117
88344
lmmunohisto
antibody slide
88364
lnsitu
hybridization
(fish)
UltraView
Universal DAB
Detection Kit
NF
2
0
SL489
13NOR2
SL488
UtraView
Universal
Alkaline
Phosphatase Red
Detection Kit
microscope,
compound
NF
2
0
NF
37
22
EP024
Maintain consistency in the
type of universal detection kit
with remaining code-sets
within this family.
Maintain consistency in the
type of universal detection kit
with remaining code-sets
within this family.
Indirect Practice Expense. Not
individually allocable to a
particular patient for a
particular service
Multiplex service - 2 stains is
typical; since single stains
requires 15 minutes, 2 stains
requires no more than 30
minutes
Maintain consistency in the
type of universal detection kit
with remaining code-sets
within this family.
Maintain consistency in the
type of universal detection kit
with remaining code-sets
within this family.
Maintain consistency in the
type of universal detection kit
with remaining code-sets
within this family.
Decreased physician work for
88341 to 60% of 88342; same
adjustment was made for
equipment used by physician.
$8.00
$-20.97
$-0.02
$-1.52
$16.00
$-20.97
$-41.28
$-0.56
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
HCPCS
Code
RUC
Recommendation or
current value
(min or qty)
67689
ER13NO14.030</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
0
Freezer
NF
1
0
Histotechnologis
t
NF
0.5
0
gloves, nonsterile, nitrile
NF
0.25
0
SL189
ethanol, 100%
NF
62.5
37.5
SL195
kit, FISH
paraffin
pretreatment
NF
2
1
ethanol, 95%
NF
62.5
37.5
EPllO
Freezer
NF
1
0
Input
Code
Input Code
Description
NFIF/PO
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
88365
ER13NO14.031</GPH>
Insitu
hybridization
(fish)
Labor Activity
(where applicable)
Clean
room/equipment
following
procedure
(including any
equipment
maintenance that
must be done after
the procedure)
CMS
Refinement
(min or
qty)
0
Comment
Add-on code. Base code
includes the hybridization
chamber, which would be used
concurrently for both stains
Add on code. Water bath is
used concurrently for the base
code and add-on code
Indirect Practice Expense. Not
individually allocable to a
particular patient for a
particular service
Add-on code. Additional
clinical labor time for postservice task not required. See
preamble.
Add-on code. Gloves are not
changed between base code
and add-on code
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
Maintain consistency in unit
of the kit between base code
and add-on code. See
preamble.
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
Indirect Practice Expense. Not
individually allocable to a
particular patient for a
particular service
Direct
Costs
Change
$-5.51
$-0.09
$-0.02
$-0.19
$-0.05
$-0.08
$-20.85
$-0.08
$-0.02
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
13
SB023
Frm 00144
NF
L037B
PO 00000
water bath, FISH
procedures (lab)
EPllO
Jkt 235001
NF
SL248
20:15 Nov 12, 2014
chamber,
hybridization
RUC
Recommendation or
current value
(min or qty)
240
EP054
HCPCSCode
Description
67690
VerDate Sep<11>2014
EP045
HCPCS
Code
ebenthall on DSK5SPTVN1PROD with $$_JOB
VerDate Sep<11>2014
Input
Code
Input Code
Description
NF/F/PO
Labor Activity
(where applicable)
VP-2000
Processor
NF
30
0
SL189
ethanol, 100%
NF
62.5
37.5
SL195
NF
2
1
Frm 00145
kit, FISH
paraffin
pretreatment
SL248
ethanol, 95%
NF
62.5
37.5
SL497
(EBER)DNA
Probe Cocktail
NF
1.6
2
EP088
Thermo Brite
NF
2.5
0
EPllO
Freezer
NF
1
0
EP116
VP-2000
Processor
NF
30
0
L037B
Histotechnologis
t
NF
20
15
Jkt 235001
EP116
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
88366
lnsitu
hybridization
(fish)
Examine signals
in each cell and
generate data for
the pathologist to
interpret
Comment
We are unable to reconcile the
new equipment item with the
increased technician time. See
preamble.
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
Stain needs to be added to the
positive control slide and the
specimen slide. See preamble.
This input is not contained
within any other code in this
family. Maintaining
consistency with all other
codes within family.
Indirect Practice Expense. Not
individually allocable to a
particular patient for a
particular service
We are unable to reconcile the
new equipment item with the
increased technician time. See
preamble.
Refmed clinical labor time for
this multiplex procedure to
reflect efficiencies in
examining two stains on a
single slide.
Direct
Costs
Change
$-2.90
$-0.08
$-20.85
$-0.08
$3.43
$-0.05
$-0.02
$-2.90
$-1.85
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCSCode
Description
CMS
Refinement
(min or
qty)
PO 00000
20:15 Nov 12, 2014
HCPCS
Code
RUC
Recommendation or
current value
(min or qty)
67691
ER13NO14.032</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
Input Code
Description
NFIF/PO
Labor Activity
(where applicable)
RUC
Recommendation or
current value
(min or qty)
CMS
Refinement
(min or
qty)
ethanol, 100%
NF
62.5
37.5
SL195
kit, FISH
paraffin
pretreatment
NF
2
1
SL248
ethanol, 95%
NF
62.5
37.5
Frm 00146
EPllO
Freezer
NF
1
0
SL189
ethanol, 100%
NF
31.25
18.75
SL195
NF
1.4
0.75
SL248
kit, FISH
paraffin
pretreatment
ethanol, 95%
NF
31.25
18.75
EPllO
Freezer
NF
1
0
EP116
VP-2000
Processor
NF
30
0
SL508
positive control
slide (proxy for
Kappa Positive
Control Slide)
NF
0.5
0.2
Jkt 235001
SL189
Fmt 4701
Sfmt 4725
88367
Insitu
hybridization
auto
E:\FR\FM\13NOR2.SGM
13NOR2
88368
ER13NO14.033</GPH>
Insitu
hybridization
manual
Comment
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
Maintain consistency in unit
of the kit between base code
and add-on code. See
preamble.
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
Indirect Practice Expense. Not
individually allocable to a
particular patient for a
particular service
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
No rationale provided for
quantity change. See
preamble.
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
Indirect Practice Expense. Not
individually allocable to a
particular patient for a
particular service
We are unable to reconcile the
new equipment item with the
increased technician time. See
preamble.
Maintain consistency in unit
of control slides within family
of codes. See preamble.
Direct
Costs
Change
$-0.08
$-20.85
$-0.08
$-0.02
$-0.04
$-13.55
$-0.04
$-0.02
$-2.90
$-3.54
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
Input
Code
PO 00000
20:15 Nov 12, 2014
HCPCSCode
Description
67692
VerDate Sep<11>2014
HCPCS
Code
ebenthall on DSK5SPTVN1PROD with $$_JOB
37.5
18.75
PO 00000
SL190
ethanol, 70%
NF
12.5
6.25
SL191
ethanol, 85%
NF
12.5
6.25
SL195
kit, FISH
paraffin
pretreatment
ethanol, 95%
NF
2
1
NF
37.5
18.75
SL498
Kappa Probe
Cocktail
NF
40
28
EP024
microscope,
compound
NF
42
25
EP045
chamber,
hybridization
NF
240
0
EP054
water bath, FISH
procedures (lab)
NF
13
0
HCPCS
Code
HCPCSCode
Description
Input
Code
SL509
Frm 00147
Fmt 4701
Sfmt 4725
SL248
E:\FR\FM\13NOR2.SGM
13NOR2
88369
M/phmtrc
alysishquant/se
miq
Input Code
Description
NF/F/PO
Labor Activity
(where applicable)
CMS
Refinement
(min or
qty)
0.2
Comment
Direct
Costs
Change
Maintain consistency in unit
of control slides within family
of codes. See preamble.
$-3.54
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
No rationale provided for
quantity change. See
preamble.
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
Maintain consistency in unit
of probe cocktails within this
family of codes. See preamble.
Refmed equipment time for
this multiplex procedure to
reflect efficiencies in time
when examining two stains on
a single slide.
Add-on code. Base code
includes the hybridization
chamber, which would be used
concurrently for both stains
Add on code. Water bath is
used concurrently for the base
code and add-on code
$-0.06
$-0.02
$-0.02
$-20.85
$-0.06
$-1.14
$-0.64
$-5.51
$-0.09
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
NF
20:15 Nov 12, 2014
Jkt 235001
VerDate Sep<11>2014
NF
SL189
positive control
slide (proxy for
Kappa Negative
Control Slide)
ethanol, 100%
RUC
Recommendation or
current value
(min or qty)
0.5
67693
ER13NO14.034</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
67694
VerDate Sep<11>2014
Input
Code
Input Code
Description
NFIF/PO
CMS
Refinement
(min or
qty)
0
0.5
0
Comment
Direct
Costs
Change
Freezer
NF
L037B
Histotechnologis
t
NF
SB023
gloves, nonsterile, nitrile
NF
0.25
0
SL510
positive control
slide (proxy for
Lambda Positive
Control Slide)
positive control
slide (proxy for
Lambda
Negative Control
Slide)
ethanol, 100%
NF
0.5
0.2
NF
0.5
0.2
Maintain consistency in unit
of control slides within family
of codes. See preamble.
$-3.54
NF
37.5
18.75
$-0.06
SL195
kit, FISH
paraffin
pretreatment
NF
2
1
SL248
ethanol, 95%
NF
37.5
18.75
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
Maintain consistency in unit
of the kit between base code
and add-on code. See
preamble.
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
Jkt 235001
EPllO
Sfmt 4725
RUC
Recommendation or
current value
(min or qty)
1
Labor Activity
(where applicable)
PO 00000
Frm 00148
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.035</GPH>
SL511
SL189
Clean
room/equipment
following
procedure
(including any
equipment
maintenance that
must be done after
the procedure)
Indirect Practice Expense. Not
individually allocable to a
particular patient for a
particular service
Add-on code. Additional
clinical labor time for postservice task not required. See
preamble.
$-0.02
Not necessary to change
gloves between the slides in
the same procedure.
Maintain consistency in unit
of control slides within family
of codes. See preamble.
$-0.05
$-0.19
$-3.54
$-20.85
$-0.06
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCSCode
Description
Fmt 4701
20:15 Nov 12, 2014
HCPCS
Code
ebenthall on DSK5SPTVN1PROD with $$_JOB
VerDate Sep<11>2014
HCPCSCode
Description
Input
Code
Input Code
Description
NF/F/PO
Labor Activity
(where applicable)
CMS
Refinement
(min or
qty)
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
25
chamber,
hybridization
NF
120
0
water bath, FISH
procedures (lab)
NF
7
0
Freezer
NF
1
0
SB023
gloves, nonsterile, nitrile
NF
0.125
0
ethanol, 100%
NF
31.25
18.75
kit, FISH
paraffin
pretreatment
NF
1.4
0.75
ethanol, 95%
NF
31.25
18.75
EPllO
Fmt 4701
42
SL248
Frm 00149
NF
SL195
PO 00000
microscope,
compound
SL189
88374
28
EPllO
M/phmtrc alys
ishquant/semiq
40
EP054
M/phmtrc alys
ishquant/semiq
NF
EP045
88373
Lambda Probe
Cocktail
EP024
Jkt 235001
SL499
Freezer
NF
1
0
Comment
Maintain consistency in unit
of probe cocktails within this
family of codes. See preamble.
Refined equipment time for
this multiplex procedure to
reflect efficiencies in time
when examining two stains on
a single slide.
Add-on code. Base code
includes the hybridization
chamber, which would be used
concurrently for both stains
Add on code. Water bath is
used concurrently for the base
code and add-on code
Indirect Practice Expense. Not
individually allocable to a
particular patient for a
particular service
Not necessary to change
gloves between the slides in
the same procedure.
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
Maintain consistency in unit
of the kit between base code
and add-on code. See
preamble.
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
Indirect Practice Expense. Not
individually allocable to a
particular patient for a
particular service
Direct
Costs
Change
$-1.14
$-0.64
$-2.75
$-0.05
$-0.02
$-0.02
$-0.04
$-13.55
$-0.04
$-0.02
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
HCPCS
Code
RUC
Recommendation or
current value
(min or qty)
67695
ER13NO14.036</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
Input Code
Description
NFIF/PO
Labor Activity
(where applicable)
RUC
Recommendation or
current value
(min or qty)
CMS
Refinement
(min or
qty)
cover slip, glass
NF
2.8
1.4
SL189
ethanol, 100%
NF
31.25
18.75
SL195
NF
1.4
0.75
Frm 00150
kit, FISH
paraffin
pretreatment
SL196
kit, HER-2/neu
DNA Probe
NF
2.4
1
SL248
ethanol, 95%
NF
31.25
18.75
EPllO
Freezer
NF
1
0
EP116
VP-2000
Processor
NF
30
0
L037B
Histotechnologis
t
NF
24
18
SL184
slide, negative
control, Her-2
NF
0.5
0.2
Jkt 235001
SL030
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.037</GPH>
88377
M/phmtrc alys
ishquant/semiq
Signal
Enumeration:
Count signals in
malignant cells
and generate data
for pathologist to
interpret
Comment
Quantity of slides required for
this multiplex procedure does
not differ from the single
procedure (only number of
stains per slide differs).
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
Maintain consistency in unit
of the kit between base code
and add-on code. See
preamble.
A single kit is required for this
procedure which involves a
single specimen with one
stain.
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
Indirect Practice Expense. Not
individually allocable to a
particular patient for a
particular service
We are unable to reconcile the
new equipment item with the
increased technician time. See
preamble.
Refmed clinical labor time for
this multiplex procedure to
reflect efficiencies in
examining two stains on a
single slide.
Maintain consistency in unit
of control slides within family
of codes. See preamble.
Direct
Costs
Change
$-0.11
$-0.04
$-13.55
$-147.00
$-0.04
$-0.02
$-2.90
$-2.22
$-8.82
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
Input
Code
PO 00000
20:15 Nov 12, 2014
HCPCSCode
Description
67696
VerDate Sep<11>2014
HCPCS
Code
ebenthall on DSK5SPTVN1PROD with $$_JOB
VerDate Sep<11>2014
HCPCSCode
Description
Input
Code
Input Code
Description
NFIF/PO
Labor Activity
(where applicable)
RUC
Recommendation or
current value
(min or qty)
CMS
Refinement
(min or
qty)
NF
0.5
0.2
ethanol, 100%
NF
37.5
18.75
SL190
ethanol, 70%
NF
12.5
6.25
SL191
ethanol, 85%
NF
12.5
6.25
SL195
kit, FISH
paraffin
pretreatment
NF
2
1
SL196
kit, HER-2/neu
DNA Probe
NF
3
1
SL248
ethanol, 95%
NF
37.5
18.75
EP087
instrument,
microdissection
(Veritas)
NF
34
32
PO 00000
slide, positive
control, Her-2
SL189
Jkt 235001
SL185
Frm 00151
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
88380
Microdissection
laser
Comment
Maintain consistency in unit
of control slides within family
of codes. See preamble.
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
Maintain consistency in unit
of the kit between base code
and add-on code. See
preamble.
A single kit is required for this
procedure which involves a
single specimen with one
stain.
No rationale was provided for
quantity change relative to
current value. Maintaining
current value.
Since physician is doing this
task, equipment time was
calculated by summing
physician intraservice time,
time to set up machine, and
time to clean machine.
Direct
Costs
Change
$-8.82
$-0.06
$-0.02
$-0.02
$-20.85
$-210.00
$-0.06
$-1.36
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
HCPCS
Code
67697
ER13NO14.038</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
67698
VerDate Sep<11>2014
HCPCSCode
Description
Input
Code
Input Code
Description
NFIF/PO
Labor Activity
(where applicable)
Comment
Direct
Costs
Change
Cytotechnologist
NF
Dispose of razor
blade, Cap tube
and vortex
specimens.
Visually inspect
tube to make sure
microdissected
material are at the
bottom of tube.
3
0
Included in clinical labor task
"clean room, equipment, and
supplies"
$-1.35
L045A
Cytotechnologist
NF
Turn on dissecting
microscope, place
slide on scope,
remove razor
blade from box.
Microdissect
tissue within
etched area, while
viewing slide
under dissecting
scope, place tissue
into cap of
collection tube
with blade.
Repeat
18
0
Work vignette indicates that
the microdissection is
performed by the pathologist
$-8.10
SL085
label for
microscope
slides
computer,
desktop, wmonitor
video SVHS
VCR (medical
grade)
video printer,
color (Sony
medical grade)
table, instrument,
mobile
NF
4
9
9 slides is typical; 9 labels are
required
$+0.15
NF
91
0
$-0.90
NF
43
0
NF
57
0
NF
105
92
Duplicative; item is in
vascular ultrasound room
(EL016)
Duplicative; item is in
vascular ultrasound room
(EL016)
Duplicative; item is in
vascular ultrasound room
(EL016)
Standard equipment and time
for moderate sedation
Jkt 235001
L045A
PO 00000
Frm 00152
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
88381
Microdissection
manual
13NOR2
ED021
ED034
93312
Echo
transesophageal
ED036
EF027
ER13NO14.039</GPH>
CMS
Refinement
(min or
qty)
$-0.21
$-0.61
$-0.02
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
HCPCS
Code
RUC
Recommendation or
current value
(min or qty)
ebenthall on DSK5SPTVN1PROD with $$_JOB
EQOll
NF
105
92
PO 00000
EQ032
ECG, 3-channel
(with Sp02,
NIBP, temp,
resp)
IV infusion
pump
RNILPN/MTA
NF
0
92
HCPCSCode
Description
Input
Code
Frm 00153
L037D
Input Code
Description
NF/F/PO
Labor Activity
(where applicable)
CMS
Refinement
(min or
qty)
43
Exam documents
scanned into
PACS.Exam
completed in RIS
system to generate
billing process
and to populate
images into
Radiologist work
queue
3
1
Fmt 4701
NF
Sfmt 4725
E:\FR\FM\13NOR2.SGM
Cardiac
Sonographer
NF
Clean scope
0
10
L050A
Cardiac
Sonographer
NF
Clean surgical
instrument
package
10
0
L050A
Cardiac
Sonographer
NF
8
0
L050A
Cardiac
Sonographer
NF
Process data:
measure, record,
preliminary
findings
Review images
with MD
0
2
13NOR2
L050A
Comment
Direct
Costs
Change
Refined equipment time to
conform to established
policies for highly technical
equipment.
Standard equipment and time
for moderate sedation
$-24.75
Standard equipment and time
for moderate sedation
Standard times for clinical
labor tasks associated with
digital imaging
$0.58
Time for cleaning probes
moved from activity "clean
surgical instrument package"
to "clean scope". 10 minutes
unchanged
Time for cleaning probes
moved from activity "clean
surgical instrument package"
to "clean scope". 10 minutes
unchanged
Standard times for clinical
labor tasks associated with
digital imaging
Standard times for clinical
labor tasks associated with
digital imaging
$-0.18
$-0.74
$5.00
$-5.00
$-4.00
$1.00
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
NF
20:15 Nov 12, 2014
room,
ultrasound,
vascular
Jkt 235001
VerDate Sep<11>2014
EL016
RUC
Recommendation or
current value
(min or qty)
57
HCPCS
Code
67699
ER13NO14.040</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
67700
VerDate Sep<11>2014
Input
Code
Input Code
Description
NFIF/PO
Labor Activity
(where applicable)
Cardiac
Sonographer
NF
SB026
gown, patient
NF
1
0
Frm 00154
SB036
paper, exam
table
NF
7
0
SB037
pillow case
NF
1
0
ED021
computer,
desktop, wmonitor
video SVHS
VCR (medical
grade)
video printer,
color (Sony
medical grade)
table, instrument,
mobile
room,
ultrasound,
vascular
ECG, 3-channel
(with Sp02,
NIBP, temp,
resp)
IV infusion
pump
NF
61
0
NF
53
0
NF
67
0
NF
115
92
NF
67
43
NF
115
92
NF
0
92
Jkt 235001
L050A
Fmt 4701
Sfmt 4725
ED034
E:\FR\FM\13NOR2.SGM
ED036
93314
Echo
transesophageal
EF027
13NOR2
EL016
EQOll
EQ032
ER13NO14.041</GPH>
Technologist QCs
images in PACS,
checking all
images, reformats,
and dose page
Comment
Direct
Costs
Change
Standard times for clinical
labor tasks associated with
digital imaging
$-1.50
Duplicative; items are
included in pack, minimum
multi-specialty visit (SA048)
Duplicative; items are
included in pack, minimum
multi-specialty visit (SA048)
Duplicative; items are
included in pack, minimum
multi-specialty visit (SA048)
Duplicative; item is in
vascular ultrasound room
(EL016)
Duplicative; item is in
vascular ultrasound room
(EL016)
Duplicative; item is in
vascular ultrasound room
(EL016)
Standard equipment and time
for moderate sedation
Refmed equipment time to
conform to changes in clinical
labor time; See preamble.
Standard equipment and time
for moderate sedation
$-0.53
Standard equipment and time
for moderate sedation
$-0.10
$-0.31
$-0.60
$-0.26
$-0.71
$-0.03
$-42.42
$-0.32
$0.58
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCSCode
Description
CMS
Refinement
(min or
qty)
2
PO 00000
20:15 Nov 12, 2014
HCPCS
Code
RUC
Recommendation or
current value
(min or qty)
5
ebenthall on DSK5SPTVN1PROD with $$_JOB
VerDate Sep<11>2014
20:15 Nov 12, 2014
HCPCSCode
Description
Input
Code
Input Code
Description
L037D
RN/LPN/MTA
NF
Exam documents
scanned into
PACS.Exam
completed in RIS
system to generate
billing process
and to populate
images into
Radiologist work
queue
L050A
Cardiac
Sonographer
NF
40
30
L050A
Cardiac
Sonographer
NF
Assist physician
in performing
procedure
(acquire
ultrasound data)
Clean scope
0
10
L050A
Cardiac
Sonographer
NF
Clean surgical
instrument
package
10
0
L050A
Cardiac
Sonographer
NF
Process data:
measure, record,
preliminary
findings
8
0
L050A
Cardiac
Sonographer
NF
Review images
with MD
0
Cardiac
Sonographer
NF
Technologist QCs
images in PACS,
checking all
images, reformats,
and dose page
5
NF/F/PO
Comment
Direct
Costs
Change
Jkt 235001
PO 00000
Frm 00155
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
Standard times for clinical
labor tasks associated with
digital imaging
$-0.74
CPT code 93314 is a less
involved service than CPT
code 93 312, clinical labor time
would not be higher. See
preamble.
Time for cleaning probes
moved from activity "clean
surgical instrument package"
to "clean scope". 10 minutes
unchanged
Time for cleaning probes
moved from activity "clean
surgical instrument package"
to "clean scope". 10 minutes
unchanged
Standard times for clinical
labor tasks associated with
digital imaging
$-5.00
2
Standard times for clinical
labor tasks associated with
digital imaging
$1.00
2
Standard times for clinical
labor tasks associated with
digital imaging
$-1.50
$5.00
$-5.00
$-4.00
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
CMS
Refinement
(min or
qty)
1
L050A
HCPCS
Code
Labor Activity
(where applicable)
RUC
Recommendation or
current value
(min or qty)
3
67701
ER13NO14.042</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
67702
VerDate Sep<11>2014
Input
Code
Input Code
Description
Labor Activity
(where applicable)
Assist
physician/moderat
e sedation (% of
physician time)
40
30
Comment
RN
NF
SB026
gown, patient
NF
1
0
SB036
paper, exam
table
NF
7
0
SB037
pillow case
NF
1
0
ED021
computer,
desktop, wmonitor
NF
5
0
ED021
computer,
desktop, wmonitor
NF
2
0
Duplicative; item is in
vascular ultrasound room
(EL016)
$-0.02
ED021
computer,
desktop, wmonitor
NF
2
0
Duplicative; item is in
vascular ultrasound room
(EL016)
$-0.02
L037D
RN/LPN/MTA
NF
2
0
Included as an automatic
process for the new device.
$-0.74
ED036
video printer,
color (Sony
medical grade)
Vascular
Technologist
NF
10
0
$-0.11
4
0
Duplicative; item is in
vascular ultrasound room
(EL016)
Included in overall clinical
labor time; see preamble text
Frm 00156
L051A
Doppler echo
exam heart
Sfmt 4725
93321
Doppler echo
exam heart
93325
Doppler color
flow add-on
E:\FR\FM\13NOR2.SGM
Fmt 4701
93320
13NOR2
93702
93880
ER13NO14.043</GPH>
Bis xtracell
fluid analysis
Extracranial
bilat study
L054A
NF
Results are
uploaded from the
device into the
analysis software
and a report is
generated and
printed for
physician review.
QA
Documentation
CPT code 93314 is a less
involved service than CPT
code 93312, clinical labor time
would not be higher. See
preamble.
Duplicative; items are
included in pack, minimum
multi-specialty visit (SA048)
Duplicative; items are
included in pack, minimum
multi-specialty visit (SA048)
Duplicative; items are
included in pack, minimum
multi-specialty visit (SA048)
Duplicative; item is in
vascular ultrasound room
(EL016)
Direct
Costs
Change
PO 00000
NFIF/PO
CMS
Refinement
(min or
qty)
$-5.10
$-0.53
$-0.10
$-0.31
$-0.05
$-2.16
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCSCode
Description
RUC
Recommendation or
current value
(min or qty)
Jkt 235001
20:15 Nov 12, 2014
HCPCS
Code
ebenthall on DSK5SPTVN1PROD with $$_JOB
VerDate Sep<11>2014
Input
Code
Input Code
Description
NFIF/PO
Labor Activity
(where applicable)
CMS
Refinement
(min or
qty)
2
NF
ED021
NF
4
0
ED036
computer,
desktop, wmonitor
video printer,
color (Sony
medical grade)
Vascular
Technologist
NF
10
0
NF
QA
Documentation
4
0
L054A
Vascular
Technologist
NF
Technologist QCs
images in PACS,
checking all
images, reformats,
and dose page
5
ED021
computer,
desktop, wmonitor
video printer,
color (Sony
medical grade)
Vascular
Technologist
NF
NF
PO 00000
Frm 00157
E:\FR\FM\13NOR2.SGM
93882
Extracrania1
uni/ltd study
L054A
13NOR2
93886
Intracranial
complete study
ED036
L054A
ER13NO14.044</GPH>
NF
Technologist
reviews &
optimizes all
duplex images;
reviews &
optimizes
spectrum analysis
measuring
velocities &
assuring proper
angle acquisition.
Compiles fmdings
with sufficient
data for physician
review &
diagnosis.
Comment
Direct
Costs
Change
$-3.24
Duplicative; item is in
vascular ultrasound room
(EL016)
Duplicative; item is in
vascular ultrasound room
(EL016)
Included in overall clinical
labor time; see preamble text
$-0.04
2
Standard times for clinical
labor tasks associated with
digital imaging
$-1.62
7
0
0
4
0
Duplicative; item is in
vascular ultrasound room
(EL016)
Duplicative; item is in
vascular ultrasound room
(EL016)
Included in overall clinical
labor time; see preamble text
$-0.07
10
QA
Documentation
Standard times for clinical
labor tasks associated with
digital imaging
$-0.11
$-2.16
$-0.11
$-2.16
67703
Vascular
Technologist
Jkt 235001
L054A
Sfmt 4725
RUC
Recommendation or
current value
(min or qty)
8
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCSCode
Description
Fmt 4701
20:15 Nov 12, 2014
HCPCS
Code
ebenthall on DSK5SPTVN1PROD with $$_JOB
67704
VerDate Sep<11>2014
HCPCSCode
Description
Input
Code
Jkt 235001
NF/F/PO
Labor Activity
(where applicable)
Technologist QCs
images in PACS,
checking all
images, reformats,
and dose page
CMS
Refinement
(min or
qty)
8
2
Standard times for clinical
labor tasks associated with
digital imaging
$-3.24
Duplicative; item is in
vascular ultrasound room
(EL016)
Duplicative; item is in
vascular ultrasound room
(EL016)
Included in overall clinical
labor time; see preamble text
$-0.04
Comment
Direct
Costs
Change
computer,
desktop, wmonitor
video printer,
color (Sony
medical grade)
Vascular
Technologist
NF
4
0
NF
10
0
NF
QA
Documentation
4
0
Vascular
Technologist
NF
Technologist QCs
images in PACS,
checking all
images, reformats,
and dose page
4
2
Standard times for clinical
labor tasks associated with
digital imaging
$-1.08
ED021
computer,
desktop, wmonitor
video printer,
color (Sony
medical grade)
video printer,
color (Sony
medical grade)
Vascular
Technologist
NF
7
0
$-0.07
NF
10
0
NF
10
0
4
0
Duplicative; item is in
vascular ultrasound room
(EL016)
Duplicative; item is in
vascular ultrasound room
(EL016)
Duplicative; item is in
vascular ultrasound room
(EL016)
Included in overall clinical
labor time; see preamble text
ED036
93888
Intracranial
limited study
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
NF
L054A
Frm 00158
Vascular
Technologist
ED021
PO 00000
Fmt 4701
RUC
Recommendation or
current value
(min or qty)
L054A
L054A
ED036
93925
Lower
extremity study
ED036
L054A
ER13NO14.045</GPH>
Input Code
Description
NF
QA
Documentation
$-0.11
$-2.16
$-0.11
$-0.11
$-2.16
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
HCPCS
Code
ebenthall on DSK5SPTVN1PROD with $$_JOB
VerDate Sep<11>2014
Jkt 235001
HCPCSCode
Description
Input
Code
Input Code
Description
NFIF/PO
Labor Activity
(where applicable)
CMS
Refinement
(min or
qty)
2
NF
computer,
desktop, wmonitor
video printer,
color (Sony
medical grade)
Vascular
Technologist
NF
4
0
NF
10
0
4
0
Frm 00159
Vascular
Technologist
ED021
PO 00000
L054A
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
93926
13NOR2
Lower
extremity study
ED036
L054A
----------·---
-------
----------
NF
Technologist
reviews &
optimizes all
duplex images;
reviews&
optimizes
spectrum analysis
measuring
velocities &
assuring proper
angle acquisition.
Compiles findings
with sufficient
data for physician
review &
diagnosis.
RUC
Recommendation or
current value
(min or qty)
8
QA
Documentation
-------------
Comment
Direct
Costs
Change
Standard times for clinical
labor tasks associated with
digital imaging
$-3.24
Duplicative; item is in
vascular ultrasound room
(EL016)
Duplicative; item is in
vascular ultrasound room
(EL016)
Included in overall clinical
labor time; see preamble text
$-0.04
$-0.11
$-2.16
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
HCPCS
Code
67705
ER13NO14.046</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
67706
VerDate Sep<11>2014
HCPCSCode
Description
Input
Code
Input Code
Description
NFIF/PO
Labor Activity
(where applicable)
Technologist
reviews &
optimizes all
duplex images;
reviews &
optimizes
spectrum analysis
measuring
velocities &
assuring proper
angle acquisition.
Compiles fmdings
with sufficient
data for physician
review &
diagnosis.
2
Standard times for clinical
labor tasks associated with
digital imaging
$-1.62
Duplicative; item is in
vascular ultrasound room
(EL016)
Duplicative; item is in
vascular ultrasound room
(EL016)
Included in overall clinical
labor time; see preamble text
$-0.07
Duplicative; item is in
vascular ultrasound room
(EL016)
Duplicative; item is in
vascular ultrasound room
(EL016)
Included in overall clinical
labor time; see preamble text
$-0.04
Duplicative; item is in
vascular ultrasound room
(EL016)
$-0.07
NF
ED021
computer,
desktop, wmonitor
video printer,
color (Sony
medical grade)
Vascular
Technologist
NF
7
0
NF
10
0
4
0
computer,
desktop, wmonitor
video printer,
color (Sony
medical grade)
Vascular
Technologist
NF
4
0
NF
10
0
4
0
computer,
desktop, wmonitor
NF
7
0
PO 00000
Frm 00160
Fmt 4701
Sfmt 4725
13NOR2
5
Vascular
Technologist
Jkt 235001
E:\FR\FM\13NOR2.SGM
CMS
Refinement
(min or
qty)
L054A
93930
Upper
extremity study
ED036
L054A
ED021
93931
Upper
extremity study
ED036
L054A
ED021
93970
ER13NO14.047</GPH>
RUC
Recommendation or
current value
(min or qty)
Extremity study
NF
NF
QA
Documentation
QA
Documentation
Comment
Direct
Costs
Change
$-0.11
$-2.16
$-0.11
$-2.16
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
HCPCS
Code
ebenthall on DSK5SPTVN1PROD with $$_JOB
VerDate Sep<11>2014
Jkt 235001
0
PO 00000
13NOR2
NF
computer,
desktop, wmonitor
video printer,
color (Sony
medical grade)
Vascular
Teclmologist
NF
4
0
NF
10
0
4
0
computer,
desktop, wmonitor
video printer,
color (Sony
medical grade)
Vascular
Teclmologist
NF
7
0
NF
10
0
4
0
ED021
Fmt 4701
E:\FR\FM\13NOR2.SGM
video printer,
color (Sony
medical grade)
Vascular
Teclmologist
L054A
Frm 00161
Sfmt 4725
Input Code
Description
ED036
93971
Extremity study
L054A
ED021
ED036
93975
Vascular study
L054A
NF
NF
NF
QA
Documentation
QA
Documentation
QA
Documentation
Comment
Direct
Costs
Change
Duplicative; item is in
vascular ultrasound room
(EL016)
Included in overall clinical
labor time; see preamble text
$-0.11
Duplicative; item is in
vascular ultrasound room
(EL016)
Duplicative; item is in
vascular ultrasound room
(EL016)
Included in overall clinical
labor time; see preamble text
$-0.04
Duplicative; item is in
vascular ultrasound room
(EL016)
Duplicative; item is in
vascular ultrasound room
(EL016)
Included in overall clinical
labor time; see preamble text
$-2.16
$-0.11
$-2.16
$-0.07
$-0.11
$-2.16
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
4
Input
Code
NF/F/PO
Labor Activity
(where applicable)
CMS
Refinement
(min or
qty)
0
ED036
HCPCS
Code
HCPCSCode
Description
RUC
Recommendation or
current value
(min or qty)
10
67707
ER13NO14.048</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
67708
VerDate Sep<11>2014
Jkt 235001
HCPCSCode
Description
Input
Code
Input Code
Description
NF/F/PO
Labor Activity
(where applicable)
Technologist
reviews &
optimizes all
duplex images;
reviews&
optimizes
spectrum analysis
measuring
velocities &
assuring proper
angle acquisition.
Compiles fmdings
with sufficient
data for physician
review &
diagnosis.
Standard times for clinical
labor tasks associated with
digital imaging
$-3.24
Duplicative; item is in
vascular ultrasound room
(EL016)
Duplicative; item is in
vascular ultrasound room
(EL016)
Included in overall clinical
labor time; see preamble text
$-0.04
NF
ED021
computer,
desktop, wmonitor
video printer,
color (Sony
medical grade)
Vascular
Technologist
NF
4
0
NF
10
0
4
0
Fmt 4701
Sfmt 4725
13NOR2
2
Vascular
Technologist
Frm 00162
E:\FR\FM\13NOR2.SGM
8
L054A
PO 00000
ER13NO14.049</GPH>
CMS
Refinement
(min or
qty)
ED036
93976
Vascular study
L054A
NF
QA
Documentation
Comment
Direct
Costs
Change
$-0.11
$-2.16
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
HCPCS
Code
RUC
Recommendation or
current value
(min or qty)
ebenthall on DSK5SPTVN1PROD with $$_JOB
VerDate Sep<11>2014
Input
Code
Input Code
Description
NFIF/PO
Labor Activity
(where applicable)
CMS
Refinement
(min or
qty)
2
NF
ED021
NF
7
0
ED021
computer,
desktop, wmonitor
computer,
desktop, wmonitor
video printer,
color (Sony
medical grade)
Vascular
Technologist
computer,
desktop, wmonitor
video printer,
color (Sony
medical grade)
Vascular
Technologist
NF
7
0
NF
10
0
4
0
NF
4
0
NF
10
0
4
0
computer,
desktop, w-
NF
4
0
PO 00000
Frm 00163
E:\FR\FM\13NOR2.SGM
93978
Vascular study
ED036
L054A
ED021
13NOR2
ED036
93979
Vascular study
L054A
93990
ER13NO14.050</GPH>
Doppler flow
testing
ED021
NF
NF
Technologist
reviews &
optimizes all
duplex images;
reviews &
optimizes
spectrum analysis
measuring
velocities &
assuring proper
angle acquisition.
Compiles findings
with sufficient
data for physician
review &
diagnosis.
QA
Documentation
QA
Documentation
Comment
Direct
Costs
Change
Standard times for clinical
labor tasks associated with
digital imaging
$-1.62
Duplicative; item is in
vascular ultrasound room
(EL016)
Duplicative; item is in
vascular ultrasound room
(EL016)
Duplicative; item is in
vascular ultrasound room
(EL016)
Included in overall clinical
labor time; see preamble text
Duplicative; item is in
vascular ultrasound room
(EL016)
Duplicative; item is in
vascular ultrasound room
(EL016)
Included in overall clinical
labor time; see preamble text
$-0.07
Duplicative; item is in
vascular ultrasound room
$-0.04
$-0.07
$-0.11
$-2.16
$-0.04
$-0.11
$-2.16
67709
Vascular
Technologist
Jkt 235001
L054A
Sfmt 4725
RUC
Recommendation or
current value
(min or qty)
5
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCSCode
Description
Fmt 4701
20:15 Nov 12, 2014
HCPCS
Code
ebenthall on DSK5SPTVN1PROD with $$_JOB
67710
VerDate Sep<11>2014
HCPCSCode
Description
Input
Code
Input Code
Description
NF/F/PO
Labor Activity
(where applicable)
CMS
Refinement
(min or
qty)
monitor
Jkt 235001
ED036
PO 00000
L054A
EF023
Frm 00164
9597I
Analyze
neurostim
simple
video printer,
color (Sony
medical grade)
Vascular
Teclmologist
table, exam
NF
4
0
4
0
NF
27
33
NF
QA
Documentation
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
97605
ER13NO14.051</GPH>
programmer,
neurostimulator
(w-printer)
NF
27
33
table, exam
NF
30
36
EQ209
programmer,
neurostimulator
(w-printer)
NF
30
36
Medical/Teclmic
al Assistant
NF
I5
7
EFOI4
96127
EQ209
L026A
Analyze
neurostim
complex
light, surgical
NF
28
25
EF031
table, power
NF
28
25
Brief
emotionallbeha
v assmt
Neg press
wound tx </=50
em
Direct
Costs
Change
(EL016)
EF023
95972
Comment
Scoring
completed
behavior
assessment tool
Duplicative; item is in
vascular ultrasound room
(EL016)
Included in overall clinical
labor time; see preamble text
Include 100% of intraservice
time for equipment even when
clinical labor assist time is
66% of physician time.
Include I 00% of intraservice
time for equipment even when
clinical labor assist time is
66% of physician time.
Include I 00% of intraservice
time for equipment even when
clinical labor assist time is
66% of physician time.
Include 100% of intraservice
time for equipment even when
clinical labor time is 66% of
assist physician time.
Instructions suggest that it
typically takes 7 minutes for
scoring the tests included as
standardized tests for this
procedure.
$-0.04
Refmed equipment time to
conform to changes in clinical
labor time.
Refined equipment time to
conform to changes in clinical
labor time.
$-0.03
$-2.16
$0.02
$0.04
$0.02
$0.04
$-2.08
$-0.05
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
HCPCS
Code
RUC
Recommendation or
current value
(min or qty)
ebenthall on DSK5SPTVN1PROD with $$_JOB
VerDate Sep<11>2014
Input
Code
Input Code
Description
Labor Activity
(where applicable)
Check dressings
& wound/ home
care instructions
/coordinate office
visits
/prescriptions
5
2
Intraservice clinical labor time
also includes time for wound
checking
$-1.11
Refined equipment time to
conform to changes in clinical
labor time.
Refmed equipment time to
conform to changes in clinical
labor time.
Intraservice clinical labor time
also includes time for wound
checking
$-0.03
Refined equipment time to
conform to changes in clinical
labor time.
Intraservice clinical labor time
also includes time for wound
checking
$-0.05
Comment
Direct
Costs
Change
RN/LPN/MTA
NF
EF014
light, surgical
NF
38
35
EF031
table, power
NF
38
35
L037D
RN/LPN/MTA
NF
5
2
EF031
table, power
NF
38
35
L037D
RN/LPN/MTA
NF
Check dressings
& wound/ home
care instructions
/coordinate office
visits
/prescriptions
5
2
L051A
RN
NF
Care management
activities
performed by
clinical staff
60
0
20 minutes RN/LPN/MTA
time reflects the typical
service; see CCM preamble.
$-30.60
L037D
RN/LPN/MTA
NF
Care management
activities
performed by
clinical staff
0
20
20 minutes RN/LPN/MTA
time reflects the typical
service; see CCM preamble.
$7.40
Jkt 235001
L037D
Frm 00165
NFIF/PO
Fmt 4701
Sfmt 4700
97606
Neg press
wound tx >50
em
E:\FR\FM\13NOR2.SGM
13NOR2
99490
Chron care
mgmtsrvc 20
min
Chroncare
mgmtsrvc 20
min
Check dressings
& wound/ home
care instructions
/coordinate office
visits
/prescriptions
$-0.05
$-1.11
$-1.11
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HCPCSCode
Description
CMS
Refinement
(min or
qty)
PO 00000
20:15 Nov 12, 2014
HCPCS
Code
RUC
Recommendation or
current value
(min or qty)
67711
ER13NO14.052</GPH>
67712
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
BILLING CODE 4120–01–C
iii. Procedures Subject to the Cap on
Imaging Codes Defined by Section
5102(b) of the DRA
ebenthall on DSK5SPTVN1PROD with $$_JOB
We are proposing to add the new
codes to the list of procedures subject to
the DRA cap, effective January 1, 2015.
The codes are: (76641 (Ultrasound
breast complete), 76642 (Ultrasound
breast limited), 77085 (Dxa bone density
study), 77086 (Fracture assessment via
dxa), 77387 (Guidance for radiaj tx
dlvr), G6001 (Stereoscopic x-ray
guidance), and G6002 (Echo guidance
radiotherapy). These codes, which are
new for CY 2015, replace codes deleted
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
for CY 2015 that were subject to the cap,
and meet the definition of imaging
under section 5102(b) of the DRA. These
codes are being added on an interim
final basis and are open to public
comment in this final rule with
comment period.
d. Establishing CY 2015 Interim Final
Malpractice RVUs
According to our malpractice
methodology discussed in section II.C,
we are assigning malpractice RVUs for
CY 2015 new, revised, and potentially
misvalued codes by utilizing a
crosswalk to a source code with a
similar malpractice risk. We have
PO 00000
Frm 00166
Fmt 4701
Sfmt 4700
reviewed the RUC recommended
malpractice source code crosswalks for
CY 2015 new, revised, and potentially
misvalued codes, and we are accepting
all of them on an interim final basis for
CY 2015. For G-codes that we are
creating, we are also assigning source
code crosswalks to similar codes.
Table 32 lists the CY 2015 HCPCS
codes and their respective source codes
used to set the interim final CY 2015 MP
RVUs. The MP RVUs for these services
are reflected in Addendum B of this CY
2015 PFS final rule with comment
period.
BILLING CODE 4120–01–P
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
67713
TABLE 32: Crosswalk for Establishing CY 2015 New/Revised/Potentially
Misvalued Codes Malpractice RVUs
20604
20606
20611
20983
21811
21812
21813
22510
22511
22512
22513
22514
22515
22858
27279
33270
33271
33272
33273
33418
33419
33946
33947
33948
33949
33951
33952
33953
33954
33955
33956
33957
33958
33959
33962
33963
33964
33965
33966
33969
33984
33985
33986
VerDate Sep<11>2014
Drain/inj joint/bursa w/us
Drain/inj joint/bursa w/us
Drain/inj joint/bursa w/us
Ablate bone tumor(s) perq
Optx of rib fx w/fixj scope
Treatment of rib fracture
Treatment of rib fracture
Perq cervicothoracic inject
Perq lumbosacral injection
Vertebroplasty addl inject
Perq vertebral augmentation
Perq vertebral augmentation
Perq vertebral augmentation
Second level cer diskectomy
Arthrodesis sacroiliac joint
Ins/rep subq defibrillator
Insj subq impltbl dtb elctrd
Rmvl of subq defibrillator
Repos prev impltbl subq dtb
Repair teat mitral valve
Repair teat mitral valve
Ecmo/ecls initiation venous
Ecmo/ecls initiation artery
Ecmo/ecls daily mgmt-venous
Ecmo/ecls daily mgmt artery
Ecmo/ecls insj prph cannula
Ecmo/ecls insj prph cannula
Ecmo/ecls insj prph cannula
Ecmo/ecls insj prph cannula
Ecmo/ecls insj ctr cannula
Ecmo/ecls insj ctr cannula
Ecmo/ecls repos perph cnula
Ecmo/ecls repos perph cnula
Ecmo/ecls repos perph cnula
Ecmo/ecls repos perph cnula
Ecmo/ecls repos perph cnula
Ecmo/ecls repos perph cnula
Ecmo/ecls rmvl perph cannula
Ecmo/ecls rmvl prph cannula
Ecmo/ecls rmvl perph cannula
Ecmo/ecls rmvl prph cannula
Ecmo/ecls rmvl ctr cannula
Ecmo/ecls rmvl ctr cannula
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00167
Malpractice Risk Factor Crosswalk Code
20600
20605
20610
20982
21805
21805
21805
22520
22521
22522
22523
22524
22525
22856
62287
33249
33216
33244
33215
92987
92987
33960
33960
33961
33961
36822
36822
36822
36822
33981
33981
33981
33981
33981
33981
33981
33981
33981
33981
33971
33971
33977
33977
Fmt 4701
Sfmt 4725
Drain/inject joint/bursa
Drain/inject joint/bursa
Drain/inject joint/bursa
Ablate bone tumor(s) perq
Treatment of rib fracture
Treatment of rib fracture
Treatment of rib fracture
Percut vertebroplasty thor
Percut vertebroplasty lumb
Percut vertebroplasty addl
Percut kyphoplasty thor
Percut kyphoplasty lumbar
Percut kyphoplasty add-on
Cerv artific diskectomy
Percutaneous diskectomy
Nsert pace-defib wllead
Insert 1 electrode pm-defib
Remove eltrd transven
Reposition pacing-defib lead
Revision of mitral valve
Revision of mitral valve
External circulation assist
External circulation assist
External circulation assist
External circulation assist
Insertion of cannula( s)
Insertion of cannula( s)
Insertion of cannula( s)
Insertion of cannula( s)
Replace vad pump ext
Replace vad pump ext
Replace vad pump ext
Replace vad pump ext
Replace vad pump ext
Replace vad pump ext
Replace vad pump ext
Replace vad pump ext
Replace vad pump ext
Replace vad pump ext
Aortic circulation assist
Aortic circulation assist
Remove ventricular device
Remove ventricular device
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.053</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
CY 2015 New, Revised or Misvalued Code
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
CY 2015 New, Revised or Misvalued Code
33987
33988
33989
37218
43180
44381
44384
45346
45347
45349
45350
45388
45389
45390
45393
45398
47383
52441
52442
62302
62303
62304
62305
64486
64487
64488
64489
66179
66184
76641
76642
77063
77085
77086
77306
77307
77316
77317
77318
88341
88344
88364
88366
88369
88373
88374
VerDate Sep<11>2014
33530
33530
33257
37217
43130
45340
44383
45339
45345
43236
45332
45383
45387
45385
45379
45379
47382
52282
52282
62284
62284
62284
62284
64447
64448
64447
64448
66180
66185
76645
76645
77057
77080
77082
77305
77315
77326
77327
77328
88342
88342
88365
88365
88368
88367
88367
Artery expos/graft artery
Insertion ofleft heart vent
Removal ofleft heart vent
Stent placemt ante carotid
Esophagoscopy rigid trnso
Small bowel endoscopy br/wa
Small bowel endoscopy
Sigmoidoscopy w/ablation
Sigmoidoscopy w/plcmt stent
Sigmoidoscopy w/resection
Sgmdsc w/band ligation
Colonoscopy w/ablation
Colonoscopy w/stent plcmt
Colonoscopy w/resection
Colonoscopy w/decompression
Colonoscopy w/band ligation
Perq abltj lvr cryoablation
Cystourethro w/implant
Cystourethro w/addl implant
Myelography lumbar injection
Myelography lumbar injection
Myelography lumbar injection
Myelography lumbar injection
Tap block unil by injection
Tap block uni by infusion
Tap block hi injection
Tap block bi by infusion
Aqueous shunt eye w/o graft
Revision of aqueous shunt
Ultrasound breast complete
Ultrasound breast limited
Breast tomosynthesis bi
Dxa bone density study
Fracture assessment via dxa
Telethx isodose plan simple
Telethx isodose plan cplx
Brachytx isodose plan simple
Brachytx isodose intermed
Brachytx isodose complex
Immunohisto antibody slide
Immunohisto antibody slide
Insitu hybridization (fish)
Insitu hybridization (fish)
M/phmtrc alysishquant/semiq
M/phmtrc alys ishquant/semiq
M/phmtrc alys ishquant/semiq
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00168
Malpractice Risk Factor Crosswalk Code
Fmt 4701
Sfmt 4725
Coronary artery bypass/reop
Coronary artery bypass/reop
Ablate atria lmtd add-on
Stent placemt retro carotid
Removal of esophagus pouch
Sig w/balloon dilation
Ileoscopy w/stent
Sigmoidoscopy w/ablate turnr
Sigmoidoscopy w/stent
Uppr gi scope w/submuc inj
Sigmoidoscopy w/fb removal
Lesion removal colonoscopy
Colonoscopy w/stent
Lesion removal colonoscopy
Colonoscopy w/fb removal
Colonoscopy w/fb removal
Percut ablate liver rf
Cystoscopy implant stent
Cystoscopy implant stent
Injection for myelogram
Injection for myelogram
Injection for myelogram
Injection for myelogram
N block inj fern single
N block inj fern cont inf
N block inj fern single
N block inj fern cont inf
Implant eye shunt
Revise eye shunt
Us exam breast(s)
Us exam breast(s)
Mammogram screening
Dxa bone density axial
Dxa bone density vert fx
Teletx isodose plan simple
Teletx isodose plan complex
Brachytx isodose calc simp
Brachytx isodose calc interm
Brachytx isodose plan compl
Immunohisto antibody slide
Immunohisto antibody slide
Insitu hybridization (fish)
Insitu hybridization (fish)
Insitu hybridization manual
Insitu hybridization auto
Insitu hybridization auto
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.054</GPH>
67714
BILLING CODE 4120–01–C
ebenthall on DSK5SPTVN1PROD with $$_JOB
H. Chronic Care Management (CCM)
As we discussed in the CY 2013 PFS
final rule with comment period, we are
committed to supporting primary care
and we have increasingly recognized
care management as one of the critical
components of primary care that
contributes to better health for
individuals and reduced expenditure
growth (77 FR 68978). Accordingly, we
have prioritized the development and
implementation of a series of initiatives
designed to improve payment for, and
encourage long-term investment in, care
management services. These initiatives
include the following programs and
demonstrations:
• The Medicare Shared Savings
Program (described in ‘‘Medicare
Program; Medicare Shared Savings
Program: Accountable Care
Organizations; Final Rule,’’ which
appeared in the November 2, 2011
Federal Register (76 FR 67802)).
• The testing of the Pioneer ACO
model, designed for experienced health
care organizations (described on the
Centers for Medicare and Medicaid
Innovation’s (Innovation Center’s) Web
site at https://innovation.cms.gov/
initiatives/Pioneer-ACO-Model/
index.html).
• The testing of the Advance Payment
ACO model, designed to support
organizations participating in the
Medicare Shared Savings Program
(described on the Innovation Center’s
Web site at https://innovation.cms.gov/
initiatives/Advance-Payment-ACOModel/).
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
• The Primary Care Incentive
Payment (PCIP) Program (described on
the CMS Web site at www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/
Downloads/PCIP-2011-Payments.pdf).
• The patient-centered medical home
model in the Multi-payer Advanced
Primary Care Practice (MAPCP)
Demonstration designed to test whether
the quality and coordination of health
care services are improved by making
advanced primary care practices more
broadly available (described on the CMS
Web site at www.cms.gov/Medicare/
Demonstration-Projects/
DemoProjectsEvalRpts/downloads/
mapcpdemo_Factsheet.pdf).
• The Federally Qualified Health
Center (FQHC) Advanced Primary Care
Practice demonstration (described on
the CMS Web site at https://
www.cms.gov/Medicare/DemonstrationProjects/DemoProjectsEvalRpts/
Downloads/FQHC_APCP_Demo_
FAQsOct2011.pdf and the Innovation
Center’s Web site at
www.innovations.cms.gov/initiatives/
FQHCs/).
• The Comprehensive Primary Care
(CPC) initiative (described on the
Innovation Center’s Web site at https://
innovations.cms.gov/initiatives/
Comprehensive-Primary-Care-Initiative/
index.html). The CPC initiative is a
multi-payer initiative fostering
collaboration between public and
private health care payers to strengthen
primary care in certain markets across
the country.
In addition, HHS leads a broad
initiative focused on optimizing health
and quality of life for individuals with
PO 00000
Frm 00169
Fmt 4701
Sfmt 4700
67715
multiple chronic conditions. HHS’s
Strategic Framework on Multiple
Chronic Conditions outlines specific
objectives and strategies for HHS and
private sector partners centered on
strengthening the health care and public
health systems; empowering the
individual to use self-care management
with the assistance of a healthcare
provider who can assess the patient’s
health literacy level; equipping care
providers with tools, information, and
other interventions; and supporting
targeted research about individuals with
multiple chronic conditions and
effective interventions. Further
information on this initiative is
available on the HHS Web site at
https://www.hhs.gov/ash/initiatives/mcc/
index.html.
In coordination with all of these
initiatives, we also have continued to
explore potential refinements to the PFS
that would appropriately value care
management within Medicare’s
statutory structure for fee-for-service
physician payment and quality
reporting. For example, in the CY 2013
PFS final rule with comment period, we
adopted a policy to pay separately for
care management involving the
transition of a beneficiary from care
furnished by a treating physician during
a hospital stay to care furnished by the
beneficiary’s primary physician in the
community (77 FR 68978 through
68993).
In the CY 2014 PFS final rule with
comment period, we finalized a policy
to pay separately for care management
services furnished to Medicare
beneficiaries with two or more chronic
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.055</GPH>
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
67716
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
conditions beginning in CY 2015 (78 FR
74414).
1. Valuation of CCM Services—GXXX1
CCM is a unique PFS service designed
to pay separately for non-face-to-face
care coordination services furnished to
Medicare beneficiaries with multiple
chronic conditions. (See 78 FR 74414
for a more thorough discussion of the
beneficiaries for whom this service may
be billed and the scope of service
elements.) In the CY 2014 PFS final rule
with comment period, we indicated
that, to recognize the additional
resources required to furnish CCM
services to patients with multiple
chronic conditions, we were creating
the following code to use for reporting
this service (78 FR 74422):
• GXXX1 Chronic care management
services furnished to patients with
multiple (two or more) chronic
conditions expected to last at least 12
months, or until the death of the patient,
that place the patient at significant risk
of death, acute exacerbation/
decompensation, or functional decline;
20 minutes or more; per 30 days.
Although this service is unique in that
it was created to separately pay for care
management services, other codes
include care management components.
To value CCM, we compared it to other
codes that involve care management. In
doing so, we concluded that the CCM
services were similar in work (time and
intensity) to that of the non-face-to-face
portion of the lower level code for
transitional care management (TCM)
services (CPT code 99495 (Transitional
Care Management Services with the
following required elements:
Communication (direct contact,
telephone, electronic) with the patient
and/or caregiver within 2 business days
of discharge Medical decision making of
at least moderate complexity during the
service period face-to-face visit, within
14 calendar days of discharge)).
Accordingly, we based the proposed
inputs on the non-face-to-face portion of
CPT code 99495.
Specifically, we proposed a work
RVU for GXXX1 of 0.61, which is the
portion of the work RVU for CPT code
99495 that remains after subtracting the
work attributable to the face-to-face
visit. (CPT code 99214 (Office/
outpatient visit est) was used to value
CPT code 99495, which has a work RVU
of 1.50). Similarly, we proposed a work
time of 15 minutes for HCPCS code
GXXX1 for CY 2015 based on the time
attributable to the non-face-to-face
portion of CPT 99495.
For direct PE inputs, we proposed 20
minutes of clinical labor time. As
established in the CY 2014 PFS final
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
rule with comment period, in order to
bill for this code, at least 20 minutes of
CCM services must be furnished during
the 30-day billing interval (78 FR
74422). Based upon input from
stakeholders and the nature of care
management services, we believed that
many aspects of this service will be
provided by clinical staff, and thus,
clinical staff would be involved in the
typical service for the full 20 minutes.
CPT code 99495 has 45 minutes of nonface-to-face clinical labor time and we
assumed the typical case for CCM
would involve 20 minutes based upon
the code descriptor and a broad eligible
population that would require limited
monthly services. The proposed CY
2015 direct PE input database reflected
the input of 20 minutes of clinical labor
time and is available on the CMS Web
site under the supporting data files for
the CY 2015 PFS proposed rule at
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-Notices.html. The resulting
proposed PE RVUs were 0.57 for CCM
furnished in non-facility locations and
0.26 for CCM furnished in a facility.
The proposed MP RVU of 0.04 was
calculated using the weighted risk
factors for the specialties that we
believed would furnish this service. We
believed the proposed malpractice risk
factor would appropriately reflect the
relative malpractice risk associated with
furnishing CCM services.
We received many public comments
on our proposed valuation. In general,
the commenters commended CMS for
ongoing recognition of the value of nonface-to-face time expended by
physicians and staff to improve
outcomes for beneficiaries with chronic
conditions, and the proposal to pay
separately for the non-face-to-face
services. However, the commenters
generally believed the proposed
valuation for CCM services
underestimated the resources involved
with complex beneficiaries, and
recommended various alternatives for
valuing the services. We summarize
these comments in the following
paragraphs.
Comment: Several commenters noted
that the CPT Editorial Panel created a
new code for CY 2015 that is extremely
similar to the G-code we developed to
report these services. These commenters
suggested that we use the new CPT code
99490 (Chronic care management
services, at least 20 minutes of clinical
staff time directed by a physician or
other qualified health care professional,
per calendar month, with the following
required elements:
PO 00000
Frm 00170
Fmt 4701
Sfmt 4700
• Multiple (two or more) chronic
conditions expected to last at least 12
months, or until the death of the patient;
• Chronic conditions place the
patient at significant risk of death, acute
exacerbation/decompensation, or
functional decline;
• Comprehensive care plan
established, implemented, revised, or
monitored).
Many of these commenters expressed
a preference for the ‘‘per calendar
month’’ used in the CPT descriptor to
the ‘‘per 30 days’’ used in the G-code.
The commenters said a calendar month
rather than 30 days would be less
complex administratively.
Response: It is our preference to use
CPT codes unless Medicare has a
programmatic need that is not met by
the CPT coding structure. Accordingly,
in the CY 2014 final rule with comment
period we indicated that we would
consider using a CPT code if one was
created that reflected the service we
were describing with the G-code. We
believe that the new CPT code 99490
appropriately describes CCM services
for Medicare beneficiaries.
We had used 30 days rather than a
calendar month as the service period for
the G-code so that the number of days
in the service period would not vary
based upon when CCM services were
initiated for a given period. For
example, if the services were initiated
near the end of a calendar month, using
the CPT code’s period of ‘‘per calendar
month’’ would make it harder for the
practitioner to meet the required
minimum time for the month and be
able to bill CMM for that month.
However, after learning about the
administrative difficulties that the 30day period would create, we believe that
the calendar month creates a reasonable
period. Accordingly, we will adopt CPT
code 99490 for Medicare CCM services,
effective January 1, 2015 instead of the
G code.
Comment: Several commenters
suggested alternative approaches to the
use of codes that describe CCM services.
For example, one commenter said that
the code should be for one year, with
average of 20 minutes per month across
the year. Another commenter was
concerned about how the 20 minutes of
care per month per patient will be
calculated, because some patients (those
whose condition is less well controlled)
will demand more attention and care
than average patients, while those
whose condition is well controlled
might require very little attention. This
commenter suggested that a reasonable
solution would be for the care minutes
per patient per month to be calculated
as an average across a number of CCM
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
patients. The commenter added that for
patients entering and exiting midmonth, the average minutes of care
could be calculated on a pro rata basis
which adjusts for the partial months
they are eligible for CCM services.
Several other commenters said that CMS
should use a capitated payment
methodology for CCM services in the
long run, but supported CCM services
using the CPT codes as valued by the
RUC as a short-term transitional strategy
until CMS is able to expand the per
beneficiary per month care management
fee under CMS’s primary care
demonstration initiatives to all
physicians. Others commented similarly
that the long-term goal is capitated
payments like the demonstrations/
models that better encourage
population-based health management
and reducing utilization.
Several commenters submitted
recommendations for valuation based
on their experience in CMS’s PatientCentered Medical Home multipayer
initiative. Assuming CCM services are
furnished by a care manager receiving
an annual salary of $150,000, and taking
into account a commonly accepted
patient to care manager ratio of 1:150,
these commenters believed that under
the proposed payment rate, the average
service time possible would be a ceiling
of 23 minutes (not a floor of 20
minutes). Based on one tracking study
of care manager activity in minutes per
patient per month, they believed
complex care management would
require 42 minutes of face-to-face and
non-face-to-face time per month.
Assuming the same care manger salary
and patient load, the commenters
asserted that the monthly payment
amount necessary to provide this
amount of care would be $83 per
beneficiary per month.
Response: Our proposal to pay
separately for these services is part of a
broader series of potential refinements
to the PFS that appropriately value care
management within Medicare’s
statutory structure for fee-for-service
physician payment. We do not have
statutory authority to base payment
under the PFS on a recurring per
beneficiary per month basis. The PFS is
limited to a fee-for-service model at
present, and as such we do not use
capitated payment for services that may
or may not be furnished in a given
month. We refer the commenter and
other interested stakeholders to the
preceding paragraphs that describe a
broader set of initiatives that are
designed to improve payment for, and
encourage long-term investment in, care
management services, including a
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
variety of CMS and HHS programs and
demonstrations.
Comment: Many commenters
recommended a higher valuation for
CCM services than was proposed, with
some commenters providing specific
suggestions as to changes in inputs and
others simply asserting that a higher
payment was appropriate or necessary
to achieve access or the desired benefit.
One commenter recommended a
payment of $75 but did not provide
supporting information. Several other
commenters recommended that CMS
adopt the RUC-recommended values for
CPT code 99490 (work time of 30
minutes, work RVU of 1.0, and 60
minutes of clinical labor time). Several
commenters believed CMS should adopt
the work, PE and MP RVUs for CPT
code 99495, with one commenter
suggesting that CMS crosswalk the PE
and MP RVU from the TCM code and
not just the work RVU from the code in
order to equalize payment for the CCM
code with a per beneficiary per month
payment that is made for similar
services through a state Medicaid
program. Another commenter pointed
out that the proposed combined MP and
PE RVU of 0.61 for CCM is significantly
lower than for the following similar
services that cannot be billed during
same period with CCM: HCPCS code
G0181 (Home Healthcare Oversight)
which has a combined MP and PE RVU
of 1.28; HCPCS code G0182 (Hospice
Care Plan Oversight) which has a
combined MP and PE RVU of 1.30; CPT
code 99339 (Care Plan Oversight
Services) which has a combined MP and
PE RVU of 0.94; and CPT code 99358
(Prolonged Services without Direct
Patient Contact) which has a combined
MP and PE RVU of 0.98.
Several commenters suggested that
CMS’s comparison with TCM, CPT code
99495, was not an appropriate
comparison. One commenter asked
what codes other than CPT code 99495
CMS considered as similar to CCM for
purposes of CCM valuation. This
commenter believed the time and
intensity required for the non-face-toface portion of CPT code 99495 is not
the same as for CCM services.
Several commenters suggested that
CMS should develop PE RVUs for the
service using alternative methodologies
than for other PFS services. For
example, several commenters stated that
CMS should adjust the PE RVUs to
account for major infrastructure and
other costs required for CCM, especially
health information technology,
computer equipment, 24/7 beneficiary
access, extensive documentation,
nursing staff and other overhead costs.
One commenter believed the proposed
PO 00000
Frm 00171
Fmt 4701
Sfmt 4700
67717
RVUs accounted for personnel costs but
not the practice expense for health
information technology, workforce
retooling, and analytics.
We received many public comments
on the appropriate work time and direct
PE inputs for clinical staff time. Most
suggested that the proposed inputs for
time were too low and recommended
using the RUC-recommended values
(work time of 30 minutes and 60
minutes of clinical labor time).
Regarding clinical labor time, some
commenters believed the proposed 20
minutes of clinical labor was too low,
being the 25th percentile for work time
in the RUC survey, and they noted the
significantly higher time reported in
response to the RUC survey of 60
minutes of clinical labor time. Another
commenter said that assuming 20
minutes of service time per month as
typical significantly undervalues the
service and questioned how CMS
arrived at that number. Regarding the
work time, several commenters
addressed the work RVU,
recommending that the proposed RVU
be adjusted upwards but did not specify
by how much. Several commenters
noted that the RUC recommendation of
1.0 work RVU for CPT codes 99490 and
99487 (Cmplx chron care w/o pt visit)
is based on median survey work times
of 30 minutes and 26 minutes,
respectively, for these CCM codes. (The
long descriptor for CPT code 99487 is,
Complex chronic care management
services, with the following required
elements:
• Multiple (two or more) chronic
conditions expected to last at least 12
months, or until the death of the patient;
• Chronic conditions place the
patient at significant risk of death, acute
exacerbation/decompensation, or
functional decline;
• Establishment or substantial
revision of a comprehensive care plan;
• Moderate or high complexity
medical decision making;
• 60 minutes of clinical staff time
directed by a physician or other
qualified health care professional, per
calendar month).
However several commenters did not
object to the proposed valuation for
GXXX1 and recommended that CMS
monitor payment adequacy and
appropriate valuation once the code is
implemented.
Response: After consideration of the
various comments on the work RVUs,
we continue to believe that the most
appropriate mechanism for determining
the appropriate work RVU for this
service is by using the non-face-to-face
portion of the lower level TCM code,
CPT code 99495. We continue to believe
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67718
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
that the work and intensity for CCM
services furnished to the eligible
beneficiaries is comparable to the work
and intensity involved in furnishing the
non-face-to-face portion of the service
described by CPT code 99495.
Therefore, we believe that using CPT
code 99495 as the comparison code
assures appropriate relativity with other
similar services. The services suggested
by the commenters as comparable to the
CCM code require significantly more
time. CPT code 99358 is for an hour of
non-face-to-face time and has a work
time of 60 minutes. CPT code 99339 has
a work time of 40 minutes and is
furnished to a significantly different
patient population (those in a
domiciliary or rest home). HCPCS codes
G0181 and G0182 have work time of
almost 60 minutes and also are
furnished to significantly different
patient populations.
We appreciate commenters’ concerns
regarding the various kinds of practice
expense and malpractice liability costs
that practices incur as they manage
beneficiaries requiring CCM services.
However, we continue to believe that
our established PE and MP methodology
used to value the wide ranges of
services across the PFS assures that we
have the appropriate relativity in our
payments.
Although many commenters
recommended that we use the time from
the RUC survey of 60 minutes of clinical
labor and 30 minutes of work time, we
believe that since CCM is a new
separately billable service, the survey
data may be less reliable as the
practitioners would have no experience
with the code. Since at least 20 minutes
of services are required to be furnished
in order to report the service and our
information, including comments,
suggests that many beneficiaries who
meet Medicare’s criteria for CCM
services would not need more than the
minimum required minutes of service,
we believe 60 minutes would
overestimate the typical number of
clinical labor minutes during one month
for the typical eligible beneficiary.
Accordingly, we are finalizing our
proposed work and clinical labor times.
Comment: A number of commenters
recommended that coinsurance should
not apply to CCM services. These
commenters were concerned that the $8
estimated coinsurance amount in the
proposed rule would hinder beneficiary
access. Several commenters believed
that CCM is a preventive service that
should be exempt from beneficiary cost
sharing. They noted that cost-sharing
will make it challenging to reach the 20
minutes required for billing, because
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
beneficiaries will delay care until faceto-face is necessary.
Response: CCM services do not fall
into any of the statutory preventive
services benefit categories of the Act.
The Secretary has the authority to add
‘‘additional preventive services’’ that,
among other things, have been assigned
an ‘‘A’’ or ‘‘B’’ rating by the United
States Preventive Services Task Force,
but CCM has not earned such a rating.
Since CCM does not meet the criteria,
we cannot designate it as an additional
preventive service under section
1861(s)(2)(BB) of the Act. Further, we do
not have other statutory authority that
would allow us to waive the applicable
coinsurance for CCM services. As
discussed in the CY 2014 PFS final rule
with comment period (78 FR 74424), in
order to assure that beneficiaries are
aware of the coinsurance for this nonface-to-face service, we are requiring
that providers explain to beneficiaries
the cost-sharing obligation involved in
receiving CCM services and obtain their
consent prior to furnishing the service.
Practitioners should explain that a
likely benefit of agreeing to receive CCM
services is that although cost-sharing
applies to these services, CCM services
may help them avoid the need for more
costly face to face services that entail
greater cost-sharing.
Comment: Most of the commenters
were concerned that the proposed
payment would not be adequate for
beneficiaries with complex needs who
would benefit the most from CCM
services. Most of the commenters
recommended that we adopt more than
one code to provide differential
payment for more and less complex
beneficiaries, using CPT CCM codes, Gcode(s) or some combination thereof.
Many commenters distinguished
between beneficiaries that require
significantly different clinical
resources—those needing ‘‘complex
chronic care management’’ and those
needing only ‘‘standard chronic care or
disease management.’’ Some
commenters asserted that there is a
disconnect between the code descriptor
for GXXX1 and the Medicare CCM
scope of service, such that ambiguity in
the descriptor will result in use of
GXXX1 to treat a very broad spectrum
of beneficiaries inconsistent with the
scope of service that the commenters
believed was consistent with
beneficiaries with more complex needs.
They believed the proposed payment
amount is appropriate for beneficiaries
on needing only standard chronic care
management, but would significantly
underpay for beneficiaries requiring
complex chronic care management.
PO 00000
Frm 00172
Fmt 4701
Sfmt 4700
Many commenters recommended that
CMS adopt the three CPT codes
describing chronic care management. In
addition to the CPT code that is similar
to the G-code described above (CPT
code 99490), there are two additional
complex chronic care coordination
codes (a base code and an add-on code).
Since CY 2013 when the complex
chronic care coordination codes became
available, CMS has bundled these codes.
The base code is CPT code 99487
(Cmplx chron care w/o pt visit), and the
add-on is CPT code 99489 (Complex
chronic care coordination services; each
additional 30 minutes of clinical staff
time directed by a physician or other
qualified health care professional, per
calendar month (list separately in
addition to code for primary procedure).
Other commenters recommended
using two codes to describe CCM for
different patient populations, or a base
code and an add-on code to describe
CCM for a single patient population.
Some commenters recommended
adoption of GXXX1 or CPT code 99490,
plus CPT code 99487 along with the
RUC-recommended values, to describe
CCM for the two distinct populations
that require different services. These
commenters stated that there is no
‘‘typical’’ patient that characterizes both
groups of patients, and that a large
number of eligible beneficiaries (those
having 2 or more chronic conditions)
have serious mental health and/or
substance abuse disorders and would
benefit greatly from CCM services).
Other commenters recommended using
two G-codes, one being an add-on code
for each additional 20 minutes or other
time spent caring for a beneficiary with
more complex needs. One commenter
urged CMS to adopt an add-on code for
time increments over 60 minutes.
Several commenters recommended a
cap on additional minutes, particularly
if CMS finalizes an applicable
beneficiary coinsurance for CCM
services. One commenter recommended
that we finalize the proposed valuation
for GXXX1, also recognize CPT code
99490 (Chron care mgmt srvc 20 min)
with a higher payment amount, and
then collect data on the impacts of
differential payment amounts.
Other commenters recommended that
CMS adopt CPT code 99487 (Cmplx
chron care w/o pt visit) with the scope
of services for GXXX1. One commenter
recommended that CMS redefine its
requirements and the scope of services
for GXXX1 to be more consistent with
chronic disease management, using CPT
code 99487. The commenter believed
we should adopt CPT code 99487 with
the RUC-recommended valuation. One
commenter more generally
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
recommended that CMS adopt a higher
intensity code for patients requiring 45–
60 minutes or more of clinical staff time
for assessment, medication
management, care planning,
coordination, education and advocacy.
Response: At this time, we believe
that Medicare beneficiaries with two or
more chronic conditions as defined
under the CCM code can benefit from
care management and want to make this
service available to all such
beneficiaries. Like all services, we
recognize that some beneficiaries will
need more services and some less, and
thus we pay based upon the typical
service. However all scope of service
elements apply for delivery of CCM
services to any eligible Medicare
beneficiary. We will evaluate the
utilization of this service to evaluate
what types of beneficiaries receive the
service described by this CPT code,
what types of practitioners are reporting
it, and consider any changes in payment
that may be warranted in the coming
years. We are maintaining the status
indicator ‘‘B’’ (Bundled) for CY 2015 for
the complex care coordination codes,
CPT codes 99487 and 99489.
Comment: Several commenters
requested that CMS create codes
specific to remote patient biometric
monitoring (recording vital signs and
other physiological data and
transmitting real-time data to
physicians). Several commenters
requested codes specific to or inclusive
of certain hematology, nephrology,
endocrine and allergy/immunology
conditions, such as chronic kidney
disease, end-stage renal disease,
diabetes and severe asthma. One
commenter recommended that CMS
delay implementation of this service for
CY 2015 and propose for CY 2016
specific complex chronic care codes for
each of the major chronic diseases,
especially diabetes.
Response: We are not convinced that
the care management services are
sufficiently unique based upon the
beneficiary’s specific chronic conditions
to warrant separate codes, especially
given the beneficiary must have at least
two chronic conditions. As noted above,
we will be monitoring this service and
will consider making changes if they
appear warranted.
After consideration of the comments
received on this proposal, we are
finalizing the proposal with the
following modification. Rather than
creating a G-code we are adopting the
new CPT code, 99490, to describe CCM
services effective January 1, 2015. We
intend to evaluate this service closely to
assess whether the service is targeted to
the right population and whether the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
payment is appropriate for the services
being furnished. As part of our
evaluation, we will consider the
whether this new service meets the care
coordination needs of Medicare
beneficiaries and if not how best to
address the unmet needs.
2. CCM and TCM Services Furnished
Incident to a Physician’s Service Under
General Physician Supervision
In the CY 2014 PFS final rule with
comment period (78 FR 74425 through
74427), we discussed how the policies
relating to services furnished incident to
a practitioner’s professional services
apply to CCM services. (In this
discussion, the term practitioner means
both physicians and NPPs who are
permitted to bill for services furnished
incident to their own professional
services.) Specifically, we addressed the
policy for counting clinical staff time for
services furnished incident to the billing
practitioner’s services toward the
minimum amount of service time
required to bill for CCM services.
We established an exception to the
usual rules that apply to services
furnished incident to the services of a
billing practitioner. Generally, under the
‘‘incident to’’ rules, practitioners may
bill for services furnished incident to
their own services if the services meet
the requirements specified in our
regulations at § 410.26. One of these
requirements is that the ‘‘incident to’’
services must be furnished under direct
supervision, which means that the
supervising practitioner must be present
in the office suite and be immediately
available to provide assistance and
direction throughout the service (but
does not mean that the supervising
practitioner must be present in the room
where the service is furnished). We
noted in last year’s PFS final rule with
comment period that, because one of the
required elements of the CCM service is
beneficiary access to the practice 24hours-a-day, 7-days-a-week, to address
the beneficiary’s chronic care needs (78
FR 74426), we expect the beneficiary to
be provided with a means to make
timely contact with health care
providers in the practice whenever
necessary to address chronic care needs
regardless of the time of day or day of
the week. In those cases when the need
for contact arises outside normal
business hours, it is likely that the
beneficiary’s initial contact would be
with clinical staff employed by the
practice (for example, a nurse) and not
necessarily with a practitioner. Under
these circumstances, it would be
unlikely that a practitioner would be
available to provide direct supervision
of the service.
PO 00000
Frm 00173
Fmt 4701
Sfmt 4700
67719
Therefore, in the CY 2014 PFS final
rule with comment period, we created
an exception to the generally applicable
requirement that ‘‘incident to’’ services
must be furnished under direct
supervision. Specifically, we finalized a
policy to require only general, rather
than direct, supervision when CCM
services are furnished incident to a
practitioner’s services outside of the
practice’s normal business hours by
clinical staff who are direct employees
of the practitioner or practice. We
explained that, given the potential risk
to beneficiaries that the exception to
direct supervision could create, we
believed that it was appropriate to
design the exception as narrowly as
possible (78 FR 74426). The direct
employment requirement was intended
to balance the less stringent general
supervision requirement by ensuring
that there is a direct oversight
relationship between the supervising
practitioner and the clinical staff
personnel who provide after-hours
services.
In the CY 2015 PFS proposed rule, we
proposed to revise the policy that we
adopted in the CY 2014 PFS final rule
with comment period. We also proposed
to amend our regulations to codify the
requirements for CCM and TCM services
furnished incident to a practitioner’s
services. Specifically, we proposed to
remove the requirement that, in order to
count the time spent by clinical staff
providing aspects of CCM services
toward the CCM time requirement, the
clinical staff person must be a direct
employee of the practitioner or the
practitioner’s practice. (We note that the
existing requirement that these services
be provided by clinical staff,
specifically, rather than by other
auxiliary personnel is an element of the
service for both CCM and TCM services,
rather than a requirement imposed by
the ‘‘incident to’’ rules themselves.) We
also proposed to remove the restriction
that services provided by clinical staff
under general (rather than direct)
supervision may be counted only if they
are provided outside of the practice’s
normal business hours. Under our
proposed revised policy, then, the time
spent by clinical staff providing aspects
of CCM services can be counted toward
the CCM time requirement at any time,
provided that the clinical staff are under
the general supervision of a practitioner
and all other requirements of the
‘‘incident to’’ regulations at § 410.26 are
met.
We proposed to revise these aspects of
the policy for several reasons. First, one
of the required elements of the CCM
service is the availability of a means for
the beneficiary to make contact with
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67720
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
health care practitioners in the practice
to address a beneficiary’s urgent chronic
care needs (78 FR 74418 through
74419). Other elements within the scope
of CCM services are similarly required
to be furnished by practitioners or
clinical staff. We believe that these
elements of the CCM scope of service
require the presence of an
organizational infrastructure sufficient
to adequately support CCM services,
irrespective of the nature of the
employment or contractual relationship
between the clinical staff and the
practitioner or practice. We also believe
that the elements of the CCM scope of
service, such as the requirement of a
care plan, ensure a close relationship
between a practitioner furnishing
ongoing care for a beneficiary and
clinical staff providing aspects of CCM
services under general supervision; and
that this close working relationship is
sufficient to render a requirement of a
direct employment relationship or
direct supervision unnecessary. Under
our proposal, CCM services could be
furnished ‘‘incident to’’ if the services
are provided by clinical staff under
general supervision of a practitioner
whether or not they are direct
employees of the practitioner or practice
that is billing for the service; but the
clinical staff must meet the other
requirements for auxiliary personnel
including those at § 410.26(a)(1). Other
than the exception to permit general
supervision for clinical staff, the same
requirements apply to CCM services
furnished incident to a practitioner’s
professional services as apply to other
‘‘incident to’’ services. Furthermore,
since last year’s final rule, we have had
many consultations with physicians and
others about the organizational
structures and other factors that
contribute to effective provision of CCM
services. These consultations have
convinced us that, for purposes of
clinical staff providing aspects of CCM
services, it does not matter whether the
practitioner is directly available to
supervise because the nature of the
services are such that they can be, and
frequently are, provided outside of
normal business hours or while the
physician is away from the office during
normal business hours. This is because,
unlike most other services to which the
‘‘incident to’’ rules apply, the CCM
services are intrinsically non-face-toface care coordination services.
In conjunction with this proposed
revision to the requirements for CCM
services provided by clinical staff
incident to the services of a practitioner,
we also proposed to adopt the same
requirements for equivalent purposes in
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
relation to TCM services. As in the case
of CCM, TCM explicitly includes
separate payment for services that are
not necessarily furnished face-to-face,
such as coordination with other
providers and follow-up with
beneficiaries. It would also not be
uncommon for auxiliary personnel to
provide elements of the TCM services
when the physician was not in the
office. Generally, we believe that it is
appropriate to treat separately billable
care coordination services similarly
whether in the form of CCM or TCM.
We also believe that it would be
appropriate to apply the same ‘‘incident
to’’ rules that we are proposing for CCM
services to TCM services. We did not
propose to extend this policy to the
required face-to-face portion of TCM.
Rather, the required face-to-face portion
of the service must still be furnished
under direct supervision.
Therefore, we proposed to revise our
regulation at § 410.26, which sets out
the applicable requirements for
‘‘incident to’’ services, to permit TCM
and CCM services provided by clinical
staff incident to the services of a
practitioner to be furnished under the
general supervision of a physician or
other practitioner. As with other
‘‘incident to’’ services, the physician (or
other practitioner) supervising the
auxiliary personnel need not be the
same physician (or other practitioner)
upon whose professional service the
‘‘incident to’’ service is based. We note
that all other ‘‘incident to’’ requirements
continue to apply and that the usual
documentation of services provided
must be included in the medical record.
Commenters uniformly supported our
proposal to revise our regulation at
§ 410.26, which sets out the applicable
requirements for ‘‘incident to’’ services,
to permit TCM and CCM services
provided by clinical staff incident to the
services of a practitioner to be furnished
under the general supervision of a
physician or other practitioner. Under
the revised regulation, then, the time
spent by clinical staff providing aspects
of TCM and CCM services can be
counted toward the TCM or CCM time
requirement at any time, provided that
the clinical staff are under the general
supervision of a practitioner and all
requirements of the revised ‘‘incident
to’’ regulations at § 410.26 are met.
Comment: One commenter requested
guidance concerning whether (as has
been the case with E/M codes) activities
billed under ‘‘incident to’’ will not be
able to also be billed under the CCM
code.
Response: The purpose of our
proposal was to allow elements of CCM
services that are furnished by clinical
PO 00000
Frm 00174
Fmt 4701
Sfmt 4700
staff incident to a practitioner’s
professional services (under the
‘‘incident to’’ regulations) to be
included and reported as CCM services.
We are not entirely clear what the
commenter is asking, but the time spent
furnishing CCM services can only be
counted once and for only one purpose,
and each discrete service can be billed
only once. Although we and our
contractors provide many educational
materials, practitioners who furnish
Medicare covered items and services are
responsible for learning how to
appropriately bill each service.
Comment: One commenter urged us
to revise the terminology by which we
define the CCM and TCM services to
reflect non-hierarchical
interdisciplinary team care, rather than
relying on an incident-to structure that
obscures the actual provider of direct
patient care. This commenter expressed
concern about loss of benefits to
clinicians under contract with a
practice, rather than being employed by
the practice. Another commenter
similarly expressed concern that the
expanded authorization for ‘‘general
supervision’’ rather than ‘‘direct
supervision’’ would provide an even
greater incentive for physicians to
require that any E/M service provided
by an Advanced Practice Registered
Nurse (APRN) in their practice be billed
as ‘‘incident to’’ a physician’s service.
This could reduce transparency in
billing data and diminish accountability
for services for Part B beneficiaries.
Response: We do not entirely
understand the basis for these concerns.
We have accommodated numerous
requests to include contracted
employees within the scope of the
‘‘incident to’’ rules for purposes of
counting time toward the TCM and
CCM requirements. We have not
otherwise proposed to revise the
‘‘incident to’’ and other regulations
within which practitioners operate as
they make decisions about whether to
contract or directly employ clinical
staff, or about how to bill for services
provided. Although they are important
within the context of the new TCM and
CCM services, we believe that the
revisions to our ‘‘incident to’’ regulation
that are adopted in this final rule, are
peripheral in the context of the overall
employment and billing practices of
physicians and group practices.
After consideration of the comments,
we are finalizing our proposal to revise
our regulation at § 410.26, which sets
out the applicable requirements for
‘‘incident to’’ services, to permit the
CCM and non-face-to-face portion of the
TCM services provided by clinical staff
incident to the services of a practitioner
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
to be furnished under the general
supervision of a physician or other
practitioner.
3. Scope of Services and Standards for
CCM Services
In the CY 2014 final rule with
comment period (78 FR 74414 through
74428), we defined the elements of the
scope of service for CCM that are
required for a practitioner to bill
Medicare for the CCM service. In
addition, we indicated that we intended
to develop standards for practices that
furnish CCM services to ensure that the
practitioners who bill for these services
have the capability to fully furnish them
(78 FR 74415, 74418). At that time, we
anticipated that we would propose these
standards in the CY 2015 PFS proposed
rule. We actively sought input toward
development of these standards by
soliciting public comments on the CY
2014 PFS final rule with comment
period, through outreach to stakeholders
in meetings, by convening a Technical
Expert Panel, and by collaborating with
federal partners such as the Office of the
Assistant Secretary for Planning and
Evaluation, the Office of the Assistant
Secretary for Health, the Office of the
National Coordinator for Health
Information Technology (ONC), and the
Health Resources and Services
Administration. Our goal is to recognize
the trend toward practice transformation
and overall improved quality of care,
while preventing unwanted and
unnecessary care.
As we worked to develop appropriate
practice standards that would meet this
goal, we consistently found that many of
the standards we thought were
important overlapped in significant
ways with the scope of service or with
the billing requirements for the CCM
services that had been finalized in the
CY 2014 final rule with comment
period. In cases where the standards we
identified were not unique to CCM
requirements, we found that the
standards overlapped with other
Medicare requirements or other federal
requirements that apply generally to
health care practitioners. Based upon
the feedback we received, we sought to
avoid duplicating other requirements or,
worse, imposing conflicting
requirements on practitioners that
would furnish CCM services. Given the
standards and requirements that are
already in place for health care
practitioners and applicable to those
who furnish and bill for CCM services,
we decided not to propose an additional
set of standards that would have to be
met in order for practitioners to furnish
and bill for CCM services. Instead of
proposing a new set of standards
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
applicable to only CCM services, we
decided to emphasize that certain
requirements are inherent in the
elements of the existing scope of service
for CCM services, and clarify that these
must be met in order to bill for CCM
services. The CCM scope of service
elements finalized in the CY 2014 PFS
final rule (78 FR 74414 through 74428)
are as follows.
• The provision of 24-hour-a-day, 7day-a-week access to address the
patient’s acute chronic care needs. To
accomplish this, the patient must be
provided with a means to make timely
contact with health care providers in the
practice to address the patient’s urgent
chronic care needs regardless of the
time of day or day of the week.
• Continuity of care with a designated
practitioner or member of the care team
with whom the patient is able to get
successive routine appointments.
• Care management for chronic
conditions including systematic
assessment of the patient’s medical,
functional, and psychosocial needs;
system-based approaches to ensure
timely receipt of all recommended
preventive care services; medication
reconciliation with review of adherence
and potential interactions; and oversight
of patient self-management of
medications.
• In consultation with the patient,
any caregiver and other key
practitioners treating the patient, the
practitioner furnishing CCM services
must create a patient-centered care plan
document to assure that care is provided
in a way that is congruent with patient
choices and values. The care plan is
based on a physical, mental, cognitive,
psychosocial, functional and
environmental (re)assessment and an
inventory of resources and supports. It
is a comprehensive plan of care for all
health issues, and typically includes,
but is not limited to, the following
elements: problem list, expected
outcome and prognosis, measurable
treatment goals, symptom management,
planned interventions, medication
management, community/social services
ordered, how the services of agencies
and specialists unconnected to the
billing practice will be directed/
coordinated, identify the individuals
responsible for each intervention,
requirements for periodic review and,
when applicable, revision of the care
plan. A full list of problems,
medications and medication allergies in
the EHR must inform the care plan, care
coordination and ongoing clinical care.
• Management of care transitions
within health care, including referrals to
other clinicians, follow-up after the
patient’s visit to an emergency
PO 00000
Frm 00175
Fmt 4701
Sfmt 4700
67721
department, and follow-up after
discharges from hospitals, skilled
nursing facilities, or other health care
facilities. The practice must facilitate
communication of relevant patient
information through electronic
exchange of a summary care record with
other health care providers regarding
these transitions. The practice must also
have qualified personnel who are
available to deliver transitional care
services to the patient in a timely way
so as to reduce the need for repeat visits
to emergency departments and
readmissions to hospitals, skilled
nursing facilities or other health care
facilities.
• Coordination with home and
community based clinical service
providers required to support the
patient’s psychosocial needs and
functional deficits. Communication to
and from home and community based
providers regarding these patient needs
must be documented in the patient’s
medical record.
• Enhanced opportunities for the
beneficiary and any relevant caregiver to
communicate with the practitioner
regarding the beneficiary’s care through,
not only telephone access, but also
through the use of secure messaging,
internet or other asynchronous non faceto-face consultation methods.
Similarly, we reminded stakeholders
of the following additional billing
requirements established in the CY 2014
final rule with comment period (in the
following list, we have changed the
service period from the 2015 proposed
30-day period to the final 2015 service
period of one calendar month):
• Inform the beneficiary about the
availability of the CCM services from
the practitioner and obtain his or her
written agreement to have the services
provided, including the beneficiary’s
authorization for the electronic
communication of the patient’s medical
information with other treating
providers as part of care coordination.
• Document in the beneficiary’s
medical record that all elements of the
CCM service were explained and offered
to the beneficiary, and note the
beneficiary’s decision to accept or
decline the service.
• Provide the beneficiary a written or
electronic copy of the care plan and
document in the electronic medical
record that the care plan was provided
to the beneficiary.
• Inform the beneficiary of the right
to stop the CCM services at any time
(effective at the end of a calendar
month) and the effect of a revocation of
the agreement to receive CCM services.
• Inform the beneficiary that only one
practitioner can furnish and be paid for
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67722
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
these services during the calendar
month service period.
In one area, electronic health records
(EHRs), we were concerned that the
existing elements of the CCM service
could leave some gaps in assuring that
beneficiaries consistently receive care
management services that offer the
benefits of advanced primary care as it
was envisioned when this service was
created. It is clear that effective care
management can be accomplished only
through regular monitoring of the
patient’s health status, needs, and
services, and through frequent
communication and exchange of
information with the patient and among
the various health care practitioners and
providers treating the patient. After
gathering input from stakeholders
through the CY 2014 rulemaking cycle,
for 2015 we proposed a new scope of
service element that would require use
of a certified EHR and electronic care
planning to furnish CCM services. We
believed that requiring those who
furnish CCM services to utilize EHR
technology that has been certified by a
certifying body authorized by the
National Coordinator for Health
Information Technology was necessary
to ensure that key patient information is
stored, shared and reconciled among the
many practitioners and providers
involved in managing the patient’s
chronic conditions, otherwise care
could not be coordinated and managed.
Requiring a certified EHR would enable
members of the interdisciplinary care
team to have immediate access to the
most updated information informing the
care plan. Therefore we proposed that
the billing practitioner must utilize EHR
technology certified by a certifying body
authorized by the National Coordinator
for Health Information Technology to an
edition of the EHR certification criteria
identified in the then-applicable version
of 45 CFR part 170. We proposed that
at a minimum, the practice must utilize
EHR technology that meets the
certification criteria adopted at 45 CFR
170.314(a)(3), 170.314(a)(4),
170.314(a)(5), 170.314(a)(6),
170.314(a)(7) and 170.314(e)(2)
pertaining to the capture of
demographics, problem lists,
medications, and other key elements
related to the ultimate creation of an
electronic summary care record. These
sections of the regulation comprise the
certification criteria for specific core
technology capabilities (structured
recording of demographics, problems,
medications, medication allergies, and
the creation of a structured clinical
summary) for the 2014 edition. Under
the proposal, practitioners furnishing
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
CCM services beginning in CY 2015
would be required to utilize an EHR
certified to at least these 2014 edition
certification criteria. Given these 2014
edition criteria, the EHR technology
would be certified to capture data and
ultimately produce summary records
according to the HL7 Consolidated
Clinical Document Architecture
standard (see 45 CFR 170.205(a)(3)).
In addition, when any of the CCM
scope of service elements refers to a
health or medical record, we proposed
to require use of an EHR certified to at
least the 2014 edition certification
criteria to fulfill the scope of service
element in relation to the health or
medical record. As finalized in the CY
2014 PFS final rule, the scope of service
elements that reference a health or
medical record are:
• A full list of problems, medications
and medication allergies in the EHR
must inform the care plan, care
coordination and ongoing clinical care.
• Communication to and from home
and community based providers
regarding the patient’s psychosocial
needs and functional deficits must be
documented in the patient’s medical
record.
• Inform the beneficiary of the
availability of CCM services and obtain
his or her written agreement to have the
services provided, including
authorization for the electronic
communication of his or her medical
information with other treating
providers. Document in the
beneficiary’s medical record that all of
the CCM services were explained and
offered, and note the beneficiary’s
decision to accept or decline these
services.
• Provide the beneficiary a written or
electronic copy of the care plan and
document in the electronic medical
record that the care plan was provided
to the beneficiary.
Regarding the care plan in particular,
we believed that requiring practitioners
furnishing CCM services to maintain
and share an electronic care plan would
alleviate the errors that can occur when
care plans are not systematically
reconciled. To ensure that practices
offering CCM services meet these needs,
we proposed that CCM services must be
furnished with the use of an EHR or
other health IT or health information
exchange platform that includes an
electronic care plan that is accessible to
all practitioners within the practice,
including being accessible to those who
are furnishing care outside of normal
business hours, and that is available to
be shared electronically with care team
members outside of the practice. This
was a more limited proposal compared
PO 00000
Frm 00176
Fmt 4701
Sfmt 4700
to our CY 2014 proposal that we did not
finalize that would have required
members of the chronic care team who
are involved in the after-hours care of
the patient to have access to the
beneficiary’s full electronic medical
record (78 FR 74416 through 74417).
Regarding the clinical summary, we
proposed to require technology certified
to the 2014 edition for the electronic
creation of the clinical summary,
formatted according to the standard
adopted at 45 CFR 170.205(a)(3), but we
did not specify that this format must be
used for the exchange of beneficiary
information (79 FR 40367). For instance,
we did not propose that practitioners
billing for CCM services must adopt
certified technology related to the
exchange of a summary care record such
as the transmission standard related to
Direct Project Transport in 45 CFR
170.314(b)(2)(ii).
We indicated that we believed our
proposed new scope of service element
for a certified EHR and electronic care
planning would ensure that
practitioners billing for CCM could fully
furnish the services, allow practitioners
to innovate around the systems that they
use to furnish these services, and avoid
overburdening small practices. We
indicated that we believed that allowing
flexibility as to how practitioners
capture, update, and share care plan
information was important at this stage
given the maturity of current EHR
standards and other electronic tools in
use in the market today for care
planning.
In addition to seeking comment on
this new proposed scope of service
element, we sought comment on any
changes to the scope of service or billing
requirements for CCM services that may
be necessary to ensure that the
practitioners who bill for these services
have the capability to furnish them and
that we can appropriately monitor
billing for these services. With the
addition of the electronic health
information technology element that we
proposed, we believed that the elements
of the scope of service for CCM services,
when combined with other important
federal health and safety regulations,
would provide sufficient assurance that
practitioners billing for CCM could fully
furnish the services, and that Medicare
beneficiaries receiving CCM would
receive appropriate services. However
we expressed special interest in
receiving public feedback regarding any
meaningful elements of the CCM service
or beneficiary protections that may be
missing from the scope of service
elements and billing requirements.
The following paragraphs summarize
the comments we received regarding
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
these elements of the scope of service
for CCM services and our responses.
Comment: Some commenters were
disappointed that CMS did not propose
an additional set of standards. The
commenters expressed concern that
there would not be sufficient
accountability for high quality CCM
services. Some commenters
recommended further development of
standards such as inclusion of evidencebased self-management programs
offered by community organizations,
quality measures that engage patients
and demonstrate improved outcomes, or
a best practices guide to assist the
physician community with
implementation. However, many
commenters opposed further standards,
and agreed with CMS that additional
standards would largely overlap with
other Medicare requirements or were
already reflected in the scope of service
elements.
Response: We appreciate the
commenters’ concerns about ensuring
quality of care. We continue to believe
that with the addition of the EHR
element, the required scope of service
elements are sufficient for ensuring high
quality CCM services in 2015. We note
that section III.K of this final rule with
comment period addresses quality
measures for physicians’ services, and
stakeholders may submit suggestions for
quality measures related to CCM in
response to this section of the
regulation.
Comment: Many commenters
expressed broad support for our EHR
proposal. The commenters commended
the strong emphasis on data sharing and
requirements for a robust EHR as vital
to successful care coordination and
continuity of care. Several commenters
did not believe the proposal would pose
a significant administrative burden. One
commenter noted that use of an EHR
would help practitioners to document
the time spent furnishing CCM services.
Although commenters supported
adoption of certified EHR technology
(CEHRT) generally, many were
concerned that an insufficient number
of physicians have adopted CEHRT with
the functionalities we proposed for
CCM, especially interoperability with
other providers. The commenters were
also concerned that physicians
practicing in rural or economically
depressed areas would not have the
resources to implement such technology
and would be disqualified from
furnishing separately billable CCM
services. Many believed the proposal
was laudable but premature,
recommending that CMS delay adoption
of the 2014 EHR certification criteria for
CCM services by 3 to 4 years when they
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
will be more widely adopted, or phase
in the 2014 certification criteria over 2
years as a requirement for 2017. Several
commenters recommended that we
finalize our proposal but provide
hardship exceptions for certain smaller
or rural practices to enable them to bill
separately for CCM services in the
absence of an interoperable EHR in
certain circumstances, provide financial
incentives, or allow other flexibility
around the requirements for physicians
who cannot meet them at this time. One
commenter supported the proposal but
suggested we allow aspects of CCM
services to be furnished using fax and
secure messaging technology if
physicians encounter challenges with
interoperability. Until EHR systems are
interoperable, some commenters
suggested allowing practitioners to
attest that all requirements for billing
CCM were met using CEHRT or an
alternative technology, or to attest that
all members of the care team have
timely access (24/7 access in ‘‘real time’’
or ‘‘near real time’’) to the most updated
information regarding the care plan
through either electronic or nonelectronic means, with ongoing efforts
to implement interoperable EHRs. The
commenters stated many practices are
making patient information accessible
in a timely manner to the entire care
team, but have not yet fully
implemented an interoperable EHR with
other providers. Several commenters
were concerned about the ability of
current EHR technologies to share
information across different providers
and EHR systems. Commenters
requested that CMS ensure that no
certified EHR contains technological or
business impediments to data sharing
across disparate technology platforms
used by multiple providers trying to
coordinate care. In addition, many
commenters were concerned about
access to CCM services, and
recommended that CMS prioritize
access over adoption of CEHRT. Several
commenters stated that not all types of
physicians have access to an EHR that
meets the needs of their specialty.
A number of commenters stated that
CCM could be (and already is)
effectively provided without any EHR or
a without a certified EHR, and
recommended that CMS rescind the
proposal or make the EHR requirement
optional. These commenters disagreed
with the requirement that CCM services
must be furnished with use of a certified
EHR, information technology (IT)
platform or exchange platform that
includes a care plan, with some stating
that certified EHR systems have not
demonstrated improvements in the
PO 00000
Frm 00177
Fmt 4701
Sfmt 4700
67723
management of chronic conditions,
especially complex cases, and suggested
postponing the care plan and other EHR
requirements until they are proven
effective and adopted by most
providers. Others stated that an EHR
was necessary and that CMS should
require an EHR that promotes
communication among various
professional on the care team, includes
the patient as part of the team, and
enables clinical monitoring and
effective care planning. Commenters
indicated that many physicians
accomplish this through generating or
receiving electronic discharge
summaries, clinical documentation, and
patient-centered plans of care, but are
not using certified technologies to carry
out these functions and should not be
penalized.
One commenter stated that only about
half of all physicians had an EHR
system with advanced functionalities in
2013, many current systems were not
designed with interoperability in mind
and transition costs are high. The
commenter believed the proposed
payment amount would not sufficiently
cover the cost of purchasing or
upgrading an EHR system, and requiring
a certified EHR would limit the number
of eligible physicians without
significantly adding value to CCM
services. Another commenter stated that
only 1,000 physicians and other eligible
health professionals have achieved
Stage 2 of Meaningful Use of certified
EHR technology, compared with more
than 300,000 physicians and eligible
professionals who have achieved Stage
1.
Response: We continue to believe that
it is necessary to require the use of EHR
technology that has been certified under
the ONC Health IT Certification Program
as requisite for receiving separate
payment for CCM services, to ensure
that practitioners have adequate
capabilities to allow members of the
interdisciplinary care team to have
timely access to the most updated
information informing the care plan. We
agree with commenters that health IT
tools are most effective when there are
no technological or business
impediments to data sharing, or
disparate technology platforms used by
multiple providers trying to coordinate
care, and that we should ensure
common functionalities as much as
possible across providers. However, we
also agree with commenters who
expressed concern that requiring the
most recent edition of EHR certification
criteria could be an impediment to the
broad utilization of the CCM service. In
response to comments, we are
modifying our proposal regarding which
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67724
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
edition of certified EHR technology will
be required, in order to allow more
flexibility as practitioners transition to
the use of certified EHR technology.
Accordingly, we are modifying our
proposal to specify that the CCM service
must be furnished using, at a minimum,
the edition(s) of certification criteria
that is acceptable for purposes of the
EHR Incentive Programs as of December
31st of the calendar year preceding each
PFS payment year (hereinafter ‘‘CCM
certified technology’’) to meet the final
core technology capabilities (structured
recording of demographics, problems,
medications, medication allergies, and
the creation of a structured clinical
summary). Practitioners must also use
this CCM certified technology to fulfill
the CCM scope of service requirements
whenever the requirements reference a
health or medical record. This will
ensure that requirements for CCM
billing under the PFS are consistent
throughout each PFS payment year and
are automatically updated annually
according to the certification criteria
required for the EHR Incentive
Programs. For CCM payment in CY
2015, this policy will allow
practitioners to use EHR technology
certified to either the 2011 or 2014
edition(s) of certification criteria to meet
the final core capabilities for CCM and
to fulfill the CCM scope of service
requirements whenever the
requirements reference a health or
medical record. We are finalizing the
separate provision we proposed for the
electronic care plan scope of service
element without modification as
discussed below. We remind
stakeholders that for all electronic
sharing of beneficiary information under
our final CCM policies, HIPAA
standards apply in the usual manner.
Comment: Several commenters
questioned the relationship between the
Meaningful Use criteria and the
proposed EHR scope of service element
for CCM. One commenter stated that
none of the requirements for EHR
capability for payment of CCM services
should be tied to or related to
Meaningful Use, because many of the
Meaningful Use requirements do not
apply to CCM. Another commenter
supported what they understood to be
our proposal, to require billing
physicians to adopt an EHR and utilize
it to meet the most recent standard for
Meaningful Use. However, the
commenter noted (similar to the
previous commenter) that the current
functionalities and standards for EHR
technology required for Meaningful Use
are not entirely aligned with the
functionalities required for CCM, for
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
example the commenter believed that
the electronic care plan need only be
shared 10 percent of the time to meet
Meaningful Use measures, but that CCM
would require it to be available 24/7 and
to all practitioners. The commenter
expressed concern that practitioners
might not be able to furnish CCM as
envisioned by CMS due to discrepancies
with the Meaningful Use criteria, and
urged CMS to adopt interoperability
standards for Meaningful Use that
would enable successful care
coordination models. Another
commenter recommended that
enforcement of the proposed EHR
requirement be coterminous with the
enforcement of Meaningful Use Stage 2
to ensure practices have the ability to
comply.
Response: Although we understand
why some commenters would like for
the requirements for the EHR Incentive
Programs and the EHR scope of service
element for CCM to be identical, we do
not believe that is entirely possible
because of the different nature and
purpose of the respective EHR
specifications. In many respects they are
not comparable requirements. For
example, the PFS sets payment
requirements prospectively for a given
calendar year, while the EHR Incentive
Program may change requirements midyear. In addition, many of the
Meaningful Use measures are not
relevant for the provision of CCM and
we believe we should only require
practitioners to adopt the certified
technology that is relevant to the scope
of CCM services. In their attempts to
meet Meaningful Use criteria for a given
year, practitioners are required to use
technology certified to a specific
edition(s) of certification criteria to meet
the CEHRT definition, and as we
discussed above we are aligning the
edition required to bill CCM with the
edition(s) required for Meaningful Use
each year. However, it is conceivable
that a practitioner could use CCM
certified technology to provide and be
paid for CCM in a given calendar year
that will not be sufficient for achieving
Meaningful Use in that same year
because CCM must be furnished using at
least the edition(s) of certified EHR
technology required for the EHR
Incentive Programs as of December 31st
of the prior calendar year. Also, it is
possible that a practitioner could use
technology certified to an edition that
qualifies for CCM payment that could
also be used to achieve Meaningful Use
for a given calendar year, but still not
meet the objectives and associated
measures of a particular stage of
Meaningful Use that are required to
PO 00000
Frm 00178
Fmt 4701
Sfmt 4700
qualify for an EHR Incentive payment or
avoid a downward adjustment to
payments. As the commenters noted,
the Meaningful Use measures are not all
relevant to the provision of CCM
services, and the practitioner may not
have sufficient certified technology to
support all the necessary or relevant
Meaningful Use objectives and measures
under the EHR Incentive Programs.
Certified technology is used in different
ways to meet the requirements of each
program. We believe that the policy we
are finalizing here aligns the CCM scope
of service element to the extent
appropriate with the EHR Incentive
Programs to achieve maximum
consistency.
Comment: Several commenters asked
us to clarify the requirement for the
electronic care plan in relationship to
the overall requirement for a certified
EHR and in relationship to the 24/7
access requirement. The commenters
stated they were not sure whether these
proposals were independent provisions
or impacted one another. The
commenters stated that if CMS intended
these as independent provisions, the
agency should identify objective criteria
to evaluate whether a particular health
IT product has adequate capabilities to
meet the separate requirement for the
electronic care plan. The commenters
stated they were not sure whether the
electronic care plan would require a
certified EHR, or whether there would
be an exception to use of CEHRT for the
care plan. The commenters
recommended flexibility in how
practitioners and providers capture,
develop, update and share care plan
information. One commenter
recommended that if practitioners must
attest to use of a qualifying electronic
care plan, CMS should only require a
simple yes/no response to minimize
billing impediments. One commenter
asked us to clarify the required elements
of the care plan in relation to different
EHR systems.
In addition, several commenters
requested that we clarify whether the
care plan must be electronically
accessible 24/7 to all providers treating
the patient’s chronic conditions, those
within the billing practice, or those
within the billing practice who are
communicating with the patient after
hours. The commenters noted that
providers other than the billing
practitioner may not use the same
certified EHR, so it would be
unreasonable to expect the same care
plan and other relevant information to
be accessible to all providers at all
times. Other commenters believed we
proposed flexibility around the certified
EHR requirement in relation to the
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
electronic care plan, and supported this
proposed flexibility.
Response: Regarding the care plan, we
proposed that CCM services must be
furnished with the use of an EHR or
other health IT or health information
exchange platform (not necessarily a
certified EHR) that includes an
electronic care plan that is accessible at
all times to the practitioners within the
practice, including those who are
furnishing CCM outside of normal
business hours. By practitioners ‘‘within
the practice,’’ we mean any practitioners
furnishing CCM services whose minutes
count towards a given practice’s time
requirement for reporting the CCM
billing code.
In addition, we proposed that the
electronic care plan must be available to
be shared electronically with care team
members outside the practice (who are
not billing for CCM). We sought to
convey that practitioners could satisfy
these requirements related to the care
plan without using the certified EHR
technology. We specified that the
certified EHR technology is only
required to accomplish activities
described in the scope of service
elements that specifically mention a
medical record or EHR. We said that a
full list of problems, medications and
medication allergies in the certified EHR
(which would follow structured
recording formats) must inform the care
plan, not that the care plan itself must
be created or transmitted among
providers using certified EHR
technology. We note that this was a
limited proposal compared to our CY
2014 proposal that we did not finalize
that would have required members of
the chronic care team who are involved
in the after-hours care of the patient to
have access to the patient’s full
electronic medical record instead of just
the care plan (78 FR 74416 through
74417).
Through separate requirements for the
electronic care plan and the certified
EHR, our intent was to require
practitioners to use some form of
electronic technology tool or service in
fulfilling the care plan element (other
than facsimile transmission),
recognizing that certified EHR
technology is limited in its ability to
support electronic care planning at this
time, and that practitioners must have
flexibility to use a wide range of tools
and services beyond certified EHR
technology now available in the market
to support electronic care planning. We
intended that all care team members
furnishing CCM services that are billed
by a given practice (contributing to the
minimum time required for billing)
must have access to the electronic care
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
plan at all times when furnishing CCM
services. However, the electronic care
plan would not have to be available at
all times to other non-billing practices,
recognizing that other practices may not
be using compatible electronic
technology or participating in a health
information exchange.
We are finalizing the electronic care
plan and 24/7 access elements as
proposed, clarifying that to satisfy the
care plan scope of service element,
practitioners must electronically capture
care plan information and make this
information available to all care team
members furnishing CCM services that
are billed by a given practice (counting
towards the minimum monthly service
time), even when furnishing CCM
outside of normal business hours. In
addition, practitioners must
electronically share care plan
information as appropriate with other
providers and practitioners who are
furnishing care to the patient. We are
not requiring that practitioners use a
specific electronic technology to meet
the requirement for 24/7 access to the
care plan or its transmission, only that
they use an electronic technology other
than facsimile. For instance, practices
may satisfy the 24/7 care plan access
requirement through remote access to an
EHR, web-based access to a care
management application, or web-based
access to a health information exchange
service that captures and maintains care
plan information. Likewise, we are not
requiring that practitioners use a
specific electronic technology to meet
the requirement to share care plan
information electronically with other
practitioners and providers who are not
billing for CCM. For instance,
practitioners may meet this sharing
requirement through the use of secure
messaging or participation in a health
information exchange with those
practitioners and providers, although
they may not use facsimile
transmission.
While we are not requiring that
practitioners use a specific electronic
technology at this time (other than not
allowing facsimile), we may revisit this
requirement as standards-based
exchange of care plan information
becomes more widely available in the
future. We remind stakeholders that for
all electronic sharing of beneficiary
information under our final CCM
policies, HIPAA standards apply in the
usual manner.
Comment: Several commenters asked
us to clarify the relationship between
the certified EHR proposal and the
summary record exchange requirement.
Commenters believed that CMS had
cited specific regulatory provisions
PO 00000
Frm 00179
Fmt 4701
Sfmt 4700
67725
around exchange in the proposed rule
(identified by the commenter as a
Summary Record Exchange (SRE)
capability tag, referring to a designation
used to identify those products on the
Certified Health IT Product List
maintained by ONC offering technology
certified to criteria around the exchange
of summary care records) and should
consider alternatives. The commenters
were not clear as to whether they
objected to what they believed to be the
proposed format or the transmission
method of the summary record
exchange.
Response: In the CY 2014 PFS final
rule with comment period, as part of the
care transitions management scope of
service element, we indicated that the
practice must be able to facilitate the
communication of relevant patient
information through electronic
exchange of a summary care record with
other health care providers (78 FR
74418). We did not specify a standard
for the ‘‘summary care record’’ that
providers must exchange electronically,
nor did we specify a method by which
providers must facilitate the
communication of beneficiary
information, such as use of certified
EHR technology. In the CY 2015 PFS
proposed rule (79 FR 40367), we
proposed that the practitioner must
utilize EHR technology certified by a
certifying body authorized by the
National Coordinator for Health
Information Technology to an edition of
the EHR certification criteria identified
in the then-applicable version of 45 CFR
part 170. Under one of the specific
certification criteria cited, we proposed
that practitioners must use technology
that meets the criterion adopted at
§ 170.314(e)(2), which would ensure
that they produce summary records
formatted according to the standard
adopted at § 170.205(a)(3). However, we
did not propose that this formatting
standard must be used for the exchange
of patient information, only that in
furnishing CCM services, practitioners
must format their summaries according
to this standard. We did not propose
that providers billing for CCM services
must adopt any certified technology for
the exchange of a summary care record,
such as the transmission standard
related to Direct Project Transport in
§ 170.314(b)(2)(ii). We recognized that
providers are currently exchanging
patient information to support
transitions of care in a variety of
meaningful ways beyond the methods
specified with 2014 edition certified
technology, with the exception of faxing
which would not meet the proposed
scope of service requirement. The 2014
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67726
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
edition sets specific requirements for
transmission or exchange of the
summary record that technology must
meet for certification, and we expected
that only some practitioners could adopt
and use such technology in CY 2015.
Therefore we did not constrain
practitioners to the exchange
functionality in the 2014 edition if they
utilized an alternative electronic tool.
As discussed above, our final policy
will allow practitioners billing the PFS
for CCM services to use the edition(s) of
certification criteria that is acceptable
for the EHR Incentive Programs as of
December 31st of each calendar year
preceding each PFS payment year to
meet the final core technology
capabilities (structured recording of
demographics, problems, medications,
medication allergies, and the creation of
a structured clinical summary). (Also
practitioners must use this CCM
certified technology to fulfill the CCM
scope of service requirements whenever
the requirements reference a health or
medical record). Under this final policy,
practitioners must format their
structured clinical summaries according
to, at a minimum, the standard that is
acceptable for the EHR Incentive
Programs as of December 31st of the
calendar year preceding each PFS
payment year.
We are finalizing our proposal that
practitioners must communicate
relevant patient information through
electronic exchange of a summary care
record to support transitions of care,
with a clarification that practitioners do
not have to use any specific content
exchange standard in CY 2015. We did
not propose and are not finalizing a
requirement to use a specific tool or
service to communicate beneficiary
information, as long as providers do so
electronically. We note however that
faxing will not fulfill this requirement
for exchange of the summary care
record. We did not propose to modify
our view, discussed in the CY 2014 PFS
final rule with comment period, that
practitioners furnishing and billing for
CCM services must be able to support
care transitions through the electronic
exchange of beneficiary information in a
summary care record (78 FR 74418).
While certain 2014 edition certification
criteria address a content standard and
transmission method for exchange of a
summary record, we continue to expect
that only some practitioners could adopt
and use such technology. Moreover, we
recognize that providers are currently
exchanging patient information to
support transitions of care in a variety
of meaningful ways beyond the methods
specified in 2014 edition certification
criteria. We continue to believe that at
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
least for CY 2015, we should allow
flexibility in the selection of the
electronic tool or service that is used to
transmit beneficiary information in
support of care transitions, as long as
practitioners electronically share
beneficiary information to support
transitions of care. Finally we remind
stakeholders that for all electronic
sharing of beneficiary information under
our final CCM policies, HIPAA
standards apply in the usual manner.
Comment: Several commenters
expressed concern about requiring a
certified EHR for billing CCM. The
commenters were concerned that CMS
would not allow the use of non-certified
technologies that may be more
innovative and effective than certified
technologies. Commenters requested
that we clarify whether only the
certified EHR (and no other electronic
tool) could be used to conduct CCM
services, for example the use of
enhanced communication methods
other than telephone. One commenter
stated that many times the practice will
be using the certified EHR system to
carry out such activities, and there are
strong Meaningful Use incentives to
employ the certified EHR for these
activities. However, a practice may also
have other capabilities and tools that
would support elements of the CCM
services. These commenters asked us to
clarify whether the requirement to
utilize certified EHR technology is a
literal statement that only certified EHR
technology may be used in furnishing
the scope of service elements for CCM
services.
Response: We continue to believe that
health IT tools are most effective when
there are no technological or business
impediments to data sharing, or
disparate technology platforms used by
multiple practitioners trying to
coordinate care. For the separately
billable CCM service, we believe it is
necessary to establish as part of the
scope of the service a certified EHR that
allows for the data capture, accessibility
and sharing capabilities necessary to
furnish the service. Therefore, we are
finalizing our proposal to require use of
CCM certified technology to meet the
final core technology capabilities
(structured recording of demographics,
problems, medications, medication
allergies, and the creation of a
structured clinical summary). In
addition, whenever a scope of service
element references a health or medical
record, CCM certified technology must
be used to fulfill that scope of service
element in relation to the health or
medical record. We have listed above
the current scope of service elements
that include a reference to a health or
PO 00000
Frm 00180
Fmt 4701
Sfmt 4700
medical record. If both CCM certified
technology and other methods are
available to the practitioner to fulfill the
final core technology capabilities for
CCM (structured recording of
demographics, problems, medications,
medication allergies, and the creation of
a structured clinical summary) or the
CCM scope of service elements
referencing a the health or medical
record, practitioners may only use the
certified capability. We remind
stakeholders that for all electronic
sharing of beneficiary information under
our final CCM policies, HIPAA
standards apply in the usual manner.
Comment: One commenter
recommended that we adopt the
following additional 2014 EHR
certification criteria:
• Patient List Creation (45 CFR
170.314(a)(14)), which would support
the required element of service for
preventive services and routine
appointments, and could help provide
registry types of functions for the
practice to use in managing patients
who have agreed to participate in the
chronic care management service.
• Patient-Specific Education
Resources (§ 170.314(a)(15)), which
would help assure the ability to provide
the patient with relevant educational
materials about their chronic disease
conditions.
• Clinical Reconciliation
(§ 170.314(b)(4)), which would serve
support the medication reconciliation
requirement and the requirement to
review patient adherence to their
medication regime.
• View/Download/Transmit to a 3rd
Party (§ 170.314(e)(1)), which would
enable patients to access their own
electronic health record and have access
to information related to their care at
their own convenience.
• Secure Messaging, Ambulatory
Setting Only (§ 170.314(e)(3)).
Response: Some of these 2014
certification criteria are not relevant
(have no corollary) in the 2011
certification criteria, so we would not
require them because practitioners are
not required to use the 2014 edition in
CY 2015. In addition, we are requiring
that providers use certified EHR
technology to fulfill a limited number of
the scope of service elements
(summarized in Table 33). We are
requiring the certified technology only
for certain foundational elements, and
believe we should avoid making the
EHR requirement for CCM unnecessarily
complex at this time. While we agree
that the other features of certified EHR
products mentioned by the commenter
would certainly help many practitioners
fulfill the other elements of the CCM
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
service, practitioners may be using tools
other than certified technology that are
adequate for the required task(s), for
example, registry tools for patient list
creation, educational resources, patient
portals, third party reconciliation
services, and secure messaging systems.
Comment: We received many
comments on the scope of service
elements other than the EHR, some
requesting that we implement
additional standards. A few commenters
said CMS should consider adding a
requirement for use of community based
providers through a home visit at least
once every 12 months to assess the
home environment and the need for
community based resources, or that
CMS should include home and
domiciliary care, group visits and
community based care. Several
commenters wanted us to include
‘‘remote patient monitoring’’ or ‘‘patient
generated health data’’ in the scope of
services, such as daily remote
monitoring of physiology and
biometrics. Several commenters
recommended additional tools for
patient self-management education and
training, or ‘‘patient activation’’ tools.
One commenter recommended we
require a patient experience survey to
assess the patient’s perspective
regarding the CCM services they receive.
Several commenters believed we should
expand the medication management and
medication reconciliation element to
include more comprehensive
medication management and more
clearly define ‘‘review of adherence’’ to
the medication regimen.
Response: Other than the scope of
service element for EHR and other
electronic technology, we do not believe
additional changes to the scope of
service elements for CCM are warranted
at this time. We are requiring certified
EHR technology for certain foundational
or ‘‘core’’ elements, including structured
recording of medications and
medication allergies. As finalized in the
scope of service in the CY 2014 PFS
final rule with comment period we are
also requiring medication reconciliation
with review of adherence and potential
interactions, and oversight of patient
self-management of medications. We
believe it would be overly burdensome,
especially given the broad eligible
beneficiary population and final RVU
inputs, to include more specific
requirements related to medication
management, especially when greater
specificity is likely not necessary to
ensure adequate care. The CCM services
are by definition non-face-to-face
services; therefore we are not including
a requirement for home or domiciliary
visits or community based care
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
(although there is a requirement related
to coordinating home and community
based care). Practitioners who engage in
remote monitoring of patient
physiological data of eligible
beneficiaries may count the time they
spend reviewing the reported data
towards the monthly minimum time for
billing the CCM code, but cannot
include the entire time the beneficiary
spends under monitoring or wearing a
monitoring device. If we believe
changes to the scope of service elements
are warranted in the future, we will
propose them through notice and
comment rulemaking taking the
comments we received to date into
consideration.
Comment: We received many
comments on the scope of service
elements other than the EHR, requesting
that CMS implement fewer standards.
Some commenters believed that other
than the ‘‘incident to’’ provisions, the
scope of service elements are
administratively burdensome and it will
be difficult for physicians to adequately
document that they have fulfilled the
requirements. Several commenters did
not believe it was necessary to require
written beneficiary consent. Others
asked that CMS develop model
beneficiary consent forms.
Response: We understand the
commenters’ concerns about adequate
documentation, although this issue is
not unique to CCM services. We believe
the additional scope of service element
for the EHR and electronic sharing of
the care plan and clinical summary
record will create an electronic
‘‘footprint’’ that will facilitate
documentation, including
documentation of the minimum
monthly amount of time spent in
providing CCM services.
Regarding beneficiary consent, we
believe written beneficiary consent and
its documentation in the medical record
is necessary because we are requiring
practices to share beneficiaries’
protected health information both
within and outside of the billing
practice in the course of furnishing CCM
services and because beneficiaries will
be required to pay coinsurance on nonface-to-face services. We do not believe
the content or nature of the required
consent is so complex that we should
develop model formats. If we believe
changes to the scope of service elements
are warranted in the future, we will
propose them through notice and
comment rulemaking taking the
comments we received to date into
consideration.
In summary, we are finalizing our
proposal for the CCM scope of service
element for EHR technology as
PO 00000
Frm 00181
Fmt 4701
Sfmt 4700
67727
proposed, with the following
modification. We are including as an
element of the separately billable CCM
service the use of, at a minimum,
technology certified to the edition(s) of
certification criteria that is acceptable
for the EHR Incentive Programs as of
December 31st of the calendar year prior
to the PFS payment year (CCM certified
technology), to meet the final core EHR
capabilities (structured recording of
demographics, problems, medications,
medication allergies and the creation of
a structured clinical summary record)
and to fulfill all activities within the
final scope of service elements that
reference a health or medical record. For
CCM payment in CY 2015, this policy
will allow practitioners to use EHR
technology certified to either the 2011
or 2014 edition(s) of certification
criteria. The final scope of service
elements that refer to a health or
medical record, and that must be
fulfilled using the CCM certified
technology, are summarized in Table 33
and include the following:
• A full list of problems, medications
and medication allergies in the EHR
must inform the care plan, care
coordination and ongoing clinical care.
• Communication to and from home
and community based providers
regarding the patient’s psychosocial
needs and functional deficits must be
documented in the patient’s medical
record.
• Inform the beneficiary of the
availability of CCM services and obtain
his or her written agreement to have the
services provided, including
authorization for the electronic
communication of his or her medical
information with other treating
providers. Document in the
beneficiary’s medical record that all of
the CCM services were explained and
offered, and note the beneficiary’s
decision to accept or decline these
services.
• Provide the beneficiary a written or
electronic copy of the care plan and
document in the electronic medical
record that the care plan was provided
to the beneficiary.
We are finalizing our proposal
regarding the electronic care plan scope
of service element without modification.
To satisfy this element, practitioners
must at least electronically capture care
plan information; make this information
available on a 24/7 basis to all
practitioners within the practice who
are furnishing CCM services whose time
counts towards the time requirement for
the practice to bill the CCM code; and
share care plan information
electronically (other than by facsimile)
as appropriate with other practitioners
E:\FR\FM\13NOR2.SGM
13NOR2
67728
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
and providers who are furnishing care
to the beneficiary. We are not requiring
practitioners to use a specific electronic
solution to furnish the care plan
element of the CCM service, only that
the method must be electronic and
cannot include facsimile transmission.
Similarly, we are not requiring
practitioners to use a specific tool or
service to communicate clinical
summaries in managing care transitions,
as long as practitioners transmit the
clinical summaries electronically, with
the exception of faxing which will not
fulfill the requirement for exchange of a
summary care record. However
practitioners must format their clinical
summaries according to, at a minimum,
the standard that is acceptable for the
EHR Incentive Programs as of December
31st of the calendar year preceding each
PFS payment year.
We remind stakeholders that for all
electronic sharing of beneficiary
information under our final CCM
policies, HIPAA standards apply in the
usual manner. We summarize the final
requirements for the CCM scope of
service elements and billing
requirements for CY 2015 and their
relationship to the final EHR
requirements in Table 33.
TABLE 33—SUMMARY OF FINAL CCM SCOPE OF SERVICE ELEMENTS AND BILLING REQUIREMENTS FOR CY 2015
CCM Scope of service element/billing requirement
Certified EHR or other electronic technology requirement
Structured recording of demographics, problems, medications, medication allergies, and the creation of a structured clinical summary
record. A full list of problems, medications and medication allergies
in the EHR must inform the care plan, care coordination and ongoing
clinical care.
Access to care management services 24/7 (providing the beneficiary
with a means to make timely contact with health care providers in
the practice to address his or her urgent chronic care needs regardless of the time of day or day of the week).
Continuity of care with a designated practitioner or member of the care
team with whom the beneficiary is able to get successive routine appointments.
Care management for chronic conditions including systematic assessment of the beneficiary’s medical, functional, and psychosocial
needs; system-based approaches to ensure timely receipt of all recommended preventive care services; medication reconciliation with
review of adherence and potential interactions; and oversight of beneficiary self-management of medications.
Creation of a patient-centered care plan based on a physical, mental,
cognitive, psychosocial, functional and environmental (re)assessment
and an inventory of resources and supports; a comprehensive care
plan for all health issues. Share the care plan as appropriate with
other practitioners and providers.
Structured recording of demographics, problems, medications, medication allergies, and creation of structured clinical summary records
using CCM certified technology.
ebenthall on DSK5SPTVN1PROD with $$_JOB
Provide the beneficiary with a written or electronic copy of the care
plan and document its provision in the electronic medical record.
Management of care transitions between and among health care providers and settings, including referrals to other clinicians; follow-up
after an emergency department visit; and follow-up after discharges
from hospitals, skilled nursing facilities or other health care facilities.
Coordination with home and community based clinical service providers
Enhanced opportunities for the beneficiary and any caregiver to communicate with the practitioner regarding the beneficiary’s care
through not only telephone access, but also through the use of secure messaging, internet or other asynchronous non face-to-face
consultation methods.
Beneficiary consent—Inform the beneficiary of the availability of CCM
services and obtain his or her written agreement to have the services
provided, including authorization for the electronic communication of
his or her medical information with other treating providers. Document in the beneficiary’s medical record that all of the CCM services
were explained and offered, and note the beneficiary’s decision to
accept or decline these services.
Beneficiary consent—Inform the beneficiary of the right to stop the
CCM services at any time (effective at the end of the calendar
month) and the effect of a revocation of the agreement on CCM
services.
Beneficiary consent—Inform the beneficiary that only one practitioner
can furnish and be paid for these services during a calendar month.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00182
Fmt 4701
None.
None.
None.
Must at least electronically capture care plan information; make this information available on a 24/7 basis to all practitioners within the
practice whose time counts towards the time requirement for the
practice to bill the CCM code; and share care plan information electronically (other than by fax) as appropriate with other practitioners
and providers.
Document provision of the care plan as required to the beneficiary in
the EHR using CCM certified technology.
• Format clinical summaries according to CCM certified technology.
• Not required to use a specific tool or service to exchange/transmit
clinical summaries, as long as they are transmitted electronically
(other than by fax).
Communication to and from home and community based providers regarding the patient’s psychosocial needs and functional deficits must
be documented in the patient’s medical record using CCM certified
technology.
None.
Document the beneficiary’s written consent and authorization in the
EHR using CCM certified technology.
None.
None.
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
4. Payment of CCM Services in CMS
Models and Demonstrations
As discussed in section II.G., several
CMS models and demonstrations
address payment for care management
services. The Multi-payer Advanced
Primary Care Practice (MAPCP)
Demonstration and the Comprehensive
Primary Care (CPC) Initiative both
include payments for care management
services that closely overlap with the
scope of service for the new chronic
care management services code. In these
two initiatives, primary care practices
are receiving per beneficiary per month
payments for care management services
furnished to Medicare fee-for-service
beneficiaries attributed to their
practices. We proposed that
practitioners participating in one of
these two models may not bill Medicare
for CCM services furnished to any
beneficiary attributed to the practice for
purposes of participating in one of these
initiatives, as we believe the payment
for CCM services would be a duplicative
payment for substantially the same
services for which payment is made
through the per beneficiary per month
payment. However, we proposed that
these practitioners may bill Medicare for
CCM services furnished to eligible
beneficiaries who are not attributed to
the practice for the purpose of the
practice’s participation as part of one of
these initiatives. As the Innovation
Center implements new models or
demonstrations that include payments
for care management services, or as
changes take place that affect existing
models or demonstrations, we will
address potential overlaps with the
CCM service and seek to implement
appropriate reimbursement policies. We
solicited comments on this proposal.
We also solicited comments on the
extent to which these services may not
actually be duplicative and, if so, how
our reimbursement policy could be
tailored to address those situations.
We received several comments that
either supported or did not oppose our
proposed policy regarding the payment
of CCM services in CMS models and
demonstrations that also pay for care
management services.
The following is a summary of the
other comments we received regarding
our proposals on reimbursement
policies.
Comment: Two commenters requested
that we reconsider our proposed policy
to exclude demonstration practitioners
from billing for CCM services to ensure
that these practitioners are not
disadvantaged relative to those
practitioners who do not participate in
demonstrations or models.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Response: Our proposed policy does
not exclude practitioners participating
in demonstrations or models from
billing for CCM services. To reiterate,
practitioners participating in
demonstrations or models may bill
Medicare for CCM services for
beneficiaries who are not attributed to
the practices for purposes of
participating in either the MAPCP or
CPC. For beneficiaries who are not
attributed to the practice, no care
management payment is made under the
MAPCP or CPC models. If the
beneficiary otherwise meets the criteria
for CCM services, the practitioner may
furnish and bill Medicare for CCM.
However, Medicare will not pay
practitioners participating in MAPCP or
CPC for CCM services furnished to
beneficiaries attributed to the practice
for the purpose of the practice’s
participation in either these models. We
believe we have created a pathway to
enable practitioners participating in
CPC or MAPCP to bill Medicare for the
CCM services, as not all beneficiaries
treated in a practice will be attributed to
the practice.
Comment: We received two comments
expressing concern for confusion that
might occur regarding the interaction of
CCM services and the CPC model.
Response: We acknowledge that the
Innovation Center will need to engage in
extensive communications efforts with
practitioners participating in either CPC
or MAPCP to inform them of our
policies regarding billing for CCM
services.
Comment: One individual commented
that payment for CCM ‘‘should not be
constrained’’ by the payment in a
demonstration. The commenter also
said, ‘‘The two payments are completely
unrelated and are made for different
purposes to very different physician
practices. Also, we do not believe it is
possible to know with certainty whether
there is overlap between a
fee-for-service chronic care management
payment and a payment for care
coordination in a demonstration.’’
Response: The proposed policy aims
not to constrain practitioners
voluntarily participating in Innovation
Center models and demonstrations,
specifically CPC and MAPCP, by
allowing them to bill Medicare for CCM
services furnished to beneficiaries for
whom they are not receiving payments
as part of these initiatives. We expect
the practitioners participating in these
initiatives will be eligible to bill the
CCM service for some beneficiaries, as
there is overlap between elements of the
CCM service and the models. For
example, the CPC model requires
practitioners to use electronic health
PO 00000
Frm 00183
Fmt 4701
Sfmt 4700
67729
records that have been certified by the
National Coordinator for Health
Information Technology, provide
patients with 24/7 access to the practice,
ensure continuity of care with a
designated practitioner or care team for
each patient, provide care management
that includes a systematic assessment of
patient needs, use patient-centered care
plans, and give enhanced opportunities
for patient and caregiver
communications. Similarly, the MAPCP
demonstration is testing the patientcentered medical home model, which
focuses on care management, continuity
of care, and care coordination. All
practitioners, who are voluntarily
participating in these initiatives, receive
quarterly reports indicating which
beneficiaries have been attributed to
their practices. After reviewing and
comparing the features of the CPC and
MAPCP models with the CCM service,
we continue to be convinced that there
is overlap. The CCM service provides
appropriate payment for care
management and care coordination
furnished to beneficiaries with multiple
chronic conditions within the current
fee-for-service Medicare program, while
Innovation Center models and
demonstrations test alternative payment
methods that promote less reliance on a
fee-for-service funding stream and
support primary care delivery
transformation at the practice level to
identify potential future alternative
approaches to payment.
In response to these comments, we
will engage in extensive
communications explaining to practices
participating in CMMI models and
demonstrations, specifically the CPC
and MAPCP initiatives, the policies
related to care management payments
under these initiatives and the CCM
service. We continue to believe the
payment for CCM services would be a
duplicative payment for substantially
the same services included in the per
beneficiary per month payment under
the CPC and MAPCP models. Therefore,
we are finalizing our proposed policy
that CMS will not pay practitioners
participating in one of these two
initiatives for CCM services furnished to
any beneficiary attributed by the
initiative to the practice. These
practitioners may bill Medicare for CCM
services furnished to eligible
beneficiaries who are not attributed by
the initiative to the practice. As the
Innovation Center implements new
models or demonstrations that include
payments for care management services,
or as changes take place that affect
existing models or demonstrations, we
will address potential overlaps with the
E:\FR\FM\13NOR2.SGM
13NOR2
67730
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
CCM service and seek to implement
appropriate payment policies.
I. Outpatient Therapy Caps for CY 2015
Section 1833(g) of the Act requires
application of annual, per beneficiary,
limitations on the amount of expenses
that can be considered as incurred
expenses for outpatient therapy services
under Medicare Part B, commonly
referred to as ‘‘therapy caps.’’ There is
one therapy cap for outpatient
occupational therapy (OT) services and
another separate therapy cap for
physical therapy (PT) and speechlanguage pathology (SLP) services
combined.
The therapy caps apply to outpatient
therapy services furnished in all
settings, including the once-exempt
outpatient hospital setting (effective
October 1, 2012) and critical access
hospitals (effective January 1, 2014).
The therapy cap amounts under
section 1833(g) of the Act are updated
each year based on the Medicare
Economic Index (MEI). Specifically, the
annual caps are calculated by updating
the previous year’s cap by the MEI for
the upcoming calendar year and
rounding to the nearest $10.00.
Increasing the CY 2014 therapy cap of
$1,920 by the CY 2015 MEI of 0.8
percent and rounding to the nearest
$10.00 results in a CY 2015 therapy cap
amount of $1,940.
An exceptions process for the therapy
caps has been in effect since January 1,
2006. Originally required by section
5107 of the Deficit Reduction Act of
2005 (DRA), which amended section
1833(g)(5) of the Act, the exceptions
process for the therapy caps has been
extended multiple times through
subsequent legislation (MIEA–TRHCA,
MMSEA, MIPPA, the Affordable Care
Act, MMEA, TPTCCA, MCTRJCA,
ATRA and PAMA). The Agency’s
current authority to provide an
exceptions process for therapy caps
expires on March 31, 2015.
After expenses incurred for the
beneficiary’s outpatient therapy services
for the year have exceeded one or both
of the therapy caps, therapy suppliers
and providers use the KX modifier on
claims for subsequent services to
request an exception to the therapy
caps. By use of the KX modifier, the
therapist is attesting that the services
above the therapy caps are reasonable
and necessary and that there is
documentation of medical necessity for
the services in the beneficiary’s medical
record.
Under section 1833(g)(5)(C) of the
Act, we are required to apply a manual
medical review process to therapy
claims when a beneficiary’s incurred
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
expenses for outpatient therapy services
exceed a threshold amount of $3,700.
There are two separate thresholds of
$3,700, just as there are two separate
therapy caps, one for OT services and
one for PT and SLP services combined,
and incurred expenses are counted
towards the thresholds in the same
manner as the caps. The statutorily
required manual medical review expires
March 31, 2015, consistent with the
expiration of the Agency’s authority to
provide an exceptions process for the
therapy caps. For information on the
manual medical review process, go to
www.cms.gov/Research-Statistics-Dataand-Systems/Monitoring-Programs/
Medical-Review/TherapyCap.html.
J. Definition of Colorectal Cancer
Screening Tests
As discussed in the proposed rule (79
FR 40368), section 1861(pp) of the Act
defines ‘‘colorectal cancer screening
tests’’ and, under section 1861(pp)(1)(C),
a ‘‘screening colonoscopy’’ is one of the
recognized procedures. Among other
things, section 1861(pp)(1)(D) of the Act
authorizes the Secretary to modify the
tests and procedures covered under this
subsection, ‘‘with such frequency and
payment limits, as the Secretary
determines appropriate,’’ in
consultation with appropriate
organizations. The current definition of
‘‘colorectal cancer screening tests’’ at
§ 410.37(a)(1) includes ‘‘screening
colonoscopies.’’ Until recently, the
prevailing practice for screening
colonoscopies has been moderate
sedation provided intravenously by the
endoscopist, without resort to separately
provided anesthesia.3 Based on this
prevailing practice, payment for
moderate sedation has accordingly been
bundled into the payment for the
colorectal cancer screening tests, (for
example, G0104, G0105). For these
procedures, because moderate sedation
is bundled into the payment, the same
physician cannot also report a sedation
code. An anesthesia service can be
billed by a second physician.
However, a recent study in The
Journal of the American Medical
Association (JAMA) cited an increase in
the percentage of colonoscopies and
upper endoscopy procedures furnished
using an anesthesia professional, from
13.5 percent in 2003 to 30.2 percent in
2009 within the Medicare population,
with a similar increase in the
commercially-insured population.4 A
3 Faulx, A. L. et al. (2005). The changing
landscape of practice patterns regarding unsedated
colonoscopy and propofol use: A national web
survey. Gastrointestinal Endoscopy, 62. 9–15.
4 Liu H, Waxman DA, Main R, Mattke S.
Utilization of Anesthesia Services during
PO 00000
Frm 00184
Fmt 4701
Sfmt 4700
2010 study projected that the percentage
of this class of procedures involving an
anesthesia professional would grow to
53.4 percent by 2015.5 These studies
suggest that the prevailing practice for
endoscopies in general and screening
colonoscopies in particular is
undergoing a transition, and that
anesthesia separately provided by an
anesthesia professional is becoming the
prevalent practice. In preparation for the
proposed rule, we reviewed these
studies and analyzed Medicare claims
data. We saw the same trend in
screening colonoscopies for Medicare
beneficiaries with 53 percent of the
screening colonoscopies for Medicare
claims submitted in 2013 had a separate
anesthesia claim reported.
In light of these developments, we
expressed our concern in the proposed
rule that the mere reference to
‘‘screening colonoscopies’’ in the
definition of ‘‘colorectal cancer
screening tests’’ has become inadequate.
Indeed, we were convinced that the
growing prevalence of separately
provided anesthesia services in
conjunction with screening
colonoscopies reflects a change in
practice patterns. Therefore, consistent
with the authority delegated by section
1861(pp)(1)(D) of the Act, we proposed
to revise the definition of ‘‘colorectal
cancer screening tests’’ to adequately
reflect these new patterns. Specifically,
we proposed to revise the definition of
‘‘colorectal cancer screening tests’’ at
§ 410.37(a)(1)(iii) to include anesthesia
that is separately furnished in
conjunction with screening
colonoscopies (79 FR 40369).
We also stated that our proposal to
revise the definition of ‘‘colorectal
cancer screening tests’’ in this manner
would further reduce our beneficiaries’
cost-sharing obligations under Part B.
Screening colonoscopies have been
recommended with a grade of A by the
United States Preventive Services Task
Force (USPSTF) and § 410.152(l)(5)
provides that Medicare Part B pays 100
percent of the Medicare payment
amount established under the PFS for
colorectal cancer screening tests except
for barium enemas (which do not have
a grade A or B recommendation from
the USPSTF). This regulation is based
on section 1833(a)(1) of the Act, as
amended by section 4104 of the
Affordable Care Act, which requires 100
Outpatient Endoscopies and Colonoscopies and
Associated Spending in 2003–2009. (2012). JAMA,
307(11):1178–1184.
5 Inadomi, J. M. et al. (2010). Projected increased
growth rate of anesthesia professional–delivered
sedation for colonoscopy and EGD in the United
States: 2009 to 2015. Gastrointestinal Endoscopy,
72, 580–586.
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
percent Medicare payment of the fee
schedule amount for those ‘‘preventive
services’’ that are appropriate for the
individual and are recommended with a
grade of A or B by the USPSTF. Section
4104 of the Affordable Care Act
amended section 1833(a)(1) of the Act to
effectively waive any Part B coinsurance
that would otherwise apply for certain
recommended preventive services,
including screening colonoscopies For
additional discussion of the impact of
section 4104 of the Affordable Care Act,
and our prior rulemaking based on this
provision see the CY 2011 PFS final rule
with comment period (75 FR 73412
through 73431). We also noted that
under § 410.160(b)(7) colorectal cancer
screening tests are not subject to the Part
B annual deductible and do not count
toward meeting that deductible.
In implementing the amendments
made by section 4104 of the Affordable
Care Act, we did not provide at that
time for waiving the Part B deductible
and coinsurance for covered anesthesia
services separately furnished in
conjunction with screening
colonoscopies. At that time, we believed
that our payment for the screening
colonoscopy, which included payment
for moderate sedation services, reflected
the typical screening colonoscopy.
Under the current regulations, Medicare
beneficiaries who receive anesthesia
from a different professional than the
one furnishing the screening
colonoscopy would be incurring costs
for the coinsurance and deductible
under Part B for those separate services.
With the changes in the standard of care
and shifting practice patterns toward
increased use of anesthesia in
conjunction with screening
colonoscopy, beneficiaries who receive
covered anesthesia services from a
different professional than the one
furnishing the colonoscopy would incur
costs for any coinsurance and any
unmet part of the deductible for this
component of the service. However, our
proposed revision to the definition of
‘‘colorectal cancer screening tests’’
would lead to Medicare paying 100
percent of the fee schedule amounts for
screening colonoscopies, including any
portion attributable to anesthesia
services furnished by a separate
practitioner in conjunction with such
tests, under § 410.152(l)(5). Similarly,
this revision would also mean that
expenses incurred for a screening
colonoscopy, and the anesthesia
services furnished in conjunction with
such tests, will not be subject to the Part
B deductible and will not count toward
meeting that deductible under
§ 410.160(b)(7). We believe the proposal
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
encourages more beneficiaries to obtain
a screening colonoscopy, which is
consistent with the intent of the
statutory provision to waive Medicare
cost-sharing for certain recommended
preventive services, and is consistent
with the authority delegated to the
Secretary in section 1861(pp)(1)(D) of
the Act.
In light of the changing practice
patterns for screening colonoscopies,
continuing to require Medicare
beneficiaries to bear the deductible and
coinsurance expenses for separately
billed anesthesia services furnished and
covered by Medicare in conjunction
with screening colonoscopies could
become a significant barrier to these
essential preventive services. As we
noted when we implemented the
provisions of the Affordable Care Act
waiving the Part B deductible and
coinsurance for these preventive
services, the goal of these provisions
was to eliminate financial barriers so
that beneficiaries would not be deterred
from receiving them (75 FR 73412).
Therefore, we proposed to exercise our
authority under section 1861(pp)(1)(D)
of the Act to revise the definition of
colorectal cancer screening tests to
encourage beneficiaries to seek these
services by extending the waiver of
coinsurance and deductible to
anesthesia or sedation services
furnished in conjunction with a
screening colonoscopy.
We noted in the proposed rule (79 FR
40370) that, in implementing these
proposed revisions to the regulations, it
would be necessary to establish a
modifier for use when billing the
relevant anesthesia codes for services
that are furnished in conjunction with a
screening colonoscopy, and thus,
qualify for the waiver of the Part B
deductible and coinsurance. Therefore,
we noted that we would provide
appropriate and timely information on
this new modifier and its proper use so
that physicians will be able to bill
correctly for these services when the
revised regulations become effective.
We also noted that the valuation of
colonoscopy codes, which include
moderate sedation, would be subject to
the same proposed review as other
codes that include moderate sedation, as
discussed in section II.B.6 of this final
rule with comment period.
The following is a summary of the
comments received on this proposal.
Comment: The majority of
commenters strongly supported
finalizing our proposal to revise the
definition of ‘‘colorectal cancer
screening tests’’ at § 410.37(a)(1)(iii) to
include anesthesia that is furnished in
conjunction with screening
PO 00000
Frm 00185
Fmt 4701
Sfmt 4700
67731
colonoscopies. However, one
commenter expressed concern about the
timing of the proposal, and specifically
that it leaves little time for
implementation in CY 2015. Therefore,
the commenter recommended that the
proposal should be considered for
implementation in CY 2016.
Response: We appreciate the support
for our proposal and are finalizing it as
proposed. Specifically, we are revising
the definition of ‘‘colorectal cancer
screening tests’’ at § 410.37(a)(1)(iii) to
include anesthesia that is furnished in
conjunction with screening
colonoscopies. We disagree with the
recommendation to delay
implementation until CY 2016. The
proposed implementation on January
1st following the finalization of the
policy in the final rule follows the usual
PFS schedule for implementation of
payment changes. We are not aware of
a reason for deviating from the usual
schedule for this policy. Therefore, we
are implementing this final rule,
effective January 1, 2015.
Comment: Many commenters urged
us to extend our proposed revision, by
identifying a way under our existing
authority to redefine colorectal cancer
screening to include screening
colonoscopy with removal of polyp,
abnormal growth, or tissue during the
screening encounter. Commenters stated
that there is already substantial
confusion among beneficiaries about
why colonoscopy with polyp removal
requires payment of coinsurance, while
colonoscopy without polyp removal
does not. The commenters maintained
that our proposal to include anesthesia
that is separately furnished in
conjunction with screening
colonoscopies within the definition of
screening colonoscopy would only
cause additional confusion, unless
screening colonoscopies with removal
of polyp, along with any anesthesia
separately furnished in conjunction
with such procedures, are also included
within the definition. Because our
proposal rule did not seek to make
changes to our policies with respect to
diagnostic colonoscopies, the
commenters were concerned that,
beneficiaries may be liable for part B
coinsurance for both diagnostic
colonoscopy and any anesthesia
furnished in conjunction with the
colonoscopy when a polyp is removed.
Commenters also stated that extending
our proposal in this manner would be
good public policy, because it would
reduce the disincentives to this essential
preventive service posed by possible
liability for coinsurance if a polyp is
discovered and removed during a
screening colonoscopy. The commenters
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67732
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
also emphasized that further extending
the definition in this way would remove
an inconsistency between Medicare
policy and the new requirements for
private health plans that prohibit the
imposition of cost sharing when a polyp
is removed under the Affordable Care
Act.
Response: We understand the
commenters’ concerns, however, we do
not have the authority to adopt the
recommended revisions by regulation.
Our authority is limited by the
language of the Medicare Act.
Specifically, section 1834(d)(3)(D) of the
Act states that, ‘‘[i]f during the course of
such a screening colonoscopy, a lesion
or growth is detected which results in
a biopsy or removal of the lesion or
growth, payment under this part shall
not be made for the screening
colonoscopy but shall be made for the
procedure classified as a colonoscopy
with such biopsy or removal.’’ As a
result of this statutory provision, when
an anticipated screening colonoscopy
ends up involving a biopsy or polyp
removal, Medicare cannot pay for this
procedure as a screening colonoscopy.
In these circumstances, Medicare pays
80 percent of the diagnostic
colonoscopy procedure and the
beneficiary is responsible for paying
Part B coinsurance. Under the statute,
when a polyp or other growth is
removed, beneficiaries are responsible
for Part B coinsurance for the diagnostic
colonoscopy, and similarly, any Part B
coinsurance for any covered anesthesia.
Comment: Commenters stated that the
proposal was not clear on how the
deductible will be treated in the case of
anesthesia services when a polyp or
other tissue is removed during a
screening colonoscopy.
Response: Section 1833(b)(1) of the
Act, as amended by section 4104(c) of
the Affordable Care Act, waives the Part
B deductible for ‘‘colorectal screening
tests regardless of the code billed for the
establishment of a diagnosis as a result
of the test, or the removal of tissue or
other matter or other procedure that is
furnished in connection with, as a result
of, and in the same clinical encounter as
a screening test.’’ We explained this
provision in the CY 2011 PFS final rule
with comment period (75 FR 73431). We
apply this policy to any surgical service
furnished on the same date as a planned
colorectal cancer screening test. Our
regulations at § 410.152(l)(5) already
require Medicare Part B to pay 100
percent of the Medicare payment
amount for colorectal cancer screening
tests (excluding barium enema). The
statutory waiver of deductible will
apply to the anesthesia services
furnished in conjunction with a
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
colorectal cancer screening test even
when a polyp or other tissue is removed
during a colonoscopy. As in the case of
the physician furnishing the
colonoscopy service, the anesthesia
professional reporting the anesthesia in
conjunction with the colonoscopy
where a polyp is removed would also
report the PT modifier.
Comment: Commenters urged CMS to
provide guidance as to whether CPT
code 00810 (Anesthesia for lower
intestinal endoscopic procedures,
endoscope introduced distal to
duodenum) would be billed with a
modifier to indicate whether the
procedure was screening or not.
Response: Effective January 1, 2015,
beneficiary coinsurance and deductible
do not apply to the following anesthesia
claim lines billed when furnished in
conjunction with screening colonoscopy
services and billed with the appropriate
modifier (33): 00810 (Anesthesia for
lower intestinal endoscopic procedures,
endoscope introduced distal to
duodenum). Anesthesia professionals
who furnish a separately payable
anesthesia service in conjunction with a
colorectal cancer screening test should
include the 33 modifier on the claim
line with the anesthesia service. As
noted above in situations that begin as
a colorectal cancer screening test, but
for which another service such as
colonoscopy with polyp removal is
actually furnished, the anesthesia
professional should report a PT modifier
on the claim line rather than the 33
modifier.
Comment: Several commenters
recommended that we not only finalize
the revised definition of ‘‘colorectal
cancer screening tests,’’ but also take
steps to ensure that our Medicare
Administrative Contractors (MACs) are
not inappropriately taking actions that
have the effect of nullifying some or
much of the intended benefit of this
policy change. Specifically, these
commenters requested that we prevent
the current efforts by one or more
Medicare contractors to limit Medicare
coverage for anesthesia services
furnished during a screening
colonoscopy by an anesthesia
professional. Another commenter urged
us to clarify that this proposed
expanded definition of colorectal cancer
screening to include anesthesia services
should not be construed to override or
preempt existing or planned coverage
policies on the appropriate use of these
services by MACs.
Response: This final rule with
comment period establishes national
policy and takes precedence over any
local coverage policy that limits
Medicare coverage for anesthesia
PO 00000
Frm 00186
Fmt 4701
Sfmt 4700
services furnished during a screening
colonoscopy by an anesthesia
professional.
K. Payment of Secondary Interpretation
of Images
In general, Medicare makes one
payment for the professional component
of an imaging service for each technical
component (TC) service that is
furnished. Under ‘‘unusual
circumstances,’’ physicians can bill for
a secondary interpretation using
modifier -77, for instance, when an
emergency room physician conducts an
x-ray, provides an interpretation,
identified a questionable finding, and
subsequently requests a second
interpretation from a radiologist to
inform treatment decisions. In all cases,
a ‘‘professional component’’ (PC)
interpretation service should only be
billed for a full interpretation and
report, rather than a ‘‘review,’’ which is
paid for as part of an E/M payment.
In recent years, technological
advances such as the integration of
picture and archiving communications
systems across health systems, growth
in image sharing networks and health
information exchange platforms through
which providers can share images, and
consumer-mediated exchange of images,
have greatly increased physicians’
access to existing diagnostic-quality
radiology images. Accessing and
utilizing these images to inform the
diagnosis and record an interpretation
in the medical record may allow
physicians to avoid ordering duplicative
tests.
We solicited comments on the
appropriateness of more routine billing
for secondary interpretations, although
we did not propose to make any changes
to the treatment of these services in
2015. We wanted to determine whether
there were an expanded set of
circumstances under which more
routine Medicare payment for a second
PC for radiology services would be
appropriate, and whether such a policy
would be likely to reduce the incidence
of duplicative advanced imaging
studies.
To achieve that goal, we solicited
comments on the following: the
circumstances under which physicians
are currently conducting secondary
interpretations and whether they are
seeking payment for these
interpretations; whether more routine
payment for secondary interpretations
should be restricted to certain high-cost
advanced diagnostic imaging services;
considerations for valuing secondary
interpretation services; the settings in
which secondary interpretations chiefly
occur; and considerations for
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
operationalizing more routine payment
of secondary interpretations in a manner
that would minimize burden on
providers and others.
Comment: Many commenters
responded to our secondary
interpretation solicitation. In addition to
comments on the merits of the
proposals, commenters also provided
helpful information about how to
implement this policy. Commenters
offered diverse opinions on the time
period for which an existing image
would be pertinent in support of a
secondary interpretation. Most
commenters were in agreement that cost
savings would be derived from the
implementation of a secondary
interpretation policy but there was no
consensus as to the amount of such
savings. Moreover, many commenters
pointed out that they were already
furnishing secondary interpretations
and would appreciate adoption of a
policy that would allow them to receive
payment for these services.
Response: We thank all the
commenters for their input. Any
changes to our current policy on
allowing physicians to more routinely
bill for secondary interpretations of
images will be addressed in future
rulemaking.
L. Conditions Regarding Permissible
Practice Types for Therapists in Private
Practice
Section 1861(p) of the Act defines
outpatient therapy services to include
physical therapy (PT), occupational
therapy (OT), and speech-language
pathology (SLP) services furnished by
qualified occupational therapists,
physical therapists, and speechlanguage pathologists in their offices
and in the homes of beneficiaries. The
regulations at §§ 410.59(c), 410.60(c),
and 410.62(c) set forth special
provisions for services furnished by
therapists in private practice, including
basic qualifications necessary to qualify
as a supplier of OT, PT, and SLP
services, respectively. As part of these
basic qualifications, the current
regulatory language includes
descriptions of the various practice
types for therapists’ private practices.
Based on our review of these three
sections of our regulations, we became
concerned that the language is not as
clear as it could be—especially with
regard to the relevance of whether a
practice is incorporated. The regulations
appear to make distinctions between
unincorporated and incorporated
practices, and some practice types are
listed twice. Accordingly, we proposed
changes to the regulatory language to
remove unnecessary distinctions and
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
redundancies within the regulations for
OT, PT, and SLP. We noted that these
changes are for clarification only, and
do not reflect any change in our current
policy.
To consistently specify the
permissible practice types (a solo
practice, partnership, or group practice;
or as an employee of one of these) for
suppliers of outpatient therapy services
in private practice (specifically for
occupational therapists, physical
therapists and speech-language
pathologists), we proposed to replace
the regulatory text at
§ 410.59(c)(1)(ii)(A) through (E),
§ 410.60(c)(1)(ii)(A) through (E), and
§ 410.62(c)(1)(ii)(A) through (E) and to
replace it with language listing the
permissible practice types without
limitations for incorporated or
unincorporated.
Comment: We received comments
from two therapist membership
associations supporting our proposed
changes to the regulations. Both
commenters agree that the proposed
language more consistently and
accurately reflects the permissible
practice types for therapists in private
practice.
Another commenter representing a
membership association of
rehabilitation physicians told us that,
rather than clarifying or simplifying the
existing regulations, the proposed
language is more ambiguous. The
commenter urged us to clarify that our
proposed language would continue to
allow therapists in private practice to be
employed by physician groups as
specified in current provisions.
Response: We appreciate the
commenters’ support for our proposal.
With regard to the commenter that
expressed concern about the clarity of
the proposed regulation text as to
whether therapists in private practice
can be employed by a physician group,
we acknowledge that the current
regulation explicitly permits that
practice arrangement. However, we
believe that our proposed language
describing the practice arrangements of
private practice therapists–a solo
practice, partnership, or group practice;
or as an employee of one of these–
clearly continues to permit therapists to
practice as an employee of a physician
group, whether or not incorporated. We
believe the reference in the proposed
regulation to ‘‘group practice’’ is
sufficiently broad to encompass a
physician group, and thus permits
therapists in private practice to practice
as employees of these groups, where
permissible under state law.
Therefore, we are finalizing our
proposed changes to the regulations for
PO 00000
Frm 00187
Fmt 4701
Sfmt 4700
67733
permissible practice types for therapists
in private practice at
§ 410.59(c)(1)(ii)(A) through (E),
§ 410.60(c)(1)(ii)(A) through (E), and
§ 410.62(c)(1)(ii)(A) through(E).
M. Payments for Practitioners Managing
Patients on Home Dialysis
In the CY 2005 PFS final rule with
comment period (69 FR 66357 through
66359), we established criteria for
furnishing outpatient per diem ESRDrelated services in partial month
scenarios. We specified that use of per
diem ESRD-related services is intended
to accommodate unusual circumstances
when the outpatient ESRD-related
services would not be paid for under the
monthly capitation payment (MCP), and
that use of the per diem services is
limited to the circumstances listed
below.
• Transient patients—Patients
traveling away from home (less than full
month);
• Home dialysis patients (less than
full month);
• Partial month where there were one
or more face-to-face visits without the
comprehensive visit and either the
patient was hospitalized before a
complete assessment was furnished,
dialysis stopped due to death, or the
patient received a kidney transplant.
• Patients who have a permanent
change in their MCP physician during
the month.
Additionally, we provided billing
guidelines for partial month scenarios in
the Medicare claims processing manual,
publication 100–04, chapter 8, section
140.2.1. For center-based patients, we
specified that if the MCP practitioner
furnishes a complete assessment of the
ESRD beneficiary, the MCP practitioner
should bill for the full MCP service that
reflects the number of visits furnished
during the month. However, we did not
extend this policy to home dialysis (less
than a full month) because the home
dialysis MCP service did not include a
specific frequency of required patient
visits. In other words, unlike the ESRD
MCP service for center-based patients, a
visit was not required for the home
dialysis MCP service as a condition of
payment.
In the CY 2011 PFS final rule with
comment period (75 FR 73295 through
73296), we changed our policy for the
home dialysis MCP service to require
the MCP practitioner to furnish at least
one face-to-face patient visit per month
as a condition of payment. However, we
inadvertently did not modify our billing
guidelines for home dialysis (less than
a full month) to be consistent with
partial month scenarios for center-based
dialysis patients. As discussed in the CY
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67734
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
2015 proposed rule (79 FR 40371)
stakeholders have recently brought this
inconsistency to our attention. After
reviewing this issue, we proposed to
allow the MCP physician or practitioner
to bill for the age appropriate home
dialysis MCP service (as described by
HCPCS codes 90963 through 90966) for
the home dialysis (less than a full
month) scenario if the MCP practitioner
furnishes a complete monthly
assessment of the ESRD beneficiary and
at least one face-to-face patient visit. For
example, if a home dialysis patient was
hospitalized during the month and at
least one face-to-face outpatient visit
and complete monthly assessment was
furnished, the MCP practitioner should
bill for the full home dialysis MCP
service. We explained that this
proposed change to home dialysis (less
than a full month) would provide
consistency with our policy for partial
month scenarios pertaining to patients
dialyzing in a dialysis center. We also
stated that if this proposal is adopted,
we would modify the Medicare Claims
Processing Manual to reflect the revised
billing guidelines for home dialysis in
the less than a full month scenario.
A summary of the comments on this
proposal and our response is provided
below.
Comment: Several stakeholders
strongly supported our proposed change
for practitioners managing patients on
home dialysis. Specifically, the
commenters stated that the proposed
change in policy for the home dialysis
MCP service is necessary to
appropriately align practitioner
payment for managing home dialysis
patients with center based patients, and
encouraged us to finalize the change in
policy as proposed. One commenter
explained that the current policy for
home dialysis less than a full month
requires the nephrologist to ‘‘separate
out the time their home dialysis patients
spend in the hospital and bill for
outpatient services at a daily rate
instead of the full capitated payment.’’
The same commenter stated that
‘‘properly aligning physician payments
for managing home dialysis patients
(with managing center based dialysis
patients) may enable more patients to
consider dialyzing at home, when
appropriate.’’
Response: We agree with the
commenters and will finalize our
proposed policy change for home
dialysis. We will allow the MCP
practitioner to bill for the home dialysis
MCP service for the home dialysis (less
than a full month) scenario if the MCP
practitioner furnishes a complete
monthly assessment of the ESRD
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
beneficiary and at least one face-to-face
patient visit during the month.
N. Allowed Expenditures for Physicians’
Services and the Sustainable Growth
Rate
1. Medicare Sustainable Growth Rate
(SGR)
The SGR is an annual growth rate that
applies to physicians’ services paid by
Medicare. The use of the SGR is
intended to control growth in aggregate
Medicare expenditures for physicians’
services. Payments for services are not
withheld if the percentage increase in
actual expenditures exceeds the SGR.
Rather, the PFS update, as specified in
section 1848(d)(4) of the Act, is adjusted
based on a comparison of allowed
expenditures (determined using the
SGR) and actual expenditures. If actual
expenditures exceed allowed
expenditures, the update is reduced. If
actual expenditures are less than
allowed expenditures, the update is
increased.
Section 1848(f)(2) of the Act specifies
that the SGR for a year (beginning with
CY 2001) is equal to the product of the
following four factors:
(1) The estimated change in fees for
physicians’ services;
(2) The estimated change in the
average number of Medicare fee-forservice beneficiaries;
(3) The estimated projected growth in
real Gross Domestic Product per capita;
and
(4) The estimated change in
expenditures due to changes in statute
or regulations.
In general, section 1848(f)(3) of the
Act requires us to determine the SGRs
for 3 different time periods, using the
best data available as of September 1 of
each year. Under section 1848(f)(3) of
the Act, (beginning with the FY and CY
2000 SGRs) the SGR is estimated and
subsequently revised twice based on
later data. (The Act also provides for
adjustments to be made to the SGRs for
FY 1998 and FY 1999. See the February
28, 2003 Federal Register (68 FR 9567)
for a discussion of these SGRs). Under
section 1848(f)(3)(C)(ii) of the Act, there
are no further revisions to the SGR once
it has been estimated and subsequently
revised in each of the 2 years following
the preliminary estimate. In this final
rule with comment, we are making our
preliminary estimate of the CY 2015
SGR, a revision to the CY 2014 SGR, and
our final revision to the CY 2013 SGR.
a. Physicians’ Services
Section 1848(f)(4)(A) of the Act
defines the scope of physicians’ services
covered by the SGR. The statute
PO 00000
Frm 00188
Fmt 4701
Sfmt 4700
indicates that ‘‘the term ‘physicians’
services’ includes other items and
services (such as clinical diagnostic
laboratory tests and radiology services),
specified by the Secretary, that are
commonly performed or furnished by a
physician or in a physician’s office, but
does not include services furnished to a
Medicare+Choice plan enrollee.’’
We published a definition of
physicians’ services for use in the SGR
in the November 1, 2001 Federal
Register (66 FR 55316). We defined
physicians’ services to include many of
the medical and other health services
listed in section 1861(s) of the Act.
Since that time, the statute has been
amended to add new Medicare benefits.
As the statute changed, we modified the
definition of physicians’ services for the
SGR to include the additional benefits
added to the statute that meet the
criteria specified in section
1848(f)(4)(A).
As discussed in the CY 2010 PFS final
rule with comment period (74 FR
61961), the statute provides the
Secretary with clear discretion to decide
whether physician-administered drugs
should be included or excluded from
the definition of ‘‘physicians’ services.’’
Exercising this discretion, we removed
physician-administered drugs from the
definition of physicians’ services in
section 1848(f)(4)(A) of the Act for
purposes of computing the SGR and the
levels of allowed expenditures and
actual expenditures beginning with CY
2010, and for all subsequent years.
Furthermore, in order to effectuate fully
the Secretary’s policy decision to
remove drugs from the definition of
physicians’ services, we removed
physician-administered drugs from the
calculation of allowed and actual
expenditures for all prior years.
Thus, for purposes of determining
allowed expenditures, actual
expenditures for all years, and SGRs
beginning with CY 2010 and for all
subsequent years, we specified that
physicians’ services include the
following medical and other health
services if bills for the items and
services are processed and paid by
Medicare carriers (and those paid
through intermediaries where specified)
or the equivalent services processed by
the Medicare Administrative
Contractors:
• Physicians’ services.
• Services and supplies furnished
incident to physicians’ services, except
for the expenditures for ‘‘drugs and
biologicals which are not usually selfadministered by the patient.’’
• Outpatient physical therapy
services and outpatient occupational
therapy services,
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
• Services of PAs, certified registered
nurse anesthetists, certified nurse
midwives, clinical psychologists,
clinical social workers, nurse
practitioners, and certified nurse
specialists.
• Screening tests for prostate cancer,
colorectal cancer, and glaucoma.
• Screening mammography,
screening pap smears, and screening
pelvic exams.
• Diabetes outpatient selfmanagement training (DSMT) services.
• Medical Nutrition Therapy (MNT)
services.
• Diagnostic x-ray tests, diagnostic
laboratory tests, and other diagnostic
tests (including outpatient diagnostic
laboratory tests paid through
intermediaries).
• X-ray, radium, and radioactive
isotope therapy.
• Surgical dressings, splints, casts,
and other devices used for the reduction
of fractures and dislocations.
• Bone mass measurements.
• An initial preventive physical
exam.
• Cardiovascular screening blood
tests.
• Diabetes screening tests.
• Telehealth services.
• Physician work and resources to
establish and document the need for a
power mobility device.
• Additional preventive services.
• Pulmonary rehabilitation.
• Cardiac rehabilitation.
• Intensive cardiac rehabilitation.
• Kidney disease education (KDE)
services.
• Personalized prevention plan
services
b. Preliminary Estimate of the SGR for
2015
We first estimated the CY 2015 SGR
in March 2014, and we made the
estimate available to the MedPAC and
on our Web site. Table 34 shows the
March 2014 estimate and our current
estimates of the factors included in the
2015 SGR. Our March 2014 estimate of
the SGR was ¥3.6 percent. Our current
estimate of the 2015 SGR is ¥13.7
percent. The majority of the difference
between the March estimate and our
current estimate of the CY 2015 SGR is
explained by adjustments to reflect
intervening legislative changes that
67735
occurred after our March estimate was
prepared. Subsequent to the display of
the March 2014 estimate, section 101 of
the Protecting Access to Medicare Act
(PAMA) of 2014 continued a 0.5 percent
update to the PFS conversion factor
from April 1, 2014, through December
31, 2014 (relative to the 2013 conversion
factor), in place of the 24.1 percent
reduction that would have occurred
under the SGR system on April 1, 2014.
In addition, section 101 of PAMA also
provides for a 0.0 percent update for
services furnished on or after January 1,
2015, through March 31, 2015. While
PAMA averted the large reduction in
PFS rates scheduled to occur on April
1, 2014, there will be a large reduction
in PFS rates on April 1, 2015, as a result
of the expiration of the temporary 0.0
percent update. The law and regulation
factor of the current estimate of the SGR
is now a much larger reduction than
previously estimated to account for the
current law reduction in PFS rates
scheduled to occur on April 1, 2015. We
will provide more detail on the change
in each of these factors below.
TABLE 34—CY 2015 SGR CALCULATION
Statutory factors
March estimate
Current estimate
Fees ...................................................................
Enrollment ..........................................................
Real Per Capita GDP ........................................
Law and Regulation ...........................................
1.1 percent (1.011) ...........................................
4.0 percent (1.040) ...........................................
0.8 percent (1.008) ...........................................
¥9.0 percent (0.910) .......................................
0.7 percent (1.007).
3.9 percent (1.039).
0.7 percent (1.007).
¥18.1 percent (0.819).
Total ............................................................
¥3.6 percent (0.964) .......................................
¥13.7 percent (0.863).
Note: Consistent with section 1848(f)(2) of the Act, the statutory factors are multiplied, not added, to produce the total (that is, 1.007 × 1.039 ×
1.007 × 0.819 = 0.863). A more detailed explanation of each figure is provided in section II.N.1.e. of this final rule with comment period.
c. Revised Sustainable Growth Rate for
CY 2014
Our current estimate of the CY 2014
SGR is ¥0.8 percent. Table 35 shows
our preliminary estimate of the CY 2014
SGR, which was published in the CY
2014 PFS final rule with comment
period, and our current estimate. The
majority of the difference between the
preliminary estimate and our current
estimate of the CY 2014 SGR is
explained by adjustments to reflect
intervening legislative changes that have
occurred since publication of the CY
2014 PFS final rule with comment
period. The PFS update reduction that
would have occurred on April 1, 2014
was averted by PAMA, which has
resulted in a much higher legislative
factor than our estimate of the 2014 SGR
in CY 2014 PFS final rule with comment
period. We will provide more detail on
the change in each of these factors
below.
TABLE 35—CY 2014 SGR CALCULATION
Estimate from CY 2014 final rule
Fees ...................................................................
Enrollment ..........................................................
Real Per Capita GDP ........................................
Law and Regulation ...........................................
ebenthall on DSK5SPTVN1PROD with $$_JOB
Statutory factors
Current estimate
0.6 percent (1.006) ...........................................
2.2 percent (1.022) ...........................................
0.8 percent (1.008) ...........................................
¥19.6 percent (0.804) .....................................
0.7 Percent (1.007).
0.2 Percent (1.002).
0.7 Percent (1.007).
¥2.4 Percent (0.976).
Total ............................................................
¥16.7 percent (0.833) .....................................
¥0.8 Percent (0.992).
Note: Consistent with section 1848(f)(2) of the Act, the statutory factors are multiplied, not added, to produce the total (that is, 1.007 × 1.002 ×
1.007 × 0.976 = 0.992). A more detailed explanation of each figure is provided in section II.N.1.e. of this final rule with comment period.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00189
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
67736
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
d. Final Sustainable Growth Rate for CY
2013
The SGR for CY 2013 is 1.3 percent.
Table 36 shows our preliminary
estimate of the CY 2013 SGR from the
CY 2013 PFS final rule with comment
period, our revised estimate from the CY
2014 PFS final rule with comment
period, and the final figures determined
using the best available data as of
September 1, 2014. We will provide
more detail on the change in each of
these factors below.
TABLE 36—CY 2013 SGR CALCULATION
Statutory factors
Estimate from CY 2013 final rule
Estimate from CY 2014 final rule
Final
Fees ..............................
Enrollment ....................
Real Per Capita GDP ...
Law and Regulation .....
0.3 percent (1.003) .............................
3.6 percent (1.036) .............................
0.7 percent (1.007) .............................
¥23.3 percent (0.767) .......................
0.4 percent (1.004) .............................
1.0 percent (1.010) .............................
0.9 percent (1.009) .............................
¥.05 percent (.995) ...........................
0.4 Percent (1.004).
0.5 Percent (1.005).
0.9 Percent (1.009).
¥0.5 Percent (0.995).
Total ......................
¥19.7 percent (0.803 ........................
1.8 percent (1.018) .............................
1.3 Percent (1.013).
Note: Consistent with section 1848(f)(2) of the Act, the statutory factors are multiplied, not added, to produce the total (that is, 1.004 × 1.005 ×
1.009 × 0.995 = 1.013). A more detailed explanation of each figure is provided in section II.N.1.e. of this final rule with comment period.
e. Calculation of CYs 2015, 2014, and
2013 SGRs
ebenthall on DSK5SPTVN1PROD with $$_JOB
(1) Detail on the CY 2015 SGR
All of the figures used to determine
the CY 2015 SGR are estimates that will
be revised based on subsequent data.
Any differences between these estimates
and the actual measurement of these
figures will be included in future
revisions of the SGR and allowed
expenditures and incorporated into
subsequent PFS updates.
(a) Factor 1—Changes in Fees for
Physicians’ Services (Before Applying
Legislative Adjustments) for CY 2015
This factor is calculated as a weighted
average of the CY 2015 changes in fees
for the different types of services
included in the definition of physicians’
services for the SGR. Medical and other
health services paid using the PFS are
estimated to account for approximately
89.6 percent of total allowed charges
included in the SGR in CY 2015 and are
updated using the percent change in the
MEI. As discussed in section A of this
final rule with comment period, the
percent change in the MEI for CY 2015
is 0.8 percent. Diagnostic laboratory
tests are estimated to represent
approximately 10.4 percent of Medicare
allowed charges included in the SGR for
CY 2015. Medicare payments for these
tests are updated by the Consumer Price
Index for Urban Areas (CPI–U), which is
2.1 percent for CY 2015. Section
1833(h)(2)(A)(iv) of the Act requires that
the CPI–U update applied to clinical
laboratory tests be reduced by a multifactor productivity adjustment (MFP
adjustment) and, for each of years 2011
through 2015, by 1.75 percentage points
(percentage adjustment). The MFP
adjustment will not apply in a year
where the CPI–U is zero or a percentage
decrease. Further, the application of the
MFP adjustment shall not result in an
adjustment to the fee schedule of less
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
than zero for a year. However, the
application of the percentage
adjustment may result in an adjustment
to the fee schedule being less than zero
for a year and may result in payment
rates for a year being less than such
payment rates for the preceding year.
The applicable productivity adjustment
for CY 2015 is ¥0.6 percent. Adjusting
the CPI–U update by the productivity
adjustment results in a 1.5 percent (2.1
percent (CPI–U) minus 0.6 percent (MFP
adjustment)) update for CY 2015.
Additionally, the percentage reduction
of 1.75 percent is applied for CYs 2011
through 2015, as discussed previously.
Therefore, for CY 2015, diagnostic
laboratory tests will receive an update of
¥0.3 percent. Table 37 shows the
weighted average of the MEI and
laboratory price changes for CY 2015.
TABLE 37—WEIGHTED-AVERAGE OF
THE MEI AND LABORATORY PRICE
CHANGES FOR CY 2015
number of Medicare Part B fee-forservice enrollees will increase by 3.9
percent from CY 2014 to CY 2015. Table
38 illustrates how this figure was
determined.
TABLE 38—AVERAGE NUMBER OF
MEDICARE PART B FEE-FOR-SERVICE ENROLLEES FROM CY 2014 TO
CY 2015 (EXCLUDING BENEFICIARIES ENROLLED IN MA PLANS)
CY 2014
Overall ...
Medicare
Advantage
(MA).
Net .........
Percent
Increase.
CY 2015
49.350 million ..
16.237 million ..
50.794 million.
16.389 million.
33.113 million ..
0.2 percent ......
34.405 million.
3.9 percent.
An important factor affecting fee-forservice enrollment is beneficiary
enrollment in MA plans. Because it is
Weight
Update
difficult to estimate the size of the MA
enrollee population before the start of a
Physician ..........
0.896
0.8%
CY, at this time we do not know how
Laboratory .........
0.104
¥0.3%
actual enrollment in MA plans will
Weighted-average ................
1.000
0.7% compare to current estimates. For this
reason, the estimate may change
We estimate that the weighted average substantially as actual Medicare fee-forservice enrollment for CY 2015 becomes
increase in fees for physicians’ services
known.
in CY 2015 under the SGR (before
applying any legislative adjustments)
(c) Factor 3—Estimated Real Gross
will be 0.7 percent.
Domestic Product Per Capita Growth in
CY 2015
(b) Factor 2—Percentage Change in the
Average Number of Part B Enrollees
We estimate that the growth in real
from CY 2014 to CY 2015
GDP per capita from CY 2014 to CY
2015 will be 0.7 percent (based on the
This factor is our estimate of the
percent change in the average number of annual growth in the 10-year moving
average of real GDP per capita 2006
fee-for-service enrollees from CY 2014
through 2015). Our past experience
to CY 2015. Services provided to
indicates that there have also been
Medicare Advantage (MA) plan
changes in estimates of real GDP per
enrollees are outside the scope of the
capita growth made before the year
SGR and are excluded from this
begins and the actual change in real
estimate. We estimate that the average
PO 00000
Frm 00190
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
67737
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
GDP per capita growth computed after
the year is complete. Thus, it is possible
that this figure will change as actual
information on economic performance
becomes available to us in CY 2015.
(d) Factor 4—Percentage Change in
Expenditures for Physicians’ Services
Resulting From Changes in Statute or
Regulations in CY 2015 Compared With
CY 2014
The statutory and regulatory
provisions that will affect expenditures
for CY 2015 relative to CY 2014 are
estimated to have an impact on
expenditures of ¥18.1 percent. This is
primarily due to payment reductions for
eligible professionals that are not
meaningful users of health information
technology, the estimated reduction in
PFS rates that will occur on April 1,
2015 absent a change in law, and
expiration of the work GPCI floor.
the SGR was 0.7 percent. Our estimate
of this factor in the CY 2014 PFS final
rule with comment period was 0.6
percent (78 FR 74393).
(b) Factor 2—Percentage Change in the
Average Number of Part B Enrollees
from CY 2013 to CY 2014
We estimate that the average number
of Medicare Part B fee-for-service
enrollees (excluding beneficiaries
enrolled in Medicare Advantage plans)
increased by 0.2 percent in CY 2014.
Table 40 illustrates how we determined
this figure.
CY 2013
(a) Factor 1—Changes in Fees for
Physicians’ Services (Before Applying
Legislative Adjustments) for CY 2014
ebenthall on DSK5SPTVN1PROD with $$_JOB
This factor was calculated as a
weighted-average of the CY 2014
changes in fees that apply for the
different types of services included in
the definition of physicians’ services for
the SGR in CY 2014.
We estimate that services paid using
the PFS account for approximately 91.1
percent of total allowed charges
included in the SGR in CY 2014. These
services were updated using the CY
2014 percent change in the MEI of 0.8
percent. We estimate that diagnostic
laboratory tests represent approximately
8.9 percent of total allowed charges
included in the SGR in CY 2014. For CY
2014, diagnostic laboratory tests
received an update of ¥0.8 percent.
Table 39 shows the weighted-average
of the MEI and laboratory price changes
for CY 2014.
Overall .......
Medicare
Advantage (MA).
Net .............
Percent Increase.
CY 2014
47.878 million
14.842 million
49.350 million.
16.237 million.
33.036 million
0.5 percent ....
33.113 million.
0.2 percent.
Our estimate of the 0.2 percent change
in the number of fee-for-service
enrollees, net of Medicare Advantage
enrollment for CY 2014 compared to CY
2013, is different than our estimate of an
increase of 2.2 percent in the CY 2014
PFS final rule with comment period (78
FR 74393). While our current projection
based on data from 8 months of CY 2014
differs from our estimate of 2.2 percent
when we had no actual data, it is still
possible that our final estimate of this
figure will be different once we have
complete information on CY 2014 feefor-service enrollment.
(c) Factor 3—Estimated Real GDP Per
Capita Growth in CY 2014
We estimate that the growth in real
GDP per capita will be 0.7 percent for
TABLE 39—WEIGHTED-AVERAGE OF CY 2014 (based on the annual growth in
THE MEI, AND LABORATORY PRICE the 10-year moving average of real GDP
CHANGES FOR CY 2014
per capita (2005 through 2014)). Our
past experience indicates that there
Weight
Update
have also been differences between our
Physician ..........
0.911
0.8 estimates of real per capita GDP growth
Laboratory .........
0.089
¥0.8 made prior to the year’s end and the
actual change in this factor. Thus, it is
Weighted-average ................
1.000
0.7 possible that this figure will change
further as complete actual information
After considering the elements
on CY 2014 economic performance
described in Table 39, we estimate that
becomes available to us in CY 2015.
the weighted-average increase in fees for
physicians’ services in CY 2014 under
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
The statutory and regulatory
provisions that affected expenditures in
CY 2014 relative to CY 2013 are
estimated to have an impact on
expenditures of ¥2.4 percent. This
impact is due to many different
legislative or regulatory provisions
affecting spending in 2014 relative to
2013 including a 0.5 percent update for
PFS services in 2014.
TABLE 40—AVERAGE NUMBER OF
(3) Detail on the CY 2013 SGR
MEDICARE PART B FEE-FOR-SERVA more detailed discussion of our
ICE ENROLLEES FROM CY 2013 TO
final revised estimates of the four
CY 2014 (EXCLUDING BENEelements of the CY 2013 SGR follows.
FICIARIES ENROLLED IN MA PLANS)
(2) Detail on the CY 2014 SGR
A more detailed discussion of our
revised estimates of the four elements of
the CY 2014 SGR follows.
(d) Factor 4—Percentage Change in
Expenditures for Physicians’ Services
Resulting From Changes in Statute or
Regulations in CY 2014 Compared With
CY 2013
PO 00000
Frm 00191
Fmt 4701
Sfmt 4700
(a) Factor 1—Changes in Fees for
Physicians’ Services for CY 2013
This factor was calculated as a
weighted average of the CY 2013
changes in fees that apply for the
different types of services included in
the definition of physicians’ services for
the SGR in CY 2013.
We estimate that services paid under
the PFS account for approximately 90.1
percent of total allowed charges
included in the SGR in CY 2013. These
services were updated using the CY
2013 percent change in the MEI of 0.8
percent. We estimate that diagnostic
laboratory tests represent approximately
9.9 percent of total allowed charges
included in the SGR in CY 2013. For CY
2013, diagnostic laboratory tests
received an update of ¥3.0 percent.
Table 41 shows the weighted-average
of the MEI and laboratory price changes
for CY 2013.
TABLE 41—WEIGHTED-AVERAGE OF
THE MEI, LABORATORY, AND DRUG
PRICE CHANGES FOR 2013
Weight
Physician ..........
Laboratory .........
Weighted-average ................
Update
0.901
0.099
0.8
¥3.0
1.00
0.4
After considering the elements
described in Table 41, we estimate that
the weighted-average increase in fees for
physicians’ services in CY 2013 under
the SGR (before applying any legislative
adjustments) was 0.4 percent. This
figure is a final one based on complete
data for CY 2013.
E:\FR\FM\13NOR2.SGM
13NOR2
67738
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
(b) Factor 2—Percentage Change in the
Average Number of Part B Enrollees
From CY 2012 to CY 2013
provisions of the American Taxpayer
Relief Act in 2013.
We estimate the change in the number
of fee-for-service enrollees (excluding
beneficiaries enrolled in MA plans)
from CY 2012 to CY 2013 was 0.5
percent. Our calculation of this factor is
based on complete data from CY 2013.
Table 42 illustrates the calculation of
this factor.
Section 1848(d) of the Act provides
that the PFS update is equal to the
product of the MEI and the UAF. The
UAF is applied to make actual and
target expenditures (referred to in the
statute as ‘‘allowed expenditures’’)
equal. As discussed previously, allowed
expenditures are equal to actual
expenditures in a base period updated
each year by the SGR. The SGR sets the
annual rate of growth in allowed
expenditures and is determined by a
formula specified in section 1848(f) of
the Act. We note that the conversion
factor for the time period from January
1, 2015 through March 31, 2015 will
reflect a 0.0 percent update based on
section 101 of PAMA. Beginning on
April 1, 2015 through December 31,
2015, the standard calculation of the
PFS CF under the SGR formula would
apply.
The calculation of the UAF is not
affected by sequestration. Pursuant to 2
U.S.C. 906(d)(6), ‘‘The Secretary of
Health and Human Services shall not
take into account any reductions in
payment amounts which have been or
may be effected under [sequestration],
for purposes of computing any
adjustments to payment rates under
such title XVIII.’’ Therefore, allowed
charges, which are unaffected by
sequestration, were used to calculate
physician expenditures in lieu of
Medicare payments plus beneficiary
cost-sharing. As a result, neither actual
expenditures nor allowed expenditures
were adjusted to reflect the impact of
sequestration.
TABLE 42—AVERAGE NUMBER OF
MEDICARE PART B FEE-FOR-SERVICE ENROLLEES FROM CY 2012 TO
CY 2013 (EXCLUDING BENEFICIARIES ENROLLED IN MA PLANS)
CY 2012
Overall ....... 46.468 million
Medicare
13.587 million
Advantage (MA).
Net ............. 32.881 million
Percent
.......................
Change.
CY 2013
47.878 million.
14.842 million.
33.036 million.
0.5 percent.
(c) Factor 3—Estimated Real GDP Per
Capita Growth in CY 2013
We estimate that the growth in real
per capita GDP was 0.9 percent in CY
2013 (based on the annual growth in the
10-year moving average of real GDP per
capita (2004 through 2013)). This figure
is a final one based on complete data for
CY 2013.
(d) Factor 4—Percentage Change in
Expenditures for Physicians’ Services
Resulting From Changes in Statute or
Regulations in CY 2013 Compared With
CY 2012
ebenthall on DSK5SPTVN1PROD with $$_JOB
Our final estimate for the net impact
on expenditures from the statutory and
regulatory provisions that affect
expenditures in CY 2013 relative to CY
2012 is ¥0.5 percent. This impact is
due to many different legislative or
regulatory provisions affecting spending
in 2013 relative to 2012, including
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
2. The Update Adjustment Factor (UAF)
a. Calculation Under Current Law
Under section 1848(d)(4)(B) of the
Act, the UAF for a year beginning with
CY 2001 is equal to the sum of the
following—
• Prior Year Adjustment Component.
An amount determined by—
PO 00000
Frm 00192
Fmt 4701
Sfmt 4700
++ Computing the difference (which
may be positive or negative) between
the amount of the allowed expenditures
for physicians’ services for the prior
year (the year prior to the year for which
the update is being determined) and the
amount of the actual expenditures for
those services for that year;
++ Dividing that difference by the
amount of the actual expenditures for
those services for that year; and
++ Multiplying that quotient by 0.75.
• Cumulative Adjustment
Component. An amount determined
by—
++ Computing the difference (which
may be positive or negative) between
the amount of the allowed expenditures
for physicians’ services from April 1,
1996, through the end of the prior year
and the amount of the actual
expenditures for those services during
that period;
++ Dividing that difference by actual
expenditures for those services for the
prior year as increased by the SGR for
the year for which the UAF is to be
determined; and
++ Multiplying that quotient by 0.33.
Section 1848(d)(4)(E) of the Act
requires the Secretary to recalculate
allowed expenditures consistent with
section 1848(f)(3) of the Act. As
discussed previously, section 1848(f)(3)
specifies that the SGR (and, in turn,
allowed expenditures) for the upcoming
CY (CY 2015 in this case), the current
CY (that is, CY 2014) and the preceding
CY (that is, CY 2013) are to be
determined on the basis of the best data
available as of September 1 of the
current year. Allowed expenditures for
a year generally are estimated initially
and subsequently revised twice. The
second revision occurs after the CY has
ended (that is, we are making the
second revision to CY 2013 allowed
expenditures in this final rule with
comment).
Table 43 shows the historical SGRs
corresponding to each period through
CY 2015.
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
use allowed and actual expenditures
from April 1, 1996 through December
31, 2014 and the CY 2015 SGR.
Consistent with section 1848(d)(4)(E) of
the Act, we will be making revisions to
the CY 2014 and CY 2015 SGRs and CY
2014 and CY 2015 allowed
expenditures. Because we have
PO 00000
Frm 00193
Fmt 4701
Sfmt 4700
incomplete actual expenditure data for
CY 2014, we are using an estimate for
this period. Any difference between
current estimates and final figures will
be taken into account in determining the
UAF for future years.
We are using figures from EE10 in the
following statutory formula:
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.059</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
Consistent with section 1848(d)(4)(E)
of the Act, Table 43 includes our second
revision of allowed expenditures for CY
2013, a recalculation of allowed
expenditures for CY 2014, and our
initial estimate of allowed expenditures
for CY 2015. To determine the UAF for
CY 2015, the statute requires that we
67739
67740
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
Section 1848(d)(4)(D) of the Act
indicates that the UAF determined
under section 1848(d)(4)(B) of the Act
for a year may not be less than ¥0.07
or greater than 0.03. Since 0.049 (4.9
percent) is greater than 0.03, the UAF
for CY 2015 will be 3 percent.
Section 1848(d)(4)(A)(ii) of the Act
indicates that 1.0 should be added to the
UAF determined under section
1848(d)(4)(B) of the Act. Thus, adding
1.0 to 0.03 makes the UAF equal to 1.03.
supplies; professional liability
insurance; medical equipment; medical
materials and supplies; and other
professional expenses.
Table 44 lists the MEI cost categories
with associated weights and percent
changes for price proxies for the CY
2015 update. The CY 2015 nonproductivity adjusted MEI update is 1.7
percent and reflects a 1.9 percent
increase in physician’s own time and a
1.5 percent increase in physician’s PE.
Within the physician’s PE, the largest
increase occurred in postage, which
increased 5.4 percent.
For CY 2015, the increase in the MEI
is 0.8 percent, which reflects an increase
in the non-productivity adjusted MEI of
1.7 percent and a productivity
adjustment of 0.9 percent (which is
based on the 10-year moving average of
economy-wide private nonfarm business
multifactor productivity). The BLS is
the agency that publishes the official
measure of private non-farm business
MFP. Please see https://www.bls.gov/
mfp, which is the link to the BLS
historical published data on the
measure of MFP.
TABLE 44—INCREASE IN THE MEDICARE ECONOMIC INDEX UPDATE FOR CY 2015 1
Revised cost category
2006 revised cost
weight
(percent) 2
CY15
update
(percent)
MEI Total, productivity adjusted ........................................................................................................................
Productivity: 10-year moving average of MFP 1 ................................................................................................
100.000
5 N/A
0.8
0.9
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00194
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.060</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
3. Percentage Change in the MEI for CY
2015
The MEI is required by section
1842(b)(3) of the Act, which states that
prevailing charge levels beginning after
June 30, 1973, may not exceed the level
from the previous year except to the
extent that the Secretary finds, on the
basis of appropriate economic index
data, that the higher level is justified by
year-to-year economic changes. The
current form of the MEI was detailed in
the CY 2014 PFS final rule (78 FR
74264), which revised and reclassified
certain cost categories, price proxies,
and expense categories.
The MEI measures the weightedaverage annual price change for various
inputs needed to produce physicians’
services. The MEI is a fixed-weight
input price index, with an adjustment
for the change in economy-wide
multifactor productivity. This index,
which has CY 2006 base year weights,
is comprised of two broad categories: (1)
Physician’s own time; and (2)
physician’s practice expense (PE).
The physician’s compensation (own
time) component represents the net
income portion of business receipts and
primarily reflects the input of the
physician’s own time into the
production of physicians’ services in
physicians’ offices. This category
consists of two subcomponents: (1)
Wages and salaries; and (2) fringe
benefits.
The physician’s practice expense (PE)
category represents nonphysician inputs
used in the production of services in
physicians’ offices. This category
consists of wages and salaries and fringe
benefits for nonphysician staff (who
cannot bill independently) and other
nonlabor inputs. The physician’s PE
component also includes the following
categories of nonlabor inputs: office
expenses; medical materials and
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
67741
TABLE 44—INCREASE IN THE MEDICARE ECONOMIC INDEX UPDATE FOR CY 2015 1—Continued
Revised cost category
2006 revised cost
weight
(percent) 2
CY15
update
(percent)
MEI Total, without productivity adjustment ........................................................................................................
Physician Compensation 3 .................................................................................................................................
Wages and Salaries ...................................................................................................................................
Benefits .......................................................................................................................................................
Practice Expense ...............................................................................................................................................
Non-physician compensation .....................................................................................................................
Non-physician wages .................................................................................................................................
Non-health, non-physician wages .......................................................................................................
Professional & Related ........................................................................................................................
Management ........................................................................................................................................
Clerical .................................................................................................................................................
Services ...............................................................................................................................................
Health related, non-physician wages .........................................................................................................
Non-physician benefits ...............................................................................................................................
Other Practice Expense .............................................................................................................................
Utilities .................................................................................................................................................
Miscellaneous Office Expenses ..........................................................................................................
Chemicals ............................................................................................................................................
Paper ...................................................................................................................................................
Rubber & Plastics ................................................................................................................................
All other products ................................................................................................................................
Telephone ...................................................................................................................................................
Postage .......................................................................................................................................................
All Other Professional Services ..................................................................................................................
Professional, Scientific, and Tech. Services .......................................................................................
Administrative and support & waste ...................................................................................................
All Other Services ...............................................................................................................................
Capital .........................................................................................................................................................
Fixed ....................................................................................................................................................
Moveable .............................................................................................................................................
Professional Liability Insurance 4 ................................................................................................................
Medical Equipment .....................................................................................................................................
Medical supplies .........................................................................................................................................
100.000
50.866
43.641
7.225
49.134
16.553
11.885
7.249
0.800
1.529
4.720
0.200
4.636
4.668
32.581
1.266
2.478
0.723
0.656
0.598
0.500
1.501
0.898
8.095
2.592
3.052
2.451
10.310
8.957
1.353
4.295
1.978
1.760
1.7
1.9
1.9
2.0
1.5
1.8
1.8
2.0
1.9
2.2
1.9
1.2
1.5
1.9
1.4
4.0
1.0
¥1.1
3.3
1.0
1.7
0.0
5.4
1.7
1.8
1.9
1.2
1.8
1.9
0.8
¥0.1
¥0.3
¥0.2
1 The forecasts are based upon the latest available Bureau of Labor Statistics data on the 10-year average of BLS private nonfarm business
multifactor productivity published on July 9, 2014. (https://www.bls.gov/news.release/prod3.nr0.htm).
2 The weights shown for the MEI components are the 2006 base-year weights, which may not sum to subtotals or totals because of rounding.
The MEI is a fixed-weight, Laspeyres-type input price index whose category weights indicate the distribution of expenditures among the inputs to
physicians’ services for CY 2006. To determine the MEI level for a given year, the price proxy level for each component is multiplied by its 2006
weight. The sum of these products (weights multiplied by the price index levels) over all cost categories yields the composite MEI level for a
given year. The annual percent change in the MEI levels is an estimate of price change over time for a fixed market basket of inputs to physicians’ services.
3 The measures of Productivity, Employment Cost Indexes, as well as the various Producer and Consumer Price Indexes can be found on the
Bureau of Labor Statistics Web site at https://stats.bls.gov.
4 Derived from a CMS survey of several major commercial insurers.
5 Productivity is factored into the MEI categories as an adjustment; therefore, no explicit weight exists for productivity in the MEI.
4. Physician and Anesthesia Fee
Schedule Conversion Factors for CY
2015
ebenthall on DSK5SPTVN1PROD with $$_JOB
The CY 2015 PFS CF for January 1,
2015 through March 31, 2015 is
$35.8013. The CY 2015 PFS CF for April
1, 2015 through December 31, 2015 is
$28.2239. The CY 2015 national average
anesthesia CF for January 1, 2015
through March 31, 2015 is $22.5550.
The CY 2015 national average
anesthesia CF for April 1, 2015 through
December 31, 2015 is $17.7913.
a. PFS Update and Conversion Factors
(1) CY 2014 PFS Update
The formula for calculating the PFS
update is set forth in section
1848(d)(4)(A) of the Act. In general, the
PFS update is determined by
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
multiplying the CF for the previous year
by the percentage increase in the MEI
less productivity times the UAF, which
is calculated as specified under section
1848(d)(4)(B) of the Act.
(2) CY 2015 PFS Conversion Factors
Generally, the PFS CF for a year is
calculated in accordance with section
1848(d)(1)(A) of the Act by multiplying
the previous year’s CF by the PFS
update.
We note section 101 of the Medicare
Improvements and Extension Act,
Division B of the Tax Relief and Health
Care Act of 2006 (MIEA–TRHCA)
provided a 1-year increase in the CY
2007 CF and specified that the CF for
CY 2008 must be computed as if the 1year increase had never applied.
PO 00000
Frm 00195
Fmt 4701
Sfmt 4700
Section 101 of the Medicare,
Medicaid, and SCHIP Extension Act of
2007 (MMSEA) provided a 6-month
increase in the CY 2008 CF, from
January 1, 2008, through June 30, 2008,
and specified that the CF for the
remaining portion of CY 2008 and the
CFs for CY 2009 and subsequent years
must be computed as if the 6-month
increase had never applied.
Section 131 of the MIPPA extended
the increase in the CY 2008 CF that
applied during the first half of the year
to the entire year, provided for a 1.1
percent increase to the CY 2009 CF, and
specified that the CFs for CY 2010 and
subsequent years must be computed as
if the increases for CYs 2007, 2008, and
2009 had never applied.
Section 1011(a) of the DODAA and
section 5 of the TEA specified a zero
E:\FR\FM\13NOR2.SGM
13NOR2
67742
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
percent update for CY 2010, effective
January 1, 2010 through March 31, 2010.
Section 4 of the Continuing Extension
Act of 2010 (CEA) extended the zero
percent update for CY 2010 through
May 31, 2010.
Subsequently, section 101(a)(2) of the
PACMBPRA provided for a 2.2 percent
update to the CF, effective from June 1,
2010 to November 30, 2010.
Section 2 of the Physician Payment
and Therapy Relief Act of 2010 (Pub. L.
111–286) extended the 2.2 percent
update through the end of CY 2010.
Section 101 of the MMEA provided a
zero percent update for CY 2011,
effective January 1, 2011 through
December 31, 2011, and specified that
the CFs for CY 2012 and subsequent
years must be computed as if the
increases in previous years had never
applied.
Section 301 of the Temporary Payroll
Tax Cut Continuation Act of 2011
(TPTCCA) provided a zero percent
update effective January 1, 2012 through
February 29, 2012, and specified that
the CFs for subsequent time periods
must be computed as if the increases in
previous years had never applied.
Section 3003 of the Middle Class Tax
Relief and Job Creation Act of 2012 (Job
Creation Act) provided a zero percent
update effective March 1, 2012 through
December 31, 2012, and specified that
the CFs for subsequent time periods
must be computed as if the increases in
previous years had never applied.
Section 601 of the American Taxpayer
Relief Act (ATRA) of 2012 (Pub. L. 112–
240) provided a zero percent update for
CY 2013, effective January 1, 2013
through December 31, 2013, and
specified that the CFs for subsequent
time periods must be computed as if the
increases in previous years had not been
applied.
Section 1101 of the Pathway for SGR
Reform Act of 2013 (Pub. L. 113–67)
provided a 0.5 percent update to the
PFS CF, effective January 1, 2014
through March 31, 2014 and specified
that the CFs for subsequent time periods
must be computed as if the increases in
previous years had not been applied.
Section 101 of the Protecting Access
to Medicare Act of 2014 (Pub. L. 113–
93) (PAMA) extended this 0.5 percent
update through December 31, 2014.
Section 101 of the PAMA also provides
a 0.0 percent update for services
furnished on or after January 1, 2015,
through March 31, 2015, and specified
that the CFs for subsequent time periods
must be computed as if the increases in
previous years had not been applied.
Therefore, under current law, the CF
that would be in effect in CY 2014 had
the prior increases specified above not
applied is $27.2006.
In addition, when calculating the PFS
CF for a year, section 1848(c)(2)(B)(ii)(II)
of the Act requires that increases or
decreases in RVUs may not cause the
amount of expenditures for the year to
differ more than $20 million from what
it would have been in the absence of
these changes. If this threshold is
exceeded, we must make adjustments to
preserve budget neutrality. We estimate
that CY 2015 RVU changes would result
in an increase in Medicare physician
expenditures of more than $20 million.
Accordingly, we are decreasing the CF
by 0.06 percent to offset this estimated
increase in Medicare physician
expenditures due to the CY 2015 RVU
changes.
For January 1, 2015 through March
31, 2015, the PFS update will be 0.0
percent consistent with section 101 of
PAMA. After applying the budget
neutrality adjustment described above,
the conversion factor for January 1, 2015
through March 31, 2015 will be
$35.8013.
After March 31, 2015 the standard
calculation of the PFS CF under the SGR
formula would apply. Therefore, from
April 1, 2015 through December 31,
2015 the conversion factor would be
$28.2239. This final rule with comment
period announces a reduction to
payment rates for physicians’ services of
21.2 percent during this time period in
CY 2015 under the SGR formula.
By law, we are required to make these
reductions in accordance with section
1848(d) and (f) of the Act, and these
reductions can only be averted by an
Act of Congress. While Congress has
provided temporary relief from these
reductions every year since 2003, a
long-term solution is critical. We will
continue to work with Congress to fix
this untenable situation so doctors and
beneficiaries no longer have to worry
about the stability and adequacy of
payments from Medicare under the PFS.
We illustrate the calculation of the CY
2015 PFS CF in Table 45.
TABLE 45—CALCULATION OF THE CY 2015 PFS CF
January 1, 2015 through March 31, 2015
Conversion Factor in effect in CY 2014 .......................................................................
Update ..........................................................................................................................
CY 2015 RVU Budget Neutrality Adjustment ..............................................................
CY 2015 Conversion Factor (1/1/2015 through 3/31/2015) ........................................
...................................................................
0.0 percent (1.00) .....................................
¥0.06 percent (0.9994) ............................
...................................................................
$35.8228
$35.8013
April 1, 2015 through December 31, 2015
ebenthall on DSK5SPTVN1PROD with $$_JOB
Conversion Factor in effect in CY 2014 .......................................................................
CY 2014 Conversion Factor had statutory increases not applied ...............................
CY 2015 Medicare Economic Index ............................................................................
CY 2015 Update Adjustment Factor ............................................................................
CY 2015 RVU Budget Neutrality Adjustment ..............................................................
CY 2015 Conversion Factor (4/1/2015 through 12/31/2015) ......................................
Percent Change in Conversion Factor on 4/1/2015 (relative to the CY 2014 CF) .....
Percent Change in Update (without budget neutrality adjustment) on 4/1/2015 (relative to the CY 2014 CF).
We note payment for services under
the PFS will be calculated as follows:
b. Anesthesia Conversion Factors
Payment = [(Work RVU × Work GPCI) +
(PE RVU × PE GPCI) + (Malpractice RVU
× Malpractice GPCI)] × CF.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
...................................................................
...................................................................
0.8 percent (1.008) ...................................
¥3.0 percent (1.03) ..................................
¥0.06 percent (0.9994) ............................
...................................................................
...................................................................
...................................................................
We calculate the anesthesia CFs as
indicated in Table 46. Anesthesia
services do not have RVUs like other
PFS services. Therefore, we account for
any necessary RVU adjustments through
PO 00000
Frm 00196
Fmt 4701
Sfmt 4700
$35.8228
$27.2006
$28.2239
¥21.2%
¥20.9%
an adjustment to the anesthesia CF to
simulate changes to RVUs. More
specifically, if there is an adjustment to
the work, PE, or malpractice RVUs,
these adjustments are applied to the
respective shares of the anesthesia CF as
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
these shares are proxies for the work,
PE, and malpractice RVUs for anesthesia
services. Information regarding the
anesthesia work, PE, and malpractice
shares can be found at the following:
https://www.cms.gov/center/anesth.asp.
The anesthesia CF in effect in CY
2014 is $22.6765. Section 101 of PAMA
provides for a 0.0 percent update from
January 1, 2015 through March 31, 2015.
After applying the 0.9994 budget
neutrality factor described above, the
anesthesia CF in effect from January 1,
2015 through March 31, 2015 will be
$22.5550.
The table below includes adjustments
to the anesthesia CF that are analogous
to the physician fee schedule CF with
other adjustments that are specific to
anesthesia. In order to calculate the CY
2015 anesthesia CF for April 1, 2015
through December 31, 2015, the statute
requires us to calculate the CFs for all
previous years as if the various
legislative changes to the CFs for those
years had not occurred. The resulting
CF is then adjusted for the update (the
67743
MEI, less multi-factor productivity and
increased by the UAF). The national
average CF is then adjusted for
anesthesia specific work, practice
expense and malpractice factors that
must be applied to the anesthesia CF as
the anesthesia fee schedule does not
have RVUs. Accordingly, under current
law, the anesthesia CF in effect in CY
2015 for the time period from April 1,
2015 through December 31, 2015 is
$17.7913. We illustrate the calculation
of the CY 2015 anesthesia CFs in Table
45.
TABLE 46—CALCULATION OF THE CY 2015 ANESTHESIA CF
January 1, 2015 through March 31, 2015
CY 2014 National Average Anesthesia CF .................................................................
Update ..........................................................................................................................
CY 2015 RVU Budget Neutrality Adjustment ..............................................................
CY 2015 Anesthesia Fee Schedule Practice Expense Adjustment ............................
CY 2015 National Average Anesthesia CF (1/1/2015 through 3/31/2015) .................
...................................................................
0.0 percent (1.00) .....................................
0.0006 percent (0.9994) ...........................
0.005 percent (.99524) .............................
...................................................................
$22.6765
$22.5550
April 1, 2015 through December 31, 2015
2014 National Average Anesthesia Conversion Factor in effect in CY 2015 .............
2014 National Anesthesia Conversion Factor had Statutory Increases Not Applied ..
CY 2015 Medicare Economic Index ............................................................................
CY 2015 Update Adjustment Factor ............................................................................
CY 2015 Budget Neutrality Work and Malpractice Adjustment ...................................
CY 2015 Anesthesia Fee Schedule Practice Expense Adjustment ............................
CY 2015 Anesthesia Conversion Factor (4/1/2015 through 12/31/2015) ...................
Percent Change from 2014 to 2015 (4/1/2015 through 12/31/2015) ..........................
III. Other Provisions of the Final Rule
With Comment Period Regulation
ebenthall on DSK5SPTVN1PROD with $$_JOB
A. Ambulance Extender Provisions
1. Amendment to Section 1834(l)(13) of
the Act
Section 146(a) of the MIPPA amended
section 1834(l)(13)(A) of the Act to
specify that, effective for ground
ambulance services furnished on or after
July 1, 2008 and before January 1, 2010,
the ambulance fee schedule amounts for
ground ambulance services shall be
increased as follows:
• For covered ground ambulance
transports that originate in a rural area
or in a rural census tract of a
metropolitan statistical area, the fee
schedule amounts shall be increased by
3 percent.
• For covered ground ambulance
transports that do not originate in a
rural area or in a rural census tract of
a metropolitan statistical area, the fee
schedule amounts shall be increased by
2 percent.
The payment add-ons under section
1834(l)(13)(A) of the Act have been
extended several times. Recently,
section 1104(a) of the Pathway for SGR
Reform Act of 2013, enacted on
December 26, 2013, as Division B
(Medicare and Other Health Provisions)
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
...................................................................
...................................................................
0.8 percent (1.008) ...................................
3.0 percent (0.9994) .................................
¥0.06 percent (0.9994) ............................
0.005 percent (.99524) .............................
...................................................................
...................................................................
of Pub L. 113–67, amended section
1834(l)(13)(A) of the Act to extend the
payment add-ons described above
through March 31, 2014. Subsequently,
section 104(a) of the Protecting Access
to Medicare Act of 2014 (Pub. L. 113–
93, enacted on April 1, 2014) amended
section 1834(l)(13)(A) of the Act to
extend the payment add-ons again
through March 31, 2015. Thus, these
payment add-ons also apply to covered
ground ambulance transports furnished
before April 1, 2015. (For a discussion
of past legislation extending section
1834(l)(13) of the Act, please see the CY
2014 PFS final rule (78 FR 74438
through 74439)).
These statutory requirements are selfimplementing. A plain reading of the
statute requires only a ministerial
application of the mandated rate
increase, and does not require any
substantive exercise of discretion on the
part of the Secretary. In the CY 2015
PFS proposed rule (79 FR 40372), we
proposed to revise § 414.610(c)(1)(ii) to
conform the regulations to these
statutory requirements. We received one
comment regarding this proposal. A
summary of the comment we received
and our response are set forth below.
Comment: One commenter supported
the implementation of the ambulance
PO 00000
Frm 00197
Fmt 4701
Sfmt 4700
$22.6765
$17.2283
$17.7913
¥21.5%
payment add-ons. The commenter also
agreed that these provisions are selfimplementing.
Response: We thank the commenter
for their support of these provisions.
After consideration of the public
comment received, we are finalizing our
proposal to revise § 414.610(c)(1)(ii) to
conform the regulations to these
statutory requirements.
2. Amendment to Section 1834(l)(12) of
the Act
Section 414(c) of the Medicare
Prescription Drug, Improvement and
Modernization Act of 2003 (Pub. L. 108–
173, enacted on December 8, 2003)
(MMA) added section 1834(l)(12) to the
Act, which specified that in the case of
ground ambulance services furnished on
or after July 1, 2004, and before January
1, 2010, for which transportation
originates in a qualified rural area (as
described in the statute), the Secretary
shall provide for a percent increase in
the base rate of the fee schedule for such
transports. The statute requires this
percent increase to be based on the
Secretary’s estimate of the average cost
per trip for such services (not taking
into account mileage) in the lowest
quartile of all rural county populations
as compared to the average cost per trip
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67744
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
for such services (not taking into
account mileage) in the highest quartile
of rural county populations. Using the
methodology specified in the July 1,
2004 interim final rule (69 FR 40288),
we determined that this percent
increase was equal to 22.6 percent. As
required by the MMA, this payment
increase was applied to ground
ambulance transports that originated in
a ‘‘qualified rural area’’; that is, to
transports that originated in a rural area
included in those areas comprising the
lowest 25th percentile of all rural
populations arrayed by population
density. For this purpose, rural areas
included Goldsmith areas (a type of
rural census tract). This rural bonus is
sometimes referred to as the ‘‘Super
Rural Bonus’’ and the qualified rural
areas (also known as ‘‘super rural’’
areas) are identified during the claims
adjudicative process via the use of a
data field included on the CMSsupplied ZIP code File.
The Super Rural Bonus under section
1834(l)(12) of the Act has been extended
several times. Recently, section 1104(b)
of the Pathway for SGR Reform Act of
2013, enacted on December 26, 2013, as
Division B (Medicare and Other Health
Provisions) of Pub. L. 113–67, amended
section 1834(l)(12)(A) of the Act to
extend this rural bonus through March
31, 2014. Subsequently, section 104(b)
of the Protecting Access to Medicare Act
of 2014 (Pub. L. 113–93, enacted on
April 1, 2014) amended section
1834(l)(12)(A) of the Act to extend this
rural bonus again through March 31,
2015. Therefore, we are continuing to
apply the 22.6 percent rural bonus
described above (in the same manner as
in previous years) to ground ambulance
services with dates of service before
April 1, 2015 where transportation
originates in a qualified rural area. (For
a discussion of past legislation
extending section 1834(l)(12) of the Act,
please see the CY 2014 PFS final rule
(78 FR 74439 through 74440)).
These statutory provisions are selfimplementing. Together, these statutory
provisions require a 15-month extension
of this rural bonus (which was
previously established by the Secretary)
through March 31, 2015, and do not
require any substantive exercise of
discretion on the part of the Secretary.
In the CY 2015 PFS proposed rule (79
FR 40372), we proposed to revise
§ 414.610(c)(5)(ii) to conform the
regulations to these statutory
requirements. We received one
comment regarding this proposal. A
summary of the comment we received
and our response are set forth below.
Comment: One commenter supported
the implementation of the percent
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
increase in the base rate of the fee
schedule for transports in areas defined
as super rural. The commenter also
agreed with CMS that these provisions
are self-implementing.
Response: We thank the commenter
for their support of these provisions.
After consideration of the public
comment received, we are finalizing our
proposal to revise § 414.610(c)(5)(ii) to
conform the regulations to these
statutory requirements.
B. Changes in Geographic Area
Delineations for Ambulance Payment
1. Background
Under the ambulance fee schedule,
the Medicare program pays for
ambulance transportation services for
Medicare beneficiaries when other
means of transportation are
contraindicated by the beneficiary’s
medical condition, and all other
coverage requirements are met.
Ambulance services are classified into
different levels of ground (including
water) and air ambulance services based
on the medically necessary treatment
provided during transport.
These services include the following
levels of service:
• For Ground—
++ Basic Life Support (BLS)
(emergency and non-emergency)
++ Advanced Life Support, Level 1
(ALS1) (emergency and non-emergency)
++ Advanced Life Support, Level 2
(ALS2)
++ Paramedic ALS Intercept (PI)
++ Specialty Care Transport (SCT)
• For Air—
++ Fixed Wing Air Ambulance (FW)
++ Rotary Wing Air Ambulance (RW)
a. Statutory Coverage of Ambulance
Services
Under sections 1834(l) and 1861(s)(7)
of the Act, Medicare Part B
(Supplemental Medical Insurance)
covers and pays for ambulance services,
to the extent prescribed in regulations,
when the use of other methods of
transportation would be contraindicated
by the beneficiary’s medical condition.
The House Ways and Means
Committee and Senate Finance
Committee Reports that accompanied
the 1965 Social Security Amendments
suggest that the Congress intended
that—
• The ambulance benefit cover
transportation services only if other
means of transportation are
contraindicated by the beneficiary’s
medical condition; and
• Only ambulance service to local
facilities be covered unless necessary
services are not available locally, in
PO 00000
Frm 00198
Fmt 4701
Sfmt 4700
which case, transportation to the nearest
facility furnishing those services is
covered (H.R. Rep. No. 213, 89th Cong.,
1st Sess. 37 and Rep. No. 404, 89th
Cong., 1st Sess. Pt 1, 43 (1965)).
The reports indicate that
transportation may also be provided
from one hospital to another, to the
beneficiary’s home, or to an extended
care facility.
b. Medicare Regulations for Ambulance
Services
Our regulations relating to ambulance
services are set forth at 42 CFR part 410,
subpart B and 42 CFR part 414, subpart
H. Section 410.10(i) lists ambulance
services as one of the covered medical
and other health services under
Medicare Part B. Therefore, ambulance
services are subject to basic conditions
and limitations set forth at § 410.12 and
to specific conditions and limitations
included at § 410.40 and § 410.41. Part
414, subpart H, describes how payment
is made for ambulance services covered
by Medicare.
2. Provisions of the Final Rule
Historically, the Medicare ambulance
fee schedule has used the same
geographic area designations as the
acute care hospital inpatient prospective
payment system (IPPS) and other
Medicare payment systems to take into
account appropriate urban and rural
differences. This promotes consistency
across the Medicare program, and it
provides for use of consistent
geographic standards for Medicare
payment purposes.
The current geographic areas used
under the ambulance fee schedule are
based on OMB standards published on
December 27, 2000 (65 FR 82228
through 82238), Census 2000 data, and
Census Bureau population estimates for
2007 and 2008 (OMB Bulletin No. 10–
02). For a discussion of OMB’s
delineation of Core-Based Statistical
Areas (CBSAs) and our implementation
of the CBSA definitions under the
ambulance fee schedule, we refer
readers to the preamble of the CY 2007
Ambulance Fee Schedule proposed rule
(71 FR 30358 through 30361) and the
CY 2007 PFS final rule (71 FR 69712
through 69716). On February 28, 2013,
OMB issued OMB Bulletin No. 13–01,
which established revised delineations
for Metropolitan Statistical Areas
(MSAs), Micropolitan Statistical Areas,
and Combined Statistical Areas, and
provided guidance on the use of the
delineations of these statistical areas. A
copy of this bulletin may be obtained at
https://www.whitehouse.gov/sites/
default/files/omb/bulletins/2013/b-1301.pdf. According to OMB, ‘‘[t]his
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
bulletin provides the delineations of all
Metropolitan Statistical Areas,
Metropolitan Divisions, Micropolitan
Statistical Areas, Combined Statistical
Areas, and New England City and Town
Areas in the United States and Puerto
Rico based on the standards published
on June 28, 2010, in the Federal
Register (75 FR 37246–37252) and
Census Bureau data.’’ OMB defines an
MSA as a CBSA associated with at least
one urbanized area that has a
population of at least 50,000, and a
Micropolitan Statistical Area (referred to
in this discussion as a Micropolitan
Area) as a CBSA associated with at least
one urban cluster that has a population
of at least 10,000 but less than 50,000
(75 FR 37252). Counties that do not
qualify for inclusion in a CBSA are
deemed ‘‘Outside CBSAs.’’ We note
that, when referencing the new OMB
geographic boundaries of statistical
areas, we are using the term
‘‘delineations’’ consistent with OMB’s
use of the term (75 FR 37249).
Although the revisions OMB
published on February 28, 2013 are not
as sweeping as the changes made when
we adopted the CBSA geographic
designations for CY 2007, the February
28, 2013 OMB bulletin does contain a
number of significant changes. For
example, we stated in the CY 2015 PFS
proposed rule (79 FR 40373) that if we
adopt the revised OMB delineations,
there would be new CBSAs, urban
counties that would become rural, rural
counties that would become urban, and
existing CBSAs that would be split
apart. We have reviewed our findings
and impacts relating to the new OMB
delineations, and find no compelling
reason to further delay implementation.
We stated in the proposed rule that we
believe it is important for the ambulance
fee schedule to use the latest labor
market area delineations available as
soon as reasonably possible to maintain
a more accurate and up-to-date payment
system that reflects the reality of
population shifts.
Additionally, in the FY 2015 IPPS
proposed rule (79 FR 28055), we also
proposed to adopt OMB’s revised
delineations to identify urban areas and
rural areas for purposes of the IPPS
wage index. This proposal was finalized
in the FY 2015 IPPS final rule (79 FR
49952). For the reasons discussed above,
we believe it would be appropriate to
adopt the same geographic area
delineations for use under the
ambulance fee schedule as are used
under the IPPS and other Medicare
payment systems. Thus, we proposed to
implement the new OMB delineations
as described in the February 28, 2013
OMB Bulletin No. 13–01 beginning in
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
CY 2015 to more accurately identify
urban and rural areas for ambulance fee
schedule payment purposes. We believe
that the updated OMB delineations
more realistically reflect rural and urban
populations, and that the use of such
delineations under the ambulance fee
schedule would result in more accurate
payment. Under the ambulance fee
schedule, consistent with our current
definitions of urban and rural areas
(§ 414.605), MSAs would continue to be
recognized as urban areas, while
Micropolitan and other areas outside
MSAs, and rural census tracts within
MSAs (as discussed below), would be
recognized as rural areas.
In addition to the OMB’s statistical
area delineations, the current
geographic areas used in the ambulance
fee schedule also are based on rural
census tracts determined under the most
recent version of the Goldsmith
Modification. These rural census tracts
are considered rural areas under the
ambulance fee schedule (see § 414.605).
For certain rural add-ons, section
1834(l) of the Act requires that we use
the most recent version of the
Goldsmith Modification to determine
rural census tracts within MSAs. In the
CY 2007 PFS final rule (71 FR 69714
through 69716), we adopted the most
recent (at that time) version of the
Goldsmith Modification, designated as
Rural-Urban Commuting Area (RUCA)
codes. RUCA codes use urbanization,
population density, and daily
commuting data to categorize every
census tract in the country. For a
discussion about RUCA codes, we refer
the reader to the CY 2007 PFS final rule
(71 FR 69714 through 69716). As stated
previously, on February 28, 2013, OMB
issued OMB Bulletin No. 13–01, which
established revised delineations for
Metropolitan Statistical Areas,
Micropolitan Statistical Areas, and
Combined Statistical Areas, and
provided guidance on the use of the
delineations of these statistical areas.
Several modifications of the RUCA
codes were necessary to take into
account updated commuting data and
the revised OMB delineations. We refer
readers to the U.S. Department of
Agriculture’s Economic Research
Service Web site for a detailed listing of
updated RUCA codes found at https://
www.ers.usda.gov/data-products/ruralurban-commuting-area-codes.aspx. The
updated RUCA code definitions were
introduced in late 2013 and are based
on data from the 2010 decennial census
and the 2006–10 American Community
Survey. We proposed to adopt the most
recent modifications of the RUCA codes
beginning in CY 2015, to recognize
PO 00000
Frm 00199
Fmt 4701
Sfmt 4700
67745
levels of rurality in census tracts located
in every county across the nation, for
purposes of payment under the
ambulance fee schedule. In the CY 2015
PFS proposed rule (79 FR 40373), we
stated that if we adopt the most recent
RUCA codes, many counties that are
designated as urban at the county level
based on population would have rural
census tracts within them that would be
recognized as rural areas through our
use of RUCA codes.
As we stated in the CY 2015 PFS
proposed rule (79 FR 40373 through
40374), the 2010 Primary RUCA codes
are as follows:
(1) Metropolitan area core: primary
flow with an urbanized area (UA).
(2) Metropolitan area high
commuting: primary flow 30 percent or
more to a UA.
(3) Metropolitan area low commuting:
primary flow 10 to 30 percent to a UA.
(4) Micropolitan area core: primary
flow within an Urban Cluster of 10,000
to 49,999 (large UC).
(5) Micropolitan high commuting:
primary flow 30 percent or more to a
large UC.
(6) Micropolitan low commuting:
primary flow 10 to 30 percent to a large
UC.
(7) Small town core: primary flow
within an Urban Cluster of 2,500 to
9,999 (small UC).
(8) Small town high commuting:
primary flow 30 percent or more to a
small UC.
(9) Small town low commuting:
primary flow 10 to 30 percent to a small
UC.
(10) Rural areas: primary flow to a
tract outside a UA or UC.
Based on this classification, and
consistent with our current policy (71
FR 69715), we proposed to continue to
designate any census tracts falling at or
above RUCA level 4.0 as rural areas for
purposes of payment for ambulance
services under the ambulance fee
schedule. As discussed in the CY 2007
PFS final rule (71 FR 69715), the Office
of Rural Health Policy within the Health
Resources and Services Administration
(HRSA) determines eligibility for its
rural grant programs through the use of
the RUCA code methodology. Under
this methodology, HRSA designates any
census tract that falls in RUCA level 4.0
or higher as a rural census tract. In
addition to designating any census
tracts falling at or above RUCA level 4.0
as rural areas, under the updated RUCA
code definitions, HRSA has also
designated as rural census tracts those
census tracts with RUCA codes 2 or 3
that are at least 400 square miles in area
with a population density of no more
than 35 people. We refer readers to
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67746
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
HRSA’s Web site: ftp://ftp.hrsa.gov/
ruralhealth/Eligibility2005.pdf for
additional information. Consistent with
the HRSA guidelines discussed above,
we proposed, beginning in CY 2015, to
designate as rural areas (1) those census
tracts that fall at or above RUCA level
4.0, and (2) those census tracts that fall
within RUCA levels 2 or 3 that are at
least 400 square miles in area with a
population density of no more than 35
people. We stated in the CY 2015 PFS
proposed rule (79 FR 40374) that we
continue to believe that HRSA’s
guidelines accurately identify rural
census tracts throughout the country,
and thus would be appropriate to apply
for ambulance payment purposes. We
invited comments on this proposal.
We stated in the CY 2015 PFS
proposed rule (79 FR 40374) that the
adoption of the most current OMB
delineations and the updated RUCA
codes would affect whether certain
areas are recognized as rural or urban.
The distinction between urban and rural
is important for ambulance payment
purposes because urban and rural
transports are paid differently. The
determination of whether a transport is
urban or rural is based on the point of
pick-up for the transport, and thus a
transport is paid differently depending
on whether the point of pick-up is in an
urban or a rural area. During claims
processing, a geographic designation of
urban, rural, or super rural is assigned
to each claim for an ambulance
transport based on the point of pick-up
ZIP code that is indicated on the claim.
Currently, section 1834(l)(12) of the
Act (as amended by section 104(b) of the
PAMA) specifies that, for services
furnished during the period July 1, 2004
through March 31, 2015, the payment
amount for the ground ambulance base
rate is increased by a ‘‘percent increase’’
(Super Rural Bonus) where the
ambulance transport originates in a
‘‘qualified rural area,’’ which is a rural
area that we determine to be in the
lowest 25th percentile of all rural
populations arrayed by population
density (also known as a ‘‘super rural
area’’). We implement this Super Rural
Bonus in § 414.610(c)(5)(ii). We stated
in the CY 2015 PFS proposed rule (79
FR 40374) that adoption of the revised
OMB delineations and the updated
RUCA codes would have no negative
impact on ambulance transports in
super rural areas, as none of the current
super rural areas would lose their status
due to the revised OMB delineations
and the updated RUCA codes.
As we stated in the CY 2015 PFS
proposed rule (79 FR 40374), the
adoption of the new OMB delineations
and the updated RUCA codes would
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
affect whether or not transports would
be eligible for other rural adjustments
under the ambulance fee schedule
statute and regulations. For ground
ambulance transports where the point of
pick-up is in a rural area, the mileage
rate is increased by 50 percent for each
of the first 17 miles (§ 414.610(c)(5)(i)).
For air ambulance services where the
point of pick-up is in a rural area, the
total payment (base rate and mileage
rate) is increased by 50 percent
(§ 414.610(c)(5)(i)). Furthermore, under
section 1834(l)(13) of the Act (as
amended by section 104(a) of the
PAMA), for ground ambulance
transports furnished through March 31,
2015, transports originating in rural
areas are paid based on a rate (both base
rate and mileage rate) that is 3 percent
higher than otherwise is applicable. (See
also § 414.610(c)(1)(ii)).
We stated in the CY 2015 PFS
proposed rule (79 FR 40374) that if we
adopt OMB’s revised delineations and
the updated RUCA codes, ambulance
providers and suppliers that pick up
Medicare beneficiaries in areas that
would be Micropolitan or otherwise
outside of MSAs based on OMB’s
revised delineations or in a rural census
tract of an MSA based on the updated
RUCA codes (but are currently within
urban areas) may experience increases
in payment for such transports because
they may be eligible for the rural
adjustment factors discussed above,
while those ambulance providers and
suppliers that pick up Medicare
beneficiaries in areas that would be
urban based on OMB’s revised
delineations and the updated RUCA
codes (but are currently in Micropolitan
Areas or otherwise outside of MSAs, or
in a rural census tract of an MSA) may
experience decreases in payment for
such transports because they would no
longer be eligible for the rural
adjustment factors discussed above.
The use of the revised OMB
delineations and the updated RUCA
codes would mean the recognition of
new urban and rural boundaries based
on the population migration that
occurred over a 10-year period, between
2000 and 2010. In the CY 2015 PFS
proposed rule (79 FR 40374), we stated
that, based on the latest United States
Postal Service (USPS) ZIP code file,
there are a total of 42,914 ZIP codes in
the U.S. We stated in the proposed rule
that the geographic designations for
approximately 99.48 percent of ZIP
codes would be unchanged by OMB’s
revised delineations and the updated
RUCA codes, and that a similar number
of ZIP codes would change from rural to
urban (122, or 0.28 percent) as would
change from urban to rural (100, or 0.23
PO 00000
Frm 00200
Fmt 4701
Sfmt 4700
percent). We stated in the proposed rule
that, in general, it was expected that
ambulance providers and suppliers in
100 ZIP codes within 11 states may
experience payment increases if we
adopt the revised OMB delineations and
the updated RUCA codes, as these areas
would be redesignated from urban to
rural. We stated that the state of Ohio
would have the most ZIP codes
changing from urban to rural with a
total of 40, or 2.69 percent. We also
stated in the CY 2015 PFS proposed rule
that ambulance providers and suppliers
in 122 ZIP codes within 22 states may
experience payment decreases if we
adopt the revised OMB delineations and
the updated RUCA codes, as these areas
would be redesignated from rural to
urban. We stated that the state of West
Virginia would have the most ZIP codes
changing from rural to urban (17, or 1.82
percent), while Connecticut would have
the greatest percentage of ZIP codes
changing from rural to urban (15 ZIP
codes, or 3.37 percent). Our findings
were illustrated in Table 17 of the CY
2015 PFS proposed rule (79 FR 40375).
We stated in the CY 2015 PFS
proposed rule (79 FR 40375 and 40376)
that we believe the most current OMB
statistical area delineations, coupled
with the updated RUCA codes, more
accurately reflect the contemporary
urban and rural nature of areas across
the country, and that use of the most
current OMB delineations and RUCA
codes under the ambulance fee schedule
would enhance the accuracy of
ambulance fee schedule payments. We
solicited comments on our proposal to
implement the new OMB delineations
and the updated RUCA codes as
discussed above beginning in CY 2015,
for purposes of payment under the
Medicare ambulance fee schedule.
We received four comments from two
associations representing ambulance
service providers and suppliers and two
ambulance suppliers on our proposal to
implement the new OMB delineations
and the updated RUCA codes for
purposes of payment under the
Medicare ambulance fee schedule.
Those comments are summarized below
along with our responses.
Comment: All of the commenters
agreed with CMS that it is appropriate
to adjust the geographic area
designations periodically so that the
ambulance fee schedule reflects
population shifts.
Response: We appreciate the support
of the commenters.
Comment: Commenters expressed
concern that the analysis of the
proposed modification in the CY 2015
PFS proposed rule did not describe the
actual impact of the proposed change
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
because it did not take into account the
most recent modifications to the RUCA
codes. When these codes are applied,
the commenters stated that there would
be substantially more ZIP codes that
would shift. The commenters estimated
that more than 1,500 ZIP codes would
shift from rural to urban and about three
times the number of ZIP codes
identified in the proposed rule would
change from urban to rural. The
commenters also stated that some ZIP
codes would no longer have super rural
status.
Response: The commenters are correct
that the analysis published in the CY
2015 PFS proposed rule (see Table 17
(79 FR 40375)) presented the impact of
the revised OMB delineations only and
did not include the impact of the
updated RUCA codes. We did not
receive the ZIP code approximation of
the 2010 RUCA codes file in time to be
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
included in our analysis in the proposed
rule.
We have completed an updated
analysis of both the revised OMB
delineations and the updated RUCA
codes. Based on the latest United States
Postal Service (USPS) ZIP code file,
there are a total of 42,918 ZIP codes in
the U.S. Based on our updated analysis,
we have concluded that the geographic
designations for approximately 92.02
percent of ZIP codes would be
unchanged by OMB’s revised
delineations and the updated RUCA
codes. There are more ZIP codes that
would change from rural to urban (3,038
or 7.08 percent) than from urban to rural
(387 or 0.90 percent). The differences in
the data provided in the proposed rule
compared to the final rule are due to
inclusion of the updated RUCA codes.
In general, it is expected that ambulance
providers and suppliers in 387 ZIP
PO 00000
Frm 00201
Fmt 4701
Sfmt 4700
67747
codes within 41 states, may experience
payment increases under the revised
OMB delineations and the updated
RUCA codes, as these areas have been
redesignated from urban to rural. The
state of California has the most ZIP
codes changing from urban to rural with
a total of 43, or 1.58 percent. Ambulance
providers and suppliers in 3,038 ZIP
codes within 46 states and Puerto Rico
may experience payment decreases
under the revised OMB delineations and
the updated RUCA codes, as these areas
have been redesignated from rural to
urban. The state of Pennsylvania has the
most ZIP codes changing from rural to
urban (293, or 13.06 percent), while
West Virginia has the greatest
percentage of ZIP codes changing from
rural to urban (269 ZIP codes, or 28.74
percent). Our findings are illustrated in
Table 47.
BILLING CODE 4120–01–P
E:\FR\FM\13NOR2.SGM
13NOR2
67748
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 47: Updated ZIP Codes Analysis Based on OMB's Revised Delineations
and Updated RUCA Codes
Total ZIP
Codes
AK
276
AL
AR
AS
854
725
AZ
569
1
CA
2723
co
677
CT
DC
DE
EK
EM
FL
FM
GA
GU
HI
lA
445
303
99
63
856
1513
4
1032
21
143
1080
ID
335
IL
1628
IN
1000
KY
LA
1030
MA
751
MD
ME
MH
505
MI
1185
MN
1043
ebenthall on DSK5SPTVN1PROD with $$_JOB
MP
MS
MT
NC
ND
NE
NH
NJ
739
630
2
3
541
411
1101
419
632
292
747
NM
438
NV
257
VerDate Sep<11>2014
20:15 Nov 12, 2014
Total ZIP
Codes
Changed
Rural to
Urban
0
83
41
0
21
94
4
56
0
6
0
71
105
0
101
0
9
42
3
159
110
81
101
14
84
19
0
63
47
0
36
0
163
2
7
6
1
4
4
Jkt 235001
PO 00000
Percentage of
Total ZIP
Codes
0.00%
9.72%
5.66%
0.00%
3.69%
3.45%
0.59%
12.58%
0.00%
6.06%
0.00%
8.29%
6.94%
0.00%
9.79%
0.00%
6.29%
3.89%
0.90%
9.77%
11.00%
7.86%
13.67%
1.86%
13.33%
3.76%
0.00%
5.32%
4.51%
0.00%
6.65%
0.00%
14.80%
0.48%
1.11%
2.05%
0.13%
0.91%
1.56%
Frm 00202
Fmt 4701
Total ZIP
Codes
Changed
Urban to
Rural
0
8
6
0
7
43
9
0
0
0
0
2
9
0
4
0
3
3
0
7
7
5
1
6
0
12
0
13
7
0
1
3
6
0
6
2
2
2
2
Sfmt 4725
Percentage
ofTotalZIP
Codes
Total
ZIP
Codes
Not
Percentage
ofTotalZIP
Codes Not
Changed
Cham~ed
0.00%
276
100.00%
0.94%
763
89.34%
0.83%
678
93.52%
0.00%
1
100.00%
1.23%
541
95.08%
1.58%
2586
94.97%
1.33%
664
98.08%
0.00%
389
87.42%
0.00%
303
100.00%
0.00%
93
93.94%
0.00%
63
100.00%
0.23%
783
91.47%
0.59%
1399
92.47%
0.00%
4
100.00%
0.39%
927
89.83%
0.00%
21
100.00%
2.10%
131
91.61%
0.28%
1035
95.83%
0.00%
332
99.10%
0.43%
1462
89.80%
0.70%
883
88.30%
0.49%
944
91.65%
0.14%
637
86.20%
0.80%
731
97.34%
0.00%
546
86.67%
2.38%
474
93.86%
0.00%
2
100.00%
1.10%
1109
93.59%
0.67%
989
94.82%
0.00%
3
100.00%
0.18%
504
93.16%
0.73%
408
99.27%
0.54%
932
84.65%
0.00%
417
99.52%
0.95%
619
97.94%
0.68%
284
97.26%
0.27%
744
99.60%
0.46%
432
98.63%
0.78%
251
97.67%
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.062</GPH>
State/
Territory*
ebenthall on DSK5SPTVN1PROD with $$_JOB
BILLING CODE 4120–01–C
As discussed above, in the CY 2015
PFS proposed rule (79 FR 40374), we
proposed to designate as rural those
census tracts that fall in RUCA codes 2
or 3 that are at least 400 square miles
in area with a population density of no
more than 35 people. However, upon
further analysis, we have determined
that it is not feasible to implement this
proposal. Payment under the ambulance
fee schedule is based on the ZIP codes;
therefore, if the ZIP code is
predominantly metropolitan but has
some rural census tracts, we do not split
the ZIP code areas to distinguish further
granularity to provide different
payments within the same ZIP code. We
believe that payment for all ambulance
transportation services at the ZIP code
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
level provides a consistent payment
system. Therefore, such census tracts
were not considered rural areas in the
updated analysis set forth above.
For more detail on the impact of these
changes, in addition to Table 47, the
following files are available through the
Internet on the AFS Web site at
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
AmbulanceFeeSchedule/:
ZIP codes by state that changed from
urban to rural, ZIP codes by state that
changed from rural to urban, list of ZIP
codes with RUCA code designations,
and a complete list of ZIP codes
identifying their designation as super
rural, rural or urban.
As reflected in Table 47, our findings
are generally consistent with the
PO 00000
Frm 00203
Fmt 4701
Sfmt 4700
67749
commenters’ findings that more than
1,500 ZIP codes would change from
rural to urban (our updated analysis
indicates that 3,038 ZIP codes are
changing), and that about three times
the number of ZIP codes identified in
the proposed rule (100) would change
from urban to rural (our updated
analysis indicates 387 ZIP codes are
changing).
As we stated in the proposed rule (79
FR 40374), none of the current super
rural areas will lose their super rural
status upon implementation of the
revised OMB delineations and the
updated RUCA codes.
Comment: One commenter suggested
that we delay the implementation of the
adjustment until CY 2016 to allow CMS
sufficient time to publish the changes in
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.063</GPH>
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
67750
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
rural and urban status and allow all
interested parties to provide comments
on the proposal. In addition to delaying
implementation, the commenter
suggested implementing a 4-year
transition that would phase-in the
payment reduction over a specified
period for those ZIP codes losing rural
status.
Other commenters requested that the
implementation of the geographic
adjustments outlined in the proposed
rule be delayed until such time as the
data is available to complete a full and
accurate analysis of the ZIP codes
affected and the financial impact to
industry. Absent such a delay, the
commenters stated that the final rule
must clarify, in a complete and
transparent manner, the accuracy of the
analysis used in the proposed rule.
Response: We believe that ambulance
providers and suppliers had sufficient
notice of and opportunity to comment
on the proposed adoption of the revised
OMB delineations and the updated
RUCA codes under the ambulance fee
schedule, and thus we do not believe a
delay in implementation is warranted.
In the proposed rule, we proposed to
adopt the revised OMB delineations as
set forth in OMB Bulletin No. 13–01 and
the updated RUCA codes for purposes
of payment under the ambulance fee
schedule consistent with the policy we
implemented in CY 2007 (see the CY
2007 PFS final rule (71 FR 69713
through 69716)). We explained in the
proposed rule that the adoption of the
revised OMB delineations and updated
RUCA codes would affect the urban/
rural designation of certain areas, and
thus would affect whether transports in
certain areas would be eligible for rural
adjustments under the ambulance fee
schedule. In addition, OMB Bulletin No.
13–01was available on February 28,
2013, and contained additional
information regarding the changes in
OMB geographic area delineations. As
discussed above, the ZIP code analysis
set forth in the proposed rule reflected
the impact of the revised OMB
delineations. The 2010 RUCA codes and
definitions were available on December
31, 2013 on the U.S. Department of
Agriculture’s Economic Research
Service’s Web site, which provided
ambulance providers and suppliers with
additional information regarding
changes to the level of rurality in census
tracts. Furthermore, section 1834(l)
requires that we use the most recent
modification of the Goldsmith
Modification to determine rural census
tracts for purposes of certain rural addons, and our established policy, as set
forth in § 414.605, is that rural areas
include rural census tracts as
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
determined under the most recent
version of the Goldsmith modification.
As discussed above and in the CY
2015 PFS proposed rule, we believe the
most current OMB statistical area
delineations, coupled with the updated
RUCA codes, more accurately reflect the
contemporary urban and rural nature of
areas across the country, and thus we
believe the use of the most current OMB
delineations and RUCA codes under the
ambulance fee schedule will enhance
the accuracy of ambulance fee schedule
payments. We believe that it is
important to use the most current OMB
delineations and RUCA codes available
as soon as reasonably possible to
maintain a more accurate and up-to-date
payment system that reflects the reality
of population shifts. Because we believe
the revised OMB delineations and
updated RUCA codes more accurately
identify urban and rural areas and
enhance the accuracy of the Medicare
ambulance fee schedule, we do not
believe a delay in implementation or a
transition period would be appropriate.
Areas that lose their rural status and
become urban have become urban
because of recent population shifts. We
believe it is important to base payment
on the most accurate and up-to-date
geographic area delineations available.
Furthermore, we believe a delay would
disadvantage the ambulance providers
or suppliers experiencing payment
increases based on these updated and
more accurate OMB delineations and
RUCA codes.
Finally, given the relatively small
percentage of ZIP codes affected by the
revised OMB delineations and updated
RUCA codes (a total of 3,425 ZIP codes
changing their urban/rural status out of
42,918 ZIP codes, or 7.98 percent), we
do not believe that a delay is warranted.
As commenters requested, we have
included in Table 47 our updated
analysis of the impact of adopting the
revised OMB delineations and the
updated RUCA codes.
Comment: One commenter
recommended that if any ZIP codes
would lose their super rural status as a
result of the proposed adoption of the
revised OMB delineations and the
updated RUCA codes, then CMS should
grandfather the current super rural ZIP
codes. Another commenter stated that
the ambulance providers must have
verification from CMS that the super
rural ZIP codes will not be affected by
the changes described in the proposed
rule in advance of their implementation
in the final rule.
Response: As we stated previously,
the adoption of the OMB’s revised
delineations and the updated RUCA
codes will have no negative impact on
PO 00000
Frm 00204
Fmt 4701
Sfmt 4700
ambulance transports in super rural
areas, as none of the current super rural
areas will lose their status upon
implementation of the revised OMB
delineations and the updated RUCA
codes. Current areas designated as super
rural areas will continue to be eligible
for the super rural bonus.
After consideration of the public
comments received, and for the reasons
discussed above, we are finalizing our
proposals to adopt, beginning in CY
2015, the revised OMB delineations as
set forth in OMB’s February 28, 2013
bulletin (No. 13–01) and the most recent
modifications of the RUCA codes for
purposes of payment under the
ambulance fee schedule. As we
proposed, using the updated RUCA
codes definitions, we will continue to
designate any census tracts falling at or
above RUCA level 4.0 as rural areas.
However, as discussed above, we are not
finalizing our proposal to designate as
rural those census tracts that fall within
RUCA codes 2 or 3 that are at least 400
square miles in area with a population
density of no more than 35 people.
Finally, as discussed above, none of the
current super rural areas will lose their
super rural status upon implementation
of the revised OMB delineations and the
updated RUCA codes.
C. Clinical Laboratory Fee Schedule
In the CY 2014 PFS final rule with
comment period (78 FR 74440 through
74445, 74820), we finalized a process
under which we would reexamine the
payment amounts for test codes on the
Clinical Laboratory Fee Schedule
(CLFS) for possible payment revision
based on technological changes
beginning with the CY 2015 proposed
rule, and we codified this process at
§ 414.511. After we finalized this
process, the Congress enacted the
PAMA. Section 216 of the PAMA
creates new section 1834A of the Act,
which requires us to implement a new
Medicare payment system for clinical
diagnostic laboratory tests based on
private payor rates. Section 216 of the
PAMA also rescinds the statutory
authority in section 1833(h)(2)(A)(i) of
the Act for adjustments based on
technological changes for tests
furnished on or after April 1, 2014
(PAMA’s enactment date). As a result of
these provisions, we did not propose
any revisions to payment amounts for
test codes on the CLFS based on
technological changes, and we proposed
to remove § 414.511.
We did not receive any public
comments on this proposal. Therefore,
we are finalizing our proposal to remove
§ 414.511. In addition, we will establish
through rulemaking the parameters for
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
the collection of private payor rate
information and other requirements to
implement section 216 of the PAMA.
ebenthall on DSK5SPTVN1PROD with $$_JOB
D. Removal of Employment
Requirements for Services Furnished
‘‘Incident to’’ Rural Health Clinics
(RHC) and Federally Qualified Health
Center (FQHC) Visits
1. Background
Rural Health Clinics (RHCs) and
Federally Qualified Health Centers
(FQHCs) furnish physicians’ services;
services and supplies ‘‘incident to’’ the
services of physicians: Nurse
practitioner (NP), physician assistant
(PA), certified nurse-midwife (CNM),
clinical psychologist (CP), and clinical
social worker (CSW) services; and
services and supplies incident to the
services of NPs, PAs, CNMs, CPs, and
CSWs. They may also furnish diabetes
self-management training and medical
nutrition therapy (DSMT/MNT),
transitional care management services,
and in some cases, visiting nurse
services furnished by a registered
professional nurse or a licensed
practical nurse. (For additional
information on coverage requirements
for services furnished in RHCs and
FQHCs, see Chapter 13 of the CMS
Benefit Policy Manual.)
In the May 2, 2014 final rule with
comment period entitled ‘‘Prospective
Payment System for Federally Qualified
Health Centers; Changes to Contracting
Policies for Rural Health Clinics; and
Changes to Clinical Laboratory
Improvement Amendments of 1988
Enforcement Actions for Proficiency
Testing Referral’’ (79 FR 25436), we
removed the regulatory requirements
that NPs, PAs, CNMs, CSWs, and CPs
furnishing services in a RHC must be
employees of the RHC. RHCs are now
allowed to contract with NPs, PAs,
CNMs, CSWs, and CPs, as long as at
least one NP or PA is employed by the
RHC, as required under clause (iii) in
the first sentence of the flush material
following subparagraph (K) of section
1861(aa)(2) of the Act.
Services furnished in RHCs and
FQHCs by nurses, medical assistants,
and other auxiliary personnel are
considered ‘‘incident to’’ a RHC or
FQHC visit furnished by a RHC or
FQHC practitioner. Sections
405.2413(a)(6), 405.2415(a)(6), and
405.2452(a)(6) currently state that
services furnished incident to an RHC or
FQHC visit must be furnished by an
employee of the RHC or FQHC. Since
there is no separate benefit under
Medicare law that specifically
authorizes payment to nurses, medical
assistants, and other auxiliary personnel
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
for their professional services, they
cannot bill the program directly and
receive payment for their services, and
can only be remunerated when
furnishing services to Medicare patients
in an ‘‘incident to’’ capacity.
To provide RHCs and FQHCs with as
much flexibility as possible to meet
their staffing needs, we proposed to
revise § 405.2413(a)(5), § 405.2415(a)(5)
and § 405.2452(a)(5) and delete
§ 405.2413(a)(6), § 405.2415(a)(6) and
§ 405.2452(a)(6) to remove the
requirement that services furnished
incident to an RHC or FQHC visit must
be furnished by an employee of the RHC
or FQHC, in order to allow nurses,
medical assistants, and other auxiliary
personnel to furnish ‘‘incident to’’
services under contract in RHCs and
FQHCs. We believe that removing the
requirements will provide RHCs and
FQHCs with additional flexibility
without adversely impacting the quality
or continuity of care.
We received 23 comments on our
proposal. The following is a summary of
the comments received.
Comment: Most commenters were
strongly in favor of removing these
employment requirements. Several
commenters stated that this flexibility
will assist RHCs and FQHCs in
increasing access to care, enable them to
recruit highly qualified health
professionals, and fill temporary staffing
voids without adversely impacting the
quality of care. Some commenters
expressed concerns about maintaining
professional standards, and others were
concerned about the potential loss of
benefits for contracted staff.
A few commenters stated that they
support removal of the employment
requirement, provided that RHC and
FQHC auxiliary personnel are held to
the same high professional standards for
the quality of care, regardless of whether
they are working under contract or as
employees. Commenters also added that
all members of a physician-led health
care team should be enabled to perform
medical interventions that they are
capable of performing according to their
education, training, licensure, and
experience.
Response: The proposal to remove the
requirement that auxiliary workers in
RHCs and FQHCs be employees of the
RHC or FQHC does not change either
their professional standards of care or
their scope of practice. Nurses, medical
assistants, and other auxiliary personnel
are expected to maintain their
professional standards of care and
furnish services in adherence to their
scope of practice, regardless of whether
they are employed or contracted by the
RHC or FQHC.
PO 00000
Frm 00205
Fmt 4701
Sfmt 4700
67751
Comment: Some commenters stated
that although they understand the need
for greater staffing flexibility, they were
concerned about the potential loss of
benefit packages to individuals that are
contracted and not employed. The
commenters questioned whether the
issue was investigated or vetted, and
how RHCs and FQHCs would
compensate for this loss of
compensation for individuals providing
incident to services under contract
rather than as an employee.
Response: We appreciate the concern
that these commenters raised regarding
the potential loss of benefit packages for
contracted individuals; however, we do
not regulate employment agreements or
benefit packages for individuals
working at RHCs and FQHCs.
After consideration of the public
comments, we are finalizing this
provision as proposed.
E. Access to Identifiable Data for the
Center for Medicare and Medicaid
Innovation Models
1. Background and Statutory Authority
Section 3021 of the Affordable Care
Act amended the Social Security Act to
include a new section 1115A, which
established the Center for Medicare and
Medicaid Innovation (Innovation
Center). Section 1115A tasks the
Innovation Center with testing
innovative payment and service
delivery models that could reduce
program expenditures while preserving
and/or enhancing the quality of care
furnished to individuals under titles
XVIII, XIX, and XXI of the Act. The
Secretary is also required to conduct an
evaluation of each model tested.
Evaluations will typically include
quantitative and qualitative methods to
assess the impact of the model on
quality of care and health care
expenditures. To comply with the
statutory requirement to evaluate all
models conducted under section 1115A
of the Act, we will conduct rigorous
quantitative analyses of the impact of
the model test on health care
expenditures, as well as an assessment
of measures of the quality of care
furnished under the model test.
Evaluations will also include qualitative
analyses to capture the qualitative
differences between model participants,
and to form the context within which to
interpret the quantitative findings.
Through the qualitative analyses, we
will assess the experiences and
perceptions of model participants,
providers, and individuals affected by
the model.
In the evaluations we use advanced
statistical methods to measure
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67752
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
effectiveness. Our methods are intended
to provide results that meet a high
standard of evidence, even when
randomization is not feasible. To
successfully carry out evaluations of
Innovation Center models, we must be
able to determine specifically which
individuals are receiving services from
or are the subject of the intervention
being tested by the entity participating
in the model test. Identification of such
individuals is necessary for a variety of
purposes, including the construction of
control groups against which model
performance can be compared. In
addition, to determine whether the
observed impacts are due to the model
being tested and not due to differences
between the intervention and
comparison groups, our evaluations will
have to account for potential
confounding factors at the individual
level, which will require the ability to
identify every individual associated
with the model test, control or
comparison groups, and the details of
the intervention at the individual level.
Evaluations will need to consider
such factors as outcomes, clinical
quality, adverse effects, access,
utilization, patient and provider
satisfaction, sustainability, potential for
the model to be applied on a broader
scale, and total cost of care. Individuals
receiving services from or who are the
subjects of the intervention will be
compared to clinically, sociodemographically, and geographically
similar matched individuals along
various process, outcome, and patientreported measures. Research questions
in a typical evaluation will include, but
are not limited to, the following:
• Clinical Quality:
++ Did the model improve or have a
negative impact on clinical process
measures, such as adherence to
evidence-based guidelines? If so, how,
how much, and for which individuals?
++ Did the model improve or have a
negative impact on clinical outcome
measures, such as mortality rates, and
the incidence and prevalence of chronic
conditions? If so, how, how much, and
for which individuals?
++ Did the model improve or have a
negative impact on access to care? If so,
how, how much, and for which
individuals?
++ Did the model improve or have a
negative impact on care coordination
among providers? If so, how, how much,
and for which individuals?
++ Did the model improve or have a
negative impact on medication
management? If so, how, how much,
and for which individuals?
• Patient Experience:
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
++ Did the model improve or have a
negative impact on patient-provider
communication? If so, how, how much,
and for which individuals?
++ Did the model improve or have a
negative impact on patient experiences
of care, quality of life, or functional
status? If so, how, how much, and for
which individuals?
• Utilization/Expenditures:
++ Did the model result in decreased
utilization of emergency department
visits, hospitalizations, and
readmissions? If so how, how much,
and for which individuals?
++ Did the model result in increased
utilization of physician or pharmacy
services? If so how, how much, and for
which individuals?
++ Did the model result in decreased
total cost of care? Were changes in total
costs of care driven by changes in
utilization for specific types of settings
or health care services? What specific
aspects of the model led to these
changes? Were any savings due to
improper cost-shifting to the Medicaid
program?
To carry out this research we must
have access to patient records not
generally available to us. As such, we
proposed to exercise our authority in
section 1115A(b)(4)(B) of the Act to
establish requirements for states and
other entities participating in the testing
of past, present, and future models
under section 1115A of the Act to
collect and report information that we
have determined is necessary to monitor
and evaluate such models. Thus, we
proposed to require model participants,
and providers and suppliers working
under the models operated by such
participants, to produce such
individually identifiable health
information and such other information
as the Secretary identifies as being
necessary to conduct the statutorily
mandated research described above.
Such research will include the
monitoring and evaluation of such
models. Further, we view engagement
with other payers, both public and
private, as a critical driver of the success
of these models. CMS programs
constitute only a share of any provider’s
revenue. Therefore, efforts to improve
quality and reduce cost are more likely
to be successful if efforts are aligned
across payers. Section 1115A of the Act
specifically allows the Secretary of
Health and Human Services to consider,
in selecting which models to choose for
testing, ‘‘whether the model
demonstrates effective linkage with
other public sector or private sector
payers.’’ Multi-payer models, such as
but not limited to the Comprehensive
Primary Care model, will conduct
PO 00000
Frm 00206
Fmt 4701
Sfmt 4700
quality measurement across all patients
regardless of payer in order to maximize
alignment and increase efficiency.
Construction of multi-payer quality
measures requires the ability to identify
all individuals subject to the model test
regardless of payer. In addition, section
1115A also permits the Secretary to
consider models that allow states to test
and evaluate systems of all-payer
payment reform for the medical care of
residents of the state, including dual
eligible individuals. Under the State
Innovation Model (SIM), the Innovation
Center is testing the ability for state
governments to accelerate
transformation. The premise of the SIM
initiative is to support Governorsponsored, multi-payer models that are
focused on public and private sector
collaboration to transform the state’s
payment and delivery system. States
have policy and regulatory authorities,
as well as ongoing relationships with
private payers, health plans, and
providers that can accelerate delivery
system reform. SIM models must impact
the preponderance of care in the state
and are expected to work with public
and private payers to create multi-payer
alignment. The evaluation of SIM will
include all populations and payers
involved in the state initiative, which in
many cases includes private payers. The
absence of identifiable data from private
payers would result in considerable
limitations on the level of evaluation
conducted. Therefore, under this
authority, we also proposed to require
the submission of identifiable health
and utilization information for patients
of private payers treated by providers/
suppliers participating in the testing of
a model under section 1115A of the Act
when an explicit purpose of the model
test is to engage private sector payers.
This regulation will provide clear legal
authority for Health Insurance
Portability and Accountability Act
(HIPAA) Covered Entities to disclose
any required protected health
information. Identifiable data submitted
by entities participating in the testing of
models under section 1115A of the Act
will meet CMS Acceptable Risks
Safeguards (ARS) guidelines. When data
is expected to be exchanged over the
internet, such exchange will also meet
all E-Gov requirements. In accordance
with the requirements of the Privacy Act
of 1974, upon receipt by CMS or its
contractors, these data will be covered
under a CMS-established system of
records (System No. 09–70–0591),
which serves as the Master system for
all demonstrations, evaluations, and
research studies administered by the
Innovation Center. These data will be
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
stored until the evaluation is complete
and all necessary policy deliberations
have been finalized.
2. Provisions of the Proposed
Regulations
Wherever possible, evaluations will
make use of claims, assessment, and
enrollment data available through CMS’
existing administrative systems.
However, evaluations will generally also
need to include additional data not
available through existing CMS
administrative systems. As such,
depending on the particular project,
CMS or its contractor will require the
production of the minimum data
necessary to carry out the statutorily
mandated research work described in
section E.1. of this final rule with
comment period. Such data may include
the identities of the patients served
under the model, relevant clinical
details about the services furnished and
outcomes achieved, and any
confounding factors that might
influence the evaluation results
achieved through the delivery of such
services. For illustrative purposes,
below are examples of some of the types
of information that could be required to
carry out an evaluation, and for which
the evaluator would need patient-level
identifiers.
• Utilization data not otherwise
available through existing Centers for
Medicare & Medicaid Services (CMS)
systems.
• Beneficiary, patient, participant,
family, and provider experiences.
• Beneficiary, patient, participant,
and provider rosters with identifiers
that allow linkages across time and
datasets.
• Beneficiary, patient, participant,
and family socio-demographic and
ethnic characteristics.
• Care management details, such as
details regarding the provision of
services, payments or goods to
beneficiaries, patients, participants,
families, or other providers.
• Beneficiary, patient, and participant
functional status and assessment data.
• Beneficiary, patient, and participant
health behaviors.
• Clinical data, such as, but not
limited to lab values and information
from EHRs.
• Beneficiary, patient, participant
quality data not otherwise available
through claims.
• Other data relevant to identified
outcomes—for example, participant
employment status, participant
educational degrees pursued/achieved,
and income.
We invited public comment on this
proposal to mandate the production of
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
the individually identifiable
information necessary to conduct the
statutorily mandated research under
section 1115A of the Act.
In addition, we proposed a new
subpart K in part 403 to implement
section 1115A of the Act.
The following is a summary of the
comments we received regarding our
proposal to mandate the production of
the individually identifiable
information necessary to conduct the
statutorily mandated research under
section 1115A of the Act.
Comment: Commenters consistently
recognized the need to evaluate
Innovation Center models as an
important component of the effort to test
new payment and service delivery
models. Further, several commenters
supported the need for rigorous
evaluations that include control groups.
One commenter further recommended
the Innovation Center make the
aggregated de-identified data from
evaluations available to external
researchers. Although supportive of the
need to evaluate Innovation Center
models, several commenters stated the
Innovation Center had not sufficiently
justified the need for individually
identifiable patient information, and
suggested aggregate or de-identified data
should be sufficient. One commenter
suggested the submission of
performance rates, patient outcomes
information, and/or composite scores
for participating providers instead of
individual patient-level data. The
commenter further stated that CMS
should not have access to proprietary
patient-level data in registries. Some of
the commenters stated CMS should
publish its evaluation methodologies
and solicit feedback from independent
research experts as to the need for
patient-level data.
Response: We appreciate the
commenters’ support for rigorous
evaluations, and understand the desire
for access to the aggregate de-identified
data from these evaluations. We always
make our data available in accordance
with applicable law, HHS and CMS
policies, and, where relevant, the
availability of funding. Such laws
include HIPAA, the Privacy Act, the
Trade Secrets Act and the Freedom of
Information Act. With respect to
comments recommending the use of
aggregate or de-identified data instead of
individually identifiable data, as we
discussed in the preamble of the
proposed rule, we believe individually
identifiable data is necessary. As noted
in this final rule with comment and in
the preamble of our proposed rule,
evaluations will need to consider such
factors as outcomes, clinical quality,
PO 00000
Frm 00207
Fmt 4701
Sfmt 4700
67753
adverse effects, access, utilization,
patient and provider satisfaction,
sustainability, potential for the model to
be applied on a broader scale, and total
cost of care. Furthermore, individuals
receiving services from or who are the
subjects of the intervention will be
compared to clinically, sociodemographically, and geographically
similar matched individuals along
various process, outcome, and patientreported measures. Many of these
assessments will require person-level
data. We will make use of aggregate
information on system performance
through the use of provider submitted
aggregate performance rates for selected
measures, patient outcomes
information, and/or composite scores.
However, without the ability to identify
specifically which beneficiaries are
receiving services as a result of the
model, the evaluation analyses could
include individuals not even subject to
the intervention, and therefore, there
would be a very real possibility that
positive impacts of the model may be
diluted and unobservable. While
aggregate data could be limited to the
target population, identification of
which individuals are within the target
population of the model, are receiving
items and services under the model, or
are subject to the interventions being
tested under the model will also allow
the evaluators to construct matched
comparison groups that look as similar
as possible to the intervention group.
The absence of a well-matched
comparison group, which can only be
achieved when individually identifiable
characteristics are known, could result
in impact estimates that are inaccurate
because these impact estimates could be
due to differences between the
intervention group and the comparison
group and not the intervention itself.
Further, while we will need to know the
identifiers of beneficiaries that are the
subject of the model test, the submission
of other patient-level data from
proprietary registries would be limited
to data necessary to conduct a credible
evaluation. Data on individuals are also
needed to assess differential impacts
among subgroups of beneficiaries to
identify who benefits most from the
intervention. We agree it is important to
seek expert opinion on the structure of
our assessment methods, and so these
models are developed in concert with
and run through our evaluation
contractors, which are independent
research firms and academic
institutions. Where needed, these
contractors also reach out to technical
expert panels for added guidance. As a
result, the design and implementation of
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67754
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
these assessments are informed by those
with expertise in health services
research, economics, statistics, program
evaluation, epidemiology, and public
health.
Comment: Although generally
supportive of the need for rigorous
evaluations, some commenters worried
that any requirement to provide
individually identifiable data for
monitoring and/or assessment purposes
would impose an undue administrative
burden on model participants, and
could lead to the need to submit large
(and, potentially, overbroad) amounts of
individually identifiable patient-level
data. A few commenters suggested that
the Innovation Center should first look
to other federal government sources
before requesting data from model
participants. Several commenters noted
that it would be costly to produce
patient-level data for models with a
multi-payer focus, and others stated
additional payment should be made to
model participants to offset the cost of
data reporting. Further, it was suggested
that CMS estimate the potential burden
and cost on physicians and other
providers, and if found to be
burdensome, give physicians the right to
opt out of producing information that
may not be available due to cost
limitations or other administrative
barriers, such as barriers to producing
data stored in electronic health records.
Response: We agree that our
determination of what data are
necessary to evaluate a model should be
made taking into consideration the
burden and cost associated with
collecting and reporting such data,
including the complexities associated
with abstracting data from electronic
health records. We further agree that in
making such determinations, we should
take advantage of all existing federal
data systems, wherever possible so that
we may minimize the amount of data
that we must obtain from model
participants. Our regulation will only
require that model participants collect
and report data as is necessary for
monitoring or evaluation; thus, if we do
not need the data, we would not seek to
collect it from model participants.
Reimbursement may be considered for
future models, but if adopted, any such
reimbursement, and any conditions for
such reimbursement, would be
prominently noted in the solicitation or
modifications to model agreements. To
the extent feasible, we also agree that it
is important for potential model
participants to understand the data
collection requirements before the
model begins, so that they may take
these requirements into consideration.
We do not agree, though, that model
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
participants should be given the
opportunity to opt out of producing the
required information, as this would
undermine the evaluation and skew
results.
With respect to the specific data
needed for evaluation purposes, in
many models, the evaluators will be
able to determine who the individuals
are that are the subjects of the model
test without the need to obtain
identifiers from the model participants.
In those cases, there is a beneficiaryspecific payment under the model and
the evaluator can use our existing
administrative data systems to identify
which beneficiaries are in the model. In
this last example, although we may not
need to obtain the identifiers, we may
still need to obtain other person-level
data, such as clinical information. In
other models, where a specific
beneficiary-level payment is not being
made, the evaluation contractor will not
have an ability to identify the
individuals targeted by the model
participants. In this latter circumstance,
the participants will need to provide the
identifiers that would then be used by
the evaluator to link to existing
administrative data systems. Although
the exact data needs will vary by model,
in some cases we would determine that
only the identifiers (such as, but not
limited to, the Medicare Health
Insurance Claim number) are required.
In other circumstances, it is possible the
evaluators will need other data, such as
clinical data not otherwise available in
claims to properly account for severity
of disease. In this manner we will limit
data demands, and the attendant costs,
to the data necessary to accomplish the
required monitoring and assessment.
Comment: Some commenters stated
the requirement could result in requests
for data from providers tangentially
involved in an Innovation Center project
to report any data the agency decides it
needs. A few commenters further stated
the Innovation Center should ensure
that all participating entities seek
patient authorizations to use their
records for the purpose of evaluating the
model.
Response: Section 1115A(b)(4) of the
Act authorizes us to establish
requirements for ‘‘States and other
entities participating in the testing of
models’’ to collect and report data
necessary for monitoring and evaluating
the models. Our regulation, therefore,
establishes this requirement only with
respect to model participants. We
consider model participants to include
any party that has agreed to participate
in, or that receives payment from us
under, a model we are testing. In
response to the comment suggesting that
PO 00000
Frm 00208
Fmt 4701
Sfmt 4700
the Innovation Center ensure that all
participating entities seek patient
authorizations to use their records for
the purpose of evaluating the model, we
decline to impose such a requirement in
implementing section 1115A(b)(4) of the
Act, and we refer such entities to their
own legal counsel for advice on whether
any form of consent would be required
by other applicable law.
Comment: Some commenters stated
the Innovation Center should publish
and be transparent about what the exact
data reporting and collection
requirements would be so that
participants would have notice of what
data they would be required to collect.
Commenters stated that without a notice
and comment period as part of the
model test, there will be no opportunity
for stakeholders to weigh in with their
perspective of what constitutes the
minimum necessary information to
achieve the evaluation goals. A few
commenters stated the Innovation
Center should first determine the
specific data elements that are required
for evaluation purposes for the existing
programs and this information should
be shared with participants who should,
at minimum, be given an opportunity to
provide comment on the required inputs
for which they will be responsible as
part of the evaluation. These
commenters also stated the Innovation
Center should develop such
requirements in advance of the program
start for participants to allow them an
opportunity to provide feedback and
weigh the information as part of their
decision to participate in the model.
Response: We agree it is important to
restrict data requests to the data
necessary to conduct credible
monitoring and evaluation. We
frequently provide stakeholders the
opportunity to weigh in on what data
they believe would be necessary to
evaluate a model, generally through
webinars that we conduct during model
development and implementation.
Further, in order for potential model
participants to understand the likely
data reporting requirements, to the
extent feasible, these requirements are
incorporated into the solicitation
process. However, we decline to adopt
a requirement to undertake a notice and
comment process as part of our
determination of what data are
necessary for monitoring or evaluation
because we believe the process already
in place allows for model participant
feedback. We also disagree with
commenters who recommend that we
make the determination and specify the
particular data elements that will be
required for monitoring and evaluation
prior to the start of the model. It is not
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
always possible at that early stage of the
model to know precisely what data
elements will be necessary. However,
we will strive to provide as much
relevant detail as possible about data
collection and reporting requirements in
any solicitation process and in any
ongoing communications with potential
participants, and we will continue to
take any comments received into
account in determining our data needs.
Comment: A few commenters stated
that CMS has not provided sufficient
assurances that providers, in responding
to these data requests, would be
protected or deemed to be in
compliance with the HIPAA
requirements for the use and disclosure
of protected health information (PHI).
These commenters stated the Innovation
Center reference to requiring reporting
of individually identifiable patient-level
data raises significant privacy concerns
for providers who would be required to
report such data. These commenters
stated HIPAA requires that providers
limit the use and disclosure of personal
health information to the minimum
necessary to accomplish the intended
purpose of the disclosure. These
commenters stated the Innovation
Center requests for such data must be in
compliance with providers’ HIPAA
obligations. As such, some commenters
stated CMS should work with the Office
for Civil Rights (OCR) to ensure
providers reporting data as part of an
evaluation are doing so consistent with
their HIPAA obligations. These
commenters stated it is HHS’s Office for
Civil Rights (OCR)—not CMS—that
ultimately determines whether a
particular provider is properly
compliant and not subject to penalties.
These same commenters suggested that
the Innovation Center should work with
OCR to issue OCR guidance stating that
providers reporting data as part of an
evaluation are doing so consistent with
their HIPAA obligations. Some
commenters stated CMS should
consider the necessary data elements on
a program-by-program basis rather than
establishing a blanket approval, or at
minimum limit the scope of the
approved data requirements and uses,
and should provide clear instructions
and other educational resources to
ensure that collection and reporting of
the data complies with the HIPAA
Privacy and Security rules.
Response: We appreciate the concerns
expressed about compliance with the
HIPAA requirements and the
recommendation to work with OCR.
However, we respectfully disagree that
sufficient assurances have not been
provided. The disclosure would be
required by a regulation, so it would be
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
‘‘required by law’’ under HIPAA. See 45
CFR 164.512(a) and the definition of
‘‘required by law’’ at 45 CFR 164.103. A
HIPAA covered entity is permitted to
disclose protected health information as
required by law under these provisions
so long as the disclosure complies with
and is limited to the relevant
requirements of the law. A separate
minimum data necessary determination
is not required under the HIPAA
Privacy Rule for required by law
disclosures under 45 CFR 164.512(a).
See 45 CFR 164.502(b)(2). Although a
separate minimum data necessary
determination is not required, as a
policy matter and consistent with the
statutory authority under 1115A(b)(4),
CMS will only require that data we
determine is necessary for evaluation
and monitoring of Innovation Center
models.
Comment: Several commenters stated
that collection of beneficiary-level
health information raises significant
security concerns. Although supportive
of sharing relevant and medically
necessary patient information, one
commenter raised a particular concern
that some data could be sensitive
information related to mental health or
substance abuse. Some commenters
stated CMS should adopt safeguards
against inappropriate use or disclosure
of patient identifiable data.
Response: We agree that it is critical
to abide by rigorous security standards,
and we take patient privacy seriously.
As CMMI is part of Fee-for-Service
Medicare, a Health Care Component that
is subject to the HIPAA requirements,
providers’ and suppliers’ data will
generally be subject to the same HIPAA
privacy and security requirements as
that data was subject to in the hands of
the providers and suppliers from which
it came. Furthermore, if stored in a
manner searchable by individual
identifiers, it will also be subject to the
Privacy Act of 1974.
As HIPAA Business Associates, this
data will be equally well protected
when held by one of our evaluation
contractors. In addition, the disclosure
of substance abuse records will, where
applicable, also be subject to the Part 2
regulations.
Comment: One commenter stated
CMS should not use these data for
purposes other than those articulated in
the proposed rule, and that the
assessments should comply with the
applicable statutory requirements,
meaning that: (1) The assessments
should take into account all of the
factors outlined under section
1115A(b)(4) of the Act (that is, quality
of care, including patient-level
outcomes and patient-centeredness
PO 00000
Frm 00209
Fmt 4701
Sfmt 4700
67755
criteria); (2) the assessments should be
made publicly available; and (3) CMS
should pursue notice-and-comment
rulemaking before any of the CMS
demonstrations are expanded based on
these assessments, as required by
section 1115A(c) of the Act.
Response: We agree that evaluations
should assess quality of care, and the
patient-de-identified results should be
made publicly available, as required by
section 1115A(b)(4) of the Act. We
would pursue model expansion
according to the terms of the statute.
After consideration of the public
comments we received, we are
finalizing our proposal to mandate the
production of the individually
identifiable information necessary to
conduct the statutorily mandated
research under section 1115A of the
Act. We are accepting the
recommendations made by commenters
to minimize participant burden, seek
input from providers, and use
independent researchers. In addition,
we are finalizing our proposal to add a
new subpart K in part 403 to implement
section 1115A of the Act without
modification.
F. Local Coverage Determination
Process for Clinical Diagnostic
Laboratory Testing
The CY 2015 proposed rule (79 FR
40378 through 40380), section III.F.,
included discussion of a proposal to
modify the existing process used by the
Medicare Administrative Contractors
(MACs) in developing local coverage
determinations (LCDs) for clinical
diagnostic laboratory tests. Briefly, the
proposal would have expedited the
timeline for LCD development for
clinical diagnostic laboratory test LCDs
by reducing the calendar days for some
of the steps and by making optional or
eliminating other steps within the
current process. A detailed discussion
of the proposal is available in section
III.F. of the CY 2015 PFS Proposed Rule.
We would like to thank the numerous
public commenters for their time in
submitting thoughtful comments to the
agency on this issue. Comments were
received from individual members of
the public, insurers, drug
manufacturers, medical specialty
societies, laboratory groups and
individual laboratories. The
commenters focused their comments on
the following issues: The proposal to
reduce the draft LCD public comment
period to 30 days; the proposal for a
meeting of the Carrier Advisory
Committee to be optional; the proposal
to remove the requirement for a public
meeting; and the proposal to eliminate
the 45-day notice period prior to final
E:\FR\FM\13NOR2.SGM
13NOR2
67756
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
LCDs becoming effective. In addition,
commenters were concerned about the
proposed changes in light of section 216
of the Protecting Access to Medicare Act
of 2014 (PAMA), titled ‘‘Improving
Medicare Policies for Clinical
Diagnostic Laboratory Tests.’’ The
comments received have given the
agency much to consider prior to
moving forward with any changes to the
LCD process; therefore, we will not
finalize any changes to the LCD process
in this final rule. We will explore the
possibility of future notice-andcomment rulemaking on this issue.
G. Private Contracting/Opt-Out
ebenthall on DSK5SPTVN1PROD with $$_JOB
1. Background
Effective January 1, 1998, section
1802(b) of the Act permits certain
physicians and practitioners to opt-out
of Medicare if certain conditions are
met, and to furnish through private
contracts services that would otherwise
be covered by Medicare. For those
physicians and practitioners who optout of Medicare in accordance with
section 1802(b) of the Act, the
mandatory claims submission and
limiting charge rules of section 1848(g)
of the Act would not apply. As a result,
if the conditions necessary for an
effective opt-out are met, physicians and
practitioners are permitted to privately
contract with Medicare beneficiaries
and to charge them without regard to
Medicare’s limiting charge rules.
Regulations governing the requirements
and procedures for private contracts
appear at 42 CFR part 405, subpart D.
a. Opt-Out Determinations (§ 405.450)
The private contracting regulation at
§ 405.450 describes certain opt-out
determinations made by Medicare, and
the process that physicians,
practitioners, and beneficiaries may use
to appeal those determinations. Section
405.450(a) describes the process
available for physicians or practitioners
to appeal Medicare enrollment
determinations related to opting out of
the program, and § 405.450(b) describes
the process available to challenge
payment determinations related to
claims for services furnished by
physicians who have opted out. Both
provisions refer to § 405.803, the Part B
claims appeals process that was in place
at the time the opt-out regulations were
issued (November 2, 1998). When those
regulations were issued, a process for a
physician or practitioner to appeal
enrollment related decisions had not
been implemented in regulation. Thus,
to ensure an appeals process was
available to physicians and practitioners
for opt-out related issues, we chose to
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
utilize the existing claims appeals
process in § 405.803 for both enrollment
and claims related appeals.
In May 16, 2012 Federal Register (77
FR 29002), we published a final rule
entitled ‘‘Medicare and Medicaid
Program; Regulatory Provisions to
Promote Program Efficiency,
Transparency and Burden Reduction.’’
In that final rule, we deleted the
provisions relating to initial
determinations, appeals, and reopenings
of Medicare Part A and Part B claims,
and relating to determinations and
appeals regarding an individual’s
entitlement to benefits under Medicare
Part A and Part B, which were
contained in part 405, subparts G and H
(including § 405.803) because these
provisions were obsolete and had been
replaced by the regulations at part 405,
subpart I. We inadvertently neglected to
revise the cross-reference in § 405.450(a)
and (b) of the private contracting
regulations to direct appeals of opt-out
determinations through the current
appeal process. However, it is important
to note that our policy regarding the
appeal of opt-out determinations did not
change when the appeal regulations at
part 405, subpart I were finalized.
The procedures set forth in current
part 498 establish the appeals
procedures regarding decisions made by
Medicare that affect enrollment in the
program. We believe this process, and
not the appeal process in part 405,
subpart I, is the appropriate channel for
physicians and practitioners to
challenge an enrollment related opt-out
decision made by Medicare. There are
now two different sets of appeal
regulations for initial determinations;
and the appeal of enrollment related
opt-out determinations is more like the
types of determinations now addressed
under part 498 than those under part
405, subpart I. Specifically, the appeal
process under part 405, subpart I
focuses on reviews of determinations
regarding beneficiary entitlement to
Medicare and claims for benefits for
particular services. The appeal process
under part 498 is focused on the review
of determinations regarding the
participation or enrollment status of
providers and suppliers. Enrollment
related opt-out determinations involve
only the status of particular physician or
practitioners under Medicare, and do
not involve beneficiary eligibility or
claims for specific services. As such, the
appeal process under part 498 is better
suited for the review of enrollment
related opt-out determinations.
However, we do not believe the
enrollment appeals process established
in part 498 is the appropriate
mechanism for challenging payment
PO 00000
Frm 00210
Fmt 4701
Sfmt 4700
decisions on claims for services
furnished by a physician and
practitioner who has opted out of the
program. Appeals for such claims
should continue to follow the appeals
procedures now set forth in part 405
subpart I.
b. Definitions, Requirements of the Opt
Out Affidavit, Effects of Opting Out of
Medicare, Application to Medicare
Advantage Contracts (§§ 405.400,
405.420(e), 405.425(a), and 405.455)
Section 405.400 sets forth certain
definitions for purposes of the private
contracting regulations. Among the
defined terms is ‘‘Emergency care
services’’ which means services
furnished to an individual for treatment
of an ‘‘emergency medical condition’’ as
that term is defined in § 422.2. The
cross-referenced regulation at § 422.2
included within the definition of
emergency care services was deleted on
June 29, 2000 (65 FR 40314) and at that
time we inadvertently neglected to
revise that cross-reference. The crossreference within the definition of
emergency care services should have
been amended at that time to cite the
definition of ‘‘emergency services’’ in
§ 424.101.
The private contracting regulations at
§ 405.420(e), § 405.425(a) and § 405.455
all use the term Medicare+Choice when
referring to Part C plans. However, we
no longer use the term Medicare+Choice
when referring to Part C plans; instead
the plans are referred to as Medicare
Advantage plans. When part 422 of the
regulations was updated on January 28,
2005 (70 FR 4741), we inadvertently
neglected to revise § 405.420(e),
§ 405.425(a) and § 405.455 to replace the
term Medicare+Choice with Medicare
Advantage plan.
2. Provisions of the Proposed Regulation
For the reasons discussed above, we
proposed that a determination described
in § 405.450(a) (relating to the status of
opt-out or private contracts) is an initial
determination for purposes of § 498.3(b),
and a physician or practitioner who is
dissatisfied with a Medicare
determination under § 405.450(a) may
utilize the enrollment appeals process
currently available for providers and
suppliers in part 498. In addition, we
proposed that a determination described
in § 405.450(b) (that payment cannot be
made to a beneficiary for services
furnished by a physician or practitioner
who has opted out) is an initial
determination for the purposes of
§ 405.924 and may be challenged
through the existing claims appeals
procedures in part 405 subpart I.
Accordingly, we proposed that the cross
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
reference to § 405.803 in § 405.450(a) be
replaced with a cross reference to
§ 498.3(b). We also proposed that the
cross reference to § 405.803 in
§ 405.450(b) be replaced with a cross
reference to § 405.924. We also
proposed corresponding edits to
§ 498.3(b) and § 405.924 to note that the
determinations under § 405.450(a) and
(b), respectively, are initial
determinations.
For the reasons discussed above, we
also proposed that the definition of
Emergency care services at § 405.400 be
revised to cite the definition of
Emergency services in § 424.101 and
that all references to Medicare+Choice
in § 405.420(e), § 405.425(a) and
§ 405.455 be replaced with the term
‘‘Medicare Advantage.’’
The following is a summary of the
comments we received regarding our
proposals.
Comment: Commenters requested that
physicians and practitioners be allowed
to opt out of Medicare indefinitely
instead of submitting a new affidavit
every 2 years.
Response: These comments are
outside the scope of this rule as they are
not related to the proposed changes to
the opt-out regulations. Nevertheless,
we note that section 1802(b)(3)(B)(ii) of
the Act specifies that the opt-out
affidavit must provide that the
‘‘physician or practitioner will not
submit any claim under this title for any
item or service provided to any
medicare beneficiary. . . during the 2year period beginning on the date the
affidavit is signed.’’ As such, the longest
interval for which an opt-out can be
effective is 2 years. We have no
authority to modify that statutory
requirement.
Because we did not receive any
comments on our proposals, we are
finalizing the rule as proposed.
H. Solicitation of Comments on the
Payment Policy for Substitute Physician
Billing Arrangements
ebenthall on DSK5SPTVN1PROD with $$_JOB
1. Background
In accordance with section 1842(b)(6)
of the Act, no payment under Medicare
Part B may be made to anyone other
than to the beneficiary to whom a
service was furnished or to the
physician or other person who
furnished the service. However, there
are certain limited exceptions to this
general prohibition. For example,
section 1842(b)(6)(D) of the Act
describes an exception for substitute
physician billing arrangements, which
states that ‘‘payment may be made to a
physician for physicians’ services (and
services furnished incident to such
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
services) furnished by a second
physician to patients of the first
physician if (i) the first physician is
unavailable to provide the services; (ii)
the services are furnished pursuant to
an arrangement between the two
physicians that (I) is informal and
reciprocal, or (II) involves per diem or
other fee-for-time compensation for
such services; (iii) the services are not
provided by the second physician over
a continuous period of more than 60
days or are provided over a longer
continuous period during all of which
the first physician has been called or
ordered to active duty as a member of
a reserve component of the Armed
Forces; and (iv) the claim form
submitted to the [Medicare
Administrative contractor (MAC)] for
such services includes the second
physician’s unique identifier . . . and
indicates that the claim meets the
requirements of this subparagraph for
payment to the first physician.’’ Section
1842(b)(6) of the Act is selfimplementing and we have not
interpreted the statutory provisions
through regulations.
In practice, section 1842(b)(6)(D) of
the Act generally allows for two types
of substitute physician billing
arrangements: (1) An informal
reciprocal arrangement where doctor A
substitutes for doctor B on an occasional
basis and doctor B substitutes for doctor
A on an occasional basis; and (2) an
arrangement where the services of the
substitute physician are paid for on a
per diem basis or according to the
amount of time worked. Substitute
physicians in the second type of
arrangement are sometimes referred to
as ‘‘locum tenens’’ physicians. It is our
understanding that locum tenens
physicians are substitute physicians
who often do not have a practice of their
own, are geographically mobile, and
work on an as-needed basis as
independent contractors. They are
utilized by physician practices,
hospitals, and health care entities
enrolled in Part B as Medicare suppliers
to cover for physicians who are absent
for reasons such as illness, pregnancy,
vacation, or continuing medical
education. Also, we have heard
anecdotally that locum tenens
physicians are used to fill staffing needs
(for example, in physician shortage
areas) or, on a temporary basis, to
replace physicians who have
permanently left a medical group or
employer.
We are concerned about the
operational and program integrity issues
that result from the use of substitute
physicians to fill staffing needs or to
replace a physician who has
PO 00000
Frm 00211
Fmt 4701
Sfmt 4700
67757
permanently left a medical group or
employer. For example, although our
Medicare enrollment rules require
physicians and physician groups or
organizations to notify us promptly of
any enrollment changes (including
reassignment changes) (see
§ 424.516(d)), processing delays or
miscommunication between the
departing physician and his or her
former medical group or employer
regarding which party would report the
change to Medicare could result in the
Provider Transaction Access Number
(PTAN) that links the departed
physician and his or her former medical
group remaining ‘‘open’’ or ‘‘attached’’
for a period of time. During such period,
both the departed physician and the
departed physician’s former medical
group might bill Medicare under the
departed physician’s National Provider
Identifier (NPI) for furnished services.
This could occur where a substitute
physician is furnishing services in place
of the departed physician in the
departed physician’s former medical
group, while the departed physician is
also furnishing services to beneficiaries
following departure from the former
group. Operationally, either or both
types of claims could be rejected or
denied, even though the claims filed by
the departed physician were billed
appropriately. Moreover, the continued
use of a departed physician’s NPI to bill
for services furnished to beneficiaries by
a substitute physician raises program
integrity issues, particularly if the
departed physician is unaware of his or
her former medical group or employer’s
actions.
Finally, as noted above, section
1842(b)(6)(D)(iv) of the Act requires that
the claim form submitted to the MAC
include the substitute physician’s
unique identifier. Currently, the unique
identifier used to identify a physician is
the physician’s NPI. Prior to the
implementation of the NPI, the Unique
Physician Identification Number (UPIN)
was used. Because a substitute
physician’s NPI is not captured on the
CMS–1500 claim form or on the
appropriate electronic claim, physicians
and other entities that furnish services
to beneficiaries through the use of a
substitute physician are required to
enter a modifier on the CMS–1500 claim
form or on the appropriate electronic
claim indicating that the services were
furnished by a substitute physician; and
to keep a record of each service
provided by the substitute physician,
associated with the substitute
physician’s UPIN or NPI; and to make
this record available to the MAC upon
request. (See Medicare Claims
E:\FR\FM\13NOR2.SGM
13NOR2
67758
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
Processing Manual (Pub. 100–4),
Chapter 1, Sections 30.2.10 and 30.2.11)
However, having a NPI or UPIN does
not necessarily mean that the substitute
physician is enrolled in the Medicare
program. Without being enrolled in
Medicare, we do not know whether the
substitute physician has the proper
credentials to furnish the services being
billed under section 1842(b)(6)(D) of the
Act or if the substitute physician is
sanctioned or excluded from Medicare.
The importance of enrollment and the
resulting transparency afforded the
Medicare program and its beneficiaries
was recognized by the Congress when it
included in the Affordable Care Act a
requirement that physicians and other
eligible non-physician practitioners
(NPPs) enroll in the Medicare program
if they wish to order or refer certain
items or services for Medicare
beneficiaries. This includes those
physicians and other eligible NPPs who
do not and will not submit claims to a
Medicare contractor for the services
they furnish. We solicited comments
regarding how to achieve similar
transparency in the context of substitute
physician billing arrangements for the
identity of the individual actually
furnishing the service to a beneficiary.
2. Analysis of Comments
ebenthall on DSK5SPTVN1PROD with $$_JOB
To help inform our decision whether
and, if so, how to address the issues
discussed in section III.H.1., and
whether to adopt regulations
interpreting section 1842(b)(6)(D) of the
Act, we solicited comments on the
policy for substitute physician billing
arrangements. We noted that any
regulations would be proposed in a
future rulemaking with opportunity for
public comment. Through this
solicitation, we hoped to understand
better current industry practices for the
use of substitute physicians and the
impact that policy changes limiting the
use of substitute physicians might have
on beneficiary access to physician
services.
We received a few comments on the
issues raised in this solicitation. We
thank the commenters for their input,
and we will carefully consider their
comments in any future rulemaking on
this subject.
I. Reports of Payments or Other
Transfers of Value to Covered
Recipients
1. Background
In the February 8, 2013 Federal
Register (78 FR 9458), we published the
‘‘Transparency Reports and Reporting of
Physician Ownership or Investment
Interests’’ final rule which implemented
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
section 1128G of the Social Security Act
(‘‘Act’’), as added by section 6002 of the
Affordable Care Act. Under section
1128G(a)(1) of the Act, manufacturers of
covered drugs, devices, biologicals, and
medical supplies (applicable
manufacturers) are required to submit
on an annual basis information about
certain payments or other transfers of
value made to physicians and teaching
hospitals (collectively called covered
recipients) during the course of the
preceding calendar year. Section
1128G(a)(2) of the Act requires
applicable manufacturers and
applicable group purchasing
organizations (GPOs) to disclose any
ownership or investment interests in
such entities held by physicians or their
immediate family members, as well as
information on any payments or other
transfers of value provided to such
physician owners or investors. The
implementing regulations are at 42 CFR
part 402, subpart A, and part 403,
subpart I. We have organized these
reporting requirements under the ‘‘Open
Payments’’ program.
The Open Payments program creates
transparency around the nature and
extent of relationships that exist
between drug, device, biologicals and
medical supply manufacturers, and
physicians and teaching hospitals
(covered recipients and physician
owner or investors). The implementing
regulations, which describe procedures
for applicable manufacturers and
applicable GPOs to submit electronic
reports detailing payments or other
transfers of value and ownership or
investment interests provided to
covered recipients and physician
owners or investors, are codified at
§ 403.908.
Since the publication and
implementation of the February 8, 2013
final rule, various stakeholders have
provided feedback to CMS regarding
certain aspects of these reporting
requirements. Specifically,
§ 403.904(g)(1) excludes the reporting of
payments associated with certain
continuing education events, and
§ 403.904(c)(8) requires reporting of the
marketed name for drugs and biologicals
but makes reporting the marketed name
of devices or medical supplies optional.
We proposed a change to § 403.904(g) to
correct an unintended consequence of
the current regulatory text.
Additionally, at § 403.904(c)(8), we
proposed to make the reporting
requirements consistent by requiring the
reporting of the marketed name for
drugs, devices, biologicals, or medical
supplies which are associated with a
payment or other transfer of value.
PO 00000
Frm 00212
Fmt 4701
Sfmt 4700
Additionally, at § 403.902, we
proposed to remove the definition of a
‘‘covered device’’ because we believe it
is duplicative of the definition of
‘‘covered drug, device, biological or
medical supply’’ which is codified in
the same section. We also proposed to
require the reporting of the following
distinct forms of payment: stock; stock
option; or any other ownership interests
specified in § 403.904(d)(3) to collect
more specific data regarding the forms
of payment.
2. Continuing Education Exclusion
(§ 403.904(g)(1))
In the February 8, 2013 final rule,
many commenters recommended that
accredited or certified continuing
education payments to speakers should
not be reported because there are
safeguards already in place, and they are
not direct payments to a covered
recipient. In the final rule preamble, we
noted that ‘‘industry support for
accredited or certified continuing
education is a unique relationship’’ (78
FR 9492). Section 403.904(g)(1) states
that payments or other transfers of value
provided as compensation for speaking
at a continuing education program need
not be reported if the following three
conditions are met:
• The event at which the covered
recipient is speaking must meet the
accreditation or certification
requirements and standards for
continuing education for one of the
following organizations: the
Accreditation Council for Continuing
Medical Education (ACCME); the
American Academy of Family
Physicians (AAFP); the American
Dental Association’s Continuing
Education Recognition Program (ADA
CERP); the American Medical
Association (AMA); or the American
Osteopathic Association (AOA).
• The applicable manufacturer does
not pay the covered recipient speaker
directly.
• The applicable manufacturer does
not select the covered recipient speaker
or provide the third party (such as a
continuing education vendor) with a
distinct, identifiable set of individuals
to be considered as speakers for the
continuing education program.
Since the implementation of
§ 403.904(g)(1), other accrediting
organizations have requested that
payments made to speakers at their
events also be exempted from reporting.
These organizations have stated that
they follow the same accreditation
standards as the organizations specified
in § 403.904(g)(1)(i). Other stakeholders
have recommended that the exemption
be removed in its entirety stating
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
removal of the exclusion will allow for
consistent reporting for compensation
provided to physician speakers at all
continuing education events, as well as
transparency regarding compensation
paid to physician speakers. Many
stakeholders raised concerns that the
reporting requirements are inconsistent
because certain continuing education
payments are reportable, while others
are not. CMS’ apparent endorsement or
support to organizations sponsoring
continuing education events was an
unintended consequence of the final
rule.
After consideration of these
comments, we proposed to remove the
language in § 403.904(g) in its entirety,
in part because it is redundant with the
exclusion in § 403.904(i)(1). That
provision excludes indirect payments or
other transfers of value where the
applicable manufacturer is ‘‘unaware’’
of, that is, ‘‘does not know,’’ the identity
of the covered recipient during the
reporting year or by the end of the
second quarter of the following
reporting year. When an applicable
manufacturer or applicable GPO
provides funding to a continuing
education provider, but does not either
select or pay the covered recipient
speaker directly, or provide the
continuing education provider with a
distinct, identifiable set of covered
recipients to be considered as speakers
for the continuing education program,
CMS will consider those payments to be
excluded from reporting under
§ 403.904(i)(1). This approach is
consistent with our discussion in the
preamble to the final rule, in which we
explained that if an applicable
manufacturer conveys ‘‘full discretion’’
to the continuing education provider,
those payments are outside the scope of
the rule (78 FR 9492). In contrast, for
example, when an applicable
manufacturer conditions its financial
sponsorship of a continuing education
event on the participation of particular
covered recipients, or pays a covered
recipient directly for speaking at such
an event, those payments are subject to
disclosure.
We considered two alternative
approaches to address this issue. First,
we explored expanding the list of
organizations in § 403.904(g)(1)(i) by
name; however, we believe that this
approach might imply CMS’s
endorsement of the named continuing
education providers over others.
Second, we considered expansion of the
organizations in § 403.904(g)(1)(i) by
articulating accreditation or certification
standards that would allow a CME
program to qualify for the exclusion.
This approach is not easily
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
implemented because it would require
evaluating both the language of the
standards, as well as the enforcement of
the standards of any organization
professing to meet the criteria. We
solicited comments on both alternatives
presented, including commenters’
suggestions about what standards, if
any, CMS should incorporate.
The following is summary of the
comments we received regarding both
alternatives presented, and what
standards, if any, CMS should
incorporate.
Comment: We received numerous
comments addressing our proposal to
remove the exclusion for compensation
for speaking at a continuing education
program. Some comments were in
support to remove the exclusion stating
it is an important step toward ensuring
transparency. Supporting comments
also agreed removing the exclusion will
level the playing field with the medical
education community. Numerous
commenters questioned our proposal to
remove the exclusion for compensation
for speaking at a continuing education
program. Commenters provided
background regarding accrediting
continuing education organizations
stating that creating continuing
education accreditation standards is a
function of professional self-regulation
and additional government regulation is
not necessary.
Many commenters recommend
modifying the indirect payment
exclusion currently at § 403.904(i)(1) to
specify a continuing education indirect
payment should be excluded if the
manufacturer did not know the identity
of the covered recipient before
providing the payment to a third party,
such as a continuing education
organization. This differs from the
current indirect payment exclusion
language which states the payment is
excluded if the manufacturer did not
know the identity of the covered
recipient during the reporting year or by
the end of the second quarter of the
following reporting year. Commenters
stated it is not practical for a
manufacturer to not know the identity
of a physician speaker receiving
compensation for speaking at a
continuing education event during the
reporting year or by the end of the
second quarter of the following
reporting year because manufacturers
could learn the identities of physician
speakers through brochures, programs
and other publications. Therefore,
commenters assert that the indirect
payment exclusion is not applicable to
exclude compensation provided to
physicians at a continuing education
event and recommend the indirect
PO 00000
Frm 00213
Fmt 4701
Sfmt 4700
67759
payment exclusion is modified to
accommodate indirect payments
provided to a physician covered
recipient through a continuing medical
education organization.
Additionally, commenters suggested
an alternative approach where CMS
would adopt established criteria, such
as the Standards for Commercial
Support: Standards to Ensure
Independence in CME Activities, in
order to have payments provided to
physicians at continuing education
events excluded. Similar criteria
suggested by commenters to modify the
exclusion were: does not pay covered
speakers or attendees directly, does not
select covered recipient speakers or
provide a third party with a distinct,
identifiable set of individuals to be
considered as speakers or attendees for
the continuing education program, and
does not control the continuing
education program content.
Response: We appreciate commenters
support to remove the exclusion for
compensation for speaking at a
continuing education program. We
appreciate the comments stating that
continuing medical education
accrediting organizations is a function
of professional self-regulation. We
believe creating consistent reporting
requirements for all continuing
education events, by removing the
language in § 403.904(g) in its entirety,
will provide enhanced regulatory clarity
for stakeholders. Manufacturers
reporting compensation paid to
physician speakers may opt to
distinguish if the payment was provided
at an accredited or certified continuing
education program versus an
unaccredited or non-certified
continuing education program by
selecting the appropriate nature of
payment category at § 403.904(e).
We understand commenters concern
regarding learning the identity of the
physician during the reporting year or
by the end of the second quarter of the
following reporting year. In the situation
of an applicable manufacturer providing
an indirect payment through a
continuing education organization and
learning the identity of the physician
covered recipient in the allotted
timeframe (during the reporting year or
by the end of the second quarter of the
following reporting year) the indirect
payment would not meet the criteria of
the indirect payment exclusion and
would need to be reported. However,
payments or other transfers of value,
including payments made to physician
covered recipients for purposes of
attending or speaking at continuing
education events, which do not meet the
definition of an indirect payment, as
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67760
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
defined at § 403.902, are not reportable.
For example, if an applicable
manufacturer or applicable GPO
provides funding to support a
continuing education event but does not
require, instruct, direct, or otherwise
cause the continuing education event
provider to provide the payment or
other transfer or value in whole or in
part to a covered recipient, the
applicable manufacturer or applicable
GPO is not required to report the
payment or other transfer of value. The
payment is not reportable regardless if
the applicable manufacturer or
applicable GPO learns the identity of
the covered recipient during the
reporting year or by the end of the
second quarter of the following
reporting year because the payment or
other transfer of value did not meet the
definition of an indirect payment. This
approach is also consistent with our
statement at (78 FR 9490), where we
explained that ‘‘if an applicable
manufacturer provided an unrestricted
donation to a physician professional
organization to use at the organization’s
discretion, and the organization chose to
use the donation to make grants to
physicians, those grants would not
constitute ‘indirect payments’ because
the applicable manufacturer did not
require, instruct, or direct the
organization to use the donation for
grants to physicians.’’ Therefore,
because such payments are not indirect
payments, we do not need to create an
additional exclusion specific to
continuing education indirect payments
by modifying the indirect payment
exclusion at § 403.904(i)(1).
Comment: Many commenters
interpreted the removal of physician
speaker compensation at continuing
education events would also remove the
reporting exclusion for attendees at
accredited or certified continuing
education events whose fees have been
subsidized through the continuing
medical education organization by an
applicable manufacturers.
Response: We did not intend to
remove the exclusion regarding
subsidized fees provided to physician
attendees by manufacturers at
continuing education events. However,
we intend for physician speaker
compensation and physician attendees
fees which have been subsidized
through the continuing medical
education organization by an applicable
manufacturer to be reported unless the
payment meets the indirect payment
exclusion at § 403.904(i)(1). This allows
for consistent reporting for physician
attendees and speakers at continuing
education events. We will provide subregulatory guidance specifying tuition
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
fees provided to physician attendees
that have been generally subsidized at
continuing education events by
manufacturers are not expected to be
reported. However, if a manufacturer
does instruct, direct, or otherwise cause
the subsidized tuition fee for a
continuing education event to go to a
specific physician attendee, the
payment will not be excluded, since the
indirect payment exclusion only applies
if the manufacturer did not know the
identity of the physician attendee.
Comment: Many commenters
interpreted the proposed removal
of§ 403.904(g) to expand the exclusion
to account for continuing education
programs accredited or certified for
nurses, optometrists, pharmacists, and
others.
Response: We appreciate the
comments, but the removal
of§ 403.904(g) was not intended to
expand the exclusion. The intent is to
allow for consistent reporting for
compensation provided to physician
speakers at all continuing education
events, as well as transparency
regarding compensation paid to
physician speakers.
Comment: A few commenters
requested CMS provide clear and
realistic timeframes regarding payments
related to continuing education events
to allow manufacturers to provide
sponsor notice as it considers proposals
to eliminate the current CME exclusion.
Response: We agree with commenters
that manufacturers may need additional
time to comply with reporting
requirements; therefore, we are
finalizing data collection requirements
that would begin January 1, 2016
according to this final rule for
applicable manufacturers.
3. Reporting of Marketed Name
(§ 403.904(c)(8))
Section 1128G(a)(1)(A)(vii) of the Act
requires applicable manufacturers to
report the name of the covered drug,
device, biological or medical supply
associated with that payment, if the
payment is related to ‘‘marketing,
education, or research’’ of a particular
covered drug, device, biological, or
medical supply. Section 403.904(c)(8)(i)
requires applicable manufacturers to
report the marketed name for each drug
or biological related to a payment or
other transfer of value. At
§ 403.904(c)(8)(ii), we require an
applicable manufacturer of devices or
medical supplies to report one of the
following: the marketed name; product
category; or therapeutic area. In the
February 8, 2013, final rule, we
provided applicable manufactures with
flexibility when it was determined that
PO 00000
Frm 00214
Fmt 4701
Sfmt 4700
the marketed name for all devices and
medical supplies may not be useful for
the general audience. We did not define
product categories or therapeutic areas
in § 403.904(c). However, since
implementation of the February 8, 2013
final rule and the development of the
Open Payments system, we have
determined that aligning the reporting
requirements for marketed name across
drugs, biologics, devices and medical
supplies will make the data fields
consistent within the system, and also
enhance consumer’s use of the data.
Accordingly, we proposed to revise
§ 403.904(c)(8) to require applicable
manufacturers to report the marketed
name for all covered drugs, devices,
biologicals or medical supplies. We
believe this would facilitate consistent
reporting for the consumers and
researchers using the data displayed
publicly on the Open Payments.
Manufacturers would still have the
option to report product category or
therapeutic area, in addition to
reporting the market name, for devices
and medical supplies.
Comment: We received a few
comments regarding revising reporting
requirements at § 403.904(c)(8). These
comments mainly stated that the
marketed name for a device or medical
supply is not useful for the public
because the public is not familiar with
device or medical supply marketed
names. We also received a few
comments that supported requiring the
reporting of marketed name for devices
and medical supplies. Supporting
commenters believe that reporting
marketed name for all products will
allow the public (including researchers
and consumers) to search the data via
the Open Payments public Web site for
a specific device or medical supply.
Commenters also stated that reporting
marketed name for non-covered
products is not required by the statute
and therefore manufacturers should not
be required to report marketed names
for non-covered products. Additionally,
some comments indicated reporting
marketed name for devices and medical
supplies for research payments is not
practical because there is not a marketed
name for every device or medical
supply associated with research
payments; rather there may only be a
connection to an associated research
study. A few commenters addressed that
manufacturers will have an increased
burden to modify reporting systems to
accommodate reporting marketed name
for devices and medical supplies.
Response: We appreciate the
comments supporting our proposed
revisions requiring reporting marketed
name for devices and medical supplies.
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
We have finalized a modified approach
to accommodate concerns regarding
reporting related covered drug, device,
biological or medical supply
information. We agree manufacturers
should not be required to report
marketed names for non-covered
products; therefore, we are finalizing the
proposal that reporting marketed names
for non-covered drugs, devices,
biologicals, or medical supplies will
continue to be optional. We also agree
a payment or other transfer of value
associated with a research payment
regarding a device or medical supply
may not have a marketed name.
Therefore, we are finalizing the proposal
that manufacturers will continue to
have an option to report either a device
or medical supply marketed name,
therapeutic area or product category
when reporting research payments.
After consideration of comments
received, we agree that displaying
therapeutic areas or product categories
are useful for the public reviewing data
on the Open Payments public Web site
because the public is not familiar with
marketed names for devices and
medical supplies. We agree therapeutic
areas and products categories are more
recognizable by the public. Yet,
reporting marketed names for all
covered products is necessary to achieve
consistent reporting and to have the
ability to aggregate all payments or other
transfers of value associated with a
specific device or medical supply.
Therefore to achieve consistent
reporting by manufacturers, we will
require manufacturers to report
marketed name and therapeutic area or
product category for all covered drugs,
devices, biologicals or medical supplies.
We also agree with commenters that
complying with this reporting
requirement will require a change in
manufacturers’ reporting systems;
therefore, data collection for this
reporting requirement would begin
January 1, 2016.
4. Reporting of Stock, Stock Option, or
Any Other Ownership Interest
Section 403.904(d)(3) requires the
reporting of stock, stock option, or any
other ownership interest. We proposed
to require applicable manufacturers to
report such payments as distinct
categories. This will enable us to collect
more specific data regarding the forms
of payment made by applicable
manufacturers. After issuing the
February 8, 2013 final rule and the
development of the Open Payments
system, we determined that this
specificity will increase the ease of data
aggregation within the system, and also
enhance consumer’s use of the data. We
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
solicited comments on the extent to
which users of this data set find this
disaggregation to be useful, and whether
this change presents operational or
other issues on the part of applicable
manufacturers.
The following is summary of the
comments we received regarding the
extent to which users of this data set
find this disaggregation to be useful,
requiring reporting of marketed name
for covered devices and medical
supplies, and whether this change
presents operational or other issues on
the part of applicable manufacturers.
Comment: Commenters agreed that
requiring reporting of stock, stock
option or any other ownership interest
in distinct categories is useful.
Response: We agree the disaggregation
of reporting stock, stock option or any
other ownership interest in distinct
categories. Therefore, we have finalized
this provision as proposed, which
requires reporting stock, stock option, or
any other ownership interest form of
payment or other transfer of value in
distinct categories.
J. Physician Compare Web Site
1. Background and Statutory Authority
Section 10331(a)(1) of the Affordable
Care Act, requires that, by no later than
January 1, 2011, we develop a Physician
Compare Internet Web site with
information on physicians enrolled in
the Medicare program under section
1866(j) of the Act, as well as information
on other eligible professionals (EPs)
who participate in the Physician Quality
Reporting System (PQRS) under section
1848 of the Act.
CMS launched the first phase of
Physician Compare on December 30,
2010 (https://www.medicare.gov/
physiciancompare). In the initial phase,
we posted the names of EPs that
satisfactorily submitted quality data for
the 2009 PQRS, as required by section
1848(m)(5)(G) of the Act.
Section 10331(a)(2) of the Affordable
Care Act also requires that, no later than
January 1, 2013, and for reporting
periods that began no earlier than
January 1, 2012, we implement a plan
for making publicly available through
Physician Compare information on
physician performance that provides
comparable information on quality and
patient experience measures. We met
this requirement in advance of January
1, 2013, as outlined below, and plan to
continue addressing elements of the
plan through rulemaking.
To the extent that scientifically sound
measures are developed and are
available, we are required to include, to
PO 00000
Frm 00215
Fmt 4701
Sfmt 4700
67761
the extent practicable, the following
types of measures for public reporting:
• Measures collected under the
Physician Quality Reporting System
(PQRS).
• An assessment of patient health
outcomes and functional status of
patients.
• An assessment of the continuity
and coordination of care and care
transitions, including episodes of care
and risk-adjusted resource use.
• An assessment of efficiency.
• An assessment of patient
experience and patient, caregiver, and
family engagement.
• An assessment of the safety,
effectiveness, and timeliness of care.
• Other information as determined
appropriate by the Secretary.
As required under section 10331(b) of
the Affordable Care Act, in developing
and implementing the plan, we must
include, to the extent practicable, the
following:
• Processes to ensure that data made
public are statistically valid, reliable,
and accurate, including risk adjustment
mechanisms used by the Secretary.
• Processes for physicians and
eligible professionals whose information
is being publicly reported to have a
reasonable opportunity, as determined
by the Secretary, to review their results
before posting to Physician Compare.
We have established a 30-day preview
period for all measurement performance
data that will allow physicians and
other EPs to view their data as it will
appear on the Web site in advance of
publication on Physician Compare (77
FR 69166 and 78 FR 74450). Details of
the preview process will be
communicated directly to those with
measures to preview and will also be
published on the Physician Compare
Initiative page (https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/physiciancompare-initiative/) in advance of the
preview period.
• Processes to ensure the data
published on Physician Compare
provides a robust and accurate portrayal
of a physician’s performance.
• Data that reflects the care provided
to all patients seen by physicians, under
both the Medicare program and, to the
extent applicable, other payers, to the
extent such information would provide
a more accurate portrayal of physician
performance.
• Processes to ensure appropriate
attribution of care when multiple
physicians and other providers are
involved in the care of the patient.
• Processes to ensure timely
statistical performance feedback is
E:\FR\FM\13NOR2.SGM
13NOR2
67762
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
provided to physicians concerning the
data published on Physician Compare.
• Implementation of computer and
data infrastructure and systems used to
support valid, reliable and accurate
reporting activities.
Section 10331(d) of the Affordable
Care Act requires us to consider input
from multi-stakeholder groups,
consistent with sections 1890(b)(7) and
1890A of the Act, when selecting
quality measures for Physician
Compare. We also continue to get
general input from stakeholders on
Physician Compare through a variety of
means, including rulemaking and
different forms of stakeholder outreach
(for example, Town Hall meetings, Open
Door Forums, webinars, education and
outreach, Technical Expert Panels, etc.).
In developing the plan for making
information on physician performance
publicly available through Physician
Compare, section 10331(e) of the
Affordable Care Act requires the
Secretary, as the Secretary determines
appropriate, to consider the plan to
transition to value-based purchasing for
physicians and other practitioners that
was developed under section 131(d) of
the MIPPA.
Under section 10331(f) of the
Affordable Care Act, we are required to
submit a report to the Congress by
January 1, 2015, on Physician Compare
development, and include information
on the efforts and plans to collect and
publish data on physician quality and
efficiency and on patient experience of
care in support of value-based
purchasing and consumer choice.
Section 10331(g) of the Affordable Care
Act provides that any time before that
date, we may continue to expand the
information made available on
Physician Compare.
We believe section 10331 of the
Affordable Care Act supports our
overarching goals of providing
consumers with quality of care
information that will help them make
informed decisions about their health
care, while encouraging clinicians to
improve the quality of care they provide
to their patients. In accordance with
section 10331 of the Affordable Care
Act, we plan to publicly report
physician performance information on
Physician Compare.
2. Public Reporting of Performance and
Other Data
Since the initial launch of the Web
site, we have continued to build on and
improve Physician Compare. On June
27, 2013, we launched a full redesign of
Physician Compare bringing significant
improvements including a complete
overhaul of the underlying database and
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
a new Intelligent Search feature,
addressing two of our stakeholders’
primary critiques of the site—the
accuracy and currency of the database
and the limitations of the search
function—and considerably improving
Web site functionality and usability.
Provider Enrollment, Chain, and
Ownership System (PECOS), as the sole
source of verified Medicare professional
information, is the primary source of
administrative information on Physician
Compare. With the redesign, however,
we incorporated the use of Medicare
Fee-For-Service claims information to
verify the information in PECOS to help
ensure only the most current and
accurate information is included on the
site. For example, claims information is
used to determine which of the active
and approved practice locations in
PECOS are where the professional is
currently providing services. Claims
information helps confirm that only the
most current group practice affiliations
are included on the site. Our use of
claims also helps ensure that we are
posting on Physician Compare the most
current and accurate information
available about the professionals for
Medicare consumers.
We received several comments about
the enhancements made to the
Physician Compare Web site and the
data currently on the Web site.
Comment: Several commenters noted
the improvements made to the
Physician Compare Web site, including
the additional labeling, improvements
to the ‘‘Is this you?’’ link, the reordering
of the search results, the Intelligent
Search functionality, the use of claims
data to verify professionals’
demographic information, denoting
board certified physicians with
contextual text, and explanations and
disclaimers about each of the federal
quality reporting programs included on
the Web site. Commenters also noted an
appreciation for the transparency and
easy-to-use, comprehensive information
available on the site to aid consumers in
making informed health care decisions.
Some commenters provided
suggestions for future Physician
Compare enhancements. A few
commenters suggested continued
improvements to the Intelligent Search
functionality to better find health care
professionals other than physicians and
additional specialty labels for Advanced
Practice Registered Nurses (APRNs) and
allied health professionals.
Response: We appreciate the
commenters’ feedback and the
continued support for the Physician
Compare Web site. We are committed to
continuing to improve the site and its
functionality to ensure it is a useful
PO 00000
Frm 00216
Fmt 4701
Sfmt 4700
resource for Medicare consumers,
including information that can help
these consumers make informed health
care decisions. We also appreciate the
recommendations regarding other health
care professionals, and we will evaluate
these recommendations for potential
future inclusion. Also, we are
continually working to improve and
enhance the Intelligent Search
functionality.
Comment: Some commenters
expressed concerns about the accuracy
of data such as demographic
information, specialty classification,
and hospital affiliation. Several
commenters urged CMS to address these
concerns prior to posting additional
quality measure performance
information on the Web site. Other
commenters requested we implement a
streamlined process by which
professionals can confirm or correct
their information in a timely manner.
One commenter urged CMS to ensure
that updates made in PECOS are
reflected on Physician Compare within
30 days, while another commenter
cautioned against using PECOS for
updating information. Several
commenters suggested continuing to
work with stakeholders, particularly
health care professionals, and/or
providing educational material
regarding how to keep data current to
ensure the accuracy of the Web site.
Response: We appreciate the
commenters’ feedback regarding
concerns over the accuracy of the
information currently available on
Physician Compare. We are committed
to including accurate and up-to-date
information on Physician Compare and
continue to work to make improvements
to the information presented.
The underlying database on Physician
Compare is generated from PECOS, as
well as Fee-For-Service (FFS) claims,
and it is therefore critical that
physicians, other health care
professionals, and group practices
ensure that their information is up-todate and as complete as possible in the
national PECOS database. Currently, the
most immediate way to address
inaccurate PECOS data on Physician
Compare is by updating information via
Internet-based PECOS at https://
pecos.cms.hhs.gov/pecos/login.do.
Please note that the specialties as
reported on Physician Compare are
those specialties reported to Medicare
when a physician or other health care
professional enrolls in Medicare and are
limited to the specialties noted on the
855i Enrollment Form. All addresses
listed on Physician Compare must be
entered in and verified in PECOS.
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
There is a lag between when an edit
is made in PECOS and when that edit
is processed by the Medicare
Administrative Contractor (MAC) and
available in the PECOS data pulled for
Physician Compare. This time is
necessary for data verification but
unfortunately results in a delay
updating information. We are
continually working to find ways to
minimize this delay.
To update information not found in
PECOS, such as hospital affiliation and
foreign language, professionals and
group practices should contact the
Physician Compare support team
directly at PhysicianCompare@
Westat.com. Information regarding how
to keep your information current can
also be found on the Physician Compare
Initiative page on CMS.gov (https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/physician-compareinitiative/).
Although we appreciate the concerns
raised around the PECOS data included
on Physician Compare, it is necessary to
continue the use of the PECOS data as
it is the sole, verified source of Medicare
information. However, we are aware of
its limitations. For these reasons, we
have instituted the use of claims
information and are continuing to work
to find ways to further improve the data.
The data are significantly better today
than they were prior to the 2013
redesign and continues to improve. We
strongly encourage all professionals and
group practices listed on the site to
regularly check their data and to contact
the support team with any questions or
concerns.
Currently, Web site users can view
information about approved Medicare
professionals such as name, primary
and secondary specialties, practice
locations, group affiliations, hospital
affiliations that link to the hospital’s
profile on Hospital Compare as
available, Medicare Assignment status,
education, languages spoken, and
American Board of Medical Specialties
(ABMS) board certification information.
In addition, for group practices, users
can also view group practice names,
specialties, practice locations, Medicare
assignment status, and affiliated
professionals.
We post on the Web site the names of
individual EPs who satisfactorily report
under PQRS, as well as those EPs who
are successful electronic prescribers
under the Medicare Electronic
Prescribing (eRx) Incentive Program.
Physician Compare contains a link to a
downloadable database of all
information on Physician Compare
(https://data.medicare.gov/data/
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
physician-compare), including
information on this quality program
participation. In addition, there is a
section on each Medicare professional’s
profile page indicating with a green
check mark the quality programs under
which the EP satisfactorily or
successfully reported. We proposed (79
FR 40386) to continue to include this
information annually in the year
following the year it is reported (for
example, 2015 PQRS reporting will be
included on the Web site in 2016). We
did not receive any comments on this
proposal. We are finalizing this proposal
at this time, and therefore, will include
satisfactory 2015 PQRS reporters on the
Web site in 2016. The eRx Incentive
Program ends in 2014 so those data will
not be available in 2015 or beyond.
With the Physician Compare redesign,
we added a quality programs section to
each group practice profile page in order
to indicate which group practices are
satisfactorily reporting in the Group
Practice Reporting Option (GPRO) under
PQRS or are successful electronic
prescribers under the eRx Incentive
Program. We have also included a
notation and check mark for individuals
that successfully participate in the
Medicare EHR Incentive Program, as
authorized by section 1848(o)(3)(D) of
the Act. We proposed (79 FR 40386) to
continue to include this information
annually in the year following the year
it is reported (for example, 2015 data
will be included on the Web site in
2016).
We did not receive any comments
regarding our proposal regarding this
PQRS GPRO. We are finalizing the
proposal to include a notation for
satisfactory PQRS GPRO reporters. As
noted above, the eRx Incentive Program
is ending in 2014, and therefore, there
will not be data for this program in 2015
or beyond. We did receive comments
regarding including a notation for
individuals that successfully participate
in the Medicare EHR Incentive Program.
Comment: Two commenters urged
CMS to reconsider its decision to
publicly report participation in the
Medicare EHR Incentive Program due to
ongoing issues related to the program—
including unresolved challenges related
to vendor certification delays, concerns
about the relevancy to consumers, and
limited ability to implement core
measures. One commenter suggested
including a disclaimer next to the
indicator explaining these barriers and
clarifying that successful participation
in the EHR Incentive Program is only
one of various ways to demonstrate an
investment in higher quality care.
Response: We appreciate the
commenters’ feedback, and we will take
PO 00000
Frm 00217
Fmt 4701
Sfmt 4700
67763
the suggestions provided regarding a
disclaimer into consideration for
possible future enhancements. We also
appreciate the concerns raised about the
program, specifically around vendor
certification and core measures.
However, despite those potential
limitations, a number of professionals
and groups are successfully taking part
at this time and we believe it is
important to continue to recognize
them. Also, consumers find this
information interesting and helpful.
This is only one of multiple quality
programs included on Physician
Compare that we find important to
highlight. As a result, we are going to
finalize our proposal to continue
including an indicator for participation
in the EHR Incentive Program on the
Web site.
We previously finalized a decision to
publicly report the names of those EPs
who report the 2014 PQRS
Cardiovascular Prevention measures
group in support of Million Hearts on
Physician Compare in 2015, by
including a check mark in the quality
programs section of the profile page (78
FR 74450). We proposed (79 FR 40386)
to also continue to include this
information annually in the year
following the year it is reported (for
example, 2015 data will be included on
Physician Compare in 2016).
Comment: Some commenters
supported our proposal to publicly
report and include an indicator for EPs
who report the 2015 PQRS
Cardiovascular Prevention measures
group in support of Million Hearts.
Commenters noted that Million Hearts
is an important initiative for supporting
cardiovascular health.
Response: We appreciate the
commenters’ support. We agree that
Million Hearts is an important initiative
that is improving outcomes for
cardiovascular health. However, we are
finalizing the removal of the
Cardiovascular Prevention measure
group from the PQRS program given
that the two cholesterol control
measures included in the measure group
are no longer clinically relevant, and
therefore, the measure group no longer
meets the necessary threshold for PQRS
of six measures and will no longer be
available for reporting under the
program. With the removal of the 2
cholesterol control measures, the
remaining measures from the original
Cardiovascular Prevention measure
group are:
• Ischemic Vascular Disease (IVD):
Use of Aspirin or Another
Antithrombotic.
• Preventive Care and Screening:
Tobacco Use.
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67764
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
• Controlling High Blood Pressure.
• Preventive Care and Screening:
Screening for High Blood Pressure and
Follow-Up Documented.
All of these measures are available as
individual measures under PQRS. Given
that the Cardiovascular Prevention
measure group is being eliminated from
the PQRS, but that the remaining
measures identified above will be
available for individual reporting, we
are modifying our final policy with
regard to our proposal to support
Million Hearts on Physician Compare.
Specifically, we are finalizing that any
EP that satisfactorily reports all four of
the individual measures noted above
will receive a green check mark
indicating support for Million Hearts. A
key strategy of the Million Hearts
initiative is to reduce the number of
heart attacks and strokes, and the
program has found that reporting these
quality measures is a first step toward
performance improvement. We are
committed to supporting this initiative,
and even though the measure group is
no longer available under PQRS, we
think it is important to continue
recognizing those individual EPs who
are reporting these quality measures as
individual measures. Even though the
individual measures require that a
potentially higher number of patients
are reported on—50 percent of patients
that meet the sample requirements
versus just 20 patients for the measure
group—we believe this does not
increase burden on reporters because as
currently available claims data show,
significantly more EPs are already
reporting these measures as individual
PQRS measures versus as part of the
Cardiovascular Prevention measures
group. Ensuring these professionals are
recognized for reporting these measures
is important in ensuring we are
continuing support for this important
program despite the measure group no
longer being available for reporting.
Finally, we will also indicate with a
green check mark those individuals who
have earned the 2014 PQRS
Maintenance of Certification Incentive
(Additional Incentive) on the Web site
in 2015 (78 FR 74450).
Comment: Several commenters
supported publicly reporting earners of
the PQRS Maintenance of Certification
(MOC) program Additional Incentive, as
well as ABMS Board Certification data,
while other commenters are concerned
that ABMS data are not complete or
only include some specialists. Multiple
commenters suggested including other
Boards’ certifications and MOC
programs, contextual certification
process information, and the certifying
Board’s identification.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Response: We appreciate the
commenters’ feedback and support for
including ABMS and PQRS MOC
information on Physician Compare. We
also understand the concerns that not
all specialties are presented by the
ABMS data and will review the
recommendations made to include
additional certification and MOC
program information on the Web site for
possible inclusion in the future.
We continue to implement our plan
for a phased approach to public
reporting performance information on
Physician Compare. The first phase of
this plan was finalized with the CY
2012 PFS final rule with comment
period (76 FR 73419–73420), where we
established that PQRS GPRO measures
collected through the GPRO Web
Interface for 2012 would be publicly
reported on Physician Compare. The
plan was expanded with the CY 2013
PFS final rule with comment period (77
FR 69166), where we established that
the specific GPRO Web Interface
measures that would be posted on
Physician Compare would include the
PQRS GPRO measures for Diabetes
Mellitus (DM) and Coronary Artery
Disease (CAD), and we noted that we
would report composite measures for
these measure groups in 2014, if
technically feasible.6 The 2012 PQRS
GPRO measures were publicly reported
on Physician Compare in February
2014. Data reported in 2013 on the
GPRO DM and GPRO CAD measures
and composites collected via the GPRO
Web Interface that meet the minimum
sample size of 20 patients and prove to
be statistically valid and reliable will be
publicly reported on Physician Compare
in December CY 2014, if technically
feasible. If the minimum threshold is
not met for a particular measure, or the
measure is otherwise deemed not to be
suitable for public reporting, the group’s
performance rate on that measure will
not be publicly reported. We will only
publish on Physician Compare those
measures that are statistically valid and
reliable, and therefore, most likely to
help consumers make informed
decisions about the Medicare
professionals they choose to meet their
health care needs.
Measures must be based on reliable
and valid data elements to be useful to
consumers and thus included on
Physician Compare. A reliable data
element is consistently measuring the
6 By ‘‘technically feasible’’ we mean that there are
no operational constraints inhibiting us from
moving forward on a given public reporting
objective. Operational constraints include delays
and/or issues related to data collection which
render a set of quality data unavailable in the
timeframe necessary for public reporting.
PO 00000
Frm 00218
Fmt 4701
Sfmt 4700
same thing regardless of when or where
it is collected, while a valid data
element is measuring what it is meant
to measure. To address the reliability of
performance scores, we will measure
the extent to which differences in each
quality measure are due to actual
differences in clinician performance
versus variation that arises from
measurement error. Statistically,
reliability depends on performance
variation for a measure across clinicians
(‘‘signal’’), the random variation in
performance for a measure within a
clinician’s panel of attributed
beneficiaries (‘‘noise’’), and the number
of beneficiaries attributed to the
clinician. High reliability for a measure
suggests that comparisons of relative
performance across clinicians are likely
to be stable over different performance
periods and that the performance of one
clinician on the quality measure can
confidently be distinguished from
another. Potential reliability values
range from zero to one, where one
(highest possible reliability) means that
all variation in the measure’s rates is the
result of variation in differences in
performance, while zero (lowest
possible reliability) means that all
variation is a result of measurement
error. Reliability testing methods
included in the CMS Measures
Management System Blueprint (https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/MMS/Measures
ManagementSystemBlueprint.html)
include test-retest reliability and
analysis of variance (ANOVA).
Reliability tests endorsed by the NQF
include the beta-binomial model test.
The validity of a measure refers to the
ability to record or quantify what it
claims to measure. To analyze validity,
we can investigate the extent to which
each quality measure is correlated with
related, previously validated, measures.
We can assess both concurrent and
predictive validity. Predictive validity is
most appropriate for process measures
or intermediate outcome measures, in
which a cause-and-effect relationship is
hypothesized between the measure in
question and a validated outcome
measure. Therefore, the measure in
question is computed first, and the
validated measure is computed using
data from a later period. To examine
concurrent validity, the measure in
question and a previously validated
measure are computed using
contemporaneous data. In this context,
the previously validated measure
should measure a health outcome
related to the outcome of interest.
Comment: Many commenters
supported only publishing on Physician
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
Compare those measures that are
statistically valid and reliable. Several
commenters urged CMS to carefully
assess if all GPRO measure data is
sufficiently reliable and valid for public
reporting before posting the data. One
commenter recommended removing any
measures deemed unreliable or
inaccurate. One commenter
recommended a one-year delay in
public reporting of all new measures to
enable professionals to accurately report
the measures and to account for
measure testing and validity.
One commenter requested CMS
publish the results of validity and
reliability studies, as well as the
methodology for choosing measures
prior to posting on Physician Compare.
Another commenter is concerned that
measures related to patient behavior,
preferences, or abilities do not provide
a statistically valid portrayal of a health
care professional’s performance and
should not be published unless the data
is appropriately risk adjusted. Several
other commenters also strongly urged
CMS to move forward with expanding
its risk adjustment methodology.
Response: We appreciate the
commenters’ feedback, and understand
the concerns raised. As required under
section 10331(b) of the Affordable Care
Act, in developing and implementing
the plan to include performance data on
Physician Compare, we must include, to
the extent practicable, processes to
ensure that the data posted on the Web
site are statistically valid, reliable, and
accurate, including risk adjustment
mechanisms used by the Secretary. We
understand that this information is
complex and are committed to
providing data on Physician Compare
that are useful to beneficiaries in
assisting them in making informed
health care decisions, while being
accurate, valid, reliable, and complete.
We will closely evaluate all quality
measures under consideration for public
reporting on the Web site to ensure they
are meeting these standards. We will
also only post data that meet the
established standards of reliability and
validity regardless of threshold, and
regardless of measure type. Should we
find a measure meeting the minimum
threshold to be invalid or unreliable for
any reason, the measure will not be
reported. We are also making changes in
light of the concerns about first year
measures. We will not publicly post
measures that are in their first year
given the concerns raised about their
validity, reliability, accuracy, and
comparability. After a measure’s first
year in the program, CMS will evaluate
the measure to see if and when the
measure is suitable for pubic reporting.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Also, we will continue to analyze the
measure data to ensure that risk
adjustment concerns are taken into
consideration. All data are analyzed and
reviewed by our Technical Expert Panel
(TEP). A summary of the TEP
recommendations is made public on the
Physician Compare Initiative page
(https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/physician-compareinitiative/Informational-Materials.html)
when available.
In the November 2011 Medicare
Shared Savings Program final rule (76
FR 67948), we noted that because
Accountable Care Organization (ACO)
providers/suppliers that are EPs are
considered to be a group practice for
purposes of qualifying for a PQRS
incentive under the Shared Savings
Program, we would publicly report ACO
performance on quality measures on
Physician Compare in the same way as
we report performance on quality
measures for PQRS GPRO group
practices. Public reporting of
performance on these measures is
presented at the ACO level only. The
first sub-set of ACO measures was also
published on the Web site in February
2014. ACO measures can be viewed by
following the link for Accountable Care
Organization (ACO) Quality Data on the
homepage of the Physician Compare
Web site (https://medicare.gov/
physiciancompare/aco/search.html).
As part of our public reporting plan
for Physician Compare, in the CY 2013
PFS final rule with comment period (77
FR 69166 and 69167), we also finalized
the decision to publicly report Clinician
and Group Consumer Assessment of
Healthcare Providers and Systems (CG–
CAHPS) data for group practices of 100
or more eligible professionals reporting
data in 2013 under the GPRO and for
ACOs participating in the Shared
Savings Program, if technically feasible.
We anticipate posting these data on
Physician Compare in late 2014, if
available.
We continued to expand our plan for
public reporting data on Physician
Compare in the CY 2014 PFS final rule
with comment period (78 FR 74449). In
that final rule we finalized a decision
that all measures collected through the
GPRO Web Interface for groups of two
or more EPs participating in 2014 under
the PQRS GPRO and for ACOs
participating in the Medicare Shared
Savings Program would be available for
public reporting in CY 2015. As with all
measures we finalized with regard to
Physician Compare, these data would
include measure performance rates for
measures reported that meet the
minimum sample size of 20 patients and
PO 00000
Frm 00219
Fmt 4701
Sfmt 4700
67765
prove to be statistically valid and
reliable. We also finalized a 30-day
preview period prior to publication of
quality data on Physician Compare. This
will allow group practices to view their
data as it will appear on Physician
Compare before it is publicly reported.
We decided that we will detail the
process for the 30-day preview and
provide a detailed timeline and
instructions for preview in advance of
the start of the preview period. ACOs
will be able to view their quality data
that will be publicly reported on
Physician Compare through the ACO
Quality Reports, which will be made
available to ACOs for review at least 30
days prior to the start of public
reporting on Physician Compare.
We also finalized a decision to
publicly report in CY 2015 on Physician
Compare performance on certain
measures that group practices report via
registries and EHRs in 2014 for the
PQRS GPRO (78 FR 74451). Specifically,
we finalized making available for public
reporting performance on 16 registry
measures and 13 EHR measures (78 FR
74451). These measures are consistent
with the measures available for public
reporting via the Web Interface. We will
indicate the mechanism by which these
data were collected and only those data
deemed statistically comparable, valid,
and reliable would be published on the
site.
We also finalized publicly reporting
patient experience survey-based
measures from the CG–CAHPS measures
for groups of 100 or more eligible
professionals who participate in PQRS
GPRO, regardless of GPRO submission
method, and for Shared Savings
Program ACOs reporting through the
GPRO Web Interface or other CMSapproved tool or interface (78 FR
74452). For 2014 data, we finalized
publicly reporting data for the 12
summary survey measures also finalized
for groups of 25 to 99 for PQRS
reporting requirements (78 FR 74452).
These summary survey measures would
be available for public reporting group
practices of 100 or more EPs
participating in PQRS GPRO, as well as
group practices of 25 to 99 EPs when
collected via any certified CAHPS
vendor regardless of PQRS
participation, as technically feasible.
For ACOs participating in the Shared
Savings Program, the patient experience
measures that are included in the
Patient/Caregiver Experience domain of
the Quality Performance Standard under
the Shared Savings Program (78 FR
74452) will be available for public
reporting in 2015.
For 2014, we also finalized publicly
reporting 2014 PQRS measure data
E:\FR\FM\13NOR2.SGM
13NOR2
67766
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
reported by individual EPs in late CY
2015 for individual PQRS quality
measures specifically identified in the
final rule with comment period, if
technically feasible. Specifically, we
finalized to make available for public
reporting 20 individual measures
collected through a registry, EHR, or
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
claims (78 FR 74453–74454). These are
measures that are in line with those
measures reported by groups via the
GPRO Web Interface.
Finally, in support of the HHS-wide
Million Hearts Initiative, we finalized a
decision to publicly report, no earlier
than CY 2015, performance rates on
PO 00000
Frm 00220
Fmt 4701
Sfmt 4700
measures in the PQRS Cardiovascular
Prevention measures group at the
individual EP level for data collected in
2014 for the PQRS (78 FR 74454). See
Table 48 for a summary of our final
policies for public reporting data on
Physician Compare.
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
67767
TABLE 48: Summary of Previously Finalized Policies for Public Reporting on
PhlYSICian Compare
Public
Reporting
Year
2013
2012
2014
2013
2014
WI,EHR,
Registry, Claims
2013
Expected to
be
December
2014
WI
2013
Expected to
be
December
2014
Expected to
be 2015
WI
2014
Reporting
Mechanism(s)
Quality Measures and Data for Public Reporting
Web Interface
(WI),EHR,
Registry, Claims
WI
Include an indicator for satisfactory reporters under PQRS
successful e-prescribers under eRx, and participants in the
EHR Incentive Program.
5 Diabetes Mellitus (DM) and Coronary Artery Disease
(CAD) measures collected via the WI for group practices
reporting under PQRS GPRO with a minimum sample size of
25 patients and Shared Savings Program A COs.
Include an indicator for satisfactory reporters under PQRS,
successful e-prescribers under eRx, and participants in the
EHR Incentive Program. Include an indicator for EPs who
earn a PQRS Maintenance of Certification Incentive and EPs
who report the PQRS Cardiovascular
Prevention measures group in support of Million Hearts.
Up to 6 DM and 2 CAD measures collected via the GPRO WI
for groups of 25 or more EPs and Shared Savings Program
A COs with a minimum sample size of 20 patients.
Will include composites for DM and CAD, if feasible.
Up to 5 CG-CAHPS summary measures for groups of 100 or
more EPs reporting under PQRS GPRO via the WI and up to
6 ACO CAHPS summary measures for Shared Savings
Program A COs.
Include an indicator for satisfactory reporters under PQRS
and participants in the EHR Incentive Program. Include an
indicator for EPs who earn a PQRS Maintenance of
Certification Incentive and EPs who report the PQRS
Cardiovascular Prevention measures group in support of
Million Hearts.
All measures reported via the GPRO WI, 13 EHR, and 16
Registry GPRO measures are also available for group
practices of 2 or more EPs reporting under PQRS GPRO with
a minimum sample size of 20 patients. Also, all Shared
Savings Program ACO measures are available for public
reporting.
WI,EHR,
Registry, Claims
Expected to
be late 2015
WI,EHR,
Registry,
Administrative
Claims
2014
Expected to
be late 2015
WI, Certified
Survey Vendor
2014
ebenthall on DSK5SPTVN1PROD with $$_JOB
2014
Expected to
be late 2015
Registry, EHR, or
Claims
2014
Expected to
be late 2015
Registry
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00221
Include composites for DM and CAD, iffeasible.
Up to 12 CG-CAHPS summary measures for groups of 100 or
more EPs reporting via the WI and group practices of 25 to 99
EPs reporting via a CMS-approved certified survey vendor, as
well as 6 ACO CAHPS summary measures for Shared
Savings Program ACOs reporting through the GPRO Web
Interface or other CMS-approved tool or interface.
A sub-set of 20 PQRS measures submitted by individual EPs
that align with those available for group reporting via the WI
and that are collected through a Registry, EHR, or claims with
a minimum sample size of 20 patients.
Measures from the Cardiovascular Prevention measures group
reported by individual EPs in support of the Million Hearts
Initiative with a minimum sample size of 20 patients.
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.064</GPH>
Data
Collection
Year
2012
67768
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
3. Final Policies for Public Data
Disclosure on Physician Compare in
2015 and 2016
We are continuing the expansion of
public reporting on Physician Compare
by making an even broader set of quality
measures available for publication on
the Web site. We started the phased
approach with a small number of
possible PQRS GPRO Web Interface
measures for 2012 and have been
steadily building on this to provide
Medicare consumers with more
information to help them make
informed health care decisions. As a
result, we proposed (79 FR 40388) to
increase the measures available for
public reporting in the CY 2015
proposed PFS rule.
Comment: Although multiple
commenters supported continuing the
phased approach to public reporting of
quality data, a number of commenters
are concerned with the aggressive
timeline for publicly reporting
performance data. Several commenters
supported a more gradual approach to
public reporting to evaluate the public
response to data prior to widespread
implementation, ensure accuracy, and
present data in a format that is easy to
understand, meaningful, and actionable
for both patients and health care
professionals. A few commenters were
unsure if CMS conducted analysis of
consumer use of the site and urged CMS
to do so. Other commenters opposed the
extensive expansion until existing Web
site problems are addressed.
Response: We appreciate the
commenters’ feedback, and we
appreciate the concerns raised.
However, we believe that public
reporting of quality data has been a
measured, phased approach which
started with the publication of just five
2012 PQRS GPRO measures collected
via the Web Interface for 66 group
practices and 141 ACOs (76 FR 73417)
and continues with a similarly limited
set of 2013 PQRS GPRO Web Interface
measures (77 FR 69166). We started to
build on this plan with the 2014
Physician Fee Schedule (PFS) final rule
(78 FR 74446). This rule made
additional PQRS GPRO measures
available for public reporting, including
a subset of measures reported via
Registry and EHR, as well as a sub-set
of 20 individual EP PQRS measures.
Therefore, the proposals put forth this
year are just the next step in the process
to realize goals for authorization of
Physician Compare. We are confident
that taking this phased approach has
afforded us the opportunity to prepare
for this significant expansion.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Throughout this process, we have
been engaging with consumers and
stakeholders and regularly testing the
site and the information to be included
to ensure it is accurately presented and
understood. We are also continually
working to improve the Web site and
the administrative and demographic
information included. We continue to
encourage physicians, other health care
professionals, and group practices to
ensure their information is updated in
PECOS so that we can ensure the most
accurate information is available on
Physician Compare. We also encourage
individuals and groups to reach out to
the Physician Compare support team at
PhysicianCompare@Westat.com for any
questions or concerns regarding the
information included on the Web site.
We proposed (79 FR 40388) to expand
public reporting of group-level measures
by making all 2015 PQRS GPRO
measure sets across group reporting
mechanisms—GPRO Web Interface,
registry, and EHR—available for public
reporting on Physician Compare in CY
2016 for groups of 2 or more EPs, as
appropriate by reporting mechanism.7
Similarly, we also proposed that all
measures reported by Shared Savings
Program ACOs would be available for
public reporting on Physician Compare.
As with all quality measures proposed
for inclusion on Physician Compare, we
noted that only measures that prove to
be valid, reliable, and accurate upon
analysis and review at the conclusion of
data collection would be included on
the Web site.
Comment: Commenters were both
positive and negative in regard to our
proposal to expand the group-level
measures available for public reporting
to all measures reported under 2015
PQRS GPRO. Commenters in support of
the proposal noted group-level measures
are a robust indication of care team
quality and helpful to consumers. Some
commenters opposed the expansion and
cited concerns with the accuracy of
current data as well as measure fidelity.
One commenter encouraged CMS to
ensure that GPRO quality data is
accurately labeled and accessible
through the group entry only to ensure
it is clear what the quality measure
represents. One commenter asked for
clarification on the availability of the
PQRS GPRO Web Interface reporting
option for groups of two or more EPs.
Response: We appreciate the
commenters’ feedback on our proposal
7 Tables Q1–Q27 detail proposed changes to
available PQRS measures. Additional information
on PQRS measures can be found on the CMS.gov
PQRS Web site at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-Assessment-Instruments/
PQRS/.
PO 00000
Frm 00222
Fmt 4701
Sfmt 4700
to report all 2015 PQRS measures
reported via the Web Interface, EHR,
and Registry for group practices of 2 or
more EPs participating in the PQRS
GPRO. As noted, Physician Compare
will only publicly report those measures
evaluated to be comparable, reliable,
and valid. Also, we will continue to
work to ensure that measures are
labeled accurately and accompanied by
explanations that are both true to the
measure specifications and accurately
understood by health care consumers,
while adhering to HHS plain language
guidelines. Measure data accuracy is of
paramount importance to CMS. The
measure data currently available on
Physician Compare was previewed by
those group practices that currently
have 2012 PQRS GPRO data available
on Physician Compare prior to
publication with no concerns raised
regarding accuracy. Since being
published, no group practices with
GPRO data have raised concerns
regarding the accuracy of the measure
data available. To confirm, the Web
Interface reporting option will remain
limited to groups of 25 or more EPs.
Smaller groups, groups of 2 to 24 EPs,
can report under the PQRS via EHR or
Registry. We also clarify that group-level
data is only published at the group
level—included on the group practice
profile page—on Physician Compare.
And, in response to comments that
raised concern about measures reported
in the first year, we have decided that
we will not publicly report a measure
that is in its first year. By first year we
mean a measure that is newly available
for reporting under PQRS.
We also received comments
specifically about EHR measures.
Comment: Commenters were opposed
to publicly reporting EHR measures,
citing that it is too soon to publicly post
performance data from eCQMs without
additional work to verify the validity
and accuracy of the measure results.
One commenter suggested that new
quality measures could be piloted by
health care professionals prior to
requiring their use within a federal
program. One commenter strongly
encouraged developing a tutorial that
allows the public to better understand
this data.
Response: We appreciate the
commenters’ feedback regarding
including measures collected via EHRs.
Group practices will have the ability to
report measures via an EHR prior the
2015 data collection. Therefore, this
reporting mechanism will not be in its
first year of use at this time. As a result,
we do not believe it is too soon to report
these quality measures. As noted, only
comparable, valid, reliable, and accurate
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
data will be included on Physician
Compare. All measures slated for public
reporting will be consumer tested to
ensure they are accurately understood
prior to publication. If concerns surface
from this testing, we will evaluate if the
requirements for public reporting are
not suitably met and if the measure or
measures in question should be
suppressed and not publicly reported to
ensure only those measures that are
valid, reliable, and accurate and inform
quality choice are included on the site.
Given the value of these group-level
data, and the successful publication of
such data to date, we are finalizing our
proposal to report all 2015 PQRS
measures for all reporting options for
group practices of 2 or more EPs
participating in PQRS GPRO, and all
2015 measures reported by ACOs.
Consistent with this final policy, we are
making a conforming change to the
regulation at § 425.308(e) to provide that
all quality measures reported by ACOs
will be reported on Physician Compare
in the same way as for group practices
that report under the PQRS.
We also proposed (79 FR 40389) that
measures must meet the public
reporting criteria of a minimum sample
size of 20 patients.
Comment: Several commenters
supported the proposed minimum
sample size of 20 patients. However, the
majority of commenters believed a
patient threshold of 20 is too low to be
statistically valid, which commenters
claim may result in inaccurate quality
scores based on one outlier.
Commenters recommended CMS use a
higher threshold to ensure validity.
Several commenters also urged CMS to
test measures and composites with 20
patients and to provide an opportunity
for public comment and to review
reliability and validity.
Response: We appreciate the
commenters’ feedback and understand
the concerns raised regarding the 20
patient minimum sample size. However,
we believe this threshold of 20 patients
is a large enough sample to protect
patient privacy for reporting on the Web
site, and aligns with the reliability
threshold previously finalized for the
Value-Based Modifier (VM) (77 FR
69166). As we continue to work to align
quality initiatives and minimize
reporting burden on physicians and
other health care professionals, we are
finalizing a patient sample size of 20
patients.
We proposed to include an indicator
of which reporting mechanism was used
and to only include on the site measures
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
deemed statistically comparable.8 We
received several comments regarding
data comparability, generally.
Comment: Some commenters
expressed concern with the
comparability of measures reported
through different reporting mechanisms
and requested notation specifying the
measure differences. One commenter
supported only publicly reporting
measures with specifications consistent
across all reporting mechanisms, while
another commenter recommended that
CMS group results by the data collection
methodology to improve comparability.
Response: Though we understand
concerns regarding including measures
collected via different mechanisms,
CMS is conducting analyses to ensure
that these measures align across
different reporting mechanisms. This
analysis is done on a measure per
measure basis. For example, if a
measure is reported via claims, then the
measure specifications would be aligned
with a measure being reported via EHR
as long as it stays consistent with the
original measure intent. Only those
measures that are proven to be
comparable and most suitable for public
reporting will be included on Physician
Compare and made publicly available.
Therefore, we are finalizing our
proposal to report data from the
available reporting mechanisms and to
include a notation indicating which
reporting mechanism was used.
We proposed (79 FR 40389) to
publicly report all measures submitted
and reviewed and found to be
statistically valid and reliable in the
Physician Compare downloadable file.
However, we proposed that not all of
these measures necessarily would be
included on the Physician Compare
profile pages. As we noted, consumer
testing has shown profile pages with too
much information and/or measures that
are not well understood by consumers
can negatively impact a consumer’s
ability to make informed decisions. Our
analysis of the collected measure data,
along with consumer testing and
stakeholder feedback, will determine
specifically which measures are
published on profile pages on the Web
site. Statistical analyses will ensure the
measures included are statistically valid
and reliable and comparable across data
collection mechanisms. Stakeholder
feedback will ensure all measures meet
current clinical standards. CMS will
continue to reach out to stakeholders in
the professional community, such as
8 By statistically comparable, CMS means that the
quality measures are analyzed and proven to
measure the same phenomena in the same way
regardless of the mechanism through which they
were collected.
PO 00000
Frm 00223
Fmt 4701
Sfmt 4700
67769
specialty societies, to ensure that the
measures under consideration for public
reporting remain clinically relevant and
accurate. When measures are finalized
significantly in advance of moment they
are collected, it is possible that clinical
guidelines can change rendering a
measure no longer relevant. Publishing
that measure can lead to consumer
confusion regarding what best practices
their health care professional should be
subscribing to.
As we noted in the proposed rule (79
FR 40389), the primary goal of
Physician Compare is to help consumers
make informed health care decisions. If
a consumer does not properly interpret
a quality measure and thus
misunderstands what the quality score
represents, the consumer cannot use
this information to make an informed
decision. Through concept testing, CMS
will test with consumers how well they
understand each measure under
consideration for public reporting. If a
measure is not consistently understood
and/or if consumers do not understand
the relevance of the measure to their
health care decision making process,
CMS will not include the measure on
the Physician Compare profile page as
inclusion will not aid informed decision
making. Finally, consumer testing will
help ensure the measures included on
the profile pages are accurately
understood and relevant to consumers,
thus helping them make informed
decisions. This will be done to ensure
that the information included on
Physician Compare is consumer friendly
and consumer focused.
Comment: Several commenters
supported the proposal to have all 2015
measures available for download with
only a select group of measures on the
Web site. One commenter further
emphasized CMS should create
consistent formatting with Hospital
Compare downloadable files.
Response: We appreciate the
commenters’ feedback and support for
this proposal. We are finalizing the
proposal to include all measures in a
downloadable file and limiting the
measures available on Physician
Compare profile pages to those
measures that not only meet the
requirements of public reporting such as
validity, reliability, accuracy, and
comparability, but that also are
accurately understood and interpreted
by consumers as evidenced via
consumer testing. This will ensure that
the measures presented on Physician
Compare help them make informed
health care decisions without
overwhelming them with too much
information. We will also take into
future consideration the
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67770
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
recommendation regarding the Hospital
Compare file.
We also received comments regarding
stakeholder involvement and consumer
testing.
Comment: Commenters encouraged
continued involvement of measure
developers and stakeholders in the
public reporting development process.
Several commenters appreciated the
continued collaboration with specialty
societies via town hall meetings and
other mechanisms. Several commenters
advocated for more transparency by
providing the opportunity for the public
to comment on the deliberations of the
Physician Compare TEP; regular
engagement with interested
stakeholders; and increased
communication about the measure
consideration process, including
methods and interpretation of
performance. Some commenters
appreciated that CMS will continue to
reach out to stakeholders in the
professional community to ensure that
the measures under consideration for
public reporting remain clinically
relevant and accurate. One commenter
suggested an opportunity for
stakeholder associations to participate
in the 30-day measure preview process.
Response: We appreciate the
commenters’ feedback regarding
stakeholder outreach and involvement
in Physician Compare. As we noted,
section 10331(d) of the Affordable Care
Act requires that the Secretary take into
consideration input provided by multistakeholder groups, consistent with
sections 1890(b)(7) and 1890A of the
Act, as added by section 3014 of the
Act, in selecting quality measures for
use on Physician Compare. We also are
dedicated to providing opportunities for
stakeholders to provide input. We will
continue to identify the best ways to
accomplish this. We will also review all
recommendations provided for future
consideration.
Comment: Many commenters
supported consumer testing to ensure
only meaningful measures are included
on the site. One commenter suggested
CMS first focus on communicating
validated and meaningful information
in a user-friendly way. One commenter
urged CMS to consult a broader array of
stakeholders during concept testing,
while another commenter specified the
inclusion of health care professionals.
Some commenters requested that CMS
share with professional associations or
measure developers any information
obtained through consumer concept
testing. A few commenters asked for
more details on concept testing plans,
while another recommended CMS use
concept testing for the information
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
currently on the Physician Compare.
One commenter emphasized testing
must occur prior to placing these
additional measures on the Web site in
late 2016. One commenter believed
health care professionals must be aware
of what measures will be reported to the
Physician Compare Web site before the
reporting period begins.
Response: We appreciate the
commenters’ feedback. We will
continue to conduct consumer testing in
terms of both usability testing—to
ensure the site is easy to navigate and
functioning appropriately—and concept
testing—to ensure users understand the
information included on the Web site
and that information included resonates
with health care consumers. We are
continually working to test the
information planned for public
reporting with consumers. We regularly
test the information currently on the
Web site with site users. We are
planning concept testing of the
measures being finalized in this rule
prior to publication in 2016 and we will
work to ensure that valid, reliable, and
meaningful information is included on
the Web site. This testing ensures that
the best information is shared and that
it is shared in a way that is correctly
interpreted.
We will also engage stakeholders for
feedback, including input from the
public, consumers, and health care
professionals, as appropriate and
feasible through such opportunities as
Town Halls, Listening Sessions, Open
Door Forums, and Webinars. We will
review feedback for future
consideration. Although we establish in
rulemaking the subset of measures
available for posting on the Physician
Compare Web site, at this time,
however, it is not possible for us to
provide stakeholders with the exact list
of measures that will be included on the
Web site prior to our analysis of the
reported data to know which measures
meet the criteria we specified
previously for public reporting.
As is the case for all measures
published on Physician Compare, group
practices will be given a 30-day preview
period to view their measures as they
will appear on Physician Compare prior
to the measures being published. As in
previous years, we will detail the
process for the 30-day preview and
provide a detailed timeline and
instructions for preview in advance of
the start of the preview period. ACOs
will be able to view their quality data
that will be publicly reported on
Physician Compare through the ACO
Quality Reports, which will be made
available to ACOs for review at least 30
PO 00000
Frm 00224
Fmt 4701
Sfmt 4700
days prior to the start of public
reporting on Physician Compare.
Comment: Several commenters were
in support of the 30-day preview period
prior to publication of quality data.
Many commenters urged CMS to also
allow group practices, ACOs, and EPs
the opportunity to correct and/or appeal
any errors found in the performance
information before it is posted on the
Web site. Several commenters
recommended CMS postpone posting
information if a group practice or EP
files an appeal and flags their
demographic data or quality information
as problematic. Other commenters noted
that a 30-day preview period is
insufficient and requested that CMS
extend the period to 60 or 90 days. One
commenter believed the preview period
should match the PQRS committee’s
measure review timeline of 9 months.
Some commenters sought clarification
on how CMS plans to notify EPs of the
preview period and requested more
detail about correcting errors found
during the preview period.
Response: We appreciate the
commenters’ feedback regarding the 30day preview period for quality measures
on Physician Compare. Detailed
instructions regarding how to preview
measure data, the time frame for the
measure preview, and directions for
how to address any concerns or get
additional help during this process is
shared at the start of the preview period
with all groups and individuals that
have data to preview. If an error is
found in the measure display during
this 30-day preview, the directions
explain how to contact the Physician
Compare team by both phone and email
to have concerns addressed. Errors will
be corrected prior to publication. If
measure data has been collected and the
measure has been deemed suitable for
pubic reporting, the data will be
published. This 30-day period is in line
with the preview period provided for
other public reporting programs such as
Hospital Compare. To date, our
experience with this preview period for
group practices demonstrates that 30
days is sufficient time to allow for
preview to be conducted. It is important
that quality data be shared with the
public as soon as possible so it is as
current and relevant as possible when
published. To avoid further delaying
this publication we will maintain the
30-day preview period.
Group practices and EPs with
available data for public reporting will
be informed via email when the preview
period is going to take place. Group
practices and EPs will be provided
instructions for previewing data and
information for on how to request help
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
or have questions answered.
Additionally, information regarding the
preview period will be included on the
Physician Compare Initiative page on
CMS.gov. As noted, ACOs will preview
their data via their ACO Quality
Reports, which will be sent at least 30
days before data are publicly reported.
There is no preview period for
demographic data. These data are
currently publicly available. If a group
practice or EP has questions about their
demographic data, they should contact
the Physician Compare support team at
PhysicianCompare@Westat.com.
In addition to making all 2015 PQRS
GPRO measures available for public
reporting, we solicited comment (78 FR
40389) on creating composites using
2015 data and publishing composite
scores in 2016 by grouping measures
based on the PQRS GPRO measure
groups, if technically feasible. We
indicated we would analyze the data
collected in 2015 and conduct
psychometric and statistical analyses,
looking at how the measures best fit
together and how accurately they are
measuring the composite concept, to
create composites for certain PQRS
GPRO measure groups, including but
not limited to:
• Care Coordination/Patient Safety
(CARE) Measures
• Coronary Artery Disease (CAD)
Disease Module
• Diabetes Mellitus (DM) Disease
Module
• Preventive (PREV) Care Measures
In particular, we would analyze the
component measures that make up each
of these measure groups to see if a
statistically viable composite can be
constructed with the data reported for
2015. Composite scores have proven to
be beneficial in providing consumers a
better way to understand quality
measure data, as composites provide a
more concise, easy to understand
picture of physician quality.
Comment: Commenters were both
positive and negative in regard to our
request for information on publicly
reporting composite scores. Some
commenters stated composites should
only be publicly reported if statistically
reliable, risk adjusted, or medically
meaningful, and should be scientifically
or consumer tested prior to public
display. A few commenters also
suggested NQF endorsement of
individual components and composites
before finalizing any composites.
Several commenters strongly urged CMS
to seek input from relevant specialty
societies, measure developers,
consumers, and other stakeholders on
the construction and display of the
composites. A few commenters opposed
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
public reporting of composites, but
suggested providing physicians the
composite scores confidentially through
the QRURs. Several commenters noted
concerns about the proposal to create
composites given the variability in the
methodologies, difficulty validating the
results, and use of stand-alone measures
developed to be reported individually.
One commenter suggested stand-alone
measures are preferable to composites in
relatively small and heterogeneous
measure sets. A few commenters
suggested posting additional
information about composite measures
on Physician Compare clarifying that
composite groups are not readily
available at this time for all measure
groups. One commenter urged CMS to
retain more comprehensive information
about the measures within each
composite measure in the downloadable
file. One commenter does not
specifically support the Oncology
Composite Score on Physician Compare.
Response: We appreciate the
commenters’ feedback on this request
for information. We will be carefully
reviewing all concerns raised and
recommendations made as we continue
to evaluate options for including
composites in future rulemaking. This
concept was put forth merely to seek
comment and no formal proposal was
made, so we are not finalizing any
decisions regarding composite scores at
this time. However, given that we
received feedback from stakeholders
indicating such composite scores are
desired, we plan to analyze the data
once it is collected to establish the best
possible composite, which would help
consumers use these quality data to
make informed health care decisions,
and will consider proposing such
composites in future rulemaking.
Similar to composite scores,
benchmarks are also important to
ensuring that the quality data published
on Physician Compare are accurately
interpreted and appropriately
understood. A benchmark will allow
consumers to more easily evaluate the
information published by providing a
point of comparison between groups.
We continue to receive requests from all
stakeholders, but especially consumers,
to add this information to Physician
Compare. As a result, we proposed (79
FR 40389) to publicly report on
Physician Compare in 2016 benchmarks
for 2015 PQRS GPRO data using the
same methodology currently used under
the Shared Savings Program. This ACO
benchmark methodology was previously
finalized in the November 2011 Shared
Savings Program final rule (76 FR
67898), as amended in the CY 2014 PFS
final rule with comment period (78 FR
PO 00000
Frm 00225
Fmt 4701
Sfmt 4700
67771
74759). Details on this methodology can
be found on CMS.gov at https://cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/sharedsavingsprogram/
Downloads/MSSP–QM-Benchmarks.pdf.
We proposed to follow this
methodology using the 2014 PQRS
GPRO data.
We proposed to calculate benchmarks
using data at the group practice TIN
level for all EPs who have at least 20
cases in the denominator. A benchmark
per this methodology is the performance
rate a group practice must achieve to
earn the corresponding quality points
for each measure. Benchmarks would be
established for each percentile, starting
with the 30th percentile (corresponding
to the minimum attainment level) and
ending with the 90th percentile
(corresponding to the maximum
attainment level). A quality scoring
point system would then be determined.
Quality scoring would be based on the
group practice’s actual level of
performance on each measure. A group
practice would earn quality points on a
sliding scale based on level of
performance: performance below the
minimum attainment level (the 30th
percentile) for a measure would receive
zero points for that measure;
performance at or above the 90th
percentile of the performance
benchmark would earn the maximum
points available for the measure. The
total points earned for measures in each
measure group would be summed and
divided by the total points available for
that measure group to produce an
overall measure group score of the
percentage of points earned versus
points available. The percentage score
for each measure group would be
averaged together to generate a final
overall quality score for each group
practice. The goal of including such
benchmarks would be to help
consumers see how each group practice
performs on each measure, measure
group, and overall in relation to other
group practices.
Comment: Many commenters
supported the use of benchmarks to
help consumers make informed health
care decisions. However, several
commenters did not support the
calculation of an overall quality score,
as they believe it will result in the
unfair comparison of all group practices.
Additional commenters noted that
benchmarks using percentiles will be
difficult for consumers to understand
and encouraged consumer testing to
remedy this problem. Some commenters
noted appropriate methodology is
needed when potential data constraints
impact the calculation of benchmarks.
Several commenters also asked for
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67772
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
clarification on the impact of exception
rates on quality scores and how
benchmarks will be displayed, noting
the risk of arbitrary thresholds
potentially exaggerating minor
performance differences. A commenter
asked for the opportunity to review
sample data prior to supporting the
proposed methodology, while another
noted that benchmarks need to be set
prior to the beginning of the new
measurement period. One commenter
sought clarification on whether the
benchmarking methodology would be
the same as the methodology applied
under the Value-Modifier. Several
commenters urged CMS to use
consistent benchmarking across its
programs to promote consistency and
minimize confusion. One commenter
cautioned the use of benchmarks, noting
it can lead to an incomplete and
potentially misleading indicator of
quality.
Response: We appreciate the
commenters’ feedback on our proposal
to include on Physician Compare a
benchmark for 2015 PQRS GPRO
measures (and measures reported by
individual EPs) measures based on the
current Shared Savings Program
benchmark methodology. Although we
agree benchmarks can add great value
for consumers, we understand the many
concerns raised. As a result, we have
made a decision not to finalize this
proposal at this time. We want to be
sure to discuss more thoroughly
potential benchmarking methodologies
with our stakeholders prior to finalizing
the proposal. We also want to evaluate
other programs’ methodologies,
including the Value Modifier, to work
toward better alignment across
programs. We therefore feel it would be
best to forgo finalizing a methodology at
this time in favor of a stronger,
potentially better aligned methodology
that can be included in future
rulemaking.
Understanding the value consumers
place on patient experience data and the
commitment to reporting these data on
Physician Compare, we proposed (79 FR
40390) publicly reporting in CY 2016
patient experience data from 2015 for all
group practices of two or more EPs, who
meet the specified sample size
requirements and collect data via a
CMS-specified certified CAHPS vendor.
The patient experience data available
are specifically the CAHPS for PQRS
and CAHPS for ACO measures, which
include the CG–CAHPS core measures.
For group practices, we proposed to
make available for public reporting
these 12 summary survey measures:
• Getting Timely Care, Appointments,
and Information.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
• How Well Providers Communicate.
• Patient’s Rating of Provider.
• Access to Specialists.
• Health Promotion & Education.
• Shared Decision Making.
• Health Status/Functional Status.
• Courteous and Helpful Office Staff.
• Care Coordination.
• Between Visit Communication.
• Helping You to Take Medication as
Directed.
• Stewardship of Patient Resources.
We proposed that these 12 summary
survey measures would be available for
public reporting for all group practices.
For ACOs participating in the Shared
Savings Program, we proposed (79 FR
40390) that the patient experience
measures that are included in the
Patient/Caregiver Experience domain of
the Quality Performance Standard under
the Shared Savings Program in 2015
would be available for public reporting
in 2016. We would review all quality
measures after they are collected to
ensure that only those measures deemed
valid and reliable are included on the
Web site.
We received a number of comments
around our proposals to include CAHPS
measures on Physician Compare.
Comment: Several commenters
supported our proposal to publicly
report CAHPS for PQRS data for all
group practices that have met the
minimum sample size requirements and
collect the data using a certified CMSapproved vendor. One commenter
strongly encouraged CMS to make
public reporting on patient experience
measures mandatory for groups of all
sizes and individual EPs. However, a
few commenters were concerned with
public reporting of CAHPS or other
patient experience survey data due to
the subjectivity of the surveys or the
cost of administering the surveys.
Response: We appreciate the
commenters’ feedback. At this time
reporting of CAHPS measures for PQRS
is only available at the group practice
level, so we will continue to consider
these data for group practices. We
understand the concerns raised
regarding subjectivity and cost.
However, we are confident that CAHPS
is a well-tested collection mechanism
that produces valid and comparable
measures of physician quality based on
the extensive testing and work that has
been done by the Agency for Healthcare
Research and Quality’s (AHRQ) and
specifically the CAHPS Consortium (for
more information visit https://
cahps.ahrq.gov/). This work illustrates
that these measures are accurate
measures of patient experience. Because
CAHPS for PQRS can be one part of a
group’s participation in PQRS and are
PO 00000
Frm 00226
Fmt 4701
Sfmt 4700
data greatly desired by consumers, we
also believe concerns regarding cost are
outweighed. For these reasons, we are
finalizing our proposal to make
available for public reporting the 12
summary survey CAHPS measures
outlined in this rule on Physician
Compare for group practices and ACOs,
as appropriate.
Comment: Commenters were
generally supportive of the proposal to
publicly report 12 summary CAHPS
scores; however, some are concerned
that several CAHPS summary survey
measures cannot accurately capture
aspects of care over which an individual
physician does not have direct control,
such as ‘‘Getting Timely Care,
Appointments and Information’’ and
‘‘Access to Specialists,’’ and urged CMS
to only report these measures on an
aggregate, group level. Another
commenter is concerned with
‘‘Stewardship of Patient Resources’’
survey measure, noting that it is not a
physician’s role to manage a patient’s
pocketbook and that other barriers, apart
from costs, can impede access to care.
One commenter supported the
creation of benchmarks for CAHPS for
PQRS measures, and suggested CMS
clarify whether those benchmarks will
be the same as the ACO CAHPS measure
benchmarks, or whether the benchmarks
will be specific to the PQRS program,
but calculated using the same
methodology.
Response: The CAHPS for PQRS
measures are designed to be group-level
measures. These data will not be
calculated for individual EPs; they will
be evaluated at the group practice level.
We do appreciate the commenters’
feedback regarding concerns over
specific measures. One important
consideration is that because the
CAHPS measures are group-level, they
are not attributing aspects of care to an
individual EP, as not all aspects of care
can be easily attributed to a single
professional. Prior to deciding the
specific measures that will be publicly
reported on Physician Compare, we will
ensure the measures meet the reliability
and validity requirements set for public
reporting and that the measures are
understood and accurately interpreted
by consumers. If a summary survey
measure does not meet these criteria, it
will not be publicly reported on
Physician Compare. At this time, we are
not adopting any benchmarks for
CAHPS for PQRS on Physician
Compare.
Comment: One commenter sought
additional information on how CAHPS
for PQRS performance measures will be
displayed. Another commenter
suggested that public reporting of
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
CAHPS for PQRS utilize the Hospital
Compare model by displaying aggregate
scores for measures with a footnote or
click-through option to view the
performance data.
Response: We appreciate the
commenters’ feedback regarding display
of CAHPS for PQRS measures. We
generally make decisions about measure
display after consumer testing and
stakeholder outreach, so we will take
these recommendations into
consideration.
We previously finalized in the 2014
PFS final rule with comment period (78
FR 74454) that 20 measures in the 2014
PQRS measures for individual EPs
collected via registry, EHR, or claims
would be available for public reporting
in late 2015, if technically feasible. We
proposed (79 FR 40390) to expand on
this in two ways. First, we proposed to
publicly report these same 20 measures
for 2013 PQRS data in early 2015. We
stated that publicly reporting these 2013
individual measures would help ensure
individual level measures are made
available as soon as possible. We believe
that consumers are looking for measures
about individual doctors and other
health care professionals, and this
would make these quality data available
to the public sooner.
Comment: One commenter supported
our proposal to publicly report 20
individual EP-level 2013 PQRS
measures in early 2015, while another
commenter opposed the proposal noting
that physicians were unaware at the
time of data collection that these
performance rates would be published.
Concerns were raised that timelines
needed to be finalized before the public
reporting period had ended.
Response: We appreciate the
commenters’ feedback and understand
concerns that the 2013 individual EP
PQRS data were submitted without an
explicit understanding that these data
would be made public. As a result, we
are not finalizing this proposal.
Second, we proposed (79 FR 40390) to
make all individual EP-level PQRS
measures collected via registry, EHR, or
claims available for public reporting on
Physician Compare for data collected in
2015 to be publicly reported in late CY
2016, if technically feasible.9 We stated
that this would provide the opportunity
for more EPs to have measures included
on Physician Compare, and it would
provide more information to consumers
to make informed decisions about their
9 Tables Q1–Q27 detail proposed changes to
available PQRS measures. Additional information
on PQRS measures can be found on the CMS.gov
PQRS Web site at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-Assessment-Instruments/
PQRS/.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
health care. As with group-level
measures, we proposed to publicly
report all measures submitted and
reviewed and deemed valid and reliable
in the Physician Compare downloadable
file. However, not all of these measures
necessarily would be included on the
Physician Compare profile pages. Our
analysis of the reported measure data,
along with consumer testing and
stakeholder feedback, would determine
specifically which measures are
published on profile pages on the Web
site. In this way, quality information on
individual practitioners would be
available, as has been regularly
requested by Medicare consumers,
without overwhelming consumers with
too much information.
Comment: Some commenters
supported expanding public reporting of
individual-level quality measures to all
2015 PQRS measures collected through
a Registry, EHR, or claims, noting
consumers are looking for individual
doctors so this information is helpful.
Several commenters opposed making
2015 PQRS individual EP measures
available for public reporting in 2016
and are concerned that individual
quality measurement is technically
challenging to validate and may be
difficult for consumers to understand.
Another commenter suggested it is too
much information for consumers. One
commenter stated that data reported
through different reporting mechanisms
is not comparable so this proposal
should not be finalized. One commenter
believed that the relatively small
numbers of patients seen by individual
physicians raises questions about the
ability to truly differentiate quality.
Several commenters supported group
practice level public reporting as an
alternative to individual public
reporting.
Response: We appreciate the
commenters’ feedback and agree with
those comments that support
individual-level measure data should be
posted on the site as soon as technically
feasible. We also strongly agree with
commenters that these data will help
health care consumers make informed
decisions about the care they receive.
However, we appreciate the concerns
raised by other commenters’ in
opposition to posting individual EP
measures. We are committed to
including only the most accurate,
statistically reliable, and valid quality of
care measure data on Physician
Compare. We will also ensure that only
those data that are evaluated to be
comparable will be publicly reported
understanding the concerns regarding
data collected via different reporting
mechanisms.
PO 00000
Frm 00227
Fmt 4701
Sfmt 4700
67773
We will continue to test the PQRS
measures with consumers to ensure the
measures are presented and described in
a way that is accurately understood. We
will only include on the Web site those
measures that resonate with consumers
to ensure they are not overwhelmed
with too much information. Regarding
concerns around the number of patients
seen, only those measures that are
reported for the accepted sample size of
20 patients will be publicly reported.
Because of the overwhelming consumer
demand for individual EP data and the
value these data provide to patients, we
are finalizing our proposal to publicly
report all 2015 individual EP PQRS
measures collected through a Registry,
EHR, or claims, except for those
measure that are new to PQRS and thus
in their first year.
As noted above for group-level
reporting, composite scores and
benchmarks are critical in helping
consumers best understand the quality
measure information presented. For that
reason, in addition to making all 2015
PQRS measures available for public
reporting, we sought comment (79 FR
40390) to create composites and publish
composite scores by grouping measures
based on the PQRS measure groups, if
technically feasible. We indicated that
we would analyze the data collected in
2015 and conduct psychometric and
statistical analyses to create composites
for PQRS measure groups to be
published in 2016, including:
• Coronary Artery Disease (CAD) (see
Table 30)
• Diabetes Mellitus (DM) (see Table
32)
• General Surgery (see Table 33)
• Oncology (see Table 38)
• Preventive Care (see Table 41)
• Rheumatoid Arthritis (RA) (see
Table 42)
• Total Knee Replacement (TKR) (see
Table 45)
We would analyze the component
measures that make up each of these
measure groups to see if a statistically
viable composite can be constructed
with the data reported for 2015. As
noted for group practices, we believe
that providing composite scores will
give consumers the tools needed to most
accurately interpret the quality data
published on Physician Compare. We
would analyze the component measures
that make up each of these measure
groups to see if a statistically viable
composite can be constructed with the
data reported for 2015.
As noted above, we received multiple
comments about creating composites at
both the group practice and individual
EP-level. Those comments are addressed
above. Since we were only seeking
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67774
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
comments on possible future
composites, we are not finalizing any at
this time, but we will take those
comments into consideration for the
future.
In addition, we proposed (79 FR
40390) to use the same methodology
outlined above for group practices to
develop benchmarks for individual
practitioners. We believe that providing
benchmarks will give consumers the
tools needed to most accurately
interpret the quality data published on
Physician Compare. As discussed above,
we received comments on the proposed
benchmarking methodology for both
group practices and individual EPs.
Those comments were previously
addressed. As noted, we are not
finalizing this proposed benchmarking
methodology at this time.
Previously, we indicated an interest
in including specialty society measures
on Physician Compare. In the proposed
rule, we solicited comment (79 FR
40390) on posting these measures on the
Web site. We also solicited comment on
the option of linking from Physician
Compare to specialty society Web sites
that publish non-PQRS measures.
Including specialty society measures on
the site or linking to specific specialty
society measures would provide the
opportunity for more eligible
professionals to have measures included
on Physician Compare and thus help
Medicare consumers make more
informed choices. The quality measures
developed by specialty societies that
would be considered for future posting
on Physician Compare are those that
have been comprehensively vetted and
tested and are trusted by the physician
community. These measures would
provide access to available specialty
specific quality measures that are often
highly regarded and trusted by the
stakeholder community and, most
importantly, by the specialties they
represent. We indicated that we were
working to identify possible societies to
reach out to, and solicited comment on
the concept, as well as potential specific
society measures of interest.
Comment: Many commenters
supported specialty society measures on
Physician Compare or linking to
specialty society Web sites that publish
non-PQRS measures. Several
commenters specified that the specialty
society measures should be supported
by scientific evidence, developed by
relevant clinical experts, and adequately
vetted. Some commenters suggested a
disclaimer specifying, along with the
measure description, the limitations of
PQRS or clarification that CMS is not
endorsing and has not validated
specialty society measures. One
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
commenter supported specialty
measures as long as data is open
sourced, provided at no cost, and made
available to all. One commenter
suggested also including links to
additional patient-friendly educational
materials on specialty societies’ Web
sites.
Several commenters opposed posting
non-PQRS data or linking to nongovernmental, privately managed Web
sites. One commenter stated CMS
should maintain control over the public
disclosure process to reduce potential
for variable data. One commenter is
concerned that the approach will lead to
more confusion for consumers and
added burden for physicians, and
another commenter cautioned CMS to
ensure measures that are meaningful to
consumers and comparable to those
reported upon under the PQRS. A few
commenters sought additional
information on this process if this
becomes a formal proposal in future
years.
Response: We appreciate commenters’
feedback on our request for information.
We were only seeking comment at this
time. We will consider feedback,
recommendations made, and concerns
raised, and may consider addressing
specialty society measures and Web site
links on Physician Compare in future
rulemaking.
Finally, we proposed (79 FR 40390) to
make available on Physician Compare,
2015 Qualified Clinical Data Registry
(QCDR) measure data collected at the
individual level or aggregated to a
higher level of the QCDR’s choosing—
such as the group practice level, if
technically feasible. QCDRs are able to
collect both PQRS measures and nonPQRS measures.10 We believe that
making QCDR data available on
Physician Compare further supports the
expansion of quality measure data
available for EPs and group practices
regardless of specialty therefore
providing more quality data to
consumers to help them make informed
decisions. Per the proposal, the QCDR
would be required to declare during
their self-nomination if they plan to post
data on their own Web site and allow
Physician Compare to link to it or if
they will provide data to CMS for public
reporting on Physician Compare. We
proposed that measures collected via
QCDRs must also meet the established
public reporting criteria, including a 20
patient minimum sample size. As with
PQRS data, we proposed to publicly
10 https://www.cms.gov/apps/ama/
license.asp?file=/PQRS/downloads/2014_PQRS_
IndClaimsRegistry_MeasureSpecs_SupportingDocs_
12132013.zip
PO 00000
Frm 00228
Fmt 4701
Sfmt 4700
report in the Physician Compare
downloadable file all measures
submitted, reviewed, and deemed valid
and reliable. However, not all of these
measures necessarily would be included
on the Physician Compare profile pages.
Our analysis of the reported measure
data, along with consumer testing and
stakeholder feedback would determine
specifically which measures are
published on profile pages on the Web
site.
Comment: We received many
comments on publicly reporting 2015
QCDR measure data. Some commenters
supported publicly reporting QCDR data
to provide specialty-specific quality
information for patients. One
commenter proposed CMS consumer
test QCDR measures to ensure valid
sampling, consistent methods, and
comparable results across specialties.
A number of commenters did not
support the proposal, however. Most
notably, commenters believed that
public reporting first year data for new
measures would be problematic. Other
commenters opposed publicly reporting
QCDR data until accurate benchmarking
data can be developed, or professionals
have the opportunity to analyze the data
and make improvements. Several
commenters requested NQF
endorsement for all QCDR measures,
and one commenter suggested that CMS
develop rules and guidelines for
measure stewards who develop nonPQRS measures housed in QCDR’s. One
commenter stated society-sponsored
non-PQRS measures need to be
subjected to the same reliability,
validity, and consumer testing that CMS
promises for other information on
Physician Compare. Another commenter
noted that QCDR measures are collected
for quality improvement purposes and
have not been vetted for public
reporting.
Response: We appreciate the
commenters’ feedback on our proposal
to include all 2015 QCDR data at the
individual level or aggregated to a
higher level of the QCDR’s choosing. We
understand the many concerns raised.
We specifically appreciate the concerns
that the QCDR non-PQRS measures be
held to the same standards as the PQRS
measures in terms of reliability, validity,
and accuracy, and that these measures
be adequately tested and vetted for
public reporting. Understanding these
concerns, we will review all data prior
to public reporting to ensure that the
measures included meet the same
standards as the PQRS measures being
publicly reported. As with the PQRS
measures being made available for
public reporting, if the QCDR measures
do not meet the requirements for public
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
reporting we have set out, the measures
will not be publicly reported. Regarding
the comment that QCDR data should not
be publicly reported until accurate
benchmarks are available, we appreciate
this concern but are moving forward
with the proposal because we believe
that even without benchmarks, these
data can provide consumers with very
valuable and instructive information as
is the case, and thus consistent, with the
PQRS measures we are finalizing for
publication without a benchmark. We
do feel it is important to include QCDR
data in our public reporting plan, as
some commenters agreed, because using
QCDR data can ultimately provide an
opportunity to have measures available
for public reporting for a greater number
of health care professionals covering
more specialties, providing more and
more useful information to health care
consumers. We are therefore finalizing
our proposal to publicly report QCDR
measures with some modifications.
We agree that it may be problematic
to publicly report first year measures.
Health care professionals should be
afforded the opportunity to simply learn
from the first year data, and not have
this information shared publicly until
the measure can be vetted for accuracy.
As a result, we will not publicly report
any QCDR measures newly available for
reporting for at least one year. This is
consistent with the VM policy regarding
first year measures and addresses a
significant number of the concerns
raised, which were specifically in regard
to not including first year measures for
public reporting. If first year measures
are not publicly reported this will
provide us the necessary time to review
and vet the QCDR measures to ensure
that only those truly suitable for public
reporting are posted on Physician
Compare when they mature.
Comment: A number of commenters
considered the proposed timeline for
publicly reporting 2015 QCDR measure
data too aggressive to ensure that data
will be valid and reliable and in a
format which consumers can
understand; some suggested delaying or
implementing a gradual approach. A
few commenters were concerned public
reporting so soon will damage start up
efforts of new registries.
Several commenters supported the
proposal only if the QCDR measures are
posted on Physician Compare. One
commenter believed this will streamline
the public reporting process. One
commenter noted that QCDRs Web sites
are not intended for public consumption
and would require new infrastructure,
while another commenter was
concerned with a potential conflict of
interest by linking to nongovernmental
Web sites. Two commenters support
linking to the QCDR Web sites to view
the data to reduce consumer confusion.
Another commenter urged consistent
and uniform public reporting.
Response: We appreciate the
commenters’ feedback and do
acknowledge the concerns regarding the
timeline. To mitigate some of these
concerns, we are adopting some
refinements to what we proposed, such
as not reporting first year measures. We
believe that not publicly reporting
measures on Physician Compare that are
not ready for public reporting will help
QCDRs early in their development and
not reflect negatively on the new QCDR.
We are also finalizing a decision to
publish QCDR 2015 data on the
Physician Compare Web site in 2016.
However, as finalized in the PQRS
section of this rule, we are not requiring
these data to be publicly reported on the
QCDR Web sites in order to address
concerns that there is not enough time
for QCDRs to establish user-friendly
Web sites for sharing data as well as
concerns about data consistency.
Publicly reporting the QCDR data on
Physician Compare also provides a
uniform public reporting approach,
eliminates the need for health care
professionals to verify their data in
multiple locations, and provides one,
user-friendly Web site for consumers
trying to locate quality data. After this
first year of pubic reporting QCDR data,
we will evaluate if maintaining this
policy is most desirable.
67775
Comment: A few commenters
supported reporting individual or data
aggregating to a higher level, but the
majority recommend QCDR measure
data only be reported on Physician
Compare at the group practice level.
One commenter suggested requiring the
individual level data to be made
publicly available, so long as results are
valid and reliable. One commenter
believed QCDRs should have the option
to publicly disclose performance data by
physician specialty within a group, in
addition to at the individual or group
levels.
Response: We appreciate the
commenters’ feedback. As stated above,
only those data that are deemed valid,
reliable, and accurate will be publicly
reported on Physician Compare. This
will be true for all QCDR data as well.
Given that we will publish QCDR data
on Physician Compare, but not first year
measures, this will enable us to review
and vet the QCDR measures prior to
public reporting in 2016. In this way,
we can ensure only the most
appropriate available QCDR measures
are publicly reported, and that they are
reported in a way that will help
consumers make informed decisions.
QCDR data will only be publicly
reported at the individual-EP level. We
appreciate the commenters’ concerns
and support for group-level data.
However, QCDR data is not necessarily
aggregated to a level consistent with
how PQRS defines a group practice.
Therefore, aggregated data cannot be
accommodated on Physician Compare at
this time. And, under PQRS, only
individual EPs can report via a QCDR.
Therefore, only including individuallevel QCDR data on Physician Compare
is consistent with the PQRS program’s
implementation of the data. As with all
data included on Physician Compare,
only data deemed valid, reliable, and
accurate will be publicly reported on
the Web site.
Table 49 summarizes the Physician
Compare proposals we are finalizing for
with regard to 2015 data.
TABLE 49—SUMMARY OF FINALIZED DATA FOR PUBLIC REPORTING
Publication
year
2015 .......
ebenthall on DSK5SPTVN1PROD with $$_JOB
Data collection
year
2016
PQRS, PQRS GPRO,
EHR, and Million
Hearts.
Web Interface, EHR,
Registry, Claims.
2015 .......
2016
PQRS GPRO & ACO
GPRO.
Web Interface, EHR,
Registry, and Administrative Claims.
VerDate Sep<11>2014
Data type
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Reporting mechanism
Frm 00229
Fmt 4701
Finalized proposals regarding quality measures and data for
public reporting
Include an indicator for satisfactory reporters under PQRS, participants in the EHR Incentive Program, and EPs who satisfactorily
report the individual PQRS Cardiovascular Prevention measures in support of Million Hearts.
All 2015 PQRS GPRO measures reported via the Web Interface,
EHR, and Registry that are available for public reporting for
group practices of 2 or more EPs and all measures reported by
ACOs with a minimum sample size of 20 patients.
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
67776
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 49—SUMMARY OF FINALIZED DATA FOR PUBLIC REPORTING—Continued
Publication
year
2015 .......
2016
CAHPS for PQRS&
CAHPS for ACOs.
2015 .......
2016
PQRS ..........................
2015 .......
ebenthall on DSK5SPTVN1PROD with $$_JOB
Data collection
year
2016
QCDR data .................
Data type
4. Additional Comments Received
Beyond the Scope of This Rulemaking
We received comments regarding the
availability of measures at the
individual and group-levels for certain
types of specialties and for other health
care professionals, but that were beyond
the scope of this rule. We have
summarized and addressed those
comments below.
Comment: Several commenters are
concerned about the availability of
specialty-specific and non-physician
measures available for public reporting
due to the proposed removal of PQRS
measures and/or limitations of measures
reported via claims or the Web Interface.
Two commenters noted that some
specialty specific measures are not
suitable for public reporting, as the data
is not meaningful to consumers.
Commenters also noted that the absence
of measure data on Physician Compare
due to limited available or meaningful
measures may mislead consumers.
Commenters requested disclaimers be
added or additional education be
conducted to explain that there could be
the absence of measure data due to
measure limitations and not poor
quality. Several commenters expressed
concern with publicly reporting any
data until measure limitations can be
analyzed or addressed. Two
commenters supported the continued
work of CMS with professional societies
to address measure concerns.
Response: We appreciate the
commenters’ feedback. We understand
that availability of PQRS measures may
make it difficult for some specialties to
report. We hope that the introduction of
additional measures, such as QCDR
measures and patient experience
measures, will help mitigate concerns
regarding quality data availability in the
short term. And, it is important to
realize that as most searches on
Physician Compare are specialty based,
if there are not measures for a given
specialty, users will not be evaluating
some physicians or non-physicians with
measures and some without within that
specialty. That can also work to mitigate
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Reporting mechanism
Finalized proposals regarding quality measures and data for
public reporting
CMS-Specified Cer2015 CAHPS for PQRS for groups of 2 or more EPs and CAHPS
tified CAHPS Vendor.
for ACOs for those who meet the specified sample size requirements and collect data via a CMS-specified certified CAHPS
vendor.
Registry, EHR, or
All 2015 PQRS measures for individual EPs collected through a
Claims.
Registry, EHR, or claims.
QCDR ......................... All individual-EP level 2015 QCDR data.
these concerns. Finally, we also
understand that disclaimers and other
types of explanatory language are
necessary to help inform health care
consumers as they use the Web site. We
will continue to work to ensure that the
language included on Physician
Compare addresses the concerns raised
and helps users understand that there
are a number of reasons a physician or
other health care professional may not
have quality data on the Web site.
Comment: We received comments on
how quality measures are displayed on
Physician Compare. Several
commenters opposed star rankings or
similar systems and are concerned that
disparate quality scores will result in
inappropriate distinctions of quality for
physicians whose performance scores
are not statistically different. One
commenter suggested increased efforts
to establish the best method for
presenting performance information to
consumers and to educate consumers on
the meaning of performance differences.
Response: At the time this rule is
finalized, Physician Compare does not
employ a ranking system—the site does
not provide a system that determines
that one professional is better than other
professionals based on any set of
defined criteria. Performance scores are
displayed visually using five stars as a
pictographic representation of the
percent. In this way, each star
represents 20 percentage points. The
performance rate is also displayed as a
percent. Consumer testing has shown
that this display is most accurately
understood and interpreted by Web site
users. Stakeholders were provided
opportunities to view alternate display
options and this display was also
supported by a majority of those who
took part in review sessions prior to the
initial publication of measure data. That
said, we intend to continue to work
with consumers and stakeholders to
find the best way to display data that
will best serve consumers and most
accurately represent the data.
Comment: Several commenters are
concerned with the use of physician-
PO 00000
Frm 00230
Fmt 4701
Sfmt 4700
centric language in the proposed rule
and on Physician Compare, noting that
the name of the site could be more
inclusive of all eligible health care
professionals. One commenter suggested
providing information throughout the
Web site about the full array of qualified
professionals. One commenter requested
the definition of the Clinical Nurse
Specialist change, while another
specified changes for Registered
Dietitian/Nutrition Professionals. One
commenter asked CMS to assure that
audiologists are meaningfully
represented and can be easily identified
by other professionals and patients. One
commenter recommended that the
enrollment application process also be
refined to provide a provider neutral
enrollment process.
Response: We appreciate the
commenters’ feedback, and will take all
recommendations into consideration for
the future. The site was named
consistent with section 10331 of the
Affordable Care Act. Throughout the
site we note that both physicians and
other health care professionals are
available to search and view. If a
professional is in approved status in
PECOS and has submitted Medicare
Fee-For-Service claims in their name in
the last 12 months, they will be
included on Physician Compare. We are
always working to ensure the plain
language definitions of the various types
of professionals included on the site are
accurate and up-to-date. We will review
the recommendations made around this
information and work with relevant
stakeholders to update as appropriate.
Comment: Commenters provided
suggestions for additional information
to publicly report on Physician
Compare, including participation in a
quality improvement registry for certain
services, fellowship status, other
voluntary quality improvement
initiatives, educational materials about a
disease or procedure, specialist-specific
training and certification data, and other
qualifications, such as the Certified
Medical Director designation and the
Certificate of Added Qualifications in
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
Geriatric Medicine. One commenter
supported inclusion of information
about physician compliance with
Medicare rules. Another commenter
suggested including measures related to
cancer care.
Response: We appreciate the
commenters’ feedback and
recommendations for including
additional information on the Web site.
We will review all recommendations
provided and evaluate the feasibility for
potential inclusion in the future. One
important consideration around many of
these recommendations is whether there
is a readily available national-level data
source. With this in mind, the
recommendations will be closely
evaluated.
Comment: Several commenters noted
the limitations of CAHPS for PQRS
measures for some health care
professionals and supported adding
other types of patient experience data to
Physician Compare, including the
Surgical CAHPS® and experience data
collected via other sources. One
commenter suggested publicly reporting
beneficiary satisfaction information in
addition to CAHPS for PQRS measures.
Another commenter suggested reporting
patient experience data for primary care
physicians and clinical quality
performance for specialists.
Response: We appreciate the
commenters’ feedback. We agree that
Surgical CAHPS® data is useful to
consumers and we are exploring how
we can incorporate this information into
Physician Compare.
Comment: One commenter
encouraged CMS to recognize
improvements by individual
professionals and groups over time,
while another noted the benefits of
cross-sectional and cross-time
comparisons.
Response: We appreciate the
commenters’ feedback and the
recommendation to consider
longitudinal as well as other
comparisons. We will evaluate these
recommendations as we move forward
with Physician Compare.
Comment: One commenter suggested
that the measures being removed from
PQRS due to 100 percent performance
be added to the Physician Compare Web
site as display measures believing that
these topped out measures would add
value to Physician Compare.
Response: We appreciate the
commenter’s feedback. However, if the
measure data are no longer going to be
reported in PQRS, these data will not be
available to consider for posting on
Physician Compare.
Comment: One commenter urged
CMS to create mechanisms to attribute
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Medicare Advantage quality data to
physician groups for display on
Physician Compare and enable CG–
CAHPS vendors to include beneficiaries
enrolled in MA, as well as in traditional
Medicare fee-for-service.
Response: We appreciate the
commenters’ suggestions and will
evaluate the feasibility of these
recommendations for the future.
5. Report to Congress
Section 10331(f) of the Affordable
Care Act, requires that no later than
January 1, 2015, we submit a report to
Congress on the Physician Compare
Web site that includes information on
the efforts of and plans made by the
Secretary of Health and Human Services
to collect and publish data on physician
quality and efficiency and on patient
experience of care in support of
consumer choice and value-based
purchasing. We anticipate timely
submission of this report, including
discussion about the phase-in of the
Web site and developments to date. The
report will also address the expansion of
data on the Web site, in regard to
section 10331(g) of the Affordable Care
Act, and future plans for the Web site.
K. Physician Payment, Efficiency, and
Quality Improvements—Physician
Quality Reporting System
This section contains the
requirements for the Physician Quality
Reporting System (PQRS). The PQRS, as
set forth in sections 1848(a), (k), and (m)
of the Act, is a quality reporting
program that provides incentive
payments (ending with 2014) and
payment adjustments (beginning in
2015) to eligible professionals and group
practices based on whether they
satisfactorily report data on quality
measures for covered professional
services furnished during a specified
reporting period or to individual eligible
professionals that satisfactorily
participate in a qualified clinical data
registry (QCDR).
The requirements in this rule
primarily focus on the 2017 PQRS
payment adjustment, which will be
based on an eligible professional’s or a
group practice’s reporting of quality
measures data during the 12-month
calendar year reporting period occurring
in 2015 (that is, January 1 through
December 31, 2015). Please note that,
during the comment period, we received
comments that were not related to our
specific proposals for the requirements
for the 2017 PQRS payment adjustment
in the CY 2015 PFS proposed rule.
While we appreciate the commenters’
feedback, these comments will not be
specifically addressed in this CY 2015
PO 00000
Frm 00231
Fmt 4701
Sfmt 4700
67777
PFS final rule with comment period, as
they are beyond the scope of this rule.
However, we will consider these
comments when developing policies
and program requirements for future
years. Please note that we continue to
focus on aligning our requirements with
other quality reporting programs, such
as the Medicare EHR Incentive Program
for Eligible Professionals, the VM, and
the Medicare Shared Savings Program,
where and to the extent appropriate and
feasible.
The PQRS regulations are located at
§ 414.90. The program requirements for
the 2007 through 2014 PQRS incentives
and the 2015 and 2016 PQRS payment
adjustment that were previously
established, as well as information on
the PQRS, including related laws and
established requirements, are available
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/PQRS/. In
addition, the 2012 PQRS and eRx
Experience Report, which provides
information about eligible professional
participation in PQRS, is available for
download at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/PQRS/
Downloads/2012–PQRS-and-eRxExperience-Report.zip.
We note that eligible professionals in
critical access hospitals billing under
Method II (CAH–IIs) were previously
not able to participate in the PQRS. Due
to a change we made in the manner in
which Medicare reimburses eligible
professionals in CAH–IIs, it is feasible
for eligible professionals in CAH–IIs to
participate in the PQRS for reporting
beginning in 2014. Although eligible
professionals in CAH–IIs are not able to
use the claims-based reporting
mechanism to report PQRS quality
measures data in 2014, beginning in
2015, these eligible professionals in
CAH–IIs may participate in the PQRS
using ALL reporting mechanisms
available, including the claims-based
reporting mechanism. Finally, please
note that in accordance with section
1848(a)(8) of the Act, all eligible
professionals who do not meet the
criteria for satisfactory reporting or
satisfactory participation for the 2017
PQRS payment adjustment will be
subject to the 2017 PQRS payment
adjustment with no exceptions.
In addition, in the CY 2013 PFS final
rule with comment period, we
introduced the reporting of the Agency
for Healthcare Research and Quality’s
(AHRQ’s) Clinician & Group (CG)
Consumer Assessment of Healthcare
Providers and Systems (CAHPS) survey
measures, referenced at https://
cahps.ahrq.gov/Surveys-Guidance/CG/
E:\FR\FM\13NOR2.SGM
13NOR2
67778
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
index.html. AHRQ’s CAHPS Clinician &
Group Survey Version 2.0 (CG–CAHPS)
includes 34 core CG–CAHPS survey
questions. In addition to these 34 core
questions, the CAHPS survey measures
that are used in the PQRS include
supplemental questions from CAHPS
Patient-Centered Medical Home Survey,
Core CAHPS Health Plan Survey
Version 5.0, other CAHPS supplemental
items, and some additional questions.
Since the CAHPS survey used in the
PQRS covers more than just the 34 core
CG–CAHPS survey measures, we will
refer to the CG–CAHPS survey measures
used in the PQRS as ‘‘CAHPS for
PQRS.’’ We proposed to make this
revision throughout § 414.90. We did
not receive comments on referring to the
CG–CAHPS survey measures as reported
in the PQRS as CAHPS for PQRS, and
are therefore finalizing this proposal as
proposed.
1. Requirements for the PQRS Reporting
Mechanisms
The PQRS includes the following
reporting mechanisms: claims; qualified
registry; EHR (including direct EHR
products and EHR data submission
vendor products); the Group Practice
Reporting Option (GPRO) web interface;
certified survey vendors, for the CAHPS
for PQRS survey measures; and the
QCDR. Under the existing PQRS
regulation, § 414.90(h) through (k)
govern which reporting mechanisms are
available for use by individuals and
group practices for the PQRS incentive
and payment adjustment. This section
III.K.1 contains our proposals to change
the qualified registry, direct EHR and
EHR data submission vendor products,
QCDR, and GPRO web interface
reporting mechanisms, as well as public
comments and our final decisions on
those proposals. Please note that we did
not propose to make changes to the
claims-based reporting mechanism.
Please note that, in the CY 2015 PFS
proposed rule, we solicited comments
on whether, in future years, we should
allow for more frequent submissions,
such as quarterly or year-round
submissions, for PQRS quality measures
data submitted via the qualified registry,
EHR, QCDR, and GPRO web interface
reporting mechanisms (79 FR 40392,
40393, and 40395 respectively). Many
commenters supported this concept, as
it would provide vendors and their
products greater flexibility in data
submission. However, some of these
commenters who expressed support for
more frequent submissions of data
preferred that the ability to provide
more frequent submission of data be
optional, not mandatory. We appreciate
the commenters’ support for this
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
concept and will consider the
commenters’ feedback if and when we
propose this policy in future
rulemaking.
a. Changes to the Requirements for the
Qualified Registry
In the CY 2013 and 2014 PFS final
rules with comment period, we
established certain requirements for
entities to become qualified registries
for the purpose of verifying that a
qualified registry is prepared to submit
data on PQRS quality measures for the
reporting period in which the qualified
registry seeks to be qualified (77 FR
69179 through 69180 and 78 FR 74456).
Specifically, in the CY 2014 PFS final
rule with comment period, in
accordance with the satisfactory
reporting criterion we finalized for
individual eligible professionals or
group practices reporting PQRS quality
measures via qualified registry, we
finalized the following requirement that
a qualified registry must be able to
collect all needed data elements and
transmit to CMS the data at the TIN/NPI
level for at least 9 measures covering at
least 3 of the National Quality Strategy
(NQS) domains (78 FR 74456).
As we explain in further detail in this
section III.K, we proposed that—in
addition to requiring that an eligible
professional or group practice report on
at least 9 measures covering 3 NQS
domains—an eligible professional or
group practice who sees at least 1
Medicare patient in a face-to-face
encounter, as we define that term in
section III.K.2.a., and wishes to meet the
criterion for satisfactory reporting of
PQRS quality measures via a qualified
registry for the 2017 PQRS payment
adjustment would be required to report
on at least 2 cross-cutting PQRS
measures specified in Table 52. In
accordance with this proposal, we
proposed to require that, in addition to
being required to be able to collect all
needed data elements and transmit to
CMS the data at the TIN/NPI level for
at least 9 measures covering at least 3 of
the NQS domains for which a qualified
registry transmits data, a qualified
registry would be required to be able to
collect all needed data elements and
transmit to CMS the data at the TIN/NPI
level for ALL cross-cutting measures
specified in Table 52 for which the
registry’s participating eligible
professionals are able to report.
Comment: Some commenters opposed
this proposed requirement, stating that
this requirement seems overly
burdensome. The commenters noted
that, in some instances, certain registries
report PQRS quality measures data for
certain specialties for which the
PO 00000
Frm 00232
Fmt 4701
Sfmt 4700
proposed cross-cutting measure set does
not apply. Commenters also requested
exceptions to this requirement for
‘‘closed registries,’’ which the
commenter defined as registries not
open to all eligible professionals for
participation.
Response: We understand the
commenters’ concerns regarding
requiring registries to be able to report
on all cross-cutting measures specified
in Table 52. We made this proposal to
allow eligible professionals and group
practices the option to report on as
many cross-cutting measures as are
applicable. However, we understand
that it may be overly burdensome for
certain registries, such as those
registries geared towards specialties for
which the cross-cutting measures do not
apply or ‘‘closed registries.’’ Therefore,
based on the comments received, we are
not finalizing our proposal to require
that qualified registries be able to report
on all cross-cutting measures specified
in Table 52 for which the registry’s
participating eligible professionals are
able to report. We note, however, as we
describe in greater detail below, eligible
professionals and group practices using
the registry-based reporting mechanism
that see at least 1 Medicare patient in a
face-to-face encounter must still report
on 1 cross-cutting measure to meet the
criteria for satisfactory reporting for the
2017 PQRS payment adjustment.
Therefore, in order for the registry’s
participating eligible professionals and
group practices to meet the criteria for
satisfactory reporting for the 2017 PQRS
payment adjustment, the registry must
be able to report to report on at least 1
cross-cutting measure on behalf of its
participating eligible professionals and
group practices.
Furthermore, in the CY 2013 PFS final
rule, we noted that qualified registries
have until the last Friday of February
following the applicable reporting
period (for example, February 28, 2014,
for reporting periods ending in 2013) to
submit quality measures data on behalf
of its eligible professionals (77 FR
69182). We continue to receive
stakeholder feedback, particularly from
qualified registries currently
participating in the PQRS, urging us to
extend this submission deadline due to
the time it takes for these qualified
registries to collect and analyze the
quality measures data received after the
end of the reporting period. Although, at
the time, we emphasized the need to
have quality measures data received by
CMS no later than the last Friday of the
February occurring after the end of the
applicable reporting period, we believe
it is now feasible to extend this
deadline. Therefore, we proposed to
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
extend the deadline for qualified
registries to submit quality measures
data, including, but not limited to,
calculations and results, to March 31
following the end of the applicable
reporting period (for example, March
31, 2016, for reporting periods ending in
2015). We invited and received the
following public comments on this
proposal:
Comment: Commenters supported
this proposal, as it would allow
qualified registries an additional month
to submit quality measures data.
Response: We appreciate the
commenters’ positive feedback. Based
on the comments received and for the
reasons stated in the proposed rule, we
are finalizing our proposal to extend the
deadline for qualified registries to
submit quality measures data,
including, but not limited to,
calculations and results, to March 31
following the end of the applicable
reporting period (for example, March
31, 2016, for reporting periods ending in
2015).
b. Changes to the Requirements for the
Direct EHR and EHR Data Submission
Vendor Products That Are CEHRT
In the CY 2013 PFS final rule with
comment period, we finalized
requirements that although EHR
vendors and their products would no
longer be required to undergo the
previously existing qualification
process, we would only accept the data
if the data are: (1) Transmitted in a
CMS-approved XML format utilizing a
Clinical Document Architecture (CDA)
standard such as Quality Reporting Data
Architecture (QRDA) level 1 (and for
EHR data submission vendor products
that intend to report for purposes of the
proposed PQRS-Medicare EHR
Incentive Program Pilot, if the aggregate
data are transmitted in a CMS-approved
XML format); and (2) in compliance
with a CMS-specified secure method for
data submission (77 FR 69183 through
69187). To further clarify, EHR vendors
and their products must be able to
submit data in the form and manner
specified by CMS. Accordingly, direct
EHRs and EHR data submission vendors
must comply with CMS Implementation
Guides for both the QRDA–I and
QRDA–III data file formats. The
Implementation Guides for 2014 are
available at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
EHRIncentivePrograms/Downloads/
Guide_QRDA_2014eCQM.pdf. Updated
guides for 2015, when available, will be
posted on the CMS EHR Incentive
Program Web site at https://
www.cms.gov/Regulations-andGuidance/Legislation/
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
EHRIncentivePrograms. These
implementation guides further describe
the technical requirements for data
submission to ensure the data elements
required for measure calculation and
verification are provided. We proposed
to continue applying these requirements
to direct EHR products and EHR data
submission vendor products for 2015
and beyond. We received no public
comment on our proposal to continue
applying these requirements. Therefore,
we are finalizing our proposal to have
direct EHRs and EHR data submission
vendors comply with CMS
Implementation Guides for both the
QRDA–I and QRDA–III data file formats
for 2015 and beyond.
For 2015 and beyond, we also
proposed to have the eligible
professional or group practice provide
the CMS EHR Certification Number of
the product used by the eligible
professional or group practice for direct
EHRs and EHR data submission
vendors. We believe this requirement is
necessary to ensure that the eligible
professionals and group practices that
are using EHR technology are using a
product that is certified EHR technology
(CEHRT) and will allow CMS to ensure
that the eligible professional or group
practice’s data is derived from a product
that is CEHRT. We solicited but
received no public comment on this
proposal. However, we do not believe it
is feasible for us to collect this
information at this time, because we do
not have a venue in which to store this
information. Therefore, we are not
finalizing this proposal.
c. Changes to the Requirements for the
QCDR
Reporting Outcome Measures:
In accordance with the criterion for
satisfactory participation in a QCDR that
we proposed for the 2017 PQRS
payment adjustment, we proposed to
require a QCDR to possess at least 3
outcome measures (or, in lieu of 3
outcome measures, at least 2 outcome
measures and at least 1 of the following
other types of measures—resource use,
patient experience of care, or efficiency/
appropriate use) (79 FR 40393). We
solicited and received the following
comment on this proposal:
Comment: The majority of
commenters opposed this proposal. The
commenters believed this proposed
requirement was overly burdensome,
particularly for the QCDRs that do not
have 3 outcome measures available for
reporting currently. The commenters
urged CMS not to bring about change to
a reporting option that is still relatively
new.
PO 00000
Frm 00233
Fmt 4701
Sfmt 4700
67779
Response: We understand the
commenters’ concerns. As we describe
in greater detail in section III.K.3.a.
below, we are modifying our final
criterion for satisfactory participation in
a QCDR for the 2017 PQRS payment
adjustment by only requiring that an
eligible professional report on at least 2
outcome measures (or, in lieu of 2
outcome measures, at least 1 outcome
measure and 1 of the following other
types of measures—resource use, patient
experience of care, efficiency/
appropriate use, or safety). Since this
proposal was intended to be consistent
with our final criterion for the
satisfactory participation in a QCDR for
the 2017 PQRS payment adjustment, we
are modifying this proposal and
finalizing the following requirement for
QCDRs: A QCDR must possess at least
2 outcome measures. If the QCDR does
not possess 2 outcome measures, then,
in lieu of 2 outcome measures, the
QCDR must possess at least 1 outcome
measures and 1 of the following other
types of measures—resource use, patient
experience of care, efficiency/
appropriate use, or safety. We believe
this modification does not significantly
change the current QCDR requirement
to possess at least 1 outcome measure,
as a QCDR may still possess only one
measure for reporting in 2015 and still
qualify to become or remain a QCDR
provided that the QCDR possesses 1 of
the following other types of measures—
resource use, patient experience of care,
efficiency/appropriate use, or safety.
Reporting Non-PQRS Measures:
To establish the minimum number of
measures (9 measures covering at least
3 NQS domains) a QCDR may report for
the PQRS, we placed a limit on the
number of non-PQRS measures (20) that
a QCDR may submit on behalf of an
eligible professional at this time (78 FR
74476). We proposed to change this
limit from 20 measures to 30 (79 FR
40393). We solicited and received the
following public comment on this
proposal:
Comment: Some commenters
supported this proposal, as it would
allow QCDRs to report on more
measures that may cover a broader range
of specialties and sub-specialties. A few
commenters opposed this proposal, as
the commenters urged CMS not to bring
about change to a reporting option that
is still relatively new.
Response: We appreciate the
commenters’ positive feedback. While
we understand the need to provide
continuity and stability in this reporting
option, particularly during its early
stages, we believe that the benefits of
allowing QCDRs potentially to cover a
broader range of specialties and sub-
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67780
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
specialties outweigh the commenters’
concerns. Therefore, we are finalizing
our proposal that beginning with the
criteria for satisfactory participation for
the 2017 PQRS payment adjustment, a
QCDR may submit quality measures
data for a maximum of 30 non-PQRS
measures. Please note that this limit
does not apply to measures contained in
the PQRS measure set, as QCDRs can
report on as many measures in the
PQRS measure set as they wish. Also,
please note that QCDRs are not required
to report on 30 non-PQRS measures.
Rather, the reporting of non-PQRS
measures is optional, and our final rule
here increases the number of optional
additional measures that a QCDR may
elect to submit.
Definition of a Non-PQRS Measure:
Additionally, CMS’ experience during
the 2014 self-nomination process shed
light on clarifications needed on what is
considered a non-PQRS measure.
Therefore, to clarify the definition of
non-PQRS measures, we proposed the
following parameters for a measure to be
considered a non-PQRS measure:
• A measure that is not contained in
the PQRS measure set for the applicable
reporting period.
• A measure that may be in the PQRS
measure set but has substantive
differences in the manner it is reported
by the QCDR. For example, PQRS
measure 319 is reportable only via the
GPRO Web interface. A QCDR wishes to
report this measure on behalf of its
eligible professionals. However, as CMS
has only extracted the data collected
from this quality measure using the
GPRO Web interface, in which CMS
utilizes a claims-based assignment and
sampling methodology to inform the
groups on which patients they are to
report, the reporting of this measure
would require changes to the way that
the measure is calculated and reported
to CMS via a QCDR instead of through
the GPRO Web interface. Therefore, due
to the substantive changes needed to
report this measure via a QCDR, PQRS
measure 319 would be considered a
non-PQRS measure. In addition, CAHPS
for PQRS is currently reportable only
via a CMS-certified survey vendor.
However, although CAHPS for PQRS is
technically contained in the PQRS
measure set, we consider the changes
that will need to be made to be available
for reporting by individual eligible
professionals (and not as a part of a
group practice) significant enough as to
treat CAHPS for PQRS as a non-PQRS
measure for purposes of reporting
CAHPS for PQRS via a QCDR.
To the extent that further clarification
on the distinction between a PQRS and
a non-PQRS measure is necessary, we
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
will provide additional guidance on our
Web site at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/pqrs/
index.html.
Public Reporting of QCDR Quality
Measures Data:
Furthermore, under our authority to
establish the requirements for an entity
to be considered a QCDR under section
1848(m)(3)(E)(i) of the Act, we
established certain requirements for an
entity to be considered a QCDR in the
CY 2014 PFS final rule with comment
period (78 FR 74467 through 74473).
Under this same authority, we proposed
here to add the following requirement
that an entity must meet to serve as a
QCDR under the PQRS for reporting
periods beginning in 2015:
• Require that the entity make
available to the public the quality
measures data for which its eligible
professionals report.
To clarify this proposal, we proposed
that, at a minimum, the QCDR publicly
report the following quality measures
data information that we believe will
give patients adequate information on
the care provided by an eligible
professional: The title and description
of the measures that a QCDR reports for
purposes of the PQRS, as well as the
performance results for each measure
the QCDR reports. We solicited and
received the following public comment
on this proposal:
Comment: Some commenters
supported this proposal, as the
commenters believed it was reasonable
to require that this information be made
available to the public. These
commenters supported our proposal to
defer to the QCDR in terms of what
platform and in what manner this data
may be made available to the public.
Some commenters opposed this
proposal, stating that the public
reporting requirement was overly
burdensome, and urged CMS to delay
requiring the posting of measures data
until the measures have been tested for
validity and reliability. The commenters
believed that CMS should not make
substantial changes in the QCDR
requirements as the QCDR option is new
and the entities need time to familiarize
themselves with the QCDR option
before new requirements are
established.
Response: With respect to the
commenters who opposed this proposal
and urged CMS not to make additional
changes to the QCDR option while
entities become more familiar with this
option, we understand the commenters’
concerns. However, we believe that
transparency of data is a key component
of a QCDR option. We believe that it is
PO 00000
Frm 00234
Fmt 4701
Sfmt 4700
appropriate to finalize this public
reporting requirement at this time. In
the CY 2014 PFS final rule, while we
did not finalize our proposal that a
QCDR have a plan to publicly report
quality measures data, we noted that we
encouraged ‘‘these qualified clinical
data registries to move towards the
public reporting of quality measures
data’’ and that we planned to ‘‘establish
such a requirement in the future’’ and
would ‘‘revisit this proposed
requirement as part of CY 2015
rulemaking’’ (78 FR 74471). Therefore,
we believe that QCDRs were on notice
that we would propose and finalize a
requirement to make quality measures
data available to the public beginning
with the CY 2015 reporting.
However, although we do not believe
we should further delay requiring
public report of QCDR quality measures
data, we do agree with the commenters
on delaying public posting of measures
information until a measure has been
tested for validity and reliability.
Therefore, we are providing an
exception to this requirement for new
measures (both PQRS and non-PQRS
measures) that are in their first year of
reporting by a QCDR under the PQRS.
We define a measure being introduced
in the PQRS for the first time as the first
time a quality measure is either
introduced in the PQRS measure set in
rulemaking as a new measure for that
reporting period or, for non-PQRS
measures that can be reported by a
QCDR, the first time a QCDR submits a
measure (including its measure
specifications) for reporting for the
PQRS for the first time. Please note that,
to the extent that a QCDR first reports
on a non-PQRS measure that is already
being reported by another QCDR, we
would consider the measure a measure
that is in its first year of reporting for
that respective QCDR who is reporting
the measure for the first time. We
believe that providing QCDRs with one
year to test and validate new measures
provides sufficient time for QCDRs to
find potential data issues and correct
those issues prior to a measure’s second
year of reporting in the PQRS.
Based on the comments received and
for the reasons stated in the proposed
rule, we are finalizing this proposal to
require that the entity make available to
the public the quality measures data for
which its eligible professionals report.
However, as we explained above, we are
providing an exception to this
requirement for new PQRS and nonPQRS measures that are in their first
year of reporting by a QCDR under the
PQRS. Therefore, quality measure data
for a PQRS or non-PQRS measure that
is being reported by a QCDR in the
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
PQRS for the first time does not need to
be posted for at least the initial year.
After the initial year of reporting a new
measure, as we believe it is important
for a QCDR to be transparent in the
quality performance of its eligible
professionals, quality measures
performance data for the measure
(except for the data collected in the
measure’s first year of reporting in the
PQRS) would be required to be made
available to the public.
Please note that, in finalizing these
requirements on public reporting, we
defer to the entity in terms of the
method it will use to publicly report the
quality measures data it collects for the
PQRS. For example, to meet this
requirement, it would be sufficient for a
QCDR to publicly report performance
rates of eligible professionals through
means such as board or specialty Web
sites, or listserv dashboards or
announcements. We also note that a
QCDR would meet this public reporting
requirement if the QCDR’s measures
data were posted on Physician Compare.
In addition, we defer to the QCDR to
determine whether to report
performance results at the individual
eligible professional level or aggregate
the results for certain sets of eligible
professionals who are in the same
practice together (but who are not
registered as a group practice for the
purposes of PQRS reporting). We
believe it is appropriate to allow a
QCDR to publicly report performance
results at an aggregate level for certain
eligible professionals when those who
are in the same practice contribute to
the overall care provided to a patient.
• With respect to when the quality
measures data must be publicly
reported, we proposed that the QCDR
must have the quality measures data by
April 31 of the year following the
applicable reporting period (that is,
April 31, 2016, for reporting periods
occurring in 2015). The deadline of
April 31 will provide QCDRs with one
month to post quality measures data and
information following the March 31
deadline for the QCDRs to transmit
quality measures data for purposes of
the PQRS payment adjustments. Please
note that we erroneously stated the
proposed deadline as April 31, which
does not exist in the calendar. We
intended to propose a deadline that falls
at the end of April—specifically, a
deadline of April 30, not April 31, of the
year following the applicable reporting
period (that is, April 30, 2016, for
reporting periods occurring in 2015).
This was an inadvertent technical error,
and we are therefore correcting this
proposal here and our responses to
comments below to reflect our intention
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
to propose a deadline of April 30 of the
year following the applicable reporting
period. We believe this does not
materially modify this proposal, and as
April 31 does not exist in the calendar,
we believe that the public and
commenters could reasonably infer that
we intended to refer to the end of April
in this proposed deadline, which is
April 30 and thus reasonably foresee
that we would adopt such a deadline.
Therefore, we will address the
comments and frame our responses
below as they relate to an April 30
deadline of the year following the
applicable reporting period (that is,
April 30, 2016, for reporting periods
occurring in 2015). We also proposed
that this data be available on a
continuous basis and be continuously
updated as the measures undergo
changes in measure title and
description, as well as when new
performance results are calculated. We
solicited and received the following
public comments on this proposal:
Comment: A few commenters
opposed our proposal to require that a
QCDR must have the quality measures
data by April 30 of the year following
the applicable reporting period. The
commenter noted that any performance
data publicly posted should be tested
for accuracy and reliability. One
commenter stated that QCDRs need
more time following the QCDR
submission deadline of March 31 to
publicly post quality measures data.
Another commenter noted that this
timeline is more aggressive than that
proposed on Physician Compare.
Response: We believe that the
proposed April 30 deadline to make
available quality measures data (except
for PQRS and non-PQRS measures in
their initial year of reporting under the
PQRS) is reasonable, as we assume
QCDRs would have already tested
quality measures data and results for
accuracy and reliability for the
particular reporting period prior to
submitting these quality measures data
calculations and results by the March 31
submission deadline. However, we
agree with the commenter on the need
to provide accurate and reliable data
prior to the data being publicly
reported. Therefore, given concerns
from commenters that April 30 does not
provide the QCDRs with enough time to
accurately post quality measures data,
we are extending the deadline by which
a QCDR must publicly report quality
measures data outside of Physician
Compare to the deadline by which
Physician Compare posts QCDR quality
measures data as discussed in section
III.J above. That is, as indicated in Table
49 in section III.J.3 above, QCDRs
PO 00000
Frm 00235
Fmt 4701
Sfmt 4700
67781
wishing to publicly report quality
measures data outside of Physician
Compare must do so in 2016.
Proposals Related to Collaboration of
Entities To Become a QCDR:
Based on our experience with the
qualifying entities wishing to become
QCDRs for reporting periods occurring
in 2014, we received feedback from
many organizations who expressed
concern that the entity wishing to
become a QCDR may not meet the
requirements of a QCDR solely on its
own. Therefore, we provided the
following proposals beginning in 2015
on situations where an entity may not
meet the requirements of a QCDR solely
on its own but, in conjunction with
another entity, may be able to meet the
requirements of a QCDR and therefore
be eligible for qualification:
• We proposed to allow that an entity
that uses an external organization for
purposes of data collection, calculation
or transmission may meet the definition
of a QCDR so long as the entity has a
signed, written agreement that
specifically details the relationship and
responsibilities of the entity with the
external organizations effective as of
January 1 the year prior to the year for
which the entity seeks to become a
QCDR (for example, January 1, 2014, to
be eligible to participate for purposes of
data collected in 2015). Entities that
have a mere verbal, non-written
agreement to work together to become a
QCDR by January 1 the year prior to the
year for which the entity seeks to
become a QCDR would not fulfill this
proposed requirement. We solicited and
received the following public comment
on this proposal:
Comment: A few commenters
supported this proposal, as it allowed
entities such as medical boards that may
not have the technical capabilities to
submit quality measures data
calculations and results to CMS to
collaborate with other entities.
Response: We appreciate the
commenters’ support. Based on the
comments received, for the reasons
stated here, and in the proposed rule,
we are finalizing this proposal.
• In addition, we proposed that an
entity that has broken off from a larger
organization may be considered to be in
existence for the purposes of QCDR
qualification as of the earliest date the
larger organization begins continual
existence. We received questions from
entities who used to be part of a larger
organization but have recently become
independent from the larger
organization as to whether the entities
would meet the requirement established
in the CY 2014 PFS final rule with
comment period that the entity be in
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67782
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
existence as of January 1 the year prior
to the year for which the entity seeks to
become a QCDR (78 FR 74467). For
example, a registry that was previously
a part of a larger medical society as of
January 1, 2013, could have broken off
from the medical society and become an
independent registry in 2014. Likewise,
a member of a medical society could
create a registry separate from the
medical society. As such, there would
be concern as to whether that entity
would meet the requirement of being in
existence prior to January 1, 2013, to be
considered for qualification for
reporting periods occurring in 2014. In
these examples, for purposes of meeting
the requirement that the entity be in
existence as of January 1 the year prior
to the year for which the entity seeks to
become a QCDR, we may consider this
entity as being in existence as of the
date the larger medical society was in
existence. We solicited and received the
following comments on this proposal:
Comment: Commenters supported
this proposal.
Response: We appreciate the
commenters’ support and, based on the
comments received and for the reasons
stated above, we are finalizing this
proposal.
Data Submission Deadline:
In the CY 2014 PFS final rule with
comment period, in accordance with the
submission deadline of quality
measures data for qualified registries,
we noted a deadline of the last Friday
in February occurring after the end of
the applicable reporting period to
submit quality measures data to CMS
(78 FR 74471). In accordance with our
proposal to extend this deadline for
qualified registries, we proposed to
extend the deadline for QCDRs to
submit quality measures data
calculations and results by March 31
following the end of the applicable
reporting period (that is, March 31,
2016, for reporting periods ending in
2015).
We solicited and received the
following public comments on this
proposal:
Comment: Commenters supported
this proposal, as it would allow
qualified registries an additional month
to submit quality measures data and
aligns with our proposal to extend the
submission deadline for qualified
registries.
Response: We appreciate the
commenters’ positive feedback. Based
on the comments received and for the
reasons stated in the proposed rule, we
are finalizing our proposal to extend the
deadline for QCDRs to submit quality
measures data, including, but not
limited to, calculations and results, to
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
March 31 following the end of the
applicable reporting period (for
example, March 31, 2016, for reporting
periods ending in 2015).
d. Changes to the GPRO Web Interface
In the CY 2014 PFS final rule with
comment period (78 FR 74456), we
finalized our proposal to require ‘‘that
group practices register to participate in
the GPRO by September 30 of the year
in which the reporting period occurs
(that is September 30, 2014 for reporting
periods occurring in 2014), as
proposed.’’ However, we noted that, in
order ‘‘to respond to the commenters
concerns to provide timelier feedback
on performance on CG CAHPS in the
future, we anticipate proposing an
earlier deadline for group practices to
register to participate in the GPRO in
future years’’ (78 FR 74456). Indeed, to
provide timelier feedback on
performance on CAHPS for PQRS, we
proposed to modify the deadline that a
group practice must register to
participate in the GPRO to June 30 of
the year in which the reporting period
occurs (that is, June 30, 2015, for
reporting periods occurring in 2015).
Specifically, although we still seek to
provide group practices with as much
time as feasible to decide whether to
register to participate in the PQRS as a
GPRO, we weigh this priority with
others, such as our desire to provide
more timely feedback to participants of
the PQRS, as well as other CMS quality
reporting programs such as the VM.
Therefore, in an effort to provide
timelier feedback, we proposed to
change the deadline by which a group
practice must register to participate in
the GPRO to June 30 of the applicable
12-month reporting period (that is, June
30, 2015, for reporting periods occurring
in 2015). This proposed change would
allow us to provide timelier feedback
while still providing group practices
with over 6 months to determine
whether they should participate in the
PQRS GPRO or, in the alternative,
participate in the PQRS as individual
eligible professionals. Although this
proposed GPRO registration deadline
would provide less time for a group
practice to decide whether to participate
in the GPRO, we believe the benefit of
providing timelier feedback reports
outweighs this concern. We solicited
and received the following public
comments on these proposals:
Comment: Some commenters
supported our proposal to shorten the
deadline that a group practice must
register to participate in the GPRO to
June 30 of the year in which the
reporting period occurs (that is, June 30,
2015, for reporting periods occurring in
PO 00000
Frm 00236
Fmt 4701
Sfmt 4700
2015) in order to provide timelier
feedback reports. Other commenters
opposed our proposal to shorten the
deadline from September 30 to June 30,
as the commenters believed that the
extra time was needed to weigh the
advantages and disadvantages of all the
reporting options prior to registering for
the GPRO and electing a reporting
mechanism. One commenter noted that
this is particularly important when
reporting via EHR, as updates are
required for EHR products. Some
commenters requested that information
for the various reporting mechanisms,
such as the list of qualified registries for
the reporting period, be made available
earlier. Other commenters believed that
it would be difficult for group practices
to transition to an earlier registration
date and requested that CMS delay
finalizing this proposal to 2016. Other
commenters stated that the proposed
deadline would negatively affect group
practices that change their Taxpayer
Identification Number (TIN) after June
30, as the group practice would be
required to report individually, adding
to administrative and reporting burden.
Response: With respect to the
comments opposing this proposal, we
believe that June 30 provides group
practices with ample time to decide to
register to participate in the PQRS as a
GPRO, as well as choose a reporting
mechanism. With respect to the concern
of having to choose a reporting option
and not having all information on the
PQRS reporting options prior to the June
30 deadline, we note that CMS makes
numerous guidance documents
available on the CMS Web site at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/pqrs/, and group
practices can submit any questions to
the QualityNet Help Desk at
Qnetsupport@hcqis.org. With respect to
some commenters’ requests that
information for the various reporting
mechanisms, such as the list of qualified
registries for the reporting period, be
made available earlier, we note that the
list of qualified registries for 2014—
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/PQRS/
Downloads/
2014QualifiedRegistries.pdf—was made
available in May 2014, prior to June 30,
2014, and we anticipate making the list
of qualified registries for the given
reporting period available in advance of
the proposed June 30 registration
deadline. With respect to the
commenters who stated that the
proposed deadline would negatively
affect group practices that change their
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
Taxpayer Identification Numbers (TINs)
after June 30, as the group practice
would be required to report
individually, adding to administrative
and reporting burden, we understand
this potential burden. We note that this
proposed deadline is only 3 months
earlier than the September 30
registration deadline we finalized in the
CY 2014 PFS final rule (78 FR 74455).
Therefore, we believe the issues
associated with group practices that
change their TINs would be exacerbated
by finalizing the proposed June 30th
registration deadline or ameliorated by
keeping the current September 30
registration deadline. To the extent that
finalizing an earlier deadline would
increase the number of group practices
affected by these issues, we believe that
our interest in providing feedback
sooner outweighs the concern of those
group practices that change their TINs
after June 30 not being able to
participate in the GPRO. Based on the
reasons stated here and in the proposed
rule, we are finalizing our proposal to
modify the deadline that a group
practice must register to participate in
the GPRO to June 30 of the year in
which the reporting period occurs (that
is, June 30, 2015, for reporting periods
occurring in 2015). Please note that this
GPRO registration deadline refers to all
group practices wishing to participate in
the GPRO using any reporting
mechanism available for reporting in the
GPRO (that is, GPRO web interface,
registry, EHR, and/or CMS-certified
survey vendor).
ebenthall on DSK5SPTVN1PROD with $$_JOB
2. Criteria for the Satisfactory Reporting
for Individual Eligible Professionals for
the 2017 PQRS Payment Adjustment
Section 1848(a)(8) of the Act, as
added by section 3002(b) of the
Affordable Care Act, provides that for
covered professional services furnished
by an eligible professional during 2015
or any subsequent year, if the eligible
professional does not satisfactorily
report data on quality measures for
covered professional services for the
quality reporting period for the year, the
fee schedule amount for services
furnished by such professional during
the year (including the fee schedule
amount for purposes of determining a
payment based on such amount) shall
be equal to the applicable percent of the
fee schedule amount that would
otherwise apply to such services. For
2016 and subsequent years, the
applicable percent is 98.0 percent.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
a. Criterion for the Satisfactory
Reporting of Individual Quality
Measures via Claims and Registry for
Individual Eligible Professionals for the
2017 PQRS Payment Adjustment
In the CY 2014 PFS final rule with
comment period (see Table 47 at 78 FR
74479), we finalized the following
criteria for satisfactory reporting for the
submission of individual quality
measures via claims and registry for the
2014 PQRS incentive: For the 12-month
reporting period for the 2014 PQRS
incentive, the eligible professional
would report at least 9 measures,
covering at least 3 of the NQS domains,
OR, if less than 9 measures apply to the
eligible professional, report 1—8
measures, AND report each measure for
at least 50 percent of the Medicare Part
B FFS patients seen during the reporting
period to which the measure applies.
Measures with a 0 percent performance
rate would not be counted. For an
eligible professional who reports fewer
than 9 measures covering less than 3
NQS domains via the claims- or registrybased reporting mechanism, the eligible
professional would be subject to the
measure application validity (MAV)
process, which would allow us to
determine whether the eligible
professional should have reported
quality data codes for additional
measures.
To be consistent with the satisfactory
reporting criterion we finalized for the
2014 PQRS incentive, for the 2017
PQRS payment adjustment, we
proposed to modify § 414.90(j) and
proposed the following criterion for
individual eligible professionals
reporting via claims and registry: For
the 12-month reporting period for the
2017 PQRS payment adjustment, the
eligible professional would report at
least 9 measures, covering at least 3 of
the NQS domains AND report each
measure for at least 50 percent of the
eligible professional’s Medicare Part B
FFS patients seen during the reporting
period to which the measure applies. Of
the measures reported, if the eligible
professional sees at least 1 Medicare
patient in a face-to-face encounter, as
we proposed to define that term below,
the eligible professional would report
on at least 2 measures contained in the
proposed cross-cutting measure set
specified in Table 52. If less than 9
measures apply to the eligible
professional, the eligible professional
would report up to 8 measure(s), AND
report each measure for at least 50
percent of the Medicare Part B FFS
patients seen during the reporting
period to which the measure applies.
Measures with a 0 percent performance
PO 00000
Frm 00237
Fmt 4701
Sfmt 4700
67783
rate would not be counted (79 FR
40395).
We noted that, unlike the criterion we
finalized for the 2014 PQRS incentive,
we proposed to require an eligible
professional who sees at least 1
Medicare patient in a face-to-face
encounter, as we defined that term
below, during the 12-month 2017 PQRS
payment adjustment reporting period to
report at least 2 measures contained in
the cross-cutting measure set specified
in Table 52. As we noted in the CY 2014
PFS proposed rule (78 FR 43359), we
are dedicated to collecting data that
provides us with a better picture of the
overall quality of care furnished by
eligible professionals, particularly for
the purpose of having PQRS reporting
being used to assess quality
performance under the VM. We believe
that requiring an eligible professional to
report on at least 2 broadly applicable,
cross-cutting measures will provide us
with quality data on more varied aspects
of an eligible professional’s practice. We
also noted that in its 2014 prerulemaking final report (available at
https://www.qualityforum.org/
Publications/2014/01/MAP_PreRulemaking_Report-2014_
Recommendations_on_Measures_for_
More_than_20_Federal_Programs.aspx),
the Measure Applications Partnership
(MAP) encouraged the development of a
core measure set (see page 16 of the
‘‘MAP Pre-Rulemaking Report: 2014
Recommendations on Measures for
More than 20 Federal Programs’’). The
MAP stated, ‘‘a core [measure set]
would address critical improvement
gaps, align payment incentives across
clinician types, and reduce reporting
burden.’’
For what defines a ‘‘face-to-face’’
encounter, for purposes of reporting of
at least 2 cross-cutting measures
specified in Table 52, we proposed to
determine whether an eligible
professional had a ‘‘face-to-face’’
encounter by seeing whether the eligible
professional billed for services under
the PFS that are associated with face-toface encounters, such as whether an
eligible professional billed general office
visit codes, outpatient visits, and
surgical procedures. We would not
include telehealth visits as face-to-face
encounters for purposes of the required
reporting of at least 2 cross-cutting
measures specified in Table 52 (79 FR
40395 and 40396).
In addition, we understand that there
may be instances where an eligible
professional may not have at least 9
measures applicable to an eligible
professional’s practice. In this instance,
like the criterion we finalized for the
2014 PQRS incentive (see Table 47 at 78
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67784
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
FR 74479), an eligible professional
reporting on less than 9 measures would
still be able to meet the satisfactory
reporting criterion via claims and
registry if the eligible professional
reports on 1–8 measures, as applicable,
to the eligible professional’s practice. If
an eligible professional reports on 1–8
measures, the eligible professional
would be subject to the MAV process,
which would allow us to determine
whether an eligible professional should
have reported quality data codes for
additional measures. In addition, the
MAV will also allow us to determine
whether a group practice should have
reported on any of the cross-cutting
measures specified in Table 52. The
MAV process we proposed (79 FR
40396) to implement for claims and
registry is the same process that was
established for reporting periods
occurring in 2014 for the 2014 PQRS
incentive.
We solicited public comment on our
satisfactory reporting criterion for
individual eligible professionals
reporting via claims or registry for the
2017 PQRS payment adjustment. The
following is a summary of the comments
we received regarding our proposal for
satisfactory reporting criterion for
individual eligible professionals
reporting via claims or registry for the
2017 PQRS payment adjustment.
Comment: A few commenters
supported our intention to move
towards eliminating the claims-based
reporting option, while the majority of
the commenters opposed our proposals
related to moving away from the claimsbased reporting option. Some of these
commenters noted that, for certain
eligible professionals, the claims-based
reporting mechanism remains the only
option by which eligible professionals
may report PQRS quality measures data,
as many eligible professionals do not
have the capabilities to report via EHR
or registry. The commenters believe the
claim-based reporting mechanism is a
necessary option for eligible
professionals with limited resources,
such as solo practitioners. Should we
intend to phase out this reporting
mechanism, commenters urged a
gradual phase out of the claims-based
reporting mechanism.
Response: We appreciate the
commenters’ feedback. We understand
the concerns associated with moving
away from the claims-based reporting
mechanism. For the 2017 PQRS
payment adjustment, we are finalizing
an option by which eligible
professionals may meet the criteria for
satisfactory reporting by using the
claims-based reporting mechanism.
Eligible professionals using the other
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
reporting mechanisms have seen greater
success at meeting the criteria for
satisfactory reporting for the PQRS.
However, while we continue to
eliminate measures available for
reporting via claims, we understand the
importance of maintaining the claimsbased reporting mechanism as an option
at this time. We understand that the
claims-based reporting mechanism
remains the most popular reporting
mechanism. However, to streamline the
PQRS reporting options, as well as to
encourage reporting options where
eligible professionals are found to be
more successful in reporting, it is our
intention to eliminate the claims-based
reporting mechanism in future
rulemaking. During this time, we
encourage eligible professionals to use
alternative reporting methods to become
familiar with reporting mechanisms
other than the claims-based reporting
mechanism.
Comment: The majority of
commenters opposed our proposal to
require the reporting of 9 measures to
meet the criteria for satisfactory
reporting for the 2017 PQRS payment
adjustment. Some of these commenters
noted that eligible professionals have
been successful at meeting the criteria
for satisfactory reporting for the PQRS
incentives and payment adjustments in
the past by reporting 3 measures, and
increasing the number of measures to be
reported would make it more difficult
for these eligible professionals to meet
the criteria for satisfactory reporting for
the 2017 PQRS payment adjustment.
Other commenters also noted that
certain eligible professionals do not
have 9 measures covering 3 NQS
domains to report. For these reasons,
some commenters suggested a more
gradual approach to requiring the
reporting of at least 9 measures covering
3 NQS domains, such as requiring the
reporting of 5 or 6 measures rather than
9 measures. A few commenters also
recommended establishing a lower
reporting threshold for those eligible
professionals practicing in specialties
for which few PQRS measures exist.
Response: While we understand the
commenters concerns related to
requiring the reporting of 9 measures
covering up to 3 NQS domains, we
believe we provided the public with
adequate time to prepare for reporting
criteria that requires the reporting of 9
measures. For example, we finalized
criteria for the satisfactory reporting for
the 2016 PQRS payment adjustment via
claims and registry that only required
the reporting of 3 measures covering 1
NQS domain (see Table 48 at 78 FR
74480). However, we also finalized
criteria for the 2016 PQRS payment
PO 00000
Frm 00238
Fmt 4701
Sfmt 4700
adjustment using the claims- and
registry-based reporting mechanisms
that aligned with the following criteria
we finalized for the 2014 PQRS
incentive: Report at least 9 measures
covering at least 3 NQS domains, OR, if
less than 9 measures covering at least 3
NQS domains apply to the eligible
professional, report 1–9 measures
covering 1–3 NQS domains, AND report
each measure for at least 50 percent of
the Medicare Part B FFS patients seen
during the reporting period to which the
measures applies (see Table 48 at 78 FR
74480). Additionally, in the CY 2014
PFS final rule, we noted that ‘‘it is our
intent to ramp up the criteria for
satisfactory reporting for the 2017 PQRS
payment adjustment to be on par or
more stringent than the criteria for
satisfactory reporting for the 2014 PQRS
incentive’’ (78 FR 74465). We believe
that establishing criteria for the
satisfactory reporting of the 2016 PQRS
payment adjustment that are consistent
with these proposed criteria, as well as
signaling our intent to ramp up the
satisfactory reporting criteria, provided
enough advance notice to encourage
eligible professionals to prepare to
report 9 measures to meet the criteria for
satisfactory reporting for the 2017 PQRS
payment adjustment.
Furthermore, with respect to those
commenters concerned that an eligible
professional may not have 9 measures
covering at least 3 NQS domains
applicable to his/her practice, in the
proposed rule we noted that in this
instance, like the criterion we finalized
for the 2014 PQRS incentive (see Table
47 at 78 FR 74479), an eligible
professional reporting on less than 9
measures would still be able to meet the
satisfactory reporting criterion via
claims and registry if the eligible
professional reports on 1–8 measures, as
applicable, to the eligible professional’s
practice. If an eligible professional
reports on 1–8 measures, the eligible
professional would be subject to the
MAV process, which would allow us to
determine whether an eligible
professional should have reported
quality data codes for additional
measures. In addition, the MAV process
will also allow us to determine whether
a group practice should have reported
on any of the cross-cutting measures
specified in Table 52. As such, under
this proposed criteria for satisfactory
reporting for the 2017 PQRS payment
adjustment, an eligible professional who
does not have at least 9 measures
covering at least 3 NQS domains
applicable to his/her practice may still
meet the criteria for satisfactory
reporting for the 2017 PQRS payment
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
adjustment provided that the eligible
professional reports all measures as are
applicable to his/her practice.
Based on the comments received and
for the reasons stated above and in the
proposed rule, we are finalizing our
proposal to require the reporting of 9
measures covering at least 3 NQS
domains to meet the criteria for
satisfactory reporting for the 2017 PQRS
payment adjustment.
In the case that an eligible
professional may not have at least 9
measures applicable to an eligible
professional’s practice, the eligible
professional may still be able to meet
the satisfactory reporting criterion via
claims and/or registry for the 2017
PQRS payment adjustment if the eligible
professional reports on 1–8 measures.
The eligible professional would be
required to report as many measures as
are applicable to the eligible
professional’s practice. If reporting less
than 9 measures covering 3 NQS
domains, the eligible professional
would be subject to the MAV process,
which would allow us to determine
whether an eligible professional should
have reported quality data codes for
additional measures.
Comment: Some commenters
provided general support for the option
to report cross-cutting measures, as it
may help bring alignment with respect
to a set of measures all eligible
professionals may report. However,
most of these commenters believed that
the reporting of cross-cutting measures
should be voluntary, not mandatory.
The majority of commenters opposed
our proposal to require an eligible
professional who sees at least 1
Medicare patient in a face-to-face
encounter during the 12-month 2017
PQRS payment adjustment reporting
period to report at least 2 measures
contained in the proposed cross-cutting
measure set specified in Table 52 (78 FR
40395). Some of these commenters
believed that the proposed requirement
is unfair, as the requirement to report on
at least 2 cross-cutting measures placed
an additional burden on certain
specialists, such as those that do not
provide primary care services, and not
on others. Other commenters
emphasized that the cross-cutting
measures did not apply to many
specialty practices. Contrary to these
commenters, some commenters
expressed support for this proposal.
Some of those who supported, this
proposal, however, recommended a
more phased-in approach to the
reporting of cross-cutting measures. One
of these commenters recommended that
the proposal be amended to require only
the reporting of 1 measure in the cross-
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
cutting measure set. Some of these
commenters were confused as to
whether this proposal would increase
the proposed number of measures to be
reported to 11 measures.
Response: With respect to the
commenters’ concerns that requiring
reporting of at least 2 cross-cutting
measures for eligible professionals who
see at least 1 Medicare patient in a faceto-face encounter, we understand that
the cross-cutting measures we are
finalizing in Table 52 are limited and
should only apply to certain eligible
professionals for which the measures
apply. We believe we sufficiently
exclude eligible professionals for which
the cross-cutting measures do not apply
by only proposing this requirement for
eligible professionals who see at least 1
Medicare patient in a face-to-face
encounter. We believe our interest in
collecting data that are more varied to
better capture the overall quality of care
provided to patients as well as our
desire to create a core set of measures
for PQRS outweighs this concern. In the
future, we will consider adding to this
cross-cutting measures set so that more
professionals that are eligible may be
able to participate in the reporting of a
core set of measures. With respect to the
commenters who expressed concern
that the proposed measures in the
proposed cross-cutting measures set did
not apply to many specialties, we note
that an eligible professional would not
be required to report on the measures
contained in the cross-cutting measures
set if none of the measures applied to
the eligible professional’s practice. With
respect to taking a more phased-in
approach to introducing the crosscutting measure set, for the 2017 PQRS
payment adjustment, we agree with
these commenters and will therefore
phase-in the requirement to report on
cross-cutting measures by only requiring
the reporting of 1 cross-cutting measure.
We do note, however, that we believe
that requiring the reporting of 2
measures in the cross-cutting measures
set is not overly burdensome. Rather, we
believe it helps eligible professionals
narrow the choices of measures for
which to report in the PQRS measure
set. Regardless, we understand the
commenters’ concerns regarding the
need for a gradual phase in of the crosscutting measure set. Therefore, based on
the comments received and for the
reasons stated above and in the
proposed rule, we are modifying our
proposal to require that an eligible
professional who sees at least 1
Medicare patient in a face-to-face
encounter during the 12-month 2017
PQRS payment adjustment reporting
PO 00000
Frm 00239
Fmt 4701
Sfmt 4700
67785
period report at least 1 measure
contained in the cross-cutting measure
set we are finalizing specified in Table
52. Please note that it is our intention
to move towards requiring the reporting
of more cross-cutting measures in the
future.
Please also note that this does not
bring the total number of measures
required to be reported under this
criterion to 10 measures. Rather, if an
eligible professional sees at least 1
Medicare patient in a face-to-face
encounter during the 12-month PQRS
payment adjustment reporting period, 1
of the 9 measures the eligible
professional reports must be measures
contained in the cross-cutting measure
set. Therefore, an eligible professional
would report at least 1 cross-cutting
measure and 8 additional PQRS
measures covering 3 NQS domains.
In the instance where an eligible
professional may not have at least 9
measures applicable to his/her practice,
the eligible professional would still be
required to report at least 1 cross-cutting
measure, if applicable. As we noted, we
believe we sufficiently exclude eligible
professionals for which the cross-cutting
measures do not apply by only
proposing this requirement for eligible
professionals who see at least 1
Medicare patient in a face-to-face
encounter.
Comment: One commenter believes
that the threshold of seeing 1 Medicare
patient in a face-to-face encounter for
the requirement to report on crosscutting measures is too low. The
commenter was concerned that this
would further burden eligible
professionals who rarely see Medicare
patients.
Response: We understand the
commenter’s concern. However, as we
believe in the importance of the crosscutting measures set we are finalizing in
Table 52, it is our desire to encourage
reporting of the measures contained in
the cross-cutting measures set when
applicable. We proposed this threshold
to exclude certain specialties that do not
see Medicare patients. However, we
expect those eligible professionals who
see Medicare patients to report on the
cross-cutting measures we specify in
Table 52.
Comment: One commenter sought
clarification on the definition of a faceto-face encounter by specifying which
codes apply to this definition and urged
that procedural encounters not be
included in the list of face-to-face
encounters.
Response: As we stated in the
proposed rule, we will determine
whether an eligible professional had a
‘‘face-to-face’’ encounter by seeing
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67786
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
whether the eligible professional billed
for services under the PFS that are
associated with face-to-face encounters,
such as whether an eligible professional
billed general office visit codes,
outpatient visits, and surgical
procedures. We would not include
telehealth visits as face-to-face
encounters for purposes of the
requirements to report at least 1 crosscutting measure specified in Table 52
(79 FR 40395 through 40396). While we
will not provide the specific codes for
what we define as a ‘‘face-to-face’’
encounter here, we will provide the
codes and any additional guidance on
the PQRS Web site at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/PQRS/.
Comment: Some commenters opposed
our proposal to require that, to meet the
criteria for satisfactory reporting for the
2017 PQRS payment adjustment, an
eligible professional reporting
individual measures via claims or
registry report each measure for at least
50 percent of the eligible professional’s
Medicare Part B FFS patients seen
during the reporting period to which the
measure applies. The commenters noted
that, particularly for those eligible
professionals who see many patients,
requiring the reporting of quality
measures for more than 50 percent of
the eligible professional’s Medicare Part
B FFS patients is burdensome.
Response: We understand this
concern, particularly with those eligible
professionals who see a large number of
patients. However, it is important to
collect sufficient quality measures data
to ensure an adequate sample. We
believe that the 50 percent threshold
provides us with an adequate sample to
properly determine the quality of care
provided. We also believe that requiring
that an eligible professional report on at
least 50 percent of his/her Medicare Part
B FFS patients helps to prevent
potential selection bias that could skew
the representation of quality of care;
while the potential for selection bias
still remains, we were mindful of
concerns about provider burden during
this period where eligible professionals
are still becoming accustomed to PQRS
reporting. Based on the comments
received and for the reasons stated
above and in the proposed rule, we are
finalizing our proposal to require that,
to meet the criteria for satisfactory
reporting for the 2017 PQRS payment
adjustment, an eligible professional
reporting individual measures via
claims or registry report each measure
for at least 50 percent of the eligible
professional’s Medicare Part B FFS
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
patients seen during the reporting
period to which the measure applies.
Comment: Some commenters
generally supported the MAV process.
However, some commenters expressed
the need to clarify the MAV process for
both claims and registry as well as to
provide greater transparency in this
process.
Response: We understand the need to
further clarify the MAV process for both
claims and registry, as well as to
provide transparency in this process.
We believe the 2015 MAV process that
we proposed for the 2017 PQRS
payment adjustment is transparent, as it
is very similar to the 2014 MAV process
that we finalized for the 2014 PQRS
incentive and 2016 PQRS payment
adjustment, for which we have already
provided detailed technical guidance.
Specifically, we have made education
and outreach documents, as well as the
MAV measure clusters, (that is, sets of
measures that determine when other
measures could have been reported and
therefore trigger use of the MAV
process), available for the 2014 MAV
process at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/PQRS/
AnalysisAndPayment.html, and we will
update these materials as necessary for
the 2015 MAV process. Please note that,
as the MAV process evolves, we expect
to be able to provide further guidance to
aid eligible professionals in
understanding the MAV process. We
will post additional clarifying
information, including a document
explaining the MAV process for 2015,
on the PQRS Web site at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/pqrs/. We
believe that posting this guidance as we
have in years prior provides adequate
transparency in this process. Moreover,
should an eligible professional have
further questions regarding the MAV
process, he or she may contact our
QualityNet Help Desk for more
information. The contact information for
the Help Desk can be found here:
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/PQRS/
HelpDeskSupport.html.
After reviewing the comments, we are
finalizing our proposal to modify
§ 414.90(j) and finalize the following
criterion for individual eligible
professionals reporting via claims and
registry:
For the 12-month reporting period for
the 2017 PQRS payment adjustment,
report at least 9 measures, covering at
least 3 of the NQS domains AND report
each measure for at least 50 percent of
PO 00000
Frm 00240
Fmt 4701
Sfmt 4700
the eligible professional’s Medicare Part
B FFS patients seen during the reporting
period to which the measure applies. Of
the measures reported, if the eligible
professional sees at least 1 Medicare
patient in a face-to-face encounter, the
eligible professional will report on at
least 1 measure contained in the
proposed cross-cutting measure set
specified in Table 52. If less than 9
measures apply to the eligible
professional, the eligible professional
would report up to 8 measure(s), AND
report each measure for at least 50
percent of the Medicare Part B FFS
patients seen during the reporting
period to which the measure applies.
Measures with a 0 percent performance
rate would not be counted.
We understand that there may be
instances where an eligible professional
may not have at least 9 measures
applicable to an eligible professional’s
practice. In this instance, an eligible
professional reporting on less than 9
measures would still be able to meet the
satisfactory reporting criterion via
claims and registry if the eligible
professional reports on 1–8 measures, as
applicable, to the eligible professional’s
practice. If an eligible professional
reports on 1–8 measures, the eligible
professional would be subject to the
MAV process, which would allow us to
determine whether an eligible
professional should have reported
quality data codes for additional
measures. In addition, the MAV process
will also allow us to determine whether
a group practice should have reported
on any of the cross-cutting measures
specified in Table 52. The MAV process
we will implement for claims and
registry for the 2017 PQRS payment
adjustment is the same process that was
established for reporting periods
occurring in 2014 for the 2014 PQRS
incentive. For more information on the
claims MAV process, please visit
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/PQRS/Downloads/2014_
PQRS_Claims_
MeasureApplicabilityValidation_
12132013.zip. For more information on
the registry MAV process, please visit
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/PQRS/Downloads/2014_
PQRS_Registry_
MeasureApplicabilityValidation_
12132013.zip.
b. Criterion for Satisfactory Reporting of
Individual Quality Measures via EHR
for Individual Eligible Professionals for
the 2017 PQRS Payment Adjustment
In the CY 2013 PFS final rule with
comment period, we finalized the
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
following criterion for the satisfactory
reporting for individual eligible
professionals reporting individual
measures via a direct EHR product that
is CEHRT or an EHR data submission
vendor product that is CEHRT for the
2014 PQRS incentive: Report 9
measures covering at least 3 of the NQS
domains. If an eligible professional’s
CEHRT does not contain patient data for
at least 9 measures covering at least 3
domains, then the eligible professional
must report all of the measures for
which there is Medicare patient data.
An eligible professional must report on
at least 1 measure for which there is
Medicare patient data (see Table 47 at
78 FR 74479).
To be consistent with the criterion we
finalized for the 2014 PQRS incentive,
as well as to continue to align with the
final criterion for meeting the clinical
quality measure (CQM) component of
achieving meaningful use under the
Medicare EHR Incentive Program, we
proposed to modify § 414.90(j) and
proposed the following criterion for the
satisfactory reporting for individual
eligible professionals to report
individual measures via a direct EHR
product that is CEHRT or an EHR data
submission vendor product that is
CEHRT for the 2017 PQRS payment
adjustment: The eligible professional
would report 9 measures covering at
least 3 of the NQS domains. If an
eligible professional’s CEHRT does not
contain patient data for at least 9
measures covering at least 3 domains,
then the eligible professional would be
required to report all of the measures for
which there is Medicare patient data.
An eligible professional would be
required to report on at least 1 measure
for which there is Medicare patient data.
We solicited public comment on this
proposal.
The following is summary of the
comments we received regarding our
proposed criterion for the satisfactory
reporting for individual eligible
professionals to report individual
measures via a direct EHR product that
is CEHRT or an EHR data submission
vendor product that is CEHRT for the
2017 PQRS payment adjustment.
Comment: The majority of
commenters opposed our proposal to
require the reporting of 9 measures to
meet the criteria for satisfactory
reporting for the 2017 PQRS payment
adjustment. Commenters also noted that
certain eligible professionals do not
have 9 measures covering 3 NQS
domains to report. For these reasons,
some commenters suggested a more
gradual approach to requiring the
reporting of at least 9 measures covering
3 NQS domains, such as requiring the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
reporting of 5 or 6 measures rather than
9 measures. A few commenters also
recommended establishing a lower
reporting threshold for those eligible
professionals practicing in specialties
for which few PQRS measures exist.
Response: We understand the
commenters’ concerns. We note that we
addressed these comments related to the
reporting of 9 measures covering 3
domains as it relates to reporting via
claims and registry above in section
III.K.1.a., and that explanation also
applies here with reporting via a direct
EHR product that is CEHRT or EHR data
submission vendor product that is
CEHRT. Furthermore, we believe that
aligning our EHR reporting options with
the CQM component of meaningful use
under the EHR Incentive Program
actually reduces burden on eligible
professionals when reporting. For the
reasons explained above and to be
consistent with the criterion we are
finalizing for claims and registry as well
as to be consistent with the
requirements to meet the CQM
component of meaningful use under the
EHR Incentive Program, we are
finalizing this proposal.
After reviewing the comments, we are
finalizing our proposal as proposed to
modify § 414.90(j) and to indicate the
following criterion for the satisfactory
reporting for individual eligible
professionals to report individual
measures via a direct EHR product that
is CEHRT or an EHR data submission
vendor product that is CEHRT for the
2017 PQRS payment adjustment: For the
12-month reporting period for the 2017
PQRS payment adjustment, report 9
measures covering at least 3 of the NQS
domains. If an eligible professional’s
CEHRT does not contain patient data for
at least 9 measures covering at least 3
domains, then the eligible professional
would be required to report all of the
measures for which there is Medicare
patient data. An eligible professional
would be required to report on at least
1 measure for which there is Medicare
patient data.
c. Criterion for Satisfactory Reporting of
Measures Groups via Registry for
Individual Eligible Professionals for the
2017 PQRS Payment Adjustment
In the CY 2013 PFS final rule with
comment period, we finalized the
following criterion for the satisfactory
reporting for individual eligible
professionals to report measures groups
via registry for the 2014 PQRS incentive:
For the 12-month reporting period for
the 2014 PQRS incentive, report at least
1 measures group AND report each
measures group for at least 20 patients,
the majority (11 patients) of which must
PO 00000
Frm 00241
Fmt 4701
Sfmt 4700
67787
be Medicare Part B FFS patients.
Measures groups containing a measure
with a 0 percent performance rate will
not be counted (see Table 47 at 78 FR
74479).
To be consistent with the criterion we
finalized for the 2014 PQRS incentive,
we proposed to modify § 414.90(j) to
indicate the following criterion for the
satisfactory reporting for individual
eligible professionals to report measures
groups via registry for the 2017 PQRS
payment adjustment: For the 12-month
reporting period for the 2017 PQRS
payment adjustment, the eligible
professional would report at least 1
measures group AND report each
measures group for at least 20 patients,
the majority (11 patients) of which
would be required to be Medicare Part
B FFS patients. Measures groups
containing a measure with a 0 percent
performance rate would not be counted.
Although we proposed a satisfactory
reporting criterion for individual
eligible professionals to report measures
groups via registry for the 2017 PQRS
payment adjustment that is consistent
with criterion finalized for the 2014
PQRS incentive, please note that in
section III.K of this final rule with
comment period, we are changing the
definition of a PQRS measures group.
We solicited but received no public
comment on our proposed satisfactory
reporting criterion for individual
eligible professionals reporting
measures groups via registry for the
2017 PQRS payment adjustment.
Therefore, we are finalizing our
proposal as proposed to modify
§ 414.90(j) to indicate the following
criterion for the satisfactory reporting
for individual eligible professionals to
report measures groups via registry for
the 2017 PQRS payment adjustment: For
the 12-month reporting period for the
2017 PQRS payment adjustment, report
at least 1 measures group AND report
each measures group for at least 20
patients, the majority (11 patients) of
which are required to be Medicare Part
B FFS patients. Measures groups
containing a measure with a 0 percent
performance rate will not be counted.
3. Satisfactory Participation in a QCDR
by Individual Eligible Professionals
Section 601(b) of the ATRA amended
section 1848(m)(3) of the Act, by
redesignating subparagraph (D) as
subparagraph (F) and adding new
subparagraphs (D) and (E), to provide
for a new standard for individual
eligible professionals to satisfy the
PQRS beginning in 2014, based on
satisfactory participation in a QCDR.
E:\FR\FM\13NOR2.SGM
13NOR2
67788
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
a. Criterion for the Satisfactory
Participation for Individual Eligible
Professionals in a QCDR for the 2017
PQRS Payment Adjustment
Section 1848(a)(8) of the Act provides
that for covered professional services
furnished by an eligible professional
during 2015 or any subsequent year, if
the eligible professional does not
satisfactorily report data on quality
measures for covered professional
services for the quality reporting period
for the year, the fee schedule amount for
services furnished by such professional
during the year shall be equal to the
applicable percent of the fee schedule
amount that would otherwise apply to
such services. For 2016 and subsequent
years, the applicable percent is 98.0
percent.
Section 1848(m)(3)(D) of the Act, as
added by section 601(b) of the ATRA,
authorizes the Secretary to treat an
individual eligible professional as
satisfactorily submitting data on quality
measures under section 1848(m)(3)(A)
of the Act if, in lieu of reporting
measures under section 1848(k)(2)(C) of
the Act, the eligible professional is
satisfactorily participating in a QCDR
for the year. ‘‘Satisfactory participation’’
is a new standard under the PQRS and
is a substitute for the underlying
standard of ‘‘satisfactory reporting’’ data
on covered professional services that
eligible professionals must meet to
avoid the PQRS payment adjustment.
Currently, § 414.90(e)(2) states that
individual eligible professionals must
be treated as satisfactorily reporting data
on quality measures if the individual
eligible professional satisfactorily
participates in a QCDR.
In the CY 2014 PFS final rule with
comment period, although we finalized
satisfactory participation criteria for the
2016 PQRS payment adjustment that are
less stringent than the satisfactory
participation criteria we finalized for
the 2014 PQRS incentive, we noted that
it was ‘‘our intention to fully move
towards the reporting of 9 measures
covering at least 3 domains to meet the
criteria for satisfactory participation for
the 2017 PQRS payment adjustment’’
(78 FR 74477). Specifically, we finalized
the following two criteria for the
satisfactory participation in a QCDR for
the 2014 PQRS incentive at
§ 414.90(i)(3): For the 12-month 2014
reporting period, report at least 9
measures available for reporting under
the QCDR covering at least 3 of the NQS
domains, and report each measure for at
least 50 percent of the eligible
professional’s applicable patients. Of
the measures reported via a QCDR, the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
eligible professional must report on at
least 1 outcome measure.
To be consistent with the number of
measures reported for the satisfactory
participation criterion we finalized for
the 2014 PQRS incentive, for purposes
of the 2017 PQRS payment adjustment
(which would be based on data reported
during the 12-month period that falls in
CY 2015), we proposed to modify
§ 414.90(k) to add the following criteria
for individual eligible professionals to
satisfactorily participate in a QCDR for
the 2017 PQRS payment adjustment: For
the 12-month reporting period for the
2017 PQRS payment adjustment, the
eligible professional would report at
least 9 measures available for reporting
under a QCDR covering at least 3 of the
NQS domains, AND report each
measure for at least 50 percent of the
eligible professional’s patients. Of these
measures, the eligible professional
would report on at least 3 outcome
measures, OR, if 3 outcomes measures
are not available, report on at least 2
outcome measures and at least 1 of the
following types of measures—resource
use, patient experience of care, or
efficiency/appropriate use.
Unlike the satisfactory participation
criteria that were established for the
2014 PQRS incentive, we proposed to
modify § 414.90(k)(4) to require that an
eligible professional report on not only
1 but at least 3 outcome measures (or,
2 outcome measures and at least 1
resource use, patient experience of care,
or efficiency/appropriate use if 3
outcomes measures are not available).
We proposed this increase because it is
our goal to, when appropriate, move
towards the reporting of more outcome
measures. We believe the reporting of
outcome measures (for example,
unplanned hospital readmission after a
procedure) better captures the quality of
care an eligible professional provides
than, for example, process measures (for
example, whether a Hemoglobin A1c
test was performed for diabetic
patients). In establishing this proposal,
we understood that a QCDR may not
have 3 outcomes measures within its
quality measure data set. Therefore, as
an alternative to a third outcome
measure, we proposed to allow an
eligible professional to report on at least
1 resource use, patient experience of
care, or efficiency/appropriate use
measure in lieu of an outcome measure.
We solicited public comment on these
proposals. The following is summary of
the comments we received regarding on
these proposals.
Comment: Commenters generally
urged more flexibility in allowing
QCDRs to determine reporting criteria
under this option.
PO 00000
Frm 00242
Fmt 4701
Sfmt 4700
Response: While we agree that QCDRs
should generally be given some
flexibility when participating in the
PQRS, we do not agree that QCDRs be
given flexibility in determining
reporting criteria. We believe it is
necessary to have consistent reporting
criteria, so that quality measures data on
eligible professionals may be more
easily compared for purposes of other
programs that use PQRS quality data to
rate and compare eligible professionals,
such as the VM.
Comment: The majority of
commenters opposed our proposal to
require the reporting of 9 measures to
meet the criteria for satisfactory
reporting for the 2017 PQRS payment
adjustment. Commenters also noted that
certain eligible professionals do not
have 9 measures covering 3 NQS
domains to report. For these reasons,
some commenters suggested a more
gradual approach to requiring the
reporting of at least 9 measures covering
3 NQS domains, such as requiring the
reporting of 5 or 6 measures rather than
9 measures.
Response: While we understand the
commenters’ concerns related to
requiring the reporting of 9 measures
covering up to 3 NQS domains, we
believe we provided the public with
adequate time to prepare to reporting
criteria that requires the reporting of 9
measures. For example, we finalized
criteria for satisfactory participation for
the 2016 PQRS payment adjustment via
a QCDR that aligned with the criteria we
finalized for the 2014 PQRS incentive:
For the 12-month 2016 PQRS payment
adjustment reporting period, report at
least 9 measures covering at least 3 NQS
domains AND report each measure for
at least 50 percent of the applicable
patients seen during the reporting
period to which the measure applies.
Measures with a 0 percent performance
rate would not be counted. Of the
measures reported via a QCDR, the
eligible professional must report on at
least 1 outcome measure (78 FR 74478).
Additionally, in the CY 2014 PFS final
rule, we noted that ‘‘it is our intent to
ramp up the criteria for satisfactory
reporting for the 2017 PQRS payment
adjustment to be on par or more
stringent than the criteria for
satisfactory reporting for the 2014 PQRS
incentive’’ (78 FR 74465). We believe
that establishing criteria for the
satisfactory reporting of the 2017 PQRS
payment adjustment that are consistent
with these proposed criteria as well as
signaling our intent to ramp up the
satisfactory reporting criteria provided
enough advance notice to encourage
eligible professionals to prepare to
report 9 measures to meet the criteria for
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
satisfactory reporting for the 2017 PQRS
payment adjustment. Based on the
comments received and for the reasons
stated, we are finalizing our proposal for
QCDRs to require the reporting of 9
measures to meet the criteria for
satisfactory reporting for the 2017 PQRS
payment adjustment.
Comment: Some commenters opposed
our proposal to require that, to meet the
criteria for satisfactory reporting for the
2017 PQRS payment adjustment, an
eligible professional reporting
individual measures via a QCDR report
each measure for at least 50 percent of
the eligible professional’s patients seen
during the reporting period to which the
measure applies. The commenters noted
that, particularly for those eligible
professionals who see many patients,
requiring the reporting of quality
measures for more than 50 percent of
the eligible professional’s patients is an
enormous burden.
Response: We understand this
concern, particularly with respect to
those eligible professionals who see a
large number of patients. However, it is
important to collect sufficient quality
measures data to ensure an adequate
sample. We also believe that requiring
that an eligible professional report on at
least 50 percent of his/her Medicare Part
B FFS patients helps to prevent
potential selection bias that could skew
the representation of quality of care;
while the potential for selection bias
still remains, we were mindful of
concerns about provider burden during
this period where eligible professionals
are still becoming accustomed to PQRS
reporting. Based on the comments
received and for the reasons stated
above and in the proposed rule, we are
finalizing our proposal to require that,
to meet the criteria for satisfactory
participation for the 2017 PQRS
payment adjustment, an eligible
professional reporting individual
measures via a QCDR report each
measure for at least 50 percent of the
eligible professional’s patients seen
during the reporting period to which the
measure applies. Please note that,
unlike the claims and registry-based
reporting mechanisms, if using a QCDR,
an eligible professional must report on
ALL (Medicare and non-Medicare)
patients.
Comment: The majority of
commenters opposed our proposal to
report on at least 3 outcome measures,
as many of these commenters believed
QCDRs might not have 3 outcome
measures available to report. The
commenters urged a more gradual
approach to the reporting of outcome
measures via a QCDR.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Response: We understand the
commenters’ concerns. To accommodate
these concerns, we are modifying this
proposal to require only reporting of 2
outcome measures or, if 2 outcome
measures are not available, report on 1
outcome measure and 1 of the following
types of measures—resource use, patient
experience of care, efficiency/
appropriate use or patient safety. We
believe this compromise still raises the
bar on the types of measures eligible
professionals must report, but allows
QCDRs that may only have 1 outcome
measure available to still qualify and
participate in the PQRS. We note,
however, our intention to increase the
number of outcome measures that must
be reported in the future.
In addition, we note that we are
adding another category—patient
safety—of measures that an eligible
professional may report in lieu of an
outcome measure. While we did not
include this category before, we believe
the addition of the patient safety
category is appropriate, as we believe
that it is equally important to measure
patient safety, as it is to measure
resource use, patient experience of care,
or appropriate use. Furthermore, we
believe the addition of another category
of measures that may be reported in lieu
of an outcome measure benefits eligible
professionals and QCDRs and is
responsive to some of the commenters’
concerns regarding having enough
measures to report, as it provides more
options in terms of the measures an
eligible professional may report in lieu
of an outcome measure. We define the
term ‘‘patient safety’’ as it applies to
QCDRs in the QCDR measure section in
III.K.6 below.
As a result of the comments, we are
revising our proposal to modify
§ 414.90(k) to indicate the following
criterion for satisfactory participation in
a QCDR for the 2017 PQRS payment
adjustment: For the 12-month reporting
period for the 2017 PQRS payment
adjustment, report at least 9 measures
available for reporting under a QCDR
covering at least 3 of the NQS domains,
AND report each measure for at least 50
percent of the eligible professional’s
patients. Of these measures, the eligible
professional would report on at least 2
outcome measures, OR, if 2 outcomes
measures are not available, report on at
least 1 outcome measures and at least 1
of the following types of measures—
resource use, patient experience of care,
efficiency/appropriate use, or patient
safety.
PO 00000
Frm 00243
Fmt 4701
Sfmt 4700
67789
4. Criteria for Satisfactory Reporting for
Group Practices Selected To Participate
in the Group Practice Reporting Option
(GPRO)
In lieu of reporting measures under
section 1848(k)(2)(C) of the Act, section
1848(m)(3)(C) of the Act provides the
Secretary with the authority to establish
and have in place a process under
which eligible professionals in a group
practice (as defined by the Secretary)
shall be treated as satisfactorily
submitting data on quality measures.
Accordingly, this section III.K.4
contains our satisfactory reporting
criteria for group practices selected to
participate in the GPRO. Please note
that, for a group practice to participate
in the PQRS GPRO in lieu of
participating as individual eligible
professionals, a group practice is
required to register to participate in the
PQRS GPRO. For more information on
GPRO participation, please visit https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/PQRS/Group_Practice_
Reporting_Option.html. For more
information on registration, please visit
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
PhysicianFeedbackProgram/SelfNomination-Registration.html.
a. Criteria for Satisfactory Reporting on
PQRS Quality Measures Via the GPRO
Web Interface for the 2017 PQRS
Payment Adjustment
Consistent with the group practice
reporting requirements under section
1848(m)(3)(C) of the Act, we proposed
to modify § 414.90(j) to incorporate the
following criterion for the satisfactory
reporting of PQRS quality measures for
group practices registered to participate
in the GPRO for the 12-month reporting
period for the 2017 PQRS payment
adjustment using the GPRO web
interface for groups practices of 25–99
eligible professionals: The group
practice would report on all measures
included in the web interface; AND
populate data fields for the first 248
consecutively ranked and assigned
beneficiaries in the order in which they
appear in the group’s sample for each
module or preventive care measure. If
the pool of eligible assigned
beneficiaries is less than 248, then the
group practice would report on 100
percent of assigned beneficiaries. In
other words, we understand that, in
some instances, the sampling
methodology CMS provides will not be
able to assign at least 248 patients on
which a group practice may report,
particularly those group practices on the
smaller end of the range of 25–99
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67790
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
eligible professionals. If the group
practice is assigned less than 248
Medicare beneficiaries, then the group
practice would report on 100 percent of
its assigned beneficiaries. A group
practice would be required to report on
at least 1 measure for which there is
Medicare patient data.
In addition, we proposed to modify
§ 414.90(j) to incorporate the following
criteria for the satisfactory reporting of
PQRS quality measures for group
practices that registered to participate in
the GPRO for the 12-month reporting
period for the 2017 PQRS payment
adjustment using the GPRO web
interface for groups practices of 100 or
more eligible professionals: The group
practice would report all CAHPS for
PQRS survey measures via a certified
survey vendor. In addition, the group
practice would report on all measures
included in the GPRO web interface;
AND populate data fields for the first
248 consecutively ranked and assigned
beneficiaries in the order in which they
appear in the group’s sample for each
module or preventive care measure. If
the pool of eligible assigned
beneficiaries is less than 248, then the
group practice would report on 100
percent of assigned beneficiaries. A
group practice would be required to
report on at least 1 measure for which
there is Medicare patient data.
To maintain consistency in this
reporting criteria, we note that this
criteria is similar to the criterion we
finalized for the satisfactory reporting of
PQRS quality measures for group
practices selected to participate in the
GPRO for the 12-month reporting
periods for the 2013 and 2014 PQRS
incentives for group practices of 100 or
more eligible professionals in the CY
2013 PFS final rule with comment
period (see Table 49 at 78 FR 74486).
However, we proposed to reduce the
patient sample size on which a group
practice is required to report quality
measures data from 411 to 248. We
examined the sample size of this
reporting criterion and determined that
the sample size we proposed reduces
provider reporting burden while still
allowing for statistically valid and
reliable performance results. For the 25–
99 sized groups reporting via the web
interface, we recognized the proposal to
move from reporting 218 to 248 patients
per sample represents a slight increase
in reporting. However, based on
experience with the 218 count and
subsequent statistical analysis, we
believe that there are increased
performance reliabilities and validities
gained when changing the minimum
reporting requirement to 248. We
believe statistical reliability and validity
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
is extremely important when measuring
provider performance, particularly
given the implications of the Physician
VM and Physician Compare public
reporting, discussed in section III.N and
section III.J respectively. Therefore, we
believe this criterion improves on the
criterion previously finalized.
For assignment of patients for group
practices reporting via the GPRO web
interface, in previous years, we have
aligned with the Medicare Shared
Savings Program methodology of
beneficiary assignment (see 77 FR
69195). We note that, in section III.N. of
the CY 2015 PFS proposed rule, we
proposed to use a beneficiary attribution
methodology for the VM for the claimsbased quality measures and cost
measures that is slightly different from
the Medicare Shared Savings Program
methodology, namely (1) eliminating
the primary care service pre-step that is
statutorily required for the Shared
Savings Program and (2) including NPs,
PA, and CNSs in step 1 rather than in
step 2 of the attribution process. We
believe that aligning with the VM’s
proposed method of attribution is
appropriate, as the VM is directly tied
to participation in the PQRS. Therefore,
to achieve further alignment with the
VM and for the reasons proposed in
section III.N., we proposed to adopt the
attribution methodology changes
proposed for the VM into the GPRO web
interface beneficiary assignment
methodology. We invited public
comment on these proposals. The
following is summary of the comments
we received regarding on these
proposals.
Comment: A majority of the
commenters supported our proposal for
a group practice of 25 or more eligible
professionals using the GPRO web
interface to report on a patient sample
of 248. With respect to having group
practices of 100 or more eligible
professionals report on a patient sample
of 248 in lieu of 411 (the required
patient sample for group practices of
100 or more eligible professionals for
the 2014 PQRS incentive), the
commenters agreed that this would
reduce the reporting burden while still
ensuring statistically valid and reliable
performance results.
Response: We appreciate the
commenters’ feedback. Based on the
positive comments received and for the
reasons stated in the proposed rule, we
are finalizing this proposal. Therefore,
to meet the criteria for satisfactory
reporting for the 2017 PQRS payment
adjustment for a group practice of 25 or
more eligible professionals using the
GPRO web interface, a group practice
PO 00000
Frm 00244
Fmt 4701
Sfmt 4700
would be required to report on at least
248 patients.
As a result of the comments, we are
finalizing the following criteria for
satisfactory reporting for the 2017 PQRS
payment adjustment for group practices
comprised of 25 to 99 eligible
professionals using the GPRO web
interface: report on all measures
included in the web interface; AND
populate data fields for the first 248
consecutively ranked and assigned
beneficiaries in the order in which they
appear in the group’s sample for each
module or preventive care measure. If
the pool of eligible assigned
beneficiaries is less than 248, then the
group practice must report on 100
percent of assigned beneficiaries. In
other words, we understand that, in
some instances, the sampling
methodology we provide will not be
able to assign at least 248 patients on
which a group practice may report,
particularly those group practices on the
smaller end of the range of 25–99
eligible professionals. If the group
practice is assigned less than 248
Medicare beneficiaries, then the group
practice must report on 100 percent of
its assigned beneficiaries. A group
practice must report on at least 1
measure for which there is Medicare
patient data.
In addition, we note that, in the past,
we have not provided guidance on those
group practices that choose the GPRO
web interface to report PQRS quality
measures but have seen no Medicare
patients for which the GPRO measures
are applicable, or if they have no (that
is, 0 percent) responses for a particular
module or measure. Since we are
moving solely towards the
implementation of PQRS payment
adjustments, we sought to clarify this
scenario here. If a group practice has no
Medicare patients for which any of the
GPRO measures are applicable, the
group practice will not meet the criteria
for satisfactory reporting using the
GPRO web interface. Therefore, to meet
the criteria for satisfactory reporting
using the GPRO web interface, a group
practice must be assigned and have
sampled at least 1 Medicare patient for
any of the applicable GPRO web
interface measures (specified in Table
52). If a group practice does not
typically see Medicare patients for
which the GPRO web interface measures
are applicable, we advise the group
practice to participate in the PQRS via
another reporting mechanism.
Please note that the discussion in this
section III.K.4.a is limited to the criteria
for satisfactory reporting for the 2017
PQRS payment adjustment for group
practices comprised of 25–99 eligible
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
professionals who register to participate
in the GPRO and who have at least 1
Medicare patient for which any of the
GPRO measures are applicable. As we
discuss in greater detail in section
III.K.4 below, since we are requiring that
group practices report on CAHPS for
PQRS, the final criteria for group
practices comprised of 100 or more
eligible professionals are addressed in
section III.K.4.c .
b. Criteria for Satisfactory Reporting on
Individual PQRS Quality Measures for
Group Practices Registered To
Participate in the GPRO via Registry and
EHR for the 2017 PQRS Payment
Adjustment
For registry reporting in the GPRO, in
the CY 2014 PFS final rule with
comment period (see Table 49 at 78 FR
74486), we finalized the following
satisfactory reporting criteria for the
submission of individual quality
measures via registry for group practices
comprised of 2 or more eligible
professionals in the GPRO for the 2014
PQRS incentive: Report at least 9
measures, covering at least 3 of the NQS
domains, OR, if less than 9 measures
covering at least 3 NQS domains apply
to the group practice, report 1–8
measures covering 1–3 NQS domains for
which there is Medicare patient data,
AND report each measure for at least 50
percent of the group practice’s Medicare
Part B FFS patients seen during the
reporting period to which the measure
applies. Measures with a 0 percent
performance rate would not be counted.
In the CY 2014 PFS final rule with
comment period, we signaled that it was
‘‘our intent to ramp up the criteria for
satisfactory reporting for the 2017 PQRS
payment adjustment to be on par or
more stringent than the criteria for
satisfactory reporting for the 2014 PQRS
incentive’’ (78 FR 74465).
Consistent with the criterion finalized
for the 2014 PQRS incentive and the
group practice reporting requirements
under section 1848(m)(3)(C) of the Act,
for those group practices that choose to
report using a qualified registry, we
modified § 414.90(j) to include the
following satisfactory reporting criterion
via qualified registry for ALL group
practices who select to participate in the
GPRO for the 2017 PQRS payment
adjustment: The group practice would
report at least 9 measures, covering at
least 3 of the NQS domains. Of these
measures, if a group practice sees at
least 1 Medicare patient in a face-to-face
encounter, the group practice would
report on at least 2 measures in the
cross-cutting measure set specified in
Table 52. If less than 9 measures
covering at least 3 NQS domains apply
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
to the eligible professional, the group
practice would report up to 8 measures
covering 1–3 NQS domains for which
there is Medicare patient data, AND
report each measure for at least 50
percent of the eligible professional’s
Medicare Part B FFS patients seen
during the reporting period to which the
measure applies. Measures with a 0
percent performance rate would not be
counted.
As with individual reporting, we
understand that there may be instances
where a group practice may not have at
least 9 measures applicable to a group
practice’s practice. In this instance, like
the criterion we finalized for the 2014
PQRS incentive (see Table 49 at 78 FR
74486), a group practice reporting on
less than 9 measures would still be able
to meet the satisfactory reporting
criterion via registry if the group
practice reports on as many measures as
are applicable to the group practice’s
practice. If a group practice reports on
less than 9 measures, the group practice
would be subject to the MAV process,
which would allow us to determine
whether a group practice should have
reported quality data codes for
additional measures and/or measures
covering additional NQS domains.
Please note that this MAV process does
not apply to the application of the crosscutting measure reporting requirement,
as we require that all group practices
report on at least 1 cross-cutting
measure if an eligible professional in the
group practice see at least sees at least
1 Medicare patient in a face-to-face
encounter. The MAV process we
proposed to implement for registry
reporting is the same process that was
established for reporting periods
occurring in 2014 for the 2014 PQRS
incentive. For more information on the
registry MAV process, please visit
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/PQRS/Downloads/2014_
PQRS_Registry_
MeasureApplicabilityValidation_
12132013.zip.
For EHR reporting, consistent with
the criterion finalized for the 2014
PQRS incentive that aligns with the
criteria established for meeting the CQM
component of meaningful use under the
Medicare EHR Incentive Program and in
accordance with the group practice
reporting requirements under section
1848(m)(3)(C) of the Act, for those group
practices that choose to report using an
EHR, we proposed to modify § 414.90(j)
to indicate the following satisfactory
reporting criterion via a direct EHR
product that is CEHRT or an EHR data
submission vendor that is CEHRT for
ALL group practices who select to
PO 00000
Frm 00245
Fmt 4701
Sfmt 4700
67791
participate in the GPRO for the 2017
PQRS payment adjustment: For the 12month reporting period for the 2017
PQRS payment adjustment, the group
practice would report 9 measures
covering at least 3 domains. If the group
practice’s CEHRT does not contain
patient data for at least 9 measures
covering at least 3 domains, then the
group practice must report the measures
for which there is patient data. A group
practice must report on at least 1
measure for which there is Medicare
patient data. We invited public
comment on these proposals. The
following is summary of the comments
we received regarding on these
proposals.
Comment: The majority of
commenters opposed our proposal to
require the reporting of 9 measures to
meet the criteria for satisfactory
reporting for the 2017 PQRS payment
adjustment. Some commenters
supported the reporting of 9 measures
when using the EHR reporting
mechanisms, indicating that the
proposed criterion aligns with the
criterion for meeting the eCQM
component of meaningful use under the
EHR Incentive Program. Some of the
commenters opposing this proposal
noted that group practices have been
successful at meeting the criteria for
satisfactory reporting for the PQRS
incentives and payment adjustments in
the past by reporting 3 measures, and
increasing the number of measures to be
reported would make it more difficult
for these group practices to meet the
criteria for satisfactory reporting for the
2017 PQRS payment adjustment. Other
commenters also noted that certain
group practices do not have 9 measures
covering 3 NQS domains to report. For
these reasons, some commenters
suggested a more gradual approach to
requiring the reporting of at least 9
measures covering 3 NQS domains,
such as requiring the reporting of 5 or
6 measures rather than 9 measures. A
few commenters also recommended
establishing a lower reporting threshold
for those group practices practicing in
specialties for which few PQRS
measures exist.
Response: While we understand the
commenters concerns related to
requiring the reporting of 9 measures
covering up to 3 NQS domains, we
believe we provided the public with
adequate time to prepare to reporting
criteria that requires the reporting of 9
measures. For example, we finalized
criteria for the satisfactory reporting for
the 2016 PQRS payment adjustment via
registry that only required the reporting
of 3 measures covering 1 NQS domain
(see Table 50 at 78 FR 74486). However,
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67792
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
we also finalized criteria for the 2016
PQRS payment adjustment using the
registry- and EHR-based reporting
mechanisms that aligned with the
criteria we finalized for the 2014 PQRS
incentive that generally required
reporting of at least 9 measures covering
at least 3 NQS domains. Additionally, in
the CY 2014 PFS final rule, we noted
that ‘‘it is our intent to ramp up the
criteria for satisfactory reporting for the
2017 PQRS payment adjustment to be
on par or more stringent than the
criteria for satisfactory reporting for the
2014 PQRS incentive’’ (78 FR 74465).
We believe that establishing criteria for
the satisfactory reporting of the 2016
PQRS payment adjustment that are
consistent with this proposed criteria, as
well as signaling our intent to ramp up
the satisfactory reporting criteria,
provided enough advanced notice to
encourage eligible professionals to
prepare to report 9 measures to meet the
criteria for satisfactory reporting for the
2017 PQRS payment adjustment.
Furthermore, with respect to those
commenters concerned that a group
practice may not have 9 measures
covering at least 3 NQS domains
applicable to his or her practice, in the
proposed rule, with respect to reporting
via registry, we noted that ‘‘as with
individual reporting, we understand
that there may be instances where a
group practice may not have at least 9
measures applicable to a group
practice’s practice. In this instance, like
the criterion we finalized for the 2014
PQRS incentive (see Table 49 at 78 FR
74486), a group practice reporting on
less than 9 measures would still be able
to meet the satisfactory reporting
criterion via registry if the group
practice reports on as many measures as
are applicable to the group practice’s
practice’’ (79 FR 40399). Under this
proposed criterion for satisfactory
reporting for the 2017 PQRS payment
adjustment for group practices reporting
via registry, a group practice who does
not have at least 9 measures covering at
least 3 NQS domains applicable to the
practice may still meet the criteria for
satisfactory reporting for the 2017 PQRS
payment adjustment provided that the
group practice reports all measures as
are applicable to his or her practice.
With respect to reporting via an EHR,
we noted that if the group practice’s
CEHRT does not contain patient data for
at least 9 measures covering at least 3
domains, then the group practice must
report the measures for which there is
patient data. A group practice must
report on at least 1 measure for which
there is Medicare patient data.
Based on the comments received and
for the reasons stated above and in the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
proposed rule, we are finalizing our
proposal to require the reporting of 9
measures covering at least 3 NQS
domains via registry and EHR to meet
the criteria for satisfactory reporting for
the 2017 PQRS payment adjustment.
Comment: Commenters provided the
same comments for requiring the
reporting of cross-cutting measures for
group practice reporting as individual
reporting in section III.K.2.a. Some
commenters provided general support
for the option to report cross-cutting
measures via registry, as it may help
bring alignment with respect to a set of
measures all group practices may report.
However, most of these commenters
believed that the reporting of crosscutting measures should be voluntary,
not mandatory. The majority of
commenters opposed our proposal to
require a group practice that sees at least
1 Medicare patient in a face-to-face
encounter during the 12-month 2017
PQRS payment adjustment reporting
period to report at least 2 measures
contained in the proposed cross-cutting
measure set specified in Table 21 of the
CY 2015 PFS proposed rule (79 FR
40395). Some of these commenters
believed the proposed requirement to be
unfair, as the requirement to report on
at least 2 cross-cutting measures placed
an additional burden on certain
specialists and not others. Other
commenters emphasized that the crosscutting measures did not apply to many
specialty practices. Contrary to these
commenters, some commenters
expressed support for this proposal.
Some of those who supported, this
proposal, however, recommended a
more phased-in approach to the
reporting of cross-cutting measures. One
of these commenters recommended that
the proposal be amended to require only
the reporting of 1 measure in the crosscutting measure set. Some of these
commenters were confused as to
whether this proposal would increase
the proposed number of measures to be
reported to 11 measures.
Response: Please note that our
responses to these comments are the
same responses we provided previously
regarding our proposal to require the
reporting of cross-cutting measures for
individual reporting. Therefore, based
on the comments received and for the
reasons stated previously and in the
proposed rule, we are modifying our
proposal to require that a group practice
who sees at least 1 Medicare patient in
a face-to-face encounter during the 12month 2017 PQRS payment adjustment
reporting period report at least 1
measure contained in the cross-cutting
measure set we are finalizing specified
in Table 52.
PO 00000
Frm 00246
Fmt 4701
Sfmt 4700
Please note that this does not bring
the total number of measures required to
be reported under this criterion to 10
measures. Rather, if a group practice
sees at least 1 Medicare patient in a
face-to-face encounter during the 12month PQRS payment adjustment
reporting period, 1 of the 9 measures the
group practice reports must be measures
contained in the cross-cutting measure
set. Therefore, a group practice would
report at least 1 cross-cutting measure
and 8 additional PQRS measures.
In the instance where a group practice
may not have at least 9 measures
applicable to his/her practice, the
eligible professional would still be
required to report at least 1 cross-cutting
measure, if applicable. If a group
practice reporting on less than 9
measures does not have at least 1 crosscutting measure applicable to his or her
practice, then the group practice would
report on as many measures as our
applicable to his or her practice.
Comment: One commenter believes
that the threshold of seeing 1 Medicare
patient in a face-to-face encounter for
the requirement to report on crosscutting measures is too low. The
commenter was concerned that this
would further burden group practices
who rarely see Medicare patients.
Response: We understand the
commenter’s concern. However, as we
believe in the importance of the crosscutting measures set we are finalizing in
Table 52, it is our desire to encourage
reporting of the measures contained in
the cross-cutting measures set when
applicable. We proposed this threshold
to exclude certain specialties that do not
see Medicare patients. However, we
expect those group practices that see
Medicare patients to report on the crosscutting measures we specify in Table 52.
Comment: One commenter sought
clarification on the definition of a faceto-face encounter by specifying which
codes apply to this definition and urged
that procedural encounters not be
included in the list of face-to-face
encounters.
Response: As we stated in the
proposed rule, we will determine
whether an eligible professional in a
group practice had a ‘‘face-to-face’’
encounter by seeing whether the eligible
professional billed for services under
the PFS that are associated with face-toface encounters, such as whether an
eligible professional billed general office
visit codes, outpatient visits, and
surgical procedures. We would not
include telehealth visits as face-to-face
encounters for purposes of the proposals
requiring reporting of at least 2 crosscutting measures specified in Table 52.
While we will not provide the specific
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
codes for what we definite as a ‘‘face-toface’’ encounter here, we will provide
additional guidance on the PQRS Web
site at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/PQRS/.
Comment: Some commenters opposed
our proposal to require that, to meet the
criteria for satisfactory reporting for the
2017 PQRS payment adjustment, a
group practice reporting individual
measures via registry report each
measure for at least 50 percent of the
group practice’s Medicare Part B FFS
patients seen during the reporting
period to which the measure applies.
The commenters noted that, particularly
for those group practices that see many
patients, requiring the reporting of
quality measures for more than 50
percent of the group practice’s Medicare
Part B FFS patients is an enormous
burden.
Response: We understand this
concern, particularly with those group
practices that see a large number of
patients. However, it is important to
collect sufficient quality measures data
to ensure an adequate sample. We also
believe that requiring that a group
practice report on at least 50 percent of
its Medicare Part B FFS patients helps
to prevent potential selection bias that
could skew the representation of quality
of care; while the potential for selection
bias still remains, we were mindful of
concerns about provider burden during
this period where group practices are
still becoming accustomed to PQRS
reporting. Based on the comments
received and for the reasons stated
above and in the proposed rule, we are
finalizing our proposal to require that,
to meet the criteria for satisfactory
reporting for the 2017 PQRS payment
adjustment, a group practice reporting
individual measures via registry report
each measure for at least 50 percent of
the group practice’s Medicare Part B
FFS patients seen during the reporting
period to which the measure applies.
Comment: Some commenters
generally supported the MAV process.
However, some commenters expressed
the need to clarify the MAV process for
registry as well as to provide greater
transparency in this process.
Response: We understand the need to
clarify further the MAV process for both
claims and registry. Please note that, as
the MAV process evolves, we expect to
be able to provide further guidance to
aid group practices in understanding the
MAV process. We will post additional
clarifying information, including a
‘‘made simple’’ document on the MAV
process for 2015 on the PQRS Web site
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-Assessment-
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Instruments/pqrs/. We
believe that posting this guidance as we
have in years prior provides adequate
transparency in this process. Moreover,
should a group practice have further
questions regarding the MAV process,
he/she may contact our QualityNet Help
Desk for more information. The contact
information for the Help Desk can be
found here: https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/PQRS/
HelpDeskSupport.html.
Because of the comments, we are
finalizing our proposal to modify
§ 414.90(j) and finalize the following
criteria for satisfactory reporting for
group practices participating in the
GPRO via registry and EHR for the 2017
PQRS payment adjustment:
For group practices comprised of 2–99
eligible professionals reporting for the
12-month reporting period for the 2017
PQRS payment adjustment via registry,
report at least 9 measures, covering at
least 3 of the NQS domains. Of these
measures, if a group practice sees at
least 1 Medicare patient in a face-to-face
encounter, the group practice would
report on at least 1 measure in the crosscutting measure set specified in Table
52. If less than 9 measures covering at
least 3 NQS domains apply to the group
practice, the group practice would
report up to 8 measures covering 1–3
NQS domains for which there is
Medicare patient data, AND report each
measure for at least 50 percent of the
group’s Medicare Part B FFS patients
seen during the reporting period to
which the measure applies. Measures
with a 0 percent performance rate
would not be counted.
We understand that there may be
instances where a group practice may
not have at least 9 measures applicable
to an eligible professional’s practice. In
this instance, a group practice reporting
on less than 9 measures would still be
able to meet the satisfactory reporting
criterion via claims and registry if the
group practice reports on 1–8 measures,
as applicable, to the group’s practice. If
a group practice reports on 1–8
measures, the group practice would be
subject to the MAV process, which
would allow us to determine whether a
group practice should have reported
quality data codes for additional
measures. In addition, the MAV will
also allow us to determine whether a
group practice should have reported on
any of the cross-cutting measures
specified in Table 52. The MAV process
we will implement for claims and
registry for the 2017 PQRS payment
adjustment is the same process that was
established for reporting periods
occurring in 2014 for the 2014 PQRS
PO 00000
Frm 00247
Fmt 4701
Sfmt 4700
67793
incentive. For more information on the
claims MAV process, please visit https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/PQRS/Downloads/2014_
PQRS_Claims_
MeasureApplicabilityValidation_
12132013.zip. For more information on
the registry MAV process, please visit
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/PQRS/Downloads/2014_
PQRS_Registry_
MeasureApplicabilityValidation_
12132013.zip.
For group practices comprised of 2–99
eligible professionals reporting for the
12-month reporting period for the 2017
PQRS payment adjustment via EHR:
report 9 measures covering at least 3
domains. If the group practice’s CEHRT
does not contain patient data for at least
9 measures covering at least 3 domains,
then the group practice must report the
measures for which there is patient data.
A group practice must report on at least
1 measure for which there is Medicare
patient data.
Please note that the discussion in this
section III.K.4.b is limited to the criteria
for the satisfactory reporting of group
practices registered to participate in the
GPRO for the 2017 PQRS payment
adjustment using the EHR-based
reporting mechanism to group practices
comprised of 2–99 eligible
professionals. The final criteria for
group practices comprised of 100 or
more eligible professionals are
addressed in section III.K.1.c. following
this section.
c. Criteria for Satisfactory Reporting on
Individual PQRS Quality Measures for
Group Practices Registered to
Participate in the GPRO via a CMSCertified Survey Vendor for the 2017
PQRS Payment Adjustment
In the CY 2014 PFS final rule with
comment period, we introduced
satisfactory reporting criterion for the
2014 PQRS incentive related to
reporting the CG CAHPS survey
measures via a CMS-certified survey
vendor (see Table 49 at 78 FR 74486).
Consistent with the criterion finalized
for the 2014 PQRS incentive and the
group practice reporting requirements
under section 1848(m)(3)(C) of the Act,
we proposed 3 options (of which a
group practice would be able to select
1 out of the 3 options) for satisfactory
reporting for the 2017 PQRS payment
adjustment for group practices
comprised of 25 or more eligible
professionals (79 FR 40399).
Furthermore, as was required for
group practices reporting via the GPRO
web interface for the reporting periods
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67794
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
occurring in 2014 (78 FR 74485), we
proposed that all group practices
comprised of 100 or more eligible
professionals that register to participate
in the PQRS GPRO, regardless of the
reporting mechanism the group practice
chooses, would be required to select a
CMS-certified survey vendor to
administer the CAHPS for PQRS survey
on their behalf. As such, for purposes of
meeting the criteria for satisfactory
reporting for the 2017 PQRS payment
adjustment, a group practice
participating in the PQRS GPRO would
be required to use 1 of these 3 proposed
reporting options mentioned above (that
is, GPRO web interface, qualified
registry or EHR). We noted that, for
reporting periods occurring in 2014, we
stated that we would administer and
fund the collection of (CG–CAHPS) data
for these groups (of 100 or more eligible
professionals using the GPRO web
interface that are required to report on
CAHPS for PQRS survey measures) (78
FR 74452). We stated that we would
bear the cost of administering the
CAHPS for PQRS survey measures, as
we were requiring the group practices to
report on CAHPS for PQRS survey
measures. Unfortunately, beginning in
2015, it will no longer be feasible for us
to continue to bear the cost of group
practices of 100 or more eligible
professionals to report the CAHPS for
PQRS survey measures. Therefore, the
group practice would be required to
bear the cost of administering the
CAHPS for PQRS survey measures.
However, as CAHPS for PQRS was
optional for group practices comprised
of 25–99 eligible professionals in 2014
(78 FR 74485) and whereas we proposed
to require reporting of CAHPS for PQRS
for group practices comprised of 100 or
more eligible professionals, we
proposed that CAHPS for PQRS would
be optional for groups of 25–99 and 2–
24 eligible professionals. We noted that
all group practices that would be
required to report or voluntarily elect to
report CAHPS for PQRS would need to
select and pay a CMS-certified survey
vendor to administer the CAHPS for
PQRS survey on their behalf.
We invited public comment on these
proposals related to our proposals to
require reporting of CAHPS for PQRS
for group practices comprised of 100 or
more eligible professionals that register
to participate in the PQRS GPRO as well
as our proposal making the reporting of
CAHPS for PQRS optional for group
practices comprised of 2–99 eligible
professionals that registry to participate
in the PQRS GPRO to meet the criteria
for satisfactory reporting for the 2017
PQRS payment adjustment. The
following is a summary of the comments
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
we received regarding on these
proposals.
Comment: Commenters supported the
option to report CAHPS for PQRS, as
long as reporting CAHPS for PQRS
remained optional. The majority of
commenters opposed our proposal to
require group practices comprised of
100 or more eligible professionals that
register to participate in the PQRS
GPRO, regardless of the reporting
mechanism the group practice chooses,
to select a CMS-certified survey vendor
to administer the CAHPS for PQRS
survey on their behalf. These
commenters believe that this
requirement was too burdensome,
particularly because CMS is not bearing
the cost of administering the survey.
Some of these commenters requested
that CMS delay requiring the reporting
of CAHPS for PQRS to the 2016
reporting period. Other commenters
requested that CMS continue to bear the
cost of administering the CAHPS for
PQRS survey.
Response: While we understand the
commenters’ concerns regarding
requiring the reporting of CAHPS for
PQRS, group practices comprised of 100
or more eligible professionals
participating in the GPRO web interface
reporting option have had 2 years of
experience reporting CAHPS for PQRS
as they have been required to report
CAHPS for PQRS for both the 2013 and
2014 PQRS incentive. Groups of 25–99
eligible professionals reporting via
GPRO web interface, qualified registry
or EHR and groups of 100 or more
eligible professionals reporting via
qualified registry or EHR had the option
to report CAHPS for PQRS in 2014. We
believe that 2 years is enough time to
become familiar with how the survey is
administered. Therefore, we believe it is
reasonable to require group practices of
100 of more eligible professionals to
report on CAHPS for PQRS. With
respect to some commenters’ concerns
about the additional burden the
proposal to require group practices
comprised of 100 or more eligible
professionals that register to participate
in the PQRS GPRO to report CAHPS for
PQRS places on these group practices,
we understand that this proposed
requirement could bring additional
reporting burden on these larger group
practices. We believe that the value of
the information contained in the CAHPS
for PQRS survey outweighs this
concern. In addition, we note that large
group practices tend to be more
sophisticated than other group practices
with respect to resources, and, as such,
we believe that this mitigates any
additional burden on group practices of
100 or more eligible professionals.
PO 00000
Frm 00248
Fmt 4701
Sfmt 4700
Therefore, based on the reasons we state
here and in the proposed rule, we are
finalizing our proposal to require
reporting of CAHPS for PQRS for group
practices comprised of 100 or more
eligible professionals that register to
participate in the PQRS GPRO.
We are also finalizing our proposal to
make the reporting of CAHPS for PQRS
optional for group practices comprised
of 2–99 eligible professionals that
register to participate in the PQRS
GPRO to meet the criteria for
satisfactory reporting for the 2017 PQRS
payment adjustment.
Furthermore, we understand the
commenters’ concerns regarding having
the group practices bear the cost of
administering the CAHPS for PQRS
survey, particularly for those group
practices who will be required to report
CAHPS for PQRS to meet the criteria for
satisfactory reporting for the 2017 PQRS
payment adjustment. However, it is not
feasible for us to continue to bear the
cost of administering the CAHPS for
PQRS survey. We believe that bearing
the cost of the CAHPS for PQRS survey
for 2013 and 2014 provided adequate
time for group practices to become
familiar with administering the CAHPS
for PQRS survey as well as signaled our
commitment to reporting of the CAHPS
for PQRS survey into the future.
Because of the comments received, we
are finalizing the following final criteria
for satisfactory reporting for the 2017
PQRS payment adjustment for group
practices comprised of 2 or more
eligible professionals. The following
options are voluntary ways to meet the
criteria for satisfactory reporting for the
2017 PQRS payment adjustment for
groups comprised of 2–99 eligible
professionals. However, group practices
comprised of 100 or more eligible
professionals that are registered to
participate in the GPRO must select one
of these options to meet the criteria for
satisfactory reporting for the 2017 PQRS
payment adjustment.
Option 1—Registry: If a group practice
of 2 or more eligible professionals
chooses to use a qualified registry, in
conjunction with reporting the CAHPS
for PQRS survey measures, for the 12month reporting period for the 2017
PQRS payment adjustment, the group
practice must have all CAHPS for PQRS
survey measures reported on its behalf
via a CMS-certified survey vendor, and
report at least 6 additional measures,
outside of CAHPS for PQRS, covering at
least 2 of the NQS domains using the
qualified registry. If less than 6
measures apply to the group practice,
the group practice must report up to 5
measures. Of the additional measures
that must be reported in conjunction
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
with reporting the CAHPS for PQRS
survey measures, if any eligible
professional in the group practice sees
at least 1 Medicare patient in a face-toface encounter, the group practice must
report on at least 1 measure in the crosscutting measure set specified in Table
52.
Consistent with the group practice
reporting option solely using a qualified
registry for the 2017 PQRS payment
adjustment, we understand that there
may be instances where a group practice
may not have at least 6 measures
applicable to a group practice’s practice.
In this instance, a group practice
reporting on less than 6 measures would
still be able to meet the satisfactory
reporting criterion via registry if the
group practice reports on as many
measures as are applicable to the group
practice’s practice, including the
measures in the cross-cutting measure
set specified in Table 52. If a group
practice reports on less than 6
individual measures using the qualified
registry reporting mechanism in
conjunction with a CMS-certified survey
vendor to report CAHPS for PQRS, the
group practice would be subject to the
MAV process, which would allow us to
determine whether a group practice
should have reported quality data codes
for additional measures and/or
measures covering additional NQS
domains. For more information on the
registry MAV process, please visit
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/PQRS/Downloads/2014_
PQRS_Registry_
MeasureApplicabilityValidation_
12132013.zip.
Option 2—EHR: If a group practice of
2 or more eligible professionals chooses
to use a direct EHR product that is
CEHRT or EHR data submission vendor
that is CEHRT in conjunction with
reporting the CAHPS for PQRS survey
measures, for the 12-month reporting
period for the 2017 PQRS payment
adjustment, the group practice must
have all CAHPS for PQRS survey
measures reported on its behalf via a
CMS-certified survey vendor, and report
at least 6 additional measures, outside
of CAHPS for PQRS, covering at least 2
of the NQS domains using the direct
EHR product that is CEHRT or EHR data
submission vendor product that is
CEHRT. If less than 6 measures apply to
the group practice, the group practice
must report up to 5 measures. Of the
additional 6 measures that must be
reported in conjunction with reporting
the CAHPS for PQRS survey measures,
a group practice would be required to
report on at least 1 measure for which
there is Medicare patient data.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Option 3—GPRO Web Interface:
Alternatively, if a group practice of 25–
99 eligible professionals chooses to use
the GPRO web interface in conjunction
with reporting the CAHPS for PQRS
survey measures, for the 12-month
reporting period for the 2017 PQRS
payment adjustment, the group practice
must have all CAHPS for PQRS survey
measures reported on its behalf via a
CMS-certified survey vendor. In
addition, the group practice must report
on all measures included in the GPRO
web interface; AND populate data fields
for the first 248 consecutively ranked
and assigned beneficiaries in the order
in which they appear in the group’s
sample for each module or preventive
care measure. If the pool of eligible
assigned beneficiaries is less than 248,
then the group practice must report on
100 percent of assigned beneficiaries. A
group practice will be required to report
on at least 1 measure for which there is
Medicare patient data.
Tables 50 and 51 provide a summary
of the final criteria for satisfactory
reporting—or, in lieu of satisfactory
reporting, satisfactory participation in a
QCDR—for the 2017 PQRS payment
adjustment for eligible professionals and
group practices. As you can see below,
there are a total of 5 individual
reporting options and 9 group practice
reporting options. Therefore, there are a
total of 14 reporting options under the
PQRS for purposes of meeting the
criteria for satisfactory reporting—or, in
lieu of satisfactory reporting,
satisfactory participation in a QCDR—
for the 2017 PQRS payment adjustment.
d. The Consumer Assessment of
Healthcare Providers Surgical Care
Survey (S–CAHPS)
In addition to CAHPS for PQRS, we
received comments last year supporting
the inclusion of the Consumer
Assessment of Healthcare Providers
Surgical Care Survey (S–CAHPS). The
S–CAHPS expands on the CG–CAHPS
by focusing on aspects of surgical
quality, which are important from the
patient’s perspective and for which the
patient is the best source of information.
The survey asks patients to provide
feedback on surgical care, surgeons,
their staff, and anesthesia care. It
assesses patients’ experiences with
surgical care in both the inpatient and
outpatient settings by asking
respondents about their experience
before, during and after surgery. The
commenters stated that the CG–CAHPS
survey would not accurately reflect the
care provided by single- or
multispecialty surgical or anesthesia
groups. The commenters noted that S–
CAHPS has been tested by the same
PO 00000
Frm 00249
Fmt 4701
Sfmt 4700
67795
standards as CG–CAHPS and follows
the same collection mechanism as the
CG–CAHPS. We agree with the
commenters on the importance of
allowing for the administration of S–
CAHPS reporting and wish to allow for
reporting of S–CAHPS in the PQRS for
reporting mechanisms other than the
QCDR. However, at this time, due to the
cost and time it would take to find
vendors to collect S–CAHPS data, it is
not technically feasible to implement
the reporting of the S–CAHPS survey
measures for the 2017 PQRS payment
adjustment. In the CY 2015 PFS
proposed rule (79 FR 40400), we
solicited comments on how to allow for
reporting of the S–CAHPS survey
measures for the 2018 PQRS payment
adjustment and beyond. In addition, we
sought comments on how to allow for
reporting of the S–CAHPS survey
measures for the 2018 PQRS payment
adjustment and beyond. The following
is a summary of the comments we
received on these proposal:
Comment: The majority of
commenters supported the introduction
of S–CAHPS in the PQRS. These
commenters supported our proposal to
allow the reporting of S–CAHPS via a
QCDR, and other commenters requested
that group practices be able to report S–
CAHPS via a CMS-certified survey
vendor, similar to the way CAHPS for
PQRS is currently being reported under
the PQRS. Other commenters expressed
concerns on introducing S–CAHPS for
the PQRS. One commenter stated that
S–CAHPS does not adequately capture
the patient and caregiver experience
with all types of anesthesia
professionals. Another commenter
expressed concerns related to
determining how to select patients for
which to administer S–CAHPS.
Commenters were also concerned with
the financial burden of administering
the S–CAHPS survey, and asked CMS to
explore ways to fund the administration
of the S–CAHPS survey.
Response: We appreciate the
commenters’ feedback. However, at this
time, due to the cost and time it would
take to find vendors to collect S–CAHPS
data, it is not technically feasible to
implement the reporting of the S–
CAHPS survey measures for the 2017 or
2018 PQRS payment adjustments. We
note, however, that if a QCDR wishes to
administer the S–CAHPS as a non-PQRS
measure for the 2017 or 2018 PQRS
payment adjustments, we would allow
the QCDR to do so. We will take these
comments into consideration as we
continue to work to introduce S–CAHPS
in the PQRS measure set for future
years.
E:\FR\FM\13NOR2.SGM
13NOR2
67796
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 50: Summary of Requirements for the 2017 PQRS Payment Adjustment:
Individual Reporting Criteria for the Satisfactory Reporting of Quality Measures Data via Claims,
Qualified Registry, and EHRs and Satisfactory Participation Criterion in QCDRs
Reporting
Mechanism
Claims
Individual
Measures
Qualified
Registry
12-month
(Jan 1Dec 31,
2015)
Individual
Measures
DirectEHR
Product or
EHRData
Submission
Vendor
Product
12-month
(Jan 1Dec 31,
2015)
Measures
Groups
Qualified
Registry
12-month
(Jan 1Dec 31,
2015)
Individual
PQRS
measures
and/or nonPQRS
measures
reportable
viaaQCDR
Qualified
Clinical Data
Registry
(QCDR)
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Satisfactory Reporting/Satisfactory Participation Criteria
Report at least 9 measures, covering at least 3 of the NQS domains
AND report each measure for at least 50 percent of the eligible
professional's Medicare Part B FFS patients seen during the
reporting period to which the measure applies. Of the measures
reported, if the eligible professional sees at least 1 Medicare patient
in a face-to-face encounter, the eligible professional will report on at
least 1 measure contained in the proposed cross-cutting measure set
specified in Table 52. Ifless than 9 measures apply to the eligible
professional, the eligible professional would report up to 8
measure(s), AND report each measure for at least 50 percent of the
Medicare Part B FFS patients seen during the reporting period to
which the measure applies. Measures with a 0 percent performance
rate would not be counted.
Report at least 9 measures, covering at least 3 of the NQS domains
AND report each measure for at least 50 percent of the eligible
professional's Medicare Part B FFS patients seen during the
reporting period to which the measure applies. Of the measures
reported, if the eligible professional sees at least 1 Medicare patient
in a face-to-face encounter, the eligible professional will report on at
least 1 measure contained in the proposed cross-cutting measure set
specified in Table 52. Ifless than 9 measures apply to the eligible
professional, the eligible professional would report up to 8
measure(s), AND report each measure for at least 50 percent of the
Medicare Part B FFS patients seen during the reporting period to
which the measure applies. Measures with a 0 percent performance
rate would not be counted.
Report 9 measures covering at least 3 of the NQS domains. If an
eligible professional's direct EHR product or EHR data submission
vendor product does not contain patient data for at least 9 measures
covering at least 3 domains, then the eligible professional would be
required to report all of the measures for which there is Medicare
patient data. An eligible professional would be required to report on
at least 1 measure for which there is Medicare patient data.
Report at least 1 measures group AND report each measures group
for at least 20 patients, the majority (11 patients) of which are
required to be Medicare Part B FFS patients. Measures groups
containing a measure with a 0 percent performance rate will not be
counted.
Report at least 9 measures available for reporting under a QCDR
covering at least 3 of the NQS domains, AND report each measure
for at least 50 percent ofthe eligible professional's patients. Of these
measures, the eligible professional would report on at least 2
outcome measures, OR, if2 outcomes measures are not available,
report on at least 1 outcome measures and at least 1 of the following
types of measures - resource use, patient experience of care,
efficiency/appropriate use, or patient safety
Frm 00250
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.065</GPH>
Measure
Type
Individual
Measures
12-month
(Jan 1Dec 31,
2015)
ebenthall on DSK5SPTVN1PROD with $$_JOB
Reporting
Period
12-month
(Jan 1Dec 31,
2015)
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
67797
TABLE 51: Summary of Requirements for the 2017 PQRS Payment Adjustment: Group Practice
Reporting Criteria for Satisfactory Reporting of Quality Measures Data via the GPRO
12-month
(Jan 1Dec 31,
2015)
Group
Practice
Size
25-99
eligible
professio
nals
Measure
Type
Reporting
Mechanism
Satisfactory Reporting Criteria
Individual
GPRO
Measures in
theGPRO
Web
Interface
GPROWeb
Interface
Report on all measures included in the web interface;
AND populate data fields for the first 248 consecutively
ranked and assigned beneficiaries in the order in which
they appear in the group's sample for each module or
preventive care measure. If the pool of eligible assigned
beneficiaries is less than 248, then the group practice
must report on 100 percent of assigned beneficiaries. In
other words, we understand that, in some instances, the
sampling methodology we provide will not be able to
assign at least 248 patients on which a group practice
may report, particularly those group practices on the
smaller end ofthe range of 25-99 eligible professionals.
If the group practice is assigned less than 248 Medicare
beneficiaries, then the group practice must report on 100
percent of its assigned beneficiaries. A group practice
must report on at least 1 measure for which there is
Medicare patient data.
The group practice must have all CARPS for PQRS
survey measures reported on its behalf via a CMScertified survey vendor. In addition, the group practice
must report on all measures included in the GPRO web
interface; AND populate data fields for the first 248
consecutively ranked and assigned beneficiaries in the
order in which they appear in the group's sample for
each module or preventive care measure. If the pool of
eligible assigned beneficiaries is less than 248, then the
group practice must report on 100 percent of assigned
beneficiaries. A group practice will be required to report
on at least 1 measure for which there is Medicare patient
data.
Report at least 9 measures, covering at least 3 of the
NQS domains. Of these measures, if a group practice
sees at least 1 Medicare patient in a face-to-face
encounter, the group practice would report on at least 1
measure in the cross-cutting measure set specified in
Table 52. If less than 9 measures covering at least 3
NQS domains apply to the group practice, the group
practice would report up to 8 measures covering 1-3
NQS domains for which there is Medicare patient data,
AND report each measure for at least 50 percent ofthe
group's Medicare Part B FFS patients seen during the
reporting period to which the measure applies.
Measures with a 0 percent performance rate would not
be counted.
The group practice must have all CARPS for PQRS
survey measures reported on its behalf via a CMScertified survey vendor, and report at least 6 additional
measures, outside of CARPS for PQRS, covering at
least 2 of the NQS domains using the qualified registry.
If less than 6 measures apply to the group practice, the
group practice must report up to 5 measures. Of the
25-99
eligible
professio
nals
andlOO+
eligible
professio
nals
Individual
GPRO
Measures in
theGPRO
Web
Interface+
CAHPSfor
PQRS
GPROWeb
Interface+
CMSCertified
Survey
Vendor
12-month
(Jan 1Dec 31,
2015)
2-99
eligible
professio
nals
Individual
Measures
Qualified
Registry
12-month
(Jan 1Dec 31,
2015)
ebenthall on DSK5SPTVN1PROD with $$_JOB
12-month
(Jan 1Dec 31,
2015)
2-99
eligible
professio
nals and
100+
eligible
professio
Individual
Measures+
CAHPSfor
PQRS
Qualified
Registry+
CMSCertified
Survey
Vendor
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00251
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.066</GPH>
Reporting
Period
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
5. Statutory Requirements and Other
Considerations for the Selection of
PQRS Quality Measures for Meeting the
Criteria for Satisfactory Reporting for
2015 and Beyond for Individual Eligible
Professionals and Group Practices
CMS undergoes an annual Call for
Measures that solicits new measures
from the public for possible inclusion in
the PQRS. During the Call for Measures,
we request measures for inclusion in
PQRS that meet the following statutory
and non-statutory criteria.
Sections 1848(k)(2)(C) and
1848(m)(3)(C)(i) of the Act, respectively,
govern the quality measures reported by
individual eligible professionals and
group practices under the PQRS. Under
section 1848(k)(2)(C)(i) of the Act, the
PQRS quality measures shall be such
measures selected by the Secretary from
measures that have been endorsed by
the entity with a contract with the
Secretary under section 1890(a) of the
Act, which is currently the National
Quality Forum (NQF). However, in the
case of a specified area or medical topic
determined appropriate by the Secretary
for which a feasible and practical
measure has not been endorsed by the
NQF, section 1848(k)(2)(C)(ii) of the Act
authorizes the Secretary to specify a
measure that is not so endorsed as long
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
as due consideration is given to
measures that have been endorsed or
adopted by a consensus organization
identified by the Secretary, such as the
Ambulatory Quality Alliance (AQA). In
light of these statutory requirements, we
believe that, except in the circumstances
specified in the statute, each PQRS
quality measure must be endorsed by
the NQF. Additionally, section
1848(k)(2)(D) of the Act requires that for
each PQRS quality measure, ‘‘the
Secretary shall ensure that eligible
professionals have the opportunity to
provide input during the development,
endorsement, or selection of measures
applicable to services they furnish.’’ The
statutory requirements under section
1848(k)(2)(C) of the Act, subject to the
exception noted previously, require
only that the measures be selected from
measures that have been endorsed by
the entity with a contract with the
Secretary under section 1890(a) of the
Act (that is, the NQF) and are silent as
to how the measures that are submitted
to the NQF for endorsement are
developed.
The basic steps for developing
measures applicable to physicians and
other eligible professionals prior to
submission of the measures for
endorsement may be carried out by a
variety of different organizations. We do
PO 00000
Frm 00252
Fmt 4701
Sfmt 4700
not believe there need to be special
restrictions on the type or make-up of
the organizations carrying out this basic
process of development of physician
measures, such as restricting the initial
development to physician-controlled
organizations. Any such restriction
would unduly limit the basic
development of quality measures and
the scope and utility of measures that
may be considered for endorsement as
voluntary consensus standards for
purposes of the PQRS.
In addition to section 1848(k)(2)(C) of
the Act, section 1890A of the Act, which
was added by section 3014(b) of the
Affordable Care Act, requires that the
Secretary establish a pre-rulemaking
process under which certain steps occur
with respect to the selection of certain
categories of quality and efficiency
measures, one of which is that the entity
with a contract with the Secretary under
section 1890(a) of the Act (that is, the
NQF) convene multi-stakeholder groups
to provide input to the Secretary on the
selection of such measures. These
categories are described in section
1890(b)(7)(B) of the Act, and include
such measures as the quality measures
selected for reporting under the PQRS.
In accordance with section 1890A(a)(1)
of the Act, the NQF convened multistakeholder groups by creating the
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.067</GPH>
67798
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
Measure Applications Partnership
(MAP). Section 1890A(a)(2) of the Act
requires that the Secretary must make
publicly available by December 1st of
each year a list of the quality and
efficiency measures that the Secretary is
considering for selection through
rulemaking for use in the Medicare
program. The NQF must provide CMS
with the MAP’s input on the selection
of measures by February 1st of each
year. The lists of measures under
consideration for selection through
rulemaking in 2014 are available at
https://www.qualityforum.org/map/.
As we noted above, section
1848(k)(2)(C)(ii) of the Act provides an
exception to the requirement that the
Secretary select measures that have been
endorsed by the entity with a contract
under section 1890(a) of the Act (that is,
the NQF). We may select measures
under this exception if there is a
specified area or medical topic for
which a feasible and practical measure
has not been endorsed by the entity, as
long as due consideration is given to
measures that have been endorsed or
adopted by a consensus organization
identified by the Secretary. Under this
exception, aside from NQF
endorsement, we requested that
stakeholders apply the following
considerations when submitting
measures for possible inclusion in the
PQRS measure set:
• Measures that are not duplicative of
another existing or proposed measure.
• Measures that are further along in
development than a measure concept.
• CMS is not accepting claims-basedonly reporting measures in this process.
• Measures that are outcome-based
are preferred to clinical process
measures.
• Measures that address patient safety
and adverse events.
• Measures that identify appropriate
use of diagnosis and therapeutics.
• Measures that identify care
coordination and communication.
• Measures that identify care
coordination of patient experience and
patient-reported outcomes.
• Measures that address efficiency,
cost and resource use.
As a general matter, please note that the
measure tables contained in this section
III.K. may also contain discussions of
comments we received related to
proposed changes to the measures
included in the quality performance
standard under the Shared Savings
Program.
a. PQRS Quality Measures
Taking into consideration the
statutory and non-statutory criteria we
described previously, this section
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
contains our responses to our proposals
related to the measures in the PQRS for
2015 and beyond. We classified all
measures against six domains based on
the NQS’s six priorities, as follows:
(1) Patient Safety. These measures
reflect the safe delivery of clinical
services in all healthcare settings. These
measures may address a structure or
process that is designed to reduce risk
in the delivery of healthcare or measure
the occurrence of an untoward outcome
such as adverse events and
complications of procedures or other
interventions.
(2) Person and Caregiver-Centered
Experience and Outcomes. These are
measures that reflect the potential to
improve patient-centered care and the
quality of care delivered to patients.
They emphasize the importance of
collecting patient-reported data and the
ability to impact care at the individual
patient level, as well as the population
level. These are measures of
organizational structures or processes
that foster both the inclusion of persons
and family members as active members
of the health care team and collaborative
partnerships with providers and
provider organizations or can be
measures of patient-reported
experiences and outcomes that reflect
greater involvement of patients and
families in decision making, self-care,
activation, and understanding of their
health condition and its effective
management.
(3) Communication and care
coordination. These measures
demonstrate appropriate and timely
sharing of information and coordination
of clinical and preventive services
among health professionals in the care
team and with patients, caregivers, and
families to improve appropriate and
timely patient and care team
communication. They may also be
measures that reflect outcomes of
successful coordination of care.
(4) Effective clinical care. These are
measures that reflect clinical care
processes closely linked to outcomes
based on evidence and practice
guidelines or measures of patientcentered outcomes of disease states.
(5) Community/population health.
These measures reflect the use of
clinical and preventive services and
achieve improvements in the health of
the population served. They may be
measures of processes focused on
primary prevention of disease or general
screening for early detection of disease
unrelated to a current or prior
condition.
(6) Efficiency and cost reduction.
These measures reflect efforts to lower
costs and to significantly improve
PO 00000
Frm 00253
Fmt 4701
Sfmt 4700
67799
outcomes and reduce errors. These are
measures of cost, resource use and
appropriate use of healthcare resources
or inefficiencies in healthcare delivery.
Please note that the PQRS quality
measure specifications for any given
PQRS individual quality measure may
differ from specifications for the same
quality measure used in prior years. For
example, for the PQRS quality measures
that were selected for reporting in 2014
and beyond, please note that detailed
measure specifications, including the
measure’s title, for the individual PQRS
quality measures for 2013 and beyond
may have been updated or modified
during the NQF endorsement process or
for other reasons.
In addition, due to our desire to align
measure titles with the measure titles
that have been finalized for 2013, 2014,
2015, and potentially subsequent years
of the EHR Incentive Program for
Eligible Professionals, we note that the
measure titles for measures available for
reporting via EHR may change. To the
extent that the EHR Incentive Program
for Eligible Professionals updates its
measure titles to include version
numbers (77 FR 13744), we will use
these version numbers to describe the
PQRS EHR measures that will also be
available for reporting for the EHR
Incentive Program for Eligible
Professionals. We will continue to work
toward complete alignment of measure
specifications across programs,
whenever possible.
Through NQF’s measure maintenance
process, NQF-endorsed measures are
sometimes updated to incorporate
changes that we believe do not
substantively change the nature of the
measure. Examples of such changes
could be updated diagnosis or
procedure codes or changes to
exclusions to the patient population or
definitions. We believe these types of
maintenance changes are distinct from
substantive changes to measures that
result in what are considered new or
different measures. Further, we believe
that non-substantive maintenance
changes of this type do not trigger the
same agency obligations under the
Administrative Procedure Act.
In the CY 2013 PFS final rule with
comment period, we finalized our
proposal providing that if the NQF
updates an endorsed measure that we
have adopted for the PQRS in a manner
that we consider to not substantively
change the nature of the measure, we
would use a subregulatory process to
incorporate those updates to the
measure specifications that apply to the
program (77 FR 69207). We believe this
adequately balances our need to
incorporate non-substantive NQF
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67800
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
updates to NQF-endorsed measures in
the most expeditious manner possible,
while preserving the public’s ability to
comment on updates that so
fundamentally change an endorsed
measure that it is no longer the same
measure that we originally adopted. We
also noted that the NQF process
incorporates an opportunity for public
comment and engagement in the
measure maintenance process. We will
revise the Specifications Manual and
post notices to clearly identify the
updates and provide links to where
additional information on the updates
can be found. Updates will also be
available on the CMS PQRS Web site at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/PQRS/.
CMS is not the measure steward for
most of the measures available for
reporting under the PQRS. We rely on
outside measure stewards and
developers to maintain these measures.
In Table 55, we proposed that certain
measures be removed from the PQRS
measure set due to the measure owner/
developer indicating that it will not be
able to maintain the measure. We noted
that this proposal is contingent upon the
measure owner/developer not being able
to maintain the measure. Should we
learn that a certain measure owner/
developer is able to maintain the
measure, or that another entity is able to
maintain the measure in a manner that
allows the measure to be available for
reporting under the PQRS for the CY
2017 PQRS payment adjustment, we
proposed to keep the measure available
for reporting under the PQRS and
therefore not finalize our proposal to
remove the measure. In addition, if,
after the display of this final rule with
comment period, we discover additional
measures within the current PQRS
measure set that a measure owner/
developer can no longer maintain, we
proposed to remove these measures
from reporting for the PQRS beginning
in 2015. We will discuss any such
instances in the PQRS measure tables
below.
In addition, we noted that we have
received feedback from stakeholders,
particularly first-time participants who
find it difficult to understand which
measures are applicable to their
particular practice. In an effort to aid
eligible professionals and group
practices to determine what measures
best fit their practice, and in
collaboration with specialty societies,
we are beginning to group our final
measures available for reporting
according to specialty. The current
listing of our measures by specialty can
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
be found on our Web site at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/PQRS/. Please
note that these groups of measures are
meant to provide guidance to those
eligible professionals seeking to
determine what measures to report.
Eligible professionals are not required to
report measures according to these
suggested groups of measures. In
addition to group measures according to
specialty, we also plan to have a
measure subset for measures that
specifically addresses multiple chronic
conditions. As measures are adopted or
revised, we will continue to update
these groups to reflect the measures
available under the PQRS, as well as
add more specialties.
In the CY 2014 PFS final rule with
comment period, we stated that ‘‘unless
there are errors discovered in updated
electronic measure specifications, the
PQRS intends to use the most recent,
updated versions of electronically
specified clinical quality measures for
that year’’ (78 FR 74489). We proposed
that, if we discovered errors in the most
recently updated electronic measure
specifications for a certain measure, we
would use the version of electronic
measure specifications that immediately
precedes the most recently updated
electronic measure specifications. Any
such change to a measure is also
described in the PQRS measure tables
below.
Additionally, we noted that, with
respect to the following e-measure
CMS140v2, Breast Cancer Hormonal
Therapy for Stage IC–IIIC Estrogen
Receptor/Progesterone Receptor (ER/PR)
Positive Breast Cancer (NQF 0387), a
substantive error was discovered in the
June 2013 version of this electronically
specified clinical quality measure.
Therefore, the PQRS required the use of
the prior, December 2012 version of this
measure, which is CMS140v1 (78 FR
74489). Please note that, consistent with
other EHR measures, since a more
recent and corrected version of this
measure has been developed, we will
require the reporting of the most recent,
updated versions of the measure Breast
Cancer Hormonal Therapy for Stage IC–
IIIC Estrogen Receptor/Progesterone
Receptor (ER/PR) Positive Breast Cancer
(NQF 0387)—currently version
CMS140v3—for the year.
b. Cross-Cutting Measure Set for 2015
and Beyond
In accordance with our criteria for the
satisfactory reporting of PQRS measures
for the 2017 PQRS payment adjustment
via claims and registry that requires an
PO 00000
Frm 00254
Fmt 4701
Sfmt 4700
eligible professional or group practice to
report on at least 2 cross-cutting
measures, we proposed 18 cross-cutting
measure set specified in Table 21 in the
CY 2015 PFS proposed rule for 2015
and beyond (79 FR 40404). Please note
that we are finalizing all measures as
proposed (see Table 52). We are also
adding a measure to the list of crosscutting measures, based on comments
that were submitted. Please note that
our response and final decision for each
of these measures is found in Table 52.
We have also indicated the PQRS
reporting mechanism or mechanisms
through which each measure could be
submitted. Please note that we are
changing some of the reporting
mechanisms available for certain crosscutting measures in Table 52 from the
reporting options we proposed would be
available in the CY 2015 PFS proposed
rule (79 FR 40404). To the extent that
changes to the reporting mechanisms for
the cross-cutting measures specified in
Table 52 were made from what was
specified in the proposed rule, we
provide the explanation and rationale
for those changes in Table 53.
The following are high-level
comments regarding our proposals
related to the proposed cross-cutting
measure set:
Comment: Several commenters
supported the development of a crosscutting measure set as well as the
composition as proposed, while other
commenters were concerned about this
new requirement noting the measures
may not be as applicable to some
specialists.
Response: With respect to the
commenters who expressed concern
that the proposed measures in the
proposed cross-cutting measures set did
not apply to many specialties, we note
that limitations such as only requiring
reporting of a cross-cutting measures in
a face-to-face encounter would exclude
those eligible professionals for which
the measures do not apply. With respect
to taking a more phased-in approach to
introducing the cross-cutting measure
set, please note that we have modified
this proposal to only require the
reporting of 1 cross-cutting measure. We
believe that requiring the reporting of 1
measure in the cross-cutting measures
set is not overly burdensome and may
help eligible professionals by providing
direction on what measures to report.
We are modifying our proposal to only
require eligible professionals who see at
least 1 Medicare patient in a face-to-face
encounter to report on 1 cross-cutting
measure.
E:\FR\FM\13NOR2.SGM
13NOR2
67801
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 52: Individual Quality Cross-Cutting Measures for the PQRS to Be Available for
Satisfactory Reporting Via Claims, Registry, and EHR Beginning in 2015
~
....
~00.
0'~
00.
lo;
~ ;J
z~ u
~
~
I
Q,
"'
.Q
Q,l"CC
Q,l
=~
~ ~
lo;
NQS
Domain
Q,l
Measure Title and Description¥
lo;
Q,l
~00
Q,l,.....,
= -.... = e
=...
~
c;.!)
ot:~
c
lo;
...
"'
~]
.5 > "61J ~ 0
00.
.s u "' f,;il ~~ "'
u
~
=... = "'
=
c;,!)'"'
"
lo;
Q,l
lo;
~
f,;il
Q,l
~
Mcasutcs hnaltzcd as l'toposcd or
N/A
/402
N/AI
400
N/
A
N/
A
Communit
y/Populati
on Health
Effective
Clinical
Care
Communi
cation and
Care
Coordinati
on
Q,l
lo;
;9~=...
0
tth f\locltlicattons
11
Tobacco Use and Help with Quitting
Among Adolescents: The percentage of
adolescents 12 to 20 years of age with a
primary care visit during the
measurement year for whom tobacco use
status was documented and received help
with quitting if identified as a tobacco
user
Commenters agreed this measure was
appropriately classified as cross-cutting.
For this reason, CMS is finalizing its
proposal to make this measure reportable
as a cross-cutting measure for 2015
PQRS.
Hepatitis C: One-Time Screening for
Hepatitis C Virus (HCV) for Patients
at Risk: Percentage of patients aged 18
years and older with one or more of the
following: a history of injection drug use,
receipt of a blood transfusion prior to
1992, receiving maintenance
hemodialysis OR birthdate in the years
1945-1965 who received a one-time
screening for HCV infection
c lo;
1-;Q,~
Q,l
NCQA/
NCIQM
X
AGA/
AASLD/
AMAPCPI
X
Commenters agreed this measure was
appropriately classified as cross-cutting.
For this reason, CMS is finalizing its
proposal to make this measure reportable
as a cross-cutting measure for 2015
PQRS.
Medication Reconciliation: Percentage
of patients aged 18 years and older
discharged from any inpatient facility (for
example, hospital, skilled nursing facility,
or rehabilitation facility) and seen within
30 days following discharge in the office
by the physician, prescribing practitioner,
registered nurse, or clinical pharmacist
providing on-going care who had a
reconciliation of the discharge
medications with the current medication
list in the outpatient medical record
documented
NCQA/
AMAPCPI
X
X
X
This measure is reported as two rates
stratified by age group:
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00255
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.068</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
0097
/046
N/
A
/)J)r,tj
67802
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
-.oo
r.-.~
oo
z~
~
....
..
~ ~
00
-
u
~
~
I
"'
a >
·; 00
u
"'
"Sii
"'
= ;;...
= - =a
~ ~ C!l
'-'~
~ t: "'
~ 0 - .. Cl=•
"' •c..OJ)
fioil ~~
.. .. =
~ = = ;~t
"' 0
C!l""' ..
"'
~
NCQA/
AMAPCPI
X
X
X
AMAPCPI
X
X
X
X
X
ACO
MU2
NCQA
X
X
X
X
X
ACO
MU2
-= "'
.. ..
"'-=
NQS
Domain
Measure Title and Description¥
~ ~
~~
u
"
~
fioil
..
.Q
c..
__.._
-
::::
OJ:) r:IJ
0326
/047
ebenthall on DSK5SPTVN1PROD with $$_JOB
0041
/110
0043
/111
VerDate Sep<11>2014
N/
A
147
v4
127
v3
Communi
cation and
Care
Coordinati
on
Communit
y/Populati
on Health
Communit
y/Populati
on Health
20:15 Nov 12, 2014
Commenters supported the inclusion of
this measure as cross cutting "due to its
focus on critical care coordination
transitions between hospitals and
ambulatory care providers." As such,
CMS is finalizing its proposal to make
this measure reportable as a cross-cutting
measure for 2015 PQRS. We note that
while the proposed rule limited the
applicability of this measure to patients
65 years and older, the range of this
mesaure was changed to include patients
18-64 years of age by the measure
steward. This measure update is endorsed
byNQF.
Care Plan: Percentage of patients aged
65 years and older who have an advance
care plan or surrogate decision maker
documented in the medical record or
documentation in the medical record that
an advance care plan was discussed but
the patient did not wish or was not able to
name a surrogate decision maker or
provide an advance care plan
Commenters agreed this measure was
appropriately classified as cross-cutting.
For this reason, CMS is finalizing its
proposal to make this measure reportable
as a cross-cutting measure for 2015
PQRS.
Preventive Care and Screening:
Influenza Immunization: Percentage of
patients aged 6 months and older seen for
a visit between October 1 and March 31
who received an influenza immunization
OR who reported previous receipt of an
influenza immunization
Commenters agreed this measure was
appropriately classified as cross-cutting.
For this reason, CMS is finalizing its
proposal to make this measure reportable
as a cross-cutting measure for 2015
PQRS.
Pneumonia Vaccination Status for
Older Adults: Percentage of patients 65
years of age and older who have ever
received a pneumococcal vaccine
Jkt 235001
PO 00000
Frm 00256
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.069</GPH>
Reporting Age Criteria 1: 18-64 years of
age
Reporting Age Criteria 2: 65 years and
older.
67803
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
r.-.~
oo
z~
~ ~
00
-
u
~
~
I
"'
a >
·; 00
u
.Sii
"'
"
"'
= ;;...
= - =a
~ ~ C!l
'-'~
~ t: "'
~ 0 - .. Cl=•
"' •c..OJ)
fioil ~~
.. .. =
~ = = ;~t
"' 0
C!l""' ..
"'
~
CMS/QIP
X
X
X
X
X
ACO
MU2
CMS/QIP
X
X
X
X
X
ACO
MU2
CMS/QIP
X
X
-= "'
.. ..
"'-=
NQS
Domain
~ ~
Measure Title and Description¥
~~
u
~
fioil
0421
1128
0419
/130
ebenthall on DSK5SPTVN1PROD with $$_JOB
0420
/131
VerDate Sep<11>2014
69v
3
68v
4
N/
A
Communit
y/Populati
on Health
Communi
cation and
Care
Coordinati
on
20:15 Nov 12, 2014
c..
__.._
-
Commenters agreed this measure was
appropriately classified as cross-cutting.
For this reason, CMS is finalizing its
proposal to make this measure reportable
as a cross-cutting measure for 2015
PQRS.
Preventive Care and Screening: Body
Mass Index (BMI) Screening and
Follow-Up Plan: Percentage of patients
aged 18 years and older with a BMI
documented during the current encounter
or during the previous six months AND
with a BMI outside of normal parameters,
a follow-up plan is documented during
the encounter or during the previous six
months of the current encounter
Normal Parameters: Age 65 years and
older BMI 2:23 and< 30 kg/m2; Age 1864 years BMI 2: 18.5 and< 25 kg/m2
Commenters agreed this measure was
appropriately classified as cross-cutting.
For this reason, CMS is finalizing its
proposal to make this measure reportable
as a cross-cutting measure for 2015
PQRS.
Documentation of Current Medications
in the Medical Record: Percentage of
visits for patients aged 18 years and older
for which the eligible professional attests
to documenting a list of current
medications using all immediate
resources available on the date of the
encounter. This list must include ALL
known prescriptions, over-the-counters,
herbals, and vitamin/mineral/dietary
(nutritional) supplements AND must
contain the medications' name, dosage,
frequency and route of administration
Patient
Safety
..
.Q
Commenters agreed this measure was
appropriately classified as cross-cutting.
For this reason, CMS is finalizing its
proposal to make this measure reportable
as a cross-cutting measure for 2015
PQRS.
Pain Assessment and Follow-Up:
Percentage of visits for patients aged 18
years and older with documentation of a
pain assessment using a standardized
tool( s) on each visit AND documentation
of a follow-up plan when pain is present
Jkt 235001
PO 00000
Frm 00257
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
::::
OJ:) r:IJ
X
ER13NO14.070</GPH>
-.oo
~
....
..
67804
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
~
....
~00.
0~
Q;
00. "'
~ el
z~ u
~
~
I
"' "'
==
~ ~
Measure Title and Description"'
"'
.5 >
00.
~00
NQS
Domain
u
Q;
Q;
s
u
~
"'
!:1.
= ==
~
~
"' - ... e
... ~ E-] c;.!) ot:=
"'
"61J
c "'
0 "' "'
"'!:~.~
~~ "'
~
~ = =
.;~~
"'
c;,!)""'
=
.c
Q;
Q;-=
,-.._
c
~
/)J)riJ
Q;
~
Q;
Q;
~
Q;
"'
0
No comments were received regarding
this measure being classified as crosscutting. CMS is fmalizing its proposal to
make this measure reportable as a crosscutting measure for 2015 PQRS.
N/A
/182
ebenthall on DSK5SPTVN1PROD with $$_JOB
0028
/226
2v4
N/
A
138
v3
Communit
y/Populati
on Health
Communi
cation and
Care
Coordinati
on
Communit
y/Populati
on Health
Commenters agreed this measure was
appropriately classified as cross-cutting.
For this reason, CMS is finalizing its
proposal to make this measure reportable
as a cross-cutting measure for 2015
PQRS.
Functional Outcome Assessment:
Percentage of visits for patients aged 18
years and older with documentation of a
current functional outcome assessment
using a standardized functional outcome
assessment tool on the date of encounter
AND documentation of a care plan based
on identified functional outcome
deficiencies on the date ofthe identified
deficiencies
CMS/QIP
X
X
CMS/QIP
X
AMAPCPI
X
X
X
Commenters agreed this measure was
appropriately classified as cross-cutting.
For this reason, CMS is finalizing its
proposal to make this measure reportable
as a cross-cutting measure for 2015
PQRS.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00258
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
X
X
ACO
MU2
X
ACO
MU2
Million
Hearts
X
No comments were received regarding
this measure being classified as crosscutting. CMS is finalizing its proposal to
make this measure reportable as a crosscutting measure for 2015 PQRS.
Preventive Care and Screening:
Tobacco Use: Screening and Cessation
Intervention: Percentage of patients aged
18 years and older who were screened for
tobacco use one or more times within 24
months AND who received cessation
counseling intervention if identified as a
tobacco user
X
X
ER13NO14.071</GPH>
0418
/134
Preventive Care and Screening:
Screening for Clinical Depression and
Follow-Up Plan: Percentage of patients
aged 12 years and older screened for
clinical depression on the date of the
encounter using an age appropriate
standardized depression screening tool
AND if positive, a follow-up plan is
documented on the date ofthe positive
screen
67805
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
~
....
~00.
0~
Q;
00. "'
~ el
z~ u
~
~
I
Measure Title and Description"'
"' "'
==
~ ~
"'
.5 >
00.
~00
NQS
Domain
u
Q;
Q;
s
u
~
"'
!:1.
= ==
~
~
"' - ... e
... ~ E-] c;.!) ot:=
"'
"61J
c "'
0 "' "'
"'!:~.~
~~ "'
~
~ = =
.;~~
"'
c;,!)""'
=
.c
Q;
Q;-=
,-.._
c
~
/)J)riJ
Q;
~
Q;
Q;
~
Q;
"'
0
Controlling High Blood Pressure:
Percentage of patients 18-85 years of age
who had a diagnosis of hypertension and
whose blood pressure was adequately
controlled (<140/90 mmHg) during the
measurement period
0018
/236
165
v3
Effective
Clinical
Care
0038
/240
117
v3
Communit
y/Populati
on Health
Commenters agreed this measure was
appropriately classified as cross-cutting.
For this reason, CMS is finalizing its
proposal to make this measure reportable
as a cross-cutting measure for 2015
PQRS. This measure was part of the
cardiovascular prevention and ischemic
vascular disease measures group.
Therefore, the details and rationale
regarding the changes we are making to
this measure can be found in our
discussion of the cardiovascular
prevention and ischemic vascular disease
measures group in section III.K.5.d ofthis
final rule.
Childhood Immunization Status:
Percentage of children 2 years of age who
had four diphtheria, tetanus and acellular
pertussis (DTaP); three polio (IPV), one
measles, mumps and rubella (MMR);
three H influenza type B (HiB); three
hepatitis B (Hep B); one chicken pox
(VZV); four pneumococcal conjugate
(PCV); one hepatitis A (Hep A); two or
three rotavirus (RV); and two influenza
(flu) vaccines by their second birthday
NCQA
X
NCQA
X
X
X
X
ACO
MU2
Million
Hearts
MU2
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00259
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.072</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
Commenters agreed this measure was
appropriately classified as cross-cutting.
For this reason, CMS is finalizing its
proposal to make this measure reportable
as a cross-cutting measure for 2015
PQRS.
67806
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
~
....
~00.
0~
00. "'
~
z~ u
el
~
~
I
"' "'
==
~ ~
Measure Title and Description"'
"'
.5 >
00.
~00
NQS
Domain
u
Q;
Q;
s u
22v
3
,-.._
c
c;.!)
~
Communit
y/Populati
on Health
CMS/QIP
/)J)riJ
Q;
~
Q;
Preventive Care and Screening:
Screening for High Blood Pressure and
Follow-Up Documented: Percentage of
patients aged 18 years and older seen
during the reporting period who were
screened for high blood pressure (BP)
AND a recommended follow-up plan is
documented based on the current blood
pressure reading as indicated
~
Q;
~
N/A
/317
"'
!:1.
= - =e
=...
~
~
... ~ E-] "' ot:=
"'
"61J
c "'
0 "' "'
"'!:~.~
~~ "'
~
~ = =
.;~~
"'
c;,!)""'
=
.c
Q;
Q;-=
Q;
X
X
X
X
X
X
X
Q;
"'
0
ACO
MU2
Million
Hearts
Commenters agreed this measure was
appropriately classified as cross-cutting.
For this reason, CMS is finalizing its
proposal to make this measure reportable
as a cross-cutting measure for 2015
PQRS.
Falls: Screening for Fall Risk:
Percentage of patients 65 years of age and
older who were screened for future fall
risk at least once during the measurement
period
0101
/318
0005
&00
06
/321
139
v3
Patient
Safety
N/
A
Person
and
Caregiver
Experienc
eand
Outcomes
Commenters agreed this measure was
appropriately classified as cross-cutting.
For this reason, CMS is finalizing its
proposal to make this measure reportable
as a cross-cutting measure for 2015
PQRS.
CAHPS for PQRS Clinician/Group
Survey:
• Getting timely care, appointments, and
information;
• How well providers Communicate;
• Patient's Rating of Provider;
• Access to Specialists;
• Health Promotion & Education;
• Shared Decision Making;
• Health Status/Functional Status;
• Courteous and Helpful Office Staff;
• Care Coordination;
• Between Visit Communication;
• Helping Your to Take Medication as
Directed; and
• Stewardship of Patient Resources
NCQA
AHRQ
X
ACO
MU2
ACO
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00260
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.073</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
No comments were received regarding
this measure being classified as crosscutting. CMS is finalizing its proposal to
make this measure reportable as a crosscutting measure for 2015 PQRS.
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
Table 22 in the CY 2015 PFS
proposed rule (79 FR 40410) contained
the additional measures we proposed to
include in the PQRS measure set for CY
2015 and beyond. In Table 53, we
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
provide our response to the comments
we received on these measures as well
as our final decisions on these proposed
measures. We have also indicated the
PQRS reporting mechanism or
mechanisms through which each
measure could be submitted. As stated
PO 00000
Frm 00261
Fmt 4701
Sfmt 4700
above, please note that the following
tables may also contain discussions of
comments we received related to
proposed changes to the measures
included in the quality performance
standard under the Shared Savings
Program.
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.074</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
c. New PQRS Measures Available for
Reporting for 2015 and Beyond
67807
67808
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 53: New Individual Quality Measures and Those Included in Measures Groups
for the PQRS to Be Available for Satisfactory Reporting Beginning in 2015
..
=
...
....
...
..
=
'0
rJ)_
8
...
z~ u
~
f;ii;"'
0'~
..
~ ;l
~
.c
~
NQS
Domain
Measure Title and Description¥
rJ)_
"'
=
...
~
"'
.§
!:!
u
;,
rJ)_
u
t'
....
"'
'Q
~
~
~
~'E
.;:
~
~~
= 0 ..
~.s
"'
=
.="'
....
=
\.!)
"'
=
...
c
=
~ ~ El
o;~
... .=-~
. .e
0
0
~
OJ)
rl.l
;9~~
Measu1 es Fmal1zed as Pwposed or\\ Jth Mlllllficatwns
N/
A
/38
N/
A
ebenthall on DSK5SPTVN1PROD with $$_JOB
VerDate Sep<11>2014
CMS/
FMQAI
X
American
Associatio
nofEye
and Ear
Centers of
Excellenc
e
X
American
Associatio
nofEye
and Ear
Centers of
Excellenc
e/The
Australian
Council
X
Commenters supported the inclusion of this
measure in PQRS but request this measure
also be reportable through claims. Although
CMS understands commenters' concern
regarding reporting via registry only, we
have determined that the complexity of the
measure warrants reportability only through
the registry reporting option. For this
reason, CMS is finalizing this measure to
be reportable beginning in 2015 for PQRS.
Adult Primary Rhegmatogenous Retinal
Detachment Repair Success Rate:
Percentage of surgeries for primary
rhegmatogenous retinal detachment where
the retina remains attached after only one
surgery
N/
A
4
N/
A
/38
5
Patient
Safety
N/
A
Effective
Clinical
Care
Effective
Clinical
Care
CMS received no comments on this
measure. This is an outcome-based measure
that addresses a new clinical concept not
currently captured within PQRS and targets
a specialty provider group,
ophthalmologist, who are often
underrepresented in the PQRS program. As
such, this measure provides meaningful
value for the PQRS program. For these
reasons, CMS is finalizing its proposal to
make this measure reportable beginning in
2015 for PQRS.
Adult Primary Rhegmatogenous Retinal
Detachment Surgery Success Rate:
Percentage of retinal detachment cases
achieving flat retinas six months postsurgery
Commenters disagreed with CMS's
proposal to include this measure in PQRS,
noting the measure has not been broadly
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00262
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.075</GPH>
187
9
/38
3
Adherence to Antipsychotic Medications
for Individuals with Schizophrenia: The
percentage of individuals 18 years of age or
greater as of the beginning of the
measurement period with schizophrenia or
schizoaffective disorder who are prescribed
an antipsychotic medication, with
adherence to the antipsychotic medication
[defined as a Proportion of Days Covered
(PDC)] of at least 0.8 during the
measurement period (12 consecutive
months)
67809
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
...
"0
~
1-o
Q>
~"' "' ;l
0'~ ~ 1-o
.....
~
~
I
NQS
Domain
Measure Title and Description¥
A
/38
6
Nl
A
Nl
A
/38
7
Nl
A
Person and
CaregiverCentered
Experience
and
Outcomes
Effective
Clinical
Care
ebenthall on DSK5SPTVN1PROD with $$_JOB
Nl
A
/38
8
VerDate Sep<11>2014
Nl
A
1-o
"'
.§
.!
u
~
>
u
"'
!:
"'
"5li
~
~
r-1
Patient
Safety
20:15 Nov 12, 2014
tested and possible unintended
consequences that may drive physicians to
perform retinal detachment surgeries in the
hospital setting. This is an outcome-based
measure that addresses a new clinical
concept not currently captured within
PQRS and targets a specialty provider
group, ophthalmologists, who are often
underrepresented in the PQRS program.
Furthermore, the steward confirmed the
setting of service is not relevant as a
negative consequence of this measure.
CMS agrees with this assessment that the
setting of care is not an unintended
consequence that would negatively impact
the patient if this surgery were conducted in
a hospital and believes this measure
provides meaningful value for the PQRS
program. For these reasons, CMS is
finalizing its proposal to make this measure
reportable beginning in 2015 for PQRS.
Amyotrophic Lateral Sclerosis (ALS)
Patient Care Preferences: Percentage of
patients diagnosed with Amyotrophic
Lateral Sclerosis (ALS) who were offered
assistance in planning for end oflife issues
(for example, advance directives, invasive
ventilation, hospice) at least once annually
=
= ~ell
1-o
~'E
.s
(,!)
~~
1-o
"'
~ ~ 5
"' o~E
1-oQ.,ell
=
= ;:~=':
~ = "'
c""' = 0
=0
Q>
r-1
Nl
"'
=
"'
=
~
Q>
c.
"'
,.Q
~
Q>
1-o
Q>
Q>
Q>
Q>
~
on
Healthcar
e
Standards
AAN
X
AGA/
AASLD/
PCPI
X
AAEECE
/ACHS
X
No comments were received regarding this
measure being added to PQRS. CMS is
finalizing its proposal to make this measure
reportable beginning in 2015 for PQRS.
Annual Hepatitis C Virus (HCV)
Screening for Patients who are Active
Injection Drug Users: Percentage of
patients regardless of age who are active
injection drug users who received screening
for HCV infection within the 12 month
reporting period
Although one commenter requested this
measure be adjusted to include more than
"injection drug use," citing its limiting risk
factor, several commenters supported the
inclusion of this measure in PQRS.
Injection drug use has been associated as a
high risk factor for HCV. Therefore, CMS
is finalizing its proposal to make this
measure reportable beginning in 2015 for
PQRS.
Cataract Surgery with Intra-Operative
Complications (Unplanned Rupture of
Posterior Capsule Requiring Unplanned
Vsitrectomy): Rupture of the posterior
capsule during anterior segment surgery
Jkt 235001
PO 00000
Frm 00263
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
X
ER13NO14.076</GPH>
z~ u
=
67810
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
~
fi;OO
0'~
~
....
~
~ ~
00 -
z~ u
~
~
I
=
=
=
"CC
...
NQS
Domain
Measure Title and Description¥
00
~
"'
"'
·;
=
u
>
00
u
~
~
-=
>.
....
•f!;l
1)1)
~
~
~
~
=
=
==
l~
~
0 ~.2:!
~
"'
!:1.
r;,:~""'
Q
(J
"'
"'
~
~
~
gl)j)[ll
~
.s e
o~f
1-oQ,I)l)
~
~
Q
;9~~
0
requiring vsitrectomy
Several commenters submitted positive
comments about the inclusion of this
measure in the PQRS program and
requested that CMS make this measure
reportable via claims. In addition, there
were commenters that encouraged CMS to
"test this measure before implementation."
Commenters did not specify the type of
testing. This measure, per the guidelines of
quality measure inclusion required for the
PQRS program, has been tested by the
steward. Furthermore, this is an outcome
measure that complements the existing
cataracts measures with a clinical focus not
currently captured within PQRS. For these
reasons, CMS is finalizing its proposal to
make this measure reportable beginning in
2015 for PQRS for registry and measure
group reporting only. CMS is moving away
from claims-based reporting and as such is
not finalizing this measure for claims
reporting in 2015 PQRS.
Cataract Surgery: Difference Between
Planned and Final Refraction: Percentage
of patients who achieve planned refraction
within +-1,0 D
N/
A
Effective
Clinical
Care
N/
A
/39
0
N/
A
Person and
CaregiverCentered
Experience
and
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00264
Fmt 4701
Sfmt 4725
AAEECE
/ACHS
X
X
AGA/
AASLD/
PCPI
X
X
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.077</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
N/
A
/38
9
Several commenters submitted positive
comments about the inclusion of this
measure in the PQRS program and
requested that CMS make this measure
reportable via claims. In addition, there
were commenters that encouraged CMS to
test this measure before implementation.
Commenters did not specify the type of
testing. This measure, per the guidelines of
quality measure inclusion in the PQRS
program, has been tested by the steward.
Furthermore, this is an outcome measure
that complements the existing cataracts
measures with a clinical focus not currently
captured within PQRS. For these reasons,
CMS is finalizing its proposal to make this
measure reportable beginning in 2015 for
PQRS for registry and measure group
reporting only. CMS is moving away from
the claims reporting option and as such is
not finalizing this measure as reportable for
claims in 2015 PQRS.
Discussion and Shared Decision Making
Surrounding Treatment Options:
Percentage of patients aged 18 years and
older with a diagnosis of hepatitis C with
whom a physician or other qualified
67811
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
-=
lo
~
....
~00.
0'~
0:1
00.
lo
~ ;l
z~ u
g!
~
I
Q;
NQS
Domain
Measure Title and Description¥
0:1
"'
e 00.
·; >
......
.:l
0
~
u
~
:E
Communica
tion and
Care
Coordinatio
n
lo
~
= =-- = "'
=
r..l
lo
(J'"'
Q;
lo
0:1
Q;
~
Q;
Q;
-5~~
0
healthcare professional reviewed the range
of treatment options appropriate to their
genotype and demonstrated a shared
decision making approach with the patient.
To meet the measure, there must be
documentation in the patient record of a
discussion between the physician or other
qualified healthcare professional and the
patient that includes all of the following:
treatment choices appropriate to genotype,
risks and benefits, evidence of
effectiveness, and patient preferences
toward treatment
Some commenters expressed concern that
this measure might incentivize providers
not to treat patients, indicating a provider
might "simply note "the patient expressed
reservations about potential side effects and
we decided to defer treatment," rather than
working with the patient to address
concerns and optimize uptake of the
appropriate care." However, CMS feels
strongly that patients need to be provided
appropriate information that would help
patients to make their decision on treatment
options. This measure focuses on
discussion and shared decision making on
treatment options. For these reasons, CMS
is finalizing its proposal to include this
measure for registry and measure group
reporting in 2015 PQRS.
Follow-up After Hospitalization for
Mental Illness (FUH): The percentage of
discharges for patients 6 years of age and
older who were hospitalized for treatment
of selected mental illness diagnoses and
who had an outpatient visit, an intensive
outpatient encounter or partial
hospitalization with a mental health
practitioner. Two rates are reported:
- The percentage of discharges for which
the patient received follow-up within 30
days of discharge
- The percentage of discharges for which
the patient received follow-up within 7
days of discharge
NCQA
X
Commenters supported the inclusion of this
measure in PQRS but request this measure
also be reportable through claims. It is a
priority for PQRS to ultimately increase the
quality of health care. In order to achieve
this goal, PQRS needs reliable and robust
data on health service delivery and claimsbased reporting has demonstrated, over
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00265
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.078</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
A
lo
.....
lo
Q;
Outcomes
N/
Q;
=
"'
r..l
N/
A
/39
1
~
g.
"'
=
= ~~"'
~~ (J ~ .s a
.s "' oi f
0
:.g.~
~~
=
,.Q
~
Q;
67812
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
..
"CC
...
-.oo
rJ:l
oo
ZQ.;
u
~
9
...
..
~ ~
~
~
I
001
~
...
....
NQS
Domain
Measure Title and Description¥
"'
...
001
f;o1
Nl
A
several years, the highest error rate among
the PQRS reporting options. For this
reason, CMS is finalizing its proposal to
make this measure reportable beginning in
2015 for PQRS for registry reporting only.
HRS-12: Cardiac Tamponade and/or
Pericardiocentesis Following Atrial
Fibrillation Ablation: Rate of cardiac
tamponade and/or pericardiocentesis
following atrial fibrillation ablation
Patient
Safety
140
7
/39
4
Nl
A
Nl
A
Nl
A
/39
5
Nl
A
A
/39
6
Nl
A
Patient
Safety
Community/
Population
Health
Communica
tionand
Care
Coordinatio
n
Communica
tionand
Care
Coordinatio
n
Q.;
001
...
~
HRS
X
HRS
0
X
X
Commenters supported the inclusion of this
measure in PQRS. For this reason, CMS is
finalizing its proposal to make this measure
reportable beginning in 2015 for PQRS.
Immunizations for Adolescents: The
percentage of adolescents 13 years of age
who had the recommended immunizations
by their 13th birthday
Commenters supported the inclusion of this
measure in PQRS. For this reason, CMS is
finalizing its proposal to make this measure
reportable beginning in 2015 for PQRS.
Lung Cancer Reporting
(Biopsy/Cytology Specimens): Pathology
reports based on biopsy and/or cytology
specimens with a diagnosis of primary
nonsmall cell lung cancer classified into
specific histologic type or classified as
NSCLC-NOS with an explanation included
in the pathology report
Commenters supported the inclusion of this
measure in PQRS. For this reason, CMS is
finalizing its proposal to make this measure
reportable beginning in 2015 for PQRS.
Lung Cancer Reporting (Resection
Specimens): Pathology reports based on
resection specimens with a diagnosis of
primary lung carcinoma that include the pT
category, pN category and for non-small
cell lung cancer, histologic type
CAP
X
X
CAP
X
X
Commenters supported the inclusion of this
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00266
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.079</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
Nl
u
NCQA
Commenters supported the inclusion of this
measure in PQRS. For this reason, CMS is
finalizing its proposal to make this measure
reportable beginning in 2015 for PQRS.
HRS-9: Infection within 180 Days of
Cardiac Implantable Electronic Device
(CIED) Implantation, Replacement, or
Revision: Infection rate following CIED
device implantation, replacement, or
revision
Nl
A
/39
3
"'
.s!
.:.'
~
Nl
A
/39
2
...
..
=
rJ:l
"'
= :$ ~ ~
c
.Co-'=- ~ :6 e
t'
~'E
....
> "' ~ -e ... o;f
rJ:l
"'
..
u "5li f;o1 ~~ ..
...
... =.,gf
... ..
~
= = -=~Q.;
Co-' .... "'
..c
67813
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
...
"0
~"' "' ;l
0'~ ~ 1-o
.....
=
~
~
I
Q>
NQS
Domain
Measure Title and Description¥
N/
A
/39
8
N/
A
ebenthall on DSK5SPTVN1PROD with $$_JOB
/39
9
VerDate Sep<11>2014
N/
A
N/
A
N/
A
CAP
X
Q>
1-o
>
u
"'
!:
"'
'5li
~
~
Communica
tion and
Care
Coordinatio
n
Effective
Clinical
Care
Effective
Clinical
Care
measure in PQRS. For this reason, CMS is
finalizing its proposal to make this measure
reportable beginning in 2015 for PQRS.
Melanoma Reporting: Pathology reports
for primary malignant cutaneous melanoma
that include the pT category and a
statement on thickness and ulceration and
for pTl, mitotic rate
~'E
.s
(,!)
"'
~ ~ 5
"' o~E
1-oQ.,ell
1-o
=
= ;:~=':
~ = "'
c""' = 0
=0
r-1
=
= ~ell
1-o
1-o
~~
Q>
Q>
Q>
Q>
~
X
Commenters supported the inclusion of this
measure in PQRS. For this reason, CMS is
finalizing its proposal to make this measure
reportable beginning in 2015 for PQRS.
Optimal Asthma Control: Patients ages 550 (pediatrics ages 5-17) whose asthma is
well-controlled as demonstrated by one of
three age appropriate patient reported
outcome tools
Several commenters disagreed with CMS's
proposal to replace existing measure
(PQRS #064 "Asthma: Assessment of
Asthma Control - Ambulatory Care
Setting") with this new measure. Details
regarding commenters concerns with
removing PQRS #064 can be found in
Table 56. Although CMS understands the
limitations of the current measure as it
relates to the upper age limit, risk
adjustment and the calculation of
improvement over time, this measure
represents a more robust clinical outcome
for asthma care. For this reason, CMS is
finalizing its proposal to make this measure
reportable beginning in 2015 for PQRS for
registry only.
In addition, CMS re-evaluated the
categorization of this measure to the Person
and Caregiver Experience and Outcomes
domain and determined it was more
appropriately categorized under Effective
Clinical Care. As such, CMS is finalizing
this measure under Effective Clinical Care
for 2015 PQRS program.
Post-Procedural Optimal Medical
Therapy Composite (Percutaneous
Coronary Intervention): Percentage of
patients aged 18 years and older for whom
PCI is performed who are prescribed
optimal medical therapy at discharge
MNCM
X
ACCAHA
X
Commenters supported the inclusion of this
measure in PQRS. For this reason, CMS is
finalizing its proposal to make this measure
reportable beginning in 2015 for PQRS.
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00267
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.080</GPH>
/39
7
"'
=
"'
=
~
"'
.§
.!
u
~
Q>
r-1
N/
A
,.Q
~
Q>
z~ u
c.
"'
1-o
~
67814
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
-=
~00.
0'~
0:1
lo
~ ;l
z~ u
g!
~
I
,.Q
~
Q;
00.
g.
"'
lo
~
....
Q;
NQS
Domain
Measure Title and Description¥
~
Q;
lo
=
"'
0:1
.....
lo
"'
e 00.
·; >
......
.:l
0
~
u
~
Q;
r..l
:E
~
=
= ~~"'
~~
.s
(J
~~
lo
lo
= =-- = "'
=
"'
r..l
0
lo
(J'"'
Q;
0:1
Q;
~
~
.s a
oi
f
:.g.~
Q;
Q;
=
-5~~
0
Hepatitis C: One-Time Screening for
Hepatitis C Virus (HCV) for Patients at
Risk: Percentage of patients aged 18 years
and older with one or more of the
following: a history of injection drug use,
receipt of a blood transfusion prior to 1992,
receiving maintenance hemodialysis OR
birthdate in the years 1945-1965 who
received a one-time screening for HCV
infection
Effective
Clinical
Care
N/
A
Effective
Clinical
Care
VerDate Sep<11>2014
20:15 Nov 12, 2014
Commenters supported the inclusion of this
measure in PQRS, but also suggested CMS
refine the measure language to include
other risk groups and diagnosis. We
appreciate the commenters' support for this
measure. With respect to the measure
language, we note that we have decided not
to make changes to this measure in order to
maintain consistency with the
specifications maintained by the measure
Jkt 235001
PO 00000
Frm 00268
Fmt 4701
Sfmt 4725
AGA/
AASLD/
AMAPCPI
X
AGA/
AASLD/
AMAPCPI
X
E:\FR\FM\13NOR2.SGM
13NOR2
X
ER13NO14.081</GPH>
N/
A
N/
A
/40
1
ebenthall on DSK5SPTVN1PROD with $$_JOB
N/
AI
/40
0
Although one commenter requested this
measure be adjusted to include more than
"injection drug use," citing its limiting risk
factor, injection drug use has been
associated as a high-risk factor for HCV.
Additionally, the commenter suggested that
this measure include "risk groups" to
encompass men who have sex with men
(MSM). Transmission ofHCV by sex is
low and does not necessitate routine
screening. Furthermore, several
commenters supported the inclusion of this
measure in PQRS. CMS received public
comment from the measure steward
indicating this measure should be classified
under the domain of Effective Clinical
Care. After further review, CMS
determined this measure was more
appropriately categorized under the
Effective Clinical Care domain based on
the HHS decision rule guidelines for
categorizing measures. For these reasons,
CMS is finalizing its proposal to make this
measure reportable begiuning in 2015 for
PQRS.
Screening for Hepatocellular Carcinoma
(HCC) in patients with Hepatitis C
Cirrhosis: Percentage of patients aged 18
years and older with a diagnosis of chronic
hepatitis C cirrhosis who underwent
imaging with either ultrasound, contrast
enhanced CT or MRI for hepatocellular
carcinoma (HCC) at least once within the
12 month reporting period
67815
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
...
=
...
"CC
-.oo
~
....
...
""~ ::E
oo u ;l
~
Z=.
::E
00 -
0:
~
...
.....
NQS
Domain
Measure Title and Description¥
0:
"'
I
~
Nl
A
/40
2
Nl
A
00
"'
.§
.:'!
u
>
00
u
::E
Community/
Population
Health
developper and owner. Based on the
comments received, CMS is finalizing its
proposal to make this measure reportable
beginning in 2015 for PQRS.
Tobacco Use and Help with Quitting
Among Adolescents: The percentage of
adolescents 12 to 20 years of age with a
primary care visit during the measurement
year for whom tobacco use status was
documented and received help with quitting
if identified as a tobacco user
"'
=-
=
- = ...
=
=- = ...
,.Q
;..,
.....
"'
"51!
...
~
~
~
~~
~
<:>
\.!)
"'
~~
0 0:
l.!l'"' "'
::E
NCQA/
NCIQM
X
~Ill)"'
~ ~ s
o~f
~ooo=.,gf
... ...
-
-s~=-
0
X
Commenters supported the inclusion of this
measure in PQRS. For this reason, CMS is
finalizing its proposal to make this measure
reportable beginning in 2015 for PQRS.
Measures Not FmalJzcd as Proposed
IN/
N/
A
Patient
Safety
N/
A
Person and
CaregiverCentered
Experience
and
Outcomes
A
N/
A
IN/
ebenthall on DSK5SPTVN1PROD with $$_JOB
A
VerDate Sep<11>2014
20:15 Nov 12, 2014
Commenters supported the inclusion of this
measure in PQRS but request this measure
also be reportable through registry. CMS
confirmed with the measure steward that
this measure was tested for reportability
through claims and not registry. Given this,
CMS does not believe this measure is ready
for implementation in 2015 PQRS as CMS
does not believe this measure is appropriate
for claims-based reporting and thus CMS is
not finalizing this measure for reporting in
2015 PQRS.
Average change in functional status
following lumbar spine fusion surgery:
Average change from pre-operative
functional status assessment to one year
(nine to fifteen months) post-operative
functional status using the Oswestry
Disability Index (ODI version 2.1a) patient
reported outcome tool
CMS/FM
QAI
X
MNCM
X
E:\FR\FM\13NOR2.SGM
13NOR2
Commenters note this measure has not been
fully vetted or tested. Furthermore, there
are analytic challenges to implementing this
measure and the lack of a performance
target to assess this measure against. For
this reason, CMS is not finalizing this
measure for inclusion in 2015 PQRS.
Jkt 235001
PO 00000
Frm 00269
Fmt 4701
Sfmt 4725
ER13NO14.082</GPH>
188
0
Adherence to Mood Stabilizers for
Individuals with Bipolar I Disorder: The
measure calculates the percentage of
individuals aged 18 years and older with
bipolar I disorder who are prescribed a
mood stabilizer medication, with adherence
to the mood stabilizer medication [defined
as a Proportion of Days Covered (PDC)] of
at least 0.8 during the measurement period
(12 consecutive months)
67816
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
~
fi;OO
0'~
~
....
~
~ ~
00 -
z~ u
~
~
I
=
=
=
"CC
...
NQS
Domain
Measure Title and Description¥
00
~
"'
"'
·;
=
u
>
00
u
~
~
-=
>.
....
•f!;l
1)1)
~
~
~
~
"'
!:1.
=
=
==
l~
~
0 ~.2:!
~
r;,:~""'
Q
(J
"'
"'
~
~
~
gl)j)[ll
~
.s e
o~f
1-oQ,I)l)
~
~
Q
;9~~
0
Avoidance of inappropriate use of
imaging for adult ED patients with
traumatic low back pain: Avoidance of
inappropriate use of imaging for adult ED
patients with traumatic low back pain
N/
A
IN/
N/
A
Efficiency
and Cost
Reduction
N/
A
Person and
CaregiverCentered
Experience
and
Outcomes
A
188
5
IN/
A
While one commenter supported the
addition of this measure to PQRS noting it
"will incentivize providers to minimize
unnecessary or excessive radiation
exposure, which insures to the benefit of
beneficiaries," the measure steward
withdrew support of this measure as the
measure is not yet sufficiently specified nor
has it undergone public review and
comment. For this reason, CMS is not
finalizing this measure for PQRS 2015.
Depression Response at Twelve MonthsProgress Towards Remission: Adult
patients age 18 and older with major
depression or dysthymia and an initial
PHQ-9 (Patient Health Questionnaire 9)
score greater than nine who demonstrate a
response to treatment at twelve months
defmed as a PHQ-9 score that is reduced by
50% or greater from the initial PHQ-9
score. This measure applies to both patients
with newly diagnosed or existing
depression identified during the defined
measurement period whose current PHQ-9
score indicates a need for treatment
ACEP
X
MNCM
X
AGA/
AASLD/
PCPI
X
N/
A
IN/
N/
A
Patient
Safety
ebenthall on DSK5SPTVN1PROD with $$_JOB
A
VerDate Sep<11>2014
20:15 Nov 12, 2014
Commenters, including the measure
steward, suggest clinical guidelines are
changing for Hepatitis C virus therapy,
impacting the clinical appropriateness of
this measure specifically. No other
measures under consideration were
affected. As such, CMS is not fmalizing
this measure for PQRS 2015, allowing time
for the evolving clinical guidance to be
finalized.
Jkt 235001
PO 00000
Frm 00270
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.083</GPH>
CMS believes that NQF 1885 is duplicative
ofPQRS 370 "Depression Remission at
Twelve Months." As such, CMS is not
finalizing its proposal to add NQF 1885 as
a new measure for reporting in the 2015
PQRS Program.
Discontinuation of Antiviral Therapy for
Inadequate Viral Response: Percentage of
patients aged 18 years and older with a
diagnosis of hepatitis C genotype 1 who
had an inadequate response to antiviral
treatment for whom antiviral treatment was
discontinued
67817
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
~
fi;OO
0'~
~
....
~
~ ~
00 -
z~ u
~
~
I
NQS
Domain
Measure Title and Description¥
A
IN/
A
N/
A
N/
A
IN/
A
N/
A
00
~
"'
"'
·;
=
u
-=
>.
>
00
u
~
~
N/
=
=
=
"CC
...
....
•f!;l
1)1)
~
~
~
~
Effective
Clinical
Care
Freedom from Reintervention or
Amputation Following Endovascular
Infrainguinal Lower Extremity
Revascularization for Non-limb
threatening ischemia: Percentage of
patients undergoing endovascular
infrainguinal revascularization for non-limb
threatening ischemia (claudication or
asymptomatic) who do not require
ipsilateral repeat revascularization or any
amputation within one year
Effective
Clinical
Care
The measure steward withdrew support of
this measure as the measure specifications
are incomplete at this time. For this reason,
CMS is not fmalizing this measure for
PQRS 2015 but may consider this measure
for a future program year.
Freedom from Reintervention or
Amputation Following Open
Infrainguinal Lower Extremity
Revascularization for non-limb
threatening ischemia: Percentage of
patients undergoing open infrainguinal
revascularization for non-limb threatening
ischemia (claudication or asymptomatic)
who do not require ipsilateral repeat
revascularization or any amputation within
one year
"'
!:1.
=
=
==
l~
~
0 ~.2:!
~
r;,:~""'
Q
(J
"'
"'
~
~
~
svs
.s e
1-oQ,I)l)
~
~
Q
;9~~
0
X
CMS/OF
MQ
~
o~f
X
svs
gl)j)[ll
X
662
ebenthall on DSK5SPTVN1PROD with $$_JOB
IN/
A
VerDate Sep<11>2014
N/
A
Communica
tion and
Care
Coordinatio
n
20:15 Nov 12, 2014
While some commenters supported the
inclusion of this measure in PQRS, after
further review CMS determined that
comparison across measurement periods,
particularly when the reporting period for
the PQRS payment adjustments is a 12month calendar year, poses an analytic
challenge for reporting purposes. CMS
currently does not have a measure in the
PQRS where data is collected outside a
respective reporting period and compared
to an existing reporting period without an
Jkt 235001
PO 00000
Frm 00271
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.084</GPH>
The measure steward withdrew support of
this measure as the measure specifications
are incomplete at this time. For this reason,
CMS is not finalizing this measure for
PQRS 2015 but may consider this measure
for a future program year.
Median Time to Pain Management for
Long Bone Fracture: Median time from
emergency department (ED) arrival to time
of initial oral, intranasal or parenteral pain
medication administration for emergency
department patients with a principal
diagnosis oflong bone fracture (LBF)
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
In Table 54, we provide our responses
and final decisions on the measures for
which we proposed a NQS domain
change for reporting under the PQRS (79
FR 40419). Please note that we received
comments regarding the process for
changing a measure’s domain. With
respect to these comments, we
appreciate the commenters’ suggestions
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
regarding the process for domain
changes for measures and will take
these comments under consideration.
We are developing guidelines for
assigning measure domains and will use
these guidelines to assign each measure
in the PQRS program to a NQS domain
when measure stewards submit
measures through the Call for Measures
PO 00000
Frm 00272
Fmt 4701
Sfmt 4700
process each program year. We value
feedback from measure developers and
are dedicated to making updates to the
PQRS program a transparent and
collaborative process as it works to
establish measures that are applicable to
various domain categories.
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.085</GPH>
67818
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
67819
TABLE 54: NQS Domain Changes for Individual Quality Measures and Those
Included in Measures Groups for the PQRS Beginning in 2015
=
NQS
Domain
2015
......
a.;oo
00
"'
...
0'.:.:: ~ 5l
z~ u ~
~
I
NQS
Domain
2014
Measure Title and Description
~
...
'"...
.s"
....
"'
t'
=
......
"' > ....
j ·Q ~ "'
u u ~ ~ ~
,.Q
00
0
~
Cl.
"'
=
...
0
~
"'
...
"'
=
<'ll
"'
.:.:: ~
"'
~
009
7/0
46
N/
A
Patient
Safety
Commun
ication
and Care
Coordina
tion
~
...
0
Cl.
"' e
.:.:: "'
.ce
=~
<'ll ...
&=-...
"'
..=
....
0
Measu1es fmal!zed as P10posed
Medication Reconciliation: Percentage of patients
aged 18 years and older discharged from any inpatient
facility (for example, hospital, skilled nursing facility,
or rehabilitation facility) and seen within 30 days
following discharge in the office by the physician,
prescribing practitioner, registered nurse, or clinical
pharmacist providing on-going care who had a
reconciliation of the discharge medications with the
current medication list in the outpatient medical record
documented.
This measure is reported as two rates stratified by age
group:
X
X
Reporting Age Criteria 1: 18-64 years of age
Reporting Age Criteria 2: 65 years and older.
ebenthall on DSK5SPTVN1PROD with $$_JOB
N/
A/2
88
VerDate Sep<11>2014
N/
A
N/
A
Effective
Clinical
Care
Effective
Clinical
Care
20:15 Nov 12, 2014
Commun
ication
and Care
Co ordina
tion
Commun
ication
and Care
Coordina
tion
Jkt 235001
X
Commenters supported the proposed domain change
for PQRS #137 from Effective Clinical Care to
Communication and Care Coordination. For this
reason, CMS is finalizing its proposal to change the
domain of this measure for 2015 PQRS.
Dementia: Caregiver Education and Support:
Percentage of patients, regardless of age, with a
diagnosis of dementia whose caregiver(s) were
provided with education on dementia disease
management and health behavior changes AND
referred to additional sources for support within a 12
month period
X
Commenters disagreed with the proposed domain
change but did not explain why. However, while this
measure does fall into both the Communication and
Care Coordination and Person and Caregiver-Centered
PO 00000
Frm 00273
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.086</GPH>
065
0/1
37
Commenters supported the proposed domain change
for PQRS #46 from Patient Safety to Communication
and Care Coordination. For this reason, CMS is
fmalizing its proposal to change the domain of this
measure for 2015 PQRS.
Melanoma: Continuity of Care- Recall System:
Percentage of patients, regardless of age, with a current
diagnosis of melanoma or a history of melanoma
whose information was entered, at least once within a
12 month period, into a recall system that includes:
• A target date for the next complete physical skin
exam, AND
• A process to follow up with patients who either did
not make an appointment within the specified
timeframe or who missed a scheduled appointment
67820
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
z~
rJ:J "'
~ ;l
u ~
~
I
le
1)11
NQS
Domain
2014
Measure Title and Description
-
=
.... "'
......
"'
"'
.5 > ·Q ~ ~ ~ .c~
rJ:J
...
"'
= u ... ~
0
"' = =
~
~ "' o==
... = "'
0 =
~ ~
...
"'
.;
;;.,
=
1)11
~
=~
N/
A/2
93
N/
A/2
94
ebenthall on DSK5SPTVN1PROD with $$_JOB
N/
A/3
25
N/
A/3
03
VerDate Sep<11>2014
N/
A
N/
A
N/
A
N/
A
Effective
Clinical
Care
Effective
Clinical
Care
Effective
Clinical
Care
Effective
Clinical
Care
20:15 Nov 12, 2014
Commun
ication
and Care
Coordina
tion
Commun
ication
and Care
Coordina
tion
Commun
ication
and Care
Coordina
tion
Person
and
Care give
r-
Jkt 235001
Experience and Outcomes domains, Communication
and Care Coordination should become the new primary
domain. While the measure does target the education
and referral of the patient's caregiver to supportive
services, this is a secondary goal of the measure -- the
primary intent is to disseminate information related to
caring for a patient with dementia, including making
connections to all potentially necessary providers. For
these reasons, CMS is finalizing its proposal to change
the domain of this measure for 2015 PQRS.
Parkinson's Disease: Rehabilitative Therapy
Options: All patients with a diagnosis of Parkinson's
disease (or caregiver(s), as appropriate) who had
rehabilitative therapy options (for example, physical,
occupational, or speech therapy) discussed at least
annually
X
No comments were received regarding the domain for
this measure. CMS is finalizing its proposal to change
the domain of this measure for 2015 PQRS.
Parkinson's Disease: Parkinson's Disease Medical
and Surgical Treatment Options Reviewed: All
patients with a diagnosis of Parkinson's disease (or
caregiver(s), as appropriate) who had the Parkinson's
disease treatment options (for example, nonpharmacological treatment, pharmacological treatment,
or surgical treatment) reviewed at least once annually
No comments were received regarding the domain for
this measure. CMS is fmalizing its proposal to change
the domain of this measure for 2015 PQRS.
Adult Major Depressive Disorder (MDD):
Coordination of Care of Patients with Specific
Comorbid Conditions: Percentage of medical records
of patients aged 18 years and older with a diagnosis of
major depressive disorder (MDD) and a specific
diagnosed comorbid condition (diabetes, coronary
artery disease, ischemic stroke, intracranial
hemorrhage, chronic kidney disease [stages 4 or 5],
End Stage Renal Disease [ESRD] or congestive heart
failure) being treated by another clinician with
communication to the clinician treating the comorbid
condition
Commenters supported the proposed domain change
for PQRS #325 from Effective Clinical Care to
Communication and Care Coordination. For this
reason, CMS is finalizing its proposal to change the
domain of this measure for 2015 PQRS.
Cataracts: Improvement in Patient's Visual
Function within 90 Days Following Cataract
Surgery: Percentage of patients aged 18 years and
older in sample who had cataract surgery and had
PO 00000
Frm 00274
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
0
X
X
X
13NOR2
X
ER13NO14.087</GPH>
a.;"'
0'~
~
....
...
...
.$
...
~ "'
Q.
... = =
"' = "'
,.-.
NQS
Domain
2015
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
z~ u a1
~
I
...
"'
Measure Title and Description
"'
.§ >
00
....
..
...
·Q
=
0 u ~
~
Q.
Q.
~
"'
"'
= ~ ..
"' =
"'
~
=
"'
~ ~
~
r;,!j
Centered
Experien
ceand
Outcome
s
N/
A/3
31
N/
A/3
32
N!
A/3
47
ebenthall on DSK5SPTVN1PROD with $$_JOB
N/
A/3
48
N/
A/3
54
VerDate Sep<11>2014
N/
A
N/
A
N!
A
N/
A
N/
A
Effective
Clinical
Care
Efficienc
yand
Cost
Reductio
n
Effective
Clinical
Care
Efficienc
yand
Cost
Reductio
n
Effective
Clinical
Care
Patient
Safety
Effective
Clinical
Care
Patient
Safety
Effective
Clinical
Care
20:15 Nov 12, 2014
Patient
Safety
Jkt 235001
..
.. ."' =
... = "' "'
"' =
.... r;,!j ~ =
=
..c
.toE:
~
NQS
Domain
2014
1)1)
=
.:
=~
= ..
g~
.
"'
...
-=
0
improvement in visual function achieved within 90
days following the cataract surgery, based on
completing a pre-operative and post-operative visual
function survey
No comments were received regarding the domain for
this measure. CMS is finalizing its proposal to change
the domain of this measure for 2015 PQRS.
Adult Sinusitis: Antibiotic Prescribed for Acute
Sinusitis (Appropriate Use): Percentage of patients,
aged 18 years and older, with a diagnosis of acute
sinusitis who were prescribed an antibiotic within 7
days of diagnosis or within 10 days after onset of
symptoms
Commenters supported the proposed domain change
for PQRS #331 from Effective Clinical Care to
Efficiency and Cost Reduction. For this reason, CMS is
finalizing its proposal to change the domain of this
measure for 2015 PQRS.
Adult Sinusitis: Appropriate Choice of Antibiotic:
Amoxicillin Prescribed for Patients with Acute
Bacterial Sinusitis (Appropriate Use): Percentage of
patients aged 18 years and older with a diagnosis of
acute bacterial sinusitis that were prescribed
amoxicillin, with or without clavulante, as a first line
antibiotic at the time of diagnosis
Commenters supported the proposed domain change
for PQRS #332 from Effective Clinical Care to
Efficiency and Cost Reduction. For this reason, CMS is
finalizing its proposal to change the domain of this
measure for 2015 PQRS.
Rate of Endovascular Aneurysm Repair (EVAR) of
Small or Moderate Non-Ruptured Abdominal
Aortic Aneurysms (AAA) Who Die While in
Hospital: Percent of patients undergoing endovascular
repair of small or moderate abdominal aortic
aneurysms (AAA) who die while in the hospital
No comments were received regarding the domain for
this measure. CMS is finalizing its proposal to change
the domain of this measure for 2015 PQRS.
HRS-3: Implantable Cardioverter-Defibrillator
(lCD) Complications Rate: Patients with physicianspecific risk-standardized rates of procedural
complications following the first time implantation of
anlCD
X
X
X
X
X
X
No comments were received regarding the domain for
this measure. CMS is finalizing its proposal to change
the domain of this measure for 2015 PQRS.
Anastomotic Leak Intervention: Percentage of
patients aged 18 years and older who required an
anastomotic leak intervention following gastric bypass
PO 00000
Frm 00275
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
X
13NOR2
ER13NO14.088</GPH>
~
....
ii;oo 00 ..
"'
0'~ ~ ;l
,-.,
NQS
Domain
2015
67821
67822
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
~
....
ii;oo 00 ..
"'
0'~ ~ ;l
z~ u a1
~
I
,-.,
NQS
Domain
2015
...
"'
Measure Title and Description
"'
.§ >
00
....
..
...
·Q
=
0 u ~
~
..
.. ."' =
... = "' "'
"' =
.... r;,!j ~ =
=
..c
.toE:
~
NQS
Domain
2014
1)1)
=
.:
Q.
Q.
~
"'
"'
= ~ ..
"' =
"'
~
=
"'
~ ~
~
r;,!j
=~
= ..
g~
.
"'
...
-=
0
or colectomy surgery
N/
A/3
55
N/
A
004
3
Ill
1
032
1/0
82
N/
A/2
80
Patient
Safety
12
7v
3
Effective
Clinical
Care
Commun
ity/Popul
ation
Health
N/
A
Commun
ication
and Care
Coordina
tion
Effective
Clinical
Care
Commun
ication
and Care
Coordina
tion
Effective
Clinical
Care
Commun
ication
and Care
Coordina
tion
Effective
Clinical
Care
N/
A
N/
A
X
No comments were received regarding the domain for
this measure. CMS is finalizing its proposal to change
the domain of this measure for 2015 PQRS.
Pneumonia Vaccination Status for Older Adults:
Percentage of patients 65 years of age and older who
have ever received a pneumococcal vaccine
X
No comments were received regarding the domain for
this measure. CMS is finalizing its proposal to change
the domain of this measure for 2015 PQRS.
Adult Kidney Disease: Peritoneal Dialysis
Adequacy: Solute: Percentage of patients aged 18
years and older with a diagnosis of End Stage Renal
Disease (ESRD) receiving peritoneal dialysis who have
a total KtN ~ 1. 7 per week measured once every 4
months
X
X
X
ACO
MU2
X
X
AQA
X
Commenters supported the proposed domain change
for PQRS #82 from Communication and Care
Coordination to Effective Clinical Care. For this
reason, CMS is finalizing its proposal to change the
domain of this measure for 2015 PQRS.
Rheumatoid Arthritis (RA): Glucocorticoid
Management: Percentage of patients aged 18 years
and older with a diagnosis of rheumatoid arthritis (RA)
who have been assessed for glucocorticoid use and, for
those on prolonged doses of prednisone ~ 10 mg daily
(or equivalent) with improvement or no change in
disease activity, documentation of glucocorticoid
management plan within 12 months
Commenters supported the proposed domain change
for PQRS #180 from Communication and Care
Coordination to Effective Clinical Care. For this
reason, CMS is finalizing its proposal to change the
domain of this measure for 2015 PQRS.
Dementia: Staging of Dementia: Percentage of
patients, regardless of age, with a diagnosis of
dementia whose severity of dementia was classified as
mild, moderate or severe at least once within a 12
month period
X
Commenters supported the proposed domain change
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00276
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.089</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
N/
All
80
Effective
Clinical
Care
No comments were received regarding the domain for
this measure. CMS is finalizing its proposal to change
the domain of this measure for 2015 PQRS.
Unplanned Reoperation within the 30 Day
Postoperative Period: Percentage of patients aged 18
years and older who had any unplanned reoperation
within the 30 day postoperative period
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
z~ u a1
~
I
...
"'
Measure Title and Description
"'
.§ >
00
....
..
...
·Q
=
0 u ~
~
Q.
Q.
~
"'
"'
= ~ ..
"' =
"'
~
=
"'
~ ~
~
r;,!j
065
4/0
93
N/
A/2
58
N/
A/2
59
ebenthall on DSK5SPTVN1PROD with $$_JOB
N/
A/2
60
152
5/3
26
VerDate Sep<11>2014
N/
A
Commun
ication
and Care
Coordina
tion
Efficienc
yand
Cost
Reductio
n
N/
A
Commun
ication
and Care
Coordina
tion
Patient
Safety
N/
A
N/
A
N/
A
Commun
ication
and Care
Coordina
tion
Patient
Safety
X
Commenters supported the proposed domain change
for PQRS #93 from Communication and Care
Coordination to Efficiency and Cost Reduction. For
this reason, CMS is finalizing its proposal to change
the domain of this measure for 2015 PQRS.
Rate of Open Repair of Small or Moderate NonRuptured Abdominal Aortic Aneurysms (AAA)
without Major Complications (Discharged to Home
by Post-Operative Day #7): Percent of patients
undergoing open repair of small or moderate sized nonruptured abdominal aortic aneurysms who do not
experience a major complication (discharge to home no
later than post-operative day #7)
.
"'
...
-=
0
Patient
Safety
Patient
Safety
Effective
Clinical
Care
No comments were received regarding the domain for
this measure. CMS is finalizing its proposal to change
the domain of this measure for 2015 PQRS.
Atrial Fibrillation and Atrial Flutter: Chronic
Anticoagulation Therapy: Percentage of patients aged
18 years and older with a diagnosis of nonvalvular
PO 00000
Frm 00277
Fmt 4701
Sfmt 4725
X
X
X
No comments were received regarding the domain for
this measure. CMS is finalizing its proposal to change
the domain of this measure for 2015 PQRS.
Rate of Endovascular Aneurysm Repair (EVAR) of
Small or Moderate Non-Ruptured Abdominal
Aortic Aneurysms (AAA) without Major
Complications (Discharged to Home by PostOperative Day #2): Percent of patients undergoing
endovascular repair of small or moderate non-ruptured
abdominal aortic aneurysms (AAA) that do not
experience a major complication (discharged to home
no later than post-operative day #2)
Commun
ication
and Care
Coordina
tion
Jkt 235001
=~
= ..
g~
for PQRS #280 from Communication and Care
Coordination to Effective Clinical Care. For this
reason, CMS is finalizing its proposal to change the
domain of this measure for 2015 PQRS.
Acute Otitis Extema (AOE): Systemic
Antimicrobial Therapy- Avoidance of
Inappropriate Use: Percentage of patients aged 2
years and older with a diagnosis of AOE who were not
prescribed systemic antimicrobial therapy
X
No comments were received regarding the domain for
this measure. CMS is finalizing its proposal to change
the domain of this measure for 2015 PQRS.
Rate of Carotid Endarterectomy (CEA) for
Asymptomatic Patients, without Major
Complications (Discharged to Home by PostOperative Day #2): Percent of asymptomatic patients
undergoing CEA who are discharged to home no later
than post-operative day #2
20:15 Nov 12, 2014
..
.. ."' =
... = "' "'
"' =
.... r;,!j ~ =
=
..c
.toE:
~
NQS
Domain
2014
1)1)
=
.:
X
X
E:\FR\FM\13NOR2.SGM
X
13NOR2
ER13NO14.090</GPH>
~
....
ii;oo 00 ..
"'
0'~ ~ ;l
,-.,
NQS
Domain
2015
67823
67824
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
i.i;;"'
~
....
...
0'~ ~ ;l
rJ).
"'
z~ u
~
~
I
...
...
OJ)
,-.,
NQS
Domain
2015
.:s
"'
"' "' ...
=
c ..... ~ ~ "'
= = "' Ei
"'
"' > ....
.5
"'
'Sii ~ ~ ...
"' cf
.s
...
u u ~ f;;;l ~ "'
= ==
"'
01
"' 0'=0 ...
~ ~
...
"'
-=
....
=~
NQS
Domain
2014
Measure Title and Description
.e
....
"'
=
=
rJ).
01
f;;;l
~
OJ)
0
atrial fibrillation (AF) or atrial flutter whose assessment
of the specified thromboembolic risk factors indicate
one or more high-risk factors or more than one
moderate risk factor, as determined by CHADS2 risk
stratification, who are prescribed warfarin OR another
oral anticoagulant drug that is FDA approved for the
prevention of thromboembolism
N/
A/3
21
N/
A
Commun
ication
and Care
Coordina
tion
Person
and
Caregive
r
Experien
ce and
Outcome
s
One commenter agreed while another commenter
disagreed with the proposal to change the domain of
PQRS #326 from Patient Safety to Effective Clinical
Care noting "providing anticoagulation therapy for
atrial fibrillation and atrial flutter patients is a means of
reducing the risk of stroke in patients presenting for
more high- or moderate-risk factors." While not using
warfarin or another anticoagulation therapy is "a means
of reducing the risk of stroke in patients presenting for
more high- or moderate-risk factors," this is a
secondary outcome of providing the medication, not a
direct risk caused by the delivery of care. So, while
taking warfarin or another anticoagulant may provide
protection against stroke, it is not the primary intent of
the measure. For these reasons, CMS is fmalizing its
proposal to change the domain of this measure for 2015
PQRS.
CARPS for PQRS Clinician/Group Survey:
• Getting timely care, appointments, and information;
• How well providers Communicate;
• Patient's Rating of Provider;
• Access to Specialists;
• Health Promotion & Education;
• Shared Decision Making;
• Health Status/Functional Status;
• Courteous and Helpful Office Staff;
• Care Coordination;
• Between Visit Communication;
• Helping Your to Take Medication as Directed; and
• Stewardship of Patient Resources
X
ACO
No comments were received regarding the domain for
this measure. CMS is finalizing its proposal to change
the domain of this measure for 2015 PQRS.
Me,\SU!es Not Fm,dJzed ds Pwposed
VerDate Sep<11>2014
N/
A
Effective
Clinical
Care
20:15 Nov 12, 2014
Commun
ication
and Care
Coordina
tion
Jkt 235001
X
One commenter disagreed with CMS' proposal to
change the domain of this measure noting that
"unplanned readmissions can be the result of many
factors which extend well beyond communication and
care coordination." The commenter suggested keeping
PO 00000
Frm 00278
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.091</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
N/
A/3
56
Unplanned Hospital Readmission within 30 Days of
Principal Procedure: Percentage of patients aged 18
years and older who had an unplanned hospital
readmission within 30 days of principal procedure
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
reporting under the PQRS (79 FR
40426).
PO 00000
Frm 00279
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.092</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
In Table 55, we provide the responses
and final decisions related to the
measures we proposed to remove from
67825
67826
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 55: Measures Being Removed from the Existing PQRS Measure Set Beginning
in 2015
"Cl
[.i;rLl
0'~
z2'
NQS
Domain
;
~
....
rJ1
Measure Title and Description¥
Q;
'"'
=
"'
=
"'
.§
u
.!
>
rJ1
u
....'
'"
"'
'S'JJ
Q;
~
~
=0
~
Q;
g.
"'
=
= i~"'
~ .s s
~'E c' ot:~
'"
~
..c
~
'"
~::'
~
"'
Q;
'=
"
= "''
c"'"' =
Q;
~
~
:...8-gf
Q;
Q;
'"'
-s~~
0
McdsuJcs f malizcd as Proposed
Perioperative Care: Timing of
Prophylactic Parenteral Antibiotic Ordering Physician: Percentage of surgical
patients aged 18 years and older undergoing
procedures with the indications for
prophylactic parenteral antibiotics, who
have an order for prophylactic parenteral
antibiotic to be given within one hour (if
fluoroquinolone or vancomycin, 2 hours),
prior to the surgical incision (or start of
procedure when no incision is required)
Some commenters disagreed with CMS'
proposal to remove this measure noting
"disparate practice patterns among
clinicians when selecting the more
appropriate prophylactic antibiotic."
However, other commenters agreed with
CMS' proposal to remove this measure
given the measure's "emphasis on
administration rather than ordering of
antibiotics." For this reason and given the
measure's high rate of performance in
previous reporting years, CMS is finalizing
its proposal to remove this measure from
reporting in 2015 PQRS.
Aspirin at Arrival for Acute Myocardial
Infarction (AMI): Percentage of patients,
regardless of age, with an emergency
department discharge diagnosis of acute
myocardial infarction (AMI) who had
documentation of receiving aspirin within
24 hours before emergency department
arrival or during emergency department stay
Effective
Clinical
Care
0269/030
Patient
Safety
Commenters disagreed with CMS' proposal
to remove this measure noting it presents a
"reporting opportunity for emergency
physicians" which could create a reporting
gap for that segment of providers reporting
to PQRS. However, CMS continues to
believe this measure represents a clinical
concept that has been substantially adopted
for initial treatment of patients suffering
from acute myocardial infarction when
clinically indicated. For this reason, CMS is
finalizing its proposal to remove this
measure from reporting in 2015 PQRS.
Perioperative Care: Timing of
Prophylactic Antibiotic-Administering
Physician: Percentage of surgical patients
aged 18 years and older who receive an
anesthetic when undergoing procedures
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00280
Fmt 4701
Sfmt 4725
AMAPCPI
NCQA
X
X
AMAPCPI
NCQA
X
X
AAO
X
X
E:\FR\FM\13NOR2.SGM
13NOR2
X
ER13NO14.093</GPH>
Patient
Safety
0092/028
ebenthall on DSK5SPTVN1PROD with $$_JOB
0270/020
67827
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
=
...
...
=
...
"CC
~
fi;r:Ll
0'~
z~
NQS
Domain
....
r:Ll
Measure Title and Description¥
"'
~
~
g.
"'
= ~
=
... ~ ~~ Co-' = = e
=t: =
"' > ....
.s ... 0'=•
=
.5 r:Ll "S'Ji
"' f;l;l
"'
..!': u
:.g.~
... = 0 ~~
u
... ...
~
~ = =
-=~~
"' 0
c.:l'"' ...
=
-
,.Q
-
bll rr,
-
~
with the indications for prophylactic
parenteral antibiotics for whom
administration of a prophylactic parenteral
antibiotic ordered has been initiated within
I hour (iffluoroquinolone or vancomycin, 2
hours) prior to the surgical incision (or start
of procedure when no incision is required)
Commenters disagreed with CMS' proposal
to remove this measure noting "it is
premature to remove a measure based on a
high-performance rate when the EP
reporting rate within the PQRS program is
low." With a performance rate above 90
percent for multiple consecutive years,
CMS considers the measure to have reached
its potential, and no longer represents a
clinical performance gap that should be
measured by the PQRS Program.
Additionally, CMS will apply the Measure
Applicability Validation (MAV) process for
claims-based reporting in those cases where
specialists do not have enough relevant
measures to report. For this reason, CMS is
finalizing its proposal to remove this
measure from reporting in 2015 PQRS.
Stroke and Stroke Rehabilitation:
Venous Thromboembolism (VTE)
Prophylaxis for Ischemic Stroke or
Intracranial Hemorrhage: Percentage of
patients aged 18 years and older with a
diagnosis of ischemic stroke or intracranial
hemorrhage who were administered venous
thromboembolism (VTE) prophylaxis the
day of or the day after hospital admission
Effective
Clinical
Care
VerDate Sep<11>2014
20:15 Nov 12, 2014
Commenters disagreed with CMS' proposal
to remove this measure. Commenters
maintain that these clinical concepts are
appropriate for measurement at the
individual physician level in addition to the
facility level to help ensure the continuous
care of stroke patients. CMS believes this
measure represents a basic standard of care
and does not add clinical value to PQRS at
this time. For this reason, CMS is fmalizing
its proposal to remove this measure from
reporting in 2015 PQRS.
Stroke and Stroke Rehabilitation:
Screening for Dysphagia: Percentage of
patients aged 18 years and older with a
diagnosis of ischemic stroke or intracranial
hemorrhage who receive any food, fluids or
medication by mouth (PO) for whom a
dysphagia screening was performed prior to
PO intake in accordance with a dysphagia
screening tool approved by the institution in
Jkt 235001
PO 00000
Frm 00281
Fmt 4701
Sfmt 4725
AANI
X
X
AANI
X
X
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.094</GPH>
Effective
Clinical
Care
0243/035
ebenthall on DSK5SPTVN1PROD with $$_JOB
0240/031
67828
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
=
...
...
=
...
"CC
~
fi;r:Ll
0'~
z~
NQS
Domain
....
r:Ll
Measure Title and Description¥
"'
~
~
g.
"'
= ~
=
... ~ ~~ Co-' = = e
=t: =
"' > ....
.s ... 0'=•
=
.5 r:Ll "S'Ji
"' f;l;l
"'
..!': u
:.g.~
... = 0 ~~
u
... ...
~
~ = =
-=~~
"' 0
c.:l'"' ...
=
-
,.Q
-
bll rr,
-
~
which the patient is receiving care
Effective
Clinical
Care
0637/045
Patient
Safety
Commenters disagreed with CMS' proposal
to remove this measure as they maintain that
these clinical concepts are appropriate for
measurement at the individual physician
level in addition to the facility level to help
ensure the continuous care of stroke
patients. CMS continues to believe this
measure represents a basic standard of care
and does not add clinical value to PQRS at
this time. For this reason, CMS is finalizing
its proposal to remove this measure from
reporting in 2015 PQRS.
Perioperative Care: Discontinuation of
Prophylactic Parenteral Antibiotics
(Cardiac Procedures): Percentage of
cardiac surgical patients aged 18 years and
older undergoing procedures with the
indications for prophylactic parenteral
antibiotics AND who received a
prophylactic parenteral antibiotic, who have
an order for discontinuation of prophylactic
parenteral antibiotics within 48 hours of
surgical end time
AANI
X
X
AMAPCPI
NCQA
X
X
Commenters disagreed with CMS' proposal
to remove this measure, noting "it is
premature to remove a measure based on a
high-performance rate when the EP
reporting rate within the PQRS program is
low." With a performance rate above 90
percent for multiple consecutive years,
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00282
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.095</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
0244/036
Commenters disagreed with CMS' proposal
to remove this measure as they maintain that
these clinical concepts are appropriate for
measurement at the individual physician
level in addition to the facility level to help
ensure the continuous care of stroke
patients. CMS continues to believe this
measure represents a basic standard of care
and does not add clinical value to PQRS at
this time. For this reason, CMS is finalizing
its proposal to remove this measure from
reporting in 2015 PQRS.
Stroke and Stroke Rehabilitation:
Rehabilitation Services Ordered:
Percentage of patients aged 18 years and
older with a diagnosis of ischemic stroke or
intracranial hemorrhage for whom
occupational, physical, or speech
rehabilitation services were ordered at or
prior to inpatient discharge OR
documentation that no rehabilitation
services are indicated at or prior to inpatient
discharge
67829
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
=
...
...
=
...
"CC
~
fi;r:Ll
0'~
z~
NQS
Domain
....
r:Ll
Measure Title and Description¥
"'
~
~
g.
"'
= ~
=
... ~ ~~ Co-' = = e
=t: =
"' > ....
.s ... 0'=•
=
.5 r:Ll 'S'Ji
"' f;l;l
"'
..!': u
:.g.~
... = 0 ~~
u
... ...
~
~ = =
-=~~
"' 0
c.:l'"' ...
=
-
,.Q
-
bll
rr,
-
~
CMS considers the measure to have reached
its potential, and no longer represent a
clinical performance gap that should be
measured by the PQRS Program. The
PQRS will continue to focus on measures
with maximal potential for improvement
and that answer a clinical performance gap.
For this reason, CMS is finalizing its
proposal to remove this measure from
reporting in 2015 PQRS.
Urinary Incontinence: Characterization
of Urinary Incontinence in Women Aged
65 Years and Older: Percentage of female
patients aged 65 years and older with a
diagnosis of urinary incontinence whose
urinary incontinence was characterized at
least once within 12 months
ebenthall on DSK5SPTVN1PROD with $$_JOB
0093
1055
VerDate Sep<11>2014
Effective
Clinical
Care
Effective
Clinical
Care
20:15 Nov 12, 2014
Commenters disagreed with CMS' proposal
to remove this measure, noting "it is
premature to remove a measure based on a
high-performance rate when the EP
reporting rate within the PQRS program is
low." With a performance rate above 90
percent for multiple consecutive years,
CMS considers the measure to have reached
its potential, and no longer represent a
clinical performance gap that should be
measured by the PQRS Program. The
PQRS will continue to focus on measures
with maximal potential for improvement
and that answer a clinical performance gap.
For this reason, CMS is finalizing its
proposal to remove this measure from
Jkt 235001
PO 00000
Frm 00283
Fmt 4701
Sfmt 4725
NCQA/
AMAPCPI
X
X
AMAPCPI
/NCQA
X
X
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.096</GPH>
0099/049
Commenters disagreed with removal of this
measure due to high performance rates
indicating this is not a good enough reason
to remove a measure from the program.
With a performance rate above 90 percent
for multiple consecutive years, CMS
considers the measure to have reached its
potential, and no longer represent a clinical
performance gap that should be measured
by the PQRS Program. The PQRS will
continue to focus on measures with
maximal potential for improvement and that
answer a clinical performance gap. For this
reason, CMS is finalizing its proposal to
remove this measure from 2015 PQRS.
Emergency Medicine: 12-Lead
Electrocardiogram (ECG) Performed for
Syncope: Percentage of patients aged 60
years and older with an emergency
department discharge diagnosis of syncope
who had a 12-lead electrocardiogram (ECG)
performed
67830
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
-=
:..
OS
fi;oo
0~
z~
:t
NQS
Domain
....
"'
rLl
Measure Title and Description¥
:..
"'
=
OS
"'
"'
::s
"'
c
= =~"'
!:1.
..Q
~
"'
.5 > .... ~
rLl
..!!! u
fool
~~
:..
.:!;l
u
'-':!
~
Q.o
~
~
0 :..
~~
=
....
c
:..
~
"'
:..
"'
=
OS
"'
"'
::s
~ .s e
oiE
:..Q,~
"' "' :..
;~e~.o
0
reporting in 2015 PQRS.
Emergency Medicine: CommunityAcquired Bacterial Pneumonia (CAP):
Vital Signs: Percentage of patients aged 18
years and older with a diagnosis of
community-acquired bacterial pneumonia
(CAP) with vital signs documented and
reviewed
Effective
Clinical
Care
ebenthall on DSK5SPTVN1PROD with $$_JOB
0096
/059
Effective
Clinical
Care
0001/064
Effective
Clinical
Care
VerDate Sep<11>2014
20:15 Nov 12, 2014
Commenters disagreed with CMS' proposal
to remove this measure noting "it is
premature to remove a measure based on a
high-performance rate when the EP
reporting rate within the PQRS program is
low." With a performance rate above 90
percent for multiple consecutive years,
CMS considers the measure to have reached
its potential, and no longer represent a
clinical performance gap that should be
measured by the PQRS Program. The
PQRS will continue to focus on measures
with maximal potential for improvement
and that answer a clinical performance gap.
For this reason, CMS is fmalizing its
proposal to remove this measure from
reporting in 2015 PQRS.
Asthma: Assessment of Asthma ControlAmbulatory Care Setting: Percentage of
patients aged 5 through 64 years with a
diagnosis of asthma who were evaluated at
least once during the measurement period
Jkt 235001
PO 00000
Frm 00284
Fmt 4701
Sfmt 4725
AMAPCPI
/NCQA
X
X
AMAPCPI
/NCQA
X
X
AMAPCPI
NCQA
E:\FR\FM\13NOR2.SGM
X
13NOR2
X
ER13NO14.097</GPH>
0232
/056
Commenters disagreed with CMS' proposal
to remove this measure noting "it is
premature to remove a measure based on a
high-performance rate when the EP
reporting rate within the PQRS program is
low." With a performance rate above 90
percent for multiple consecutive years,
CMS considers the measure to have reached
its potential, and no longer represent a
clinical performance gap that should be
measured by the PQRS Program. The PQRS
will continue to focus on measures with
maximal potential for improvement and that
answer a clinical performance gap. For this
reason, CMS is finalizing its proposal to
remove this measure from reporting in 2015
PQRS.
Emergency Medicine: CommunityAcquired Bacterial Pneumonia (CAP):
Empiric Antibiotic: Percentage of patients
aged 18 years and older with a diagnosis of
community-acquired bacterial pneumonia
(CAP) with an appropriate empiric
antibiotic prescribed
67831
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
=
...
...
=
...
"CC
~
fi;r:Ll
0'~
z~
NQS
Domain
....
r:Ll
Measure Title and Description¥
"'
~
~
g.
"'
= ~
=
... ~ ~~ Co-' = = e
=t: =
"' > ....
.s ... 0'=•
=
.5 r:Ll "S'Ji
"' f;l;l
"'
..!': u
:.g.~
... = 0 ~~
u
... ...
~
~ = =
-=~~
"' 0
c.:l'"' ...
=
-
,.Q
-
bll
rr,
-
~
for asthma control (comprising asthma
impairment and asthma risk)
Some commenters disagreed with the
removal of this measure noting "this
[assessment] is essential in order to ensure
appropriate treatment for asthma which
currently is less than optimal." However,
other commenters supported the removal of
this measure. CMS continues to believe this
measure represents a basic clinical concept
that does not add clinical value to PQRS
because in order to provide effective
treatment for asthma, assessment of asthma
control is essential. As such, CMS is
finalizing its proposal to remove PQRS
#064, "Asthma: Assessment of Asthma
Control- Ambulatory Care Setting," which
is a process measure, and replace it with the
more robust outcome measure, Optimal
Asthma - Control Component based on our
exception authority under section
1848(k)(2)(C)(ii) of the Act that provides an
exception to the requirement that the
Secretary select measures must be endorsed
byNQF.
Hepatitis C: Confirmation of Hepatitis C
Viremia: Percentage of patients aged 18
years and older who are hepatitis C antibody
positive seen for an initial evaluation for
whom hepatitis C virus (HCV) RNA testing
was ordered or previously performed
Effective
Clinical
Care
0103/106
Effective
Clinical
Care
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00285
Fmt 4701
Sfmt 4725
AGA
APA
X
X
E:\FR\FM\13NOR2.SGM
X
13NOR2
ER13NO14.098</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
0393/083
One commenter disagreed with the removal
of this measure noting a recent study of four
large health systems revealed that "less than
two-thirds of persons with positive HCV
antibody test had a follow-up RNA test."
Despite these findings, eligible
professionals have consistently reported
performance rates close to 100% for this
measure. With a performance rate above 90
percent for multiple consecutive years,
CMS considers the measure to have reached
its potential, and no longer represents a
clinical performance gap that should be
measured by the PQRS Program. The
PQRS will continue to focus on measures
with maximal potential for improvement
and that answer a clinical performance gap.
For these reasons, CMS is fmalizing its
proposal to remove this measure from
reporting in 2015 PQRS.
Adult Major Depressive Disorder
(MDD): Comprehensive Depression
Evaluation: Diagnosis and Severity:
Percentage of patients aged 18 years and
67832
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
=
.,
....
.,
=
.,
=
"CS
~
i,ji;OO
01~
z~
NQS
Domain
00
Measure Title and Description¥
"'
"'
.5
.!
u
>
00
u
...
....
-
"'
"6b
~
~
Q,
"'
.c
= =
=t: e
===
~ 0 - ., 01~·
"'
-Q,~
liol ~~
~ .... "'
= ., ;~~
= ., .,
=
,.Q
~'E
:!
~
~
bll r'-1
~
~
0
-
older with a new diagnosis or recurrent
episode of major depressive disorder
(MDD) with evidence that they met the
Diagnostic and Statistical Manual of Mental
Disorders (DSM)-5 criteria for MDD AND
for whom there is an assessment of
depression severity during the visit in which
a new diagnosis or recurrent episode was
identified
Effective
Clinical
Care
RPA
X
X
X
Some commenters suggested CMS not
remove this measure, noting it is "an
assessment that is required for making
treatment decisions." CMS agrees this
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00286
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.099</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
1666/123
Commenters disagreed with CMS' proposal
to remove this measure noting "appropriate
diagnosis and classification of severity are
essential in order to ensure appropriate
treatment for major depressive disorder. The
use of the diagnostic tools included in the
measure is currently less than optimal."
Furthermore, commenters suggest the other
MDD measure (PQRS #370) "does not
include screening for bipolar disorder and
could potentially exclude some patients
from screening." However, CMS continues
to believe it represents a clinically
diagnostic reference that is commonly
utilized as a standard practice of care in
order to diagnose and treat mental health
disorders. This measure is not robust and
does not add clinical value to the PQRS
program. It is a goal of CMS to increase the
number of outcome-based measures in the
PQRS program, and measures that work to
appropriately diagnose and classify the
severity of illnesses and include quality care
action are essential for this effort. For these
reasons, CMS is finalizing its proposal to
remove this measure from reporting in 2015
PQRS.
Adult Kidney Disease: Patients On
Erythropoiesis-Stimulating Agent (ESA) Hemoglobin Level> 12.0 g/dL: Percentage
of calendar months within a 12-month
period during which a hemoglobin level is
measured for patients aged 18 years and
older with a diagnosis of advanced chronic
kidney disease (CKD) (stage 4 or 5, not
receiving Renal Replacement Therapy
([RRT]) or End Stage Renal Disease
(ESRD) (who are on hemodialysis or
peritoneal dialysis) who are also receiving
erythropoiesis-stimulating agent (ESA)
therapy AND have a hemoglobin level >
12.0 g/dL
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
-=
:..
OS
z~
00511142
NQS
Domain
Effective
Clinical
Care
....
"'
rLl
Measure Title and Description¥
:..
"'
=
OS
"'
"'
::s
measure is both an effective clinical care
and overuse measure. However,
commenters that agreed with removal of
this measure came from specialists who
would most likely be reporting this measure.
As such, CMS is finalizing its proposal to
remove PQRS 123.
Osteoarthritis (OA): Assessment for Use
of Anti-Inflammatory or Analgesic Overthe-Counter (OTC) Medications:
Percentage of patient visits for patients aged
21 years and older with a diagnosis of
osteoarthritis (OA) with an assessment for
use of anti-inflammatory or analgesic overthe-counter (OTC) medications
A steward has still not been identified for
this measure, and for this reason CMS is
finalizing its proposal to remove this
measure from reporting in 2015 PQRS.
Back Pain: Initial Visit: The percentage of
patients aged 18 through 79 years with a
diagnosis of back pain or undergoing back
surgery who had back pain and function
assessed during the initial visit to the
clinician for the episode of back pain
03221148
ebenthall on DSK5SPTVN1PROD with $$_JOB
0319/149
VerDate Sep<11>2014
Efficiency
and Cost
Reduction
Effective
Clinical
Care
20:15 Nov 12, 2014
Some commenters supported the removal of
this measure while others expressed concern
over its removal and the negative impact on
anesthesiologists and pain medicine
physicians to report PQRS. CMS
understands the commenters' concerns. It is
a priority for PQRS to ultimately increase
the quality of health care, and promoting
outcome-based measures is part of this
effort. This measure and others in the Back
Pain Measure Group represent clinical
assessments and recommendations
commonly utilized to provide effective
treatment for patients diagnosed with back
pain, and thus, were determined to be low
bar, process-based measures that do not
meaningfully contribute to improved patient
outcomes or the PQRS program. For this
reason, CMS is finalizing its proposal to
remove this measure and other measures in
the Back Pain Measures Group from the
PQRS program in 2015.
Back Pain: Physical Exam: Percentage of
patients aged 18 through 79 years with a
diagnosis of back pain or undergoing back
surgery who received a physical
examination at the initial visit to the
clinician for the episode of back pain
Jkt 235001
PO 00000
Frm 00287
Fmt 4701
AMAPCPI
"'
c
= =~"'
!:1.
..Q
~
"'
.5 > .... ~
rLl
..!!! u
fool
~~
:..
.:!;l
u
X
'-':!
~
Q.o
~
~
0 :..
~~
=
....
c
:..
~
"'
:..
"'
=
OS
"'
"'
::s
~ .s e
oiE
:..Q,~
"' "' :..
;~e~.o
0
X
NCQA
X
NCQA
X
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.100</GPH>
fi;oo
0~
:t
67833
67834
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
=
...
...
=
...
"CC
~
0'~
z~
NQS
Domain
....
r:Ll
Measure Title and Description¥
"'
~
~
Some commenters supported the removal of
this measure while others expressed concern
over its removal and the negative impact on
anesthesiologists and pain medicine
physicians to report PRQS. CMS
understands the commenters' concerns. It is
a priority for PQRS to ultimately increase
the quality of health care and promoting
outcome-based measures is part of this
effort. This measure and others in the Back
Pain Measure Group represent clinical
assessments and recommendations
commonly utilized to provide effective
treatment for patients diagnosed with back
pain, and thus, were determined to be low
bar, process-based measures that do not
meaningfully contribute to improved patient
outcomes or the PQRS program. For this
reason, CMS is finalizing its proposal to
remove this measure and other measures in
the Back Pain Measures Group from the
PQRS program in 2015.
Back Pain: Advice for Normal Activities:
The percentage of patients aged 18 through
79 years with a diagnosis of back pain or
undergoing back surgery who received
advice for normal activities at the initial
visit to the clinician for the episode of back
pain
ebenthall on DSK5SPTVN1PROD with $$_JOB
0314/150
0313/151
VerDate Sep<11>2014
Effective
Clinical
Care
Effective
Clinical
Care
20:15 Nov 12, 2014
Some commenters expressed concern over
the removal of this measure and the
negative impact on anesthesiologists and
pain medicine physicians to report PRQS.
CMS understands the commenters'
concerns. It is a priority for PQRS to
ultimately increase the quality of health care
and promoting outcome-based measures is
part of this effort. This measure and others
in the Back Pain Measure Group represent
clinical assessments and recommendations
commonly utilized to provide effective
treatment for patients diagnosed with back
pain, and thus, were determined to be low
bar, process-based measures that do not
meaningfully contribute to improved patient
outcomes or the PQRS program. For this
reason, CMS is finalizing its proposal to
remove this measure and other measures in
the Back Pain Measures Group from the
PQRS program in 2015.
Back Pain: Advice Against Bed Rest: The
percentage of patients aged 18 through 79
years with a diagnosis of back pain or
undergoing back surgery who received
advice against bed rest lasting four days or
longer at the initial visit to the clinician for
Jkt 235001
PO 00000
Frm 00288
Fmt 4701
-
-
bll
rr,
-
~
NCQA
X
NCQA
X
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.101</GPH>
fi;r:Ll
g.
"'
= ~
=
... ~ ~~ Co-' = = e
=t: =
"' > ....
.s ... 0'=•
=
.5 r:Ll 'S'Ji
"' f;l;l
"'
..!': u
:.g.~
... = 0 ~~
u
... ...
~
~ = =
-=~~
"' 0
c.:l'"' ...
=
,.Q
67835
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
=
...
...
=
...
"CC
~
fi;r:Ll
0'~
z~
NQS
Domain
....
r:Ll
Measure Title and Description¥
"'
~
~
g.
"'
= ~
=
... ~ ~~ Co-' = = e
=t: =
"' > ....
.s ... 0'=•
=
.5 r:Ll "S'Ji
"' f;l;l
"'
..!': u
:.g.~
... = 0 ~~
u
... ...
~
~ = =
-=~~
"' 0
c.:l'"' ...
=
-
,.Q
-
bll
rr,
-
~
the episode of back pain
Some commenters supported the removal of
this measure while others expressed concern
over its removal and the negative impact on
anesthesiologists and pain medicine
physicians to report PRQS. CMS
understands the commenters• concerns. It is
a priority for PQRS to ultimately increase
the quality of health care and promoting
outcome-based measures is part of this
effort. This measure and others in the Back
Pain Measure Group represent clinical
assessments and recommendations
commonly utilized to provide effective
treatment for patients diagnosed with back
pain, and thus, were determined to be low
bar, process-based measures that do not
meaningfully contribute to improved patient
outcomes or the PQRS program. For this
reason, CMS is finalizing its proposal to
remove this measure and other measures in
the Back Pain Measures Group from the
PQRS program in 2015.
Thoracic Surgery: Recording of Clinical
Stage Prior to Lung Cancer or
Esophageal Cancer Resection: Percentage
of surgical patients aged 18 years and older
undergoing resection for lung or esophageal
cancer who had clinical staging provided
prior to surgery
Patient
Safety
0404/159
Effective
Clinical
Care
STS
X
AMAPCPI
NCQA
X
X
X
Commenters disagreed with the removal of
this measure based on a rationale of a high
performance rate. With a performance rate
above 90 percent for multiple consecutive
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00289
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.102</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
0455/157
Commenters disagreed with removal of this
measure noting that removal based on a
high-performance rate. With a performance
rate above 90 percent for multiple
consecutive years, CMS considers the
measure to have reached its potential, and
no longer represent a clinical performance
gap that should be measured by the PQRS
Program. The PQRS will continue to focus
on measures with maximal potential for
improvement and that answer a clinical
performance gap. For this reason, CMS is
finalizing its proposal to remove this
measure from 2015 PQRS.
HIV/AIDS: CD4+ Cell Count or CD4+
Percentage Performed: Percentage of
patients aged 6 months and older with a
diagnosis of HIVIAIDS for whom a CD4+
cell count or CD4+ cell percentage was
performed at least once every 6 months
67836
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
"'
"CS
I.
...
oo
-..oo
~
Z=.,
NQS
Domain
6::
"'
....
"'
rLl
Measure Title and Description¥
"'
=
"'
"'
"'
~
I.
!:1.
~
= =
...
"'
e > -= ~ ~'E ~
:!
rLl
"'
"'
:i u ·sn lioil 0
~~ "'
,.Q
~
I.
I.
u
~
I.
=- .... =
~ = "'
"'
"'
~
bl) rl:l
:~=
0'~1.
1.!:1.011
"' "' e
-=~=0
years, CMS considers the measure to have
reached its potential, and no longer
represent a clinical performance gap that
should be measured by the PQRS Program.
The PQRS will continue to focus on
measures with maximal potential for
improvement and that answer a clinical
performance gap. Furthermore, other
commenters agreed with the removal of this
measure indicating "this measure is no
longer as relevant now that we are
measuring CD4 less frequently and such
measurement is optional in the Department
of Health and Human Services Guidelines
for the Use of Antiretroviral Agents in HIV1-Infected Adults and Adolescents for those
suppressed for at least 2 years." For these
reasons, CMS is finalizing its proposal to
remove this measure from reporting in 2015
PQRS.
Coronary Artery Bypass Graft (CABG):
Antiplatelet Medications at Discharge:
Percentage of patients aged 18 years and
older undergoing isolated CABG surgery
who were discharged on antiplatelet
medication
Effective
Clinical
Care
VerDate Sep<11>2014
20:15 Nov 12, 2014
Commenters disagreed with removal of this
measure noting that removal based on a
high-performance rate. With a performance
rate above 90 percent for multiple
consecutive years, CMS considers the
measure to have reached its potential, and
no longer represent a clinical performance
gap that should be measured by the PQRS
Program. The PQRS will continue to focus
Jkt 235001
PO 00000
Frm 00290
Fmt 4701
Sfmt 4725
STS
X
X
STS
X
X
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.103</GPH>
Effective
Clinical
Care
0117/170
ebenthall on DSK5SPTVN1PROD with $$_JOB
0116/169
Commenters disagreed with removal of this
measure noting that removal based on a
high-performance rate. With a performance
rate above 90 percent for multiple
consecutive years, CMS considers the
measure to have reached its potential, and
no longer represent a clinical performance
gap that should be measured by the PQRS
Program. The PQRS will continue to focus
on measures with maximal potential for
improvement and that answer a clinical
performance gap. For this reason, CMS is
finalizing its proposal to remove this
measure from 2015 PQRS.
Coronary Artery Bypass Graft (CABG):
Beta-Blockers Administered at
Discharge: Percentage of patients aged 18
years and older undergoing isolated CABG
surgery who were discharged on betablockers
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
-=
:..
OS
fi;oo
0~
z~
:t
NQS
Domain
....
"'
rLl
Measure Title and Description¥
:..
"'
=
OS
"'
"'
::s
67837
"'
c
= =~"'
!:1.
..Q
~
"'
.5 > .... ~
rLl
..!!! u
fool
~~
:..
.:!;l
u
'-':!
~
Q.o
~
~
0 :..
~~
=
....
c
:..
~
"'
:..
"'
=
OS
"'
"'
::s
~ .s e
oiE
:..Q,~
"' "' :..
;~e~.o
0
on measures with maximal potential for
improvement and that answer a clinical
performance gap. For this reason, CMS is
finalizing its proposal to remove this
measure from 2015 PQRS.
Coronary Artery Bypass Graft (CABG):
Anti-Lipid Treatment at Discharge:
Percentage of patients aged 18 years and
older undergoing isolated CABG surgery
who were discharged on a statin or other
lipid-lowering regimen
Effective
Clinical
Care
0079/198
Effective
Clinical
Care
VerDate Sep<11>2014
20:15 Nov 12, 2014
Many commenters supported the proposed
removal of the measure because the
measure may not align with current clinical
guidelines. Other commenters disagreed
with the removal of this measure indicating
the measure is currently in the process of
being updated. CMS continues to believe
that because of changes to the applicable
evidence-based guidelines, this measure is
no longer clinically valid. For this reason,
CMS is fmalizing its proposal to remove
this measure from reporting for 2015 PQRS
and Medicare Shared Savings Program.
Heart Failure: Left Ventricular Ejection
Fraction (LVEF) Assessment: Percentage
of patients aged 18 years and older with a
diagnosis of heart failure for whom the
quantitative or qualitative results of a recent
or prior [any time in the past] LVEF
assessment is documented within a 12
Jkt 235001
PO 00000
Frm 00291
Fmt 4701
Sfmt 4725
STS
X
AMAPCPI
ACCF
AHA
X
AMAPCPI
ACCF
AHA
X
E:\FR\FM\13NOR2.SGM
13NOR2
X
X
X
X
ER13NO14.104</GPH>
Effective
Clinical
Care
0074/197
ebenthall on DSK5SPTVN1PROD with $$_JOB
0118/171
Commenters disagreed with removal of this
measure noting that removal based on a
high-performance rate. With a performance
rate above 90 percent for multiple
consecutive years, CMS considers the
measure to have reached its potential, and
no longer represent a clinical performance
gap that should be measured by the PQRS
Program. The PQRS will continue to focus
on measures with maximal potential for
improvement and that answer a clinical
performance gap. For this reason, CMS is
finalizing its proposal to remove this
measure from 2015 PQRS.
Coronary Artery Disease (CAD): Lipid
Control: Percentage of patients aged 18
years and older with a diagnosis of coronary
artery disease seen within a 12 month period
who have a LDL-C result< 100 mg/dL OR
patients who have a LDL-C result 2: 100
mg/dL and have a documented plan of care
to achieve LDL-C <100 mg/dL, including at
a minimum the prescription of a statin
67838
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
=
...
...
=
...
"CC
~
fi;r:Ll
0'~
z~
NQS
Domain
....
r:Ll
Measure Title and Description¥
"'
~
~
g.
"'
= ~
=
... ~ ~~ Co-' = = e
=t: =
"' > ....
.s ... 0'=•
=
.5 r:Ll "S'Ji
"' f;l;l
"'
..!': u
:.g.~
... = 0 ~~
u
... ...
~
~ = =
-=~~
"' 0
c.:l'"' ...
=
-
,.Q
-
bll rr,
-
~
month period
Effective
Clinical
Care
VerDate Sep<11>2014
20:15 Nov 12, 2014
CMS/QIP
X
Several comments suggested CMS maintain
this measure as it is important to clinical
practice. However, CMS continues to
believe this measure represents a clinical
concept that does not add clinical value to
PQRS. LVF testing is basic assessment for
patients with heart failure. For these
reasons, CMS is finalizing its proposal to
remove this measure from reporting in 2015
PQRS.
Asthma: Tobacco Use: Screening Ambulatory Care Setting: Percentage of
patients aged 5 through 64 years with a
diagnosis of asthma (or their primary
caregiver) who were queried about tobacco
use and exposure to second hand smoke
within their home environment at least once
during the one-year measurement period
Commenters disagreed with CMS' proposal
to replace PQRS #231 (Asthma: Tobacco
Use: Screening- Ambulatory Care Setting)
with PQRS #226 "Preventive Care and
Screening: Tobacco Use: Screening and
Cessation Intervention" because PQRS #231
includes an age range of 5-64 while the
lower bound age for PQRS #226 is 18 years,
missing the pediatric population.
Furthermore, PQRS #226 does not include
the query regarding exposure to second
hand smoke which is critical for the 18 and
under population with Asthma. However,
CMS continues to believe this is measure is
Jkt 235001
PO 00000
Frm 00292
Fmt 4701
Sfmt 4725
AMAPCPI
NCQA
X
E:\FR\FM\13NOR2.SGM
X
13NOR2
X
ER13NO14.105</GPH>
Effective
Clinical
Care
N/A/231
ebenthall on DSK5SPTVN1PROD with $$_JOB
N/A
/228
Several comments suggested CMS maintain
this measure as it is important to clinical
practice and has strong impact on patient
symptom management. However, CMS
continues to believe this measure represents
a clinical concept that does not add clinical
value to PQRS. LVEF testing is basic
assessment for patients with heart failure.
For these reasons, CMS is finalizing its
proposal to remove this measure from 2015
PQRS.
Heart Failure (HF): Left Ventricular
Function (LVF) Testing: Percentage of
patients 18 years and older with Left
Ventricular Fnnction (LVF) testing
documented as being performed within the
previous 12 months or LVF testing
performed prior to discharge for patients
who are hospitalized with a principal
diagnosis of Heart Failure (HF) during the
reporting period
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
-=
:..
OS
fi;oo
0~
z~
:t
NQS
Domain
....
"'
rLl
Measure Title and Description¥
:..
"'
=
OS
"'
"'
::s
67839
"'
c
= =~"'
!:1.
..Q
~
"'
.5 > .... ~
rLl
..!!! u
fool
~~
:..
.:!;l
u
'-':!
~
Q.o
~
~
0 :..
~~
=
....
c
:..
~
"'
:..
"'
=
OS
"'
"'
::s
~ .s e
oiE
:..Q,~
"' "' :..
;~e~.o
0
appropriate and more broadly applicable
and for this reason is finalizing the proposal
to remove this measure from 2015 PQRS
reporting.
Asthma: Tobacco Use: InterventionAmbulatory Care Setting: Percentage of
patients aged 5 through 64 years with a
diagnosis of asthma who were identified as
tobacco users (or their primary caregiver)
who received tobacco cessation intervention
at least once during the one-year
measurement period
Effective
Clinical
Care
0458/234
Patient
Safety
VerDate Sep<11>2014
20:15 Nov 12, 2014
Commenters disagreed with removal of this
measure noting that removal based on a
high-performance rate. With a performance
rate above 90 percent for multiple
consecutive years, CMS considers the
measure to have reached its potential, and
no longer represent a clinical performance
gap that should be measured by the PQRS
Program. The PQRS will continue to focus
on measures with maximal potential for
improvement and that answer a clinical
performance gap. For this reason, CMS is
finalizing its proposal to remove this
measure from 2015 PQRS.
Thoracic Surgery: Pulmonary Function
Tests Before Major Anatomic Lung
Resection (Pneumonectomy, Lobectomy,
Jkt 235001
PO 00000
Frm 00293
Fmt 4701
Sfmt 4725
AMAPCPI
NCQA
X
X
STS
X
STS
X
X
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.106</GPH>
Effective
Clinical
Care
0457/233
ebenthall on DSK5SPTVN1PROD with $$_JOB
N/A/232
Commenters disagreed with CMS' proposal
to replace PQRS #232 (Asthma: Tobacco
Use: Intervention- Ambulatory Care
Setting) with PQRS #226 "Preventive Care
and Screening: Tobacco Use: Screening and
Cessation Intervention" because PQRS #231
and #232 include an age range of 5-64 while
the lower bound age for PQRS #226 is 18
years, missing the pediatric population.
Furthermore, PQRS #226 does not include
the query regarding exposure to second
hand smoke which is critical for the 18 and
under population with Asthma. However,
CMS continues to believe #226 is
appropriate and more broadly applicable
and for this reason is finalizing its proposal
to remove #232 from 2015 PQRS reporting.
Thoracic Surgery: Recording of
Performance Status Prior to Lung or
Esophageal Cancer Resection: Percentage
of patients aged 18 years and older
undergoing resection for lung or esophageal
cancer for whom performance status was
documented and reviewed within 2 weeks
prior to surgery
67840
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
=
...
...
=
...
"CC
~
fi;r:Ll
0'~
z~
NQS
Domain
....
r:Ll
Measure Title and Description¥
"'
~
~
g.
"'
= ~
=
... ~ ~~ Co-' = = e
=t: =
"' > ....
.s ... 0'=•
=
.5 r:Ll "S'Ji
"' f;l;l
"'
..!': u
:.g.~
... = 0 ~~
u
... ...
~
~ = =
-=~~
"' 0
c.:l'"' ...
=
-
,.Q
-
bll rr,
-
~
or Formal Segmentectomy): Percentage of
thoracic surgical patients aged 18 years and
older undergoing at least one pulmonary
function test within 12 months prior to a
major lung resection (pneumonectomy,
lobectomy, or formal segmentectomy)
Commenters disagreed with removal of this
measure noting that removal based on a
high-performance rate. With a performance
rate above 90 percent for multiple
consecutive years, CMS considers the
measure to have reached its potential, and
no longer represent a clinical performance
gap that should be measured by the PQRS
Program. The PQRS will continue to focus
on measures with maximal potential for
improvement and that answer a clinical
performance gap. For this reason, CMS is
finalizing its proposal to remove this
measure from 2015 PQRS.
Chronic Wound Care: Use of Wound
Surface Culture Technique in Patients
with Chronic Skin Ulcers (Overuse
Measure): Percentage of patient visits for
those patients aged 18 years and older with
a diagnosis of chronic skin ulcer without the
use of a wound surface culture technique
Effective
Clinical
Care
AQA
Adopted
/246
Effective
Clinical
Care
ASPS
X
X
ASPS
X
X
Commenters disagreed with removal of this
measure based on a rationale of high
performance rates. With a performance rate
above 90 percent for multiple consecutive
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00294
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.107</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
AQA
Adopted
/245
Commenters disagreed with removal of this
measure based on a rationale of high
performance rates. With a performance rate
above 90 percent for multiple consecutive
years, CMS considers the measure to have
reached its potential, and no longer
represent a clinical performance gap that
should be measured by the PQRS Program.
The PQRS will continue to focus on
measures with maximal potential for
improvement and that answer a clinical
performance gap. However, other
commenters supported the removal of this
measure. For these reasons, CMS is
finalizing its proposal to remove this
measure from reporting in 2015 PQRS.
Chronic Wound Care: Use of Wet to Dry
Dressings in Patients with Chronic Skin
Ulcers (Overuse Measure): Percentage of
patient visits for those patients aged 18
years and older with a diagnosis of chronic
skin ulcer without a prescription or
recommendation to use wet to dry dressings
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
-=
:..
OS
fi;oo
0~
z~
:t
NQS
Domain
....
"'
rLl
Measure Title and Description¥
:..
"'
=
OS
"'
"'
::s
67841
"'
c
= =~"'
!:1.
..Q
~
"'
.5 > .... ~
rLl
..!!! u
fool
~~
:..
.:!;l
u
'-':!
~
Q.o
~
~
0 :..
~~
=
....
c
:..
~
"'
:..
"'
=
OS
"'
"'
::s
~ .s e
oiE
:..Q,~
"' "' :..
;~e~.o
0
years, CMS considers the measure to have
reached its potential, and no longer
represent a clinical performance gap that
should be measured by the PQRS Program.
The PQRS will continue to focus on
measures with maximal potential for
improvement and that answer a clinical
performance gap. However, other
commenters supported the removal of this
measure. For these reasons, CMS is
finalizing its proposal to remove this
measure from reporting in 2015 PQRS.
Substance Use Disorders: Counseling
Regarding Psychosocial and
Pharmacologic Treatment Options for
Alcohol Dependence: Percentage of
patients aged 18 years and older with a
diagnosis of current alcohol dependence
who were counseled regarding psychosocial
AND pharmacologic treatment options for
alcohol dependence within the 12-month
reporting period
Effective
Clinical
Care
N/A
/266
VerDate Sep<11>2014
Effective
Clinical
Care
20:15 Nov 12, 2014
Commenters disagreed with removal of this
measure based on a rationale of high
performance rates. With a performance rate
above 90 percent for multiple consecutive
years, CMS considers the measure to have
reached its potential, and no longer
represent a clinical performance gap that
should be measured by the PQRS Program.
The PQRS will continue to focus on
measures with maximal potential for
improvement and that answer a clinical
performance gap. For this reason, CMS is
finalizing its proposal to remove this
measure from reporting in 2015 PQRS.
Substance Use Disorders: Screening for
Depression Among Patients with
Substance Abuse or Dependence:
Percentage of patients aged 18 years and
older with a diagnosis of current substance
abuse or dependence who were screened for
depression within the 12-month reporting
period
One commenter reported this measure is not
applicable to nursing home providers. No
other comments were received regarding
this measure. CMS is finalizing its proposal
to remove this measure from reporting in
2015 PQRS.
Epilepsy: Seizure Type(s) and Current
Seizure Frequency(ies): Percentage of
patient visits with a diagnosis of epilepsy
who had the type(s) ofseizure(s) and
Jkt 235001
PO 00000
Frm 00295
Fmt 4701
Sfmt 4725
APA
X
X
AQA
APA
X
X
AQA
AAN
X
X
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.108</GPH>
Effective
Clinical
Care
AQA
Adopted/
248
ebenthall on DSK5SPTVN1PROD with $$_JOB
AQA
Adopted/
247
67842
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
-=
:..
OS
fi;oo
0~
z~
:t
NQS
Domain
....
"'
rLl
Measure Title and Description¥
:..
"'
=
OS
"'
"'
::s
"'
c
= =~"'
!:1.
..Q
~
"'
.5 > .... ~
rLl
..!!! u
fool
~~
:..
.:!;l
u
'-':!
~
Q.o
~
~
0 :..
~~
=
....
c
:..
~
"'
:..
"'
=
OS
"'
"'
::s
~ .s e
oiE
:..Q,~
"' "' :..
;~e~.o
0
current seizure frequency(ies) for each
seizure type documented in the medical
record
N/A/
267
Effective
Clinical
Care
No comments were received regarding this
measure. CMS is finalizing its proposal to
remove this measure from reporting in 2015
PQRS.
Epilepsy: Documentation of Etiology of
Epilepsy or Epilepsy Syndrome: All visits
for patients with a diagnosis of epilepsy
who had their etiology of epilepsy or with
epilepsy syndrome(s) reviewed and
documented if known, or documented as
unknown or cryptogenic
AAN
X
X
No comments were received regarding this
measure. CMS is finalizing its proposal to
remove this measure from reporting in 2015
PQRS.
Inflammatory Bowel Disease (IBD):
Type, Anatomic Location and Activity
All Documented: Percentage of patients
aged 18 years and older with a diagnosis of
inflammatory bowel disease who have
documented the disease type, anatomic
location and activity, at least once during
the reporting period
Effective
Clinical
Care
VerDate Sep<11>2014
20:15 Nov 12, 2014
One commenter disagreed with the removal
of this measure but did not provide a reason.
However, CMS continues to believe that, as
a measurement tool, PQRS #269 did not add
clinical value to the PQRS Program because
in order to provide care for IBD patients,
documentation of type, anatomic location
and activity would be essential for effective
treatment of the disease. For this reason,
CMS is fmalizing its proposal to remove
this measure from reporting in 2015 PQRS.
Inflammatory Bowel Disease (ffiD):
Preventive Care: Influenza
Immunization: Percentage of patients aged
18 years and older with a diagnosis of
inflammatory bowel disease for whom
influenza immunization was recommended,
administered or previously received during
the reporting year
AGA
X
AGA
X
Commenters were supportive of the removal
of this measure and its replacement with
PQRS #110 (Preventive Care and
Screening: Influenza Immunization) if
language were added to the replacement
measure to include IBD. CMS continues to
believe this measure is duplicative ofPQRS
Jkt 235001
PO 00000
Frm 00296
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.109</GPH>
Effective
Clinical
Care
N/AI
272
ebenthall on DSK5SPTVN1PROD with $$_JOB
N/AI
269
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
.,
"CC
""
=
~
f;ii;oo
0'~
z~
NQS
Domain
..
..
.,
""
....
00
Measure Title and Description¥
.=
=
67843
.,
.5
..c
;;.,
>
00
=
0 u
....
.,
""
'Sil
~
~
f;l;1
~
Q,
=
C>
""
~'E Co-'
~ .,
~ ~.,
===
=
.. .. t.. e
""
.,
= .=
=
0 ""
~~
~
Co-' ....
~
O'c.•
-Q,~
""
-=~~
0
#110, which is also more broadly
applicable. For this reason, CMS is
finalizing its proposal to remove this
measure from reporting in 2015 PQRS and
will work with the measure steward to
address the question of expanding the age
range ofPQRS #110.
Inflammatory Bowel Disease (IBD):
Preventive Care: Pneumococcal
Immunization: Percentage of patients aged
18 years and older with a diagnosis of
inflammatory bowel disease that had
pneumococcal vaccination administered or
previously received
N/A/295
Effective
Clinical
Care
ebenthall on DSK5SPTVN1PROD with $$_JOB
NIAI
296
N/A/297
VerDate Sep<11>2014
Effective
Clinical
Care
Effective
Clinical
Care
20:15 Nov 12, 2014
Commenters were supportive of the removal
of this measure and its replacement with
PQRS #Ill (Pneumonia Vaccination Status
for Older Adults) iflanguage were added to
the replacement measure to include IBD
patients and address age range differences
between the two measures as PQRS # 111
does not address the under 65 population.
CMS has confirmed with the measure
steward for PQRS #111 that the age range
can be adjusted. For this reason, CMS is
finalizing its proposal to remove this
measure from reporting in 2015 PQRS.
Hypertension: Use of Aspirin or Other
Antithrombotic Therapy: Percentage of
patients aged 30 through 90 years old with a
diagnosis of hypertension and are eligible
for aspirin or other antithrombotic therapy
who were prescribed aspirin or other
antithrombotic therapy
A steward has not been identified for this
measure, and for this reason CMS is
finalizing its proposal to remove this
measure from reporting in 2015 PQRS.
Hypertension: Complete Lipid Profile:
Percentage of patients aged 18 through 90
years old with a diagnosis of hypertension
who received a complete lipid profile within
60months
A steward has not been identified for this
measure, and for this reason CMS is
finalizing its proposal to remove this
measure from reporting in 2015 PQRS.
Hypertension: Urine Protein Test:
Percentage of patients aged 18 through 90
years old with a diagnosis of hypertension
who either have chronic kidney disease
diagnosis documented or had a urine protein
test done within 36 months.
Jkt 235001
PO 00000
Frm 00297
Fmt 4701
Sfmt 4725
AGA
X
ABIM
X
ABIM
X
ABIM
X
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.110</GPH>
N!AI
273
Effective
Clinical
Care
67844
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
.,
"CC
""
=
~
z~
NQS
Domain
..
..
.,
""
....
00
Measure Title and Description¥
.=
=
.,
;;.,
>
00
.5
=
0 u
....
.,
""
'Sil
~
~
f;l;1
~
N/A/298
N/A/299
N/A/300
ebenthall on DSK5SPTVN1PROD with $$_JOB
N/A/
301
VerDate Sep<11>2014
Effective
Clinical
Care
Effective
Clinical
Care
Effective
Clinical
Care
Effective
Clinical
Care
20:15 Nov 12, 2014
Commenters disagreed with the removal of
this measure noting that without it, there
will "no longer be a quality measure in
PQRS that assesses kidney function for
people at high risk of chronic kidney
disease." Unfortunately, these measures
cannot remain in the PQRS program
without a measure steward. Given a steward
has not been identified for this measure
CMS is finalizing its proposal to remove
this measure from reporting in 2015 PQRS.
Hypertension: Annual Serum Creatinine
Test: Percentage of patients aged 18
through 90 years old with a diagnosis of
hypertension who had a serum creatinine
test done within 12 months
A steward has not been identified for this
measure, and for this reason CMS is
finalizing its proposal to remove this
measure from reporting in 2015 PQRS.
Hypertension: Diabetes Mellitus
Screening Test: Percentage of patients aged
18 through 90 years old with a diagnosis of
hypertension who had a diabetes screening
test within 36 months
A steward has not been identified for this
measure, and for this reason CMS is
finalizing its proposal to remove this
measure from reporting in 2015 PQRS.
Hypertension: Blood Pressure Control:
Percentage of patients aged 18 through 90
years old with a diagnosis of hypertension
whose most recent blood pressure was
under control (< 140/90 mmHg)
Q,
=
C>
""
~'E Co-'
~ .,
~ ~.,
===
=
.. .. t.. e
""
.,
= .=
=
0 ""
~~
~
Co-' ....
~
ABIM
X
ABIM
X
ABIM
0
X
ABIM
O'c.•
-Q,~
""
-=~~
X
A steward has not been identified for this
measure, and for this reason CMS is
finalizing its proposal to remove this
measure from reporting in 2015 PQRS.
Hypertension: Low Density Lipoprotein
(LDL-C) Control: Percentage of patients
aged 18 through 90 years old with a
diagnosis of hypertension who had most
recent LDL cholesterol level nnder control
(at goal)
Commenters disagreed with the proposal to
remove this measure "until new measures
that are more consistent with new and
existing guidelines are put in place to
replace it." However, this measure is no
longer in accordance with new evidencebased clinical guidelines regarding lipid
Jkt 235001
PO 00000
Frm 00298
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.111</GPH>
f;ii;oo
0'~
..c
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
.,
"CC
""
=
~
f;ii;oo
0'~
z~
NQS
Domain
..
..
.,
""
....
00
Measure Title and Description¥
.=
=
.,
.5
..c
;;.,
>
00
=
0 u
....
.,
""
'Sil
~
~
f;l;1
~
N/A/302
2080/341
Effective
Clinical
Care
Efficiency
and Cost
Reduction
control. CMS understands the commenters'
concerns that removing measures may lead
to program gaps; however, it is a priority for
PQRS to ultimately increase the quality of
health care and this goal was at the forefront
of consideration for the removal of these
measures. For this reason, CMS is finalizing
its proposal to remove this measure from
reporting in 2015 PQRS.
Hypertension: Dietary and Physical
Activity Modifications Appropriately
Prescribed: Percentage of patients aged 18
through 90 years old with a diagnosis of
hypertension who received dietary and
physical activity counseling at least once
within 12 months
67845
Q,
=
C>
""
~'E Co-'
~ .,
===
=
.. .. t.. e
""
.,
= .=
=
0 ""
~~
~
Co-' ....
~
ABIM
~ ~.,
O'c.•
-Q,~
""
-=~~
0
X
A steward has not been identified for this
measure, and for this reason CMS is
finalizing its proposal to remove this
measure from reporting in 2015 PQRS.
Gap in HIV Medical Visits: Percentage of
patients, regardless of age, with a diagnosis
ofHIV who did not have a medical visit in
the last 6 months
HRSA
X
X
No comments were received regarding this
measure. CMS is finalizing its proposal to
remove this measure from reporting in 2015
PQRS.
Age-Related Macular Degeneration
(AMD): Dilated Macular Examination:
Percentage of patients aged 50 years and
older with a diagnosis of age-related
macular degeneration (AMD) who had a
dilated macular examination performed
which included documentation of the
presence or absence of macular thickening
or hemorrhage AND the level of macular
degeneration severity during one or more
office visits within 12 months
VerDate Sep<11>2014
Effective
Clinical
Care
20:15 Nov 12, 2014
Commenters disagreed with removal of this
measure, noting that removal based on a
"high-performance rate when EP reporting
within the PQRS program is low" may not
be appropriate. We have also received
strong comments and feedback from outside
stakeholders that this measure is still
relevant to its eligible professionals. Some
commenters note that the "high performance
rate" may be skewed and not accurately
reflect the existing gap addressed by this
measure. CMS agrees with commenters and
therefore is not finalizing its proposal to
Jkt 235001
PO 00000
Frm 00299
Fmt 4701
Sfmt 4725
AAO
X
E:\FR\FM\13NOR2.SGM
X
13NOR2
ER13NO14.112</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
0087/014
67846
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
=
...
...
=
...
"CC
~
fi;r:Ll
0'~
z~
NQS
Domain
....
r:Ll
Measure Title and Description¥
"'
~
~
g.
"'
= ~
=
... ~ ~~ Co-' = = e
=t: =
"' > ....
.s ... 0'=•
=
.5 r:Ll 'S'Ji
"' f;l;l
"'
..!': u
:.g.~
... = 0 ~~
u
... ...
~
~ = =
-=~~
"' 0
c.:l'"' ...
=
-
,.Q
-
bll
rr,
-
~
remove this measure from 2015 PQRS.
However, CMS continues to look for better
outcome measures, and as such this measure
may be considered for removal in a future
program year.
Perioperative Care: Selection of
Prophylactic Antibiotic- First OR
Second Generation Cephalosporin:
Percentage of surgical patients aged 18
years and older undergoing procedures with
the indications for a first OR second
generation cephalosporin prophylactic
antibiotic, who had an order for a first OR
second generation cephalosporin for
antimicrobial prophylaxis
Patient
Safety
VerDate Sep<11>2014
20:15 Nov 12, 2014
Some commenters disagreed with CMS'
proposal to remove this measure, noting
"disparate practice patterns among
clinicians when selecting the more
appropriate prophylactic antibiotic."
Furthermore, commenters note it might be
premature to remove a measure based on a
high-performance rate. CMS agrees with
commenters and therefore is not finalizing
its proposal to remove this measure from
2015 PQRS. However, CMS is fmalizing its
Jkt 235001
PO 00000
Frm 00300
Fmt 4701
Sfmt 4725
AMAPCPI
NCQA
X
X
AMAPCPI
NCQA
X
X
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.113</GPH>
Patient
Safety
0271/022
ebenthall on DSK5SPTVN1PROD with $$_JOB
0268/021
Commenters disagreed with CMS' proposal
to remove this measure, noting "it is
premature to remove a measure based on a
high-performance rate when the EP
reporting rate within the PQRS program is
low." CMS agrees with commenters that
removing this measure may negatively
impact providers' ability to report to PQRS
and therefore is not finalizing its proposal to
remove this measure from 2015 PQRS.
However, CMS is finalizing its proposal to
remove the Perioperative Care Measure
Group, and for this reason this measure will
only be reportable through claims and
registry for 2015 PQRS. CMS continues to
look for better outcome measures, and as
such this measure may be considered for
removal in a future program year.
Perioperative Care: Discontinuation of
Prophylactic Parenteral Antibiotics (NonCardiac Procedures): Percentage of noncardiac surgical patients aged 18 years and
older undergoing procedures with the
indications for prophylactic parenteral
antibiotics AND who received a
prophylactic parenteral antibiotic, who have
an order for discontinuation of prophylactic
parenteral antibiotics within 24 hours of
surgical end time
67847
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
=
...
...
=
...
"CC
~
fi;r:Ll
0'~
z~
NQS
Domain
....
r:Ll
Measure Title and Description¥
"'
~
~
g.
"'
= ~
=
... ~ ~~ Co-' = = e
=t: =
"' > ....
.s ... 0'=•
=
.5 r:Ll 'S'Ji
"' f;l;l
"'
..!': u
:.g.~
... = 0 ~~
u
... ...
~
~ = =
-=~~
"' 0
c.:l'"' ...
=
-
,.Q
-
bll
rr,
-
~
proposal to remove the Perioperative Care
Measure Group, and for this reason this
measure will only be reportable through
claims and registry for 2015 PQRS. CMS
continues to look for better outcome
measures, and as such this measure may be
considered for removal in a future program
year.
Perioperative Care: Venous
Thromboembolism (VTE) Prophylaxis
(When Indicated in ALL Patients):
Percentage of surgical patients aged 18
years and older undergoing procedures for
which VTE prophylaxis is indicated in all
patients, who had an order for Low
Molecular Weight Heparin (LMWH), LowDose Unfractionated Heparin (LDUH),
adjusted-dose warfarin, fondaparinux or
mechanical prophylaxis to be given within
24 hours prior to incision time or within 24
hours after surgery end time
Commenters disagreed with removal of this
measure noting that removal based on a
high-performance rate. CMS agrees with
commenters that removing this measure
may negatively impact providers' ability to
report to PQRS and therefore is not
finalizing its proposal to remove this
measure from 2015 PQRS. However, CMS
is finalizing its proposal to remove the
Perioperative Care Measure Group, and for
this reason this measure will only be
reportable through claims and registry for
2015 PQRS. CMS continues to look for
better outcome measures, and as such this
measure may be considered for removal in a
future program year.
Stroke and Stroke Rehabilitation:
Discharged on Antithrombotic Therapy:
Percentage of patients aged 18 years and
older with a diagnosis of ischemic stroke or
transient ischemic attack (TIA) who were
prescribed antithrombotic therapy at
discharge
Effective
Clinical
Care
Some commenters agreed while others
disagreed with CMS' proposal to remove
this measure due to this measure
representing a clinical concept that is
currently included within inpatient standard
of care to decrease risk of complications in
patients diagnosed with ischemic or
intracranial stroke when clinically indicated.
CMS agrees with commenters, and for this
reason CMS is not finalizing its proposal to
remove this measure from reporting for
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00301
Fmt 4701
Sfmt 4725
AMAPCPI
NCQA
X
X
AANI
X
X
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.114</GPH>
Patient
Safety
0325/032
ebenthall on DSK5SPTVN1PROD with $$_JOB
0239/023
67848
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
-=
:..
OS
fi;oo
0~
z~
:t
NQS
Domain
....
"'
rLl
Measure Title and Description¥
:..
"'
=
OS
"'
"'
::s
"'
c
= =~"'
!:1.
..Q
~
"'
.5 > .... ~
rLl
..!!! u
fool
~~
:..
.:!;l
u
'-':!
~
Q.o
~
~
0 :..
~~
=
....
c
:..
~
"'
:..
"'
=
OS
"'
"'
::s
~ .s e
oiE
:..Q,~
"' "' :..
;~e~.o
0
2015 PQRS. However, CMS continues to
look for better outcome measures, and as
such this measure may be considered for
removal in a future program year.
Stroke and Stroke Rehabilitation:
Anticoagulant Therapy Prescribed for
Atrial Fibrillation (AF) at Discharge:
Percentage of patients aged 18 years and
older with a diagnosis of ischemic stroke or
transient ischemic attack (TIA) with
documented permanent, persistent, or
paroxysmal atrial fibrillation who were
prescribed an anticoagulant at discharge
0241/033
Effective
Clinical
Care
0091/051
Effective
Clinical
Care
A steward has been identified for this
measure, and for this reason CMS is not
finalizing its proposal to remove this
measure from reporting in 2015 PQRS.
Chronic Obstructive Pulmonary Disease
(COPD): Inhaled Bronchodilator
Therapy: Percentage of patients aged 18
years and older with a diagnosis of COPD
and who have an FEV 1/FVC less than 60%
and have symptoms who were prescribed an
inhaled bronchodilator
AANI
X
American
Thoracic
Society
X
X
American
Thoracic
Society
X
X
A steward has been identified for this
measure, and for this reason CMS is not
finalizing its proposal to remove this
measure from reporting in 2015 PQRS.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00302
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.115</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
0102/052
Effective
Clinical
Care
Commenters disagreed with CMS' proposal
to remove this measures based on the
rationale that they represent clinical
concepts that are currently included within
inpatient standards of care to improve
patient outcomes for those diagnosed with
ischemic or intracranial stroke when
clinically indicated. Commenters maintain
that these clinical concepts are appropriate
for measurement at the individual physician
level in addition to the facility level to help
ensure the continuous care of stroke
patients. CMS agrees with commenters, and
for this reason CMS is not finalizing its
proposal to remove this measure from
reporting for 2015 PQRS. However, CMS
continues to look for better outcome
measures, and as such this measure may be
considered for removal in a future program
year.
Chronic Obstructive Pulmonary Disease
(COPD): Spirometry Evaluation:
Percentage of patients aged 18 years and
older with a diagnosis of COPD who had
spirometry evaluation results documented
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
-=
:..
OS
z~
0050/109
0566/140
NQS
Domain
Person and
CaregiverCentered
Experience
and
Outcomes
Effective
Clinical
Care
ebenthall on DSK5SPTVN1PROD with $$_JOB
05081146
Efficiency
and Cost
Reduction
N/A/147
Communic
ation and
Care
Coordinatio
VerDate Sep<11>2014
20:15 Nov 12, 2014
....
"'
rLl
Measure Title and Description¥
:..
"'
=
OS
"'
"'
::s
Osteoarthritis (OA): Function and Pain
Assessment: Percentage of patient visits for
patients aged 21 years and older with a
diagnosis of osteoarthritis (OA) with
assessment for function and pain
"'
c
= =~"'
!:1.
..Q
~
"'
.5 > .... ~
rLl
..!!! u
fool
~~
:..
.:!;l
u
AAOS
'-':!
~
Q.o
~
~
0 :..
~~
=
....
c
:..
~
"'
:..
"'
=
OS
"'
"'
::s
~ .s e
oiE
:..Q,~
"' "' :..
;~e~.o
0
X
A steward has been identified for this
measure, and for this reason CMS is not
finalizing its proposal to remove this
measure from reporting in 2015 PQRS.
Age-Related Macular Degeneration
(AMD): Counseling on Antioxidant
Supplement: Percentage of patients aged
50 years and older with a diagnosis of agerelated macular degeneration (AMD) or
their caregiver(s) who were counseled
within 12 months on the benefits and/or
risks of the Age-Related Eye Disease Study
(AREDS) formulation for preventing
progression of AMD
Commenters disagreed with removal of this
measure noting that removal based on a
"high-performance rate when EP reporting
within the PQRS program is low" may not
be appropriate. CMS agrees with
commenters, and for this reason CMS is not
finalizing its proposal to remove this
measure from reporting for 2015 PQRS.
However, CMS continues to look for better
outcome measures, and as such this measure
may be considered for removal in a future
program year.
Radiology: Inappropriate Use of
"Probably Benign" Assessment Category
in Mammography Screening: Percentage
of fmal reports for screening mammograms
that are classified as "probably benign"
Commenters disagreed with the removal of
this measure based on a rationale of a high
performance rate. Furthermore one
commenter notes "this measure is important
in that it ensures the integrity of the
complete mammography audit." CMS
agrees with commenters, and for this reason
CMS is not finalizing its proposal to remove
this measure from reporting for 2015 PQRS.
However, CMS continues to look for better
outcome measures, and as such this measure
may be considered for removal in a future
program year.
Nuclear Medicine: Correlation with
Existing Imaging Studies for All Patients
Undergoing Bone Scintigraphy:
Percentage of final reports for all patients,
Jkt 235001
PO 00000
Frm 00303
Fmt 4701
AAO
X
X
AC
Radiology
lAMAPCPI
X
X
SNMMI
X
X
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.116</GPH>
fi;oo
0~
:t
67849
67850
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
-=
:..
OS
fi;oo
0~
z~
:t
NQS
Domain
n
....
"'
rLl
Measure Title and Description¥
:..
"'
=
OS
"'
"'
::s
"'
c
= =~"'
!:1.
..Q
~
"'
.5 > .... ~
rLl
..!!! u
fool
~~
:..
.:!;l
u
'-':!
~
Q.o
~
~
0 :..
~~
=
....
c
:..
~
"'
:..
"'
=
OS
"'
"'
::s
~ .s e
oiE
:..Q,~
"' "' :..
;~e~.o
0
regardless of age, undergoing bone
scintigraphy that include physician
documentation of correlation with existing
relevant imaging studies (for example, xray, MRI, CT, etc.) that were performed.
A steward has been identified for this
measure, and as a result CMS is not
finalizing its proposal to remove this
measure from reporting in 2015 PQRS.
Coronary Artery Bypass Graft (CABG):
Surgical Re-Exploration: Percentage of
patients aged 18 years and older undergoing
isolated CABG surgery who require a return
to the operating room (OR) during the
current hospitalization for mediastinal
bleeding with or without tamponade, graft
occlusion, valve dysfunction, or other
cardiac reason
AQA
Adopted/
173
ebenthall on DSK5SPTVN1PROD with $$_JOB
0643/243
VerDate Sep<11>2014
Effective
Clinical
Care
Community
/Population
Health
Effective
Clinical
Care
20:15 Nov 12, 2014
Commenters disagreed with removal of this
measure noting that removal based on a
high-performance rate. CMS agrees with
commenters that this may negatively impact
the ability of certain specialties to report
PQRS, and for this reason CMS is not
finalizing its proposal to remove this
measure from reporting for 2015 PQRS.
However, CMS continues to look for better
outcome measures, and as such this measure
may be considered for removal in a future
program year.
Preventive Care and Screening:
Unhealthy Alcohol Use- Screening:
Percentage of patients aged 18 years and
older who were screened for unhealthy
alcohol use using a systematic screening
method within 24 months
STS
PO 00000
Frm 00304
Fmt 4701
X
X
X
AMAPCPI
A measure steward has been identified for
this measure, and as such CMS is not
finalizing its proposal to remove this
measure from reporting in 2015 PQRS.
Cardiac Rehabilitation Patient Referral
from an Outpatient Setting: Percentage of
patients evaluated in an outpatient setting
who within the previous 12 months have
experienced an acute myocardial infarction
(MI), coronary artery bypass graft (CABG)
surgery, a percutaneous coronary
intervention (PCI), cardiac valve surgery, or
cardiac transplantation, or who have chronic
stable angina (CSA) and have not already
participated in an early outpatient cardiac
rehabilitation/secondary prevention (CR)
program for the qualifying event/diagnosis
Jkt 235001
X
Sfmt 4725
ACCF
AHA
E:\FR\FM\13NOR2.SGM
X
13NOR2
ER13NO14.117</GPH>
0115/168
67851
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
=
...
...
=
...
"CC
~
fi;r:Ll
0'~
z~
NQS
Domain
....
r:Ll
Measure Title and Description¥
"'
~
~
g.
"'
= ~
=
... ~ ~~ Co-' = = e
=t: =
"' > ....
.s ... 0'=•
=
.5 r:Ll 'S"''Ji
"'
..!': u
:.g.~
f;l;l ~~
... = 0 u
... ...
~
~ = =
-=~~
"' 0
c.:l'"' ...
=
-
,.Q
-
bll rr,
-
~
who were referred to a CR program
Commenters disagreed with CMS' proposal
to remove this measure, suggesting that
"while the clinical condition may initiate in
the inpatient setting, the clinical process
being measured is limited to the outpatient
setting and would therefore add clinical
value to outpatient care of the cardiac
rehabilitation patient." Further, commenters
note that there is "clear evidence that
processes to improve referral of eligible
patients to cardiac rehabilitation result in
improved cardiac rehabilitation participation
rates and improved patient outcomes." CMS
agrees with the commenters, and for this
reason CMS is not finalizing its proposal to
remove this measure from reporting for
2015 PQRS. However, CMS continues to
look for better outcome measures, and as
such this measure may be considered for
removal in a future program year.
Statin Therapy at Discharge after Lower
Extremity Bypass (LEB): Percentage of
patients aged 18 years and older undergoing
infra-inguinal lower extremity bypass who
are prescribed a statin medication at
discharge
Communic
ation and
Care
Coordinatio
n
VerDate Sep<11>2014
20:15 Nov 12, 2014
Commenters disagreed with the proposed
removal of this measure on the basis that the
measure represents a current standard of
care. CMS agrees with commenters, and for
this reason CMS is not finalizing its
proposal to remove this measure from
reporting for 2015 PQRS. However, CMS
continues to look for better outcome
measures, and as such this measure may be
considered for removal in a future program
year.
Referral for Otologic Evaluation for
Patients with Acute or Chronic Dizziness:
Percentage of patients aged birth and older
referred to a physician (preferably a
physician specially trained in disorders of
the ear) for an otologic evaluation
subsequent to an audiologic evaluation after
presenting with acute or chronic dizziness
svs
AQC
X
X
X
Commenters disagreed with CMS' proposal
to remove this measure with the rationale
that it represents a clinical concept that is
common practice in order to provide
effective treatment for patients.
Commenters request reconsideration for CY
2015 to ensure audiologists have enough
clinically-relevant measures to report. For
Jkt 235001
PO 00000
Frm 00305
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.118</GPH>
Effective
Clinical
Care
N/A/
261
ebenthall on DSK5SPTVN1PROD with $$_JOB
N/A/
257
67852
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
"0
...'
'~
"
0'~
z~
NQS
Domain
...
....
~
Measure Title and Description¥
...
'"'
=
...
"'
...
"'
5
·;
u
~
>
~
u
....'
'"
"'
'Sii
~
~
r-1
~
N/A/276
N/A/277
N/A/278
ebenthall on DSK5SPTVN1PROD with $$_JOB
N/A/279
N/A/335
VerDate Sep<11>2014
Effective
Clinical
Care
Effective
Clinical
Care
Effective
Clinical
Care
Effective
Clinical
Care
Patient
Safety
20:15 Nov 12, 2014
this reason, CMS is not finalizing its
proposal to remove this measure from
reporting in 2015 PQRS.
Sleep Apnea: Assessment of Sleep
Symptoms: Percentage of visits for patients
aged 18 years and older with a diagnosis of
obstructive sleep apnea that includes
documentation of an assessment of sleep
symptoms, including presence or absence of
snoring and daytime sleepiness
A steward has been identified for this
measure and for this reason CMS is not
finalizing its proposal to remove this
measure from reporting in 2015 PQRS.
Sleep Apnea: Severity Assessment at
Initial Diagnosis: Percentage of patients
aged 18 years and older with a diagnosis of
obstructive sleep apnea who had an apnea
hypopnea index (AHI) or a respiratory
disturbance index (RDI) measured at the
time of initial diagnosis
A steward has been identified for this
measure, and for this reason CMS is not
finalizing its proposal to remove this
measure from reporting in 2015 PQRS.
Sleep Apnea: Positive Airway Pressure
Therapy Prescribed: Percentage of
patients aged 18 years and older with a
diagnosis of moderate or severe obstructive
sleep apnea who were prescribed positive
airway pressure therapy
A steward has been identified for this
measure, and for this reason CMS is not
finalizing its proposal to remove this
measure from reporting in 2015 PQRS.
Sleep Apnea: Assessment of Adherence to
Positive Airway Pressure Therapy:
Percentage of visits for patients aged 18
years and older with a diagnosis of
obstructive sleep apnea who were
prescribed positive airway pressure therapy
who had documentation that adherence to
positive airway pressure therapy was
objectively measured
A steward has been identified for this
measure, and for this reason CMS is not
finalizing its proposal to remove this
measure from reporting in 2015 PQRS.
Maternity Care: Elective Delivery or
Early Induction Without Medical
Indication at 2:: 37 and< 39 Weeks:
Percentage of patients, regardless of age,
Jkt 235001
PO 00000
Frm 00306
Fmt 4701
Sfmt 4725
~'E
.;s
0'"'
~~
~
t;.!) ....
= ~~"'
'"'
t;.!)
...
"'
~~ ~
0'=•
'"'CI.~
'"'
-=~~
0
'"
=
= ...' ... ...
"'
...
~
AASM/
AMAPCPI
X
AASM/
AMAPCPI
X
AASM/
AMAPCPI
X
AASM/
AMAPCPI
X
AMAPCPI
E:\FR\FM\13NOR2.SGM
X
13NOR2
ER13NO14.119</GPH>
[;;;;~
Q.
"'
C>
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
proposals to change the way in which
previously established measures in the
PO 00000
Frm 00307
Fmt 4701
Sfmt 4700
PQRS will be reported beginning in
2015 (79 FR 40441).
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.120</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
In Table 56, we provide our responses
and final decisions related to our
67853
67854
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 56: Existing Individual Quality Measures and Those Included in Measures
Groups for the PQRS for Which Measure Reporting Updates Will Be Effective Beginning in 2015
Diabetes: Low Density Lipoprotein (LDLC) Control (<100 mg/Dl: Percentage of
patients 18-7 5 years of age with diabetes
whose LDL-C was adequately controlled(<
100 mg/dL) during the measurement period
163
v3
Effective
Clinical
Care
ebenthall on DSK5SPTVN1PROD with $$_JOB
006
7/0
06
010
5/0
VerDate Sep<11>2014
Effective
Clinical
Care
128
v3
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that not all eligible professionals have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. CMS appreciates the
commenters' concerns and believes that
removal of the claims-based reporting option
will not negatively impact a significant
number of providers reporting these
measures. CMS also received comments
supporting inclusion of the measure in the
Shared Savings Program CAD Composite
measure but with composite measure testing
and NQF review. Therefore, CMS is
finalizing its proposal to remove the claimsbased reporting option for this measure in
2015 PQRS as part of its goal to lower the
data error rate and decrease provider burden.
CMS will not fmalize adding this measure in
the Shared Savings Program CAD
Effective
Clinical
20:15 Nov 12, 2014
and
Jkt 235001
PO 00000
Frm 00308
Fmt 4701
Sfmt 4725
NCQA
AMAPCPI
ACCF
AHA
NCQA
E:\FR\FM\13NOR2.SGM
MU2
Million
Hearts
X
X
X
X
13NOR2
X
ACO
MU2
ER13NO14.121</GPH>
006
4/0
02
Commenters expressed concern with
maintaining this measure in PQRS for EHR
reporting only for the "sake of alignment
with the EHR Incentive Program especially
in the face of changing [clinical] evidence."
However, due to our desire to align with the
EHR Incentive Program, CMS will not make
changes to EHR measures until the EHR
Incentive Program is able to change this
measure. CMS understands commenters'
concerns and will track these issues for future
program years when changes are possible.
CMS is finalizing its proposal to make this
measure reportable in 2015 PQRS through
EHR
Coronary Artery Disease (CAD):
Antiplatelet Therapy: Percentage of
patients aged 18 years and older with a
diagnosis of coronary artery disease (CAD)
seen within a 12 month period who were
prescribed aspirin or clopidogrel
67855
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
"0
9
"'
""'
..,
=
-.rLJ.
0:
r.o.~
rLJ. "'
z~
u~
0101 ~~
09
""'
~
0:
National
Quality
Strategy
Domain
Care
=
"'
..,
""'
0:
Measure Title and Description¥
older who were diagnosed with major
depression and treated with antidepressant
medication, and who remained on
antidepressant medication treatment. Two
rates are reported:
a. Percentage of patients who remained on an
antidepressant medication for at least 84 days
(12 weeks).
b. Percentage of patients who remained on an
antidepressant medication for at least 180
days (6 months).
"'
~
£
~
~~ "' .., &.s e
o.s .., = "'= ~
""' =- a. t:
=
~ ""' 0: =
~
..= =- =
~::!
,.Q
rLJ.
..,
-~
t'
.§
.s > "Q
u rLJ.
u ~
"'
..,
1-'.S ~~
'i
bJl
0~~
CMS is finalizing its proposal to change the
reporting option ofPQRS #9 to ERR-only
reporting as part of its efforts to align with
the EHR Incentive Program. PQRS would
otherwise propose to remove this measure
from PQRS, as it is a process measure that is
analytically challenging to report.
Diabetic Retinopathy: Documentation of
Presence or Absence of Macular Edema
and Level of Severity of Retinopathy:
Percentage of patients aged 18 years and
older with a diagnosis of diabetic retinopathy
who had a dilated macular or fundus exam
performed which included documentation of
the level of severity of retinopathy and the
presence or absence of macular edema during
one or more office visits within 12 months
008
8/0
18
Effective
Clinical
Care
Effective
Clinical
Care
One commenter disagreed with the removal
of this measure. CMS initially wanted to
propose removal of this measure as eligible
professionals are consistently meeting
performance on this measure with
performance rates close to 100%. However,
due to our desire to align with the EHR
Incentive Program, under which this measure
is also available for reporting in 2015, CMS
proposed to maintain this measure in PQRS
for EHR reporting only, removing all other
reporting options, until the EHR Incentive
Program can change this measure. CMS is
finalizing removal of this measure from
reporting for 2015 PQRS for all other
reporting options.
Coronary Artery Bypass Graft (CABG):
Use oflnternal Mammary Artery (IMA)
in Patients with Isolated CABG Surgery:
Percentage of patients aged 18 years and
older undergoing isolated CABG surgery
who received an IMA graft
AMAPCPI
NCQA
STS
X
X
MU2
X
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that not all eligible professionals have the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00309
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.122</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
013
4/0
43
167
v3
67856
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
"0
-.rLJ.
0:
r.o.~
rLJ. "'
z~
u~
0101
~~
""'
~
0:
National
Quality
Strategy
Domain
Effective
Clinical
Care
037
8/0
68
ebenthall on DSK5SPTVN1PROD with $$_JOB
037
7/0
67
Effective
Clinical
Care
VerDate Sep<11>2014
20:15 Nov 12, 2014
=
"'
..,
""'
0:
Measure Title and Description¥
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. CMS appreciates the
commenters' concerns and believes that
removal of the claims-based reporting option
will not negatively impact a significant
number of providers reporting these
measures. Therefore, CMS is finalizing its
proposal to remove the claims-based
reporting option for this measure in 2015
PQRS as part of its goal to lower the data
error rate and decrease provider burden.
Hematology: Myelodysplastic Syndrome
(MDS) and Acute Leukemias: Baseline
Cytogenetic Testing Performed on Bone
Marrow: Percentage of patients aged 18
years and older with a diagnosis of
myelodysplastic syndrome (MDS) or an
acute leukemia who had baseline cytogenetic
testing performed on bone marrow
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that not all eligible professionals have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. CMS appreciates the
commenters' concerns and believes that
removal of the claims-based reporting option
will not negatively impact a significant
number of providers reporting these
measures. Therefore, CMS is finalizing its
proposal to remove the claims-based
reporting option for this measure in 2015
PQRS as part of its goal to lower the data
error rate and decrease provider burden.
Hematology: Myelodysplastic Syndrome
(MDS): Documentation oflron Stores in
Patients Receiving Erythropoietin
Therapy: Percentage of patients aged 18
years and older with a diagnosis of
myelodysplastic syndrome (MDS) who are
receiving erythropoietin therapy with
documentation of iron stores within 60 days
prior to initiating erythropoietin therapy
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that not all eligible professionals have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. CMS appreciates the
commenters' concerns and believes that
removal of the claims-based reporting option
will not negatively impact a significant
Jkt 235001
PO 00000
Frm 00310
Fmt 4701
Sfmt 4725
"'
~
£
~
~~ "' .., &.s e
o.s .., = "'= ~
""' =- a. t:
=
~ ""' 0: =
~
..= =- =
~::!
,.Q
rLJ.
..,
-~
t'
.§
.s > "Q
u rLJ.
u ~
AMAPCPI
ASH
..,
1-'.S ~~
'i
bJl
0~~
X
AMAPCPI
ASH
"'
X
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.123</GPH>
9
"'
""'
..,
=
67857
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
'0
0:
""'
~
"'
""'
.._oo.
=
0:
"'
ro.~
rLJ. "'
z~
Ul'o1
0'0'
~~
National
Quality
Strategy
Domain
Effective
Clinical
Care
037
910
70
ebenthall on DSK5SPTVN1PROD with $$_JOB
038
0/0
69
Effective
Clinical
Care
039
5
/08
4
Effective
Clinical
Care
VerDate Sep<11>2014
20:15 Nov 12, 2014
..=
rLJ.
"'
""'
=
0:
"'
Measure Title and Description¥
number of providers reporting these
measures. Therefore, CMS is finalizing its
proposal to remove the claims-based
reporting option for this measure in 2015.
Hematology: Multiple Myeloma:
Treatment with Bisphosphonates:
Percentage of patients aged 18 years and
older with a diagnosis of multiple myeloma,
not in remission, who were prescribed or
received intravenous bisphosphonate therapy
within the 12-month reporting period
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that not all eligible professionals have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. CMS appreciates the
commenters' concerns and believes that
removal of the claims-based reporting option
will not negatively impact a significant
number of providers reporting these
measures. Therefore, CMS is finalizing its
proposal to remove the claims-based
reporting option for this measure in 2015.
Hematology: Chronic Lymphocytic
Leukemia (CLL): Baseline Flow
Cytometry: Percentage of patients aged 18
years and older seen within a 12 month
reporting period with a diagnosis of chronic
lymphocytic leukemia (CLL) made at any
time during or prior to the reporting period
who had baseline flow cytometry studies
performed and documented in the chart
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that not all eligible professionals have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. CMS appreciates the
commenters' concerns and believes that
removal ofthe claims-based reporting option
will not negatively impact a significant
number of providers reporting these
measures. Therefore, CMS is finalizing its
proposal to remove the claims-based
reporting option for this measure in 2015.
Hepatitis C: Ribonucleic Acid (RNA)
Testing Before Initiating Treatment:
Percentage of patients aged 18 years and
older with a diagnosis of chronic hepatitis C
who started antiviral treatment within the 12
month reporting period for whom
quantitative hepatitis C virus (HCV) RNA
Jkt 235001
PO 00000
Frm 00311
Fmt 4701
Sfmt 4725
"'
.§
~
"'
u
.5I
-~
~
>
~
AMAPCPI
ASH
AMAPCPI
ASH
""'
.~
~
~
0~
~ t
=
bJ)
Q
~d ~lS
"'Q
~
Q
0~~
X
X
AGA
E:\FR\FM\13NOR2.SGM
£
~
&.e e
""' "' - t: f
=
0: =
"' =- ..= =-
"'
~~ "'
"'
X
13NOR2
ER13NO14.124</GPH>
-
8
67858
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
9
"'
""'
..,
=
-.rLJ.
0:
r.o.~
rLJ. "'
z~
u~
0101
~~
"0
0:
""'
~
National
Quality
Strategy
Domain
=
"'
..,
""'
0:
Measure Title and Description¥
testing was performed within 12 months
prior to initiation of antiviral treatment
"'
~
£
bJl ~
~~ "' .., &.s e
o.s .., = a. t: ~
""' ==
~ ""' 0: =
"'= ~
..= =- =
~::!
,.Q
rLJ.
..,
-~
t'
.§
.s > "Q
u rLJ.
u ~
"'
..,
1-'.S ~~
'i
0~~
While several comments were concerned
with the removal of reporting options for
some measures, CMS is finalizing its
proposal to make this individual measure
reportable via measures groups-only to lessen
the burden of eligible professionals reporting
individual measures based on the current
requirement of nine measures over three
domains. While removing reporting options
could be seen as increasing burden for
eligible professionals, as they have fewer
choices to report this measure, we do not
believe this is the case with reporting via
measures groups. For example, an individual
eligible professional reporting via a measures
group only need to report on a minimum of 6
measures rather than a minimum of 9
measures covering 3 NQS domains, as is the
case with reporting individual measures.
Hepatitis C: HCV Genotype Testing Prior
to Treatment: Percentage of patients aged
18 years and older with a diagnosis of
chronic hepatitis C who started antiviral
treatment within the 12 month reporting
period for whom hepatitis C virus (HCV)
genotype testing was performed within 12
months prior to initiation of antiviral
treatment
Effective
Clinical
Care
039
8/0
87
Effective
Clinical
Care
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00312
Fmt 4701
Sfmt 4725
AGA
X
AGA
X
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.125</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
039
6
/08
5
While several comments were concerned
with the removal of reporting options for
some measures, CMS is finalizing its
proposal to make this individual measure
reportable via measures groups-only to lessen
the burden of eligible professionals reporting
individual measures based on the current
requirement of nine measures over three
domains. While removing reporting options
could be seen as increasing burden for
eligible professionals, as they have fewer
choices to report this measure, we do not
believe this is the case with reporting via
measures groups. For example, an individual
eligible professional reporting via a measures
group only need to report on a minimum of 6
measures rather than a minimum of 9
measures covering 3 NQS domains, as is the
case with reporting individual measures
Hepatitis C: Hepatitis C Virus (HCV)
Ribonucleic Acid (RNA) Testing Between
4-12 Weeks After Initiation of Treatment:
Percentage of patients aged 18 years and
older with a diagnosis of chronic hepatitis C
who are receiving antiviral treatment for
67859
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
"0
9
"'
""'
..,
=
-.rLJ.
0:
r.o.~
rLJ. "'
z~
u~
0101 ~~
""'
~
0:
National
Quality
Strategy
Domain
=
"'
..,
""'
0:
Measure Title and Description¥
whom quantitative hepatitis C virus (HCV)
RNA testing was performed between 4-12
weeks after the initiation of antiviral
treatment
"'
~
£
~
~~ "' .., &.s e
o.s .., = "'= ~
""' =- a. t:
=
~ ""' 0: =
~
..= =- =
~::!
,.Q
rLJ.
..,
-~
t'
.§
.s > "Q
u rLJ.
u ~
"'
..,
1-'.S ~~
'i
bJl
0~~
While several comments were concerned
with the removal of reporting options for
some measures, CMS is finalizing its
proposal to make this individual measure
reportable via measures groups-only to lessen
the burden of eligible professionals reporting
individual measures based on the current
requirement of nine measures over three
domains. While removing reporting options
could be seen as increasing burden for
eligible professionals, as they have fewer
choices to report this measure, we do not
believe this is the case with reporting via
measures groups. For example, an individual
eligible professional reporting via a measures
group only need to report on a minimum of 6
measures rather than a minimum of 9
measures covering 3 NQS domains, as is the
case with reporting individual measures
Prostate Cancer: Avoidance of Overuse of
Bone Scan for Staging Low Risk Prostate
Cancer Patients: Percentage of patients,
regardless of age, with a diagnosis of prostate
cancer at low risk of recurrence receiving
interstitial prostate brachytherapy, OR
external beam radiotherapy to the prostate,
OR radical prostatectomy, OR cryotherapy
who did not have a bone scan performed at
any time since diagnosis of prostate cancer
039
0
/10
4
VerDate Sep<11>2014
129
v3
Efficiency
and Cost
Reduction
Effective
Clinical
Care
20:15 Nov 12, 2014
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that not all eligible professionals have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. CMS appreciates the
commenters' concerns and believes that
removal of the claims-based reporting option
will not negatively impact a significant
number of providers reporting these
measures. Therefore, CMS is finalizing its
proposal to remove the claims-based
reporting option for this measure in 2015.
Prostate Cancer: Adjuvant Hormonal
Therapy for High Risk Prostate Cancer
Patients: Percentage of patients, regardless
of age, with a diagnosis of prostate cancer at
high or very high risk of recurrence receiving
external beam radiotherapy to the prostate
who were prescribed adjuvant hormonal
therapy (GnRH [gonadotropin-releasing
Jkt 235001
PO 00000
Frm 00313
Fmt 4701
Sfmt 4725
AMAPCPI
X
AMAPCPI
X
E:\FR\FM\13NOR2.SGM
X
13NOR2
MU2
ER13NO14.126</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
038
9
/10
2
67860
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
"0
9
"'
""'
..,
=
-.rLJ.
0:
r.o.~
rLJ. "'
z~
u~
0101 ~~
""'
~
0:
National
Quality
Strategy
Domain
=
"'
..,
""'
0:
Measure Title and Description¥
hormone] agonist or antagonist)
"'
~
£
~
~~ "' .., &.s e
o.s .., = "'= ~
""' =- a. t:
=
~ ""' 0: =
~
..= =- =
~::!
,.Q
rLJ.
..,
-~
t'
.§
.s > "Q
u rLJ.
u ~
"'
..,
1-'.S ~~
'i
bJl
0~~
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that not all eligible professionals have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. CMS appreciates the
commenters' concerns and believes that
removal of the claims-based reporting option
will not negatively impact a significant
number of providers reporting these
measures. Therefore, CMS is finalizing its
proposal to remove the claims-based
reporting option for this measure in 2015.
Adult Major Depressive Disorder (MDD):
Suicide Risk Assessment: Percentage of
patients aged 18 years and older with a
diagnosis of major depressive disorder
(MDD) with a suicide risk assessment
completed during the visit in which a new
diagnosis or recurrent episode was identified
ebenthall on DSK5SPTVN1PROD with $$_JOB
005
4
/10
8
VerDate Sep<11>2014
161
v3
Effective
Clinical
Care
Effective
Clinical
Care
20:15 Nov 12, 2014
CMS is finalizing its proposal to change the
reporting option ofPQRS #107 to EHR-only
reporting as part of its efforts to align with
the EHR Incentive Program when PQRS
would otherwise propose to remove this
measure from PQRS, as it is a process
measure that is analytically challenging to
report. PQRS will keep this measure as EHRreportable until the EHR Incentive Program
is able to change this measure.
Rheumatoid Arthritis (RA): Disease
Modifying Anti-Rheumatic Drug
(DMARD) Therapy: Percentage of patients
aged 18 years and older who were diagnosed
with RA and were prescribed, dispensed, or
administered at least one ambulatory
prescription for a disease-modifying antirheumatic drug (DMARD)
While several comments were concerned
with the removal of reporting options for
some measures, CMS is finalizing its
proposal to make this individual measure
reportable via measures groups-only to lessen
the burden of eligible professionals reporting
individual measures based on the current
requirement of nine measures over three
domains. While removing reporting options
could be seen as increasing burden for
eligible professionals, as they have fewer
choices to report this measure, we do not
believe this is the case with reporting via
measures groups. For example, an individual
Jkt 235001
PO 00000
Frm 00314
Fmt 4701
Sfmt 4725
AMAPCPI
X
NCQA
E:\FR\FM\13NOR2.SGM
MU2
X
13NOR2
ER13NO14.127</GPH>
010
4/1
07
67861
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
'0
.._oo.
=
0:
"'
ro.~
rLJ. "'
z~
Ul'o1
0'0' ~~
""'
~
0:
National
Quality
Strategy
Domain
Effective
Clinical
Care
AQ
A
Ad
opt
ed
/12
2
ebenthall on DSK5SPTVN1PROD with $$_JOB
166
8
/12
1
Effective
Clinical
Care
040
5
/16
0
VerDate Sep<11>2014
52v
3
Effective
Clinical
Care
20:15 Nov 12, 2014
-
..=
rLJ.
"'
""'
=
0:
"'
Measure Title and Description¥
eligible professional reporting via a measures
group only need to report on a minimum of 6
measures rather than a minimum of 9
measures covering 3 NQS domains, as is the
case with reporting individual measures
Adult Kidney Disease: Laboratory Testing
(Lipid Profile): Percentage of patients aged
18 years and older with a diagnosis of
chronic kidney disease (CKD) (stage 3, 4, or
5, not receiving Renal Replacement Therapy
[RRT]) who had a fasting lipid profile
performed at least once within a 12-month
period
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that not all eligible professionals have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. CMS appreciates the
commenters' concerns and believes that
removal of the claims-based reporting option
will not negatively impact a significant
number of providers reporting these
measures. Therefore, CMS is finalizing its
proposal to remove the claims-based
reporting option for this measure in 20 15.
Adult Kidney Disease: Blood Pressure
Management: Percentage of patient visits
for those patients aged 18 years and older
with a diagnosis of chronic kidney disease
(CKD) (stage 3, 4, or 5, not receiving Renal
Replacement Therapy [RRT]) with a blood
pressure< 140/90 mmHg OR 2: 140/90
mmHg with a documented plan of care
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that not all eligible professionals have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. CMS appreciates the
commenters' concerns and believes that
removal of the claims-based reporting option
will not negatively impact a significant
number of providers reporting these
measures. Therefore, CMS is finalizing its
proposal to remove the claims-based
reporting option for this measure in 20 15.
HIV/AIDS: Pneumocystis Jiroveci
Pneumonia (PCP) Prophylaxis: Percentage
of patients aged 6 weeks and older with a
diagnosis of HIVIAIDS who were prescribed
Pneumocystis Jiroveci Pneumonia (PCP)
prophylaxis
Jkt 235001
PO 00000
Frm 00315
Fmt 4701
Sfmt 4725
"'
.§
~
"'
u
.5I
-~
~
>
~
""'
.~
~
~
£
~
&.e e
""' "' - t: f
=
0: =
"' =- ..= =-
=
"'
~~ "'
"'
0~
~ t
bJ)
Q
~d ~lS
"'Q
~
Q
0~~
RPA
X
X
RPA
X
X
AQA
X
MU2
NCQA
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.128</GPH>
8
"'
""'
67862
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
"0
9
"'
""'
..,
=
-.rLJ.
0:
r.o.~
rLJ. "'
z~
u~
0101
~~
""'
~
0:
=
"'
..,
""'
0:
Measure Title and Description¥
"'
~
£
~
~~ "' .., &.s e
o.s .., = "'= ~
""' =- a. t:
=
~ ""' 0: =
~
..= =- =
~::!
,.Q
rLJ.
National
Quality
Strategy
Domain
..,
-~
t'
.§
.s > "Q
u rLJ.
u ~
"'
..,
1-'.S ~~
'i
bJl
0~~
While several comments were concerned
with the removal of reporting options for
some measures, CMS is finalizing its
proposal to make this individual measure
reportable via measures groups-only to lessen
the burden of eligible professionals reporting
individual measures based on the current
requirement of nine measures over three
domains. While removing reporting options
could be seen as increasing burden for
eligible professionals, as they have fewer
choices to report this measure, we do not
believe this is the case with reporting via
measures groups. For example, an individual
eligible professional reporting via a measures
group only need to report on a minimum of 6
measures rather than a minimum of 9
measures covering 3 NQS domains, as is the
case with reporting individual measures
Rheumatoid Arthritis (RA): Tuberculosis
Screening: Percentage of patients aged 18
years and older with a diagnosis of
rheumatoid arthritis (RA) who have
documentation of a tuberculosis (TB)
screening performed and results interpreted
within 6 months prior to receiving a first
course of therapy using a biologic diseasemodifYing anti-rheumatic drug (DMARD)
Effective
Clinical
Care
AQ
A
Ad
opt
ed/
177
Effective
Clinical
Care
While several comments were concerned
with the removal of reporting options for
some measures, CMS is finalizing its
proposal to make this individual measure
reportable via measures groups-only to lessen
the burden of eligible professionals reporting
individual measures based on the current
requirement of nine measures over three
domains. While removing reporting options
could be seen as increasing burden for
eligible professionals, as they have fewer
choices to report this measure, we do not
believe this is the case with reporting via
measures groups. For example, an individual
eligible professional reporting via a measures
group only need to report on a minimum of 6
measures rather than a minimum of 9
measures covering 3 NQS domains, as is the
case with reporting individual measures
Rheumatoid Arthritis (RA): Periodic
Assessment of Disease Activity: Percentage
of patients aged 18 years and older with a
diagnosis of rheumatoid arthritis (RA) who
have an assessment and classification of
disease activity within 12 months
AC
Rheumat
ology
X
AQA
AC
Rheumat
ology
X
AQA
While several comments were concerned
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00316
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.129</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
AQ
A
Ad
opt
ed/
176
67863
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
"0
9
"'
""'
..,
=
-.rLJ.
0:
r.o.~
rLJ. "'
z~
u~
0101
~~
""'
~
0:
National
Quality
Strategy
Domain
Effective
Clinical
Care
AQ
A
Ad
opt
ed
/18
0
Effective
Clinical
Care
"'
..,
""'
0:
Measure Title and Description¥
with the removal of reporting options for
some measures. CMS is finalizing its
proposal to make this individual measure
reportable via measures groups-only to lessen
the burden of eligible professionals reporting
individual measures based on the current
requirement of nine measures over three
domains. While removing reporting options
could be seen as increasing burden for
eligible professionals, as they have fewer
choices to report this measure, we do not
believe this is the case with reporting via
measures groups. For example, an individual
eligible professional reporting via a measures
group only need to report on a minimum of 6
measures rather than a minimum of 9
measures covering 3 NQS domains, as is the
case with reporting individual measures
Rheumatoid Arthritis (RA): Assessment
and Classification of Disease Prognosis:
Percentage of patients aged 18 years and
older with a diagnosis of rheumatoid arthritis
(RA) who have an assessment and
classification of disease prognosis at least
once within 12 months
While several comments were concerned
with the removal of reporting options for
some measures, CMS is finalizing its
proposal to make this individual measure
reportable via measures groups-only to lessen
the burden of eligible professionals reporting
individual measures based on the current
requirement of nine measures over three
domains. While removing reporting options
could be seen as increasing burden for
eligible professionals, as they have fewer
choices to report this measure, we do not
believe this is the case with reporting via
measures groups. For example, an individual
eligible professional reporting via a measures
group only need to report on a minimum of 6
measures rather than a minimum of 9
measures covering 3 NQS domains, as is the
case with reporting individual measures
Rheumatoid Arthritis (RA):
Glucocorticoid Management: Percentage of
patients aged 18 years and older with a
diagnosis of rheumatoid arthritis (RA) who
have been assessed for glucocorticoid use
and, for those on prolonged doses of
prednisone 2: 10 mg daily (or equivalent)
with improvement or no change in disease
activity, documentation of glucocorticoid
management plan within 12 months
"'
~
£
~
~~ "' .., &.s e
o.s .., = "'= ~
""' =- a. t:
=
~ ""' 0: =
~
..= =- =
~::!
,.Q
..,
-~
t'
.§
.s > "Q
u rLJ.
u ~
"'
..,
1-'.S ~~
'i
bJl
0~~
AC
Rheumat
ology
X
AQA
AC
Rheumat
ology
X
AQA
While several comments were concerned
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00317
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.130</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
AQ
A
Ad
opt
edl
179
=
rLJ.
67864
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
9
"'
""'
..,
=
-.rLJ.
0:
r.o.~
rLJ. "'
z~
u~
0101
039
9
/18
3
038
6
/19
""'
~
=
"'
..,
""'
0:
Measure Title and Description¥
with the removal of reporting options for
some measures. CMS is finalizing its
proposal to make this individual measure
reportable via measures groups-only to lessen
the burden of eligible professionals reporting
individual measures based on the current
requirement of nine measures over three
domains. While removing reporting options
could be seen as increasing burden for
eligible professionals, as they have fewer
choices to report this measure, we do not
believe this is the case with reporting via
measures groups. For example, an individual
eligible professional reporting via a measures
group only need to report on a minimum of 6
measures rather than a minimum of 9
measures covering 3 NQS domains, as is the
case with reporting individual measures
Hepatitis C: Hepatitis A Vaccination in
Patients with Hepatitis C Virus (HCV):
Percentage of patients aged 18 years and
older with a diagnosis of chronic hepatitis C
who have received at least one injection of
hepatitis A vaccine, or who have documented
immunity to hepatitis A
Community
I
Population
Health
Effective
Clinical
Care
While several comments were concerned
with the removal of reporting options for
some measures, CMS is finalizing its
proposal to make this individual measure
reportable via measures groups-only to lessen
the burden of eligible professionals reporting
individual measures based on the current
requirement of nine measures over three
domains. While removing reporting options
could be seen as increasing burden for
eligible professionals, as they have fewer
choices to report this measure, we do not
believe this is the case with reporting via
measures groups. For example, an individual
eligible professional reporting via a measures
group only need to report on a minimum of 6
measures rather than a minimum of 9
measures covering 3 NQS domains, as is the
case with reporting individual measures
Oncology: Cancer Stage Documented:
Percentage of patients, regardless of age,
with a diagnosis of cancer who are seen in
the ambulatory setting who have a baseline
American Joint Committee on Cancer
(AJCC) cancer stage or documentation that
the cancer is metastatic in the medical record
at least once during the 12 month reporting
period
"'
~
£
bJl ~
~~ "' .., &.s e
o.s .., = a. t: ~
""' ==
~ ""' 0: =
"'= ~
..= =- =
~::!
,.Q
rLJ.
National
Quality
Strategy
Domain
..,
-~
t'
.§
.s > "Q
u rLJ.
u ~
"'
1-'.S ~~
'i
0~~
X
AGA
AMAPCPI
ASCO
..,
X
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00318
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.131</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
4
~~
"0
0:
67865
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
'0
""'
~
0:
ro.~
rLJ. "'
z~
Ul'o1
National
Quality
Strategy
Domain
002
2/2
38
156
v3
Patient
Safety
.._oo.
=
0:
"'
0'0' ~~
ebenthall on DSK5SPTVN1PROD with $$_JOB
007
5/2
41
N/
A
/32
VerDate Sep<11>2014
182
v4
Effective
Clinical
Care
Effective
Clinical
Care
20:15 Nov 12, 2014
-
..=
rLJ.
"'
""'
=
0:
"'
Measure Title and Description¥
reporting option for various measures, noting
that not all eligible professionals have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. CMS appreciates the
commenters' concerns and believes that
removal of the claims-based reporting option
will not negatively impact a significant
number of providers reporting these
measures. Therefore, CMS is finalizing its
proposal to remove the claims-based
reporting option for this measure in 20 15
PQRS as part of its goal to lower the data
error rate and decrease provider burden. Note
that this measure is no longer part of a
measures group as well.
Use of High-Risk Medications in the
Elderly: Percentage of patients 66 years of
age and older who were ordered high-risk
medications. Two rates are reported
a. Percentage of patients who were ordered at
least one high-risk medication.
b. Percentage of patients who were ordered at
least two different high-risk medications
No comments were received regarding this
measure. CMS is finalizing its proposal to
add registry as a reporting option for this
measure in 2015 PQRS.
Ischemic Vascular Disease (IVD):
Complete Lipid Profile and LDL-C
Control (<100 mg/dL): Percentage of
patients 18 years of age and older who were
discharged alive for acute myocardial
infarction (AMI), coronary artery bypass
graft (CABG) or percutaneous coronary
interventions (PCI) in the 12 months prior to
the measurement period, or who had an
active diagnosis of ischemic vascular disease
(IVD) during the measurement period, and
who had each of the following during the
measurement period: a complete lipid profile
and LDL-C was adequately controlled(< 100
mg/dL)
CMS is finalizing its proposal to change the
reporting option ofPQRS #241 to EHR-only
reporting as part of its efforts to align with
the EHR Incentive Program when PQRS
would otherwise propose to remove this
measure from PQRS 2015. PQRS will keep
this measure as EHR reportable until the
EHR Incentive Program can change this
measure.
Pediatric Kidney Disease: Adequacy of
Volume Management: Percentage of
calendar months within a 12-month period
Jkt 235001
PO 00000
Frm 00319
Fmt 4701
Sfmt 4725
"'
.§
~
"'
u
.5I
-~
~
>
~
NCQA
""'
.~
~
~
X
E:\FR\FM\13NOR2.SGM
0~
~ t
=
bJ)
Q
~d ~lS
"'Q
~
Q
0~~
X
MU2
X
NCQA
RPA
£
~
&.e e
""' "' - t: f
=
0: =
"' =- ..= =-
"'
~~ "'
"'
MU2
Million
Hearts
X
13NOR2
ER13NO14.132</GPH>
8
"'
""'
67866
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
9
"'
""'
..,
=
0:
-.rLJ.
r.o.~
rLJ. "'
z~
u~
0101
~~
"0
0:
""'
~
National
Quality
Strategy
Domain
7
=
"'
..,
""'
0:
Measure Title and Description¥
during which patients aged 17 years and
younger with a diagnosis of End Stage Renal
Disease (ESRD) undergoing maintenance
hemodialysis in an outpatient dialysis facility
have an assessment of the adequacy of
volume management from a nephrologist
"'
~
£
bJl ~
~~ "' .., &.s e
o.s .., = a. t: ~
""' ==
~ ""' 0: =
"'= ~
..= =- =
~::!
,.Q
rLJ.
..,
-~
t'
.§
.s > "Q
u rLJ.
u ~
"'
..,
1-'.S ~~
'i
0~~
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that not all eligible professionals have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. CMS appreciates the
commenters' concerns and believes that
removal of the claims-based reporting option
will not negatively impact a significant
number of providers reporting these
measures. Therefore, CMS is finalizing its
proposal to remove the claims-based
reporting option for this measure in 2015
PQRS as part of its goal to lower the data
error rate and decrease provider burden.
Pediatric Kidney Disease: ESRD Patients
Receiving Dialysis: Hemoglobin Level<
lOg/dL: Percentage of calendar months
within a 12-month period during which
patients aged 17 years and younger with a
diagnosis of End Stage Renal Disease
(ESRD) receiving hemodialysis or peritoneal
dialysis have a hemoglobin level< 10 g/dL
Effective
Clinical
Care
VerDate Sep<11>2014
20:15 Nov 12, 2014
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that not all eligible professionals have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. CMS appreciates the
commenters' concerns and believes that
removal of the claims-based reporting option
will not negatively impact a significant
number of providers reporting these
measures. Therefore, CMS is finalizing its
proposal to remove the claims-based
reporting option for this measure in 2015.
HIV Viral Load Suppression: The
percentage of patients, regardless of age,
with a diagnosis ofHIV with a HIV viral
load less than 200 copies/mL at last viral
load test during the measurement year
RPA
X
HRSA
X
While several comments were concerned
with the removal of reporting options for
some measures, CMS is finalizing its
proposal to make this individual measure
reportable via measures groups-only to lessen
Jkt 235001
PO 00000
Frm 00320
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.133</GPH>
Effective
Clinical
Care
208
2
/33
8
ebenthall on DSK5SPTVN1PROD with $$_JOB
166
7
/32
8
67867
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
'0
0:
""'
~
-
"'
""'
.._oo.
=
0:
"'
ro.~
rLJ. "'
z~
Ul'o1
0'0'
~~
National
Quality
Strategy
Domain
Effective
Clinical
Care
207
9
/34
0
ebenthall on DSK5SPTVN1PROD with $$_JOB
208
3
/33
9
Efficiency
and Cost
Reduction
071
0/
370
VerDate Sep<11>2014
159
v3
Effective
Clinical
Care
20:15 Nov 12, 2014
..=
rLJ.
"'
""'
=
0:
"'
Measure Title and Description¥
the burden of eligible professionals reporting
individual measures based on the current
requirement of nine measures over three
domains. While removing reporting options
could be seen as increasing burden for
eligible professionals, as they have fewer
choices to report this measure, we do not
believe this is the case with reporting via
measures groups. For example, an individual
eligible professional reporting via a measures
group only need to report on a minimum of 6
measures rather than a minimum of 9
measures covering 3 NQS domains, as is the
case with reporting individual measures
Prescription of HIV Antiretroviral
Therapy: Percentage of patients, regardless
of age, with a diagnosis of HIV prescribed
antiretroviral therapy for the treatment of
HIV infection during the measurement year
While several comments were concerned
with the removal of reporting options for
some measures, CMS is finalizing its
proposal to make this individual measure
reportable via measures groups-only to lessen
the burden of eligible professionals reporting
individual measures based on the current
requirement of nine measures over three
domains. While removing reporting options
could be seen as increasing burden for
eligible professionals, as they have fewer
choices to report this measure, we do not
believe this is the case with reporting via
measures groups. For example, an individual
eligible professional reporting via a measures
group only need to report on a minimum of 6
measures rather than a minimum of 9
measures covering 3 NQS domains, as is the
case with reporting individual measures
HIV Medical Visit Frequency: Percentage
of patients, regardless of age with a diagnosis
of HIV who had at least one medical visit in
each 6 month period of the 24 month
measurement period, with a minimum of 60
days between medical visits
This measure was included on this table in
error in the proposed rule. There are no
changes proposed for this measure in 2015
PQRS. This measure was reportable through
measure groups only in PQRS 2014 and will
continue to be similarly reportable in PQRS
2015.
Depression Remission at Twelve Months:
Adult patients age 18 and older with major
depression or dysthymia and an initial PHQ9 score > 9 who demonstrate remission at
Jkt 235001
PO 00000
Frm 00321
Fmt 4701
Sfmt 4725
"'
.§
~
"'
u
.5I
-~
~
>
~
""'
.~
~
~
£
~
&.e e
""' "' - t: f
=
0: =
"' =- ..= =-
=
"'
~~ "'
"'
0~
~ t
bJ)
Q
~d ~lS
HRSA
~
Q
0~~
X
HRSA
"'Q
X
MNCM
E:\FR\FM\13NOR2.SGM
X
13NOR2
X
MU2
ER13NO14.134</GPH>
8
67868
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
'0
8
"'
""'
.._oo.
=
0:
"'
ro.~
rLJ. "'
z~
Ul'o1
0'0' ~~
""'
~
0:
National
Quality
Strategy
Domain
-
..=
rLJ.
"'
""'
=
0:
"'
Measure Title and Description¥
twelve months defined as PHQ-9 score less
than 5. This measure applies to both patients
with newly diagnosed and existing
depression whose current PHQ-9 score
indicates a need for treatment
"'
.§
~
"'
u
.5I
-~
~
>
~
""'
.~
~
~
£
~
&.e e
""' "' - t: f
=
0: =
"' =- ..= =-
=
"'
~~ "'
"'
0~
~ t
bJ)
Q
~d ~lS
"'Q
~
Q
0~~
CMS did not receive any comments
regarding the proposal to add registry as a
reporting option for this measure. As such,
CMS is finalizing this proposal for 2015
PQRS.
Measures Not hnalized as Proposed
Primary Open-Angle Glaucoma (POAG):
Optic Nerve Evaluation: Percentage of
patients aged 18 years and older with a
diagnosis of primary open-angle glaucoma
(POAG) who have an optic nerve head
evaluation during one or more office visits
within 12 months
143
v3
Effective
Clinical
Care
008
9/0
19
142
v3
Effective
Clinical
Care
AMAPCPI
NCQA
X
X
X
MU2
AMAPCPI
NCQA
X
X
X
MU2
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that eligible professionals who may have
reported on these measures do not have the
resources to implement registry or EHR
reporting and will no longer be able to
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00322
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.135</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
008
6/0
12
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that eligible professionals who may have
reported on these measures do not have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. Upon further review,
CMS agrees that a significant number of
providers that report this measure will be
negatively impacted by the removal of the
claims-based option. Therefore, CMS is not
finalizing its proposal to remove the claimsbased reporting option for this measure in
2015 PQRS. However, CMS is moving away
from claims-based measures and therefore
may reconsider the reporting options for this
measure in future program years.
Diabetic Retinopathy: Communication
with the Physician Managing Ongoing
Diabetes Care: Percentage of patients aged
18 years and older with a diagnosis of
diabetic retinopathy who had a dilated
macular or fundus exam performed with
documented communication to the physician
who manages the ongoing care of the patient
with diabetes mellitus regarding the findings
of the macular or fundus exam at least once
within 12 months
67869
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
"0
9
"'
""'
..,
=
-.rLJ.
0:
r.o.~
rLJ. "'
z~
u~
0101 ~~
""'
~
0:
=
"'
..,
""'
0:
Measure Title and Description¥
participate in PQRS. Upon further review,
CMS agrees that a significant number of
providers that report this measure will be
negatively impacted by the removal of the
claims-based option. Therefore, CMS is not
finalizing its proposal to remove the claimsbased reporting option for this measure in
2015 PQRS. However, CMS is moving away
from claims-based measures and therefore
may reconsider the reporting options for this
measure in future program years.
Osteoporosis: Communication with the
Physician Managing On-going Care PostFracture of Hip, Spine or Distal Radius
for Men and Women Aged 50 Years and
Older: Percentage of patients aged 50 years
and older treated for a hip, spine or distal
radial fracture with documentation of
communication with the physician managing
the patient's on-going care that a fracture
occurred and that the patient was or should
be tested or treated for osteoporosis
Communica
tionand
Care
Coordinatio
n
004
6/0
39
Effective
Clinical
Care
..,
-~
t'
.§
.s > "Q
u rLJ.
u ~
AMAPCPI
NCQA
X
X
..,
1-'.S ~~
X
'i
bJl
0~~
X
AMAPCPI
NCQA
"'
X
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that eligible professionals who may have
reported on these measures do not have the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00323
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.136</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
004
5/0
24
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that eligible professionals who may have
reported on these measures do not have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. Upon further review,
CMS agrees that a significant number of
providers that report this measure will be
negatively impacted by the removal of the
claims-based option. Furthermore, this
measure is a preventive care measure.
Therefore, CMS is not finalizing its proposal
to remove the claims-based reporting option
for this measure in 2015 PQRS. However,
CMS is moving away from claims-based
measures and therefore may reconsider the
reporting options for this measure in future
program years.
Screening or Therapy for Osteoporosis for
Women Aged 65 Years and Older:
Percentage of female patients aged 65 years
and older who have a central dual-energy Xray absorptiometry (DXA) measurement
ordered or performed at least once since age
60 or pharmacologic therapy prescribed
within 12 months
"'
~
£
~
~~ "' .., &.s e
o.s .., = "'= ~
""' =- a. t:
=
~ ""' 0: =
~
..= =- =
~::!
,.Q
rLJ.
National
Quality
Strategy
Domain
67870
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
"0
9
"'
""'
..,
=
-.rLJ.
0:
r.o.~
rLJ. "'
z~
u~
0101 ~~
""'
~
0:
=
"'
..,
""'
0:
Measure Title and Description¥
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. Upon further review,
CMS identified this measure as a broadly
applicable, preventive care measure.
Therefore, CMS is not finalizing its proposal
to remove the claims-based reporting option
for this measure in 2015 PQRS. However,
CMS is moving away from claims-based
measures and therefore may reconsider the
reporting options for this measure in future
program years.
Osteoporosis: Management Following
Fracture of Hip, Spine or Distal Radius
for Men and Women Aged 50 Years and
Older: Percentage of patients aged 50 years
and older with fracture of the hip, spine, or
distal radius who had a central dual-energy
X-ray absorptiometry (DXA) measurement
ordered or performed or pharmacologic
therapy prescribed
Effective
Clinical
Care
009
7/0
46
Communica
tion and
Care
Coordinatio
n
..,
-~
t'
.§
.s > "Q
u rLJ.
u ~
AMAPCPI
NCQA
X
X
..,
1-'.S ~~
'i
bJl
0~~
X
AMAPCPI
NCQA
"'
X
Reporting Age Criteria 1: 18-64 years of age
Reporting Age Criteria 2: 65 years and older
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00324
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.137</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
004
8/0
40
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that eligible professionals who may have
reported on these measures do not have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. Upon further review,
CMS agrees that a significant number of
providers that report this measure will be
negatively impacted by the removal of the
claims-based option. Therefore, CMS is not
finalizing its proposal to remove the claimsbased reporting option for this measure in
2015 PQRS. However, CMS is moving away
from claims-based measures and therefore
may reconsider the reporting options for this
measure in future program years.
Medication Reconciliation: Percentage of
patients aged 18 years and older discharged
from any inpatient facility (for example,
hospital, skilled nursing facility, or
rehabilitation facility) and seen within 30
days following discharge in the office by the
physician, prescribing practitioner, registered
nurse, or clinical pharmacist providing ongoing care who had a reconciliation of the
discharge medications with the current
medication list in the outpatient medical
record documented. This measure is reported
as two rates stratified by age group:
"'
~
£
~
~~ "' .., &.s e
o.s .., = "'= ~
""' =- a. t:
=
~ ""' 0: =
~
..= =- =
~::!
,.Q
rLJ.
National
Quality
Strategy
Domain
67871
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
"0
9
"'
""'
..,
=
-.rLJ.
0:
r.o.~
rLJ. "'
z~
u~
0101 ~~
""'
~
0:
National
Quality
Strategy
Domain
009
0/0
54
Effective
Clinical
Care
"'
..,
""'
0:
Measure Title and Description¥
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that eligible professionals who may have
reported on these measures do not have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. Upon further review,
CMS agrees that a significant number of
providers that report this measure will be
negatively impacted by the removal of the
claims-based option. Therefore, CMS is not
finalizing its proposal to remove the claimsbased reporting option for this measure in
2015 PQRS. However, CMS is moving away
from claims-based measures and therefore
may reconsider the reporting options for this
measure in future program years.
Urinary Incontinence: Plan of Care for
Urinary Incontinence in Women Aged 65
Years and Older: Percentage of female
patients aged 65 years and older with a
diagnosis of urinary incontinence with a
documented plan of care for urinary
incontinence at least once within 12 months
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that eligible professionals who may have
reported on these measures do not have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. Upon further review,
CMS agrees that a significant number of
providers that report this measure will be
negatively impacted by the removal of the
claims-based option. Furthermore, CMS
identified this measure as a preventive care
measure. Therefore, CMS is not finalizing its
proposal to remove the claims-based
reporting option for this measure in 2015
PQRS. However, CMS is moving away from
claims-based measures and therefore may
reconsider the reporting options for this
measure in future program years.
Emergency Medicine: 12-Lead
Electrocardiogram (ECG) Performed for
Non-Traumatic Chest Pain: Percentage of
patients aged 40 years and older with an
emergency department discharge diagnosis
of non-traumatic chest pain who had a 12lead electrocardiogram (ECG) performed
"'
~
£
~
~~ "' .., &.s e
o.s .., = "'= ~
""' =- a. t:
=
~ ""' 0: =
~
..= =- =
~::!
,.Q
..,
-~
t'
.§
.s > "Q
u rLJ.
u ~
NCQA
AMAPCPI
X
X
..,
1-'.S ~~
'i
bJl
0~~
X
AMAPCPI
NCQA
"'
X
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00325
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.138</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
010
0/0
50
Person and
CaregiverCentered
Experience
and
Outcomes
=
rLJ.
67872
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
"0
9
"'
""'
..,
=
-.rLJ.
0:
r.o.~
rLJ. "'
z~
u~
0101 ~~
038
7/0
71
National
Quality
Strategy
Domain
140
v3
Effective
Clinical
Care
141
v3
Effective
Clinical
Care
=
"'
..,
""'
0:
Measure Title and Description¥
that eligible professionals who may have
reported on these measures do not have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. Upon further review,
CMS agrees that a significant number of
providers that report this measure will be
negatively impacted by the removal of the
claims-based option. Therefore, CMS is not
finalizing its proposal to remove the claimsbased reporting option for this measure in
2015 PQRS. However, CMS is moving away
from claims-based measures and therefore
may reconsider the reporting options for this
measure in future program years.
Breast Cancer: Hormonal Therapy for
Stage IC - IIIC Estrogen
Receptor/Progesterone Receptor (ERIPR)
Positive Breast Cancer: Percentage of
female patients aged 18 years and older with
Stage IC through IIIC, ER or PR positive
breast cancer who were prescribed tamoxifen
or aromatase inhibitor (AI) during the 12month reporting period
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that eligible professionals who may have
reported on these measures do not have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. Upon further review,
CMS agrees that a significant number of
providers that report this measure will be
negatively impacted by the removal of the
claims-based option. Therefore, CMS is not
finalizing its proposal to remove the claimsbased reporting option for this measure in
2015 PQRS. However, CMS is moving away
from claims-based measures and therefore
may reconsider the reporting options for this
measure in future program years.
Colon Cancer: Chemotherapy for AJCC
Stage III Colon Cancer Patients:
Percentage of patients aged 18 through 80
years with AJCC Stage III colon cancer who
are referred for adjuvant chemotherapy,
prescribed adjuvant chemotherapy, or have
previously received adjuvant chemotherapy
within the 12-month reporting period
"'
~
£
~
~~ "' .., &.s e
o.s .., = "'= ~
""' =- a. t:
=
~ ""' 0: =
~
..= =- =
~::!
,.Q
rLJ.
..,
-~
t'
.§
.s > "Q
u rLJ.
u ~
"'
..,
1-'.S ~~
'i
bJl
0~~
AMAPCPI
ASCO
NCCN
X
X
X
X
MU2
AMAPCPI
ASCO
NCCN
X
X
X
X
MU2
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that eligible professionals who may have
reported on these measures do not have the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00326
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.139</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
038
5/0
72
""'
~
0:
67873
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
"0
-.rLJ.
0:
r.o.~
rLJ. "'
z~
u~
0101
~~
12
ebenthall on DSK5SPTVN1PROD with $$_JOB
VerDate Sep<11>2014
National
Quality
Strategy
Domain
Effective
Clinical
Care
N/
Ali
003
4
111
3
""'
~
0:
130
v3
Effective
Clinical
Care
20:15 Nov 12, 2014
=
"'
..,
""'
0:
Measure Title and Description¥
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. Upon further review,
CMS agrees that a significant number of
providers that report this measure will be
negatively impacted by the removal of the
claims-based option. Therefore, CMS is not
finalizing its proposal to remove the claimsbased reporting option for this measure in
2015 PQRS. However, CMS is moving away
from claims-based measures and therefore
may reconsider the reporting options for this
measure in future program years.
Breast Cancer Screening: Percentage of
women 50 through 74 years of age who had a
mammogram to screen for breast cancer
within 27 months
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that eligible professionals who may have
reported on these measures do not have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. Upon further review,
CMS identified this as a broadly applicable,
preventive care measure. Therefore, CMS is
not finalizing its proposal to remove the
claims-based reporting option for this
measure in 2015 PQRS. However, CMS is
moving away from claims-based measures
and therefore may reconsider the reporting
options for this measure in future program
years.
Colorectal Cancer Screening: Percentage
of patients 50 through 75 years of age who
had appropriate screening for colorectal
cancer
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that eligible professionals who may have
reported on these measures do not have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. Upon further review,
CMS identified this as a broadly applicable,
preventive care measure. Therefore, CMS is
not finalizing its proposal to remove the
claims-based reporting option for this
measure in 2015 PQRS. However, CMS is
moving away from claims-based measures
and therefore may reconsider the reporting
options for this measure in future program
years.
Jkt 235001
PO 00000
Frm 00327
Fmt 4701
Sfmt 4725
"'
~
£
~
~~ "' .., &.s e
o.s .., = "'= ~
""' =- a. t:
=
~ ""' 0: =
~
..= =- =
~::!
,.Q
rLJ.
..,
-~
t'
.§
.s > "Q
u rLJ.
u ~
"'
..,
1-'.S ~~
'i
bJl
0~~
NCQA
X
X
X
X
X
MU2
NCQA
X
X
X
X
X
MU2
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.140</GPH>
9
"'
""'
..,
=
67874
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
"0
""'
-..r:LJ.
r.o.~
=
"'
[LJ. ...
~~
~
0'0'
ZQ.. Ur-l
""'
~
~
...
...
National
Quality
Strategy
Domain
131
v3
Effective
Clinical
Care
006
2
/11
9
ebenthall on DSK5SPTVN1PROD with $$_JOB
005
5
/11
7
134
v3
Effective
Clinical
Care
VerDate Sep<11>2014
20:15 Nov 12, 2014
...
=
"'
...
""'
~
Measure Title and Description¥
Diabetes: Eye Exam: Percentage of patients
18 through 75 years of age with a diagnosis
of diabetes (type 1 and type 2) who had a
retinal or dilated eye exam by an eye care
professional in the measurement period or a
negative retinal or dilated eye exam (negative
for retinopathy) in the year prior to the
measurement period
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that eligible professionals who may have
reported on these measures do not have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. Upon further review,
CMS agrees that a significant number of
providers that report this measure will be
negatively impacted by the removal of the
claims-based option. In addition, many
commenters supported the inclusion of the
measure within the Shared Savings Program
Diabetes Composite, but requested testing of
the Composite measure and submission to
NQF. Some commenters did not support the
addition of a process measure to the Shared
Savings Program measure set and questioned
the measure's link to improving outcomes.
Therefore, CMS is not finalizing its proposal
to remove the claims-based reporting option
for this measure in 2015 PQRS. However,
CMS is moving away from claims-based
measures and therefore may reconsider the
reporting options for this measure in future
program years. CMS will finalize adding the
measure to the Shared Savings Program
Diabetes Composite due to its clinical
importance, alignment with PQRS, and
stakeholder support.
Diabetes: Medical Attention for
Nephropathy: The percentage of patients
18-75 years of age with diabetes who had a
nephropathy screening test or evidence of
nephropathy during the measurement period
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that eligible professionals who may have
reported on these measures do not have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. Upon further review,
CMS agrees that a significant number of
providers that report this measure will be
negatively impacted by the removal of the
Jkt 235001
PO 00000
Frm 00328
Fmt 4701
Sfmt 4725
~
NCQA
NCQA
£
...
..c
[LJ.
"'
~t ...
t'
...
"'
5
·a > -~ ~
0 u ~ ~
[LJ.
Qj)
X
X
X
~
""' c ""'
==- ~
ll
~~
X
X
ACO
MU2
X
MU2
X
E:\FR\FM\13NOR2.SGM
""' === "'
"' c
=
bJ:) rl.l
==
(J,$
X
X
0~
~ ""'
Q.,~
-;
0' 1: 5
~
13NOR2
0~~
ER13NO14.141</GPH>
~
....
...
67875
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
"0
-.rLJ.
0:
r.o.~
rLJ. "'
z~
u~
0101 ~~
ebenthall on DSK5SPTVN1PROD with $$_JOB
VerDate Sep<11>2014
=
"'
..,
""'
0:
Measure Title and Description¥
claims-based option. Furthermore, CMS
identified this measure as a preventive care
measure. Therefore, CMS is not fmalizing its
proposal to remove the claims-based
reporting option for this measure in 2015
PQRS. However, CMS is moving away from
claims-based measures and therefore may
reconsider the reporting options for this
measure in future program years.
Primary Open-Angle Glaucoma (POAG):
Reduction oflntraocular Pressure (lOP)
by 15% OR Documentation of a Plan of
Care: Percentage of patients aged 18 years
and older with a diagnosis of primary openangle glaucoma (POAG) whose glaucoma
treatment has not failed (the most recent lOP
was reduced by at least 15% from the preintervention level) OR if the most recent lOP
was not reduced by at least 15% from the
pre-intervention level, a plan of care was
documented within 12 months
123
v3
Effective
Clinical
Care
20:15 Nov 12, 2014
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that eligible professionals who may have
reported on these measures do not have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. Upon further review,
CMS agrees that a significant number of
providers that report this measure will be
negatively impacted by the removal of the
claims-based option. Therefore, CMS is not
finalizing its proposal to remove the claimsbased reporting option for this measure in
2015 PQRS. However, CMS is moving away
from claims-based measures and therefore
may reconsider the reporting options for this
measure in future program years.
Diabetes: Foot Exam: Percentage of
patients aged 18-75 years of age with
diabetes who had a foot exam during the
measurement period
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that eligible professionals who may have
reported on these measures do not have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. Upon further review,
CMS agrees that a significant number of
providers that report this measure will be
negatively impacted by the removal of the
claims-based option. Furthermore, CMS
Jkt 235001
PO 00000
Frm 00329
Fmt 4701
Sfmt 4725
"'
~
£
~
~~ "' .., &.s e
o.s .., = "'= ~
""' =- a. t:
=
~ ""' 0: =
~
..= =- =
~::!
,.Q
rLJ.
National
Quality
Strategy
Domain
Communica
tion and
Care
Coordinatio
n
056
3
/14
1
005
6
/16
3
""'
~
0:
..,
-~
t'
.§
.s > "Q
u rLJ.
u ~
AAO
X
X
X
..,
1-'.S ~~
'i
bJl
0~~
X
NCQA
"'
E:\FR\FM\13NOR2.SGM
X
13NOR2
X
ACO
MU2
ER13NO14.142</GPH>
9
"'
""'
..,
=
67876
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
"0
9
"'
""'
..,
=
-.rLJ.
0:
r.o.~
rLJ. "'
z~
u~
0101 ~~
"'
..,
""'
0:
Measure Title and Description¥
identified this as a preventive care measure.
Therefore, CMS is not finalizing its proposal
to remove the claims-based reporting option
for this measure in 2015 PQRS. However,
CMS is moving away from claims-based
measures and therefore may reconsider the
reporting options for this measure in future
program years.
Colonoscopy Interval for Patients with a
History of Adenomatous Polyps Avoidance oflnappropriate Use:
Percentage of patients aged 18 years and
older receiving a surveillance colonoscopy
with a history of a prior adenomatous
polyp(s) in previous colonoscopy findings,
who had an interval of 3 or more years since
their last colonoscopy
164
v3
Effective
Clinical
Care
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that eligible professionals who may have
reported on these measures do not have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. Upon further review,
CMS agrees that a significant number of
providers that report this measure will be
negatively impacted by the removal of the
claims-based option. Therefore, CMS is not
finalizing its proposal to remove the claimsbased reporting option for this measure in
2015 PQRS. However, CMS is moving away
from claims-based measures and therefore
may reconsider the reporting options for this
measure in future program years.
Ischemic Vascular Disease (IVD): Use of
Aspirin or Another Antithrombotic:
Percentage of patients 18 years of age and
older who were discharged alive for acute
myocardial infarction (AMI), coronary artery
bypass graft (CABG) or percutaneous
coronary interventions (PCI) in the 12
months prior to the measurement period, or
who had an active diagnosis of ischemic
vascular disease (IVD) during the
measurement period and who had
documentation of use of aspirin or another
antithrombotic during the measurement
period
"'
~
£
~
~~ "' .., &.s e
o.s .., = "'= ~
""' =- a. t:
=
~ ""' 0: =
~
..= =- =
~::!
,.Q
..,
-~
t'
.§
.s > "Q
u rLJ.
u ~
AGA
ASGE
ACG
X
X
X
..,
1-'.S ~~
'i
bJl
0~~
X
NCQA
"'
X
X
MU2
Million
Hearts
Commenters expressed concern with
maintaining this measure in PQRS for EHR
reporting only for the "sake of alignment
with the EHR Incentive Program especially
in the face of changing [clinical] evidence."
However, due to CMS's desire to maintain
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00330
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.143</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
=
rLJ.
National
Quality
Strategy
Domain
Communica
tion and
Care
Coordinatio
n
065
9
/18
5
006
8/2
04
""'
~
0:
67877
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
"0
9
"'
""'
..,
=
-.rLJ.
0:
r.o.~
rLJ. "'
z~
u~
0101 ~~
""'
~
0:
National
Quality
Strategy
Domain
Effective
Clinical
Care
065
1
/25
4
Effective
Clinical
Care
"'
..,
""'
0:
Measure Title and Description¥
alignment with the EHR Incentive Program,
CMS will not make changes to EHR
measures until the EHR Incentive Program is
able to change this measure.
commentsfrombut CMS is not finalizing its
proposal to remove the claims, registry and
GPRO reporting options for this measure.
This measure will continue to be reportable
through claims, registry, GPRO (including
the Shared Savings Program), as well as
EHR in PQRS 2015. However, CMS is
moving away from claims-based measures
and therefore may reconsider the reporting
options for this measure in future program
years.
HIV/AIDS: Sexually Transmitted Disease
Screening for Chlamydia, Gonorrhea, and
Syphilis: Percentage of patients aged 13
years and older with a diagnosis of
HIVI AIDS for whom chlamydia, gonorrhea
and syphilis screenings were performed at
least once since the diagnosis ofHIV
infection
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that eligible professionals who may have
reported on these measures do not have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. Upon further review,
CMS agrees that a significant number of
providers that report this measure will be
negatively impacted by the removal of the
claims-based option. Therefore, CMS is not
finalizing its proposal to remove the claimsbased reporting option for this measure in
2015 PQRS. However, CMS is moving away
from claims-based measures and therefore
may reconsider the reporting options for this
measure in future program years.
Ultrasound Determination of Pregnancy
Location for Pregnant Patients with
Abdominal Pain: Percentage of pregnant
female patients aged 14 to 50 who present to
the emergency department (ED) with a chief
complaint of abdominal pain or vaginal
bleeding who receive a trans-abdominal or
trans-vaginal ultrasound to determine
pregnancy location
"'
~
NCQA
AMAPCPI
ACEP
£
~
~~ "' .., &.s e
o.s .., = "'= ~
""' =- a. t:
=
~ ""' 0: =
~
..= =- =
~::!
,.Q
..,
-~
t'
.§
.s > "Q
u rLJ.
u ~
"'
1-'.S ~~
X
X
..,
'i
bJl
0~~
X
X
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that eligible professionals who may have
reported on these measures do not have the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00331
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.144</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
040
9
/20
5
=
rLJ.
67878
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
"0
-.rLJ.
0:
r.o.~
rLJ. "'
z~
u~
0101 ~~
""'
~
0:
National
Quality
Strategy
Domain
Effective
Clinical
Care
N/
A
/26
8
ebenthall on DSK5SPTVN1PROD with $$_JOB
065
2
/25
5
Effective
Clinical
Care
VerDate Sep<11>2014
20:15 Nov 12, 2014
=
"'
..,
""'
0:
Measure Title and Description¥
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. Upon further review,
CMS agrees that a significant number of
providers that report this measure will be
negatively impacted by the removal of the
claims-based option. Therefore, CMS is not
finalizing its proposal to remove the claimsbased reporting option for this measure in
2015 PQRS. However, CMS is moving away
from claims-based measures and therefore
may reconsider the reporting options for this
measure in future program years.
Rh Immunoglobulin (Rhogam) for RhNegative Pregnant Women at Risk of Fetal
Blood Exposure: Percentage ofRh-negative
pregnant women aged 14-50 years at risk of
fetal blood exposure who receive RhImmunoglobulin (Rhogam) in the emergency
department (ED)
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that eligible professionals who may have
reported on these measures do not have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. Upon further review,
CMS agrees that a significant number of
providers that report this measure will be
negatively impacted by the removal of the
claims-based option. Therefore, CMS is not
finalizing its proposal to remove the claimsbased reporting option for this measure in
2015 PQRS. However, CMS is moving away
from claims-based measures and therefore
may reconsider the reporting options for this
measure in future program years.
Epilepsy: Counseling for Women of
Childbearing Potential with Epilepsy: All
female patients of childbearing potential (1244 years old) diagnosed with epilepsy who
were counseled about epilepsy and how its
treatment may affect contraception and
pregnancy at least once a year
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that eligible professionals who may have
reported on these measures do not have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. Upon further review,
CMS agrees that a significant number of
providers that report this measure will be
Jkt 235001
PO 00000
Frm 00332
Fmt 4701
Sfmt 4725
"'
~
ACEP
AAN
£
~
~~ "' .., &.s e
o.s .., = "'= ~
""' =- a. t:
=
~ ""' 0: =
~
..= =- =
~::!
,.Q
rLJ.
..,
-~
t'
.§
.s > "Q
u rLJ.
u ~
X
..,
1-'.S ~~
'i
bJl
0~~
X
X
"'
X
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.145</GPH>
9
"'
""'
..,
=
67879
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
'0
.._oo.
=
0:
"'
ro.~
rLJ. "'
z~
Ul'o1
0'0' ~~
N/
A/2
70
ebenthall on DSK5SPTVN1PROD with $$_JOB
N/
A/2
71
N/
A/2
74
VerDate Sep<11>2014
""'
~
0:
National
Quality
Strategy
Domain
Effective
Clinical
Care
"'
""'
=
0:
"'
Measure Title and Description¥
negatively impacted by the removal of the
claims-based option. Therefore, CMS is not
finalizing its proposal to remove the claimsbased reporting option for this measure in
2015 PQRS. However, CMS is moving away
from claims-based measures and therefore
may reconsider the reporting options for this
measure in future program years.
Inflammatory Bowel Disease (ffiD):
Preventive Care: Corticosteroid Sparing
Therapy: Percentage of patients aged 18
years and older with a diagnosis of
inflammatory bowel disease who have been
managed by corticosteroids greater than or
equal to 10 mg/day of prednisone equivalents
for 60 or greater consecutive days or a single
prescription equating to 600mg prednisone or
greater for all fills that have been prescribed
corticosteroid sparing therapy in the last
reporting year
Effective
Clinical
Care
Commenters requested this IBD measure and
others noted in this table be reportable
through registry in addition to the IBD
Measure Group to better support providers
reporting these measures. CMS agrees, and
for this reason CMS is finalizing this
measure with modifications as reportable in
2015 PQRS through registry and measure
group.
Inflammatory Bowel Disease (ffiD):
Preventive Care: Corticosteroid Related
Iatrogenic Injury - Bone Loss Assessment:
Percentage of patients aged 18 years and
older with an inflammatory bowel disease
encounter who were prescribed prednisone
equivalents greater than or equal to 10
mg/day for 60 or greater consecutive days or
a single prescription equating to 600mg
prednisone or greater for all fills and were
documented for risk of bone loss once during
the reporting year or the previous calendar
year
Effective
Clinical
Care
Commenters requested this IBD measure and
others noted in this table be reportable
through registry in addition to the IBD
Measure Group to better support providers
reporting these measures. CMS agrees, and
for this reason CMS is finalizing this
measure with modifications as reportable in
2015 PQRS through registry and measure
group.
Inflammatory Bowel Disease (ffiD):
Testing for Latent Tuberculosis (TB)
Before Initiating Anti-TNF (Tumor
Necrosis Factor) Therapy: Percentage of
20:15 Nov 12, 2014
..=
rLJ.
Jkt 235001
PO 00000
Frm 00333
Fmt 4701
Sfmt 4725
"'
.§
~
"'
u
.5I
-~
~
>
~
""'
.~
~
~
£
~
&.e e
""' "' - t: f
=
0: =
"' =- ..= =-
=
"'
~~ "'
"'
0~
~ t
bJ)
Q
~d ~lS
AGA
X
X
X
0~~
X
AGA
~
Q
X
AGA
"'Q
X
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.146</GPH>
8
"'
""'
67880
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
"0
-.rLJ.
0:
r.o.~
rLJ. "'
z~
u~
0101 ~~
""'
~
0:
=
"'
..,
""'
0:
Measure Title and Description¥
patients aged 18 years and older with a
diagnosis of inflammatory bowel disease for
whom a tuberculosis (TB) screening was
performed and results interpreted within six
months prior to receiving a first course of
anti-TNF (tumor necrosis factor) therapy
Commenters requested this IBD measure and
others noted in this table be reportable
through registry in addition to the IBD
Measure Group to better support providers
reporting these measures. CMS agrees, and
for this reason CMS is finalizing this
measure with modifications as reportable in
2015 PQRS through registry and measure
group.
Inflammatory Bowel Disease (IBD):
Assessment of Hepatitis B Virus (HBV)
Status Before Initiating Anti-TNF (Tumor
Necrosis Factor) Therapy: Percentage of
patients aged 18 years and older with a
diagnosis of inflammatory bowel disease
(IBD) who had Hepatitis B Virus (HBV)
status assessed and results interpreted within
one year prior to receiving a first course of
anti-TNF (tumor necrosis factor) therapy
Effective
Clinical
Care
065
8
/32
0
ebenthall on DSK5SPTVN1PROD with $$_JOB
N/
A/2
75
Communica
tion and
Care
Coordinatio
n
VerDate Sep<11>2014
20:15 Nov 12, 2014
"'
~
£
~
~~ "' .., &.s e
o.s .., = "'= ~
""' =- a. t:
=
~ ""' 0: =
~
..= =- =
~::!
,.Q
rLJ.
National
Quality
Strategy
Domain
..,
-~
t'
.§
.s > "Q
u rLJ.
u ~
AGA
"'
..,
1-'.S ~~
X
'i
bJl
0~~
X
Commenters requested this IBD measure and
others noted in this table be reportable
through registry in addition to the IBD
Measure Group to better support providers
reporting these measures. CMS agrees, and
for this reason CMS is finalizing this
measure with modifications as reportable in
2015 PQRS through registry and measure
group.
Appropriate Follow-Up Interval for
Normal Colonoscopy in Average Risk
Patients: Percentage of patients aged 50
years and older receiving a screening
colonoscopy without biopsy or polypectomy
who had a recommended follow-up interval
of at least 10 years for repeat colonoscopy
documented in their colonoscopy report
Several commenters were concerned with
CMS' proposal to eliminate the claims-based
reporting option for various measures, noting
that eligible professionals who may have
reported on these measures do not have the
resources to implement registry or EHR
reporting and will no longer be able to
participate in PQRS. Upon further review,
CMS agrees that a significant number of
providers that report this measure will be
negatively impacted by the removal of the
claims-based option. Therefore, CMS is not
Jkt 235001
PO 00000
Frm 00334
Fmt 4701
Sfmt 4725
AGA
ASGE
ACG
X
X
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.147</GPH>
9
"'
""'
..,
=
ebenthall on DSK5SPTVN1PROD with $$_JOB
d. PQRS Measures Groups
Section 414.90(b) defines a measures
group as a subset of four or more PQRS
measures that have a particular clinical
condition or focus in common. The
denominator definition and coding of
the measures group identifies the
condition or focus that is shared across
the measures within a particular
measures group.
In the CY 2014 PFS proposed rule, we
proposed (78 FR 43448) to increase the
number of measures that may be
included in a measures group from a
minimum of 4 measures to a minimum
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
of 6. We proposed increasing the
minimum number of measures that may
be contained in a measures group in
accordance with increasing the number
of individual measures to be reported
via claims and registry. However, we
did not finalize this proposal, stating
that, although we still plan to increase
the minimum number of measures in a
measures group in the future, we would
work with the measure developers and
owners of these measures groups
appropriately to add measures to
measures groups that only contain four
measures within the measures group (78
FR 74730). For CY 2015, we again we
PO 00000
Frm 00335
Fmt 4701
Sfmt 4700
67881
proposed to modify § 414.90(b) to define
a measures group as a subset of six or
more PQRS measures that have a
particular clinical condition or focus in
common (79 FR 40457). We solicited
and received the following public
comment on this proposal:
Comment: Several commenters
opposed this proposal. Commenters
noted that CMS did not work with the
measure group developers and owners
to create the proposed measures groups
that consist of at least 6 measures and
were concerned that the additional
measures in the proposed measures
groups were arbitrarily added and not
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.148</GPH>
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
67882
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
relevant to the measures already
contained in the measures group.
Response: While we understand the
commenters’ concerns that the
additional measures may not be relevant
to the measure group topic or condition,
we note that we have performed clinical
analyses to ensure that the added
measures relate to the measure group
topics and conditions. The addition of
measures within the measures groups
was not arbitrary. While some of the
measures did not address the specific
topic or condition depicted, we added
measures within the measures groups
that we believed were clinically relevant
to report, as we believe these measures
address topics and clinical conditions
that are accepted in the clinical
community as critical to monitor. For
example, in most instances, we added
measures from the cross-cutting
measures set such as Tobacco Screening
and Cessation and Medication
Reconciliation. With respect to the
concern that measures developers and
measure owners were not consulted
when developing our proposal to add
measures to the measures groups, we
will continue to work with the measure
developers and owners to address any
concerns they may have with the final
measures groups and address changes
when needed through future
rulemaking. Based on the reasons stated
here and in the proposed rule, we are
finalizing our proposal to modify
§ 414.90(b) to define a measures group
as a subset of six or more PQRS
measures that have a particular clinical
condition or focus in common.
In addition, we proposed to add two
new measures groups that will be
available for reporting in the PQRS
beginning in 2015: The Sinusitis and
Acute Otitis Externa (AOE) measures
groups (79 FR 40457).
Furthermore, we proposed to remove
the following measures groups (79 FR
40457):
• Perioperative care measures group;
• Back pain measures group;
• Cardiovascular prevention
measures group;
• Ischemic Vascular Disease (IVD)
measures group;
• Sleep Apnea measures group; and
• Chronic obstructive pulmonary
disease (COPD) measures group.
We received the following comments
on our proposals related to our
proposals related to either the proposed
addition or removal of the following
measures groups:
Comments on the proposed removal
of the Perioperative Care Measures
Group: Several commenters requested
that CMS retain the Perioperative Care
Measures Group and the related
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
individual measures noting the
following: ‘‘There is a bias in measuring
that improves performance; (2) there are
few measures applicable to surgeons it
will be much harder to participate in
PQRS without the perioperative
measures.’’
Response: While there has been
evidence to suggest there may be a bias
in measuring that improves
performance, there is an equal amount
of evidence to the contrary that suggest
this bias is not impactful. Additionally,
we believe that there are a number of
broadly applicable measures that these
specialty surgeons can report. For these
reasons, we are finalizing our proposal
to remove the Perioperative Care
Measure Group from reporting in 2015
PQRS.
Comments on the proposed removal
of the Back Pain Measures Group:
Several commenters were concerned
with the proposal to remove the Back
Pain measures group, noting it would
negatively impact physician
anesthesiologists’, pain medicine
physicians’ and physical therapists’
ability to report. Other commenters
supported the removal of some of the
Back Pain measure group measures such
as ‘‘Back Pain: Initial Visit’’ and ‘‘Back
Pain: Physical Exam.’’
Response: The measures in this
measure group reflect clinical concepts
that do not add clinical value to PQRS.
Specifically, the measures in this group
are entirely clinical process measures
that do not meaningfully contribute to
improved patient outcomes, and CMS
believes that removal of this measure
group will not negatively impact
physician anesthesiologists’, pain
medicine physicians’, and physical
therapists’ ability to report. For these
reasons, we are finalizing our proposal
to remove the Back Pain Measure Group
from reporting in 2015 PQRS.
Comments on the proposed removal
of the Cardiovascular Prevention
Measures Group: We proposed to
remove the cardiovascular prevention
measures group because a number of
individual measures contained in this
measures group are proposed to be
removed from all PQRS program
reporting options with the exception of
EHR reporting. No comments were
received about the removal of this
measure group. For these reasons, we
are finalizing our proposal to remove
the Cardiovascular Prevention Measure
Group from reporting in 2015 PQRS.
Comments on the proposed removal
of the Ischemic Vascular Disease
Measures Group: We proposed to
remove the cardiovascular prevention
measures group because a number of
individual measures contained in this
PO 00000
Frm 00336
Fmt 4701
Sfmt 4700
measures group are proposed to be
removed from all PQRS program
reporting options with the exception of
EHR reporting. No comments were
received about the removal of this
measure group. For these reasons, we
are finalizing our proposal to remove
the Ischemic Vascular Disease Measure
Group from reporting in 2015 PQRS.
Comments on the proposed addition
of the Acute Otitis Externa (AOE)
Measures Group: One commenter
supported the addition of this measure
group.
Response: We did not receive any
dissenting comments. For these reasons,
we are finalizing our proposal to
include the AOE measure group for
reporting in 2015 PQRS.
Comments on the proposed removal
of the Chronic Obstructive Pulmonary
Disorder (COPD) Measures Group: We
initially proposed to remove this
measure group contingent on the
measure steward not being able to
maintain certain measures contained in
this measures group (79 FR 40457). A
new steward has been identified for the
measures at risk, and for this reason we
are not finalizing our proposal to
remove this measures group in 2015.
Comments on the proposed removal
of the Sleep Apnea Measures Group: We
initially proposed to remove this
measures group contingent on the
measure steward not being able to
maintain certain measures contained in
this measures group. A new steward has
been identified for the measures at risk,
and for this reason we are not finalizing
our proposal to remove this measures
group in 2015.
Comments on the proposed
Rheumatoid Arthritis Measures Group:
Commenters disagreed with CMS’s
proposal to add the Preventive Care and
Screening: Influenza Immunization
(PQRS #110) and Preventive Care and
Screening: Tobacco Use: Screening and
Cessation Intervention (PQRS #226)
measures to the Rheumatoid Arthritis
Measures Group for CY 2015.
Commenters did not believe these
measures provide substantial value to
the specific clinical focus of this
measures group. Instead, commenters
recommend the addition of cross-cutting
measure Preventive Care and Screening:
Body Mass Index (BMI) Screening and
Follow (PQRS #128) and Pain
Assessment and Follow-up (PQRS #131)
to achieve the goal of six measures
while retaining clinical relevance. CMS
agrees with commenters’ suggestions
and thus is not finalizing the proposal
to add PQRS #110 and #226 to this
measure group, but rather will add
PQRS #128 and #131 to better support
the clinical purpose of this measure
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
group while meeting the six measure
minimum requirement.
Tables 57 through 79 specify our final
measures groups in light of the reasons
stated in the proposed rule and the
comments received. Please note that
some measures groups were not
addressed above. With respect to the
measures groups that were not
67883
addressed above, we did not receive any
comments on these proposed measures
groups and are therefore finalizing the
respective measures groups as proposed.
TABLE 57—ASTHMA MEASURES GROUP FOR 2015 AND BEYOND
NQF/PQRS
Measure title and description
0047/053 ....
Asthma: Pharmacologic Therapy for Persistent Asthma—Ambulatory Care Setting: Percentage of patients aged 5 through 64 years with a diagnosis of persistent asthma who were prescribed longterm control medication.
Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and
older seen for a visit between October 1 and March 31 who received an influenza immunization
OR who reported previous receipt of an influenza immunization.
Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged
18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications’ name, dosage, frequency and route of administration.
Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of
patients aged 18 years and older who were screened for tobacco use one or more times within 24
months AND who received cessation counseling intervention if identified as a tobacco user.
Tobacco Use and Help with Quitting Among Adolescents: Percentage of adolescents 13 to 20 years
of age with a primary care visit during the measurement period for whom tobacco use status was
documented and received help quitting if identified as a tobacco user.
Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: Percentage
of patients aged 18 years and older with a BMI documented during the current encounter or during the previous six months AND with a BMI outisde of normal parameters, a follow-up plan is
documented during the encounter or during the previous six months of the encounter.
Normal Parameters: Age 65 years and older BMI ≥ 23 and < 30 kg/m2 ; Age 18—64 years BMI ≥
18.5 and < 25 kg/m2.
0041/110 ....
0419/130 ....
0028/226 ....
N/A/402 ......
0421/128 ....
Measure developer
AMA–PCPI/NCQA
AMA–PCPI
CMS/QIP
AMA–PCPI
NCQA/NCIQM
CMS/QIP
TABLE 58—ACUTE OTITIS EXTERNA (AOE) MEASURES GROUP FOR 2015 AND BEYOND
NQF/PQRS
Measure title and description
0653/091 ....
Acute Otitis Externa (AOE): Topical Therapy: Percentage of patients aged 2 years and older with a
diagnosis of AOE who were prescribed topical preparations.
Acute Otitis Externa (AOE): Systemic Antimicrobial Therapy—Avoidance of Inappropriate Use: Percentage of patients aged 2 years and older with a diagnosis of AOE who were not prescribed systemic antimicrobial therapy.
Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged
18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications’ name, dosage, frequency and route of administration.
Pain Assessment and Follow-Up: Percentage of visits for patients aged 18 years and older with documentation of a pain assessment using a standardized tool(s) on each visit AND documentation of
a follow-up plan when pain is present.
Falls: Risk Assessment: Percentage of patients aged 65 years and older with a history of falls who
had a risk assessment for falls completed within 12 months.
Falls: Plan of Care: Percentage of patients aged 65 years and older with a history of falls who had a
plan of care for falls documented within 12 months.
Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of
patients 18 years and older who were screened for tobacco use one or more times within 24
months AND who received cessation counseling intervention if identified as a tobacco user.
Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented:
Percentage of patients aged 18 years and older seen during the reporting period who were
screened for high blood pressure AND a recommended follow-up plan is documented based on
the current blood pressure (BP) reading as indicated.
0654/093 ....
0419/130 ....
0420/131 ....
0101/154 ....
0101/155 ....
0028/226 ....
ebenthall on DSK5SPTVN1PROD with $$_JOB
N/A/317 ......
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00337
Fmt 4701
Sfmt 4700
Measure developer
E:\FR\FM\13NOR2.SGM
13NOR2
AMA–PCPI
AMA–PCPI
CMS/QIP
CMS/QIP
AMA–PCPI
AMA–PCPI
AMA–PCPI
CMS/QIP
67884
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 59—CATARACTS MEASURES GROUP FOR 2015 AND BEYOND
NQF/PQRS
Measure title and description
0419/130 ....
Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged
18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications’ name, dosage, frequency and route of administration.
Cataracts: 20/40 or Better Visual Acuity within 90 Days Following Cataract Surgery: Percentage of
patients aged 18 years and older with a diagnosis of uncomplicated cataract who had cataract
surgery and no significant ocular conditions impacting the visual outcome of surgery and had bestcorrected visual acuity of 20/40 or better (distance or near) achieved within 90 days following the
cataract surgery.
Cataracts: Complications within 30 Days Following Cataract Surgery Requiring Additional Surgical
Procedures: Percentage of patients aged 18 years and older with a diagnosis of uncomplicated
cataract who had cataract surgery and had any of a specified list of surgical procedures in the 30
days following cataract surgery which would indicate the occurrence of any of the following major
complications: retained nuclear fragments, endophthalmitis, dislocated or wrong power IOL, retinal
detachment, or wound dehiscence.
Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of
patients 18 years and older who were screened for tobacco use one or more times within 24
months AND who received cessation counseling intervention if identified as a tobacco user.
Cataracts: Improvement in Patient’s Visual Function within 90 Days Following Cataract Surgery: Percentage of patients aged 18 years and older in sample who had cataract surgery and had improvement in visual function achieved within 90 days following the cataract surgery, based on
completing a pre-operative and post-operative visual function survey.
Cataracts: Patient Satisfaction within 90 Days Following Cataract Surgery: Percentage of patients
aged 18 years and older in sample who had cataract surgery and were satisfied with their care
within 90 days following the cataract surgery, based on completion of the Consumer Assessment
of Healthcare Providers and Systems Surgical Care Survey.
Cataract Surgery with Intra-Operative Complications (Unplanned Rupture of Posterior Capsule Requiring Unplanned Vsitrectomy): Rupture of the posterior capsule during anterior segment surgery
requiring vsitrectomy.
Cataract Surgery: Difference Between Planned and Final Refraction: Percentage of patients who
achieve planned refraction within +/¥1,0 D.
0565/191 ....
0564/192 ....
0028/226 ....
N/A/303 ......
N/A/304 ......
N/A/388 ......
N/A/389 ......
Measure developer
CMS/QIP
AMA–PCPI/NCQA
AMA–PCPI/NCQA
AMA–PCPI
AAO
AAO
AAEECE/ACHS
AAEECE/ACHS
TABLE 60—CHRONIC KIDNEY DISEASE (CKD) MEASURES GROUP FOR 2015 AND BEYOND
NQF/PQRS
Measure title and description
0326/047 ....
Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record
that an advance care plan was discussed but the patient did not wish or was not able to name a
surrogate decision maker or provide an advance care plan.
Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and
older seen for a visit between October 1 and March 31 who received an influenza immunization
OR who reported previous receipt of an influenza immunization.
Adult Kidney Disease: Laboratory Testing (Lipid Profile): Percentage of patients aged 18 years and
older with a diagnosis of chronic kidney disease (CKD) (stage 3, 4, or 5, not receiving Renal Replacement Therapy [RRT]) who had a fasting lipid profile performed at least once within a 12month period.
Adult Kidney Disease: Blood Pressure Management: Percentage of patient visits for those patients
aged 18 years and older with a diagnosis of chronic kidney disease (CKD) (stage 3, 4, or 5, not
receiving Renal Replacement Therapy [RRT]) and proteinuria with a blood pressure < 140/90
mmHg OR ≥ 140/90 mmHg with a documented plan of care.
Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged
18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications’ name, dosage, frequency and route of administration.
Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of
patients 18 years and older who were screened for tobacco use one or more times within 24
months AND who received cessation counseling intervention if identified as a tobacco user.
0041/110 ....
1668/121 ....
N/A/122 ......
0419/130 ....
ebenthall on DSK5SPTVN1PROD with $$_JOB
0028/226 ....
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00338
Fmt 4701
Sfmt 4700
Measure developer
E:\FR\FM\13NOR2.SGM
13NOR2
AMA–PCPI/NCQA
AMA–PCPI
AMA–PCPI
AMA–PCPI
CMS/QIP
AMA–PCPI
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
67885
TABLE 61—CHRONIC OBSTRUCTIVE PULMONARY DISORDER (COPD) MEASURES GROUP FOR 2015 AND BEYOND
[Please note that CMS initially proposed to remove this measure group contingent on the measure steward not being able to maintain certain
measures contained in this measures group. A new steward has been identified for the measures at risk and for this reason CMS is not finalizing its proposal to remove this measures group in 2015.]
NQF/PQRS
Measure title and description
0326/047 ....
Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record
that an advance care plan was discussed but the patient did not wish or was not able to name a
surrogate decision maker or provide an advance care plan.
Chronic Obstructive Pulmonary Disease (COPD): Spirometry Evaluation: Percentage of patients
aged 18 years and older with a diagnosis of COPD who had spirometry evaluation results documented.
Chronic Obstructive Pulmonary Disease (COPD): Inhaled Bronchodilator Therapy: Percentage of patients aged 18 years and older with a diagnosis of COPD and who have an FEV1/FVC less than
60% and have symptoms who were prescribed an inhaled bronchodilator.
Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and
older seen for a visit between October 1 and March 31 who received an influenza immunization
OR who reported previous receipt of an influenza immunization.
Pneumonia Vaccination Status for Older Adults: Percentage of patients 65 years of age and older
who have ever received a pneumococcal vaccine.
Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged
18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications’ name, dosage, frequency and route of administration.
Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of
patients 18 years and older who were screened for tobacco use one or more times within 24
months AND who received cessation counseling intervention if identified as a tobacco user.
0091/051 ....
0102/052 ....
0041/110 ....
0043/111 ....
0419/130 ....
0028/226 ....
Measure developer
AMA–PCPI/NCQA
AMA–PCPI
AMA–PCPI
AMA–PCPI
NCQA
CMS/QIP
AMA–PCPI
TABLE 62—CORONARY ARTERY BYPASS GRAFT (CABG) MEASURES GROUP FOR 2015 AND BEYOND
NQF/PQRS
Measure title and description
0134/043 ....
Coronary Artery Bypass Graft (CABG): Use of Internal Mammary Artery (IMA) in Patients with Isolated CABG Surgery: Percentage of patients aged 18 years and older undergoing isolated CABG
surgery who received an IMA graft.
Coronary Artery Bypass Graft (CABG): Preoperative Beta-Blocker in Patients with Isolated CABG
Surgery: Percentage of isolated Coronary Artery Bypass Graft (CABG) surgeries for patients aged
18 years and older who received a beta-blocker within 24 hours prior to surgical incision.
Coronary Artery Bypass Graft (CABG): Prolonged Intubation: Percentage of patients aged 18 years
and older undergoing isolated CABG surgery who require postoperative intubation > 24 hours.
Coronary Artery Bypass Graft (CABG): Deep Sternal Wound Infection Rate: Percentage of patients
aged 18 years and older undergoing isolated CABG surgery who, within 30 days postoperatively,
develop deep sternal wound infection involving muscle, bone, and/or mediastinum requiring operative intervention.
Coronary Artery Bypass Graft (CABG): Stroke: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who have a postoperative stroke (that is, any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain) that did not resolve within 24 hours.
Coronary Artery Bypass Graft (CABG): Postoperative Renal Failure: Percentage of patients aged 18
years and older undergoing isolated CABG surgery (without pre-existing renal failure) who develop
postoperative renal failure or require dialysis.
Coronary Artery Bypass Graft (CABG): Surgical Re-Exploration: Percentage of patients aged 18
years and older undergoing isolated CABG surgery who require a return to the operating room
(OR) during the current hospitalization for mediastinal bleeding with or without tamponade, graft
occlusion, valve dysfunction, or other cardiac reason..
Please note that CMS had proposed to remove this measure from the program and thus this measure group as a result in the NPRM. However, as noted above in Table 55, CMS is not finalizing its
proposal to remove this measure, and as such, the measure is not being removed from this measure group either..
0236/044 ....
0129/164 ....
0130/165 ....
0131/166 ....
0114/167 ....
ebenthall on DSK5SPTVN1PROD with $$_JOB
0115/168 ....
Measure developer
STS
CMS/QIP
STS
STS
STS
STS
STS
TABLE 63—CORONARY ARTERY DISEASE (CAD) MEASURES GROUP FOR 2015 AND BEYOND
NQF/PQRS
Measure title and description
0067/006 ....
Coronary Artery Disease (CAD): Antiplatelet Therapy: Percentage of patients aged 18 years and
older with a diagnosis of coronary artery disease seen within a 12 month period who were prescribed aspirin or clopidogrel.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00339
Fmt 4701
Sfmt 4700
Measure developer
E:\FR\FM\13NOR2.SGM
13NOR2
AMA–PCPI/ACCF/AHA
67886
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 63—CORONARY ARTERY DISEASE (CAD) MEASURES GROUP FOR 2015 AND BEYOND—Continued
NQF/PQRS
Measure title and description
0070/007 ....
Coronary Artery Disease (CAD): Beta-Blocker Therapy—Prior Myocardial Infarction (MI) or Left Ventricular Systolic Dysfunction (LVEF < 40%: Percentage of patients aged 18 years and older with a
diagnosis of coronary artery disease seen within a 12 month period who also have prior MI OR a
current or prior LVEF < 40% who were prescribed beta-blocker therapy.
Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: Percentage
of patients aged 18 years and older with a BMI documented during the current encounter or during the previous six months AND with a BMI outside of normal parameters, a follow-up plan is
documented during the encounter or during the previous six months of the encounter.
Normal Parameters: Age 65 years and older BMI ≥ 23 and < 30 kg/m2; Age 18—64 years BMI ≥
18.5 and < 25 kg/m2.
Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged
18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications’ name, dosage, frequency and route of administration.
Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of
patients 18 years and older who were screened for tobacco use one or more times within 24
months AND who received cessation counseling intervention if identified as a tobacco user.
Coronary Artery Disease (CAD): Symptom Management: Percentage of patients aged 18 years and
older with a diagnosis of coronary artery disease seen within a 12 month period with results of an
evaluation of level of activity and an assessment of whether anginal symptoms are present or absent with appropriate management of anginal symptoms within a 12 month period.
0421/128 ....
0419/130 ....
0028/226 ....
N/A/242 ......
Measure developer
AMA–PCPI
CMS/QIP
CMS/QIP
AMA–PCPI
AMA–PCPI/ACCF/AHA
TABLE 64—DEMENTIA MEASURES GROUP FOR 2015 AND BEYOND
NQF/PQRS
Measure title and description
0326/047 ....
Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record
that an advance care plan was discussed but the patient did not wish or was not able to name a
surrogate decision maker or provide an advance care plan.
Dementia: Staging of Dementia: Percentage of patients, regardless of age, with a diagnosis of dementia whose severity of dementia was classified as mild, moderate or severe at least once within
a 12 month period.
Dementia: Cognitive Assessment: Percentage of patients, regardless of age, with a diagnosis of dementia for whom an assessment of cognition is performed and the results reviewed at least once
within a 12 month period.
Dementia: Functional Status Assessment: Percentage of patients, regardless of age, with a diagnosis of dementia for whom an assessment of functional status is performed and the results reviewed at least once within a 12 month period.
Dementia: Neuropsychiatric Symptom Assessment: Percentage of patients, regardless of age, with a
diagnosis of dementia and for whom an assessment of neuropsychiatric symptoms is performed
and results reviewed at least once in a 12 month period.
Dementia: Management of Neuropsychiatric Symptoms: Percentage of patients, regardless of age,
with a diagnosis of dementia who have one or more neuropsychiatric symptoms who received or
were recommended to receive an intervention for neuropsychiatric symptoms within a 12 month
period.
Dementia: Screening for Depressive Symptoms: Percentage of patients, regardless of age, with a diagnosis of dementia who were screened for depressive symptoms within a 12 month period.
Dementia: Counseling Regarding Safety Concerns: Percentage of patients, regardless of age, with a
diagnosis of dementia or their caregiver(s) who were counseled or referred for counseling regarding safety concerns within a 12 month period.
Dementia: Counseling Regarding Risks of Driving: Percentage of patients, regardless of age, with a
diagnosis of dementia or their caregiver(s) who were counseled regarding the risks of driving and
the alternatives to driving at least once within a 12 month period.
Dementia: Caregiver Education and Support: Percentage of patients, regardless of age, with a diagnosis of dementia whose caregiver(s) were provided with education on dementia disease management and health behavior changes AND referred to additional sources for support within a 12
month period.
N/A/280 ......
N/A/281 ......
N/A/282 ......
N/A/283 ......
N/A/284 ......
N/A/285 ......
N/A/286 ......
N/A/287 ......
N/A/288 ......
Measure developer
AMA–PCPI/NCQA
AMA–PCPI
AMA–PCPI
AMA–PCPI
AMA–PCPI
AMA–PCPI
AMA–PCPI
AMA–PCPI
AMA–PCPI
AMA–PCPI
ebenthall on DSK5SPTVN1PROD with $$_JOB
TABLE 65—DIABETES MEASURES GROUP FOR 2015 AND BEYOND
NQF/PQRS
Measure title and description
0059/001 ....
Diabetes: Hemoglobin A1c Poor Control: Percentage of patients 18–75 years of age with diabetes
who had hemoglobin A1c > 9.0% during the measurement period.
Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and
older seen for a visit between October 1 and March 31 who received an influenza immunization
OR who reported previous receipt of an influenza immunization.
0041/110 ....
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00340
Fmt 4701
Sfmt 4700
Measure developer
E:\FR\FM\13NOR2.SGM
13NOR2
NCQA
AMA–PCPI
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
67887
TABLE 65—DIABETES MEASURES GROUP FOR 2015 AND BEYOND—Continued
NQF/PQRS
Measure title and description
0055/117 ....
Diabetes: Eye Exam: Percentage of patients 18 through 75 years of age with a diagnosis of diabetes
(type 1 and type 2) who had a retinal or dilated eye exam in the measurement period or a negative retinal or dilated eye exam (negative for retinopathy) in the year prior to the measurement period.
Diabetes: Medical Attention for Neuropathy: The percentage of patients 18–75 years of age with diabetes who had a nephropathy screening test or evidence of nephropathy during the measurement
period.
Diabetes: Foot Exam: Percentage of patients aged 18–75 years of age with diabetes who had a foot
exam during the measurement period.
Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of
patients 18 years and older who were screened for tobacco use one or more times within 24
months AND who received cessation counseling intervention if identified as a tobacco user.
0062/119 ....
0056/163 ....
0028/226 ....
Measure developer
NCQA
NCQA
NCQA
AMA–PCPI
TABLE 66—GENERAL SURGERY MEASURES GROUP FOR 2015 AND BEYOND
NQF/PQRS
Measure title and description
0419/130 ....
Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged
18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications’ name, dosage, frequency and route of administration.
Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of
patients 18 years and older who were screened for tobacco use one or more times within 24
months AND who received cessation counseling intervention if identified as a tobacco user.
Anastomotic Leak Intervention: Percentage of patients aged 18 years and older who required an
anastomotic leak intervention following gastric bypass or colectomy surgery.
Unplanned Reoperation within the 30 Day Postoperative Period: Percentage of patients aged 18
years and older who had any unplanned reoperation within the 30 day postoperative period.
Unplanned Hospital Readmission within 30 Days of Principal Procedure: Percentage of patients
aged 18 years and older who had an unplanned hospital readmission within 30 days of principal
procedure.
Surgical Site Infection (SSI): Percentage of patients aged 18 years and older who had a surgical site
infection (SSI).
Patient-Centered Surgical Risk Assessment and Communication: Percentage of patients who underwent a non-emergency surgery who had their personalized risks of postoperative complications
assessed by their surgical team prior to surgery using a clinical data-based, patient-specific risk
calculator and who received personal discussion of those risks with the surgeon.
0028/226 ....
N/A/354 ......
N/A/355 ......
N/A/356 ......
N/A/357 ......
N/A/358 ......
Measure developer
CMS/QIP
AMA–PCPI
ACS
ACS
ACS
ACS
ACS
TABLE 67—HEART FAILURE (HF) MEASURES GROUP FOR 2015 AND BEYOND
NQF/PQRS
Measure title and description
0081/005 ....
Heart Failure (HF): Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker
(ARB) Therapy for Left Ventricular Systolic Dysfunction (LVSD): Percentage of patients aged 18
years and older with a diagnosis of heart failure (HF) with a current or prior left ventricular ejection
fraction (LVEF) < 40% who were prescribed ACE inhibitor or ARB therapy either within a 12
month period when seen in the outpatient setting OR at each hospital discharge.
Heart Failure (HF): Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD): Percentage of patients aged 18 years and older with a diagnosis of heart failure (HF) with a current or
prior left ventricular ejection fraction (LVEF) < 40% who were prescribed beta-blocker therapy either within a 12 month period when seen in the outpatient setting OR at each hospital discharge.
Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record
that an advance care plan was discussed but the patient did not wish or was not able to name a
surrogate decision maker or provide an advance care plan.
Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and
older seen for a visit between October 1 and March 31 who received an influenza immunization
OR who reported previous receipt of an influenza immunization..
Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged
18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications’ name, dosage, frequency and route of administration.
Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of
patients 18 years and older who were screened for tobacco use one or more times within 24
months AND who received cessation counseling intervention if identified as a tobacco user.
0083/008 ....
0326/047 ....
0041/110 ....
ebenthall on DSK5SPTVN1PROD with $$_JOB
0419/130 ....
0028/226 ....
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00341
Fmt 4701
Sfmt 4700
Measure developer
E:\FR\FM\13NOR2.SGM
13NOR2
AMA–PCPI/ACCF/AHA
AMA–PCPI/ACCF/AHA
AMA–PCPI/NCQA
AMA–PCPI
CMS/QIP
AMA–PCPI
67888
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 68—HEPATITIS C MEASURES GROUP FOR 2015 AND BEYOND
NQF/PQRS
Measure title and description
0395/084 ....
Hepatitis C: Ribonucleic Acid (RNA) Testing Before Initiating Treatment: Percentage of patients aged
18 years and older with a diagnosis of chronic hepatitis C who started antiviral treatment within
the 12 month reporting period for whom quantitative hepatitis C virus (HCV) RNA testing was performed within 12 months prior to initiation of antiviral treatment.
Hepatitis C: HCV Genotype Testing Prior to Treatment: Percentage of patients aged 18 years and
older with a diagnosis of chronic hepatitis C who started antiviral treatment within the 12 month reporting period for whom hepatitis C virus (HCV) genotype testing was performed within 12 months
prior to initiation of antiviral treatment.
Hepatitis C: Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Testing Between 4–12 Weeks After Initiation of Treatment: Percentage of patients aged 18 years and older with a diagnosis of chronic
hepatitis C who are receiving antiviral treatment for whom quantitative hepatitis C virus (HCV)
RNA testing was performed between 4–12 weeks after the initiation of antiviral treatment.
Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged
18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications’ name, dosage, frequency and route of administration.
Hepatitis C: Hepatitis A Vaccination in Patients with Hepatitis C Virus (HCV): Percentage of patients
aged 18 years and older with a diagnosis of chronic hepatitis C who have received at least one injection of hepatitis A vaccine, or who have documented immunity to hepatitis A.
Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of
patients 18 years and older who were screened for tobacco use one or more times within 24
months AND who received cessation counseling intervention if identified as a tobacco user.
Screening for Hepatocellular Carcinoma (HCC) in patients with Hepatitis C Cirrhosis: Percentage of
patients aged 18 years and older with a diagnosis of chronic hepatitis C cirrhosis who underwent
imaging with either ultrasound, contrast enhanced CT or MRI for hepatocellular carcinoma (HCC)
at least once within the 12 month reporting period.
Discussion and Shared Decision Making Surrounding Treatment Options: Percentage of patients
aged 18 years and older with a diagnosis of hepatitis C with whom a physician or other qualified
healthcare professional reviewed the range of treatment options appropriate to their genotype and
demonstrated a shared decision making approach with the patient. To meet the measure, there
must be documentation in the patient record of a discussion between the physician or other qualified healthcare professional and the patient that includes all of the following: treatment choices appropriate to genotype, risks and benefits, evidence of effectiveness, and patient preferences toward treatment.
0396/085 ....
0398/087 ....
0419/130 ....
0399/183 ....
0028/226 ....
N/A/401 ......
N/A/390 ......
Measure developer
AMA–PCPI
AMA–PCPI
AMA–PCPI
CMS/QIP
AMA–PCPI
AMA–PCPI
AGA/AASLD/AMA–PCPI
AGA/AASLD/AMA–PCPI
TABLE 69—HIV/AIDS MEASURES GROUP FOR 2015 AND BEYOND
NQF/PQRS
Measure title and description
0326/047 ....
Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record
that an advance care plan was discussed but the patient did not wish or was not able to name a
surrogate decision maker or provide an advance care plan.
Preventive Care and Screening: Screening for Clinical Depression and Follow-Up Plan: Percentage
of patients aged 12 years and older screened for clinical depression on the date of the encounter
using an age appropriate standardized depression screening tool AND if positive, a follow-up plan
is documented on the date of the positive screen.
HIV/AIDS: Pneumocystis Jiroveci Pneumonia (PCP) Prophylaxis: Percentage of patients aged 6
weeks and older with a diagnosis of HIV/AIDS who were prescribed Pneumocystis Jiroveci Pneumonia (PCP) prophylaxis.
HIV/AIDS: Sexually Transmitted Disease Screening for Chlamydia, Gonorrhea, and Syphilis: Percentage of patients aged 13 years and older with a diagnosis of HIV/AIDS for whom chlamydia,
gonorrhea and syphilis screenings were performed at least once since the diagnosis of HIV infection.
Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of
patients aged 18 years and older who were screened for tobacco use one or more times within 24
months AND who received cessation counseling intervention if identified as a tobacco user.
HIV Viral Load Suppression: The percentage of patients, regardless of age, with a diagnosis of HIV
with a HIV viral load less than 200 copies/mL at last HIV viral load test during the measurement
year.
Prescription of HIV Antiretroviral Therapy: Percentage of patients, regardless of age, with a diagnosis of HIV prescribed antiretroviral therapy for the treatment of HIV infection during the measurement year.
HIV Medical Visit Frequency: Percentage of patients, regardless of age with a diagnosis of HIV who
had at least one medical visit in each 6 month period of the 24 month measurement period, with a
minimum of 60 days between medical visits.
0418/134 ....
0405/160 ....
0409/205 ....
0028/226 ....
ebenthall on DSK5SPTVN1PROD with $$_JOB
2082/338 ....
2083/339 ....
2079/340 ....
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00342
Fmt 4701
Sfmt 4700
Measure developer
E:\FR\FM\13NOR2.SGM
13NOR2
AMA–PCPI/NCQA
CMS/QIP
NCQA
AMA–PCPI/NCQA
AMA–PCPI
HRSA
HRSA
HRSA
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
67889
TABLE 70—INFLAMMATORY BOWEL DISEASE (IBD) MEASURES GROUP FOR 2015 AND BEYOND
NQF/PQRS
Measure title and description
0041/110 ....
Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and
older seen for a visit between October 1 and March 31 who received an influenza immunization
OR who reported previous receipt of an influenza immunization.
Pneumonia Vaccination Status for Older Adults: Percentage of patients 65 years of age and older
who have ever received a pneumococcal vaccine.
Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of
patients 18 years and older who were screened for tobacco use one or more times within 24
months AND who received cessation counseling intervention if identified as a tobacco user.
Inflammatory Bowel Disease (IBD): Preventive Care: Corticosteroid Sparing Therapy: Percentage of
patients aged 18 years and older with a diagnosis of inflammatory bowel disease who have been
managed by corticosteroids greater than or equal to 10 mg/day of prednisone equivalents for 60
or greater consecutive days or a single prescription equating to 600 mg prednisone or greater for
all fills that have been prescribed corticosteroid sparing therapy in the last reporting year.
Inflammatory Bowel Disease (IBD): Preventive Care: Corticosteroid Related Iatrogenic Injury—Bone
Loss Assessment: Percentage of patients aged 18 years and older with an inflammatory bowel
disease encounter who were prescribed prednisone equivalents greater than or equal to 10 mg/
day for 60 or greater consecutive days or a single prescription equating to 600 mg prednisone or
greater for all fills and were documented for risk of bone loss once during the reporting year or the
previous calendar year.
Inflammatory Bowel Disease (IBD): Testing for Latent Tuberculosis (TB) Before Initiating Anti-TNF
(Tumor Necrosis Factor) Therapy: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease for whom a tuberculosis (TB) screening was performed and
results interpreted within 6 months prior to receiving a first course of anti-TNF (tumor necrosis factor) therapy.
Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating
Anti-TNF (Tumor Necrosis Factor) Therapy: Percentage of patients aged 18 years and older with
a diagnosis of inflammatory bowel disease (IBD) who had Hepatitis B Virus (HBV) status assessed and results interpreted within 1 year prior to receiving a first course of anti-TNF (tumor necrosis factor) therapy.
0043/111 ....
0028/226 ....
N/A/270 ......
N/A/271 ......
N/A/274 ......
N/A/275 ......
Measure developer
AMA–PCPI
NCQA
AMA–PCPI
AGA
AGA
AGA
AGA
TABLE 71—ONCOLOGY MEASURES GROUP FOR 2015 AND BEYOND
NQF/PQRS
Measure title and description
Measure developer
0387/071 ....
Breast Cancer: Hormonal Therapy for Stage IC–IIIC Estrogen Receptor/Progesterone Receptor (ER/
PR) Positive Breast Cancer: Percentage of female patients aged 18 years and older with Stage IC
through IIIC, ER or PR positive breast cancer who were prescribed tamoxifen or aromatase inhibitor (AI) during the 12-month reporting period.
Colon Cancer: Chemotherapy for AJCC Stage III Colon Cancer Patients: Percentage of patients
aged 18 through 80 years with AJCC Stage III colon cancer who are referred for adjuvant chemotherapy, prescribed adjuvant chemotherapy, or have previously received adjuvant chemotherapy
within the 12-month reporting period.
Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and
older seen for a visit between October 1 and March 31 who received an influenza immunization
OR who reported previous receipt of an influenza immunization.
Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged
18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications’ name, dosage, frequency and route of administration.
Oncology: Medical and Radiation—Pain Intensity Quantified: Percentage of patients, regardless of
patient age, with a diagnosis of cancer currently receiving chemotherapy or radiation therapy in
which pain intensity is quantified.
Oncology: Medical and Radiation—Plan of Care for Pain: Percentage of visits for patients, regardless of age, with a diagnosis of cancer currently receiving chemotherapy or radiation therapy who
report having pain with a documented plan of care to address pain.
Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of
patients 18 years and older who were screened for tobacco use one or more times within 24
months AND who received cessation counseling intervention if identified as a tobacco user.
AMA–PCPI/ASCO/NCCN
0385/072 ....
0041/110 ....
0419/130 ....
0384/143 ....
0383/144 ....
0028/226 ....
AMA–PCPI/ASCO/NCCN
AMA–PCPI
CMS/QIP
AMA–PCPI
AMA–PCPI
AMA–PCPI
ebenthall on DSK5SPTVN1PROD with $$_JOB
TABLE 72—OPTIMIZING PATIENT EXPOSURE TO IONIZING RADIATION MEASURES GROUP FOR 2015 AND BEYOND
NQF/PQRS
Measure title and description
N/A/359 ......
Optimizing Patient Exposure to Ionizing Radiation: Utilization of a Standardized Nomenclature for
Computed Tomography (CT) Imaging Description: Percentage of computed tomography (CT) imaging reports for all patients, regardless of age, with the imaging study named according to a
standardized nomenclature and the standardized nomenclature is used in institution’s computer
systems.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00343
Fmt 4701
Sfmt 4700
Measure developer
E:\FR\FM\13NOR2.SGM
13NOR2
AMA–PCPI
67890
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 72—OPTIMIZING PATIENT EXPOSURE TO IONIZING RADIATION MEASURES GROUP FOR 2015 AND BEYOND—
Continued
NQF/PQRS
Measure title and description
N/A/360 ......
Optimizing Patient Exposure to Ionizing Radiation: Count of Potential High Dose Radiation Imaging
Studies: Computed Tomography (CT) and Cardiac Nuclear Medicine Studies: Percentage of computed tomography (CT) and cardiac nuclear medicine (myocardial perfusion studies) imaging reports for all patients, regardless of age, that document a count of known previous CT (any type of
CT) and cardiac nuclear medicine (myocardial perfusion) studies that the patient has received in
the 12-month period prior to the current study.
Optimizing Patient Exposure to Ionizing Radiation: Reporting to a Radiation Dose Index Registry:
Percentage of total computed tomography (CT) studies performed for all patients, regardless of
age, that are reported to a radiation dose index registry AND that include at a minimum selected
data elements.
Optimizing Patient Exposure to Ionizing Radiation: Computed Tomography (CT) Images Available for
Patient Follow-up and Comparison Purposes: Percentage of final reports for computed tomography (CT) studies performed for all patients, regardless of age, which document that Digital Imaging and Communications in Medicine (DICOM) format image data are available to non-affiliated
external entities on a secure, media free, reciprocally searchable basis with patient authorization
for at least a 12-month period after the study.
Optimizing Patient Exposure to Ionizing Radiation: Search for Prior Computed Tomography (CT) Imaging Studies Through a Secure, Authorized, Media-Free, Shared Archive: Percentage of final reports of computed tomography (CT) studies performed for all patients, regardless of age, which
document that a search for Digital Imaging and Communications in Medicine (DICOM) format images was conducted for prior patient CT imaging studies completed at non-affiliated external
healthcare facilities or entities within the past 12-months and are available through a secure, authorized, media free, shared archive prior to an imaging study being performed.
Optimizing Patient Exposure to Ionizing Radiation: Appropriateness: Follow-up CT Imaging for Incidentally Detected Pulmonary Nodules According to Recommended Guidelines: Percentage of final
reports for CT imaging studies of the thorax for patients aged 18 years and older with documented
follow-up recommendations for incidentally detected pulmonary nodules (for example, follow-up CT
imaging studies needed or that no follow-up is needed) based at a minimum on nodule size AND
patient risk factors.
N/A/361 ......
N/A/362 ......
N/A/363 ......
N/A/364 ......
Measure developer
AMA–PCPI
AMA–PCPI
AMA–PCPI
AMA–PCPI
AMA–PCPI
TABLE 73—PARKINSON’S DISEASE MEASURES GROUP FOR 2015 AND BEYOND
NQF/PQRS
Measure title and description
0326/047 ....
Care Plan: Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record
that an advance care plan was discussed but the patient did not wish or was not able to name a
surrogate decision maker or provide an advance care plan.
Parkinson’s Disease: Annual Parkinson’s Disease Diagnosis Review: All patients with a diagnosis of
Parkinson’s disease who had an annual assessment including a review of current medications (for
example, medications that can produce Parkinson-like signs or symptoms) and a review for the
presence of atypical features (for example, falls at presentation and early in the disease course,
poor response to levodopa, symmetry at onset, rapid progression [to Hoehn and Yahr stage 3 in 3
years], lack of tremor or dysautonomia) at least annually.
Parkinson’s Disease: Psychiatric Disorders or Disturbances Assessment: All patients with a diagnosis of Parkinson’s disease who were assessed for psychiatric disorders or disturbances (for example, psychosis, depression, anxiety disorder, apathy, or impulse control disorder) at least annually.
Parkinson’s Disease: Cognitive Impairment or Dysfunction Assessment: All patients with a diagnosis
of Parkinson’s disease who were assessed for cognitive impairment or dysfunction at least annually.
Parkinson’s Disease: Querying about Sleep Disturbances: All patients with a diagnosis of Parkinson’s disease (or caregivers, as appropriate) who were queried about sleep disturbances at least
annually.
Parkinson’s Disease: Rehabilitative Therapy Options: All patients with a diagnosis of Parkinson’s disease (or caregiver(s), as appropriate) who had rehabilitative therapy options (for example, physical, occupational, or speech therapy) discussed at least annually.
Parkinson’s Disease: Parkinson’s Disease Medical and Surgical Treatment Options Reviewed: All
patients with a diagnosis of Parkinson’s disease (or caregiver(s), as appropriate) who had the Parkinson’s disease treatment options (for example, non-pharmacological treatment, pharmacological
treatment, or surgical treatment) reviewed at least once annually.
N/A/289 ......
N/A/290 ......
N/A/291 ......
N/A/292 ......
N/A/293 ......
ebenthall on DSK5SPTVN1PROD with $$_JOB
N/A/294 ......
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00344
Fmt 4701
Sfmt 4700
Measure developer
E:\FR\FM\13NOR2.SGM
13NOR2
AMA–PCPI/NCQA
AAN
AAN
AAN
AAN
AAN
AAN
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
67891
TABLE 74—PREVENTIVE CARE MEASURES GROUP FOR 2015 AND BEYOND
NQF/PQRS
Measure title and description
0046/039 ....
Screening or Therapy for Osteoporosis for Women Aged 65 Years and Older: Percentage of female
patients aged 65 years and older who have a central dual-energy X-ray absorptiometry (DXA)
measurement ordered or performed at least once since age 60 or pharmacologic therapy prescribed within 12 months.
Urinary Incontinence: Assessment of Presence or Absence of Urinary Incontinence in Women Aged
65 Years and Older: Percentage of female patients aged 65 years and older who were assessed
for the presence or absence of urinary incontinence within 12 months.
Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and
older seen for a visit between October 1 and March 31 who received an influenza immunization
OR who reported previous receipt of an influenza immunization.
Pneumonia Vaccination Status for Older Adults: Percentage of patients 65 years of age and older
who have ever received a pneumococcal vaccine.
Breast Cancer Screening: Percentage of women 50 through 74 years of age who had a mammogram to screen for breast cancer within 27 months.
Colorectal Cancer Screening: Percentage of patients 50 through 75 years of age who had appropriate screening for colorectal cancer.
Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: Percentage
of patients aged 18 years and older with a BMI documented during the current encounter or during
the previous six months AND with a BMI outside of normal parameters, a follow-up plan is documented during the encounter or during the previous six months of the current encounter.
Normal Parameters: Age 65 years and older BMI ≥ 23 and < 30 kg/m2; Age 18—64 years BMI ≥
18.5 and < 25 kg/m2.
Preventive Care and Screening: Screening for Clinical Depression and Follow-Up Plan: Percentage
of patients aged 12 years and older screened for clinical depression on the date of the encounter
using an age appropriate standardized depression screening tool AND if positive, a follow-up plan
is documented on the date of the positive screen.
Preventive Care and Screening: Unhealthy Alcohol Use—Screening: Percentage of patients aged 18
years and older who were screened for unhealthy alcohol use at least once within 24 months
using a systematic screening method**.
Please note that CMS had proposed to remove this measure from the program and thus this measure group as a result in the NPRM. However, as noted above in Table 55, CMS is not finalizing its
proposal to remove this measure, and as such, the measure is not being removed from this measure group either..
Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of
patients 18 years and older who were screened for tobacco use one or more times within 24
months AND who received cessation counseling intervention if identified as a tobacco user.
N/A/48 ........
0041/110 ....
0043/111 ....
N/A/112 ......
0034/113 ....
0421/128 ....
0418/134 ....
AQA Adopted/173.
0028/226 ....
Measure developer
AMA–PCPI/NCQA
AMA–PCPI/NCQA
AMA–PCPI
NCQA
NCQA
NCQA
CMS/QIP
CMS/QIP
AMA–PCPI
AMA–PCPI
TABLE 75—RHEUMATOID ARTHRITIS (RA) MEASURES GROUP FOR 2015 AND BEYOND
NQF/PQRS
Measure title and description
0054/108 ....
Rheumatoid Arthritis (RA): Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy: Percentage
of patients aged 18 years and older who were diagnosed with RA and were prescribed, dispensed,
or administered at least one ambulatory prescription for a disease-modifying anti-rheumatic drug
(DMARD).
Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: Percentage
of patients aged 18 years and older with a BMI documented during the current encounter or during
the previous six months AND with a BMI outside of normal parameters, a follow-up plan is documented during the encounter or during the previous six months of the current encounter.
Normal Parameters: Age 65 years and older BMI ≥ 23 and < 30 kg/m2; Age 18—64 years BMI ≥
18.5 and < 25 kg/m2.
Pain Assessment and Follow-Up: Percentage of visits for patients aged 18 years and older with documentation of a pain assessment using a standardized tool(s) on each visit AND documentation of
a follow-up plan when pain is present.
Rheumatoid Arthritis (RA): Tuberculosis Screening: Percentage of patients aged 18 years and older
with a diagnosis of rheumatoid arthritis (RA) who have documentation of a tuberculosis (TB)
screening performed and results interpreted within 6 months prior to receiving a first course of
therapy using a biologic disease-modifying anti-rheumatic drug (DMARD).
Rheumatoid Arthritis (RA): Periodic Assessment of Disease Activity: Percentage of patients aged 18
years and older with a diagnosis of rheumatoid arthritis (RA) who have an assessment and classification of disease activity within 12 months.
Rheumatoid Arthritis (RA): Functional Status Assessment: Percentage of patients aged 18 years and
older with a diagnosis of rheumatoid arthritis (RA) for whom a functional status assessment was
performed at least once within 12 months.
Rheumatoid Arthritis (RA): Assessment and Classification of Disease Prognosis: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who have an assessment and classification of disease prognosis at least once within 12 months.
0421/128 ....
0420/131 ....
N/A/176 ......
ebenthall on DSK5SPTVN1PROD with $$_JOB
N/A/177 ......
N/A/178 ......
N/A/179 ......
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00345
Fmt 4701
Sfmt 4700
Measure developer
E:\FR\FM\13NOR2.SGM
13NOR2
NCQA
CMS/QIP
CMS/QIP
AMA–PCPI
AMA–PCPI
AMA–PCPI
AMA–PCPI
67892
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 75—RHEUMATOID ARTHRITIS (RA) MEASURES GROUP FOR 2015 AND BEYOND—Continued
NQF/PQRS
Measure title and description
Measure developer
N/A/180 ......
Rheumatoid Arthritis (RA): Glucocorticoid Management: Percentage of patients aged 18 years and
older with a diagnosis of rheumatoid arthritis (RA) who have been assessed for glucocorticoid use
and, for those on prolonged doses of prednisone ≥ 10 mg daily (or equivalent) with improvement
or no change in disease activity, documentation of glucocorticoid management plan within 12
months.
AMA–PCPI
TABLE 76—SINUSITIS MEASURES GROUP FOR 2015 AND BEYOND
NQF/PQRS
Measure title and description
0419/130 ....
Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged
18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications’ name, dosage, frequency and route of administration.
Pain Assessment and Follow-Up: Percentage of visits for patients aged 18 years and older with documentation of a pain assessment using a standardized tool(s) on each visit AND documentation of
a follow-up plan when pain is present.
Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of
patients 18 years and older who were screened for tobacco use one or more times within 24
months AND who received cessation counseling intervention if identified as a tobacco user.
Adult Sinusitis: Antibiotic Prescribed for Acute Sinusitis (Appropriate Use): Percentage of patients,
aged 18 years and older, with a diagnosis of acute sinusitis who were prescribed an antibiotic
within 7 days of diagnosis or within 10 days after onset of symptoms.
Adult Sinusitis: Appropriate Choice of Antibiotic: Amoxicillin Prescribed for Patients with Acute Bacterial Sinusitis: Percentage of patients aged 18 years and older with a diagnosis of acute bacterial
sinusitis that were prescribed amoxicillin, with or without clavulante, as a first line antibiotic at the
time of diagnosis.
Adult Sinusitis: Computerized Tomography for Acute Sinusitis (Overuse): Percentage of patients
aged 18 years and older with a diagnosis of acute sinusitis who had a computerized tomography
(CT) scan of the paranasal sinuses ordered at the time of diagnosis or received within 28 days
after date of diagnosis.
0420/131 ....
0028/226 ....
N/A/331 ......
N/A/332 ......
N/A/333 ......
Measure developer
CMS/QIP
CMS/QIP
AMA–PCPI
AMA–PCPI
AMA–PCPI
AMA–PCPI
TABLE 77—SLEEP APNEA MEASURES GROUP FOR 2015 AND BEYOND
[Please note that CMS initially proposed to remove this measure group contingent on the measure steward not being able to maintain certain
measures contained in this measures group. A new steward has been identified for the measures at risk and for this reason CMS is not finalizing its proposal to remove this measures group in 2015.]
NQF/PQRS
Measure title and description
0421/128 ....
Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: Percentage
of patients aged 18 years and older with a BMI documented during the current encounter or during the previous six months AND with a BMI outside of normal parameters, a follow-up plan is
documented during the encounter or during the previous six months of the current encounter.
Normal Parameters: Age 65 years and older BMI ≥ 23 and < 30 kg/m2; Age 18—64 years BMI ≥
18.5 and < 25 kg/m2.
Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged
18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications’ name, dosage, frequency and route of administration.
Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of
patients 18 years and older who were screened for tobacco use one or more times within 24
months AND who received cessation counseling intervention if identified as a tobacco user.
Sleep Apnea: Assessment of Sleep Symptoms: Percentage of visits for patients aged 18 years and
older with a diagnosis of obstructive sleep apnea that includes documentation of an assessment of
sleep symptoms, including presence or absence of snoring and daytime sleepiness.
Sleep Apnea: Severity Assessment at Initial Diagnosis: Percentage of patients aged 18 years and
older with a diagnosis of obstructive sleep apnea who had an apnea hypopnea index (AHI) or a
respiratory disturbance index (RDI) measured at the time of initial diagnosis.
Sleep Apnea: Positive Airway Pressure Therapy Prescribed: Percentage of patients aged 18 years
and older with a diagnosis of moderate or severe obstructive sleep apnea who were prescribed
positive airway pressure therapy.
Sleep Apnea: Assessment of Adherence to Positive Airway Pressure Therapy: Percentage of visits
for patients aged 18 years and older with a diagnosis of obstructive sleep apnea who were prescribed positive airway pressure therapy who had documentation that adherence to positive airway
pressure therapy was objectively measured.
0419/130 ....
0028/226 ....
N/A/276 ......
ebenthall on DSK5SPTVN1PROD with $$_JOB
N/A/277 ......
N/A/278 ......
N/A/279 ......
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00346
Fmt 4701
Sfmt 4700
Measure developer
E:\FR\FM\13NOR2.SGM
13NOR2
CMS/QIP
CMS/QIP
AMA–PCPI
AMA–PCPI/NCQA
AMA–PCPI/NCQA
AMA–PCPI/NCQA
AMA–PCPI/NCQA
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
67893
TABLE 78—TOTAL KNEE REPLACEMENT (TKR) MEASURES GROUP FOR 2015 AND BEYOND
NQF/PQRS
Measure title and description
0419/130 ....
Documentation of Current Medications in the Medical Record: Percentage of visits for patients aged
18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional)
supplements AND must contain the medications’ name, dosage, frequency and route of administration.
Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of
patients 18 years and older who were screened for tobacco use one or more times within 24
months AND who received cessation counseling intervention if identified as a tobacco user.
Total Knee Replacement: Shared Decision-Making: Trial of Conservative (Non-surgical) Therapy:
Percentage of patients regardless of age or gender undergoing a total knee replacement with documented shared decision-making with discussion of conservative (non-surgical) therapy (for example, NSAIDS, analgesics, weight loss, exercise, injections) prior to the procedure.
Total Knee Replacement: Venous Thromboembolic and Cardiovascular Risk Evaluation: Percentage
of patients regardless of age or gender undergoing a total knee replacement who are evaluated
for the presence or absence of venous thromboembolic and cardiovascular risk factors within 30
days prior to the procedure (for example, history of Deep Vein Thrombosis, Pulmonary Embolism,
Myocardial Infarction, Arrhythmia and Stroke) and Stroke.
Total Knee Replacement: Preoperative Antibiotic Infusion with Proximal Tourniquet: Percentage of
patients regardless of age undergoing a total knee replacement who had the prophylactic antibiotic
completely infused prior to the inflation of the proximal tourniquet.
Total Knee Replacement: Identification of Implanted Prosthesis in Operative Report: Percentage of
patients regardless of age or gender undergoing total knee replacement whose operative report
identifies the prosthetic implant specifications including the prosthetic implant manufacturer, the
brand name of the prosthetic implant and the size of prosthetic implant.
0028/226 ....
N/A/350 ......
N/A/351 ......
N/A/352 ......
N/A/353 ......
e. Measures Available for Reporting in
the GPRO Web Interface
ebenthall on DSK5SPTVN1PROD with $$_JOB
We finalized the measures that are
available for reporting in the GPRO web
interface for 2014 and beyond in the CY
2013 PFS final rule (77 FR 69269).
However, we proposed to remove and
add measures in the GPRO web
interface measure set as reflected in
Tables 47 and 48 in the CY 2015 PFS
proposed rule for 2015 and beyond (79
FR 40468). Specifically, Table 47
specified the measures we proposed to
remove for reporting from the GPRO
web interface, and Table 48 specified
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Measure developer
the measures we proposed to add for
reporting in the GPRO web interface.
CMS proposed to adopt Depression
Remission at Twelve Months (NQF
#0710) in the 2015 GPRO Web Interface
reporting option for ACOs and group
practices (79 FR 40469). This measure is
currently reportable in the PQRS
program through the EHR reporting
option only and has not been tested
using claims level data or sampling
methodology. Depression Remission at
Twelve Months (NQF #0710) requires a
look-back period and a look-forward
period possibly spanning multiple
calendar years. Additionally, this
PO 00000
Frm 00347
Fmt 4701
Sfmt 4700
CMS/QIP
AMA–PCPI
AAHKS
AAHKS
AAHKS
AAHKS
measure requires utilization of a PHQ–
9 depression screening tool with a score
greater than 9 and a diagnosis of
depression/dysthymia to identify the
beginning of the episode (initial patient
population). Successful completion of
the quality action for this measure looks
for a PHQ–9 score of less than 5 at the
twelve month mark (plus or minus 30
days) from the initial onset of the
episode. CMS solicited comments
regarding these proposals, and the
comments are addressed in Tables 79
and 80.
BILLING CODE 4120–01–P
E:\FR\FM\13NOR2.SGM
13NOR2
67894
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 79: Measures Being Removed from the Group Practice Reporting Option Web Interface
Beginning in 2015 and Beyond
NQS
Domain
GPRO
Module
Measure and Title Description"'
Mectsures Fmal1zed as Proposed
0097/
046
0074/
197
Care
Coordination/
Patient Safety
Coronary
Artery Disease
Patient
Safety
Effective
Clinical
Care
Medication Reconciliation: Percentage of patients aged 65
years and older discharged from any inpatient facility (for
example, hospital, skilled nursing facility, or rehabilitation
facility) and seen within 30 days following discharge in the
office by the physician, prescribing practitioner, registered
nurse, or clinical pharmacist providing on-going care who had a
reconciliation of the discharge medications with the current
medication list in the outpatient medical record documented
Several commenters agreed with CMS' proposal to remove this
measure, noting "full medication reconciliation should be done
at least annually with all patients." However, other commenters
disagreed, indicating this measure "specifically evaluates the
medication reconciliation during a time period when patients are
most vulnerable during a time of transitions of care that may
result in adverse consequences to the patient including
preventable readmission to the hospital." However, CMS
continues to believe NQF #0419 Documentation ofMedications
in the Medical Record is a more robust and broadly applicable
measure. Furthermore, there have been implementation issues
with this measure in the web interface, despite CMS believing
this is a valuable measure. Finally, CMS is continuing to work
to align the GPRO with the EHR Incentive Programs, and NQF
#0419 is in the Incentive Program, whereas PQRS #046 is not.
For these reasons, CMS is finalizing its proposal to remove this
measure from reporting through the GPRO WI in 2015 PQRS
and the Shared Savings Program.
Coronary Artery Disease (CAD): Lipid Control: Percentage
of patients aged 18 years and older with a diagnosis of coronary
artery disease seen within a 12 month period who have a LDLC result < 100 mg/dL OR patients who have a LDL-C result ~
100 mg/dL and have a documented plan of care to achieve
LDL-C < 100 mg/dL, including at a minimum the prescription
of a statin
AMAPCPI/
NCQA
AMAPCPI/
ACCFI
AHA
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00348
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.149</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
While some commenters disagreed with CMS' s proposal to
remove this measure "unless or until new measures that are
more consistent with new and existing guidelines are put in
place to replace them", several commenters supported the
proposal to retire this and the two other lipid control measures
listed as a result of new clinical guidelines released in 20 13 by
the American College of Cardiology and American Heart
Association. For this reason, CMS is finalizing its proposal to
remove this measure from reporting in 2015 PQRS and the
Shared Savings Program.
67895
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
;;..
...
---oo
~
oo
z~
GPRO
Module
"'-=
=~
~
~
lo.
NQS
Domain
Measure and Title Description¥
lo.
... ...
~(;i
ell"'
:; = s
=....
ot::~
0
lo.
...
lo.
lo.Q..~
...
-::~~
0
0729/
319
Diabetes
Mellitus
Effective
Clinical
Care
Diabetes Composite: Optimal Diabetes Care: Patients ages
18 through 7 5 with a diagnosis of diabetes, who meet all the
numerator targets ofthis composite measure:
• Diabetes Mellitus: High Blood Pressure Control.
• Diabetes Mellitus: Low Density Lipoprotein (LDL-C)
Control.
• Diabetes Mellitus: Hemoglobin Ale Control(< 8%).
• Diabetes Mellitus: Tobacco Non-Use
MNCM
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00349
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.150</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
CMS proposed retiring 4 components of the 5 part diabetes
composite measure as noted above. Specifically, commenters:
• Disagreed with removing the blood pressure component,
noting "important that diabetic patients have their blood
pressure and cholesterol monitored in order to prevent comorbidities; if assessing quality of their care is folded into the
general Medicare patient population, the focus on their care and
desirable health care outcomes is effectively "watered down."
However, other commenters supported this change noting "a
measure that is based on a specific Ale level is no longer an
accurate measure of a physician's ability to provide high quality
care for their patients." CMS agrees this measure may no longer
be the best measure of quality care in this area. Further, CMS
continues to believe this measure is somewhat duplicative of the
measure Controlling High Blood Pressure (NQF #0018) and
that the diabetes measure may capture a subpopulation of the
broader Controlling High Blood Pressure measure.
• Agreed with removing the LDL component as a result of
new clinical guidelines released in 2013 by the American
College of Cardiology and American Heart Association
(https://circ.ahajournals.org/content/early/20 13/11 I 11/0l.cir.OOO
0437738.63853.7a.full.pdt).
• Agreed with removing the Hemoglobin A1 c Control
(<8%) component, noting it is "too restrictive for a small cohort
of patients and not restrictive enough for the majority of
patients."
• Disagreed with removing the Tobacco Non-Use
component, noting "this outcome based measure (as opposed to
the screening and counseling measure) is not only a critical
measure for diabetic best management, but removing it is
stepping away from a known shared goal of moving towards
outcome based measures." However, other commenters
supported this change nothing that this measure, in addition to
other measures, "were either duplicative of other measures or
the guidelines for the measure have been changed." CMS
continues to believe this component is somewhat duplicative of
the Tobacco Screening and Cessation Counseling measure
(NQF 0028) and NQF 0028 is more broadly applicable.
For these reasons, CMS is finalizing its proposal to remove
these four components of the diabetes composite measure from
reporting in 2015 PQRS and the Shared Savings Program.
67896
i:i:<oo.
01~
z~
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
-=
., =
<>-o
GPRO
Module
NQS
Domain
Measure and Title Description'~'
~
:::
.,
~00
£1:,1),
- ... e
~ =
01
0
0075/
241
Ischemic
Vascular
Disease
Effective
Clinical
Care
Ischemic Vascular Disease (IVD): Complete Lipid Profile
and LDL-C Control(< 100 mg/dL): Percentage of patients 18
years of age and older who were discharged alive for acute
myocardial infarction (AMI), coronary artery bypass graft
(CABG) or percutaneous coronary interventions (PCI) in the 12
months prior to the measurement period, or who had an active
diagnosis of ischemic vascular disease (IVD) during the
measurement period, and who had each ofthe following during
the measurement period: a complete lipid profile and LDL-C
was adequately controlled(< 100 mg/dL)
t:
=
-
J.Q,~
=
., ., ;9~~
NCQA
MU2
Million
Hearts
NCQA
MU2
Million
Hearts
Commenters supported the proposal to retire this lipid control
related measure because of the new clinical guidelines for statin
treatment, as discussed for other LDL measures in this table.
For this reason, CMS is finalizing its proposal to remove this
measure from reporting in 2015 PQRS and the Shared Savings
p
0068/
204
Ischemic
Vascular
Disease
Effective
Clinical
Care
-1\lcasurcs Not lmahzcd as Proposed
Ischemic Vascular Disease (IVD): Use of Aspirin or Another
Antithrombotic: Percentage of patients 18 years of age and
older who were discharged alive for acute myocardial infarction
(AMI), coronary artery bypass graft (CABG) or percutaneous
coronary interventions (PCI) in the 12 months prior to the
measurement period, or who had an active diagnosis of
ischemic vascular disease (IVD) during the measurement period
and who had documentation of use of aspirin or another
antithrombotic during the measurement period
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00350
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.151</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
CMS received comments about this measure being proposed for
removal from the Web Interface for PQRS and the Shared
Savings Program. Some commenters requested clarification of
CMS's previous concern that the measure may not align with
current guidelines when proposing its removal. After reviewing
the measure further, we have determined the measure does not
conflict with current guidelines the updated ATP-4 cholesterol
guidelines, which have gone away from focusing on specific
LDL targets, but do not impact this measure as previously
thought. This measure is also a core measure for the Million
Hearts Initiative. It is CMS's intent to maintain alignment with
other quality reporting programs and HHS Initiatives. CMS also
received comments supporting the removal of the measure from
the Shared Savings Program, but requesting clarification of
guideline changes impacting the measure Therefore, CMS will
maintain alignment with the Million Hearts program and for this
reason CMS is retaining this measure and it will be available for
reporting through the GPRO WI in 2015 PQRS and the Shared
Savings Program.
67897
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
-.oo
.... ~
0101
z~
.. .
=
a.-=
GPRO
Module
NQS
Domain
01
~ ~
a. a.
Measure and Title Description¥
::g~
t>
=
~~a
Oil "'
Q
..
01"'"'
o.c..~
a. a. ..
;~~
0
0729/
319
Diabetes
Mellitus
Effective
Clinical
Care
Diabetes Composite: Optimal Diabetes Care: Patients ages
18 through 7 5 with a diagnosis of diabetes, who meet all the
numerator targets of this composite measure:
• Diabetes Mellitus: Daily Oral Aspirin or Antiplatelet
Medication Use for Patients with Diabetes and Ischemic
Vascular Disease
MNCM
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00351
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.152</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
CMS did not originally propose to remove this measure.
However, this measure was reported in the PQRS as a
component of the diabetes composite reportable via the GPRO
Web Interface. We note that, while we did not originally
propose to remove this measure, we proposed to remove all of
the other components of the diabetes composite of which this
measure was a part. Specifically, we proposed to remove the
following components of the diabetes composite:
• Diabetes Mellitus: High Blood Pressure Control.
• Diabetes Mellitus: Low Density Lipoprotein (LDL-C) Control.
• Diabetes Mellitus: Hemoglobin A I c Control ( < 8% ).
• Diabetes Mellitus: Tobacco Non-Use
Since we proposed to remove all other components of the
diabetes composite listed above, we believe the public could
reasonably foresee that we would remove this measure from the
PQRS and Shared Savings Program measure set if all other
components of the diabetes composite were removed. In
addition, CMS believes the Daily Oral Aspirin component of
this measure may be somewhat duplicative ofPQRS #204
(Ischemic Vascular Disease (IVD): Use of Aspirin or Another
Antithrombotic). Therefore, we are removing this measure from
the PQRS measure set.
To maintain alignment with PQRS and reduce reporting burden
for ACOs, we are also removing this measure from the Shared
Savings Program measure set. CMS believes that removing this
measure will reduce burden on A COs and allow them to
improve their performance on the diabetes composite by
reducing the number of measures included in the composite.
Therefore, for the reasons stated above, we are removing this
measure from the PQRS and Shared Savings Program measure
set beginning in 2015
67898
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 80: New Measures That Will Be Available for Reporting by the Group Practice Reporting
Option Web Interface Beginning in 2015 and Beyond
NQS
Domain
GPRO
Module
00591
001
0055/
117
Diabetes
Mellitus
Diabetes
Mellitus
Effective
Clinical
Care
Effective
Clinical
Care
Measure and Title Description'~'
Measures I mahzcd as Proposed
Diabetes: Hemoglobin Ale Poor Control: Percentage of
patients 18-75 years of age with diabetes who had
hemoglobin Ale> 9.0% during the measurement period
NCQA
The Shared Savings Program and PQRS received many
comments supporting removal of the Diabetes: Hemogolobin
Ale control (<8 percent) (AC0-22), since <8 percent seems
restrictive. CMS received some comments suggesting we
move toward more outcome measures than process measures.
CMS is finalizing its proposal to include this measure in the
new Diabetes Management (DM) composite as a more
appropriate Ale component for reporting in 2015 PQRS and
the Shared Savings Program. This measure, Hemogolobin
Ale Poor Control is being finalized because it addresses a
clinically important area for diabetic patients and replaces the
previous measure in the DM composite.
Diabetes: Eye Exam: Percentage of patients 18 through 75
years of age with a diagnosis of diabetes (type 1 and type 2)
who had a retinal or dilated eye exam by an eye care
professional in the measurement period or a negative retinal
or dilated eye exam (negative for retinopathy) in the year
prior to the measurement period
MU2
NCQA
MU2
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00352
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.153</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
Several commenters supported the addition of this measure to
the GPRO WI for PQRS and the Shared Savings Program,
noting eye exams are an important part of quality care for
diabetic patients. CMS also received some comments
suggesting that we not finalize additional process measures
and questioning the improvement to outcomes, noting while
"foot and eye exams are an important part of good diabetes
care, we recommend that they not replace the current
outcomes measures in the Diabetes Composite measure set."
CMS agrees foot and eye exams are a valuable addition that
reflect good diabetes care. Please see Table 79 for additional
discussion of the rationale for the removal of the previous
diabetes composite. CMS is finalizing its proposal to include
this measure in the new Diabetes Management composite in
the GPRO WI for reporting in 2015 PQRS and Shared
Savings Program due to the clinical importance of the
measure and alignment of programs.
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
r:.;oo.
0~
z~
0419/
130
GPRO
Module
Care
Coordinati
on!
Patient
Safety
Patient
Safety
-.. .
"'"=
NQS
Domain
=~
~
e'll
Measure and Title Description'~'
~00
Documentation of Current Medications in the Medical
Record: Percentage of visits for patients aged 18 years and
older for which the eligible professional attests to
documenting a list of current medications using all immediate
resources available on the date of the encounter. This list
must include ALL known prescriptions, over-the-counters,
herbals, and vitamin/mineraVdietary (nutritional)
supplements AND must contain the medications' name,
dosage, frequency and route of administration
CMS/Q
IP
67899
1:.11"'
- .e-.5 El
..... t: e'll
;-;=51>
0 = g.=
o~t
MU2
While some commenters disagreed with the addition of this
measure, others suggested medication reconciliation should
be performed at all office visits and not just those visits
occurring after an inpatient discharge. Furthermore, the
steward of CARE-l (PQRS #46) Medication Reconciliation:
Reconciliation After Discharge from an Inpatient Facility
indicated this measure is not appropriate for the GPRO WI
reporting mechanism. Some commenters recommended
limiting documentation of current medications to only the last
visit due to potential reporting burden.
We disagree with the commenters who disagree with the
addition of this measure. We believe this measure adequately
captures an important aspect of patient safety - the need to
understand a patient's current medications. We believe
documenting current medications is key to determining the
most appropriate care for a patient. With respect to the
commenters who believed that medication reconciliation
should be performed on all office visits, please note that the
title and description of the measure does not limit this
measure to documentation after an inpatient discharge. With
respect to a measure steward's concern that this measure is
not appropriate for the GPRO WI reporting mechanism, we
disagree with the measure steward. As we note above, we
believe this measure is appropriate for the GPRO WI as it
captures an important aspect of patient safety.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00353
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.154</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
Based on the comments received and for the reasons stated
above, CMS is finalizing its proposal to replace PQRS #46
with PQRS #130 Documentation of Current Medications in
the Medical Record for reporting in the GPRO WI in 2015
PQRS and Shared Savings Program and will consider
reporting burden in finalizing specifications for GPRO
reporting.
67900
r:.;oo.
0~
z~
0710/
370
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
Mental
Health
Effective
Clinical
Care
-.. .
"'"=
NQS
Domain
GPRO
Module
=~
~
e'll
Measure and Title Description'~'
~00
Depression Remission at Twelve Months: Adult patients
age 18 and older with major depression or dysthymia and an
initial PHQ-9 score > 9 who demonstrate remission at twelve
months defined as PHQ-9 score less than 5. This measure
applies to both patients with newly diagnosed and existing
depression whose current PHQ-9 score indicates a need for
treatment.
1:.11"'
- .e-.5 El
..... t: e'll
;-;=51>
0 = g.=
o~t
MNCM
MU2
AMAPCPI/
ACCF/
AHA
MU2
Several commenters for PQRS and the Shared Savings
Program expressed concern over use of the PHQ-9, indicating
not all practices use this tool. CMS appreciates commenter
feedback and concerns regarding issues with the use ofPHQ9. CMS recognizes there may beEPs reporting who do not
currently use this tool and because of the look back period
may not be able to implement this tool in time for the next
reporting period, and as such CMS is considered adjustments
to how this measure will be reported, specifically for the
Shared Savings Program. CMS continues to believe this
Depression Remission measure represents an important
outcome. Depression management is particularly important
due the effects on patient adherence with treatment for other
chronic conditions. For these reasons, CMS is finalizing its
proposal to make this measure reportable through the GPRO
WI in 2015 PQRS and the Shared Savings Program. Given
the comments and concerns raised regarding the use of the
PHQ-9 tool and providing ACOs with time to make
necessary adjustments for implementation, the measure will
be designated as pay-for-reporting under the Shared Savings
Program for all3 years of an A CO's first agreement period,
in the
's final measure set.
0067/
006
Coronary
Artery
Disease
Effective
Clinical
Care
Coronary Artery Disease (CAD): Antiplatelet Therapy:
Percentage of patients aged 18 years and older with a
diagnosis of coronary artery disease (CAD) seen within a 12
month period who were prescribed aspirin or clopidogrel.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00354
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.155</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
Commenters agreed with the addition of this measure, but
recommended testing the composite and maintaining as only
pay-for-reporting for the Shared Savings Program. Other
commenters did not agree with including this measure due to
concerns that the composite has not been reviewed by NQF
and has not been tested before implementation. CMS agrees
this measure needs to be tested as part of the composite prior
to implementation and as such, CMS is not finalizing its
proposal to include this measure for reporting in for the
GPRO web interface and Shared
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
r:.;oo.
0~
z~
0070/
007
0056/
163
N/A/
242
GPRO
Module
Coronary
Artery
Disease
Diabetes
Mellitus
Coronary
Artery
Disease
Effective
Clinical
Care
Effective
Clinical
Care
Effective
Clinical
Care
=
-.. .
"'"=
NQS
Domain
e'll
Measure and Title Description'~'
~ ~
~00
Coronary Artery Disease (CAD): Beta-Blocker TherapyPrior Myocardial Infarction (MI) or Left Ventricular
Systolic Dysfunction (LVEF < 40%): Percentage of patients
aged 18 years and older with a diagnosis of coronary artery
disease seen within a 12 month period who also have prior
MI OR a current or LVEF < 40% who were prescribed betablocker therapy
Some commenters agreed with the addition of this measure
while others did not agree with including this measure and
suggested testing and submission to NQF. We also believe
this measure is topped out. Therefore, CMS is not finalizing
its proposal to include this measure for reporting for the
PQRS and Shared Savings Program GPRO web interface.
Diabetes: Foot Exam: Percentage of patients aged 18-75
years of age with diabetes who had a foot exam during the
measurement period
While several commenters supported the addition of this
measure, many commenters did not support the inclusion of
this process measure and suggested further testing of the
composite as well as identifying the link to improved
outcomes. Furthermore, CMS believes the measures that are
being finalized for the Diabetes Composite represent a robust,
outcome focused set of measures with room for quality
improvement. Therefore, CMS is not finalizing its proposal to
make this measure reportable through the GPRO WI in 2015
PQRS and the Shared Savings Program.
Coronary Artery Disease (CAD): Symptom Management:
Percentage of patients aged 18 years and older with a
diagnosis of coronary artery disease (CAD) seen within a 12
month period with results of an evaluation oflevel of activity
and an assessment of whether anginal symptoms are present
or absent with appropriate management of anginal symptoms
within a 12 month period
67901
1:.11"'
- .e-.5 El
..... t: e'll
;-;=51>
0 = g.=
o~t
AMAPCPI/
ACCF/
AHA
MU2
NCQA
MU2
AMAPCPI/
ACCF/
AHA
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00355
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.156</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
Some commenters agreed with CMS' proposal to include this
measure in the GPRO WI. However, most commenters did
not support including the measure due to lack ofNQF
endorsement and the reporting burden/challenges if the
measure is finalized. Due to the comments received not
supporting the measure due to reporting burden, CMS is not
fmalizing its proposal to include this measure for reporting in
2015 PQRS and Shared Savings Program GPRO web
interface.
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
BILLING CODE 4120–01–C
f. The Clinician Group (CG) Consumer
Assessment of Healthcare Providers and
Systems (CAHPS) Survey
ebenthall on DSK5SPTVN1PROD with $$_JOB
In the CY 2014 PFS final rule with
comment period, we finalized the CG–
CAHPS survey available for reporting
under the PQRS for 2014 and beyond
(78 FR 74750 through 74751), to which
we are now referring as the CAHPS for
PQRS. Please note that, in the CY 2014
PFS final rule with comment period, we
classified the CAHPS for PQRS survey
under the care coordination and
communication NQS domain. We noted
that this was an error on our part, as the
CAHPS for PQRS survey has typically
been classified under the Person and
Caregiver-Centered Experience and
Outcomes domain as the CAHPS for
PQRS survey assesses beneficiary
experience of care and outcomes.
Therefore, as we indicated in Table 21
of the CY 2015 proposed rule, we
proposed to reclassify the CAHPS for
PQRS survey under the Person and
Caregiver-Centered Experience and
Outcomes domain. We invited public
comment on this proposal. Please note
that the comments on this proposal are
addressed in Table 54, where the
domain change for CAHPS for PQRS as
well as other PQRS measures is
indicated.
6. Statutory Requirements and Other
Considerations for the Selection of
PQRS Quality Measures for Meeting the
Criteria for Satisfactory Participation in
a QCDR for 2014 and Beyond for
Individual Eligible Professionals
For the measures which eligible
professionals participating in a QCDR
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
must report, section 1848(m)(3)(D) of
the Act, as amended and added by
section 601(b) of the ATRA, provides
that the Secretary shall treat eligible
professionals as satisfactorily submitting
data on quality measures if they
satisfactorily participate in a QCDR.
Section 1848(m)(3)(E) of the Act, as
added by section 601(b) of the ATRA,
provides some flexibility with regard to
the types of measures applicable to
satisfactory participation in a QCDR, by
specifying that for measures used by a
QCDR, sections 1890(b)(7) and 1890A(a)
of the Act shall not apply, and measures
endorsed by the entity with a contract
with the Secretary under section 1890(a)
of the Act may be used.
In the CY 2014 PFS final rule with
comment period, we finalized
requirements related to the parameters
for the measures that would have to be
reported to CMS by a QCDR for the
purpose of its individual eligible
professionals meeting the criteria for
satisfactory participation under the
PQRS (78 FR 74751 through 74753).
Although we did not propose to remove
any of the requirements we finalized
related to these parameters, we
proposed to modify the following
parameters we finalized in the CY 2014
PFS final rule with comment period
related to measures that may be reported
by a QCDR (79 FR 40472 through
40473):
• The QCDR must have at least 1
outcome measure available for
reporting, which is a measure that
assesses the results of health care that
are experienced by patients (that is,
patients’ clinical events; patients’
recovery and health status; patients’
PO 00000
Frm 00356
Fmt 4701
Sfmt 4700
experiences in the health system; and
efficiency/cost).
As we proposed that for an eligible
professional to meet the criterion for
satisfactory participation in a QCDR for
the 2017 PQRS payment adjustment, the
eligible professional must report on at
least 3 outcome measures or, in lieu of
3 outcome measures, at least 2 outcome
measures and 1 resource use, patient
experience of care, or efficiency/
appropriate use measure, we modified
this requirement to conform to this
satisfactory participation criterion.
Therefore, we proposed that a QCDR
must have at least 3 outcome measures
available for reporting, which is a
measure that assesses the results of
health care that are experienced by
patients (that is, patients’ clinical
events; patients’ recovery and health
status; patients’ experiences in the
health system; and efficiency/cost). In
lieu of having 3 outcome measures
available for reporting, the QCDR must
have at least 2 outcome measures
available for reporting and at least 1
resource use, patient experience of care,
or efficiency/appropriate use measure
(79 FR 40473). We solicited and
received the following comments on
this proposal:
Comment: As the majority of
commenters opposed our proposal to
require the reporting of 3 outcomes
measures to meet the criteria for
satisfactory participation for the 2017
PQRS payment adjustment, for the same
reasons, the majority of commenters
also opposed our proposal to require
that a QCDR must have at least 3
outcome measures available for
reporting, or, in lieu of 3 outcome
measures, a QCDR have at least 2
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.157</GPH>
67902
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
outcome measures available for
reporting and at least 1 resource use,
patient experience of care, or efficiency/
appropriate use measure. The
commenters believed this proposed
requirement was overly burdensome for
QCDRs.
Response: We responded to the
commenters’ concerns regarding our
proposal to require the reporting of 3
outcomes measures to meet the criteria
for satisfactory participation for the
2017 PQRS payment adjustment at
III.K.3.a. For the same reasons discussed
in that section, we are modifying our
proposal to require that a QCDR must
have at least 3 outcome measures
available for reporting, or, in lieu of 3
outcome measures, a QCDR have at least
2 outcome measures available for
reporting and at least 1 resource use,
patient experience of care, or efficiency/
appropriate use measure. To correspond
with the final criteria for the satisfactory
participation for the 2017 PQRS
payment adjustment, for 2015 and
beyond, we are modifying this proposal
to require that a QCDR have at least 2
outcome measures available for
reporting. An outcomes measure is a
measure that assesses the results of
health care that are experienced by
patients (that is, patients’ clinical
events; patients’ recovery and health
status; patients’ experiences in the
health system; and efficiency/cost). In
lieu of having 2 outcomes measures
available for reporting, the QCDR must
at least have 1 outcome measure
available for reporting and at least 1
resource use, patient experience of care,
efficiency/appropriate use measure, or
patient safety measure. We believe this
is an appropriate modification, as
QCDRs that only have the ability to
report 1 outcome measure may still
report 1 outcome measure as long as the
QCDR has another measure (resource
use, patient experience of care,
efficiency/appropriate use measure, or
patient safety measure) in another
domain available for reporting.
We proposed to define resource use,
patient experience of care, or efficiency/
appropriate use measures in the
following manner (79 FR 40473):
• A resource use measure is a
measure that is a comparable measure of
actual dollars or standardized units of
resources applied to the care given to a
specific population or event, such as a
specific diagnosis, procedure, or type of
medical encounter. We did not receive
any comments on this proposed
definition of a resource use measure. As
such, we are finalizing this definition of
a resource use measure as proposed.
• A patient experience of care
measure is a measure of person- or
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
family-reported experiences (outcomes)
of being engaged as active members of
the health care team and in
collaborative partnerships with
providers and provider organizations.
We did not receive any comments on
this proposed definition of a patient
experience of care measure. As such, we
are finalizing this definition of a patient
experience of care measure as proposed.
• An efficiency/appropriate use
measure is a measure of the appropriate
use of health care services (such as
diagnostics or therapeutics) based upon
evidence-based guidelines of care, or for
which the potential for harm exceeds
the possible benefits of care. We did not
receive any comments this proposed
definition of an efficiency/appropriate
use measure. As such, we are finalizing
this definition of an efficiency/
appropriate use measure as proposed.
Please note that, for purposes of
meeting the criteria for satisfactory
participation in a QCDR, we allow
QCDRs to report on any measure if it
meets the measure parameters we
finalize. We noted that we would allow
and encourage the reporting of the
Consumer Assessment of Healthcare
Providers Surgical Care Survey (S–
CAHPS) through a QCDR.
Finally, in the CY 2014 PFS final rule
with comment period, we stated that a
QCDR must provide to CMS
descriptions and narrative specifications
for the measures for which it will report
to CMS by no later than March 31, 2014.
In keeping with this timeframe, we
proposed that a QCDR must provide to
CMS descriptions for the measures for
which it will report to CMS for a
particular year by no later than March
31 of the applicable reporting period for
which the QCDR wishes to submit
quality measures data. We solicited and
received the following comments on
this proposal:
Comment: Commenters believed that
it was reasonable to require a QCDR to
provide to CMS descriptions and
narrative specifications for the measures
for which it will report to CMS by no
later than March 31, 2014.
Response: We appreciate the
commenters’ feedback. Based on the
comments received, we are finalizing
our proposal to require that a QCDR
must provide to CMS descriptions for
the measures for which it will report to
CMS for a particular year by no later
than March 31 of the applicable
reporting period for which the QCDR
wishes to submit quality measures data.
For example, if a QCDR wishes to
submit quality measures data for the
2017 PQRS payment adjustment (the 12month reporting period of which occurs
in 2015), the QCDR must provide to
PO 00000
Frm 00357
Fmt 4701
Sfmt 4700
67903
CMS descriptions for the measures for
which it will report to CMS by no later
than March 31, 2015. The descriptions
must include: name/title of measures,
NQF # (if NQF-endorsed), descriptions
of the denominator, numerator, and
when applicable, denominator
exceptions and denominator exclusions
of the measure. The narrative
specifications provided must be similar
to the narrative specifications we
provide in our measures list, available at
https://www.cms.gov/apps/ama/
license.asp?file=/PQRS/downloads/
2014_PQRS_IndClaimsRegistry_
MeasureSpecs_SupportingDocs_
12132013.zip.
Related to this proposal, we proposed
that, 15 days following CMS approval of
these measure specifications, the QCDR
must publicly post the measures
specifications for the measures it
intends to report for the PQRS using any
public format it prefers. Immediately
following posting of the measures
specification information, the QCDR
must provide CMS with the link to
where this information is posted. CMS
will then post this information when it
provides its list of QCDRs for the year.
We believe providing this information
will further aid in creating transparency
of reporting. We solicited and received
the following comment on this proposal:
Comment: Some commenters
supported this proposal, as the
commenters believe it was reasonable to
require that this information be made
available to the public. The commenters
supported our proposal to defer to the
QCDR in terms of what platform and in
what manner this data may be made
available to the public. Some
commenters opposed this proposal
based on their concerns that the public
reporting requirement was overly
burdensome and urged CMS to delay
requiring the posting of measures data
until the measures have been tested for
validity and reliability. The commenters
believed that CMS should not make
substantial changes in the QCDR
requirements, as the QCDR option is
new and the entities need time to
familiarize themselves with the QCDR
option before new requirements are
established. One commenter preferred
public reporting of QCDR quality
measures data through a single site so
that information would be easily
accessible and people seeking this
information would not be forced to look
through multiple sites.
Response: With respect to the
commenters who opposed this proposal
and urged us not to make additional
changes to the QCDR option while
entities become more familiar with this
option, we understand the commenters’
E:\FR\FM\13NOR2.SGM
13NOR2
67904
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
concerns. However, we believe that
transparency of data is a key component
of a QCDR option. Furthermore, in the
CY 2014 PFS final rule, while we did
not finalize our proposal that a QCDR
have a plan to publicly report quality
measures data, we noted that we
encouraged QCDRs ‘‘to move towards
the public reporting of quality measures
data’’ and stated that ‘‘[w]e plan to
establish such a requirement in the
future and will revisit this proposed
requirement as part of CY 2015
rulemaking’’ (78 FR 74471). Therefore,
we believe that QCDRs were on notice
that we would finalize a requirement to
make quality measures data available to
the public. With respect to the
commenter that preferred this
information to be posted on a single site,
we note that the Physician Compare
Web site will provide quality measures
data information on eligible
professionals participating in QCDRs.
Therefore, while the QCDRs are free to
provide this information elsewhere, the
Physician Compare Web site will serve
as a point where all information will be
accessible. Based on the reasons we
stated above and in the proposed rule,
we are finalizing our proposal to require
that, 15 days following CMS approval of
these measure specifications, a QCDR
must publicly post the measures
specifications for the measures it
intends to report for the PQRS using any
public format it prefers. Immediately
following posting of the measures
specification information, the QCDR
must provide CMS with the link to
where this information is posted. CMS
will then post this information when it
provides its list of QCDRs for the year.
7. Informal Review
In the CY 2013 PFS final rule with
comment period (77 FR 69289), we
established that ‘‘an eligible
professional electing to utilize the
informal review process must request an
informal review by February 28 of the
year in which the payment adjustment
is being applied. For example, if an
eligible professional requests an
informal review related to the 2015
payment adjustment, the eligible
professional would be required to
submit his/her request for an informal
review by February 28, 2015.’’ As stated
in the CY 2013 PFS final rule with
comment period, we believed this
deadline provided ample time for
eligible professionals and group
practices after their respective claims
begin to be adjusted due to the payment
adjustment. However, because PQRS
data is used to establish the quality
composite of the VM, we believe it is
necessary to expand the informal review
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
process to allow for some limited
corrections of the PQRS data to be
made. Therefore, we proposed to modify
the payment adjustment informal
review deadline to within 30 days of the
release of the feedback reports. For
example, if the feedback reports for the
2016 payment adjustment (based on
data collected for 2014 reporting
periods) were released on August 31,
2015, an eligible professional or group
practice would be required to submit a
request for an informal review by
September 30, 2015. We believe that by
being able to notify eligible
professionals and group practices of
CMS’ decision on the informal review
request much earlier than we would
have been able to do with the previous
informal review request deadline we
can provide a brief period for an eligible
or group practice to make some limited
corrections to its PQRS data. This
resubmitted data could then be used to
make corrections to the VM
calculations, when appropriate.
The PQRS regulations at
§ 414.90(m)(1) currently require an
eligible professional or group practice to
submit an informal review request to
CMS within 90 days of the release of the
feedback reports. Therefore, we
proposed to revise § 414.90(m)(1) to
require the request of the informal
review within 30 days of release of the
feedback reports.
Regarding the eligible professional’s
or group practice’s ability to provide
additional information to assist in the
informal review process, we proposed to
provide the following limitations as to
what information might be taken into
consideration:
• CMS would only allow
resubmission of data that was submitted
using a third-party vendor using the
qualified registry, EHR data submission
vendor, or QCDR reporting mechanisms.
Therefore, CMS would not allow
resubmission of data submitted via
claims, direct EHR, or the GPRO web
interface reporting mechanisms. We are
limiting resubmission to third-party
vendors, because we believe that thirdparty vendors are more easily able to
detect errors than direct users.
• CMS would only allow
resubmission of data that was already
previously submitted to CMS.
Submission of new data—such as new
measures data not previously submitted
or new data for eligible professionals for
which data was not submitted during
the original submission period—would
not be accepted.
• For any given resubmission period,
CMS would only accept data that was
previously submitted for the reporting
periods for which the corresponding
PO 00000
Frm 00358
Fmt 4701
Sfmt 4700
informal review period applies. For
example, the resubmission period
immediately following the informal
review period for the 2017 PQRS
payment adjustment would only allow
resubmission for data previously
submitted for the 2017 PQRS payment
adjustment reporting periods occurring
in 2015.
As such, we proposed to add
§ 414.90(m)(3) to reflect this proposal as
follows: (3) If, during the informal
review process, CMS finds errors in data
that was submitted using a third-party
vendor using either the qualified
registry, EHR data submission vendor,
or QCDR reporting mechanisms, CMS
may allow for the resubmission of data
to correct these errors. (i) CMS will not
allow resubmission of data submitted
via claims, direct EHR, and the GPRO
web interface reporting mechanisms. (ii)
CMS will only allow resubmission of
data that was already previously
submitted to CMS. (iii) CMS will only
accept data that was previously
submitted for the reporting periods for
which the corresponding informal
review period applies.
We invited public comment on these
proposals. The following is summary of
the comments we received regarding on
these proposals.
Comment: Several commenters
opposed our proposal to change the
amount of time an eligible professional
or group practice would have to submit
an informal review request to 30 days.
One commenter stated that it was
necessary to have a longer timeframe, as
accessing PQRS feedback reports can be
extremely cumbersome and timeintensive. The commenters believed that
30 days was an insufficient amount of
time to access, analyze, and identify
errors in the PQRS feedback reports.
Some of these commenters urged CMS
to extend the request period to 60 or 90
days in lieu of 30 days.
Response: We understand that this
provides eligible professionals and
group practices with a much shorter
timeline with which to submit an
informal review request. We also
understand the commenters’ concerns
regarding having to access and analyze
the feedback reports as well as
submitting an informal review request
within 30 days. As we stated in the
proposed rule, it is necessary to shorten
the timeline in order to be allow for the
resubmission of data, if applicable to the
eligible professional or group practice.
However, given these concerns, we will
increase the amount of time in which
eligible professionals and group
practices may submit an informal
review request. In order to finalize our
proposal to allow for the resubmission
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
of data, it is necessary to receive all
informal review requests within 60 days
of the release of the feedback reports. At
this time, we believe the 60-day
deadline still provides us with enough
time to allow for the resubmission of
data. However, should we find that
more time is needed to process
resubmissions, we reserve the right to
propose further changes to this deadline
in future rulemaking. Therefore, for the
reasons stated above and in the
proposed rule, we are finalizing our
proposal to modify § 414.90(m)(1) to
indicate the payment adjustment
informal review deadline to within 60
days of the release of the feedback
reports beginning in 2015.
Comment: Several commenters
generally supported our proposal to
allow for resubmission of data.
Response: We appreciate the
commenters’ support for this proposal.
Based on the support for this proposal
and for the reasons we stated in the
proposed rule, we are finalizing our
proposal to allow for resubmission of
data as proposed. As we proposed, we
are providing the following limitations
as to what information might be taken
into consideration:
• CMS would only allow
resubmission of data that was submitted
by a third-party vendor on behalf of an
eligible professional or group practice
using the qualified registry, EHR data
submission vendor, or QCDR reporting
mechanisms. Therefore, CMS would not
allow resubmission of data submitted
via claims, direct EHR, or the GPRO web
interface reporting mechanisms. We are
limiting resubmission to third-party
vendors, because we believe that thirdparty vendors are more easily able to
detect errors than direct users.
• CMS would only allow
resubmission of data that was already
previously submitted to CMS.
Submission of new data—such as new
measures data not previously submitted
or new data for eligible professionals for
which data was not submitted during
the original submission period—would
not be accepted.
• For any given resubmission period,
CMS would only accept data that was
previously submitted for the reporting
periods for which the corresponding
informal review period applies. For
example, the resubmission period
immediately following the informal
review period for the 2017 PQRS
payment adjustment would only allow
resubmission for data previously
submitted for the 2017 PQRS payment
adjustment reporting periods occurring
in 2015.
Because of the comments received
and for the reasons stated above and in
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
the proposed rule, we are finalizing our
proposal to modify the payment
adjustment informal review deadline to
within 60 days of the release of the
feedback reports. In addition, to allow
resubmission of data, we are finalizing
our proposal, as proposed, to add
§ 414.90(m)(3) as follows: (3) If, during
the informal review process, CMS finds
errors in data that was submitted using
a third-party vendor using either the
qualified registry, EHR data submission
vendor, or QCDR reporting mechanisms,
CMS may allow for the resubmission of
data to correct these errors. (i) CMS will
not allow resubmission of data
submitted via claims, direct EHR, and
the GPRO web interface reporting
mechanisms. (ii) CMS will only allow
resubmission of data that was already
previously submitted to CMS. (iii) CMS
will only accept data that was
previously submitted for the reporting
periods for which the corresponding
informal review period applies.
L. Electronic Health Record (EHR)
Incentive Program
The HITECH Act (Title IV of Division
B of the ARRA, together with Title XIII
of Division A of the ARRA) authorizes
incentive payments under Medicare and
Medicaid for the adoption and
meaningful use of certified EHR
technology (CEHRT). Section
1848(o)(2)(B)(iii) of the Act requires that
in selecting CQMs for eligible
professionals (EPs) to report under the
EHR Incentive Program, and in
establishing the form and manner of
reporting, the Secretary shall seek to
avoid redundant or duplicative
reporting otherwise required. As such,
we have taken steps to establish
alignments among various quality
reporting and payment programs that
include the submission of CQMs.
For CY 2012 and subsequent years,
§ 495.8(a)(2)(ii) requires an EP to
successfully report the clinical quality
measures selected by CMS to CMS or
the states, as applicable, in the form and
manner specified by CMS or the states,
as applicable.
In the CY 2014 PFS final rule with
comment period (78 FR 74756), we
finalized our proposal to require EPs
who seek to report CQMs electronically
under the Medicare EHR Incentive
Program to use the most recent version
of the electronic specifications for the
CQMs and have CEHRT that is tested
and certified to the most recent version
of the electronic specifications for the
CQMs. We noted it is important for EPs
to electronically report the most recent
versions of the electronic specifications
for the CQMs as updated measure
versions correct minor inaccuracies
PO 00000
Frm 00359
Fmt 4701
Sfmt 4700
67905
found in prior measure versions. We
stated that to ensure that CEHRT
products can successfully transmit CQM
data using the most recent version of the
electronic specifications for the CQMs,
it is important that the product be tested
and certified to the most recent version
of the electronic specifications for the
CQMs.
Since finalizing this proposal, we
have received feedback from
stakeholders regarding the difficulty and
expense of having to test and recertify
CEHRT products to the most recent
version of the electronic specifications
for the CQMs. Although we still believe
EPs should test and certify their
products to the most recent version of
the electronic specifications for the
CQMs when feasible, we understand the
burdens associated with this
requirement. Therefore, to eliminate this
added burden, we proposed that,
beginning in CY 2015, EPs would not be
required to ensure that their CEHRT
products are recertified to the most
recent version of the electronic
specifications for the CQMs. Please note
that, although we are not requiring
recertification, EPs must still report the
most recent version of the electronic
specifications for the CQMs.
In the CY 2014 PFS final rule with
comment period, we established the
requirement that EPs who seek to report
CQMs electronically under the Medicare
EHR Incentive Program must use the
most recent version of the electronic
specifications for the CQMs (78 FR
74756). We solicited and received the
following public comments on these
proposals:
Comment: The majority of
commenters supported our proposal not
to require EPs to recertify their EHR
products to the most recent version of
the eCQMs. One commenter opposed
this proposal, stating that if we did not
require recertification some products
run the risk of not being able to perform
critical Stage 2 functions such as secure
messaging between patients and
providers, offering patients the ability to
view, download, and transmit their own
health information, and improving care
transitions with a summary of care
record for transitions and referrals.
Response: We appreciate the
commenters’ support for this proposal.
With respect to the commenter who
opposed this proposal, we agree that it
is important to recertify as frequently as
possible for the reasons the commenter
stated. However, at this time, we
understand that requiring recertification
to the most recent version of the
electronic specifications for the CQMs,
which could occur annually, may be
overly burdensome and time-consuming
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67906
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
for providers. Please note that this
proposal was limited to EPs and not
intended to apply to eligible hospitals
(EHs) or critical access hospitals. Based
on the comments received and for the
reasons stated in the proposed rule, we
are finalizing our proposal that,
beginning in CY 2015, EPs are not
required to ensure that their CEHRT
products are recertified to the most
recent version of the electronic
specifications for the CQMs. Although
we are not requiring recertification, EPs
must still report the most recent version
of the electronic specifications for the
CQMs.
Additionally, we noted in the
proposed rule that, with respect to the
following measure CMS140v2, Breast
Cancer Hormonal Therapy for Stage IC–
IIIC Estrogen Receptor/Progesterone
Receptor (ER/PR) Positive Breast Cancer
(NQF 0387), a substantive error was
discovered in the June 2013 version of
this electronically specified clinical
quality measure (79 FR 40474). If an EP
chooses to report this measure
electronically under the EHR Incentive
Program in CY 2014, the prior,
December 2012 version of the measure,
which is CMS140v1, must be used (78
FR 74757). In the proposed rule (79 FR
40474), we stated that because a more
recent and corrected version of this
measure has been developed, we will
require the reporting of the most recent,
updated version of the measure Breast
Cancer Hormonal Therapy for Stage IC–
IIIC Estrogen Receptor/Progesterone
Receptor (ER/PR) Positive Breast Cancer
(NQF 0387), if an EP chooses to report
the measure electronically in CY 2015.
In the EHR Incentive Program Stage 2
final rule, we established CQM
reporting options for the Medicare EHR
Incentive Program for CY 2014 and
subsequent years that include one
individual reporting option that aligns
with the PQRS’s EHR reporting option
(77 FR 54058) and two group reporting
options that align with the PQRS GPRO
and Medicare Shared Savings Program
(MSSP) and Pioneer ACOs (77 FR 54076
to 54078). In the CY 2014 PFS final rule
with comment period, we finalized two
additional aligned options for EPs to
report CQMs for the Medicare EHR
Incentive Program for CY 2014 and
subsequent years with the intention of
minimizing the reporting burden on EPs
(78 FR 74753 through 74757). One of the
aligned options finalized in the CY 2014
PFS final rule with comment period (78
FR 74754 through 74755) is a reporting
option for CQMs for the Medicare EHR
Incentive Program under which EPs can
submit CQM information using
qualified clinical data registries,
according the definition and
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
requirements for qualified clinical data
registries established under the PQRS.
The second aligned option finalized
in the CY 2014 PFS final rule with
comment period (78 FR 74755 through
74756) is a group reporting option for
CQMs for the Medicare EHR Incentive
Program beginning in CY 2014 under
which EPs who are part of a
Comprehensive Primary Care (CPC)
initiative practice site that successfully
reports at least nine electronically
specified CQMs across three domains
for the relevant reporting period in
accordance with the requirements
established for the CPC initiative and
using CEHRT would satisfy the CQM
reporting component of meaningful use
for the Medicare EHR Incentive
Program. If a CPC practice site is not
successful in reporting, EPs who are
part of the site would still have the
opportunity to report CQMs in
accordance with the requirements
established for the Medicare EHR
Incentive Program in the Stage 2 final
rule. Additionally, only those EPs who
are beyond their first year of
demonstrating meaningful use may use
this CPC group reporting option. The
CPC practice sites must submit the CQM
data in the form and manner required by
the CPC initiative. Therefore, whether
CPC required electronic submission or
attestation of CQMs, the CPC practice
site must submit the CQM data in the
form and manner required by the CPC
initiative.
The CPC initiative, under the
authority of section 3021 of the
Affordable Care Act, is a multi-payer
initiative fostering collaboration
between public and private health care
payers to strengthen primary care.
Under this initiative, we will pay
participating primary care practices a
care management fee to support
enhanced, coordinated services.
Simultaneously, participating
commercial, state, and other federal
insurance plans are also offering
enhanced support to primary care
practices that provide high-quality
primary care. There are approximately
483 CPC practice sites across 7 health
care markets in the U.S. More details on
the CPC initiative can be found at
https://innovation.cms.gov/initiatives/
Comprehensive-Primary-Care-Initiative/
index.html.
Under the CPC initiative, CPC
practice sites are required to report to
CMS a subset of the CQMs that were
selected in the EHR Incentive Program
Stage 2 final rule for EPs to report under
the EHR Incentive Program beginning in
CY 2014 (for a list of CQMs that were
selected in the EHR Incentive Program
Stage 2 final rule for EPs to report under
PO 00000
Frm 00360
Fmt 4701
Sfmt 4700
the EHR Incentive Program beginning in
CY 2014, see 77 FR 54069 through
54075). We proposed to retain the group
reporting option for CPC practice sites
as finalized in the CY 2014 PFS final
rule, but to relax the requirement for the
CQMs to cover three domains. Instead,
we proposed that, for CY 2015 only,
under this group reporting option, the
CPC practice site must report a
minimum of nine CQMs from the CPC
subset, and the nine CQMs reported
must cover at least 2 domains, although
we strongly encouraged practice sites to
report across more domains if feasible.
Although the requirement to report
across three domains is important
because the domains are linked to the
National Quality Strategy and used
throughout CMS quality programs, the
CPC practice sites are required to report
from a limited number of CQMs that
were selected for the EHR Incentive
Program and are focused on a primary
care population. Therefore, these CPC
practice sites may not have measures to
select from that cover three domains.
Additionally, CPC practice sites are
assessed for quality performance on
measures other than electronically
specified CQMs which do cover other
National Quality Strategy domains. We
invited public comment on this
proposal.
The following is a summary of the
comments we received regarding our
proposal on the group reporting option
for CPC practice sites.
Comment: A few commenters
indicated general support for relaxing
the domain requirement for the primary
care physicians, indicating providers
should be able to select the measures
most applicable to their population.
Response: We appreciate the support
for this proposal. The CPC CQM set
targets a primary care patient
population and therefore is appropriate
for reporting by CPC practice sites in the
model.
Comment: One commenter opposed
relaxing the reporting requirements for
CPC practice sites to only report 2
domains instead of 3. The commenter
indicated consumers and purchasers
want to see measures across these
domains reported electronically. The
commenter believed CPC practice sites
have sufficient measures to choose from
to report 9 measures that cover 3
domains.
Response: The CPC initiative is a
model tested by the Center for Medicare
and Medicaid Innovation. As such, CPC
includes specific quality measure
reporting requirements for each CPC
practice site to be eligible to participate
in any Medicare shared savings, which
is a component of the model. The
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
quality reporting requirements include
reporting on a subset of the CQMs
selected for the EHR Incentive Program
beginning in CY 2014.
The CPC measure subset includes a
total of 11 measures, of which 7 fall in
the clinical process/effectiveness
domain, 3 in the population health
domain, and 1 in the safety domain. We
proposed to reduce the number of
domains required to at least 2 domains
to allow CPC practice sites that would
be unable to obtain in their EHR the one
safety CQM in the CPC measure subset
to meet the MU CQM requirement. This
would provide CPC practice sites an
opportunity to successfully report to the
CPC model and satisfy the CQM
reporting component of meaningful use,
so they would not have to report quality
measures twice to both CPC and the
Medicare EHR Incentive Program.
After consideration of the comments
received, and for the reasons stated
previously, we are finalizing the
proposal to reduce the required number
of domains for CY 2015 only as
proposed.
M. Medicare Shared Savings Program
Under section 1899 of the Act, CMS
has established the Medicare Shared
Savings program (Shared Savings
Program) to facilitate coordination and
cooperation among providers to
improve the quality of care for Medicare
Fee-For-Service (FFS) beneficiaries and
reduce the rate of growth in health care
costs. Eligible groups of providers and
suppliers, including physicians,
hospitals, and other health care
providers, may participate in the Shared
Savings Program by forming or
participating in an Accountable Care
Organization (ACO). The final rule
implementing the Shared Savings
Program appeared in the November 2,
2011 Federal Register (Medicare Shared
Savings Program: Accountable Care
Organizations Final Rule (76 FR
67802)).
Section 1899(b)(3)(A) of the Act
requires the Secretary to determine
appropriate measures to assess the
quality of care furnished by ACOs, such
as measures of clinical processes and
outcomes; patient, and, wherever
practicable, caregiver experience of care;
and utilization such as rates of hospital
admission for ambulatory sensitive
conditions. Section 1899(b)(3)(B) of the
Act requires ACOs to submit data in a
form and manner specified by the
Secretary on measures that the Secretary
determines necessary for ACOs to report
to evaluate the quality of care furnished
by ACOs. Section 1899(b)(3)(C) of the
Act requires the Secretary to establish
quality performance standards to assess
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
the quality of care furnished by ACOs,
and to seek to improve the quality of
care furnished by ACOs over time by
specifying higher standards, new
measures, or both for the purposes of
assessing the quality of care.
Additionally, section 1899(b)(3)(D) of
the Act gives the Secretary authority to
incorporate reporting requirements and
incentive payments related to the PQRS,
EHR Incentive Program and other
similar initiatives under section 1848 of
the Act. Finally, section 1899(d)(1)(A) of
the Act states that an ACO is eligible to
receive payment for shared savings, if
they are generated, only after meeting
the quality performance standards
established by the Secretary.
In the November 2011 final rule
establishing the Shared Savings
Program, we established the quality
performance standards that ACOs must
meet to be eligible to share in savings
that are generated (76 FR 67870 through
67904). Quality performance measures
are submitted by ACOs through a CMS
web interface, currently the group
practice reporting option (GPRO) web
interface, calculated by CMS from
internal and claims data, and collected
through a patient and caregiver
experience of care survey.
Consistent with the directive under
section 1899(b)(3)(C) of the Act, we
believe the existing Shared Savings
Program regulations incorporate a built
in mechanism for encouraging ACOs to
improve care over the course of their 3year agreement period, and to reward
quality improvement over time. During
the first year of the agreement period,
ACOs can qualify for the maximum
sharing rate by completely and
accurately reporting all quality
measures. After that, ACOs must meet
certain thresholds of performance,
which are currently phased in over the
course of the ACO’s first agreement
period, and are rewarded for improved
performance on a sliding scale in which
higher levels of quality performance
translate to higher rates of shared
savings (or, for ACOs subject to
performance-based risk that
demonstrate losses, lower rates of
shared losses). In this way, the quality
performance standard increases over the
course of the ACO’s agreement period.
Additionally, we have made an effort
to align quality performance measures,
submission methods, and incentives
under the Shared Savings Program with
the PQRS. Eligible professionals
participating in an ACO may qualify for
the PQRS incentive payment under the
Shared Savings Program or avoid the
downward PQRS payment adjustment
when the ACO satisfactorily reports the
PO 00000
Frm 00361
Fmt 4701
Sfmt 4700
67907
ACO GPRO measures on their behalf
using the GPRO web interface.
Since the November 2011 final rule
establishing the Shared Savings Program
was issued, we have revisited certain
aspects of the quality performance
standard in the annual PFS rulemaking
out of a desire to ensure thoughtful
alignment with the agency’s other
quality incentive programs that are
addressed in that rule. Specifically, we
have updated our rules to align with
PQRS and the EHR Incentive Program,
and addressed issues related to
benchmarking and scoring ACO quality
performance (77 FR 69301 through
69304; 78 FR 74757 through 74764).
This year, as part of the CY 2015
Physician Fee Schedule proposed rule,
we addressed several issues related to
the Shared Savings Program quality
performance standard and alignment
with other CMS quality initiatives.
Specifically, we revisited the current
quality performance standard, proposed
changes to the quality measures, and
sought comment on future quality
performance measures. We also
proposed to modify the timeframe
between updates to the quality
performance benchmarks, to establish
an additional incentive to reward ACO
quality improvement, and to make
several technical corrections to the
regulations in subpart F of Part 425.
1. Existing Quality Measures and
Performance Standard
As discussed previously,
section1899(b)(3)(C) of the Act states
that the Secretary may establish quality
performance standards to assess the
quality of care furnished by ACOs and
‘‘seek to improve the quality of care
furnished by ACOs over time by
specifying higher standards, new
measures, or both. . . .’’ In the
November 2011 Shared Savings Program
final rule, we established a quality
performance standard that consists of 33
measures. These measures are submitted
by the ACO through the GPRO web
interface, calculated by CMS from
administrative and claims data, and
collected via a patient experience of
care survey based on the Clinician and
Group Consumer Assessment of
Healthcare Providers and Systems (CG–
CAHPS) survey. Although the patient
experience of care survey used for the
Shared Savings Program includes the
core CG–CAHPS modules, this patient
experience of care survey also includes
some additional modules. Therefore, we
will refer to the patient experience of
care survey that is used under the
Shared Savings Program as CAHPS for
ACOs. The measures span four domains,
including patient experience of care,
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67908
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
care coordination/patient safety,
preventive health, and at-risk
population. The measures collected
through the GPRO web interface are also
used to determine whether eligible
professionals participating in an ACO
qualify for the 2013 and 2014 PQRS
incentive payment or avoid the PQRS
payment adjustment for 2015 and
subsequent years. Eligible professionals
in an ACO may qualify for the PQRS
incentive payment or avoid the
downward PQRS payment adjustment
when the ACO satisfactorily reports all
of the ACO GPRO measures on their
behalf using the GPRO web interface.
In selecting the 33 measure set, we
balanced a wide variety of important
considerations. Given that many ACOs
were expected to be newly formed
organizations, in the November 2011
Shared Savings Program final rule (76
FR 67886), we concluded that ACO
quality measures should focus on
discrete processes and short-term
measurable outcomes derived from
administrative claims and limited
medical record review facilitated by a
CMS-provided web interface to lessen
the burden of reporting. Because of the
focus on Medicare FFS beneficiaries,
our measure selection emphasized
prevention and management of chronic
diseases that have high impact on these
beneficiaries such as heart disease,
diabetes mellitus, and chronic
obstructive pulmonary disease. We
believed that the quality measures used
in the Shared Savings Program should
be tested, evidence-based, target
conditions of high cost and high
prevalence in the Medicare FFS
population, reflect priorities of the
National Quality Strategy, address the
continuum of care to reflect the
requirement that ACOs accept
accountability for their patient
populations, and align with existing
quality programs and value-based
purchasing initiatives.
At this time, we continue to believe
it is most appropriate to focus on quality
measures that directly assess the overall
quality of care furnished to FFS
beneficiaries. The set of 33 measures
that we adopted in the November 2011
Shared Savings Program final rule
includes measures addressing patient
experience, outcomes, and evidencebased care processes. Thus far, we have
not included any specific measures
addressing high cost services or
utilization since we believe that the
potential to earn shared savings offers
an important and direct incentive for
ACOs to address utilization issues in a
way that is most appropriate for their
organization, patient population, and
local healthcare environment. We note
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
that while the quality performance
standard is limited to these 33
measures, the performance of ACOs is
measured on many more metrics and
ACOs are informed of their performance
in these areas. For example, an
assessment of an ACO’s utilization of
certain resources is provided to the ACO
via quarterly reports that contain
information such as the utilization of
emergency services or the utilization of
CTs and MRIs.
As we have stated previously (76 FR
67872), our principal goal in selecting
quality measures for ACOs was to
identify measures of success in the
delivery of high-quality health care at
the individual and population levels.
We believe endorsed measures have
been tested, validated, and clinically
accepted, and therefore, selected the 33
measures with a preference for NQFendorsed measures. However, the
statute does not limit us to using
endorsed measures in the Shared
Savings Program. As a result we also
exercised our discretion to include
certain measures that we believe to be
high impact but that are not currently
endorsed, for example, ACO#11, Percent
of PCPs Who Successfully Qualify for an
EHR Incentive Program Payment.
In selecting the final set of 33
measures, we sought to include both
process and outcome measures,
including patient experience of care (76
FR 67873). Because ACOs are charged
with improving and coordinating care
and delivering high quality care, but
also need time to form, acquire
infrastructure and develop clinical care
processes, we continue to believe it is
important to have a combination of both
process and outcomes measures. We
note, however, that as other CMS
quality reporting programs, such as
PQRS, move to more outcomes-based
measures and fewer process measures
over time, we may also revise the
quality performance standard for the
Shared Savings Program to incorporate
more outcomes-based measures over
time.
Therefore, we viewed the 33 measures
adopted in the November 2011 Shared
Savings Program final rule as a starting
point for ACO quality measurement. As
we stated in that rule (67 FR 67891), we
plan to modify the measures in future
reporting cycles to reflect changes in
practice and improvements in quality of
care and to continue aligning with other
quality reporting programs and will add
and/or retire measures as appropriate
through the rulemaking process. In
addition, we are working with the
measures community to ensure that the
specifications for the measures used
under the Shared Savings Program are
PO 00000
Frm 00362
Fmt 4701
Sfmt 4700
up-to-date. We note that we must
balance the timing of the release of
specifications so they are as up-to-date
as possible, while also giving ACOs
sufficient time to review specifications.
Our intention is to issue the
specifications annually, prior to the start
of the reporting period for which they
will apply.
In the November 2011 Shared Savings
Program final rule (76 FR 67873), we
combined care coordination and patient
safety into a single domain to better
align with the National Quality Strategy
and to emphasize the importance of
ambulatory patient safety and care
coordination. We also intended to
continue exploring ways to best capture
ACO care coordination metrics and
noted that we would consider adding
new care coordination measures for
future years (67 FR 67877).
2. Changes to the Quality Measures
Used in Establishing Quality
Performance Standards That ACOs Must
Meet To Be Eligible for Shared Savings
a. Background and Proposal
Since the November 2011 Shared
Savings Program final rule, we have
continued to review the quality
measures used for the Shared Savings
Program to ensure that they are up to
date with current clinical practice and
are aligned with the GPRO web interface
reporting for PQRS. Based on these
reviews, in the CY 2015 Physician Fee
Schedule proposed rule, we proposed a
number of measure additions, deletions
and other revisions that we believed
would be appropriate for the Shared
Savings Program. An overview of
changes we proposed is provided in
Table 50 of the proposed rule (79 FR
40479 through 40481) which lists the
measures that we proposed would be
used to assess ACO quality under the
Shared Savings Program starting in
2015. To summarize, we proposed to
add 12 new measures and retire eight
measures. We also proposed to rename
the EHR measure in order to reflect the
transition from an incentive payment to
a payment adjustment under the EHR
Incentive Program and to revise the
component measures within the
Diabetes and CAD composites. In total,
we proposed to use 37 measures for
establishing the quality performance
standard that ACOs must meet to be
eligible for shared savings. Although the
total number of measures would
increase from the current 33 measures to
37 measures under this proposal, we
stated we did not anticipate that this
would increase the reporting burden on
ACOs because the increased number of
measures is accounted for by measures
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
that would be calculated by CMS using
administrative claims data or from a
patient survey. The total number of
measures that the ACO would need to
directly report through the CMS Web
site interface would actually decrease by
one, in addition to removing
redundancy in measures reported.
Finally, as part of the proposed
changes, we proposed to replace the
current five component diabetes
composite measure with a new four
component diabetes composite measure.
In addition, we proposed to replace the
current two component coronary artery
disease composite measure with a new
four component coronary artery disease
composite measure. Under this
proposal, 21 measures would be
reported by ACOs through the GPRO
web interface and scored as 15
measures.
Below, we summarize and group
comments received on these proposals
by first responding to general comments
on our proposals and then by the
method of data submission for the
measure as listed in Table 50 of the
proposed rule (79 FR 40479 through
40481) (that is, survey, claims, EHR
incentive program, and the CMS web
interface). In order to align the measures
submitted through the CMS web
interface with the PQRS and VM
programs, we discuss specific comments
in response to the proposed changes to
the measures submitted through the
CMS web interface with the comments
received for these same measures for the
PQRS and the VM programs. See Tables
79 and 80 in section III.K., for a
discussion of and response to these
comments.
General Comment: In addition to the
comments that focus on individual
measures, we received many general
comments about the quality
performance measures used in the
Shared Savings Program. For example,
we received many comments supporting
the alignment between ACO, PQRS and
VM quality measures and an increased
focus on outcomes-based quality
measures. Some commenters objected to
the net increase in measures, believing
there is underlying burden for providers
even for claims-based measures.
Additionally, many ACOs did not
support the proposed new measures,
suggesting, for example, they would be
unnecessary because of the incentives
inherent to the Shared Savings Program,
or that, in general, the new proposed
measures are inadequately defined,
tested or benchmarked. These ACOs
believed that many of the proposed new
measures address clinical issues beyond
an ACO’s control and therefore should
not be added. Other concerns about the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
new measures were that they would
require substantial change in clinical
practice, would substantially add to the
reporting burden, and/or are
questionably related to improving care
quality and/or patient outcomes.
Other commenters supported adding
the new measures. One commenter, for
example, stated that ‘‘the expanded
measures are important utilization and
management measures that our
developing ACO would have likely
considered and built into our ACO Cost,
Utilization, and Risk dashboard anyway.
From a clinical and system standpoint,
these additions are key components of
better managing avoidable utilization
and costs. They are measures we would
want to know regardless of the Proposed
Rule.’’ MedPAC suggested that CMS
move quality measurement for ACOs,
MA plans, and FFS Medicare in the
direction of a small set of populationbased outcome measures, such as
potentially preventable inpatient
hospital admissions, emergency
department visits, and readmissions.
Response: We continue to believe it is
appropriate to add, remove, and modify
quality measures for the Shared Savings
Program to reflect changes in clinical
practice and for other program needs.
We want to minimize any additional
burdens this could create for ACOs and
their ACO participants and ACO
providers/suppliers. Therefore, we agree
with the comments in support of the
alignment between ACO, PQRS and VM
for the quality measures submitted
through the CMS web interface, and an
increased focus on outcomes-based
quality measures. We disagree with
those ACOs that suggested certain
proposed new measures would be
unnecessary because of the incentives
inherent to the Shared Savings Program.
Instead, we agree with the commenter
who noted that such measures can be
important utilization and management
tools that many ACOs may consider and
build into their own internal monitoring
systems as a way to help manage
avoidable utilization and costs. Further,
we believe certain proposed new
measures highlight the value of
discussions with patients about their
care.
b. Survey Based Measure
• CAHPS Stewardship of Patient
Resources. This measure is one of the
unscored survey measures currently
collected in addition to the seven scored
survey measures that are already part of
the current set of 33 measures under the
Shared Savings Program. Information on
the unscored survey measure modules is
currently shared with the ACOs for
informational purposes only. The
PO 00000
Frm 00363
Fmt 4701
Sfmt 4700
67909
Stewardship of Patient Resources
measure asks the patient whether the
care team talked with the patient about
prescription medicine costs. The
measure exhibited high reliability
during the first two administrations of
the CAHPS survey, and during testing,
the beneficiaries that participated in
cognitive testing said that prescription
drug costs were important to them. We
proposed to add Stewardship of Patient
Resources as a scored measure in the
patient experience domain because we
believe, based on testing, that this is an
important factor for measuring a
beneficiary’s engagement and
experience with healthcare providers.
We also proposed that the measure
would be phased into pay for
performance as we plan to do for other
new measures, using a similar process
to the phase in that was used for the
scored measure modules in the survey
that are currently used to assess ACO
quality performance.
Comment: Some commenters
supported the proposed addition of this
measure, agreeing that discussing the
cost of medications is important to
assess the possibility that medication
costs may be a barrier to care or that the
measure may be an indicator of a
patient’s satisfaction with the care he or
she is receiving. Other commenters
questioned how this discussion leads to
a plan of action or a modified plan of
treatment to improve care if the patient
is unable to pay for the medication.
These commenters asked us to further
explain how we envision this measure
improving patient care. Some believe it
would be reasonable to include this
measure under pay for reporting, but
that additional discussions with the
community would be needed in order to
establish an appropriate benchmark for
this measure, as this is a relatively new
measure. Some thought that physician
discussions with patients regarding
medication cost would be appropriate
for ‘‘high tier,’’ costly medications, but
would be of questionable value relative
to measuring patient-centered, quality
care delivery for more frequently
prescribed, lower cost, generic
medications and/or the extent to which
patients take medications as prescribed.
Some commenters suggested that it
would be unnecessary and/or
burdensome to add this measure. For
example, commenters indicated that
physicians do not and cannot know the
co-pays for each drug under each
insurance plan and product and that
there would be tremendous patient
dissatisfaction when inaccurate pricing
or cost information is provided to the
patient by the provider. Some
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67910
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
commenters believe this measure is
unnecessary since encouraging
adherence to medications is a key
strategy for ACOs to reduce avoidable
costs, and inability to afford
medications is a key barrier to
adherence, so ACOs already have an
incentive to discuss the cost of
medications with their patients.
Response: This measure asks patients
whether any health care provider spoke
to them about their prescription
medication costs and does not require
that physicians know the co-pays for
each drug under each insurance plan
and product. Additionally, discussing
this topic with beneficiaries can lead a
clinician to understand whether and
how the beneficiary may struggle with
payment for medications, a factor that
can affect adherence to prescribed
regimens. We can therefore envision a
scenario where, once the issue is
identified, a clinician participating in an
ACO could inform and educate the
beneficiary about less expensive
options, such as the use of generic
medications, or about available
community resources, as part of the
ACO’s care coordination processes
required under § 425.112(b)(4). This in
turn could directly improve the quality
of care the beneficiary receives by
improving medication adherence and
leading to greater beneficiary
engagement. Because this measure is
already part of the CAHPS survey, we
do not believe it will increase reporting
burden for the ACO. The CAHPS survey
question is available in the CAHPS
Survey for ACOs Quality Assurance
Guidelines on the CAHPS for ACOs
Web site. As discussed below, because
this is a new measure, the measure will
be pay-for-reporting for the first two
reporting periods it is in use for all
ACOs, regardless of the phase-in
schedule to pay-for-performance, in
order to provide time for the
development of an appropriate
benchmark.
Final Decision: We are finalizing our
proposed addition of the CAHPS:
Stewardship of Patient Resources
measure. After the measure has been
used in the program under pay for
reporting for two reporting periods, it
will be pay-for-reporting for the first
performance year of an ACO’s first
agreement period and pay-forperformance for the ACO’s second and
third performance years. We continue to
believe that it is important for
physicians and others to discuss the
beneficiary’s perspective on the cost of
medications because is important to
assess the possibility that medication
costs may be a barrier to care. The
measure exhibited high reliability
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
during the first two administrations of
the CAHPS survey, and during testing,
the beneficiaries that participated in
cognitive testing said that prescription
drug costs were important to them.
c. Claims Based Measures To Be
Computed by CMS
• Skilled Nursing Facility 30-Day AllCause Readmission Measure (SNFRM).
We proposed to add a 30-day all cause
skilled nursing facility (SNF)
readmission measure. CMS is the
measure steward for this claims-based
measure, which is under review at NQF
under NQF #2510. This measure
estimates the risk-standardized rate of
all-cause, unplanned, hospital
readmissions for patients who have
been admitted to a SNF within 30 days
of discharge from a prior inpatient
admission to a hospital, CAH, or a
psychiatric hospital. The measure is
based on data for 12 months of SNF
admissions. We believe this measure
would help fill a gap in the current
Shared Savings Program measure set
and would provide a focus on an area
where ACOs are targeting care redesign.
ACOs and their ACO participants often
include post-acute care (PAC) settings
and the addition of this measure would
enhance the participation of and
alignment with these facilities. Even
when the ACO does not include postacute facilities formally as part of its
organization, ACO providers/suppliers
furnish other services that have the
potential to affect PAC outcomes. Thus,
this measure would emphasize the
importance of coordinating the care of
beneficiaries across these sites of care.
Additionally, because this measure
would be calculated from claims, there
would not be a burden on ACOs to
collect this information.
Comment: A number of commenters
supported including the measure and/or
the concept to align the incentives of
ACOs and SNFs to lower their
readmission rates. Some provided
suggestions to further refine the
measure, such as to use a risk-adjusted
measure of potentially avoidable
readmissions for SNFs. Although
MedPAC recommended that CMS
consider a risk-adjusted, potentially
avoidable readmission measure for
SNFs, they did support the addition of
a SNF readmission measure because of
the importance of post-acute care
management and care transitions
between settings in improving
beneficiary care. Another commenter
supported the measure but encouraged
delay until such time as Medicare
readmission policy links a portion of
SNF payments to their readmission rates
so that SNFs would bear risk/penalty
PO 00000
Frm 00364
Fmt 4701
Sfmt 4700
equal to that of other providers in order
to incent readmissions reduction. Some
commenters believe that it is
unnecessary and duplicative to add this
quality measure since it is an inherent
part of the Shared Savings Program that
an ACO will be penalized through a
reduction in shared savings if it has a
high rate of readmissions. They also
argue that ACOs that use SNFs for
higher-acuity patients could see an
increase in SNF readmission rates and
thus be inappropriately penalized. A
commenter suggested ACO scores will
be inappropriately affected when
beneficiaries return to an ACO
participant hospital after being
discharged to a SNF that is not
participating in the ACO. In such cases,
an ACO may be unable to achieve the
same level of collaboration needed to
affect change as compared to ACOs that
include one or more SNFs as ACO
participants or ACO providers/
suppliers. Concern was also expressed
regarding the ability of ACOs to
consistently monitor psychiatric
hospital discharges since federal laws
limit the use and disclosure of
documentation regarding drug and
substance abuse as well as mental
health therapies. These commenters
recommend removing psychiatric
hospital admissions from this measure
since ACOs currently do not receive
mental health claims data and should
not be held accountable for measures for
which they are not able to collect and
monitor data over the performance
period. Operational concerns were also
raised including data lags and that
ACOs can only derive raw admissions/
readmission rates from the monthly
claims files and the commenters believe
these rates are not useful for improving
performance against benchmarks unless
CMS provides the algorithm to apply
the appropriate risk adjustment. These
commenters indicate that ACOs face
significant challenges in monitoring
performance when reliable risk-adjusted
rates of admissions and readmissions
are not provided on a regular basis.
Response: We appreciate the
numerous thoughtful comments. We
disagree with commenters that this
measure is unnecessary and duplicative
because we continue to believe that
including this measure would reinforce
the importance of coordinating the care
of beneficiaries across hospital and SNF
sites of care. We have previously
expressed our expectation that ACOs
coordinate the care of beneficiaries
across these sites regardless of whether
there are any post-acute care (PAC)
providers participating in the ACO
(§ 425.112(b)(4)). Even when the ACO
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
does not include post-acute facilities
formally as ACO participants or ACO
providers/suppliers, ACO providers/
suppliers furnish other services that
have the potential to affect PAC
outcomes. Thus, this measure would
emphasize the importance of
coordinating the care of beneficiaries
across these sites of care. Additionally,
because this measure is calculated from
claims, there would not be a reporting
burden on ACOs to collect this
information. We appreciate the
recommendations that we use a riskadjusted, potentially avoidable SNF
readmission measure, however, there is
currently no such measure available for
use. We note that the SNF 30-day allcause readmission measure does
exclude planned readmissions using a
similar methodology to ACO–8 RiskStandardized, All Condition
Readmission. Unplanned readmission
rates do provide ACOs with useful
information to better coordinate care
and work toward reducing the risk of
readmissions for all patients, including
patients coming from a SNF. Further,
contrary to the assertion of some
commenters, we note that the HIPAA
Privacy Rule generally provides the
same protections for mental health
information as it does for all protected
health information (with the exception
of psychotherapy notes). See the
Department’s guidance on the HIPAA
Privacy Rule and sharing information
related to mental health, available at
https://www.hhs.gov/ocr/privacy/hipaa/
understanding/special/
mhguidance.html. Thus, ACOs that
request claims data under § 425.704 for
purposes of their own health care
operations or the health care operations
of their covered entity ACO participants
and ACO providers/suppliers, in
accordance with HIPAA requirements,
already receive information about
mental health therapies as part of those
data sets.
Final Decision: We are finalizing our
proposal to add this 30-day all-cause
SNF readmission measure. After the
measure has been used in the program
under pay for reporting for two
reporting periods, the measure will be
pay-for-reporting in the first two
performance years of an ACO’s first
agreement period and will transition to
pay-for-performance in the final year of
the ACO’s agreement period. We believe
this measure will help fill a gap in the
current Shared Savings Program
measure set and will provide a focus on
an area where ACOs are targeting care
redesign.
• All-Cause Unplanned Admissions
for Patients with Diabetes Mellitus (DM),
Heart Failure (HF) and Multiple Chronic
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Conditions. We proposed to add three
new measures to the Care Coordination/
Patient Safety domain. The three new
measures are for: All-cause unplanned
Admissions for Patients with Diabetes
Mellitus (DM), all-cause unplanned
Admissions for Patients with Heart
Failure (HF) and all-cause unplanned
Admissions for Patients with Multiple
Chronic Conditions (MCC). These three
measures are under development
through a CMS contract with Yale New
Haven Health Services Corporation/
Center for Outcomes Research and
Evaluation (CORE) to develop quality
measures specifically for ACO patients
with heart failure, diabetes, and
multiple chronic conditions. We believe
that these measures are important to
promote and assess ACO quality as it
relates to chronic condition inpatient
admission because these chronic
conditions are major causes for
unplanned admissions and the addition
of these measures will support the
ACOs’ efforts to improve care
coordination for these chronic
conditions. These measures are claimsbased, and therefore, we do not expect
that they would impose any additional
burden on ACOs.
The following is a summary of the
comments we received regarding our
proposal to add these three new claimsbased measures for All-Cause
Unplanned Admissions for Patients
with DM, HF and MCC.
Comment: We received a wide variety
of comments in response to the proposal
to add these claims-based measures.
Many commenters supported the use of
claims-based outcome measures to
reduce reporting burden for providers,
however, concerns were raised
regarding the lack of NQF endorsement.
Some commenters supported adding
one or more of these measures, agreeing
that chronic condition inpatient
admissions are major causes for
unplanned admissions and that the
addition of one or more of these
measures would support the ACOs’
efforts to improve care coordination. For
example, a few commenters supported
the addition of a measure for All Cause
Unplanned Admission for Patients with
Multiple Chronic Conditions as all
efforts to manage chronic disease may
help lead to better patient outcomes and
control cost. Another commenter
supported the measures but preferred
collapsing them into one measure of
potentially avoidable hospitalizations,
because of concern that the proposed
condition-specific measures will be
statistically unreliable and subject to
random variation that will limit their
usefulness in distinguishing ACOs’
actual performance. In addition, some
PO 00000
Frm 00365
Fmt 4701
Sfmt 4700
67911
commenters urged CMS to ensure the
measures are adjusted for planned
readmissions, unrelated readmissions
and socio-demographic status. Other
commenters supported applying these
measures in the Shared Savings Program
as pay for reporting only at this time
since these measures are still under
development, accepted target rates are
not available and the measures are not
yet endorsed by NQF. Commenters
requested additional definition of what
‘‘other multiple chronic conditions’’
would be measured. MedPAC supported
an increase of outcome measures.
Finally, some commenters believe it is
not possible to comment on measures
that are still under development, and
questioned the added benefit of
including these measures since ACOs
have an inherent incentive to avoid or
reduce unplanned hospital admissions.
Response: We continue to believe that
these measures are important to
promote and assess ACO quality
because these chronic conditions are
major causes for unplanned admissions
and the addition of these measures will
support the ACOs’ efforts to improve
care coordination for beneficiaries with
these chronic conditions. These
measures are claims-based, and
therefore, we do not expect that they
would impose any additional reporting
burden on ACOs. Many concerns were
raised regarding the lack of NQF
endorsement, but CMS intends on
submitting all three measures to NQF
for review in the future. Draft measure
specifications were made available to
the public during the measure
development comment period during
the spring and summer of 2014. CMS
will provide final measure
specifications to the public when
available (typically in the early part of
the performance year). The MCC
measure cohort definition aligns with
the NQF MCC Measurement
Framework, which defines patients with
MCCs as people ‘‘having two or more
concurrent chronic conditions that . . .
act together to significantly increase the
complexity of management, and affect
functional roles and health outcomes,
compromise life expectancy, or hinder
self-management.’’ 11 The MCC measure
cohort of chronic conditions includes
conditions such as, but not limited to,
Acute Myocardial Infarction, Stroke,
and Chronic Obstructive Pulmonary
Disease.
Final Decision: After considering the
comments received in response to our
11 National Quality Forum (NQF). Multiple
Chronic Conditions Measurement Framework.
2012; https://www.qualityforum.org/WorkArea/
linkit.aspx?LinkIdentifier=id&ItemID=71227.
E:\FR\FM\13NOR2.SGM
13NOR2
67912
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
proposal to add these three measures,
we will add the All-Cause Unplanned
Admissions for Patients with MCC, HF,
and DM measures as pay-for-reporting
for two performance years. After this
time, the measure will be pay-forreporting for the first two performance
years for new ACOs in their first
agreement period before transitioning to
pay for performance in performance
year three. We believe that it is
important to include these measures in
the Shared Savings Program measure set
since they were specifically developed
for ACO populations and move the
quality performance standard under the
Shared Savings Program toward more
outcome-based measures. DM, HF, and
MCCs affect a large volume of Medicare
beneficiaries and can result in high
costs due to poorly coordinated care. As
a result, these chronic conditions are a
focus of many ACO care redesign
activities. Finally, these measures are
claims-based and therefore do not
impose an additional burden on ACOs
for data reporting.
d. Measure Submitted Through the EHR
Incentive Program
• Percent of PCPs who Successfully
Meet Meaningful Use Requirements.
Because downward adjustments to
Medicare payments will begin in 2015
under the EHR Incentive Program, we
proposed to modify the name and
specifications for ACO #11 Percent of
PCPs who Successfully Qualify for an
EHR Incentive Program Payment so that
it more accurately depicts successful
use and adoption of EHR technology in
the coming years. We note this measure
would continue to be doubly weighted.
Comment: We received a range of
comments regarding this proposal.
Some agreed that it is necessary to
rename the measure given that the EHR
Incentive Program begins its transition
to a payment adjustment effective in
2015. Some of the commenters, while
agreeing with the proposed change, also
provided additional specification
suggestions such as to exclude certain
physicians, such as hospitalists, from
the denominator of this measure, stating
that hospitalists are not PCPs when
providing observation services. Another
commenter requested that CMS clarify
‘‘the interaction of the Medicaid
Meaningful Use program and the
MSSP’’ and ‘‘the impact to non-PCP
EPs’’. Another commenter requested
that CMS make the list of EPs available
to ACOs intermittently throughout the
performance year to aid ACOs in
ensuring that all EPs attest in a timely
manner. A commenter questioned why
this measure in its current form is
limited only to PCPs, as opposed to all
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
EPs that are ACO providers/suppliers.
Others were concerned that there
appeared to be no opportunity to
exclude physicians such as those who
retired, died, moved out the country,
from the denominator of this measure.
Finally, there were a number of
commenters that suggested the measure
should be dropped and not renamed,
since it is a process measure and the
commenters believe that this measure
has no direct relationship to the quality
of patient care.
Response: We continue to believe, as
do a number of commenters, that this is
an important measure that should be
retained and renamed given that
downward adjustments to Medicare
payments will begin in 2015 under the
EHR Incentive Program. We appreciate
the suggestions from commenters that
agree with the proposed change and
provided additional specification
suggestions. We are not persuaded by
commenters that suggest this measure
should be removed from the quality
performance standard for the Shared
Savings Program. On the contrary, we
believe the measure directly supports
the adoption and meaningful use of
certified EHR technology, which is an
important tool to support change in the
health care delivery system including
the steps being taken by ACOs to
improve the quality and efficiency of
care. The measure specifications will
continue to align with the EHR
Incentive Program definitions of
hospital-based providers and will
exclude observation services,
accordingly. The measure specifications
include Medicare and Medicaid eligible
PCPs. Practitioners other than PCPs are
not included in the measure at this time
in efforts to focus on the meaningful use
of certified EHRs in the provision of
primary care services. This measure
aligns with other HHS initiatives that
support the adoption and meaningful
use of certified EHR technology. For
example, the HHS Office of the National
Coordinator for Health Information
Technology and CMS are managing $27
billion in funding from the American
Recovery and Reinvestment Act of 2009
and other sources to promote the
adoption of electronic health records
(EHR) in hospitals and doctor’s
offices.12 More than 75 percent of
eligible health care professionals, and
over 90 percent of eligible hospitals,
have already qualified for EHR incentive
payments for using certified EHR
technology. Retaining this measure in
the quality performance standard for the
Shared Savings Program will help
12 https://www.hhs.gov/news/press/2014pres/09/
20140916a.html.
PO 00000
Frm 00366
Fmt 4701
Sfmt 4700
provide an additional and appropriate
incentive to reinforce the adoption and
meaningful use of certified EHR
technology. Finally, performance on this
measure is determined using EHR
Incentive Program data and due to the
EHR Incentive Program timelines and
data collection, CMS will not be able to
provide lists of EPs to ACOs throughout
the performance year.
Final Decision: After consideration of
the comments received, we are
finalizing the proposal to modify the
name and specifications of ACO–11 to
the Percent of PCPs who successfully
meet MU requirements.
e. Measures Submitted Through the
CMS Web Interface
To align with PQRS, we proposed to
add several measures submitted through
the CMS web interface that we believed
were appropriate for the ACO quality
performance standard. The measures we
proposed to add were:
• Depression Remission at Twelve
Months (NQF #0710).
• Diabetes Measures for Foot Exam
and Eye Exam (NQF #0056 and #0055).
• Coronary Artery Disease (CAD):
Symptom Management.
• Coronary Artery Disease (CAD):
Beta Blocker Therapy—Prior Myocardial
Infarction (MI) or Left Ventricular
Systolic Dysfunction (LVEF<40%) (NQF
#0070).
• Coronary Artery Disease (CAD):
Antiplatelet Therapy (NQF #0067).
• Documentation of Current
Medications in the Medical Record
(NQF #0419).
Additionally, we identified a number
of the existing measures submitted
through the CMS web interface that
have not kept up with clinical best
practice, are redundant with other
measures that make up the quality
performance standard, or that could be
replaced by similar measures that are
more appropriate for ACO quality
reporting. For the reasons specified in
the proposed rule, we proposed to no
longer collect data on the following
measures, and these measures would no
longer be used for establishing the
quality performance standards that
ACOs must meet to be eligible to share
in savings:
• ACO #12, Medication
Reconciliation after Discharge from an
Inpatient Facility.
• ACO #22, Diabetes Composite
measure: Hemoglobin A1c control (<8
percent).
• ACO #23, Diabetes Composite: Low
Density Lipoprotein (<100) (NQF
#0729).
• ACO #24, Diabetes Composite:
Blood Pressure (<140/90) (NQF #0729).
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
• ACO #25, Diabetes Composite:
Tobacco Non-use (NQF #0729).
• ACO #29, Ischemic Vascular
Disease: Complete Lipid Profile and LDL
Control (<100 mg/dl) (NQF #0075).
• ACO #30, Ischemic Vascular
Disease: Use of Aspirin or another
Antithrombotic (NQF #0068).
• ACO #32, Coronary Artery Disease
(CAD) Composite: Drug Therapy for
Lowering LDL Cholesterol (NQF #74).
Finally, given these proposed
changes, we also proposed updates and
revisions to the Diabetes and CAD
Composite measures. We proposed that
the Diabetes Composite include the
following measures:
• ACO #26: Diabetes Mellitus: Daily
Aspirin or Antiplatelet Medication Use
for Patients with Diabetes Mellitus and
Ischemic Vascular Disease.
• ACO #27: Diabetes: Hemoglobin
A1c Poor Control.
• ACO #41: Diabetes: Foot Exam.
• ACO #42: Diabetes: Eye Exam.
We further proposed that the CAD
Composite include the following
measures:
• ACO #33: Angiotensin-Converting
Enzyme (ACE) Inhibitor or Angiotensin
Receptor Blocker (ARB) Therapy—
Diabetes or Left Ventricular Systolic
Dysfunction (LVEF<40%).
• ACO #43: Antiplatelet Therapy.
• ACO #44: Symptom Management.
• ACO #45: Beta-Blocker Therapy—
Prior Myocardial Infarction (MI) or Left
Ventricular Systolic Dysfunction
(LVEF<40%).
We solicited comment on these
composite measures and whether there
are any concerns regarding the
calculation of a composite score. Given
the general concerns around composite
measures and their use, we also
solicited comment on how we combine
and incorporate component measure
scoring for the composite.
Comment: Most commenters
supported the proposed removal and
replacement of measures that may not
align with current clinical guidelines or
that appear to overlap with other
measures currently in the measure set.
At least one commenter specifically
opposed removal of ACO #30, Ischemic
Vascular Disease: Use of Aspirin or
another Antithrombotic (NQF #0068)
and the LDL measures, stating that there
is disagreement on guidelines among
professional organizations. Others
expressed concern about the number of
proposed changes that will require
ACOs, in turn, to make changes to their
internal processes and their EHRs to
facilitate data collection. Some
commenters raised general clinical or
other methodological concerns about
individual proposed measures
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
submitted through the CMS web
interface. Our detailed responses to
those comments can be found in Table
79 of section III.K. of this final rule with
comment period.
We do, however, wish to note some
specific comments relevant to our final
policy decisions with respect to the
quality performance measures used in
the Shared Savings Program: (1)
Commenters noted that the Patient
Health Questionnaire 9 (PHQ–9) is
specified for use in the Depression
Remission measure (proposed ACO #
40), and that this tool is only one of
several options available to
practitioners. These commenters
suggested not adding this measure until
ACOs have had the opportunity to
uniformly phase in the use of the PHQ–
9 in order to meet the measure
specification requirements.
Additionally, commenters suggested
that their ability to perform well on this
measure may be limited if they cannot
access the PHQ–9 score data from
mental health care providers. (2) Many
commenters did not support the
proposed addition of the CAD:
Symptom Management measure
(proposed ACO # 44), stating they
believe the measure lack primary care
focus and that there are potential
challenges in data collection. CMS also
received a comment supporting the
proposed addition of the CAD:
Antiplatelet Therapy measure (proposed
ACO # 43), however, this commenter
recommended that if added, the
measure only be used for pay-forreporting. (3) Some commenters did not
support the retirement of the 4 Diabetes
Composite measures and 1 CAD
Composite measure proposed to be
removed due to the resources already
invested in reporting these 5 measures.
(4) CMS received comments suggesting
that the quality performance standard
under the Shared Savings Program
should focus on broader categories of
measures (such as preventive health
measures) that are generalizable across
providers and care settings, rather than
measures that target specific providers
or care settings.
Response: We continue to believe that
the quality performance measures used
in the Shared Savings Program should
reflect current clinical guidelines. We
appreciate the commenters’ agreement
with our proposed changes to remove
and replace measures that are not in
adherence with current clinical
guidelines. In response to comments,
included in Table 79 in section III.K, we
will retain ACO #30, Ischemic Vascular
Disease: Use of Aspirin or another
Antithrombotic (NQF #0068). We note
that we erroneously made the assertion
PO 00000
Frm 00367
Fmt 4701
Sfmt 4700
67913
that this measure conflicts with current
clinical guidelines. Therefore, due to the
clinical importance of the measure, the
measurement gap it addresses, and its
alignment with the Million Hearts
Campaign and PQRS, we will retain this
measure.
Given the concerns raised by
commenters, included in Table 80 of
section III.K, regarding our proposal to
use PHQ–9 for the Depression
Remission measure, we will not finalize
our proposal that the measure would be
phased-in to pay-for-performance
during the second and third
performance years of an ACO’s first
agreement period. We will, however,
finalize our proposal to use the measure
to assess ACO quality, but only as payfor-reporting for all three performance
years of an ACO’s first agreement
period. We believe this approach will
provide flexibility for ACOs to continue
to use tools other than the PHQ–9, while
providing the opportunity for ACOs to
begin adopting this tool without
harming their ability to achieve full
points on the measure. Additionally, as
noted above, the HIPAA Privacy Rule
generally provides the same protections
for mental health information as it does
for all protected health information
(with the exception of psychotherapy
notes). We therefore do not believe there
would be any unusual impediments to
accessing the information required for
reporting of this particular measure.
After consideration of the comments
received and in order to align with the
final measures that will be used in the
PQRS program, we will not finalize the
CAD: Symptom Management (proposed
ACO–44) and CAD: Antiplatelet
Therapy (proposed ACO–43) measures
for the Shared Savings Program. See
section III.K, Table 79, for comment
discussion and response.
We believe it is important to make
changes in the measures used to assess
ACO quality to address the statutory
mandate in section 1899(b)(3)(A) of the
Act which requires the Secretary to
determine appropriate measures to
assess the quality of care furnished by
the ACO, reflect current clinical
practice, promote high quality care, and
alignment with PQRS and National
Quality Strategy. We therefore disagree
with commenters that internal
operational challenges that arise from
changes in the measure set outweigh the
benefit of such changes.
After considering the comments
received regarding the proposed new
measures, we are finalizing our proposal
to add the following new measures that
will be submitted by the ACO through
the CMS web interface:
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67914
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
• Documentation of Current
Medications in the Medical Record
(NQF #0419).
• Depression Remission at Twelve
Months (NQF #0710).
• Diabetes Measures for Eye Exam
(NQF #0055).
For the reasons stated in section III.K.,
we decline to finalize our proposals to
add the following measures:
• Diabetes: Foot Exam (NQF #0056)
• CAD: Antiplatelet Therapy (NQF
#0067)
• CAD: Symptom Management
• CAD: Beta-Blocker Therapy—Prior
Myocardial Infarction or Left
Ventricular Systolic Dysfunction (LVSD)
(NQF #0070)
We are not finalizing our proposal to
add the CAD: Antiplatelet Therapy
(NQF #0067) measure and instead will
keep the measure it was designed to
replace, ACO #30, Ischemic Vascular
Disease: Use of Aspirin or another
Antithrombotic (NQF #0068) because
we have determined that it does not
conflict with clinical guidelines,
remains clinically important, addresses
a measurement gap, and aligns with the
Million Hearts Campaign and PQRS. We
believe that retention of this measure in
lieu of the proposed Antiplatelet
Therapy measure will additionally
reduce burden on ACOs that would
otherwise need to revise their data
collection processes to accommodate
this change.
Additionally, we are finalizing our
proposal to remove certain measures
from the ACO quality performance
standard including the following:
• ACO #12, Medication
Reconciliation after Discharge from an
Inpatient Facility.
• ACO #22, Diabetes Composite
measure: Hemoglobin A1c control (<8
percent).
• ACO #23, Diabetes Composite: Low
Density Lipoprotein (<100) (NQF
#0729).
• ACO #24, Diabetes Composite:
Blood Pressure (<140/90) (NQF #0729).
• ACO #25, Diabetes Composite:
Tobacco Non-use (NQF #0729).
• ACO #29, Ischemic Vascular
Disease: Complete Lipid Profile and LDL
Control (<100 mg/dl) (NQF #0075).
• ACO #32, Coronary Artery Disease
(CAD) Composite: Drug Therapy for
Lowering LDL Cholesterol (NQF #74).
Finally, given these changes, we are
revising the Diabetes Composite to
include the following measures:
• ACO #27: Diabetes: Hemoglobin
A1c Poor Control (NQF #0059).
• ACO #42: Diabetes: Eye Exam (NQF
#0055).
Although not previously proposed, in
order to align with PQRS and in
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
response to commenter concerns about
using this measure outside the
composite, we are removing ACO #26,
Diabetes Mellitus: Daily Aspirin or
Antiplatelet Medication Use for Patients
with Diabetes Mellitus and Ischemic
Vascular Disease. While we believe the
measure may be valid apart from the
composite, we are swayed by the
concerns raised by commenters as
discussed in Table 79 in section III.K.
We believe removing ACO–26 is
consistent with our proposals to align
with the PQRS program and remove
redundancy of measures within the
Shared Savings Program measure set. In
addition, we believe removing this
measure will reduce reporting burden
for ACOs and may also help to improve
performance on the diabetes composite.
We also note that the removal of this
measure would additionally alleviate
some redundancy with ACO #30
Ischemic Vascular Disease: Use of
Aspirin or another Antithrombotic (NQF
#0068) which we are retaining for the
reasons discussed above.
The CAD Composite will be removed
since there is only one CAD measure
remaining.
We believe that the final measure set
as adopted in this final rule is
appropriate for purposes of the ACO
quality performance standard and in
order to align with changes being made
to the PQRS for the reasons specified
above and in Tables 79 and 80 in
section III.K. Additionally, we believe
that our final decision to remove certain
measures will improve alignment with
best practices and reduce reporting
burden for ACOs.
f. Summary of Changes to the ACO
Quality Measures
We are finalizing the ACO quality
performance measures as follows. In
total, we will use 33 measures to
establish the quality performance
standards that ACOs must meet to be
eligible for shared savings. Although the
number of measures in the measure set
remains at 33, we are reducing the
number of measures reported through
the CMS web interface by 5 to reduce
burden. In addition, as discussed in
section III.K., we are also reducing the
number of patients ACOs are required to
report on for each measure. This change
will also reduce the burden of quality
reporting for ACOs. The new measures
will be pay-for-reporting for the first two
performance years for all ACOs. After
this initial period, the measures will be
phased in to pay-for-performance over
the course of an ACO’s first agreement
period with the exception of Depression
Remission at 12 Months which will stay
PO 00000
Frm 00368
Fmt 4701
Sfmt 4700
at pay-for-reporting for all three
performance years.
Specifically, we are finalizing the
following changes to the Shared Savings
Program quality measure set (see Table
81 for a list of the final measures and
for further details of phase in to pay-forperformance during the agreement
period):
• Add the CAHPS: Stewardship of
Patient Resources measure as pay-forreporting in the first performance year
of an ACO’s first agreement period and
pay-for-performance in the second and
third performance years.
• Add SNF 30-Day All-Cause
Readmission measure and All-Cause
Unplanned Admissions measures for
Patients with Multiple Clinical
Conditions, Heart Failure, and Diabetes
as pay-for-reporting for the first two
years of an ACO’s first agreement period
before transitioning to pay-forperformance in performance year three.
• Add Depression Remission at 12
Months (NQF #0710) measure as payfor-reporting for all three performance
years of an ACO’s first agreement
period.
• Replace ACO–12 Medication
Reconciliation (NQF #0097) with
‘‘Documentation of Current Medications
in the Medical Record’’ (NQF #0419).
• Add Diabetes: Eye Exam (NQF
#0055).
• Modify name and specifications of
ACO–11 from Percent of PCPS who
successfully Qualify for an EHR
Incentive Program Payment to the
Percent of PCPs who Successfully Meet
MU Requirements.
In addition, we are finalizing the
retirement of 6 of the 7 measures we
proposed to delete because they do not
align with updated clinical guidelines
or are similar to existing measures
(ACO–22, 23, 24, 25, 29, and 32). We are
not finalizing our proposal to remove
ACO–30 Ischemic Vascular Disease: Use
of Aspirin or Another Antithrombotic
and are removing ACO–26 Diabetes
Mellitus: Daily Aspirin or Antiplatelet
Medication Use for Patients with
Diabetes Mellitus and Ischemic Vascular
Disease due to comments received and
for the reasons discussed above and in
section III.K, Table 79.
We are also not finalizing the
following proposed measures, but
instead will continue to consider them
for the future given the measurement
gaps and high-cost, high-volume
conditions these measures address for
the quality performance standard as
discussed in Table 79 in section III.K:
• Diabetes: Foot Exam (NQF #0056).
• CAD: Antiplatelet therapy (NQF
#0067).
• CAD: Symptom management.
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
• CAD: Beta-blocker therapy—prior
Myocardial Infarction (MI) or LVSD
(NQF #0070).
ebenthall on DSK5SPTVN1PROD with $$_JOB
As a result, we will no longer have a
CAD composite in the measure set and
will only have 1 CAD measure in the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Clinical Care in the At-Risk Population
domain (ACO# 33: AngiotensinConverting Enzyme (ACE) Inhibitor or
Angiotensin Receptor Blocker (ARB)
Therapy—Diabetes or Left Ventricular
Systolic Dysfunction (LVEF<40%)).
PO 00000
An overview of the changes we are
finalizing is provided in Table 81,
which lists the measures that will be
used to assess ACO quality under the
Shared Savings Program starting with
the 2015 performance year.
BILLING CODE 4120-01-P
Frm 00369
Fmt 4701
Sfmt 4700
67915
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67916
VerDate Sep<11>2014
Pay for Performance Phase In
Domain
ACO
Measure#
New Measure
NQF #/Measure
Steward
Method of Data
Submission
R- Reporting
P -Performance
Jkt 235001
PYl
AC0-1
PO 00000
AC0-2
AC0-3
Frm 00370
Patient/Caregiver
Experience
AC0-4
AC0-5
Fmt 4701
AC0-6
AC0-7
Sfmt 4725
AC0-34
CARPS: Getting Timely Care, Appointments, and
Information
CARPS: How Well Your Doctors Communicate
CARPS: Patients' Rating of Doctor
CARPS: Access to Specialists
CARPS: Health Promotion and Education
CARPS: Shared Decision Making
CARPS: Health Status/Functional Status
CARPS: Stewardship of Patient Resources
X
Risk-Standardized, All Condition Readmission
E:\FR\FM\13NOR2.SGM
ACO- 8
ACO- 35
ACO- 36
AC0-37
13NOR2
Care Coordination/
Safety
AC0-38
AC0-9
ACO -10
ACO -11
ER13NO14.158</GPH>
Measure Title
Skilled Nursing Facility 30-Day All-Cause
Readmission Measure (SNFRM)
All-Cause Unplanned Admissions for Patients with
Diabetes
All-Cause Unplanned Admissions for Patients with
Heart Failure
All-Cause Unplanned Admissions for Patients with
Multiple Chronic Conditions
Ambulatory Sensitive Conditions Admissions:
Chronic Obstructive Pulmonary Disease or Asthma
in Older Adults
(AHRQ Prevention Quality Indicator (PQI) #5)
Ambulatory Sensitive Conditions Admissions:
Heart Failure
(AHRQ Prevention Quality Indicator (PQI) #8 )
Percent ofPCPs who Successfully Meet Meaningful
Use Requirements
X
X
X
X
NQF #0005,
AHRQ
NQF #0005
AHRQ
NQF #0005
AHRQ
NQF#N/A
CMS/ARRQ
NQF#N/A
CMS/ARRQ
NQF#N/A
CMS/ARRQ
NQF#N/A
CMS/ARRQ
NQF#N/A
CMS/ARRQ
AdaptedNQF
#1789
CMS
NQF#TBD
CMS
NQF#TBD
CMS
NQF#TBD
CMS
NQF#TBD
CMS
AdaptedNQF
#0275
AHRQ
AdaptedNQF
#0277
AHRQ
NQF#N/A
CMS
PY2
PY3
Survey
R
p
p
Survey
R
p
p
Survey
R
p
p
Survey
R
p
p
Survey
R
p
p
Survey
R
p
p
Survey
R
R
R
Survey
R
p
p
Claims
R
R
p
Claims
R
R
p
Claims
R
R
p
Claims
R
R
p
Claims
R
R
p
Claims
R
p
p
Claims
R
p
p
EHR Incentive
Program
R
p
p
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
TABLE 81: Measures for Use in Establishing Quality Performance Standards that ACOs Must Meet for Shared
Savings
ebenthall on DSK5SPTVN1PROD with $$_JOB
VerDate Sep<11>2014
Domain
ACO
Measure#
Measure Title
New Measure
NQF #/Measure
Steward
Method of Data
Submission
R- Reporting
P -Performance
PYl
p
p
R
p
p
R
p
p
R
p
p
R
p
p
R
p
p
R
p
p
R
R
p
R
R
p
R
R
p
R
R
R
CMSWeb
Interface
R
p
p
CMSWeb
Interface
R
p
p
ACO- 28
ACO - 41: Diabetes: Eye Exam
Hypertension (HTN): Controlling High Blood
Pressure
NQF #0055
NCQA (individual
component)
NQF#0018
NCQA
CMSWeb
Interface
R
p
p
AC0-30
Ischemic Vascular Disease (IVD): Use of Aspirin or
Another Antithrombotic
NQF #0068
NCQA
CMSWeb
Interface
R
p
p
ACO- 31
Heart Failure (HF): Beta-Blocker Therapy for Left
Ventricular Systolic Dysfunction (LVSD)
NQF #0083
AMA-PCPI
CMSWeb
Interface
R
R
p
ACO -14
AC0-15
Frm 00371
AC0-16
AC0-17
Preventive Health
AC0-18
AC0-19
Sfmt 4725
13NOR2
R
ACO -13
PO 00000
E:\FR\FM\13NOR2.SGM
PY3
AC0-39
Jkt 235001
Fmt 4701
PY2
AC0-20
ACO- 21
Clinical Care for At Risk
Population - Depression
AC0-40
Documentation of Current Medications in the
Medical Record
Falls: Screening for Future Fall Risk
X
Preventive Care and Screening: Influenza
Immunization
Pneumonia Vaccination Status for Older Adults
NQF #0041
AMA-PCPI
NQF #0043
NCQA
NQF#0421
CMS
NQF #0028
AMA-PCPI
NQF#0418
CMS
NQF #0034
NCQA
NQF#NA
NCQA
CMS
Preventive Care and Screening: Body Mass Index
(BMI) Screening and Follow Up
Preventive Care and Screening: Tobacco Use:
Screening and Cessation Intervention
Preventive Care and Screening: Screening for
Clinical Depression and Follow-up Plan
Colorectal Cancer Screening
Breast Cancer Screening
Preventive Care and Screening: Screening for High
Blood Pressure and Follow-up Documented
Depression Remission at Twelve Months
X
Diabetes Composite (All or Nothing Scoring):
Clinical Care for At Risk
Population - Diabetes
AC0-27
ACO- 27: Diabetes Mellitus: Hemoglobin
Ale Poor Control
ACO- 41
Clinical Care for At Risk
Population Hypertension
Clinical Care for At Risk
Population - Ischemic
Vascular Disease
Clinical Care for At Risk
Population Heart Failure
NQF#0419
CMS
NQF#0101
NCQA
X
NQF#0710
MNCM
CMS Composite
NQF #0059
NCQA (individual
component)
Reporting
CMSWeb
Interface
CMSWeb
Interface
CMSWeb
Interface
CMSWeb
Interface
CMS Web
Interface
CMSWeb
Interface
CMSWeb
Interface
CMSWeb
Interface
CMSWeb
Interface
CMSWeb
Interface
CMS Web
Interface
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
Pay for Performance Phase In
67917
ER13NO14.159</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
67918
Jkt 235001
Frm 00372
Fmt 4701
Sfmt 4700
13NOR2
regulations at § 425.502 and in the
preamble to the November 2011 final
E:\FR\FM\13NOR2.SGM
The current quality scoring
methodology is explained in the
PO 00000
Domain
ACO
Measure#
Measure Title
New Measure
NQF #/Measure
Steward
Method of Data
Submission
R- Reporting
P -Performance
PYl
Clinical Care for At Risk
Population- Coronary
Artery Disease
ACO- 33
Angiotensin-Converting Enzyme (ACE)
Inhibitor or Angiotensin Receptor Blocker
(ARB) Therapy- for patients with CAD and
Diabetes or Left Ventricular Systolic
Dysfunction (LVEF <40%)
NQF#0066
ACC
PY2
PY3
R
R
p
CMSWeb
Interface
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
BILLING CODE 4120-01-C
VerDate Sep<11>2014
ER13NO14.160</GPH>
Pay for Performance Phase In
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
• Care Coordination/Patient Safety—
10 measures
• Preventive Health—8 measures
• At Risk Population—6 measures
(including 5 individual measures and a
2-component diabetes composite
measure)
Table 82 provides a summary of the
number of measures by domain and the
rule (76 FR 67895 through 67900). As a
result of the additions, deletions, and
revisions to the quality measure set
being made in this final rule, each of the
four domains will include the following
number of quality measures (See Table
82 for details.):
• Patient/Caregiver Experience of
Care—8 measures
67919
total points and domain weights that
will be used for scoring purposes under
these changes. Otherwise, the current
methodology for calculating an ACO’s
overall quality performance score will
continue to apply. Table 83 provides the
measures that are retired/replaced.
TABLE 82: NUMBER OF MEASURES AND TOTAL POINTS FOR EACH DOMAIN WITHIN THE QUALITY PERFORMANCE
STANDARD
Number of
individual
measures
Domain
Total measures for scoring purposes
Patient/Caregiver Experience
Care Coordination/Patient
Safety.
Preventive Health ...................
At-Risk Population ..................
8
10
Total in all Domains ........
33
8
7
Total possible
points
Domain weight
(percent)
8 individual survey module measures ....................................
10 measures. Note that the EHR measure is double-weighted (4 points).
8 measures .............................................................................
5 individual measures, plus a 2-component diabetes composite measure, scored as one..
16
22
25
25
16
12
25
25
32 ............................................................................................
66
100
TABLE 83: SHARED SAVINGS PROGRAM MEASURES RETIRED/REPLACED
Notes
Domain
Measure title
Care Coordination/
Patient Safety.
ACO #22
Retired.
At Risk Population—Diabetes.
ACO #23
Retired.
ebenthall on DSK5SPTVN1PROD with $$_JOB
ACO #12
Replaced.
At Risk Population—Diabetes.
ACO #24
Retired—
Redundant
Measure.
ACO #25
Retired—
Redundant
measure.
ACO # 26
Retired—
redundant
measure.
At Risk Population—Diabetes.
VerDate Sep<11>2014
At Risk Population—Diabetes.
At Risk Population—Diabetes.
20:15 Nov 12, 2014
NQF measure #/
measure steward
Medication Reconciliation: Reconciliation After
Discharge from
an Inpatient Facility.
Diabetes Composite (All or
Nothing Scoring):
Hemoglobin A1c
Control (<8 percent).
Diabetes Composite (All or
Nothing Scoring):
Low Density
Lipoprotein
(<100).
Diabetes Composite (All or
Nothing Scoring):
Blood Pressure
<140/90.
Diabetes Composite (All or
Nothing Scoring):
Tobacco Non
Use.
Diabetes Composite: Daily Aspirin or
Antiplatelet Medication Use for
Patients with Diabetes Mellitus
and Ischemic
Vascular Disease.
Jkt 235001
PO 00000
Method of data
submission
Pay for Performance Phase In
R = Reporting P=Performance
Performance Year 1
Performance Year 2
Performance Year 3
NQF #97 AMA–
PCPI/NCQA.
GPRO Web Interface.
R
P
P
NQF #0729 MN
Community
Measurement.
GPRO Web Interface.
R
P
P
NQF #0729 MN
Community
Measurement.
GPRO Web Interface.
R
P
P
NQF #0729 MN
Community
Measurement.
GPRO Web Interface.
R
P
P
NQF #0729 MN
Community
Measurement.
GPRO Web Interface.
R
P
P
...............................
GPRO Web Interface.
R
P
P
Frm 00373
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
67920
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 83: SHARED SAVINGS PROGRAM MEASURES RETIRED/REPLACED—Continued
Notes
Domain
Measure title
ACO #29
Retired.
At Risk Population—Ischemic
Vascular Disease.
ACO #32
Retired.
At Risk Population—Coronary
Artery Disease.
Ischemic Vascular
Disease (IVD):
Complete Lipid
Profile and LDL
Control <100 mg/
dl.
Coronary Artery
Disease (CAD)
Composite: All or
Nothing Scoring:
Drug Therapy for
Lowering LDLCholesterol.
We believe that these modifications to
the quality measure set for the Shared
Savings Program will further enhance
the quality of care patients receive from
ACO participants and ACO providers/
suppliers, better reflect clinical practice
guidelines, streamline measures
reporting, and enhance alignment with
PQRS and the EHR Incentive Program.
ebenthall on DSK5SPTVN1PROD with $$_JOB
g. Effective Date and Phase In of Quality
Measures
Proposal: We proposed that these
measures changes would become
effective beginning with the 2015
reporting period, and the 2015
performance year (PY). We also
proposed that all quality measures
would be phased in for ACOs with 2015
start dates according to the phase-in
schedule in Table 81. We proposed that
ACOs with start dates before 2015
would be responsible only for complete
and accurate reporting of the new
measures for the 2015 performance year
and then responsible for either reporting
or performance on measures according
to the phase in schedule.
Comment: Most commenters did not
separately provide comments on this
specific proposal regarding the effective
date for measure changes but addressed
the general issue as part of their
comments on individual measures or
related issues, especially with respect to
the effective date for benchmarking
purposes. However, a number of
commenters disagreed with the proposal
to move certain new measures to pay for
performance after only one year of pay
for reporting. They suggested that an
additional year of pay for reporting
would be needed in order to adequately
and fairly set benchmarks for pay for
performance, especially for measures
that have not been previously tested in
any large scale health system and may
VerDate Sep<11>2014
20:15 Nov 12, 2014
NQF measure #/
measure steward
Jkt 235001
Method of data
submission
Performance Year 1
Performance Year 2
Performance Year 3
NQF #75 NCQA ....
GPRO Web Interface.
R
P
P
NQF #74 CMS
(composite)/
AMA–PCPI (individual component).
GPRO Web Interface.
R
R
P
be newly or not yet accredited by the
National Quality Forum (NQF).
Response: We are finalizing our
proposal that quality measures will
become effective for the Shared Savings
Program quality performance standard
beginning in 2015 and the phase-in
schedule indicated in Table 81.
Additionally, we are convinced by
commenters that believe that an
additional year of pay for reporting is
needed by CMS and ACOs to fully
implement new measures. Therefore,
each new measure will be pay-forreporting for its first two reporting
periods in use. This additional time will
help to ensure that ACOs have adequate
time to phase in their own care
processes and infrastructure before they
are held accountable for performance
and that CMS has adequate data to set
benchmarks for new measures before
they transition to pay for performance
according to the phase-in schedule in
Table 81. In other words, the phase-in
schedule indicated in Table 81 applies
to a measure after it has been pay-forreporting for the first two reporting
periods it is in use. In this case, the new
measures we are finalizing will be payfor-reporting for the 2015 and 2016
reporting periods, which will take
precedence over the phase-in schedule
for ACOs that are currently participating
in the Shared Savings Program. Using
new measures as pay-for-reporting for
the first two reporting periods they are
in use will provide adequate time and
data necessary to set the benchmarks for
the 2017 reporting period when the
measures will transition to pay for
performance under the phase in
schedule indicated in Table 81.
For example, assume a new measure
is scheduled to phase in with reporting
in PY1, reporting in PY2, and
performance in PY3. Further assume
PO 00000
Pay for Performance Phase In
R = Reporting P=Performance
Frm 00374
Fmt 4701
Sfmt 4700
that an ACO with a 2014 start date will
be in its second performance year (PY2)
when the measure becomes effective. In
this example, according to the
performance year phase-in schedule, the
ACO would be responsible for complete
and accurate reporting of the new
measure in PY2 and for performance on
the measure in PY3. However, because
the measure is new and will be pay-forreporting for the 2015 and 2016
reporting periods, this overrides the
phase-in schedule because we would
not have benchmark information for this
ACO’s PY3. In this example, if the ACO
renews its participation agreement for a
new agreement period then the ACO
would be responsible for performance
on the measure in PY1 of its new
agreement period, because the measure
was scheduled to be pay-forperformance in PY3 of the previous
agreement period. If we change the
assumptions in the example to an ACO
with a start date of 2015, under the
phase-in schedule the ACO would be
responsible for performance in PY3
which corresponds with the 2017
reporting period, the first year in which
the measure is available to be used for
pay-for-performance. In other words,
each new measure is pay-for-reporting
until it is possible to use it as pay-forperformance, and whether the ACO is
subject to pay-for-performance at that
time is determined by the phase-in
schedule in Table 81.
We are also revising § 425.502(a)(4) to
provide that the quality performance
standard for a newly introduced
measure is set at the level of complete
and accurate reporting for the first two
reporting periods for which reporting of
the measure is required. For subsequent
reporting periods, the quality
performance standard for the measure
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
will be assessed according to the phasein schedule for the measure.
h. Aligning with PQRS sampling
methodology
Proposal: As noted in the November
2011 Shared Savings Program final rule
(76 FR 67900), the Shared Savings
Program uses the same sampling
method used by PQRS GPRO.
Specifically, the sample for the ACO
GPRO must consist of at least 411
assigned beneficiaries per measure set/
domain. If the pool of eligible, assigned
beneficiaries is less than 411, the ACO
must report on 100 percent, or all, of the
assigned beneficiaries sampled. In the
proposed rule, we stated that to the
extent that PQRS modifies and finalizes
changes in the reporting requirements
for group practices reporting via the
GPRO web interface, we proposed to
make similar modifications to ACO
reporting through the GPRO web
interface. Specifically, as discussed in
section III.K. of this final rule with
comment period, we proposed to reduce
the GPRO web interface minimum
reporting requirements for PQRS
reporting from 411 to 248 consecutively
ranked and assigned patients for each
measure or 100 percent of the sample
for each measure if there are less than
248 patients in a given sample. We
proposed that the reduced sample for
each measure for reporting through the
GPRO web interface would also apply to
ACOs. We stated that we believe that a
reduction in the number of sampled
beneficiaries would reduce reporting
burden for ACOs while maintaining
high statistical validity and reliability in
results.
Comment: We received relatively few
comments on this proposal, but most of
those that commented supported the
proposal. A majority of commenters also
supported the PQRS proposal to reduce
the reported sample size for groups of
100 or more EPs, and agreed that this
smaller sample size would reduce
reporting burden (please refer to section
III.K.). However, a few commenters were
concerned that a sample size of 248 may
not adequately or accurately represent
the diversity of an ACO’s providers and
suppliers, especially for larger ACOs.
These ACOs can include mixed models
of employed and independent-affiliated
provider practices. Therefore, these
commenters support reducing the
sample size requirement only for
smaller ACOs, such as those ACOs with
5,000 to 10,000 assigned beneficiaries.
Alternatively, these commenters request
that ACOs be given the option to
continue to report a larger sample size
if they prefer. A commenter also asked
that CMS publish results that support
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
the statistical validity and reliability of
the proposed reduction of the sample
from 411 to 248.
Response: Specific responses to
comments on this proposal can be found
in section III.K.4.a. of this final rule
with comment period. We appreciate
the comments from stakeholders that
support the proposal to reduce the
sample size and agree that this change
will reduce reporting burden for ACOs.
Moreover, commenters agreed that a
reduction in the sample size to 248
would continue to be statistically valid
and reliable. As discussed in section
III.K.4.a, our internal assessments
performed for PQRS confirm this
conclusion. Additionally, we clarify that
the GPRO web interface tool will
continue to contain an oversample of
616 patients at it has previously,
however, the number required for
reporting is being reduced from 411 to
248. Because we have concluded that a
sample of 248 is statistically valid and
reliable, we disagree that the reduced
sample size will not adequately
represent the diversity of the ACO’s
providers and suppliers. Further, we do
not have a mechanism that would allow
us to deviate from the established
methodology used by the GPRO web
interface, and therefore cannot offer an
option at this time for ACOs to choose
to be assessed on more than 248
patients. As noted above, the tool
oversamples up to 616 patients, and
ACOs may choose, but are not required,
to report on all 616. We oversample to
allow ACOs to include beneficiaries for
quality reporting to replace beneficiaries
ACOs are unable to report on, due to
exclusions, so they can complete the
minimum required number of patients.
However, in accordance with the
methodology previously adopted under
PQRS, the ACO would only be assessed
based on reporting for 248 patients
using the existing sampling
methodology that otherwise has been
previously established.
In order to align with the policy being
finalized for PQRS, we are reducing the
required number of consecutively
ranked patients reported for each
measure module through the CMS web
interface from 411 to 248. Because
ACOs report using the same web
interface tool used by PQRS, this
reduction in the required sample size
for reporting will reduce burden, while
ensuring statistical validity and
reliability is maintained. It also ensures
consistency and equal treatment for all
groups reporting through the GPRO web
interface.
PO 00000
Frm 00375
Fmt 4701
Sfmt 4700
67921
3. Request for Comments for Future
Quality Measures
In the proposed rule (79 FR 40483),
we indicated that in addition to the
changes to the current set of measures
for the Shared Savings Program
discussed above, we were interested in
public comment on additional measures
that we may consider in future
rulemaking. We particularly welcomed
comments regarding the following
issues:
• Gaps in measures and additional
specific measures: We solicited
comments on specific measures or
measure groups that may be considered
in future rulemaking to fill in gaps that
may exist for assessing ACO quality
performance.
• Caregiver experience of care: We
solicited comment on additional
specific caregiver experience of care
measures that might be considered in
future rulemaking.
• Alignment with Value-Based
Payment Modifier (VM) measures: We
solicited comment on whether there are
synergies that can be created by aligning
the ACO quality measure set with the
measures used under the VM. Although
we did not propose any changes to align
with the measures used under the VM,
we did seek comment on whether the
VM composites should be considered in
the future as a replacement for the two
ACO claims-based ambulatory sensitive
conditions admissions (ASCA)
measures.
• Specific measures to assess care in
the frail elderly population: We
welcomed comments with suggestions
of new measures of the quality of care
furnished to the frail elderly population
that we may consider adopting in future
rulemaking.
• Utilization: We welcomed
comments on whether it is sufficient for
utilization information to be included in
the aggregate quarterly reports to ACOs
or whether utilization measures should
also be used to assess the ACO’s quality
performance as an added incentive to
provide more efficient care. If
commenters were interested in having
utilization measures included in the
quality performance standard, we
welcomed specific comments on what
utilization measures would be most
appropriate for future consideration and
suggestions for how to risk adjust these
measures.
• Health outcomes: We welcomed
suggestions as to whether and when it
would be appropriate to include a selfreported health and functional status
measure in the quality performance
standard. We specifically welcomed
comments on the appropriateness of
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67922
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
using a tool such the Health Outcomes
Survey for health plans which assesses
changes in the physical and mental
health of individual beneficiaries over
time. We also welcomed suggestions for
alternatives to self-reported measures
that may be considered in the future.
• Measures for retirement: We
solicited input from commenters on any
measures that should be considered for
retirement in future rulemaking. We
welcomed comments on whether to
continue to require ‘‘topped out’’
measures be included as pay for
reporting measures. In addition, we
noted that we were proposing changes
to the benchmarking methodology for
topped out measures.
• Additional public health measures:
In the proposed rule, we noted that we
may propose to include an additional
preventive health measure in the quality
measure set under the Shared Savings
Program in future rulemaking.
Specifically, we indicated that we were
considering adding ‘‘Preventive Care
and Screening: Unhealthy Alcohol Use:
Screening and Brief Counseling’’ (NQF
#2152). This measure would reflect
screening of Medicare beneficiaries
covered under the existing Medicare
benefit referred to as the ‘‘Screening and
Behavioral Counseling Interventions in
Primary Care to Reduce Alcohol
Misuse’’ benefit. We welcomed
comments on the potential addition of
this measure and noted that we would
consider any comments received in
developing any future proposal with
respect to this measure.
Comment: Commenters identified a
wide variety of specific measure gap
areas that we should address, such as
COPD, care coordination, medication
management and adherence, preventive
care/adult immunizations, pain,
malnutrition, wounds, bladder control,
outcome measures and cost/efficiency/
utilization related measures. Some
commenters provided suggestions for
specific measures that we should
consider in future rulemaking while
other commenters provided more
general suggestions about the types of
additional measures that we should
consider. For example, some
commenters suggested that quality
measures should be primarily designed
to protect beneficiaries from
inappropriate reductions in services by
ACOs. Other commenters noted that to
improve care for beneficiaries, the
measures should focus on areas where:
(a) CMS believes Medicare beneficiaries
are receiving poor care today; and (b) it
is feasible for an ACO to make changes
in care that would improve care in those
areas using the limited resources
available in the Shared Savings
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Program. Others opposed utilization
measures, believing these types of
measures are not necessary within the
Shared Savings Program because of the
inherent incentive for ACOs
participating in the program to reduce
unnecessary services and achieve
savings. A commenter supported adding
public health measures ‘‘. . . to help
overcome the difficulties inherent in
procedure-based measures that capture
limited volumes of experience in rural
settings.’’ This commenter provided
additional suggestions, such as that we
exercise caution in interpreting results
from self-reported measures, because of
a tendency of rural respondents to
understate the true burden of chronic
illness and travel. Another commenter
emphasized that measure development
should not entirely focus on outcomes
measures because process measures can
also improve outcomes. Some measures
without clear clinical evidence (that is,
lacking NQF endorsement) should be
avoided. Furthermore, survey measures
should be minimal (and not heavily
weighted) due to subjectivity, cost of
collection, and risk of inaccurate
representation based on response rate.
This commenter also recommended that
the number of measures required to be
reported should be realistic and CMS
should move toward the use of
composites and outcome measures.
Refining the measurement strategy in
this way over time will allow for ACOs
to mature in function, which takes a few
years, and CMS should structure
measure selection and performance
measurement to reflect growth from
fledgling ACO to a mature ACO. CMS
should set up data reporting to be
automated as much as possible. Finally,
a commenter suggested that
complementing the measurement
strategy should be a forum for
communication among ACO
participants to share best practices and
lessons learned. Comments regarding
‘‘topped out’’ measures for retirement
are included in the discussion below
regarding the adjustment of the
benchmarks for ‘‘topped out’’ measures.
Response: We appreciate receiving the
many thoughtful suggestions. We will
consider these suggestions further as we
develop any future proposals for
additional measures for the Shared
Savings Program, which we would
implement through rulemaking.
4. Electronic Reporting of Quality
Measure Data
We believe that certified EHR
technology used in a meaningful way is
one piece of a broader health
information technology infrastructure
needed to reform the health care system
PO 00000
Frm 00376
Fmt 4701
Sfmt 4700
and improve health care quality,
efficiency, and patient safety. Through
our programs such as the Medicare and
Medicaid EHR Incentive Programs and
the Stage 2 meaningful use (MU)
requirements we seek to expand the
meaningful use of certified EHR
technology (CEHRT). Adoption of
CEHRT by ACO participants and ACO
providers/suppliers may help support
efforts to achieve improvements in
patient care and quality, including
reductions in medical errors, increased
access to and availability of records and
data, improved clinical decision
support, and the convenience of
electronic prescribing. Additionally, we
believe that the potential for the Shared
Savings Program to achieve its goals
could be further advanced by direct
EHR-based quality data reporting by
ACOs and their ACO participants and
ACO providers/suppliers. This could
help reinforce the use of CEHRT, reduce
errors in quality measure submission,
and achieve data submission
efficiencies. We believe ACOs and their
providers should be leaders in
encouraging EHR adoption and should
be using CEHRT to improve quality of
care and patient safety and to reduce
errors.
Furthermore, beginning in 2015,
eligible professionals that do not
successfully demonstrate meaningful
use of CEHRT will be subject to a
downward payment adjustment under
Medicare that starts at ¥1 percent and
increases each year that an eligible
professional does not demonstrate
meaningful use, to a maximum of ¥5
percent. A final rule establishing the
requirements of Stage 2 of the Medicare
EHR Incentive Program appeared in the
September 4, 2012 Federal Register
(Medicare and Medicaid Programs;
Electronic Health Record Incentive
Program—Stage 2 Final Rule) (77 FR
53968). Included in this final rule are
the meaningful use and other
requirements that apply for the payment
adjustments under Medicare for covered
professional services provided by
eligible professionals failing to
demonstrate meaningful use of CEHRT,
including the CQM reporting
component of meaningful use. As
previously discussed in section III.M.2,
we are finalizing a proposal to revise the
name and the specifications for the
quality measure regarding EHR adoption
to take the changing incentives into
account. Specifically, we are changing
the name of ACO #11 from ‘‘Percent of
PCPs Who Successfully Qualify for an
EHR Incentive Program Payment’’ to
‘‘Percent of PCPs Who Successfully
Meet Meaningful Use Requirements’’ to
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
more accurately reflect what is being
measured.
Additionally, under a group reporting
option established for the Medicare EHR
Incentive Program (77 FR 54076 through
54078), EPs participating in an ACO
under the Shared Savings Program who
extract the data necessary for the ACO
to satisfy the quality reporting
requirements of the Shared Savings
Program from CEHRT would satisfy the
CQM reporting component of
meaningful use as a group for the
Medicare EHR Incentive Program. In
addition to submitting CQMs as part of
an ACO, EPs have to individually satisfy
the other objectives and associated
measures for their respective stage of
meaningful use.
However, we clarified that if an EP
intends to use this group reporting
option to meet the CQM reporting
component of meaningful use, then the
EP would have to extract all of its CQM
data from a CEHRT and report it to the
ACO (in a form and manner specified by
the ACO) in order for the EP to
potentially qualify for the Medicare EHR
Incentive Program. The ACO must also
report the GPRO web interface measures
and satisfy the reporting requirements
under the Shared Savings Program in
order to its EPs to satisfy the CQM
reporting component of meaningful use
for the Medicare EHR Incentive
Program.
Although these group reporting
requirements were established under
the Medicare EHR Incentive Program,
the Shared Savings Program regulations
were not amended to reflect these
reporting requirements. Therefore, we
proposed to amend the regulations
governing the Shared Savings Program
to align with the requirements
previously adopted under the Medicare
EHR Incentive Program in order to
provide that EPs participating in an
ACO under the Shared Savings Program
can satisfy the CQM reporting
component of meaningful use for the
Medicare EHR Incentive Program when
the ACO reports GPRO web interface
measures by adding new paragraph (d)
to § 425.506. We proposed that this new
paragraph would provide that EPs
participating in an ACO under the
Shared Savings Program satisfy the
CQM reporting component of
meaningful use for the Medicare EHR
Incentive Program when: (1) The
eligible professional extracts data
necessary for the ACO to satisfy its
quality reporting requirements from
CEHRT; and (2) the ACO satisfactorily
reports the ACO GPRO measures
through a CMS web interface.
Although we did not propose any new
requirements regarding EHR based
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
reporting under the Shared Savings
Program, we welcomed suggestions and
comments about issues which we would
consider in developing any future
proposals. We especially solicited
comment on the feasibility of an ACO to
be a convener and submitter of quality
measures through an EHR or alternative
method of electronically reporting
quality measures to us. We indicated
our interest in the opportunities and
barriers to ACO EHR quality measure
reporting, as well as ways to overcome
any barriers. We also welcomed
suggestions on alternative ways that we
might implement EHR-based reporting
of quality measures in the Shared
Savings Program, such as directly from
EHRs or via data submission vendors.
We solicited comment on whether EHR
reporting should be a requirement for all
Shared Savings Program ACOs or if the
requirement for EHR reporting should
be phased in gradually, for instance
through a separate risk track or by the
establishment of a ‘‘core and menu’’
quality measure set approach in which
we would establish a core set of
required quality measures and then
supplement these required measures
with a menu of additional measures
(such as EHR-based reporting) from
which an ACO could choose. This
approach could provide ACOs with
additional flexibility and allow them to
report on quality measures that better
reflect any special services they provide.
As an alternative, we also solicited
comment on whether ACO providers/
suppliers could use a local registry-like
version of the GPRO web interface to
capture relevant clinical information
and to monitor performance on all
Medicare patients throughout the year
and to more easily report quality data to
CMS annually.
Comment: We received a wide variety
of suggestions from ACOs and other
stakeholders. Most ACOs support CMS’s
decision not to propose any new
requirements at this time regarding EHR
based reporting, and they agree with
aligning the Shared Savings Program
with the EHR Incentive Program
whereby EPs participating in an ACO
can satisfy the CQM reporting
component of meaningful use when the
EP extracts data necessary for the ACO
to satisfy its quality reporting
requirements using a CEHRT and the
ACO satisfactorily reports the GPRO
measures through the CMS web
interface. Some commenters believe the
technical and operational barriers
outlined in the proposed rule were
severely understated. Healthcare
Information and Management Systems
Society (HIMSS) considered requiring
PO 00000
Frm 00377
Fmt 4701
Sfmt 4700
67923
EHR-based reporting of quality
measures in the Shared Savings Program
to be premature. Commenters raised
concerns that the current lack of
interoperability capabilities for ACOs
that are formed by disparate
organizations, often hospitals and
physician groups coming together, but
using differing EHR platforms that do
not communicate electronic data
sufficiently to centralize data for quality
reporting would limit the ability of
ACOs to successfully report quality
through an EHR. They state it will take
significant resources and time to ensure
that interoperability is achieved. Rather
than requiring EHR-based reporting,
some commenters suggested that CMS
should give providers the option to
report through EHRs.
Response: We appreciate the
comments recommending that we not
establish any new requirements at this
time regarding EHR based reporting
under the Shared Savings Program. We
also appreciate the comments
supporting aligning the Shared Savings
Program with the EHR Incentive
Program whereby EP participating in an
ACO can satisfy the CQM reporting
component of meaningful use when the
EP extracts data necessary for the ACO
to satisfy its GPRO reporting
requirement using a CEHRT and the
ACO satisfactorily reports the GPRO
measures through the CMS web
interface.
We will continue to work toward
electronic reporting of quality measures,
keeping in mind the unique relationship
ACOs have with their ACO participants
and ACO providers/suppliers. We
understand and appreciate the feedback
from those stakeholders who raised
important concerns about the readiness
of ACOs and EHR systems to report
quality electronically under the Shared
Savings Program. We will use the
information provided by commenters to
work with ACOs and other stakeholders
to develop possible ways to encourage
EHR adoption taking into account input
from ACOs on challenges for ACO
electronic collection and submission of
measures. In addition, we will consider
the input we have received from
stakeholders when deciding what
additional requirements should be
proposed in future rulemaking to
encourage EHR adoption and use by
ACOs and their ACO participants and
ACO providers/suppliers.
After consideration of the comments
received regarding this proposal, we are
finalizing our proposal to codify in the
Shared Savings Program rules for 2015
and beyond that an eligible professional
that is an ACO provider/supplier can
satisfy the CQM reporting component of
E:\FR\FM\13NOR2.SGM
13NOR2
67924
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
meaningful use when the eligible
professional extracts data from CEHRT
necessary for the ACO to satisfy its
quality reporting requirements under
the Shared Savings Program and the
ACO reports the GPRO measures
through the CMS web interface. This
policy will be codified at § 425.506(d) of
the Shared Savings Program regulations.
We emphasize that if an EP intends to
use this group reporting option to meet
the CQM reporting component of
meaningful use, then the EP would have
to extract all its CQM data from a
CEHRT and report it to the ACO (in a
form and manner specified by the ACO)
in order for the EP to potentially qualify
for the Medicare EHR Incentive
Program. The ACO must also report the
GPRO measures through the CMS web
interface in order for its EPs to satisfy
the CQM reporting component of
meaningful use for the Medicare EHR
Incentive Program.
Although this amendment to the
regulations will align the Medicare
Shared Savings Program regulations
with the existing requirements under
the Medicare EHR Incentive Program,
we intend to take steps in the future to
better align and integrate EHR use into
quality reporting under the Shared
Savings Program.
ebenthall on DSK5SPTVN1PROD with $$_JOB
5. Quality Performance Benchmarks
a. Overview of Current Requirements
Section 1899(b)(3)(C) of the Act
directs the Secretary to ‘‘establish
quality performance standards to assess
the quality of care furnished by ACOs’’
and to ‘‘seek to improve the quality of
care furnished by ACOs over time by
specifying higher standards, new
measures, or both for purposes of
assessing such quality of care.’’ Under
the current Shared Savings Program
regulations at § 425.502, the following
requirements with regard to establishing
a quality performance benchmark for
measures apply: (1) During the first
performance year of an ACO’s
agreement period, the quality
performance standard is set at the level
of complete and accurate reporting; (2)
during subsequent performance years,
the quality performance standard will
be phased in such that ACOs will be
assessed on their performance on
certain measures (see Table 1 of the
November 2011 Shared Savings Program
final rule (76 FR 67889 through 67890),
for details of the transition for each of
the 33 measures); (3) we designate a
quality performance benchmark and
minimum attainment level for each
measure, and establish a point scale for
the level of achievement on each
measure; and (4) we define quality
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
performance benchmarks using FFS
Medicare data or using flat percentages
when the 60th percentile is equal to or
greater than 80.00 percent.
Section 425.502(b)(2) governs the data
that CMS uses to establish the quality
performance benchmarks for quality
performance measures under the Shared
Savings Program. Consistent with
section 1899(b)(3)(C) of the Act, which
requires CMS to seek to improve the
quality of care furnished by ACOs
participating in the Shared Savings
Program over time, § 425.500(b)(3) states
that in establishing the measures to
assess the quality of care furnished by
an ACO, CMS seeks to improve the
quality of care furnished by ACOs over
time by specifying higher standards,
new measures, or both.
Subsequently, we discussed several
issues related to the establishment of
quality performance benchmarks in the
CY 2014 PFS final rule with comment
period (78 FR 74759 through 74764). In
that rule (78 FR 74760), we finalized a
proposal to combine all available
Medicare FFS quality data, including
data gathered under PQRS (through both
the GPRO web interface tool and other
quality reporting mechanisms) and
other relevant FFS quality data reported
to CMS (including data submitted by
Shared Savings Program and Pioneer
ACOs) to set the quality performance
benchmarks for 2014 and subsequent
reporting periods. In establishing this
policy, we determined that it was
appropriate to use all FFS data rather
than only ACO data, at least in the early
years of the program, to avoid the
possibility of punishing high performers
where performance is generally high
among all ACOs. We did not finalize a
proposal to use Medicare Advantage
(MA) data alone or in combination with
FFS data in the short-term. Instead, we
stated in the CY 2014 PFS final rule
with comment period (78 FR 74760) that
we intended to revisit the policy of
using MA data in future rulemaking
when we have more experience setting
benchmarks for ACOs.
Additionally, in the CY 2014 PFS
final rule with comment period, we
retained the ability to use flat
percentages to set benchmarks when
many reporters demonstrate high
achievement on a measure, so that
ACOs with high performance on a
measure are not penalized (78 FR
74760). More specifically, we will now
use all available FFS data to calculate
benchmarks, including ACO data,
except where performance at the 60th
percentile is equal to or greater than 80
percent for individual measures. In
these cases, a flat percentage will be
used to set the benchmark for the
PO 00000
Frm 00378
Fmt 4701
Sfmt 4700
measure. This policy allows ACOs with
high scores to earn maximum or near
maximum quality points while still
allowing room for improvement and
rewarding that improvement in
subsequent years.
As previously discussed, the first
performance year of an ACO’s
agreement period is pay for reporting
only, so ACOs earn their maximum
sharing rate for completely and
accurately reporting all 33 quality
measures. Quality performance
benchmarks are released in
subregulatory guidance prior to the start
of the quality reporting period for which
they apply so that as we phase in
measures to pay for performance, ACOs
are aware of the actual performance
rates they will need to achieve to earn
the maximum quality points under each
domain. In the November 2011 Shared
Savings Program final rule, we indicated
our intent to gradually raise the
minimum attainment level to continue
to incentivize quality improvement over
time and noted that we would do so
through future rulemaking after
providing sufficient advance notice with
a comment period to allow for industry
input (76 FR 67898). In the CY 2014 PFS
final rule with comment period, we
reiterated our policy of setting quality
performance benchmarks prior to the
reporting year for which they would
apply (78 FR 74759). Specifically, we
use data submitted in 2013 for the 2012
reporting period to set the quality
performance benchmarks for the 2014
reporting period. However, we
recognize that in the first few years of
the Shared Savings Program, we will
only have a limited amount of data for
some measures, which may cause the
benchmarks for these measures to
fluctuate, possibly making it difficult for
ACOs to improve upon their previous
year’s performance. Stakeholders have
also told us that they prefer to have a
stable benchmark target so that they can
be rewarded for quality improvement
from one year to the next. Therefore,
instead of modifying quality
performance benchmarks annually, in
the CY 2014 PFS final rule with
comment period (78 FR 74761) we
stated that we would set the
benchmarks for the 2014 reporting year
in advance using data submitted during
2013 for the 2012 reporting year, and
continue to use that benchmark for 2
reporting years (specifically, the 2014
and 2015 reporting years). We further
indicated our intention to revisit this
issue in future rulemaking to allow for
public comment on the appropriate
number of years that a benchmark
should apply before it is updated.
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
b. Revisions for Benchmarking Measures
That Are ‘‘Topped Out’’
In the discussion of measures in the
CY 2015 Physician Fee Schedule
proposed rule, we indicated that some
measures may be topped out, meaning
that all but a very few organizations
achieve near perfect performance on the
measure. Since publication of the
quality performance benchmarks for the
2014 and 2015 quality reporting years,
a number of ACOs have noted that using
available national FFS data has resulted
in some benchmarks where the 80th or
90th percentiles approach 100 percent
performance on the measure.
Stakeholders have suggested it is
unreasonable to hold organizations,
especially very large organizations such
as ACOs to this high standard and that
it may be easier for smaller and medium
size physician practices to achieve
higher levels of performance given their
smaller patient populations. We believe
these concerns have merit because we
have looked at the FFS data submitted
to CMS and agree it is possible that
smaller practices or practices with
smaller populations may be able to
achieve these higher levels of
performance more easily than larger
practices or organizations with larger
patient populations. Therefore, we
proposed certain modifications to our
benchmarking methodology to address
the way that such ‘‘topped out’’
measures are treated for purposes of
evaluating an ACO’s performance.
Specifically, when the national FFS data
results in the 90th percentile for a
measure are greater than or equal to 95
percent, we would use flat percentages
for the measure, similar to our policy
under § 425.502(b)(2)(ii) of using flat
percentages when the 60th percentile is
greater than 80 percent to address
clustered measures. We believe this
approach would address concerns about
how topped out measures affect the
quality performance standard while
continuing to reward high performance,
and being readily understandable to all.
We proposed to revise § 425.502(b)(2)(ii)
to reflect this policy. We invited
comments on this proposal. We also
invited comments on other potential
approaches for addressing topped out
measures. We indicated that we would
use any comments received to help
develop any future proposals regarding
topped out measures. For example, we
welcomed comments on whether we
should drop topped out measures from
the measures set, fold them into
composites, or retain them but make
them pay for reporting only.
Comment: Commenters were
generally in agreement with our
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
proposal to use flat percentages for
topped out measures, which is
consistent with our policy of using flat
percentages when the 60th percentile is
greater than 80 percent to address
clustered measures. We received a wide
variety of responses to our request for
comment on what should be done with
topped out measures through future
rulemaking. Many commenters
supported retaining such measures with
the view that quality measures are
intended to protect Medicare
beneficiaries from receiving
inappropriate care. If all but a few
organizations achieve near perfect
performance, the commenters believe it
would be important to retain that
measure to encourage better
performance from the low performing
organizations, and to prevent
backsliding by the high performers.
Other commenters, including MedPAC,
suggested removing topped out
measures to reduce reporting burden.
Others suggested that topped out
measures could be dropped or moved
from being process-based to clinical
outcome-based and be folded into
composites to prevent ‘‘back sliding,’’ or
that they could be considered ‘‘deemed
met’’ without a reporting requirement
but available for audit if so chosen.
Response: We appreciate the
commenters’ support for the proposal to
use flat percentages when the national
FFS data results in the 90th percentile
performing at greater than or equal to 95
percent. We also appreciate the
additional suggestions regarding
treatment of topped out measures and
intend to consider this issue further in
future rulemaking.
Final Decision: After consideration of
the comments received on this issue, we
are finalizing our proposal to use flat
percentages when the national FFS data
results in the 90th percentile for a
measure are greater than or equal to 95
percent. We are also finalizing our
proposed revisions to § 425.502(b)(2)(ii)
to reflect this policy. Although this final
policy is similar to our current policy
for setting benchmarks based on flat
percentages when the 60th percentile is
equal to or greater than 80.00 percent,
we clarify that this methodology would
apply to all measures, including
measures whose performance rates are
calculated as ratios, for example,
measures such as the ACO Ambulatory
Sensitive Conditions Admissions and
the All Condition Readmission measure.
We believe it is appropriate to apply
this methodology to all topped out
measures, including measures whose
performance rates are calculated as
ratios. Measures calculated and reported
as ratios may also become topped out
PO 00000
Frm 00379
Fmt 4701
Sfmt 4700
67925
and we believe it is important to keep
a consistent approach for addressing all
Shared Savings Program measures that
become topped out.
c. Quality Performance Standard for
Measures That Apply to ACOs That
Enter a Second or Subsequent
Participation Agreement
As discussed previously, during an
ACO’s first participation agreement
period, the quality performance
standard during the first performance
year is initially set at the level of
complete and accurate reporting, and
then, during performance years 2 and 3
within the ACO’s first agreement period,
the quality performance standard is
phased in such that the ACO is assessed
on its performance on selected
measures. We did not directly indicate
the quality performance standard that
would apply if an ACO were to
subsequently enter into a second or
subsequent participation agreement.
However, § 425.502(a)(1) provides that
during the first performance year of an
ACO’s agreement period, CMS will
define the quality performance standard
at the level of complete and accurate
reporting of all quality measures. As
drafted, this regulation could be read to
imply that the quality performance
standard for ACOs in the first
performance year of a subsequent
agreement period would also be set at
the standard of full and accurate
reporting. We do not believe it is
appropriate for an ACO in a second or
subsequent agreement period to report
quality measures on a pay-for-reporting
basis if they have previously reported
these measures in a prior agreement
period. The ACO would have gained
experience reporting the quality
measures during the earlier agreement
period, and as a result, we do not
believe it would be necessary to provide
any further transition period. Rather, we
believe it would be appropriate to assess
the ACO’s actual performance on
measures that have been designated as
pay for performance during all 3 years
of the second or subsequent
participation agreement period.
Accordingly, we proposed to revise
our regulations to expressly provide that
during a second or subsequent
participation agreement period, the
ACO would continue to be assessed on
its performance on each measure that
has been designated as pay for
performance. That is, the ACO would
continue to be assessed on the quality
performance standard that would
otherwise apply to an ACO if it were in
the third performance year of the first
agreement period. We will do this by
modifying § 425.502(a)(1) and (a)(2) to
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67926
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
indicate that the performance standard
will be set at the level of complete and
accurate reporting of all quality
measures only for the first performance
year of an ACO’s first agreement period,
and that during subsequent agreement
periods, pay for performance will apply
for all three performance years.
Comment: We received relatively few
comments on this proposal. A number
of those that responded supported the
proposal. A few were hesitant to
support it, suggesting that a
performance standard for a quality
measure should not be continued into a
second or a subsequent participation
agreement period if there have been any
significant changes in the measure set
and/or in the specifications used to
calculate performance on the measures.
In such cases, those measures that have
changed should follow the same
schedule as would apply to an ACO in
its first agreement period. Another
example of a concern these commenters
raised is if an ACO with a 2013 start
date (three year agreement for 2013
through 2015) chooses to sign a
subsequent three year agreement (for
2016 through 2018), that requires it to
accept risk, then the ACO would
possibly be facing new benchmarks
beginning in PY 2016 and would not be
afforded a one year pay for reporting
transition period to gain experience
with the new benchmarks.
Response: We appreciate the
comments in support of this proposal.
We believe that concerns that were
expressed by some commenters about
changes in the measure set are
addressed through the phase-in
schedule for new measures, as outlined
in Table 81, and our policy, finalized
above, that all new measures will be
pay-for-reporting for all ACOs for the
first two reporting periods in which
they are in use, regardless of the phasein schedule. This will permit time for
CMS to gather data for benchmarking
and publish benchmarks prior to the
start of the third reporting period in
which a new measure is in use. This
two year grace period will also permit
ACOs to become accustomed to the
measure before it becomes pay-forperformance. So in the example given
by the commenter, the ACO with a 2013
start date would not be subject to payfor-performance in its first year of the
subsequent agreement period (starting
in 2016) for any of the new measures
finalized in this rule. The first
opportunity for the new measures to be
used as pay-for-performance would be
for the 2017 reporting period, which
would correspond to this ACO’s second
performance year of its subsequent
agreement period. Because the ACO
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
would be in its subsequent agreement
period, all measures would be pay-forperformance at that time, with the
exception of measures that remain payfor-reporting in all years, according to
the phase-in schedule indicated in
Table 81. For example, the Depression
Remission at 12 Months measure (ACO#
40) is pay-for-reporting for all three
years of an ACO’s first agreement
period. In a subsequent agreement
period, ACOs will continue to be
assessed on this measure as pay-forreporting, which corresponds to the
level of performance required in PY3 of
the first agreement period.
Final Decision: We are finalizing our
proposal to modify § 425.502(a) to
indicate that for ACOs in a second or
subsequent agreement period, all
measures will be pay for performance
for all three performance years unless
the measure is designated as pay-forreporting for all three years, as indicated
in Table 81. We clarify that, as
discussed in more detail above, this
policy applies only to measures that
have been in use for two years or more,
for which benchmarks are available, and
thus, would not apply to new measures,
which are designated as pay-forreporting during the first two reporting
periods they are in use.
d. Timing for Updating Benchmarks
As discussed in the CY 2014 PFS final
rule with comment (78 FR 74761), we
have further considered suggestions
from ACOs regarding the appropriate
number of years that a benchmark
should apply before it is updated. ACOs
suggested that there be a longer period
of time to gain experience with the
performance measure, before the
benchmark is further updated. ACOs
also indicated that it would be desirable
to set and leave benchmarks static for
additional performance years so that
they have a quality improvement target
to strive for that does not change
frequently. ACOs believe that a stable
benchmark would enhance their ability
to be rewarded for quality improvement,
as well as quality achievement, from
one year to the next. We recognize,
however, that there could be some
concerns about lengthening the period
between updates to the quality
performance benchmarks. The current
benchmarks as discussed previously, for
example, are based on a combination of
all available Medicare FFS quality data,
including data gathered under PQRS,
the Shared Savings Program and Pioneer
ACO Model, but not MA quality data.
To the extent that the benchmarks are
based on quality data reported by a large
number of ACOs and other FFS entities,
we believe it is reasonable to use them
PO 00000
Frm 00380
Fmt 4701
Sfmt 4700
to assess the quality performance of
ACOs. Furthermore, as discussed in the
2014 PFS final rule with comment
period (78 FR 74761), we are also
persuaded that we should establish a
longer period between updates to the
benchmarks in order to provide ACOs
with a more stable target for measuring
quality improvement. In the absence of
this stability, it could be very difficult
to assess quality improvement from year
to year.
In the 2014 PFS final rule with
comment period, we noted that we
intended to address the number of years
between updates to the benchmarks
again in future rulemaking in order to
allow for public comment. Therefore,
we considered how long benchmarks
should be in place before they are
updated. We considered a range of
options, from setting benchmarks every
2 years to setting benchmarks every 5
years. For example, we considered the
option of setting benchmarks every 3
years. However, we note that ACO
agreement periods are 3 years long and
a new cohort of ACOs enters the
program each year. As a result, setting
benchmarks every 3 years might
advantage some ACOs over others,
particularly ACOs that have an
agreement period during which
benchmarks are not updated. Therefore,
we proposed to update benchmarks
every 2 years. We believe 2 years is an
appropriate amount of time because the
Shared Savings Program is relatively
new and we do not have extensive
experience in setting benchmarks under
the Shared Savings Program. Updating
the benchmarks every 2 years would
enable us to be more flexible and give
us the ability to make adjustments more
frequently if appropriate. We note,
however, that we may revisit this policy
as more ACOs enter the program, more
FFS data is collected which could help
us better understand to what extent
benchmarks should vary from year to
year, or if we make any future proposals
regarding the use of MA quality data for
setting benchmarks.
Accordingly, we proposed to revise
§ 425.502(b) to add a new paragraph
(b)(4)(i), which would provide that CMS
will update benchmarks every 2 years.
To illustrate this proposed policy, the
existing quality performance
benchmarks, which are based on data
submitted in 2013 for the 2012 reporting
period would apply for a total of 2
performance years (the 2014 and 2015
performance years) after which we
would reset the benchmarks for all
ACOs based on data for the 2014
reporting period that is reported during
2015. These updated benchmarks would
apply for the 2016 and 2017
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
performance years. This timeline is
summarized in Table 85. Under this
proposal, ACOs would have a stable
target for quality achievement for 2
years, which should improve the
opportunity for ACOs to be rewarded for
improvement from year to year
compared to that benchmark. We also
proposed to revise § 425.502(b) to add a
new paragraph (b)(4)(ii), which would
provide that for measures introduced in
the first year of the 2-year benchmarking
cycle, the benchmark will be established
in the second year and updated along
with the other measures at the start of
the next 2-year benchmarking cycle.
We solicited comment on this
proposal. We specifically solicited
comment on the appropriate number of
years that a benchmark should remain
stable before it is updated. We also
welcomed comments about when
annual updates might be appropriate
such as when there is a substantive
specification change to a measure
between years. For instance, the age
range used for the breast cancer
screening measure is different in 2014
than in 2013, or when the measure
owner modifies or retires a measure.
Additionally, although we proposed to
retain our current policy of using the
most recent available data to set the
quality performance benchmarks, we
also solicited comment on whether data
from other reporting periods should also
be considered in establishing
benchmarks that will apply for 2
performance years. Specifically, we
sought input on whether data from
multiple years should be used to help
provide more stable benchmarks. For
example, should data submitted for the
2013 and 2014 reporting periods be
combined to set benchmarks for the
2016 and 2017 performance years?
Comment: We received a wide range
of comments in response to this
proposal. In general most commenters
supported setting benchmarks for at
least two years but many, including
some ACOs, supported a longer period
of at least three years to align with the
Shared Savings Program agreement
period to provide more stability for
ACOs. There were some commenters
that suggested more frequent adjustment
of benchmarks under certain situations,
suggesting that more frequent
benchmark updates may be necessary
whenever there are substantive
specification changes for a measure,
such as changes in the dominator or
frequency. For example, a commenter
stated that even slight modifications to
a measure specification could eliminate
any opportunity to establish a valid
benchmark and that CMS must therefore
consider establishing new benchmarks
when even ‘‘non-substantive’’ changes
are made to measure. A commenter
suggested that instead of the proposed
two year interval, benchmarks should be
adjusted annually if there is a
statistically significant performance
change across all organizations. Some
commenters suggested the use of
multiple years of data to set
benchmarks, suggesting, for example,
that some measures could be susceptible
to year specific events that could skew
results.
Response: We are finalizing our
proposal to set benchmarks for two
years to provide ACOs with stable
quality improvement targets. We believe
that setting benchmarks for two years
provides ACOs with stable quality
improvement targets while not
advantaging some ACOs over others by
setting them for three years. We also
agree with commenters who suggested
the use of multiple years of data to set
benchmarks to reduce the effect that
year to year variation might have on the
benchmarks. Therefore, we will use up
to 3 years of FFS data to set
benchmarks, if available. This should
provide sufficient stability to minimize
67927
year to year variation while also
representing reasonably current
practices, if the data is available. The
use of multiple years of FFS data to set
benchmarks will apply to all newly
established benchmarks, but will not
affect existing benchmarks, which apply
to the 2014 and 2015 performance years.
We are finalizing our proposal to set
benchmarks for two years to provide
ACOs with stable targets for quality
improvement. In addition, we will use
up to three years of FFS data to set
benchmarks, if available. The use of
multiple years of FFS data to set
benchmarks will apply to all newly
established benchmarks, but will not
affect existing benchmarks, which apply
to the 2014 and 2015 performance years.
We are finalizing our proposal to revise
§ 425.502(b) to add a new paragraph
(b)(4)(i) providing that CMS will update
benchmarks every 2 years. In light of
our decision to set the quality
performance standard for a newly
introduced measure at the level of
complete and accurate reporting for the
first two reporting periods for which the
measure is in use, we are revising
proposed § 425.502(b)(4)(ii) to provide
that for newly introduced measures that
transition to pay for performance in the
second year of the 2-year benchmarking
cycle, the benchmark will be established
in that year and updated along with the
other measures at the start of the next
2-year benchmarking cycle. For
example, if a new measure is scheduled
to become pay for performance in 2017
after being used for pay-for-reporting for
2015 and 2016, it will be set for the
2017 performance year and
subsequently reset at the beginning of
the next 2-year benchmarking cycle
(2018–2019). In other words, such a
measure would have its benchmark set
for a single year before phasing into the
biennial benchmarking schedule
outlined in Table 84.
TABLE 84—TIMELINE FOR SETTING AND UPDATING QUALITY PERFORMANCE BENCHMARKS
Year data is analyzed,
and benchmark is published
Reporting period for data used to set benchmark
ebenthall on DSK5SPTVN1PROD with $$_JOB
2012 .........................................................................................................................................
2012, 2013, 2014 .....................................................................................................................
2014, 2015, 2016 .....................................................................................................................
6. Rewarding Quality Improvement
a. Current Approach to Rewarding
ACOs for Both Quality Attainment and
Quality Improvement
ACOs must meet a CMS-specified
quality performance standard in order to
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
be eligible to share in savings. The
Shared Savings Program quality
performance standard currently consists
of a set of quality measures spanning
four domains that are collected via the
patient and caregiver experience of care
survey, calculated by CMS from internal
PO 00000
Frm 00381
Fmt 4701
Sfmt 4700
2013
2015
2017
Performance year and
reporting period to which
benchmark applies
2014 & 2015
2016 & 2017
2018 & 2019
administrative and claims data, and
submitted by the ACO through the CMS
web interface. The four domains include
patient/caregiver experience of care,
care coordination/patient safety,
preventive health, and at-risk
populations. The measures collected
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67928
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
through the CMS web interface are also
used to determine whether eligible
professionals that bill through the TIN
of an ACO participant qualify for the
PQRS incentive payment or avoid the
downward PQRS payment adjustment.
Eligible professionals that bill through
the TIN of an ACO participant may
qualify for the PQRS incentive payment
or avoid the downward PQRS payment
adjustment when the ACO satisfactorily
reports the ACO GPRO quality measures
on their behalf.
Under current policy, the quality
performance standard is defined at the
level of full and complete reporting for
the first performance year of an ACO’s
agreement period. After that, an ACO
must meet certain thresholds of
performance and is rewarded on a
sliding scale in which higher levels of
quality performance translate to higher
rates of shared savings. This scale,
therefore, rewards improvement over
time, since higher performance
translates to higher shared savings. For
example, an ACO that performs at the
80th percentile one year and then at the
90th percentile the next year would
receive a higher level of shared savings
in its second year than its first year,
based on its improved quality
performance. In this way, ACOs are
rewarded for both attainment and
improvement. This is particularly true
when benchmarks are stable for more
than one year, as discussed earlier in
this section.
We recognize that rewards for both
quality attainment, as well as quality
improvement are not always built in to
pay-for-performance initiatives. For
example, in HVBP (Hospital ValueBased Purchasing) hospitals are scored
based on the higher of their
achievement or improvement on
specified quality measures, with some
hospitals receiving incentive payments
if their overall performance is high
enough relative to their peers. In the
November 2011 final rule establishing
the Shared Savings Program (76 FR
67897), we indicated in response to
comments that we believe the approach
of offering more points for better quality
performance also offers an implicit
incentive for continuous quality
improvements, since it incorporates a
sliding scale in which higher levels of
quality performance translate to higher
sharing rates. We believed that high
performing ACOs should do well under
this approach since it recognizes and
provides incentives for ACOs to
maintain high quality performance in
order to maximize their share of savings
and minimize their share of losses.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
b. Additional Rewards for Quality
Improvement
ACOs and other stakeholders have
suggested that the current quality points
scale described above does not
adequately reward ACOs for both
quality attainment and improvement.
They request that we further strengthen
the incentives for quality improvement
by including an additional explicit
reward for those ACOs that improve
from one year to the next.
As discussed previously, the existing
quality performance standard includes a
sliding point scale that rewards ACOs
for certain levels of attainment. In
addition, we note that under the final
policy discussed above in which we
will establish a stable quality
performance benchmark for a period of
2 years, there should be an even greater
opportunity for every ACO to
demonstrate improvement and be
rewarded for that improvement from
year to year. However, we were
persuaded by suggestions from
stakeholders that an additional, more
explicit reward should be included for
ACOs that improve their quality scores
from year to year. Therefore, we
proposed to revise our existing quality
scoring strategy to explicitly recognize
and reward ACOs that make year-to-year
improvements in their quality
performance scores on individual
measures.
To develop such an approach, we
looked to the MA program, which has
already successfully developed and
implemented a formula for measuring
quality improvement. The MA five star
rating program computes an
improvement change score which is
defined as the score for a measure in a
performance year minus the score in the
previous performance year. The MA five
star rating program then measures each
plan’s net quality improvement by
calculating the total number of
significantly improved quality measures
and subtracting the total number of
significantly declined quality measures.
This is an approach that we believed
was also appropriate for measuring
quality improvement for ACOs. (For
more details on the formula for
calculating the MA quality
improvement measure, see the
discussion in ‘‘Medicare 2014 Part C &
D Star Rating Technical Notes’’,
Attachment I, page 80, which can be
downloaded from the CMS Web site at
https://www.cms.gov/Medicare/
Prescription-Drug-Coverage/
PrescriptionDrugCovGenIn/
PerformanceData.html.)
We continue to believe it is important
to recognize that the Shared Savings
PO 00000
Frm 00382
Fmt 4701
Sfmt 4700
Program is not a managed care program.
Unlike MA, this program’s design
retains FFS flexibility and the freedom
of choice available to beneficiaries
under Medicare Parts A and B which
generally necessitates different program
requirements. However, in this case we
believe there would be significant
advantages for the Shared Savings
Program to adopt the formula for a
quality improvement measure that MA
has already developed and implemented
rather than attempt to develop a new
formula for a quality improvement
measure. In particular, the MA measure
formula has already been fully
developed and vetted with stakeholders,
in the context of the MA program, with
detailed operational specifications and
previously shared with the public.
In addition, we believe it is important
to add a quality improvement measure
to the Shared Savings Program in a
manner that would minimize disruption
for ACOs. We believe it would be
undesirable for both ACOs and the
program if the quality improvement
measure were added in a way that
required extensive revisions to the
current quality measurement
methodology, for example, reweighting
of the four quality measure domains.
Therefore, we proposed to add a quality
improvement measure to award bonus
points for quality improvement to each
of the existing four quality measure
domains. For each quality measure
domain, we proposed to award an ACO
up to two additional bonus points for
quality performance improvement on
the quality measures within the domain.
These bonus points would be added to
the total points that the ACO achieved
within each of the four domains. Under
this proposal, the total possible points
that could be achieved in a domain,
including up to 2 bonus points, could
not exceed the current maximum total
points achievable within the domain.
ACOs would achieve bonus points for
this quality improvement measure in a
domain if they achieve statistically
significant levels of quality
improvement for measures within the
domain, as discussed below. Otherwise,
the current methodology for calculating
the ACO’s overall quality performance
score would continue to apply (see
§ 425.502(e) and 76 FR 67895 through
67900). Additional details about the
proposal to incorporate bonus points
into the quality performance scoring
methodology are discussed in the CY
2015 Physician Fee Schedule proposed
rule (79 FR 40490 through 40492).
Highlights of the methodology we
proposed are as follows:
The quality improvement measure
scoring for a domain would be based on
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
the ACO’s net improvement in quality
for the other measures in the domain.
The calculation of the quality
improvement measure for each domain
would generally be based on the
formula used for the MA five star rating
program, as follows:
Improvement Change Score = score
for a measure in performance year
minus score in previous performance
year.
In general, for a measure to be eligible
to be included for purposes of
determining quality improvement and
awarding bonus points in a domain for
a performance year, the measure must
be a measure for which an ACO was
scored in both the performance year and
the immediately preceding performance
year. Measures that were not scored in
both the performance year and the
immediately preceding performance
year, for example, new measures, would
not be included in the assessment of
improvement. Otherwise, for purposes
of determining quality improvement
and awarding bonus points, we would
include all of the individual measures
within the domain, including both payfor-reporting measures and pay-forperformance measures. In determining
improvement, the actual performance
score achieved by the ACO on the
measure would be used, not the score
used to determine shared savings. In
other words, we would calculate a
performance score for each measure,
regardless of whether it is pay for
reporting or pay for performance, and
include the score in the report we
provide to the ACO. For example, all
measures are pay for reporting in the
first year of an ACO’s first agreement
period, but even though the ACO will
receive full credit for all reported
measures, its actual performance on
those measures will also be scored and
provided to the ACO for informational
purposes. We believe it is appropriate to
use these actual performance scores to
assess improvement on a measure from
year to year, regardless of whether the
measure is designated as a pay for
reporting or a pay for performance
measure in that performance year
because the performance scores
achieved by the ACO provide the best
indication of the actual change in
quality performance by the ACO.
If the ACO is in its first performance
year of its first agreement period, then
it would not be possible, of course, to
measure quality improvement.
Therefore, for these ACOs the existing
scoring methodology would continue to
apply and no bonus points would be
awarded. If an ACO in its second or
subsequent performance year does not
experience an improvement nor a
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
decline in quality performance for any
of the selected measures compared to its
previous reporting period, or it
experiences an improvement for some
measures but has an equal or greater
number of measures where quality
performance has declined, then the
ACO would likewise not be awarded
any bonus points. If an ACO renews a
participation agreement, then the
measurement of quality improvement
would be based on a comparison
between performance in the first year of
the new agreement period and
performance in the 3rd year of the
previous agreement period.
For each qualifying measure, we
would determine whether there was a
significant improvement or decline
between the two performance years by
applying a common standard statistical
test. (See the discussion of the t-test for
calculating the MA quality
improvement measure in ‘‘Medicare
2014 Part C & D Star Rating Technical
Notes’’, Attachment I, page 80, which
can be downloaded from the CMS Web
site at https://www.cms.gov/Medicare/
Prescription-Drug-Coverage/
PrescriptionDrugCovGenIn/
PerformanceData.html). Statistical
significance testing in this case assesses
how unlikely it is that differences as big
as those observed would be due to
chance when the performance is
actually the same. The test recognizes
and appropriately adjusts measures at
both high and low levels of performance
for statistically significant levels of
change. Under this methodology, we
can be reasonably certain, at a 95
percent level of confidence, that
statistically significant differences in an
ACO’s quality measure performance for
a year compared to the previous year are
real and not simply due to random
variation in measure sampling.
The awarding of bonus points would
be based on an ACO’s net improvement
within a domain, and would be
calculated by determining the total
number of significantly improved
measures and subtracting the total
number of significantly declined
measures. Up to 2 bonus points would
be awarded on a sliding scale based on
the ACO’s net improvement for the
domain compared to the total number of
individual measures in the domain.
Consistent with our current quality
methodology, the total points earned for
measures in each domain, including any
quality improvement points, would be
summed and divided by the total points
available for that domain to produce an
overall domain score of the percentage
of points earned versus points available.
The percentage score for each domain
will be averaged together to generate a
PO 00000
Frm 00383
Fmt 4701
Sfmt 4700
67929
final overall quality performance score
and sharing rate for each ACO that will
be used to determine the amount of
shared savings or, if applicable the
amount of losses it owes, consistent
with the requirements under
§ 425.502(e).
In developing this proposal to award
bonus points for quality improvement,
we considered several alternative
options. Specifically, we considered
whether it would be more appropriate
not to award bonus points but instead
to include a computed quality
improvement measure that would be
incorporated into the current scoring
methodology just as any other measure
would be added. Under this alternative
approach, we would increase the total
possible points that could be awarded in
a domain. However, we did not propose
that approach because we believe that
awarding bonus points would provide
the desired incentive, would be more
understandable and less disruptive, and
would not require extensive changes to
the quality performance standard. By
awarding bonus points we also avoid
the need to develop ways to avoid
unfairly penalizing new ACOs.
Similarly, ACOs that have already
achieved a very high level of quality for
an individual measure may not be able
to achieve further statistically
significant improvement for the
measure. Such ACOs could otherwise be
disadvantaged if they were not able to
earn performance points for a new
quality improvement measure added to
the total measures in the domain. We
believe our quality improvement
proposal mitigates these concerns
because the measure recognizes
incremental improvement at higher
levels of performance and does not
impose any penalty on ACOs that have
already achieved a high level of
performance.
We also considered whether we
should provide an even greater
additional incentive by increasing the
total possible bonus points, perhaps up
to 4 points to provide a higher incentive
for greater levels of quality
improvement. However, we did not
propose that option because we were
concerned that awarding 4 points for the
quality improvement measure could
overweight the additional incentive for
quality improvement given that the
program already rewards higher
performance with a greater share of any
savings.
In addition, we had some concerns
about whether it would be appropriate
to use the ‘‘pay for reporting’’ data
reported to us, given that this
information does not affect an ACO’s
quality performance score in the first
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67930
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
performance year. Therefore, we
considered whether the quality
improvement score should apply only to
those ACOs that have completed at least
two performance years. Under this
alternative approach, ACOs would have
an opportunity to be assessed based on
their actual quality measure
performance before being assessed on
their quality improvement scores. We
did not select this approach because we
wanted to provide an incentive that
would apply as soon as possible in the
agreement period. Furthermore, as
noted earlier, we believe it would be
appropriate to include pay-for-reporting
measures for purposes of awarding
bonus points since under § 425.500(f)
ACOs are required to report pay-forreporting measures completely,
accurately, and timely.
We proposed to add a new paragraph
(e)(4) to § 425.502 to incorporate this
process for calculating bonus points for
quality improvement into the quality
performance scoring methodology. We
solicited comments on this proposal and
welcomed comments on the alternative
approaches discussed in the proposed
rule. We also solicited comments on
whether there are other alternative
approaches to explicitly rewarding
quality improvement for ACOs, and
whether the implicit reward for quality
improvement provided under the
current regulations is sufficient.
We also welcomed any suggestions on
how the Shared Savings Program might
integrate elements of other quality
improvement methodologies such as
those employed by HVBP or MA. Such
comments would be considered in
developing possible future proposals to
further align with other Medicare
quality improvement programs.
Comment: Commenters were
supportive of explicitly recognizing and
rewarding ACOs that make year to year
improvements in the manner proposed.
Many commenters, however, felt that
our proposal did not go far enough and
recommended instead that CMS award
up to four bonus points (rather than
two) for quality improvement in each of
the existing four quality measure
domains, or permit bonus points in one
domain to influence the weighting of
the domain. These commenters pointed
out that the proposal to award up to two
bonus points would increase the overall
quality performance score for an ACO
by at most 14 percent. Some
commenters suggested additional
approaches, such as awarding an
additional 10 percent of shared savings
for those ACOs that score in the top 10
percent on quality measures. Another
example is a suggestion that ACOs be
allowed to retain 50% of their share of
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
savings regardless of the MSR if their
overall quality score improves yearover-year.
Response: We appreciate the overall
support from commenters who generally
agreed with the proposal to offer an
additional and explicit reward for
improving quality performance in the
Shared Savings Program. This
additional reward would complement
and reinforce our current quality
performance scoring system that
implicitly takes into account
improvements over prior performance
and rewards ACOs with a greater share
in savings for greater quality
performance. We believe that adding an
explicit incentive places even greater
emphasis on quality improvement,
encouraging all ACOs to continue to
improve quality for their patient
populations over time, in addition to
maintaining existing high quality levels.
The success of the Shared Savings
Program is dependent in large part on
ACOs further improving the quality of
the care they provide, not merely
maintaining current levels of quality.
Further, we believe that the suggestions
from some commenters to increase the
additional quality improvement award
to up to four bonus points have merit.
Although we proposed the improvement
measure to increase the domain score by
up to 2 points, similar to other measures
in the domain, we agree with
commenters that increasing this to four
bonus points would not appear to
overweight the additional incentive
since the additional bonus points can
only increase a quality score by at most
25 percent overall. (That is, 4 bonus
points per domain times 4 domains
equals 16, which when divided by the
66 total points possible equals
approximately 25 percent).
Additionally, we have at least one
measure (ACO #11, Percent of PCPs
Who Successfully Qualify for an EHR
Incentive Program Payment) that is
doubly weighted at 4 points in order to
emphasize the importance of adoption
of EHR meaningful use. Permitting the
quality improvement measure to be
double weighted would similarly
emphasize the importance of quality
improvement, further encouraging
ACOs to improve overall quality for
their patient populations over time.
Final Decision: We are finalizing our
proposal to provide an additional
quality improvement reward for Shared
Savings Program ACOs who
demonstrate quality improvement on
measures in a domain. We believe that
this additional and explicit reward for
quality improvement would
complement and reinforce our current
quality performance approach.
PO 00000
Frm 00384
Fmt 4701
Sfmt 4700
Specifically, for each quality measure
domain, we will award an ACO up to
four additional bonus points for quality
performance improvement on the
quality measures within the domain.
These bonus points would be added to
the total points that the ACO achieves
within each of the four domains. The
total possible points that can be
achieved in a domain, including up to
4 bonus points, could not exceed the
maximum total points achievable within
the domain. For example, as shown in
Table 82, the total possible points for
the patient/caregiver experience
domain, which has eight individual
measures, is 16 total possible points.
Under this new policy that we are
finalizing to provide for quality
improvement bonus points, the
maximum possible points within this
domain will remain 16. If an ACO
scores 12 points and is awarded four
additional bonus points for quality
improvement then the ACO’s total
points for this domain would be 16.
However, if instead this same ACO had
scored 13 points, then this ACO’s total
points after adding the bonus points
would still not exceed 16. Table 82,
which shows the number of points
available per domain under the revised
quality performance standard, reflects
the current quality measure scoring
methodology which will continue.
Consistent with our current quality
scoring methodology, the total points
earned for measures in each domain,
including any quality improvement
bonus points up to the total possible
points for the domain, would be
summed and divided by the total points
available for that domain to produce an
overall domain score of the percentage
of points earned versus points available.
The percentage score for each domain
will be averaged together to generate a
final overall quality performance score
and sharing rate for each ACO that will
be used to determine the percentage of
savings it shares or, if applicable, the
percentage of losses it owes, consistent
with the methodology established under
§ 425.502(e).
The calculation of the quality
improvement measure for each domain
would generally be based on the
formula used for the MA five star rating
program, as follows:
Improvement Change Score = score
for a measure in performance year
minus score in previous performance
year.
For each qualifying measure, we will
determine whether there was a
significant improvement or decline
between the two performance years by
applying a ‘‘t-test’’ which is a common
standard statistical test, at a 95 percent
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
level of confidence. (See the discussion
of the t-test for calculating the MA
quality improvement measure in
‘‘Medicare 2014 Part C & D Star Rating
Technical Notes’’, Attachment I, page
80, which can be downloaded from the
CMS Web site at https://www.cms.gov/
Medicare/Prescription-Drug-Coverage/
PrescriptionDrugCovGenIn/
PerformanceData.html). This test
assesses how unlikely it is that
differences as big as those observed
would be due to chance when the
performance is actually the same.
The bonus points, up to a maximum
of 4 points, will be awarded in direct
proportion to the ACO’s net
improvement for the domain to the total
number of individual measures in the
domain. For example, there are eight
individual measures for the patient/
caregiver experience of care domain. If
an ACO achieves a significant quality
increase in all eight measures then the
ACO would be awarded the maximum
of four bonus points for this domain.
However, if the ACO achieved a
significant quality increase in only one
of the eight measures in this domain
and no significant quality decline on
any of the measures then the ACO
would be awarded bonus points for
quality improvement in the domain that
is 1/8 times 4 = 0.50. The total points
that the ACO could achieve in this
domain could still not exceed the
current maximum of 16 points shown in
Table 82. We are also finalizing our
proposal to add a new paragraph (4) to
§ 425.502(e) to incorporate the new
bonus points scoring methodology, but
are revising the proposed language in
order to reflect our decision to award up
to 4 bonus points per domain.
ebenthall on DSK5SPTVN1PROD with $$_JOB
7. Technical Corrections
Currently § 425.502(d)(2)(ii) states
that ACOs must score above the
minimum attainment level determined
by CMS on 70 percent of the measures
in each domain. If an ACO fails to
achieve the minimum attainment level
on at least 70 percent of the measures
in a domain, CMS will take the actions
described in § 425.216(c). We note that
§ 425.216, which addresses the actions
we may take prior to termination of an
ACO from the Shared Savings Program
does not include a paragraph (c). To
encompass all of the actions we may
take prior to termination, we believe the
correct reference should be to § 425.216
generally, and therefore, proposed to
make a technical correction to
§ 425.502(d)(2)(ii) to eliminate the
specific reference to paragraph (c) of
§ 425.216. We also proposed to correct
a typographical error in this provision
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
by revising ‘‘actions describe’’ to read
‘‘actions described.’’
In addition, we also proposed to make
a technical correction to § 425.502(a)(2).
This provision currently states that
ACOs will be assessed on performance
based on the minimum attainment level
for certain measures. However, as
explained above and in the November
2011 Shared Savings Program final rule
(76 FR 67895 through 67896), ACO
performance on a measure is assessed
not only based on the minimum
attainment level for the measure but
also based upon the quality performance
benchmark that has been established for
that measure. This methodology for
calculating the performance score for a
measure is codified in the regulations at
§ 425.502(c). Accordingly, we proposed
to amend § 425.502(a)(2) to state that
ACO performance will be assessed
based on the quality performance
benchmark and minimum attainment
level for certain measures.
We requested comments on these
proposed technical corrections.
We received no objections to
correcting the typographical errors and
making these other minor technical
corrections and are finalizing them as
proposed.
N. Value-Based Payment Modifier and
Physician Feedback Program
1. Overview
Section 1848(p) of the Act requires
that we establish a value-based payment
modifier (VM) and apply it to specific
physicians and groups of physicians the
Secretary determines appropriate
starting January 1, 2015, and to all
physicians and groups of physicians by
January 1, 2017. On or after January 1,
2017, section 1848(p)(7) of the Act
provides the Secretary discretion to
apply the VM to eligible professionals as
defined in section 1848(k)(3)(B) of the
Act. Section 1848(p)(4)(C) of the Act
requires the VM to be budget neutral.
The VM program continues CMS’s
initiative to increase the transparency of
health care quality information and to
assist providers and beneficiaries in
improving medical decision-making and
health care delivery.13
2. Governing Principles for VM
Implementation
In the CY 2013 PFS final rule with
comment period, we discussed the goals
of the VM and also established that
13 Kate Goodrich, et al. ‘‘A History and a Vision
for CMS Quality Measurement Programs’’. Joint
Comm’n J. Quality & Patient Safety. 2012. 38,465,
available at https://www.ingentaconnect.com/
content/jcaho/jcjqs/2012/00000038/00000010/
art00006.
PO 00000
Frm 00385
Fmt 4701
Sfmt 4700
67931
specific principles should govern the
implementation of the VM (77 FR
69307). We refer readers to that rule for
a detailed discussion and list those
principles here for reference.
• A focus on measurement and
alignment. Measures for the VM should
consistently reflect differences in
performance among groups or solo
practitioners, reflect the diversity of
services furnished, and be consistent
with the National and CMS Quality
Strategies and other CMS quality
initiatives, including the PQRS, the
Shared Savings Program, and the
Medicare EHR Incentive Program.
• A focus on physician and eligible
professional choice. Physicians and
other nonphysician eligible
professionals should be able to choose
the level (individual or group) at which
their quality performance will be
assessed, reflecting eligible
professionals’ choice over their practice
configurations. The choice of level
should align with the requirements of
other physician quality reporting
programs.
• A focus on shared accountability.
The VM can facilitate shared
accountability by assessing performance
at the group level and by focusing on
the total costs of care, not just the costs
of care furnished by an individual
professional.
• A focus on actionable information.
The Quality and Resource Use Reports
(QRURs) should provide meaningful
and actionable information to help
groups and solo practitioners identify
clinical, efficiency and effectiveness
areas where they are doing well, as well
as areas in which performance could be
improved by providing groups and solo
practitioners with QRURs on the quality
and cost of care they furnish to their
patients.
• A focus on a gradual
implementation. The VM should focus
initially on identifying high and low
performing groups and solo
practitioners. As we gain more
experience with physician measurement
tools and methodologies, we can
broaden the scope of measures assessed,
refine physician peer groups, create
finer payment distinctions, and provide
greater payment incentives for high
performance.
3. Overview of Existing Policies for the
Physician VM
In the CY 2013 PFS final rule with
comment period (77 FR 69310), we
finalized policies to phase-in the VM by
applying it beginning January 1, 2015, to
Medicare PFS payments to physicians
in groups of 100 or more eligible
professionals. A summary of the
E:\FR\FM\13NOR2.SGM
13NOR2
67932
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
existing policies that we finalized for
the CY 2015 VM can be found in the CY
2014 PFS proposed rule (78 FR 43486
through 43488). Subsequently, in the CY
2014 PFS final rule with comment
period (78 FR 74765 through 74787), we
finalized policies to continue the phasein of the VM by applying it starting
January 1, 2016 to payments under the
Medicare PFS for physicians in groups
of 10 or more eligible professionals.
4. Provisions of This Final Rule With
Comment Period
As a general summary, we proposed
the following VM policies in the CY
2015 PFS proposed rule:
• To apply the VM to all physicians
and nonphysician eligible professionals
in groups with two or more eligible
professionals and to solo practitioners
starting in CY 2017.
• To make quality-tiering mandatory
for groups and solo practitioners within
Category 1 for the CY 2017 VM. Where
solo practitioners and groups with two
to nine eligible professionals would be
subject only to any upward or neutral
adjustment determined under the
quality-tiering methodology.
• To tailor the application of the VM
to physicians and nonphysician eligible
professionals participating in the
Medicare Shared Savings Program
(Shared Savings Program), the Pioneer
ACO Model, the CPC Initiative, or other
similar Innovation Center models or
CMS initiatives starting in CY 2017.
• To clarify the exclusion of nonassigned claims for non-participating
providers from the VM.
• To increase the amount of payment
at risk under the VM from 2.0 percent
in CY 2016 to 4.0 percent in CY 2017.
• To align the quality measures and
quality reporting mechanisms for the
VM with those available to groups and
individuals under the PQRS during the
CY 2015 performance period.
• To expand the current informal
inquiry process to allow additional
corrections for the CY 2015 payment
adjustment period.
• To address the concerns raised by
NQF regarding the per capita cost
measures in the cost composite.
In this final rule with comment
period, we discuss the proposed
policies, the comments received, our
responses to the comments, and a brief
statement of our final policy.
Comment: We received some
comments on the VM in general that
were not related to any specific proposal
that we made in the proposed rule.
Several commenters suggested that the
CMS-hierarchical condition categories
(HCC) Risk Adjustment methodology
used in the total per capita cost
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
measures for the VM does not accurately
capture the additional costs associated
with treating the sickest beneficiaries.
Some of these commenters stated that
groups that work exclusively in postacute and long-term care settings would
be unable to perform well on cost
measures under the current
methodology. Commenters suggested
that we should include the place of
service where the beneficiary received
care in our methodology to set cost
benchmarks such that groups would be
compared against other groups that treat
beneficiaries who are also receiving care
in that type of location.
Another commenter suggested that we
add an additional adjustment for SNF
CPT codes to account for higher costs of
beneficiaries in this location. One
commenter suggested that CMS exclude
beneficiaries who receive a major organ
transplant from our cost and quality
measures because he believes that
prospective HCC risk adjustment would
not account for these added costs in the
performance period. Another
commenter stated that beneficiaries who
receive care at home typically have high
HCC scores and higher costs. This
commenter suggested that CMS should
consider exempting practices from the
VM who treat a high number of
beneficiaries with the highest HCC
scores or those with more than a certain
number of chronic conditions or
activities of daily living dependencies,
change the risk adjustment methodology
to include the frailty adjuster used in
the PACE program, or add ‘‘recognition
of savings from expected costs.’’
Response: We appreciate the concerns
raised by commenters and agree that it
is important to make adjustments for
differences in beneficiary characteristics
that impact health and cost outcomes
and are outside of the control of the
provider. We continue to believe that
our current methodology of using HCC
scores that include adjustments for
Medicare and Medicaid eligibility status
in addition to diagnoses, and truncating
costs at the 99th percentile for the
highest cost beneficiaries, help address
these concerns. While, the VM program
does not, in the aggregate, adjust costs
using an institutional risk score, the
Medicare Spending per Beneficiary
measure that will be used as part of the
cost composite in 2014 does adjust costs
based on whether a beneficiary recently
required long-term institutional care as
well as for whether a beneficiary is new
to the Medicare program. We addressed
the idea of adjusting cost measures for
differences in site of service, as it
pertained to hospitals, in the FY 2012
IPPS Final Rule (76 FR 51825). We
continue to believe that such
PO 00000
Frm 00386
Fmt 4701
Sfmt 4700
adjustments would undermine the
ability of our measures to meaningfully
capture differences in Medicare
spending. To address concerns
regarding specialties that might
routinely treat more complex and
consequently more costly beneficiaries,
we finalized in the CY 2013 PFS final
rule with comment period that we
would apply a specialty adjustment to
all cost measures used in the VM (78 FR
74776). This enables groups’ costs to be
compared to similarly-comprised
groups, based on specialty. In 2011, an
independent analysis concluded that
this risk-adjustment methodology is
effective at predicting actual costs, even
for beneficiaries with serious or
multiple chronic illnesses.14 Moreover,
the academic literature notes the multivariant nature of care quality and the
importance of defining measures across
rather than simply within care
settings.15
We note that high costs within the
post-acute and long-term care settings
present a unique opportunity for these
providers to improve performance on
cost and quality measures. While we
continue to encourage providers to
report quality measures for patients in
these settings and to use the information
contained in their QRUR to improve and
achieve high levels of performance, we
will continue to monitor these groups
and solo practitioners’ performance
under the VM and continue to explore
potential risk adjustment refinements..
a. Group Size
As noted in section III.N.1, section
1848(p)(4)(B)(iii)(II) of the Act requires
the Secretary to apply the VM to items
and services furnished under the PFS
beginning not later than January 1, 2017,
for all physicians and groups of
physicians. Therefore, we proposed to
apply the VM in CY 2017 and each
subsequent calendar year payment
adjustment period to physicians in
groups of physicians with two or more
eligible professionals and to physicians
who are solo practitioners (79 FR
40493–40495). For purposes of the VM,
we defined a physician, a group of
physicians, and an eligible professional
in the CY 2013 PFS final rule with
comment period (77 FR 69307–69310).
We proposed to define a ‘‘solo
practitioner’’ at § 414.1205 as a single
Tax Identification Number (TIN) with
one eligible professional who is
identified by an individual National
14 Gregory C. Pope, et al. ‘‘Evaluation of the CMS–
HCC Risk Adjustment Model: Final Report.’’ (March
2011).
15 Tracy E. Spinks, et al. Delivering high-quality
cancer care: The critical role of quality
measurement. Healthcare. 2014. 2,53–62.
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
Provider Identifier (NPI) billing under
that TIN. We noted that this proposal to
apply the VM to all solo practitioner
physicians and all groups of physicians
would complete our phase-in of the VM
as required by the Act.
In the proposed rule, we stated our
belief that we can validly and reliably
apply the VM to groups with two or
more eligible professionals and to solo
practitioners (79 FR 40494). We noted
that we conducted statistical reliability
analysis on the PQRS quality measures
and the VM cost measures reported in
the 2010 and 2011 group and individual
Quality and Resource Use Reports
(QRURs) (78 FR 43500 through 43502)
and found that 98 percent of the PQRS
measures included in the analysis,
which were substantially similar to the
PQRS measures that will be assessed
during performance period CY 2015 for
purposes of the VM, were highly
reliable. As stated in the proposed rule,
we believe that these results suggest that
we can reliably apply these measures to
solo practitioners and groups (79 FR
40494). In section III.N.4.h, we discuss
the reliability of the all-cause
readmission measure and the policy we
are finalizing to address reliability
concerns regarding that measure.
In Table 55 of the proposed rule, we
presented the number of groups, eligible
professionals, physicians, and
nonphysician eligible professionals in
groups of various sizes based on an
analysis of CY 2012 claims with a 90day run-out period (79 FR 40494). We
estimated that our proposals to apply
the VM to all groups with two or more
eligible professionals and to all solo
practitioners in CY 2017 would affect
approximately 83,500 groups and
210,000 solo practitioners (as identified
by their TINs). We further estimated that
the groups consist of approximately
815,000 physicians and 315,000
67933
nonphysician eligible professionals (79
FR 40493).
For this final rule with comment
period, we have updated Table 55 from
the proposed rule, using CY 2013 claims
with a 90-day claim run-out period and
including TINs that participated in the
Shared Savings Program, the Pioneer
ACO Model, or the Comprehensive
Primary Care Initiative in 2013. Table 86
shows the number of groups, eligible
professionals, physicians, and
nonphysician eligible professionals in
groups of various sizes. We note that the
number of eligible professionals
includes other practitioners, such as
physician assistants and nurse
practitioners, in addition to physicians.
We estimate that final policy to apply
the VM to all physicians in groups with
two or more eligible professionals and
to all physicians who are solo
practitioners in CY 2017 would affect
approximately 900,000 physicians.
TABLE 86—ELIGIBLE PROFESSIONAL/PHYSICIAN GROUP SIZE DISTRIBUTION (2013 CLAIMS)
Number of
groups (TINs)*
Group size
Eligible professionals (EPs)
1,345
1,753
3,926
1,957
8,697
69,455
205,084
292,217
404,738
119,979
134,038
42,733
117,164
244,800
205,084
1,268,536
100+ EPs .................................................
50–99EPs .................................................
25–49 EPs ...............................................
20–24 EPs ...............................................
10–19 EPs ...............................................
2–9 EPs ...................................................
1 EP .........................................................
Total ..................................................
Number of
physicians
297,175
81,679
90,141
29,112
78,893
171,627
159,770
908,397
Number of
nonphysician
EPs
107,563
38,300
43,897
13,621
38,271
73,173
45,314
360,139
Percent of
physicians
33
9
10
3
9
19
18
100
Percent of
nonphysician
EPs
30
11
12
4
11
20
13
100
ebenthall on DSK5SPTVN1PROD with $$_JOB
* The number of groups (TINs) include TINs that have one or more EPs participating in the Shared Savings Program, the Pioneer ACO Model,
or the Comprehensive Primary Care Initiative.
In the proposed rule (79 FR 40494),
we stated that in the CY 2014 PFS final
rule with comment period, we finalized
the proposal that if we are unable to
attribute a sufficient number of
beneficiaries to a group of physicians
subject to the VM, and thus, are unable
to calculate any of the cost measures
with at least 20 cases, then the group’s
cost composite score would be classified
as ‘‘average’’ under the quality-tiering
methodology (78 FR 74780 through
74781). However, we noted this policy
was codified in § 414.1270(b)(5) as a
group of physicians subject to the valuebased payment modifier will receive a
cost composite score that is classified as
‘‘average’’ under § 414.1275(b)(2) if such
group does not have at least one cost
measure with at least 20 cases. We
stated that we believe the regulation text
at § 414.1270(b)(5) better reflects the
intent of this policy, and accordingly,
we proposed to clarify that the
description of this policy in the
preamble of the CY 2014 PFS final rule
with comment period (78 FR 74780
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
through 74781) should be the same as
the regulation text at § 414.1270(b)(5).
We also proposed to apply the same
policy to groups and solo practitioners
beginning in CY 2017. That is, a group
or solo practitioner would receive a cost
composite score that is classified as
‘‘average’’ under the quality-tiering
methodology if the group or solo
practitioner does not have at least one
cost measure with at least 20 cases. We
proposed to revise § 414.1270
accordingly.
We proposed to revise § 414.1210 to
reflect that beginning in the CY 2017
payment adjustment period, the VM
would be applied to physician and
nonphysician eligible professionals in
groups with two or more eligible
professionals and to solo practitioners
based on the performance period
described at § 414.1215 (79 FR 40495).
Accordingly, we proposed to amend the
regulations under subpart N to add
references to solo practitioners. We
solicited comments on all of these
proposals.
PO 00000
Frm 00387
Fmt 4701
Sfmt 4700
The following is summary of the
comments we received on these
proposals.
Comment: We received one comment
that supported our proposed definition
of a ‘‘solo practitioner.’’
Response: We appreciate this
comment and are finalizing the
definition of a ‘‘solo practitioner’’ to
mean, ‘‘a single Taxpayer Identification
Number (TIN) with one eligible
professional who is identified by an
individual National Provider Identifier
(NPI) billing under the TIN.’’ We are
codifying this definition at § 414.1205.
Comment: Several commenters
expressed concern that the cost
measures potentially have little
relevance to some provider groups and
may leave some with an arbitrary label
of ‘‘average’’ cost, if the minimum case
number requirement for the cost
measure is not met due to an
insufficient number of beneficiaries
being attributed to the group.
Response: As we stated in the CY
2014 PFS final rule with comment
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67934
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
period (78 FR 74780), we continue to
believe that groups that are attributed
fewer than the minimum case size of 20
beneficiaries would not allow for the
calculation of reliable cost measures.
We are concerned that not classifying
the group as ‘‘average’’ when it has
fewer than 20 attributed beneficiaries
for at least one cost measure would
increase the likelihood that its cost
measures could fluctuate greatly from
year to year. Therefore, we are finalizing
our proposal that beginning in CY 2017
a group or solo practitioner will receive
a cost composite score that is classified
as ‘‘average’’ under the quality-tiering
methodology if the group or solo
practitioner does not have at least one
cost measure with at least 20 cases and
codifying the policy as proposed in
§ 414.1270. We are also finalizing our
proposal to clarify that the description
of this policy in the preamble of the CY
2014 PFS final rule with comment
period (78 FR 74780 through 74781) for
groups of physicians should be the same
as the regulation text at § 414.1270(b)(5).
Comment: Several commenters, citing
the Secretary’s statutory obligation,
supported our proposal to apply the VM
in the CY 2017 payment adjustment
year to solo practitioner physicians and
to groups of physicians with two or
more eligible professionals. Other
commenters opposed our proposed
policy notwithstanding the statutory
obligation to apply the VM to all
physicians and groups of physicians
beginning not later than January 1, 2017.
Commenters stated that we should delay
the application of the VM to all
physicians, either through selective
implementation or requesting that
Congress amend the statute. Some
commenters stated that, due to provider
resource constraints, lack of access to
adequate technical support, and
potential lack of understanding of the
information provided through the
Physician Feedback Program, we should
postpone the extension of the VM to
smaller group practices and solo
practitioners. Some commenters
suggested that the VM would negatively
impact physicians, especially given the
proposed increase in the amount of
payment at risk for CY 2017.
Response: We disagree that the VM’s
application to smaller groups and solo
practitioners should be delayed. In
addition to the statutory requirement to
apply the VM to all physicians and
groups of physicians beginning not later
than January 1, 2017, the application of
the VM to all physician groups and solo
practitioners is essential to our ongoing
efforts to encourage improvement in the
quality and efficiency of care provided
to Medicare beneficiaries and should
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
not be delayed. The literature highlights
that the majority of patients receive care
in group practices with one or two
physicians 16 and that historically,
smaller group practices have
participated in quality improvement
programs at lower rates than larger
group practices.17 Recent research also
concludes that EHR-enabled small
practices responded to incentives to
improve quality of care on process and
intermediate-outcome measures.18 For
these reasons, we believe that the
application of the VM to smaller group
practices and solo practitioners has the
potential to incentivize increased
participation in quality reporting and
quality improvement activities and that
smaller groups and solo practitioners
have the potential to perform well under
the VM.
The application of the VM to groups
of two to nine eligible professionals and
to solo practitioners in CY 2017 is
consistent with our principle to focus
on a gradual implementation of the VM.
The financial impact of applying the
VM to groups of two to nine eligible
professionals and to solo practitioners
will be eased since, we are finalizing a
policy to hold them harmless from any
downward payment adjustments under
quality-tiering in CY 2017 (as discussed
in section III.N.4.c.) and also finalizing
a smaller downward payment
adjustment under the VM for these
groups and solo practitioners that are in
Category 2 in CY 2017 (as discussed in
section III.N.4.f below). Please note that
in section III.N.4.b of this final rule with
comment period, we are finalizing that
the VM will apply to nonphysician
eligible professionals in groups subject
to the VM and to nonphysician eligible
professionals who are solo practitioners
beginning in the CY 2018 payment
adjustment period.
Comment: Several commenters stated
that CMS should ensure that the quality
and cost measures are reliable and valid
for small practices and solo
practitioners before expanding the VM
to all physicians.
Response: Since the inception of the
VM program, we have committed to
establish a payment modifier that relies
on a focused core set of measures
appropriate to each specific provider
category that reflects the level of care
16 Sowmya R Rao, et al. Electronic health records
in small physician practices: availability, use, and
perceived benefits. J. Am. Med. Information Ass’n.
2011. 18, 271–275.
17 Anne-Marie J. Audet, et al. Measure, Learn,
And Improve: Physicians’ Involvement in Quality
Improvement. Health Affairs. 2005. 24,843–853.
18 Naomi S. Bardach, et al., Effect of Pay-forPerformance Incentives on Quality of Care in Small
Practices With Electronic Health Records. J. Amer.
Med. Ass’n. 2013. 310,1051–1059.
PO 00000
Frm 00388
Fmt 4701
Sfmt 4700
and the most important areas of service
and measures for that provider (77 FR
69306). Analysis of the Physician
Feedback Program confirms that the
measures on which the VM is based are
highly reliable, especially those that are
self-reported.19 As stated in the
proposed rule (79 FR 40494), we will be
basing the quality of care composite on
the PQRS measures selected, and
reported on, by the groups (or the
eligible professionals in the groups) and
the solo practitioners, which enables us
to recognize the diversity of reporting
options for individuals and groups
under the PQRS program and provide
flexibility on the data they report for
quality measures under the PQRS. This
also allows these groups and solo
practitioners the opportunity to choose
measures that are relevant to their
patient populations and consistent with
clinical practice and high quality care.
Moreover, our policy will mitigate any
unintended consequences of the VM
payment adjustment on smaller groups
by holding harmless solo practitioner
physicians and physicians in groups
with two to nine eligible professionals
from any downward payment
adjustments under quality-tiering in CY
2017 (see section III.N.4.c of this final
rule with comment period).
We conducted an additional analysis
of the cost measures for the VM, using
our specialty benchmarking
methodology and found the per capita
cost measures to be reliable for solo
practitioners and groups of two or more
eligible professionals. That analysis may
be found at: https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeedbackProgram/
ValueBasedPaymentModifier.html.
Comment: Some commenters
expressed concern about the VM’s
impact on providers who treat high-cost
patients and on certain specialties, such
as anesthesiology, for which few quality
measures are available.
Response: The VM program continues
to believe in the importance of
stakeholder engagement for establishing
quality metrics. To that end, we engage
the National Quality Forum to pursue
national endorsement of measures used
in PQRS and the VM program. We are
committed to using PQRS as the
foundation for measurement of the
performance rates for solo practitioner
physicians and groups of physicians
subject to the VM (77 FR 69314).
Moreover, we recognized early in the
19 Mathematica Policy Research, Experience
Report for the Performance Year 2012 Quality and
Resource Use Reports (January 8, 2014), available
at https://www.cms.gov/Medicare/Medicare-Fee-forService-Payment/PhysicianFeedbackProgram/
Downloads/2012-QRUR_Experience_Report.pdf.
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
VM program that the PQRS may not
provide specialists and sub-specialists
the flexibility to report on measures that
are relevant to their unique patient
panels. As discussed later, in section
III.N.4.h, in previous rulemakings, we
have committed to expanding the
specialty measures available in the
PQRS in order to more accurately
measure the performance on quality of
care furnished by specialists. We also
reaffirm our commitment to using
measures of performance across
specialties that are reliable and valid for
the VM program (77 FR 69315; 78 FR
74773).
Physicians have sufficient flexibility
to choose the quality reporting method–
PQRS GPRO web-interface, claims,
registries, qualified clinical data
registries, and EHR reporting
mechanisms, as well as the measures on
which to report information. The
expansion of the GPRO to registries in
2013 and to EHRs in 2014 allowed subspecialists to participate in PQRS as
members of a group practice, such that
the group could report data on measures
of broad applicability (77 FR 69315).
The claims-based outcome measures
used in the VM afford groups and solo
practitioners an additional opportunity
to earn a quality composite score that is
above average. Where a group or solo
practitioner falls in Category 1 under the
VM (that is, meets the criteria to avoid
the CY 2017 PQRS payment
adjustment), but the group or solo
practitioner does not have at least 20
cases for each PQRS measure on which
it reports as required for inclusion in the
quality composite of the VM, the group
or solo practitioner’s quality composite
score would be based on the three
claims-based outcome measures
described at § 414.1230, provided that
the group or solo practitioner has at
least 20 cases for at least one of the
claims-based outcome measures.
In addition, as discussed in section
III.N.4.h of this final rule with comment
period, eligible professionals and groups
should note that PQRS has a Measure
Applicability Validation (MAV) process.
MAV determines PQRS incentive
eligibility or potential applicability of
the payment adjustment for eligible
professionals and groups reporting less
than nine measures across three
domains or nine or more across less
than three domains. We recommend
that commenters refer to the Measure
Application Validation (MAV) Process
to alleviate concerns that lack of
applicable measures would result in an
automatic downward adjustment under
the VM . https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/PQRS/Downloads/2014_
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PQRS_Claims_
MeasureApplicabilityValidation_
12132013.zip. Also, please refer to
section III.K.2 of this final rule with
comment period for the final 2017
policies for MAV and the criteria for
satisfactory reporting for the 2017 PQRS
payment adjustment.
Comment: Commenters cited that solo
practitioners and groups with 2 to 24
eligible professionals, who received a
QRUR in fall 2014, will have a short
period of time to analyze their
performance data and to prepare for the
CY 2015 performance period.
Response: On September 30, 2014, we
made Quality and Resource Use Reports
(QRURs) available to all group of
physicians and physicians who are solo
practitioners based on their performance
in CY 2013. As we stated in the CY 2015
proposed rule (79 FR 40494–95), we
believe that we have provided small
groups and solo practitioners sufficient
time to understand how the VM works
and how to participate in the PQRS. We
are sensitive to groups and solo
practitioners who may need adequate
lead time to understand the impact of
the beneficiary attribution method used
for the VM. At the time that we made
our proposal to apply the VM to solo
practitioners and groups of 2 to 25 EPs,
available research suggested that the
information provided in the QRURs is
relevant to solo practitioners and groups
for future quality improvement efforts.
Published literature suggests that, of the
beneficiaries assigned in one year to a
group practice under the Shared Savings
Program attribution rule, which is
substantially similar to the one used in
the VM program—80 percent were
assigned to that same group practice the
following year.20 In response to
commenters’ concerns, we also
conducted an additional analysis using
the VM attribution methodology and
determined that, of the beneficiaries
assigned to a given TIN for the five cost
and 3 outcome measures included in the
VM for 2017, approximately 76% were
assigned to the same TIN for these
measures, in both 2012 and 2013.
More importantly, we believe our
final policy to hold harmless groups
with two to nine eligible professionals
and solo practitioners from any
downward payment adjustments under
quality-tiering in CY 2017 would likely
mitigate unintended consequences that
could occur (see section III.N.4.c of this
final rule). We note that in the 2013
QRUR Experience Report, which will be
released in the next few months, we will
20 J. Michael McWilliams, et al. Outpatient Care
Patterns and Organizational Accountability in
Medicare. 2014. 174,938–945.
PO 00000
Frm 00389
Fmt 4701
Sfmt 4700
67935
provide a detailed analysis of the impact
of the 2015 VM policies on groups of
100 or more eligible professionals
subject to the VM in CY 2015, including
findings based on the data contained in
the 2013 QRURs for all groups of
physicians and solo practitioners.
Comment: Several commenters
believed that physicians had have little
experience with the PQRS program and
physicians generally do not understand
the methodology used to calculate the
VM and therefore urged CMS to increase
its outreach and education efforts. One
commenter urged CMS to publicly share
the VM methodology, as well as the
results of the reliability and validity
testing of the measures used in the
calculation of the VM.
Response: In response to the
comments about physicians not being
familiar with the PQRS program or not
understanding the methodology used to
calculate the VM, we strongly encourage
physicians to proactively educate
themselves about the PQRS and VM
programs by visiting the PQRS Web site
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/PQRS/ and VM/
QRUR Web site https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeedbackProgram/
index.html. The PQRS Web site contains
detailed information about how groups
and individual eligible professionals
can participate in the PQRS program,
including information on how to avoid
the PQRS payment adjustment. The
VM/QRUR Web site (https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeedbackProgram/)
contains information on the VM policies
for each applicable payment adjustment
year, including detailed information on
the methodology used to calculate the
CY 2015 VM shown in the CY 2013
QRURs and how to use the information
contained in the QRURs. We note that
we work with medical and specialty
associations throughout the year to
educate them about the PQRS and VM
programs and the QRURs. Further
outreach will be also be undertaken by
our Quality Improvement Organizations
(QIOs), who will provide technical
assistance to physicians and groups of
physicians in an effort to help them
improve quality and consequently,
performance under the VM program.
As we expand the application of the
VM to all physicians, we will continue
to monitor the VM program and
continue to examine the characteristic
of those groups of physicians and solo
practitioners that could be subject to an
upward or downward payment
adjustment under our quality-tiering
E:\FR\FM\13NOR2.SGM
13NOR2
67936
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
methodology to determine whether our
policies create anomalous effects in
ways that do not reflect consistent
differences in performance among
physicians and physician groups.
After considering the public
comments, we are finalizing the
proposal and regulation text at
§ 414.1210(a)(3) that, beginning with the
CY 2017 payment adjustment period,
the VM will apply to physicians in
groups with two or more eligible
professionals and to physicians who are
solo practitioners based on the
performance period described at
§ 414.1215. We are finalizing the
definition of a ‘‘solo practitioner’’ at
§ 414.1205 and amending the
regulations under subpart N to add
references to solo practitioners. We are
also finalizing our proposal and the
regulation text at § 414.1270(c)(5) that
beginning in CY 2017 a group or solo
practitioner will receive a cost
composite score that is classified as
‘‘average’’ under the quality-tiering
methodology if the group or solo
practitioner does not have at least one
cost measure with at least 20 cases. We
are also finalizing our proposal to clarify
that the description of this policy in the
preamble of the CY 2014 PFS final rule
with comment period (78 FR 74780
through 74781) for groups of physicians
should be the same as the regulation
text at § 414.1270(b)(5).
b. Application of the VM to
Nonphysician EPs
As noted above, section 1848(p) of the
Act requires that we establish the VM
and apply it to items and services
furnished under the PFS beginning on
January 1, 2015, for specific physicians
and groups of physicians the Secretary
determines appropriate, and beginning
not later than January 1, 2017, for all
physicians and groups of physicians.
Section 1848(p)(7) of the Act provides
the Secretary discretion to apply the VM
on or after January 1, 2017 to eligible
professionals as defined in section
1848(k)(3)(B) of the Act. As previously
finalized in the CY 2013 PFS final rule
with comment period, in payment
adjustment years CY 2015 and CY 2016,
we will apply the VM to Medicare
payments for items and services billed
under the PFS by physicians in groups
(as identified by their Medicare-enrolled
TIN) subject to the VM, but not to the
other eligible professionals that also
may bill under the TIN (77 FR 69312).
We finalized in the CY 2013 PFS final
rule with comment period (77 FR 69307
through 69310) that physicians, as
defined in section 1861(r) of the Act,
include doctors of medicine or
osteopathy, doctors of dental surgery or
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
dental medicine, doctors of podiatric
medicine, doctors of optometry, and
chiropractors.
In section III.N.4.a of this final rule
with comment period, we finalized our
proposal to apply the VM in the CY
2017 payment adjustment period and
each subsequent calendar year payment
adjustment period to physicians in
groups of physicians with two or more
eligible professionals and to physicians
who are solo practitioners as required
by section 1848(p)(4)(B)(iii)(II) of the
Act.
In the CY 2015 PFS proposed rule,
based on the Secretary’s discretion
under section 1848(p)(7) of the Act, we
proposed to apply the VM beginning in
the CY 2017 payment adjustment period
to all of the eligible professionals in
groups with two or more eligible
professionals and to eligible
professionals who are solo practitioners
(79 FR 40495–40496). That is, we
proposed to apply the VM beginning in
CY 2017 to the items and services billed
under the PFS by all of the physicians
and nonphysician eligible professionals
who bill under a group’s TIN. We
proposed to apply the VM beginning in
CY 2017 to groups that consist only of
nonphysician eligible professionals (for
example, groups with only nurse
practitioners or physician assistants).
We also proposed to modify the
definition of ‘‘group of physicians’’
under § 414.1205 to also include the
term ‘‘group’’ to reflect these proposals.
We also proposed to apply the VM
beginning in CY 2017 to nonphysician
eligible professionals who are solo
practitioners. Additionally, we
proposed that physicians and
nonphysician eligible professionals
would be subject to the same VM
policies established in earlier
rulemakings and under 42 CFR part 414,
subpart N. For example, nonphysician
eligible professionals would be subject
to the same amount of payment at risk
and quality-tiering policies as
physicians. We proposed to modify the
regulations under 42 CFR part 414,
subpart N, accordingly.
We finalized in the CY 2013 PFS final
rule with comment period (77 FR 69307
through 69310) that, for purposes of
establishing group size, we will use the
definition of an eligible professional as
specified in section 1848(k)(3)(B) of the
Act. This section defines an eligible
professional as any of the following: (1)
A physician; (2) a practitioner described
in section 1842(b)(18)(C) of the Act:
Physician assistant, nurse practitioner,
clinical nurse specialist, certified
registered nurse anesthetist, certified
nurse-midwife, clinical social worker,
clinical psychologist, registered
PO 00000
Frm 00390
Fmt 4701
Sfmt 4700
dietician, or nutrition professional; (3) a
physical or occupational therapist or a
qualified speech-language pathologist;
or (4) a qualified audiologist.
Beginning CY 2017, under our
proposal, the VM would apply to all of
the eligible professionals, as specified in
section 1848(k)(3)(B) of the Act, that bill
under a group’s TIN based on the TIN’s
performance during the applicable
performance period. During the
payment adjustment period, all of the
nonphysician eligible professionals who
bill under a group’s TIN would be
subject to the same VM that would
apply to the physicians who bill under
that TIN.
This proposal was consistent with our
stated principle that the VM should
focus on shared accountability (77 FR
69307). We continue to believe that the
VM can facilitate shared accountability
by assessing performance at the group
practice level and by focusing on the
total costs of care, not just the costs of
care furnished by an individual
physician.
Moreover, section 1848(p)(5) of the
Act requires us to, as appropriate, apply
the VM ‘‘in a manner that promotes
systems-based care.’’ We stated in the
CY 2013 PFS proposed rule that, in this
context, systems-based care is the
processes and workflows that (1) make
effective use of information
technologies, (2) develop effective
teams, (3) coordinate care across patient
conditions, services, and settings over
time, and (4) incorporate performance
and outcome measurements for
improvement and accountability.21 (77
FR 44996) We stated in the CY 2015 PFS
proposed rule, we believe that applying
the VM to all of the eligible
professionals in a group, rather than
only the physicians in the group, would
enhance the group’s ability and
resources to redesign processes and
workflows to achieve these objectives
and furnish high-quality and costeffective clinical care with greater care
coordination (79 FR 40496).
As mentioned above, we also
proposed to apply the VM to groups that
consist only of nonphysician eligible
professionals, as well as solo
practitioners who are nonphysician
eligible professionals beginning in CY
2017 (79 FR 40496). Consistent with the
application of the VM to groups of
21 Johnson JK, Miller SH, Horowitz SD. Systemsbased practice: Improving the safety and quality of
patient care by recognizing and improving the
systems in which we work. In: Henriksen K, Battles
JB, Keyes MA, Grady ML, editors. Advances in
Patient Safety: New Directions and Alternative
Approaches, Vol 2: Culture and Redesign. AHRQ
Publication No. 08–0034–2. Rockville, MD: Agency
for Healthcare Research and Quality; August 2008.
p. 321–330.
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
physicians and groups that contain both
physicians and nonphysician EPs, the
quality of care composite for groups that
consist only of nonphysician EPs and
solo practitioner nonphysician EPs
would be based on the quality data
submitted under the PQRS at the group
or individual level in accordance with
our existing policy. To the extent we are
able to attribute beneficiaries to these
groups and solo practitioners under the
attribution methodology proposed in
section III.N.4.j of the proposed rule to
calculate cost measures, we proposed to
calculate the cost composite using those
cost measures. If a cost composite could
not be calculated for a group or solo
practitioner, then we proposed to
classify the group or solo practitioner’s
cost composite as ‘‘average’’ as specified
in § 414.1270. We solicited comments
on all of our proposed policies for
applying the VM to nonphysician
eligible professionals beginning in CY
2017.
The following is summary of the
comments we received on all of our
proposed policies for applying the VM
to nonphysician eligible professionals
beginning in CY 2017.
Comment: Several commenters
supported our proposal to apply the VM
to nonphysician eligible professionals
beginning in CY 2017. These
commenters stated that the proposal
would support the goal of shared
accountability and urged CMS to
include their cost and quality data in
the QRURs. Some of the commenters
wanted nonphysician eligible
professionals to be held harmless from
any downward payment adjustments
under the VM.
Most of the commenters urged CMS to
delay implementation of the VM for
nonphysician eligible professionals and
suggested that CMS adopt a phased
approach that gives nonphysician
eligible professionals more time to
understand and prepare for the
implementation of the VM. One
commenter was specifically concerned
about nonphysician eligible
professionals who are solo practitioners
or in groups with two to nine eligible
professionals not having time to prepare
for the implementation of the VM.
Commenters expressed concern that
nonphysician eligible professionals
have not been sufficiently prepared for
the VM because: prior PFS rules did not
indicate that nonphysician eligible
professionals may be included in the
VM in the future; nonphysician eligible
professional groups have not yet
received a QRUR; nonphysician eligible
professionals have not received targeted
education regarding application of the
VM to them; and the proposal does not
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
allow nonphysician eligible
professionals the same phased-in
approach to the VM that CMS provided
to physician groups. One commenter
recommended that CMS not apply the
VM to nonphysician eligible
professionals until CMS adopts
meaningful specialty designations.
Other commenters indicated that some
nonphysician eligible professionals
groups will not be attributed cost
measures since they do not bill
evaluation and management codes. A
few commenters were concerned about
the low participation rates of
nonphysician eligible professionals in
the PQRS program. A few commenters
proposed a phased-in approach for
implementation of the VM for
nonphysician eligible professionals,
which they stated would be consistent
with the implementation of the VM for
physician groups.
Response: We agree with the
commenters that nonphysician eligible
professionals would benefit from
additional time to become familiar with
participation in the PQRS program and
the VM methodology. Therefore, we are
not finalizing our proposal to apply the
VM beginning in the CY 2017 payment
adjustment period to nonphysician
eligible professionals in groups with
two or more eligible professionals and
to nonphysician eligible professionals
who are solo practitioners. Instead, we
are finalizing that we will apply the VM
beginning in the CY 2018 payment
adjustment period to nonphysician
eligible professionals in groups with
two or more eligible professionals and
to nonphysician eligible professionals
who are solo practitioners. We added
paragraph (a)(4) to § 414.1210 to reflect
this policy. We note that in the CY 2015
PFS proposed rule, we did not propose
a performance period for the CY 2018
payment adjustment period for the VM.
The performance periods we have
established in prior rulemaking for the
VM have been two calendar years prior
to the beginning of the payment
adjustment year (for example, CY 2013
was the performance period for the VM
applied in CY 2015). We expect to
propose the performance period for the
CY 2018 payment adjustment period for
the VM in the CY 2016 PFS proposed
rule.
We believe that delaying the
implementation of the VM to
nonphysician eligible professionals
until CY 2018 is consistent with our
stated objective to focus on gradual
implementation of the VM. The delay
would also provide additional time for
nonphysician eligible professionals to
learn about how to participate in the
PQRS program and to become
PO 00000
Frm 00391
Fmt 4701
Sfmt 4700
67937
knowledgeable about the policies for
calculating the VM. Information about
the VM is available on the VM/QRUR
Web site at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeedbackProgram/
index.html.
Under our final policy, we will apply
the VM beginning in CY 2018 to the
items and services billed under the PFS
by all of the physicians and
nonphysician eligible professionals who
bill under a group’s TIN. We are
finalizing that we will apply the VM
beginning in CY 2018 to groups that
consist only of nonphysician eligible
professionals (for example, groups with
only nurse practitioners or physician
assistants). Beginning in CY 2018, the
VM will apply to all of the eligible
professionals, as specified in section
1848(k)(3)(B) of the Act, that bill under
a group’s TIN based on the TIN’s
performance during the applicable
performance period. During the
payment adjustment period, all of the
nonphysician eligible professionals who
bill under a group’s TIN will be subject
to the same VM that will apply to the
physicians who bill under that TIN. We
are finalizing the proposed modification
to the definition of ‘‘group of
physicians’’ under § 414.1205 to also
include the term ‘‘group’’ to reflect these
final policies. We are also finalizing the
policy to apply the VM beginning in CY
2018 to nonphysician eligible
professionals who are solo practitioners.
Additionally, we are finalizing that
beginning in CY 2018, physicians and
nonphysician eligible professionals will
be subject to the same VM policies
established in earlier rulemakings and
under subpart N. For example,
nonphysician eligible professionals will
be subject to the same amount of
payment at risk and quality-tiering
policies as physicians. We are finalizing
the proposed modifications to the
regulations under subpart N
accordingly.
However, since CY 2018 will be the
first year that groups that consist only
of nonphysician eligible professionals
and solo practitioners who are
nonphysician eligible professionals will
be subject to the VM, we are finalizing
a policy to hold these groups and solo
practitioners harmless from downward
adjustments under the quality-tiering
methodology in CY 2018. We will add
regulation text under § 414.1270 to
reflect this policy when we establish the
policies for the VM for the CY 2018
payment adjustment period in future
rulemaking.
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67938
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
c. Approach to Setting the VM
Adjustment Based on PQRS
Participation
In the CY 2014 PFS final rule with
comment period (78 FR 74767–74768),
we adopted a policy to categorize
groups of physicians subject to the VM
in CY 2016 based on a group’s
participation in the PQRS. Specifically,
we categorize groups of physicians
eligible for the CY 2016 VM into two
categories. Category 1 includes groups
of physicians that (a) meet the criteria
for satisfactory reporting of data on
PQRS quality measures through the
GPRO for the CY 2016 PQRS payment
adjustment or (b) do not register to
participate in the PQRS as a group
practice in CY 2014 and that have at
least 50 percent of the group’s eligible
professionals meet the criteria for
satisfactory reporting of data on PQRS
quality measures as individuals for the
CY 2016 PQRS payment adjustment, or
in lieu of satisfactory reporting,
satisfactorily participate in a PQRSqualified clinical data registry for the
CY 2016 PQRS payment adjustment. For
a group of physicians that is subject to
the CY 2016 VM to be included in
Category 1, the criteria for satisfactory
reporting (or the criteria for satisfactory
participation, if the PQRS-qualified
clinical data registry reporting
mechanism is selected) must be met
during the CY 2014 reporting period for
the PQRS CY 2016 payment adjustment.
For the CY 2016 VM, Category 2
includes those groups of physicians that
are subject to the CY 2016 VM and do
not fall within Category 1. For those
groups of physicians in Category 2, the
VM for CY 2016 is -2.0 percent.
We proposed to use a similar twocategory approach for the CY 2017 VM
based on participation in the PQRS by
groups and solo practitioners (79 FR
40496). To continue to align the VM
with the PQRS and accommodate the
various ways in which EPs can
participate in the PQRS, for purposes of
the CY 2017 VM, we proposed that
Category 1 would include those groups
that meet the criteria for satisfactory
reporting of data on PQRS quality
measures via the GPRO (through use of
the web-interface, EHR, or registry
reporting mechanisms, as proposed in
section III.K of the proposed rule) for
the CY 2017 PQRS payment adjustment.
Our proposed criteria for satisfactory
reporting of data on PQRS quality
measures via the GPRO for the PQRS
payment adjustment for CY 2017 are
described in section III.K of the
proposed rule. We also proposed to
include in Category 1 groups that do not
register to participate in the PQRS as a
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
group practice participating in the PQRS
group practice reporting option (GPRO)
in CY 2015 and that have at least 50
percent of the group’s eligible
professionals meet the criteria for
satisfactory reporting of data on PQRS
quality measures as individuals
(through the use of claims, EHR, or
registry reporting mechanism,) for the
CY 2017 PQRS payment adjustment, or
in lieu of satisfactory reporting,
satisfactorily participate in a PQRSqualified clinical data registry for the
CY 2017 PQRS payment adjustment, all
as proposed in section III.K of the
proposed rule. We noted that these
proposals are consistent with the
policies for inclusion in Category 1 as
established for the CY 2016 VM (78 FR
74767 through 74768). We would
maintain the 50 percent threshold for
the CY 2017 VM as we expand the
application of the VM to all groups and
solo practitioners in CY 2017. Our
proposed criteria for satisfactory
reporting by individual eligible
professionals for the claims, EHR, and
registry reporting mechanisms and for
satisfactory participation in a qualified
clinical data registry for the CY 2017
PQRS payment adjustment are
described in section III.K of the
proposed rule. Lastly, we proposed to
include in Category 1 those solo
practitioners that meet the criteria for
satisfactory reporting of data on PQRS
quality measures as individuals
(through the use of claims, registry, or
EHR reporting mechanism) for the CY
2017 PQRS payment adjustment, or in
lieu of satisfactory reporting,
satisfactorily participate in a PQRSqualified clinical data registry for the
CY 2017 PQRS payment adjustment, all
as proposed in section III.K of the
proposed rule. Category 2 would
include those groups and solo
practitioners that are subject to the CY
2017 VM and do not fall within
Category 1. As discussed in the
proposed rule (79 FR 40505), for CY
2017, we proposed to apply a -4.0
percent VM to groups with two or more
eligible professionals and solo
practitioners that fall in Category 2. We
solicited comment on these proposals.
The following is summary of the
comments we received on these
proposals.
Comment: A number of commenters
supported our proposal to continue to
account for eligible professionals that
participate in the PQRS as individuals
in the determination of groups and solo
practitioners that would be in Category
1. One commenter indicated that our
proposals allow groups to have the
flexibility to choose a PQRS reporting
mechanism that best fits the practice.
PO 00000
Frm 00392
Fmt 4701
Sfmt 4700
One commenter did not support the use
of both group and individual reporting
mechanisms to determine whether a
group falls in Category 1, indicating that
it makes comparisons among groups
that choose to report as a group
compared to a group whose eligible
professionals report as individuals
inequitable.
Response: We appreciate commenters’
support for our proposal to provide a
way to combine individually reported
PQRS measures into a group score for
purposes of the CY 2017 VM. In
response to the commenter’s concern
about the use of the individual reporting
mechanisms in the VM, we believe that
the use of both the individually reported
PQRS measures and the PQRS GPRO
measures to calculate the quality
composite of the VM recognizes
recognize the diversity of physician
practices and the various measures used
to assess quality of care furnished by
these practices. As we stated in the CY
2014 PFS final rule with comment
period (78 FR 74767), one of the
principles governing our
implementation of the VM is to align
program requirements to the extent
possible. Thus, we expect to continue to
align the VM with the PQRS program
requirements and reporting mechanisms
to ensure physicians and groups of
physicians report data on quality
measures that reflect their practice.
Furthermore, we do not believe that
comparing quality composite scores
based on PQRS GPRO measures or
individually reported PQRS measures
would create inequities because a
group’s performance reflects the
underlying eligible professionals on
whose behalf the group reports and the
quality measure benchmarks are
inclusive of data gathered through both
PQRS GPRO and individually-reported
PQRS measures. Lastly, we note that the
inclusion of individual PQRS measure
in the VM provides an additional
mechanism and reduces additional
reporting burden for groups that are
subject to the VM and do not report
under the PQRS as a group to avoid an
automatic VM downward payment
adjustment.
After consideration of the comments
received, and for the reasons stated
previously, we are finalizing the twocategory approach for the CY 2017 VM
based on participation in the PQRS by
groups and solo practitioners as
proposed. For purposes of the CY 2017
VM, Category 1 will include those
groups that meet the criteria for
satisfactory reporting of data on PQRS
quality measures via the GPRO (through
use of the web-interface, EHR, or
registry reporting mechanism, as
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
finalized in section III.K of this final
rule with comment period) for the CY
2017 PQRS payment adjustment. Our
final criteria for satisfactory reporting of
data on PQRS quality measures via the
GPRO for the PQRS payment adjustment
for CY 2017 are described in Table 51
in section III.K of this final rule with
comment period. We also are finalizing
to include in Category 1 groups that do
not register to participate in the PQRS
as a group practice participating in the
PQRS GPRO in CY 2015 and that have
at least 50 percent of the group’s eligible
professionals meet the criteria for
satisfactory reporting of data on PQRS
quality measures as individuals
(through the use of claims, EHR, or
registry reporting mechanism) for the
CY 2017 PQRS payment adjustment, or
in lieu of satisfactory reporting,
satisfactorily participate in a PQRSqualified clinical data registry for the
CY 2017 PQRS payment adjustment, all
as finalized in Table 50 in section III.K
of this final rule with comment period.
Our final criteria for satisfactory
reporting by individual eligible
professionals for the claims, EHR, and
registry reporting mechanisms and for
satisfactory participation in a qualified
clinical data registry for the CY 2017
PQRS payment adjustment are
described in section III.K of this final
rule with comment period. Lastly, we
are finalizing to include in Category 1
those solo practitioners that meet the
criteria for satisfactory reporting of data
on PQRS quality measures as
individuals (through the use of claims,
registry, or EHR reporting mechanism)
for the CY 2017 PQRS payment
adjustment, or in lieu of satisfactory
reporting, satisfactorily participate in a
PQRS-qualified clinical data registry for
the CY 2017 PQRS payment adjustment,
all as finalized in Table 50 in section
III.K of this final rule with comment
period. Category 2 will include those
groups and solo practitioners that are
subject to the CY 2017 VM and do not
fall within Category 1. We will continue
to explore how to include additional
data for specialists, including
potentially incorporating Hospital VBP
Program performance into the VM, as
discussed in section III.N.4.k of this
final rule with comment period. We
would adopt any such changes through
future notice and comment rulemaking.
As discussed in section III.N.4.f of this
final rule with comment period, for CY
2017, we are finalizing policies to (1)
apply a -4.0 percent VM to groups with
10 or more eligible professionals that
fall in Category 2, and (2) apply a -2.0
percent VM to groups with two to nine
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
eligible professionals and solo
practitioners that fall in Category 2.
For a group and a solo practitioner
subject to the CY 2017 VM to be
included in Category 1, the criteria for
satisfactory reporting (or the criteria for
satisfactory participation, in the case of
solo practitioners and the 50 percent
option described above for groups) must
be met during the reporting periods
occurring in CY 2015 for the CY 2017
PQRS payment adjustment. As noted in
section III.5.g of this final rule with
comment period earlier, CY 2015 is the
performance period for the CY 2017
payment adjustment period for the VM.
In the CY 2014 PFS final rule with
comment period (78 FR 74768–74770),
we finalized that the quality-tiering
methodology will apply to all groups in
Category 1 for the VM for CY 2016,
except that groups of physicians with
between 10 and 99 eligible professionals
would be subject only to upward or
neutral adjustments derived under the
quality-tiering methodology, while
groups of physicians with 100 or more
eligible professionals would be subject
to upward, neutral, or downward
adjustments derived under the qualitytiering methodology. In other words, we
finalized that groups of physicians in
Category 1 with between 10 and 99
eligible professionals would be held
harmless from any downward
adjustments derived from the qualitytiering methodology for the CY 2016
VM.
For the CY 2017 VM, we proposed to
continue a similar phase-in of the
quality-tiering based on the number of
eligible professionals in the group (79
FR 40497). We proposed to apply the
quality-tiering methodology to all
groups and solo practitioners in
Category 1 for the VM for CY 2017,
except that groups with two to nine
eligible professionals and solo
practitioners would be subject only to
upward or neutral adjustments derived
under the quality-tiering methodology,
while groups with 10 or more eligible
professionals would be subject to
upward, neutral, or downward
adjustments derived under the qualitytiering methodology. That is, we
proposed that solo practitioners and
groups with two to nine eligible
professionals in Category 1 would be
held harmless from any downward
adjustments derived from the qualitytiering methodology for the CY 2017
VM. Accordingly, we proposed to revise
§ 414.1270 to reflect these proposals. We
believe this approach would reward
groups and solo practitioners that
provide high-quality/low-cost care,
reduce program complexity, and would
also fully engage groups and solo
PO 00000
Frm 00393
Fmt 4701
Sfmt 4700
67939
practitioners into the VM as we
complete the phase-in of the VM in CY
2017. We solicited comments on these
proposals.
We stated in the CY 2015 PFS
proposed rule (79 FR 40497) that we
believe it is appropriate to hold groups
with two to nine eligible professionals
and solo practitioners in Category 1
harmless from any downward
adjustments under the quality-tiering
methodology, which is similar to the
policy we apply to groups with between
10 and 99 eligible professionals during
the first year the VM applies to them
(CY 2016). We noted that we anticipate
applying the CY 2018 VM with both
upward and downward adjustments
based on a performance period of CY
2016 to all groups and solo
practitioners, and therefore, we would
make proposals in future rulemaking
accordingly.
We stated that, for groups with
between 10 and 99 eligible
professionals, we believe it is
appropriate to begin both the upward
and the downward payment
adjustments under the quality-tiering
methodology for the CY 2017 VM. As
stated in the CY 2014 PFS final rule
with comment period (78 FR 74769), on
September 16, 2013, we made available
to all groups of 25 or more eligible
professionals an annual QRUR based on
2012 data to help groups estimate their
quality and cost composites. As
discussed in section III.N.4.a. of this
final rule with comment period, in
September 2014, we made available
QRURs based on CY 2013 data to all
groups of physicians and physicians
who are solo practitioners. These
QRURs contain performance
information on the quality and cost
measures used to calculate the quality
and cost composites of the VM and
show how all TINs fare under the
policies established for the VM for the
CY 2015 payment adjustment period. As
noted above, we are considering
providing semi-annual QRURs with
updated cost and resource use
information to groups and solo
practitioners. Then, during the summer
of 2015, we intend to disseminate
QRURs based on CY 2014 data to all
groups and solo practitioners, and the
reports would show how all TINs would
fare under the policies established for
the VM for the CY 2016 payment
adjustment period. The QRURs will also
include additional information about
the TINs’ performance on the MSPB
measure, individually-reported PQRS
measures, and the specialty-adjusted
cost measures.
Thus, we stated that we believe
groups with between 10 and 99 eligible
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67940
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
professionals will have adequate data to
improve performance on the quality and
cost measures that will be used to
calculate the VM in CY 2017. As a
result, we believe it is appropriate to
apply both upward and downward
adjustments under the quality-tiering
methodology to groups with 10 or more
eligible professionals in 2017.
Based on an analysis of CY 2012
claims, we estimate that approximately
6 percent of all eligible professionals are
in a Category 1 TIN that would be
classified in tiers that would earn an
upward adjustment by having a
composite score that is at least 1
standard deviation away from the mean
composite and it is statistically
significant, approximately 11 percent of
all eligible professionals are in a
Category 1 TIN that would be classified
in tiers that would receive a downward
adjustment by having a composite score
that is at least 1 standard deviation
away from the mean composite and it is
statistically significant, and
approximately 83 percent of all eligible
professionals are in a Category 1 TIN
that would receive no payment
adjustment in CY 2017. These results
suggest that our quality-tiering
methodology identifies a small number
of groups and solo practitioners that are
outliers—both high and low
performers—in terms of whose
payments would be affected by the VM,
thus limiting any widespread
unintended consequences.
We stated in the CY 2015 PFS
proposed rule that we will continue to
monitor the VM program and continue
to examine the characteristics of those
groups that could be subject to an
upward or downward payment
adjustment under our quality-tiering
methodology to determine whether our
policies create anomalous effects in
ways that do not reflect consistent
differences in performance among
physicians and physician groups.
The following is a summary of the
comments we received on these
proposals.
Comment: Several commenters
supported applying quality-tiering to all
groups and solo practitioners. One
commenter did not support the concept
of quality-tiering and indicated that it
should be voluntary for all practices.
Most commenters strongly supported
our proposal to hold harmless groups
with two to nine eligible professionals
and solo practitioners from downward
payment adjustments in CY 2017,
although one commenter suggested that
CMS should apply downward
adjustments to them. Some commenters
supported our proposal to apply
upward, neutral, or downward payment
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
adjustment to physician groups with 10
or more eligible professionals. However,
many commenters had concerns about
applying the downward adjustment to
groups with 10 or more eligible
professionals, since we proposed a
maximum downward adjustment of -4.0
percent. A commenter indicated that
there is a substantial operational
difference between large practices and
small practices since larger practices
have more resources and revenue and
are better suited to absorb downward
payment adjustments under the VM.
Some commenters were concerned that
implementation of the downward
adjustment to smaller physician
practices, particularly given that the
downward adjustment is slated to be
-4.0 percent in 2017, may negatively
impact beneficiary access to care. Other
comments stated that solo practitioners
and groups with two to twenty-four
eligible professionals would not have a
QRUR until the fall 2014 and will have
little time to analyze their performance
data. A number of commenters
recommended more intermediate,
phased-in approach to the downward
adjustment such as holding harmless
groups with less than 25 eligible
professionals, 50 eligible professionals,
or all groups regardless of size.
Commenters suggested that we give only
upward or neutral payment adjustments
to all groups and solo practitioners or
keep the CY 2016 policies in place for
the CY 2017 VM. One commenter
suggested that physician groups be able
to file for a hardship exception with
CMS in the event they face a downward
adjustment under the VM. One
commenter suggested that the payment
adjustments under quality-tiering apply
to all groups regardless of size so that
primary care physicians who practice in
larger groups are not disadvantaged,
while another suggested that CMS
should not change the program in 2017.
Some commenters requested
demographic information about the
outliers that would receive upward or
downward adjustments based on
quality-tiering.
Response: We appreciate the
commenters’ support of our proposal to
apply the quality-tiering methodology to
all groups and solo practitioners in
Category 1 for the VM for CY 2017 and
to hold solo practitioners and groups
with two to nine eligible professionals
in Category 1 harmless from any
downward adjustments derived from
the quality-tiering methodology for the
CY 2017 VM. We disagree with
commenters who suggested that we
should not apply upward, neutral, or
downward payment adjustments
PO 00000
Frm 00394
Fmt 4701
Sfmt 4700
derived under the quality-tiering
methodology to physician groups with
10 or more eligible professionals in CY
2017. For groups with 10 or more
eligible professionals, we believe it is
appropriate to apply both the upward
and the downward payment
adjustments under the quality-tiering
methodology for the CY 2017 VM. As
stated in the CY 2014 PFS final rule
with comment period (78 FR 74769), on
September 16, 2013, we made available
to all groups of 25 or more eligible
professionals an annual QRUR based on
2012 data to help groups estimate their
quality and cost composites. As
discussed in section III.N.a. of this final
rule with comment period, in
September 2014, we made available
QRURs based on CY 2013 data to all
groups of physicians and physicians
who are solo practitioners. We believe
that groups of 10 or more eligible
professionals will have adequate data to
improve performance on the quality and
cost measures that will be used to
calculate the VM in CY 2017. As a
result, we believe it is appropriate to
apply both upward and downward
adjustments under the quality-tiering
methodology to groups with 10 or more
eligible professionals in 2017.
With regard to the commenters’
concerns over the impact of the
proposed maximum ¥4.0 percent
downward adjustments on small
practices, as discussed in section
III.N.4.f of this final rule with comment
period, we are finalizing a policy to
apply a ¥2.0 percent VM to groups with
two to nine eligible professionals and
solo practitioners that fall in Category 2.
We believe the revised policy will
alleviate some of the commenters’
concerns about the financial impact of
applying quality-tiering to small groups
and solo practitioners in CY 2017.
With regard to the suggestion that
physicians in groups of 10 to 24 eligible
professionals have not had sufficient
experience with the quality measures
used in the VM, we note that on
September 30, 2014, we made QRURs
available to all group of physicians and
physicians who are solo practitioners
based on their performance in CY 2013.
Each QRUR contains the group or solo
practitioner’s performance information
on the quality and cost measures used
to calculate the quality and cost
composites of the VM and show how
the TIN would fare under the policies
established for the VM for the CY 2015
payment adjustment period. As we
stated in the CY 2015 PFS proposed
rule, we believe it is appropriate to hold
groups with two to nine eligible
professionals and solo practitioners in
Category 1 harmless from any
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
downward adjustments under the
quality-tiering methodology, which is
similar to the policy we apply to groups
with between 10 and 99 eligible
professionals during the first year the
VM applies to them (CY 2016). For
groups with between 10 and 99 eligible
professionals, we believe it is
appropriate to begin both the upward
and the downward payment
adjustments under the quality-tiering
methodology for the CY 2017 VM. We
believe that these groups have had
sufficient time to understand how the
VM works and how to participate in the
PQRS. We note that the 2013 QRUR
Experience Report, as described in
section III.N.4.a of this final rule, will
also contain additional information
about the groups that were determined
to have cost and/or quality performance
that was significantly different than
average, as determined under the
policies established for the VM for the
CY 2015 payment adjustment period.
We reiterate our belief that the final
policies will reward groups and solo
practitioners that provide high-quality/
low-cost care, reduce program
complexity, and will also fully engage
groups and solo practitioners into the
VM as we complete the phase-in of the
VM in CY 2017.
After considering the public
comments received, we are finalizing
the application of the quality-tiering
methodology to all groups and solo
practitioners in Category 1 for the VM
for CY 2017, except that groups with
two to nine eligible professionals and
solo practitioners would be subject only
to upward or neutral adjustments
derived under the quality-tiering
methodology, while groups with 10 or
more eligible professionals would be
subject to upward, neutral, or
downward adjustments derived under
the quality-tiering methodology. In
other words, solo practitioners and
groups with two to nine eligible
professionals in Category 1 would be
held harmless from any downward
adjustments derived from the qualitytiering methodology for the CY 2017
VM.
d. Application of the VM to Physicians
and Nonphysician Eligible Professionals
That Participate in the Shared Savings
Program, the Pioneer ACO Model, the
CPC Initiative, or Other Similar
Innovation Center Models or CMS
Initiatives
We established a policy in the CY
2013 PFS final rule with comment
period (77 FR 69313) to not apply the
VM in CY 2015 and CY 2016 to groups
of physicians that participate in the
Shared Savings Program Accountable
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Care Organizations (ACOs), the Pioneer
ACO Model, the Comprehensive
Primary Care (CPC) Initiative, or other
similar Innovation Center or CMS
initiatives. We stated in the CY 2014
PFS final rule with comment period (78
FR 74766) that from an operational
perspective, we will apply this policy to
any group of physicians that otherwise
would be subject to the VM, if one or
more physician(s) in the group
participate(s) in one of these programs
or initiatives during the relevant
performance period (CY 2013 for the CY
2015 VM, and CY 2014 for the CY 2016
VM).
Although section 1848(p)(4)(B)(iii)(I)
of the Act gives the Secretary discretion
to apply the VM beginning on January
1, 2015 to specific physicians and
groups of physicians the Secretary
determines appropriate, section
1848(p)(4)(B)(iii)(II) of the Act requires
application of the VM beginning not
later than January 1, 2017 to all
physicians and groups of physicians.
Therefore, as discussed in section
III.N.4.a. of this final rule with comment
period, we proposed to apply the VM to
all physicians in groups with two or
more eligible professionals and to solo
practitioners who are physicians
starting in CY 2017. In section III.N.4.b
of this final rule with comment period,
we discussed our proposal to also apply
the VM starting in CY 2017 to all
nonphysician eligible professionals in
groups with two or more eligible
professionals and to solo practitioners
who are nonphysician eligible
professionals. We describe in this
section how we proposed to apply the
VM beginning in the CY 2017 payment
adjustment period to the physicians and
nonphysician eligible professionals in
groups, as well as those who are solo
practitioners, participating in the
Shared Savings Program, Pioneer ACO
Model, the CPC Initiative, or other
similar Innovation Center models or
CMS initiatives.
(1) Physicians and Nonphysician
Eligible Professionals That Participate in
ACOs Under the Shared Savings
Program
(a) Application of the VM to
participants in the Shared Savings
Program. Beginning with the CY 2017
payment adjustment period, we
proposed to apply the VM to physicians
and nonphysician eligible professionals
in groups with two or more eligible
professionals and to physicians and
nonphysician eligible professionals who
are solo practitioners participating in
the Shared Savings Program (79 FR
40497). Groups and solo practitioners
participate in the Shared Savings
PO 00000
Frm 00395
Fmt 4701
Sfmt 4700
67941
Program as part of an ACO as provided
in section 1899 of the Act. Under the
Shared Savings Program, an ACO may
consist of multiple participating groups
and solo practitioners (as identified by
the ACO participants’ TINs). As of April
1, 2014, there are 338 ACOs
participating in the Shared Savings
Program. This number includes 31
ACOs that consist of only one ACO
participant TIN. The ACO submits
quality data on behalf of all the ACO
participant TINs in that ACO under the
Shared Savings Program.
Comment: Many commenters
suggested that we should continue to
exempt Shared Savings Program
participants from the VM. These
commenters stated that because
participants in the Shared Savings
Program have already taken on
accountability for quality improvement
and cost reduction, it is unnecessary
and confusing to apply the VM to these
providers. Several commenters
suggested that this option is available
under the existing language of the
statute or that, if CMS believes it does
not have this authority, we should seek
it from Congress. Commenters also
expressed concern that applying the VM
to participants in the Shared Savings
Program would cause inappropriate
comparisons of performance and create
confusion by sending mixed signals
about cost and quality benchmarks.
Several of these commenters stated that
organizations participating in Shared
Savings Program and Pioneer ACOs are
making significant investments and that
they believe this further underscores the
importance of allowing these groups to
focus on one set of pay for performance
metrics to avoid creating additional
investment costs. A few commenters
supported the application of the VM to
Shared Savings Program participants
because they believe that applying the
VM broadly will encourage value-based
change.
Response: We disagree with
commenters who believe we should
continue to exempt groups and solo
practitioners who participate in the
Shared Savings Program from the VM.
We are required under section
1848(p)(4)(B)(iii)(II) of the Act to apply
the VM to all physicians and groups of
physicians no later than January 1,
2017, and we believe that alignment of
these programs emphasizes the
importance of quality reporting and
quality measurement, for improvement
of the quality of care provided to
Medicare beneficiaries. We understand
the concerns presented by the
commenters regarding calculation of the
cost and quality composites under the
VM, and we address them below, in
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67942
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
sections III.N.4.d.1(b) and (c) of this
final rule with comment period.
After considering the public
comments on this proposal, we are
finalizing our policy to apply the VM,
beginning with the CY 2017 payment
adjustment period, to physicians in
groups with two or more eligible
professionals and physicians who are
solo practitioners that participate in an
ACO under the Shared Savings Program.
We note that, in response to
commenters’ concerns, we are not
finalizing the proposal to apply the VM
to nonphysician eligible professionals in
the CY 2017 payment adjustment period
that participate in an ACO under the
Shared Savings Program, consistent
with the final policy for groups and solo
practitioners that do not participate in
the Shared Savings Program as
discussed in section III.N.4.b of this
final rule with comment period. Also,
consistent with our policy discussed in
section III.N.4.b to apply the VM
beginning with the CY 2018 payment
adjustment period to nonphysician
eligible professionals who are not in an
ACO under the Shared Savings Program,
we will apply the VM beginning with
the CY 2018 payment adjustment period
to nonphysician eligible professionals in
groups with two or more eligible
professionals and nonphysician eligible
professionals who are solo practitioners
that participate in an ACO under the
Shared Savings Program. We further
note that, based in part on concerns
identified by commenters, we are
finalizing policies in sections
III.N.4.d.1(b) and (c) of this final rule
with comment period that take into
consideration a group or solo
practitioner’s participation in an ACO
under the Shared Savings Program
during the performance period for the
VM, rather than participation during the
payment adjustment period for the VM
as proposed.
(b) Calculation of the cost composite
of the VM for Shared Savings Program
participants. Beginning with the CY
2017 payment adjustment period, we
proposed to classify the cost composite
for the VM as ‘‘average cost’’ for groups
and solo practitioners (as identified by
the ACO’s participant TINs) that
participate in the Shared Savings
Program during the payment adjustment
period (for example, CY 2017) (79 FR
40498). We proposed to apply ‘‘average
cost’’ to these groups and solo
practitioners regardless of whether they
participated in the Shared Savings
Program during the performance period
(for example, in CY 2015 for the CY
2017 VM). We believe that it would not
be appropriate to apply the qualitytiering methodology to calculate the cost
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
composite for these groups and solo
practitioners because of the differences
in the methodology used to calculate the
cost benchmarks under the Shared
Savings Program and the VM. Under the
Shared Savings Program, cost
benchmarks are based on the actual
historical Medicare fee-for-service
expenditures for beneficiaries that
would have been assigned to the ACO
during the historical benchmark period,
and are updated to reflect changes in
national FFS spending; however, the
cost benchmarks under the VM are
based on national averages. We believe
that these are significant differences in
the methodology for calculating the cost
benchmarks under the two programs.
Consequently, we believe that any
attempt to calculate the VM cost
composite for groups and solo
practitioners participating in the Shared
Savings Program using the VM qualitytiering methodology would create two
sets of standards for ACOs for their cost
performance. We believe that having
two sets of standards for participants in
ACOs for cost performance would be
inappropriate and confusing and could
send conflicting messages and create
conflicting incentives. We solicited
comments on our proposals to classify
the cost composite as ‘‘average cost’’ for
groups and solo practitioners who
participate in the Shared Savings
Program during the payment adjustment
period.
For groups and solo practitioners who
participate in the Shared Savings
Program during the performance period
(for example, CY 2015), but no longer
participate in the Shared Savings
Program during the payment adjustment
period (for example, CY 2017), we
proposed to apply the quality-tiering
methodology to calculate the cost
composite for the VM for the payment
adjustment period based on the groups’
and solo practitioners’ performance on
the cost measures, as identified under
§ 414.1235, during the performance
period (79 FR 40499). We stated that it
would be appropriate to calculate their
cost composite under the quality-tiering
methodology because these groups and
solo practitioners are no longer part of
the Shared Savings Program during the
payment adjustment period.
Comment: As noted above, many
commenters expressed concern that
applying the VM to ACO participants in
the Shared Savings Program would
cause inappropriate comparisons of
performance and create confusion by
sending mixed signals about cost
benchmarks. Several of these
commenters who were opposed to the
application of the VM to Shared Savings
Program ACO participants suggested
PO 00000
Frm 00396
Fmt 4701
Sfmt 4700
that we should continue to exempt
Shared Savings Program participants
from the VM, but stated that if we were
to apply the VM to Shared Savings
Program ACO participants, we should
classify the cost composite as ‘‘average
cost’’ because of the differing
methodologies for assessing cost
performance for the VM and the Shared
Savings Programs. A few commenters
stated that groups or solo practitioners
participating in the Shared Savings
Program should have their cost
composite calculated without regard to
participation in the Shared Savings
Program and disagreed with our
proposed policy because it limits the
potential upward adjustment under the
VM available to groups and solo
practitioners participating in the Shared
Savings Program.
Response: We understand the
concerns presented by these
commenters that calculating a cost
composite for these groups and solo
practitioners could cause confusion and
send mixed signals. The VM and Shared
Savings Programs are sufficiently
different such that it would be
counterproductive at this point in the
programs’ development to measure
groups and solo practitioners using
different cost measures under each
program. To allow Shared Savings
Program participants to focus their
energy and resources on the Shared
Savings Program targets for slowing
expenditure growth, a different
approach under the VM program for
groups and physicians participating in
the Shared Savings Program is
appropriate. We will finalize our
proposal to classify the cost composite
for groups and solo practitioners
participating in an ACO under the
Shared Savings Program as ‘‘average
cost’’ to avoid confusion and prevent
conflicting incentives for these
providers who have already committed
to reducing cost growth through their
participation in the Shared Savings
Program. We plan to investigate the
possibility of calculating a VM cost
composite at the ACO level in the
future, so that groups and solo
practitioners in ACOs would have the
opportunity to earn the full upward
adjustment in the future, and we would
address this issue in future rulemaking.
Comment: We received several
comments objecting to our proposal to
take into account a group or solo
practitioner’s participation in a Shared
Savings Program ACO during the
payment adjustment period for the VM.
A few commenters did not support our
proposal to apply ‘‘average cost’’ to
groups and solo practitioners that join a
Shared Savings Program ACO in the
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
payment adjustment period, but were
not in a Shared Savings Program ACO
in the performance period. These
commenters pointed out that this policy
could discourage groups and solo
practitioners from joining an ACO if it
would mean they would not receive an
earned upward adjustment in the
payment adjustment period. One of
these commenters suggested that groups
or solo practitioners should be given the
option to have their cost composite
calculated under the quality-tiering
methodology if they were not in an ACO
in the performance period. Several
commenters suggested that all groups
and solo practitioners should be given
the opportunity to ‘‘opt in’’ to having
their cost composite calculated
regardless of whether they were in an
ACO in the performance period.
Another commenter objected to our
proposal to apply the quality-tiering
methodology to calculate the cost
composite for groups and solo
practitioners that participate in the
Shared Savings Program in the
performance period but do not
participate in the Shared Savings
Program during the payment adjustment
period. The commenter suggested that
these groups should be classified as
‘‘average cost’’ because they would have
been working toward ACO cost
benchmarks during the performance
year.
Response: We are convinced by
commenters who raised concerns with
our proposal to consider a group or solo
practitioner’s participation in a Shared
Savings Program ACO during the
payment adjustment period for the
purpose of determining the applicability
of the VM to the group or solo
practitioner. We believe that
commenters have accurately pointed out
that Shared Savings Program ACO
participants would be working toward a
specified set of quality and cost metrics
during the performance period, and that
the performance period would therefore,
best define their status as a Shared
Savings Program participant for the
purpose of determining the applicability
of the VM during the associated
payment adjustment period. We agree
with the points raised in the comments
about assessing a group or solo
practitioner under the VM cost
measures and benchmarks in the
payment adjustment period if that group
or solo practitioner was participating in
an ACO under the Shared Savings
Program in the performance period. A
group or solo practitioner is unlikely to
know two years in advance that it plans
to leave an ACO, and we do not believe
it would be appropriate to assess the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
group or solo practitioner under a
different set of cost measures than those
that the group or solo practitioner had
been working toward in the
performance period as part of an ACO.
As stated in our proposed rule (79 FR
40498), we believe that having two sets
of standards for ACOs for cost
performance would be inappropriate
and confusing. We believe that the
Shared Savings Program has the
potential to reduce expenditure growth
and improve quality and we do not
want to discourage groups or solo
practitioners from participating in that
program (79 FR 40498). Consistent with
that stated intent, and in light of the
comments we received pointing out the
potential conflict if we were to calculate
a cost composite for groups and solo
practitioners that participated in an
ACO under the Shared Savings Program
but did not participate in the payment
adjustment period, we believe it is
appropriate to apply ‘‘average cost’’ to
all groups and solo practitioners that
participate in an ACO under the Shared
Savings Program in the performance
period regardless of whether the group
or solo practitioner remains in the ACO
in the payment adjustment period. We
do not, however, believe that it would
be appropriate to use an ‘‘opt in’’ policy
for groups or solo practitioners
participating in Shared Savings Program
ACOs. We believe that allowing groups
and solo practitioners who participate
in the Shared Savings Program in the
performance period to ‘‘opt in’’ to
having their cost composite calculated
would conflict with our intent to avoid
setting multiple financial benchmarks
for these groups and solo practitioners.
After considering the public
comments received, we are finalizing
our policy to classify the cost composite
as ‘‘average cost’’ for groups and solo
practitioners that participate in an ACO
under the Shared Savings Program.
Unlike our proposed policy, which
considered participation in a Shared
Savings Program ACO during the
payment adjustment period for the VM
(for example, CY 2017), we are
finalizing a policy that, if a group or
solo practitioner participates in a
Shared Savings Program ACO during
the applicable performance period (for
example, the CY 2015 performance
period for the CY 2017 payment
adjustment period), then that group or
solo practitioner’s cost composite will
be classified as ‘‘average cost,’’
regardless of whether the group or solo
practitioner participates in a Shared
Savings Program ACO during the
payment adjustment period. In addition
to addressing some of the concerns
PO 00000
Frm 00397
Fmt 4701
Sfmt 4700
67943
raised by commenters, we believe this
final policy is consistent with our
existing policy for CYs 2015 and 2016,
under which a group’s participation in
the Shared Savings Program during the
performance period (CYs 2013 and
2014, respectively) is relevant for
purposes of determining whether to
exempt the group from application of
the VM during the relevant payment
adjustment period. Further, utilizing the
performance period for the purpose of
determining whether the group or solo
practitioner is a Shared Savings Program
ACO participant eliminates the need for
us to calculate preliminary payment
adjustment factors prior to the
beginning of the payment adjustment
period, and then recalculate the
payment adjustment factors after the
final ACO participation list is
completed, as we had proposed to do
(79 FR 40506).
As requested by commenters, this
final policy is also simpler than our
proposal, because it does not take into
account a group’s status during the
payment adjustment period.
(c) Calculation of the quality
composite under the VM for Shared
Savings Program participants. Beginning
with the CY 2017 payment adjustment
period, we proposed to calculate the
quality of care composite score for the
VM for groups and solo practitioners
who participate in an ACO under the
Shared Savings Program in accordance
with the following policies (79 FR
40498–40499):
• We proposed to calculate the
quality of care composite score based on
the quality-tiering methodology using
quality data submitted by the ACO, as
discussed in section III.N.4.h of this
final rule with comment period, from
the performance period and apply the
same score to all of the groups and solo
practitioners under the ACO during the
payment adjustment period. In other
words, using CY 2017 as an example,
we proposed to calculate the quality of
care composite score for the CY 2017
VM for all of the groups and solo
practitioners participating in the ACO in
CY 2017 based on the ACO’s CY 2015
quality data. We note that in section
III.N.4.h of this final rule with comment
period, we are finalizing our proposal to
exclude the claims-based outcome
measures identified under § 414.1230
from the calculation of the quality of
care composite score for groups and solo
practitioners who participate in the
Shared Savings Program as described in
section III.N.4.d.1 of this final rule with
comment period.
• For groups and solo practitioners
who participate in the ACO during the
payment adjustment period (for
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67944
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
example, CY 2017) and either did not
participate in the Shared Savings
Program or were part of a different ACO
during the performance period (for
example, CY 2015), we proposed to
calculate the quality of care composite
score based on the quality-tiering
methodology using the quality data
submitted by the ACO from the
performance period. For example, if a
group or solo practitioner is in ACO 1
during CY 2017, and either was not in
the Shared Savings Program or was part
of ACO 2 during CY 2015, we would use
ACO 1’s quality data from CY 2015 to
calculate the quality of care composite.
This approach is consistent with our
policy not to ‘‘track’’ or ‘‘carry’’ an
individual professional’s performance
from one TIN to another TIN (see 77 FR
69308 through 69310). In other words,
if a professional changes groups from
TIN A in the performance period to TIN
B in the payment adjustment period, we
would apply TIN B’s VM to the
professional’s payments for items and
services billed under TIN B during the
payment adjustment period.
• If the ACO did not exist during the
performance period (for example, CY
2015), then we would not have the
ACO’s quality data to use in the
calculation of the quality of care
composite score for the payment
adjustment period (for example, CY
2017). Therefore, if the ACO exists
during the payment adjustment period
but did not exist during the performance
period, we proposed to classify the
quality of care composite for all groups
and solo practitioners who participate
in the ACO during the payment
adjustment period as ‘‘average quality’’
for the payment adjustment period. We
proposed to apply this policy to groups
and solo practitioners regardless of their
status during the performance period—
in other words, regardless of whether
they participated in the Shared Savings
Program as part of a different ACO, or
did not exist during the performance
period (for example, a TIN forms or
newly enrolls in Medicare after the end
of the performance period). We believed
this proposal was appropriate since we
would not have the ACO’s quality data
from the performance period to
calculate a quality of care composite for
all of the groups and solo practitioners
participating in the ACO during the
payment adjustment period. We noted
that some of these groups and solo
practitioners may have participated in
the PQRS during the performance
period; therefore, we would have
quality data for those groups and solo
practitioners. If they were part of a
different ACO during the performance
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
period, then we would also have that
ACO’s quality data. We stated that we
did not, however, believe that it would
be appropriate to use the groups’ and
solo practitioners’ PQRS or other ACO
quality data from the performance
period to calculate a quality of care
composite because the groups and solo
practitioners are part of a new ACO
during the payment adjustment period.
We stated our belief that this approach
would be consistent with our policy not
to ‘‘track’’ or ‘‘carry’’ an individual
professional’s performance from one
TIN to another TIN (see 77 FR 69308
through 69310). In this case, if a TIN’s
status changes from the performance
period to the payment adjustment
period (that is, participating in ACO 2
or not participating in the Shared
Savings Program in the performance
period, to participating in ACO 1 in the
payment adjustment period), then we
proposed that we would not ‘‘track’’ or
‘‘carry’’ ACO 2’s quality data or the
TIN’s PQRS quality data to determine
the quality of care composite for groups
and solo practitioners who participate
in ACO 1.
• For groups and solo practitioners
who participate in the Shared Savings
Program during the performance period
(for example, CY 2015) but no longer
participate in the Shared Savings
Program during the payment adjustment
period (for example, CY 2017), we
proposed to classify the quality of care
composite as ‘‘average quality’’ for the
VM for the payment adjustment period.
Since these groups and solo
practitioners were part of an ACO
during the performance period, we
would have the ACO’s quality data from
that period. We stated that we did not
believe it would be appropriate to use
the ACO’s quality data from the
performance period to calculate a
quality of care composite because the
groups and solo practitioners are no
longer part of the ACO during the
payment adjustment period. We stated
this approach is also consistent with our
policy not to ‘‘track’’ or ‘‘carry’’ an
individual professional’s performance
from one TIN to another TIN (see 77 FR
69308 through 69310). Even though we
proposed to classify the quality of care
composite for these groups and solo
practitioners as ‘‘average quality,’’ we
solicited comments on whether we
should use the ACO’s quality data from
the performance period to calculate the
quality composite for these groups and
solo practitioners for the payment
adjustment period.
We solicited comments on all of our
proposals to calculate the quality
composite for groups and solo
practitioners participating in the Shared
PO 00000
Frm 00398
Fmt 4701
Sfmt 4700
Savings Program. We provided a
summary of the proposals in the
proposed rule in Table 56 using TIN A
and ACO 1 and ACO 2 as examples (79
FR 40499).
Comment: As noted above, in the
discussion of the cost composite, we
received many comments stating that
we should exempt groups and solo
practitioners from the 2017 VM. Many
commenters also suggested an
‘‘Innovation Pathway’’ approach for
participants in the Shared Savings
Program and Innovation Center
initiatives. Under this suggested
approach, groups and solo practitioners
participating in the Shared Savings
Program or other Innovation Center
initiatives would receive ‘‘average cost’’
and ‘‘average quality’’ unless they opted
to have their VM calculated. The
reasoning behind this approach,
provided by commenters, is to allow
ACOs and the participating groups and
solo practitioners to focus on one set of
cost and quality benchmarks and avoid
confusion predicted by some
commenters. Many commenters also
believe that applying the VM to these
groups and solo practitioners could lead
to ‘‘double counting’’ positive or
negative performance. A few
commenters stated that if we are to
apply the VM to groups and solo
practitioners in the Shared Savings
Program, they should only be subject to
a neutral or an upward adjustment.
Some commenters supported our
proposed policies related to cost and
quality composites, and one commenter
stated that if the VM is applied to these
groups, they believed that only a quality
composite should be calculated because
they believe that ACOs are already
rewarded for reducing costs. We also
received comments on the specific
quality measures and benchmarks that
we proposed to use for the VM for
groups and solo practitioners
participating in the Shared Savings
Program, which we address in section
III.N.4.h of this final rule with comment
period.
Response: We appreciate commenters’
concern about the potential for
conflicting incentives on cost and
quality performance when applying the
VM to Shared Savings Program
participants given that these
participants are already working toward
a set of cost efficiency and quality
improvement goals through the Shared
Savings Program. We continue to
believe, however, that it is appropriate
to calculate a quality composite for
groups and solo practitioners
participating in the Shared Savings
Program based on the ACO’s quality
data. We appreciate the support of
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
commenters who agreed that it is
appropriate to calculate a quality
composite for these groups and solo
practitioners based on the ACO’s quality
data. We disagree with commenters who
believe it would be inappropriate to
calculate a VM for groups and solo
practitioners that participate in the
Shared Savings Program because this
could be seen as ‘‘double counting’’
performance. We believe that
application of the VM to providers who
participate in the Shared Savings
Program reinforces the importance of
quality improvement and quality
reporting by offering participants in the
Shared Savings Program an opportunity
to earn an upward adjustment for
improved performance. We agree with
the commenter who stated if calculating
a VM for Shared Savings Program
participants, we should only calculate
the quality composite. However, we
would like to point out that the Shared
Savings Program does also reward high
quality care in addition to rewarding
reductions in cost growth. Unlike the
differences between the methodologies
for evaluating costs under the Shared
Savings Program and the VM, we do not
believe that the differences between the
quality methodologies for these two
programs will create significant
confusion or conflicting incentives.
Because the GPRO web interface
measures are consistent across the VM
and Shared Savings Program, we believe
that it will not create undue burden on
ACO participants or cause significant
confusion to calculate a quality
composite for these groups and solo
practitioners. More specifically, the cost
measures and cost benchmarks used to
determine the cost composite under the
VM are different than the methodology
used to calculate financial performance
under the Shared Savings Program. In
contrast, the GPRO web interface quality
measures used in the Shared Savings
Program are the same as those used to
calculate the quality composite of the
VM for groups that are not in Shared
Savings Program ACOs that report
through GPRO. Furthermore, ACOs in
the Shared Savings Program report on
quality measures on behalf of all the
groups and solo practitioners that
participate in the ACO, which allows us
to calculate a single quality composite
that can be applied to all participants.
We do not have this same capability for
the cost composite, which would need
to be calculated separately for each
group or solo practitioner and thus
could create conflicting incentives and
add more confusion. By calculating a
quality composite for groups and solo
practitioners that participate in ACOs
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
under the Shared Savings Program we
are providing an additional incentive to
improve the quality of care for their
beneficiaries. As stated in section
III.N.4.d.1.b., where we discuss the
calculation of the cost composite for
Shared Savings Program ACO
participants, we do not believe it would
be appropriate to allow groups or solo
practitioners to ‘‘opt in’’ to having their
VM calculated based on the TIN’s,
rather than the whole ACO’s,
performance. Allowing groups or solo
practitioners to ‘‘opt in’’ to having their
own VM calculated could create
conflicting incentives and competing
priorities between the ACO’s goals and
the specific group’s or solo
practitioner’s goals. An ‘‘opt in’’ policy
would result in Shared Savings Program
ACO participants reporting quality data
outside of the ACO, which is not
consistent with the policies of the
Shared Savings Program.
Comment: As noted in the section
III.N.4.d.1.b., we received a few
comments related to scenarios in which
a group or solo practitioner enters or
leaves the Shared Savings Program.
Commenters pointed out that applying
an ACO’s quality performance to groups
or solo practitioners that were not in the
ACO in the performance period could
discourage groups and solo practitioners
from joining an ACO in the payment
adjustment period if it would mean they
would not receive an earned upward
adjustment. One commenter indicated
that it would not be fair to assess a
group or solo practitioner that was in
the Shared Savings Program in the
performance period, but is not in the
payment adjustment period, without
consideration of the incentives in place
in the performance period. This
commenter, however, did not object to
the application of ‘‘average quality’’ to
groups and solo practitioners in this
situation. We also received some general
comments that the many different
scenarios proposed were confusing and
added additional complexity to the VM
program.
Response: We appreciate the
comments that pointed out the potential
problems with using participation
during the payment adjustment period
to determine the quality performance of
groups and solo practitioners. As stated
in the comments and responses in
section III.N.4.d.1.b., we agree that using
a group or solo practitioner’s status in
the payment adjustment period could
discourage future participation in the
Shared Savings Program. Consistent
with our response to the cost composite
comments, we believe that it would be
inappropriate to ignore the quality
performance of a group or solo
PO 00000
Frm 00399
Fmt 4701
Sfmt 4700
67945
practitioner in the performance period
because they choose to join an ACO in
the payment adjustment period, as well
as in the opposite scenario (if a group
or solo practitioner participated in an
ACO in the performance period and
then left the ACO in the payment
adjustment period). As discussed in our
earlier response, we believe it would be
appropriate to use the ACO’s quality
performance because the group or solo
practitioner was part of the ACO during
the performance period and should be
assessed based on the incentives that
existed during the performance period.
Our proposal to consider a group or solo
practitioner’s participation in a Shared
Savings Program ACO during the
payment adjustment period was
intended to be consistent with our
existing policy to not ‘‘track’’ or ‘‘carry’’
an individual’s performance from one
TIN to another from performance period
to payment adjustment period. Given
the comments we received on our
proposals concerning the cost and
quality composites for groups and solo
practitioners that participate in an ACO
under the Shared Savings Program, we
agree that it is preferable to consider a
group or solo practitioner’s participation
in an ACO during the performance
period to determine how the VM should
be applied. Given that we would have
ACO-level quality data available for
group and solo practitioners that were
in an ACO in the performance period,
we believe this data should be used to
calculate a quality composite for those
groups and solo practitioners. This is
consistent with the policy regarding the
cost composite that we are finalizing in
section III.N.4.d.1.b of this final rule
with comment period, which focuses on
the cost and quality performance
incentives that existed for the group or
solo practitioner in the performance
period, not the payment adjustment
period when applying the VM to groups
and solo practitioners that are in the
Shared Savings Program. As noted
above, it is also consistent with the way
in which we have determined
participation in the Shared Savings
Program for the 2015 and 2016 VM,
based on whether the group or solo
practitioner participated in the Shared
Savings Program during the
performance period. Further, as noted in
the cost composite section III.N.4.d.1.b,
utilizing the performance period for the
purpose of determining whether the
group or solo practitioner is a Shared
Savings Program ACO participant
eliminates the need for us to calculate
preliminary payment adjustment factors
prior to the beginning of the payment
adjustment period, and then recalculate
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67946
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
the payment adjustment factors after the
final ACO participation list is
completed, as we had proposed to do
(79 FR 40506). We are also convinced by
commenters who stated that our
proposed policies were too complex. We
believe that using a TIN’s participation
in an ACO in the performance period to
determine the cost composite, while
considering the TIN’s status in the
payment adjustment period to
determine the quality composite, would
add unnecessary complexity and
inconsistency, especially as new ACOs
continue to be established and existing
ACOs expand.
In the proposed rule (79 FR 40498),
we stated that if a group or solo
practitioner was in ACO 2 in the
performance period and then joined
ACO 1 in the payment adjustment
period, we would use ACO 1’s quality
performance to calculate the quality
composite for that group or solo
practitioner. Although we did not
receive specific comments on this
policy, we believe that based on the
other comments received and the policy
we are finalizing it would no longer be
appropriate to use ACO 1’s quality data
to calculate a quality composite for
these groups and solo practitioners.
Given that in all other scenarios, we are
finalizing policies that we will consider
the group or solo practitioner’s (as
identified by taxpayer identification
number (TIN)) status during the
performance period, rather than the
payment adjustment period to
determine how the group’s or solo
practitioner’s quality and cost
composite should be calculated, we also
believe this is the appropriate approach
for groups and solo practitioners that
move between ACOs. We have
previously stated our rationale for using
the performance period to determine a
TIN’s association with an ACO and we
believe that reasoning applies to this
scenario as well. Furthermore, it would
be unnecessarily complex to apply a
different policy for groups and solo
practitioners in this scenario (where the
TIN is part of one ACO during the
performance period and a different ACO
during the payment adjustment period)
than in the other scenarios previously
discussed.
After considering the public
comments received, we are finalizing a
policy to calculate a quality of care
composite score based on the qualitytiering methodology using quality data
submitted by a Shared Savings Program
ACO during the performance period and
apply the same quality composite to all
of the groups and solo practitioners, as
identified by TIN, under that ACO.
Unlike our proposed policy, which
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
considered whether a group or solo
practitioner participates in a Shared
Savings Program ACO during the
payment adjustment period for the VM
(for example, CY 2017), our final policy
is if a group or solo practitioner
participates in a Shared Savings
Program ACO during the applicable
performance period (for example, the
CY 2015 performance period for the CY
2017 payment adjustment period), then
that group or solo practitioner’s quality
composite is calculated using the ACOlevel quality data from the performance
period, regardless of whether the group
or solo practitioner participates in a
Shared Savings Program ACO during
the payment adjustment period. The VM
calculated under this policy will apply
to all physicians billing under the
group’s TIN in the CY 2017 payment
adjustment period, and beginning in the
CY 2018 payment adjustment period, to
all physician and nonphysician eligible
professionals billing under the group’s
TIN, regardless of whether the
professional was part of the group in the
performance period. This is consistent
with our policy for other groups subject
to the VM, in that we will not ‘‘track’’
or ‘‘carry’’ an individual professional’s
performance from one TIN to another
TIN.
Comment: Several commenters
requested that we provide further
guidance on how groups that leave the
Shared Savings Program will be treated
under the VM. Specifically one
commenter suggested that we consider
how we would apply the VM in
situations in which an ACO dissolves
mid-year and does not report quality
data. The commenter stated that we
should ensure that those groups and
solo practitioners participating in the
ACO are not subject to the automatic
downward adjustment.
Response: We appreciate commenters
raising these questions and concerns.
We did not specifically address in the
proposed rule the scenario in which a
Shared Savings Program ACO does not
successfully report on quality as
required under the Shared Savings
Program during the performance period
for the VM. We clarify that we intended
to adopt for groups and solo
practitioners that participate in a Shared
Savings Program ACO the same policy
that is generally applicable to groups
and solo practitioners that fail to
satisfactorily report or participate under
PQRS and thus fall in Category 2 and
are subject to an automatic downward
adjustment under the VM in CY 2017
(79 FR 40496—40497). We are finalizing
this policy for groups and solo
practitioners that participate in a Shared
Savings Program ACO under
PO 00000
Frm 00400
Fmt 4701
Sfmt 4700
§ 414.1210(b)(2). Consistent with the
application of the VM to other groups
and solo practitioners that report under
PQRS as described in section III.N.4.c,
if the ACO does not successfully report
quality data as required by the Shared
Savings Program under § 425.504, all
groups and solo practitioners
participating in the ACO will fall in
Category 2 for the VM and therefore will
be subject to a downward payment
adjustment as described in section
III.N.4.f. We also plan to issue programspecific guidance to provide
participants with more information
about how these various situations may
be addressed. Our final policy focusing
on the group or solo practitioner’s status
in the performance period will simplify
the operational issues related to
determining the answers to these
questions.
(d) Treatment of groups with two to
nine eligible professionals and solo
practitioners in the Shared Savings
Program. In section III.N.4.c of this final
rule with comment period, we
discussed our proposal to hold groups
with two to nine eligible professionals
and solo practitioners who are in
Category 1 harmless from any
downward adjustments under the
quality-tiering methodology for the CY
2017 payment adjustment period. We
proposed to also hold harmless from
any downward adjustments groups with
two to nine eligible professionals and
solo practitioners who participate in
ACOs under the Shared Savings
Program during the CY 2017 payment
adjustment period based on their size
during the performance period. We
would follow our established process
for determining group size, which is
described at § 414.1210(c). Therefore, to
the extent that a quality of care
composite can be calculated for an ACO,
and the cost composite would be
classified as ‘‘average cost,’’ groups with
10 or more eligible professionals
participating in the Shared Savings
Program would be subject to an upward,
neutral, or downward payment
adjustment in CY 2017, and groups with
two to nine eligible professionals and
solo practitioners would be subject to an
upward or neutral payment adjustment
in CY 2017. We also proposed that
groups and solo practitioners
participating in ACOs under the Shared
Savings Program would be eligible for
the additional upward payment
adjustment of +1.0x for caring for highrisk beneficiaries, as proposed in section
III.N.4.f. We proposed to modify
§ 414.1210 to reflect these proposals.
Comment: We did not receive any
comments on these proposals specific to
the Shared Savings Program. General
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
comments on these proposals are
addressed in section III.N.4.c of this
final rule with comment period.
Consistent with final policies in this
final rule with comment period to use
a group or solo practitioner’s status in
the performance period to determine
participation in the Shared Savings
Program, we are finalizing a policy to
hold harmless from any downward
adjustments groups with two to nine
eligible professionals and solo
practitioners who participate in ACOs
under the Shared Savings Program
during the performance period (for
example, the CY 2015 performance
period for the CY 2017 payment
adjustment period) based on their size
during the performance period.
We have modified § 414.1210 to
reflect these final policies for
application of the VM beginning with
the CY 2017 payment adjustment period
to groups and solo practitioners that
participate in an ACO under the Shared
Savings Program ACO.
(2) Physicians and Nonphysician
Eligible Professionals That Participate in
the Pioneer ACO Model, the
Comprehensive Primary Care (CPC)
Initiative, or Other Similar Innovation
Center Models or CMS Initiatives
Section 1115A of the Act authorizes
the Innovation Center to test innovative
payment and service delivery models to
reduce Medicare, Medicaid, or
Children’s Health Insurance Program
(CHIP) expenditures, while preserving
or enhancing the quality of care
furnished to beneficiaries under those
programs. Therefore, all models tested
by the Innovation Center would be
expected to assess participating entities
(for example, providers, ACOs, states)
based on quality and cost performance.
As noted above, we established a policy
in the CY 2013 PFS final rule with
comment period (77 FR 69313) to not
apply the VM in CY 2015 and CY 2016
to groups of physicians that are
participating in the Pioneer ACO Model,
the CPC Initiative, or in other
Innovation Center initiatives or other
CMS programs which also involve
shared savings and where participants
make substantial investments to report
quality measures and to furnish higher
quality, more efficient and effective
healthcare.
The Pioneer ACO Model and the CPC
Initiative are scheduled to end on
December 31, 2016. Therefore, the
relevant performance periods for
consideration for participants in these
initiatives are CY 2015 for the CY 2017
VM payment adjustment period and
potentially CY 2016 for the CY 2018 VM
payment adjustment period. Under the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Pioneer ACO Model, an ACO may
consist of practitioners from multiple
participating groups and solo
practitioners (as identified by their
individual TIN/NPI combination). Thus,
a group practice may consist of one or
more eligible professionals who
participate in the Pioneer ACO Model
and other eligible professionals who do
not participate in the Pioneer ACO
Model. In the case of the CPC Initiative,
a practice site may participate in the
model even if one or more other practice
sites that use the same TIN does not
participate.
(a) Application of the VM to
participants in the Pioneer ACO Model
and CPC Initiative. Beginning with the
CY 2017 payment adjustment period,
we proposed to apply the VM to
physicians and nonphysician eligible
professionals in groups with two or
more eligible professionals and to
physicians and nonphysician eligible
professionals who are solo practitioners
who participate in the Pioneer ACO
Model or the CPC Initiative during the
relevant performance period in
accordance with the policies described
below (79 FR 40500).
Comment: The majority of comments
we received stated that CMS should not
apply the VM to group practices and
solo practitioners participating in the
Pioneer ACO Model or CPC Initiative.
These comments largely mirrored the
comments summarized in section
III.N.4.d.1.a of this final rule with
comment period regarding the
application of the VM to Shared Savings
Program participants. A few
commenters also suggested that the
application of the VM to Innovation
Center initiatives should be waived
under section 1115A of the Act.
Additionally, one organization
expressed concern that the number of
varying approaches to calculating the
VM in our proposed rule would be too
complex to implement and may not
create equitable comparisons among
Pioneer, CPC, other Innovation Center
model participants, and other
individuals and groups under the VM
program. This commenter suggested that
we exempt group practices and solo
practitioners who participate in the
Pioneer ACO Model until that model
ends. As noted in section III.N.4.d.1.a, a
few commenters supported the
application of the VM to as many groups
and solo practitioners as possible to
encourage value-based change.
Response: We are required to apply
the VM to all physicians and groups of
physicians beginning no later than
January 1, 2017, and we believe that
alignment of the VM program and the
Pioneer ACO Model, CPC Initiative, and
PO 00000
Frm 00401
Fmt 4701
Sfmt 4700
67947
other similar models emphasizes the
importance of quality reporting and
quality measurement, for improvement
of the quality of care provided to
Medicare beneficiaries. We understand
the concerns presented by these
commenters and summarized in section
III.N.4.d.1 regarding calculation of the
cost and quality composites under the
VM, and we address them below, in
section III.N.4.d.2.b of this final rule
with comment period.
After considering the public
comments on this proposal, we are
finalizing a policy to apply the VM in
the CY 2017 payment adjustment
period, to physicians in groups with two
or more eligible professionals in which
at least one eligible professional
participates in the Pioneer ACO Model
or the CPC Initiative during the
performance period, and to physicians
who are solo practitioners that
participate in the Pioneer ACO Model or
the CPC Initiative during the
performance period.
We note that, in response to
commenters’ concerns, we are not
finalizing the proposal to apply the VM
to nonphysician eligible professionals in
the CY 2017 payment adjustment period
that participate in the Pioneer ACO
Model or CPC Initiative. This policy is
consistent with the policy for the
Shared Savings Program in the CY 2017
payment adjustment period described in
section III.M.4.d.1 and for groups and
solo practitioners that do not participate
in these models or in the Shared
Savings Program, as discussed in
section III.N.4.b of this final rule with
comment period.
(b) Calculation of the cost and quality
composite of the VM for Pioneer ACO
and CPC Initiative participants.
• For groups and solo practitioners
who participate in the Pioneer ACO
Model or the CPC Initiative during the
performance period for the VM, we
proposed policies for how we would
calculate the cost and quality
composites in a number of scenarios
depending on whether or not all eligible
professionals in the group participate in
the model, whether or not the group or
solo practitioner report through PQRS
outside of the model, and if so, through
which reporting mechanism, and
whether or not the group or solo
practitioner participate in the Shared
Savings Program in the payment
adjustment period. Additionally, we
described several alternatives that we
considered to the proposed policies.
Specifically, we described two
alternatives to Scenario 2 described in
the proposed rule (79 FR 40501). Under
one alternative, for groups that have
some eligible professionals participating
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67948
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
in the model and some eligible
professionals that are not participating
in the model, we considered applying
‘‘average quality’’ without regard to any
PQRS data reported outside of the
model. Another alternative we
considered was to apply ‘‘average
quality’’ to groups where less than 50
percent of all eligible professionals in
the group meet the criteria for
satisfactory reporting of data on PQRS
quality measures as individuals or
satisfactorily participate in a PQRSqualified clinical data registry, because
we would not have quality data for more
than half of the group that we could use
to calculate a quality composite. For a
detailed description of these scenarios
and proposed policies, as well as the
alternatives considered, we refer readers
to the proposed rule at 79 FR 40500–
40504. We also provided a summary of
these proposals, as Table 57 in the
proposed rule (79 FR 40504).
We solicited comments on these
proposals and the alternatives
considered.
Comment: We received comments on
our proposals for calculating the quality
and cost composites for Pioneer ACO
Model and CPC Initiative participants.
As noted in section III.N.4.d.2.a of this
final rule with comment period, most
commenters did not support our
proposal to apply the VM to Pioneer
ACO and CPC participants in general.
However, many of these commenters
stated that if the VM were to be applied
to these providers, then CMS should
classify the cost and quality composites
as average to avoid sending what they
see as conflicting messages about cost
and quality benchmarks. These
commenters did not make any
distinction between the reporting
mechanism used when quality data is
reported to PQRS outside of the model
(for example, GPRO vs. individual
reporting). Instead, they argued that we
should apply average cost and average
quality for all groups and solo
practitioners participating in these
models because they have already taken
on accountability for cost and quality
measures, and it would be confusing
and unnecessary to hold them to a
different set of measures or benchmarks.
The ‘‘Innovation Pathway’’ suggestion
referenced in the summary of comments
on section III.N.4.d.1 was also
recommended for groups and solo
practitioners participating in the
Pioneer Model and CPC Initiative. A few
commenters suggested that providers
participating in Pioneer or CPC should
only be eligible for upward VM
adjustments. Some commenters
suggested that groups and solo
practitioners should be able to opt-in to
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
having their cost and quality composites
calculated as described in the proposed
rule. We also received a comment
indicating that providers in the Pioneer
and CPC models should have their VM
calculated the same as any other TIN
subject to the VM.
Response: We are convinced by
commenters who suggested that groups
and solo practitioners in these models
should be classified as ‘‘average cost’’
and ‘‘average quality.’’ In section
III.N.4.d.1, we described our rationale
for classifying the cost composite as
‘‘average’’ for groups and solo
practitioners that participate in an ACO
under the Shared Savings Program.
Similar to the Shared Savings Program,
the Pioneer ACO Model and CPC
Initiative use a shared savings
methodology that is significantly
different than the cost measures and
benchmarks used to calculate the cost
composite under the VM program.
Because of these significant differences,
we are persuaded by commenters who
stated that the calculating a cost
composite for groups and solo
practitioners in these models could
create conflicting incentives. Moreover,
it is challenging to meaningfully assess
the quality performance of groups that
participate in these models for purposes
of calculating a quality composite for
the VM given that for many of these
groups, some eligible professionals in
the group participate in these models
while other eligible professionals within
the same group do not participate (79
FR 40502). Although the Pioneer ACO
Model uses the same set of quality
measures as the Shared Savings
Program, this quality data does not
necessarily represent all eligible
professionals in the group because some
do not participate in the model. The
CPC Initiative presents similar
challenges because of groups in which
only a subset of eligible professionals
may be participating in the model.
Because some of the groups with
eligible professionals participating in
these models could choose to report
outside of the model through a PQRS
reporting mechanism, we may have
quality data for a subset of groups or for
a subset of individuals within a group,
depending on the reporting mechanism.
The policies in our proposed rule
indicated that we would make use of
this quality data when available,
however, as noted above, we also
considered other options including
applying ‘‘average quality’’ to certain
groups. We agree that it is important for
these participants to focus on the cost
and quality measures within their
respective models and are persuaded by
PO 00000
Frm 00402
Fmt 4701
Sfmt 4700
the vast majority of commenters who
indicated that these policies could
create conflicting incentives for model
participants and several commenters
who stated that they were unnecessarily
complex and likely to cause confusion.
We do not agree with commenters who
suggested giving groups and solo
practitioners an opportunity to ‘‘opt-in’’
for the reasons stated in response to
comments on section III.N.4.d.1. We
appreciate the support of commenters
who agreed that applying the VM to
groups and solo practitioners in these
initiatives would support the VM
program goals of improving quality and
cost efficiency. To the extent possible,
we intend to provide QRURs showing
cost and, where available, quality
performance on VM measures, to these
groups and solo practitioners to further
support the goals of the VM program.
Comment: We also received
comments on our proposal to calculate
the cost composite for groups and solo
practitioners who are not in the Shared
Savings Program or similar CMS
initiative in the payment adjustment
year. These commenters stated that
groups and solo practitioners should be
assessed based on the cost and quality
incentives that were in place in the
performance period, not the payment
adjustment period. Under our proposed
policies, we would calculate a cost
composite for groups that participated
in Pioneer or CPC in the performance
period but did not participate in another
similar initiative or the Shared Savings
Program in the payment adjustment
period. One commenter stated these
groups and solo practitioners should be
classified as average cost because at
least a portion of their eligible
professionals were operating under a
different set of cost measures during the
performance period.
Response: As noted in section
III.N.4.d.1, we are persuaded by
commenters who suggested that taking
into account the status of the group or
solo practitioner in the payment
adjustment period does not fully
acknowledge the incentives that existed
for the group or solo practitioner in the
performance period and, consistent with
the approach taken for Shared Savings
Program participants, we are finalizing
a policy that takes into account whether
a group or solo practitioner participates
in the Pioneer ACO Model or CPC
Initiative during the performance period
for the VM. As discussed above, we
believe the differences in methodology
between the VM cost measures and the
methodologies used to determine shared
savings under the Pioneer ACO Model
and the CPC Initiative are significant
and that it would be inappropriate to
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
calculate a cost composite for these
groups and solo practitioners. In the
proposed rule (79 FR 40502), we stated
that for groups and solo practitioners
that participate in the Pioneer ACO
Model or CPC Initiative in the
performance period and then participate
in an ACO under the Shared Savings
Program in the payment adjustment
period, we would use the Shared
Savings Program ACO’s quality data to
calculate the quality composite, or
classify the quality composite as average
if the ACO did not exist in the
performance period. We are modifying
this policy such that groups or solo
practitioners who participate in the
Pioneer ACO Model or CPC Initiative in
the performance period and then
participate in an ACO under the Shared
Savings Program in the payment
adjustment period will also receive
‘‘average cost’’ and ‘‘average quality’’.
This is consistent with the policies we
are finalizing for the groups and solo
practitioners that participate in an ACO
under the Shared Savings Program to
consider the group or solo practitioner’s
status during the performance period, in
order to determine how the VM will be
applied.
After considering the public
comments, we are finalizing a policy
that for solo practitioners and groups
with at least one eligible professional
participating in the Pioneer ACO Model
or CPC Initiative during the
performance period, we will classify the
cost composite as ‘‘average cost’’ and
the quality composite as ‘‘average
quality’’ for the CY 2017 payment
adjustment period. This policy is
similar to the alternative to scenario 2
we considered in the proposed rule (79
FR 40501), though with a broader
application to address commenters’
concerns about the level of complexity
in the proposals. We are not finalizing
our proposals regarding the
requirements for groups and solo
practitioners in the Pioneer ACO Model
and CPC Initiative to avoid Category 2
and the downward payment adjustment.
Instead, for the CY 2017 payment
adjustment period, the policy to classify
the cost composite as ‘‘average cost’’
and the quality composite as ‘‘average
quality’’ will apply to all solo
practitioners who participate in the
Pioneer ACO Model or the CPC
Initiative in the performance period and
all groups with at least one eligible
professional who participates in the
Pioneer ACO Model or the CPC
Initiative in the performance period.
Given the concerns about distracting
from the goals of the models in which
these groups and solo practitioners
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
participate, the complexity of
determining whether groups that have
some eligible professionals in the model
and some who are not in the model
successfully reported quality
performance data, and the commenters’
requests for a simpler policy, we believe
this is an appropriate policy.
The VM calculated under this policy
will apply to all physicians billing
under the group’s TIN in the CY 2017
payment adjustment period regardless
of whether the physician was part of the
group in the performance period. This is
consistent with our policy for other
groups subject to the VM, in that we
will not ‘‘track’’ or ‘‘carry’’ an
individual professional’s performance
from one TIN to another TIN.
(c) Treatment of groups of two to nine
eligible professionals and solo
practitioners that participate in the
Pioneer ACO Model or CPC Initiative.
In section III.N.4.c of this final rule
with comment period, we discussed our
proposal to hold groups with two to
nine eligible professionals and solo
practitioners who are in Category 1
harmless from any downward
adjustments under the quality-tiering
methodology for the CY 2017 payment
adjustment period. We proposed to also
hold harmless from any downward
adjustments for CY 2017 groups with
two to nine eligible professionals, where
one or more eligible professionals
participate in the Pioneer ACO Model or
the CPC, and solo practitioners who
participate in the Pioneer ACO Model or
the CPC during the CY 2015
performance period based on their size
during the performance period. We
would follow our established process
for determining group size, which is
described at § 414.1210(c). We also
proposed that groups where one or more
eligible professionals participate in the
Pioneer ACO Model or the CPC during
the performance period, and solo
practitioners participating in the
Pioneer ACO Model or the CPC during
the performance period would be
eligible for the additional upward
payment adjustment of +1.0x for caring
for high-risk beneficiaries, as proposed
in section III.N.4.f below.
Comment: We did not receive
comments specific to this proposal. The
comments we received on our general
policy to hold harmless groups of two
to nine eligible professionals and solo
practitioners are discussed in III.N.4.a of
this final rule with comment period.
Given the modified policy we are
finalizing for group practices and solo
practitioners participating in the
Pioneer ACO Model and CPC Initiative
to classify the cost composite as
‘‘average cost’’ and the quality
PO 00000
Frm 00403
Fmt 4701
Sfmt 4700
67949
composite as ‘‘average quality,’’ these
proposals are no longer relevant and
will not be finalized.
(d) In addition, beginning with the CY
2017 payment adjustment period, we
proposed to apply the VM to physicians
and nonphysician eligible professionals
in groups with two or more eligible
professionals and to physicians and
nonphysician eligible professionals who
are solo practitioners who participate in
other similar Innovation Center models
or CMS initiatives during the relevant
performance period for the VM in
accordance with the proposed policies
described above for the Pioneer ACO
Model and the CPC Initiative. We are
unable to propose an exhaustive list of
the models and initiatives that would
fall under this category because many of
them have not yet been developed. In
addition, it is possible that the timeline
for implementing some of these new
models and initiatives may not coincide
with the timeline for rulemaking for the
VM. To address these issues, we
proposed to rely on the following
general criteria to determine whether a
model or initiative would fall in this
‘‘other similar’’ category and thus would
be subject to the policies described
above for the Pioneer ACO Model and
the CPC Initiative: (1) The model or
initiative evaluates the quality of care
and/or requires reporting on quality
measures; (2) the model or initiative
evaluates the cost of care and/or
requires reporting on cost measures; (3)
participants in the model or initiative
receive payment based at least in part
on their performance on quality
measures and/or cost measures; (4)
potential for conflict between the
methodologies used for the VM and the
methodologies used for the model or
initiative; or (5) other relevant factors
specific to a model or initiative. We
noted that a model or initiative would
not have to satisfy or address all of these
criteria to be included in this ‘‘other
similar’’ category. Rather, the criteria are
intended to serve as a general
framework for evaluating models and
initiatives with regard to the application
of the VM to groups and solo
practitioners who participate (79 FR
40502). We solicited public comment on
these or other appropriate criteria for
determining which models or initiatives
we should classify as ‘‘other similar’’
models, for the purposes of applying the
policies for the Pioneer ACO Model and
the CPC Initiative described above.
Comment: We did not receive any
comments on the criteria proposed to
determine ‘‘other similar’’ models,
though many of the comments received
on our proposals related to the
application of the VM to groups and
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67950
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
solo practitioners participating in the
Shared Savings Program, Pioneer ACO
Model, or CPC Initiative.
Response: As stated in our response to
comments on the application of the VM
to Pioneer ACO and CPC Initiative
participants, we are convinced by
commenters who suggested that we
apply ‘‘average cost’’ and ‘‘average
quality’’ to these groups and solo
practitioners. We believe many of these
‘‘other similar’’ models would be testing
new quality measures, reporting
methods, or both, and we want to
encourage innovation, including
standing up new infrastructure to
capture performance on quality
measures that could be used in the VM
program in the future.
After consideration of the comments,
we are finalizing our general criteria as
proposed for determining if a model or
initiative should be classified as an
‘‘other similar’’ model or initiative. We
will apply the final policies adopted for
applying the VM to groups and solo
practitioners that participate in the
Pioneer Model or the CPC Initiative to
Innovation Center models and CMS
initiatives that we determine are
‘‘similar’’ based on these criteria.
We recognize that the policies we
finalize for the Pioneer ACO Model and
the CPC Initiative might not be
applicable to all of the various models
and initiatives that could be developed
in future years. If we believe a different
approach to applying the VM would be
appropriate for a model or initiative, we
intend to address it in future
rulemaking. In addition, if we were to
determine that a model or initiative falls
under this ‘‘other similar’’ category
based on the general criteria, we will
provide notice to participants in the
model or initiative through the methods
of communication that are typically
used for the model or initiative.
Additionally, consistent with our
final policies for the Pioneer ACO
Model and CPC Initiative, Shared
Savings Program, and groups and solo
practitioners that do not participate in
these programs or models, we will not
apply the VM to nonphysician eligible
professionals in similar Innovation
Center models or CMS initiatives in the
CY 2017 payment adjustment period.
We modified § 414.1210 to reflect all
of these policies.
In addition to the comments
described above, we received a few
comments that were outside the scope
of what was proposed in this rule:
Comment: One commenter stated that
ACOs should have an opportunity to
receive confidential reports on their
performance on all Medicare FFS
beneficiaries—not just MSSP-attributed
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
beneficiaries—through the Physician
Feedback Program prior to application
of the VM program. This commenter
also stated that CMS should reduce the
administrative burden associated with
the ‘‘opt out’’ process for data sharing
for Shared Savings Program ACOs.
Other commenters stated that CMS
should adjust the financial benchmarks
for ACOs based on VM adjustments.
Response: We appreciate the input
from these commenters but believe
these suggestions are outside the scope
of this rule. Data sharing policies and
financial benchmarking methodologies
for the Medicare Shared Savings
Program are described in the Final Rule
for that program released in November
2011. The rule can be accessed https://
www.gpo.gov/fdsys/pkg/FR-2011-11-02/
pdf/2011-27461.pdf. Information on the
Pioneer ACO Model, can be found here:
https://innovation.cms.gov/initiatives/
Pioneer-ACO-Model/.
e. Clarification Regarding Treatment of
Non-assigned Claims for NonParticipating Physicians
In the CY 2013 PFS final rule with
comment period in which we
established a number of key policies for
the VM, we stated that we had received
few comments on our proposal to apply
the VM to the Medicare paid amounts
for the items and services billed under
the PFS so that beneficiary cost-sharing
or coinsurance would not be affected
(77 FR 69309). These commenters
generally agreed with the proposal to
apply the VM to the Medicare paid
amounts for the items and services
billed under the PFS at the TIN level so
that beneficiary cost-sharing would not
be affected. Therefore, we finalized this
policy and accordingly established a
definition of the VM at § 414.1205 that
was consistent with the proposal and
the statutory requirement to provide for
differential payment to a physician or a
group of physicians under the fee
schedule based upon the quality of care
furnished compared to cost during a
performance period.
We continue to believe that it is
important that beneficiary cost-sharing
not be affected by the VM and that the
VM should be applied to the amount
that Medicare pays to physicians.
However, in previous rulemaking, we
did not directly address whether the VM
would be applied to both assigned
services for which Medicare makes
payment to the physician, and to nonassigned services for which Medicare
makes payment to the beneficiary.
Participating physicians are those who
have signed an agreement in accordance
with section 1842(h)(1) of the Act to
accept payment on an assignment-
PO 00000
Frm 00404
Fmt 4701
Sfmt 4700
related basis for all items and services
furnished to Medicare beneficiaries. In
other words, participating physicians
agree to accept the Medicare approved
amount as payment in full and to charge
the beneficiary only the Medicare
deductible and coinsurance amount. In
contrast, non-participating physicians
have not signed an agreement to accept
assignment for all services furnished to
beneficiaries, but they can still choose
to accept assignment for individual
services. If they choose not to accept
assignment for particular services, nonparticipating physicians can charge the
beneficiary more than the Medicareapproved amount, up to a limit called
the ‘‘limiting charge.’’ The limiting
charge is defined at section
1848(g)(2)(C) of the Act as 115 percent
of the recognized payment amount for
nonparticipating physicians. In contrast,
if a non-participating physician chooses
to accept assignment for a service, they
receive payment from Medicare at the
approved amount for non-participating
physicians, which is 95 percent of the
fee schedule amount. Over 99 percent of
Medicare physician services are billed
on an assignment related basis by both
participating and non-participating
physicians and other suppliers, with the
remainder billed as non-assigned
services by non-participating physicians
and other suppliers.
For assigned claims, Medicare makes
payment directly to the physician. In
accordance with section 1848(p)(1) of
the Act and the regulations at
§ 414.1205 and § 414.1210(a), the VM
should be applied to assigned claims.
However, for non-assigned claims, the
limiting charge (the amount that the
physician can bill a beneficiary for a
non-assigned service) would not be
affected if the VM were applied to the
claim. This is so, because for nonassigned claims, application of the VM
would not affect the limiting charge.
Rather, Medicare makes payment for the
non-assigned services directly to the
beneficiary and the physician receives
all payment for a non-assigned service
directly from the beneficiary. If the VM
were to be applied to non-assigned
services, then the Medicare payment to
a beneficiary would be increased when
the VM is positive and decreased when
the VM is negative. The application of
the VM to non-assigned claims would
therefore directly affect beneficiaries
and not physicians, contrary to our
intent as discussed in previous
rulemaking (77 FR 69309). On that
basis, we proposed to clarify that we
would apply the VM only to assigned
services and not to non-assigned
services starting in CY 2015 (79 FR
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
40504). We do not expect this proposed
clarification, to not apply the VM to
non-assigned claims, would be likely to
affect a physician’s decision to
participate in Medicare or to otherwise
accept assignment for a particular claim.
This is because the amount that a
provider is entitled to receive from the
beneficiary for non-assigned claims is
not affected by whether or not the VM
is applicable to non-assigned claims.
Additionally, to the extent our proposal
to expand application of the VM to
nonphysician eligible professionals is
finalized, we would likewise apply the
VM only to services billed on an
assignment-related basis and not to nonassigned services. We invited comments
on this proposed clarification.
The following is summary of the
comments we received on this proposed
clarification.
Comment: We received relatively few
comments on this technical issue. For
those that did comment, nearly all
agreed with the proposed clarification
and agreed it is important that
beneficiary cost-sharing not be affected
by the VM, and that the VM should be
applied to the amount that Medicare
pays to physicians. Some commenters
requested a similar policy be applied to
the payment adjustments for PQRS and
EHR Meaningful Use. A commenter
opposed the proposed clarification,
encouraging CMS to support nonparticipating providers by applying the
value modifier adjustment to nonassigned claims at the group practice
level (TIN), and to evaluate alternative
solutions to paying providers other than
at the claim level.
Response: We appreciate receiving the
comments that supported this technical
clarification. However, we are unable to
agree with the commenter that
suggested an alternative approach to
apply the VM to claims submitted by
non-participating physicians. As
explained above and in the proposal,
the application of the VM to nonassigned claims by non-participating
physicians would directly affect
beneficiaries and not physicians,
contrary to our intent. However, we
further clarify that the VM will apply to
all assigned claims, including those
submitted by both participating and
non-participating physicians, and
nonphysician eligible professionals to
the extent the VM is applied to them.
Therefore, the VM will affect nonparticipating physicians to the extent
that they submit assigned claims.
With regard to the comment that a
similar policy for non-assigned claims
be applied to the PQRS and EHR
meaningful use adjustments, we believe
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
the comment is outside of the scope of
the proposed rule, although we note that
the VM is quite different from the PQRS
and EHR-meaningful use adjustments,
which apply to the Medicare allowed
amount rather than the Medicare paid
amount.
After considering the public
comments, we are finalizing the
proposed clarification to not apply the
VM to non-assigned claims for nonparticipating physicians, and
nonphysician eligible professionals to
the extent the VM is applied to them.
f. Payment Adjustment Amount
Section 1848(p) of the Act does not
specify the amount of payment that
should be subject to the adjustment for
the VM; however, section 1848(p)(4)(C)
of the Act requires the VM be
implemented in a budget neutral
manner. Budget neutrality means that
payments will increase for some groups
and solo practitioners based on high
performance and decrease for others
based on low performance, but the
aggregate expected amount of Medicare
spending in any given year for
physician and nonphysician eligible
professional services paid under the
Medicare PFS will not change as a result
of application of the VM.
In the CY 2014 PFS final rule with
comment period (78 FR 74770–74771),
we adopted a policy to apply a
maximum downward adjustment of
¥2.0 percent for the CY 2016 VM for
those groups of physicians with 10 or
more eligible professionals that are in
Category 2 and for groups of physicians
with 100 or more eligible professionals
that are in Category 1 and are classified
as low quality/high cost groups.
In the CY 2013 PFS final rule with
comment period, we adopted a modest
payment reduction of ¥1.0 percent for
groups of physicians in Category 1 that
elected quality tiering and were
classified as low quality/high cost and
for groups of physicians in Category 2
(77 FR 69323–24). Although we
received comments suggesting that
larger payment adjustments (both
upward and downward) would be
necessary to more strongly encourage
quality improvements, we finalized our
proposed adjustments as we believed
they better aligned with our goal to
gradually phase in the VM. However,
we noted that as we gained experience
with our VM methodologies we would
likely consider ways to increase the
amount of payment at risk, as suggested
by some commenters (77 FR 69324).
We believe that we can increase the
amount of payment at risk because we
can reliably apply the VM to groups
PO 00000
Frm 00405
Fmt 4701
Sfmt 4700
67951
with two or more eligible professionals
and to solo practitioners in CY 2017 as
discussed in section III.N.4.a of this
final rule with comment period.
Therefore, we proposed to increase the
downward adjustment under the VM by
doubling the amount of payment at risk
from ¥2.0 percent in CY 2016 to ¥4.0
percent in CY 2017 (79 FR 40505–
40506). That is, for CY 2017, we
proposed to apply a ¥4.0 percent VM
to groups with two or more eligible
professionals and solo practitioners that
fall in Category 2. In addition, we
proposed to increase the maximum
downward adjustment under the
quality-tiering methodology in CY 2017
to ¥4.0 percent for groups and solo
practitioners classified as low quality/
high cost and to set the adjustment to
¥2.0 percent for groups and solo
practitioners classified as either low
quality/average cost or average quality/
high cost. However, as discussed in
section III.N.4.c of this final rule with
comment period, we proposed to hold
solo practitioners and groups with two
to nine eligible professionals that are in
Category 1 harmless from any
downward adjustments under the
quality-tiering methodology in CY 2017.
Consistent with our previous policy, we
note that the estimated funds derived
from the application of the downward
adjustments to groups and solo
practitioners in Category 1 and Category
2 would be available to all groups and
solo practitioners eligible for VM
upward payment adjustments.
Accordingly, we also proposed to
increase the maximum upward
adjustment under the quality-tiering
methodology in CY 2017 to +4.0x for
groups and solo practitioners classified
as high quality/low cost and to set the
adjustment to +2.0x for groups and solo
practitioners classified as either average
quality/low cost or high quality/average
cost (79 FR 40505). We also proposed to
continue to provide an additional
upward payment adjustment of +1.0x to
groups and solo practitioners that care
for high-risk beneficiaries (as evidenced
by the average HCC risk score of the
attributed beneficiary population).
Lastly, we proposed to revise § 414.1270
and § 414.1275(c) and (d) to reflect the
changes to the payment adjustments
under the VM for the CY 2017 payment
adjustment period. Table 87 shows the
proposed quality-tiering payment
adjustment amounts for CY 2017 (based
on CY 2015 performance). We believe
that the VM amount differentiates
between cost and quality-tiers in a more
meaningful way. We solicited comments
on all of these proposals.
E:\FR\FM\13NOR2.SGM
13NOR2
67952
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 87—PROPOSED CY 2017 VM PAYMENT ADJUSTMENT AMOUNTS
Cost/quality
Low quality
Low Cost ....................................................................................................................
Average Cost .............................................................................................................
High Cost ...................................................................................................................
Average quality
+0.0%
¥2.0%
¥4.0%
*+2.0x
+0.0%
¥2.0%
High quality
*+4.0x
*+2.0x
+0.0%
ebenthall on DSK5SPTVN1PROD with $$_JOB
* Groups and solo practitioners eligible for an additional +1.0x if reporting Physician Quality Reporting System quality measures and average
beneficiary risk score is in the top 25 percent of all beneficiary risk scores.
The following is summary of the
comments we received on all these
proposals.
Comment: The majority of the
comments were opposed to our
proposals to increase the downward
payment adjustments from CY 2016 to
CY 2017 for groups and solo
practitioners that fall in Category 2 and
those that are low quality/high cost
under the quality-tiering methodology
to ¥4.0 percent. Commenters expressed
their belief that the changes are
aggressive. Several commenters
indicated that CY 2017 will be the first
year that many physicians and all
nonphysician eligible professionals will
be subject to the VM, and therefore,
recommended maintaining the
maximum downward payment
adjustment at ¥2.0 percent for Category
2 and those that are low quality/high
cost under the quality-tiering
methodology. Commenters indicated
that many of these groups and solo
practitioners have not yet received their
QRURs; therefore, it would be
premature to raise the adjustment
amount until all groups and solo
practitioners have applicable cost and
quality metrics and have had an
opportunity to participate in the PQRS
and VM programs. Commenters
indicated that CMS should not increase
the amount of payment at risk under
quality-tiering and for Category 2
without providing an opportunity for
both providers and CMS to understand
the implications of the current policies
as no group has had experience with the
VM since it will be implemented in CY
2015. Other commenters suggested that
groups and solo practitioners will have
little time to fully understand their
baseline performance under the VM.
They suggested by delaying the increase
of the maximum penalty, CMS would
gain experience with applying the VM
to a broader variety of groups, and that
groups and solo practitioners would
increase their understanding of the
methodology used to calculate the VM
and review their QRURs. Few
commenters suggested that if CMS is
concerned about PQRS reporting, then it
should separate the amount at risk for
not reporting under the PQRS (Category
2) from the amount at risk under
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
quality-tiering (Category 1) and that
these adjustments should not be at the
same level.
Other commenters noted that the
cumulative impact of penalties for
PQRS, EHR, and the VM would add up
to a potential ¥9.0 percent adjustment
to Medicare payments and expressed
that this cumulative impact would be
overly burdensome. One commenter
indicated that the proposed changes
would occur in a post-sequester
payment environment where providers
already experience a ¥2.0 percent
reduction in Medicare payment. Some
commenters indicated it was unfair to
hold solo practitioners and groups with
two to nine eligible professionals at
¥4.0 percent for the first year of the VM
when groups with of 10 to 99 eligible
professionals and groups with 100 or
more eligible professionals EPs were at
risk for only ¥2.0 percent and ¥1.0
percent respectively in their first year of
the VM. These commenters suggested
that we reduce their Category 2
downward payment adjustment for
groups and solo practitioners during
their first year in the VM.
By contrast, some supported all of our
VM payment adjustment proposals and
expressed their belief that a ¥4.0
percent downward adjustment and
+4.0x upward adjustment factor was not
sufficient to incentivize physicians to
improve quality. A few of these
commenters suggested that the amount
at risk should eventually be
approximately 10.0 percent and that
CMS should create a plan in the final
rule to continually increase the weight
of the VM over time. One commenter
noted that there is evidence in the
private sector that higher incentives and
penalties have a great impact on quality
improvement.
Response: We acknowledge the
commenters’ concerns about doubling
the amount of payment at risk from
¥2.0 percent in CY 2016 to ¥4.0
percent in CY 2017 under the VM.
However, the literature documents a
positive correlation between physician
participation in quality improvement
activities and the extent of the payment
PO 00000
Frm 00406
Fmt 4701
Sfmt 4700
adjustment.22 We agree with the
commenters who suggested that smaller
groups should be subject to a more
gradual phase-in of the VM’s
application to them, consistent with the
experience of the larger groups. We
acknowledge that our proposal would
have held solo practitioners and groups
with two to nine eligible professionals
in Category 2 at risk for up to a ¥4.0
percent payment adjustment for the first
year of the VM when groups with of 10
to 99 eligible professionals and groups
with 100 or more eligible professionals
EPs were at risk for only ¥2.0 percent
and ¥1.0 percent respectively in the
first year that the VM applied to them.
In light of these comments, we agree
that a smaller increase in the maximum
amount of payment at risk for groups
with two to nine eligible professionals
and solo practitioners would be
consistent with our stated focus on
gradual implementation and would
allow small groups and solo
practitioners to gain more experience
with the QRURs and the application of
the VM. Therefore, we are finalizing
¥2.0 percent as the maximum amount
of payment at risk in CY 2017 for groups
with two to nine eligible professionals
and solo practitioners. Specifically, in
CY 2017, for groups with two to nine
eligible professionals and solo
practitioners, we will apply a ¥2.0
percent VM to a group or solo
practitioner that falls in Category 2. We
note that, as discussed in section
III.N.4.c of this final rule with comment
period, we are finalizing our proposal to
hold solo practitioners and groups with
two to nine eligible professionals that
are in Category 1 harmless from any
downward adjustments under the
quality-tiering methodology in CY 2017,
if classified as low quality/high cost,
low quality/average cost, or average
quality/high cost. Additionally, for
groups with two to nine eligible
professionals and solo practitioners, we
22 Francois S. de Brantes & B. Guy D’Andrea.
Physicians Respond to Pay-for-Performance
Incentives: Larger Incentives Yield Greater
Participation. Am. J. of Managed Care. 2009.
15,305–310. With regard to hospital participation,
this correlation has been documented. Rachel M.
Werner, et al. The Effect of Pay-For-Performance In
Hospitals: Lessons for Quality Improvement. Health
Affairs. 2011. 30,690–698.
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
are finalizing a policy to set the
maximum upward adjustment under the
quality-tiering methodology in CY 2017
to +2.0x if a group or solo practitioner
is classified as high quality/low cost and
set the adjustment to +1.0x if a group or
solo practitioner is classified as either
average quality/low cost or high quality/
average cost. Table 88 shows the final
quality-tiering payment adjustment
amounts for CY 2017 (based on CY 2015
performance) for groups with two to
nine eligible professionals and solo
practitioners.
For groups with ten or more eligible
professionals, we are finalizing the
payment adjustments as proposed for
CY 2017 (79 FR 40505–40506). As stated
in the proposed rule (79 FR 40505), we
believe that we can increase the amount
of payment at risk because groups of
this size will have had sufficient
experience with the VM prior to the CY
2017 payment adjustment period. By CY
2017, groups with 10 or more eligible
professionals will have had at least one
year experience under the VM program.
As stated in the CY 2014 PFS final rule
with comment period (78 FR 74769), on
September 16, 2013, we made available
to all groups of 25 or more eligible
professionals an annual QRUR based on
2012 data to help groups estimate their
quality and cost composites. As
discussed in section III.N.4.a. of this
final rule with comment period, in
September 2014, we made available
QRURs based on CY 2013 data to all
groups of physicians and physicians
who are solo practitioners. We believe
that groups of 10 or more eligible
professionals will have had adequate
data to improve performance on the
quality and cost measures that will be
used to calculate the VM in CY 2017. As
a result, we believe it is appropriate to
increase the amount of payment at risk
for groups with ten or more eligible
professionals in CY 2017.
Consequently, for CY 2017, we will
apply a ¥4.0 percent VM to groups with
ten or more eligible professionals that
fall in Category 2. In addition, we will
set the maximum downward adjustment
under the quality-tiering methodology
in CY 2017 to ¥4.0 percent for groups
with ten or more eligible professionals
classified as low quality/high cost and
set the adjustment to ¥2.0 percent for
groups with ten or more eligible
professionals classified as either low
quality/average cost or average quality/
high cost. We will also set the maximum
upward adjustment under the qualitytiering methodology in CY 2017 to +4.0x
for groups with ten or more eligible
professionals classified as high quality/
low cost and set the adjustment to +2.0x
for groups with ten or more eligible
professionals classified as either average
67953
quality/low cost or high quality/average
cost. Table 89 shows the final qualitytiering payment adjustment amounts for
CY 2017 (based on CY 2015
performance) for groups with ten or
more eligible professionals.
We are also finalizing our proposal to
continue to provide an additional
upward payment adjustment of +1.0x to
groups with two or more eligible
professionals and solo practitioners that
care for high-risk beneficiaries (as
evidenced by the average HCC risk score
of the attributed beneficiary
population). Lastly, we are finalizing the
revisions at § 414.1270(c) and
§ 414.1275(c) and (d) to reflect the
payment adjustments under the VM for
the CY 2017 payment adjustment
period. Tables 88 and 89 show the
quality-tiering payment adjustment
amounts for CY 2017 (based on CY 2015
performance). We believe that these
final policies will alleviate commenters’
concern that our proposals were too
aggressive for smaller groups and solo
practitioners that are new to the VM in
CY 2017, while continuing the gradual
phase-in of the VM for groups with ten
or more eligible professionals with an
emphasis on the importance of reporting
under the PQRS program and improving
the quality and efficiency of services
provided to Medicare beneficiaries.
TABLE 88—FINAL CY 2017 VM PAYMENT ADJUSTMENT AMOUNTS FOR GROUPS WITH TWO TO NINE ELIGIBLE
PROFESSIONALS AND SOLO PRACTITIONERS
Cost/quality
Low quality
Low cost .....................................................................................................................
Average cost ..............................................................................................................
High cost ....................................................................................................................
Average quality
+0.0%
+0.0%
+0.0%
High quality
*+1.0x
+0.0%
+0.0%
*+2.0x
*+1.0x
+0.0%
* Groups and solo practitioners eligible for an additional +1.0x if reporting measures and average beneficiary risk score is in the top 25 percent
of all beneficiary risk scores, where ‘x’ represents the upward payment adjustment factor.
TABLE 89—FINAL CY 2017 VM PAYMENT ADJUSTMENT AMOUNTS FOR GROUPS WITH TEN OR MORE ELIGIBLE
PROFESSIONALS
Cost/quality
Low quality
Low cost .....................................................................................................................
Average cost ..............................................................................................................
High cost ....................................................................................................................
Average quality
+0.0%
¥2.0%
¥4.0%
*+2.0x
+0.0%
¥2.0%
High quality
*+4.0x
*+2.0x
+0.0%
ebenthall on DSK5SPTVN1PROD with $$_JOB
* Groups eligible for an additional +1.0x if reporting measures and average beneficiary risk score is in the top 25 percent of all beneficiary risk
scores, where ‘x’ represents the upward payment adjustment factor.
Consistent with the policy adopted in
the CY 2013 PFS final rule with
comment period (77 FR 69324 through
69325), the upward payment adjustment
factor (‘‘x’’ in Tables 88 and 89) will be
determined after the performance period
has ended based on the aggregate
amount of downward payment
adjustments. We noted in the proposed
rule that the estimated funds derived
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
from the application of the downward
adjustments to groups and solo
practitioners in Category 1 and Category
2 would be available to all groups and
solo practitioners eligible for VM
upward payment adjustments (79 FR
40504).
In section III.N.4.d of the proposed
rule (79 FR 40506), we discussed our
proposal to apply the VM to physicians
PO 00000
Frm 00407
Fmt 4701
Sfmt 4700
in groups with two or more eligible
professionals and to physicians who are
solo practitioners that participate in the
Shared Savings Program during the
payment adjustment period beginning
with the CY 2017 payment adjustment
period. We noted in the CY 2015 PFS
proposed rule that will have the final
list of ACOs that will participate in the
Shared Savings Program during the
E:\FR\FM\13NOR2.SGM
13NOR2
67954
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
payment adjustment period and their
participant TINs during the late fall
prior to the beginning of the payment
adjustment period (for example, the late
fall of CY 2016 prior to the CY 2017
payment adjustment period) (79 FR
40506). We also noted that this final list
may not be available until after the
beginning of the payment adjustment
period. Therefore, we proposed to
calculate preliminary payment
adjustment factors (‘‘x’’ in Table 87)
prior to the beginning of the payment
adjustment period, and subsequently
finalize the payment adjustment factors
after the final ACO participation list is
completed. We note that the final
payment adjustment factors may be
updated depending on the outcome of
the informal inquiry process described
later at section III.N.4.i of this final rule
with comment period.
We did not receive any comments on
these proposals.
As discussed in section III.N.4.d of
this final rule with comment period, we
are finalizing a policy to use the
performance period to determine which
groups and solo practitioners participate
in the Shared Savings Program for
purposes of calculating their VM in CY
2017. Therefore, we are not finalizing
our proposal to calculate preliminary
payment adjustment factors (‘‘x’’ in
Tables 88 and 89) prior to the beginning
of the payment adjustment period, and
then recalculating the payment
adjustment factors after the final ACO
participation list is completed.
However, we are finalizing our proposal
that we may update the payment
adjustment factors, depending on the
outcome of the informal inquiry process
described later at section III.N.4.i of this
final rule with comment period.
ebenthall on DSK5SPTVN1PROD with $$_JOB
g. Performance Period
In the CY 2014 PFS final rule with
comment period (78 FR 74771 through
74772), we adopted a policy that
performance on quality and cost
measures in CY 2015 will be used to
calculate the VM that is applied to items
and services for which payment is made
under the PFS during CY 2017.
Accordingly, we added a new paragraph
(c) to § 414.1215 to indicate that the
performance period is CY 2015 for VM
adjustments made in the CY 2017
payment adjustment period.
h. Quality Measures
In the CY 2014 PFS final rule with
comment period (78 FR 74773), we
aligned our policies for the VM for CY
2016 with the PQRS group reporting
mechanisms available to groups in CY
2014 and the PQRS reporting
mechanisms available to individual
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
eligible professionals in CY 2014, such
that data that groups submit for quality
reporting purposes through any of the
PQRS group reporting mechanisms in
CY 2014 and the data that individual
eligible professionals submit through
any of the individual PQRS reporting
mechanisms in CY 2014 will be used for
calculating the quality composite under
the quality-tiering approach for the VM
for CY 2016. Moreover, all of the quality
measures for which groups and
individual eligible professionals are
eligible to report under the PQRS in CY
2014 would be used to calculate the VM
for a group for CY 2016 to the extent the
group or individual eligible
professionals in the group submits data
on such measure in accordance with our
50 percent threshold policy (78 FR
74768). We also noted that, in
accordance with 42 CFR 414.1230, three
additional quality measures (outcome
measures) for groups subject to the VM
will continue to be included in the
quality measures used for the VM in CY
2016. These measures are: (1) A
composite of rates of potentially
preventable hospital admissions for
heart failure, chronic obstructive
pulmonary disease, and diabetes; (2) a
composite rate of potentially
preventable hospital admissions for
dehydration, urinary tract infections,
and bacterial pneumonia; and (3) rates
of an all-cause hospital readmissions
measure (77 FR 69315).
PQRS Reporting Mechanisms: It is
important to continue to align the VM
for CY 2017 with the requirements of
the PQRS, because quality reporting is
a necessary component of quality
improvement. We also seek not to place
an undue burden on eligible
professionals to report such data.
Accordingly, for purposes of the VM for
CY 2017, we proposed to continue to
include in the VM all of the PQRS
GPRO reporting mechanisms available
to groups for the PQRS reporting
periods in CY 2015 and all of the PQRS
reporting mechanisms available to
individual eligible professionals for the
PQRS reporting periods in CY 2015.
These reporting mechanisms were
described in Tables 21 through 49 of the
proposed rule (79 FR 40404).
PQRS Quality Measures: We proposed
to continue to use all of the quality
measures that are available to be
reported under these various PQRS
reporting mechanisms to calculate a
group or solo practitioner’s VM in CY
2017 to the extent that a group (or
individual eligible professionals in the
group, in the case of the ‘‘50 percent
option’’) or solo practitioner submits
data on these measures. These PQRS
quality measures were described in
PO 00000
Frm 00408
Fmt 4701
Sfmt 4700
Tables 21 through 49 of the proposed
rule (79 FR 40404).
We proposed that groups with two or
more eligible professionals would be
able to elect to include the patient
experience of care measures collected
through the PQRS CAHPS survey for CY
2015 in their VM for CY 2017 (79 FR
40506). We also proposed to continue to
include the three outcome measures in
§ 414.1230 in the quality measures used
for the VM in CY 2017. For groups that
are assessed under the ‘‘50 percent
option’’ for the CY 2017 VM, we
proposed to calculate the group’s
performance rate for each measure
reported by at least one eligible
professional in the group by combining
the weighted average of the performance
rates of those eligible professionals
reporting the measure. We also
proposed for groups that are assessed
under the ‘‘50 percent option’’ for the
CY 2017 VM to classify a group’s quality
composite score as ‘‘average’’ under the
quality-tiering methodology, if all of the
eligible professionals in the group
satisfactorily participate in a PQRS
qualified clinical data registry in CY
2015 and we are unable to receive
quality performance data for those
eligible professionals. We wish to clarify
that in this proposal, the phrase ‘‘all of
the eligible professionals in the group’’
refers to the at least 50 percent of
eligible professionals in the group who
report as individuals under PQRS. In
other words, we proposed for groups
that are assessed under the ‘‘50 percent
option’’ for the CY 2017 VM, where all
of the eligible professionals in the group
who report as individuals under PQRS
do so by satisfactorily participating in a
PQRS qualified clinical data registry in
CY 2015, and we are unable to receive
quality performance data for those
eligible professionals, then we would
classify the group’s quality composite
score as ‘‘average’’ under the qualitytiering methodology. If some EPs in the
group report data using a qualified
clinical data registry and we are unable
to obtain the data, but other EPs in the
group report data using the other PQRS
reporting mechanisms for individuals,
we would calculate the group’s score
based on the reported performance data
that we obtain through those other
mechanisms (79 FR 40507).
Although we finalized policies in the
CY 2014 final rule with comment period
that would allow groups assessed under
the ‘‘50 percent option’’ to have data
reported through a PQRS qualified
clinical data registry in CY 2014 used
for the purposes of their CY 2016 VM
to the extent performance data are
available, we noted that we did not
directly address the issue of how we
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
would compute the national
benchmarks for these measures. Under
§ 414.1250, benchmarks for the quality
of care measures for the VM are the
national mean performance rate for a
measure during the year prior to the
performance period. In the CY 2013 PFS
final rule (77 FR 69322), we finalized a
policy that if a measure is new to the
PQRS, we will be unable to calculate a
benchmark and performance on that
measure and will therefore not be
included in the quality composite.
Consistent with these existing policies,
we proposed to not include in the VM
quality composite those measures
reported through a PQRS qualified
clinical data registry that are new to
PQRS (in other words, measures that
were not previously reported in PQRS)
(79 FR 40507). This policy would apply
beginning with the measures reported
through a PQRS qualified clinical data
registry in the CY 2014 performance
period for the CY 2016 payment
adjustment period. We welcomed public
comment on this proposal.
We noted that the PQRS
administrative claims option described
in § 414.1230, is no longer available
through PQRS (79 FR 40507). However,
we are clarifying that the three claimsbased outcome measures described in
§ 414.1230, are still used in calculating
the quality composite for purposes of
the VM. We proposed to clarify that we
calculate benchmarks for those outcome
measures described in § 414.1230 using
the national mean for a measure’s
performance rate during the year prior
to the performance period in accordance
with our regulation at § 414.1250(b) (79
FR 40507). We welcomed public
comment on this proposal.
The following is summary of the
comments we received on these
proposals.
Comment: Several commenters
supported the alignment of VM with
PQRS requirements. Other commenters,
however, raised concerns about the lack
of applicable quality measures for
multiple specialties and nonphysician
eligible professionals, which they
believe could result in an automatic
downward payment adjustment for
professionals who are unable to report.
Several commenters also suggested CMS
should include measures in the VM
only after physicians had reported on
the measures under PQRS for at least a
year. Several commenters supported our
proposal to continue our existing VM
benchmarking policy for measures that
are new to PQRS or reported via a
Qualified Clinical Data Registry (QCDR).
Several commenters supported our
proposal to allow optional reporting of
patient experience of care measures for
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
groups of two or more physicians.
However several commenters urged us
to consider additional patient
experience measures that are relevant to
beneficiaries using specific Medicare
benefits. One commenter suggested that
CAHPS data should be collected
throughout the year, allowing providers
to prioritize and monitor the
effectiveness of improvement efforts,
especially as patient experience of care
data will be incorporated into the VM in
CY 2017. One commenter suggested that
the patient experience of care measures
should be optional for quality tiering for
the CY 2017 VM, as the 2013 GPRO web
participants are still awaiting the results
of the survey administration. A number
of commenters stated that CMS should
not make patient experience measures a
required component of the VM in the
future.
Response: PQRS measures are highly
reliable measures for understanding the
health and functional status of
beneficiaries after treatment by a
participating group or solo
practitioner.23 In previous rulemakings
we have committed to expanding the
specialty measures available in PQRS in
order to more accurately measure the
performance on quality of care
furnished by specialists and we reaffirm
our commitment to using measures of
performance across specialties that are
reliable and valid for the VM program
(77 FR 69315; 78 FR 74773). Moreover,
we believe group reporting can
ameliorate the commenters’ concerns
that the current set of PQRS measures
does not capture all of the clinical care
that some specialists and sub-specialists
furnish. We also continue to believe that
alignment with the PQRS program is an
important goal for the VM, because it
minimizes burden on providers and
encourages widespread participation in
quality reporting.
As we stated in section III.N.4.a of
this final rule with comment period,
where a group or solo practitioner falls
in Category 1 under the VM (that is,
meets the criteria to avoid the CY 2017
PQRS payment adjustment), but the
group or solo practitioner does not have
at least 20 cases for each PQRS measure
on which it reports as required for
inclusion in the quality composite of the
VM, the group or solo practitioner’s
quality composite score would be based
on the three claims-based outcome
measures described at § 414.1230,
provided that the group or solo
practitioner has at least 20 cases for at
least one of the claims-based outcome
23 Mathematica Policy Research, ‘‘Experience
Report for the Performance Year 2012 Quality and
Resource Use Reports.’’ (January 8, 2014).
PO 00000
Frm 00409
Fmt 4701
Sfmt 4700
67955
measures. As discussed in section
III.N.4.h of this final rule with comment
period, eligible professionals and groups
concerned about the lack of specialty
measures to meet PQRS reporting
requirements should note that PQRS has
a Measure Applicability Validation
(MAV) process. MAV determines PQRS
incentive eligibility for eligible
professionals and groups reporting less
than nine measures across three
domains or nine or more across less
than three domains. We recommend
that commenters refer to the Measure
Application Validation (MAV) Process
to alleviate concerns that lack of
applicable measures would result in an
automatic downward adjustment under
the VM . https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/PQRS/Downloads/2014_
PQRS_Claims_
MeasureApplicabilityValidation_
12132013.zip. Also, please refer to
section III.K.2 of this final rule with
comment period for the final 2017
policies for MAV and the criteria for
satisfactory reporting for the 2017 PQRS
payment adjustment.
With regard to the commenters’
suggestion that the VM should include
only measures on which physicians
have reported under PQRS for at least
one year, we note that we are
maintaining the policy set forth in
§ 414.1250 that benchmarks for the
quality of care measures are the national
mean of a measure’s performance rate
during the year prior to the performance
period. Measures reported through a
PQRS qualified clinical data registry
that are new to PQRS would not be
included in the quality composite for
the VM because we would not be able
to calculate benchmarks for them. We
acknowledge the interest in ensuring
that physicians report on measures for
at least one year before they are
included in the VM. Our current policy
achieves that end by precluding the use
of measures for which no benchmarking
data is available. We acknowledge the
comments suggesting that CMS expand
the data collected on the patient
experience of care (CAHPS) measures
and note that we seek to align with the
PQRS program in order to minimize
reporting burden and align incentives
across CMS incentive payment
programs. We will consider these
suggestions for any future refinements
to the patient experience measures
included in the PQRS program and the
VM. CMS will provide survey results
and post benchmarks for the patient
experience of care measures; this data as
well as the survey questions that can be
accessed on the CMS Web site can be
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67956
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
utilized to prioritize performance
improvement efforts. We also
acknowledge the commenters’ concerns
with expansion of mandatory CAHPS
inclusion in the VM and note that we
would propose any such policy change
through future notice and comment
rulemaking.
After consideration of the comments,
we are finalizing our proposal to use all
of the quality measures that are
available to be reported under these
various PQRS reporting mechanisms to
calculate a group or solo practitioner’s
VM in CY 2017, to the extent that a
group (or individual eligible
professionals in the group, in the case
of the ‘‘50 percent option’’) or solo
practitioner submits data on these
measures. We are finalizing our policy
that groups with two or more eligible
professionals can elect to include the
patient experience of care measures
collected through the PQRS CAHPS
survey for CY 2015 in their VM for CY
2017. We are finalizing our policy to
continue to include the three outcome
measures in § 414.1230 in the quality
measures used for the VM in CY 2017.
We are finalizing our policy that for
groups that are assessed under the ‘‘50
percent option’’ for the CY 2017 VM, we
will calculate the group’s performance
rate for each measure reported by at
least one eligible professional in the
group by combining the weighted
average of the performance rates of
those eligible professionals reporting the
measure.
We are finalizing our policy at
§ 414.1270(c)(4) that, for groups that are
assessed under the ‘‘50 percent option’’
for the CY 2017 VM, where all of the
eligible professionals in the group who
report as individuals under PQRS do so
by satisfactorily participating in a PQRS
qualified clinical data registry in CY
2015, and we are unable to receive
quality performance data for those
eligible professionals, then we will
classify the group’s quality composite
score as ‘‘average’’ under the qualitytiering methodology. Because this is the
same policy as for the CY 2016 payment
adjustment period, we are also making
a conforming revision to
§ 414.1270(b)(4).
We are finalizing a policy that, for
groups that are assessed under the ‘‘50
percent option’’ where some EPs in the
group report data using a qualified
clinical data registry and we are unable
to obtain the data, but other EPs in the
group report data using the other PQRS
reporting mechanisms for individuals,
then we will calculate the group’s score
based on the reported performance data
that we obtain through those other
PQRS reporting mechanisms. We are
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
finalizing a policy that, beginning with
the CY 2014 performance period,
measures reported through a PQRS
qualified clinical data registry that are
new to PQRS will not be included in the
quality composite for the VM until such
time as we have historical data to
calculate benchmarks for them. Once we
have historical data from measures
submitted via QCDRs, the benchmark
for quality of care measures will be the
national mean for the measure’s
performance rate during the year prior
to the performance period (§ 414.1250).
We are finalizing our proposed
clarification that we calculate
benchmarks for the outcome measures
described in § 414.1230 using the
national mean for a measure’s
performance rate during the year prior
to the performance period in accordance
with our regulation at § 414.1250(b).
Although we did not include proposed
regulation text for this proposed
clarification of our policy, we are
finalizing revisions to regulation text at
414.1250(b) to reflect this final policy.
Quality Measures for the Shared
Savings Program: Starting with the CY
2017 payment adjustment period, as
described in section III.M. of this final
rule with comment period, we proposed
to apply the value modifier to groups
and solo practitioners participating in
ACOs under the Shared Savings
Program. To do so, we proposed quality
measures and benchmarks for use with
these groups and solo practitioners and
solicited public comment on these
proposals. We describe these proposals
more fully below.
With regard to quality measures, we
noted that there is substantial overlap
between those used to evaluate the
ACOs under the Shared Savings
Program and those used in the PQRS
program and for the value modifier
payment adjustment. For the CY 2017
payment adjustment period and
subsequent payment adjustment
periods, to determine a quality
composite for the VM for groups and
solo practitioners who participate in an
ACO under the Shared Savings Program,
we proposed to use the quality measures
that are identical for the two programs.
Specifically, for the CY 2017 payment
adjustment period, we proposed to use
the PQRS GPRO Web Interface measures
and the outcome measure described at
§ 414.1230(c) to determine a quality
composite for groups and solo
practitioners who participate in an ACO
under the Shared Savings Program.
Because the ACO GPRO Web Interface
measures and PQRS GPRO Web
Interface measures will be the same in
CY 2015, we proposed to use the GPRO
Web Interface measures reported by
PO 00000
Frm 00410
Fmt 4701
Sfmt 4700
ACOs in determining the quality
composite for groups and solo
practitioners participating in ACOs
under the Shared Savings Program in
CY 2017 (79 FR 40507). Utilizing these
GPRO Web Interface measures in this
regard further encourages successful
quality reporting for Shared Savings
Program ACOs. Additionally, we stated
our belief that the all-cause hospital
readmissions measure as calculated for
ACOs under the Shared Savings
Program is equivalent to the all-cause
hospital readmissions measure we have
adopted for the VM at § 414.1230(c), and
therefore, proposed use of that measure
as calculated for ACOs in the Shared
Savings Program for inclusion in the
VM for the CY 2017 payment
adjustment period (79 FR 40507). We
note that the outcome measures
described at § 414.1230(a) and
§ 414.1230(b) are not currently
calculated for ACOs in the Shared
Savings Program. These measures are:
(1) A composite of rates of potentially
preventable hospital admissions for
heart failure, chronic obstructive
pulmonary disease, and diabetes; and
(2) a composite rate of potentially
preventable hospital admissions for
dehydration, urinary tract infections,
and bacterial pneumonia. Because we
have no experience with these measures
in the Shared Savings Program, at this
time, we did not propose to include
these measures for groups and solo
practitioners who participate in ACOs
under that program. We proposed to
modify the regulations at § 412.1210
accordingly.
The following is summary of the
comments we received on these
proposals.
Comment: The majority of
commenters opposed the proposals for
two reasons. First, these commenters
expressed their belief that the ACO
would be required to report measures
twice or report additional measures.
Second, these commenters suggested
that aligning the measures used in the
Shared Savings Program and those in
the VM program could lead to ACOs
scoring well in one program while
performing poorly in the other.
Commenters believe that the VM and
Shared Savings Program use different
performance benchmarks and different
approaches for determining good versus
bad performance.
A few medical societies supported the
proposals, recognizing CMS’s intent to
align the measures and quality
improvement goals of the Shared
Savings Program and VM program.
Several commenters suggested allowing
groups that are new to GPRO Web
Interface reporting to have at least one
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
year to report measures before they are
measured for performance. A few
commenters recommended aligning the
Shared Savings and the VM programs by
removing the three claims-based
outcome measures from the VM.
Response: We disagree with the
commenters’ suggestion that utilizing
GPRO Web Interface measures to
calculate Shared Savings Program
ACO’s quality composites would cause
them additional reporting burden,
because the ACO GPRO Web-Interface
measures and PQRS GPRO WebInterface measures are the same. We
believe, therefore, that utilizing the
GPRO web interface measures for
Shared Savings Program ACO quality
composite calculation under the VM
will further encourage successful
quality reporting for ACOs in the Shared
Savings Program and will not add
burdensome reporting requirements.
ACOs in the Shared Savings Program
would not have to report measures
twice for purposes of the VM. Moreover,
the use of the GPRO Web Interface
measures fosters alignment among the
various CMS quality reporting
programs. With regard to commenters’
suggestion that Shared Savings Program
ACO participants might fare well on
measures reported under the Shared
Savings Program and poorly under the
VM program, we do not believe this
situation is likely to occur, because
within the Shared Savings Program,
ACOs will be measured against national
benchmarks that are calculated using
Medicare fee-for service data. The VM
program also develops benchmarks
using all available Medicare fee-forservice data. Although the
benchmarking methodology differs in
that the VM uses a national weighted
mean and the Shared Savings Program
use a decile distribution for measuring
performance, we believe using the same
data source enables a fair comparison
for all groups and solo practitioners
subject to the value modifier.
Further, we believe it is appropriate to
use the Shared Savings Program ACOs’
all-cause readmission measure for
calculating the VM for the CY 2017
payment adjustment period. As we
stated in the proposed rule, we believe
that the Shared Savings Program ACO
all-cause readmission measure is
equivalent to the all-cause hospital
readmission measure adopted for the
VM. The use of this measure will not
impose any additional reporting burden
on Shared Savings Program ACOs (79
FR 40508).
After considering the public
comments, we are finalizing a policy to
use the ACO Group Practice Reporting
Option (GRPO) Web Interface measures
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
and the Shared Savings Program ACO
all-cause readmission measure to
calculate a quality composite score for
groups and solo practitioners who
participate in an ACO under the Shared
Savings Program.
To determine the standardized scores
for these quality measures for use with
those participating in ACOs under the
Shared Savings Program, we proposed
to apply the benchmark policy for
quality measures for the VM as
described under § 414.1250. Under this
policy, the VM benchmarks are the
national mean for a measure’s
performance rate based on data from
one year prior to the performance
period. We believe these are the
appropriate benchmarks to use when
determining the value modifier payment
adjustment because they are the same
benchmarks used to determine the value
modifier payment adjustment for other
groups and solo practitioners and they
are similar to the benchmarks used
under the Shared Savings Program. As
stated above, within the Shared Savings
Program, ACOs will be measured
against national benchmarks that are
calculated using Medicare fee-for
service data and the VM program also
develops benchmarks using all available
Medicare fee-for-service data. We
believe that use of the VM benchmarks
creates a reasonable comparison among
groups and solo practitioners and it is
appropriate to evaluate those that
participate in Shared Savings Program
ACOs on the same basis as those that do
not participate in the Shared Savings
Program for the purpose of the value
modifier. We believe that the VM
benchmarks are appropriate because
they include all PQRS data available (77
FR 69322), including quality data used
for the Shared Savings Program. We
stated that, while the Shared Savings
Program develops benchmarks using all
available Medicare fee-for-service data,
we do not believe it is appropriate to
use benchmarks from the Shared
Savings Program to determine
standardized scores for the quality
composite of the value modifier
payment adjustment. We do not think
this enables a fair comparison among
groups and solo practitioners subject to
the value modifier because the Shared
Savings Program benchmarks use
gradients by decile (including the
median) of national performance based
on data two years prior to the
performance period (78 FR 74759
through 74760).
The following is summary of the
comments we received on these
proposals.
Comment: A number of commenters
opposed the proposal for the following
PO 00000
Frm 00411
Fmt 4701
Sfmt 4700
67957
reasons: The belief that a difference in
performance benchmarks for the VM
and Shared Savings Program could
cause ACOs to score well in one
program and perform poorly in the
other; and the belief that the application
of the VM benchmarking policy to the
quality measures used by ACOs under
the Shared Savings Program could
introduce potential bias into the broader
VM program. One commenter supported
our proposal, noting that alignment of
quality measures for the VM and Shared
Savings Program would strengthen the
benchmarks by establishing a larger
pool of providers with comparable
measures.
Response: We appreciated the
comments received. As stated above,
with regard to the suggestion that
Shared Savings Program ACO
participants might fare well on
measures reported under the Shared
Savings Program and poorly under the
VM program, we do not believe this
situation is likely to occur, because the
GPRO Web Interface measures used for
the Shared Savings Program ACOs and
the VM are the same and benchmarks
used for performance measurement on
use the same data source (fee-for-service
Medicare data). We also do not believe
that introduction of SSP ACO data into
the benchmarks would create a bias. We
utilize national data for benchmarking,
and we agree with the commenter who
stated that this will strengthen the
benchmarks by expanding the pool of
participants. After consideration of the
public comments received, we are
finalizing the proposal to apply the
benchmark policy for quality measures
for the VM as described under
§ 414.1250 to determine the
standardized score for quality measures
for groups and solo practitioners
participating in ACOs under the Shared
Savings Program.
All-Cause Hospital Readmissions
Measure: We finalized the inclusion of
the all-cause hospital readmissions
measure described at § 414.1230(c) in
the CY 2013 PFS final rule with
comment (77 FR 69285). We
subsequently investigated the reliability
of this measure. We also have an
existing policy at § 414.1265, that a
claims-based cost or quality measure
must have a minimum of 20 cases, to be
included in a composite score
calculation. Furthermore, according to
§ 414.1265(a), if a group has fewer than
20 cases for a measure in a performance
period, that measure is excluded from
its domain and the remaining measures
in the domain are given equal weight.
Based on 2012 data, we found that the
average reliability for the all-cause
hospital readmissions measure was
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67958
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
below 0.4 when we examined groups
with fewer than 200 cases but exceeded
0.4 for groups with 200 or more cases.
Although we do not believe there is a
universal consensus concerning a
minimum reliability threshold,
reliability scores in the 0.4 to 0.7 range
are often considered moderate, and
scores greater than 0.7 are considered
high. In general, we found that the
groups with at least 10 eligible
professionals were more likely to have
200 or more cases as compared to
groups with fewer eligible professionals.
Thirty percent of groups with 10 or
more eligible professionals had 200 or
more cases, as compared to 3 percent of
groups with 1–9 eligible professionals.
We found that the average reliability
exceeded 0.4 for groups of all sizes (1
or more eligible professionals), with 200
or more cases.
After examining the reliability of the
all-cause hospital readmissions measure
data for 2012 across all group sizes and
considering its impacts on the cost
composite of the VM as discussed
below, we proposed to change the
reliability policy (minimum number of
cases) with respect to this measure.
Specifically, beginning with the CY
2017 payment adjustment period, we
proposed to change the reliability policy
(minimum number of cases) with
respect to the all-cause hospital
readmissions measure as described in
§ 414.1230(c) from a minimum of 20
cases to a minimum of 200 cases for this
measure to be included in the quality
composite for the VM. For this measure
only, we proposed to exclude the
measure from the quality domain for a
group or solo practitioner if the group or
solo practitioner has fewer than 200
cases for the measure during the
relevant performance period. In
implementing this proposal, we noted
that we would only apply it to the allcause hospital readmissions measure as
it is calculated for groups or solo
practitioners who are not part of a
Shared Savings Program ACO. In
instances where we are including
Shared Savings Program data for groups
or solo practitioners who are part of a
Shared Savings Program ACO, we
would include their all-cause hospital
readmissions measure as it is calculated
for the Shared Savings Program. This
approach to implementing this proposal
is appropriate because the Shared
Savings Program has taken into
consideration the size of its groups in
finalizing inclusion of this measure, and
we value consistency with the Shared
Savings Program’s reporting
requirements for its participants, to the
extent it is practicable. We would
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
continue to include the measure in the
VM quality domain for groups or solo
practitioners who have 200 or more
cases. We proposed to modify
§ 414.1265 to reflect this proposal. We
welcomed comments on this proposal.
We noted that, if we were to revise the
minimum case size for the all-cause
hospital readmissions measure for the
quality composite of the VM, poor
performance on controlling
readmissions would continue to have an
effect on the VM for groups with
between 20 and 199 cases through the
cost composite of the VM. The Medicare
Spending per Beneficiary (MSPB)
measure, as finalized in the CY 2014
PFS final rule (78 FR 74775–74780), is
a measure of all Medicare Part A and
Part B payments during an episode
spanning from 3 days prior to an index
hospital admission through 30 days
post-discharge with certain exclusions.
Since all Part A and Part B spending is
included in the 30 day post-discharge
window, Medicare Part A payments for
a readmission that are included in an
MSPB episode will increase the MSPB
amount relative to an MSPB episode
without a readmission in the 30-day
post-discharge window. Additionally,
the cost of readmissions is incorporated
as part of the 5 total per capita cost
measures that comprise the remainder
of the cost composite of the VM. The 5
total per capita cost measures are annual
measures that include the costs of all
Part A and Part B spending during the
year, including the costs of
readmissions. Therefore, readmission
costs will have the effect of increasing
total per capita cost spending for the
groups attributed these patients’ costs.
As a result, poor performance on
controlling readmissions already will
have an adverse effect on an attributed
group’s cost composite of the VM, even
if poor performance on the all-cause
hospital readmissions measure would
no longer be reflected in certain groups’
or solo practitioners’ quality composite
of the VM due to having fewer than 200
all-cause hospital readmission cases.
Even for those groups for which the allcause hospital readmissions measure
would be excluded from the quality
composite calculations, groups would
continue to have incentive to control
readmissions, since doing so would
reduce readmission costs, thereby
improving performance on the paymentstandardized, risk-adjusted cost
measures used for the cost composite of
the VM.
The following is summary of the
comments we received on this proposal.
Comment: We received few comments
on this proposal. Some commenters
supported the inclusion of the all-cause
PO 00000
Frm 00412
Fmt 4701
Sfmt 4700
readmission measure. One commenter
supported the proposed change in the
reliability policy for the hospital allcause readmission measure, stating that
this will provide valid and reliable
estimates for hospital admissions to
each group. Several commenters
supported the need for reliable
measures; however, one commenter
expressed concern that even with an
increased case minimum, the all-cause
readmission measure was still not
appropriate for physician accountability
because the readmission costs are
already included in the total per capita
costs, the measure was not specified for
group level measurement, and the
measure was not supported by the
Measures Application Partnership
(MAP). This commenter stated that the
all-cause readmission measure does not
add value to the VM, further suggesting
that if CMS chooses to keep the
measure, then it should be adjusted for
clinical and socioeconomic factors.
Another commenter recommended CMS
undertake an analysis to ensure this
change would not result in
disproportionate penalties for certain
groups (such as surgeons) prior to
finalizing this proposal.
One commenter stated that this
measure is not appropriate for physician
practices because 2012 data indicates
that the measure could not meet a 0.4
percent reliability threshold at a 20-case
minimum. This commenter also
questioned the justification for
including a measure that will be
applicable only to 30 percent of groups
with 10 or more practitioners and three
percent of smaller groups, even when
the proposed minimum 200 case
threshold is utilized.
Response: We disagree with the
commenters’ assessment of the
reliability of the all-cause hospital
readmission measure, which quantifies
the unplanned readmissions for any
cause within 30 days from the date of
discharge of an index admission. Our
analysis of this measure based on 2012
data found that the average reliability
exceeded 0.4 for groups with 200 or
more cases included all group sizes (1
or more eligible professionals). We are
committed to monitoring this measure,
as well as others to ensure that the
minimum patient panel size is sufficient
to meet the reliability standard for the
VM program. With regard to concern
that readmission costs are included in
other spending measures, we disagree
that this fact makes the all-cause
hospital readmissions measure
inappropriate for inclusion in the VM.
The all-cause hospital readmissions
measure is a measure of readmission
rates, not of costs and we believe that
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
readmission reduction is an important
goal that we can emphasize through the
VM. We note that the measure’s
direction was supported by the MAP
and also that the has been specified for
groups. The group specifications may be
found at: https://cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
sharedsavingsprogram/Downloads/
ACO-8.pdf
With regard to commenters’ concerns
related to the issue of socioeconomic
status adjustment, we continue to
monitor activities at the National
Quality Forum (NQF), such as the July
23, 2014 decision by the NQF Board in
which the Board approved a trial period
to test the impact of sociodemographic
factor risk adjustment of performance
measures (available at https://
www.qualityforum.org/Press_Release/
2014/NQF_Board_Approves_Trial_Risk_
Adjustment.aspx). While we continue to
evaluate the appropriateness of applying
different standards for the outcomes of
patients of low socioeconomic status
and the potential for a socioeconomic
status adjustment to mask potential
disparities or minimize incentives to
improve the outcomes of economically
disadvantaged populations, we would
take any future decision by the NQF on
this issue into consideration for any
potential future refinements to this or
any measure included in the VM.
After consideration of the comments,
we are finalizing the policy, beginning
with the CY 2017 payment adjustment
period, to increase the case minimum
from 20 cases to 200 cases for the allcause hospital readmissions measure as
described in § 414.1230(c) to be
included in the quality composite for
the VM as proposed. Therefore, we are
finalizing the proposal to exclude the
measure from the quality domain for a
group or solo practitioner if the group or
solo practitioner has fewer than 200
cases for the measure during the
relevant performance period and all
remaining measures in the domain will
be given equal weight. We are codifying
this change with a revision to the
regulation at § 414.1265.
ebenthall on DSK5SPTVN1PROD with $$_JOB
i. Expansion of the Informal Inquiry
Process To Allow Corrections for the
Value-Based Payment Modifier
Section 1848(p)(10) of the Act
provides that there shall be no
administrative or judicial review under
section 1869 of the Act, section 1878 of
the Act, or otherwise of the following:
• The establishment of the VM;
• The evaluation of the quality of care
composite, including the establishment
of appropriate measures of the quality of
care;
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
• The evaluation of the cost
composite, including the establishment
of appropriate measures of costs;
• The dates of implementation of the
VM;
• The specification of the initial
performance period and any other
performance period;
• The application of the VM; and
• The determination of costs.
These statutory requirements
regarding limitations of review are
reflected in § 414.1280. Despite the
preclusion of administrative and
judicial review, we previously indicated
in the CY 2013 PFS final rule with
comment period (77 FR 69326) that we
believed an informal review mechanism
is appropriate for groups of physicians
to review and to identify any possible
errors prior to application of the VM,
and we established an informal inquiry
process at § 414.1285. We stated that we
intend to disseminate reports containing
CY 2013 data in the fall of 2014 to
groups of physicians subject to the VM
in 2015 and that we will make a help
desk available to address questions
related to the reports.
We stated it would be appropriate to
align with PQRS to consider requests for
informal review of whether a group or
solo practitioner successfully reported
under the PQRS program and requests
for reconsideration of PQRS data as
described in section III.K, as well as to
expand our current informal inquiry
process to accept requests from groups
and solo practitioners to review and
correct certain other errors related to the
VM, such as errors made by CMS in
assessing the eligibility of a group or
solo practitioner for the value modifier
based on participation in a Shared
Savings Program ACO, the Pioneer ACO
Model, the CPC Initiative, or other
similar Innovation Center models or
CMS initiatives; computing
standardized scores; computing domain
scores; computing composite scores; or
computing outcome or cost measures.
We are working to develop and
operationalize the necessary
infrastructure to support such a
corrections process, but at this time, we
do not believe we would be able to
implement the process until 2016 at the
earliest.
Therefore, for the CY 2015 payment
adjustment period, to align with PQRS,
we proposed to expand the informal
inquiry process at § 414.1285 to
establish an initial corrections process
that would allow for some limited
corrections to be made (79 FR 40509).
Specifically, under this initial
corrections process, for the CY 2015
payment adjustment period, we
proposed to establish a deadline of
PO 00000
Frm 00413
Fmt 4701
Sfmt 4700
67959
January 31, 2015 for a group to request
correction of a perceived error made by
CMS in the determination of its CY 2015
VM payment adjustment. Alternatively,
we solicited comment on a deadline of
no later than the end of February 2015
to align with the PQRS informal review
process. We would then make a
determination regarding the request. At
this time, we do not anticipate it would
be operationally feasible for us to fully
evaluate errors with regard to quality
measure data and accept data as
described above under section III.K. for
the CY 2015 payment adjustment
period, and thus we proposed to classify
a TIN as ‘‘average quality’’ in the event
we determine that we have made an
error in the calculation of quality
composite. We proposed to recompute a
TIN’s cost composite in the event we
determine that we have made an error
in its calculation. We proposed to adjust
a TIN’s quality-tier if we make
corrections to a TIN’s quality and/or
cost composites as a result of this initial
corrections process. We noted that there
would be no administrative or judicial
review of the determinations resulting
from this expanded informal inquiry
process under section 1848(p)(10) of the
Act.
Starting with the CY 2016 payment
adjustment period (which has a
performance period of CY 2014), we
proposed to continue the expanded
informal inquiry process at § 414.1285
as described above. However, in
anticipation of having the necessary
operational infrastructure to support the
reconsideration of quality measure data,
we proposed to establish a 30-day
period that would start after the release
of the QRURs for the applicable
performance period for a group or solo
practitioner to request correction of a
perceived error made by CMS in the
determination of the group or solo
practitioner’s VM for that payment
adjustment period. These QRURs
contain performance information on the
quality and cost measures used to
calculate the quality and cost
composites of the VM and will show
how all TINs would fare under the
policies established for the VM for the
CY 2015 payment adjustment period.
Similar to our proposal for the initial
corrections process in CY 2015, we
would then make a determination
regarding the requests received. Since
we anticipate it would be operationally
feasible for us to fully evaluate errors
with regard to quality measure data at
that point, and accept data, consistent
with PQRS policies, as described above
under section III.K. for the CY 2016
payment adjustment period, we
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67960
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
proposed to recompute a TIN’s quality
composite and/or cost composite in the
event we determine that we have made
an error in the calculation. We noted
that if the operational infrastructure is
not available to allow this
recomputation, we proposed to continue
the approach of the initial corrections
process to classify a TIN as ‘‘average
quality’’ in the event we determine that
we have made an error in the
calculation of the quality composite. We
proposed to adjust a TIN’s quality-tier if
we make a correction to a TIN’s quality
and/or cost composites as a result of this
corrections process.
We welcomed comment on these
proposals.
The following is summary of the
comments we received on both the
initial corrections process in the CY
2015 payment adjustment period and
the corrections process we proposed
beginning with the CY 2016 payment
adjustment period.
Comment: Commenters supported
implementing an expanded informal
inquiry process to allow for corrections
to the VM. However, almost all
commenters requested later deadlines
for submission of VM corrections.
Specifically:
• For 2015, most commenters
supported establishing a deadline of no
later than the end of February 2015,
rather than January 31, to align with the
PQRS informal review process.
• For subsequent years, most
commenters requested a longer period
of 60 to 90 days (rather than 30 days)
that would start after the release of the
QRURs for the applicable performance
period for a group or individual to
request a correction of a perceived error
related to the VM calculation.
In addition, some commenters
objected to the proposal for 2015 to
classify a TIN as ‘‘average quality’’ in
the event we determined that we have
made an error in the calculation of the
quality composite. These commenters
believe it would be inappropriate to
deem a group ‘‘average quality’’ simply
because CMS does not have the capacity
to correct its own errors, especially if an
‘‘average quality’’ rating could
potentially lead to penalties or lost
incentive payments. Some commenters
suggested that we consider requests for
providers to resubmit their quality data.
Other commenters asked that we
provide additional clarification
regarding what situations will be
considered in the informal review
process.
Response: We are persuaded by
commenters who request that we
establish later deadlines for the VM
informal review process so that such
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
deadlines are consistent with those of
the PQRS informal review process. We
agree with these comments since data
reported under PQRS is an important
component of the VM and that
corrections to PQRS measure rates could
affect the calculation of the VM
payment adjustment amount. Therefore,
for the CY 2015 payment adjustment
period, the deadline for submission of a
request for VM informal review will be
the end of February, 2015. Likewise, for
subsequent payment adjustment years,
we are persuaded by commenters that
requested a longer period beyond 30
days, which would start after the release
of the QRURs for the applicable
performance period, for a group or
individual to request a correction of a
perceived error related to the VM
calculation. However, we believe that 60
days, not 90 days, would be a sufficient
amount of time for providers to access
their QRUR reports, review the
information, which includes the VM
payment adjustment amount that will
apply for the subsequent payment
adjustment year and make a decision
whether or not to submit a VM
correction request. Establishing a 60-day
deadline enables us to make corrections
prior to, or relatively soon after, the start
of the applicable payment adjustment
year. This helps reduce the number of
claims that would need to subsequently
be reprocessed during the applicable
payment adjustment year.
Finally, as we discussed in the
proposal and above, it is not
operationally feasible to fully evaluate
errors with regard to quality measure
data and accept data as described above
under section III.K. for the CY 2015
payment adjustment period. Therefore,
to minimize the impact on providers,
we will classify a TIN as ‘‘average
quality’’ in the event that we determine
that we have made an error in the
calculation of the quality composite.
However, we understand the point
made by a few commenters about this
policy. It is possible that an ‘‘average
quality’’ rating for the CY 2015 payment
adjustment period could potentially
result in a higher or lower VM payment
adjustment amount for an individual
TIN than if the quality composite were
recalculated. Therefore, we are working
to develop the operational infrastructure
to allow us to re-compute a TIN’s
quality composite and accept data,
consistent with PQRS quality data
resubmission policies, as described
above under section III.K. for the CY
2016 payment adjustment period in the
event we determine that we have made
an error in the calculation.
After consideration of the public
comments received:
PO 00000
Frm 00414
Fmt 4701
Sfmt 4700
• For the CY 2015 payment
adjustment period, we are: (1) Finalizing
a February 28, 2015, deadline for a
group to request correction of a
perceived error made by CMS in the
determination of its VM, and (2)
finalizing a policy to classify a TIN as
‘‘average quality’’ in the event we
determined that we have made an error
in the calculation of the quality
composite.
• Beginning with the CY 2016
payment adjustment period, (1) we are
finalizing a deadline of 60 days that
would start after the release of the
QRURs for the applicable performance
period for a group or solo practitioner to
request a correction of a perceived error
related to the VM calculation, and (2)
we will take steps to establish a process
for accepting requests from providers to
correct certain errors made by CMS or
a third-party vendor (for example,
registry). We intend to design this
process as a means to re-compute a
TIN’s quality composite and/or cost
composite in the event we determine
that we initially made an erroneous
calculation. We note that if the
operational infrastructure is not
available to allow this re-computation,
we will continue the approach for the
CY 2015 payment adjustment period to
classify a TIN as ‘‘average quality’’ in
the event we determine that we have
made an error in the calculation of the
quality composite.
For both the CY 2015 payment
adjustment period and future
adjustment periods, we will adjust a
TIN’s quality-tier if we make a
correction to a TIN’s quality and/or cost
composites as a result of this corrections
process. We will provide additional
operational details as necessary in subregulatory guidance.
We further note that there is no
administrative or judicial review of the
determinations resulting from this
expanded informal inquiry process
under section 1848(p)(10) of the Act.
j. Potential Methods To Address NQF
Concerns Regarding the Total Per Capita
Cost Measures
In the CY 2013 PFS final rule with
comment period (77 FR 69322), we
established a policy to create a cost
composite for each group subject to the
VM that includes five paymentstandardized and risk-adjusted annual
per capita cost measures. To calculate
each group’s per capita cost measures,
we first attribute beneficiaries to the
group. We attribute beneficiaries using a
two-step attribution methodology that is
based on the assignment methodology
used for the Shared Savings Program
and the PQRS GPRO and that focuses on
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
the delivery of primary care services (77
FR 69320) by both primary care
physicians and specialists.
In the CY 2014 PFS final rule with
comment period (78 FR 74780), we
finalized inclusion of the Medicare
Spending Per Beneficiary (MSPB)
measure as proposed in the cost
composite beginning with the CY 2016
VM, with a CY 2014 performance
period. As we proposed, we are using
the MSPB amount as the measure’s
performance rate rather than converting
it to a ratio as is done under the Hospital
Inpatient Quality Reporting (IQR) and
VBP Programs. We finalized that the
MSPB measure is added to the total per
capita costs for all attributed
beneficiaries domain and equally
weighted with the total per capita cost
measure in that domain. Additionally,
we finalized that an MSPB episode is
attributed to a single group of
physicians that provides the plurality of
Part B services (as measured by
standardized allowed charges) during
the index admission, for the purpose of
calculating that group’s MSPB measure
rate. Finally, we finalized a minimum of
20 MSPB episodes for inclusion of the
MSPB measure in a physician group’s
cost composite.
Additionally, in the CY 2014 PFS
final rule with comment period (78 FR
74780), we finalized our proposal to use
the specialty adjustment method to
create the standardized score for each
group’s cost measures beginning with
the CY 2016 VM. That is, we refined our
current peer group methodology to
account for specialty mix using the
specialty adjustment method. We also
finalized our proposal to include this
policy in our cost composite
methodology. Additionally, we finalized
our proposal to identify the specialty for
each EP based on the specialty that is
listed on the largest share of the EP’s
Part B claims.
As discussed in the CY 2014 PFS final
rule with comment period (78 FR
74781), we submitted the total per
capita cost measure for National Quality
Forum (NQF) endorsement in January
2013. In the final voting in September
2013, the NQF Cost and Resource Use
Committee narrowly voted against the
measure by a count of 12 in support and
13 in opposition. We proposed to
address two of the major concerns that
Committee raised in its review of the
measure. First, we proposed
modifications to our two-step
attribution methodology. Second, we
proposed to reverse the current
exclusion of certain Medicare
beneficiaries during the performance
period. We stated that these proposals
would apply beginning with the CY
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
2017 payment adjustment period for the
VM and would apply to all five of the
total per capita cost measures under
§ 414.1235(a)(1) through (5) (79 FR
40510). The modifications to the twostep attribution methodology also would
apply to the methodology used for
attributing beneficiaries for the
computation of claims based quality
measures under § 414.1230, except for
participants in the Shared Savings
Program as described later.
The attribution methodology for the
five total per capita cost measures and
claims based quality measures in the
VM, as finalized in the CY 2013 PFS
final rule with comment period (77 FR
66318 through 66320), includes two
steps. Before applying the two steps,
however, we first identify all
beneficiaries who have had at least one
primary care service rendered by a
physician in the group. Primary care
services include evaluation and
management visits in office, other
outpatient, skilled nursing facility, and
home settings. After this ‘‘pre-step’’, we
assign, under Step 1, beneficiaries to the
group practice who had a plurality of
primary care services (as measured by
allowed charges) rendered by primary
care physicians in the group, which
include Family Practice, Internal
Medicine, General Practice, and
Geriatric Medicine. If a beneficiary is
non-assigned under Step 1, we proceed
to Step 2, which is to assign
beneficiaries to the group practice
whose affiliated non-primary care
physicians, nurse practitioners (NPs),
physician assistants (PAs), and clinical
nurse specialists (CNSs) together
provided the plurality of primary care
services (as measured by allowed
charges), as long as at least one primary
care service was provided by a nonprimary care physician in the group.
To address NQF concerns regarding
the attribution methodology of the total
per capita cost measure, we proposed
two modifications to the two-step
attribution methodology as applied to
the five total per capita cost measures,
as well as the claims based quality
measures in the VM. NQF Committee
members discussed how primary care
services often are provided by NPs, PAs,
or CNSs, but Step 1 of the attribution
methodology assigns beneficiaries to the
group who had a plurality of primary
care services rendered by primary care
physicians in the group. After further
consideration, we agreed that it is
appropriate to include NPs, PAs, and
CNSs in Step 1 of the attribution
method insofar as they provide primary
care services. Consequently, we
proposed to move these NPs, PAs, and
CNSs from Step 2 of the attribution
PO 00000
Frm 00415
Fmt 4701
Sfmt 4700
67961
method to Step 1. This change would
affect all five of the total per capita cost
measures under § 414.1235(a)(1)
through (5) and the claims-based quality
measures under § 414.1230.
Additionally, we proposed to remove
the ‘‘pre-step’’ described above for the
purposes of the value modifier. The
‘‘pre-step’’ was included in the Shared
Savings Program assignment
methodology to comply with the
statutory requirement (77 FR 67851) that
beneficiary assignment be based upon
the utilization of primary care services
furnished by a physician. However, no
such limitation exists for the VM.
Consequently, we proposed to remove
the ‘‘pre-step’’ that identifies a pool of
assignable beneficiaries that have had at
least one primary care service furnished
by a physician in the group. Removing
the ‘‘pre-step’’ would result in
streamlining the attribution process and
attributing beneficiaries based on a
plurality of primary care services
according to Step 1 and Step 2. In
addition, we believe that this proposal
would help ensure that beneficiaries can
be assigned to group practices made up
of nonphysician eligible professionals
because it would eliminate the criterion
that a beneficiary have at least one
primary care service furnished by a
physician in the group practice. This
change (removing the ‘‘pre-step’’) would
affect all five of the total per capita cost
measures under § 414.1235(a)(1)
through (5) and the claims-based quality
measures under § 414.1230.
The two-step attribution rule would
remain intact after these two
modifications, and the method would
continue to be generally consistent with
the method of assignment of
beneficiaries under the Shared Savings
Program, as specified under § 414.1240.
As discussed previously, the ‘‘pre-step’’
would be removed. We would assign,
under Step 1, beneficiaries to the group
who had a plurality of primary care
services (as measured by allowed
charges) rendered by primary care
physicians, NPs, PAs, or CNSs in the
group. If a beneficiary is non-assigned
under Step 1, we still would proceed to
Step 2, which would assign
beneficiaries to the group practice
whose affiliated non-primary care
physicians provided the plurality of
primary care services (as measured by
allowed charges). We proposed these
modifications only for groups and solo
practitioners who are not participating
in the Shared Savings Program. We
noted that for groups and solo
practitioners who participate in the
Shared Savings Program, we would not
remove the pre-step or change the
attribution methodology for quality
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67962
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
measures and cost measures, but would
continue to rely on the methodology
used by the Shared Savings Program to
attribute beneficiaries to ACOs in the
Shared Savings Program. Because we
are not applying these assignment
changes to Shared Savings Program
ACO participants, there is no need to
recalculate Shared Savings Program
assignment.
One of the reasons we originally
proposed this two-step attribution
process for the total per capita cost
measures and claims based quality
measures was that it was aligned with
the attribution methodologies used by
the Shared Savings Program and also
the PQRS GPRO Web interface (77 FR
69318 through 69320). We recognize
that these programs may seek to
establish changes to their
methodologies, and noted that for the
purposes of the VM, we intended to
retain the two-step beneficiary
attribution methodology that was
described in the CY 2013 PFS final rule
with comment period (77 FR 69318
through 69320), subject to the changes
proposed above. However, to address
the concerns raised by NQF, we believe
the proposed modification to the twostep beneficiary attribution method
would more appropriately reflect the
multiple ways in which primary care
services are provided, which are not
limited to physician groups. We
welcomed comments on our proposed
modification to the two-step attribution
methodology as applied to the five total
per capita cost measures under
§ 414.1235(a)(1) through (a)(5) and to
the claims-based quality measures
under § 414.1230 of the VM.
The following is summary of the
comments we received on our proposed
modification to the two-step attribution
methodology as applied to the five total
per capita cost measures under
§ 414.1235(a)(1) through (5) and to the
claims-based quality measures under
§ 414.1230 for the VM.
Comment: Many commenters opposed
our proposal to modify the two-step
attribution methodology. The
commenters stated that it would not be
appropriate to include NPs, PAs and
CNSs in the first step of the attribution
methodology because these
nonphysician practitioners are not
necessarily practicing in a primary care
setting. The commenters expressed
concern that, unlike for physicians,
there is no specialty distinction on
claims billed by NPs, PAs, or CNSs.
Therefore, CMS would not be able to
distinguish between those practitioners
who are practicing in primary care
settings and those who are in nonprimary care settings. Commenters
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
believe that moving NPs, PAs, and CNSs
to the first step could result in
beneficiaries being attributed to a
specialty practice instead of a primary
care practice. A few commenters stated
that this would unfairly affect the cost
measure calculations for specialist
groups with large numbers of
nonphysician practitioners. We did not
receive any comments specifically
opposing the removal of the ‘‘pre-step’’
from the methodology. Several
commenters supported our proposal to
modify the attribution methodology.
The commenters stated that it is
important to recognize the role of
nonphysician practitioners in providing
primary care to beneficiaries and that
these changes create a methodology that
more accurately reflects team-based
approaches to care.
Response: We appreciate the concerns
raised by commenters about the
potential impact that the lack of
specialty designation for NPs, PAs, and
CNSs could have on the cost and claims
based quality measures. However, we do
not believe that this is likely to occur.
In an analysis of the impact of including
NPs and PAs in step 1 of the attribution
methodology using 2011 data for groups
of twenty-five or more eligible
professionals, we found that over 97
percent of beneficiaries were attributed
to the same group that they had been
attributed to under the current
methodology. Although this analysis
does not exactly replicate the changes
we proposed, we believe it is a
reasonable indication that the changes
will not have the significant impact
predicted by commenters. We are
conducting additional analysis and will
monitor the effect of these changes to
ensure they are not having a
disproportionately negative effect on a
subset of provider types. We appreciate
the support of and agree with
commenters who believe it is important
to recognize the role that many NPs,
PAs, and CNSs play as primary care
providers. The analysis referenced
earlier also found that the inclusion of
NPs and PAs in step 1 resulted in an
increase of 2.55 percent to the number
of beneficiaries attributed to a group and
the number of groups to which at least
20 beneficiaries were attributed
increased by 3.4 percent. For these
reasons, we agree with the NQF
recommendation to include these
nonphysician practitioners in the
attribution methodology. Further, this
attribution change will become even
more important as we expand the
application of the VM to smaller groups
and solo practitioners, to increase the
number of patients whom they can be
PO 00000
Frm 00416
Fmt 4701
Sfmt 4700
assigned, to receive a cost composite
that is other than ‘‘average’’ under the
VM.
We are finalizing our policy as
proposed. Beginning in the CY 2017
payment adjustment period, we will
move NPs, PAs, and CNSs from step 2
of the attribution method to step 1.
Additionally we are removing the prestep under which we first identify all
beneficiaries who have had at least one
primary care service rendered by a
physician in the group. These changes
apply to all five total per capita cost
measures under § 414.1235(a)(1)
through (5) and the claims-based quality
measures under § 414.1230.
Second, NQF committee members
raised concerns about the exclusion of
certain beneficiaries in the methodology
used for the total per capita cost
measure. Committee members expressed
concern that end-of-life costs were not
being captured by the measure. We
considered this argument and agreed
that it is important to include certain
beneficiaries with these costs during the
performance period. As a result, we
proposed to include certain part-year
Medicare FFS beneficiaries. This change
would affect all five of the total per
capita cost measures under
§ 414.1235(a)(1) through (a)(5). The
change would provide a more complete
assessment of end of life costs
associated with the patients a physician
group sees during the year (79 FR
40510).
We proposed to continue excluding
other part-year beneficiaries (those who
spend part of the performance period in
a Medicare Advantage (Part C) plan and
those enrolled in Part A only or Part B
only for part of the performance period
and both Part A and Part B for the
remainder of the performance period)
(79 FR 40511). Since 2012 we have
applied the same attribution rule as that
used for the Medicare Shared Savings
Program and the PQRS GPRO Web
Interface (77 FR 69318–20). In this
regard, excluding part-year Medicare
Advantage enrollees would remain
consistent with the Shared Savings
Program and PQRS GPRO Web interface
reporting policy. If we were to include
these part-year Medicare Advantage
enrollees, we would need to determine
a method to impute their costs for the
portion of the performance period in
which they were enrolled in FFS
Medicare Parts A and B so that we could
compare beneficiaries’ annual per capita
costs appropriately. Similarly, Medicare
Part A only or Medicare Part B only
enrollees who were enrolled in both
Part A and Part B for only part of the
performance period would also require
a method to impute their costs if they
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
were no longer excluded. Furthermore,
these Part A only or Part B only
beneficiaries are excluded from the
Shared Savings Program and PQRS
GPRO methodology.
We proposed including Medicare FFS
beneficiaries who are newly enrolled to
Medicare during the performance period
and enrolled in both Part A and Part B
while in Medicare FFS. Additionally,
we noted that while the inclusion of
new enrollees is inconsistent with
GPRO’s methodology, it would be
consistent with the Shared Savings
Program’s methodology (79 FR 40511).
We welcomed comments on the
inclusion of these part-year
beneficiaries. We also welcomed
comments on whether other part-year
Medicare FFS beneficiaries (that is,
those who are part-year Medicare
Advantage enrollees or part-year
Medicare Part A only or Part B only
enrollees) should be included in the five
total per capita cost measures under
§ 414.1235(a)(1) through (5) in the VM.
Comment: Some commenters opposed
our proposal to include certain part-year
Medicare FFS beneficiaries in the five
total per capita cost measures because
they believe the inclusion of these
typically higher cost beneficiaries
would inappropriately disadvantage
groups that treat a large percentage of
beneficiaries at the end of life. We also
received comments in support of our
proposal to include certain part-year
beneficiaries. These commenters stated
that it is important to include as many
Medicare beneficiaries in the cost
measure calculations as feasible and
especially important to capture the often
significant costs incurred by
beneficiaries at the end of life. One
commenter suggested that we should
develop an end of life specific cost and
quality measure rather than including
these costs in the per capita cost
measures. We did not receive any
comments in opposition to the inclusion
of newly eligible beneficiaries in the
five total per capita cost measures. One
commenter indicated that they do not
understand why we would exclude any
of the part-year beneficiaries, stating
that if we can impute costs for some
part-year beneficiaries, we should be
able to do so for all part-year
beneficiaries.
Response: We appreciate the support
of commenters who supported our
proposal to include some part-year
beneficiaries in the five total per capita
cost measures. Part-year beneficiaries
include those who receive end-of-life
care, which has been correlated with
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
high-cost episodes of care.24 However,
analysis submitted to the Institute of
Medicine produced an inconclusive
causal relationship between the end of
a beneficiary’s life and the cost of that
care.25 Indeed, research refutes the
assumption that Medicare beneficiaries
near the end of life have substantially
similar health statuses.26 Rather, prior
diagnoses, a characteristic that we
currently adjust for in the VM, accounts
for a substantial percentage of the
geographic variation in the end-of-life
costs. In other words, we believe that
the risk adjustment system under the
VM program explains approximately the
same extent of costs in the general
Medicare population as it does for the
cohort of Medicare beneficiaries near
the end of life.27 In response to concerns
raised by commenters, we conducted
additional analyses to ensure the
inclusion of part-year beneficiaries does
not inappropriately negatively impact
certain groups or solo practitioners. This
analysis, which we plan to post to the
Value Modifier Web site in the near
future, showed moderate reliability for
the five per capita cost measures
continued to be high with the inclusion
of certain part-year beneficiaries. For
example, for the overall per capita cost
measure, 83 percent of TINs had
reliability equal to or higher than 0.4
when these part-year beneficiaries were
included. We agree that it is important
to capture as many beneficiaries and
costs in these measures as is reasonably
possible especially as the number of
beneficiaries new to Medicare increases
and we continue to agree with the
NQF’s recommendation to capture end
of life costs in our measures. We believe
that the inclusion of newly eligible
beneficiaries, who are typically much
lower cost and a growing portion of the
Medicare program, may offset some of
the increased costs associated with
beneficiaries at the end of life. We
appreciate the suggestion to include cost
and quality measures that specifically
24 Congressional Budget Office, ‘‘High-Cost
Medicare Beneficiaries.’’ Final Paper (May 2005),
available at https://www.cbo.gov/sites/default/files/
05-03-medispending.pdf.
25 Acumen, ‘‘Geographic Variation in Spending,
Utilization and Quality: Medicare and Medicaid
Beneficiaries’’ (May 2013), available at https://
www.iom.edu/Reports/2013/-/media/Files/Report
%20Files/2013/Geographic-Variation/SubContractor/Acumen-Medicare-Medicaid.pdf.
26 Reschovsky JD, et al. ‘‘Geographic Variation in
Fee-for-Service Medicare Beneficiaries’ Medical
Costs Is Largely Explained by Disease Burden.’’
Med. Care Res. & Rev. 2013; XX,1–22.
27 Medicare decedents and Medicare survivors
with similar diagnoses and utilization in the
previous year had substantially similar cost
profiles. Hogan C, et al. ‘‘Medicare Beneficiaries’
Costs of Care In the Last Year Of Life.’’ Health
Affairs. 2001; 20, 188–195.
PO 00000
Frm 00417
Fmt 4701
Sfmt 4700
67963
measure care at the end of life and will
take this into consideration as we
continue to develop the VM program.
We also appreciate the comments in
support of including other part-year
beneficiaries in our measures and we
will continue to look into this
possibility.
We are finalizing our policies as
proposed. Beginning in the CY 2017
payment adjustment period, we will
include certain part-year beneficiaries in
the five total per capita cost measures
under § 414.1235(a)(1) through (5).
These part-year beneficiaries include
Medicare FFS beneficiaries who are at
the end of life in the performance period
and Medicare FFS beneficiaries who are
newly enrolled in Medicare during the
performance period and enrolled in
both Part A and Part B while in
Medicare FFS.
In this final rule with comment
period, we chose not to address the
other concerns about the total per capita
cost measures that were raised by NQF.
First, we deferred addressing the issue
of whether to incorporate
socioeconomic status in our measures
until after the NQF has finalized its
guidance regarding risk adjustment for
resource use measures. Second, we did
not propose to include Part D data in the
total per capita cost measures at this
time due to the complexity of the issue
and uncertainty of how to fairly and
equitably incorporate the costs. Based
on data compiled by the Medicare
Payment Advisory Commission
(MedPAC), we estimated that
approximately 60 percent of Medicare
FFS beneficiaries were enrolled in
stand-alone Part D in 2013.28 A
significant minority of beneficiaries has
prescription drug coverage from a
source that is outside of Medicare—such
as through retiree coverage from a
former employer—but for which
Medicare does not have access to the
data. Including Part D data would
incorrectly indicate higher costs for
these beneficiaries with Part D coverage
relative to otherwise comparable
beneficiaries without such coverage and
for whom prescription drug costs cannot
be measured directly by CMS. Before we
are able to propose inclusion of Part D
data, we would need to determine an
28 Please see https://www.medpac.gov/documents/
Mar14_EntireReport.pdf for underlying data. We
estimated that there were 37.3 million Medicare
FFS beneficiaries by subtracting the number of
beneficiaries enrolled in Medicare Advantage (14.5
million) from the estimated total number of
Medicare beneficiaries using data in table 13–1 (P.
328). We estimated that there were 22.4 million
beneficiaries with a stand-alone prescription drug
plan, which represented 64 percent of the 35
million beneficiaries with Medicare Part D coverage
(p. 355).
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67964
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
approach to address this issue. We
welcomed comments on suggested
methods for including Part D data in the
total per capita cost measures.
Comment: Many commenters
expressed concern that we are not
currently including Part D expenditures
in our cost measures. These commenters
stated that the exclusion of Part D costs
could push providers to prescribe Part
D drugs even when the Part B drug is
more appropriate for the patient.
Additionally, commenter stated that
they believe the exclusion of Part D
unfairly harms providers that see sicker
patients because they believe that these
patients are more likely to require Part
B medications. Several commenters
suggested that CMS either include Part
D costs or exclude Part B drug costs.
Others suggested excluding only those
Part B costs for drugs that have a Part
D equivalent or capping the Part B costs
for certain high cost drugs. We did not
receive any comments specifically
recommending an approach for how
Part D costs could be included in our
cost measurement.
Response: We appreciate the
comments and understand the concerns
raised in regard to exclusion of Part D
costs. We remain committed to
capturing a full picture of the total cost
of care and to assessing cost in a fair and
consistent manner. We are actively
investigating options for operationally
including Part D costs in our cost
measures and would propose any viable
options under future notice and
comment rulemaking.
Comment: We received many
comments emphasizing the importance
of including socioeconomic status in
our measures. Commenters believe that
this is critical to accurately comparing
performance between providers that
serve different populations. One
commenter stated that socioeconomic
status should be used in risk adjusting
outcomes measures but should not be
used in process measures.
Response: As noted above, we will
continue to consider whether it would
be appropriate to apply a socioeconomic
status adjustment to the measures
included in the VM. In August 2014,
NQF released a report on this topic with
recommendations for the development
of socioeconomic risk adjustment
methodologies.29 Consistent with that
report, we believe it is important to
proceed cautiously on this question. We
will take the recommendations in this
29 National Quality Forum, ‘‘Risk Adjustment for
Socioeconomic Status or Other Sociodemographic
Factors.’’ Final Report (2014), available at https://
www.qualityforum.org/Publications/2014/08/Risk_
Adjustment_for_Socioeconomic_Status_or_Other_
Sociodemographic_Factors.aspx.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
report into account as we consider
potential future refinements to our risk
adjustment methodologies. Any changes
would be made through rulemaking.
We also received the following
comment, which we believe is outside
of the scope of our proposals:
Comment: One commenter stated that
CMS should revise our attribution
methodology to look at ‘‘allowed
services,’’ rather than ‘‘allowed
charges.’’ The commenter believes that
by looking at ‘‘allowed charges’’ we may
be inaccurately attributing beneficiaries
to the provider that bills using higher
level E&M codes, rather than the
provider that sees the patient most
often.
Response: We believe that a focus on
allowed charges is appropriate for
attribution in Medicare payment
measures, because the intent is to assess
which eligible professional should be
held accountable for the payments
made. Further, the use of allowed
charges in the scenario presented by the
commenter would further incentivize
providers to correctly code E&M
services rendered.
k. Discussion Regarding Treatment of
Hospital-Based Physicians
We considered including or allowing
groups that include hospital-based
physicians or solo practitioners who are
hospital-based to elect the inclusion of
Hospital Value-Based Purchasing (VBP)
Program performance in their VM
calculation in future years of the
program. We stated that would include
hospital performance for the hospital or
hospitals in which they practice. We
would propose such a change through
future notice and comment rulemaking,
taking into consideration public
comment and any relevant empirical
evidence available at that time. We
considered this potential policy to
expand the performance data included
for hospital-based physicians and to
better align incentives for quality
improvement and cost control across
CMS programs. Such a policy would
also address public comments we
received on the CY 2014 PFS proposed
rule (78 FR 74775), suggesting that the
Hospital VBP Program total performance
score for the hospital in which a
specialist practices should be used in
the VM. Commenters made this
suggestion, noting that there were
limited measures that apply to certain
specialties and that those specialties
may exercise wide influence over the
quality of care provided in a hospital.
We noted that a hospital’s final Hospital
VBP Program performance for a given
performance period would not be
available to a group at the time that they
PO 00000
Frm 00418
Fmt 4701
Sfmt 4700
registered for PQRS reporting, so if we
were to establish a voluntary policy
where groups could elect to include
hospital performance, they would make
the election to have that performance
included in their VM for a payment
adjustment period based on the
hospital’s historic VBP Program
performance which would be known to
the TIN at the time of election.
We sought public comment on the
appropriate methodology to identify
hospital-based groups and solo
practitioners for the purpose of having
Hospital VBP Program data included or
allowing them to elect inclusion of
Hospital VBP Program performance data
in the VM at the TIN level (70 FR
40511–40512). We suggested that we
could either allow self-nomination or
set a threshold based on physician
billing, in order to determine whether a
given physician was hospital-based. We
sought comment on whether we should
set a threshold for a certain proportion
of a group’s physicians that would have
to meet the criteria, in order for
hospital-level performance to be
included in the group’s VM calculation.
We also sought comment on whether to
use a set of criteria to determine
whether non-physician eligible
professionals should be allowed to selfnominate or should automatically have
hospital-level performance data
included in the calculation of their VM.
We requested public comment on
potential methods for determining
which hospital or hospitals’ Hospital
VBP Program performance data should
be included in a physician TIN’s VM
and how to weight the hospitals, if more
than one was included (79 FR 40512).
We welcomed public comment on the
approaches we considered, as well as
alternative approaches for inclusion of
all or part of the Hospital VBP Program
TPS into the VM. In the interest of
aligning the HVBP and VM programs,
we sought public comment on what
criteria we should consider in selecting
a subset of Hospital VBP Program
measures or domains in the VM, if we
were to adopt such a policy. Finally, we
requested public comment on the most
appropriate approach for including
Hospital VBP Program performance into
a TIN’s VM.
Comment: Commenters generally
supported including the Hospital VBP
Program performance in the VM,
suggesting that it be made voluntary for
physicians who meet some threshold of
services rendered in the hospital setting.
Commenters stated that a 90 percent
threshold would be too high.
Response: We appreciate the
comments and will take these into
consideration as we continue to refine
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
the VM program and improve the
coordination between the HVBP and
VM programs. We would propose any
policy changes through future notice
and comment rulemaking.
ebenthall on DSK5SPTVN1PROD with $$_JOB
5. Physician Feedback Program
Section 1848(n) of the Act requires us
to provide confidential reports to
physicians (and, as determined
appropriate by the Secretary, to groups
of physicians) that measure the
resources involved in furnishing care to
Medicare FFS beneficiaries. Section
1848(n)(1)(A)(iii) of the Act also
authorizes us to include information on
the quality of care furnished to
Medicare FFS beneficiaries.
a. CY 2013 Quality and Resource Use
Reports Based on CY 2013 Data and
Disseminated in CY 2014
In September 2014, we made available
the QRURs based on CY 2013 data to all
physicians (that is, TINs of any size)
even though groups with fewer than 100
eligible professionals will not be subject
to the VM in CY 2015. These reports
provide clinically meaningful and
actionable information on several
aspects of the performance of a group
practice or solo practitioner. The reports
present not only data assessing a group
practice’s or solo practitioner’s
performance on cost measures and
information about the services and
procedures contributing most to
beneficiaries’ costs, but also provide
data on their performance on quality
measures they report under the PQRS as
well as the three outcome measures
under § 414.1230. For groups of 100 or
more eligible professionals that are
subject to the VM starting in 2015, the
QRURs provide information on how the
group’s quality and cost performance
affects their physicians’ Medicare
payments in 2015. The reports also
contain additional supplementary
information on the specialty adjusted
benchmarks; inclusion of the individual
PQRS measures for informational
purposes for EPs reporting PQRS
measures as individuals; enhanced drill
down tables; and a dashboard with key
performance measures. The reports are
based on the VM policies that were
finalized in the CY 2013 PFS final rule
(77 FR 69310) for physician payment
adjustments under the VM beginning
January 1, 2015, and they provide
groups with an opportunity to see how
the policies adopted will apply to them.
b. Episode Costs and the Supplemental
QRURs
Section 1848(n)(9)(A) of the Act
requires CMS to develop an episode
grouper and include episode-based costs
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
in the QRURs. An episode of care
consists of medical and/or procedural
services that address a specific medical
condition or procedure that are
delivered to a patient within a defined
time period and are captured by claims
data. An episode grouper organizes
administrative claims data into
episodes.
We developed a prototype set of
episodes that expands upon the set of
episodes that were described in the CY
2014 PFS final rule with comment
period (78 FR 74785). In summer 2014,
we distributed Supplemental QRURs
based on 2012 data to a greater number
of groups (groups with at least 100
EPs 30 EPs) that included a broader set of
episodes than the 2011 Supplemental
QRURs. In addition to the five clinical
conditions in the 2011 Supplemental
QRURs, the 2012 Supplemental QRURs
included: Chronic congestive heart
failure (CHF); chronic obstructive
pulmonary disease (COPD)/asthma;
acute COPD/asthma; permanent
pacemaker system replacement/
insertion; and bilateral cataract removal
with lens implant. For the 2012
Supplemental QRURs, we broke down
these episode types into 20 subtypes
altogether. In addition to these 20
episode subtypes, we included in the
2012 Supplemental QRURs 6 clinical
episode-based measures that we are
adapting from those considered for
inclusion in the Hospital VBP program
(79 FR 28122 through 28124). We
described the 20 episode subtypes and
six clinical episode-based measures in
the proposed rule and sought comment
on the three medical and three surgical
episode measures that we included in
the 2012 Supplemental QRURs.
We did not receive any general
comments on the three medical and
three surgical episode measures that we
included in the 2012 Supplemental
QRURs.
Attribution for the six clinical
episode-based measures at the group
level are the same as the rules used for
comparable types of the 20 episode
subtypes in the 2012 Supplemental
QRURs as discussed above. Attribution
rules varied depending on whether a
clinical episode-based measure was one
of the three surgical (or procedural)
episodes or one of the three medical (or
acute condition) episodes. Further
details on attribution rules can be found
30 For Supplemental QRUR purposes, groups
were also included if they did not to participate in
multiple accountable care organizations (ACOs) and
did not to participate in more than one of the
following initiatives in program year 2012: The
Shared Savings Program, the Pioneer Accountable
Care Organization (ACO) Model, or the
Comprehensive Primary Care Initiative (CPCI).
PO 00000
Frm 00419
Fmt 4701
Sfmt 4700
67965
in ‘‘Detailed Methods of the 2012
Medical Group Practice Supplemental
Quality and Resource Use Reports
(QRURs)’’ at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeedbackProgram/
Episode-Costs-and-Medicare-EpisodeGrouper.html.
Specifications for these six clinical
episode-based measures, including the
MS–DRG and procedure codes used to
identify each of the episodes, and
details of episode construction
methodology, are available in ‘‘Detailed
Methods of the 2012 Medical Group
Practice Supplemental Quality and
Resource Use Reports (QRURs)’’ at
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
PhysicianFeedbackProgram/EpisodeCosts-and-Medicare-EpisodeGrouper.html. We welcomed public
comments on these specifications and
the construction of the six clinical
episode-based measures that we
included in the 2012 Supplemental
QRURs.
The following is summary of the
comments we received on these
specifications and the construction of
the six clinical episode-based measures
that we included in the 2012
Supplemental QRURs.
Comment: One commenter stated that
because E&M services are used as the
basis for attribution for acute and
chronic episodes, they believe it is
unlikely that most radiology groups
would have a score calculated for these
measures. The commenter also noted
that certain procedural episode
measures, not currently under
consideration for inclusion in the VM,
may be calculated for radiology groups.
Another commenter stated that he
believes there are inconsistencies and
errors in the attribution methodology
used for episode measures.
Response: We understand the
concerns of specialists, including
radiology groups, about the challenge of
identifying measures for which they
would have a sufficient number of
attributed beneficiaries to have the
measures calculated. We will take these
into consideration as we continue to
refine the measures and consider them
for future use in the VM.
CMS’ episodes will continue to evolve
over the coming years as more
experience is gained. More information
about the Supplemental QRURs can be
found at https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
PhysicianFeedbackProgram/EpisodeCosts-and-Medicare-EpisodeGrouper.html.
We will continue to seek stakeholder
input as we develop the episode
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67966
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
framework. We considered proposing to
add episode-based payment measures to
the VM through future rulemaking for
all 12 episode subtypes, or some subset
of these episode subtypes, of the
selected respiratory and selected heart
conditions that have appeared in both
the 2011 Supplemental QRURs and
2012 Supplemental QRURs. These 12
episode subtypes include: Pneumonia
(all), pneumonia without an inpatient
hospitalization, pneumonia with an
inpatient hospitalization, acute
myocardial infarction (now called acute
coronary syndrome or ACS), ACS
without percutaneous coronary
interventions (PCI) or coronary artery
bypass graft (CABG), ACS with PCI,
ACS with CABG, coronary artery
disease (now called ischemic heart
disease or IHD), IHD without ACS, IHD
with ACS, CABG without preceding
ACS, and PCI without preceding ACS.
Additionally, we are considering
proposing to add hospital episode-based
payment measures to the VM at a later
time, such as the six hospital episodes
described above. We welcomed public
comments on the specifications
included on the Web site and the
construction of the episode-based
payment measures that we considered.
The following is summary of the
comments we received on the
specifications included on the Web site
and the construction of the episodebased payment measures that we
considered.
Comment: Several commenters
supported our continued efforts to
develop episode-based payment
measures. Two of these commenters
indicated that they believe these
measures will support better
coordination of care across settings. One
commenter suggested that the
development of episode measures
should follow a similar process to that
used for quality measures, including
multi-stakeholder expert consensus,
evidence-based medicine, and clinical
guidelines, as appropriate. We received
a few comments stating that the episode
measures should not be included in the
VM at this time. Two commenters stated
their belief that the episode measures
are not currently tied to quality
measures and suggested that we address
that concern before incorporating the
measures into the VM. Another
commenter stated that they believe the
episode measures are duplicative of the
care already captured in the MSPB
measure and expressed concern about
the reliability of the measures. This
commenter suggested that these
measures should be removed from the
supplemental QRURs until these
reliability concerns are addressed.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Another commenter suggested that CMS
conduct a more thorough analysis of the
attribution methodology used in the
episode measures and that we narrow
the scope of the conditions that are
currently included in the episode
measures before introducing them into
the VM.
Response: We appreciate the input of
commenters. We share the commenters’
beliefs that coordination across care
settings is an important factor in
improving quality of care and cost
performance. We understand the
concerns raised about duplication
across cost measures and will take that
and the other feedback we received
regarding attribution, tying the cost
measures to quality measures and the
vetting process for measures as we
continue to refine the measures and
consider them for future use in the VM.
Developing a more robust set of cost
measures for the VM remains an
important goal.
following calendar year. Several
commenters also suggested that QRURs
should be distributed to all providers,
including nonphysician eligible
professionals. Some commenters
suggested that CMS increase our
education and outreach efforts to ensure
that providers know how to access and
use the QRURs.
Response: We appreciate commenters
support for the Physician Feedback
Program and we will take these
comments into consideration as we
continue to develop and improve the
Physician Feedback Program. While it is
not feasible to provide the annual
QRURs earlier in the year while still
allowing sufficient time for claims run
out and reporting period, we are
exploring how to provide semi-annual
reports that will allow groups and solo
practitioners to better track their
performance on cost and utilization
during the year.
c. Future Plans for the Physician
Feedback Reports
In the proposed rule, we stated that
we will continue to develop and refine
the annual QRURs in an iterative
manner and we will seek to further
improve the reports by welcoming
suggestions from our stakeholders.
As noted previously, on September
30, 2014, we made available the QRURs
based on CY 2013 data to all physicians
(that is, TINs of any size) even though
groups with fewer than 100 eligible
professionals will not be subject to the
VM in CY 2015. These reports contain
performance on the quality and cost
measures used to score the composites
and additional information to help
physicians coordinate care and improve
the quality of care furnished. We also
intend to provide semi-annual reports
with updated cost and utilization data.
We will again solicit feedback from
physicians and continue to work with
our partners to improve them. We note
that physicians will have some time to
determine the impact of our revised
policies and revise their practices
accordingly before the new policies
impact them. We look forward to
continue working with the physician
community to improve the QRURs.
We received the following general
comments on the Physician Feedback
Program:
Comment: Many commenters stated
their support for the Physician Feedback
Program and applauded CMS’s efforts to
improve the QRURs. Many commenters
stated that we should provide QRURs to
providers earlier in the year to give
them more time to analyze the results
and make adjustments prior to the
O. Establishment of the Federally
Qualified Health Center Prospective
Payment System (FQHC PPS)
PO 00000
Frm 00420
Fmt 4701
Sfmt 4700
In the May 2, 2014 Federal Register,
we published the final rule with
comment period (79 FR 25436) entitled
‘‘Medicare Program; Prospective
Payment System for Federally Qualified
Health Centers; Changes to Contracting
Policies for Rural Health Clinics; and
Changes to Clinical Laboratory
Improvement Amendments of 1998
Enforcement Actions for Proficiency
Testing Referral; Final Rule’’ (herein,
‘‘FQHC PPS final rule’’). This final rule
with comment period implemented
methodology and payment rates for
federally qualified health center (FQHC)
services under Medicare Part B
beginning on October 1, 2014, in
compliance with the statutory
requirement of the Affordable Care Act,
and contained other provisions. In this
final rule with comment period, we
invited comments on how payment for
chronic care management (CCM)
services could promote integrated and
coordinated care in FQHCs and rural
health clinics (RHCs). We also invited
comments on the modification of our
proposed policy to allow exceptions to
the FQHC PPS per diem payment for
subsequent illness or injury and mental
health services furnished on the same
day as a medical visit; the establishment
of FQHC G-codes to report and bill
FQHC visits to Medicare under the PPS;
and the modification of our proposed
approach to waiving coinsurance for
preventive services when furnished
with other services under the FQHC
PPS.
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
1. Promoting Integrated and
Coordinated Care in FQHCs and RHCs
Through Payment for Chronic Care
Management (CCM) Services
In the FQHC PPS final rule with
comment period, we invited comments
from FQHCs and RHCs on how payment
for CCM services could help to promote
integrated and coordinated care in
FQHCs and RHCs. We cited the CCM
information in the CY 2014 PFS final
rule with comment period (78 FR
74230) for physicians billing under the
PFS in 2015. We encouraged FQHCs
and RHCs to review this information
and submit comments to us on how the
CCM services payment could be adapted
for FQHCs and RHCs to promote
integrated and coordinated care.
We received a few comments
regarding how the CCM services
payment could be adapted for FQHCs in
CY 2015 to provide integrated and
coordinated care in FQHCs.
Commenters supported adopting the
CCM provisions in FQHCs but had
concerns about the unique challenges
FQHCs would face implementing these
provisions. The following is a summary
of these comments.
Comment: Commenters stated that the
seven initiatives outlined in the CY
2014 PFS final rule with comment
period are viable in FQHCs, but noted
that FQHCs would face unique
challenges when implementing this
provision. Commenters stated that the
provisions requiring electronic
exchange of information might prove
difficult at this time since many FQHCs
are using electronic health records but
are still working on developing the
interoperability with other providers.
Commenters suggested the requirement
to provide patients with secure
messages via the internet would be
difficult since many FQHC patients are
at or below 200 percent of the federal
poverty level (FPL) and do not have
access to internet or email. For example,
a commenter stated that 94 percent of
all FQHC patients in one state were
below 200 percent of the FPL in 2012.
Commenters supported adopting these
provisions for FQHCs and suggested
that we implement requirements that do
not place an undue burden on the
health centers or the patient population.
One commenter urged that the
additional G-codes for CCM services be
sufficient to cover the associated costs
of documenting care coordination and
another commenter expressed concern
for appropriate payment and requested
that we develop a risk-adjusted per
patient per month CCM fee.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Response: We appreciate the
comments and will take them into
consideration.
2. Exceptions to the Per Diem FQHC
PPS Payment for Subsequent Illness or
Injury and Mental Health Services
Furnished on the Same Day as a
Medical Visit
FQHCs receive enhanced payment to
reflect all costs associated with a visit in
a single day by a Medicare beneficiary,
regardless of the length or complexity of
the visit or the number or type of
practitioners seen. Under the allinclusive rate (AIR) system, an
exception to the one encounter payment
per day policy was made for situations
when a patient comes into the FQHC for
a medically necessary visit, and after
leaving the FQHC, has a medical issue
that was not present at the visit earlier
that day, such as an injury or
unexpected onset of illness. In these
situations, the FQHC has been paid
separately for two visits on the same day
for the same beneficiary. Under the AIR
system, we also allowed separate
payment for mental health services
furnished on the same day as a medical
visit, separate payment for diabetes selfmanagement training/medical nutrition
therapy (DSMT/MNT), and separate
payment for the initial preventive
physical exam (IPPE).
In the FQHC PPS proposed rule,
published in the September 23, 2013
Federal Register (78 FR 58386), we
stated that 2011 Medicare FQHC claims
data was reviewed to determine the
frequency of FQHCs billing for more
than one visit per day for a beneficiary,
and we analyzed the potential financial
impact on both FQHCs and on access to
care if billing for more than 1 visit per
day for these situations was no longer
permitted. We also considered several
alternative options, such as an
adjustment of the per visit rate when
multiple visits occur in the same day, or
the establishment of a separate per visit
rate for subsequent visit due to illness
or injury, mental health services,
DSMT/MNT, or IPPE.
An analysis of data from Medicare
FQHC claims with dates of service
between January 1, 2011 and June 30,
2012, indicated that multiple visits
billed on the same day constituted less
than 0.5 percent of all visits, even
though the ability to do so has been in
place since 1992 for subsequent illness/
injury, since 1996 for mental health
services, and since 2007 for DSMT/
MNT. We concluded that even allowing
for any underreporting in the data,
eliminating the ability to bill for
multiple visits on the same day would
not significantly impact either the
PO 00000
Frm 00421
Fmt 4701
Sfmt 4700
67967
FQHC payment or a beneficiary’s access
to care. Therefore, we proposed to revise
§ 405.2463(b) to remove the exception to
the single encounter payment per day
for FQHCs paid under the proposed
PPS, and we stated that this policy is
consistent with an all-inclusive
methodology and reasonable cost
principles and would simplify billing
and payment procedures.
In the FQHC PPS proposed rule, we
solicited comments to address whether
there are factors that we have not
considered, particularly in regards to
the provision of mental health services,
and whether this change would impact
access to these services or the
integration of services in underserved
communities.
Although we did not receive any
information that showed a direct link
between multiple billing on the same
day and increasing access to care, we
modified our proposal in the final rule
and stated that we will allow separate
billing for subsequent illness or injury
occurring on the same day as another
medical visit. We also modified our
proposal in the FQHC PPS final rule to
allow separate billing for mental health
services furnished on the same day as a
medical visit, as the comments we
received led us to conclude that this had
the potential to increase access to care,
even if the current claims data did not
show that this option was being
utilized. We invited comments on these
modifications.
We received many comments on the
modifications to our proposed policy,
which would allow an exception to the
per diem PPS payment for subsequent
injury or illness and for mental health
services furnished on the same day as a
medical visit. All of the commenters
were supportive of this modification;
however, most of the commenters
requested additional exceptions to the
per diem PPS payment. The following is
a summary of these comments.
Comment: Most commenters strongly
supported our decision to allow
separate payment for subsequent injury
or illness and mental health services
furnished on the same day as a medical
visit. Commenters stated that allowing
separate payment for mental health
services when primary care services are
furnished would facilitate integrated
and comprehensive health care to
Medicare beneficiaries, and agreed with
our assertion that separate payment for
mental health services has the potential
to increase access to mental health
services in underserved areas. The
commenters also stated that our
modification demonstrated our
commitment to the value of furnishing
mental health services in FQHCs.
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67968
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
Many of the commenters who
supported our modification allowing
subsequent injury or illness and mental
health services to be billed separately
when furnished on the same day as
another billable visit also requested
additional exceptions to the PPS per
diem payment system. They noted that
under the AIR payment system, DSMT/
MNT services and the IPPE can be billed
separately when furnished on the same
day as another billable visit, and
requested that these services also have
an exception under the PPS.
Commenters particularly emphasized
the need for separate payment for
DSMT/MNT services and suggested that
not being able to bill separately for a
DSMT/MNT visit that occurs on the
same day as another billable medical
visit would deter efficient provision of
these services.
Response: We appreciate the support
for allowing an exception to the per
diem payment when a subsequent
injury or illness occurs and for mental
health services furnished on the same
day as a medical visit.
Commenters are correct that IPPE and
DSMT/MNT can be billed as a separate
visit under the AIR payment system
when furnished on the same day as
another medical visit, and that we did
not include IPPE or DSMT/MNT in the
exceptions under the PPS. As explained
in the FQHC PPS proposed rule, an
analysis of claims data from FQHCs
indicated that the estimated cost per
encounter was approximately 33
percent higher when a FQHC furnished
care to a patient that was new to the
FQHC or to a beneficiary receiving an
IPPE or an annual wellness visit (AWV).
If we allowed FQHCs to bill separately
for an IPPE that occurred on the same
day as another medical visit, we would
be overpaying the FQHC for the cost of
the IPPE. To accurately pay FQHCs for
the costs of furnishing an IPPE, we
added an adjustment factor of 1.333 to
the PPS rate when an IPPE is furnished
at a FQHC. We also extended the
adjustment factor to both initial and
subsequent AWVs, in order to
appropriately compensate FQHCs for
the costs of furnishing these services.
In the FQHC PPS proposed rule and
final rules, we discussed that we did not
include an exception to the per-diem
payment for DSMT/MNT because an
analysis of the claims and cost reporting
data did not justify either a separate perdiem payment or an adjustment to the
PPS rate. We also stated our belief that
a DSMT/MNT visit is part of the broad
category of primary care services that
are included in the services of a FQHC
and are part of the PPS per diem
payment. We noted that visits with
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
multiple practitioners that occur on the
same day, including visits for different
conditions or visits with a specialist
physician, are not separately payable in
a FQHC, and we do not believe that
DSMT/MNT visits should be considered
differently than other primary care
services.
Although the comments we received
did not persuade us to allow DSMT/
MNT to be billed separately in a FQHC
when it occurs on the same day as
another billable medical visit, or to add
an adjustment to the PPS rate for DSMT/
MNT when it is furnished on the same
day as another billable visit, we believe
it is a valuable service, particularly in
FQHCs that serve areas with high rates
of people with diabetes and related
illnesses, and we encourage FQHCs to
furnish this service as necessary.
We are retaining § 405.2463(c)(4)(i)
and § 405.2463(c)(4)(ii) as finalized in
79 FR 25478, which states that for
FQHCs billing under the PPS, Medicare
pays for more than 1 visit per day when
the patient (i) suffers an illness or injury
subsequent to the first visit that requires
additional diagnosis or treatment on the
same day; or (ii) has a medical visit and
a mental health visit on the same day.
3. Establishment of FQHC G-Codes To
Report and Bill FQHC Visits to
Medicare Under the PPS
In the FQHC PPS proposed rule (78
FR 58386), we cited section
1833(a)(1)(Z) of the Act and proposed
that Medicare payment under the FQHC
PPS would be 80 percent of the lesser
of the provider’s actual charge or the
PPS rate. Commenters were concerned
that comparing actual charges with a
bundled PPS rate would distort the true
cost of services furnished and would
result in FQHCs either being forced to
increase their charges, or receive
payment far below actual cost of
furnishing services. In response to these
comments, we established a new set of
HCPCS G-codes to report an established
Medicare patient visit, a new or initial
patient visit, and an IPPE or AWV.
We stated that a FQHC would set its
charge for the specific payment codes
based on its own determination of what
would be appropriate for the services
normally provided and the population
served at that FQHC, and that the charge
for a specific payment code would
reflect the sum of regular rates charged
to both beneficiaries and other paying
patients for a typical bundle of services
that would be furnished per diem to a
Medicare beneficiary. We emphasized
that the use of these payment codes
does not dictate to providers how to set
their charges, and that detailed HCPCS
coding with the associated line item
PO 00000
Frm 00422
Fmt 4701
Sfmt 4700
charges would continue to be required
along with the payment codes when
billing Medicare under the PPS.
Medicare would pay FQHCs 80 percent
of either the actual charge reported for
the specific payment code or the PPS
rate on each claim, whichever is lower.
We stated that establishing HCPCS Gcodes for FQHCs to report and bill for
Medicare visits would allow
comparison between the PPS per diem
rate and a FQHC’s charge for a per diem
visit (as defined by the specific payment
codes), and that this would be
responsive to commenters’ concerns. As
we did not propose the establishment of
HCPCS G-codes in the proposed rule,
nor did we receive public comments
specifically requesting such codes, we
invited comments on the establishment
of G-codes for FQHCs to report and bill
FQHC visits to Medicare under the
FQHC PPS.
We received several comments on the
establishment of G-codes for FQHCs to
report and bill FQHC visits to Medicare
under the FQHC PPS. Most commenters
favored using G-codes to report and bill
FQHC visits under the PPS; however,
commenters expressed concerns about
the complexity and administrative
burden of implementing these codes.
The following is a summary of these
comments.
Comment: Commenters appreciated
that we carefully considered the
comments related to the Medicare
claims payment process and prefer our
development of FQHC payment G-codes
to compare the FQHC PPS encounterbased rate with the FQHC’s actual
charges. Commenters stated that the use
of G-codes to implement the ‘‘lesser of’’
provision of the statute is a positive
solution that allows for parity between
the PPS payment rate and the actual
charges being compared. Commenters
stated that we resolved what they
believe would have resulted in an
‘‘apples to oranges’’ comparison by
implementing a system that compares
the PPS per diem rate, defined by the
specific payment HCPCS G-codes, to a
FQHC’s actual charge for a per diem
visit.
Although many of the commenters
were supportive of the establishment of
G-codes for FQHCs to report and bill
FQHC visits to Medicare under the
FQHC PPS, many of these commenters
stated that the process of developing
charges for typical bundles of services
will be complex for FQHCs.
Commenters stated that FQHCs have
had limited experience working with
payors who use a ‘‘lesser of’’ or ‘‘actual
charges’’ payment methodology.
Commenters acknowledged that
Medicare regulations require that
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
charges must be neutral among payors;
however, given that other payors and
paying patients would not be
purchasing a precise bundle of services
corresponding to the Medicare FQHC
visit, commenters stated that the policy
to develop G-codes charges is not
straightforward. Commenters stated that
the charges developed for the FQHC
payment G-codes would not be used for
any non-Medicare patient. Commenters
also stated that it would be challenging
for FQHCs to develop charges for a
typical bundle of services and adhere to
requirements under section 330 of the
Public Health Service (PHS) Act, which
requires FQHCs to develop charges
consistent with locally prevailing rates
that cover their reasonable costs of
operation. Commenters stated that in
developing actual charges, FQHCs
would need to perfect their coding
capabilities and appropriately capture
the bundle of services they provide in
the charges. Although some commenters
emphasized the complexity of
developing G-code charges, a few
commenters appreciated that we did not
establish precise methods for FQHCs to
develop their own G-code charges.
Response: We understand that
developing G-codes for FQHC payment
under the PPS is unfamiliar to FQHCs.
To assist FQHCs in understanding the
new payment system, we held two
national training sessions which
provided detailed examples of various
billing scenarios. A transcript of the
presentations and slides from the
presentation are posted on our Web site
at https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
FQHCPPS/. Additional
information is available in the
‘‘Medicare Benefit Policy Manual,
Chapter 13—Rural Health Clinic (RHC)
and Federally Qualified Health Center
(FQHC) Services,’’ and the ‘‘Medicare
Claims Processing Manual, Chapter 9—
Rural Health Clinic (RHC)/Federally
Qualified Health Center (FQHC).’’ In the
resources, we discuss the need for each
FQHC to select a bundle of services that
reflects a typical bundle of services that
they would provide to a new or
established Medicare patient at their
FQHC for medical and mental health
services and IPPE and AWV. We also
address how FQHCs set their own
charges (which must be consistent with
the requirements under section 330 of
the PHS Act when applicable), and
since charges must be the same for all
patients, the charges for the services that
are included in the bundle would be
totaled to determine the G-code
payment amount. We expect that once
FQHCs set their charges and select the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
bundle of services that will be included
in the FQHC G-codes, they will adapt
well to the process. We would also note
that other payors could choose to utilize
the FQHC payment G-codes if they
choose.
Comment: Many commenters
suggested that the use of FQHC payment
G-codes would create an additional
administrative burden for FQHCs’
coding and billing staff. Commenters
stated that FQHCs will need to spend
additional time explaining the charges
on the Explanation of Benefits (EOB) to
Medicare beneficiaries since there could
be additional charges beyond what the
beneficiary typically sees associated
with a visit. Some commenters stated
that using FQHC payment G-codes
could artificially inflate FQHCs’ total
gross charges, although others stated
that some of the financial discrepancies
in payment would be resolved once the
FQHC receives payment. However,
many commenters stated there would be
an administrative burden to a FQHC in
the short-term as it attempts to resolve
balances and financial statements.
Response: FQHCs may initially have
to spend additional time explaining
changes in charges and the patient’s
EOB, and we encourage them to keep
their patients informed of any changes.
We also acknowledge that transitioning
to a new payment system will require
additional time and patience as all
aspects of the billing system will need
to be adapted.
We noted in the FQHC PPS final rule
that although FQHCs set their own
charges, FQHCs that receive grant
funding under section 330 of the PHS
Act are required to maintain charges
that are both consistent with locally
prevailing rates or charges and are also
reflective of their reasonable costs of
operation. Therefore, we do not expect
that the FQHCs will use the payment Gcodes to artificially inflate their charges.
Comment: Several commenters were
concerned that the use of G-codes
would limit the definition or scope of a
qualifying face-to-face visit.
Commenters stated that we were
limiting the scope of FQHC services by
requiring that only certain HCPCS codes
support the use of each FQHC payment
G-code. Commenters stated that services
described by codes other than
evaluation and management (E/M)
services also meet the definition of a
face-to-face visit with a qualifying
provider. The commenters
recommended that for each qualifying
visit, the FQHC should be able to enter
the corresponding FQHC payment Gcode to be eligible for payment.
Response: We disagree that the new
PPS may limit the scope of FQHC
PO 00000
Frm 00423
Fmt 4701
Sfmt 4700
67969
services. All services that qualified as a
billable visit under the AIR payment
system continue to qualify as a billable
visit under the PPS. There has been no
change to the scope of services that may
be furnished in a FQHC and no change
in the type of visits that qualify as a
billable visit as a result of the new
payment system. Since the previous
payment system did not utilize HCPCS
coding to determine payment, we
anticipate the new payment system will
be more transparent, as all services
furnished must have the correct HCPCS
codes for accurate payment, along with
the appropriate G-code for payment. We
would also note that in addition to E/
M visits, there are many preventive
services that can be billed as standalone visits in FQHCs under both the
AIR and PPS payment systems.
Comment: A few commenters
suggested that we develop more G-codes
to account for other types of services
furnished in a FQHC and G-codes that
address varying patient populations.
One commenter suggested that we add
an additional 10 to 15 HCPCS codes
based on the historical claims data for
FQHC visits. Another commenter
suggested that due to the complex needs
of their FQHC patient population,
additional FQHC payment G-codes
should reflect multiple services,
intensity, and cost of furnishing services
to their complex patient population.
Response: We stated in the FQHC PPS
proposed and final rules that our goal
for the FQHC PPS is to implement a
system in accordance with the statute
whereby FQHCs are fairly paid for the
services they furnish to Medicare
patients in the least burdensome
manner possible, so that they may
continue to furnish primary and
preventive health services to the
communities they serve. In developing
the FQHC G-codes, we considered
whether there should be fewer G-codes,
or more G-codes, than the five that we
ultimately proposed. The G-codes are
designed to reflect a typical bundle of
services that a FQHC furnishes to their
Medicare patients, and we determined
that having more G-codes would be
burdensome without providing any
advantage in payment accuracy.
However, we will monitor the PPS
system and will consider adding
additional G-codes if necessary.
Comment: A number of commenters
requested clarification that the bundle
of services taken into account in the Gcode charge reflects the total bundle of
services for a FQHC visit, rather than
just the services furnished on that day.
Some commenters also sought
clarification on billing the professional
component of a preventive service on a
E:\FR\FM\13NOR2.SGM
13NOR2
67970
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
day subsequent to the day of the visit.
These commenters are concerned
whether under the new billing
requirements for the FQHC PPS all
services are meaningfully included in
the encounter payment rate even when
a component of the service is furnished
on a different date than the actual visit.
Response: The FQHC G-codes reflect
the services that the FQHC typically
furnishes to a Medicare patient that is
either a new or established, medical or
mental health patient or a patient
receiving an IPPE or AWV. This may be
the same bundle of services that are
furnished to the patient on a particular
day, but is not required to be the same
services, as the patient may need more,
fewer, or a different set of services on
that particular day.
FQHCs may bill for services furnished
incident to a visit on the same claim,
even if they occur on a different day, as
long as the services are furnished in a
medically appropriate time frame. For
example, if a patient has their blood
drawn at the FQHC on a Monday, and
sees the FQHC practitioner the
following Wednesday, the FQHC would
include the venipuncture on the same
claim as the visit with the practitioner.
The FQHC G-codes are defined in
program instructions in accordance with
statutory and regulatory requirements
and will be implemented as described.
4. Waiving Coinsurance for Preventive
Services When Furnished With Other
Services Under the FQHC PPS
In the FQHC PPS proposed rule (78
FR 58386), we proposed that for FQHC
claims that include a mix of preventive
and non-preventive services, FQHCs
would use payments under the PFS to
determine the proportional amount of
coinsurance that should be waived for
payments based on the PPS encounter
rate. Since Medicare payment under the
FQHC PPS is required to be 80 percent
of the lesser of the FQHC’s charges or
the PPS rate, we proposed that we
would continue to use FQHC-reported
charges to determine the amount of
coinsurance that should be waived for
payments based on the FQHC’s charge,
and that total payment to the FQHC,
including both Medicare and
beneficiary liability, would not exceed
the lesser of the FQHC’s charge or the
PPS rate.
We acknowledged that our proposed
approach for waiving coinsurance for
preventive services when furnished
with other services was complex and
may be difficult for FQHCs to
implement, and we invited public
comment on how this proposal would
impact a FQHC’s administrative
procedures and billing practices.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Commenters responded that the
proposed system to calculate
coinsurance was too complex and
burdensome and requested that a
simplified system be established.
In the final rule referenced above, we
agreed with the commenters, and
decided to retain the current method
used under the AIR system for
calculating coinsurance, with certain
modifications. Under the new FQHC
PPS, the dollar value of the FQHC’s
reported line-item charge for the
preventive service will be subtracted
from the full payment amount, whether
payment is based on the FQHC’s charge
or the PPS rate. Medicare will pay the
FQHC 100 percent of the dollar value of
the FQHC’s reported line-item charge
for the preventive service, up to the total
payment amount. Medicare also will
pay a FQHC 80 percent of the remainder
of the full payment amount, and
beneficiary coinsurance would be
assessed at 20 percent of the remainder
of the full payment amount. If the
reported line-item charge for the
preventive service equals or exceeds the
full payment amount, Medicare will pay
100 percent of the full payment amount
and the beneficiary will not be
responsible for any coinsurance.
We believe that this revised
methodology is responsive to
commenters request for a simpler
method of calculating coinsurance and
will be more transparent to
beneficiaries. We invited comments on
this approach to waiving coinsurance
for preventive services based on the
dollar value of the FQHC’s reported
line-item charge for preventive services.
We received many comments on how
our finalized policy for calculation of
coinsurance for preventive services
would affect a FQHC’s administrative
procedures and billing practices. Most
commenters appreciated that we are
striving for policies that ease
administrative burden; however, many
of the commenters thought that our
revised approach is still too complex
and burdensome to implement. The
following is a summary of these
comments.
Comment: Most commenters
supported that we are striving for a
waiver of coinsurance calculation that
achieves greater simplicity and
promotes fair payment under Medicare.
A few commenters stated that our
revised approach is a common sense
and workable approach to applying this
important provision. One commenter
stated that this approach would allow
for FQHCs to assess coinsurance at the
time services are furnished, potentially
increase rates of collection, and reduce
administrative burden. Commenters
PO 00000
Frm 00424
Fmt 4701
Sfmt 4700
who supported the revised approach
requested that we closely monitor how
the waiver of coinsurance is calculated
and determine if further modifications
are needed in the future. Most
commenters preferred the revised
approach, but some expressed concern
that it is still too complex and
burdensome. Commenters stated that
our methodology for the calculation of
coinsurance waiver when the services
include a mix of preventive and nonpreventive services is too complex for
the FQHC staff to accurately determine
the coinsurance at the time services are
furnished. Commenters suggested that
FQHCs would be concerned with
overcharging the patient and waive all
coinsurance when a mixture of
preventive and non-preventive services
is furnished. Commenters
acknowledged that FQHCs could bill the
patient after the MAC issues a
remittance advice, but the commenters
stated that this would increase bad debt.
One commenter stated that the revised
approach creates an incentive for
FQHCs to offer fewer services at each
visit and request patients to return on
different days for additional services
that could have been furnished on the
same day.
Response: We appreciate that FQHCs
want to accurately determine
coinsurance amounts when there is a
mix of preventive and non-preventive
services furnished on the same day so
that beneficiaries are neither
overcharged nor undercharged. Since
FQHCs set their own charges and
develop their own G-codes, they should
be able to accurately determine the
coinsurance amount. We believe that
the proposed method strikes the right
balance between accuracy and
simplicity, and we will make
adjustment as necessary if problems
arise. We also note that, under certain
circumstances, FQHCs may waive
coinsurance amounts for Medicare and
Medicaid beneficiaries (see for example,
section 1128B(b)(3)(D) of the Act and
§ 1001.952(k)(2) of the regulations).
Also, most FQHCs are subject to the
statutory and regulatory requirements of
the Health Center Program (section 330
of the PHS Act; 42 CFR Part 51c; and 42
CFR 56.201 through 56.604), which,
among other requirements, mandates
that they may collect no more than a
‘‘nominal fee’’ from individuals whose
annual income is at or below 100
percent of the Federal Poverty Level.’’
We are not clear why one commenter
suggested that the method for
calculating coinsurance could create an
incentive for FQHCs to offer fewer
services at each visit and request
patients to return on different days for
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
additional services that could have been
furnished on the same day. However, as
we stated in the FQHC PPS final rule,
we expect FQHCs to act in the best
interests of their patients, which
includes scheduling visits in a manner
that maximizes the health and safety of
their patients.
Comment: Some commenters stated
that the complexity of our revised
approach does not carry out
Congressional intent to provide for
complete waiver of coinsurance when
covered preventive services are
furnished. They stated that when
Congress provided for a complete
waiver of coinsurance for specific
preventive services under section 4104
of the Affordable Care Act, it was
intended to improve access to these
services, and that requiring Medicare
beneficiaries be liable for coinsurance
when a mixture of preventive and nonpreventive services are furnished does
not remove barriers to these services.
Commenters also stated that we lack
‘‘any specific statutory authorization to
waive coinsurance for services provided
under the FQHC PPS,’’ and therefore,
CMS is not barred from implementing a
complete waiver for coinsurance when
a mixture of services are furnished.
These commenters stated that a
complete waiver of coinsurance for
visits involving a preventive service is
consistent with the regulation under
§ 410.152(l), which states that Medicare
Part B pays ‘‘100 percent of the
Medicare payment amount established
under the applicable payment
methodology for the service setting for
providers and suppliers of the following
preventive services.’’ Commenters
stated that a FQHC is a provider of such
preventive services and that the FQHC
PPS is an applicable payment
methodology. Commenters surmised
that it is more consistent with the
regulation to completely waive
coinsurance for visits involving a
mixture of preventive and nonpreventive services rather than
implement a partial coinsurance
methodology.
Response: We disagree with the
commenters’ interpretation that the
statutory and regulatory language cited
provides us with the authority to waive
coinsurance for all services when there
is a mix of preventive and nonpreventive services furnished during a
FQHC encounter. The revised
methodology for calculating
coinsurance when there is a mix of
preventive and non-preventive services
on the claim was revised in response to
commenters’ concerns that the
methodology that was first proposed
was overly complex and burdensome.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
We believe that the revised
methodology is responsive to those
concerns, and provides as much
simplicity as possible while enabling
FQHCs to comply with statutory
requirements for the collection of
coinsurance.
We are retaining § 405.2410(b)(2)(i),
§ 405.2410(b)(2)(ii), and § 405.2462(d) of
the Medicare regulations as finalized in
79 FR 25475 and will use the current
approach to waiving coinsurance for
preventive services, whether total
payment is based on the FQHC’s charge
or the PPS rate, by subtracting the dollar
value of the FQHC’s reported line-item
charge for the preventive services from
the full payment amount.
5. Other Comments
We received many comments
requesting that we provide further
information through subregulatory
guidance to the stakeholder community
regarding same-day visits, development
of G-code charges, the calculation of
coinsurance when a mixture of
preventive and non-preventive services
are furnished, what is considered the
technical and the professional
component of preventive services,
billing procedures and processing of
claims for same-day visits. Several
commenters requested specific
examples on calculating coinsurance
when the claim contains a mixture of
preventive and non-preventive services.
Response: The ‘‘Medicare Benefit
Policy Manual, Chapter 13—Rural
Health Clinic (RHC) and Federally
Qualified Health Center (FQHC)
Services,’’ and the ‘‘Medicare Claims
Processing Manual, Chapter 9—Rural
Health Clinic (RHC)/Federally Qualified
Health Center (FQHC), ’’ are regularly
updated and will address these topics.
Additional information on the FQHC
PPS is available on the CMS Web site at
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
FQHCPPS/.
We received some comments that
were not related to our specific
proposals for the FQHC PPS. Although
we appreciate the commenters’ feedback
on billing for vaccines under Medicare
part D, billing for costs relating to
language assistance and other enabling
services, adjustments to the California
GAF, FQHC PPS rate risk adjusters, and
the FQHC PPS implementation date,
payment for furnishing services to
dually eligible Medicare and Medicaid
beneficiaries, these topics are beyond
the scope of our specific proposals that
we specified were subject to public
comment in the FQHC PPS.
PO 00000
Frm 00425
Fmt 4701
Sfmt 4700
67971
6. Additional Technical Revisions
a. SNF Consolidated Billing
In this final rule with comment
period, we are making a conforming
technical revision in § 411.15(p)(2) and
§ 489.20(s). In the May 2, 2014, interim
final rule (79 FR 25462), we updated
§ 405.2411(b)(2) so that it reflects
section 1888(e)(2)(A)(iv) of the Act (as
amended by section 410 of the MMA),
which excludes certain RHC and FQHC
practitioner services from consolidated
billing and allows such services to be
separately billable under Part B when
furnished to a resident of a SNF during
a covered Part A stay. This statutory
provision was effective with services
furnished on or after January 1, 2005
and was previously implemented
through program instruction (CMS Pub
100–04, Medicare Claims Processing
Manual, Chapter 6, Section 20.1.1).
However, in making this revision, we
inadvertently neglected to make a
conforming change in § 411.15(p)(2),
which enumerates the individual
services that are excluded from the SNF
consolidated billing provision, as well
as in § 489.20(s), which specifies
compliance with consolidated billing as
a requirement of the SNF’s Medicare
provider agreement. Accordingly, we
are now rectifying that omission.
Regarding the technical corrections to
parts 411 and 489 of the regulations
discussed above, we note that we would
ordinarily publish a notice of proposed
rulemaking in the Federal Register to
provide a period for public comment
before revisions in the regulations text
would take effect; however, we can
waive this procedure if we find good
cause that a notice and comment
procedure is impracticable,
unnecessary, or contrary to the public
interest and incorporate a statement of
the finding and its reasons in the notice
issued. We find it unnecessary to
undertake notice and comment
rulemaking in connection with these
particular revisions, as they merely
provide technical corrections to the
regulations, without making any
substantive changes. Therefore, for good
cause, we waive notice and comment
procedures for the revisions that we are
making to the regulations text in parts
411 and 489.
b. Transitional Care Management
In the May 2, 2014 final rule (79 FR
25436), we added transitional care
management (TCM) to
§ 405.2463(a)(1)(ii). To clarify that TCM
does not necessarily require a face-toface visit, we revised this section of the
regulation for RHCs, but neglected to
add the appropriate reference for
E:\FR\FM\13NOR2.SGM
13NOR2
67972
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
FQHCs. Therefore, we are revising
§ 405.2463(a)(2)(i), so that a FQHC visit
includes a qualified TCM service.
P. Physician Self-Referral Prohibition:
Annual Update to the List of CPT/
HCPCS Codes
1. General
Section 1877 of the Act prohibits a
physician from referring a Medicare
beneficiary for certain designated health
services (DHS) to an entity with which
the physician (or a member of the
physician’s immediate family) has a
financial relationship, unless an
exception applies. Section 1877 of the
Act also prohibits the DHS entity from
submitting claims to Medicare or billing
the beneficiary or any other entity for
Medicare DHS that are furnished as a
result of a prohibited referral.
Section 1877(h)(6) of the Act and
§ 411.351 of our regulations specify that
the following services are DHS:
• Clinical laboratory services
• Physical therapy services
• Occupational therapy services
• Outpatient speech-language
pathology services
• Radiology services
• Radiation therapy services and
supplies
• Durable medical equipment and
supplies
• Parenteral and enteral nutrients,
equipment, and supplies
• Prosthetics, orthotics, and
prosthetic devices and supplies
• Home health services
• Outpatient prescription drugs
• Inpatient and outpatient hospital
services
2. Annual Update to the Code List
a. Background
ebenthall on DSK5SPTVN1PROD with $$_JOB
In § 411.351, we specify that the
entire scope of four DHS categories is
defined in a list of CPT/HCPCS codes
(the Code List), which is updated
annually to account for changes in the
most recent CPT and HCPCS Level II
publications. The DHS categories
defined and updated in this manner are:
• Clinical laboratory services
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
• Physical therapy, occupational
therapy, and outpatient speech-language
pathology services
• Radiology and certain other imaging
services
• Radiation therapy services and
supplies
The Code List also identifies those
items and services that may qualify for
either of the following two exceptions to
the physician self-referral prohibition:
• EPO and other dialysis-related
drugs furnished in or by an ESRD
facility (§ 411.355(g))
• Preventive screening tests,
immunizations, or vaccines
(§ 411.355(h))
The definition of DHS at § 411.351
excludes services that are reimbursed by
Medicare as part of a composite rate
(unless the services are specifically
identified as DHS and are themselves
payable through a composite rate, such
as home health and inpatient and
outpatient hospital services). Effective
January 1, 2011, EPO and dialysisrelated drugs furnished in or by an
ESRD facility (except drugs for which
there are no injectable equivalents or
other forms of administration), have
been reimbursed under a composite rate
known as the ESRD prospective
payment system (ESRD PPS) (75 FR
49030). Accordingly, EPO and any
dialysis-related drugs that are paid for
under ESRD PPS are not DHS and are
not listed among the drugs that could
qualify for the exception at § 411.355(g)
for EPO and other dialysis-related drugs
furnished by an ESRD facility.
Drugs for which there are no
injectable equivalents or other forms of
administration were scheduled to be
paid under ESRD PPS beginning January
1, 2014 (75 FR 49044). However, on
January 3, 2013, Congress enacted the
American Taxpayer Relief Act of 2012
(ATRA), (Pub. L.112–240), which will
delay payment of these drugs under
ESRD PPS until January 1, 2016. In the
meantime, such drugs furnished in or by
an ESRD facility are not reimbursed as
part of a composite rate and thus, are
DHS. For purposes of the exception at
§ 411.355(g), only those drugs that are
PO 00000
Frm 00426
Fmt 4701
Sfmt 4700
required for the efficacy of dialysis may
be identified on the List of CPT/HCPCS
Codes as eligible for the exception. As
we have explained previously in the CY
2010 PFS final rule (75 FR 73583), we
do not believe any of these drugs are
required for the efficacy of dialysis.
Therefore, we have not included any
such drugs on the list of drugs that can
qualify for the exception.
The Code List was last updated in
Addendum K of the CY 2014 PFS final
rule with comment period.
b. Response to Comments
We received no public comments
relating to the Code List that became
effective January 1, 2014.
c. Revisions Effective for 2015
The updated, comprehensive Code
List effective January 1, 2015, is
available on our Web site at https://
www.cms.gov/Medicare/Fraud-andAbuse/PhysicianSelfReferral/List_of_
Codes.html.
Additions and deletions to the Code
List conform it to the most recent
publications of CPT and HCPCS Level
II, and to changes in Medicare coverage
policy and payment status.
Tables 90 and 91 identify the
additions and deletions, respectively, to
the comprehensive Code List that
become effective January 1, 2015. Tables
90 and 91 also identify the additions
and deletions to the list of codes used
to identify the items and services that
may qualify for the exception in
§ 411.355(g) (regarding dialysis-related
outpatient prescription drugs furnished
in or by an ESRD facility) and in
§ 411.355(h) (regarding preventive
screening tests, immunizations, and
vaccines).
We will consider comments regarding
the codes listed in Tables 90 and 91.
Comments will be considered if we
receive them by the date specified in the
DATES section of this final rule with
comment period. We will not consider
any comment that advocates a
substantive change to any of the DHS
defined in § 411.351.
BILLING CODE 4120–01–P
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
67973
TABLE 90: Additions to the Physician Self-Referral List of CPT 11HCPCS Codes
CLINICAL LABORATORY SERVICES
0357T Cryopreservation oocyte(s)
PHYSICAL THERAPY, OCCUPATIONAL THERAPY, AND
OUTPATIENT SPEECH-LANGUAGE PATHOLOGY SERVICES
97607 Neg press wnd tx </=50 sq em
97608 Neg press wound tx >50 em
RADIOLOGY AND CERTAIN OTHER IMAGING SERVICES
76641 Ultrasound breast complete
76642 Ultrasound breast limited
77061 Breast tomosynthesis uni
77062 Breast tomosynthesis bi
77063 Breast tomosynthesis bi
77085 Dxa bone density study
77086 Fracture assessment via dxa
G0279 Tomosynthesis, mammo screen
RADIATION THERAPY SERVICES AND SUPPLIES
A9606 Radium Ra223 dichloride ther
C2644 Brachytx cesium-131 chloride
77306 Telethx isodose plan simple
77307 Telethx isodose plan cplx
77316 Brachytx isodose plan simple
77317 Brachytx isodose intermed
77318 Brachytx isodose complex
77385 Ntsty modul rad tx dlvr smpl
77386 Ntsty modul rad tx dlvr cplx
G600 1 Echo guidance radiotherapy
G6002 Stereoscopic x-ray guidance
G6003 Radiation treatment delivery
G6004 Radiation treatment delivery
G6005 Radiation treatment delivery
G6006 Radiation treatment delivery
G6008 Radiation treatment delivery
G6009 Radiation treatment delivery
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00427
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.161</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
G6007 Radiation treatment delivery
67974
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
G60 10 Radiation treatment delivery
G6011 Radiation treatment delivery
G6012 Radiation treatment delivery
G60 13 Radiation treatment delivery
G60 14 Radiation treatment delivery
G6015 Radiation tx delivery imrt
G60 16 Delivery comp imrt
G60 17 Intrafraction track motion
DRUGS USED BY PATIENTS UNDERGOING DIALYSIS
{No additions}
PREVENTIVE SCREENING TESTS, IMMUNIZATIONS AND
VACCINES
90630 Flu vacc iiv4 no preserv id
G0464 Colorec CA scr, sto bas DNA
..
1CPT codes and descnptions only are copynght 2014 AMA. All nghts are reserved and applicable FARS/DFARS
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00428
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.162</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
clauses apply.
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
67975
TABLE 91: Deletions from the Physician Self-Referral List of CPT 11HCPCS Codes
CLINICAL LABORATORY SERVICES
0059T Cryopreservation oocyte
PHYSICAL THERAPY, OCCUPATIONAL THERAPY, AND
OUTPATIENT SPEECH-LANGUAGE PATHOLOGY SERVICES
{No deletions}
RADIOLOGY AND CERTAIN OTHER IMAGING SERVICES
74291 Contrast x-rays gallbladder
76645 Us exam breast(s)
77082 Dxa bone density vert fx
RADIATION THERAPY SERVICES AND SUPPLIES
clauses apply.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00429
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.163</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
0073T Delivery comp imrt
0 197T Intrafraction track motion
77305 Teletx isodose plan simple
77310 Teletx isodose plan intermed
77315 Teletx isodose plan complex
77326 Brachytx isodose calc simp
77327 Brachytx isodose calc interm
77328 Brachytx isodose plan compl
77403 Radiation treatment delivery
77404 Radiation treatment delivery
77406 Radiation treatment delivery
77408 Radiation treatment delivery
77409 Radiation treatment delivery
77411 Radiation treatment delivery
77413 Radiation treatment delivery
77414 Radiation treatment delivery
77416 Radiation treatment delivery
77418 Radiation tx delivery imrt
77421 Stereoscopic x-ray guidance
G041 7 Sat biopsy prostate 21-40
G0418 Sat biopsy prostate 41-60
G0419 Sat biopsy prostate: >60
DRUGS USED BY PATIENTS UNDERGOING DIALYSIS
{No deletions}
PREVENTIVE SCREENING TESTS, IMMUNIZATIONS AND
VACCINES
{No deletions}
..
1 CPT codes and descnptwns only are copyright 2014 AMA. All nghts are reserved and applicable FARS/DFARS
67976
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
BILLING CODE 4120–01–C
Q. Interim Final Revisions to the
Electronic Health Record (EHR)
Incentive Program
1. Statutory Basis
The American Recovery and
Reinvestment Act of 2009 (Pub. L.
111–5) (ARRA) amended titles XVIII
and XIX of the Act to authorize
incentive payments to EPs, eligible
hospitals, and critical access hospitals
(CAHs), and Medicare Advantage (MA)
organizations to promote the adoption
and meaningful use of CEHRT. Sections
1848(o), 1853(l) and (m), 1886(n), and
1814(l) of the Act provide the statutory
basis for the Medicare incentive
payments made to meaningful EHR
users. These statutory provisions govern
EPs, MA organizations (for certain
qualifying EPs and hospitals that
meaningfully use CEHRT), subsection
(d) hospitals, and CAHs, respectively.
Sections 1848(a)(7), 1853(l) and (m),
1886(b)(3)(B), and 1814(l) of the Act also
establish downward payment
adjustments, beginning with calendar or
fiscal year 2015, for EPs, MA
organizations, subsection (d) hospitals
and CAHs that are not meaningful users
of CEHRT for certain associated
reporting periods. Sections 1903(a)(3)(F)
and 1903(t) of the Act provide the
statutory basis for Medicaid incentive
payments, but do not provide for
downward payment adjustments.
Sections 1848(a)(7)(B),
1886(b)(3)(B)(ix)(II), and 1814(l)(4)(C) of
the Act provide that the Secretary may,
on a case-by-case basis, exempt an EP,
eligible hospital, or CAH that is not a
meaningful EHR user for an EHR
reporting period for the year from the
application of the payment adjustment
if the Secretary determines that
compliance with the requirement for
being a meaningful EHR user would
result in a significant hardship, such as
in the case of an EP, eligible hospital, or
CAH that practices or is located in a
rural area without sufficient internet
access. The exception is subject to
annual renewal, but in no case may an
exception be granted for more than 5
years.
ebenthall on DSK5SPTVN1PROD with $$_JOB
2. Provisions of the Interim Final Rule
With Comment Period
a. Extreme and Uncontrollable
Circumstances Hardship Exception
In the September 4, 2014 Federal
Register (79 FR 52910–52933) CMS and
ONC published a final rule titled
‘‘Medicare and Medicaid Programs;
Modifications to the Medicare and
Medicaid Electronic Health Record
(EHR) Incentive Program for 2014 and
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Other Changes to the EHR Incentive
Program; and Health Information
Technology: Revisions to the Certified
EHR Technology Definition and EHR
Certification Changes Related to
Standards; Final Rule’’ (‘‘2014 CEHRT
Flexibility rule’’). The final rule
included policies allowing EPs, eligible
hospitals, and CAHs that could not fully
implement 2014 Edition CEHRT for an
EHR reporting period in 2014 due to
issues related to 2014 Edition CEHRT
availability delays to continue to use
2011 Edition CEHRT or a combination
of 2011 Edition and 2014 Edition
CEHRT for the EHR reporting periods in
CY 2014 and FY 2014, respectively.
These CEHRT options applied only to
those providers that could not fully
implement 2014 Edition CEHRT to meet
meaningful use for an EHR reporting
period in 2014 due to delays in 2014
Edition CEHRT availability. The final
rule also made changes to the attestation
process to support these flexible options
for CEHRT, although it did not alter the
attestation or hardship exception
application deadlines for 2014.
Therefore, for example, eligible
hospitals that never successfully
attested to meaningful use prior to FY
2014 were still required to attest by July
1, 2014, and eligible professionals who
never successfully attested to
meaningful use prior to CY 2014 were
required to attest by October 1, 2014, for
an EHR reporting period in FY 2014 or
CY 2014, respectively, to avoid the
Medicare payment adjustments in FY
2015 or CY 2015, respectively. To
request a hardship exception from the
Medicare payment adjustments in FY or
CY 2015, applications were due from
eligible professionals by July 1, 2014,
eligible hospitals by April 1, 2014, and
CAHs by November 30, 2015. In
addition, throughout the course of the
year, we continued to urge providers to
purchase 2014 Edition CEHRT and not
wait until the last minute to attest for
the EHR reporting period in 2014.
However, following publication of the
2014 CEHRT Flexibility rule, we became
aware that providers were confused over
their ability to use flexible options
provided under the 2014 CEHRT
Flexibility rule, especially given the
unchanged attestation deadlines. We
received numerous letters from various
health care associations, multiple
questions from stakeholders on provider
calls, and numerous emails from
providers and EHR vendors, all
expressing confusion and seeking
clarification about whether they could
use the flexible options provided under
the 2014 CEHRT Flexibility rule.
Specifically, providers were unsure how
PO 00000
Frm 00430
Fmt 4701
Sfmt 4700
they could use the flexible options given
that the attestation deadlines for both
eligible professionals (October 1, 2014)
and eligible hospitals (July 1, 2014)
would have occurred on or before the
effective date of the 2014 CEHRT
Flexibility rule (October 1, 2014).
Providers were extremely concerned
that their inability to use the flexible
options specified in the 2014 CEHRT
Flexibility rule would subject them to a
payment adjustment in 2015 under
Medicare for failing to demonstrate
meaningful use of CEHRT. This fear was
compounded by the fact that the
hardship exception application
deadlines for both eligible professionals
(July 1, 2014) and eligible hospitals
(April 1, 2014) had already passed.
In particular, we became aware that
eligible professionals who never
successfully attested to meaningful use
for the EHR Incentive Program were
especially affected by this issue because
they would not be able to use the
flexibility options outlined in the 2014
CEHRT Flexibility rule before the
October 1, 2014 deadline to avoid the
payment adjustment in CY 2015,
because these options could not be
made available in the CMS Registration
and Attestation System prior to the
October 1, 2014 effective date of the
2014 CEHRT Flexibility rule. We also
became aware that eligible professionals
also faced uncertainty if they joined
practices that were already using 2011
Edition CEHRT and experienced delays
in full implementation of 2014 Edition
CEHRT. Therefore, we understood that
eligible professionals were concerned
that the inability to attest by October 1,
2014 using the flexible options under
the 2014 CEHRT Flexibility rule would
potentially subject them to the payment
adjustment in CY 2015 authorized
under the Medicare EHR Incentive
Program if they could not receive a
hardship exception.
Accordingly, to ensure that all
providers can use the flexible options
recently finalized under the 2014
CEHRT Flexibility rule for an EHR
reporting period in 2014, and ensure
that providers are not potentially
subjected to the 2015 payment
adjustment under the Medicare EHR
Incentive Program, we are recognizing a
hardship exception under the
established category of ‘‘extreme and
uncontrollable circumstances’’ under 42
CFR § 495.102(d)(4)(iii) for eligible
professionals and § 412.64(d)(4)(ii)(B)
for eligible hospitals, pursuant to the
Secretary’s discretionary hardship
exception authority. Under this IFC, we
will consider that an extreme and
uncontrollable circumstance hardship
exists for an eligible professional or
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
eligible hospital if two criteria are met.
First, the provider must not have been
able to fully implement the 2014 Edition
CEHRT due to delays in 2014 Edition
CEHRT availability. Second, the
provider must not have been able to
attest by their attestation deadline in
2014. For example, for eligible
professionals, the eligible professional
must not have been able to attest by
October 1, 2014 using the flexibility
options under the 2014 CEHRT
Flexibility rule. For eligible hospitals,
the eligible hospital must not have been
able to attest by July 1, 2014 using the
flexibility options under the 2014
CEHRT Flexibility rule. We will
recognize an extreme and
uncontrollable circumstance hardship
exception under this IFC only for those
providers meeting both these criteria
and only for the 2015 payment
adjustment.
For CAHs, although we would
recognize a hardship exception for
CAHs under these circumstances, this
exception would have little impact on
CAHs because the hardship exception
application deadline for CAHs for the
2015 payment adjustment does not
occur until November 30, 2015.
Accordingly, CAHs will have ample
time to attest using the flexibility
options under the 2014 CEHRT
Flexibility rule and will not be impacted
in the same manner as eligible hospitals
or eligible professionals, whose
attestation and hardship exception
application deadlines have since
passed. However, as explained below, to
maximize flexibility in the hardship
exception application submission
process for all providers under the
hardship exception categories, so that
we avoid similar situations in the
future, like the ones prompting this IFC,
we are amending § 413.70(a)(6) to allow
CMS the flexibility to specify an
alternate hardship exception application
submission deadline for certain
hardship categories other than
November 30th.
b. Extension of Hardship Exception
Application Deadline to November 30,
2014 for Eligible Professionals and
Eligible Hospitals and Amendments to
§§ 495.102, 412.64, and 413.70.
Section 495.102(d)(4) provides the
categories of hardship exceptions for
EPs, including insufficient internet
access, newly practicing EPs, extreme
circumstances outside of an EP’s
control, lack of control over the
availability of CEHRT for EPs practicing
in multiple locations, lack of face-toface patient interactions and lack of
need for follow-up care, and certain
primary specialties. With the exception
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
of the newly practicing EP hardship
exception category, the EP is required to
file a hardship exception application to
CMS for the remaining hardship
categories no later than July 1st of the
year before the payment adjustment
year.
Similar to eligible professionals,
§ 412.64(d)(4) provides the categories of
hardship exceptions for eligible
hospitals, which include insufficient
internet access, new eligible hospitals,
and extreme and uncontrollable
circumstances outside of an eligible
hospital’s control. Under the hardship
exception categories for insufficient
internet access and extreme and
uncontrollable circumstances, the
eligible hospital is required to file a
hardship exception application to CMS
no later than April 1st of the year before
the payment adjustment year.
Similar to eligible hospitals,
§ 413.70(a)(6) provides the categories of
hardship exceptions that CAHs could
apply for, which include insufficient
internet access, new CAHs, and extreme
and uncontrollable circumstances
outside of a CAH’s control. Under all
hardship exception categories, the CAH
is required to file a hardship exception
application to CMS no later than
November 30th after the close of the
applicable EHR reporting period for a
payment adjustment year to be
considered for a hardship exception.
For purposes of the 2015 payment
adjustment under the Medicare EHR
Incentive Program, the hardship
exception application deadlines for both
eligible hospitals and eligible
professionals have ended. However, we
need to accommodate the extreme and
uncontrollable circumstance hardship
exception recognized under this IFC.
Therefore, for purposes of the 2015
payment adjustment under the Medicare
EHR Incentive Program, we are
extending the hardship exception
application submission deadline for
both eligible hospitals and eligible
professionals to November 30, 2014. We
believe that extending the hardship
exception application deadline to
November 30, 2014 will allow ample
time for those eligible hospitals and
eligible professionals that could not
fully implement 2014 Edition CEHRT
due to 2014 Edition CEHRT availability
delays and that could not attest by their
applicable attestation deadline using the
flexibility options provided in the 2014
CEHRT flexibility rule to file an
application for the hardship exception
recognized under this IFC.
The extension of the hardship
exception application submission
deadline to November 30, 2014, applies
only to those providers who meet the
PO 00000
Frm 00431
Fmt 4701
Sfmt 4700
67977
criteria described under this IFC. We
will not extend, reopen, or reconsider
the hardship exception application
deadline for the 2015 payment
adjustment for any other reason.
Further, as explained above, because
CAHs have still not reached their
November 30, 2015 hardship exception
application deadline, they are not
affected in the same manner as eligible
hospitals and eligible professionals, and
are still eligible to file a hardship
exception application until November
30th under any of the categories
specified under § 413.70(a)(6).
Next, to extend the hardship
exception application deadline to
November 30, 2014, for eligible
hospitals and eligible professionals, we
must amend under this IFC the July 1st
hardship exception application deadline
for extreme and uncontrollable
circumstances under § 495.102(d)(4)(iii)
for eligible professionals and the April
1st deadline under § 412.64(d)(4)(ii)(B)
for eligible hospitals. For eligible
professionals, the new amendment to
§ 495.102(d)(4)(iii) will include,
following the July 1st hardship
exception application submission
deadline specified in the regulation,
language that would enable CMS to
specify a later deadline. For eligible
hospitals, the new amendment to
§ 412.64(d)(4)(ii)(B) will include,
following the April 1st hardship
exception application submission
deadline specified in the regulation,
language that would enable CMS to
specify a later deadline. We are making
these regulatory amendments under this
IFC to allow eligible hospitals and
eligible professionals to take advantage
of the extreme and uncontrollable
circumstances hardship exception
outlined under this IFC. Without such
changes, eligible hospitals and eligible
professionals would be unable to apply
for this hardship exception because the
application deadlines have already
passed.
Finally, we note that, as with the
circumstances described in this IFC that
caused us to extend the deadline to
November 30, 2014, there may be
situations in the future that would
warrant extending the July 1st deadline
for eligible professionals, the April 1st
deadline for eligible hospitals, and the
November 30th deadline for CAHs.
Accordingly, to ensure that we do not
face similar timing constraints in the
future and to reduce administrative
burden on providers who wish to
request a hardship exception, we are
amending the regulation text for the
other hardship exception categories to
enable CMS to specify a later deadline
E:\FR\FM\13NOR2.SGM
13NOR2
67978
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
for submission of hardship exception
applications.
Specifically, for eligible professionals,
in addition to the amendments we cited
above for § 495.102(d)(4)(iii) relating to
the extreme and uncontrollable
circumstances hardship exception
category, we are also amending
§ 495.102(d)(4)(i) (insufficient internet
access) and (d)(4)(iv) (multiple
locations/lack of face-to-face encounters
and need for follow-up/certain primary
specialties) to add similar language.
For eligible hospitals, in addition to
the amendments we cited above for
§ 412.64(d)(4)(ii)(B) relating to the
extreme and uncontrollable
circumstances hardship exception
category, we are also amending
§ 412.64(d)(4)(ii)(A) (lack of internet
access) to add similar language.
For CAHs, we are amending
§ 413.70(a)(6)(ii) to add language similar
to the language added to the regulation
text for eligible professionals and
eligible hospitals, as discussed above.
We believe that the flexibility to specify
a later hardship exception application
submission deadline as set forth above
will prevent situations such as the one
addressed under this IFC where, for
example, an unforeseen circumstance
occurred, which could justify a
hardship exception, but the hardship
exception application submission
deadline has passed. However, we
emphasize that we do not intend to
exercise this flexibility to extend the
hardship exception application
submission deadline frequently. Rather,
to maintain the consistency needed for
our operations, providers should expect
to adhere to the dates specified in the
regulation text and not rely on the
possibility of changes to the hardship
application submission period occurring
on a frequent basis.
ebenthall on DSK5SPTVN1PROD with $$_JOB
IV. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995, we are required to provide 60day notice in the Federal Register and
solicit public comment before a
collection of information requirement is
submitted to the Office of Management
and Budget (OMB) for review and
approval. To fairly evaluate whether an
information collection should be
approved by OMB, section 3506(c)(2)(A)
of the Paperwork Reduction Act of 1995
requires that we solicit comment on the
following issues:
• The need for the information
collection and its usefulness in carrying
out the proper functions of our agency.
• The accuracy of our estimate of the
information collection burden.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
• The quality, utility, and clarity of
the information to be collected.
• Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
Unless noted otherwise, we used data
from the U.S. Bureau of Labor Statistics
for all salary estimates. The estimates
include the cost of fringe benefits,
calculated at 35 percent of salary, which
is based on the Bureau’s June 2012
Employer Costs for Employee
Compensation report.
In the CY 2015 PFS proposed rule (79
FR 40317), we solicited public comment
on each of the section 3506(c)(2)(A)required issues for the following
information collection requirements
(ICRs).
A. Information Collection Requirements
(ICRs)
1. ICRs Regarding the Removal of
Employment Requirements for Services
Furnished Incident to Rural Health
Clinics and Federally Qualified Health
Center Visits
This provision removes the
requirement that nonphysician RHC or
FQHC practitioners be W–2 employees.
This action does not require the
modification of existing contracts or the
creation of new contracts, nor does CMS
collect any information on contracting.
Consequently, the provision is not
subject to the requirements under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
2. ICRs Regarding Access to Identifiable
Data for the Center for Medicare and
Medicaid Models
This provision concerns the
evaluation of models tested under,
section 1115A of the Act. Section
1115(A)(d)(3) of the Act provides that
the Paperwork Reduction Act (44 U.S.C.
3501 et seq.) shall not apply to the
testing, evaluation or expansion of
models under section 1115A of the Act.
3. ICRs Regarding Local Coverage
Determination Process for Clinical
Diagnostic Laboratory Testing
The proposed Clinical Diagnostic
Laboratory LCD Process will not be
finalized. Consequently, the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.) and the LCD process do not
apply to this final rule.
4. ICRs Regarding the Solicitation of
Comments on the Payment Policy for
Substitute Physician Billing
Arrangements
The proposed rule solicited comment
on substitute billing arrangements and
did not set out any new or revised
PO 00000
Frm 00432
Fmt 4701
Sfmt 4700
collection of information requirements.
Consequently, the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.) is
not applicable.
5. ICRs Regarding Reports of Payments
or Other Transfers of Value and
Physician Ownership and Investment
Interests (§ 403.904(c)(8), (d)(3), and (g))
With regard to the following
provisions, no PRA-related comments
were received. The proposed provisions
are being adopted without change.
In § 403.904(c)(8), applicable
manufacturers and applicable group
purchasing organizations (GPOs) must
report the marketed name and
therapeutic area or product category of
covered drugs, devices, biologicals and
medical supplies. The amendment has
non-measurable effect on current
burden estimates since the
manufacturers and GPOs are already
required to report the marketed name
for drugs and biologicals and report the
marketed name, therapeutic area, or
product category for devices and
medical supplies. While the
requirement has no burden
implications, the provision will be
submitted to OMB for approval under
control number 0938–1173 (CMS–
10419).
In § 403.904(d)(3), applicable
manufacturers and applicable GPOs
must report the form of payment or
other transfers of value as: Cash or cash
equivalent, in-kind items or services,
stock, stock option, or any other
ownership investment. The burden
associated with this provision is the
time and effort it will take each
applicable manufacturer and applicable
GPO to revise their reporting system to
report the form of payment.
The removal of § 403.904(g) requires
that applicable manufacturers and
applicable GPOs of covered drugs,
devices, biologicals, and medical
supplies report annually to CMS all
payments or other transfers of value
provided as compensation for speaking
at a continuing education program. The
ongoing burden associated with this
provision is the time and effort it will
take each applicable manufacturer and
applicable GPO to report payments or
other transfers of value to CMS which
were provided to physicians at a
continuing education program. We
estimate that it will take 1.0 hour to
report payments or other transfers of
value to CMS which were provided to
physician at a continuing education
program.
We estimate that it will take 1.0 hour
to report payments or other transfers of
value to CMS which were provided to
physician covered recipients as
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
compensation for speaking at a
continuing education program and 0.5
hours to revise an applicable
manufacturer or applicable GPO’s
reporting system to report the form of
payment.
In deriving these figures, we used the
following hourly labor rates and
estimated the time to complete each
task: $26.39/hr and 1.0 hours for
support staff to report payments or other
transfers of value to CMS which were
provided to physician covered
recipients as compensation for speaking
at a continuing education program and
$4+7.55/hr and 0.5 hours for support to
revise their reporting system to report
the form of payment.
The preceding requirements and
burden estimates will be added to the
existing PRA-related requirements and
burden estimates that have been
approved by OMB under control
number 0938–1173 (CMS–10419).
ebenthall on DSK5SPTVN1PROD with $$_JOB
6. ICRs Regarding Physician Payment,
Efficiency, and Quality Improvements—
Physician Quality Reporting System
With regard to the following
provisions, no PRA-related comments
were received. The proposed provisions
are being adopted without change.
The annual burden estimate is
calculated separately for the 2017 PQRS
payment adjustment (the reporting
periods of which occur in 2015): (1)
Individual eligible professionals and
group practices using the claims (for
eligible professionals only), (2) qualified
registry and QCDR, (3) EHR-based
reporting mechanisms, and (4) group
practices using the group practice
reporting option (GPRO). Please note
that we are grouping group practices
using the qualified registry and EHRbased reporting mechanisms with the
burden estimate for individual eligible
professionals using the qualified registry
and EHR-based reporting mechanisms
because we believe the criteria for
satisfactory reporting for group practices
using these 2 reporting mechanisms
under the GPRO are similar to the
satisfactory reporting criteria for eligible
professionals using these reporting
mechanisms.
a. Burden Estimate for PQRS Reporting
by Individual Eligible Professionals:
Reporting in General
According to the 2012 Reporting
Experience, ‘‘more than 1.2 million
eligible professionals were eligible to
participate in the 2012 PQRS, Medicare
Shared Savings Program, and Pioneer
ACO Model.’’ 31 In this burden estimate,
31 Centers for Medicare and Medicaid Services,
2012 Reporting Experience Including Trends (2007–
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
we assume that 1.2 million eligible
professionals, the same number of
eligible professionals eligible to
participate in the PQRS in 2012, will be
eligible to participate in the PQRS.
Historically, the PQRS has never
experienced 100 percent participation
in reporting for the PQRS. Therefore, we
believe that although 1.2 million eligible
professionals will be subject to the 2017
PQRS payment adjustment, not all
eligible participants will report quality
measures data for purposes of the 2017
PQRS payment adjustment. In this
burden estimate, we will only provide
burden estimates for the eligible
professionals and group practices who
attempt to submit quality measures data
for purposes of the 2017 PQRS payment
adjustment.
In 2012, 435,871 eligible professionals
(36 percent of eligible professionals,
including those who belonged to group
practices that reported under the GPRO
and eligible professionals within an
ACO that participated in the PQRS via
the Shared Savings Program or Pioneer
ACO model) participated in the PQRS,
Medicare Shared Savings Program, or
Pioneer ACO Model.32 We expect to see
a significant increase in participation in
reporting for the PQRS in 2015 than
2012 as eligible professionals were not
subject to a PQRS payment adjustment
in 2012. Last year, we estimated that we
would see a 50 percent participation
rate in 2015. We still believe that a 14
percent increase in participation from
2012 is reasonable in 2015. Therefore,
we estimate that 50 percent of eligible
professionals (or approximately 600,000
eligible professionals) will report
quality measures data for purposes of
the 2017 PQRS payment adjustment.
With respect to the PQRS, the burden
associated with the requirements of this
voluntary reporting initiative is the time
and effort associated with individual
eligible professionals identifying
applicable quality measures for which
they can report the necessary
information, selecting a reporting
option, and reporting the information on
their selected measures or measures
group to CMS using their selected
reporting option.
We believe the labor associated with
eligible professionals and group
practices reporting quality measures
data in the PQRS is primarily handled
by an eligible professional’s or group
practice’s billing clerk or computer
analyst trained to report quality
measures data. Therefore, we will
2013): Physician Quality Reporting System and
Electronic Prescribing (eRx) Incentive Program,
March 14, 2014, at xiii.
32 Id. at XV.
PO 00000
Frm 00433
Fmt 4701
Sfmt 4700
67979
consider the hourly wage of a billing
clerk and computer analyst in our
estimates. For purposes of this burden
estimate, we assume that a billing clerk
will handle the administrative duties
associated with participating in the
PQRS. According to information
published by the Bureau of Labor
Statistics, available at https://
www.bls.gov/oes/current/
oes433021.htm, the mean hourly wage
for a billing clerk is approximately
$32.00/hour. Therefore, for purposes of
handling administrative duties, we
estimate an average labor cost of $32.00/
hour. In addition, for purposes of this
burden estimate, we assume that a
computer analyst will engage in the
duties associated with the reporting of
quality measures. According to
information published by the Bureau of
Labor Statistics, available at https://
www.bls.gov/oes/current/
oes151121.htm, the mean hourly wage
for a computer analyst is approximately
$82.00/hour. Therefore, for purposes of
reporting on quality measures, we
estimate an average labor cost of $82.00/
hour.
Please note that, in assessing PQRSspecific burden estimates, to account for
benefits and overhead associated with
labor in addition to the hourly wage
costs described above, we are doubling
the wage rates in our estimates. While
we accounted for fringe benefits in the
NPRM’s wage estimates, we did not
double the wage rates in those
estimates.
For individual eligible professionals,
the burden associated with the
requirements of this reporting initiative
is the time and effort associated with
eligible professionals identifying
applicable quality measures for which
they can report the necessary
information, collecting the necessary
information, and reporting the
information needed to report the eligible
professional’s measures. We believe it is
difficult to accurately quantify the
burden because eligible professionals
may have different processes for
integrating the PQRS into their
practice’s work flows. Moreover, the
time needed for an eligible professional
to review the quality measures and
other information, select measures
applicable to his or her patients and the
services he or she furnishes to them,
and incorporate the use of quality data
codes into the office work flows is
expected to vary along with the number
of measures that are potentially
applicable to a given professional’s
practice. Since eligible professionals are
generally required to report on at least
9 measures covering at least 3 National
Quality Strategy domains criteria for
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67980
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
satisfactory reporting (or, in lieu of
satisfactory reporting, satisfactory
participation in a QCDR) for the 2017
PQRS payment adjustment, we assume
that each eligible professional reports on
an average of 9 measures for this burden
analysis.
For eligible professionals who are
participating in PQRS for the first time,
we will assign 5 total hours as the
amount of time needed for an eligible
professional’s billing clerk to review the
PQRS measures list, review the various
reporting options, select the most
appropriate reporting option, identify
the applicable measures or measures
groups for which they can report the
necessary information, review the
measure specifications for the selected
measures or measures groups, and
incorporate reporting of the selected
measures or measures groups into the
office work flows. The measures list
contains the measure title and brief
summary information for the eligible
professional to review. Assuming the
eligible professional has received no
training from his/her specialty society,
we estimate it will take an eligible
professional’s billing clerk up to 2 hours
to review this list, review the reporting
options, and select a reporting option
and measures on which to report. If an
eligible professional has received
training, then we believe this would
take less time. CMS believes 3 hours is
plenty of time for an eligible
professional to review the measure
specifications of 9 measures or 1
measures group they select to report for
purposes of participating in PQRS and
to develop a mechanism for
incorporating reporting of the selected
measures or measures group into the
office work flows. Therefore, we believe
that the start-up cost for an eligible
professional to report PQRS quality
measures data is 5 hours × $32/hour =
$160.
We continue to expect the ongoing
costs associated with PQRS
participation to decline based on an
eligible professional’s familiarity with
and understanding of the PQRS,
experience with participating in the
PQRS, and increased efforts by CMS and
stakeholders to disseminate useful
educational resources and best
practices.
We believe the burden associated
with reporting the quality measures will
vary depending on the reporting
mechanism selected by the eligible
professional. As such, we break down
the burden estimates by eligible
professionals and group practices
participating in the GPRO according to
the reporting mechanism used.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
b. Burden Estimate for PQRS Reporting
by Individual Eligible Professionals and
Group Practices: Claims-Based
Reporting Mechanism
According to the 2011 PQRS and eRx
Experience Report, in 2011, 229,282 of
the 320,422 eligible professionals (or 72
percent) of eligible professionals used
the claims-based reporting mechanism.
According to the 2012 Reporting
Experience, 248,206 eligible
professionals participated in the PQRS
using the claims-based reporting
mechanism in 2012.33 Preliminary
estimates show that 252,567 eligible
professionals participated in the PQRS
using the claims-based reporting
mechanism in 2013.34
According to the historical data cited
above, while the claims-based reporting
mechanism is still the most widely-used
reporting mechanism, we are seeing a
decline in the use of the claims-based
reporting mechanism in the PQRS.
While these eligible professionals
continue to participate in the PQRS,
these eligible professionals have started
to shift towards the use of other
reporting mechanisms—mainly the
GPRO Web interface (whether used by
a PQRS GPRO or an ACO participating
in the PQRS via the Medicare Shared
Savings Program or the Pioneer ACO
Model), registry, or the EHR-based
reporting mechanisms. For purposes of
this burden estimate, based on PQRS
participation using the claims-based
reporting mechanism in 2012 and 2013,
we assume that approximately 250,000
eligible professionals will participate in
the PQRS using the claims-based
reporting mechanism.
For the claims based reporting option,
eligible professionals must gather the
required information, select the
appropriate quality data codes (QDCs),
and include the appropriate QDCs on
the claims they submit for payment. The
PQRS will collect QDCs as additional
(optional) line items on the existing
HIPAA transaction 837 P and/or CMS
form CMS–1500 (OMB control number
0938–0999). We do not anticipate any
new forms and or any modifications to
the existing transaction or form. We also
do not anticipate changes to the 837 P
or CMS–1500 for CY 2015.
We estimate the cost for an eligible
professional to review the list of quality
measures or measures groups, identify
the applicable measures or measures
groups for which they can report the
necessary information, incorporate
reporting of the selected measures into
the office work flows, and select a PQRS
33 Id.
at xvi. See Figure 4.
34 Id.
PO 00000
Frm 00434
Fmt 4701
Sfmt 4700
reporting option to be approximately
$410 per eligible professional ($82 per
hour × 5 hours).
Based on our experience with the
Physician Voluntary Reporting Program
(PVRP), we continue to estimate that the
time needed to perform all the steps
necessary to report each measure (that
is, reporting the relevant quality data
code(s) for 9 measures measure) would
range from 15 seconds (0.25 minutes) to
over 12 minutes for complicated cases
and/or measures, with the median time
being 1.75 minutes. To report 9
measures, we estimate that it will take
approximately 2.25 minutes to 108
minutes to perform all of the necessary
reporting steps.
Per measure, at an average labor cost
of $82/hour per practice, the cost
associated with this burden will range
from $0.34 to about $16.40 for more
complicated cases and/or measures,
with the cost for the median practice
being $2.40. To report 9 measures, using
an average labor cost of $82/hour, we
estimated that the cost of reporting for
an eligible professional via claims will
range from $3.07 (2.25 minutes or
0.0375 hours × $82/hour) to $147.60
(108 minutes or 1.8 hours × $82/hour)
per reported case.
The total estimated annual burden for
this requirement will also vary along
with the volume of claims on which
quality data is reported. In previous
years, when we required reporting on 80
percent of eligible cases for claims based
reporting, we found that on average, the
median number of reporting instances
for each of the PQRS measures was 9.
Since we reduced the required reporting
rate by over one-third to 50 percent,
then for purposes of this burden
analysis we assume that an eligible
professional or eligible professional in a
group practice will need to report each
selected measure for 6 reporting
instances. The actual number of cases
on which an eligible professional or
group practice is required to report
quality measures data will vary,
however, with the eligible professional’s
or group practice’s patient population
and the types of measures on which the
eligible professional or group practice
chooses to report (each measure’s
specifications includes a required
reporting frequency).
Based on these assumptions, we
estimate that the total annual reporting
burden per individual eligible
professional associated with claims
based reporting will range from 13.5
minutes (0.25 minutes per measure × 9
measures × 6 cases per measure) to 648
minutes (12 minutes per measure × 9
measures × 6 cases per measure), with
the burden to the median practice being
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
94.5 minutes (1.75 minutes per measure
× 9 measures × 6 cases). We estimate the
total annual reporting cost per eligible
professional or eligible professional in a
group practice associated with claims
based reporting will range from $18.36
($0.34 per measure × 9 measures × 6
cases per measure) to $885.60 ($16.40
per measure × 9 measures × 6 cases per
measure), with the cost to the median
practice being $129.60 per eligible
professional ($2.40 per measure × 9
measures × 6 cases per measure).
c. Burden Estimate for PQRS Reporting
by Individual Eligible Professionals and
Group Practices: Qualified RegistryBased and QCDR-Based Reporting
Mechanisms
In 2011, approximately 50,215 (or 16
percent) of the 320,422 eligible
professionals participating in PQRS
used the qualified registry-based
reporting mechanism. According to the
2012 Reporting Experience, 36,473
eligible professionals reported
individual measures via the registrybased reporting mechanism, and 10,478
eligible professionals reporting
measures groups via the registry-based
reporting mechanism in 2012.35
Therefore, approximately 47,000 eligible
professionals participated in the PQRS
using the registry-based reporting
mechanism in 2012. Please note that we
currently have no data on participation
in the PQRS via a QCDR as 2014 is the
first year in which an eligible
professional may participate in the
PQRS via a QCDR.
We believe that the rest of the eligible
professionals not participating in other
PQRS reporting mechanisms will use
either the registry or QCDR reporting
mechanisms for the following reasons:
• The PQRS measures set is moving
away from use of claims-based measures
and moving towards the use of registrybased measures.
• We believe the number of QCDR
vendors will increase as the QCDR
reporting mechanism evolves.
Therefore, based on these
assumptions, we expect to see a
significant jump from 47,000 eligible
professionals to approximately 165,000
eligible professionals using either the
registry-based reporting mechanism or
QCDR in 2015. We believe the majority
of these eligible professionals will
participate in the PQRS using a QCDR,
as we presume QCDRs will be larger
entities with more members.
For qualified registry based and
QCDR-based reporting, there will be no
additional time burden for eligible
professionals or group practices to
35 Id.
at xvi. See Figure 4.
VerDate Sep<11>2014
20:15 Nov 12, 2014
report data to a qualified registry as
eligible professionals and group
practices opting for qualified registry
based reporting or use of a QCDR will
more than likely already be reporting
data to the qualified registry for other
purposes and the qualified registry will
merely be repackaging the data for use
in the PQRS. Little, if any, additional
data will need to be reported to the
qualified registry or QCDR solely for
purposes of participation in the PQRS.
However, eligible professionals and
group practices will need to authorize or
instruct the qualified registry or QCDR
to submit quality measures results and
numerator and denominator data on
quality measures to CMS on their
behalf. We estimate that the time and
effort associated with this will be
approximately 5 minutes per eligible
professional or eligible professional
within a group practice.
Please note that, unlike the claimsbased reporting mechanism that would
require an eligible professional to report
data to CMS on quality measures on
multiple occasions, an eligible
professional would not be required to
submit this data to CMS, as the qualified
registry or QCDR would perform this
function on the eligible professional’s
behalf.
d. Burden Estimate for PQRS Reporting
by Individual Eligible Professionals and
Group Practices: EHR-Based Reporting
Mechanism
According to the 2011 PQRS and eRx
Experience Report, in 2011, 560 (or less
than 1 percent) of the 320,422 eligible
professionals participating in PQRS
used the EHR-based reporting
mechanism. In 2012 there was a sharp
increase in reporting via the EHR-based
reporting mechanism. Specifically,
according to the 2012 Reporting
Experience, in 2012, 19,817 eligible
professionals submitted quality data for
the PQRS through a qualified EHR.36
We believe the number of eligible
professionals and group practices using
the EHR-based reporting mechanism
will steadily increase as eligible
professionals become more familiar
with EHR products and more eligible
professionals participate in programs
encouraging the use of an EHR, such as
the EHR Incentive Program. In
particular, we believe eligible
professionals will transition from using
the claims-based to the EHR-based
reporting mechanism. To account for
this anticipated increase, we continue to
estimate that approximately 50,000
eligible professionals, whether
participating as an individual or part of
36 Id.
Jkt 235001
PO 00000
at xv.
Frm 00435
Fmt 4701
Sfmt 4700
67981
a group practice under the GPRO, would
use the EHR-based reporting mechanism
in CY 2015.
For EHR-based reporting, which
includes EHR reporting via a direct EHR
product and an EHR data submission
vendor’s product, the eligible
professional or group practice must
review the quality measures on which
we will be accepting PQRS data
extracted from EHRs, select the
appropriate quality measures, extract
the necessary clinical data from his or
her EHR, and submit the necessary data
to the CMS-designated clinical data
warehouse.
For EHR based reporting for the
PQRS, the individual eligible
professional or group practice may
either submit the quality measures data
directly to CMS from their EHR or
utilize an EHR data submission vendor
to submit the data to CMS on the
eligible professional’s or group
practice’s behalf. To submit data to CMS
directly from their EHR, the eligible
professional or eligible professional in a
group practice must have access to a
CMS specified identity management
system, such as IACS, which we believe
takes less than 1 hour to obtain. Once
an eligible professional or eligible
professional in a group practice has an
account for this CMS specified identity
management system, he or she will need
to extract the necessary clinical data
from his or her EHR, and submit the
necessary data to the CMS designated
clinical data warehouse. With respect to
submitting the actual data file for the
respective reporting period, we believe
that this will take an eligible
professional or group practice no more
than 2 hours, depending on the number
of patients on which the eligible
professional or group practice is
submitting. We believe that once the
EHR is programmed by the vendor to
allow data submission to CMS, the
burden to the eligible professional or
group practice associated with
submission of data on quality measures
should be minimal as all of the
information required to report the
measure should already reside in the
eligible professional’s or group
practice’s EHR.
e. Burden Estimate for PQRS Reporting
by Group Practices Using the GPRO
Web Interface
As we noted in last year’s estimate,
according to the 2011 Experience
Report, approximately 200 group
practices participated in the GPRO in
2011. According to the 2012 Reporting
Experience, 66 practices participated in
E:\FR\FM\13NOR2.SGM
13NOR2
67982
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
the PQRS GPRO.37 In addition, 144
ACOs participated in the PQRS GPRO
through either the Medicare Shared
Savings Program (112 ACOs) or Pioneer
ACO Model (32 practices).38 These
group practices encompass 134,510
eligible professionals (or approximately
140,000 eligible professionals).39 Since
it seems that roughly 200 group
practices participated in the GPRO in
2011 and 2012, based on these numbers,
we assume that 200 group practices
(accounting for approximately 135,000
eligible professionals) will participate in
the PQRS using the GPRO web interface
in 2015.
With respect to the process for group
practices to be treated as satisfactorily
submitting quality measures data under
the PQRS, group practices interested in
participating in the PQRS through the
GPRO must complete a self-nomination
process similar to the self-nomination
process required of qualified registries.
However, since a group practice using
the GPRO web interface would not need
to determine which measures to report
under PQRS, we believe that the selfnomination process is handled by a
group practice’s administrative staff.
Therefore, we estimate that the selfnomination process for the group
practices for the PQRS involves
approximately 2 hours per group
practice to review the PQRS GPRO and
make the decision to participate as a
group rather than individually and an
additional 2 hours per group practice to
draft the letter of intent for selfnomination, gather the requested TIN
and NPI information, and provide this
requested information. It is estimated
that each self-nominated entity will also
spend 2 hours undergoing the vetting
process with CMS officials. We assume
that the group practice staff involved in
the group practice self-nomination
37 Id.
at xv.
at xvi.
39 Id. at 18.
ebenthall on DSK5SPTVN1PROD with $$_JOB
38 Id.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
process has an average practice labor
cost of $32 per hour. Therefore,
assuming the total burden hours per
group practice associated with the group
practice self-nomination process is 6
hours, we estimate the total cost to a
group practice associated with the group
practice self-nomination process to be
approximately $192 ($32 per hour × 6
hours per group practice).
The burden associated with the group
practice reporting requirements under
the GPRO is the time and effort
associated with the group practice
submitting the quality measures data.
For physician group practices, this
would be the time associated with the
physician group completing the web
interface. We estimate that the time and
effort associated with using the GPRO
web interface will be comparable to the
time and effort associated to using the
PAT. As stated above, the information
collection components of the PAT have
been reviewed by OMB and are
approved under control number 0938–
0941(form CMS–10136) with an
expiration date of July 31, 2015, for use
in the PGP, MCMP, and EHR
demonstrations. As the GPRO was only
recently implemented in 2010, it is
difficult to determine the time and effort
associated with the group practice
submitting the quality measures data.
As such, we will use the same burden
estimate for group practices
participating in the GPRO as we use for
group practices participating in the PGP,
MCMP, and EHR demonstrations. Since
these changes will not have any impact
on the information collection
requirements associated with the PAT
and we will be using the same data
submission process used in the PGP
demonstration, we estimate that the
burden associated with a group practice
completing data for PQRS under the
web interface will be the same as for the
group practice to complete the PAT for
the PGP demonstration. In other words,
PO 00000
Frm 00436
Fmt 4701
Sfmt 4700
we estimate that, on average, it will take
each group practice 79 hours to submit
quality measures data via the GPRO web
interface at a cost of $82 per hour.
Therefore, the total estimated annual
cost per group practice is estimated to
be approximately $6,478.
7. ICRs Regarding the Medicare Shared
Savings Program
Section 3022 of the Affordable Care
Act exempts any collection of
information associated with the
Medicare Shared Savings Program from
the requirements of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.).
8. ICRs Regarding Interim Revisions to
the Electronic Health Record (EHR)
Incentive Program
This rule does not impose new or
alter existing reporting, recordkeeping,
or third-party disclosure requirements.
Consequently, it need not be reviewed
by OMB under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
9. ICRs Regarding the Extreme and
Uncontrollable Circumstances Hardship
Exception
With regard to the hardship
application, this rule will not impose
any new or revised reporting,
recordkeeping, or third-party disclosure
requirements and therefore, does not
require additional OMB review under
the authority of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.). The application’s information
collection requirements and burden
have been approved by OMB under
OMB control number 0938–1158 (CMS–
10336).
B. Summary of Final Burden Estimates
Table 92 summarizes this rule’s
requirements and burden estimates.
BILLING CODE 4120–01–P
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
67983
TABLE 92: Annual Recordkeepmg and Reporting ReqUirements and Burden
Regulation
Section(s)
403.904(d)(3)
OMB
&
CMS
ID#s
Respondents
09381173
(CMS10419
1,150
(manufacturers)
Responses
(total)
1,150
420
420 (GPOs)
CY 2015
PQRS (start
up for first
time
participants)
CY 2015
PQRS
(ClaimsBased
Reporting
Mechanism)
Total
Annual
Burden
(hours)
1,150
Labor Cost
of Reporting
($/hr)
26.39
Total Cost
($)
30,349
575
47.55
27,341
420
26.39
11,084
210
47.55
9,986
820,000
16.00
13,120,000
09381059
(CMS10276)
09381059
(CMS10276)
164,000
250,000
250,000
(preparation
and
reporting)
5.2241
1,306,025
82.00
107,090,000
165,000
5min
13,750
N/A*
N/A
50,000
50,000
N/A**
N/A
N/A
N/A
09381059
(CMS10276)
CY 2015
PQRS (ERRBased
Reporting
Mechanism)
164,000
165,000
09381059
(CMS10276)
CY 2015
PQRS
(Qualified
Registrybased and
QCDR-based
Reporting
Mechanisms)
17,000
1,334,000
6hr
192.00
200 (self200
CY 2015
nomination
PQRS
0938process)
(Group
1059
Practices
79 hr
200
(CMSUsing the
(reporting)
10276)
GPROWeb
Interface)
2,159,130
TOTAL
121,622,760
14,130,970
630,770
*There 1s no set cost. As explained above, the cost wtll vary dependtng on the regtstry used. Additionally, many
EPs and group practices using a registry or QCDR will most likely use a registry or QCDR for other purposes.
**As explained above, the burden associated with the submission of data is minimal.
BILLING CODE 4120–01–C
C. Submission of PRA-Related
Comments
We have submitted a copy of this rule
to OMB for its review of the rule’s
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00437
Fmt 4701
Sfmt 4700
information collection and
recordkeeping requirements. These
requirements are not effective until they
have been approved by OMB.
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.164</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
Burden
(time) per
Response
1.0 hr
(reporting)
0.5 hr
(system
upgrades)
1.0 hr
(reporting)
0.5 hr
(system
upgrades)
5hr
67984
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
To obtain copies of the supporting
statement and any related forms for the
paperwork collections referenced above,
access CMS’ Web site at https://
www.cms.hhs.gov/
PaperworkReductionActof1995; email
your request, including your address,
phone number, OMB number, and CMS
document identifier, to Paperwork@
cms.hhs.gov; or call the Reports
Clearance Office at 410–786–1326.
When commenting on the stated
information collections, please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be received by the OMB desk officer via
one of the following transmissions:
Mail: OMB, Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, Fax: (202) 395–5806 OR, Email:
OIRA_submission@omb.eop.gov.
PRA-specific comments must be
received by December 1, 2014.
V. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
VI. Waiver of Proposed Rulemaking
and Waiver of Delay in Effective Date
ebenthall on DSK5SPTVN1PROD with $$_JOB
A. PFS provisions
We ordinarily publish a notice of
proposed rulemaking in the Federal
Register and invite public comment on
the proposed rule. The notice of
proposed rulemaking includes a
reference to the legal authority under
which the rule is proposed, and the
terms and substance of the proposed
rule or a description of the subjects and
issues involved. This procedure can be
waived, however, if an agency finds
good cause that a notice-and-comment
procedure is impracticable,
unnecessary, or contrary to the public
interest and incorporates a statement of
the finding and its reasons in the rule
issued.
We utilize HCPCS codes for Medicare
payment purposes. The HCPCS is a
national coding system comprised of
Level I (CPT) codes and Level II (HCPCS
National Codes) that are intended to
provide uniformity to coding
procedures, services, and supplies
across all types of medical providers
and suppliers. Level I (CPT) codes are
copyrighted by the AMA and consist of
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
several categories, including Category I
codes which are 5-digit numeric codes,
and Category III codes which are
temporary codes to track emerging
technology, services, and procedures.
The AMA issues an annual update of
the CPT code set each Fall, with January
1 as the effective date for implementing
the updated CPT codes. The HCPCS,
including both Level I and Level II
codes, is similarly updated annually on
a CY basis. Annual coding changes are
not available to the public until the Fall
immediately preceding the annual
January update of the PFS. Because of
the timing of the release of these new
and revised codes, it is impracticable for
us to provide prior notice and solicit
comment on these codes and the RVUs
assigned to them in advance of
publication of the final rule that
implements the PFS. Yet, it is
imperative that these coding changes be
accounted for and recognized timely
under the PFS for payment because
services represented by these codes will
be furnished to Medicare beneficiaries
by physicians and practitioners during
the CY in which they become effective.
Moreover, regulations implementing
HIPAA (42 CFR parts 160 and 162)
require that the HCPCS be used to report
health care services, including services
paid under the PFS. We assign interim
RVUs to any new and revised codes
based on a review of the RUC
recommendations for valuing these
services. We also assign interim RVUs to
certain codes for which we did not
receive specific RUC recommendations,
but that are components of new
combined codes. We set interim RVUs
for the component codes in order to
conform them to the value of the
combined code. Finally, we assign
interim RVUs to certain codes for which
we received RUC recommendations for
only one component (work or PE) but
not both. By reviewing these RUC
recommendations for the new and
revised codes, we are able to assign
RVUs to services based on input from
the medical community and to establish
payment for them, on an interim basis,
that corresponds to the relative
resources associated with furnishing the
services. We are also able to determine,
on an interim final basis, whether the
codes will be subject to other payment
policies. If we did not assign RVUs to
new and revised codes on an interim
basis, the alternative would be to either
not pay for these services during the
initial CY or have each Medicare
contractor establish a payment rate for
these new codes. We believe both of
these alternatives are contrary to the
public interest, particularly since the
PO 00000
Frm 00438
Fmt 4701
Sfmt 4700
RUC process allows for an assessment of
the valuation of these services by the
medical community prior to our
establishing payment for these codes on
an interim basis. Therefore, we believe
it would be contrary to the public
interest to delay establishment of fee
schedule payment amounts for these
codes until notice and comment
procedures could be completed.
This final rule with comment period
revises the process we will use to
address new, revised in order to
minimize the need to establish RVUs on
an interim final basis beginning with
rulemaking for CY 2017. However, for
the reasons previously outlined in this
section, we find good cause to waive the
notice of proposed rulemaking for the
interim RVUs for selected procedure
codes identified in Addendum C and to
establish RVUs for these codes on an
interim final basis for CY 2015. We are
providing a 60-day public comment
period.
Section II.E. of this final rule with
comment period discusses our review
and decisions regarding the RUC
recommendations. Similar to the RUC
recommendations for new and revised
codes previously discussed, due to the
timing of the RUC recommendations for
the services identified as potentially
misvalued codes, it is impracticable for
CMS to provide for notice and comment
regarding specific revisions prior to
publication of this final rule with
comment period. We believe it is in the
public interest to implement the revised
RVUs for the codes that were identified
as misvalued, and that have been
reviewed and re-evaluated by the RUC,
on an interim final basis for CY 2015.
The revised RVUs for these codes will
establish a more appropriate payment
that better corresponds to the relative
resources involved in furnishing these
services. A delay in implementing
revised values for these misvalued
codes would not only perpetuate the
known misvaluation for these services,
it would also perpetuate distortion in
the payment for other services under the
PFS. Implementing the changes on an
interim basis allows for a more equitable
resource-based distribution of payments
across all PFS services. We believe a
delay in implementation of these
revisions would be contrary to the
public interest, particularly since the
RUC process allows for an assessment of
the valuation of these services by the
medical community prior to the RUC’s
recommendation to CMS. This final rule
with comment period revises the
process we will use to address
misvalued codes in order to minimize
the need to establish RVUs on an
interim final basis beginning with
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
rulemaking for CY 2017. However, for
the reasons previously described, we
find good cause to waive notice and
comment procedures with respect to the
misvalued codes and to revise RVUs for
these codes on an interim final basis for
CY 2015. We are providing a 60-day
public comment period.
ebenthall on DSK5SPTVN1PROD with $$_JOB
B. FQHC PPS Rates and Adjustments
We ordinarily publish a notice of
proposed rulemaking in the Federal
Register and invite public comment on
the proposed rule before publishing a
final rule that responds to comments
and sets forth final regulations that
generally take effect at least 30 days
later. This procedure can be waived,
however, if an agency finds good cause
that a notice-and-comment procedure is
impracticable, unnecessary, or contrary
to the public interest and incorporates a
statement of the finding and its reasons
in the rule issued.
In the May 2, 2014, interim final rule
(79 FR 25462), we updated
§ 405.2411(b)(2) so that it reflects
section 1888(e)(2)(A)(iv) of the Act (as
amended by section 410 of the MMA),
which excludes certain RHC and FQHC
practitioner services from consolidated
billing and allows such services to be
separately billable under Part B when
furnished to a resident of a SNF during
a covered Part A stay.
However, in making this revision, we
inadvertently neglected to make a
conforming change in § 411.15(p)(2),
which enumerates the individual
services that are excluded from the SNF
consolidated billing provision, as well
as in § 489.20(s), which specifies
compliance with consolidated billing as
a requirement of the SNF’s Medicare
provider agreement. Accordingly, we
are now rectifying that omission in this
final rule with comment period, by
making a conforming technical revision
in § 411.15(p)(2) and § 489.20(s).
These particular revisions merely
provide technical corrections to the
regulations, without making any
substantive changes. Therefore, for good
cause, we waive notice and comment
procedures for the revisions to the
regulations text in parts 411 and 489.
C. Interim Final Revisions to the
Electronic Health Record (EHR)
Incentive Program
We ordinarily publish a notice of
proposed rulemaking in the Federal
Register and invite public comment on
the proposed rule. The notice of
proposed rulemaking includes a
reference to the legal authority under
which the rule is proposed, and the
terms and substance of the proposed
rule or a description of the subjects and
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
issues involved. This procedure can be
waived, however, if an agency finds
good cause that a notice-and-comment
procedure is impracticable,
unnecessary, or contrary to the public
interest and incorporates a statement of
the finding and its reasons in the rule
issued.
With regard to the interim revisions to
the Electronic Health Record (EHR)
Incentive Program, we find good cause
to waive the notice-and-comment
procedure as contrary to the public
interest. We believe that providing
notice and a comment period would
prevent us from providing relief from
the circumstances outlined in section
III.Q. A delay would interfere with the
ability of eligible professionals and
eligible hospitals to request a hardship
exception for the extreme and
uncontrollable circumstances specified
under this IFC given that the hardship
applications deadlines have since
passed for both eligible professionals
and eligible hospitals. Any delay to this
IFC would potentially subject providers
to the 2015 payment adjustment under
the Medicare EHR Incentive Program
and potentially decrease participation in
the EHR Incentive Programs, thereby
creating a negative impact to the
forward movement of the EHR Incentive
Programs. For these reasons, we find
good cause to waive the notice of
proposed rulemaking for these revisions
to the EHR Incentive Program and to
establish these revisions on an interim
final basis. We are providing a 60-day
public comment period.
We ordinarily provide a 60-day delay
in the effective date of final rules after
the date they are issued. The 60-day
delay in effective date can be waived,
however, if the agency finds for good
cause that the delay is impracticable,
unnecessary, or contrary to the public
interest, and the agency incorporates a
statement of the findings and its reasons
in the rule issued. The delayed effective
date may also be waived in the case of
a substantive rule which grants or
recognizes an exemption or relieves a
restriction. For the reasons set forth
below, we believe it would be contrary
to the public interest to delay the
effective date of the interim final
revisions to the EHR Incentive Program
described in section III.Q of this final
rule with comment period We also
believe these interim final revisions
relieve a restriction.
The IFC recognizes a hardship
exception based on extreme and
uncontrollable circumstances, which
could potentially provide relief from the
application of the 2015 payment
adjustment under the Medicare EHR
Incentive Program to certain providers.
PO 00000
Frm 00439
Fmt 4701
Sfmt 4700
67985
This IFC would also relieve a restriction
by amending the existing deadlines in
the regulation text for providers to apply
for hardship exceptions from the
payment adjustments. Unless these
amendments to the deadlines are made
effective immediately, eligible hospitals
and eligible professionals would not
have enough time to take advantage of
the November 30th extended hardship
exception application submission
period specified in this IFC, given that
their hardship exception application
submission deadlines have since
passed. We find good cause to waive the
delayed effective date of the interim
final revisions to the EHR Incentive
Program and find that they relieve an
existing restriction by changing the
deadlines by which providers must
apply for hardship exceptions. These
provisions will be effective on October
31, 2014.
VI. Regulatory Impact Analysis
A. Statement of Need
This final rule with comment period
is necessary to make payment and
policy changes under the Medicare PFS
and to make required statutory changes
under the Pathway for SGR Reform Act
of 2013 and the PAMA. This final rule
with comment period also is necessary
to make changes to Part B payment
policy for clinical diagnostic lab tests
and other Part B related policies. This
rule also implements aspects of the data
collection required under section
1115A(b)(4) of the Act.
B. Overall Impact
We have examined the impact of this
rule as required by Executive Order
12866 on Regulatory Planning and
Review (September 30, 1993), Executive
Order 13563 on Improving Regulation
and Regulatory Review (February 2,
2013), the Regulatory Flexibility Act
(RFA) (September 19, 1980, Pub. L. 96–
354), section 1102(b) of the Social
Security Act, section 202 of the
Unfunded Mandates Reform Act of 1995
(March 22, 1995; Pub. L. 104–4),
Executive Order 13132 on Federalism
(August 4, 1999) and the Congressional
Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). A regulatory impact analysis
(RIA) must be prepared for major rules
with economically significant effects
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67986
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
($100 million or more in any 1 year). We
estimate, as discussed below in this
section, that the PFS provisions
included in this final rule with
comment period will redistribute more
than $100 million in 1 year. Therefore,
we estimate that this rulemaking is
‘‘economically significant’’ as measured
by the $100 million threshold, and
hence also a major rule under the
Congressional Review Act. Accordingly,
we have prepared a RIA that, to the best
of our ability, presents the costs and
benefits of the rulemaking. The RFA
requires agencies to analyze options for
regulatory relief of small entities. For
purposes of the RFA, small entities
include small businesses, nonprofit
organizations, and small governmental
jurisdictions. Most hospitals,
practitioners and most other providers
and suppliers are small entities, either
by nonprofit status or by having annual
revenues that qualify for small business
status under the Small Business
Administration standards. (For details
see the SBA’s Web site at https://
www.sba.gov/content/table-smallbusiness-size-standards (refer to the
620000 series)). Individuals and States
are not included in the definition of a
small entity.
The RFA requires that we analyze
regulatory options for small businesses
and other entities. We prepare a
regulatory flexibility analysis unless we
certify that a rule would not have a
significant economic impact on a
substantial number of small entities.
The analysis must include a justification
concerning the reason action is being
taken, the kinds and number of small
entities the rule affects, and an
explanation of any meaningful options
that achieve the objectives with less
significant adverse economic impact on
the small entities.
Approximately 95 percent of
practitioners, other providers and
suppliers are considered to be small
entities, based upon the SBA standards.
There are over 1 million physicians,
other practitioners, and medical
suppliers that receive Medicare
payment under the PFS. Because many
of the affected entities are small entities,
the analysis and discussion provided in
this section as well as elsewhere in this
final rule with comment period is
intended to comply with the RFA
requirements.
In addition, section 1102(b) of the Act
requires us to prepare an RIA if a rule
may have a significant impact on the
operations of a substantial number of
small rural hospitals. This analysis must
conform to the provisions of section 604
of the RFA. For purposes of section
1102(b) of the Act, we define a small
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
rural hospital as a hospital that is
located outside of a Metropolitan
Statistical Area for Medicare payment
regulations and has fewer than 100
beds. We are not preparing an analysis
for section 1102(b) of the Act because
we have determined, and the Secretary
certifies, that this final rule with
comment period would not have a
significant impact on the operations of
a substantial number of small rural
hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits on State, local, or
tribal governments or on the private
sector before issuing any rule whose
mandates require spending in any 1 year
of $100 million in 1995 dollars, updated
annually for inflation. In 2014, that
threshold is approximately $141
million. This final rule with comment
period would impose no mandates on
state, local, or tribal governments or on
the private sector.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a
proposed rule (and subsequent final
rule) that imposes substantial direct
requirement costs on State and local
governments, preempts State law, or
otherwise has Federalism implications.
Since this regulation does not impose
any costs on State or local governments,
the requirements of Executive Order
13132 are not applicable.
We have prepared the following
analysis, which together with the
information provided in the rest of this
preamble, meets all assessment
requirements. The analysis explains the
rationale for and purposes of this final
rule with comment period; details the
costs and benefits of the rule; analyzes
alternatives; and presents the measures
we would use to minimize the burden
on small entities. As indicated
elsewhere in this final rule with
comment period, we are implementing
a variety of changes to our regulations,
payments, or payment policies to ensure
that our payment systems reflect
changes in medical practice and the
relative value of services, and to
implement statutory provisions. We
provide information for each of the
policy changes in the relevant sections
of this final rule with comment period.
We are unaware of any relevant federal
rules that duplicate, overlap, or conflict
with this final rule with comment
period. The relevant sections of this
final rule with comment period contain
a description of significant alternatives
if applicable.
PO 00000
Frm 00440
Fmt 4701
Sfmt 4700
C. Relative Value Unit (RVU) Impacts
1. Resource-Based Work, PE, and
Malpractice RVUs
Section 1848(c)(2)(B)(ii)(II) of the Act
requires that increases or decreases in
RVUs may not cause the amount of
expenditures for the year to differ by
more than $20 million from what
expenditures would have been in the
absence of these changes. If this
threshold is exceeded, we make
adjustments to preserve budget
neutrality.
Our estimates of changes in Medicare
revenues for PFS services compare
payment rates for CY 2014 with
payment rates for CY 2015 using CY
2013 Medicare utilization as the basis
for the comparison. The payment
impacts reflect averages for each
specialty based on Medicare utilization.
The payment impact for an individual
physician could vary from the average
and would depend on the mix of
services the physician furnishes. The
average change in total revenues would
be less than the impact displayed here
because physicians furnish services to
both Medicare and non-Medicare
patients and specialties may receive
substantial Medicare revenues for
services that are not paid under the PFS.
For instance, independent laboratories
receive approximately 83 percent of
their Medicare revenues from clinical
laboratory services that are not paid
under the PFS.
We note that these impacts do not
include the effect of the April 2015
conversion factor changes under current
law. The annual update to the PFS
conversion factor is calculated based on
a statutory formula that measures actual
versus allowed or ‘‘target’’ expenditures,
and applies a sustainable growth rate
(SGR) calculation intended to control
growth in aggregate Medicare
expenditures for physicians’ services.
This update methodology is typically
referred to as the ‘‘SGR’’ methodology,
although the SGR is only one
component of the formula. Medicare
PFS payments for services are not
withheld if the percentage increase in
actual expenditures exceeds the SGR.
Rather, the PFS update, as specified in
section 1848(d)(4) of the Act, is adjusted
to eventually bring actual expenditures
back in line with targets. If actual
expenditures exceed allowed
expenditures, the update is reduced. If
actual expenditures are less than
allowed expenditures, the update is
increased. By law, we are required to
apply these updates in accordance with
sections 1848(d) and (f) of the Act, and
any negative updates can only be
averted by an Act of the Congress.
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
Although the Congress has provided
temporary relief from negative updates
for every year since 2003, a long-term
solution is critical. We are committed to
working with the Congress to reform
Medicare physician payments to
provide predictable payments that
incentivize quality and efficiency in a
fiscally responsible way. We provide
our most recent estimate of the SGR and
physician update for CY 2015 on our
Web site at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/SustainableGRatesConFact/
index.html?redirect=/
SustainableGRatesConFact/.
Tables 93 shows the payment impact
on PFS services. To the extent that there
are year-to-year changes in the volume
and mix of services provided by
physicians, the actual impact on total
Medicare revenues will be different
from those shown in Table 93 (CY 2015
PFS Final Rule with Comment Period
Estimated Impact on Total Allowed
Charges by Specialty).
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
The following is an explanation of the
information represented in Table 93:
• Column A (Specialty): The
Medicare specialty code as reflected in
our physician/supplier enrollment files.
• Column B (Allowed Charges): The
aggregate estimated PFS allowed
charges for the specialty based on CY
2013 utilization and CY 2014 rates. That
is, allowed charges are the PFS amounts
for covered services and include
coinsurance and deductibles (which are
the financial responsibility of the
beneficiary). These amounts have been
summed across all services furnished by
physicians, practitioners, and suppliers
within a specialty to arrive at the total
allowed charges for the specialty.
• Column C (Impact of Work RVU
Changes): This column shows the
estimated CY 2015 impact on total
allowed charges of the changes in the
work RVUs, including the impact of
changes due to new, revised, and
misvalued codes.
PO 00000
Frm 00441
Fmt 4701
Sfmt 4700
67987
• Column D (Impact of PE RVU
Changes): This column shows the
estimated CY 2015 impact on total
allowed charges of the changes in the PE
RVUs, including the impact of changes
due to new, revised, and misvalued
codes, the film-to-digital migration of
imaging inputs, and other miscellaneous
and minor provisions.
• Column E (Impact of Malpractice
(MP) Changes): This column shows the
estimated CY 2015 impact on total
allowed charges of the changes in the
MP RVUs, which are primarily driven
by the required five year review and
update of MP RVUs.
• Column F (Cumulative Impact):
This column shows the estimated CY
2015 combined impact on total allowed
charges of all the changes in the
previous columns. Column F may not
equal the sum of columns C, D, and E
due to rounding.
BILLING CODE 4120–01–P
E:\FR\FM\13NOR2.SGM
13NOR2
67988
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TOTAL
ALLERGY/IMMUNOLOGY
ANESTHESIOLOGY
AUDIOLOGIST
CARDIAC SURGERY
CARDIOLOGY
CHIROPRACTOR
CLINICAL PSYCHOLOGIST
CLINICAL SOCIAL WORKER
COLON AND RECTAL SURGERY
CRITICAL CARE
DERMATOLOGY
DIAGNOSTIC TESTING FACILITY
EMERGENCY MEDICINE
ENDOCRINOLOGY
FAMILY PRACTICE
GASTROENTEROLOGY
GENERAL PRACTICE
GENERAL SURGERY
GERIATRICS
HAND SURGERY
HEMATOLOGY/ONCOLOGY
INDEPENDENT LABORATORY
INFECTIOUS DISEASE
INTERNAL MEDICINE
INTERVENTIONAL PAIN MGMT
INTERVENTIONAL RADIOLOGY
MULTISPECIALTY
CLINIC/OTHER PHY
NEPHROLOGY
NEUROLOGY
NEUROSURGERY
NUCLEAR MEDICINE
NURSE ANES I ANES ASST
NURSE PRACTITIONER
OBSTETRICS/GYNECOLOGY
OPHTHALMOLOGY
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00442
$88,045
$216
$1,993
$60
$355
$6,470
$812
$704
$522
$159
$287
$3,177
$715
$3,046
$457
$6,107
$1,884
$506
$2,245
$227
$160
$1,811
$714
$652
$11,123
$678
$273
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
1%
0%
0%
0%
1%
0%
0%
-1%
0%
1%
0%
0%
0%
0%
0%
0%
0%
0%
0%
-1%
-1%
0%
0%
-1%
-2%
0%
0%
1%
0%
0%
0%
1%
0%
1%
0%
0%
1%
1%
1%
0%
0%
0%
0%
-1%
0%
-1%
0%
0%
0%
0%
0%
0%
1%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
-1%
0%
-1%
-1%
-1%
0%
0%
-2%
-2%
1%
0%
1%
0%
0%
0%
1%
0%
1%
-1%
1%
1%
0%
0%
$84
$2,181
$1,513
$740
$49
$1,186
$2,224
$696
$5,685
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
1%
0%
0%
0%
0%
-2%
0%
0%
0%
1%
0%
0%
1%
-1%
-2%
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.165</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
TABLE 93: CY 2015 PFS Final Rule with Comment Period Estimated Impact Table:
I mpact so f W ork , P raet• E xpense, an d M atpracf Ice RVUs
I
Ice
(A)
(B)
(C)
(D)
(E)
(F)
Specialty
Impact
Impact
Impact Combined
Allowed of Work
ofPE
ofMP
Impact
Charges
RVU
RVU
RVU
(mil)
Changes Changes Changes
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
2. CY 2015 PFS Impact Discussion
ebenthall on DSK5SPTVN1PROD with $$_JOB
a. Work RVU Impacts
The changes in work RVU impacts are
almost entirely attributable to the
payment for CCM services beginning in
CY 2015. We finalized this separately
billable CCM service in the CY 2014
final rule with comment period,
effective beginning in CY 2015 (78 FR
74414 through 74427). We are finalizing
a payment rate for CCM services for CY
2015 (see section II.G. of this final rule
with comment period.) Payment for this
service is expected to result in modest
payment increases for family practice,
internal medicine, and geriatrics.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
b. PE RVU Impacts
Payment for CCM services also has a
positive impact on the PE RVUs
attributable to family practice, internal
medicine, and geriatrics. The most
widespread specialty impacts in PE
RVUs are generally related
implementing the RUC recommendation
regarding the film-to-digital migration of
imaging inputs, which primarily affects
portable x-ray suppliers, diagnostic
testing facilities, and interventional
radiology. Other impacts result from
adjustments of PE RVUs for services as
discussed in section II.A. of this final
rule with comment period.
c. MP RVU Impacts
The changes in MP RVUs are
primarily attributable to the changes
made as part of the statutorily required
PO 00000
Frm 00443
Fmt 4701
Sfmt 4700
review of MP RVUs every five years as
described in section II.C of this final
rule with comment period. Of particular
note are the impacts on the specialties
of ophthalmology (¥2 percent) and
optometry (¥1 percent). In the course of
preparation of the proposed MP RVUs,
we discovered that we had made an
error in calculating the MP RVUs for
ophthalmology codes in the last five
year review CY that resulted in higher
MP RVUs for ophthalmology and
optometry for CY 2010 than would have
resulted had the MP RVUs been
calculated correctly. The MP RVUs have
been at a level higher than they would
have been had they been calculated
correctly since CY 2010.
E:\FR\FM\13NOR2.SGM
13NOR2
ER13NO14.166</GPH>
BILLING CODE 4120–01–C
67989
67990
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
d. Combined Impact
ebenthall on DSK5SPTVN1PROD with $$_JOB
Column F of Table 93 displays the
estimated CY 2015 combined impact on
total allowed charges by specialty of all
the RVU changes. These impacts are
estimated prior to the application of the
negative CF update effective April 1,
2015, applicable under the current
statute.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
Table 94 (Impact of Final rule with
comment period on CY 2015 Payment
for Selected Procedures) shows the
estimated impact on total payments for
selected high volume procedures of all
of the changes discussed previously. We
have included payment rates for the
period of January 1, 2015 through March
31, 2015, as well as those for April 1,
2015 through December 31, 2015. We
PO 00000
Frm 00444
Fmt 4701
Sfmt 4700
selected these procedures for the sake of
illustration from among the most
commonly furnished by a broad
spectrum of specialties. The change in
both facility rates and the nonfacility
rates are shown. For an explanation of
facility and nonfacility PE, we refer
readers to Addendum A of this final
rule with comment period.
BILLING CODE 4120–01–P
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
VerDate Sep<11>2014
TABLE 94: Impact of Final Rule with Comment Period on CY 2014 Payment for Selected Procedures
Jkt 235001
PO 00000
Frm 00445
Fmt 4701
Sfmt 4725
E:\FR\FM\13NOR2.SGM
26
26
13NOR2
26
26
Cabg arterial single
Rechanneling of artery
Egd biopsy single/multiple
After cataract laser
Cataract surg w/iol1 stage
Treatment of retinal lesion
Chest x-ray I view frontal
Chest x-ray 1 view frontal
Mammogram both breasts
Mammogram both breasts
Mammogram screening
Mammogram screening
Radiation tx management
Tissue exam by
$1,956.28
$1,200.42
$152.25
$324.55
$673.11
$523.37
NA
$9.31
NA
$44.42
NA
$35.82
$186.28
$38.33
$1,936.13
$1,192.90
$152.16
$315.05
$647.65
$506.95
NA
$9.31
NA
$44.39
NA
$35.80
$186.17
$39.02
-1%
-1%
0%
-3%
-4%
-3%
NA
0%
NA
0%
NA
0%
0%
2%
$1,526.35
$940.42
$119.95
$248.37
$510.57
$399.58
NA
$7.34
NA
$35.00
NA
$28.22
$146.76
$30.76
-22%
-22%
-21%
-23%
-24%
-24%
NA
-21%
NA
-21%
NA
-21%
-21%
-20%
NA
NA
$405.51
$342.47
NA
$540.92
$24.00
$9.31
$116.07
$44.42
$82.75
$35.82
$186.28
$38.33
NA
NA
$409.92
$333.67
NA
$524.49
$22.55
$9.31
$116.00
$44.39
$82.70
$35.80
$186.17
$39.02
NA
NA
1%
-3%
NA
-3%
-6%
0%
0%
0%
0%
0%
0%
2%
NA
NA
$323.16
$263.05
NA
$413.48
$17.78
$7.34
$91.45
$35.00
$65.20
$28.22
$146.76
$30.76
NA
NA
-20%
-23%
NA
-24%
-26%
-21%
-21%
-21%
-21%
-21%
-21%
-20%
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
33533
35301
43239
66821
66984
67210
71010
71010
77056
77056
77057
77057
77427
88305
67991
ER13NO14.167</GPH>
ebenthall on DSK5SPTVN1PROD with $$_JOB
67992
Jkt 235001
PO 00000
Frm 00446
Fmt 4701
Sfmt 4700
2
13NOR2
finalizing the addition of several new
codes to the list of Medicare telehealth
services. Although we expect these
changes to increase access to care in
E:\FR\FM\13NOR2.SGM
D. Effect of Changes to Medicare
Telehealth Services Under the PFS
As discussed in section II.E. of this
final rule with comment period, we are
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
20:15 Nov 12, 2014
BILLING CODE 4120–01–C
VerDate Sep<11>2014
ER13NO14.168</GPH>
CPT codes and descriptions are copyright 2014 American Medical Association. All Rights Reserved. Applicable FARS/DF ARS apply.
The CY 2014 conversion factor is 35.8228.
3 Payments based on the CY 20 15 conversion factor of 3 5. 80 13 effective January 1 - March 31.
4 Payments based on the CY 2015 conversion factor of28.2239 effective April I.
1
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
rural areas, based on recent utilization
of similar services already on the
telehealth list, we estimate no
significant impact on PFS expenditures
from these additions.
E. Geographic Practice Cost Indices
(GPCIs)
As discussed in section II.D of this
final rule with comment period, we are
required to review and revise the GPCIs
at least every 3 years and phase in the
adjustment over 2 years (if there has not
been an adjustment in the past year).
For CY 2015, we are not making any
revisions related to the data or the
methodologies used to calculate the
GPCIs except in regard to the Virgin
Islands locality discussed in section
II.D. However, since the 1.0 work GPCI
floor provided in section 1848(e)(1)(E)
of the Act is set to expire on March 31,
2015, we have included two set of
GPCIs and GAFs for CY 2015—one set
for January 1, 2015 through March 31,
2015 and another set for April 1, 2015
through December 31, 2015. The April
1, 2015 through December 31, 2015
GPCIs and GAFs reflect the statutory
expiration of the 1.0 work GPCI floor.
F. Other Provisions of the Final Rule
With Comment Period Regulation
ebenthall on DSK5SPTVN1PROD with $$_JOB
The statutory ambulance extender
provisions are self-implementing. As a
result, there are no policy proposals
associated with these provisions or
associated impact in this rule. We are
finalizing our proposal to correct the
dates in the Code of Federal Regulations
(CFR) at § 414.610(c)(1)(ii) and
§ 414.610(c)(5)(ii) to conform the
regulations to these self-implementing
statutory provisions.
The geographic designations for
approximately 92.02 percent of ZIP
codes would be unchanged if we adopt
OMB’s revised statistical area
delineations and the updated RUCA
codes. There are more ZIP codes that
would change from rural to urban (3,038
or 7.08 percent) than from urban to rural
(387 or 0.90 percent). The differences in
the data provided in the proposed rule
compared to the final rule are due to
inclusion of the updated RUCA codes.
In general, it is expected that ambulance
providers and suppliers in 387 ZIP
codes within 41 states may experience
payment increases under the revised
OMB delineations and the updated
RUCA codes, as these areas have been
redesignated from urban to rural.
Ambulance providers and suppliers in
3, 038 ZIP codes within 46 states and
Puerto Rico may experience payment
decreases under the revised OMB
20:15 Nov 12, 2014
Jkt 235001
2. Clinical Laboratory Fee Schedule
There is no impact because we are
merely deleting language from the Code
of Federal Regulations.
3. Removal of Employment
Requirements for Services Furnished
‘‘Incident to’’ RHC and FQHC Visits
The removal of employment
requirements for services furnished
‘‘incident to’’ RHC and FQHC visits will
provide RHCs and FQHCs with greater
flexibility in meeting their staffing
needs, which may result in increasing
access to care in underserved areas.
There is no cost to the federal
government, and we cannot estimate a
cost savings for RHCs or FQHCs.
4. Access to Identifiable Data for the
Center for Medicare and Medicaid
Models
1. Ambulance Fee Schedule
VerDate Sep<11>2014
delineations and the updated RUCA
codes, as these areas have been
redesignated from rural to urban. None
of the current super rural areas will lose
their status upon implementation of the
revised OMB delineations and the
updated RUCA codes. We estimate that
the adoption of the revised OMB
delineations and the updated RUCA
codes would have a small fiscal impact
on the Medicare program.
Given that, in general, participants in
Innovation Center models receive
funding support to participate in model
tests, we do not anticipate an impact. In
those cases where there is a cost
associated with the data reporting, such
costs will vary by project, and thus
cannot be laid out with specificity here.
We do, however, expect the costs to be
covered by payments associated with
the model test.
5. Local Coverage Determination Process
for Clinical Diagnostic Laboratory Tests
The Local Coverage Determination
Process for Clinical Diagnostic
Laboratory Tests will not be finalized.
Therefore, there is no impact to CY 2015
physician payments under the PFS.
6. Private Contracting/Opt Out
We corrected cross-references and
outdated terminology in the regulations
that we inadvertently neglected to
revise, and changed the appeals process
used for certain appeals relating to optout private contracting. We anticipate
no or minimal impact as a result of
these corrections.
7. Payment Policy for Locum Tenens
Physicians
We did not issue any new or revised
requirements. There is no impact.
PO 00000
Frm 00447
Fmt 4701
Sfmt 4700
67993
8. Reports of Payments or Other
Transfers of Value to Covered
Recipients
The changes to the Transparency
Reports and Reporting of Physician
Ownership or Investment Interests in
section III.I of this final rule with
comment period would not impact CY
2015 physician payments under the
PFS.
9. Physician Compare
There will be no impact for the
Physician Compare Web site because we
are not collecting any new information
specifically for the Physician Compare
Web site. The information derived for
Physician Compare comes from other
programs that already collect data,
including but not limited to the
Physician Quality Reporting System
(PQRS) and the Medicare Shared
Savings Program.
10. Physician Quality Reporting System
According to the 2012 Reporting
Experience, ‘‘more than 1.2 million
eligible professionals were eligible to
participate in the 2012 PQRS, Medicare
Shared Savings Program, and Pioneer
ACO Model.’’ 40 In this burden estimate,
we assume that 1.2 million eligible
professionals, the same number of
eligible professionals eligible to
participate in the PQRS in 2012, will be
eligible to participate in the PQRS.
Since all eligible professionals are
subject to the 2017 PQRS payment
adjustment, we estimate that all 1.2
million eligible professionals will
participate, (which includes, for the
purposes of this discussion, being
eligible for the 2017 PQRS payment
adjustment) in the PQRS in 2015 for
purposes of meeting the criteria for
satisfactory reporting (or, in lieu of
satisfactory reporting, satisfactory
participation in a QCDR) for the 2017
PQRS payment adjustment.
Historically, the PQRS has never
experienced 100 percent participation
in reporting for the PQRS. Therefore, we
believe that although 1.2 million eligible
professionals will be subject to the 2017
PQRS payment adjustment, not all
eligible participants will actually report
quality measures data for purposes of
the 2017 PQRS payment adjustment. In
this burden estimate, we will only
provide burden estimates for the eligible
professionals and group practices who
attempt to submit quality measures data
for purposes of the 2017 PQRS payment
40 Centers for Medicare and Medicaid Services,
2012 Reporting Experience Including Trends (2007–
2013): Physician Quality Reporting System and
Electronic Prescribing (eRx) Incentive Program,
March 14, 2014, at xiii.
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
67994
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
adjustment. In 2012, 435,871 eligible
professionals (36 percent) eligible
professionals (including those who
belonged to group practices that
reported under the GPRO and eligible
professionals within an ACO that
participated in the PQRS via the Shared
Savings Program or Pioneer ACO
Model) participated in the PQRS,
Medicare Shared Savings Program, or
Pioneer ACO Model.41 We expect to see
a significant increase in participation in
reporting for the PQRS in 2015 than
2012 as eligible professionals were not
subject to a PQRS payment adjustment
in 2012. Last year (78 FR 74793), we
estimated that we would see a 50
percent participation rate in 2015. We
still believe that a 14 percent increase in
participation from 2012 is reasonable in
2015. Therefore, we estimate that 50
percent of eligible professionals (or
approximately 600,000 eligible
professionals) will report quality
measures data for purposes of the 2017
PQRS payment adjustment.
For participation in the PQRS using
the claims-based reporting mechanism,
according to the 2011 PQRS and eRx
Experience Report, in 2011, 229,282 of
the 320,422 eligible professionals (or 72
percent) of eligible professionals used
the claims-based reporting mechanism.
According to the 2012 Reporting
Experience, 248,206 eligible
professionals participated in the PQRS
using the claims-based reporting
mechanism in 2012.42 Preliminary
estimates show that 252,567 eligible
professionals participated in the PQRS
using the claims-based reporting
mechanism in 2013.43 According to the
historical data cited above, although the
claims-based reporting mechanism is
still the most widely-used reporting
mechanism, we are seeing a decline in
the percentage of participants using the
claims-based reporting mechanism in
the PQRS. Although these eligible
professionals continue to participate in
the PQRS, these eligible professionals
have started to shift towards the use of
other reporting mechanisms—mainly
the GPRO web interface (whether used
by a PQRS GPRO or an ACO
participating in the PQRS via the
Medicare Shared Savings Program or
Pioneer ACO model), registry, or the
EHR-based reporting mechanisms. For
purposes of this burden estimate, based
on PQRS participation using the claimsbased reporting mechanism in 2012 and
2013, we will assume that
approximately 250,000 eligible
professionals will participate in the
41 Id.
42 Id.
at XV.
at xvi. See Figure 4.
20:15 Nov 12, 2014
practices using the EHR-based reporting
mechanism will steadily increase as
eligible professionals become more
familiar with EHR products and more
eligible professionals participate in
programs encouraging use of an EHR,
such as the EHR Incentive Program. In
particular, we believe eligible
professionals will transition from using
the claims-based to the EHR-based
reporting mechanisms. To account for
this anticipated increase, we continue to
estimate that approximately 50,000
eligible professionals, whether
participating as an individual or part of
a group practice under the GPRO, would
use the EHR-based reporting mechanism
in CY 2015.
For participation in the PQRS using
the GPRO web interface, as we noted in
last year’s estimate, according to the
2011 Experience Report, approximately
200 group practices participated in the
GPRO in 2011. According to the 2012
Reporting Experience, 66 practices
participated in the PQRS GPRO.46 In
addition, 144 ACOs participated in the
PQRS GPRO through either the
Medicare Shared Savings Program (112
ACOs) or Pioneer ACO Model (32
practices).47 These group practices
encompass 134,510 eligible
professionals (or approximately 140,000
eligible professionals).48 Since it seems
that roughly 200 group practices
participated in the GPRO in 2011 and
2012, based on these numbers, we will
assume that 200 group practices
(accounting for approximately 135,000
eligible professionals) will participate in
the PQRS using the GPRO web interface
in 2015.
Please note that, while we are
finalizing the reporting of CAHPS
survey measures using a CMS-certified
survey vendor, we are not including this
reporting mechanism in this impact
statement as we believe that eligible
professionals wishing to report CAHPS
survey measures will do so for purposes
other than the PQRS.
(a) Assumptions for Burden Estimates
For the PQRS, the burden associated
with the requirements of this voluntary
reporting initiative is the time and effort
associated with individual eligible
professionals identifying applicable
quality measures for which they can
report the necessary information,
selecting a reporting option, and
reporting the information on their
selected measures or measures group to
CMS using their selected reporting
option.
46 Id.
at xv.
at xvi.
48 Id. at 18.
44 Id.
at xvi. See Figure 4.
45 Id. at xv.
43 Id.
VerDate Sep<11>2014
PQRS using the claims-based reporting
mechanism.
For participation in the PQRS using a
qualified registry or QCDR, in 2011,
approximately 50,215 (or 16 percent) of
the 320,422 eligible professionals
participating in PQRS used the qualified
registry-based reporting mechanism.
According to the 2012 Reporting
Experience, 36,473 eligible
professionals reported individual
measures via the registry-based
reporting mechanism, and 10,478
eligible professionals reporting
measures groups via the registry-based
reporting mechanism in 2012.44
Therefore, approximately 47,000 eligible
professionals participated in the PQRS
using the registry-based reporting
mechanism in 2012. Please note that we
currently have no data on participation
in the PQRS via a QCDR as 2014 is the
first year in which an eligible
professional may participate in the
PQRS via a QCDR. We believe that the
rest of the eligible professionals not
participating in other PQRS reporting
mechanisms will use either the registry
or QCDR reporting mechanisms for the
following reasons: (1) The PQRS
measures set is moving away from use
of claims-based measures and moving
towards the use of registry-based
measures; or (2) we believe the number
of QCDR vendors will increase as the
QCDR reporting mechanism evolves.
Therefore, based on these assumptions,
we expect to see a significant jump from
47,000 eligible professionals (the
remaining number of eligible
professionals not participating via the
claims, EHR, or GPRO web interface
reporting mechanisms) to approximately
165,000 eligible professionals using
either the registry-based reporting
mechanism or QCDR in 2015. We
believe the majority of these eligible
professionals will participate in the
PQRS using a QCDR, as we presume
QCDRs will be larger entities with more
members.
For participation in the PQRS using
the EHR-based reporting mechanism,
according to the 2011 PQRS and eRx
Experience Report, in 2011, 560 (or less
than 1 percent) of the 320,422 eligible
professionals participating in PQRS
used the EHR-based reporting
mechanism. 2012 saw a sharp increase
in reporting via the EHR-based reporting
mechanism. Specifically, according to
the 2012 Reporting Experience, in 2012,
19,817 eligible professionals submitted
quality data for the PQRS through a
qualified EHR.45 We believe the number
of eligible professionals and group
Jkt 235001
PO 00000
Frm 00448
Fmt 4701
47 Id.
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
We believe the labor associated with
eligible professionals and group
practices reporting quality measures
data in the PQRS is primarily handled
by an eligible professional’s or group
practice’s billing clerk or computer
analyst trained to report quality
measures data. Therefore, we will
consider the hourly wage of a billing
clerk and computer analyst in our
estimates. For purposes of this burden
estimate, we will assume that a billing
clerk will handle the administrative
duties associated with participating in
the PQRS. According to information
published by the Bureau of Labor
Statistics, available at https://
www.bls.gov/oes/2013/may/
oes433021.htm, the mean hourly wage
for a billing clerk is approximately
$16.80/hour. Therefore, for purposes of
handling administrative duties, we
estimate an average labor cost of $16.00/
hour. In addition, for purposes of this
burden estimate, we will assume that a
computer analyst will engage in the
duties associated with the reporting of
quality measures. According to
information published by the Bureau of
Labor Statistics, available at https://
www.bls.gov/oes/2013/may/
oes151121.htm, the mean hourly wage
for a computer analyst is approximately
$41.00/hour. Therefore, for purposes of
reporting on quality measures, we
estimate an average labor cost of $41.00/
hour. Please note that, in assessing the
burden estimates below, to account for
benefits and overhead associated with
labor in addition to the hourly wage
costs described above, we are doubling
the wage rates in our estimates.
For individual eligible professionals,
the burden associated with the
requirements of this reporting initiative
is the time and effort associated with
eligible professionals identifying
applicable quality measures for which
they can report the necessary
information, collecting the necessary
information, and reporting the
information needed to report the eligible
professional’s measures. We believe it is
difficult to accurately quantify the
burden because eligible professionals
may have different processes for
integrating the PQRS into their
practice’s work flows. Moreover, the
time needed for an eligible professional
to review the quality measures and
other information, select measures
applicable to his or her patients and the
services he or she furnishes to them,
and incorporate the use of quality data
codes into the office work flows is
expected to vary along with the number
of measures that are potentially
applicable to a given professional’s
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
practice. Since eligible professionals are
generally required to report on at least
9 measures covering at least 3 National
Quality Strategy domains criteria for
satisfactory reporting (or, in lieu of
satisfactory reporting, satisfactory
participation in a QCDR) for the 2017
PQRS payment adjustment, we will
assume that each eligible professional
reports on an average of 9 measures for
this burden analysis.
For eligible professionals who are
participating in PQRS for the first time,
we will assign 5 total hours as the
amount of time needed for an eligible
professional’s billing clerk to review the
PQRS Measures List, review the various
reporting options, select the most
appropriate reporting option, identify
the applicable measures or measures
groups for which they can report the
necessary information, review the
measure specifications for the selected
measures or measures groups, and
incorporate reporting of the selected
measures or measures groups into the
office work flows. The measures list
contains the measure title and brief
summary information for the eligible
professional to review. Assuming the
eligible professional has received no
training from his/her specialty society,
we estimate it will take an eligible
professional’s billing clerk up to 2 hours
to review this list, review the reporting
options, and select a reporting option
and measures on which to report. If an
eligible professional has received
training, then we believe this would
take less time. We believe 3 hours is
plenty of time for an eligible
professional to review the measure
specifications of 9 measures or 1
measures group they select to report for
purposes of participating in PQRS and
to develop a mechanism for
incorporating reporting of the selected
measures or measures group into the
office work flows. Therefore, we believe
that the start-up cost for an eligible
professional to report PQRS quality
measures data is 5 hours × $32/hour =
$160.
We believe the burden associated
with actually reporting the quality
measures will vary depending on the
reporting mechanism selected by the
eligible professional. As such, we break
down the burden estimates by eligible
professionals and group practices
participating in the GPRO according to
the reporting mechanism used.
(b) Burden Estimate for PQRS Reporting
by Individual Eligible Professionals:
Claims-Based Reporting Mechanism
For the claims-based reporting option,
eligible professionals must gather the
required information, select the
PO 00000
Frm 00449
Fmt 4701
Sfmt 4700
67995
appropriate quality data codes (QDCs),
and include the appropriate QDCs on
the claims they submit for payment. The
PQRS will collects QDCs as additional
(optional) line items on the existing
HIPAA transaction 837–P and/or CMS
Form 1500 (OCN: 0938–0999). We do
not anticipate any new forms and or any
modifications to the existing transaction
or form. We also do not anticipate
changes to the 837–P or CMS Form 1500
for CY 2015.
We estimate the cost for an eligible
professional to review the list of quality
measures or measures groups, identify
the applicable measures or measures
group for which they can report the
necessary information, incorporate
reporting of the selected measures into
the office work flows, and select a PQRS
reporting option to be approximately
$410 per eligible professional ($82 per
hour × 5 hours).
Based on our experience with the
Physician Voluntary Reporting Program
(PVRP), we continue to estimate that the
time needed to perform all the steps
necessary to report each measure (that
is, reporting the relevant quality data
code(s) for 9 measures measure) would
range from 15 seconds (0.25 minutes) to
over 12 minutes for complicated cases
and/or measures, with the median time
being 1.75 minutes. To report 9
measures, we estimate that it would take
approximately 2.25 minutes to 108
minutes to perform all the steps
necessary to report 9 measures.
Per measure, at an average labor cost
of $82/hour per practice, the cost
associated with this burden will range
from $0.34 in labor to about $16.40 in
labor time for more complicated cases
and/or measures, with the cost for the
median practice being $2.40. To report
9 measures, using an average labor cost
of $82/hour, we estimated that the time
cost of reporting for an eligible
professional via claims would range
from $3.07 (2.25 minutes or 0.0375
hours × $82/hour) to $147.60 (108
minutes or 1.8 hours × $82/hour) per
reported case.
The total estimated annual burden for
this requirement will also vary along
with the volume of claims on which
quality data is reported. In previous
years, when we required reporting on 80
percent of eligible cases for claimsbased reporting, we found that on
average, the median number of reporting
instances for each of the PQRS measures
was 9. Since we reduced the required
reporting rate by over one-third to 50
percent, then for purposes of this
burden analysis we will assume that an
eligible professional or eligible
professional in a group practice will
need to report each selected measure for
E:\FR\FM\13NOR2.SGM
13NOR2
67996
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
6 reporting instances. The actual
number of cases on which an eligible
professional or group practice is
required to report quality measures data
will vary, however, with the eligible
professional’s or group practice’s patient
population and the types of measures on
which the eligible professional or group
practice chooses to report (each
measure’s specifications includes a
required reporting frequency).
Based on the assumptions discussed
previously, we estimate the total annual
reporting burden per individual eligible
professional associated with claimsbased reporting will range from 13.5
minutes (0.25 minutes per measure × 9
measures × 6 cases per measure) to 648
minutes (12 minutes per measure × 9
measures × 6 cases per measure), with
the burden to the median practice being
94.5 minutes (1.75 minutes per measure
× 9 measures × 6 cases). We estimate the
total annual reporting cost per eligible
professional or eligible professional in a
group practice associated with claimsbased reporting will range from $18.36
($0.34 per measure × 9 measures × 6
cases per measure) to $885.60 ($16.40
per measure × 9 measures × 6 cases per
measure), with the cost to the median
practice being $129.60 per eligible
professional ($2.40 per measure × 9
measures × 6 cases per measure).
(c) Burden Estimate for PQRS Reporting
by Individual Eligible Professionals and
Group Practices: Qualified Registrybased and QCDR-based Reporting
Mechanisms
For qualified registry-based and
QCDR-based reporting, there will be no
additional time burden for eligible
professionals or group practices to
report data to a qualified registry as
eligible professionals and group
practices opting for qualified registrybased reporting or use of a QCDR will
more than likely already be reporting
data to the qualified registry for other
purposes and the qualified registry will
merely be re-packaging the data for use
in the PQRS. Little, if any, additional
data will need to be reported to the
qualified registry or QCDR solely for
purposes of participation in the PQRS.
However, eligible professionals and
group practices will need to authorize or
instruct the qualified registry or QCDR
to submit quality measures results and
numerator and denominator data on
quality measures to CMS on their
behalf. We estimate that the time and
effort associated with this will be
approximately 5 minutes per eligible
professional or eligible professional
within a group practice.
Based on the assumptions discussed
above and in Part B of this supporting
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
statement, Table 95 provides an
estimate of the total annual burden
hours and total annual cost burden
associated with eligible professionals
using the qualified registry-based or
QCDR-based reporting mechanism.
Please note that, unlike the claims-based
reporting mechanism that would require
an eligible professional to report data to
us on quality measures on multiple
occasions, an eligible professional
would not be required to submit this
data to us, as the qualified registry or
QCDR would perform this function on
the eligible professional’s behalf.
(d) Burden Estimate for PQRS Reporting
by Individual Eligible Professionals and
Group Practices: EHR-Based Reporting
Mechanism
For EHR-based reporting, which
includes EHR reporting via a direct EHR
product and an EHR data submission
vendor’s product, the eligible
professional or group practice must
review the quality measures on which
we will be accepting PQRS data
extracted from EHRs, select the
appropriate quality measures, extract
the necessary clinical data from his or
her EHR, and submit the necessary data
to the our designated clinical data
warehouse.
For EHR-based reporting for the
PQRS, the individual eligible
professional or group practice may
either submit the quality measures data
directly to us from their EHR or utilize
an EHR data submission vendor to
submit the data to us on the eligible
professional’s or group practice’s behalf.
To submit data to us directly from their
EHR, the eligible professional or eligible
professional in a group practice must
have access to our specified identity
management system, such as IACS,
which we believe takes less than 1 hour
to obtain. Once an eligible professional
or eligible professional in a group
practice has an account for our specified
identity management system, he or she
will need to extract the necessary
clinical data from his or her EHR, and
submit the necessary data to the our
designated clinical data warehouse.
With respect to submitting the actual
data file for the respective reporting
period, we believe that this will take an
eligible professional or group practice
no more than 2 hours, depending on the
number of patients on which the eligible
professional or group practice is
submitting. We believe that once the
EHR is programmed by the vendor to
allow data submission to us, the burden
to the eligible professional or group
practice associated with submission of
data on quality measures should be
minimal as all of the information
PO 00000
Frm 00450
Fmt 4701
Sfmt 4700
required to report the measure should
already reside in the eligible
professional’s or group practice’s EHR.
(e) Burden Estimate for PQRS Reporting
by Group Practices Using the GPRO
Web Interface
With respect to the process for group
practices to be treated as satisfactorily
submitting quality measures data under
the PQRS, group practices interested in
participating in the PQRS through the
group practice reporting option (GPRO)
must complete a self-nomination
process similar to the self-nomination
process required of qualified registries.
However, since a group practice using
the GPRO web interface would not need
to determine which measures to report
under PQRS, we believe that the selfnomination process is handled by a
group practice’s administrative staff.
Therefore, we estimate that the selfnomination process for the group
practices for the PQRS involves
approximately 2 hours per group
practice to review the PQRS GPRO and
make the decision to participate as a
group rather than individually and an
additional 2 hours per group practice to
draft the letter of intent for selfnomination, gather the requested TIN
and NPI information, and provide this
requested information. It is estimated
that each self-nominated entity will also
spend 2 hours undergoing the vetting
process with CMS officials. We assume
that the group practice staff involved in
the group practice self-nomination
process has an average practice labor
cost of $32 per hour. Therefore,
assuming the total burden hours per
group practice associated with the group
practice self-nomination process is 6
hours, we estimate the total cost to a
group practice associated with the group
practice self-nomination process to be
approximately $192 ($32 per hour × 6
hours per group practice).
The burden associated with the group
practice reporting requirements under
the GPRO is the time and effort
associated with the group practice
submitting the quality measures data.
For physician group practices, this
would be the time associated with the
physician group completing the web
interface. We estimate that the time and
effort associated with using the GPRO
web interface will be comparable to the
time and effort associated to using the
PAT. As stated above, the information
collection components of the PAT have
been reviewed by OMB and was
approved under OMB control number
0938–0941—Form 10136, with an
expiration date of December 31, 2011 for
use in the PGP, MCMP, and EHR
demonstrations. As the GPRO was only
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
recently implemented in 2010, it is
difficult to determine the time and effort
associated with the group practice
submitting the quality measures data.
As such, we will use the same burden
estimate for group practices
participating in the GPRO as we use for
group practices participating in the PGP,
MCMP, and EHR demonstrations. Since
these changes will not have any impact
on the information collection
requirements associated with the PAT
and we will be using the same data
submission process used in the PGP
demonstration, we estimate that the
burden associated with a group practice
completing data for PQRS under the
web interface will be the same as for the
group practice to complete the PAT for
the PGP demonstration. In other words,
we estimate that, on average, it will take
each group practice 79 hours to submit
67997
quality measures data via the GPRO web
interface at a cost of $82 per hour.
Therefore, the total estimated annual
cost per group practice is estimated to
be approximately $6,478.
Tables 95 and 96 provide our total
estimated costs for reporting in the
PQRS for the 2017 PQRS payment
adjustment, the reporting periods of
which occur in CY 2015.
TABLE 95—SUMMARY OF BURDEN ESTIMATES FOR ELIGIBLE PROFESSIONALS AND/OR GROUP PRACTICES USING THE
CLAIMS, QUALIFIED REGISTRY, AND EHR-BASED REPORTING MECHANISMS FOR THE 2017 PQRS PAYMENT ADJUSTMENT
Minimum burden
estimate
Estimated Annual Burden Hours for Claims-based Reporting (for individual eligible professionals only)
Estimated Annual Burden Hours for Qualified registry-based or QCDR-based Reporting ........................
Estimated Annual Burden Hours for EHR-based Reporting .......................................................................
Estimated Total Annual Burden Hours for Eligible Professionals or Eligible Professionals in a Group
Practice ....................................................................................................................................................
Estimated Cost for Claims-based Reporting (for individual eligible professionals only) ............................
Estimated Cost for Qualified registry-based Reporting ...............................................................................
Estimated Cost for EHR-based Reporting ..................................................................................................
Estimated Total Annual Cost for Eligible Professionals or Eligible Professionals in a Group Practice .....
Maximum burden
estimate
1,306,025
1,333,695
450,000
3,948,920
1,333,695
450,000
3,089,720
$107,090,000
$109,362,000
$32,800,000
$249,252,000
5,732,615
$323,900,000
$109,362,000
$32,800,000
$466,062,000
TABLE 96—ESTIMATED COSTS OF GROUP PRACTICES USING THE GPRO WEB INTERFACE TO PARTICIPATE IN THE PQRS
FOR THE 2017 PQRS PAYMENT ADJUSTMENT
Maximum burden
estimate
Estimated # of Participating Group Practices ...............................................................................................................................
Estimated # of Burden Hours Per Group Practice to Self-Nominate to Participate in PQRS and the Electronic Prescribing Incentive Program Under the Group Practice Reporting Option ..................................................................................................
Estimated # of Burden Hours Per Group Practice to Report Quality Measures ..........................................................................
Estimated Total Annual Burden Hours Per Group Practice ..........................................................................................................
Estimated Total Annual Burden Hours for Group Practices .........................................................................................................
Estimated Cost Per Group Practice to Self-Nominate to Participate in PQRS for the Group Practice Reporting Option ...........
Estimated Cost Per Group Practice to Report Quality Measures .................................................................................................
Estimated Total Annual Cost Per Group Practice .........................................................................................................................
Annual Burden Cost for Group Practices ......................................................................................................................................
11. EHR Incentive Program
The changes to the EHR Incentive
Program in section III.L of this final rule
with comment period would not impact
CY 2015 physician payments under the
PFS.
ebenthall on DSK5SPTVN1PROD with $$_JOB
12. Medicare Shared Saving Program
The requirements for participating in
the Medicare Shared Saving Program
and the impacts of these requirements
were established in the final rule
implementing the Medicare Shared
Savings Program that appeared in the
Federal Register on November 2, 2011
(76 FR 67802). The proposals for the
Medicare Shared Savings Program set
forth in the CY 2015 MPFS proposed
rule revisited the current quality
performance standard, proposed
changes to the quality measures,
proposed modifications to the
timeframe between updates to the
quality performance benchmarks, and
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
proposed to establish an additional
incentive to reward ACO quality
improvement. Since the policies being
adopted in this final rule with comment
period do not increase the quality
reporting burden for ACOs participating
in the Shared Savings Program and their
ACO participants and ACO providers/
suppliers, there is no impact for these
policies.
13. Value-Based Payment Modifier and
the Physician Feedback Program
Section 1848(p) of the Act requires
that we establish a VM and apply it to
specific physicians and groups of
physicians the Secretary determines
appropriate starting January 1, 2015 and
to all physicians and groups of
physicians by January 1, 2017. Section
1848(p)(4)(C) of the Act requires the VM
to be budget neutral. Budget-neutrality
means that, in aggregate, the increased
payments to high performing physicians
PO 00000
Frm 00451
Fmt 4701
Sfmt 4700
200
6
79
85
17,000
$192
$6,478
$6,670
$1,334,000
and groups of physicians equal the
reduced payments to low performing
physicians and groups of physicians.
The changes to the VM in section III.N
of this final rule with comment period
will not impact CY 2015 physician
payments under the PFS. We finalized
the VM policies that would impact the
CY 2015 physician payments under the
PFS in the CY 2013 PFS final rule with
comment period (77 FR 69306–69326).
In the CY 2013 PFS final rule with
comment period, we finalized policies
to phase-in the VM by applying it
starting January 1, 2015 to payments
under the Medicare PFS for physicians
in groups of 100 or more eligible
professionals. We identify a group of
physicians as a single taxpayer
identification number (TIN). We apply
the VM to the items and services billed
by physicians under the TIN, not to
other eligible professionals that also
may bill under the TIN. We established
E:\FR\FM\13NOR2.SGM
13NOR2
67998
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
CY 2013 as the performance period for
the VM that will be applied to payments
during CY 2015 (77 FR 69314). We also
finalized that we will not apply the VM
in CYs 2015 and 2016 to any group of
physicians that is participating in the
Medicare Shared Savings Program, the
Pioneer ACO Model, or the
Comprehensive Primary Care Initiative,
or other similar Innovation Center or
CMS initiatives (77 FR 69313).
We finalized policies to determine the
amount of the VM for CY 2015 by
categorizing groups of physicians with
100 or more eligible professionals into
two categories. Category 1 includes
groups of physicians that either (a) self-
nominate for the PQRS as a group and
report at least one measure or (b) elect
the PQRS Administrative Claims option
as a group. Category 2 includes groups
that do not fall within either of the two
subcategories (a) or (b) of Category 1.
Groups within Category 1 may elect to
have their VM for CY 2015 calculated
using the quality-tiering methodology,
which could result in an upward,
neutral, or downward adjustment
amount. The VM for groups of
physicians in Category 1 that do not
elect-quality tiering is 0.0 percent,
meaning that these groups will not
receive a payment adjustment under the
VM for CY 2015. For the groups that are
in Category 2, the VM for the CY 2015
payment adjustment period is ¥1.0
percent.
Under the quality-tiering approach,
each group’s quality and cost
composites are classified into high,
average, and low categories depending
upon whether the composites are at
least one standard deviation above or
below the mean. We compare the
group’s quality of care composite
classification with the cost composite
classification to determine the VM
adjustment for the CY 2015 payment
adjustment period according to the
amounts in Table 97.
TABLE 97—2015 VALUE-BASED PAYMENT MODIFIER AMOUNTS UNDER QUALITY-TIERING
Cost/Quality
Low quality
Low Cost ....................................................................................................................
Average Cost .............................................................................................................
High Cost ...................................................................................................................
Average quality
+0.0%
¥0.5%
¥1.0%
*+1.0x
+0.0%
¥0.5%
High quality
*+2.0x
*+1.0x
+0.0%
ebenthall on DSK5SPTVN1PROD with $$_JOB
* Groups of physicians eligible for an additional +1.0x if (1) reporting Physician Quality Reporting System quality measures through the GPRO
web-interface or CMS-qualified registry, and (2) average beneficiary risk score is in the top 25 percent of all beneficiary risk scores.
To ensure budget neutrality, we first
aggregate the downward payment
adjustments in Table 97 for those groups
in Category 1 that have elected quality
tiering with the ¥1.0 percent
downward payment adjustments for
groups of physicians subject to the VM
that fall within Category 2. Using the
aggregate downward payment
adjustment amount, we then calculate
the upward payment adjustment factor
(x). These calculations will be done after
the performance period has ended.
In the proposed rule, we presented
estimates on the number of eligible
professionals and physician groups, by
group size, based on CY 2012 claims
data that were used to produce the 2012
QRURs, which were available to groups
of 25 or more eligible professionals on
September 16, 2013. The findings from
the CY 2012 QRURs are available on the
CMS Web site at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeedbackProgram/
2012-QRUR.html in a document titled
‘‘Experience Report for the Performance
Year 2012 Quality and Resource Use
Reports’’.
On September 30, 2014, we made
QRURs available to all groups of
physicians and physicians who are solo
practitioners based on their performance
in CY 2013. We also completed the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
analysis of the impact of the VM in CY
2015 on physicians in groups with 100
or more eligible professionals based on
their performance in CY 2013 and
present a summary of the findings
below. Please note that the impact of the
policies for the CY 2017 VM finalized in
this final rule with comment period will
be discussed in the PFS rule for CY
2017.
Based on the methodology codified in
§ 414.1210(c), there are 1,010 groups of
100 or more eligible professionals (as
identified by their Taxpayer
Identification Numbers (TINs)) whose
physicians’ payments under the
Medicare PFS will be subject to the VM
in the CY 2015 payment adjustment
period. Of these 1,010 groups subject to
the CY 2015 VM, 706 groups met the
criteria for inclusion in Category 1. As
noted above, Category 1 for the CY 2015
VM includes groups of physicians that
either (a) self-nominate for the PQRS as
a group and report at least one measure
or (b) elect the PQRS Administrative
Claims option as a group.
Of the 706 groups in Category 1, 133
groups elected in 2013 to have their CY
2015 VM calculated using the qualitytiering methodology; therefore, these
groups will receive an upward, neutral,
or downward adjustment in CY 2015
based on their performance on the
PO 00000
Frm 00452
Fmt 4701
Sfmt 4700
quality and cost measures finalized for
the CY 2015 VM in the CY 2013 PFS
final rule with comment period (77 FR
69306–69326). We note that there were
21 groups for which we had insufficient
data to calculate their quality or cost
composite; therefore, these groups will
receive a neutral adjustment to their
payments in CY 2015. Of the 112 groups
for which we were able to calculate both
quality and cost composites, we found
that 16 groups are in tiers that will
result in an upward adjustment of
+1.0x; 9 groups are in tiers that will
result in a downward adjustment of
between ¥0.5 and ¥1.0 percent; and 87
groups are in tiers that will result in a
neutral adjustment to their payments in
CY 2015. Of the groups that are eligible
for an upward adjustment, none of the
groups are eligible to receive an
additional +1.0x adjustment to their
Medicare payments for treating highrisk beneficiaries. Table 98 shows the
distribution of the 112 groups that
elected quality-tiering into the various
quality and cost tiers. Please note that
CMS will announce the upward
payment adjustment factor (x) in the
Fall of 2014 on the CMS Web site at
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
PhysicianFeedbackProgram/ValueBased
PaymentModifier.html.
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
67999
TABLE 98—DISTRIBUTION USING 2013 DATA OF QUALITY AND COST TIERS FOR GROUPS WITH 100 OR MORE ELIGIBLE
PROFESSIONALS THAT ELECTED QUALITY-TIERING FOR WHICH A QUALITY AND COST COMPOSITE SCORE COULD BE
CALCULATED (112 GROUPS)
Cost/Quality
Low quality
Low Cost ....................................................................................................................
+0.0%
(0)
¥0.5%
(5)
¥1.0%
(2)
Average Cost .............................................................................................................
High Cost ...................................................................................................................
Of the 706 groups in Category 1, 573
groups elected to not have their CY 2015
VM calculated using the quality-tiering
methodology; therefore, their VM will
be 0.0 percent, meaning that these
groups will not receive a payment
adjustment under the VM in CY 2015.
Of the 1,010 groups subject to the CY
2015 VM, 304 groups met the criteria for
inclusion in Category 2. As noted above,
Category 2 includes groups that do not
fall within either of the two
subcategories (a) or (b) of Category 1.
There were 289 groups that did not selfnominate for the PQRS as a group, and
15 groups that self-nominated for the
PQRS as a group, but did not report at
least one measure. Groups in Category 2
will be subject to a ¥1.0 percent
payment adjustment under the VM
during the CY 2015 payment adjustment
period.
Please note that in CY 2015, only the
physicians in groups with 100 or more
eligible professionals that are in
Category 1 and elected quality-tiering
will be subject to upward, downward, or
no payment adjustment under the VM
according to Table 98. Additionally,
physicians in groups with 100 or more
eligible professionals that fall in
Category 2 will be subject to the ¥1.0
percent VM in CY 2015.
We note that in the 2013 QRUR
Experience Report, which will be
released in the next few months, we will
provide a detailed analysis of the impact
of the 2015 VM policies on groups of
100 or more eligible professionals
subject to the VM in CY 2015, including
findings based on the data contained in
the 2013 QRURs for all groups of
physicians and solo practitioners.
ebenthall on DSK5SPTVN1PROD with $$_JOB
14. Interim Revisions to the Electronic
Health Record (EHR) Incentive Program
This interim final rule will allow us
flexibility in setting the deadline for
Average quality
significant hardship exception
applications. We refer readers to the
impact analyses included in the final
rule titled ‘‘Medicare and Medicaid
Programs; Electronic Health Record
Incentive Program—Stage 2’’ (77 FR
53698 through 54162) and Medicare and
Medicaid Programs; Modifications to
the Medicare and Medicaid Electronic
Health Record (EHR) Incentive Programs
for 2014 and Other Changes to the EHR
Incentive Program; and Health
Information Technology; Revisions to
the Certified EHR Technology Definition
and EHR Certification Changes Related
to Standards; Final Rule (79 FR 52911–
52933).
G. Alternatives Considered
This final rule with comment period
contains a range of policies, including
some provisions related to specific
statutory provisions. The preceding
preamble provides descriptions of the
statutory provisions that are addressed,
identifies those policies when discretion
has been exercised, presents rationale
for our final policies and, where
relevant, alternatives that were
considered.
H. Impact on Beneficiaries
There are a number of changes in this
final rule with comment period that
would have an effect on beneficiaries. In
general, we believe that many of the
changes, including the refinements of
the PQRS with its focus on measuring,
submitting, and analyzing quality data;
establishing the basis for the valuebased payment modifier to adjust
physician payment beginning in CY
2015; improved accuracy in payment
through revisions to the inputs used to
calculate payments under the PFS; and
revisions to payment for Part B drugs
will have a positive impact and improve
+1.0x
(2)
+0.0%
(87)
¥0.5%
(2)
High quality
+2.0x
(0)
+1.0x
(14)
+0.0%
(0)
the quality and value of care provided
to Medicare beneficiaries.
Most of the aforementioned policy
changes could result in a change in
beneficiary liability as relates to
coinsurance (which is 20 percent of the
fee schedule amount if applicable for
the particular provision after the
beneficiary has met the deductible). To
illustrate this point, as shown in Table
94, the CY 2014 national payment
amount in the nonfacility setting for
CPT code 99203 (Office/outpatient visit,
new) is $108.18, which means that in
CY 2014 a beneficiary would be
responsible for 20 percent of this
amount, or $21.64. Based on this final
rule with comment period, using the
January 1–March 31, 2015 CF of
35.8013, the CY 2015 national payment
amount in the nonfacility setting for
CPT code 99203, as shown in Table 94,
is $109.19, which means that, in CY
2015, the beneficiary coinsurance for
this service would be $21.84. In
addition, we are finalizing a change in
our definition of colorectal cancer
screening test. As a result, beneficiary
liability will not be applied to
anesthesia billed in conjunction with a
colorectal cancer screening test.
I. Accounting Statement
As required by OMB Circular A–4
(available at https://
www.whitehouse.gov/omb/circulars/
a004/a-4.pdf), in Table 99 (Accounting
Statement), we have prepared an
accounting statement. This estimate
includes growth in incurred benefits
from CY 2014 to CY 2015 based on the
FY 2015 President’s Budget baseline.
Note that subsequent legislation
changed the updates for 2015 from those
shown in the 2015 President’s Budget
baseline.
TABLE 99: ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED EXPENDITURES
Category
Transfers
CY 2015 Annualized Monetized Transfers ..............................................
Estimated decrease in expenditures of $14.7 billion for PFS conversion
factor update.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
PO 00000
Frm 00453
Fmt 4701
Sfmt 4700
E:\FR\FM\13NOR2.SGM
13NOR2
68000
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
TABLE 99: ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED EXPENDITURES—Continued
Category
Transfers
From Whom to Whom? ............................................................................
Federal Government to physicians, other practitioners and providers
and suppliers who receive payment under Medicare.
Estimated increase in payment of $234 million.
Federal Government to eligible professionals who satisfactorily participate in the Physician Quality Reporting System (PQRS).
CY 2015 Annualized Monetized Transfers ..............................................
From Whom to Whom? ............................................................................
TABLE 100: ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED COSTS, TRANSFER, AND SAVINGS
Category
Transfer
CY 2015 Annualized Monetized Transfers of beneficiary cost coinsurance.
From Whom to Whom? ............................................................................
J. Conclusion
The analysis in the previous sections,
together with the remainder of this
preamble, provides an initial
‘‘Regulatory Flexibility Analysis.’’ The
previous analysis, together with the
preceding portion of this preamble,
provides a Regulatory Impact Analysis.
In accordance with the provisions of
Executive Order 12866, this regulation
was reviewed by the Office of
Management and Budget.
42 CFR Part 403
Grant programs-health, Health
insurance, Hospitals, Intergovernmental
relations, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 405
Administrative practice and
procedure, Health facilities, Health
professions, Kidney diseases, Medical
devices, Medicare, Reporting and
recordkeeping requirements, Rural
areas, X-rays.
42 CFR Part 410
Health facilities, Health professions,
Kidney diseases, Laboratories,
Medicare, Reporting and recordkeeping
requirements, Rural areas, X-rays.
42 CFR Part 411
Kidney diseases, Medicare, Physician
Referral, Reporting and recordkeeping
requirements.
ebenthall on DSK5SPTVN1PROD with $$_JOB
42 CFR Part 412
Administrative practice and
procedure, Health facilities, Medicare,
Puerto Rico, Reporting and
recordkeeping requirements.
42 CFR Part 414
Administrative practice and
procedure, Health facilities, Health
professions, Kidney diseases, Medicare,
Reporting and recordkeeping
requirements.
42 CFR Part 425
Administrative practice and
procedure, Health facilities, Health
professions, Medicare, and Reporting
and recordkeeping requirements.
42 CFR Part 495
Administrative practice and
procedure, Electronic health records,
Health facilities, Health professions,
Health maintenance organizations
(HMO), Medicaid, Medicare, Penalties,
Privacy, Reporting and recordkeeping
requirements.
42 CFR Part 498
Administrative practice and
procedure, Health facilities, Health
professions, Medicare, Reporting and
recordkeeping requirements.
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR
chapter IV as set forth below:—
PART 403—SPECIAL PROGRAMS AND
PROJECTS
1. The authority citation for part 403
continues to read as follows:
■
Authority: 42 U.S.C. 1395b–3 and Secs.
1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
§ 403.902
[Amended]
2. In § 403.902, remove the definition
of ‘‘Covered device’’.
■ 3. Section 403.904 is amended by—
■ A. Revising paragraphs (c)(8), (d)(3),
and (d)(4).
■
42 CFR Part 413
Health facilities, Kidney diseases,
Medicare, Reporting and recordkeeping
requirements.
20:15 Nov 12, 2014
Beneficiaries to Federal Government.
42 CFR Part 489
Health facilities, Medicare, Reporting
and recordkeeping requirements.
List of Subjects
VerDate Sep<11>2014
$9 million.
Jkt 235001
PO 00000
Frm 00454
Fmt 4701
Sfmt 4700
B. Adding paragraphs (d)(5) and
(d)(6).
■ C. Revising paragraph (f)(1)(iv).
■ D. Removing paragraph (g).
■ E. Redesignating paragraphs (h) and
(i) as paragraphs (g) and (h),
respectively.
■ F. Amending newly redesignated
paragraph (h)(2)(ii) by removing
‘‘paragraph (i)(2)(i) of this section’’ and
adding in its place ‘‘paragraph (h)(2)(i)
of this section’’.
■ G. Amending newly redesignated
paragraph (h)(2)(iii) by removing
‘‘paragraph (i)(2)(ii) of this section’’ and
adding in its place ‘‘paragraph (h)(2)(i)
of this section’’.
The revisions and additions read as
follows:
■
§ 403.904 Reports of payments or other
transfers of value to covered recipients.
*
*
*
*
*
(c) * * *
(8) Related covered drug, device,
biological or medical supply. Report the
marketed name of the related covered
drugs, devices, biologicals, or medical
supplies, and therapeutic area or
product category unless the payment or
other transfer of value is not related to
a particular covered drug, device,
biological or medical supply.
(i) For drugs and biologicals, if the
marketed name has not yet been
selected, applicable manufacturers must
indicate the name registered on
clinicaltrials.gov.
(ii) Applicable manufacturers may
report the marketed name and
therapeutic area or product category for
payments or other transfers of value
related to a non-covered drug, device,
biological, or medical supply.
(iii) Applicable manufacturers must
indicate if the related drug, device,
biological, or medical supply is covered
or non-covered.
(iv) Applicable manufacturers must
indicate if the payment or other transfer
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
of value is not related to any covered or
non-covered drug, device, biological or
medical supply.
*
*
*
*
*
(d) * * *
(3) Stock.
(4) Stock option.
(5) Any other ownership interest.
(6) Dividend, profit or other return on
investment.
*
*
*
*
*
(f) * * *
(1) * * *
(iv) Name(s) of any related covered
drugs, devices, biologicals, or medical
supplies (subject to the requirements
specified in paragraph (c)(8) of this
section), for drugs and biologicals, the
relevant National Drug Code(s), if any,
for devices and medical supplies and
report a therapeutic area or product
category if a marketed name is not
available.
*
*
*
*
*
§ 403.906
[Amended]
4. In § 403.906, amend paragraph
(b)(6) by removing ‘‘§ 403.904(c) through
(i)’’ and by adding in its place
‘‘§ 403.904(c) through (h).’’
■ 5. New subpart K is added to part 403
to read as follows:
■
Subpart K—Access to Identifiable Data for
the Center for Medicare and Medicaid
Models
Sec.
403.1100 Purpose and scope.
403.1105 Definitions.
403.1110 Evaluation of models.
Subpart K—Access to Identifiable Data
for the Center for Medicare and
Medicaid Models
§ 403.1100
Purpose and scope.
The regulations in this subpart
implement section 1115A of the Act.
The intent of that section is to enable
CMS to test innovative payment and
service delivery models to reduce
program expenditures while preserving
and/or enhancing the quality of care
furnished to individuals under titles
XVIII, XIX, and XXI of the Act. The
Secretary is also required to conduct an
evaluation of each model tested.
measurement of patient-level outcomes
and patient-centeredness criteria
determined appropriate by the
Secretary.
(2) The changes in spending under the
applicable titles by reason of the model.
(b) Information. Any State or other
entity participating in the testing of a
model under section 1115A of the Act
must collect and report such
information, including ‘‘protected
health information’’ as that term is
defined at 45 CFR 160.103, as the
Secretary determines is necessary to
monitor and evaluate such model. Such
data must be produced to the Secretary
at the time and in the form and manner
specified by the Secretary.
PART 405—FEDERAL HEALTH
INSURANCE FOR THE AGED AND
DISABLED
6. The authority citation for part 405
continues to read as follows:
■
Authority: Secs. 205(a), 1102, 1861,
1862(a), 1869, 1871, 1874, 1881, and 1886(k)
of the Social Security Act (42 U.S.C. 405(a),
1302, 1395x, 1395y(a), 1395ff, 1395hh,
1395kk, 1395rr and 1395ww(k)), and sec. 353
of the Public Health Service Act (42 U.S.C.
263a).
7. Section 405.400 is amended by
revising the definition of ‘‘Emergency
care services’’ to read as follows:
■
§ 405.400
Definitions.
*
*
*
*
*
Emergency care services means
inpatient or outpatient hospital services
that are necessary to prevent death or
serious impairment of health and,
because of the danger to life or health,
require use of the most accessible
hospital available and equipped to
furnish those services.
*
*
*
*
*
§ 405.420
[Amended]
8. In § 405.420, amend paragraph (e),
by removing the phrase
‘‘Medicare+Choice’’ and adding in its
place the phrase ‘‘Medicare Advantage’’.
■
§ 405.425
[Amended]
For purposes of this subpart—
Applicable titles means Titles XVIII,
XIX, or XXI of the Act.
9. In § 405.425, amend paragraph (a)
by removing the phrase
‘‘Medicare+Choice’’ and adding in its
place the phrase ‘‘Medicare Advantage’’.
§ 403.1110
§ 405.450
ebenthall on DSK5SPTVN1PROD with $$_JOB
§ 403.1105
■
Definitions.
Evaluation of models.
(a) Evaluation. The Secretary
conducts an evaluation of each model
tested under section 1115A of the Act.
Such evaluation must include an
analysis of the following:
(1) The quality of care furnished
under the model, including the
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
[Amended]
10. In § 405.450, amend paragraph (a)
by removing the reference ‘‘§ 405.803’’
and adding in its place the reference
‘‘§ 498.3(b) of this chapter’’ and amend
paragraph (b) by removing the reference
‘‘§ 405.803’’ and adding in its place
‘‘§ 405.924’’.
■
PO 00000
Frm 00455
Fmt 4701
Sfmt 4700
§ 405.455
68001
[Amended]
11. In § 405.455, remove the phrase
‘‘Medicare+Choice’’ and add in its place
the phrase ‘‘Medicare Advantage’’
wherever it appears.
■ 12. Section 405.924 is amended by
adding paragraph (b)(15) to read as
follows:
■
§ 405.924 Actions that are initial
determinations.
*
*
*
*
*
(b) * * *
(15) A claim not payable to a
beneficiary for the services of a
physician who has opted-out.
*
*
*
*
*
■ 13. Section 405.2413 is amended by—
■ A. Amending paragraph (a)(4) by
removing ‘‘;’’ and by adding in its place
‘‘; and’’.
■ B. Revising paragraph (a)(5).
■ C. Removing paragraph (a)(6).
The revision reads as follow:
§ 405.2413 Services and supplies incident
to a physician’s services.
(a) * * *
(5) Furnished under the direct
supervision of a physician.
*
*
*
*
*
■ 14. Section 405.2415 is amended by—
■ A. Revising the section heading and
paragraph (a)(5).
■ B. Removing paragraph (a)(6).
The revision reads as follows:
§ 405.2415 Services and supplies incident
to nurse practitioner, physician assistant,
or certified nurse-midwife services.
(a) * * *
(5) Furnished under the direct
supervision of a nurse practitioner,
physician assistant, or certified nursemidwife.
*
*
*
*
*
■ 15. Section 405.2452 is amended by—
■ A. Amending paragraph (a)(4) by
removing ‘‘;’’ and by adding in its place
‘‘; and’’.
■ B. Revising paragraph (a)(5).
■ C. Removing paragraph (a)(6).
The revision reads as follows:
§ 405.2452 Services and supplies incident
to clinical psychologist and clinical social
worker services.
(a) * * *
(5) Furnished under the direct
supervision of a clinical psychologist or
clinical social worker.
*
*
*
*
*
■ 16. Section 405.2463 is revised to read
as follows:
§ 405.2463
What constitutes a visit.
(a) Visit—General. (1) For RHCs, a
visit is either of the following:
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
68002
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
(i) Face-to-face encounter between a
RHC patient and one of the following:
(A) Physician.
(B) Physician assistant.
(C) Nurse practitioner.
(D) Certified nurse midwife.
(E) Visiting registered professional or
licensed practical nurse.
(G) Clinical psychologist.
(H) Clinical social worker.
(ii) Qualified transitional care
management service.
(2) For FQHCs, a visit is either of the
following:
(i) A visit as described in paragraph
(a)(1)(i) or (ii) of this section.
(ii) A face-to-face encounter between
a patient and either of the following:
(A) A qualified provider of medical
nutrition therapy services as defined in
part 410, subpart G, of this chapter.
(B) A qualified provider of outpatient
diabetes self-management training
services as defined in part 410, subpart
H, of this chapter.
(b) Visit—Medical. (1) A medical visit
is a face-to-face encounter between a
RHC or FQHC patient and one of the
following:
(i) Physician.
(ii) Physician assistant.
(iii) Nurse practitioner.
(iv) Certified nurse midwife.
(v) Visiting registered professional or
licensed practical nurse.
(2) A medical visit for a FQHC patient
may be either of the following:
(i) Medical nutrition therapy visit.
(ii) Diabetes outpatient selfmanagement training visit.
(3) Visit—Mental health. A mental
health visit is a face-to-face encounter
between a RHC or FQHC patient and
one of the following:
(i) Clinical psychologist.
(ii) Clinical social worker.
(iii) Other RHC or FQHC practitioner,
in accordance with paragraph (b)(1) of
this section, for mental health services.
(c) Visit—Multiple. (1) For RHCs and
FQHCs that are authorized to bill under
the reasonable cost system, encounters
with more than one health professional
and multiple encounters with the same
health professional that take place on
the same day and at a single location
constitute a single visit, except when
the patient—
(i) Suffers an illness or injury
subsequent to the first visit that requires
additional diagnosis or treatment on the
same day;
(ii) Has a medical visit and a mental
health visit on the same day; or
(iii) Has an initial preventive physical
exam visit and a separate medical or
mental health visit on the same day.
(2) For RHCs and FQHCs that are
authorized to bill under the reasonable
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
cost system, Medicare pays RHCs and
FQHCs for more than 1 visit per day
when the conditions in paragraph (c)(1)
of this section are met.
(3) For FQHCs that are authorized to
bill under the reasonable cost system,
Medicare pays for more than 1 visit per
day when a DSMT or MNT visit is
furnished on the same day as a visit
described in paragraph (c)(1) of this
section are met.
(4) For FQHCs billing under the
prospective payment system, Medicare
pays for more than 1 visit per day when
the patient—
(i) Suffers an illness or injury
subsequent to the first visit that requires
additional diagnosis or treatment on the
same day; or
(ii) Has a medical visit and a mental
health visit on the same day.
PART 410—SUPPLEMENTARY
MEDICAL INSURANCE (SMI)
BENEFITS
17. The authority citation for part 410
continues to read as follows:
■
Authority: Secs. 1102, 1834, 1871, 1881,
and 1893 of the Social Security Act (42
U.S.C. 1302, 1395m, 1395hh, and 1395ddd.
18. Section 410.26 is amended by
revising paragraphs (b)(5) and (b)(6) to
read as follows:
■
§ 410.26 Services and supplies incident to
a physician’s professional services:
Conditions.
*
*
*
*
*
(b) * * *
(5) In general, services and supplies
must be furnished under the direct
supervision of the physician (or other
practitioner). Services and supplies
furnished incident to transitional care
management and chronic care
management services can be furnished
under general supervision of the
physician (or other practitioner) when
these services or supplies are provided
by clinical staff. The physician (or other
practitioner) supervising the auxiliary
personnel need not be the same
physician (or other practitioner) upon
whose professional service the incident
to service is based.
(6) Services and supplies must be
furnished by the physician, practitioner
with an incident to benefit, or auxiliary
personnel.
*
*
*
*
*
■ 19. Section 410.37 is amended by
revising paragraph (a)(1)(iii) to read as
follows:
§ 410.37 Colorectal cancer screening
tests: Conditions for and limitations on
coverage.
(a) * * *
PO 00000
Frm 00456
Fmt 4701
Sfmt 4700
(1) * * *
(iii) Screening colonoscopies,
including anesthesia furnished in
conjunction with the service.
*
*
*
*
*
■ 20. Section 410.59 is amended by
revising paragraph (c)(1)(ii) to read as
follows:
§ 410.59 Outpatient occupational therapy
services: Conditions.
*
*
*
*
*
(c) * * *
(1) * * *
(ii) Engage in the private practice of
occupational therapy on a regular basis
as an individual, in one of the following
practice types: a solo practice,
partnership, or group practice; or as an
employee of one of these.
*
*
*
*
*
■ 21. Section 410.60 is amended by
revising paragraph (c)(1)(ii) to read as
follows:
§ 410.60 Outpatient physical therapy
services: Conditions.
*
*
*
*
*
(c) * * *
(1) * * *
(ii) Engage in the private practice of
physical therapy on a regular basis as an
individual, in one of the following
practice types: a solo practice,
partnership, or group practice; or as an
employee of one of these.
*
*
*
*
*
■ 22. Section 410.62 is amended by
revising paragraph (c)(1)(ii) to read as
follows:
§ 410.62 Outpatient speech-language
pathology services: Conditions and
exclusions.
*
*
*
*
*
(c) * * *
(1) * * *
(ii) Engage in the private practice of
speech-language pathology on a regular
basis as an individual, in one of the
following practice types: a solo practice,
partnership, or group practice; or as an
employee of one of these.
*
*
*
*
*
■ 23. Section 410.78 is amended by
revising paragraph (b) introductory text
and paragraph (f) to read as follows:
§ 410.78
Telehealth services.
*
*
*
*
*
(b) General rule. Medicare Part B pays
for covered telehealth services included
on the telehealth list when furnished by
an interactive telecommunications
system if the following conditions are
met:
*
*
*
*
*
(f) Process for adding or deleting
services. Changes to the list of Medicare
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
telehealth services are made through the
annual physician fee schedule
rulemaking process. A list of the
services covered as telehealth services
under this section is available on the
CMS Web site.
PART 411—EXCLUSIONS FROM
MEDICARE AND LIMITATIONS ON
MEDICARE PAYMENT
24. The authority citation for part 411
continues to read as follows:
■
Authority: Secs. 1102, 1860D–1 through
1860D–42, 1871, and 1877 of the Social
Security Act (42 U.S.C. 1302, 1395w–101
through 1395w–152, 1395hh, and 1395nn).
25. Section 411.15 is amended by
adding paragraph (p)(2)(xvii) to read as
follows:
■
§ 411.15 Particular services excluded from
coverage.
*
*
*
*
*
(p) * * *
(2) * * *
(xvii) Those RHC and FQHC services
that are described in § 405.2411(b)(2) of
this chapter.
*
*
*
*
*
PART 412—PROSPECTIVE PAYMENT
SYSTEMS FOR INPATIENT HOSPITAL
SERVICES
26. The authority citation for part 412
continues to read as follows:
■
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh), sec. 124 of Pub. L. 106–113 (113
Stat. 1501A–332), sec. 1206 of Pub. L. 113–
67, and sec. 112 of Pub. L. 113–93.
§ 412.64
[Amended]
27. In 412.64—
A. Amend paragraph (d)(4)(ii)(A) by
removing the phrase ‘‘to April 1 of the
year before the payment adjustment
year’’ and adding in its place the phrase
‘‘to April 1 of the year before the
payment adjustment year, or a later date
specified by
CMS’’.
■ B. Amend paragraph (d)(4)(ii)(A) by
removing the phrase ‘‘by April 1 of the
year before the applicable payment
adjustment year’’ and adding in its place
the phrase ‘‘by April 1 of the year before
the applicable payment adjustment year,
or a later date specified by CMS’’.
■ C. Amend paragraph (d)(4)(ii)(B)(1) by
removing the phrase ‘‘April 1 of the year
before the applicable payment
adjustment year’’ and adding in its place
the phrase ‘‘April 1 of the year before
the applicable payment adjustment year,
or a later date specified by CMS’’.
■ D. Amend paragraph (d)(4)(ii)(B)(2) by
removing the phrase ‘‘April 1 of the year
ebenthall on DSK5SPTVN1PROD with $$_JOB
■
■
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
before the applicable payment
adjustment year’’ and adding in its place
the phrase ‘‘April 1 of the year before
the applicable payment adjustment year,
or a later date specified by CMS’’.
PART 413—PRINCIPLES OF
REASONABLE COST
REIMBURSEMENT; PAYMENT FOR
END–STAGE RENAL DISEASE
SERVICES; OPTIONAL
PROSPECTIVELY DETERMINED
PAYMENT RATES FOR SKILLED
NURSING FACILITY SERVICES
28. The authority citation for part 413
continues to read as follows:
■
Authority: Secs. 1102, 1812(d), 1814(b),
1815, 1833(a), (i), and (n), 1861(v), 1871,
1881, 1883 and 1886 of the Social Security
Act (42 U.S.C. 1302, 1395d(d), 1395f(b),
1395g, 1395l(a), (i), and (n), 1395x(v),
1395hh, 1395rr, 1395tt, and 1395ww); and
sec. 124 of Pub. L. 106–113 (113 Stat. 1501A–
332), sec. 3201 of Pub. L. 112–96 (126 Stat.
156), and sec. 632 of Pub. L. 112–240 (126
Stat. 2354).
§ 413.70
[Amended]
29. Amend § 413.70 by:
A. Amending paragraph (a)(6)(ii)
introductory text by removing the
phrase ‘‘no later than November 30 after
the close of the applicable EHR
reporting period’’ and adding in its
place the phrase ’’ no later than
November 30 after the close of the
applicable EHR reporting period, or a
later date specified by CMS’’.
■ B. Amending paragraph (a)(6)(ii)(A)
by removing the phrase ‘‘to November
30 after the end of the payment
adjustment year’’ and adding in its place
the phrase ‘‘to November 30 after the
end of the payment adjustment year, or
a later date specified by CMS’’.
■
■
PART 414—PAYMENT FOR PART B
MEDICAL AND OTHER HEALTH
SERVICES
30. The authority citation for part 414
continues to read as follows:
■
Authority: Secs. 1102, 1871, and 1881(b)(l)
of the Social Security Act (42 U.S.C. 1302,
1395hh, and 1395rr(b)(l)).
31. Section 414.24 is amended by—
A. Revising the section heading, and
paragraphs (a) and (b).
■ B. Redesignating paragraph (c) as
paragraph (d).
■ C. Adding new paragraph (c).
The revisions and addition read as
follows:
■
■
§ 414.24
inputs.
Publication of RVUs and direct PE
(a) Definitions. For purposes of this
section, the following definitions apply:
Existing code means a code that is not
a new code under paragraph (c)(2) of
PO 00000
Frm 00457
Fmt 4701
Sfmt 4700
68003
this section, and includes codes for
which the descriptor is revised and
codes that are combinations or
subdivisions of previously existing
codes.
New code means a code that describes
a service that was not previously
described or valued under the PFS using
any other code or combination of codes.
(b) Revisions of RVUs and Direct PE
Inputs. For valuations for calendar year
2017 and beyond, CMS publishes,
through notice and comment
rulemaking in the Federal Register
(including proposals in a proposed
rule), changes in RVUs or direct PE
inputs for existing codes.
(c) Establishing RVUs and Direct PE
inputs for new codes.
(1) General rule. CMS establishes
RVUs and direct PE inputs for new
codes in the manner described in
paragraph (b) of this section.
(2) Exception for new codes for which
CMS does not have sufficient
information. When CMS determines for
a new code that it does not have
sufficient information to include
proposed RVUs or direct PE inputs in
the proposed rule, but that it is in the
public interest for Medicare to use a
new code during a payment year, CMS
will publish in the Federal Register
RVUs and direct PE inputs that are
applicable on an interim basis subject to
public comment. After considering
public comments and other information
on interim RVUs and PE inputs for the
new code, CMS publishes in the Federal
Register the final RVUs and PE inputs
for the code.
*
*
*
*
*
■ 32. Section 414.90 is amended by—
■ A. In paragraph (b) by revising the
definition of ‘‘Measures group’’.
■ B. In paragraphs (h)(5)(i)(B), (h)(5)(v),
(j)(5)(i)(B) and (j)(5)(v) remove the
phrase ‘‘CG CAHPS’’ and add in its
place the phrase ‘‘CAHPS for PQRS’’.
■ C. In paragraphs (h)(4)(v) and (j)(4)(vi)
remove the phrase ‘‘CAHPS’’ and add in
its place the phrase ‘‘CAHPS for PQRS’’.
■ D. Redesignate paragraphs (j)(4) and
(j)(5) as (j)(5) and (j)(6), respectively.
■ E. Adding new paragraphs (j)(4), (j)(7),
(k)(4) and (m)(3).
■ F. Revising paragraph (m)(1).
The revisions read as follows:
§ 414.90 Physician Quality Reporting
System (PQRS).
*
*
*
*
*
(b) * * *
Measures group means a subset of six
or more PQRS measures that have a
particular clinical condition or focus in
common. The denominator definition
and coding of the measures group
identifies the condition or focus that is
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
68004
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
shared across the measures within a
particular measures group.
*
*
*
*
*
(j) * * *
(4) Satisfactory Reporting Criteria for
Individual Eligible Professionals for the
2017 PQRS Payment Adjustment. An
individual eligible professional who
wishes to meet the criteria for
satisfactory reporting for the 2017 PQRS
payment adjustment must report
information on PQRS quality measures
identified by CMS in one of the
following manners:
(i) Via Claims. (A) For the 12-month
2017 PQRS payment adjustment
reporting period—
(1)(i) Report at least 9 measures,
covering at least 3 of the NQS domains
and report each measure for at least 50
percent of the eligible professional’s
Medicare Part B FFS patients seen
during the reporting period to which the
measure applies. Of the 9 measures
reported, if the eligible professional sees
at least 1 Medicare patient in a face-toface encounter, the eligible professional
must report on at least 1 measure
contained in the cross-cutting measure
set specified by CMS. If less than 9
measures apply to the eligible
professional, report up to 8 measures
and report each measure for at least 50
percent of the Medicare Part B FFS
patients seen during the reporting
period to which the measure applies.
Measures with a 0 percent performance
rate would not be counted.
(ii) [Reserved]
(ii) Via Qualified Registry. (A) For the
12-month 2017 PQRS payment
adjustment reporting period—
(1)(i) Report at least 9 measures,
covering at least 3 of the NQS domains
and report each measure for at least 50
percent of the eligible professional’s
Medicare Part B FFS patients seen
during the reporting period to which the
measure applies. Of the 9 measures
reported, if the eligible professional sees
at least 1 Medicare patient in a face-toface encounter, the eligible professional
must report on at least 1 measure
contained in the cross-cutting measure
set specified by CMS. If less than 9
measures apply to the eligible
professional, report up to 8 measures
and report each measure for at least 50
percent of the Medicare Part B FFS
patients seen during the reporting
period to which the measure applies.
(ii) Report at least 1 measures group
and report each measures group for at
least 20 patients, a majority of which
much be Medicare Part B FFS patients.
(2) Measures with a 0 percent
performance rate or measures groups
containing a measure with a 0 percent
performance rate will not be counted.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
(iii) Via EHR Direct Product. For the
12-month 2017 PQRS payment
adjustment reporting period, report 9
measures covering at least 3 of the NQS
domains. If an eligible professional’s
direct EHR product does not contain
patient data for at least 9 measures
covering at least 3 domains, then the
eligible professional must report the
measures for which there is Medicare
patient data. An eligible professional
must report on at least 1 measure for
which there is Medicare patient data.
(iv) Via EHR Data Submission
Vendor. For the 12-month 2017 PQRS
payment adjustment reporting period,
report 9 measures covering at least 3 of
the NQS domains. If an eligible
professional’s EHR data submission
vendor product does not contain patient
data for at least 9 measures covering at
least 3 domains, then the eligible
professional must report the measures
for which there is Medicare patient data.
An eligible professional must report on
at least 1 measure for which there is
Medicare patient data.
*
*
*
*
*
(7) Satisfactory reporting criteria for
group practices for the 2017 PQRS
payment adjustment. A group practice
who wishes to meet the criteria for
satisfactory reporting for the 2017 PQRS
payment adjustment must report
information on PQRS quality measures
identified by CMS in one of the
following manners:
(i) Via the GPRO web interface. For
the 12-month 2017 PQRS payment
adjustment reporting period, for a group
practice of 25 to 99 eligible
professionals, report on all measures
included in the web interface and
populate data fields for the first 248
consecutively ranked and assigned
beneficiaries in the order in which they
appear in the group’s sample for each
module or preventive care measure. If
the pool of eligible assigned
beneficiaries is less than 248, then
report on 100 percent of assigned
beneficiaries. A group practice must
report on at least 1 measure for which
there is Medicare patient data.
(ii) Via Qualified Registry. For a group
practice of 2 to 99 eligible professionals,
for the 12-month 2017 PQRS payment
adjustment reporting period, report at
least 9 measures, covering at least 3 of
the NQS domains and report each
measure for at least 50 percent of the
group practice’s Medicare Part B FFS
patients seen during the reporting
period to which the measure applies; or
if less than 9 measures covering at least
3 NQS domains apply to the eligible
professional, then the group practice
must report up to 8 measures for which
PO 00000
Frm 00458
Fmt 4701
Sfmt 4700
there is Medicare patient data and
report each measure for at least 50
percent of the group practice’s Medicare
Part B FFS patients seen during the
reporting period to which the measure
applies. Of the measures reported, if any
eligible professional in the group
practice sees at least 1 Medicare patient
in a face-to-face encounter, the group
practice must report on at least 1
measure contained in the cross-cutting
measure set specified by CMS. Measures
with a 0 percent performance rate
would not be counted; or
(iii) Via EHR Direct Product. For a
group practice of 2 to 99 eligible
professionals, for the 12-month 2017
PQRS payment adjustment reporting
period, report 9 measures covering at
least 3 of the NQS domains. If a group
practice’s direct EHR product does not
contain patient data for at least 9
measures covering at least 3 domains,
then the group practice must report the
measures for which there is Medicare
patient data. A group practice must
report on at least 1 measure for which
there is Medicare patient data.
(iv) Via EHR Data Submission
Vendor. For a group practice of 2 to 99
eligible professionals, for the 12-month
2017 PQRS payment adjustment
reporting period, report 9 measures
covering at least 3 of the NQS domains.
If a group practice’s EHR data
submission vendor product does not
contain patient data for at least 9
measures covering at least 3 domains,
then the group practice must report the
measures for which there is Medicare
patient data. A group practice must
report on at least 1 measure for which
there is Medicare patient data.
(v) Via a Certified Survey Vendor in
addition to a Qualified Registry. For a
group practice of 2 or more eligible
professionals, for the 12-month 2017
PQRS payment adjustment reporting
period, report all CAHPS for PQRS
survey measures via a CMS-certified
survey vendor and report at least 6
additional measures covering at least 2
of the NQS domains using a qualified
registry. If less than 6 measures apply to
the group practice, the group practice
must report up to 5 measures. Of the
additional measures that must be
reported in conjunction with reporting
the CAHPS for PQRS survey measures,
if any eligible professional in the group
practice sees at least 1 Medicare patient
in a face-to-face encounter, the group
practice must report on at least 1
measure in the cross-cutting measure set
specified by CMS.
(vi) Via a Certified Survey Vendor in
addition a Direct EHR Product or EHR
Data Submission Vendor. For a group
practice of 2 or more eligible
E:\FR\FM\13NOR2.SGM
13NOR2
ebenthall on DSK5SPTVN1PROD with $$_JOB
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
professionals, for the 12-month 2017
PQRS payment adjustment reporting
period, report all CAHPS for PQRS
survey measures via a CMS-certified
survey vendor and report at least 6
additional measures, outside of CAHPS
for PQRS, covering at least 2 of the NQS
domains using the direct EHR product
that is CEHRT or EHR data submission
vendor product that is CEHRT. If less
than 6 measures apply to the group
practice, the group practice must report
up to 5 measures. Of the additional
measures that must be reported in
conjunction with reporting the CAHPS
for PQRS survey measures, the group
practice must report on at least 1
measure for which there is Medicare
patient data.
(vii) Via a Certified Survey Vendor in
addition to the GPRO Web interface. (A)
For a group practice of 25 or more
eligible professionals, for the 12-month
2017 PQRS payment adjustment
reporting period, report all CAHPS for
PQRS survey measures via a CMScertified survey vendor and report on all
measures included in the GPRO web
interface; AND populate data fields for
the first 248 consecutively ranked and
assigned beneficiaries in the order in
which they appear in the group’s
sample for each module or preventive
care measure. If the pool of eligible
assigned beneficiaries is less than 248,
then the group practice would report on
100 percent of assigned beneficiaries. A
group practice must report on at least 1
measure for which there is Medicare
patient data.
(B) [Reserved]
(k) * * *
(4) Satisfactory participation criteria
for individual eligible professionals for
the 2017 PQRS payment adjustment. An
individual eligible professional who
wishes to meet the criteria for
satisfactory participation in a QCDR for
the 2017 PQRS payment adjustment
must report information on quality
measures identified by the QCDR in one
of the following manner:
(i) For the 12-month 2017 PQRS
payment adjustment reporting period,
report at least 9 measures available for
reporting under a QCDR covering at
least 3 of the NQS domains, and report
each measure for at least 50 percent of
the eligible professional’s patients. Of
these measures, report on at least 2
outcome measures, or, if 2 outcomes
measures are not available, report on at
least 2 outcome measures and at least 1
of the following types of measures—
resource use, patient experience of care,
efficiency/appropriate use or patient
safety.
(ii) [Reserved]
*
*
*
*
*
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
(m) * * *
(1) To request an informal review for
reporting periods that occur prior to
2014, an eligible professional or group
practice must submit a request to CMS
within 90 days of the release of the
feedback reports. To request an informal
review for reporting periods that occur
in 2014 and subsequent years, an
eligible professional or group practice
must submit a request to CMS within 60
days of the release of the feedback
reports. The request must be submitted
in writing and summarize the concern(s)
and reasons for requesting an informal
review and may also include
information to assist in the review.
*
*
*
*
*
(3) If, during the informal review
process, CMS finds errors in data that
was submitted by a third-party vendor
on behalf of an eligible professional or
group practice using either the qualified
registry, EHR data submission vendor,
or QCDR reporting mechanisms, CMS
may allow for the resubmission of data
to correct these errors.
(i) CMS will not allow resubmission
of data submitted via claims, direct
EHR, and the GPRO web interface
reporting mechanisms.
(ii) CMS will only allow resubmission
of data that was already previously
submitted to CMS.
(iii) CMS will only accept data that
was previously submitted for the
reporting periods for which the
corresponding informal review period
applies.
*
*
*
*
*
§ 414.511
[Removed]
33. Section § 414.511 is removed.
34. Section 414.610 is amended by
revising paragraphs (c)(1)(ii)
introductory text and (c)(5)(ii) to read as
follows:
■
■
§ 414.610
Basis of payment.
*
*
*
*
*
(c) * * *
(1) * * *
(ii) For services furnished during the
period July 1, 2008 through March 31,
2015, ambulance services originating in:
*
*
*
*
*
(5) * * *
(ii) For services furnished during the
period July 1, 2004 through March 31,
2015, the payment amount for the
ground ambulance base rate is increased
by 22.6 percent where the point of
pickup is in a rural area determined to
be in the lowest 25 percent of rural
population arrayed by population
density. The amount of this increase is
based on CMS’s estimate of the ratio of
the average cost per trip for the rural
PO 00000
Frm 00459
Fmt 4701
Sfmt 4700
68005
areas in the lowest quartile of
population compared to the average cost
per trip for the rural areas in the highest
quartile of population. In making this
estimate, CMS may use data provided
by the GAO.
*
*
*
*
*
■ 35. Section 414.1200 is amended by
revising paragraphs (a) and (b)(5) to read
as follows:
§ 414.1200
Basis and scope.
(a) Basis. This subpart implements
section 1848(p) of the Act by
establishing a payment modifier that
provides for differential payment
starting in 2015 to a group of physicians
and starting in 2017 to a group and a
solo practitioner under the Medicare
Physician Fee Schedule based on the
quality of care furnished compared to
cost during a performance period.
(b) * * *
(5) Additional measures for groups
and solo practitioners.
*
*
*
*
*
■ 36. Section 414.1205 is amended by—
■ A. Revising the definitions of ‘‘Group
of physicians’’ and ‘‘Value-based
payment modifier.’’
■ B. Adding the definition of ‘‘Solo
practitioner’’ in alphabetical order.
The addition and revisions read as
follows:
§ 414.1205
Definitions.
*
*
*
*
*
Group of physicians (Group) means a
single Taxpayer Identification Number
(TIN) with 2 or more eligible
professionals, as identified by their
individual National Provider Identifier
(NPI), who have reassigned their
Medicare billing rights to the TIN.
*
*
*
*
*
Solo practitioner means a single
Taxpayer Identification Number (TIN)
with one eligible professional who is
identified by an individual National
Provider Identifier (NPI) billing under
the TIN.
*
*
*
*
*
Value-based payment modifier means
the percentage as determined under
§ 414.1270 by which amounts paid to a
group or solo practitioner under the
Medicare Physician Fee Schedule
established under section 1848 of the
Act are adjusted based upon a
comparison of the quality of care
furnished to cost as determined by this
subpart.
37. Section 414.1210 is amended by—
A. Adding paragraphs (a)(3), (a)(4),
(b)(2), (b)(3), and (b)(4).
■ B. Revising paragraph (c).
The additions and revision reads as
follows:
■
■
E:\FR\FM\13NOR2.SGM
13NOR2
68006
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
ebenthall on DSK5SPTVN1PROD with $$_JOB
§ 414.1210 Application of the value-based
payment modifier.
(a) * * *
(3) For the CY 2017 payment
adjustment period and each subsequent
calendar year payment adjustment
period, to physicians in groups with 2
or more eligible professionals and to
physicians who are solo practitioners
based on the performance period for the
payment adjustment period as described
at § 414.1215.
(4) For the CY 2018 payment
adjustment period and each subsequent
calendar year payment adjustment
period, to nonphysician eligible
professionals in groups with 2 or more
eligible professionals and to
nonphysician eligible professionals who
are solo practitioners based on the
performance period for the payment
adjustment period as described at
§ 414.1215.
(b) * * *
(2) Application of the value-based
payment modifier to participants in the
Shared Savings Program.
(i) For the CY 2017 payment
adjustment period and each subsequent
calendar year payment adjustment
period, the value-based payment
modifier is applicable to physicians in
groups with 2 or more eligible
professionals and to physicians who are
solo practitioners that participate in an
ACO under the Shared Savings Program
during the performance period for the
payment adjustment period as described
at § 414.1215. The value-based payment
modifier for a group or solo practitioner
that participates in an ACO under the
Shared Savings Program during the
performance period is determined based
on paragraphs (b)(2)(i)(A) through (D) of
this section.
(A) The cost composite is classified as
‘‘average’’ under § 414.1275(b).
(B) The quality composite score is
calculated under § 414.1260(a) using
quality data reported by the ACO for the
performance period through the ACO
GPRO Web interface as required under
§ 425.504(a)(1) or another mechanism
specified by CMS and the ACO all-cause
readmission measure.
(C) For the CY 2017 payment
adjustment period, the value-based
payment modifier adjustment will be
equal to the amount determined under
§ 414.1275 for the payment adjustment
period, except that if the ACO does not
successfully report quality data as
described in paragraph (b)(2)(i)(B) of
this section for the performance period,
such adjustment will be equal to ¥4%
for groups with 10 or more eligible
professionals and equal to ¥2% for
groups with two to nine eligible
professionals and for solo practitioners.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
(D) The same value-based payment
modifier adjustment will be applied in
the payment adjustment period to all
groups based on size as specified under
§ 414.1275 and solo practitioners that
participated in the ACO during the
performance period.
(ii) For the CY 2018 payment
adjustment period and each subsequent
calendar year payment adjustment
period, the value-based payment
modifier is applicable to nonphysician
eligible professionals in groups with 2
or more eligible professionals and to
nonphysician eligible professionals who
are solo practitioners that participate in
an ACO under the Shared Savings
Program during the performance period
for the payment adjustment period as
described at § 414.1215. The valuebased payment modifier for
nonphysician eligible professionals is
determined in the same manner as for
physicians as described under
paragraphs (b)(2)(i)(A) through (D) of
this section.
(3) Application of the value-based
payment modifier to participants in the
Pioneer ACO Model and the
Comprehensive Primary Care Initiative.
(i) For the CY 2017 payment
adjustment period, the value-based
payment modifier is applicable to
physicians in groups with 2 or more
eligible professionals and to physicians
who are solo practitioners that
participate in the Pioneer ACO Model or
the Comprehensive Primary Care (CPC)
Initiative during the performance period
for the payment adjustment period as
described at § 414.1215. For purposes of
the value-based payment modifier, a
group or solo practitioner is considered
to be participating in the Pioneer ACO
Model or CPC Initiative if at least one
eligible professional billing under the
TIN in the performance period is
participating in the Pioneer ACO Model
or CPC Initiative in the performance
period. The value-based payment
modifier for groups and solo
practitioners that participate in the
Pioneer ACO Model or the CPC
Initiative during the performance period
is determined based on paragraphs
(b)(3)(i)(A) through (C) of this section.
(A) The cost composite is classified as
‘‘average’’ under § 414.1275(b).
(B) The quality composite is classified
as ‘‘average’’ under § 414.1275(b).
(C) The same value-based payment
modifier adjustment will be applied in
the payment adjustment period to all
groups based on size as specified under
§ 414.1275 and solo practitioners that
participated in the Pioneer ACO or CPC
site during the performance period.
(4) Application of the value-based
payment modifier to participants in
PO 00000
Frm 00460
Fmt 4701
Sfmt 4700
other similar Innovation Center models
or CMS initiatives.
(i) For the CY 2017 payment
adjustment period and each subsequent
calendar year payment adjustment
period, the value-based payment
modifier is applicable to physicians in
groups with 2 or more eligible
professionals and to physicians who are
solo practitioners that participate in
other similar Innovation Center models
or CMS initiatives during the
performance period for the payment
adjustment period as described at
§ 414.1215. For purposes of the valuebased payment modifier, a group or solo
practitioner is considered to be
participating in a similar Innovation
Center model or CMS initiative if at
least one eligible professional billing
under the TIN in the performance
period is participating in the model or
initiative in the performance period.
The value-based payment modifier for
groups and solo practitioners that
participate in a similar Innovation
Center model or CMS initiative is
determined based on paragraphs
(b)(3)(i)(A) through (C) of this section.
(ii) [Reserved]
(c) Group size determination. The list
of groups of physicians subject to the
value-based payment modifier for the
CY 2015 payment adjustment period is
based on a query of PECOS on October
15, 2013. For each subsequent calendar
year payment adjustment period, the list
of groups and solo practitioners subject
to the value-based payment modifier is
based on a query of PECOS that occurs
within 10 days of the close of the
Physician Quality Reporting System
group registration process during the
applicable performance period
described at § 414.1215. Groups are
removed from the PECOS-generated list
if, based on a claims analysis, the group
did not have the required number of
eligible professionals, as defined in
§ 414.1210(a), that submitted claims
during the performance period for the
applicable calendar year payment
adjustment period. Solo practitioners
are removed from the PECOS-generated
list if, based on a claims analysis, the
solo practitioner did not submit claims
during the performance period for the
applicable calendar year payment
adjustment period.
§ 414.1220
[Amended]
38. In § 414.1220, remove the phrase
‘‘Groups of physicians’’ and add in its
place the phrase ‘‘Solo practitioners and
groups’’.
■ 39. Section 414.1225 is revised to read
as follows:
■
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
§ 414.1225 Alignment of Physician Quality
Reporting System quality measures and
quality measures for the value-based
payment modifier.
All of the quality measures for which
solo practitioners and groups (or
individual eligible professionals within
such groups) are eligible to report under
the Physician Quality Reporting System
in a given calendar year are used to
calculate the value-based payment
modifier for the applicable payment
adjustment period, as defined in
§ 414.1215, to the extent a solo
practitioner or a group (or individual
eligible professionals within such
group) submit data on such measures.
■ 40. Section 414.1230 is amended by
revising the section heading and the
introductory text to read as follows:
§ 414.1230 Additional measures for groups
and solo practitioners.
The value-based payment modifier
includes the following additional
quality measures (outcome measures) as
applicable for all groups and solo
practitioners subject to the value-based
payment modifier:
*
*
*
*
*
§ 414.1235
[Amended]
41. In § 414.1235, amend paragraph
(a) introductory text, by removing the
phrase ‘‘of physicians subject’’ and add
in its place the phrase ‘‘and solo
practitioners subject’’.
■ 42. Section 414.1240 is revised to read
as follows:
■
ebenthall on DSK5SPTVN1PROD with $$_JOB
§ 414.1240 Attribution for quality of care
and cost measures.
(a) Beneficiaries are attributed to
groups and solo practitioners subject to
the value-based payment modifier using
a method generally consistent with the
method of assignment of beneficiaries
under § 425.402 of this chapter, for
measures other than the Medicare
Spending per Beneficiary measure.
(b) For the Medicare Spending per
Beneficiary (MSPB) measure, an MSPB
episode is attributed to the group or the
solo practitioner subject to the valuebased payment modifier whose eligible
professionals submitted the plurality of
claims (as measured by allowable
charges) under the group’s or solo
practitioner’s TIN for Medicare Part B
services, rendered during an inpatient
hospitalization that is an index
admission for the MSPB measure during
the applicable performance period
described at § 414.1215.
§ 414.1245
[Amended]
43. In § 414.1245, amend the
introductory text, by removing the
phrase ‘‘of physicians subject’’ and add
■
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
68007
in its place the phrase ‘‘and solo
practitioner subject’’.
■ 44. Section 414.1250 is revised to read
as follows:
■
§ 414.1250 Benchmarks for quality of care
measures.
To calculate a composite score for a
quality measure or a cost measure, a
group or solo practitioner subject to the
value-based payment modifier must
have 20 or more cases for that measure.
(a) In a performance period, if a group
or solo practitioner has fewer than 20
cases for a measure, that measure is
excluded from its domain and the
remaining measures in the domain are
given equal weight.
(1) Starting with the CY 2017 payment
adjustment period, the exception to this
paragraph (a) is the all-cause hospital
readmissions measure described at
§ 414.1230(c). In a performance period,
if a group or a solo practitioner has
fewer than 200 cases for this all-cause
hospital readmissions measure, that
measure is excluded from its domain
and the remaining measures in the
domain are given equal weight.
(2) [Reserved]
*
*
*
*
*
■ 47. Section 414.1270 is amended by
revising paragraph (b)(4) and adding
paragraph (c) to read as follows:
(a) The benchmark for quality of care
measures reported through the PQRS
using the claims, registries, EHR, or web
interface is the national mean for that
measure’s performance rate (regardless
of the reporting mechanism) during the
year prior to the performance period. In
calculating the national benchmark, solo
practitioners’ and groups’ (or individual
eligible professionals’ within such
groups) performance rates are weighted
by the number of beneficiaries used to
calculate the solo practitioners’ or
groups’ (or individual eligible
professionals’ within such groups)
performance rate.
(b) The benchmark for each outcome
measure under § 414.1230, is the
national mean for that measure’s
performance rate during the year prior
to the performance period. In
calculating the national benchmark, solo
practitioners’ and groups’ (or individual
eligible professionals’ within such
groups) performance rates are weighted
by the number of beneficiaries used to
calculate the solo practitioners’ or
groups’ (or individual eligible
professionals’ within such groups)
performance rate.
45. Section 414.1255 is amended by
revising paragraphs (b) and (c) to read
as follows:
■
§ 414.1255 Benchmarks for cost
measures.
*
*
*
*
*
(b) Beginning with the CY 2016
payment adjustment period, the cost
measures of a group and solo
practitioner subject to the value-based
payment modifier are adjusted to
account for the group’s and solo
practitioner’s specialty mix, by
computing the weighted average of the
national specialty-specific expected
costs. Each national specialty-specific
expected cost is weighted by the
proportion of each specialty in the
group, the number of eligible
professionals of each specialty in the
group, and the number of beneficiaries
attributed to the group.
(c) The national specialty-specific
expected costs referenced in paragraph
(b) of this section are derived by
calculating, for each specialty, the
average cost of beneficiaries attributed
to groups and solo practitioners that
include that specialty.
PO 00000
Frm 00461
Fmt 4701
Sfmt 4700
46. Section 414.1265 is amended by
revising the introductory text and
paragraph (a) to read as follows:
§ 414.1265
Reliability of measures.
§ 414.1270 Determination and calculation
of Value-Based Payment Modifier
adjustments.
*
*
*
*
*
(b) * * *
(4) If at least fifty percent of the
eligible professionals in the group meet
the criteria as individuals to avoid the
PQRS payment adjustment for CY 2016
as specified by CMS, and all of those
eligible professionals use a qualified
clinical data registry and CMS is unable
to receive quality performance data for
them, the quality composite score for
such group will be classified as
‘‘average’’ under § 414.1275(b)(1).
*
*
*
*
*
(c) For the CY 2017 payment
adjustment period:
(1) A downward payment adjustment
of ¥2.0 percent will be applied to a
group with two to nine eligible
professionals and a solo practitioner and
a downward payment adjustment of -4.0
percent will be applied to a group with
10 or more eligible professionals subject
to the value-based payment modifier if,
during the applicable performance
period as defined in § 414.1215, the
following apply:
(i) Such group does not self-nominate
for the PQRS GPRO and meet the
criteria as a group to avoid the PQRS
payment adjustment for CY 2017 as
specified by CMS; and
E:\FR\FM\13NOR2.SGM
13NOR2
68008
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
(ii) Fifty percent of the eligible
professionals in such group do not meet
the criteria as individuals to avoid the
PQRS payment adjustment for CY 2017
as specified by CMS; or
(iii) Such solo practitioner does not
meet the criteria as an individual to
avoid the PQRS payment adjustment for
CY 2017 as specified by CMS.
(2) For a group comprised of 10 or
more eligible professionals that is not
included in paragraph (c)(1) of this
section, the value-based payment
modifier adjustment will be equal to the
amount determined under
§ 414.1275(c)(3)(i).
(3) For a group comprised of between
two to nine eligible professionals and a
solo practitioner that are not included in
paragraph (c)(1) of this section, the
value-based payment modifier
adjustment will be equal to the amount
determined under § 414.1275(c)(3)(ii).
(4) If at least fifty percent of the
eligible professionals in the group meet
the criteria as individuals to avoid the
PQRS payment adjustment for CY 2017
as specified by CMS, and all of those
eligible professionals use a qualified
clinical data registry and CMS is unable
to receive quality performance data for
them, the quality composite score for
such group will be classified as
‘‘average’’ under § 414.1275(b)(1).
(5) A group and a solo practitioner
subject to the value-based payment
modifier will receive a cost composite
score that is classified as ‘‘average’’
under § 414.1275(b)(2) if such group and
solo practitioner do not have at least one
cost measure with at least 20 cases.
48. Section 414.1275 is amended by—
A. Revising paragraph (a).
■ B. Redesignating paragraphs (d)
introductory text, (d)(1), and (d)(2) as
■
■
paragraphs (d)(1) introductory text,
(d)(1)(i), and (d)(1)(ii), respectively.
■ C. Adding paragraphs (c)(3) and (d)(2).
The revision and additions read as
follows:
§ 414.1275 Value-based payment modifier
quality-tiering scoring methodology.
(a) The value-based payment modifier
amount for a group and a solo
practitioner subject to the value-based
payment modifier is based upon a
comparison of the composite of quality
of care measures and a composite of cost
measures.
*
*
*
*
*
(c) * * *
(3) The following value-based
payment modifier percentages apply to
the CY 2017 payment adjustment
period:
(i) For groups with 10 or more eligible
professionals:
CY 2017 VALUE-BASED PAYMENT MODIFIER AMOUNTS FOR THE QUALITY-TIERING APPROACH FOR GROUPS WITH 10 OR
MORE ELIGIBLE PROFESSIONALS
Cost/quality
Low quality
Low Cost ....................................................................................................................
Average Cost .............................................................................................................
High Cost ...................................................................................................................
Average quality
+0.0%
¥2.0%
¥4.0%
High quality
* +2.0x
+0.0%
¥2.0%
* +4.0x
* +2.0x
+0.0%
* Groups eligible for an additional +1.0x if reporting Physician Quality Reporting System quality measures and average beneficiary risk score is
in the top 25 percent of all beneficiary risk scores, where ‘x’ represents the upward payment adjustment factor.
(ii) For groups with two to nine
eligible professionals and solo
practitioners:
CY 2017 VALUE-BASED PAYMENT MODIFIER AMOUNTS FOR THE QUALITY-TIERING APPROACH FOR GROUPS WITH TWO
TO NINE ELIGIBLE PROFESSIONALS AND SOLO PRACTITIONERS
Cost/quality
Low quality
Low Cost ....................................................................................................................
Average Cost .............................................................................................................
High Cost ...................................................................................................................
Average quality
+0.0%
+0.0%
+0.0%
High quality
* +1.0x
+0.0%
+0.0%
* +2.0x
* +1.0x
+0.0%
ebenthall on DSK5SPTVN1PROD with $$_JOB
* Groups and solo practitioners eligible for an additional +1.0x if reporting Physician Quality Reporting System quality measures and average
beneficiary risk score is in the top 25 percent of all beneficiary risk scores, where ‘x’ represents the upward payment adjustment factor.
(d) * * *
(2) Groups and solo practitioners
subject to the value-based payment
modifier that have an attributed
beneficiary population with an average
risk score in the top 25 percent of the
risk scores of beneficiaries nationwide
and for the CY 2017 payment
adjustment period are subject to the
quality-tiering approach, receive a
greater upward payment adjustment as
follows:
(i) Classified as high quality/low cost
receive an upward adjustment of +5x
(rather than +4x) if the group has 10 or
more eligible professionals or +3x
(rather than +2x) if a solo practitioner or
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
the group has two to nine eligible
professionals; and
(ii) Classified as either high quality/
average cost or average quality/low cost
receive an upward adjustment of +3x
(rather than +2x) if the group has 10 or
more eligible professionals or +2x
(rather than +1x) if a solo practitioner or
the group has two to nine eligible
professionals.
§ 414.1285
[Amended]
49. In § 414.1285, remove the phrase
‘‘of physicians may’’ and add in its
place the phrase ‘‘and a solo practitioner
may’’.
■
PO 00000
Frm 00462
Fmt 4701
Sfmt 4700
PART 425—MEDICARE SHARED
SAVINGS PROGRAM
50. The authority citation for part 425
continues to read as follows:
■
Authority: Secs. 1102, 1106, 1871, and
1899 of the Social Security Act (42 U.S.C.
1302 and 1395hh).
51. Section 425.308 is amended by
revising paragraph (e) to read as follows:
■
§ 425.308 Public reporting and
transparency.
*
*
*
*
*
(e) Results of claims based measures.
All quality measures will be reported on
Physician Compare in the same way as
E:\FR\FM\13NOR2.SGM
13NOR2
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
for the group practices that report under
the Physician Quality Reporting System.
■ 52. Section 425.502 is amended by—
■ A. In paragraph (a)(1), removing the
phrase ‘‘of an ACO’s agreement, CMS’’
and adding in its place the phrase ‘‘of
an ACO’s first agreement period, CMS’’
■ B. In paragraph (b)(2)(ii), removing the
phrase ‘‘80.00 percent.’’ and adding in
its place the phrase ‘‘80.00 percent, or
when the 90th percentile is equal to or
greater than 95 percent.’’
■ C. Revising paragraph (a)(2).
■ D. Adding paragraphs (a)(3), (a)(4),
(b)(4), and (e)(4).
The revision and additions read as
follows:
ebenthall on DSK5SPTVN1PROD with $$_JOB
§ 425.502 Calculating the ACO quality
performance score.
(a) * * *
(2) During subsequent performance
years of the ACO’s first agreement
period, the quality performance
standard will be phased in such that the
ACO must continue to report all
measures but the ACO will be assessed
on performance based on the quality
performance benchmark and minimum
attainment level of certain measures.
(3) Under the quality performance
standard for each performance year of
an ACO’s subsequent agreement period,
the ACO must continue to report on all
measures but the ACO will be assessed
on performance based on the quality
performance benchmark and minimum
attainment level of certain measures.
(4) The quality performance standard
for a newly introduced measure is set at
the level of complete and accurate
reporting for the first two reporting
periods for which reporting of the
measure is required. For subsequent
reporting periods, the quality
performance standard for the measure
will be assessed according to the phasein schedule for the measure.
(b) * * *
(4)(i) CMS will update the quality
performance benchmarks every 2 years.
(ii) For newly introduced measures
that transition to pay for performance in
the second year of the 2-year
benchmarking cycle, the benchmark
will be established for that year and
updated along with the other measures
at the start of the next 2-year
benchmarking cycle.
(iii) CMS will use up to three years of
data, as available, to set the benchmark
for each quality measure.
*
*
*
*
*
(e) * * *
(4)(i) ACOs that demonstrate quality
improvement on established quality
measures from year to year will be
eligible for up to 4 bonus points per
domain.
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
(ii) Bonus points are awarded based
on an ACO’s net improvement in
measures within a domain, which is
calculated by determining the total
number of significantly improved
measures and subtracting the total
number of significantly declined
measures.
(iii) Up to four bonus points are
awarded based on a comparison of the
ACO’s net improvement in performance
on the measures for the domain to the
total number of individual measures in
the domain.
(iv) When bonus points are added to
points earned for the quality measures
in the domain, the total points received
for the domain may not exceed the
maximum total points for the domain in
the absence of the quality improvement
measure.
(v) If an ACO renews its participation
agreement for a subsequent agreement
period, quality improvement will be
measured based on a comparison
between performance in the first year of
the new agreement period and
performance in the third year of the
previous agreement period.
53. Section 425.506 is amended by
revising the section heading and adding
paragraph (d) to read as follows:
■
§ 425.506 Incorporating reporting
requirements related to adoption of
Electronic health records technology.
*
*
*
*
*
(d) Eligible professionals participating
in an ACO under the Shared Savings
Program satisfy the CQM reporting
component of meaningful use for the
Medicare EHR Incentive Program when
the following occurs:
(1) The eligible professional extracts
data necessary for the ACO to satisfy the
quality reporting requirements under
this subpart from certified EHR
technology.
(2) The ACO reports the ACO GPRO
measures through a CMS web interface.
PART 489—PROVIDER AGREEMENTS
AND SUPPLIER APPROVAL
54. The authority citation for part 489
continues to read as follows:
■
Authority: Secs. 1102, 1128I and 1871 of
the Social Security Act (42 U.S.C. 1302,
1320a-7j, and 1395hh).
55. Section 489.20 is amended by
adding paragraph (s)(17) to read as
follows:
■
§ 489.20
*
PO 00000
(17) Those RHC and FQHC services
that are described in § 405.2411(b)(2) of
this chapter.
*
*
*
*
*
PART 495—STANDARDS FOR THE
ELECTRONIC HEALTH RECORD
TECHNOLOGY INCENTIVE PROGRAM
56. The authority citation for part 495
continues to read as follows:
■
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh).
§ 495.102
[Amended]
57. In 495.102—
A. Amend paragraph (d)(4)(i) by
removing the phrase in the first
sentence ‘‘to July 1 of the year preceding
the payment adjustment year’’ and
adding in its place the phrase ‘‘to July
1 of the year preceding the payment
adjustment year, or a later date specified
by CMS’’.
■ B. Amend paragraph (d)(4)(i) by
removing the phrase in the second
sentence ‘‘no later than July 1 of the
year before the applicable payment
adjustment year’’ and adding in its place
the phrase ‘‘no later than July 1 of the
year before the applicable payment
adjustment year, or a later date specified
by CMS’’.
■ C. Amend paragraph (d)(4)(iii)(A) by
removing the phrase in the second
sentence ‘‘no later than July 1 of the
year before the applicable payment
adjustment year’’ and adding in its place
the phrase ‘‘no later than July 1 of the
year before the applicable payment
adjustment year, or a later date specified
by CMS’’.
■ D. Amend paragraph (d)(4)(iii)(B) by
removing the phrase in the second
sentence ‘‘by July 1 of the year before
the applicable payment adjustment
year’’ and adding in its place the phrase
‘‘by July 1 of the year before the
applicable payment adjustment year, or
a later date specified by CMS’’.
■ E. Amend the introductory text of
paragraph (d)(4)(iv) introductory text by
removing the phrase ‘‘by July 1 of the
year before the applicable payment
adjustment year’’ and adding in its place
the phrase ‘‘by July 1 of the year before
the applicable payment adjustment year,
or a later date specified by CMS’’.
■
■
Basic commitments.
*
*
(s) * * *
Frm 00463
*
Fmt 4701
*
Sfmt 4700
68009
E:\FR\FM\13NOR2.SGM
13NOR2
68010
Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Rules and Regulations
PART 498—APPEALS PROCEDURES
FOR DETERMINATIONS THAT AFFECT
PARTICIPATION IN THE MEDICARE
PROGRAM AND FOR
DETERMINATIONS THAT AFFECT THE
PARTICIPATION OF ICFs/IID AND
CERTAIN NFs IN THE MEDICAID
PROGRAM
58. The authority citation for part 498
continues to read as follows:
■
ebenthall on DSK5SPTVN1PROD with $$_JOB
Authority: Secs. 1102, 1128I and 1871 of
the Social Security Act (42 U.S.C. 1302,
1320a-7j, and 1395hh).
VerDate Sep<11>2014
20:15 Nov 12, 2014
Jkt 235001
59. Section 498.3 is amended by
adding paragraph (b)(19) to read as
follow:
■
§ 498.3
Scope and applicability.
*
*
*
*
*
(b) * * *
(19) Whether a physician or
practitioner has failed to properly optout, failed to maintain opt-out, failed to
timely renew opt-out, failed to privately
contract, or failed to properly terminate
opt-out.
*
*
*
*
*
PO 00000
Frm 00464
Fmt 4701
Sfmt 9990
Dated: October 22, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
Dated: October 28, 2014.
Sylvia M. Burwell,
Secretary, Department of Health and Human
Services.
[FR Doc. 2014–26183 Filed 10–31–14; 4:15 pm]
BILLING CODE 4120–01–P
E:\FR\FM\13NOR2.SGM
13NOR2
]]>Agencies
[Federal Register Volume 79, Number 219 (Thursday, November 13, 2014)]
[Rules and Regulations]
[Pages 67547-68010]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26183]
[[Page 67547]]
Vol. 79
Thursday,
No. 219
November 13, 2014
Part II
Department of Health and Human Services
-----------------------------------------------------------------------
Centers for Medicare and Medicaid Services
-----------------------------------------------------------------------
42 CFR Parts 403, 405, 410, et al.
Medicare Program; Revisions to Payment Policies Under the Physician
Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable
Data for the Center for Medicare and Medicaid Innovation Models & Other
Revisions to Part B for CY 2015; Final Rule
Federal Register / Vol. 79 , No. 219 / Thursday, November 13, 2014 /
Rules and Regulations
[[Page 67548]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 403, 405, 410, 411, 412, 413, 414, 425, 489, 495, and
498
[CMS-1612-FC]
RIN 0938-AS12
Medicare Program; Revisions to Payment Policies Under the
Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to
Identifiable Data for the Center for Medicare and Medicaid Innovation
Models & Other Revisions to Part B for CY 2015
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule with comment period.
-----------------------------------------------------------------------
SUMMARY: This major final rule with comment period addresses changes to
the physician fee schedule, and other Medicare Part B payment policies
to ensure that our payment systems are updated to reflect changes in
medical practice and the relative value of services, as well as changes
in the statute. See the Table of Contents for a listing of the specific
issues addressed in this rule.
DATES: Effective date: The provisions of this final rule are effective
on January 1, 2015, with the exception of amendments to parts 412, 413,
and 495 which are effective October 31, 2014.
Comment date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on December 30, 2014.
Compliance date: The compliance date for new data collection
requirements in Sec. 403.904(c)(8) is January 1, 2016.
ADDRESSES: In commenting, please refer to file code CMS-1612-FC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to www.regulations.gov. Follow the instructions for
``submitting a comment.''
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1612-FC, P.O. Box 8013,
Baltimore, MD 21244-8013.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1612-FC, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments before the close of the comment period
to either of the following addresses:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
please call telephone number (410) 786-7195 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
FOR FURTHER INFORMATION CONTACT: Donta Henson, (410) 786-1947 for any
physician payment issues not identified below.
Gail Addis, (410) 786-4522, for issues related to the refinement
panel.
Chava Sheffield, (410) 786-2298, for issues related to practice
expense methodology, impacts, the sustainable growth rate, conscious
sedation, or conversion factors.
Kathy Kersell, (410) 786-2033, for issues related to direct
practice expense inputs.
Jessica Bruton, (410) 786-5991, for issues related to potentially
misvalued services or work RVUs.
Craig Dobyski, (410) 786-4584, for issues related to geographic
practice cost indices or malpractice RVUs.
Ken Marsalek, (410) 786-4502, for issues related to telehealth
services.
Pam West, (410) 786-2302, for issues related to conditions for
therapists in private practice or therapy caps.
Ann Marshall, (410) 786-3059, for issues related to chronic care
management.
Marianne Myers, (410) 786-5962, for issues related to ambulance
extender provisions.
Amy Gruber, (410) 786-1542, for issues related to changes in
geographic area designations for ambulance payment.
Anne Tayloe-Hauswald, (410) 786-4546, for issues related to
clinical lab fee schedule.
Corinne Axelrod, (410) 786-5620, for issues related to Rural Health
Clinics or Federally Qualified Health Centers.
Renee Mentnech, (410) 786-6692, for issues related to access to
identifiable data for the Centers for Medicare & Medicaid models.
Marie Casey, (410) 786-7861 or Karen Reinhardt, (410) 786-0189, for
issues related to local coverage determination process for clinical
diagnostic laboratory tests.
Frederick Grabau, (410) 786-0206, for issues related to private
contracting/opt-out.
David Walczak, (410) 786-4475, for issues related to payment policy
for substitute physician billing arrangements (locum tenens).
Melissa Heesters, (410) 786-0618, for issues related to reports of
payments or other transfers of value to covered recipients.
Alesia Hovatter, (410) 786-6861, for issues related to physician
compare.
Christine Estella, (410) 786-0485, for issues related to the
physician quality reporting system.
Alexandra Mugge, (410) 786-4457, for issues related to EHR
incentive program.
Patrice Holtz, (410) 786-5663, for issues related to comprehensive
primary care initiative.
Terri Postma, (410) 786-4169, for issues related to Medicare Shared
Savings Program.
Kimberly Spalding Bush, (410) 786-3232, for issues related to
value-based modifier and improvements to physician feedback.
Elizabeth Holland, (410) 786-1309, Medicare EHR Incentive Program
(Medicare payment adjustments and hardship exceptions).
Elisabeth Myers (CMS), (410) 786-4751, Medicare EHR Incentive
Program (Medicare payment adjustments and hardship exceptions).
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of
[[Page 67549]]
the comment period are available for viewing by the public, including
any personally identifiable or confidential business information that
is included in a comment. We post all comments received before the
close of the comment period on the following Web site as soon as
possible after they have been received: https://www.regulations.gov.
Follow the search instructions on that Web site to view public
comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
Table of Contents
I. Executive Summary and Background
A. Executive Summary
B. Background
C. Health Information Technology
II. Provisions of the Final Rule With Comment Period for PFS
A. Resource-Based Practice Expense (PE) Relative Value Units
(RVUs)
B. Potentially Misvalued Services Under the Physician Fee
Schedule
C. Malpractice Relative Value Units (RVUs)
D. Geographic Practice Cost Indices (GPCIs)
E. Medicare Telehealth Services
F. Valuing New, Revised and Potentially Misvalued Codes
G. Establishing RVUs for CY 2015
H. Chronic Care Management (CCM)
I. Therapy Caps for CY 2015
J. Definition of Colorectal Cancer Screening Tests
K. Payment of Secondary Interpretation of Images
L. Conditions Regarding Permissible Practice Types for
Therapists in Private Practice
M. Payments for Practitioners Managing Patients on Home Dialysis
N. Sustainable Growth Rate
III. Other Provisions of the Final Rule With Comment Period
Regulation
A. Ambulance Extender Provisions
B. Changes in Geographic Area Delineations for Ambulance Payment
C. Clinical Laboratory Fee Schedule
D. Removal of Employment Requirements for Services Furnished
``Incident to'' Rural Health Clinic (RHC) and Federally Qualified
Health Center (FQHC) Visits
E. Access to Identifiable Data for the Center for Medicare and
Medicaid Innovation Models
F. Local Coverage Determination Process for Clinical Diagnostic
Laboratory Tests
G. Private Contracting/Opt-Out
H. Solicitation of Comments on the Payment Policy for Substitute
Physician Billing Arrangements
I. Reports of Payments or Other Transfers of Value to Covered
Recipients
J. Physician Compare Web Site
K. Physician Payment, Efficiency, and Quality Improvements--
Physician Quality Reporting System
L. Electronic Health Record (EHR) Incentive Program
M. Medicare Shared Savings Program
N. Value-Based Payment Modifier and Physician Feedback Program
O. Establishment of the Federally Qualified Health Center
Prospective Payment System (FQHC PPS)
P. Physician Self-Referral Prohibition: Annual Update to the
List of CPT/HCPCS Codes
Q. Interim Final Revisions to the Electronic Health Record (EHR)
Incentive Program
IV. Collection of Information Requirements
V. Response to Comments
VI. Waiver of Proposed Rulemaking and Waiver of Delay in Effective
Date
VII. Regulatory Impact Analysis
Regulations Text
Acronyms
In addition, because of the many organizations and terms to which
we refer by acronym in this final rule with comment period, we are
listing these acronyms and their corresponding terms in alphabetical
order below:
AAA Abdominal aortic aneurysms
ACO Accountable care organization
AMA American Medical Association
ASC Ambulatory surgical center
ATA American Telehealth Association
ATRA American Taxpayer Relief Act (Pub. L. 112-240)
BBA Balanced Budget Act of 1997 (Pub. L. 105-33)
BBRA [Medicare, Medicaid and State Child Health Insurance Program]
Balanced Budget Refinement Act of 1999 (Pub. L. 106-113)
CAD Coronary artery disease
CAH Critical access hospital
CBSA Core-Based Statistical Area
CCM Chronic care management
CEHRT Certified EHR technology
CF Conversion factor
CG-CAHPS Clinician and Group Consumer Assessment of Healthcare
Providers and Systems
CLFS Clinical Laboratory Fee Schedule
CNM Certified nurse-midwife
CP Clinical psychologist
CPC Comprehensive Primary Care
CPEP Clinical Practice Expert Panel
CPT [Physicians] Current Procedural Terminology (CPT codes,
descriptions and other data only are copyright 2014 American Medical
Association. All rights reserved.)
CQM Clinical quality measure
CSW Clinical social worker
CT Computed tomography
CY Calendar year
DFAR Defense Federal Acquisition Regulations
DHS Designated health services
DM Diabetes mellitus
DSMT Diabetes self-management training
eCQM Electronic clinical quality measures
EHR Electronic health record
E/M Evaluation and management
EP Eligible professional
eRx Electronic prescribing
ESRD End-stage renal disease
FAR Federal Acquisition Regulations
FFS Fee-for-service
FQHC Federally qualified health center
FR Federal Register
GAF Geographic adjustment factor
GAO Government Accountability Office
GPCI Geographic practice cost index
GPO Group purchasing organization
GPRO Group practice reporting option
GTR Genetic Testing Registry
HCPCS Healthcare Common Procedure Coding System
HHS [Department of] Health and Human Services
HOPD Hospital outpatient department
HPSA Health professional shortage area
IDTF Independent diagnostic testing facility
IPPS Inpatient Prospective Payment System
IQR Inpatient Quality Reporting
ISO Insurance service office
IWPUT Intensity of work per unit of time
LCD Local coverage determination
MA Medicare Advantage
MAC Medicare Administrative Contractor
MAP Measure Applications Partnership
MAPCP Multi-payer Advanced Primary Care Practice
MAV Measure application validity [process]
MCP Monthly capitation payment
MedPAC Medicare Payment Advisory Commission
MEI Medicare Economic Index
MFP Multi-Factor Productivity
MIPPA Medicare Improvements for Patients and Providers Act (Pub. L.
110-275)
MMA Medicare Prescription Drug, Improvement and Modernization Act of
2003 (Pub. L. 108-173, enacted on December 8, 2003)
MP Malpractice
MPPR Multiple procedure payment reduction
MRA Magnetic resonance angiography
MRI Magnetic resonance imaging
MSA Metropolitan Statistical Areas
MSPB Medicare Spending per Beneficiary
MSSP Medicare Shared Savings Program
MU Meaningful use
NCD National coverage determination
NCQDIS National Coalition of Quality Diagnostic Imaging Services
NP Nurse practitioner
NPI National Provider Identifier
NPP Nonphysician practitioner
NQS National Quality Strategy
OACT CMS's Office of the Actuary
OBRA '89 Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239)
OBRA '90 Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508)
OES Occupational Employment Statistics
OMB Office of Management and Budget
OPPS Outpatient prospective payment system
OT Occupational therapy
PA Physician assistant
PAMA Protecting Access to Medicare Act of 2014 (Pub. L. 113-93)
PC Professional component
PCIP Primary Care Incentive Payment
[[Page 67550]]
PE Practice expense
PE/HR Practice expense per hour
PEAC Practice Expense Advisory Committee
PECOS Provider Enrollment, Chain, and Ownership System
PFS Physician Fee Schedule
PLI Professional Liability Insurance
PMA Premarket approval
PQRS Physician Quality Reporting System
PPIS Physician Practice Expense Information Survey
PT Physical therapy
PY Performance year
QCDR Qualified clinical data registry
QRUR Quality and Resources Use Report
RBRVS Resource-based relative value scale
RFA Regulatory Flexibility Act
RHC Rural health clinic
RIA Regulatory impact analysis
RUC American Medical Association/Specialty Society Relative (Value)
Update Committee
RUCA Rural Urban Commuting Area
RVU Relative value unit
SBA Small Business Administration
SGR Sustainable growth rate
SIM State Innovation Model
SLP Speech-language pathology
SMS Socioeconomic Monitoring System
SNF Skilled nursing facility
TAP Technical Advisory Panel
TC Technical component
TIN Tax identification number
UAF Update adjustment factor
UPIN Unique Physician Identification Number
USPSTF United States Preventive Services Task Force
VBP Value-based purchasing
VM Value-Based Payment Modifier
Addenda Available Only Through the Internet on the CMS Web Site
The PFS Addenda along with other supporting documents and tables
referenced in this final rule with comment period are available through
the Internet on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. Click on the link on the left side of the
screen titled, ``PFS Federal Regulations Notices'' for a chronological
list of PFS Federal Register and other related documents. For the CY
2015 PFS final rule with comment period, refer to item CMS-1612-FC.
Readers who experience any problems accessing any of the Addenda or
other documents referenced in this rule and posted on the CMS Web site
identified above should contact donta.henson1@cms.hhs.gov.
CPT (Current Procedural Terminology) Copyright Notice
Throughout this final rule with comment period, we use CPT codes
and descriptions to refer to a variety of services. We note that CPT
codes and descriptions are copyright 2013 American Medical Association.
All Rights Reserved. CPT is a registered trademark of the American
Medical Association (AMA). Applicable Federal Acquisition Regulations
(FAR) and Defense Federal Acquisition Regulations (DFAR) apply.
I. Executive Summary and Background
A. Executive Summary
1. Purpose
This major final rule with comment period revises payment polices
under the Medicare Physician Fee Schedule (PFS) and makes other policy
changes related to Medicare Part B payment. These changes are
applicable to services furnished in CY 2015.
2. Summary of the Major Provisions
The Social Security Act (the Act) requires us to establish payments
under the PFS based on national uniform relative value units (RVUs)
that account for the relative resources used in furnishing a service.
The Act requires that RVUs be established for three categories of
resources: Work, practice expense (PE); and malpractice (MP) expense;
and, that we establish by regulation each year's payment amounts for
all physicians' services, incorporating geographic adjustments to
reflect the variations in the costs of furnishing services in different
geographic areas. In this major final rule with comment period, we
establish RVUs for CY 2015 for the PFS, and other Medicare Part B
payment policies, to ensure that our payment systems are updated to
reflect changes in medical practice and the relative value of services,
as well as changes in the statute. In addition, this final rule with
comment period includes discussions and proposals regarding:
Misvalued PFS Codes.
Telehealth Services.
Chronic Care Management Services.
Establishing Values for New, Revised, and Misvalued Codes.
Updating the Ambulance Fee Schedule regulations.
Changes in Geographic Area Delineations for Ambulance
Payment.
Updating the--
++ Physician Compare Web site.
++ Physician Quality Reporting System.
++ Medicare Shared Savings Program.
++ Electronic Health Record (EHR) Incentive Program.
Value-Based Payment Modifier and the Physician Feedback
Program.
3. Summary of Costs and Benefits
The Act requires that annual adjustments to PFS RVUs may not cause
annual estimated expenditures to differ by more than $20 million from
what they would have been had the adjustments not been made. If
adjustments to RVUs would cause expenditures to change by more than $20
million, we must make adjustments to preserve budget neutrality. These
adjustments can affect the distribution of Medicare expenditures across
specialties. In addition, several proposed changes would affect the
specialty distribution of Medicare expenditures. When considering the
combined impact of work, PE, and MP RVU changes, the projected payment
impacts are small for most specialties; however, the impact would be
larger for a few specialties.
We have determined that this final rule with comment period is
economically significant. For a detailed discussion of the economic
impacts, see section VII. of this final rule with comment period.
B. Background
Since January 1, 1992, Medicare has paid for physicians' services
under section 1848 of the Act, ``Payment for Physicians' Services.''
The system relies on national relative values that are established for
work, PE, and MP, which are adjusted for geographic cost variations.
These values are multiplied by a conversion factor (CF) to convert the
RVUs into payment rates. The concepts and methodology underlying the
PFS were enacted as part of the Omnibus Budget Reconciliation Act of
1989 (Pub. L. 101-239, enacted on December 19, 1989) (OBRA '89), and
the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted
on November 5, 1990) (OBRA '90). The final rule published on November
25, 1991 (56 FR 59502) set forth the first fee schedule used for
payment for physicians' services.
We note that throughout this final rule with comment period, unless
otherwise noted, the term ``practitioner'' is used to describe both
physicians and nonphysician practitioners (NPPs) who are permitted to
bill Medicare under the PFS for services furnished to Medicare
beneficiaries.
1. Development of the Relative Values
a. Work RVUs
The work RVUs established for the initial fee schedule, which was
implemented on January 1, 1992, were developed with extensive input
from the physician community. A research team at the Harvard School of
Public Health developed the original work RVUs for most codes under a
[[Page 67551]]
cooperative agreement with the Department of Health and Human Services
(HHS). In constructing the code-specific vignettes used in determining
the original physician work RVUs, Harvard worked with panels of
experts, both inside and outside the federal government, and obtained
input from numerous physician specialty groups.
As specified in section 1848(c)(1)(A) of the Act, the work
component of physicians' services means the portion of the resources
used in furnishing the service that reflects physician time and
intensity. We establish work RVUs for new, revised and potentially
misvalued codes based on our review of information that generally
includes, but is not limited to, recommendations received from the
American Medical Association/Specialty Society Relative Value Update
Committee (RUC), the Health Care Professionals Advisory Committee
(HCPAC), the Medicare Payment Advisory Commission (MedPAC), and other
public commenters; medical literature and comparative databases; as
well as a comparison of the work for other codes within the Medicare
PFS, and consultation with other physicians and health care
professionals within CMS and the federal government. We also assess the
methodology and data used to develop the recommendations submitted to
us by the RUC and other public commenters, and the rationale for their
recommendations.
b. Practice Expense RVUs
Initially, only the work RVUs were resource-based, and the PE and
MP RVUs were based on average allowable charges. Section 121 of the
Social Security Act Amendments of 1994 (Pub. L. 103-432, enacted on
October 31, 1994), amended section 1848(c)(2)(C)(ii) of the Act and
required us to develop resource-based PE RVUs for each physicians'
service beginning in 1998. We were required to consider general
categories of expenses (such as office rent and wages of personnel, but
excluding malpractice expenses) comprising PEs. The PE RVUs continue to
represent the portion of these resources involved in furnishing PFS
services.
Originally, the resource-based method was to be used beginning in
1998, but section 4505(a) of the Balanced Budget Act of 1997 (Pub. L.
105-33, enacted on August 5, 1997) (BBA) delayed implementation of the
resource-based PE RVU system until January 1, 1999. In addition,
section 4505(b) of the BBA provided for a 4-year transition period from
the charge-based PE RVUs to the resource-based PE RVUs.
We established the resource-based PE RVUs for each physicians'
service in a final rule, published on November 2, 1998 (63 FR 58814),
effective for services furnished in CY 1999. Based on the requirement
to transition to a resource-based system for PE over a 4-year period,
payment rates were not fully based upon resource-based PE RVUs until CY
2002. This resource-based system was based on two significant sources
of actual PE data: The Clinical Practice Expert Panel (CPEP) data and
the AMA's Socioeconomic Monitoring System (SMS) data. (These data
sources are described in greater detail in the CY 2012 final rule with
comment period (76 FR 73033).)
Separate PE RVUs are established for services furnished in facility
settings, such as a hospital outpatient department (HOPD) or an
ambulatory surgical center (ASC), and in nonfacility settings, such as
a physician's office. The nonfacility RVUs reflect all of the direct
and indirect PEs involved in furnishing a service described by a
particular HCPCS code. The difference, if any, in these PE RVUs
generally results in a higher payment in the nonfacility setting
because in the facility settings some costs are borne by the facility.
Medicare's payment to the facility (such as the outpatient prospective
payment system (OPPS) payment to the HOPD) would reflect costs
typically incurred by the facility. Thus, payment associated with those
facility resources is not made under the PFS.
Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L.
106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of
Health and Human Services (the Secretary) to establish a process under
which we accept and use, to the maximum extent practicable and
consistent with sound data practices, data collected or developed by
entities and organizations to supplement the data we normally collect
in determining the PE component. On May 3, 2000, we published the
interim final rule (65 FR 25664) that set forth the criteria for the
submission of these supplemental PE survey data. The criteria were
modified in response to comments received, and published in the Federal
Register (65 FR 65376) as part of a November 1, 2000 final rule. The
PFS final rules published in 2001 and 2003, respectively, (66 FR 55246
and 68 FR 63196) extended the period during which we would accept these
supplemental data through March 1, 2005.
In the CY 2007 PFS final rule with comment period (71 FR 69624), we
revised the methodology for calculating direct PE RVUs from the top-
down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
year transition to the new PE RVUs. This transition was completed for
CY 2010. In the CY 2010 PFS final rule with comment period, we updated
the practice expense per hour (PE/HR) data that are used in the
calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010,
we began a 4-year transition to the new PE RVUs using the updated PE/HR
data, which was completed for CY 2013.
c. Malpractice RVUs
Section 4505(f) of the BBA amended section 1848(c) of the Act to
require that we implement resource-based MP RVUs for services furnished
on or after CY 2000. The resource-based MP RVUs were implemented in the
PFS final rule with comment period published November 2, 1999 (64 FR
59380). The MP RVUs are based on commercial and physician-owned
insurers' malpractice insurance premium data from all the states, the
District of Columbia, and Puerto Rico. For more information on MP RVUs,
see section II.C. of this final rule with comment period.
d. Refinements to the RVUs
Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no
less often than every 5 years. Prior to CY 2013, we conducted periodic
reviews of work RVUs and PE RVUs independently. We completed five-year
reviews of work RVUs that were effective for calendar years 1997, 2002,
2007, and 2012.
Although refinements to the direct PE inputs initially relied
heavily on input from the RUC Practice Expense Advisory Committee
(PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to
the use of the updated PE/HR data in CY 2010 have resulted in
significant refinements to the PE RVUs in recent years.
In the CY 2012 PFS final rule with comment period (76 FR 73057), we
finalized a proposal to consolidate reviews of work and PE RVUs under
section 1848(c)(2)(B) of the Act and reviews of potentially misvalued
codes under section 1848(c)(2)(K) of the Act into one annual process.
With regard to MP RVUs, we completed five-year reviews of MP that
were effective in CY 2005 and CY 2010. This final rule with comment
period establishes a five-year review for CY 2015.
[[Page 67552]]
In addition to the five-year reviews, beginning for CY 2009, CMS,
and the RUC have identified and reviewed a number of potentially
misvalued codes on an annual basis based on various identification
screens. This annual review of work and PE RVUs for potentially
misvalued codes was supplemented by the amendments to section 1848 of
the Act, as enacted by section 3134 of the Affordable Care Act, which
requires the agency to periodically identify, review and adjust values
for potentially misvalued codes.
e. Application of Budget Neutrality To Adjustments of RVUs
As described in section VI.C. of this final rule with comment
period, in accordance with section 1848(c)(2)(B)(ii)(II) of the Act, if
revisions to the RVUs caused expenditures for the year to change by
more than $20 million, we make adjustments to ensure that expenditures
did not increase or decrease by more than $20 million.
2. Calculation of Payments Based on RVUs
To calculate the payment for each physicians' service, the
components of the fee schedule (work, PE, and MP RVUs) are adjusted by
geographic practice cost indices (GPCIs) to reflect the variations in
the costs of furnishing the services. The GPCIs reflect the relative
costs of physician work, PE, and MP in an area compared to the national
average costs for each component. (See section II.D. of this final rule
with comment period for more information about GPCIs.)
RVUs are converted to dollar amounts through the application of a
CF, which is calculated based on a statutory formula by CMS's Office of
the Actuary (OACT). The CF for a given year is calculated using (a) the
productivity-adjusted increase in the Medicare Economic Index (MEI) and
(b) the Update Adjustment Factor (UAF), which is calculated by taking
into account the Medicare Sustainable Growth Rate (SGR), an annual
growth rate intended to control growth in aggregate Medicare
expenditures for physicians' services, and the allowed and actual
expenditures for physicians' services. The formula for calculating the
Medicare fee schedule payment amount for a given service and fee
schedule area can be expressed as:
Payment = [(RVU work x GPCI work) + (RVU PE x GPCI PE) + (RVU MP x GPCI
MP)] x CF.
3. Separate Fee Schedule Methodology for Anesthesia Services
Section 1848(b)(2)(B) of the Act specifies that the fee schedule
amounts for anesthesia services are to be based on a uniform relative
value guide, with appropriate adjustment of an anesthesia conversion
factor, in a manner to assure that fee schedule amounts for anesthesia
services are consistent with those for other services of comparable
value. Therefore, there is a separate fee schedule methodology for
anesthesia services. Specifically, we establish a separate conversion
factor for anesthesia services and we utilize the uniform relative
value guide, or base units, as well as time units, to calculate the fee
schedule amounts for anesthesia services. Since anesthesia services are
not valued using RVUs, a separate methodology for locality adjustments
is also necessary. This involves an adjustment to the national
anesthesia CF for each payment locality.
4. Most Recent Changes to the Fee Schedule
The CY 2014 PFS final rule with comment period (78 FR 74230)
implemented changes to the PFS and other Medicare Part B payment
policies. It also finalized many of the CY 2013 interim final RVUs and
established interim final RVUs for new and revised codes for CY 2014 to
ensure that our payment system is updated to reflect changes in medical
practice, coding changes, and the relative values of services. It also
implemented section 635 of the American Taxpayer Relief Act of 2012
(Pub. L. 112-240, enacted on January 2, 2013) (ATRA), which revised the
equipment utilization rate assumption for advanced imaging services
furnished on or after January 1, 2014.
Also, in the CY 2014 PFS final rule with comment period, we
announced the following for CY 2014: the total PFS update of -20.1
percent; the initial estimate for the SGR of -16.7 percent; and a CF of
$27.2006. These figures were calculated based on the statutory
provisions in effect on November 27, 2013, when the CY 2014 PFS final
rule with comment period was issued.
The Pathway for SGR Reform Act of 2013 (Pub. L. 113-67, enacted on
December 26, 2013) established a 0.5 percent update to the PFS CF
through March 31, 2014 and the Protecting Access to Medicare Act of
2014 (Pub. L. 113-93, enacted on April 1, 2014) (PAMA) extended this
0.5 percent update through December 31, 2014. As a result, the CF for
CY 2014 that was published in the CY 2014 final rule with comment
period (78 FR 74230) was revised to $35.8228 for services furnished on
or after January 1, 2014 and on or before December 31, 2014. The PAMA
provides for a 0.0 percent update to the PFS for services furnished on
or after January 1, 2015 and on or before March 31, 2015.
The Pathway for SGR Reform Act extended through March 31, 2014
several provisions of Medicare law that would have otherwise expired on
December 31, 2013. The PAMA extended these same provisions further
through March 31, 2015. A list of these provisions follows.
The 1.0 floor on the work geographic practice cost index
The exceptions process for outpatient therapy caps
The manual medical review process for therapy services
The application of the therapy caps and related provisions to
services furnished in HOPDs
In addition, section 220 of the PAMA included several provisions
affecting the valuation process for services under the PFS. Section
220(a) of the PAMA amended section 1848(c)(2) of the Act to add a new
subparagraph (M). The new subparagraph (M) provides that the Secretary
may collect or obtain information from any eligible professional or any
other source on the resources directly or indirectly related to
furnishing services for which payment is made under the PFS, and that
such information may be used in the determination of relative values
for services under the PFS. Such information may include the time
involved in furnishing services; the amounts, types and prices of
practice expense inputs; overhead and accounting information for
practices of physicians and other suppliers, and any other elements
that would improve the valuation of services under the PFS. This
information may be collected or obtained through surveys of physicians
or other suppliers, providers of services, manufacturers, and vendors;
surgical logs, billing systems, or other practice or facility records;
EHRs; and any other mechanism determined appropriate by the Secretary.
If we use this information, we are required to disclose the source and
use of the information in rulemaking, and to make available aggregated
information that does not disclose individual eligible professionals,
group practices, or information obtained pursuant to a nondisclosure
agreement. Beginning with fiscal year 2014, the Secretary may
compensate eligible professionals for submission of data.
[[Page 67553]]
Section 220(c) of the PAMA amended section 1848(c)(2)(K)(ii) of the
Act to expand the categories of services that the Secretary is directed
to examine for the purpose of identifying potentially misvalued codes.
The nine new categories are as follows:
Codes that account for the majority of spending under the
PFS.
Codes for services that have experienced a substantial
change in the hospital length of stay or procedure time.
Codes for which there may be a change in the typical site
of service since the code was last valued.
Codes for which there is a significant difference in
payment for the same service between different sites of service.
Codes for which there may be anomalies in relative values
within a family of codes.
Codes for services where there may be efficiencies when a
service is furnished at the same time as other services.
Codes with high intra-service work per unit of time.
Codes with high PE RVUs.
Codes with high cost supplies.
(See section II.B. of this final rule with comment period for more
information about misvalued codes.).
Section 220(i) of the PAMA also requires the Secretary to make
publicly available the information we considered when establishing the
multiple procedure payment reduction (MPPR) policy for the professional
component of advanced imaging procedures. The policy reduces the amount
paid for the professional component when two advanced imaging
procedures are furnished in the same session. The policy was effective
for individual physicians on January 1, 2012 and for physicians in the
same group practice on January 1, 2013.
In addition, section 220 of the PAMA includes other provisions
regarding valuation of services under the PFS that take effect in
future years. Section 220(d) of the PAMA establishes an annual target
from CY 2017 through CY 2020 for reductions in PFS expenditures
resulting from adjustments to relative values of misvalued services.
The target is calculated as 0.5 percent of the estimated amount of
expenditures under the fee schedule for the year. If the net reduction
in expenditures for the year is equal to or greater than the target for
the year, the funds shall be redistributed in a budget-neutral manner
within the PFS. The amount by which such reduced expenditures exceed
the target for the year shall be treated as a reduction in expenditures
for the subsequent year, for purposes of determining whether the target
has or has not been met. The legislation includes an exemption from
budget neutrality of reduced expenditures if the target is not met.
Other provisions of section 220 of the PAMA include a 2-year phase-in
for reductions in RVUs of at least 20 percent for potentially misvalued
codes that do not involve coding changes, and certain adjustments to
the fee schedule areas in California. These provisions will be
addressed as we implement them in future rulemaking.
On March 5, 2014, we submitted to MedPAC an estimate of the SGR and
CF applicable to Medicare payments for physicians' services for CY
2015, as required by section 1848(d)(1)(E) of the Act. The actual
values used to compute physician payments for CY 2015 will be based on
later data and are scheduled to be published by November 1, 2014, as
part of the CY 2015 PFS final rule with comment period.
C. Health Information Technology
The Department of Health and Human Services (HHS) believes all
patients, their families, and their health care providers should have
consistent and timely access to patient health information in a
standardized format that can be securely exchanged between the patient,
providers, and others involved in the patient's care. (HHS August 2013
Statement, ``Principles and Strategies for Accelerating Health
Information Exchange,'' see https://www.healthit.gov/sites/default/files/acceleratinghieprinciples_strategy.pdf) HHS is committed to
accelerating health information exchange (HIE) through the use of safe,
interoperable health information technology (health IT), including
electronic health records (EHRs), across the broader care continuum
through a number of initiatives: (1) Alignment of incentives and
payment adjustments to encourage provider adoption and optimization of
health IT and HIE services through Medicare and Medicaid payment
policies; (2) adoption of common standards and certification
requirements for interoperable HIT; (3) support for privacy and
security of patient information across all HIE-focused initiatives; and
(4) governance of health information. These initiatives are designed to
encourage HIE among health care providers, including professionals and
hospitals eligible for the Medicare and Medicaid EHR Incentive Programs
and those who are not eligible for the EHR Incentive Programs, and are
designed to improve care delivery and coordination across the entire
care continuum. For example, the Transition of Care Measure #2 in Stage
2 of the Medicare and Medicaid EHR Incentive Programs requires HIE to
share summary records for more than 10 percent of care transitions. In
addition, to increase flexibility in the Office of the National
Coordinator for Health Information Technology's (ONC) regulatory
certification structure, ONC expressed in the 2014 Edition Release 2
final rule (79 FR 54472-73) an intent to propose future changes to the
ONC HIT Certification Program that would permit more efficient
certification of health IT for other health care settings, such as
long-term and post-acute care and behavioral health settings.
We believe that health IT that incorporates usability features and
has been certified to interoperable standards can effectively and
efficiently help all providers improve internal care delivery
practices, support management of patient care across the continuum, and
support the reporting of electronically specified clinical quality
measures (eCQMs).
II. Provisions of the Proposed Rule for PFS
A. Resource-Based Practice Expense (PE) Relative Value Units (RVUs)
1. Overview
Practice expense (PE) is the portion of the resources used in
furnishing a service that reflects the general categories of physician
and practitioner expenses, such as office rent and personnel wages, but
excluding malpractice expenses, as specified in section 1848(c)(1)(B)
of the Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use
a resource-based system for determining PE RVUs for each physician's
service. We develop PE RVUs by considering the direct and indirect
practice resources involved in furnishing each service. Direct expense
categories include clinical labor, medical supplies, and medical
equipment. Indirect expenses include administrative labor, office
expense, and all other expenses. The sections that follow provide more
detailed information about the methodology for translating the
resources involved in furnishing each service into service-specific PE
RVUs. We refer readers to the CY 2010 PFS final rule with comment
period (74 FR 61743 through 61748) for a more detailed explanation of
the PE methodology.
[[Page 67554]]
2. Practice Expense Methodology
a. Direct Practice Expense
We determine the direct PE for a specific service by adding the
costs of the direct resources (that is, the clinical staff, medical
supplies, and medical equipment) typically involved with furnishing
that service. The costs of the resources are calculated using the
refined direct PE inputs assigned to each CPT code in our PE database,
which are generally based on our review of recommendations received
from the RUC and those provided in response to public comment periods.
For a detailed explanation of the direct PE methodology, including
examples, we refer readers to the Five-Year Review of Work Relative
Value Units under the PFS and Proposed Changes to the Practice Expense
Methodology proposed notice (71 FR 37242) and the CY 2007 PFS final
rule with comment period (71 FR 69629).
b. Indirect Practice Expense Per Hour Data
We use survey data on indirect PEs incurred per hour worked in
developing the indirect portion of the PE RVUs. Prior to CY 2010, we
primarily used the practice expense per hour (PE/HR) by specialty that
was obtained from the AMA's Socioeconomic Monitoring Surveys (SMS). The
AMA administered a new survey in CY 2007 and CY 2008, the Physician
Practice Expense Information Survey (PPIS). The PPIS is a
multispecialty, nationally representative, PE survey of both physicians
and nonphysician practitioners (NPPs) paid under the PFS using a survey
instrument and methods highly consistent with those used for the SMS
and the supplemental surveys. The PPIS gathered information from 3,656
respondents across 51 physician specialty and health care professional
groups. We believe the PPIS is the most comprehensive source of PE
survey information available. We used the PPIS data to update the PE/HR
data for the CY 2010 PFS for almost all of the Medicare-recognized
specialties that participated in the survey.
When we began using the PPIS data in CY 2010, we did not change the
PE RVU methodology itself or the manner in which the PE/HR data are
used in that methodology. We only updated the PE/HR data based on the
new survey. Furthermore, as we explained in the CY 2010 PFS final rule
with comment period (74 FR 61751), because of the magnitude of payment
reductions for some specialties resulting from the use of the PPIS
data, we transitioned its use over a 4-year period from the previous PE
RVUs to the PE RVUs developed using the new PPIS data. As provided in
the CY 2010 PFS final rule with comment period (74 FR 61751), the
transition to the PPIS data was complete for CY 2013. Therefore, PE
RVUs from CY 2013 forward are developed based entirely on the PPIS
data, except as noted in this section.
Section 1848(c)(2)(H)(i) of the Act requires us to use the medical
oncology supplemental survey data submitted in 2003 for oncology drug
administration services. Therefore, the PE/HR for medical oncology,
hematology, and hematology/oncology reflects the continued use of these
supplemental survey data.
Supplemental survey data on independent labs from the College of
American Pathologists were implemented for payments beginning in CY
2005. Supplemental survey data from the National Coalition of Quality
Diagnostic Imaging Services (NCQDIS), representing independent
diagnostic testing facilities (IDTFs), were blended with supplementary
survey data from the American College of Radiology (ACR) and
implemented for payments beginning in CY 2007. Neither IDTFs, nor
independent labs, participated in the PPIS. Therefore, we continue to
use the PE/HR that was developed from their supplemental survey data.
Consistent with our past practice, the previous indirect PE/HR
values from the supplemental surveys for these specialties were updated
to CY 2006 using the MEI to put them on a comparable basis with the
PPIS data.
We also do not use the PPIS data for reproductive endocrinology and
spine surgery since these specialties currently are not separately
recognized by Medicare, nor do we have a method to blend the PPIS data
with Medicare-recognized specialty data.
Previously, we established PE/HR values for various specialties
without SMS or supplemental survey data by crosswalking them to other
similar specialties to estimate a proxy PE/HR. For specialties that
were part of the PPIS for which we previously used a crosswalked PE/HR,
we instead used the PPIS-based PE/HR. We continue previous crosswalks
for specialties that did not participate in the PPIS. However,
beginning in CY 2010 we changed the PE/HR crosswalk for portable x-ray
suppliers from radiology to IDTF, a more appropriate crosswalk because
these specialties are more similar to each other for work time.
For registered dietician services, the resource-based PE RVUs have
been calculated in accordance with the final policy that crosswalks the
specialty to the ``All Physicians'' PE/HR data, as adopted in the CY
2010 PFS final rule with comment period (74 FR 61752) and discussed in
more detail in the CY 2011 PFS final rule with comment period (75 FR
73183).
c. Allocation of PE to Services
To establish PE RVUs for specific services, it is necessary to
establish the direct and indirect PE associated with each service.
(1) Direct Costs
The relative relationship between the direct cost portions of the
PE RVUs for any two services is determined by the relative relationship
between the sum of the direct cost resources (that is, the clinical
staff, medical supplies, and medical equipment) typically involved with
furnishing each of the services. The costs of these resources are
calculated from the refined direct PE inputs in our PE database. For
example, if one service has a direct cost sum of $400 from our PE
database and another service has a direct cost sum of $200, the direct
portion of the PE RVUs of the first service would be twice as much as
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
Section II.A.2.b. of this final rule with comment period describes
the current data sources for specialty-specific indirect costs used in
our PE calculations. We allocated the indirect costs to the code level
on the basis of the direct costs specifically associated with a code
and the greater of either the clinical labor costs or the physician
work RVUs. We also incorporated the survey data described earlier in
the PE/HR discussion. The general approach to developing the indirect
portion of the PE RVUs is as follows:
For a given service, we use the direct portion of the PE
RVUs calculated as previously described and the average percentage that
direct costs represent of total costs (based on survey data) across the
specialties that furnish the service to determine an initial indirect
allocator. In other words, the initial indirect allocator is calculated
so that the direct costs equal the average percentage of direct costs
of those specialties furnishing the service. For example, if the direct
portion of the PE RVUs for a given service is 2.00 and direct costs, on
average, represented 25 percent of total costs for the specialties that
furnished the service, the initial indirect allocator would be
calculated so that it equals 75 percent of the total PE RVUs. Thus, in
this example, the initial indirect allocator would equal 6.00,
resulting in
[[Page 67555]]
a total PE RVUs of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75
percent of 8.00).
Next, we add the greater of the work RVUs or clinical
labor portion of the direct portion of the PE RVUs to this initial
indirect allocator. In our example, if this service had work RVUs of
4.00 and the clinical labor portion of the direct PE RVUs was 1.50, we
would add 4.00 (since the 4.00 work RVUs are greater than the 1.50
clinical labor portion) to the initial indirect allocator of 6.00 to
get an indirect allocator of 10.00. In the absence of any further use
of the survey data, the relative relationship between the indirect cost
portions of the PE RVUs for any two services would be determined by the
relative relationship between these indirect cost allocators. For
example, if one service had an indirect cost allocator of 10.00 and
another service had an indirect cost allocator of 5.00, the indirect
portion of the PE RVUs of the first service would be twice as great as
the indirect portion of the PE RVUs for the second service.
Next, we incorporate the specialty-specific indirect PE/HR
data into the calculation. In our example, if, based on the survey
data, the average indirect cost of the specialties furnishing the first
service with an allocator of 10.00 was half of the average indirect
cost of the specialties furnishing the second service with an indirect
allocator of 5.00, the indirect portion of the PE RVUs of the first
service would be equal to that of the second service.
d. Facility and Nonfacility Costs
For procedures that can be furnished in a physician's office, as
well as in a hospital or other facility setting, we establish two PE
RVUs: Facility and nonfacility. The methodology for calculating PE RVUs
is the same for both the facility and nonfacility RVUs, but is applied
independently to yield two separate PE RVUs. Because in calculating the
PE RVUs for services furnished in a facility, we do not include
resources that would generally not be provided by physicians when
furnishing the service in a facility, the facility PE RVUs are
generally lower than the nonfacility PE RVUs. Medicare makes a separate
payment to the facility for its costs of furnishing a service.
e. Services With Technical Components (TCs) and Professional Components
(PCs)
Diagnostic services are generally comprised of two components: A
professional component (PC); and a technical component (TC). The PC and
TC may be furnished independently or by different providers, or they
may be furnished together as a ``global'' service. When services have
separately billable PC and TC components, the payment for the global
service equals the sum of the payment for the TC and PC. To achieve
this we use a weighted average of the ratio of indirect to direct costs
across all the specialties that furnish the global service, TCs, and
PCs; that is, we apply the same weighted average indirect percentage
factor to allocate indirect expenses to the global service, PCs, and
TCs for a service. (The direct PE RVUs for the TC and PC sum to the
global.)
f. PE RVU Methodology
For a more detailed description of the PE RVU methodology, we refer
readers to the CY 2010 PFS final rule with comment period (74 FR 61745
through 61746).
(1) Setup File
First, we create a setup file for the PE methodology. The setup
file contains the direct cost inputs, the utilization for each
procedure code at the specialty and facility/nonfacility place of
service level, and the specialty-specific PE/HR data calculated from
the surveys.
(2) Calculate the Direct Cost PE RVUs
Sum the costs of each direct input.
Step 1: Sum the direct costs of the inputs for each service. Apply
a scaling adjustment to the direct inputs.
Step 2: Calculate the aggregate pool of direct PE costs for the
current year. This is the product of the current aggregate PE (direct
and indirect) RVUs, the CF, and the average direct PE percentage from
the survey data used for calculating the PE/HR by specialty.
Step 3: Calculate the aggregate pool of direct PE costs for use in
ratesetting. This is the product of the aggregated direct costs for all
services from Step 1 and the utilization data for that service.
Step 4: Using the results of Step 2 and Step 3, calculate a direct
PE scaling adjustment to ensure that the aggregate pool of direct PE
costs calculated in Step 3 does not vary from the aggregate pool of
direct PE costs for the current year. Apply the scaling factor to the
direct costs for each service (as calculated in Step 1).
Step 5: Convert the results of Step 4 to an RVU scale for each
service. To do this, divide the results of Step 4 by the CF. Note that
the actual value of the CF used in this calculation does not influence
the final direct cost PE RVUs, as long as the same CF is used in Step 2
and Step 5. Different CFs will result in different direct PE scaling
factors, but this has no effect on the final direct cost PE RVUs since
changes in the CFs and changes in the associated direct scaling factors
offset one another.
(3) Create the Indirect Cost PE RVUs
Create indirect allocators.
Step 6: Based on the survey data, calculate direct and indirect PE
percentages for each physician specialty.
Step 7: Calculate direct and indirect PE percentages at the service
level by taking a weighted average of the results of Step 6 for the
specialties that furnish the service. Note that for services with TCs
and PCs, the direct and indirect percentages for a given service do not
vary by the PC, TC, and global service.
Step 8: Calculate the service level allocators for the indirect PEs
based on the percentages calculated in Step 7. The indirect PEs are
allocated based on the three components: The direct PE RVUs; the
clinical PE RVUs; and the work RVUs.
For most services the indirect allocator is: Indirect PE percentage
* (direct PE RVUs/direct percentage) + work RVUs.
There are two situations where this formula is modified:
If the service is a global service (that is, a service
with global, professional, and technical components), then the indirect
PE allocator is: Indirect percentage (direct PE RVUs/direct percentage)
+ clinical labor PE RVUs + work RVUs.
If the clinical labor PE RVUs exceed the work RVUs (and
the service is not a global service), then the indirect allocator is:
Indirect PE percentage (direct PE RVUs/direct percentage) + clinical
labor PE RVUs.
(Note: For global services, the indirect PE allocator is based
on both the work RVUs and the clinical labor PE RVUs. We do this to
recognize that, for the PC service, indirect PEs will be allocated
using the work RVUs, and for the TC service, indirect PEs will be
allocated using the direct PE RVUs and the clinical labor PE RVUs.
This also allows the global component RVUs to equal the sum of the
PC and TC RVUs.)
For presentation purposes in the examples in Table 1, the formulas
were divided into two parts for each service.
The first part does not vary by service and is the
indirect percentage (direct PE RVUs/direct percentage).
The second part is either the work RVU, clinical labor PE
RVU, or both depending on whether the service is a global service and
whether the clinical PE RVUs exceed the work RVUs (as described earlier
in this step).
Apply a scaling adjustment to the indirect allocators.
Step 9: Calculate the current aggregate pool of indirect PE RVUs by
multiplying
[[Page 67556]]
the current aggregate pool of PE RVUs by the average indirect PE
percentage from the survey data.
Step 10: Calculate an aggregate pool of indirect PE RVUs for all
PFS services by adding the product of the indirect PE allocators for a
service from Step 8 and the utilization data for that service.
Step 11: Using the results of Step 9 and Step 10, calculate an
indirect PE adjustment so that the aggregate indirect allocation does
not exceed the available aggregate indirect PE RVUs and apply it to
indirect allocators calculated in Step 8.
Calculate the indirect practice cost index.
Step 12: Using the results of Step 11, calculate aggregate pools of
specialty-specific adjusted indirect PE allocators for all PFS services
for a specialty by adding the product of the adjusted indirect PE
allocator for each service and the utilization data for that service.
Step 13: Using the specialty-specific indirect PE/HR data,
calculate specialty-specific aggregate pools of indirect PE for all PFS
services for that specialty by adding the product of the indirect PE/HR
for the specialty, the work time for the service, and the specialty's
utilization for the service across all services furnished by the
specialty.
Step 14: Using the results of Step 12 and Step 13, calculate the
specialty-specific indirect PE scaling factors.
Step 15: Using the results of Step 14, calculate an indirect
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor
for the entire PFS.
Step 16: Calculate the indirect practice cost index at the service
level to ensure the capture of all indirect costs. Calculate a weighted
average of the practice cost index values for the specialties that
furnish the service. (Note: For services with TCs and PCs, we calculate
the indirect practice cost index across the global service, PCs, and
TCs. Under this method, the indirect practice cost index for a given
service (for example, echocardiogram) does not vary by the PC, TC, and
global service.)
Step 17: Apply the service level indirect practice cost index
calculated in Step 16 to the service level adjusted indirect allocators
calculated in Step 11 to get the indirect PE RVUs.
(4) Calculate the Final PE RVUs
Step 18: Add the direct PE RVUs from Step 6 to the indirect PE RVUs
from Step 17 and apply the final PE budget neutrality (BN) adjustment.
The final PE BN adjustment is calculated by comparing the results of
Step 18 to the current pool of PE RVUs. This final BN adjustment is
required to redistribute RVUs from step 18 to all PE RVUs in the PFS,
and because certain specialties are excluded from the PE RVU
calculation for ratesetting purposes, but we note that all specialties
are included for purposes of calculating the final BN adjustment. (See
``Specialties excluded from ratesetting calculation'' later in this
section.)
(5) Setup File Information
Specialties excluded from ratesetting calculation: For the
purposes of calculating the PE RVUs, we exclude certain specialties,
such as certain nonphysician practitioners paid at a percentage of the
PFS and low-volume specialties, from the calculation. These specialties
are included for the purposes of calculating the BN adjustment. They
are displayed in Table 1.
Table 1--Specialties Excluded From Ratesetting Calculation
------------------------------------------------------------------------
Specialty code Specialty description
------------------------------------------------------------------------
49.................... Ambulatory surgical center.
50.................... Nurse practitioner.
51.................... Medical supply company with certified orthotist.
52.................... Medical supply company with certified
prosthetist.
53.................... Medical supply company with certified
prosthetist[dash]orthotist.
54.................... Medical supply company not included in 51, 52,
or 53.
55.................... Individual certified orthotist.
56.................... Individual certified prosthetist.
57.................... Individual certified prosthetist[dash]orthotist.
58.................... Medical supply company with registered
pharmacist.
59.................... Ambulance service supplier, e.g., private
ambulance companies, funeral homes, etc.
60.................... Public health or welfare agencies.
61.................... Voluntary health or charitable agencies.
73.................... Mass immunization roster biller.
74.................... Radiation therapy centers.
87.................... All other suppliers (e.g., drug and department
stores).
88.................... Unknown supplier/provider specialty.
89.................... Certified clinical nurse specialist.
96.................... Optician.
97.................... Physician assistant.
A0.................... Hospital.
A1.................... SNF.
A2.................... Intermediate care nursing facility.
A3.................... Nursing facility, other.
A4.................... HHA.
A5.................... Pharmacy.
A6.................... Medical supply company with respiratory
therapist.
A7.................... Department store.
B2.................... Pedorthic personnel.
B3.................... Medical supply company with pedorthic personnel.
------------------------------------------------------------------------
Crosswalk certain low volume physician specialties:
Crosswalk the utilization of certain specialties with relatively low
PFS utilization to the associated specialties.
Physical therapy utilization: Crosswalk the utilization
associated
[[Page 67557]]
with all physical therapy services to the specialty of physical
therapy.
Identify professional and technical services not
identified under the usual TC and 26 modifiers: Flag the services that
are PC and TC services, but do not use TC and 26 modifiers (for
example, electrocardiograms). This flag associates the PC and TC with
the associated global code for use in creating the indirect PE RVUs.
For example, the professional service, CPT code 93010
(Electrocardiogram, routine ECG with at least 12 leads; interpretation
and report only), is associated with the global service, CPT code 93000
(Electrocardiogram, routine ECG with at least 12 leads; with
interpretation and report).
Payment modifiers: Payment modifiers are accounted for in
the creation of the file consistent with current payment policy as
implemented in claims processing. For example, services billed with the
assistant at surgery modifier are paid 16 percent of the PFS amount for
that service; therefore, the utilization file is modified to only
account for 16 percent of any service that contains the assistant at
surgery modifier. Similarly, for those services to which volume
adjustments are made to account for the payment modifiers, time
adjustments are applied as well. For time adjustments to surgical
services, the intraoperative portion in the work time file is used;
where it is not present, the intraoperative percentage from the payment
files used by contractors to process Medicare claims is used instead.
Where neither is available, we use the payment adjustment ratio to
adjust the time accordingly. Table 2 details the manner in which the
modifiers are applied.
Table 2--Application of Payment Modifiers to Utilization Files
----------------------------------------------------------------------------------------------------------------
Modifier Description Volume adjustment Time adjustment
----------------------------------------------------------------------------------------------------------------
80,81,82...................... Assistant at Surgery.... 16%.......................... Intraoperative portion.
AS............................ Assistant at Surgery-- 14% (85% * 16%).............. Intraoperative portion.
Physician Assistant.
50 or LT and RT............... Bilateral Surgery....... 150%......................... 150% of work time.
51............................ Multiple Procedure...... 50%.......................... Intraoperative portion.
52............................ Reduced Services........ 50%.......................... 50%.
53............................ Discontinued Procedure.. 50%.......................... 50%.
54............................ Intraoperative Care only Preoperative + Intraoperative Preoperative +
Percentages on the payment Intraoperative
files used by Medicare portion.
contractors to process
Medicare claims.
55............................ Postoperative Care only. Postoperative Percentage on Postoperative portion.
the payment files used by
Medicare contractors to
process Medicare claims.
62............................ Co-surgeons............. 62.5%........................ 50%.
66............................ Team Surgeons........... 33%.......................... 33%.
----------------------------------------------------------------------------------------------------------------
We also make adjustments to volume and time that correspond to
other payment rules, including special multiple procedure endoscopy
rules and multiple procedure payment reductions (MPPR). We note that
section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments
for multiple imaging procedures and multiple therapy services from the
BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These
MPPRs are not included in the development of the RVUs.
For anesthesia services, we do not apply adjustments to volume
since the average allowed charge is used when simulating RVUs, and
therefore, includes all adjustments. A time adjustment of 33 percent is
made only for medical direction of two to four cases since that is the
only situation where time units are duplicative.
Work RVUs: The setup file contains the work RVUs from this
final rule with comment period.
(6) Equipment Cost Per Minute
The equipment cost per minute is calculated as:
(1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 +
interest rate)[caret] life of equipment)))) + maintenance)
Where:
minutes per year = maximum minutes per year if usage were continuous
(that is, usage = 1); generally 150,000 minutes.
usage = variable, see discussion below.
price = price of the particular piece of equipment.
life of equipment = useful life of the particular piece of
equipment.
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion below.
Usage: We currently use an equipment utilization rate assumption of
50 percent for most equipment, with the exception of expensive
diagnostic imaging equipment, for which we use a 90 percent assumption
as required by Section 1848(b)(4)(C) of the Act.
Maintenance: This factor for maintenance was proposed and finalized
during rulemaking for CY 1998 PFS (62 FR 33164). Several stakeholders
have suggested that this maintenance factor assumption should be
variable. We solicited comments regarding reliable data on maintenance
costs that vary for particular equipment items. We received several
comments about variable maintenance costs, which we will consider in
future rulemaking. We note, however, that we do not believe that high-
level summary data from informal surveys constitutes reliable data.
Rather than assertions that a particular maintenance rate is typical,
multiple invoices containing equipment prices that are accompanied by
maintenance contracts would provide support for a maintenance cost
other than our currently assumed 5 percent. We continue to seek
reliable data about variable maintenance costs, as we consider
adjustments to our methodology to accommodate variable maintenance
costs.
Per-use Equipment Costs: Several stakeholders have also suggested
that our PE methodology should incorporate usage fees and other per-use
equipment costs as direct costs. We also solicited comment on adjusting
our cost formula to include equipment costs that do not vary based on
the equipment time. We received a comment that addressed how to
incorporate usage fees and other per-use equipment costs into our
methodology, and received several comments that addressed how we should
reclassify the anomalous supply inputs removed from the direct PE
database. We will consider these comments in future rulemaking,
including the way these anomalous supply inputs fit in to any future
proposals related to per-use costs.
Interest Rate: In the CY 2013 final rule with comment period (77 FR
68902), we updated the interest rates used in
[[Page 67558]]
developing an equipment cost per minute calculation. The interest rate
was based on the Small Business Administration (SBA) maximum interest
rates for different categories of loan size (equipment cost) and
maturity (useful life). The interest rates are listed in Table 3. (See
77 FR 68902 for a thorough discussion of this issue.)
Table 3--SBA Maximum Interest Rates
------------------------------------------------------------------------
Interest
Price Useful life rate (%)
------------------------------------------------------------------------
<$25K................................ <7 Years 7.50
$25K to $50K......................... <7 Years 6.50
>$50K................................ <7 Years 5.50
<$25K................................ 7+ Years 8.00
$25K to $50K......................... 7+ Years 7.00
>$50K................................ 7+ Years 6.00
------------------------------------------------------------------------
[[Page 67559]]
Table 4--Calculation of PE RVUS Under Methodology for Selected Codes
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
99213 33533 93000 93005 93010
Office CABG, 71020 71020-TC 71020-26 ECG, ECG, ECG,
Factor (CF) (2nd part) Step Source Formula visit, arterial, Chest x- Chest x- Chest x- Complete, Tracing Report
est non- single ray non- ray, non- ray, non- non- non- non-
facility facility facility facility facility facility facility facility
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
(1) Labor cost (Lab)................ Step 1................. AMA................... ................. 13.32 77.52 5.74 5.74 ......... 5.10 5.10 .........
(2) Supply cost (Sup)............... Step 1................. AMA................... ................. 2.98 7.34 0.53 0.53 ......... 1.19 1.19 .........
(3) Equipment cost (Eqp)............ Step 1................. AMA................... ................. 0.17 0.58 6.92 6.92 ......... 0.09 0.09 .........
(4) Direct cost (Dir)............... Step 1................. ...................... =(1)+(2)+(3) 16.48 85.45 13.19 13.19 ......... 6.38 6.38 .........
(5) Direct adjustment (Dir. Adj.)... Steps 2-4.............. See footnote*......... ................. 0.5898 0.5898 0.5898 0.5898 0.5898 0.5898 0.5898 0.5898
(6) Adjusted Labor.................. Steps 2-4.............. =Labor * Dir Adj...... =(1)*(5) 7.86 45.72 3.39 3.39 ......... 3.01 3.01 .........
(7) Adjusted Supplies............... Steps 2-4.............. =Eqp * Dir Adj........ =(2)*(5) 1.76 4.33 0.31 0.31 ......... 0.70 0.70 .........
(8) Adjusted Equipment.............. Steps 2-4.............. =Sup * Dir Adj........ =(3)*(5) 0.10 0.34 4.08 4.08 ......... 0.05 0.05 .........
(9) Adjusted Direct................. Steps 2-4.............. ...................... =(6)+(7)+(8) 9.72 50.40 7.78 7.78 ......... 3.77 3.77 .........
(10) Conversion Factor (CF)......... Step 5................. PFS................... ................. 35.82 35.82 35.82 35.82 35.82 35.82 35.82 35.82
(11) Adj. labor cost converted-..... Step 5................. =(Lab * Dir Adj)/CF... =(6)/(10) 0.22 1.28 0.09 0.09 ......... 0.08 0.08 .........
(12) Adj. supply cost converted..... Step 5................. =(Sup * Dir Adj)/CF... =(7)/(10) 0.05 0.12 0.01 0.01 ......... 0.02 0.02 .........
(13) Adj. equipment cost converted.. Step 5................. =(Eqp * Dir Adj)/CF... =(8)/(10) ......... 0.01 0.11 0.11 ......... ......... ......... .........
(14) Adj. direct cost converted..... Step 5................. ...................... =(11)+(12)+(13) 0.27 1.41 0.22 0.22 ......... 0.11 0.11 .........
(15) Work RVU....................... Setup File............. PFS................... ................. 0.97 33.75 0.22 ......... 0.22 0.17 ......... 0.17
(16) Dir--pct....................... Steps 6,7.............. Surveys............... ................. 0.25 0.17 0.29 0.29 0.29 0.29 0.29 0.29
(17) Ind--pct....................... Steps 6,7.............. Surveys............... ................. 0.75 0.83 0.71 0.71 0.71 0.71 0.71 0.71
(18) Ind. Alloc. Formula (1st part). Step 8................. See Step 8............ ................. ((14)/ ((14)/ ((14)/ ((14)/ ((14)/ ((14)/ ((14)/ ((14)/
(16)*(17) (16)*(17) (16)*(17) (16)*(17) (16)*(17) (16)*(17) (16)*(17) (16)*(17)
(19) Ind. Alloc.(1st part).......... Step 8................. ...................... See 18 0.82 6.67 0.53 0.53 ......... 0.26 0.26 .........
(20) Ind. Alloc. Formula (2nd part). Step 8................. See Step 8............ ................. (15) (15) (15+11) (11) (15) (15+11) (11) (15)
(21) Ind. Alloc.(2nd part).......... Step 8................. ...................... See 20 0.97 33.75 0.31 0.09 0.22 0.25 0.08 0.17
(22) Indirect Allocator (1st + 2nd). Step 8................. ...................... =(19)+(21) 1.79 40.42 0.84 0.62 0.22 0.51 0.34 0.17
(23) Indirect Adjustment (Ind. Adj.) Steps 9-11............. See Footnote**........ ................. 0.3813 0.3813 0.3813 0.3813 0.3813 0.3813 0.3813 0.3813
(24) Adjusted Indirect Allocator.... Steps 9-11............. =Ind Alloc * Ind Adj.. ................. 0.68 15.41 0.32 0.24 0.08 0.20 0.13 0.06
(25) Ind. Practice Cost Index (IPCI) Steps 12-16............ ...................... ................. 1.07 0.75 0.99 0.99 0.99 0.91 0.91 0.91
(26) Adjusted Indirect.............. Step 17................ = Adj.Ind Alloc * PCI. =(24)*(25) 0.73 11.59 0.32 0.24 0.08 0.18 0.12 0.06
(27) Final PE RVU................... Step 18................ =(Adj Dir + Adj Ind) * =((14)+(26)) * 1.01 13.04 0.54 0.46 0.08 0.29 0.23 0.06
Other Adj. Other Adj)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Note: PE RVUs in Table 5, row 27, may not match Addendum B due to rounding.
* The direct adj = [current pe rvus * CF * avg dir pct]/[sum direct inputs] = [step2]/[step3].
** The indirect adj = [current pe rvus * avg ind pct]/[sum of ind allocators] = [step9]/[step10].
Note: The use of any particular conversion factor (CF) in Table 5 to illustrate the PE Calculation has no effect on the resulting RVUs.
Note: The Other Adjustment includes an adjustment for the equipment utilization change.
[[Page 67560]]
3. Changes to Direct PE Inputs for Specific Services
In this section, we discuss other CY 2015 revisions related to
direct PE inputs for specific services. The final direct PE inputs are
included in the final rule CY 2015 direct PE input database, which is
available on the CMS Web site under downloads for the CY 2015 PFS final
rule with comment period at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
a. RUC Recommendation for Monitoring Time following Moderate Sedation
We received a recommendation from the RUC regarding appropriate
clinical labor minutes for post-procedure moderate sedation monitoring
and post-procedure monitoring. The RUC recommended 15 minutes of RN
time for one hour of monitoring following moderate sedation and 15
minutes of RN time per hour for post-procedure monitoring (unrelated to
moderate sedation). For 17 procedures listed in Table 5, the
recommended clinical labor minutes differed from the clinical labor
minutes in the direct PE database. We proposed to accept, without
refinement, the RUC recommendation to adjust these clinical labor
minutes as indicated in Table 5 as ``Change to Clinical Labor Time.''
Table 5--Codes With Changes to Post-Procedure Clinical Labor Monitoring Time
----------------------------------------------------------------------------------------------------------------
RUC
recommended
Current total post- Change to
CPT Code monitoring procedure clinical labor
time (min) monitoring time (min)
time (min)
----------------------------------------------------------------------------------------------------------------
32553........................................................... 30 60 30
35471........................................................... 21 60 39
35475........................................................... 60 30 -30
35476........................................................... 60 30 -30
36147........................................................... 18 30 12
37191........................................................... 60 30 -30
47525........................................................... 6 15 9
49411........................................................... 30 60 30
50593........................................................... 30 60 30
50200........................................................... 15 60 45
31625........................................................... 20 15 -5
31626........................................................... 25 15 -10
31628........................................................... 25 15 -10
31629........................................................... 25 15 -10
31634........................................................... 25 15 -10
31645........................................................... 10 15 5
31646........................................................... 10 15 5
----------------------------------------------------------------------------------------------------------------
Comment: We received two comments supporting our proposal to accept
the RUC recommendation, without refinement, to adjust the clinical
labor minutes as indicated in Table 5. One commenter noted that the RUC
recommendation was a more accurate reflection of the monitoring time,
particularly for codes 50593 (Ablation, renal tumor(s), unilateral,
percutaneous, cryotherapy) and 50200 (Renal biopsy; percutaneous, by
trocar or needle), than the current time.
Response: We appreciate commenters' support for our proposal. After
consideration of comments received, we are finalizing our proposal to
accept, without refinement, the RUC recommendation to adjust the
clinical labor minutes as indicated in Table 5 as ``Change to Clinical
Labor Time.''
b. RUC Recommendation for Standard Moderate Sedation Package
We received a RUC recommendation to modify PE inputs included in
the standard moderate sedation package. Specifically, the RUC indicated
that several specialty societies have pointed to the need for a
stretcher during procedures for which moderate sedation is inherent in
the procedure. Although the RUC did not recommend that we make changes
to PE inputs for codes at this time, the RUC indicated that its future
recommendations would include the stretcher as a direct input for
procedures including moderate sedation.
The RUC recommended three scenarios that it would use in the future
to allocate the equipment time for the stretcher based on the procedure
time and whether the stretcher would be available for other patients to
use during a portion of the procedure. Although we appreciate the RUC's
attention to the differences in the time required for the stretcher
based on the time for the procedure, we believe that one of the
purposes of standard PE input packages is to reduce the complexity
associated with assigning appropriate PE inputs to individual
procedures while, at the same time, maintaining relativity between
procedures. Since we generally allocate inexpensive equipment items to
the entire service period when they are likely to be unavailable for
another use during the full service period, we believe it is preferable
to treat the stretcher consistently across services. Therefore, we
proposed to modify the standard moderate sedation input package to
include a stretcher for the same length of time as the other equipment
items in the moderate sedation package. The revised moderate sedation
input package will be applied to relevant codes as we review them
through future notice and comment rulemaking. In seeking comments on
the proposal, we stated that it would be useful to hear stakeholders'
views and the reasoning behind them on this issue, especially from
those who think that the stretcher, as expressed through the allocation
of equipment minutes, should be allocated with more granularity than
the equipment costs that are allocated to other similar items.
Comment: We received comments supporting our proposal to add the
stretcher to the moderate sedation package, including support to
include the stretcher for the same length of time as the other
equipment items included in the moderate sedation package since it is
used by the patient for the duration
[[Page 67561]]
of their recovery and not available to other patients during that time.
Response: We appreciate the commenters' support for our proposal.
After consideration of comments received, we are finalizing our
proposal to add the stretcher to the moderate sedation package for the
same length of time as the other equipment items in the moderate
sedation package. We note that we will not apply this change
retroactively, but will make the change to the moderate sedation
package for codes being finalized for 2015, as well as interim final
codes for 2015. For a detailed discussion of the specific codes
impacted by this change, we refer readers to sections II.F. of this
final rule with comment period.
c. RUC Recommendation for Migration From Film to Digital Practice
Expense Inputs
The RUC provided a recommendation regarding the PE inputs for
digital imaging services. Specifically, the RUC recommended that we
remove a list of supply and equipment items associated with film
technology since these items are no longer a typical resource input;
these items are detailed in Table 6. The RUC also recommended that the
Picture Archiving and Communication System (PACS) equipment be included
for these imaging services since these items are now typically used in
furnishing imaging services. We received a description of the PACS
system as part of the recommendation, which included both items that
appear to be direct PE items and items for which indirect PE RVUs are
allocated in the PE methodology. As we have previously indicated, items
which are not clinical labor, medical supplies, or medical equipment,
or are not individually allocable to a particular patient for a
particular procedure, are not categorized as direct costs in the PE
methodology. Since we did not receive any invoices for the PACS system
prior to the proposed rule, we were unable to determine the appropriate
pricing to use for the inputs. We proposed to accept the RUC
recommendation to remove the film supply and equipment items, and to
allocate minutes for a desktop computer (ED021) as a proxy for the PACS
workstation as a direct expense. Specifically, for the 31 services that
already contain ED021 (computer, desktop, w-monitor), we proposed to
retain the time that is currently included in the direct PE input
database. For the remaining services that are valued in the nonfacility
setting, we proposed to allocate the full clinical labor intraservice
time to ED021, except for codes without clinical labor, in which case
we proposed to allocate the intraservice work time to ED021. For
services valued only in the facility setting, we proposed to allocate
the post-service clinical labor time to ED021, since the film supply
and/or equipment inputs were previously associated with the post-
service period.
Table 6--RUC-Recommended Supply and Equipment Items Removed for Digital
Imaging Services
------------------------------------------------------------------------
CMS Code Description
------------------------------------------------------------------------
SK013........................... computer media, dvd.
SK014........................... computer media, floppy disk 1.44mb.
SK015........................... computer media, optical disk 128mb.
SK016........................... computer media, optical disk 2.6gb.
SK022........................... film, 8inx10in (ultrasound, MRI).
SK025........................... film, dry, radiographic, 8in x 10in.
SK028........................... film, fluoroscopic 14 x 17.
SK033........................... film, x-ray 10in x 12in.
SK034........................... film, x-ray 14in x 17in.
SK035........................... film, x-ray 14in x 36in.
SK037........................... film, x-ray 8in x 10in.
SK038........................... film, x-ray 8in x 10in (X-omat,
Radiomat).
SK086........................... video tape, VHS.
SK089........................... x-ray developer solution.
SK090........................... x-ray digitalization separator sheet.
SK091........................... x-ray envelope.
SK092........................... x-ray fixer solution.
SK093........................... x-ray ID card (flashcard).
SK094........................... x-ray marking pencil.
SK098........................... film, x-ray, laser print.
SM009........................... cleaner, x-ray cassette-screen.
ED014........................... computer workstation, 3D
reconstruction CT-MR.
ED016........................... computer workstation, MRA post
processing.
ED023........................... film processor, PET imaging.
ED024........................... film processor, dry, laser.
ED025........................... film processor, wet.
ED027........................... film processor, x-omat (M6B).
ER018........................... densitometer, film.
ER029........................... film alternator (motorized film
viewbox).
ER067........................... x-ray view box, 4 panel.
------------------------------------------------------------------------
We note that the RUC exempted certain procedures from its
recommendation because (a) the dominant specialty indicated that
digital technology is not yet typical or (b) the procedure only
contained a single input associated with film technology, and it was
determined that the sharing of images, but not actual imaging, may be
involved in the service. However, we do not believe that the most
appropriate approach in establishing relative values for services that
involve imaging is to exempt services from the transition from film to
digital PE inputs based on information reported by individual
specialties. Although we understand that the migration from film
technology to digital technology may progress at different paces for
particular specialties, we do not have information to suggest that the
migration is not occurring for all procedures that require the storage
of images. Just as it was appropriate to use film inputs as a proxy for
some services for which digital inputs were typical pending these
changes in the direct PE input database, we believe it is appropriate
to use digital inputs as a proxy for the services that may still use
film, pending their migration to digital technology. In addition, since
the RUC conducted its collection of information from the specialties
over several years, we believe the migration process from film to
digital inputs has likely continued over the time period during which
the information was gathered, and that the digital PE inputs will
reflect typical use of technology for most if not all of these services
before the change to digital inputs would take effect beginning January
1, 2015.
We noted that we believed that, for the sake of relativity, we
should remove the equipment and supply inputs noted below from all
procedures in the direct PE database, including those listed in Table
7. We sought comment on whether the computer workstation, which we
proposed to use as a proxy for the PACS workstation, is the appropriate
input for the services listed in Table 7, or whether an alternative
input is a more appropriate reflection of direct PE costs.
Table 7--Codes Containing Film Inputs But Excluded From the RUC
Recommendation
------------------------------------------------------------------------
HCPCS Short descriptor
------------------------------------------------------------------------
21077........................... Prepare face/oral prosthesis.
28293........................... Correction of bunion.
61580........................... Craniofacial approach skull.
61581........................... Craniofacial approach skull.
61582........................... Craniofacial approach skull.
61583........................... Craniofacial approach skull.
61584........................... Orbitocranial approach/skull.
61585........................... Orbitocranial approach/skull.
61586........................... Resect nasopharynx skull.
64517........................... N block inj hypogas plxs.
64681........................... Injection treatment of nerve.
70310........................... X-ray exam of teeth.
77326........................... Brachytx isodose calc simp.
77327........................... Brachytx isodose calc interm.
77328........................... Brachytx isodose plan compl.
91010........................... Esophagus motility study.
91020........................... Gastric motility studies.
91034........................... Gastroesophageal reflux test.
91035........................... G-esoph reflx tst w/electrod.
91037........................... Esoph imped function test.
91038........................... Esoph imped funct test > 1hr.
91040........................... Esoph balloon distension tst.
91120........................... Rectal sensation test.
91122........................... Anal pressure record.
91132........................... Electrogastrography.
91133........................... Electrogastrography w/test.
92521........................... Evaluation of speech fluency.
[[Page 67562]]
92523........................... Speech sound lang comprehend.
92524........................... Behavioral qualit analys voice.
92601........................... Cochlear implt f/up exam <7.
92603........................... Cochlear implt f/up exam 7/>.
92611........................... Motion fluoroscopy/swallow.
92612........................... Endoscopy swallow tst (fees).
92614........................... Laryngoscopic sensory test.
92616........................... Fees w/laryngeal sense test.
95800........................... Slp stdy unattended.
95801........................... Slp stdy unatnd w/anal.
95803........................... Actigraphy testing.
95805........................... Multiple sleep latency test.
95806........................... Sleep study unatt&resp efft.
95807........................... Sleep study attended.
95808........................... Polysom any age 1-3> param.
95810........................... Polysom 6/> yrs 4/> param.
95811........................... Polysom 6/>yrs cpap 4/> parm.
95812........................... Eeg 41-60 minutes.
95813........................... Eeg over 1 hour.
95829........................... Surgery electrocorticogram.
95950........................... Ambulatory eeg monitoring.
95953........................... Eeg monitoring/computer.
95954........................... Eeg monitoring/giving drugs.
95955........................... Eeg during surgery.
95956........................... Eeg monitor technol attended.
95957........................... Eeg digital analysis.
96904........................... Whole body photography.
G0270........................... Mnt subs tx for change dx.
G0271........................... Group mnt 2 or more 30 mins.
------------------------------------------------------------------------
Finally, we noted that the RUC recommendation also indicated that,
given the labor-intensive nature of reviewing all clinical labor tasks
associated with film technology, these times would be addressed as
these codes are reviewed. We agreed with the RUC that reviewing and
adjusting the times for each code would be difficult and labor-
intensive since the direct PE input database does not allow for a
comprehensive adjustment of the clinical labor time based on changes in
particular clinical labor tasks. To make broad adjustments such as this
across codes, the PE database would need to contain the time associated
with individual clinical labor tasks rather than reflecting only the
sum of times for the pre-service period, service period, and post-
service period, as it does now. We recognized this situation presents a
challenge in implementing RUC recommendations such as this one, and
makes it difficult to understand the basis of both the RUC's
recommended clinical labor times and our refinements of those
recommendations. Therefore, we stated that we were considering revising
the direct PE input database to include task-level clinical labor time
information for every code in the database. As an example, we referred
readers to the supporting data files for the direct PE inputs, which
include public use files that display clinical labor times as allocated
to each individual clinical labor task for a sample of procedures. We
displayed this information as we attempt to increase the transparency
of the direct PE database. We stated that we hoped that this
modification would enable us to more accurately allocate equipment
minutes to clinical labor tasks in a more consistent and efficient
manner. Given the number of procedures and the volume of information
involved, we sought comments on the feasibility of this approach. We
note that we did not propose to make any changes to PE inputs for CY
2015 based on this modification to the design of the direct PE input
database.
As discussed in section II.G. of this final rule with comment
period, some of the RUC recommendations for 2015 included film items as
practice expense inputs. For existing codes, the database from the
proposed rule already included the PACS workstation proxy. However, for
new services, as with the current items in the database, we have
replaced the film items with the PACS workstation proxy. The codes
affected by this change are listed in Table 8.
Table 8--Codes Affected by Removal of Film Inputs
------------------------------------------------------------------------
HCPCS Short descriptor
------------------------------------------------------------------------
22510........................... Perq cervicothoracic inject.
22511........................... Perq lumbosacral injection.
22513........................... Perq vertebral augmentation.
22514........................... Perq vertebral augmentation.
62302........................... Myelography lumbar injection.
62303........................... Myelography lumbar injection.
62304........................... Myelography lumbar injection.
62305........................... Myelography lumbar injection.
71275........................... Ct angiography chest.
72191........................... Ct angiograph pelv w/o&w/dye.
72240........................... Myelography neck spine.
72255........................... Myelography thoracic spine.
72265........................... Myelography l-s spine.
72270........................... Myelogphy 2/> spine regions.
74174........................... Ct angio abd&pelv w/o&w/dye.
74175........................... Ct angio abdom w/o & w/dye.
74230........................... Cine/vid x-ray throat/esoph.
76942........................... Echo guide for biopsy.
93312........................... Echo transesophageal.
93314........................... Echo transesophageal.
93320........................... Doppler echo exam heart.
93321........................... Doppler echo exam heart.
93325........................... Doppler color flow add-on.
93880........................... Extracranial bilat study.
93882........................... Extracranial uni/ltd study.
93886........................... Intracranial complete study.
93888........................... Intracranial limited study.
93895........................... Carotid intima atheroma eval.
93925........................... Lower extremity study.
93926........................... Lower extremity study.
93930........................... Upper extremity study.
93931........................... Upper extremity study.
93970........................... Extremity study.
93971........................... Extremity study.
93975........................... Vascular study.
93976........................... Vascular study.
93978........................... Vascular study.
93979........................... Vascular study.
------------------------------------------------------------------------
Comment: We received many comments on our proposal to remove the
equipment and supply inputs associated with film technology from the
direct PE database. In general, commenters supported our proposal to
remove the film inputs from the direct PE database. Some commenters
supported our use of the desktop computer as a proxy for the PACS
workstation, but other commenters opposed using this item as a proxy.
Commenters opposed to using the desktop computer as the proxy item
stated that the PACS workstation was significantly more expensive and
included greater functionality than a desktop computer. Some commenters
opposed our proposal to maintain the current equipment time allocated
to the computer desktop for the 31 services that already included this
equipment item, suggesting that it was incorrect to eliminate the film
inputs without proportionately increasing the proxy time for ED021.
Some commenters requested a delay in implementation until stakeholders
provide invoices or otherwise work with CMS to identify prices for the
PACS items. Some commenters suggested CMS should develop a means to
allocate digital technology costs to individual services, even if it is
difficult to do so. Another commenter explained that it is difficult
for stakeholders to obtain invoices that display prices for individual
items, such as the PACS workstation, since the price of the particular
items is often bundled with other related equipment and services. Many
commenters urged CMS to work with stakeholders to obtain invoices,
while other commenters requested that CMS accept the RUC recommendation
regarding the PACS workstation.
Response: We appreciate commenters' support for our proposal to
incorporate the transition from film to digital imaging technology into
the direct PE input database. With regard to the pricing of the PACS
workstation, as with all inputs, we would prefer to use actual paid
invoices to establish the input price. However, in the absence of
invoices demonstrating the actual cost, we believe that use of a proxy
to price the appropriate inputs, in this case the PACS workstation, is
preferable to
[[Page 67563]]
continuing to use inputs that we know are no longer typical. We made
the proposal to use the computer, desktop, w-monitor (ED021), priced at
$2,501, as a proxy based on our assessment of similar resource costs
between the item and the PACS workstation. Although some commenters
stated that the item was not an appropriate proxy, these commenters did
not provide any evidence to indicate that the resource costs are not
similar or to suggest a more appropriate proxy. Nor were any paid
invoices submitted. Absent such information, we continue to believe
that using the proxy item is the best approach to incorporate the
direct PE cost of the digital imaging technology.
With regard to the 31 services that already included the desktop
computer as an equipment input, we will include the desktop computer as
a proxy for the PACS workstation using the same methodology as for the
services that did not previously contain the desktop computer. To
clearly differentiate the desktop computer proxy from the desktop
computer currently included in these services, and to facilitate
accurate replacement of this input when we do receive pricing
information, we will create a new equipment item called ``desktop
computer (proxy for PACS workstation),'' which will be allocated to
each procedure using the methodology described above.
Comment: Some commenters opposed our removal of the film inputs
from services that were not included in the RUC recommendation, but did
not provide a rationale for their opposition.
Response: For the reasons we explained in making the proposal and
reiterate above, we continue to believe that it is appropriate to
remove these items from the direct PE database.
Comment: Some commenters provided specific suggestions regarding
the use of digital inputs should CMS decide to move forward with the
proposal. Commenters requested that for portable x-ray services, CMS
include a flat plate receptor/image capture plate to capture the image,
specialized software to process the image, and multiple high definition
monitors used by the interpreting radiologist. Commenters provided an
invoice for the image capture plate at a price of $25,600 indicating
that this item replaces the film as the media to record the image.
Response: We appreciate that commenters provided us with an invoice
for the image capture plate. However, services furnished by portable x-
ray providers are reported using the same procedure codes as services
provided using fixed machines. Since the typical x-ray service is
furnished using fixed equipment, we are not including the image capture
plate that is associated with portable equipment as an input for the
imaging procedure codes. We also do not believe that high definition
monitors used by the interpreting radiologist are appropriately
included in the technical component of imaging procedures; rather,
these are indirect costs associated with the professional component of
the service. Therefore, we are not including the high definition
monitors as an input for these services. Finally, to determine whether
the software is appropriately categorized as a direct PE input, we need
more information about the functionality of the software, and whether
it is used in furnishing the typical x-ray service (including services
furnished using fixed machinery). Until we have information that
supports the inclusion of this item as a direct cost, we will not
include the software for x-ray services.
Comment: Commenters were supportive of the increased transparency
with regard to the direct PE inputs, but several commenters suggested
that there may be more feasible approaches to break out the individual
clinical labor tasks associated with each portion of the service (pre-
service period, service period, and post-service period). The RUC
suggested that we post all PE worksheets and supporting materials in
code-order on our Web site. Other commenters did not suggest a specific
alternative approach to providing detail for the individual clinical
labor tasks.
Response: We appreciate the RUC's suggestion regarding the posting
of the PE worksheets, but we do not believe that this would enable us
to accomplish a comprehensive cross-code analysis and refinement to
clinical labor times within the direct PE input database to increase
consistency for identical clinical labor tasks between codes. Since we
did not receive other suggestions from commenters on an approach to
break out the individual clinical labor tasks associated with each
service period to enable us to conduct the necessary analysis, we will
pursue the approach described in the proposed rule. We will consider
the comments submitted and continue to work with interested
stakeholders regarding the best approaches to displaying the supporting
files. We note that public use files continue to be available in the
same format as in previous years, but that additional public use files
now display the clinical labor tasks for each service period, providing
greater transparency and enabling comparisons across codes. We note
that we have refined the file structure based on comments, and we
continue to seek input on whether there are additional or alternative
ways to display this information to enhance its clarity, and note that
there are challenges inherent in the display of this information in a
two-dimensional format. We refer readers to the public use files
available on the CMS Web site under downloads for the CY 2015 PFS final
rule with comment period at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html
d. Inputs for Digital Mammography Services
Mammography services are currently reported and paid using both CPT
codes and G-codes. To meet the requirements of the Medicare, Medicaid,
and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), we
established G-codes for use beginning in CY 2002 to pay for mammography
services using new digital technologies (G0202 screening mammography
digital; G0204 diagnostic mammography digital; G0206 diagnostic
mammography digital). We continued to use the CPT codes for mammography
services furnished using film technology (77055 (Mammography;
unilateral); 77056 (Mammography; bilateral); 77057 (Screening
mammography, bilateral (2-view film study of each breast)). As we
discussed previously in this section, the RUC has recommended that all
imaging codes, including mammography, be valued using digital rather
than film inputs because the use of film is no longer typical. A review
of Medicare claims data shows that the mammography CPT codes are billed
extremely infrequently, and that the G-codes are billed for the vast
majority of mammography claims, confirming the RUC's conclusion that
the typical service uses digital technology. As such, we stated that we
do not believe there is a reason to continue the separate CPT codes and
G-codes for mammography services since both sets of codes would have
the same values when priced based upon the typical digital technology.
Accordingly, we proposed to delete the mammography G-codes beginning
for CY 2015 and to pay all mammography using the CPT codes.
We indicated that, although we believed that the CPT codes should
now be used to report all mammography services, we had concerns about
whether the current values for the CPT codes accurately reflect the
resource inputs associated with furnishing the services. Because the
CPT codes have not been recently reviewed and
[[Page 67564]]
significant technological changes have occurred since the current
values were established, we did not believe it would be appropriate to
retain the current values for the CPT codes. Therefore, we proposed to
value the CPT codes using the RVUs previously established for the G-
codes. We believed these values would be most appropriate since they
were established to reflect the use of digital technology, which is now
typical.
As discussed in section II.B of this final rule with comment
period, we proposed these CPT codes as potentially misvalued and
requested that the RUC and other interested stakeholders review these
services in terms of appropriate work RVUs, work time assumptions, and
direct PE inputs. However, as discussed in section II.B. of this final
rule with comment period, we will continue to maintain separate payment
rates for film and digital mammography while we consider revaluation of
all mammography services. For CY 2015, we will therefore maintain both
the G-codes and CPT codes; we will continue using the 2014 RVUs from
each of the following codes to price them for 2015: G0202, G0204,
G0206, 77055, 77056, and 77057. 2015. We also note that we will
continue to pay for film mammography services at the 2014 rates until
we revalue the mammography services.
We refer readers to section II.B. of this final rule with comment
period, where we address comments received on this proposal.
e. Radiation Treatment Vault
In previous rulemaking (77 FR 68922, 78 FR 74346), we indicated
that we included the radiation treatment vault as a direct PE input for
several recently reviewed radiation treatment codes for the sake of
consistency with its previous inclusion as a direct PE input for some
other radiation treatment services, but that we intended to review the
radiation treatment vault input and address whether or not it should be
included in the direct PE input database for all services in future
rulemaking. Specifically, we questioned whether it was consistent with
the principles underlying the PE methodology to include the radiation
treatment vault as a direct cost given that it appears to be more
similar to building infrastructure costs than to medical equipment
costs. In response to this discussion, we received comments and
invoices from stakeholders who indicated that the vault should be
classified as a direct cost. However, upon review of the information
received, we believed that the specific structural components required
to house the linear accelerator are similar in concept to components
required to house other medical equipment such as expensive imaging
equipment. In general, the electrical, plumbing, and other building
specifications are often unique to the intended functionality of a
given building, including costs that are attributable to the specific
medical equipment housed in the building, but those building
characteristics do not represent direct medical equipment costs in our
established PE methodology. Therefore, we believed that the special
building requirements indicated for the radiation treatment vault to
house a linear accelerator do not represent a direct cost in our PE
methodology, and that the vault construction is instead accounted for
in the indirect PE methodology, just as the building and infrastructure
costs are treated for other PFS services including those with
specialized infrastructure costs to accommodate specific equipment.
Therefore, we proposed to remove the radiation treatment vault as a
direct PE input from the radiation treatment procedures listed in Table
9, because we believed that the vault is not, itself, medical
equipment; and therefore, it is accounted for in the indirect PE
methodology.
Table 9--HCPCS Codes Affected by Proposed Removal of Radiation Treatment
Vault
------------------------------------------------------------------------
HCPCS Short descriptor
------------------------------------------------------------------------
77373........................... Sbrt delivery.
77402........................... Radiation treatment delivery.
77403........................... Radiation treatment delivery.
77404........................... Radiation treatment delivery.
77406........................... Radiation treatment delivery.
77407........................... Radiation treatment delivery.
77408........................... Radiation treatment delivery.
77409........................... Radiation treatment delivery.
77411........................... Radiation treatment delivery.
77412........................... Radiation treatment delivery.
77413........................... Radiation treatment delivery.
77414........................... Radiation treatment delivery.
77416........................... Radiation treatment delivery.
77418........................... Radiation tx delivery imrt.
------------------------------------------------------------------------
Comment: We received many comments regarding our proposal to remove
the radiation treatment vault as a direct cost from the radiation
treatment delivery codes. Although one commenter supported the
proposal, most commenters opposed the proposal. In general, commenters
reiterated their rationale for inclusion of the vault as a direct
practice expense input, asserting that the vault is necessary for the
functioning of the equipment, serves a unique medical need, cannot be
separated from the treatment delivered by the linear accelerator, and
cannot be repurposed for another use. Commenters also stated that the
Internal Revenue Code treats the vault as medical equipment that is
separately depreciable from the building itself. For the most part,
commenters objected to the removal of the vault given the context of
declining Medicare payment for radiation oncology services over the
past few years, or in conjunction with the revised radiation treatment
code set. Specifically, several commenters suggested that stakeholders
cannot provide meaningful comment about the impact of the vault
proposal in the context of other pending changes. Some commenters
requested a phase-in of any decrease in payment so that providers of
radiation therapy services have an opportunity to adjust their practice
costs. Several commenters also suggested that the change in payment
could exacerbate problems in access to oncology services for Medicare
patients.
Response: We appreciate commenters' concerns regarding the proposal
to remove the vault as a direct practice expense input. We understand
the essential nature of the vault in the provision of radiation therapy
services and its uniqueness to a particular piece of medical equipment
but are not convinced that either of these factors leads to the
conclusion that the vault should be considered medical equipment for
purposes of the PE methodology under the PFS. We appreciate the
information commenters provided regarding the IRS treatment of the
vault under tax laws, but the purposes and goals of the tax code and
the PFS PE methodology are different, and, as such, attempts to draw
parallels between the two are not necessarily instructive or relevant.
We are not finalizing our proposal at this time, but intend to further
study the issues raised by the vault and how it relates to our PE
methodology.
Comment: A commenter noted that removing the vault as a direct cost
also reduces the amount of indirect PE allocated for these procedures,
and that this proposal does not shift the vault from direct PE to
indirect PE, but rather drops the cost of the vault entirely. Another
commenter stated that since the pool of indirect PE RVUs associated
with radiation oncology services is fixed, the issue in question is how
the indirect costs involved in furnishing treatment services compare to
the indirect costs in providing other radiation oncology services.
Response: We understand the concerns of commenters regarding the
importance of ensuring that the costs related to the vault are included
in the
[[Page 67565]]
PE methodology. We want to point out, however, that within the
established PE methodology, the allocation of indirect PE to individual
codes has significant impact on the PE RVUs that determine Medicare
payment for individual services. In other words, we believe it is
important for stakeholders to recognize that practice expense costs not
included in the direct PE input database contribute to the development
of PE RVUs through the data used to allocate indirect PE RVUs. We also
want to point out that the pool of indirect PE RVUs is not fixed at the
specialty level. Rather, the pool of indirect costs under the entire
PFS is maintained from year to year, as delineated in step 11 of the PE
methodology above. Therefore, changes in the allocation of indirect PE
for particular PFS services based on changes in either direct PE
inputs, work RVUs, work time, or utilization data, impacts the amount
of indirect PE allocated to all other PFS services, not just those
furnished by specialties that furnish that service.
After continued review of the issues pertaining to the vault in the
context of the comments, we believe that these issues require further
study. Therefore, at this time, we will continue to include the vault
as a direct PE input for the services listed in Table 9.
f. Clinical Labor Input Errors
Subsequent to the publication of the CY 2014 PFS final rule with
comment period, it came to our attention that, due to a clerical error,
the clinical labor type for CPT code 77293 (Respiratory Motion
Management Simulation (list separately in addition to code for primary
procedure)) was entered as L052A (Audiologist) instead of L152A
(Medical Physicist), which has a higher cost per minute. We proposed a
correction to the clinical labor type for this service.
Comment: Commenters appreciated our proposal to correct this error.
Response: We appreciate commenters' support for our proposal, and
are finalizing the assignment of clinical labor type L152A to code
77293 as proposed. The CY 2015 Direct Practice Expense Input database
reflects this correction.
In conducting a routine data review of the database, we also
discovered that, due to a clerical error, the RN time allocated to CPT
codes 33620 (Apply r&l pulm art bands), 33621 (Transthor cath for
stent), and 33622 (Redo compl cardiac anomaly) was entered in the
nonfacility setting, rather than in the facility setting where the code
is valued. When a service is not valued in a particular setting, any
inputs included in that setting are not included in the calculation of
the PE RVUs for that service. Therefore, we proposed to move the RN
time allocated to these procedures to the facility setting. The PE RVUs
listed in Addendum B reflect these technical corrections.
We did not receive any comments on this proposal; therefore, we are
finalizing our proposal to move the RN time allocated to these
procedures to the facility setting. The CY 2015 Direct Practice Expense
Input database reflects this correction.
g. Work Time
Subsequent to the publication of the CY PFS 2014 final rule with
comment period, several inconsistencies in the work time file came to
our attention. First, for some services, the total work time, which is
used in our PE methodology, did not equal the sum of the component
parts (pre-service, intra-service, post-service, and times associated
with global period visits). The times in the CY 2015 work time file
reflect our corrected values for total work time. Second, for a subset
of services, the values in the pre-positioning time, pre-evaluation
time, and pre-scrub-dress-wait time, were inadvertently transposed. We
note that this error had no impact on calculation of the total times,
but has been corrected in the CY 2015 work time file. Third, minor
discrepancies for a series of interim final codes were identified
between the work time file and the way we addressed these codes in the
preamble text. Therefore, we have made adjustments to the work time
file to reflect the decisions indicated in the preamble text. The work
time file is available on the CMS Web site under the supporting data
files for the CY 2015 PFS final rule with comment period at https://www.cms.gov/PhysicianFeeSched/. Note that for comparison purposes, the
CY 2014 work time file is located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices-Items/CMS-1600-FC.html.
Comment: A commenter supported our proposal to correct the work
times associated with the procedures affected by this proposal.
Response: We appreciate the commenter's support for our proposal.
After consideration of the comment received, we are finalizing our
proposal to adjust the work time file as proposed. The work time file
is available on the CMS Web site under the supporting data files for
the CY 2015 PFS final rule with comment period at https://www.cms.gov/
PhysicianFeeSched/
h. Updates to Price for Existing Direct Inputs.
In the CY 2011 PFS final rule with comment period (75 FR 73205), we
finalized a process to act on public requests to update equipment and
supply price and equipment useful life inputs through annual rulemaking
beginning with the CY 2012 PFS proposed rule. During 2013, we received
a request to update the price of SD216 (catheter, balloon, esophageal
or rectal (graded distention test)) from $217 to $237.50. We also
received a request to update the price of SL196 (kit, HER-2/neu DNA
Probe) from $105 to $144.50. We received invoices that documented
updated pricing for each of these supply items. We proposed to increase
the price associated with these supply items.
We continue to believe it is important to maintain a periodic and
transparent process to update the price of items to reflect typical
market prices in our ratesetting methodology, and we continue to study
the best way to improve our current process. We remind stakeholders
that we have difficulty obtaining accurate pricing information. The
goal of the current transparent process is to offer the opportunity for
the community to both request supply price updates by providing us
copies of paid invoices, and to object to proposed changes in price
inputs for particular items by providing additional information about
prices available to the practitioner community. We remind stakeholders
that PFS payment rates are developed within a budget neutral, relative
value system, and any increases in price inputs for particular supply
items result in corresponding decreases to the relative values of all
other direct PE inputs.
We also received a RUC recommendation to update the prices
associated with two supply items. Specifically, the RUC recommended
that we increase the price of SA042 (pack, cleaning and disinfecting,
endoscope) from $15.52 to $17.06 to reflect the addition of supply item
SJ009 (basin, irrigation) to the pack, and increase the price of SA019
(kit, IV starter) from $1.37 to $1.60 to reflect the addition of supply
item SA044 (underpad 2 ft. x 3 ft. (Chux)) to the kit. We proposed to
update the prices for both of these items based on these
recommendations.
Comment: We received several comments regarding our concern about
obtaining accurate pricing information for equipment and supply items
included in the direct PE database. The RUC indicated that it would
continue to work with specialty societies to obtain
[[Page 67566]]
paid invoices. A commenter suggested that a sample of paid invoices be
obtained from practices and submitted with the PE materials to the RUC,
or directly to CMS. Another commenter expressed concern regarding CMS's
assertion that invoices are difficult to obtain, given that the RUC
process collects lists of resources required to furnish services in the
physician office using a standardized process that is typically
accompanied by invoices. Another commenter stated that CMS used only
the lowest-cost invoice for a particular equipment item since the other
invoices included ``soft costs,'' and that CMS should establish an
approach that would allow invoices to be used even if they contain
``soft costs.''
Response: We appreciate the RUC's assistance in obtaining paid
invoices from the specialty societies. These invoices are helpful in
pricing inputs. We disagree that we use the lowest-cost invoice because
it had the lowest cost; rather, we often use the lowest-cost invoice
because we do not have a method to use invoices that include costs that
are not included as part of the equipment costs, so called ``soft
costs,'' within the PE methodology. We do not believe it would serve
accuracy or relativity to include as part of the pricing inputs ``soft
costs'' that increase the price of particular supply or equipment
items. We would welcome further input on potential approaches for
``backing out'' these costs.
Comment: One commenter disagreed with CMS's position that the RUC
PE Subcommittee's review results in biased or inaccurate resource input
costs because the prices are largely maintained in the direct PE input
database by CMS.
Response: Although we did not raise this point in the CY 2015 PFS
proposed rule, we refer readers to our discussion in previous
rulemaking (for example, the CY 2011 PFS final rule with comment period
at 75 FR 73250 and the CY 2014 PFS final rule with comment period at 78
FR 74246) regarding issues associated with obtaining appropriate prices
for medical equipment and supply items included in the direct PE
database. We note that the RUC provides recommendations regarding the
use of particular items in furnishing a service, but does not provide
CMS with recommendations regarding the prices of direct PE item.
Without assigning a price, the input cannot be factored in to our PE
RVU methodology. Our price information is almost exclusively anecdotal,
and generally updated only through voluntary submission of a small
number of invoices from the same practitioners that furnish and are
paid for the services that use the particular inputs. Therefore, we
continue to believe there is potential for bias in the information we
receive.
Comment: In its comment, the RUC suggested that an annual CMS
review of paid invoices for high-cost supplies would be appropriate. A
commenter referenced comments made on the CY 2014 PFS final rule with
comment period, and expressed agreement with those commenters that the
provision of pricing information is sensitive because of issues
involving proprietary pricing information and price negotiations for
individual practitioners. This commenter also agreed with CMS that such
information would be less sensitive if it confirmed inputs contained in
the direct PE database. However, the commenter noted that requiring
paid invoices from this point forward only partially addresses the
concern since many existing inputs are not based on paid invoices;
specifically, societies working on inputs for new, revised, or
potentially misvalued services are disadvantaged in comparison to many
existing inputs due to fee schedule relativity. The commenter suggested
that CMS may need to undertake a comprehensive review of all direct PE
inputs and obtain paid invoices to systematically address its concerns.
Response: We share commenters' concerns that codes that are being
reviewed may be disadvantaged relative to codes that contain input
prices that may not be based on paid invoices; and note that we rely on
the public process to ensure continued relativity within the direct PE
inputs. We encourage interested stakeholders to review updates to
prices, as well as prices for new items, to ensure that they appear
reasonable and current, and to provide us with updated pricing
information, particularly regarding high cost supplies that have a
greater impact on relativity. We refer readers to section II.F. of this
final rule with comment period, in which we detail price updates, as
well as establish new prices, for inputs included in new, revised, and
potentially misvalued codes.
Comment: We received some comments in support of our proposal to
update the price for SL196 (kit, HER-2/neu DNA Probe).
Response: We appreciate the commenters' support for our proposal to
update the price for SL196. After publication of our proposal, we
obtained new information suggesting that further study of the price of
this item is necessary before proceeding to update the input price.
Therefore, we are not finalizing our proposal to update the price for
SL196, and will consider this matter in future rulemaking.
Comment: We did not receive any comments regarding our proposal to
update the price for of SD216 (catheter, balloon, esophageal or rectal
(graded distention test)).
Response: We are finalizing the price updates for SD216.
Comment: We received comments in support of the price update to
SA019 (kit, IV starter) and SA042 (pack, cleaning and disinfecting,
endoscope).
Response: We appreciate the commenters' support for our proposal to
update the price for SA019 and SA042. After consideration of comments
received, we are finalizing the price updates for SA019 and SA042.
i. New Standard Supply Package for Contrast Imaging
The RUC recommended creating a new direct PE input standard supply
package ``Imaging w/contrast, standard package'' for contrast enhanced
imaging, with a price of $6.82. This price reflects the combined prices
of the medical supplies included in the package; these items are listed
in Table 10. We proposed to accept this recommendation, but sought
comment on whether all of the items included in the package are used in
the typical case. The CY 2015 direct PE database reflects this change
and is available on the CMS Web site under the supporting data files
for the CY 2015 PFS proposed rule at https://www.cms.gov/PhysicianFeeSched/.
Table 10--Standard Contrast Imaging Supply Package
----------------------------------------------------------------------------------------------------------------
SCMS supply
Medical supply description code Unit Quantity Price
----------------------------------------------------------------------------------------------------------------
Kit, IV starter..................... SA019 Kit..................... 1 $1.60
Gloves, non-sterile................. SB022 Pair.................... 1 0.084
[[Page 67567]]
Angiocatheter 14g-24g............... SC001 Item.................... 1 1.505
Heparin lock........................ SC012 Item.................... 1 0.917
IV tubing (extension)............... SC019 Foot.................... *3 1.590
Needle, 18-27g...................... SC029 Item.................... 1 0.089
Syringe 20ml........................ SC053 Item.................... 1 0.558
Sodium chloride 0.9% inj. SH068 Item.................... 1 0.700
bacteriostatic (30ml uou).
Swab-pad, alcohol................... SJ053 Item.................... 1 0.013
-------------------------------
Total........................... ................ ........................ .............. 7.06
----------------------------------------------------------------------------------------------------------------
* The price for SC019 (IV tubing, (extension)) is $0.53 per foot.
Comment: Commenters supported our proposal to create the standard
supply package for contrast imaging. Some commenters expressed concern
that the proposed supply package did not include the full range of
supplies typically used when performing contrast imaging. One commenter
stated that, for echocardiography labs that utilize contrast-enhanced
ultrasound, additional items are typically part of the contrast imaging
supply package, including 2x2 gauze pads, a stopcock, and tape. Another
commenter suggested that a power injector should also be included in
the standard contrast imaging supply package. Commenters also noted
that CMS provided limited information regarding how the prices were
assigned to the supply items, and pointed to discrepancies between the
direct PE database files and the prices quoted in the table.
Response: We appreciate commenters' support for our proposal. We
note that the RUC recommendation for the standard contrast imaging
supply package also noted that the inputs for CTA and MRA studies would
include the standard contrast imaging supply pack in addition to a stop
cock (SC050) and additional tubing. While we acknowledge a commenter's
suggestion that additional items may be used when echocardiography labs
conduct contrast-enhanced ultrasound studies, we do not have
information to suggest that these items are used for other imaging
studies, such as CT and MRI contrast-enhanced studies. We would welcome
more information on whether these items should be included in the newly
created standard contrast imaging kit, as well as whether the power
injector is used whenever the other inputs in the standard contrast
imaging supply package are used, or whether they are used only in
certain instances. We note that the reason for the discrepancy in the
price for the IV starter kit is that we proposed to update the price at
the same time that we proposed to create a new contrast imaging kit.
Since we are finalizing the price update for SA019 (kit, IV starter),
we are also finalizing a revised price for the new standard contrast
imaging package of $7.06. Finally, we disagree with the commenter's
suggestion that CMS provided limited information about the pricing for
the items included in the kit, as these items are existing inputs in
the direct PE database, and the codes associated with these items were
listed in the table in the proposed rule. After consideration of
comments received, we are finalizing our proposal to create a standard
contrast imaging supply pack, with a revised price of $7.06.
j. Direct PE Inputs for Stereotactic Radiosurgery (SRS) Services (CPT
Codes 77372 and 77373)
In the CY 2014 PFS final rule with comment period (78 FR 74245), we
summarized comments received about whether CPT codes 77372 and 77373
would accurately reflect the resources used in furnishing the typical
SRS delivery if there were no coding distinction between robotic and
non-robotic delivery methods. Until now, SRS services furnished using
robotic methods were billed using contractor-priced G-codes G0339
(Image-guided robotic linear accelerator based stereotactic
radiosurgery, complete course of therapy in one session or first
session of fractionated treatment), and G0340 (Image-guided robotic
linear accelerator-based stereotactic radiosurgery, delivery including
collimator changes and custom plugging, fractionated treatment, all
lesions, per session, second through fifth sessions, maximum five
sessions per course of treatment). We indicated that we would consider
deleting these codes in future rulemaking.
Most commenters responded that the CPT codes accurately described
both services, and the RUC stated that the direct PE inputs for the CPT
codes accurately accounted for the resource costs of the described
services. One commenter objected to the deletion of the G-codes but did
not include any information to suggest that the CPT codes did not
describe the services or that the direct PE inputs for the CPT codes
were inaccurate. Based on a review of the comments received, we had no
indication that the direct PE inputs included in the CPT codes would
not reflect the typical resource inputs involved in furnishing an SRS
service. Therefore, in the CY 2014 proposed rule we proposed to
recognize only the CPT codes for SRS services, and to delete the G-
codes used to report robotic delivery of SRS.
Comment: We received several comments regarding our proposal to
delete the SRS G-codes. Some commenters supported our proposal, but
most opposed our proposal on the grounds that the direct PE inputs
included in the CPT codes do not reflect the typical resource inputs
used in furnishing robotic SRS services. Some commenters urged CMS to
delay this policy change and continue to contractor price the G-codes
until a more appropriate solution can be found.
Response: After consideration of the comments regarding the
appropriate inputs to use in pricing the SRS services, we have
concluded that at this time, we lack sufficient information to make a
determination about the appropriateness of deleting the G-codes and
paying for all SRS/SBRT services using the CPT codes. Therefore, we
will not delete the G-codes for 2015, but will instead work with
stakeholders to identify an alternate approach and reconsider this
issue in future rulemaking.
k. Inclusion of Capnograph for Pediatric Polysomnography Services
We proposed to include equipment item EQ358, Sleep capnograph,
polysomnography (pediatric), for CPT codes 95782 (Polysomnography;
younger than 6 years, sleep staging with
[[Page 67568]]
4 or more additional parameters of sleep, attended by a technologist)
and 95783 (Polysomnography; younger than 6 years, sleep staging with 4
or more additional parameters of sleep, with initiation of continuous
positive airway pressure therapy or bi-level ventilation, attended by a
technologist). Based upon our understanding that capnography is a
required element of sleep studies for patients younger than 6 years, we
proposed to allocate this equipment item to 95782 for 602 minutes, and
95783 for 647 minutes. Based on the invoice we received for this
equipment item, we proposed to price EQ358 at $4,534.23.
Comment: We received two comments in support of our proposal to
include the capnograph in CPT codes 95782 and 95783.
Response: We appreciate commenters' support for our proposal. After
consideration of comments received, we are finalizing our proposal to
include the capnograph in CPT codes 95782 and 95783.
4. Using OPPS and ASC Rates in Developing PE RVUs
Accurate and reliable pricing information for both individual items
and indirect PEs is critical to establish accurate PE RVUs for PFS
services. As we have addressed in previous rulemaking, we have serious
concerns regarding the accuracy of some of the information we use in
developing PE RVUs. In particular, as discussed in the CY 2014 PFS
final rule with comment period, we have several longstanding concerns
regarding the accuracy of direct PE inputs, including both items and
procedure time assumptions, and prices of individual supplies and
equipment (78 FR 74248-74250). In addition to the concerns regarding
the inputs used in valuing particular procedures, we also noted that
the allocation of indirect PE is based on information collected several
years ago (as described above) and will likely need to be updated in
the coming years.
To mitigate the impact of some of these potentially problematic
data used in developing values for individual services, in rulemaking
for the CY 2014 PFS, we proposed to limit the nonfacility PE RVUs for
individual codes so that the total nonfacility PFS payment amount would
not exceed the total combined amount that Medicare would pay for the
same code in the facility setting. In developing the proposal, we
sought a reliable means for Medicare to set upper payment limits for
office-based procedures and believed OPPS and ASC payment rates would
provide an appropriate comparison because these rates are based on
relatively more reliable cost information in settings with cost
structures that generally would be expected to be higher than in the
office setting.
We received many comments regarding our proposal, the vast majority
of which urged us to withdraw the proposal. Some commenters questioned
the validity of our assumption that facilities' costs for providing all
services are necessarily higher than the costs of physician offices or
other nonfacility settings. Other commenters expressed serious concerns
with the asymmetrical comparisons between PFS payment amounts and OPPS/
ASC payment amounts. Finally, many commenters suggested revisions to
technical aspects of our proposed policy.
In considering all the comments, however, we were persuaded that
the comparison of OPPS (or ASC) payment amounts to PFS payment amounts
for particular procedures is not the most appropriate or effective
approach to ensuring that PFS payment rates are based on accurate cost
assumptions. Commenters noted several flaws with the approach. First,
unlike PFS payments, OPPS and ASC payments for individual services are
grouped into rates that reflect the costs of a range of services.
Second, commenters suggested that since the ASC rates reflect the OPPS
relative weights to determine payment rates under the ASC payment
system, and are not based on cost information collected from ASCs, the
ASC rates should not be used in the proposed policy. For these and
other reasons raised by commenters, we did not propose a similar policy
for the CY 2015 PFS. If we consider using OPPS or ASC payment rates in
developing PFS PE RVUs in future rulemaking, we would consider all of
the comments received regarding the technical application of the
previous proposal.
After thorough consideration of the comments regarding the CY 2014
proposal, we continue to believe that there are various possibilities
for leveraging the use of available hospital cost data in the PE RVU
methodology to ensure that the relative costs for PFS services are
developed using data that is auditable and comprehensively and
regularly updated. Although some commenters questioned the premise that
the hospital cost data are more accurate than the information used to
establish PE RVUs, we continue to believe that the routinely updated,
auditable resource cost information submitted contemporaneously by a
wide array of providers across the country is a valid reflection of
``relative'' resources and could be useful to supplement the resource
cost information developed under our current methodology based upon a
typical case that are developed with information from a small number of
representative practitioners for a small percentage of codes in any
particular year.
Section 220(a)(1) of the PAMA added a new subparagraph (M) under
section 1848(c)(2) of the Act that gives us authority to collect
information on resources used to furnish services from eligible
professionals (including physicians, non-physician practitioners, PTs,
OTs, SLPs and qualified audiologists), and other sources. It also
authorizes us to pay eligible professionals for submitting solicited
information. We will be exploring ways of collecting better and updated
resource data from physician practices, including those that are
provider-based, and other non-facility entities paid through the PFS.
We believe such efforts will be challenging given the wide variety of
practices, and that any effort will likely impose some burden on
eligible professionals paid through the PFS regardless of the scope and
manner of data collection. Currently, through one of the validation
contracts discussed in section II.B. of this final rule with comment
period, we have been gathering time data directly from physician
practices. Through this project, we have learned much about the
challenges for both CMS and the eligible professionals of collecting
data directly from practices. Our own experience has shown that is
difficult to obtain invoices for supply and equipment items that we can
use in pricing direct PE inputs.
Many specialty societies also have noted the challenges in
obtaining recent invoices for medical supplies and equipment (78 FR
74249). Further, PE calculations rely heavily on information from the
Physician Practice Expense Information Survey (PPIS) survey, which, as
discussed earlier, was conducted in 2007 and 2008. When we implemented
the results of the survey, many in the community expressed serious
concerns over the accuracy of this or other PE surveys as a way of
gathering data on PE inputs from the diversity of providers paid under
the PFS.
In addition to data collection, section 1848(c)(2)(M) of the Act as
added by section 220(a) of the PAMA provides authority to develop and
use alternative approaches to establish PE relative values, including
the use of data from other suppliers and providers of services. We are
exploring the best approaches for exercising this authority, including
with respect to use of hospital outpatient cost data. We understand
that
[[Page 67569]]
many stakeholders will have concerns regarding the possibility of using
hospital outpatient cost data in developing PE RVUs under the PFS, and
we want to be sure we are aware of these prior to considering or
developing any future proposal relying on those data.
Therefore, in the CY 2015 PFS proposed rule (79 FR 40333), we
sought comment on the possible uses of the Medicare hospital outpatient
cost data (not the APC payment amount) in potential revisions of the
PFS PE methodology. This could be as a means to validate or, perhaps,
in setting the relative resource cost assumptions within the PFS PE
methodology. We noted that the resulting PFS payment amounts would not
necessarily conform to OPPS payment amounts since OPPS payments are
grouped into APCs, while PFS payments would continue to be valued
individually and would remain subject to the relativity inherent in
establishing PE RVUs, budget neutrality adjustments, and PFS updates.
We expressed particular interest in comments that compare such
possibilities to other broad-based, auditable, mechanisms for data
collection, including any we might consider under the authority
provided under section 220(a) of the PAMA. We urged commenters to
consider a wide range of options for gathering and using the data,
including using the data to validate or set resource assumptions for
only a subset of PFS services, or as a base amount to be adjusted by
code or specialty-level recommended adjustments, or other potential
uses. We appreciate the many thoughtful comments that we received on
whether and how to use the OPPS cost data in establishing PE relative
values. We will consider these as we continue to think about mechanisms
to improve the accuracy of PE values.
In addition to soliciting comments as noted above, in the CY 2015
proposed rule we stated that we continue to seek a better understanding
regarding the growing trend toward hospital acquisition of physicians'
offices and how the subsequent treatment of those locations as off-
campus provider-based outpatient departments affects payments under PFS
and beneficiary cost-sharing. MedPAC continues to question the
appropriateness of increased Medicare payment and beneficiary cost-
sharing when physicians' offices become hospital outpatient
departments, and to recommend that Medicare pay selected hospital
outpatient services at PFS rates (MedPAC March 2012 and June 2013
Report to Congress). We noted that we also remain concerned about the
validity of the resource data as more physician practices become
provider-based. Our survey data reflects the PE costs for particular
PFS specialties, including a proportion of practices that may have
become provider-based since the survey was conducted. Additionally, as
the proportion of provider-based offices varies among physician
specialties, so do the relative accuracy of the PE survey data. Our
current PE methodology primarily distinguishes between the resources
involved in furnishing services in two sites of service: The non-
facility setting and the facility setting. In principle, when services
are furnished in the non-facility setting, the costs associated with
furnishing services include all direct and indirect PEs associated with
the work and the PE of the service. In contrast, when services are
furnished in the facility setting, some costs that would be PEs in the
office setting are incurred by the facility. Medicare makes a separate
payment to the facility to account for some portion of these costs, and
we adjust PEs accordingly under the PFS. As more physician practices
become hospital-based, it is difficult to know which PE costs typically
are actually incurred by the physician, which are incurred by the
hospital, and whether our bifurcated site-of service differential
adequately accounts for the typical resource costs given these
relationships. We also have discussed this issue as it relates to
accurate valuation of visits within the postoperative period of 10- and
90-day global codes in section II.B.4 of this final rule with comment
period.
To understand how this trend is affecting Medicare, including the
accuracy of payments made through the PFS, we need to develop data to
assess the extent to which this shift toward hospital-based physician
practices is occurring. To that end, during CY 2014 rulemaking we
sought comment regarding the best method for collecting information
that would allow us to analyze the frequency, type, and payment for
services furnished in off-campus provider-based hospital departments
(78 FR 74427). We received many thoughtful comments. However, the
commenters did not present a consensus opinion regarding the options we
presented in last year's rule. Based on our analysis of the comments,
we stated that we believed the most efficient and equitable means of
gathering this important information across two different payment
systems would be to create a HCPCS modifier to be reported with every
code for physicians' and hospital services furnished in an off-campus
provider-based department of a hospital.
We proposed that the modifier would be reported on both the CMS-
1500 claim form for physicians' services and the UB-04 (CMS form 1450)
for hospital outpatient claims. (We note that the requirements for a
determination that a facility or an organization has provider-based
status are specified in Sec. 413.65, and we define a hospital campus
to be the physical area immediately adjacent to the provider's main
buildings, other areas and structures that are not strictly contiguous
to the main buildings but are located within 250 yards of the main
buildings, and any other areas determined on an individual case basis,
by the CMS regional office.)
Therefore, we proposed to collect this information on the type and
frequency of services furnished in off-campus provider-based
departments in accordance with our authority under section
1848(c)(2)(M) of the Act (as added by section 220(a) of the PAMA)
beginning January 1, 2015. The collection of this information would
allow us to begin to assess the accuracy of the PE data, including both
the service-level direct PE inputs and the specialty-level indirect PE
information that we currently use to value PFS services. Furthermore,
this information would be critical in order to develop proposed
improvements to our PE data or methodology that would appropriately
account for the different resource costs among traditional office,
facility, and off-campus provider-based settings. We also sought
additional comment on whether a code modifier is the best mechanism for
collecting this service-level information.
Comment: Many commenters agreed on the need to collect information
on the frequency, type, and payment of services furnished in off-campus
provider-based departments of hospitals, however, several commenters
expressed concern that the HCPCS modifier would create additional
administrative burden for providers. Many of these commenters stated
that the new modifier would require significant changes to hospitals'
billing systems, including a separate charge master for outpatient off-
campus PBDs and training for staff on how to use the new modifier.
Several commenters thought that education and training would be
required for physician offices to attach a modifier to services
furnished in an off-campus provider-based department. These same
commenters suggested that a new place of service (POS) code would be
more appropriate for physician billing. Several commenters suggested
that CMS
[[Page 67570]]
should re-propose a detailed data collection methodology, test it with
providers, make adjustments, and allow additional time for
implementation.
Response: While we understand commenters' concerns about the
additional administrative burden of reporting a new HCPCS modifier, we
have weighed the burden of reporting the modifier for each service
against the benefit of having data that will allow us to obtain and
assess accurate information on the type and frequency of outpatient
hospital services furnished in off-campus provider-based departments,
and we do not believe that the modifier is excessively burdensome for
providers to report. When billing for hospital services, providers must
know where services are furnished in order to accurately complete value
code 78 of an outpatient claim or item 32 for service location on the
practitioner claim. However, as discussed later in this section, we
agree that a POS code on the professional claim allows for the same
type of data collection as a modifier and would be less burdensome than
the modifier for practitioners. We discuss the timeframe for
implementation later in this section.
Comment: Some commenters who were concerned about the
administrative burden of the new HCPCS modifier suggested several
alternative methods for CMS to collect data on services furnished in
off-campus provider-based departments. Several of these commenters
recommended that CMS consider establishing of a new POS code for
professional claims, or for both professional and hospital claims,
because they believed this approach would be less administratively
burdensome than attaching a modifier to each service reported on the
claim that was furnished in an off-campus provider-based department.
Some commenters preferred identifying services furnished in provider-
based departments on the Medicare cost report (CMS-2552-10). Some
commenters suggested using provider numbers and addresses to identify
off-campus PBDs, or changing the provider enrollment process to be able
to track this data. Yet other commenters suggested creating a new bill
type to track off-campus PBD services.
Commenters generally recommended that CMS choose the least
administratively burdensome approach that would ensure accurate data
collection, but did not necessarily agree on what approach would
optimally achieve that result. Some commenters believed that a HCPCS
modifier would more clearly identify specific services furnished at
off-campus PBDs, and would provide better information about the type
and level of care furnished. Some commenters believed that a HCPCS
modifier would be the least administratively burdensome approach
because hospitals and physicians already report a number of claims-
based modifiers. However, other commenters stated that additional
modifiers would increase administrative burden because this approach
would increase the modifiers that would need to be considered when
billing.
Response: With respect to creating a new POS code to obtain data on
services furnished in off-campus PBDs of a hospital, we note that POS
codes are only reported on professional claims and are not included on
institutional claims. Therefore, a POS code could not be easily
implemented for hospital claims. However, POS codes are already
required to be reported on every professional claim, and POS 22 is
currently used when physicians' services are furnished in an outpatient
hospital department. (More information on existing POS codes is
available on the CMS Web site at https://www.cms.gov/Medicare/Coding/place-of-service-codes/Place_of_Service_Code_Set.html).
Though we considered proposing a new POS code for professional
claims to collect data on services furnished in the off-campus hospital
setting, we note that previous GAO and OIG reports (October 2004 A-05-
04-0025, January 2005 A-06-04-00046, July 2010 A-01-09-00503, September
2011 A-01-10-00516) have noted frequent inaccuracies in the reporting
of POS codes. Additionally, at the time the proposed rule was
developed, we had concerns that using a POS code to report this
information might not give us the reliable data we are looking to
collect, especially if such data were to be cross-walked with hospital
claims for the same service, since the hospital claim would have a
modifier, not a POS code. However, we have been persuaded by public
comments suggesting that use of a POS code on professional claims would
be less administratively burdensome than use of a modifier, and would
be more familiar to those involved in practitioner billing.
Specifically, since a POS code is already required on every
professional claim, we believe that creating a new POS code to
distinguish outpatient hospital services that are furnished on the
hospital campus versus in an off-campus provider-based department would
require less staff training and education than would the use of a
modifier on the professional claim. Additionally, professional claims
only have space for four modifiers; while a very small percentage of
professional claims have four modifiers, required use of an additional
modifier for every professional claim could lead to more occurrences
where there would not be space for all applicable payment modifiers for
a specific service. Unlike institutional claims, we note that a new
professional claim is required whenever the place of service changes.
That is, even if the same practitioner treats the same patient on the
same day in the office and the hospital, the services furnished in the
office setting must be submitted on one claim with POS 11 (Office),
while those furnished in the outpatient hospital department would be
submitted on a separate claim with POS 22 (Outpatient Hospital).
Likewise, if a new POS code were to be created for off-campus
outpatient provider-based hospital department, a separate claim for
services furnished in that setting would be required relative to a
claim for outpatient services furnished on the hospital's main campus
by the same practitioner to the same patient on the same day. Based on
public comments and after further consultation with Medicare billing
experts, we believe that use of the POS code on professional claims
would be no less accurate than use of a modifier on professional claims
in identifying services furnished in off-campus PBDs. In addition, we
believe that the POS code would be less administratively burdensome for
practitioners billing using the professional claim since a POS code is
already required for every professional claim.
With respect to adding new fields to existing claim forms or
creating a new bill type, we do not believe that this data collection
warrants these measures. We believe that those changes would create
greater administrative burden than the proposed HCPCS modifier and POS
codes, especially since providers are already accustomed to using
modifiers and POS codes. Revisions to the claim form to add new fields
or an additional bill type would create significant administrative
burden to revise claims processing systems and educate providers that
is not necessary given the availability of a modifier and POS codes.
Though providers may not be familiar with this new modifier or any new
POS code; since these types of codes already exist generally for
hospital and professional claims, providers and suppliers should
already have an understanding of these types of codes and how to apply
them. Finally, we do not believe that expansions to the claim form or
use of a new bill type
[[Page 67571]]
would provide us with detailed information on exactly which services
were furnished in an off-campus PBD versus those furnished on the main
campus when those services are furnished on the same day.
We also do not believe that we could accurately determine which
services are furnished at off-campus provider-base departments (PBDs)
using currently available NPI and facility address data. Hospitals are
required to report the nine-digit ZIP code indicating where a service
was furnished for purposes of paying properly for physician and
anesthesia services paid off the PFS when that ZIP code differs from
the master address for the hospital on file in CMS claims systems in
value code 78 (pub 100-04, transmittal 1681, February 13, 2009).
However, the billing ZIP code for the hospital main campus could be
broad enough to incorporate on and off-campus provider-based
departments. Further, a ZIP code reported in value code 78 does not
allow CMS to distinguish between services furnished in different
locations on the same date. Therefore, we do not believe that a
comparison of the ZIP code captured in value code 78 and the main
campus ZIP code is sufficiently precise.
Finally, while we considered the suggestion that CMS use currently
reported Medicare hospital cost report (CMS-2552-10) data to identify
services furnished at off-campus PBDs, we note that though aggregate
data on services furnished in different settings must be reported
through the appropriate cost center, we would not be able to obtain the
service-specific level of detail that we would be able to obtain from
claims data.
We will take under consideration the suggestion that CMS create a
way for hospitals to report their acquisition of physician offices as
off-campus PBDs through the enrollment process, although this
information, as currently reported, would not allow us to know exactly
which services are furnished in off-campus provider based departments
and which services are furnished on the hospital's main campus when a
hospital provides both on the same day.
Comment: Commenters noted that the proposed modifier would not
allow CMS to know the precise location of the off-campus provider-based
department for billed services or when services are furnished at
different off-campus provider-based locations in the same day.
Response: We agree that neither the proposed modifier nor a POS
code provides details on the specific provider-based location for each
furnished service. However, we believe that collecting information on
the type and frequency of services furnished at all off-campus
locations will assist CMS in better understanding the distribution of
services between on and off-campus locations.
Comment: MedPAC believed there may be some value in collecting data
on services furnished in off-campus provider-based departments to
validate the accuracy of site-of-service reporting when the physician's
office is off-campus but bills as an outpatient department. MedPAC
indicated that any data collection effort should not prevent the
development of policies to align payment rates across settings. MedPAC
encouraged CMS to seek legislative authority to set equal payment rates
across settings for evaluation and management office visits and other
select services.
Response: We thank MedPAC for its support of our data collection
efforts to learn more about the frequency and types of services that
are being furnished in off-campus PBDs.
Comment: Many commenters suggested that providers would not be able
to accurately apply the new modifier by the January 1, 2015
implementation timeline and recommended a one-year delay before
providers would be required to apply the modifier to services furnished
at off-campus PBDs. Some commenters requested only a six-month delay in
implementation. Commenters indicated that significant revisions to
internal billing processes would require additional time to implement.
Response: Though we believe that the January 1st effective date
that applies to most policies adopted in the final rules with comment
period for both the PFS and the OPPS would provide sufficient lead
time, we understand commenters' concerns with the proposed timeline for
implementation given that the new reporting requirements may require
changes to billing systems as well as education and training for staff.
With respect to the POS code for professional claims, we will request
two new POS codes to replace POS code 22 (Hospital Outpatient) through
the POS Workgroup and expect that it will take some time for these new
codes to be established. Once the revised POS codes are ready and
integrated into CMS claims systems, practitioners would be required to
use them, as applicable. More information on the availability of the
new POS codes will be forthcoming in subregulatory guidance, but we do
not expect the new codes to be available prior to July 1, 2015. There
will be no voluntary reporting period of the POS codes for applicable
professional claims because each professional claim requires a POS code
in order to be accepted by Medicare. However, we do not view this to be
problematic because we intend to give prior notice on the POS coding
changes and, as many public commenters noted, because practitioners are
already accustomed to using a POS on every claim they submit.
We also are finalizing our proposal to create a HCPCs modifier for
hospital services furnished in an off-campus PBD setting; but we are
adopting a voluntary reporting period for the new HCPCS modifier for
one year. That is, reporting the new HCPCS modifier for services
furnished at an off-campus PBD will not be mandatory until January 1,
2016, in order to allow providers time to make systems changes, test
these changes, and train staff on use of the new modifier before
reporting is required. We welcome early reporting of the modifier and
believe a full year of preparation should provide hospitals with
sufficient time to modify their systems for accurate reporting.
Comment: Many commenters expressed concern that this data
collection would eventually lead to equalizing payment for similar
services furnished in the non-facility setting and the off-campus PBD
setting. Several commenters noted that the trend of hospitals acquiring
physician practices is due to efforts to better integrate care
delivery, and suggested that CMS weigh the benefits of care integration
when deciding payment changes. Some commenters suggested that CMS
should use the data to equalize payment for similar services between
these two settings. These commenters suggest that there is little
difference in costs and care between the two settings that would
warrant the difference in payment. Several of these commenters
highlighted beneficiary cost sharing as one reason for site-neutral
payment, noting that the total payment amount for hospital outpatient
services is generally higher than the total payment amount for those
same services when furnished in a physician's office.
Response: We appreciate the comments received. At this time, we are
only finalizing a data collection in this final rule with comment
period. We did not propose, and therefore, are not finalizing any
adjustment to payments furnished in the off-campus PBD setting.
Comment: Several commenters noted that the CMS proposal would not
provide additional information on how a physician practice billed prior
to becoming an off-campus PBD, which would be important for analyzing
the impact of this trend.
[[Page 67572]]
Response: We agree that, in analyzing the impact of this trend, it
is important to understand physician billing patterns that were in
place prior to becoming an off-campus PBD, and we will continue to
evaluate ways to analyze claims data to gather this information. We
believe that collecting data using the additional modifier and POS code
as finalized in this rule will be an important tool in furthering this
analysis.
Comment: Some commenters suggested that the term ``off-campus''
needs to be better defined. Commenters asked how billing would occur
for hospitals with multiple campuses since the CMS definition of campus
references main buildings and does not include remote locations. One
commenter also asked whether the modifier is intended to cover services
furnished in free-standing emergency departments.
Response: For purposes of the modifier and the POS codes we are
finalizing in this final rule with comment period, we define a
``campus'' using the definition at Sec. 413.65(a)(2) to be the
physical area immediately adjacent to the provider's main buildings,
other areas and structures that are not strictly contiguous to the main
buildings but are located within 250 yards of the main buildings, and
any other areas determined on an individual case basis, by the CMS
regional office, to be part of the provider's campus. We agree with
commenters that our intent is to capture data on outpatient services
furnished off of the hospital's main campus and off of any of the
hospital's other campuses. The term ``remote location of a hospital''
is defined in our regulations at section 413.65(a)(2). Under the
regulation, a ``remote location'' includes a hospital campus other than
the main hospital campus. Specifically, a remote location is ``a
facility or an organization that is either created by, or acquired by,
a hospital that is a main provider for the purposes of furnishing
inpatient hospital services under the name, ownership, and financial
and administrative control of the main provider . . . .'' Therefore, we
agree with the commenters that the new HCPCS modifier and the POS code
for off-campus PBDs should not be reported for services furnished in
remote locations of a hospital. The term ``remote location'' does not
include ``satellite'' locations of a hospital. However, since a
satellite facility is one that provides inpatient services in a
building also used by another hospital, or in one or more entire
buildings located on the same campus as buildings used by another
hospital, the new HCPCS modifier and the POS code for off-campus
hospital PBDs should not be reported for services furnished in
satellite facilities. Satellite facilities are described in our
regulations at Sec. 412.22(h). Accordingly, reporting of the modifier
and the POS code that identifies an off-campus hospital PBD would be
required for outpatient services furnished in PBDs that are located
beyond 250 yards from the main campus of the hospital, excluding
services furnished in a remote location or satellite facility of the
hospital.
We also appreciate the comment on emergency departments. We do not
intend for hospitals to report the new modifier for services furnished
in emergency departments. We note that there is already a POS code for
the emergency department, POS 23 (emergency room-hospital), and this
would continue to be used on professional claims for services furnished
in emergency departments. That is, the new POS code for off-campus
hospital PBDs that will be created for purposes of this data collection
would not apply to emergency department services. Hospitals and
practitioners that have questions about which departments are
considered to be ``off-campus PBDs'' should review additional guidance
that CMS releases on this policy and work with the appropriate CMS
regional office if individual, specific questions remain.
Comment: Several commenters asked for clarification on when to
report the modifier for services furnished both on and off-campus on
the same day. Commenters provided several scenarios of visits and
diagnostic services furnished on the same day.
Response: The location where the service is actually furnished
would dictate the use of the modifier and the POS codes, regardless of
where the order for services is initiated. We expect the modifier and
the POS code for off-campus PBDs to be reported in locations in which
the hospital expends resources to furnish the service in an off-campus
PBD setting. For example, hospitals would not report the modifier for a
diagnostic test that is ordered by a practitioner who is located in an
off-campus PBD when the service is actually furnished on the main
campus of the hospital. This issue does not impact use of the POS codes
since practitioners submit a different claim for each POS where they
furnish services for a specific beneficiary.
Comment: A few commenters asked for clarification on whether their
entity constitutes a provider-based department.
Response: Provider-based departments are departments of the
hospital that meet the criteria in Sec. 413.65.
Comment: A commenter recommended that CMS publish the data it
acquires through adoption of this modifier.
Response: Data collected through the new HCPCS modifier would be
part of the Medicare Limited Data Set and would be available to the
public for purchase along with the rest of the Limited Data Set.
Similarly, professional claims data with revised POS coding would be
available as a standard analytic file for purchase.
In summary, after consideration of the comments received, we are
finalizing our proposal with modifications. For professional claims,
instead of finalizing a HCPCS modifier, in response to comments, we
will be deleting current POS code 22 (outpatient hospital department)
and establishing two new POS codes--one to identify outpatient services
furnished in on-campus, remote or satellite locations of a hospital,
and another to identify services furnished in an off-campus hospital
PBD setting that is not a remote location of a hospital, a satellite
location of a hospital or a hospital emergency department. We will
maintain the separate POS code 23 (emergency room-hospital) to identify
services furnished in an emergency department of the hospital. These
new POS codes will be required to be reported as soon as they become
available, however advance notice of the availability of these codes
will be shared publicly as soon as practicable.
For hospital claims, we are creating a HCPCS modifier that is to be
reported with every code for outpatient hospital services furnished in
an off-campus PBD of a hospital. This code will not be required to be
reported for remote locations of a hospital defined at Sec. 412.65,
satellite facilities of a hospital defined at Sec. 412.22(h) or for
services furnished in an emergency department. This 2-digit modifier
will be added to the HCPCS annual file as of January 1, 2015, with the
label ``PO,'' the short descriptor ``Serv/proc off-campus pbd,'' and
the long descriptor ``Services, procedures and/or surgeries furnished
at off-campus provider-based outpatient departments.'' Reporting of
this new modifier will be voluntary for 1 year (CY 2015), with
reporting required beginning on January 1, 2016. Additional instruction
and provider education will be forthcoming in subregulatory guidance.
[[Page 67573]]
B. Potentially Misvalued Services Under the Physician Fee Schedule
1. Valuing Services Under the PFS
Section 1848(c) of the Act requires the Secretary to determine
relative values for physicians' services based on three components:
Work, PE, and malpractice. Section 1848(c)(1)(A) of the Act defines the
work component to mean, ``the portion of the resources used in
furnishing the service that reflects physician time and intensity in
furnishing the service.'' In addition, section 1848(c)(2)(C)(i) of the
Act specifies that ``the Secretary shall determine a number of work
relative value units (RVUs) for the service based on the relative
resources incorporating physician time and intensity required in
furnishing the service.''
Section 1848(c)(1)(B) of the Act defines the PE component as ``the
portion of the resources used in furnishing the service that reflects
the general categories of expenses (such as office rent and wages of
personnel, but excluding malpractice expenses) comprising practice
expenses.'' Section 1848(c)(2)(C)(ii) of the Act requires that PE RVUs
be determined based upon the relative PE resources involved in
furnishing the service. (See section II.A. of this final rule with
comment period for more detail on the PE component.)
Section 1848(c)(1)(C) of the Act defines the MP component as ``the
portion of the resources used in furnishing the service that reflects
malpractice expenses in furnishing the service.'' Section
1848(c)(2)(C)(iii) of the Act specifies that MP expense RVUs shall be
determined based on the relative MP expense resources involved in
furnishing the service. (See section II.C. of this final rule with
comment period for more detail on the MP component.)
2. Identifying, Reviewing, and Validating the RVUs of Potentially
Misvalued Services
a. Background
Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a
periodic review, not less often than every 5 years, of the RVUs
established under the PFS. Section 1848(c)(2)(K) of the Act requires
the Secretary to periodically identify potentially misvalued services
using certain criteria and to review and make appropriate adjustments
to the relative values for those services. Section 1848(c)(2)(L) of the
Act also requires the Secretary to develop a process to validate the
RVUs of certain potentially misvalued codes under the PFS, using the
same criteria used to identify potentially misvalued codes, and to make
appropriate adjustments.
As discussed in section I.B. of this final rule with comment
period, each year we develop appropriate adjustments to the RVUs taking
into account recommendations provided by the American Medical
Association/Specialty Society Relative Value Scale Update Committee
(RUC), the Medicare Payment Advisory Commission (MedPAC), and others.
For many years, the RUC has provided us with recommendations on the
appropriate relative values for new, revised, and potentially misvalued
PFS services. We review these recommendations on a code-by-code basis
and consider these recommendations in conjunction with analyses of
other data, such as claims data, to inform the decision-making process
as authorized by the law. We may also consider analyses of work time,
work RVUs, or direct PE inputs using other data sources, such as
Department of Veteran Affairs (VA), National Surgical Quality
Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS),
and the Physician Quality Reporting Initiative (PQRI) databases. In
addition to considering the most recently available data, we also
assess the results of physician surveys and specialty recommendations
submitted to us by the RUC. We also consider information provided by
other stakeholders. We conduct a review to assess the appropriate RVUs
in the context of contemporary medical practice. We note that section
1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and
other techniques to determine the RVUs for physicians' services for
which specific data are not available, in addition to taking into
account the results of consultations with organizations representing
physicians. In accordance with section 1848(c) of the Act, we determine
and make appropriate adjustments to the RVUs.
In its March 2006 Report to the Congress, MedPAC discussed the
importance of appropriately valuing physicians' services, noting that
``misvalued services can distort the price signals for physicians'
services as well as for other health care services that physicians
order, such as hospital services.'' In that same report MedPAC
postulated that physicians' services under the PFS can become misvalued
over time. MedPAC stated, ``When a new service is added to the
physician fee schedule, it may be assigned a relatively high value
because of the time, technical skill, and psychological stress that are
often required to furnish that service. Over time, the work required
for certain services would be expected to decline as physicians become
more familiar with the service and more efficient in furnishing it.''
We believe services can also become overvalued when PE declines. This
can happen when the costs of equipment and supplies fall, or when
equipment is used more frequently than is estimated in the PE
methodology, reducing its cost per use. Likewise, services can become
undervalued when physician work increases or PE rises.
As MedPAC noted in its March 2009 Report to Congress, in the
intervening years since MedPAC made its initial recommendations, ``CMS
and the RUC have taken several steps to improve the review process.''
Also, since that time the Congress added section 1848(c)(2)(K)(ii) to
the Act, which augments our efforts. It directs the Secretary to
specifically examine, as determined appropriate, potentially misvalued
services in the following seven categories:
Codes and families of codes for which there has been the
fastest growth;
Codes and families of codes that have experienced
substantial changes in PEs;
Codes that are recently established for new technologies
or services;
Multiple codes that are frequently billed in conjunction
with furnishing a single service;
Codes with low relative values, particularly those that
are often billed multiple times for a single treatment;
Codes which have not been subject to review since the
implementation of the RBRVS (the so-called `Harvard-valued codes'); and
Other codes determined to be appropriate by the Secretary.
Section 220(c) of the Protecting Access to Medicare Act of 2014
(PAMA) further expanded the categories of codes that the Secretary is
directed to examine by adding nine additional categories. These are:
Codes that account for the majority of spending under the
PFS;
Codes for services that have experienced a substantial
change in the hospital length of stay or procedure time;
Codes for which there may be a change in the typical site
of service since the code was last valued;
Codes for which there is a significant difference in
payment for the same service between different sites of service;
Codes for which there may be anomalies in relative values
within a family of codes;
[[Page 67574]]
Codes for services where there may be efficiencies when a
service is furnished at the same time as other services;
Codes with high intra-service work per unit of time;
Codes with high PE RVUs; and
Codes with high cost supplies.
Section 1848(c)(2)(K)(iii) of the Act also specifies that the
Secretary may use existing processes to receive recommendations on the
review and appropriate adjustment of potentially misvalued services. In
addition, the Secretary may conduct surveys, other data collection
activities, studies, or other analyses, as the Secretary determines to
be appropriate, to facilitate the review and appropriate adjustment of
potentially misvalued services. This section of the Act also authorizes
the use of analytic contractors to identify and analyze potentially
misvalued codes, conduct surveys or collect data, and make
recommendations on the review and appropriate adjustment of potentially
misvalued services. Additionally, this section provides that the
Secretary may coordinate the review and adjustment of any RVU with the
periodic review described in section 1848(c)(2)(B) of the Act. Section
1848(c)(2)(K)(iii)(V) of the Act specifies that the Secretary may make
appropriate coding revisions (including using existing processes for
consideration of coding changes) that may include consolidation of
individual services into bundled codes for payment under the physician
fee schedule.
b. Progress in Identifying and Reviewing Potentially Misvalued Codes
To fulfill our statutory mandate, we have identified and reviewed
numerous potentially misvalued codes as specified in section
1848(c)(2)(K)(ii) of the Act, and we plan to continue our work
examining potentially misvalued codes as authorized by statute over the
coming years. As part of our current process, we identify potentially
misvalued codes for review, and request recommendations from the RUC
and other public commenters on revised work RVUs and direct PE inputs
for those codes. The RUC, through its own processes, also identifies
potentially misvalued codes for review. Through our public nomination
process for potentially misvalued codes established in the CY 2012 PFS
final rule with comment period, other individuals and stakeholder
groups submit nominations for review of potentially misvalued codes as
well.
Since CY 2009, as a part of the annual potentially misvalued code
review and Five-Year Review process, we have reviewed over 1,250
potentially misvalued codes to refine work RVUs and direct PE inputs.
We have assigned appropriate work RVUs and direct PE inputs for these
services as a result of these reviews. A more detailed discussion of
the extensive prior reviews of potentially misvalued codes is included
in the CY 2012 PFS final rule with comment period (76 FR 73052 through
73055). In the CY 2012 final rule with comment period, we finalized our
policy to consolidate the review of physician work and PE at the same
time (76 FR 73055 through 73958), and established a process for the
annual public nomination of potentially misvalued services.
In the CY 2013 final rule with comment period, we built upon the
work we began in CY 2009 to review potentially misvalued codes that
have not been reviewed since the implementation of the PFS (so-called
``Harvard-valued codes''). In CY 2009, we requested recommendations
from the RUC to aid in our review of Harvard-valued codes that had not
yet been reviewed, focusing first on high-volume, low intensity codes
(73 FR 38589). In the fourth Five-Year Review, we requested
recommendations from the RUC to aid in our review of Harvard-valued
codes with annual utilization of greater than 30,000 (76 FR 32410). In
the CY 2013 final rule with comment period, we identified Harvard-
valued services with annual allowed charges that total at least
$10,000,000 as potentially misvalued. In addition to the Harvard-valued
codes, in the CY 2013 final rule with comment period we finalized for
review a list of potentially misvalued codes that have stand-alone PE
(codes with physician work and no listed work time, and codes with no
physician work that have listed work time).
In the CY 2014 final rule with comment period, we finalized for
review a list of potentially misvalued services. We included on the
list for review ultrasound guidance codes that had longer procedure
times than the typical procedure with which the code is billed to
Medicare. We also finalized our proposal to replace missing post-
operative hospital E/M visit information and work time for
approximately 100 global surgery codes. For CY 2014, we also considered
a proposal to limit PFS payments for services furnished in a
nonfacility setting when the nonfacility PFS payment for a given
service exceeds the combined Medicare Part B payment for the same
service when it is furnished in a facility (separate payments being
made to the practitioner under the PFS and to the facility under the
OPPS). Based upon extensive public comment, we did not finalize this
proposal. We address our current consideration of the potential use of
OPPS data in establishing RVUs for PFS services, as well as comments
received, in section II.B. of this final rule with comment period.
c. Validating RVUs of Potentially Misvalued Codes
Section 1848(c)(2)(L) of the Act requires the Secretary to
establish a formal process to validate RVUs under the PFS. The Act
specifies that the validation process may include validation of work
elements (such as time, mental effort and professional judgment,
technical skill and physical effort, and stress due to risk) involved
with furnishing a service and may include validation of the pre-, post-
, and intra-service components of work. The Secretary is directed, as
part of the validation, to validate a sampling of the work RVUs of
codes identified through any of the 16 categories of potentially
misvalued codes specified in section 1848(c)(2)(K)(ii)of the Act.
Furthermore, the Secretary may conduct the validation using methods
similar to those used to review potentially misvalued codes, including
conducting surveys, other data collection activities, studies, or other
analyses as the Secretary determines appropriate to facilitate the
validation of RVUs of services.
In the CY 2011 PFS proposed rule (75 FR 40068) and CY 2012 PFS
proposed rule (76 FR 42790), we solicited public comments on possible
approaches, methodologies, and data sources that we should consider for
a validation process. We provided a summary of the comments along with
our responses in the CY 2011 PFS final rule with comment period (75 FR
73217) and the CY 2012 PFS final rule with comment period (76 FR 73054
through 73055).
We contracted with two outside entities to develop validation
models for RVUs. Given the central role of time in establishing work
RVUs and the concerns that have been raised about the current time
values used in rate setting, we contracted with the Urban Institute to
collect time data from several practices for services selected by the
contractor in consultation with CMS. These data will be used to develop
time estimates. The Urban Institute will use a variety of approaches to
develop objective time estimates, depending on the type of service.
Objective time estimates will be compared to the current time values
used in the fee schedule. The project team will then convene groups of
physicians from a
[[Page 67575]]
range of specialties to review the new time data and their potential
implications for work and the ratio of work to time. The Urban
Institute has prepared an interim report, Development of a Model for
the Valuation of Work Relative Value Units, which discusses the
challenges encountered in collecting objective time data and offers
some thoughts on how these can be overcome. This interim report is
available on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/RVUs-Validation-UrbanInterimReport.pdf. Collection of time data under this project has
just begun. A final report will be available once the project is
complete.
The second contract is with the RAND Corporation, which is using
available data to build a validation model to predict work RVUs and the
individual components of work RVUs, time, and intensity. The model
design was informed by the statistical methodologies and approach used
to develop the initial work RVUs and to identify potentially misvalued
procedures under current CMS and RUC processes. RAND will use a
representative set of CMS-provided codes to test the model. RAND
consulted with a technical expert panel on model design issues and the
test results. We anticipate a report from this project by the end of
the year and will make the report available on the CMS Web site.
Descriptions of both projects are available on the CMS Web site at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/RVUs-Validation-Model.pdf.
We acknowledge comments received regarding the Urban Institute and
RAND projects, but note that we did not solicit comments on these
projects because we made no proposals related to them. Any changes to
payment policies under the PFS that we might make after considering
these reports would be issued in a proposed rule and subjected to
public comment before they would be finalized and implemented.
3. CY 2015 Identification and Review of Potentially Misvalued Services
a. Public Nomination of Potentially Misvalued Codes
In the CY 2012 PFS final rule with comment period, we finalized a
process for the public to nominate potentially misvalued codes (76 FR
73058). The public and stakeholders may nominate potentially misvalued
codes for review by submitting the code with supporting documentation
during the 60-day public comment period following the release of the
annual PFS final rule with comment period. Supporting documentation for
codes nominated for the annual review of potentially misvalued codes
may include the following:
Documentation in the peer reviewed medical literature or
other reliable data that there have been changes in physician work due
to one or more of the following: Technique; knowledge and technology;
patient population; site-of-service; length of hospital stay; and work
time.
An anomalous relationship between the code being proposed
for review and other codes.
Evidence that technology has changed physician work, that
is, diffusion of technology.
Analysis of other data on time and effort measures, such
as operating room logs or national and other representative databases.
Evidence that incorrect assumptions were made in the
previous valuation of the service, such as a misleading vignette,
survey, or flawed crosswalk assumptions in a previous evaluation.
Prices for certain high cost supplies or other direct PE
inputs that are used to determine PE RVUs are inaccurate and do not
reflect current information.
Analyses of work time, work RVU, or direct PE inputs using
other data sources (for example, VA NSQIP, STS National Database, and
the PQRS databases).
National surveys of work time and intensity from
professional and management societies and organizations, such as
hospital associations.
After we receive the nominated codes during the 60-day comment
period following the release of the annual PFS final rule with comment
period, we evaluate the supporting documentation and assess whether the
nominated codes appear to be potentially misvalued codes appropriate
for review under the annual process. In the following year's PFS
proposed rule, we publish the list of nominated codes and indicate
whether we are proposing each nominated code as a potentially misvalued
code.
During the comment period to the CY 2014 final rule with comment
period, we received nominations and supporting documentation for four
codes to be considered as potentially misvalued codes. Although we
evaluated the supporting documentation for two of the nominated codes
to ascertain whether the submitted information demonstrated that the
code should be proposed as potentially misvalued, we did not identify
the other two codes until after the publication of the proposed rule.
We apologize for this oversight and will address the nomination of CPT
codes 92227 and 92228 in the proposed rule for CY 2016.
We proposed CPT code 41530 (submucosal ablation of the tongue base,
radiofrequency, 1 or more sites, per session) as potentially misvalued
based on public nomination due to a significant decrease in two of the
direct PE inputs.
Comment: The commenter that nominated this code as potentially
misvalued thanked CMS for proposing this code as potentially misvalued,
but indicated that the RUC had made recommendations for this code for
CY 2015 and further review was no longer necessary. Another commenter
suggested that this code should be removed from the list of potentially
misvalued codes since it saves Medicare millions of dollars per year.
Response: The RUC only provided us with recommendations for PE
inputs for CPT code 41530. Under our usual process, we value work and
PE at the same time and would expect to receive RUC recommendations on
both before we revalue this service. We disagree with the commenter's
statement that codes that may save money for the Medicare program
should not be considered as potentially misvalued. Our aim, consistent
with our statutory directive, is to value all services appropriately
under the PFS to reflect the relative resources involved in furnishing
them. After consideration of public comments, we are finalizing CPT
code 41530 as potentially misvalued.
We did not propose CPT code 99174 (instrument-based ocular
screening (for example, photoscreening, automated-refraction),
bilateral) as potentially misvalued, because it is a non-covered
service, and we only consider nominations of active codes that are
covered by Medicare at the time of the nomination (see 76 FR 73059).
Comment: Commenters did not disagree with CMS not proposing this
code as potentially misvalued, but did raise a variety of comments
about the code that were unrelated to our proposal.
Response: We continue to believe that our policy to limit the
designation of potentially misvalued to those codes that are covered by
Medicare is appropriate, so that we focus our limited resources on
those services that have an impact on the Medicare program and its
beneficiaries. Therefore, we are not including CPT code 99174 on
[[Page 67576]]
our final list of potentially misvalued codes for CY 2015.
b. Potentially Misvalued Codes
(1) Review of High Expenditure Services Across Specialties With
Medicare Allowed Charges of $10,000,000 or More
We proposed 68 codes listed in Table 11 as potentially misvalued
codes under the newly established statutory category, ``codes that
account for the majority of spending under the physician fee
schedule.'' To develop this list, we identified the top 20 codes by
specialty (using the specialties used in Table 11) in terms of allowed
charges. We excluded those codes that we have reviewed since CY 2009,
those codes with fewer than $10 million in allowed charges, and E/M
services. E/M services were excluded for the same reason that we
excluded them in a similar review for CY 2012. The reason was explained
in the CY 2012 final rule with comment period (76 FR 73062 through
73065).
We stated that we believed that a review of the codes in Table 11
is warranted to assess changes in physician work and to update direct
PE inputs since these codes have not been reviewed since CY 2009 or
earlier. Furthermore, since these codes have significant impact on PFS
payment at the specialty level, a review of the relativity of the codes
is essential to ensure that the work and PE RVUs are appropriately
relative within the specialty and across specialties, as discussed
previously. For these reasons, we proposed the codes listed in Table 11
as potentially misvalued.
Table 11--Potentially Misvalued Codes Identified Through the High
Expenditure by Specialty Screen
------------------------------------------------------------------------
HCPCS Short descriptor
------------------------------------------------------------------------
11100........................... Biopsy skin lesion.
11101........................... Biopsy skin add-on.
11730........................... Removal of nail plate.
11750........................... Removal of nail bed.
14060........................... Tis trnfr e/n/e/l 10 sq cm/.
17110........................... Destruct b9 lesion 1-14.
31575........................... Diagnostic laryngoscopy.
31579........................... Diagnostic laryngoscopy.
36215........................... Place catheter in artery.
36475........................... Endovenous rf 1st vein.
36478........................... Endovenous laser 1st vein.
36870........................... Percut thrombect av fistula.
51720........................... Treatment of bladder lesion.
51728........................... Cystometrogram w/vp.
51798........................... Us urine capacity measure.
52000........................... Cystoscopy.
55700........................... Biopsy of prostate.
65855........................... Laser surgery of eye.
66821........................... After cataract laser surgery.
67228........................... Treatment of retinal lesion.
68761........................... Close tear duct opening.
71010........................... Chest x-ray 1 view frontal.
71020........................... Chest x-ray 2vw frontal&latl.
71260........................... Ct thorax w/dye.
73560........................... X-ray exam of knee 1 or 2.
73562........................... X-ray exam of knee 3.
73564........................... X-ray exam knee 4 or more.
74183........................... Mri abdomen w/o & w/dye.
75978........................... Repair venous blockage.
76536........................... Us exam of head and neck.
76700........................... Us exam abdom complete.
76770........................... Us exam abdo back wall comp.
76775........................... Us exam abdo back wall lim.
77263........................... Radiation therapy planning.
77334........................... Radiation treatment aid(s).
78452........................... Ht muscle image spect mult.
88185........................... Flowcytometry/tc add-on.
91110........................... Gi tract capsule endoscopy.
92136........................... Ophthalmic biometry.
92250........................... Eye exam with photos.
92557........................... Comprehensive hearing test.
93280........................... Pm device progr eval dual.
93306........................... Tte w/doppler complete.
93351........................... Stress tte complete.
93978........................... Vascular study.
94010........................... Breathing capacity test.
95004........................... Percut allergy skin tests.
95165........................... Antigen therapy services.
95957........................... Eeg digital analysis.
96101........................... Psycho testing by psych/phys.
96118........................... Neuropsych tst by psych/phys.
96372........................... Ther/proph/diag inj sc/im.
96375........................... Tx/pro/dx inj new drug addon.
96401........................... Chemo anti-neopl sq/im.
96409........................... Chemo iv push sngl drug.
97032........................... Electrical stimulation.
97035........................... Ultrasound therapy.
97110........................... Therapeutic exercises.
97112........................... Neuromuscular reeducation.
97113........................... Aquatic therapy/exercises.
97116........................... Gait training therapy.
97140........................... Manual therapy 1/> regions.
97530........................... Therapeutic activities.
G0283........................... Elec stim other than wound.
------------------------------------------------------------------------
Comment: Many commenters disagreed with the high expenditure screen
in principle, stating that the frequency with which a service is
furnished (and therefore the total expenditures) is not an indication
that the service is misvalued. Specifically, commenters explained that
many of the services are highly utilized because of the nature of the
Medicare beneficiary population, and not because there is abuse or
overutilization. Commenters asserted that the current misvalued code
screens can produce a redundant list of potentially misvalued codes
while failing to identify codes that are being incorrectly reported.
Another commenter urged CMS to work with the RUC to ensure that the
code lists identified by the misvalued code screens are accurate. A
commenter asked CMS to provide justification for including codes with
charges greater than $10 million on the potentially misvalued codes
list. Some commenters urged us to reconsider including particular
families of codes that were reviewed prior to 2009; others asked that
CMS exclude all codes that have been reviewed in the last 10 years; and
still others requested that we exclude codes that were bundled several
years ago. A commenter stated that the emphasis on codes with spending
of more than $10 million demonstrates an agenda to cut spending rather
than to ensure appropriate payment, and expressed concern that CMS was
simply nominating high value services. Commenters recommended that CMS
not finalize its proposed list of potentially misvalued codes, and
instead develop a more targeted list of codes that are likely to be
misvalued (not just potentially misvalued). Commenters wanted CMS to
exempt codes when there have not been fundamental changes in the way
the services are furnished or there is no indication that their values
are inaccurate, so that specialty societies do not have to go through
the work of reviewing them.
Several commenters questioned the statutory authority for CMS's
proposal. One commenter questioned CMS's authority under the relevant
statute to select potentially misvalued codes by specialty. The
commenter stated that identifying the top 20 codes by specialty in
terms of allowed charges does not appear to align with a direct reading
of the relevant statutory authority, which allows CMS to identify codes
that account for the majority of spending under the PFS, but does not
provide for the identification of codes by specialty. The commenter
said that a more direct interpretation of the statutory authority would
be to select codes based on allowed charges irrespective of specialty,
and then to narrow the universe of codes based upon the top codes in
terms of allowed charges. Another commenter believed the proposed
screen did not comport with the statutory selection criteria because
the majority or near majority of spending under the PFS is for
evaluation and management (E/M) codes, which CMS excluded from review.
The commenter said that if CMS believes that E/M services should not be
reviewed--a position the commenter said they would certainly
understand--then such a determination is sufficient to meet the
statutory mandate to review codes accounting for the majority of PFS
spending, and it would then be
[[Page 67577]]
appropriate for CMS and the RUC to focus efforts on other categories of
potentially misvalued codes. The commenter urged CMS at the very least
to develop a more targeted list of potentially misvalued services in
the category of codes accounting for the majority of PFS spending, and
to include codes that are likely to be misvalued, not just potentially
misvalued.
Response: Potentially misvalued code screens are intended to
identify codes that are possibly misvalued. By definition, these
screens do not assert that codes are certainly or even likely
misvalued. As we discussed in the CY 2012 PFS final rule with comment
period (76 FR 73056), the screens serve to focus our limited resources
on categories of codes where there is a high risk of significant
payment distortions. One goal is to avoid perpetuating payment for the
services at a rate that does not appropriately reflect the relative
resources involved in furnishing the service. In implementing this
statutory provision, we consider whether the codes meeting the
screening criteria have a significant impact on payment for all PFS
services due to the budget neutral nature of the PFS. That is, if codes
meeting the screening criteria are indeed misvalued, they would be
inappropriately impacting the relative values of all PFS services.
Addressing included codes therefore indirectly addresses other codes
that do not meet the screening criteria but are themselves misvalued
because high expenditure codes are misvalued. We agree with the
commenters that high program expenditures and high utilization have
varying causes and do not necessarily reflect misvalued codes. However,
we continue to believe that the high expenditure screen is nevertheless
an appropriate means of focusing our reviews, ensuring appropriate
relativity among PFS services, and identifying services that are either
over or undervalued. The high expenditure screen is likely to identify
misvalued codes, both directly and indirectly.
Regarding screening for codes by specialty, as we discussed above,
the included codes have significant impact on PFS payment at the
specialty level, therefore a review of the relativity of the codes is
essential to ensure that the work and PE RVUs are appropriately
relative within the specialty and across specialties. We mentioned in
the CY 2012 final rule with comment period how stakeholders have noted
that many of the services previously identified under the potentially
misvalued codes initiative were concentrated in certain specialties. To
develop a robust and representative list of codes for review, we
examine the highest PFS expenditure services by specialty and we
identify those codes that have not been recently reviewed (76 FR
73060).
Although we understand commenters' concerns that the screens can
produce redundant results, we note that we exempted codes that have
been reviewed since 2009 for this very reason. We believe that the
practice of medicine can change significantly over a 10-year period,
and disagree with commenters' suggestions that no changes would occur
over a 10-year period that would significantly affect a procedure's
valuation.
Regarding the exclusion of E/M services, we refer the commenters to
the extensive discussion in the CY 2012 PFS final rule with comment
period (76 FR 73060 through 73065). It is true that E/M services
account for significant volume under the PFS, but there are significant
issues with reviewing these codes as discussed in the CY 2012 final
rule with comment period, and as a result we did not propose to include
these codes as potentially misvalued.
Comment: Some commenters suggested other screens that could be used
to identify misvalued codes. In addition, even though our proposal only
relates to identifying potentially misvalued codes, some commenters
commented on our mechanisms for re-valuing misvalued codes.
Response: The only screen for which we made a proposal and sought
comments was the high expenditure screen. However, we will consider the
suggestions for other screens as we develop proposals in future years.
Similarly, our proposal only related to identifying potentially
misvalued codes and not how to re-value them if they were finalized as
potentially misvalued.
Comment: Several commenters requested that CMS postpone the review
of potentially misvalued codes until the revised process we proposed
for reviewing new, revised, and potentially misvalued codes is in
place.
Response: Although we believe that the revised process for
reviewing new, revised, and potentially misvalued codes will improve
the transparency of the PFS code review process, we do not believe it
is appropriate to postpone the review of all potentially misvalued
codes until the new process is implemented. We note that the codes
identified in this rule as potentially misvalued would be revalued
under the new process, which will be phased in starting for CY 2016 and
will apply for all codes revalued for CY 2017.
Comment: Commenters raised several codes that they believed should
not be included in the high expenditure screen for a variety of
reasons, for example if the code is related to other codes that were
recently reviewed and the utilization for the identified service is
expected to change significantly as a result of coding changes in the
family. Commenters also suggested that codes that have been referred to
the CPT Editorial Panel should be excluded from the potentially
misvalued codes list.
Response: We acknowledge commenters' suggestion that we exclude
particular codes from the screen, but since we are not finalizing a
particular list of codes for this screen in this final rule we are not
addressing these at this time. We note that we do not agree with
commenters that codes that have been referred to CPT by the RUC should
be excluded from the potentially misvalued list; rather, we believe
that only when these codes are either deleted or revised, and/or we
receive new RUC recommendations for re-valuing these codes, would it be
appropriate to remove these services from the list.
Comment: A commenter suggested that CMS's high expenditure screen
may not account for the fact that many radiology codes have already
gone through numerous five-year reviews; have well-established RVUs
that are included on the RUC's multispecialty point of comparison (MPC)
list; have been included in new, bundled codes; or have PE RVUs that
were affected by changes in clinical labor times or equipment
utilization assumption changes. The commenter also suggested that the
screens do not account for the value that patients receive in terms of
better, timelier diagnoses and avoidance of invasive procedures.
Response: We acknowledge that certain types of procedures have been
identified through multiple screens; however, we continue to believe
that it is appropriate to include most codes that are identified via
these screens and not to exclude codes simply because many other
procedures furnished by that specialty have already been reviewed. We
further note that the presence of codes on the MPC list makes the case
for their review more compelling, given their importance in ensuring
overall relativity throughout the PFS. With respect to changes in PE
RVUs, we note that cross-cutting policies that affect large numbers of
codes are aimed at ensuring overall relativity but do not address the
inputs associated with each procedure affected by the change. Finally,
a code's status as potentially misvalued does not imply
[[Page 67578]]
that the service itself is not of inherent value; rather, that its
valuation may be inaccurate in either direction.
After considering the comments received, as well as the other
proposals we are finalizing, we believe it is appropriate to finalize
the high expenditure screen as a tool to identify potentially misvalued
codes. However, given the resources required over the next several
years to revalue the services with global periods, we believe it is
best to concentrate our efforts on these valuations. Therefore, we are
not finalizing the codes identified through the high expenditure screen
as potentially misvalued at this time. Also, we are not responding to
comments at this time regarding whether particular codes should or
should not be included in the high expenditure code screen and
identified as potentially misvalued codes. We will re-run the high
expenditure screen at a future date, and will propose at that time the
specific set of codes to be reviewed that meet the high expenditure
criteria.
(2) Epidural Injection and Fluoroscopic Guidance--CPT Codes 62310,
62311, 62318, 62319, 77001, 77002 and 77003
For CY 2014, we established interim final rates for four epidural
injection procedures, CPT codes 62310 (Injection(s), of diagnostic or
therapeutic substance(s) (including anesthetic, antispasmodic, opioid,
steroid, other solution), not including neurolytic substances,
including needle or catheter placement, includes contrast for
localization when performed, epidural or subarachnoid; cervical or
thoracic), 62311 (Injection(s), of diagnostic or therapeutic
substance(s) (including anesthetic, antispasmodic, opioid, steroid,
other solution), not including neurolytic substances, including needle
or catheter placement, includes contrast for localization when
performed, epidural or subarachnoid; lumbar or sacral (caudal)), 62318
(Injection(s), including indwelling catheter placement, continuous
infusion or intermittent bolus, of diagnostic or therapeutic
substance(s) (including anesthetic, antispasmodic, opioid, steroid,
other solution), not including neurolytic substances, includes contrast
for localization when performed, epidural or subarachnoid; cervical or
thoracic) and 62319 (Injection(s), including indwelling catheter
placement, continuous infusion or intermittent bolus, of diagnostic or
therapeutic substance(s) (including anesthetic, antispasmodic, opioid,
steroid, other solution), not including neurolytic substances, includes
contrast for localization when performed, epidural or subarachnoid;
lumbar or sacral (caudal)). These interim final values resulted in CY
2014 payment reductions from the CY 2013 rates for all four procedures.
In the CY 2014 final rule with comment period (78 FR 74340), we
described in detail our interim valuation of these codes. We indicated
we established interim final work RVUs for these codes that were less
than those recommended by the RUC because we did not believe that the
RUC-recommended work RVUs accounted for the substantial decrease in
time it takes to furnish these services as reflected in the RUC survey
data for these four codes. Since the RUC provided no indication that
the intensity of the procedures had changed, we indicated that we
believed the work RVUs should reflect the reduction in time. We also
established interim final direct PE inputs for these four codes based
on the RUC-recommended inputs without any refinement. These
recommendations included the removal of the radiographic-fluoroscopy
room for CPT codes 62310, 62311, and 62318 and a portable C-arm for CPT
code 62319.
In response to the comments we received objecting to the CY 2014
interim final values for these codes, we looked at other injection
procedures. Other injection procedures, including some that commenters
recommended we use to value these epidural injection codes, include the
work and practice expenses of image guidance in the injection code. In
the proposed rule, we detailed many of these procedures, which include
the image guidance in the injection CPT code. Since our analysis of the
Medicare data and comments received on the CY 2014 final rule with
comment period indicated that these services are typically furnished
with imaging guidance, we believe it would be appropriate for the codes
to be bundled and the inputs for image guidance to be included in the
valuation of the epidural injection codes as it is for transforaminal
and paravertebral codes. We stated that we did not believe the epidural
injection codes can be appropriately valued without considering the
image guidance, and that bundling image guidance will help assure
relativity with other injection codes that include the image guidance.
To determine how to appropriately value resources for the combined
codes, we indicated that we believed more information is needed.
Accordingly, we proposed to include CPT codes 62310, 62311, 62318, and
62319 on the potentially misvalued code list so that we can obtain
information to value them with the image guidance included. In the
meantime, we proposed to use the CY 2013 input values for CPT codes
62310, 62311, 62318 and 62319 to value these codes for CY 2015.
Specifically, we proposed to use the CY 2013 work RVUs and work times.
Because it was clear that inputs that are specifically related to
image guidance, such as the radiographic fluoroscopic room, are
included in these proposed direct PE inputs for the epidural injection
codes, we believed allowing separate reporting of the image guidance
codes would overestimate the resources used in furnishing the overall
service. To avoid this situation, we also proposed to prohibit the
billing of image guidance codes in conjunction with these four epidural
injection codes. We stated that we believed our two-tiered proposal to
utilize CY 2013 input values for this family while prohibiting separate
billing of imaging guidance best ensures that appropriate
reimbursements continue to be made for these services, while we gather
additional data and input on the best way to value them through codes
that include both the injection and the image guidance.
Comment: The commenters did not object to identifying these codes
as potentially misvalued and generally agreed with our proposal to
revert to the 2013 inputs for CY 2015.
Response: We appreciate support for our proposal.
Comment: Several commenters agreed that it would be appropriate to
bundle the image guidance with the epidural procedures. Other
commenters suggested that we create both a bundled code and a stand-
alone epidural injection code.
Response: We appreciate commenters' support for our proposal to
bundle image guidance with the epidural procedures. As part of the
review process, consideration can be given to how to best implement
bundled codes.
Comment: Other commenters expressed concern that the bundling
approach CMS proposed to use until these codes are reviewed did not
incorporate the work or time for fluoroscopy. Some requested that we
add the payment for fluoroscopic guidance to the epidural injection
codes, as we have done in the past for facet joint injections and other
services. Commenters requested that we continue to allow the image
guidance codes to be separately billed until these services are
revalued. Another commenter suggested that it may be premature to
prohibit separate billing for image guidance, as there is considerable
variation on the
[[Page 67579]]
use of fluoroscopic guidance between codes within this family.
Response: We understand commenters' concerns about our proposal to
prohibit separate billing for image guidance, and note that these
concerns are part of the reason we are referring these codes to the RUC
as potentially misvalued. However, given that significant resources are
allocated to fluoroscopic guidance within the current injection codes,
we do not believe it is appropriate to continue to allow the image
guidance to be separately billed while we evaluate these epidural
injection codes as potentially misvalued services.
After considering comments received, we are finalizing CPT codes
62310, 62311, 62318, and 62319 as potentially misvalued, finalizing the
proposed RVUs for these services, and prohibiting separate billing of
image guidance in conjunction with these services.
(3) Neurostimulator Implantation (CPT Codes 64553 and 64555)
We proposed CPT codes 64553 (Percutaneous implantation of
neurostimulator electrode array; cranial nerve) and 64555 (Percutaneous
implantation of neurostimulator electrode array; peripheral nerve
(excludes sacral nerve)) as potentially misvalued after stakeholders
questioned whether the codes included the appropriate direct PE inputs
when furnished in the nonfacility setting.
Comment: A commenter encouraged CMS to include these codes on the
potentially misvalued code list to ensure that they are adequately
reimbursed in the nonfacility setting, while another commenter
disagreed that the work for CPT codes 64553 and 64555 needed to be
reviewed.
Response: In general, when a code is proposed as potentially
misvalued, unless we receive information that clearly demonstrates it
is not potentially misvalued, we finalize the code as potentially
misvalued. When we finalize a code as potentially misvalued, we then
review the inputs for the code. As a result of such review, inputs can
be adjusted either upward or downward.
We appreciate the support for our proposal expressed by some
commenters. Since the commenter opposing the addition of these codes to
the potentially misvalued code list did not provide justification for
its assertion that the work RVUs for CPT codes 64553 and 64555 did not
need to be reviewed, after consideration of comments received, we are
finalizing CPT codes 64553 and 64555 as potentially misvalued.
(4) Mammography (CPT Codes 77055, 77056, and 77057, and HCPCS Codes
G0202, G0204, and G0206)
Medicare currently pays for mammography services through both CPT
codes, (77055 (mammography; unilateral), 77056 (mammography; bilateral)
and 77057 (screening mammography, bilateral (2-view film study of each
breast)) and HCPCS G-codes, (G0202 (screening mammography, producing
direct digital image, bilateral, all views), G0204 (diagnostic
mammography, producing direct digital image, bilateral, all views), and
G0206 (diagnostic mammography, producing direct digital image,
unilateral, all views)). The CPT codes were designed to be used for
mammography regardless of whether film or digital technology is used.
However, for Medicare purposes, the HCPCS G-codes were created to
describe mammograms using digital technology in response to special
payment rules for digital mammography included in the Medicare Benefit
Improvements and Protection Act of 2000 (BIPA).
The RUC recommended that CMS update the direct PE inputs for all
imaging codes to reflect the migration from film-to-digital storage
technologies since digital storage is now typically used in imaging
services. Review of the Medicare data with regard to the application of
this policy to mammography confirmed that virtually all mammography is
now digital. As a result, we proposed that CPT codes 77055, 77056, and
77057 be used to report mammography regardless of whether film or
digital technology is used, and to delete the HCPCS G-codes G0202,
G0204, and G0206. We proposed to establish values for the CPT codes by
crosswalking the values established for the digital mammography G-codes
for CY 2015. (See section II.B. of this final rule with comment period
for more discussion of this policy.) In addition, since the G-code
values have not been evaluated since they were created in CY 2002 we
proposed to include CPT codes 77055, 77056, and 77057 on the list of
potentially misvalued codes.
Comment: With regard to whether the mammography codes should be
included on the potentially misvalued codes list, commenters had
differing opinions. One commenter stated that the work RVUs for digital
mammography are the same as those for analog mammography, and
maintained that the BIPA-directed payment for digital mammography of
1.5 times the TC of the analog mammography codes appropriately captures
the practice expense resources required for digital mammography.
Another commenter stated that digital mammography rates resulted from a
statutory construct and do not reflect the actual costs of the digital
resources necessary to furnish the services. One commenter noted that
moving from the non-resource-based values to resource-based values will
result in a significant reduction to the valuation of these services,
and that this reduction will result from the resource-based PE
methodology, not from the RUC review. Another commenter indicated that
the RUC should not survey these codes, but requested that if the RUC
does survey these codes, they should not do so until after CMS
finalizes the new breast tomosynthesis codes (3D mammography) and film-
to-digital transition. Another commenter indicated that CMS needed to
consider that three-dimensional (3D) mammography codes involve
additional resources over the two-dimensional (2D) mammography codes. A
commenter suggested that this proposal fails to take into account the
increasing use of tomography.
Response: The commenters' disagreement about whether these codes
are misvalued would suggest that a review is warranted. Given that more
than a decade has passed since these services were reviewed, we
continue to believe that it is appropriate to review the work RVUs for
these services. By including these codes on the potentially misvalued
code list, we will have information to determine whether the current
values are still appropriate. Finally, we anticipate that the survey
results for the mammography codes will reflect the equipment that is
typically used. We note that until these services are reviewed, we do
not have adequate information to respond to the suggestion that the
valuation for these services will be significantly reduced. However, we
do acknowledge that the PE methodology is not intended to account for
the actual costs in furnishing a service; rather, it is required to
account for the relative resources in furnishing that service. We also
note that there are new CPT codes for reporting mammography using
tomosynthesis and we have RUC recommendations for these codes. We
believe it is most appropriate to value the mammography code family
together, and receipt of RUC recommendations on the other mammography
codes will assist us in our review. Accordingly, we are including all
mammography codes except those newly created for tomosynthesis on the
potentially misvalued code list.
Comment: Although commenters agreed with our assessment that
digital
[[Page 67580]]
technology has replaced analog mammography as typical, not all agreed
that it was appropriate to delete G-codes and use the CPT codes. One
commenter supported the deletion of the G-codes. Other commenters
suggested that deletion of the G-codes was unnecessary. Another
commenter stated that the coding system frequently reflects differences
in approach and technique, and that the equipment for analog and
digital mammography are different enough to warrant separate reporting
so we should not delete the G-codes. Some who supported continuation of
the G-codes asked us to delay implementation as they were concerned
that other payers would not have time to update their requirements by
January 1, 2015. Another commenter applauded CMS's decision to delete
the G-codes.
Response: In further consideration of this proposal, we discovered
that while the CPT codes for diagnostic mammography apply to
mammography, whether film or digital technology is used, the descriptor
for the screening mammography CPT code specifically refers to film. In
light of this and that fact that we anticipate revaluing these codes
when we have the benefit of RUC recommendations for all codes in the
family, we believe it is appropriate to continue to recognize both the
CPT codes and the G-codes for mammography for CY 2015, as we consider
appropriate valuations now that digital mammography is typical.
Therefore, we are not finalizing our proposal to delete the G-codes. We
are, however, making a change in the descriptors to make clear that the
G0202, G0204, and G0206 are specific to 2-D mammography. These codes
are to be reported with either G0279 or CPT code 77063 when mammography
is furnished using 3-D mammography.
Comment: A commenter requested that CMS ensure reimbursement rates
remain adequate to protect access for Medicare beneficiaries. Another
commenter suggested that these changes could result in barriers to
access for Medicare beneficiaries.
Response: We are strongly supportive of access to mammography for
Medicare beneficiaries. As stated elsewhere in this final rule with
comment period, we believe that accurate valuation incentivizes
appropriate utilization of services.
After consideration of public comments, we are modifying our
proposal as follows: We will include CPT codes 77055, 77056, and 77057
on the potentially misvalued codes list; we will continue to recognize
G0202, G0204 and G0206 but will modify the descriptors so that they are
specific to 2-D digital mammography, and instead of using the digital
values we will continue to use the CY 2014 work and PE RVUs to value
the mammography CPT codes. We expect that the CPT Editorial Panel will
consider the descriptor for screening mammography, CPT code 77057, in
light of the prevailing use of digital mammography.
(5) Abdominal Aortic Aneurysm Ultrasound Screening (G0389)
When Medicare began paying for abdominal aortic aneurysm (AAA)
ultrasound screening, HCPCS code G0389 (Ultrasound, B-scan and/or real
time with image documentation; for abdominal aortic aneurysm (AAA)
screening) in CY 2007, we set the RVUs at the same level as CPT code
76775 (Ultrasound, retroperitoneal (e.g., renal, aorta, nodes), B-scan
and/or real time with image documentation; limited). We noted in the CY
2007 final rule with comment period that CPT code 76775 was used to
report the service when furnished as a diagnostic test and that we
believed the service reflected by G0389 used equivalent resources and
work intensity to those contained in CPT code 76775 (71 FR 69664
through 69665).
In the CY 2014 proposed rule, we proposed to replace the ultrasound
room included as a direct PE input for CPT code 76775 with a portable
ultrasound unit based upon a RUC recommendation. Since the RVUs for
G0389 were crosswalked from CPT code 76775, the proposed PE RVUs for
G0389 in the CY 2014 proposed rule were reduced as a result of this
change. However, we did not discuss the applicability of this change to
G0389 in the preamble to the proposed rule, and did not receive any
comments on G0389 in response to the proposed rule. We finalized the
change to CPT code 76775 in the CY 2014 final rule with comment period
and as a result, the PE RVUs for G0389 were also reduced.
We proposed G0389 as potentially misvalued in response to a
stakeholder suggestion that the reduction in the RVUs for G0389 did not
accurately reflect the resources involved in furnishing the service. We
sought recommendations from the public and other stakeholders,
including the RUC, regarding the appropriate work RVU, time, direct PE
input, and malpractice risk factors that reflect the typical resources
involved in furnishing the service.
Until we receive the information needed to re-value this service,
we proposed to value this code using the same work and PE RVUs we used
for CY 2013. We proposed MP RVUs based on the five-year review update
process as described in section II.C of this final rule with comment
period. We stated that we believe this valuation would ameliorate the
effect of the CY 2014 reduction that resulted from the RVUs for G0389
being tied to those for another code while we assess appropriate
valuation through our usual methodologies. Accordingly, we proposed a
work RVU of 0.58 for G0389 and proposed to assign the 2013 PE RVUs
until this procedure is reviewed.
Comment: Many commenters supported our proposal to include this
service on the potentially misvalued codes list. Some commenters agreed
that the crosswalk used to set rates for this service does not appear
to be appropriate at this time, whether due to changes in the way the
service is provided, or because the specialty mix has shifted, and
suggested that it would be appropriate to establish a Category I CPT
code for this service. Another commenter suggested that CMS consider
crosswalking G0389 to CPT code 93979 (Duplex scan of aorta, inferior
vena cava, iliac vasculature, or bypass grafts; unilateral or limited
study). One commenter believed it was unnecessary to survey this code,
but recommended that we instead maintain the general ultrasound room as
a direct PE input and 2013 PE RVUs.
Response: We appreciate commenters' support for our proposal to
include G0389 on the potentially misvalued codes list and are
finalizing this proposal. We are finalizing this code as potentially
misvalued in large part because we are unsure of the correct valuation.
Therefore, we believe it is most appropriate to retain the 2013 inputs
until we receive new recommendations, rather than making another change
or retaining these inputs indefinitely as commenters suggested.
After consideration of comments received, we are finalizing our
proposal to add G0389 to the potentially misvalued codes list, and to
maintain the 2013 work and PE RVUs while we complete our review of the
code. The MP RVUs will be calculated as discussion in section II.C. of
this rule.
(6) Prostate Biopsy Codes--(HCPCS Codes G0416, G0417, G0418, and G0419)
For CY 2014, we modified the code descriptors of G0416 through
G0419 so that these codes could be used for any method of prostate
needle biopsy services, rather than only for prostate saturation
biopsies. The CY 2014 descriptions are:
[[Page 67581]]
G0416 (Surgical pathology, gross and microscopic
examination for prostate needle biopsies, any method; 10-20 specimens).
G0417 (Surgical pathology, gross and microscopic
examination for prostate needle biopsies, any method; 21-40 specimens).
G0418 (Surgical pathology, gross and microscopic
examination for prostate needle biopsies, any method; 41-60 specimens).
G0419 (Surgical pathology, gross and microscopic
examination for prostate needle biopsies, any method; greater than 60
specimens).
Subsequently, we have discussed prostate biopsies with
stakeholders, and reviewed medical literature and Medicare claims data
in considering how best to code and value prostate biopsy pathology
services. After considering these discussions and information, we
believed it would be appropriate to use only one code to report
prostate biopsy pathology services. Therefore, we proposed to revise
the descriptor for G0416 to define the service regardless of the number
of specimens, and to delete codes G0417, G0418, and G0419. We believe
that using G0416 to report all prostate biopsy pathology services,
regardless of the number of specimens, would simplify the coding and
mitigate overutilization incentives. Given the infrequency with which
G0417, G0418, and G0419 are used, we did not believe that this was a
significant change.
Based on our review of medical literature and examination of
Medicare claims data, we indicated that we believe that the typical
number of specimens evaluated for prostate biopsies is between 10 and
12. Since G0416 currently is used for between 10 and 12 specimens, we
proposed to use the existing values for G0416 for CY 2015, since the
RVUs for this service were established based on similar assumptions.
In addition, we proposed G0416 as a potentially misvalued code for
CY 2015 and sought public comment on the appropriate work RVUs, work
time, and direct PE inputs.
Comment: One commenter supported the elimination of the G-codes as
a means of simplifying coding requirements, but other commenters
opposed our proposal to consolidate the coding into G0416, disagreeing
that this would help establish ``straightforward coding and maintain
accurate payment'' as suggested in the proposed rule. Some commenters
suggested that we retain the current codes so that biopsy procedures
requiring more than 10 specimens can be reimbursed accurately, and
indicated that consolidating the coding would further confuse
physicians and their staff who have not yet adapted to the CY 2014
coding changes for these G-codes. Other commenters asserted that these
changes threaten to undermine access to high quality pathology
services. Commenters also stated that the decision to furnish more
extensive pathological analysis is not at the discretion of the
pathologist, and the pathologist should not be penalized when he or she
receives more cores to analyze.
With respect to our proposing G0416 as potentially misvalued,
commenters stated that the recent change to these codes has already
been confusing and suggests that there is not a clear understanding of
what these codes represent, thus making an assessment of their
valuation difficult. Commenters further stated that it is unreasonable
to consider this a misvalued code when the payment is already 30
percent below what they think it should be, and that CMS has failed to
provide justification for why it is potentially misvalued.
The RUC and others suggested that it would be most accurate to
utilize CPT code 88305 (Level IV--surgical pathology, gross and
microscopic examination) for the reporting of prostate biopsies and to
allow the reporting of multiple units. Given the additional granularity
and scrutiny given to CPT code 88305 in the CY 2014 final rule, the
commenters indicated that they believe that the agency's intent to
establish straightforward coding and accurate payment for these
services would be realized with this approach.
Response: Given that the typical analysis of prostate biopsy
specimens differs significantly from the typical analyses reported
using CPT code 88305, as regards the number of blocks used to process
the specimen and thus the amount of work involved, we believe that by
distinguishing prostate biopsies from other types of biopsies results
in more accurate pricing for prostate biopsies. Since CPT code 88305
was revalued with the understanding that prostate biopsies are billed
separately, we believe that allowing CPT code 88305 to be reported in
multiple units for prostate biopsies would account for significantly
more resources than is appropriate. With respect to the concern about
higher numbers of specimens, we note that our claims data on the G-
codes shows that the vast majority of the claims used G0416, rather
than any of the G-codes for greater numbers of specimens.
After consideration of comments received, we are finalizing our
proposal to include G0416 on the potentially misvalued codes list, to
modify the descriptor to reflect all prostate biopsies, and to maintain
the current value until we receive and review information and
recommendations from the RUC. We are also finalizing our proposal to
delete codes G0417, G0418, and G0419.
(7) Obesity Behavioral Group Counseling--GXXX2 and GXXX3
Pursuant to section 1861(ddd) of the Act, we added coverage for a
new preventive benefit, Intensive Behavioral Therapy for Obesity,
effective November 29, 2011, and created HCPCS code G0447 (Face-to-face
behavioral counseling for obesity, 15 minutes) for reporting and
payment of individual behavioral counseling for obesity. Coverage
requirements specific to this service are delineated in the Medicare
National Coverage Determinations Manual, Pub. 100-03, Chapter 1,
Section 210, available at https://www.cms.gov/manuals/downloads/ncd103c1_Part4.pdf.
It was brought to our attention that behavioral counseling for
obesity is sometimes furnished in group sessions, and questions were
raised about whether group sessions could be billed using HCPCS code
G0447. To improve payment accuracy, we proposed to create two new HCPCS
codes for the reporting and payment of group behavioral counseling for
obesity. Specifically, we proposed to create GXXX2 (Face-to-face
behavioral counseling for obesity, group (2-4), 30 minutes) and GXXX3
(Face-to-face behavioral counseling for obesity, group (5-10), 30
minutes). We indicated that the coverage requirements for these
services would remain in place, as described in the National Coverage
Determination for Intensive Behavioral Therapy for Obesity cited above.
The practitioner furnishing these services would report the relevant
group code for each beneficiary participating in a group therapy
session.
Since we believed that the face-to-face behavioral counseling for
obesity services described by GXXX2 and GXXX3 would require similar per
minute work and intensity as HCPCS code G0447, we proposed work RVUs of
0.23 and 0.10 for HCPCS codes GXXX2 and GXXX3, with work times of 8
minutes and 3 minutes respectively. Since the services described by
GXXX2 and GXXX3 would be billed per beneficiary receiving the service,
the work RVUs and work time that we proposed for these codes were based
upon the assumed typical number of beneficiaries per session, 4 and 9,
respectively. Accordingly, we proposed
[[Page 67582]]
a work RVU of 0.23 with a work time of 8 minutes for GXXX2 and a work
RVU of 0.10 with a work time of 3 minutes for GXXX3. We proposed to use
the direct PE inputs for GXXX2 and GXXX3 currently included for G0447
prorated to account for the differences in time and number of
beneficiaries, and to crosswalk the malpractice risk factor from HCPCS
code G0447 to both HCPCS codes GXXX2 and GXXX3, as we believe the same
specialty mix will furnish these services. We requested public comment
on the proposed values for HCPCS codes GXXX2 and GXXX3.
Comment: Commenters generally supported our proposal to establish a
separate payment mechanism for obesity behavioral group counseling
services, but raised several concerns regarding the coding structure
and valuation of these services. Commenters stated that the work times
were inaccurate, requested that the service be valued based on a
smaller number of typical group participants, and questioned the need
for two G-codes when group counseling services under the PFS are
generally billed with a single G-code. A commenter also stated that the
lower payment for larger groups will create disincentives for
furnishing this service except when there is a full 10-person group,
which could limit access. Commenters suggested that CMS only finalize a
single G-code for group counseling for intensive behavioral therapy for
obesity, and crosswalk the work RVU and work time for this service from
the Medical Nutrition Therapy (MNT) group code.
Response: We appreciate commenters' support for our proposal to
provide new codes for group obesity counseling services. After
reviewing the comments, we agree that it is reasonable to create a
single code for group obesity counseling and crosswalk the work RVU and
work time from the MNT group code. The individual code for intensive
obesity behavioral therapy and the individual MNT code are valued the
same, so in the absence of evidence that group composition is
different, we believe it makes sense to use the same values. Therefore,
we will crosswalk the work RVU of 0.25 and the work time of 10 minutes
to a single new G-code for group obesity counseling, G0473 (Face-to-
face behavioral counseling for obesity, group (2-10), 30 minutes).
4. Improving the Valuation and Coding of the Global Package
a. Overview
Since the inception of the PFS, we have valued and paid for certain
services, such as surgery, as part of global packages that include the
procedure and the services typically furnished in the periods
immediately before and after the procedure (56 FR 59502). For each of
these codes (usually referred to as global surgery codes), we establish
a single PFS payment that includes payment for particular services that
we assume to be typically furnished during the established global
period.
There are three primary categories of global packages that are
labeled based on the number of post-operative days included in the
global period: 0-day; 10-day; and 90-day. The 0-day global codes
include the surgical procedure and the pre-operative and post-operative
physicians' services on the day of the procedure, including visits
related to the service. The 10-day global codes include these services
and, in addition, visits related to the procedure during the 10 days
following the procedure. The 90-day global codes include the same
services as the 0-day global codes plus the pre-operative services
furnished one day prior to the procedure and post-operative services
during the 90 days immediately following the day of the procedure.
Section 40.1 of the Claims Processing Manual (Pub. 100-04, Chapter
12 Physician/Nonphysician Practitioners) defines the global surgical
package to include the following services when furnished during the
global period:
Preoperative Visits--Preoperative visits after the
decision is made to operate beginning with the day before the day of
surgery for major procedures and the day of surgery for minor
procedures;
Intra-operative Services--Intra-operative services that
are normally a usual and necessary part of a surgical procedure;
Complications Following Surgery--All additional medical or
surgical services required of the surgeon during the postoperative
period of the surgery because of complications that do not require
additional trips to the operating room;
Postoperative Visits--Follow-up visits during the
postoperative period of the surgery that are related to recovery from
the surgery;
Postsurgical Pain Management--By the surgeon;
Supplies--Except for those identified as exclusions; and
Miscellaneous Services--Items such as dressing changes;
local incisional care; removal of operative pack; removal of cutaneous
sutures and staples, lines, wires, tubes, drains, casts, and splints;
insertion, irrigation and removal of urinary catheters, routine
peripheral intravenous lines, nasogastric and rectal tubes; and changes
and removal of tracheostomy tubes.
b. Concerns With the 10- and 90-Day Global Packages
CMS supports bundled payments as a mechanism to incentivize high-
quality, efficient care. Although on the surface, the PFS global codes
appear to function as bundled payments similar to those Medicare uses
to make single payments for multiple services to hospitals under the
inpatient and outpatient prospective payment systems, the practical
reality is that these global codes function significantly differently
than other bundled payments. First, the global surgical codes were
established several decades ago when surgical follow-up care was far
more homogenous than today. Today, there is more diversity in the kind
of procedures covered by global periods, the settings in which the
procedures and the follow-up care are furnished, the health care
delivery system and business arrangements used by Medicare
practitioners, and the care needs of Medicare beneficiaries. Despite
these changes, the basic structures of the global surgery packages are
the same as the packages that existed prior to the creation of the
resource-based relative value system in 1992. Another significant
difference between this and other typical models of bundled payments is
that the payment rates for the global surgery packages are not updated
regularly based on any reporting of the actual costs of patient care.
For example, the hospital inpatient and outpatient prospective payment
systems (the IPPS and OPPS, respectively) derive payment rates from
hospital cost and charge data reported through annual Medicare hospital
cost reports and the most recent year of claims data available for an
inpatient stay or primary outpatient service.
Because payment rates are based on consistently updated data, over
time, payment rates adjust to reflect the average resource costs of
current practice. Similarly, many of the new demonstration and
innovation models track costs and make adjustments to payments. Another
significant difference is that payment for the PFS global packages
relies on valuing the combined services together. This means that there
are no separate PFS values established for the procedures or the
follow-up care, making it difficult to estimate the costs of the
individual global code component services.
In the following paragraphs, we address a series of concerns
regarding the accuracy of payment for 10- and 90-day global codes,
including: The fundamental difficulties in establishing
[[Page 67583]]
appropriate relative values for these packages, the potential
inaccuracies in the current information used to price global codes, the
limitations on appropriate pricing in the future, the potential for
global packages to create unwarranted payment differentials among
specialties, the possibility that the current codes are incompatible
with current medical practice, and the potential for these codes to
present obstacles to the adoption of new payment models.
Concerns such as these commonly arise when developing payment
mechanisms, for example fee-for-service payment rates, single payments
for multiple services, or payment for episodes of care over a period of
time. However, in the case of the post-operative portion of the 10- and
90-day global codes, we believe that together with certain unique
aspects of PFS rate setting methodology, these concerns create
substantial barriers to accurate valuation of these services relative
to other PFS services.
(1) Fundamental Limitations in the Appropriate Valuation of the Global
Packages With Post-Operative Days
In general, we face many challenges in valuing PFS services as
accurately as possible. However, the unique nature of global surgery
packages with 10- and 90-day post-operative periods presents additional
challenges distinct from those presented in valuing other PFS services.
Our valuation methodology for PFS services generally relies on
assumptions regarding the resources involved in furnishing the
``typical case'' for each individual service unlike other payment
systems that rely on actual data on the costs of furnishing services.
Consistent with this valuation methodology, the RVUs for a global code
should reflect the typical number and level of E/M services furnished
in connection with the procedure. However, it is much easier to
maintain relativity among services that are valued on this basis when
each of the services is described by codes of similar unit sizes. In
other words, because codes with long post-operative periods include
such a large number of services, any variations between the ``typical''
resource costs used to value the service and the actual resource costs
associated with particular services are multiplied. The effects of this
problem can be two-fold, skewing the accuracy of both the RVUs for
individual global codes and the Medicare payment made to individual
practitioners. The RVUs of the individual global service codes are
skewed whenever there is any inaccuracy in the assumption of the
typical number or kind of services in the post-operative periods. This
inaccuracy has a greater impact than inaccuracies in assumptions for
non-global codes because it affects a greater number of service units
over a period of time than for individually priced services.
Furthermore, in contrast to prospective payment systems, such
inaccuracies under the PFS are not corrected over time through a
ratesetting process that makes year-to-year adjustments based on data
on actual costs. For example, if a 90-day global code is valued based
on an assumption or survey response that ten post-operative visits is
typical, but practitioners reporting the code in fact typically only
furnish six visits, then the resource assumptions are overestimated by
the value of the four visits multiplied by the number of the times the
procedure code is reported. In contrast, when our assumptions are
incorrect about the typical resources involved in furnishing a PFS code
that describes a single service, any inaccuracy in the RVUs is limited
to the difference between the resource costs assumed for the typical
service and the actual resource costs in furnishing one individual
service. Such a variation between the assumptions used in calculating
payment rates and the actual resource costs could be corrected if the
payments for packaged services were updated regularly using data on
actual services furnished. Medicare's prospective payment systems have
more mechanisms in place than the PFS does to adjust over time for such
variation To make adjustments to the RVUs to account for inaccurate
assumptions under the current PFS methodology, the global surgery code
would need to be identified as potentially misvalued, survey data would
have to reflect an accurate account of the number and level of typical
post-operative visits, and we (with or without a corresponding
recommendation from the RUC or others) would have to implement a change
in RVUs based on the change in the number and level of visits to
reflect the typical service.
These amplified inaccuracies may also occur whenever Medicare pays
an individual practitioner reporting a 10- or 90-day global code.
Practitioners may furnish a wide range of post-operative services to
individual Medicare beneficiaries, depending on individual patient
needs, changes in medical practice, and dynamic business models. Due to
the way the 10- and 90-day global codes are constructed, the number and
level of services included for purposes of calculating the payment for
these services may vary greatly from the number and level of services
that are actually furnished in any particular case. In contrast, the
variation between the ``typical'' and the actual resource cost for the
practitioner reporting an individually valued PFS service is
constrained because the practitioner is only reporting and being paid
for a specific service furnished on a particular date.
For most PFS services, any difference between the ``typical'' case
on which RVUs are based and the actual case for a particular service is
limited to the variation between the resources assumed to be involved
in furnishing the typical case and the actual resources involved in
furnishing the single specific service. When the global surgical
package includes more or a higher level of E/M services than are
actually furnished in the typical post-operative period, the Medicare
payment is based on an overestimate of the quantity or kind of services
furnished, not merely an overestimation of the resources involved in
furnishing an individual service. The converse is true if the RVUs for
the global surgical package are based on fewer or a lower level of
services than are typically furnished for a particular code.
(2) Questions Regarding Accuracy of Current Assumptions
In previous rulemaking (77 FR 68911 through 68913), we acknowledged
evidence suggesting that the values included in the post-operative
period for global codes may not reflect the typical number and level of
post-operative E/M visits actually furnished.
In 2005, the OIG examined whether global surgical packages are
appropriately valued. In its report on eye and ocular surgeries,
``National Review of Evaluation and Management Services Included in Eye
and Ocular Adnexa Global Surgery Fees for Calendar Year 2005'' (A-05-
07-00077), the OIG reviewed a sample of 300 eye and ocular surgeries,
and counted the actual number of face-to-face services recorded in the
patients' medical records to establish whether and, if so, how many
post-operative E/M services were furnished by the surgeons. For about
two-thirds of the claims sampled by the OIG, surgeons furnished fewer
E/M services in the post-operative period than were included in the
global surgical package payment for each procedure. A small percentage
of the surgeons furnished more E/M services than were included in the
global surgical package payment. The OIG identified the number of face-
to-face services recorded in the medical record, but did not review the
medical necessity
[[Page 67584]]
of the surgeries or the related E/M services. The OIG concluded that
the RVUs for these global surgical packages are too high because they
include a higher number of E/M services than typically are furnished
within the global period for the reviewed procedures.
Following that report, the OIG continued to investigate E/M
services furnished during global surgical periods. In May 2012, the OIG
published a report entitled ``Musculoskeletal Global Surgery Fees Often
Did Not Reflect the Number of Evaluation and Management Services
Provided'' (A-05-09-00053). For this investigation, the OIG sampled 300
musculoskeletal global surgeries and again found that, for the majority
of sampled surgeries, physicians furnished fewer E/M services than were
included as part of the global period payment for that service. Once
again, a small percentage of surgeons furnished more E/M services than
were included in the global surgical package payment. The OIG concluded
that the RVUs for these global surgical packages are too high because
they include a higher number of E/M services than typically are
furnished within the global period for the reviewed procedures.
In both reports, the OIG recommended that we adjust the number of
E/M services identified with the studied global surgical payments to
reflect the number of E/M services that are actually being furnished.
However, since it is not necessary under our current global surgery
payment policy for a surgeon to report the individual E/M services
actually furnished during the global surgical period, we do not have
objective data upon which to assess whether the RVUs for global period
surgical services reflect the typical number or level of E/M services
that are furnished. In the CY 2013 PFS proposed rule (77 FR 44738), we
previously sought public comments on collecting these data. As
summarized in the CY 2013 PFS final rule (77 FR 68913) we did not
discover a consensus among stakeholders regarding either the most
appropriate means to gather the data, or the need for, or the
appropriateness of using such data in valuing these services. In
response to our comment solicitation, some commenters urged us to
accept the RUC survey data as accurate in spite of the OIG reports and
other concerns that have been expressed regarding whether the visits
included in the global periods reflected the typical case. Others
suggested that we should conduct new surveys using the RUC approach or
that we should mine hospital data to identify the typical number of
visits furnished. Some comments suggested eliminating the 10- and 90-
day global codes.
(3) Limitations on Appropriate Future Valuations of 10- and 90-Day
Global Codes
Historically, our attempts to adjust RVUs for global services based
on changes in the typical resource costs (especially with regard to
site of service assumptions or changes to the number of post-surgery
visits) have been difficult and controversial. At least in part, this
is because the relationship between the work RVUs for the 10- and 90-
day global codes (which includes the work RVU associated with the
procedure itself) and the number of included post-operative visits in
the existing values is not always clear. Some services with global
periods have been valued by adding the work RVU of the surgical
procedure and all pre- and post-operative E/M services included in the
global period. However, in other cases, as many stakeholders have
noted, the total work RVUs for surgical procedures and post-operative
visits in global periods are estimated as a single value without any
explicit correlation to the time and intensity values for the
individual service components. Although we would welcome more objective
information to improve our determination of the ``typical'' case, we
believe that even if we engaged in the collection of better data on the
number and level of E/M services typically furnished during the global
periods for global surgery services, the valuation of individual codes
with post-operative periods would not be straightforward. Furthermore,
we believe it would be important to frequently update the data on the
number and level of visits furnished during the post-operative periods
in order to account for any changes in the patient population, medical
practice, or business arrangements. Practitioners paid through the PFS
do not report such data.
(4) Unwarranted Payment Disparities
Subsequent to our last comment solicitation regarding the valuation
of the post-operative periods (77 FR 68911 through 68913), some
stakeholders have raised concerns that global surgery packages
contribute to unwarranted payment disparities between practitioners who
do and do not furnish these services. These stakeholders have addressed
several ways the 10- and 90-day global packages may contribute to
unwarranted payment disparities.
The stakeholders noted that, through the global surgery packages,
Medicare pays practitioners who furnish E/M services during post-
surgery periods regardless of whether the services are actually
furnished, while practitioners who do not furnish global procedures
with post-operative visits are only paid for E/M services that are
actually furnished. In some cases, it is possible that the practitioner
furnishing the global surgery procedure may not furnish any post-
operative visits. Although we have policies to address the situation
when post-operative care is transferred from one practitioner to
another, the beneficiary might simply choose to seek care from another
practitioner without a formal transfer of care. The other practitioner
would then bill Medicare separately for E/M services for which payment
was included in the global payment to the original practitioner. Those
services would not have been separately billable if furnished by the
original practitioner.
These circumstances can lead to unwarranted payment differences,
allowing some practitioners to receive payment for fewer services than
reflected in the Medicare payment. Practitioners who do not furnish
global surgery services bill and are paid only for each individual
service furnished. When global surgery values are based on inaccurate
assumptions about the typical services furnished in the post-operative
periods, these payment disparities can contribute to differences in
aggregate RVUs across specialties. Since the RVUs are intended to
reflect differences in the relative resource costs involved in
furnishing a service, any disparity between assumed and actual costs
results not only in paying some practitioners for some services that
are not furnished, it also skews relativity between specialties.
Stakeholders have also pointed out that payment disparities can
arise because E/M services reflected in global periods generally
include higher PE values than the same services when billed separately.
The difference in PE values between separately billed visits and those
included in global packages result primarily from two factors that are
both inherent in the PFS pricing methodology.
First, there is a different mix of PE inputs (clinical labor/
supplies/equipment) included in the direct PE inputs for a global
period E/M service and a separately billed E/M service. For example,
the clinical labor inputs for separately reportable E/M codes includes
a staff blend listed as ``RN/LPN/MTA'' (L037D) and priced at $0.37 per
minute. Instead of this input, some codes with post-operative visits
include the staff type ``RN'' (L051A) priced at a higher rate of $0.51
per minute. For these codes, the higher resource cost
[[Page 67585]]
may accurately reflect the typical resource costs associated with those
particular visits. However, the different direct PE inputs may drive
unwarranted payment disparities among specialties who report global
surgery codes with post-operative periods and those that do not. The
only way to correct these potential discrepancies under the current
system, which result from the specialty-based differences in resource
costs, would be to include standard direct PE inputs for these services
regardless of whether or not the standard inputs are typical for the
specialties furnishing the services.
Second, the indirect PE allocated to the E/M visits included in
global surgery codes is higher than that allocated to separately
furnished E/M visits. This occurs because the range of specialties
furnishing a particular global service is generally not as broad as the
range of specialties that report separate individual E/M services.
Since the specialty mix for a service is a key factor in determining
the allocation of indirect PE to each code, a higher amount of indirect
PE can be allocated to the E/M services that are valued as part of the
global surgery codes than to the individual E/M codes. Practitioners
who use E/M codes to report visits separately are paid based on PE RVUs
that reflect the amount of indirect PE allocated across a wide range of
specialties, which has the tendency to lower the amount of indirect PE.
For practitioners who are paid for visits primarily through post-
operative periods, indirect PE is generally allocated with greater
specificity. Two significant steps would be required to alleviate the
impact of this disparity. First, we would have to identify the exact
mathematical relationship between the work RVU and the number and level
of post-operative visits for each global code; and second, we would
have to propose a significant alteration of the PE methodology in order
to allocate indirect PE that does not correlate to the specialties
reporting the code in the Medicare claims data.
Furthermore, stakeholders have pointed out that the PE RVUs for
codes with 10- or 90-day post-operative periods reflect the assumption
that all outpatient visits occur in the higher-paid non-facility office
setting, when many of these visits are likely to be furnished in
provider-based departments, which would be paid at the lower, PFS
facility rate if they were billable separately. As we note elsewhere in
this final rule with comment period, we do not have data on the volume
of physicians' services furnished in provider-based departments, but
public information suggests that it is not insignificant and that it is
growing. When these services are paid as part of a global package,
there is no adjustment made based on the site of service. Therefore,
even though the PFS payment for services furnished in post-operative
global periods might include clinical labor, disposable supply, and
medical equipment costs (and additional indirect PE allocation) that
are incurred by the facility and not the practitioner reporting the
service, the RVUs for global codes reflect all of these costs
associated with the visits.
(5) Incompatibility of Current Packages With Current Practice and
Unreliability of RVUs for Use in New Payment Models
In addition to these issues, the 10- and 90-day global periods
reflect a long-established but no longer exclusive model of post-
operative care that assumes the same practitioner who furnishes the
procedure typically furnishes the follow-up visits related to that
procedure. In many cases, we believe that models of post-operative care
are increasingly heterogeneous, particularly given the overall shift of
patient care to larger practices or team-based environments.
We believe that RVUs used to establish PFS payments are likely to
serve as critical building blocks to developing, testing, and
implementing a number of new payment models, including those that focus
on bundled payments to practitioners or payments for episodes of care.
Therefore, we believe it is critical for us to ensure that the PFS RVUs
accurately reflect the resource costs for individual PFS services
instead of reflecting potentially skewed assumptions regarding the
number of services furnished over a long period of time in the
``typical'' case. To the extent that the 10- and 90-day global periods
reflect inaccurate assumptions regarding resource costs associated with
individual PFS services, we believe they are likely to be obstacles to
a wide range of potential improvements to PFS payments, including the
potential incorporation of payment bundling designed to foster
efficiency and quality care for Medicare beneficiaries.
c. Proposed Transformation of 10- and 90-Day Global Packages Into 0-Day
Global Packages
Although we have marginally addressed some of the concerns noted
above with global packages in previous rulemaking, we do not believe
that we have made significant progress in addressing the fundamental
issues with the 10- and 90-day post-operative global packages. In the
context of the misvalued code initiative, we believe it is critical for
the RVUs used to develop PFS payment rates reflect the most accurate
resource costs associated with PFS services. Based on the issues
discussed above, we do not believe we can effectively address the
issues inherent in establishing values for the 10- and 90-day global
packages under our existing methodologies and with available data. As
such, we do not believe that maintaining the post-operative 10-and 90-
day global periods is compatible with our continued interest in using
more objective data in the valuation of PFS services and accurately
valuing services relative to each other. Because the typical number and
level of post-operative visits during global periods may vary greatly
across Medicare practitioners and beneficiaries, we believe that
continued valuation and payment of these face-to-face services as a
multi-day package may skew relativity and create unwarranted payment
disparities within PFS fee-for-service payment. We also believe that
the resource based valuation of individual physicians' services will
continue to serve as a critical foundation for Medicare payment to
physicians, whether through the current PFS or in any number of new
payment models. Therefore, we believe it is critical that the RVUs
under the PFS be based as closely and accurately as possible on the
actual resources involved in furnishing the typical occurrence of
specific services.
To address the issues discussed above, we proposed to retain global
bundles for surgical services, but to refine bundles by transforming
over several years all 10- and 90-day global codes to 0-day global
codes. Medically reasonable and necessary visits would be billed
separately during the pre- and post-operative periods outside of the
day of the surgical procedure. We propose to make this transition for
current 10-day global codes in CY 2017 and for the current 90-day
global codes in CY 2018, pending the availability of data on which to
base updated values for the global codes.
We believe that transforming all 10- and 90-day global codes to 0-
day global codes would:
Increase the accuracy of PFS payment by setting payment
rates for individual services based more closely upon the typical
resources used in furnishing the procedures;
Avoid potentially duplicative or unwarranted payments when
a beneficiary receives post-operative care
[[Page 67586]]
from a different practitioner during the global period;
Eliminate disparities between the payment for E/M services
in global periods and those furnished individually;
Maintain the same-day packaging of pre- and post-operative
physicians' services in the 0-day global; and
Facilitate availability of more accurate data for new
payment models and quality research.
As we transition these codes, we would need to establish RVUs that
reflect the change in the global period for all the codes currently
valued as 10- and 90-day global surgery services. We sought assistance
from stakeholders on various aspects of this task. Prior to
implementing these changes, we intend to gather objective data on the
number of E/M and other services furnished during the current post-
operative periods and use those data to inform both the valuation of
particular services and the overall budget neutrality adjustments
required to implement this proposal. We sought comment on the most
efficient means of acquiring accurate data regarding the number of
visits and other services actually being furnished by the practitioner
during the current post-operative periods. For all the reasons stated
above, we do not believe that survey data reflecting assumptions of the
``typical case'' meets the standards required to measure the resource
costs of the wide range of services furnished during the post-operative
periods. We acknowledge that collecting information on these services
through claims submission may be the best approach, and we would
propose such a collection through future rulemaking. However, we are
also interested in alternatives. For example, we sought information on
the extent to which individual practitioners or practices may currently
maintain their own data on services furnished during the post-operative
period, and how we might collect and objectively evaluate that data.
We also sought comment on the best means to ensure that allowing
separate payment of E/M visits during post-operative periods does not
incentivize otherwise unnecessary office visits during post-operative
periods. If we adopt this proposal, we intend to monitor any changes in
the utilization of E/M visits following its implementation but we also
solicited comment on potential payment policies that will mitigate such
a change in behavior.
In developing this proposal, we considered several alternatives to
the transformation of all global codes to 0-day global codes. First, we
again considered the possibility of gathering data and using the data
to revalue the 10- and 90-day global codes. While this option would
have maintained the status quo in terms of reporting services, it would
have required much of the same effort as this proposal without
alleviating many of the problems associated with the 10- and 90-day
global periods. For example, collecting accurate data would allow for
more accurate estimates of the number and kind of visits included in
the post-operative periods at the time of the survey. However, this
alternative approach would only mitigate part of the potential for
unwarranted payment disparities. For example, the values for the visits
in the global codes would continue to include different amounts of PE
RVUs than separately reportable visits and would continue to provide
incentives to some practitioners to minimize patient visits.
Additionally, it would not address the changes in practice patterns
that we believe have been occurring whereby the physician furnishing
the procedure is not necessarily the same physician providing the post-
procedure follow up.
This alternative option would also rest extensively on the
effectiveness of using the new data to revalue the codes accurately.
Given the unclear relationship between the assigned work RVUs and the
post-operative visits across all of these services, incorporating
objective data on the number of visits to adjust work RVUs would still
necessitate extensive review of individual codes or families of codes
by CMS and stakeholders, including the RUC. We believe the investment
of resources for such an effort would be better made to solve a broader
range of problems.
We also considered other possibilities, such as altering our PE
methodology to ensure that the PE inputs and indirect PE for visits in
the global period were valued the same as separately reportable E/M
codes or requiring reporting of the visits for all 10- and 90-day
global services while maintaining the 10- and 90-day global period
payment rates. However, we believe this option would require all of the
same effort by practitioners, CMS, and other stakeholders without
alleviating most of the problems addressed in the preceding paragraphs.
We also considered maintaining the status quo and identifying each
of the 10- and 90-day global codes as potentially misvalued through our
potentially misvalued code process for review as 10- and 90-day
globals. Inappropriate valuations of these services has a major effect
on the fee schedule due to the percentage of PFS dollars paid through
10- and 90-day global codes (3 percent and 11 percent, respectively),
and thus, valuing them appropriately is critical to appropriate
valuation and relativity throughout the PFS. Through the individual
review approach, we could review the appropriateness of the global
period and the accurate number of visits for each service. Yet
revaluing all 3,000 global surgery codes through the potentially
misvalued codes approach would not address many of the problems
identified above. Unless such an effort was combined with changes in
the PE methodology, it would only partially address the valuation and
accuracy issues and would leave all the other issues unresolved.
Moreover, the valuation and accuracy issues that could be addressed
through this approach would rapidly be out of date as medical practice
continues to change. Therefore, such an approach would be only
partially effective and would impede our ability to address other
potentially misvalued codes.
We sought stakeholder input on an accurate and efficient means to
revalue or adjust the work RVUs for the current 10- and 90-day global
codes to reflect the typical resources involved in furnishing the
services including both the pre- and post-operative care on the day of
the procedure. We believe that collecting data on the number and level
of post-operative visits furnished by the practitioner reporting
current 10- and 90-day global codes will be important to ensuring work
RVU relativity across these services. We also believe that these data
will be important to determine the relationship between current work
RVUs and current number of post-operative visits, within categories of
codes and code families. However, we believe that once we collect those
data, there is a wide range of possible approaches to the revaluation
of the large number of individual global services, some of which may
deviate from current processes like those undertaken by the RUC. To
date, the potentially misvalued code initiative has focused on several
hundred, generally high-volume codes per year. This proposal requires
revaluing a larger number of codes over a shorter period of time and
includes many services with relatively low volume in the Medicare
population. Given these circumstances, it does not seem practical to
survey time and intensity information on each of these procedures.
Absent any new survey data regarding the procedures themselves,
[[Page 67587]]
we believe that data regarding the number and level of post-service
office visits can be used in conjunction with other methods of
valuation, such as:
Using the current potentially misvalued code process to
identify and value the relatively small number of codes that represent
the majority of the volume of services that are currently reported with
codes with post-operative periods, and then adjusting the aggregate
RVUs to account for the number of visits and using magnitude estimation
to value the remaining services in the family.
Valuing one code within a family through the current
valuation process and then using magnitude estimation to value the
remaining services in the family.
Surveying a sample of codes across all procedures to
create an index that could be used to value the remaining codes.
Although we believe these are plausible options for the revaluation
of these services, we believed there may be others. Therefore, we
sought input on the best approach to achieve this proposed transition
from 10- and 90-day, to 0-day global periods, including the timing of
the changes, the means for revaluation, and the most effective and
least burdensome means to collect objective, representative data
regarding the actual number of visits currently furnished in the post-
operative global periods. We also solicited comment on whether the
effective date for the transition to 0-day global periods should be
staggered across families of codes or other categories. For example,
while we proposed to transition 10-day global periods in 2017 and 90-
day global periods in 2018, we solicited comment on whether we should
consider implementing the transition more or less quickly and over one
or several years. We also solicited comment regarding the appropriate
valuation of new, revised, or potentially misvalued 10- or 90-day
global codes before implementation of this proposal.
We received many comments regarding the proposed transition to 0-
day global packages. Many commenters expressed support or opposition to
the proposal. Some commenters offered direct responses to the topics
for which we specifically sought comment, while others raised questions
regarding how the transition would be implemented. In the following
paragraphs, we summarize and respond to these comments.
Comment: Several commenters supported the proposal, including
commenters representing several medical specialty societies and several
health systems. Many of these commenters agreed with the reasons
presented in the proposal. These commenters agreed that the current
structure of the global surgery codes prevents CMS from accurately
valuing and paying for these services, even if CMS had necessary visit
data available. Many commenters agreed that the current arrangement may
lead to unwarranted payment disparities and that the current packages
have not evolved with changes in practice and because of this, likely
provide unreliable building blocks for new payment methodologies.
In agreeing with the proposal, MedPAC stated that it ``is essential
that the individual services that make up a bundle have accurate values
and that there is a mechanism to ensure that the services that are part
of the bundle are not paid separately (unbundling). Otherwise, the
payment rate for the entire bundle will be inaccurate.'' MedPAC urged
CMS to finalize this proposal and plan to use the more accurate
valuations to create more accurate bundles in the future.
Response: We appreciate the commenters' support for the proposal,
and agree that there are many reasons why the current construction of
the global surgery packages is difficult to reconcile with accurate
valuation of individual services within the current payment construct
of the PFS. We agree that achieving the agency's goal of greater
bundling requires accurate valuation of component services in a
surgical procedure.
Comment: Some commenters, including several of those representing
specialty societies, urged CMS to postpone finalization of the proposal
pending the report of stakeholder efforts to conduct a comprehensive
analysis of the effect it would have on the provision of surgical care,
surgical patients, and the surgeons who care for them.
Response: We share stakeholders' concerns regarding the potential
impact of the change on Medicare beneficiaries and practitioners.
However, based upon our analysis and the information that stakeholders
have provided, we believe delaying the proposal to further study the
problems is not warranted given the significant concerns that have been
raised with the current construction of the global surgery packages.
Instead, as we articulated in making the proposal, we anticipate that
further analysis by stakeholders will contribute to implementing the
transition in a manner that accurately values and pays for PFS
services. We believe that accurate valuation of services furnished to
Medicare beneficiaries is overwhelmingly in the best interest of both
beneficiaries and those who care for them.
Comment: We received several comments from commenters who opposed
our proposal, and in general these commenters shared the concerns of
those who urged a delay in finalizing or implementing the proposal. In
addition, some commenters who opposed the proposal disputed our
contention that the global periods contribute to unwarranted payment
disparities, saying that the increased direct and indirect PE and MP
RVUs for E/M services furnished in the global surgical post-operative
periods accurately account for the increased PE and MP costs of
practitioners who furnish these services relative to practitioners who
typically furnish separately reportable E/M services.
Response: Just as we do not agree that we should delay addressing
significant problems with valuations while we further study the issues,
we do not believe these same issues raised by commenters opposing the
proposal are impediments to implementation. The issues relating to
valuation of global period E/M services using our PE methodology are
just one of several important considerations that led us to propose
transforming 10- and 90-day global services to 0-day global packages.
We continue to believe the proposed transformation to 0-day global
packages is a simple and immediate step to improve the valuation of the
various services included in surgical care. However, Medicare remains
committed to bundled payment as a mechanism for delivery system reform
and we will continue to explore the best way to bundle surgical
services, including alternatives to the 0-day global surgical bundle.
Comment: Many commenters who opposed the proposal addressed
valuation problems that would exist if the proposal were implemented.
Some stated that, were CMS to finalize the proposal to pay for post-
surgical E/Ms using the same codes, the PE and MP RVUs for the services
would be artificially reduced because the data from other specialties
would be incorporated. These commenters suggested CMS should consider
how to maintain the current differences in payment for these services
even if the proposal were finalized. Some commenters suggested that CMS
would need to account for the additional practice expense and
malpractice costs for post-operative surgical visits.
Response: We develop and establish work, PE, and MP RVUs for
specific services to reflect the relative resource costs involved in
furnishing the typical
[[Page 67588]]
PFS service. In developing the proposal, we noted that by including a
significant number of E/Ms in the global periods for surgical services,
the PFS ratesetting methodology distinguishes these services from other
E/Ms for purposes of developing PE and MP RVUs, potentially to the
advantage of particular specialties with higher PE and MP RVUs. In
contrast, the work RVUs for individual, separately billed E/M services
furnished, for example, by primary care practitioners are valued more
generally as individual services, and values are not maintained
separately from the work RVUs for E/Ms furnished by other
practitioners. Therefore, we do not agree with commenters that Medicare
should establish higher PE and MP values for E/M services furnished in
the post-surgical period than for other E/M services.
Comment: Several commenters suggested that CMS should not use the
OIG reports to generalize its concerns about the provision of surgical
care, because the OIG reports represent only a small sample of
observations of specific procedures and specialties. Other commenters
suggested that the OIG methodology might be flawed because, since CMS
does not require documentation of post-operative visits, many
practitioners may not document such visits in the medical record.
Response: We do not have any reason to believe that the OIG
findings on the global surgical service packages furnished by
particular specialties that the OIG reviewed are not generalizable to
other global surgery services. Nor did the commenters provide any
evidence that the OIG conclusions are likely to be less accurate than
the survey estimates that CMS uses to value the services. Finally,
having an incorrect number of postoperative visits is only one of the
many valuation problems that have been identified for global surgical
packages. Additionally, we find the suggestion that physicians do not
document medical visits that are occurring in the post-surgical period
to be concerning. As a general matter, Medicare does not require
documentation to support a billed service beyond information that the
physician would normally maintain in the patient's medical record. Even
in the absence of billing Medicare or another insurer, we believe that
physicians and other practitioners following standard medical practice
would document what occurred during a patient encounter in order to
ensure the patient's medical history is accurate and up-to-date, and to
facilitate continuity in the patient's medical care.
Comment: One commenter asserted that the 90-day global period was
created to prevent two behaviors referred to as ``fee-splitting'' and
``itinerant surgery.'' According to the commenter, these terms refer to
the practice where a surgeon would provide only the surgery and leave
postoperative care to other practitioners. The commenter believes these
practices are inconsistent with professional standards, and that it is
medically necessary and expected by patients that surgeons will
evaluate their patients on a daily basis in the hospital and as needed
on an outpatient basis during the recovery period.
Response: We do not believe that the global surgical package was
designed to ensure or allocate appropriate post-operative care among
practitioners. Under Medicare's current global surgery policy,
practitioners can agree on the transfer of care during the global
period and, in such cases, modifiers are used in order to split the
payment between the procedure and the post-operative care. We do not
agree that global surgical packages obligate the surgeon to furnish
some or all of the post-operative care. Global surgical packages are
valued based on the typical service, and we would not expect every
surgery to require the same number of follow-up visits. However, we
would expect that over a large number of services, the central tendency
would reflect the number of visits we included as typical for purposes
of valuing the global package; and as discussed above, we have not
found that this is necessarily the case. Even if Medicare maintains the
10- and 90-day global surgery packages, there would be no assurance
that the surgeon, and not another practitioner, would furnish all or a
certain amount of post-operative care (whether by the patient's choice
of practitioner or otherwise). The global payment includes payment for
post-operative care with the payment for the surgery, which makes it
difficult to know whether or by whom the post-operative care was
actually furnished unless there is an official transfer of care. We are
confident that the surgical community will continue to furnish
appropriate care for Medicare beneficiaries irrespective of changes in
the structure of payment for surgical services.
Comment: Several commenters stated that if Medicare adopts a policy
to pay for post-operative care using E/M codes rather than through a
global package, Medicare will likely pay a higher level of E/M visits
when they are separately billed than it does currently, as the existing
global packages tend to include more lower level E/M services than
those that are generally reported.
Response: We acknowledge that the visits assumed in the global
packages are generally valued as lower-level visits than are most
commonly furnished, as reflected in Medicare utilization data for
separately reportable E/Ms. However, this disparity is only pertinent
to the proposal if the global packages are inaccurately valued or, if,
under the proposed policy, practitioners who furnish these services are
likely to inaccurately report the level of E/M service that is actually
being furnished. If the former is true, then we believe this supports
the proposal to revalue these services. As with every service, we
expect physicians to bill the most appropriate E/M codes that reflect
the care that is furnished, including for post-operative care.
Comment: One commenter expressed concern that the proposal to
require separate billing for postoperative surgical care provides a
basis for the eventual denial of payment to one or more of the
postoperative care providers, based on the notion that care furnished
by other specialties is duplicative of or replaces care furnished by
the surgeon. This commenter stated that multiple providers with
differing expertise and training are essential to achieve optimal
patient outcomes and expressed concern that this proposal will provide
disincentives to optimal patient care.
Response: As we stated in the proposal, we believe that there are
various models for postoperative care that can often include multiple
providers, and this is another important reason why we believe the
services with longer global periods should be transformed to 0-day
packages to accommodate heterogeneous models of care that optimize
patient outcomes.
Comment: One commenter recommended that CMS establish G-codes for
three levels of post-operative visits furnished by the original surgeon
or another surgeon with the same board certification, as well as a
second set of three level G-codes for postoperative visits furnished by
another provider. The commenter also suggested that CMS should develop
methods to fairly measure the duration of E/M times through which a
large sample of surgeons might report the number and intensity of post-
operative visits. The commenter also recommended that CMS track E/M
services furnished to surgical patients within the global period by a
physician other than the operating surgeon, for the same or similar
diagnosis, in order to begin to understand what portion of
[[Page 67589]]
postoperative visits are being billed outside of the global period.
The RUC informed CMS that it has identified several large hospital-
based physician group practices that internally use CPT code 99024 to
report each bundled post-operative visit, and therefore data is already
being captured for some Medicare providers. The RUC also suggested that
CMS may have denied-claims data available for CPT code 99024 via the
Medicare claims processing system. The RUC recommends that CMS work
with it to explore the availability, usefulness, and appropriateness of
these data from group practices and the CMS denied-claims dataset, in
order to gather existing, objective data to validate the actual number
of post-operative visits for 10-day and 90-day procedures. The RUC also
suggested that CMS should consider reviewing Medicare Part A claims
data to determine the length of stay for surgical services furnished in
the inpatient acute care hospital setting.
MedPAC stated that data collection could take several years, would
be burdensome for CMS and providers, and may be inaccurate since
providers would have little incentive to report each visit.
Furthermore, MedPAC suggested that such data collection would be
unnecessary since the current ratesetting methodology already assumes
particular numbers of visits. MedPAC suggested that CMS should reduce
the RVUs for the 10- and 90-day global services based on the same
assumptions currently used to pay for these services.
Several other commenters agreed with the approach advocated by
MedPAC (often referred to as ``reverse-building block'') to revaluing
the services. These commenters stated that since CMS has increased RVUs
for these services proportionate to the number of E/M services assumed
to be included in the postoperative period, for the sake of relativity,
the RVUs attributed to the visits can be fairly removed in order to
value the new 0-day global codes. Many of these commenters acknowledged
that this approach would result in negative or other anomalous values
for many of these codes, but asserted that codes with anomalous values
might then be individually reviewed. MedPAC suggested that if specialty
societies or the RUC believe that the new values for specific global
codes are inaccurate, they could present evidence that the codes are
misvalued to CMS, presumably through the potentially misvalued code
public nomination process. MedPAC further states that for codes without
accurate post-operative assumptions, CMS could calculate interim RVUs
for these codes based on the average percent reduction for other global
codes in the same family.
Many other commenters were against the reverse-building block
approach to revaluation. These commenters stated that backing out the
bundled E/M services would be highly inappropriate and methodologically
unsound since the services were not necessarily valued using a
building-block methodology. Many of these commenters, including the
RUC, stated that the amount of post-operative work included in the
codes can only be appropriately surveyed, vetted, and valued by the
RUC.
Response: We appreciate the concerns of commenters regarding the
difficulty of revaluing the global surgery codes as 0-day global
packages. As we stated in making the proposal, we believe that such
stakeholder input and participation in any revaluation will be critical
to the accuracy of the resulting values. We will consider all of these
comments as we consider mechanisms for revaluations and as we propose
new values for specific services. We believe that the challenges
involved in revaluation, such as those articulated by commenters,
reinforce our understanding that the current construction of the 10-
and 90-day global packages are not a sustainable, long-term approach to
the accurate valuation of surgical care. As noted above, we will
continue to explore appropriate ways of bundling global surgical
services.
Comment: In general, commenters supporting the proposal also
supported CMS's proposed timeframe to transition 10-day global codes
and 90-day global codes to 0-day global surgical packages by 2017 and
2018, respectively. In contrast, most commenters objecting to, or
articulating reservations about, the proposal urged CMS to slow its
implementation. Some of these commenters suggested that the process
used to establish the current values for these CPT codes is ideal and
stated that it would take many years to value the many individual
services using the same methodologies.
The RUC stated that there are over 4,200 services within the PFS
with a 10-day or 90-day global period, so the scope of the proposal is
very large and the transition should be staggered over many years.
However, the RUC also pointed out that most of these services have
relatively low utilization, as only 268 of them (or 6 percent of 10- or
90-day global surgery services) were performed more than 10,000 times
annually based on 2013 Medicare claims data.
Response: We appreciate the concerns of the commenters. We agree
with those commenters who urged us to move quickly to value services as
accurately as possible. We note that most comments suggesting a delay
in revaluation were based on a common underlying view that code-level
review of the full set of services by the RUC based on practitioner
surveys is the only appropriate way to value the services.
As we stated in making the proposal, we do not believe that
surveying practitioners who furnish each of these services is a
practical or necessarily advisable approach to appropriate valuation.
Regardless of when the proposal is implemented, it seems likely that
the number of codes to be revalued is much larger than the number of
codes that should or can be surveyed. Through its normal process, the
RUC routinely makes annual recommendations regarding several hundred
codes, and we acknowledge that thousands of services cannot be valued
using the typical RUC process in one year. On the other hand we believe
that there are other options for revaluing some of the global surgery
codes as 0-day global packages, particularly those of low volume, and
we have indicated a willingness to work with the RUC to determine
appropriate mechanisms for revaluations. Therefore, although we agree
that revaluing such a high number of codes is a significant
undertaking, we do not believe that that the required revaluations
would represent an undue burden between the present and the proposed
implementation dates. We also note that in order to focus efforts on
revaluing the global surgery packages, we are not asking the RUC to
review the nearly 100 services we proposed as potentially misvalued
this year under the high expenditure screen. We continue to remain
interested in other potential data sources for accurately valuing PFS
services, especially the vast majority of 10- and 90-day global codes
for which there is not significant volume. We also urge stakeholders to
engage with us to help us understand why alternative approaches to the
revaluation of the 10- and 90-day global services would require the
kind of delay that was urged based on the assumption that the RUC
survey approach would be used for all those services.
Additionally, we request stakeholders, including the CPT Editorial
Panel and the RUC, to consider the utility of establishing and
maintaining separate coding and national Medicare RVUs for the many
procedures that have little to no utilization in the Medicare
population. For example, there are over 1,000 10-
[[Page 67590]]
and 90-day global codes with fewer than 100 annual services in the
Medicare database. Although we recognize that some portion of these
services may be utilized more extensively by non-Medicare payers, it is
also likely that many of these codes may reasonably be consolidated. We
request that appropriate coding for surgical services be considered as
part of revaluing global surgery.
Comment: Many commenters expressed concerns that requiring
beneficiary coinsurance for each follow-up visit could dissuade
beneficiaries from returning for necessary follow-up care and,
therefore, adversely affect surgical outcomes. Many of these commenters
acknowledged that overall patient liability for the total amount of
care could be reduced, depending on revaluation, but stated that paying
separate coinsurance for follow-up care can cause patients to perceive
the net payments as larger, given the frequency of payment required.
These commenters stated that the magnitude of these problems might be
directly proportionate to how sick the patient is.
Response: We understand the concerns of the commenters, but do not
agree that Medicare beneficiaries are unlikely to appreciate the
difference between frequency of payment and overall financial
liability. We also note that the significant majority of patient
encounters with Medicare practitioners generate some degree of
beneficiary liability. While liability could prompt the proportion of
beneficiaries without secondary insurance to forgo medically reasonable
and necessary care for the treatment of illness or injury, we have no
reason to conclude that this would be the case specifically for post-
operative care. We do acknowledge that surgeons may need to explain the
importance of follow-up care so that patients understand and appreciate
how compliance with follow-up care can improve the overall quality of
care and outcomes. As noted above, while our proposal is to move to 0-
day global packages as a simple, immediate adjustment, the agency
remains committed to bundling as a key component of payment system
delivery reform, and we will consider beneficiary impact as we further
consider the appropriate size and construction of a surgical bundle.
Comment: Several commenters expressed concerns that the proposal
would result in disjointed or inadequate care and/or disrupt surgical
registry data. These commenters suggested that neither patients nor
alternate providers are as qualified to determine whether or not a
postoperative visit by the surgeon is necessary.
Response: As discussed above, we do not agree that patients who
require the post-operative care of a surgeon are likely to forgo such
care if Medicare changes how we pay the surgeon for furnishing that
care. Although several commenters expressed these and similar kinds of
concerns, none explained how the proposed change in payment would
change post operative care. We continue to believe that surgeons will
continue to furnish appropriate post operative care to Medicare
beneficiaries, and we do not agree that concerns about increased
patient liability or disjointed care are warranted.
Comment: Several commenters expressed concerns over other Medicare
payment policies related to surgical procedures. Some commenters stated
that the current multiple procedure payment reduction policies that
apply to all 0-, 10-, and 90-day global codes are only appropriate for
10-day and 90-day globals due to the overlap in resource costs during
the post-operative period. Other commenters noted that potential
reductions in payment to surgeons to account for the reduced post-
operative period would negatively impact practitioners who assist at
surgery despite the fact that their professional work and
responsibilities have not changed.
Response: We appreciate the issues raised by these commenters.
Again, we seek continued input from the stakeholder community regarding
these and other issues that need to be considered in order to implement
the transition. In the case of the MPPR, we note there are several
hundred 0-day global codes where these payment policies currently
apply. We are especially interested in understanding why stakeholders
do not believe the policies effective for the current 0-day global
codes would not similarly be appropriate for the current 10-and 90-day
codes that will be revalued as 0-day global codes.
Comment: Many of the commenters who opposed or expressed concern
about the proposal urged CMS to consider the extent to which this
proposal would increase the administrative burden on CMS, MACs, and
providers. Other commenters urged CMS to consider that post-operative
visits would be subject to the same documentation requirements and
other scrutiny as other separately-reportable PFS services. One
commenter representing other payers opposed the proposal due to
concerns about predicting the usage of post-operative services.
Response: We considered the administrative burden on both CMS and
practitioners who furnish these services in making the proposal. In
both cases, we note the administrative burden would be no greater than
the burden associated with the vast majority of other services paid
through the Medicare PFS. We do not believe that the burden of
separately reporting post-operative follow-up visits is particularly or
unduly burdensome, given that most office visits paid through the PFS
are separately reported under current Medicare policies. In comparison
to the number of separately reported visits and other PFS services, the
number of visits that likely occur in post-operative periods is
relatively small. We do not agree that there are inherent reasons that
medically necessary post-operative visits should be exempt from the
same documentation and other requirements applicable to other PFS
services. We appreciate that changes in Medicare policy may affect
other insurers who choose to base their payments on the PFS; however,
it is our obligation to set our policies based upon the needs of
Medicare and its beneficiaries.
Comment: A few commenters urged CMS to consider the possibility
that there could be confusion among practitioners and payers if some
payers continue to base payment on the 10- or 90-day post-operative
periods.
Response: We believe that payment policies that are appropriate for
Medicare may not always be optimal for all payers. However, we seek
continued input and analysis from other payers as we engage
stakeholders in developing our implementation strategy for the
transition of 10- and 90-day global services to 0-day global services.
Comment: Several commenters urged CMS to consult with stakeholders
as we develop appropriate plans for the global period transition. These
commenters cautioned that the structural reorganization of these
services is challenging due to the large set of services that will be
impacted and could potentially disrupt well-established payment for
certain providers.
Response: We appreciate these recommendations and agree that we
should continue to consult with stakeholders regarding the
implementation of this proposal.
After consideration of all the comments received regarding this
proposal, we are finalizing the proposal to transition and revalue all
10- and 90-day global surgery services with 0-day global periods,
beginning with the 10-day global services in CY 2017 and following with
the 90-day global services in CY 2018. We note that as we
[[Page 67591]]
develop implementation details, including revaluations, we will take
into consideration all of the comments we received to our global
surgery proposal. We will provide additional details during the CY 2016
rulemaking. We are finalizing a transformation to 0-day global codes
because we believe this is the most straightforward way to improve the
accuracy of valuation for the various components of global surgical
packages, including pre- and post-operative visits and performance of
the surgical procedure. However, we remain committed to delivery system
reform and ensuring Medicare makes appropriate payment for bundles of
services whether our payment covers a period of 0, 10 or 90 days. As we
begin revaluation of services as 0-day globals, we will actively assess
whether there is a better construction of a bundled payment for
surgical services.
We also actively seek the analysis and perspective of all affected
stakeholders regarding the best means to revalue these services as 0-
day global codes. We urge all stakeholders to engage with us regarding
potential means of making the transition as seamless as possible, both
for patient care and provider impact. We are considering a wide range
of approaches to all details of implementation from revaluation to
communication and transition, and we are hopeful that sufficient
agreement can be reached among stakeholders on important issues such as
revaluation of the global services and appropriate coding for post-
operative care. We remain committed to collecting objective data
regarding the number of visits typically furnished during post-
operative periods and will explore the extant source options presented
by commenters as we consider other options as well.
5. Valuing Services That Include Moderate Sedation as an Inherent Part
of Furnishing the Procedure
The CPT manual includes more than 300 diagnostic and therapeutic
procedures, listed in Appendix G, for which CPT has determined that
moderate sedation is an inherent part of furnishing the procedure and,
therefore, only the single procedure code is appropriately reported
when furnishing the service and the moderate sedation. The work of
moderate sedation has been included in the work RVUs for these
diagnostic and therapeutic procedures based upon their inclusion in
Appendix G. Similarly, the direct PE inputs for these services include
those inputs associated with furnishing a typical moderate sedation
service. To the extent that moderate sedation is typically furnished as
part of the diagnostic or therapeutic service, the inclusion of
moderate sedation in the valuation of the procedure is appropriate.
In the CY 2014 PFS proposed rule (79 FR 40349), we noted that it
appeared that practice patterns for endoscopic procedures were
changing, with anesthesia increasingly being separately reported for
these procedures. For example, one study showed that while the use of a
separate anesthesia professional for colonoscopies and upper
endoscopies was just 13.5 percent in 2003, the rate more than doubled
to 30.2 percent in 2009. An analysis of Medicare claims data showed
that a similar pattern is occurring in the Medicare program. We found
that, for certain types of procedures such as digestive surgical
procedures, a separate anesthesia service is furnished 53 percent of
the time. For some of these digestive surgical procedures, the claims
analysis showed that this rate was as high as 80 percent.
Our data clearly indicated that moderate sedation was no longer
typical for all of the procedures listed in CPT's Appendix G, and, in
fact, the data suggested that the percent of cases in which it is used
is declining. For many of these procedures in Appendix G, moderate
sedation continued to be furnished. The trend away from the use of
moderate sedation toward a separately billed anesthesia service was not
universal. We found that it differed by the class of procedures,
sometimes at the procedure code level, and continued to evolve over
time. Due to the changing nature of medical practice in this area, we
noted that we were considering establishing a uniform approach to
valuation for all Appendix G services for which moderate sedation is no
longer inherent, rather than addressing this issue at the procedure
level as individual procedures are revalued.
We sought public comment on approaches to address the appropriate
valuation of these services. Specifically, we were interested in
approaches to valuing Appendix G codes that would allow Medicare to pay
accurately for moderate sedation when it is furnished while avoiding
potential duplicative payments when separate anesthesia is furnished
and billed. To the extent that Appendix G procedure values are adjusted
to no longer include moderate sedation, we requested suggestions as to
how moderate sedation should be reported and valued, and how to remove
from existing valuations the RVUs and inputs related to moderate
sedation.
We noted that in the CY 2014 PFS final rule with comment period, we
established values for many upper gastrointestinal procedures, 58 of
which were included in Appendix G. For those interim final values, we
included the inputs related to moderate sedation. We stated that we did
not expect to change existing policies for valuing moderate sedation as
inherent in these procedures until we have the opportunity to assess
and respond to the comments on the proposed rule on the overall
valuation of Appendix G codes.
We received many helpful suggestions in response to our comment
solicitation. At this time, we are not making any changes to how we
value Appendix G codes for which moderate sedation is an inherent part
of the procedure. We intend to address this topic in future notice and
comment rulemaking, taking into account the comments we received. In
section II.G. of this CY 2015 PFS final rule with comment period, we
address interim final values and establish CY 2015 inputs for the lower
gastrointestinal procedures, many of which are also listed in Appendix
G.
C. Malpractice Relative Value Units (RVUs)
1. Overview
Section 1848(c) of the Act requires that each service paid under
the PFS be comprised of three components: Work; PE; and malpractice
(MP) expense. As required by section 1848(c) of the Act, beginning in
CY 2000, MP RVUs are resource based. Malpractice RVUs for new codes
after 1991 were extrapolated from similar existing codes or as a
percentage of the corresponding work RVU. Section 1848(c)(2)(B)(i) of
the Act also requires that we review, and if necessary adjust, RVUs no
less often than every 5 years. For CY 2015, we are proposing to
implement the third comprehensive review and update of MP RVUs. For
details about prior updates, see the CY 2010 final rule with comment
period (74 FR 33537).
2. Methodology for the Proposed Revision of Resource-Based Malpractice
RVUs
The proposed MP RVUs were calculated by a CMS contractor based on
updated MP premium data obtained from state insurance rate filings. The
methodology used in calculating the proposed CY 2015 review and update
of resource-based MP RVUs largely paralleled the process used in the CY
2010 update. The calculation required using information on specialty-
specific MP premiums linked to a specific service based upon the
relative risk factors of the various specialties that furnish a
particular service. Because MP premiums vary by state and specialty,
[[Page 67592]]
the MP premium information were weighted geographically and by
specialty. Accordingly, the proposed MP RVUs were based upon three data
sources: CY 2011 and CY 2012 MP premium data; CY 2013 Medicare payment
and utilization data; and CY 2015 proposed work RVUs and geographic
practice cost indices (GPCIs).
Similar to the previous update, we calculated the proposed MP RVUs
using specialty-specific MP premium data because they represent the
actual expense incurred by practitioners to obtain MP insurance. We
obtained and used MP premium data from state departments of insurance
rate filings, primarily for physicians and surgeons. When the state
insurance departments did not provide data, we used state rate filing
data from the Perr and Knight database, which derives its data from
state insurance departments. We used information obtained from MP
insurance rate filings with effective dates in 2011 and 2012. These
were the most current data available during our data collection
process.
We collected MP insurance premium data from all 50 States, the
District of Columbia, and Puerto Rico. Rate filings were not available
in American Samoa, Guam, or the Virgin Islands. Premiums were for $1
million/$3 million, mature, claims-made policies (policies covering
claims made, rather than those covering services furnished, during the
policy term). A $1 million/$3 million liability limit policy means that
the most that would be paid on any claim is $1 million and the most
that the policy would pay for claims over the timeframe of the policy
is $3 million. We made adjustments to the premium data to reflect
mandatory surcharges for patient compensation funds (funds to pay for
any claim beyond the statutory amount, thereby limiting an individual
physician's liability in cases of a large suit) in states where
participation in such funds is mandatory. We attempted to collect
premium data representing at least 50 percent of the medical MP
premiums paid.
We included premium information for all physician and NPP
specialties, and all risk classifications available in the collected
rate filings. Most insurance companies provided crosswalks from
insurance service office (ISO) codes to named specialties. We matched
these crosswalks to Medicare primary specialty designations (specialty
codes). We also used information we obtained regarding surgical and
nonsurgical classes. Some companies provided additional surgical
subclasses; for example, distinguishing family practice physicians who
furnish obstetric services from those who do not.
Although we collected premium data from all states and the District
of Columbia, not all specialties had premium data in the rate filings
from all states. Additionally, for some specialties, MP premiums were
not available from the rate filings in any state. Therefore, for
specialties for which there was not premium data for at least 35
states, and specialties for which there was not distinct premium data
in the rate filings, we crosswalked the specialty to a similar
specialty, conceptually or by available premium data, for which we did
have sufficient and reliable data. Additionally, we crosswalked three
specialties--physician assistant, registered dietitian and optometry--
for which we had data from at least 35 states to a similar specialty
type because the available data contained such extreme variations in
premium amounts that we found it to be unreliable. The range in premium
amounts for registered dietitians is $85 to $20,813 (24,259 percent),
for physician assistants is $614 to $35,404 (5,665 percent), and for
optometry is $189 to $10,798 (5,614 percent). We crosswalked these
specialties to allergy and immunology, the specialty with the lowest
premiums for which we had sufficient and reliable data.
Our proposed methodology for updating the MP RVUs conceptually
followed the specialty-weighted approach, used in the CY 2010 update.
The specialty-weighted approach bases the MP RVUs for a given service
upon a weighted average of the risk factors of all specialties
furnishing the service. This approach ensures that all specialties
furnishing a given service are accounted for in the calculation of the
MP RVUs. We also continued to use the risk factor of the dominant
specialty for rarely billed services (that is, when CY 2013 claims data
reflected allowed services of less than 100).
We proposed minor refinements for updating the CY 2015 MP RVUs as
compared to the previous update. These refinements included calculating
a combined national average surgical premium and risk factor for
neurosurgery and neurology and updating the list of invasive cardiology
service HCPCS codes (for example, cardiac catheterization and
angioplasty) to be classified as surgery for purposes of assigning
service level risk factors. Additionally, we proposed to classify
injection procedures used in conjunction with cardiac catheterization
as surgery (for purposes of assigning a service specific risk factor).
To calculate the risk factor for TC services we proposed to use the
mean umbrella non-physician MP premiums obtained from Radiology
Business Management Association (RBMA) survey data, used for the
previous MP RVU update in 2010, and adjusted the premium data to
reflect the change in non-surgical premiums for all specialties since
the previous MP RVU update.
As discussed in the CY 2015 proposed rule (79 FR 40354 through
40355), we did not include an adjustment under the anesthesia fee
schedule to reflect updated MP premium information and stated that we
intend to propose an anesthesia adjustment for MP in the CY 2016 PFS
proposed rule. We also requested comments on how to reflect updated MP
premium amounts under the anesthesiology fee schedule.
We posted our contractors report, ``Report on the CY 2105 Update of
Malpractice RVUs'' on the CMS Web site. The report on MP RVUs for the
CY 2015 proposed rule and the proposed MP premium amounts and specialty
risk factors are accessible from the CMS Web site under the supporting
documents section of the CY 2015 PFS proposed rule at https://www.cms.gov/PhysicianFeeSched/. A more detailed explanation of our
proposed MP RVU update can be found in the CY 2015 PFS proposed rule
(79 FR 40349 through 40355).
3. Response to Public Comments
We received over 70 industry comments on the CY 2015 proposed MP
RVU update. A summary of the comments we received on the proposed MP
RVU update and our responses are discussed below.
Comment: Two commenters supported our proposal to combine the
surgical premium data for neurosurgery and neurology for establishing
the surgical risk factor for neurosurgery.
Response: We agree with the commenters and will finalize our
approach for determining the surgical premium for neurosurgery as
proposed. We will combine surgical premiums for neurology and
neurosurgery to calculate a national average surgical premium and risk
factor for neurosurgery.
Comment: Three commenters requested that we phase in the reduction
for ophthalmology and optometry services over 2 years. The commenters
stated that the reduction is due in part to an error we made in
calculating the MP RVUs for ophthalmology and optometry codes under the
previous MP RVU update in CY 2010. The commenters stated that an
immediate implementation of the correction would result in significant
[[Page 67593]]
payment reductions for ophthalmologists.
Response: We note that for the CY 2015 MP RVU update we did not
correct the mistake that was made in CY 2010. For the CY 2015 MP update
we recalculated the MP RVUs based upon the most recently available data
for all services, including ophthalmic services. Accordingly, the
proposed MP RVU update reflects the use of updated MP premium data and
risk factors by specialty and is not affected in any way by the CY 2010
MP RVUs. In doing so, even though the proposed CY 2015 ophthalmology
non-surgical risk factor was 14 percent greater than the CY 2010 non-
surgical risk factor and the proposed surgical risk factor was 17
percent greater, the proposed MP RVUs for most services with
significant ophthalmology volume decreased because the CY 2010 error
resulted in MP RVUs that were higher than they should have been. That
is, the reduction in MP RVUs for ophthalmology and optometry are solely
due to overpayments made due to a mistake during the previous MP RVU
update rather than a proposed change in methodology or the use of
updated premium data. We do not believe that a previous error is
sufficient justification for not fully implementing updated MP RVUs
based on more recent premium data. Therefore, we will implement the
updated MP RVUs for ophthalmology and optometry services as proposed.
Comment: We received comments regarding the application of our
specialty weighted approach for calculating service level risk factors
for surgical services. For instance, the same commenters that requested
a 2-year phase in of the reduction to ophthalmology services also
requested that we exclude optometry from calculating the risk factor
for ophthalmic surgery. One commenter stated that ``MP RVUs for
cataract and other ophthalmic surgeries are deflated because CMS
assumes that optometry is providing the surgical portion of the
procedure.'' The commenter also stated that optometrists are involved
only during the pre- or post-procedure periods of ophthalmic surgery.
Another specialty society stated that it appears that CMS's methodology
for calculating service level risk factors for surgical services ``may
include the allowed services for surgical assistance possibly
discounted to reflect the assistant role under payment policy.'' The
commenter also stated that ``specialties that assist at the procedure
do not perform it, and the assistant's associated MP risk factor has no
bearing on the MP cost for the surgeon.''
Response: The commenter is correct to say that we calculated
service level risk factors based on the mix of all practitioners
billing for a given service and that the specialty weighted approach is
applied to both surgical and non-surgical services . That is, we apply
the risk factor(s) of all specialties involved with furnishing the
surgical procedure to calculate service level risk factors and MP RVUs.
For assistants at surgery, we discount the utilization to reflect his
or her role in furnishing the surgical procedure. Although we agree
that MP cost for the surgeon may not be affected by the surgical
assistant's MP cost, we do not agree with the suggestion that
assistants at surgery should be excluded from our specialty weighted
approach for determining service level MP risk factors and MP RVUs for
surgical services. We believe it is appropriate to apply the specialty
risk factor(s) of all practitioners participating in and receiving a
payment for the surgical procedure for purposes of determining a
service level risk factor and thus the payment for that service. If we
were to exclude the risk factors of some specialties that bill a
specific code from the calculation of the service level risk factor,
the resulting MP RVU would not reflect all utilization. Similarly, we
also disagree with the suggestion that pre- and post- utilization
should be removed from determining MP RVUs for ophthalmic surgical
services. The resources associated with pre- and post-operative periods
for ophthalmic surgery are included in the total RVUs for the global
surgical package. Accordingly, if we did not include the portion of
utilization attributed to pre- and post-operative visits in the
calculation of service level risk factors, the MP RVUs for global
surgery would overstate the MP costs.
We note that in both of these cases by using the discounted
utilization file the weighted average that we use reflects only the
proportion of the utilization by these practitioners and only at the
payment rate made. Including specialty utilization for all
practitioners involved in furnishing the global service reflects the MP
risk for the entire global service.
Comment: We received two comments regarding how risk factors are
assigned to existing services without Medicare utilization. The
commenters stated that we crosswalk to the risk factor of an analogous
source code with Medicare utilization for new codes but assign the
average risk factor for all physicians to existing services without
Medicare utilization. The commenters contend that ``it is inappropriate
for a service to have fluctuating MP risk factors simply due to whether
it is reported in Medicare claims data for a given year.'' The
commenters requested that we crosswalk existing services without
Medicare utilization to a recommended source code.
Response: We used the most recently available Medicare claims data
(that is, from CY 2013) to determine the service level risk factors,
either based on the risk factors of the actual mix of practitioners
furnishing the service, or in the case of low volume services, the risk
factor of the dominant specialty. We disagree with the commenters'
suggestion to assign the risk factor of a recommended specialty to an
existing service without Medicare utilization as indicated by our most
recently available claims data. In the absence of Medicare utilization
we continue to believe that the most appropriate risk factor is the
weighted average risk factor for all service codes. The proposed
weighted average risk factor for all service codes was 2.11. Using the
weighted average risk factor for all services effectively neutralizes
the impact of updated MP premiums and risk factors for any specific
specialty (or mix of specialties).
Comment: The AMA and the RUC and other commenters agreed with the
majority of our proposed claims based dominant specialty designations
for codes with less than 100 allowed services; however, the commenters
disagreed with our proposed dominant specialty for some services. The
commenters believe that some claims have been miscoded, resulting in
erroneous specialty designations. One commenter stated that using the
dominant specialty from the claims data resulted in unjustifiably low
MP RVUs for congenital heart surgery. The commenter stated that
congenital heart surgery can only be done by a heart surgeon and
requested that we override the dominant specialty in our claims data
and use the RUCs recommended specialty.
Response: As discussed in the previous response, we proposed to use
CY 2013 claims data to determine the service level MP risk factors,
either based on the mix of practitioners furnishing the service, or in
the case of low volume services, assigning the risk factor of the
dominant specialty. We continue to believe that use of actual claims
data to determine the dominant specialty is preferable to using a
``recommended'' specialty. However, we recognize that anomalies in the
claims data can occur that would affect the dominant specialty for low
volume services, and therefore resulting in the need for a subjective
review of some services in place of a complete reliance on claims data.
To that end, we
[[Page 67594]]
reviewed the commenter's recommendations for overriding the dominant
specialty from our claims data with a recommended specialty. After
careful consideration of the comments, we will override the dominant
specialty from Medicare claims data when the dominant specialty from
our claims data is inconsistent with a specialty that could be
reasonably expected to furnish the service. For example, our claims
data indicates that pulmonary disease is the dominant specialty for
HCPCS code 33622 (Reconstruction of complex cardiac anomaly), however
as the commenter mentioned, this service is furnished by heart
surgeons. A complete listing of low volume services for which we will
override the claims based dominant specialty with the recommended
specialty to assign a service level risk factor is illustrated in Table
12.
Table 12--Low Volume Service Codes Where Assigned Specialty Used Rather Than Claims Based Dominant Specialty
----------------------------------------------------------------------------------------------------------------
Claims based dominant
HCPCS Code Short descriptor specialty Assigned specialty
----------------------------------------------------------------------------------------------------------------
25490................................ Reinforce radius....... Otolaryngology......... Orthopedic Surgery.
26556................................ Toe joint transfer..... Pulmonary Disease...... Orthopedic Surgery.
31320................................ Diagnostic incision Cardiology............. Otolaryngology.
larynx.
33620................................ Apply r&l pulm art Anesthesiology......... Cardiac Surgery.
bands.
33621................................ Transthor cath for Cardiology............. Cardiac Surgery.
stent.
33622................................ Redo compl cardiac Pulmonary Disease...... Cardiac Surgery.
anomaly.
33697................................ Repair of heart defects Cardiology............. Cardiac Surgery.
33766................................ Major vessel shunt..... General Surgery........ Cardiac Surgery.
36261................................ Revision of infusion General Practice....... General Surgery.
pump.
43341................................ Fuse esophagus & Gastroenterology....... Thoracic Surgery.
intestine.
43350................................ Surgical opening General Practice....... General Surgery.
esophagus.
49491................................ Rpr hern preemie reduc. General Practice....... General Surgery.
50686................................ Measure ureter pressure Internal Medicine...... Urology.
54352................................ Reconstruct urethra/ Pediatric Medicine..... Urology.
penis.
54380................................ Repair penis........... Gastroenterology....... Urology.
61000................................ Remove cranial cavity Family Practice........ Neurosurgery.
fluid.
61558................................ Excision of skull/ Family Practice........ Neurosurgery.
sutures.
61567................................ Incision of brain Cardiology............. Neurosurgery.
tissue.
74710................................ X-ray measurement of Thoracic Surgery....... Diagnostic Radiology.
pelvis.
96003................................ Dynamic fine wire emg.. Cardiology............. Physical Therapist/
Independent Practice.
96420................................ Chemo ia push technique Urology................ Hematology Oncology.
99170................................ Anogenital exam child w Ophthalmology.......... Pediatric Medicine.
imag.
99461................................ Init nb em per day non- Cardiac Pediatric Medicine.
fac. Electrophysiology.
----------------------------------------------------------------------------------------------------------------
Comment: Some commenters requested that we crosswalk gynecological
oncology to general surgery, instead of crosswalking to obstetrics/
gynecology because gynecological oncology is more akin to general
surgery procedures than obstetrics/gynecology. One specialty society
stated that gynecological oncologists are predominantly cancer surgeons
with MP risk similar to general surgery.
Response: We agree with the commenters and will crosswalk
gynecological oncology to the general surgery premium data and risk
factor.
Comment: One commenter requested that we crosswalk clinical
laboratory to pathology instead of the risk factor used for TC services
because clinical laboratories and pathologists render essentially
identical medical procedures that are paid on the Medicare PFS.
Response: We believe that the MP risk for clinical laboratories is
more akin to the MP risk of radiation therapy centers, mammography
screening centers and IDTFs, for which we assigned the TC risk factor,
than to the MP risks for pathologists. The commenters did not provide
sufficient rationale to support that MP risk for clinical laboratories
is similar to the MP risk of pathologists. Therefore, we will crosswalk
clinical laboratory to the TC risk factor as proposed.
Comment: One commenter encouraged us to crosswalk the
interventional pain management specialty to a specialty that more
closely reflects the risks and services associated with interventional
pain management, such as interventional radiology or a comparable
surgical subspecialty.
Response: We believe that the MP risk associated with
interventional pain management is conceptually similar to the MP risk
for anesthesiology more so than to the MP risk for interventional
radiology. Given that the commenters did not provide sufficient
rationale to support that MP risk for interventional pain management is
similar to interventional radiology or to a comparable surgical
specialty, we will crosswalk interventional pain management to
anesthesiology as proposed.
Comment: We received contrasting comments on our proposal to
crosswalk NPPs to the premium and risk factor calculated for allergy/
immunology. For instance, one commenter acknowledged the difficulty in
identifying comprehensive, accurate premium data across the majority of
states, especially for NPPs. To that end, the commenter supported our
decision to crosswalk the MP premiums of NPPs to the lowest physician
risk factor, allergy/immunology. Another commenter, specifically
supported crosswalking registered dieticians to the risk factor
calculated for allergy/immunology.
In contrast, the AMA and other commenters did not support
crosswalking NPPs with insufficient or unreliable premium data to the
premium amounts and risk factor used for allergy/immunology. The
commenters stated that allergy/immunology premiums overstate NPP
premiums and requested that we use the generally lower MP survey data
from the Physician Practice Information Survey (PPIS) for NPPs instead
of crosswalking NPPs to the lowest physician specialty (allergy/
immunology) or use some other measure of central tendency within the
existing collected premium data to determine accurate MP premium risk
factors for NPPs. Another commenter suggested that we work with the AMA
[[Page 67595]]
to obtain the necessary data to ensure the process for reviewing and
updating MP rates is accurate for all providers.
Response: As discussed previously in this section, the resource-
based MP RVUs are based on verifiable MP premium data. We do not
believe it would be appropriate to base the MP RVUs for nonphysician
specialties on survey data and use premium data for all other
specialties. Therefore, we do not agree with the commenters that
suggested using survey data for NPPs and will finalize the specialty
crosswalks for NPPs as proposed. However, in light of the commenter's
suggestions, we will explore ways to enhance our MP premium data
collection efforts to obtain better premium data for NPPs for future
updates. We will also explore other potential measures of central
tendency for determining the ``indexed'' specialty as an alternative to
using the premium values of the lowest specialty.
Comment: We received two comments regarding the data and or
methodology used to calculate the TC and PC of diagnostic services. One
specialty group noted that the proposed MP RVUs for the TC of some
diagnostic services increased while the MP RVUs for the PC decreased.
Specifically, the commenter questioned why the MP RVUs for the PC of
diagnostic cardiac catheterization as described by HCPCS codes 93451
through 93461 decreased by 6 to 12 percent while the TC portion for
these codes increased by 20 to 33 percent. The commenter encouraged us
to review the reasons for this shift to TC MP RVUs. Additionally, the
RBMA submitted updated MP premium information collected from IDTFs in
2014. The RBMA requested that we use the recently obtained data
reflecting the median ``50th percentile'' premium data for ``umbrella
non-physician MP liability'' for calculating CY 2015 MP RVUs for TC
services.
Response: To calculate the risk factor for TC services we used the
mean umbrella non-physician MP premiums obtained from the RBMA survey
data (used for the previous MP RVU update in 2010) and adjusted the
data to reflect the change in non-surgical premiums for all specialties
since the previous MP RVU update, for example, $9,374 deflated by -
20.41 percent = $7,455. However, given that the premiums of the lowest
physician specialty (allergy/immunology) decreased by more than 20
percent, the proposed CY 2015 risk factor for TC services increased
from the previous update in CY 2010 from 0.86 to 0.91, resulting in
minor increases in MP RVUs for TC services. However, given that the MP
RVUs for TC services are generally low, any increase to the MP RVUs
could result in a significant percentage increase. For example, the
proposed CY 2015 MP RVU for HCPCS code 93455 increased from 0.04 to
0.05 yielding a 25 percent increase. Therefore, a minor increase in MP
RVUs for a TC service could result in a significant percentage change.
We believe that using the updated RBMA premium data without further
study is problematic because the updated data reflects only the median
umbrella non-physician MP premium, rather than the mean as was used for
the 2010 MP RVU update and the proposed 2015 MP RVU update.
We believe further study is necessary to reconcile comments on the
use of updated RBMA premium data for TC services (which would result in
an increase MP RVU for TC services) and our current methodology for
calculating the risk factor for PC services relative to the global
service and TC service. Therefore, we will finalize the TC premium data
as proposed and maintain our current methodology for calculating the PC
risk factor. We will consider the request to use the updated premium
information from RBMA and alternatives to our current methodology for
calculating the PC risk factor as part of our further study and would
propose any changes through future rulemaking.
Comment: Several commenters supported our proposal to classify
cardiac catheterization and angioplasty services as surgical procedures
for the purpose of establishing service level risk factors. The
commenters also agreed with our proposal to apply the surgical risk
factor to injection procedures used in conjunction with cardiac
catheterization. The same commenters identified additional cardiac
catheterization and angioplasty services that were not included on the
proposed list of invasive cardiology services. Specifically, the
commenters requested that we consider adding HCPCS codes 92961, 92986,
92987, 92990, 92992, 92993, 92997, and 92998 to the list of invasive
cardiology procedures classified as surgery for purposes of assigning
service level risk factors because the MP risk for these services is
similar to surgery.
Response: We agree that the MP risk associated with the cardiac
catheterization and angioplasty services mentioned by the commenters
are more akin to surgical procedures than most non-surgical services.
Therefore, we will add cardiac catheterization and angioplasty services
as described by HCPCS codes 92961, 92986, 92987, 92990, 92997, and
92998 to the list of services outside of the surgical HCPCS code range
to be considered surgery for purposes of assigning service level MP
risk factors. We note that HCPCS codes 92992 and 92993 are contractor-
priced codes, wherein the Medicare claims processing contractors
establish RVUs and payment amounts for these services. Therefore, we
are not adding HCPCS codes 92992 and 92993.
Comment: One commenter stated that several injection codes were not
included in the list of services outside of the surgical HCPCS code
range considered surgery. The commenter requested that we add injection
services as described by HCPCS codes 93565, 93566, 93567, and 93568 to
the services considered as surgery.
Response: The commenter is mistaken. As discussed in the CY 2015
proposed rule (79 FR 40353 through 40354), we included the injection
procedure codes mentioned by the commenter on the list of services
outside of the surgical HCPCS code range to be considered surgery for
purposes of assigning service level MP risk factors.
Comment: One commenter questioned why the MP RVUs decrease for
cardiac catheterization services as described by HCPCS codes 93530,
93531 and 93580. The commenter stated that our proposal to assign the
surgical risk factor to invasive cardiology services outside of the
surgical HCPCS code range should result in an increase in MP RVUs.
Response: Cardiac catheterizations as described by HCPCS codes
93530, 93531 and 93580 are currently on the list of invasive cardiology
services classified as surgery for purposes of assigning service level
risk factors. Therefore, the MP RVUs for HCPCS codes 93530, 93531,
93580 were calculated in the last update using the surgical risk factor
applicable to the specialty(s) furnishing these services. As discussed
previously in this section, the service level risk factors reflect the
average risk factor (weighted by allowed services) of the specialties
furnishing a given service. Changes in the specialty mix since the
previous MP RVU update in 2010 resulted in a decrease in MP RVUs for
HCPCS codes 93530, 93531, and 93580. That is, the percentage of allowed
services attributed to cardiology decreased for these service codes
while the percentage of allowed services furnished by other specialties
with risk factors lower than cardiology, such as internal medicine and
pediatric medicine, increased.
Comment: Many commenters requested an explanation as to why the MP
RVUs decreased for 4 out of the 6 newly bundled image guided breast
biopsy procedures. The commenters
[[Page 67596]]
stated that given that the MP RVUs assigned to breast biopsy codes are
being reduced, CMS is not appropriately capturing the risk a physician
assumes when performing a procedure to diagnose cancer. Several
commenters also explained that the misdiagnosis of breast cancer is a
leading source of MP litigation and that reduction in payment for
breast biopsies will have an impact on patient care.
Response: For the image guided breast biopsy procedures as
described by HCPCS codes 19081 through 19086, we used the risk factors
from source codes as recommended by the RUC. The source codes for
breast biopsy codes 19081, 19082, 19083, 19084, 19085 and 19086 are
HCPCS codes 32553, 64480, 32551, 64480, 36565, and 76812, respectively.
Given that the proposed risk factors for HCPCS codes 32553, 64480, and
32551 decreased from 2014 to 2015, the corresponding ``destination''
service codes, that is HCPCS codes 19081, 19082, 19083, and 19084 also
decreased.
Comment: Several commenters recommended that we implement an annual
collection and review of MP premium data and rescale the MP RVUs each
year, as we do with the PE RVUs. The commenters also stated that an
annual update would provide additional transparency and allow
stakeholders to identify potential problems and or improvements to MP
RVUs more frequently.
Response: We appreciate the comments from stakeholders regarding
the frequency that we currently review changes in MP premium data. As
discussed in the CY 2015 PFS proposed rule (79 FR 40349 through 40355),
there are two main aspects to the update of MP RVUs, recalculation of
specialty risk factors based upon updated premium data and
recalculation of service level RVUs based upon the mix of practitioners
providing the service. We will consider the recommendation from
stakeholders to conduct annual MP RVU updates to reflect corrections
and changes in the mix of practitioners providing services. We will
also consider the appropriate frequency for collecting new MP premium
data. After reviewing these issues, we would address potential changes
regarding the frequency of MP RVU updates in a future proposed rule.
Comment: One commenter urged us to calculate risk factors for all
specialties approved by the American Board Medical Specialties (ABMS)
since 2010. The commenter stated that by using the approved ABMS
specialties, all specialties and subspecialties will be represented,
including the recently approved sub-specialty of Female Pelvic Medicine
and Reconstructive Surgery.
Response: We calculate service level risk factors based on the mix
of specialties that furnish a given service as indicated by our claims
data. Medicare claims data reflects the service volume by Medicare
primary specialty designations. Therefore, we can only use MP risk
factors by Medicare primary specialty codes.
Comment: We received two comments regarding our discussion of how
to reflect updated MP premium data under the anesthesiology fee
schedule. One commenter supported our decision to delay the anesthesia
MP update and requested to work with us on developing an appropriate
method for updating the MP component associated with anesthesia fee
schedule services. Another commenter suggested using mean anesthesia MP
premiums per provider over a 4- or 5-year period prorated by Medicare
utilization to yield the MP expense for anesthesia services. The
commenter stated that the calculation of premiums over a longer period
of time renders the average more accurate and less volatile than a
calculation over a 1-year period.
Response: We appreciate the comments on our potential approach for
updating the MP resource costs for anesthesia fee schedule services. We
will consider the commenter's suggestions to use multi-year average
premiums as we develop a method for updating MP payments for services
paid on the anesthesia fee schedule.
4. Result of Evaluation of Comments
After consideration of the public comments received on the CY 2015
MP RVU update, we are finalizing the CY 2015 MP RVU update as proposed
with minor modifications. We are crosswalking gynecological oncology to
the risk factor for general surgery (instead of the risk factor for
obstetrics gynecology). We are also adding HCPCS codes 92961, 92986,
92987, 92990, 92997, and 92998 to the list of services outside of the
surgical HCPCS code range considered as surgery for purposes of
assigning service level risk factors. Additionally, for determining the
risk factor for low volume services, we are overriding the dominant
specialty from our claims data with the recommended specialty for the
low volume service codes listed in Table 12. For all other low volume
services, we are finalizing our proposal to use the risk factor of the
dominant specialty from our Medicare claims data. The MP premium
amounts, specialty risk factors, and a complete list of service codes
outside the surgical HCPCS code range considered surgery for the
purpose of assigning service level risk factors, may be found on the
CMS Web site under the supporting documents section of the CY 2015 PFS
final rule with comment period.
Additional information on the CY 2015 update may be found in our
contractor's report, ``Final Report on the CY 2105 Update of
Malpractice RVUs,'' which is available on the CMS Web site. It is also
located under the supporting documents section of the CY 2015 PFS final
rule with comment period located at https://www.cms.gov/PhysicianFeeSched/.
D. Geographic Practice Cost Indices (GPCIs)
1. Background
Section 1848(e)(1)(A) of the Act requires us to develop separate
Geographic Practice Cost Indices (GPCIs) to measure relative cost
differences among localities compared to the national average for each
of the three fee schedule components (that is, work, PE, and MP).
Although the statute requires that the PE and MP GPCIs reflect the full
relative cost differences, section 1848(e)(1)(A)(iii) of the Act
requires that the work GPCIs reflect only one-quarter of the relative
cost differences compared to the national average. In addition, section
1848(e)(1)(G) of the Act sets a permanent 1.5 work GPCI floor for
services furnished in Alaska beginning January 1, 2009, and section
1848(e)(1)(I) of the Act sets a permanent 1.0 PE GPCI floor for
services furnished in frontier states (as defined in section
1848(e)(1)(I) of the Act) beginning January 1, 2011. Additionally,
section 1848(e)(1)(E) of the Act provided for a 1.0 floor for the work
GPCIs, which was set to expire on March 31, 2014. However, section 102
of the PAMA extended application of the 1.0 floor to the work GPCI
through March 31, 2015.
Section 1848(e)(1)(C) of the Act requires us to review and, if
necessary, adjust the GPCIs at least every 3 years. Section
1848(e)(1)(C) of the Act requires that ``if more than 1 year has
elapsed since the date of the last previous adjustment, the adjustment
to be applied in the first year of the next adjustment shall be 1/2 of
the adjustment that otherwise would be made.'' We completed a review
and finalized updated GPCIs in the CY 2014 PFS final rule with comment
period (78 FR 74390). Since the last GPCI update had been implemented
over 2 years prior, CY 2011 and CY 2012, we phased in 1/2 of the latest
GPCI adjustment in CY 2014. We also revised the cost share
[[Page 67597]]
weights that correspond to all three GPCIs in the CY 2014 PFS final
rule with comment period. We calculated a corresponding geographic
adjustment factor (GAF) for each PFS locality. The GAFs are a weighted
composite of each area's work, PE and MP GPCIs using the national GPCI
cost share weights. Although the GAFs are not used in computing the fee
schedule payment for a specific service, we provide them because they
are useful in comparing overall areas costs and payments. The actual
effect on payment for any actual service will deviate from the GAF to
the extent that the proportions of work, PE and MP RVUs for the service
differ from those of the GAF.
As previously noted, section 102 of the PAMA extended the 1.0 work
GPCI floor through March 31, 2015. Therefore, the CY 2015 work GPCIs
and summarized GAFs were revised to reflect the 1.0 work floor.
Additionally, as required by sections 1848(e)(1)(G) and 1848(e)(1)(I)
of the Act, the 1.5 work GPCI floor for Alaska and the 1.0 PE GPCI
floor for frontier states are permanent, and therefore, applicable in
CY 2015.
Comment: A few commenters requested that we extend the 1.0 work
GPCI floor beyond March 31, 2015.
Response: As discussed in section II.D.1, the 1.0 work GPCI floor
is established by statute and expires on March 31, 2015. We do not have
authority to extend the 1.0 work GPCI floor beyond March 31, 2015.
As discussed in the CY 2014 PFS final rule with comment period (78
FR 74380) the updated GPCIs were calculated by a contractor to CMS. We
used updated Bureau of Labor and Statistics Occupational Employment
Statistics (BLS OES) data (2009 through 2011) as a replacement for 2006
through 2008 data for purposes of calculating the work GPCI and the
employee compensation component and purchased services component of the
PE GPCI. We also used updated U.S. Census Bureau American Community
Survey (ACS) data (2008 through 2010) as a replacement for 2006 through
2008 data for calculating the office rent component of the PE GPCI. To
calculate the MP GPCI we used updated malpractice premium data (2011
and 2012) from state departments of insurance as a replacement for 2006
through 2007 premium data. We also noted that we do not adjust the
medical equipment, supplies and other miscellaneous expenses component
of the PE GPCI because we continue to believe there is a national
market for these items such that there is not a significant geographic
variation in relative costs. Additionally, we updated the GPCI cost
share weights consistent with the modifications made to the 2006-based
MEI cost share weights in the CY 2014 final rule with comment period.
As discussed in the CY 2014 final rule with comment period, use of the
revised GPCI cost share weights changed the weighting of the
subcomponents within the PE GPCI (employee wages, office rent,
purchased services, and medical equipment and supplies). For a detailed
explanation of how the GPCI update was developed, see the CY 2014 final
rule with comment period (78 FR 74380 through 74391).
2. Proposed Changes to the GPCI Values for the Virgin Islands Payment
Locality
As discussed in the CY 2015 proposed rule (79 FR 40355 through
40356) the current methodology for calculating locality level GPCIs
relies on the acquisition of county level data (when available). Where
data for a specific county are not available, we assign the data from a
similar county within the same payment locality. The Virgin Islands
have county level equivalents identified as districts. Specifically,
the Virgin Islands are divided into 3 districts: Saint Croix; Saint
Thomas; and Saint John. These districts are, in turn, subdivided into
20 sub-districts. Although the Virgin Islands are divided into these
county equivalents, county level data for the Virgin Islands are not
represented in the BLS OES wage data. Additionally, the ACS, which is
used to calculate the rent component of the PE GPCI, is not conducted
in the Virgin Islands, and we have not been able to obtain malpractice
insurance premium data for the Virgin Islands payment locality. Given
the absence of county level wage and rent data and the insufficient
malpractice premium data by specialty type, we have historically set
the three GPCI values for the Virgin Islands payment locality at 1.0.
For CY 2015, we explored using the available data from the Virgin
Islands to more accurately reflect the geographic cost differences for
the Virgin Islands payment locality as compared to other PFS
localities. Although county level data for the Virgin Islands are not
represented in the BLS OES wage data, aggregate territory level BLS OES
wage data are available. We believe that using aggregate territory
level data is a better reflection of the relative cost differences of
operating a medical practice in the Virgin Islands payment locality as
compared to other PFS localities than the current approach of assigning
a value of 1.0. At our request, our contractor calculated the work
GPCI, and the employee wage component and purchased services component
of the PE GPCI, for the Virgin Islands payment locality using
aggregated 2009 through 2011 BLS OES data.
As discussed in this section, the ACS is not conducted in the
Virgin Islands and we have not been able to obtain malpractice premium
data for the Virgin Islands payment locality. Therefore, we assigned a
value of 1.0 for the rent index of the PE GPCI and to the MP GPCI.
Using aggregate territory-level BLS OES wage data resulted in a -
2.3 percent decrease in the work GPCI, a -4.48 percent decrease in the
PE GPCI and a -3.2 percent decrease to the GAF for the Virgin Islands
payment locality. However, with the application of the 1.0 work GPCI
floor, there is no change to the work GPCI and the overall impact of
using actual BLS OES wage data on the Virgin Islands payment locality
is only reflected by the change in PE GPCI (-4.48 percent) resulting in
a -2.00 percent decrease to the GAF. As mentioned previously in this
section, since we have not been able to obtain malpractice premium data
for the Virgin Islands payment locality we maintained the MP GPCI at
1.0. As such, we did not propose any changes to the MP GPCI.
We requested comments on our proposal to use aggregate territory-
level BLS OES wage data to calculate the work GPCI and the employee
wage component and purchased services component of the PE GPCI for the
Virgin Islands payment locality beginning for CY 2015, and for future
GPCI updates. However, we did not receive any specific comments on this
proposal. As discussed above, we believe that using aggregate territory
level BLS OES wage data is a better reflection of the relative cost
differences of operating a medical practice in the Virgin Islands
payment locality as compared to other PFS localities than the current
approach of assigning a value of 1.0. Therefore, we will finalize the
changes to the GPCI values for the Virgin Islands payment locality as
proposed. See Addenda D and E for the CY 2015 GPCIs and summarized
GAFs. Additional information on the changes to GPCI values for the
Virgin Islands payment locality may be found in our contractor's
report, ``Revised Final Report on the CY 2014 Update of the Geographic
Practice Cost Index for the Medicare Physician Fee Schedule,'' which is
available on the CMS Web site. It is located under the supporting
documents section of the CY 2015 PFS final rule with comment period
located at https://www.cms.gov/PhysicianFeeSched/.
[[Page 67598]]
3. Additional Comments
We received several comments on topics that are not within the
scope of proposals in the CY 2015 PFS proposed rule. These comments are
briefly discussed below.
Comment: Many commenters continued to request an increase in the
GPCI values for the Puerto Rico payment locality. The commenters stated
that the cost of practicing medicine in Puerto Rico continues to rise.
The commenters believe that commercial rent and utility costs, and the
cost of obtaining medical equipment and supplies are higher in Puerto
Rico than many states and territories. Commenters contend that the data
used to calculate GPCIs do not accurately reflect the cost of operating
a medical practice in Puerto Rico.
Response: Aside from proposing to use territory-wide wage data for
the Virgin Islands payment locality, we finalized the methodology and
values for the 7th GPCI update in the CY 2014 PFS final rule with
comment period. We did not propose any changes to the GPCIs for the
Puerto Rico payment locality, and the commenters on the CY 2015 PFS
proposed rule raised the same issues they raised in response to the
proposed GPCI update that we finalized in CY 2014. In the CY 2014 PFS
final rule with comment period (78 FR 74380 through 74391), we
summarized these comments and responded to these issues.
Comment: A few commenters stated that GPCIs for rural areas are too
low which leads to reduced numbers of rural practitioners and reduced
access to care. Two commenters stated that the PE GPCI does not account
for differences in practice costs for x-rays and imaging studies. The
same commenters and another commenter also requested that we replace
the current method for calculating the work GPCIs with one that
reflects the labor market for physicians and other health professionals
as recommended by MedPAC. Another commenter raised questions about
state patient compensation fund surcharges for malpractice insurance
and the implications of those for the MP GPCI values. Additionally, we
received a comment about the physician fee schedule payment localities.
Response: As noted in this section, we finalized the 7th GPCI
update in the CY 2014 PFS final rule with comment period and, other
than the proposal relating to the use of territory-wide wage data for
the Virgin Islands payment locality, we did not propose any further
changes in the CY 2015 PFS proposed rule. We will consider these points
raised by commenters when we develop a proposal for the 8th GPCI
update.
E. Medicare Telehealth Services
1. Billing and Payment for Telehealth Services
Several conditions must be met in order for Medicare payments to be
made for telehealth services under the PFS. Specifically, the service
must be on the list of Medicare telehealth services and meet all of the
following additional requirements for coverage:
The service must be furnished via an interactive
telecommunications system.
The practitioner furnishing the service must meet the
telehealth requirements, as well as the usual Medicare requirements.
The service must be furnished to an eligible telehealth
individual.
The individual receiving the services must be in an
eligible originating site.
When all of these conditions are met, Medicare pays an originating
site fee to the originating site and provides separate payment to the
distant site practitioner furnishing the service.
Section 1834(m)(4)(F)(i) of the Act defines Medicare telehealth
services to include consultations, office visits, office psychiatry
services, and any additional service specified by the Secretary, when
furnished via a telecommunications system. We first implemented this
statutory provision, which was effective October 1, 2001, in the CY
2002 PFS final rule with comment period (66 FR 55246). We established a
process for annual updates to the list of Medicare telehealth services
as required by section 1834(m)(4)(F)(ii) of the Act in the CY 2003 PFS
final rule with comment period (67 FR 79988).
As specified at Sec. 410.78(b), we generally require that a
telehealth service be furnished via an interactive telecommunications
system. Under Sec. 410.78(a)(3), an interactive telecommunications
system is defined as multimedia communications equipment that includes,
at a minimum, audio and video equipment permitting two-way, real-time
interactive communication between the patient and distant site
physician or practitioner.
Telephones, facsimile machines, and electronic mail systems do not
meet the definition of an interactive telecommunications system. An
interactive telecommunications system is generally required as a
condition of payment; however, section 1834(m)(1) of the Act allows the
use of asynchronous ``store-and-forward'' technology when the
originating site is part of a federal telemedicine demonstration
program in Alaska or Hawaii. As specified in regulations at Sec.
410.78(a)(1), store-and-forward means the asynchronous transmission of
medical information from an originating site to be reviewed at a later
time by the practitioner at the distant site.
Medicare telehealth services may be furnished to an eligible
telehealth individual notwithstanding the fact that the practitioner
furnishing the telehealth service is not at the same location as the
beneficiary. An eligible telehealth individual means an individual
enrolled under Part B who receives a telehealth service furnished at an
originating site.
Practitioners furnishing Medicare telehealth services are reminded
that these services are subject to the same non-discrimination laws as
other services, including the effective communication requirements for
persons with disabilities of section 504 of the Rehabilitation Act and
language access for persons with limited English proficiency, as
required under Title VI of the Civil Rights Act of 1964. For more
information, see https://www.hhs.gov/ocr/civilrights/resources/specialtopics/hospitalcommunication.
Practitioners furnishing Medicare telehealth services submit claims
for telehealth services to the Medicare Administrative Contractors that
process claims for the service area where their distant site is
located. Section 1834(m)(2)(A) of the Act requires that a practitioner
who furnishes a telehealth service to an eligible telehealth individual
be paid an amount equal to the amount that the practitioner would have
been paid if the service had been furnished without the use of a
telecommunications system.
Originating sites, which can be one of several types of sites
specified in the statute where an eligible telehealth individual is
located at the time the service is being furnished via a
telecommunications system, are paid a fee under the PFS for each
Medicare telehealth service. The statute specifies both the types of
entities that can serve as originating sites and the geographic
qualifications for originating sites. With regard to geographic
qualifications, Sec. 410.78(b)(4) limits originating sites to those
located in rural health professional shortage areas (HPSAs) or in a
county that is not included in a metropolitan statistical areas (MSAs).
Historically, we have defined rural HPSAs to be those located
outside of MSAs. Effective January 1, 2014, we modified the regulations
regarding
[[Page 67599]]
originating sites to define rural HPSAs as those located in rural
census tracts as determined by the Office of Rural Health Policy (ORHP)
of the Health Resources and Services Administration (HRSA) (78 FR
74811). Defining ``rural'' to include geographic areas located in rural
census tracts within MSAs allows for broader inclusion of sites within
HPSAs as telehealth originating sites. Adopting the more precise
definition of ``rural'' for this purpose expands access to health care
services for Medicare beneficiaries located in rural areas. HRSA has
developed a Web site tool to provide assistance to potential
originating sites to determine their geographic status. To access this
tool, see the CMS Web site at www.cms.gov/telehealth/.
An entity participating in a federal telemedicine demonstration
project that has been approved by, or received funding from, the
Secretary as of December 31, 2000 is eligible to be an originating site
regardless of its geographic location.
Effective January 1, 2014, we also changed our policy so that
geographic eligibility for an originating site would be established and
maintained on an annual basis, consistent with other telehealth payment
policies (78 FR 74400). Geographic eligibility for Medicare telehealth
originating sites for each calendar year is now based upon the status
of the area as of December 31 of the prior calendar year.
For a detailed history of telehealth payment policy, see 78 FR
74399.
2. Adding Services to the List of Medicare Telehealth Services
As noted previously, in the December 31, 2002 Federal Register (67
FR 79988), we established a process for adding services to or deleting
services from the list of Medicare telehealth services. This process
provides the public with an ongoing opportunity to submit requests for
adding services. Under this process, we assign any qualifying request
to make additions to the list of telehealth services to one of two
categories. Revisions to criteria that we use to review requests in the
second category were finalized in the November 28, 2011 Federal
Register (76 FR 73102). The two categories are:
Category 1: Services that are similar to professional
consultations, office visits, and office psychiatry services that are
currently on the list of telehealth services. In reviewing these
requests, we look for similarities between the requested and existing
telehealth services for the roles of, and interactions among, the
beneficiary, the physician (or other practitioner) at the distant site
and, if necessary, the telepresenter, a practitioner with the
beneficiary in the originating site. We also look for similarities in
the telecommunications system used to deliver the proposed service; for
example, the use of interactive audio and video equipment.
Category 2: Services that are not similar to the current
list of telehealth services. Our review of these requests includes an
assessment of whether the service is accurately described by the
corresponding code when furnished via telehealth and whether the use of
a telecommunications system to deliver the service produces
demonstrated clinical benefit to the patient. In reviewing these
requests, we look for evidence indicating that the use of a
telecommunications system in furnishing the candidate telehealth
service produces clinical benefit to the patient. Submitted evidence
should include both a description of relevant clinical studies that
demonstrate the service furnished by telehealth to a Medicare
beneficiary improves the diagnosis or treatment of an illness or injury
or improves the functioning of a malformed body part, including dates
and findings, and a list and copies of published peer reviewed articles
relevant to the service when furnished via telehealth. Our evidentiary
standard of clinical benefit does not include minor or incidental
benefits.
Some examples of clinical benefit include the following:
Ability to diagnose a medical condition in a patient
population without access to clinically appropriate in-person
diagnostic services.
Treatment option for a patient population without access
to clinically appropriate in-person treatment options.
Reduced rate of complications.
Decreased rate of subsequent diagnostic or therapeutic
interventions (for example, due to reduced rate of recurrence of the
disease process).
Decreased number of future hospitalizations or physician
visits.
More rapid beneficial resolution of the disease process
treatment.
Decreased pain, bleeding, or other quantifiable symptom.
Reduced recovery time.
For the list of covered telehealth services, see the CMS Web site
at www.cms.gov/teleheath/. Requests to add services to the list of
Medicare telehealth services must be submitted and received no later
than December 31 of each calendar year to be considered for the next
rulemaking cycle. For example, qualifying requests submitted before the
end of CY 2014 will be considered for the CY 2016 proposed rule. Each
request to add a service to the list of Medicare telehealth services
must include any supporting documentation the requester wishes us to
consider as we review the request. Because we use the annual PFS
rulemaking process as a vehicle for making changes to the list of
Medicare telehealth services, requestors should be advised that any
information submitted is subject to public disclosure for this purpose.
For more information on submitting a request for an addition to the
list of Medicare telehealth services, including where to mail these
requests, see the CMS Web site at www.cms.gov/telehealth/.
3. Submitted Requests to the List of Telehealth Services for CY 2015
Under our existing policy, we add services to the telehealth list
on a category 1 basis when we determine that they are similar to
services on the existing telehealth list with respect to the roles of,
and interactions among, the beneficiary, physician (or other
practitioner) at the distant site and, if necessary, the telepresenter.
As we stated in the CY 2012 final rule with comment period (76 FR
73098), we believe that the category 1 criteria not only streamline our
review process for publicly requested services that fall into this
category, the criteria also expedite our ability to identify codes for
the telehealth list that resemble those services already on this list.
a. Submitted Requests
We received several requests in CY 2013 to add various services as
Medicare telehealth services effective for CY 2015. The following
presents a discussion of these requests, and our proposals for
additions to the CY 2015 telehealth list. Of the requests received, we
find that the following services are sufficiently similar to
psychiatric diagnostic procedures or office/outpatient visits currently
on the telehealth list to qualify on a category one basis. Therefore,
we propose to add the following services to the telehealth list on a
category 1 basis for CY 2015:
CPT codes 90845 (Psychoanalysis); 90846 (family
psychotherapy (without the patient present); and 90847 (family
psychotherapy (conjoint psychotherapy) (with patient present);
CPT codes 99354 (prolonged service in the office or other
outpatient setting requiring direct patient contact beyond the usual
service; first hour (list separately in addition to code for office or
other outpatient evaluation and management service); and, 99355
(prolonged service in the office or other outpatient setting requiring
direct patient contact beyond the usual service; each additional 30
minutes (list
[[Page 67600]]
separately in addition to code for prolonged service); and,
HCPCS codes G0438 (annual wellness visit; includes a
personalized prevention plan of service (pps), initial visit; and,
G0439 (annual wellness visit, includes a personalized prevention plan
of service (pps), subsequent visit).
We also received requests to add services to the telehealth list
that do not meet our criteria for being on the Medicare telehealth
list. We did not propose to add the following procedures for the
reasons noted:
CPT codes 92250 (fundus photography with interpretation
and report); 93010 (electrocardiogram, routine ECG with at least 12
leads; interpretation and report only), 93307 (echocardiography,
transthoracic, real-time with image documentation (2d), includes m-mode
recording, when performed, complete, without spectral or color Doppler
echocardiography; 93308 (echocardiography, transthoracic, real-time
with image documentation (2d), includes m-mode recording, when
performed, follow-up or limited study); 93320 (Doppler
echocardiography, pulsed wave and/or continuous wave with spectral
display (list separately in addition to codes for echocardiographic
imaging); complete); 93321 (Doppler echocardiography, pulsed wave and/
or continuous wave with spectral display (list separately in addition
to codes for echocardiographic imaging); follow-up or limited study
(list separately in addition to codes for echocardiographic imaging);
and 93325 (Doppler echocardiography color flow velocity mapping (list
separately in addition to codes for echocardiography). These services
include a technical component (TC) and a professional component (PC).
By definition, the TC portion of these services needs to be furnished
in the same location as the patient and thus cannot be furnished via
telehealth. The PC portion of these services could be (and typically
would be) furnished without the patient being present in the same
location. (Note: For services that have a TC and a PC, there is
sometimes an entirely different code that is used when only the PC
portion of the service is being furnished, and other times the same CPT
code is used with a -26 modifier to indicate that only the PC is being
billed.) For example, the interpretation by a physician of an actual
electrocardiogram or electroencephalogram tracing that has been
transmitted electronically, can be furnished without the patient being
present in the same location as the physician. Given the nature of
these services, it is not necessary to consider including the PC of
these services for addition to the telehealth list. When these PC
services are furnished remotely, they do not meet the definition of
Medicare telehealth services under section 1834(m) of the Act. Rather,
these remote services are considered physicians' services in the same
way as services that are furnished in-person without the use of
telecommunications technology; they are paid under the same conditions
as in-person physicians' services (with no requirements regarding
permissible originating sites), and should be reported in the same way
as other physicians' services (that is, without the -GT or -GQ
modifiers).
CPT codes 96103 (psychological testing (includes
psychodiagnostic assessment of emotionality, intellectual abilities,
personality and psychopathology, eg, MMPI), administered by a computer,
with qualified health care professional interpretation and report);
and, 96120 (neuropsychological testing (eg, Wisconsin Card Sorting
Test), administered by a computer, with qualified health care
professional interpretation and report). These services involve testing
by computer, can be furnished remotely without the patient being
present, and are payable in the same way as other physicians' services.
These remote services are not Medicare telehealth services as defined
under the Act; therefore, we need not consider them for addition to the
telehealth list, and the restrictions that apply to telehealth services
do not apply to these services.
CPT codes 90887 (interpretation or explanation of results
of psychiatric, other medical examinations and procedures, or other
accumulated data to family or other responsible persons, or advising
them how to assist patient); 99090 (analysis of clinical data stored in
computers (eg, ECGs, blood pressures, hematologic data); 99091
(collection and interpretation of physiologic data (eg, ECG, blood
pressure, glucose monitoring) digitally stored and/or transmitted by
the patient and/or caregiver to the physician or other qualified health
care professional, qualified by education, training, licensure/
regulation (when applicable) requiring a minimum of 30 minutes of
time); 99358 (prolonged evaluation and management service before and/or
after direct patient care; first hour); and 99359 (prolonged evaluation
and management service before and/or after direct patient care; each
additional 30 minutes (list separately in addition to code for
prolonged service). These services are not separately payable by
Medicare. It would be inappropriate to include services as telehealth
services when Medicare does not otherwise make a separate payment for
them.
CPT codes 96101 (psychological testing (includes
psychodiagnostic assessment of emotionality, intellectual abilities,
personality and psychopathology, eg, MMPI, Rorschach, WAIS), per hour
of the psychologist's or physician's time, both face-to-face time
administering tests to the patient and time interpreting these test
results and preparing the report); 96102 (psychological testing
(includes psychodiagnostic assessment of emotionality, intellectual
abilities, personality and psychopathology, eg, MMPI and WAIS), with
qualified health care professional interpretation and report,
administered by technician, per hour of technician time, face-to-face);
96118 (neuropsychological testing (eg, Halstead-Reitan
Neuropsychological Battery, Wechsler Memory Scales and Wisconsin Card
Sorting Test), per hour of the psychologist's or physician's time, both
face-to-face time administering tests to the patient and time
interpreting these test results and preparing the report); and, 96119
(neuropsychological testing (eg, Halstead-Reitan Neuropsychological
Battery, Wechsler Memory Scales and Wisconsin Card Sorting Test), with
qualified health care professional interpretation and report,
administered by technician, per hour of technician time, face-to-face).
These services are not similar to other services on the telehealth
list, as they require close observation of how a patient responds. The
requestor did not submit evidence supporting the clinical benefit of
furnishing these services on a category 2 basis. As such, we did not
propose to add these services to the list of telehealth services.
CPT codes 57452 (colposcopy of the cervix including upper/
adjacent vagina; 57454 colposcopy of the cervix including upper/
adjacent vagina; with biopsy(s) of the cervix and endocervical
curettage); and, 57460 (colposcopy of the cervix including upper/
adjacent vagina; with loop electrode biopsy(s) of the cervix). These
services are not similar to other services on the telehealth service
list. Therefore, it would not be appropriate to add them on a category
1 basis. The requestor did not submit evidence supporting the clinical
benefit of furnishing these services on a category 2 basis. As such, we
did not propose to add these services to the list of telehealth
services.
HCPCS code M0064 (brief office visit for the sole purpose
of monitoring or changing drug prescriptions used in the treatment of
mental psychoneurotic
[[Page 67601]]
and personality disorders) is being deleted for CY 2015. This code was
created specifically to describe a service that is not subject to the
statutory outpatient mental health limitation, which limited payment
amounts for certain mental health services. Section 102 of the Medicare
Improvements for Patients and Providers Act (Pub. L. 110- 275, enacted
on July 15, 2008) (MIPPA) required that the limitation on payment for
outpatient mental health treatment to 62.5 percent of incurred
expenses, in effect since the inception of the Medicare program, be
reduced over four years. This limitation on payment for mental health
treatment created a higher share of beneficiary coinsurance for these
services than for most other Medicare services paid under the PFS.
Effective January 1, 2014, 100 percent of expenses incurred for mental
health treatment services are considered as incurred for purposes of
Medicare, resulting in the same beneficiary cost sharing for these
services as for other PFS services. Since the statute was amended to
phase out the limitation, and the phase-out was complete effective
January 1, 2014, Medicare no longer has a need to distinguish services
subject to the mental health limitation from those that are not.
Accordingly, the appropriate CPT code can now be used to bill Medicare
for the services that would have otherwise been reported using M0064
and M0064 will be eliminated as a telehealth service, effective January
1, 2015.
Urgent Dermatologic Problems and Wound Care--The American
Telemedicine Association (ATA) cited several studies to support adding
dermatology services to the telehealth list. However, the request did
not include specific codes. Since we did not have specific codes to
consider for this request, we cannot evaluate whether the services are
appropriate for addition to the Medicare telehealth services list. We
note that some of the services that the requester had in mind may be
billed under the telehealth office visit codes or the telehealth
consultation G-codes.
In summary, we proposed to add the following codes to the
telehealth list on a category 1 basis:
Psychotherapy services CPT codes 90845, 90846 and 90847.
Prolonged service office CPT codes 99354 and 99355.
Annual wellness visit HCPCS codes G0438 and G0439.
3. Modifying Sec. 410.78 Regarding List of Telehealth Services
As discussed in section II.E.2. of this final rule with comment
period, under the statute, we created an annual process for considering
the addition of services to the Medicare telehealth list. Under this
process, we propose services to be added to the list in the proposed
rule in response to public nominations or our own initiative and seek
public comments on our proposals. After consideration of public
comments, we finalize additions to the list in the final rule. We have
also revised Sec. 410.78(b) each year to include the description of
the added services. Because the list of Medicare telehealth services
has grown quite lengthy, and given the other mechanisms by which we can
make the public aware of the list of Medicare telehealth services for
each year, we proposed to revise Sec. 410.78(b) by deleting the
description of the individual services for which Medicare payment can
be made when furnished via telehealth. Under this proposal, we would
continue our current policy to address requests to add to the list of
telehealth services through the PFS rulemaking process so that the
public would have the opportunity to comment on additions to the list.
We also proposed to revise Sec. 410.78(f) to indicate that a list of
Medicare telehealth codes and descriptors is available on the CMS Web
site.
The following is a summary of the comments we received regarding
the proposed addition of services to the list of Medicare telehealth
services.
Comment: All commenters supported one or more of our proposals to
add psychotherapy services (CPT codes 90845, 90846 and 90847);
prolonged service office (CPT codes 99354 and 99355); and annual
wellness visit (HCPCS codes G0438 and G0439) to the list of Medicare
telehealth services for CY 2015.
Response: We appreciate the commenters' support for the proposed
additions to the list of Medicare telehealth services. After
consideration of the public comments received, we are finalizing our CY
2015 proposal to add these services to the list of telehealth services
for CY 2015 on a category 1 basis.
Comment: Commenters also agreed with our rationale for rejecting
other requested additions to the telehealth list. However, one
commenter disagreed with our decision not to propose adding dermatology
services, including those furnished using store-and-forward technology,
to the list of telehealth services. Another commenter objected to our
proposal not to add psychological testing services to the telehealth
services list.
Response: As we noted in the proposed rule, the request to add
dermatology services did not include specific codes. Without specific
codes to consider, we cannot evaluate whether the services are
appropriate for addition to the Medicare telehealth services list. We
note that some of the services that the requester had in mind may be
billed under the telehealth office visit codes or the telehealth
consultation G-codes.
Concerning payment for services furnished using store-and-forward
technology, we note that the statute at section 1861(m) of the Act
includes store-and-forward technology as a telecommunication system for
telehealth services only in the case of federal telemedicine
demonstration programs in Alaska and Hawaii (see Sec. 410.78(d)).
Concerning psychological testing services, we noted that remote
services (CPT codes 96103 and 96120) are not Medicare telehealth
services as defined under the Act and thus can be furnished when
beneficiary is not in the same place as the practitioner. It would also
be counter-productive to add these codes to the telehealth list
because, if we did, the telehealth originating site, geographic, and
other restrictions would apply to these services.
CPT codes 90887, 90991, 93358 and 99359 are not separately payable
by Medicare. It would be inappropriate to include services as
telehealth services when Medicare does not otherwise make a separate
payment for them.
Finally, CPT codes 96101, 96102, 96118 and 96119 are not similar to
other services on the telehealth list, as they require close
observation of how a patient responds. The requestor did not submit
evidence supporting the clinical benefit of furnishing these services
on a category 2 basis. As such, we did not propose to add these
services to the list of telehealth services.
We received other public comments on matters related to Medicare
telehealth services that were not the subject of proposals in the CY
2015 PFS proposed rule. Because we did not make any proposals regarding
these matters, we generally do not summarize or respond to such
comments in the final rule. However, we are summarizing and responding
to the following comments to acknowledge the interests and concerns of
the commenters, and a mechanism to address some of those concerns.
Many commenters supported the overall expansion of telehealth by:
Removing geographic restrictions to include both rural and
urban areas.
Revising permissible originating sites to include a
patient's home, domiciliary care and first responder vehicles.
[[Page 67602]]
Adopting a broader definition of telehealth technologies
to include services provide via mobile technology, including emails,
phone calls, and store-and-forward technologies.
Adding physical and occupational therapists as
practitioners who can remotely furnish telehealth services.
Adding more services to the telehealth list, including
services under category 2.
Prioritizing coverage of services that include care
coordination with the patient's medical home and/or existing treating
physicians.
Considering the use of telehealth technology for the
purpose of furnishing direct supervision of services furnished by on-
site practitioners.
Using demonstration projects under CMS's Center for
Medicare and Medicaid Innovation (CMMI) to collect clinical evidence on
the effect of expanding telehealth and to address how telemedicine can
be integrated into new payment and delivery models.
Response: We appreciate the commenters' suggestions. As some
commenters noted, we do not have authority to implement many of these
revisions under the current statute. The CMS Innovation Center is
responsible for developing and testing new payment and service delivery
models to lower costs and improve quality for Medicare, Medicaid, and
CHIP beneficiaries. As part of that authority, the CMS Innovation
Center can consider potential new payment and service delivery models
to test changes to Medicare's telehealth payment policies.
In summary, after consideration of the comments we received, we are
finalizing our proposal to add psychotherapy services CPT codes 90845,
90846 and 90847; prolonged service office CPT codes 99354 and 99355;
and annual wellness visit HCPCS codes G0438 and G0439 to the list of
Medicare telehealth services.
In addition, we are finalizing our proposal to change our
regulation at Sec. 410.78(b) by deleting the description of the
individual services for which Medicare payment can be made when
furnished via telehealth. We will continue our current policy to
address requests to add services to the list of Medicare telehealth
services through the PFS rulemaking process so that the public has the
opportunity to comment on additions to the list. We are also finalizing
our proposal to revise Sec. 410.78(f) to indicate that a list of
Medicare telehealth codes and descriptors is available on the CMS Web
site.
We remind all interested stakeholders that we are currently
soliciting public requests to add services to the list of Medicare
telehealth services. To be considered during PFS rulemaking for CY
2016, these requests must be submitted and received by December 31,
2014. Each request to add a service to the list of Medicare telehealth
services must include any supporting documentation the requester wishes
us to consider as we review the request. For more information on
submitting a request for an addition to the list of Medicare telehealth
services, including where to mail these requests, we refer readers to
the CMS Web site at www.cms.gov/telehealth/.
5. Telehealth Originating Site Facility Fee Payment Amount Update
Section 1834(m)(2)(B) of the Act establishes the Medicare
telehealth originating site facility fee for telehealth services
furnished from October 1, 2001, through December 31 2002, at $20.00.
For telehealth services furnished on or after January 1 of each
subsequent calendar year, the telehealth originating site facility fee
is increased by the percentage increase in the MEI as defined in
section 1842(i)(3) of the Act. The MEI increase for 2015 is 0.8
percent. Therefore, for CY 2015, the payment amount for HCPCS code
Q3014 (Telehealth originating site facility fee) is 80 percent of the
lesser of the actual charge or $24.83. The Medicare telehealth
originating site facility fee and MEI increase by the applicable time
period is shown in Table 13.
Table 13--The Medicare Telehealth Originating Site Facility Fee and MEI
Increase by the Applicable Time Period
------------------------------------------------------------------------
MEI
Facility fee increase Period
------------------------------------------------------------------------
$20.00........................ N/A 10/01/2001-12/31/2002
20.60........................ 3.0 01/01/2003-12/31/2003
21.20........................ 2.9 01/01/2004-12/31/2004
21.86........................ 3.1 01/01/2005-12/31/2005
22.47........................ 2.8 01/01/2006-12/31/2006
22.94........................ 2.1 01/01/2007-12/31/2007
23.35........................ 1.8 01/01/2008-12/31/2008
23.72........................ 1.6 01/01/2009-12/31/2009
24.00........................ 1.2 01/01/2010-12/31/2010
24.10........................ 0.4 01/01/2011-12/31/2011
24.24........................ 0.6 01/01/2012-12/31/2012
24.43........................ 0.8 01/01/2013-12/31/2013
24.63........................ 0.8 01/01/2014-12/31/2014
24.83........................ 0.8 01/01/2015-12/31/2015
------------------------------------------------------------------------
F. Valuing New, Revised and Potentially Misvalued Codes
Establishing valuations for newly created and revised CPT codes is
a routine part of maintaining the PFS. Since inception of the PFS, it
has also been a priority to revalue services regularly to assure that
the payment rates reflect the changing trends in the practice of
medicine and current prices for inputs used in the PE calculations.
Initially, this was accomplished primarily through the five-year review
process, which resulted in revised RVUs for CY 1997, CY 2002, CY 2007,
and CY 2012. Under the five-year review process, revisions in RVUs were
proposed in a proposed rule and finalized in a final rule. In addition
to the five-year reviews, in each year beginning with CY 2009, CMS and
the RUC have identified a number of potentially misvalued codes using
various identification screens, such as codes with high growth rates,
codes that are frequently billed together, and high expenditure codes.
Section 3134 of the Affordable Care Act codified the misvalued code
initiative in section 1848(c)(2)(K) of the Act.
In the CY 2012 rulemaking process, we proposed and finalized
consolidation of the five-year review and the potentially misvalued
code activities into an annual review of potentially misvalued codes to
avoid redundancies in these efforts and better accomplish our goal of
assuring regular assessment of code values. Under the consolidated
process, we issue interim final RVUs for all revaluations and new codes
in the PFS final rule with comment period, and make payment based upon
those values during the calendar year covered by the final rule.
(Changes in the PFS methodology that may affect valuations of a variety
of codes are issued as proposals in the proposed rule.) We consider and
respond to any public comments on the interim final values in the final
rule with comment period for the subsequent year. When consolidating
these processes, we indicated that it was
[[Page 67603]]
appropriate to establish interim values for new, revised, and
potentially misvalued codes because of the incongruity between the PFS
rulemaking cycle and the release of codes by the AMA CPT Editorial
Panel and the RUC review process. We stated that if we did not
establish interim final values for revalued codes in the final rule
with comment period, ``a delay in implementing revised values for codes
that have been identified as misvalued would perpetuate payment for the
services at a rate that does not appropriately reflect the relative
resources involved in furnishing the service and would continue
unwarranted distortion in the payment for other services across the
PFS.'' We also reiterated that if we did not establish interim final
values for new and revised codes, we would either have to delay the use
of new and revised codes for one year, or permit each Medicare
contractor to establish its own payment rate for these codes. We
stated, ``We believe it would be contrary to the public interest to
delay adopting values for new and revised codes for the initial year,
especially since we have an opportunity to receive significant input
from the medical community [through the RUC] before adopting the
values, and the alternatives could produce undesirable levels of
uncertainty and inconsistency in payment for a year.''
1. Current Process for Valuing New, Revised, and Potentially Misvalued
Codes
Under the process finalized in the CY 2012 PFS final rule with
comment period, in each year's proposed rule, we propose specific codes
and/or groups of codes that we believe may be appropriate to consider
under our potentially misvalued code initiative. As part of our process
for developing the list of proposed potentially misvalued codes, we
consider public nominations for potentially misvalued codes under a
process also established in the CY 2012 PFS final rule with comment
period. If appropriate, we include such codes in our proposed
potentially misvalued code list. In the proposed rule, we solicit
comments on the proposed potentially misvalued codes. We then respond
to comments and establish a final list of potentially misvalued codes
in the final rule for that year. These potentially misvalued codes are
reviewed and revalued, if appropriate, in subsequent years. In
addition, the RUC regularly identifies potentially misvalued codes
using screens that have previously been identified by CMS, such as
codes performed together more than 75 percent of the time.
Generally, the first step in revaluing codes that have been
identified as potentially misvalued is for the RUC to review these
codes through its standard process, which includes active involvement
of national specialty societies for the specialties that ordinarily use
the codes. Frequently, the RUC's discussion of potentially misvalued
codes will lead the CPT Editorial Panel to make adjustments to the
codes involved, such as bundling of codes, creation of new codes or
revisions of code descriptors. The AMA has estimated that 75 percent of
all annual CPT coding changes result from the potentially misvalued
code initiative.
The RUC provides CMS with recommendations for the work values and
direct PE inputs for the codes we have identified as potentially
misvalued codes or, in the case of a coding revision, for the new or
revised codes that will replace these potentially misvalued codes.
(This process is also applied to codes that the RUC identifies using
code screens that we have identified, and to new or revised codes that
are issued for reasons unrelated to the potentially misvalued code
process.) Generally, we receive the RUC recommendations concurrently
for all codes in the same family as the potentially misvalued code(s).
We believe it is important to evaluate and establish appropriate work
and MP RVUs and direct PE inputs for an entire code family at the same
time to avoid rank order anomalies and to maintain appropriate
relativity among codes. We generally receive the RUC recommendations
for the code or replacement code(s) within a year or two following the
identification of the code as potentially misvalued.
We consider the RUC recommendations along with other information
that we have, including information submitted by other stakeholders,
and establish interim final RVUs for the potentially misvalued codes,
new codes, and any other codes for which there are coding changes in
the final rule with comment period for a year. There is a 60-day period
for the public to comment on those interim final values after we issue
the final rule. For services furnished during the calendar year
following the publication of interim final rates, we pay for services
based upon the interim final values established in the final rule. In
the final rule with comment period for the subsequent year, we consider
and respond to public comments received on the interim final values,
and make any appropriate adjustments to values based on those comments.
We then typically finalize the values for the codes.
As we discussed in the CY 2012 PFS final rule with comment period,
we adopted this consolidated review process to combine all coding
revaluations into one annual process allowing for appropriate
consideration of relativity in and across code families. In addition,
this process assures that we have the benefit of the RUC
recommendations for all codes being valued.
2. Concerns With Current Process
Some stakeholders who have experienced reductions in payments as
the result of interim final valuations have objected to the process by
which we revise or establish values for new, revised, and potentially
misvalued codes. Some have stated that they did not receive notice of
the possible reductions before they occurred. Generally, stakeholders
are aware that we are considering changes in the payment rates for
particular services either because CPT has made changes to codes or
because we have identified the codes as potentially misvalued. As the
RUC considers the appropriate value for a service, representatives of
the specialties that use the codes are involved in the process. The RUC
usually surveys physicians or other practitioners who furnish the
services described by the codes regarding the time it takes to furnish
the services, and representatives of the specialty(ies) also
participate in the RUC meetings where recommendations for work RVUs and
direct PE inputs are considered. Through this process, representatives
of the affected specialties are generally aware of the RUC
recommendations.
Some stakeholders have stated that even when they are aware that
the RUC has made recommendations, they have no opportunity to respond
to the RUC recommendations before we consider them in adopting interim
final values because the RUC actions and recommendations are not
public. Some stakeholders have also said that the individuals who
participate in the RUC review process are not able to share the
recommendations because they have signed a confidentiality agreement.
We note, however, that at least one specialty society has raised funds
via its Web site to fight a ``pending cut'' based upon its knowledge of
RUC recommendations for specific codes prior to CMS action on the
recommendation. Additionally, some stakeholders have pointed out that
some types of suppliers that are paid
[[Page 67604]]
under the PFS are not permitted to participate in the RUC process at
all.
We recognize that some stakeholders, including those practitioners
represented by societies that are not participants in the RUC process,
may not be aware of the specifics of the RUC recommendations before we
consider them in establishing interim final values for new, revised,
and potentially misvalued codes. We note that, as described above,
before we review a service as a potentially misvalued code, we go
through notice and comment rulemaking to identify it as a potentially
misvalued code. Thus, the public has notice and an opportunity to
comment on whether we should review the values for a code before we
finalize the code as potentially misvalued and begin the valuation
process. As a result, all stakeholders should be aware that a
particular code is being considered as potentially misvalued and that
we may establish revised interim final values in a subsequent final
rule with comment period. As noted above, there may be some codes for
which we receive RUC recommendations based upon their identification by
the RUC through code screens that we establish. These codes are not
specifically identified by CMS through notice and comment rulemaking as
potentially misvalued codes. We recognize that if stakeholders are not
monitoring RUC activities or evaluating Medicare claims data, they may
be unaware that these codes are being reviewed and could be revalued on
an interim final basis in a final rule with comment period for a year.
In recent years, we have increased our scrutiny of the RUC
recommendations and have increasingly found cause to modify the values
recommended by the RUC in establishing interim final values under the
PFS. Sometimes we also find it appropriate, on an interim final basis,
to refine how the CPT codes are to be used for Medicare services or to
create G-codes for reporting certain services to Medicare. Some
stakeholders have objected to such interim final decisions because they
do not learn of the CMS action until the final rule with comment period
is issued. Stakeholders said that they do not have an opportunity to
meaningfully comment and for CMS to address their comments before the
coding or valuation decision takes effect.
We received comments on the CY 2014 PFS final rule with comment
period suggesting that the existing process for review and adoption of
interim final values for new, revised, and misvalued codes violates
section 1871(a)(2) of the Act, which prescribes the rulemaking
requirements for the agency in establishing payment rates. In response
to those commenters, we note that the process we use to establish
interim final rates is in full accordance with the statute and we do
not find this a persuasive reason to consider modifying the process
that we use to establish PFS rates.
Our recent revaluation of the four epidural injection codes
provides an example of the concerns that have been expressed with the
existing process. In the CY 2014 PFS final rule with comment period, we
established interim final values for four epidural injection codes,
which resulted in payment reductions for the services when furnished in
the office setting of between 35 percent and 56 percent. (In the
facility setting, the reductions ranged from 17 percent to 33 percent.)
One of these codes had been identified as a potentially misvalued code
2 years earlier. The affected specialties had been involved in the RUC
process and were generally aware that the family of codes would be
revalued on an interim basis in an upcoming rule. They were also aware
that the RUC had made significant changes to the direct PE inputs,
including removal of the radiographic-fluoroscopy room, which explains,
in large part, the reduction to values in the office setting. The
societies representing the affected specialty were also aware of
significant reductions in the RUC-recommended ``time'' to furnish the
procedures based on the most recent survey of practitioners who furnish
the services, which resulted in reductions in both the work and PE
portion of the values. Although the specialties were aware of the
changes that the RUC was recommending to direct PE inputs, they were
not specifically aware of how those changes would affect the values and
payment rate. In addition, we decreased the work RVUs for these
procedures because we found the RUC-recommended work RVUs did not
adequately reflect the RUC-recommended decreases in time. This decision
is consistent with our general practice when the best available
information shows that the time involved in furnishing the service has
decreased, and in the absence of information suggesting an increase in
work intensity. Since the interim final values for these codes were
issued in the CY 2014 PFS final rule with comment period, we have
received numerous comments that will be useful to us as we consider
finalizing values for these codes. If we had followed a process that
involved proposing values for these codes in a proposed rule, we would
have been able to consider the additional information contained in
these comments prior to making payments for the services based upon
revised values. (See section II.B.3.b.(2) of this final rule with
comment period for a discussion of proposed valuation of these epidural
injection codes for CY 2015.)
3. Alternatives to the Current Process
In the proposed rule, we noted that given our heightened review of
the RUC recommendations and the increased concerns expressed by some
stakeholders, we believed that an assessment of our process for valuing
these codes was warranted. To that end, we considered potential
alternatives to address the timing and rulemaking issues associated
with establishing values for new, revised and potentially misvalued
codes (as well as for codes within the same families as these codes).
Specifically, we explored three alternatives to our current approach:
Propose work and MP RVUs and direct PE inputs for all new,
revised and potentially misvalued codes in a proposed rule.
Propose changes in work and MP RVUs and direct PE inputs
in the proposed rule for new, revised, and potentially misvalued codes
for which we receive RUC recommendations in time; continue to establish
interim final values in the final rule for other new, revised, and
potentially misvalued codes.
Increase our efforts to make available more information
about the specific issues being considered in the course of developing
values for new, revised and potentially misvalued codes to increase
transparency, but without making changes to the existing process for
establishing values.
In the proposed rule we discussed each of these alternatives as
follows.
(a) Propose work and MP RVUs and direct PE inputs for new, revised,
and potentially misvalued codes in the proposed rule:
Under this approach, we stated that we would evaluate the RUC
recommendations for all new, revised, and potentially misvalued codes,
and include proposed work and MP RVUs and direct PE inputs for the
codes in the first available PFS proposed rule. We would receive and
consider public comments on those proposals and establish final values
in the final rule. The primary obstacle to this approach relates to the
current timing of the CPT coding changes and RUC activities. Under the
current calendar, all CPT coding changes and most RUC recommendations
are not available to us in time to include proposed values for
[[Page 67605]]
all codes in the proposed rule for that year.
Therefore, we stated that if we were to adopt this proposal, which
would require us to propose changes in inputs before we revalue codes
based upon those values, we would need a mechanism to pay for services
for which the existing codes would no longer be available, or for which
there would be changes for a given year.
As we noted in the CY 2012 PFS final rule with comment period, the
RUC recommendations are an essential element that we consider when
valuing codes. Likewise, we recognize the significant contribution that
the CPT Editorial Panel makes to the success of the potentially
misvalued code initiative through its consideration and adoption of
coding changes. Although we have increased our scrutiny of the RUC
recommendations in recent years and accepted fewer of the
recommendations without making our own refinements, the CPT codes and
the RUC recommendations continue to play a major role in our
valuations. For many codes, the surveys conducted by specialty
societies as part of the RUC process are the best data that we have
regarding the time and intensity of work. The RUC determines the
criteria and the methodology for those surveys. It also reviews the
survey results. This process allows for development of survey data that
are more reliable and comparable across specialties and services than
would be possible without having the RUC at the center of the survey
vetting process. In addition, the debate and discussion of the services
at the RUC meetings in which CMS staff participate provides a good
understanding of what the service entails and how it compares to other
services in the family, and to services furnished by other specialties.
The debate among the specialties is also an important part of this
process. Although we increasingly consider data and information from
many other sources, and we intend to expand the scope of those data and
sources, the RUC recommendations remain a vital part of our valuation
process.
Thus, if we were to adopt this approach, we would need to address
how to make payment for the services for which new or revised codes
take effect for the following year but for which we did not receive RUC
recommendations in time to include proposed work values and PE inputs
in the proposed rule. Because the annual coding changes are effective
on January 1st of each year, we would need a mechanism for
practitioners to report services and be paid appropriately during the
interval between the date the code takes effect and the time that we
receive RUC recommendations and complete rulemaking to establish values
for the new and revised codes. One option would be to establish G-codes
with identical descriptors to the predecessors of the new and revised
codes and, to the fullest extent possible, carry over the existing
values for those codes. This would effectively preserve the status quo
for one year.
The primary advantage of this approach would be that the RVUs for
all services under the PFS would be established using a full notice and
comment procedure, including consideration of the RUC recommendations,
before they take effect. In addition to having the benefit of the RUC
recommendations, this would provide the public the opportunity to
comment on a specific proposal prior to it being implemented. This
would be a far more transparent process, and would assure that we have
the full benefit of stakeholder comments before establishing values.
One drawback to such a process is that the use of G-codes for a
significant number of codes may create an administrative burden for CMS
and for practitioners. Presumably, practitioners would need to use the
G-codes to report certain services for purposes of Medicare, but would
use the new or revised CPT codes to report the same services to private
insurers. The number of G-codes needed each year would depend on the
number of CPT code changes for which we do not receive the RUC
recommendations in time to formulate a proposal to be included in the
proposed rule for the year. To the extent that we receive the RUC
recommendations for all new and revised codes in time to develop
proposed values for inclusion in the proposed rule, there would be no
need to use G-codes for this purpose.
Another drawback is that we would need to delay for at least one
year the revision of values for any misvalued codes for which we do not
receive RUC recommendations in time to include a proposal in the
proposed rule. For a select set of codes, we would be continuing to use
the RVUs for the codes for an additional year even though we know they
do not reflect the most accurate resources. Since the PFS is a budget
neutral system, misvalued services affect payments for all services
across the fee schedule. On the other hand, if we were to take this
approach, we would have the full benefit of public comments received on
the proposed values for potentially misvalued services before
implementing any revisions.
(b) Propose changes in work and MP RVUs and PE inputs in the
proposed rule for new, revised, and potentially misvalued codes for
which we receive RUC recommendations in time; continue to establish
interim final values in the final rule for other new, revised, and
potentially misvalued codes:
This alternative approach would allow for notice and comment
rulemaking before we adopt values for some new, revised and potentially
misvalued codes (those for which we receive RUC recommendations in time
to include a proposal in the proposed rule), while others would be
valued on an interim final basis (those for which we do not receive the
RUC recommendations in time). Under this approach, we would establish
values in a year for all new, revised, and potentially misvalued codes,
and there would be no need to provide for a mechanism to continue
payment for outdated codes pending receipt of the RUC recommendations
and completion of a rulemaking cycle. For codes for which we do not
receive the RUC recommendations in time to include a proposal in the
proposed rule for a year, there would be no change from the existing
valuation process.
This would be a balanced approach that recognizes the benefits of a
full opportunity for notice and comment rulemaking before establishing
rates when timing allows, and the importance of establishing
appropriate values for the current version of CPT codes and for
potentially misvalued codes when the timing of the RUC recommendations
does not allow for a full notice and comment procedure.
However, this alternative would go only part of the way toward
addressing concerns expressed by some stakeholders. For those codes for
which the RUC recommendations are not received in time for us to
include a proposal in the proposed rule, Medicare payment for one year
would still be based on inputs established without the benefit of full
public notice and comment. Another concern with this approach is that
it could lead to the valuation of codes within the same family at
different times depending on when we receive RUC recommendations for
each code within a family. As discussed previously, we believe it is
important to value an entire code family together to make adjustments
to account appropriately for relativity within the family and between
the family and other families. If we receive RUC recommendations in
time to propose
[[Page 67606]]
values for some, but not for all, codes within a family, we would
respond to comments in the final rule to establish final values for
some of the codes while adopting interim final values for other codes
within the same family. The differences in the treatment of codes
within the same family could limit our ability to value codes within
the same family with appropriate relativity. Moreover, under this
alternative, the main determinant of how a code would be handled would
be the timing of our receipt of the RUC recommendation for the code.
Although this approach would offer stakeholders the opportunity to
comment on specific proposals in the proposed rule, the adoption of
changes for a separate group of codes in the final rule could
significantly change the proposed values simply due to the budget
neutrality adjustments due to additional codes being valued in the
final rule.
(c) Increase our efforts to make available more information about
the specific issues being considered in the course of developing values
for new, revised and potentially misvalued codes in order to increase
transparency, but without a change to the existing process for
establishing values:
The main concern with continuing our current approach is that
stakeholders have expressed the desire to have adequate and timely
information to permit the provision of relevant feedback to CMS for our
consideration prior to establishing a payment rate for new, revised,
and potentially misvalued codes. We could address some aspects of this
issue by increasing the transparency of the current process.
Specifically, we could make more information available on the CMS Web
site before interim final values are established for codes. Examples of
such information include an up-to-date list of all codes that have been
identified as potentially misvalued, a list of all codes for which RUC
recommendations have been received, and the RUC recommendations for all
codes for which we have received them.
Although the posting of this information would significantly
increase transparency for all stakeholders, it still would not allow
for full notice and comment rulemaking procedures before values are
established for payment purposes. Nor would it provide the public with
advance information about whether or how we will make refinements to
the RUC recommendations or coding decisions in the final rule with
comment period. Thus, stakeholders would not have an opportunity to
provide input on our potential modifications before interim final
values are adopted.
4. Proposal To Modify the Process for Establishing Values for New,
Revised, and Potentially Misvalued Codes
After considering the current process, including its strengths and
weaknesses, and the alternatives to the current process described
previously, we proposed to modify our process to make all changes in
the work and MP RVUs and the direct PE inputs for new, revised and
potentially misvalued services under the PFS by proposing the changes
in the proposed rule, beginning with the PFS proposed rule for CY 2016.
We proposed to include proposed values for all new, revised and
potentially misvalued codes for which we have complete RUC
recommendations by January 15th of the preceding year. We also proposed
to delay revaluing the code for one year (or until we receive RUC
recommendations for the code before January 15th of a year) and include
proposed values in the following year's rule if the RUC recommendation
was not received in time for inclusion in the proposed rule. Thus, we
would include proposed values prior to using the new code (in the case
of new or revised codes) or revising the value (in the case of
potentially misvalued codes). Due to the complexities involved in code
changes and rate setting, there could be some circumstances where, even
when we receive the RUC recommendations by January 15th of a year, we
are not able to propose values in that year's proposed rule. For
example, we might not have recommendations for the whole family or we
might need additional information to appropriately value these codes.
In situations where it would not be appropriate or possible to propose
values for certain new, revised, or potentially misvalued codes, we
would treat them in the same way as those for which we did not receive
recommendations before January 15th.
For new, revised, and potentially misvalued codes for which we do
not receive RUC recommendations before January 15th of a year, we
proposed to adopt coding policies and payment rates that conform, to
the extent possible, to the policies and rates in place for the
previous year. We would adopt these conforming policies on an interim
basis pending our consideration of the RUC recommendations and the
completion of notice and comment rulemaking to establish values for the
codes. For codes for which there is no change in the CPT code, it is a
simple matter to continue the current valuation. For services for which
there are CPT coding changes, it is more complicated to maintain the
current payment rates until the codes can be valued through the notice
and comment rulemaking process. Since the changes in CPT codes are
effective on January 1st of a year, and we would not have established
values for the new or revised codes (or other codes within the code
family), it would not be practical for Medicare to use those CPT codes.
For codes that were revised or deleted as part of the annual CPT coding
changes, when the changes could affect the value of a code and we have
not had an opportunity to consider the relevant RUC recommendations
prior to the proposed rule, we propose to create G-codes to describe
the predecessor codes to these codes. If CPT codes are revised in a
manner that would not affect the resource inputs used to value the
service (for example, a grammatical changes to CPT code descriptors),
we could use these revised codes and continue to pay at the rate
developed through the use of the same resource inputs. For example, if
a single CPT code was separated into two codes and we did not receive
RUC recommendations for the two codes before January 15th of the year,
we would assign each of those new codes an ``I'' status indicator
(which denotes that the codes are ``not valid for Medicare purposes''),
and those codes could not be used for Medicare payment during the year.
Instead, we would create a G-code with the same description as the
single predecessor CPT code and continue to use the same inputs as the
predecessor CPT code for that G-code during the year.
For new codes that describe wholly new services, as opposed to new
or revised codes that are created as part of a coding revision of a
family or that describe services are already on the PFS, we would make
every effort to work with the RUC to ensure that we receive
recommendations in time to include proposed values in the proposed
rule. However, if we do not receive timely recommendations from the RUC
for such a code and we determine that it is in the public interest for
Medicare to use a new code during the code's initial year, we would
establish values for the code's initial year. As we do under our
current policy, if we receive the RUC recommendations in time to
consider them for the final rule, we propose to establish values for
the initial year on an interim final basis subject to comment in the
final rule. In the event we do not receive RUC recommendations in time
to consider them for the final rule, or in other situations where it
would not be appropriate to establish interim final
[[Page 67607]]
values (for example, because of a lack of necessary information about
the work or the price of the PE inputs involved), we would contractor
price the code for the initial year.
We specifically sought comments on the following topics:
Is this proposal preferable to the present process? Is
another one of the alternatives better?
If we were to implement this proposal, is it better to
move forward with the changes, or is more time needed to make the
transition such that implementation should be delayed beyond CY 2016?
What factors should we consider in selecting an implementation date?
Are there alternatives other than the use of G-codes that
would allow us to address the annual CPT changes through notice and
comment rather than interim final rulemaking?
Comment: The vast majority of commenters support a process, such as
the one we proposed, that would result in having an opportunity for
public comment on specific CMS proposals to change rates prior to
payments being made based upon those rates. Commenters supporting a
more transparent process include most medical organizations. MedPAC
supported including proposals for rate changes in the proposed rule,
but disagreed with preserving existing rates when RUC recommendations
were not received in time to value in the proposed rule stating that
this perpetuates paying at rates that we know are misvalued. As an
alternative, MedPAC suggested that for codes for which we received RUC
recommendations after the deadline for the proposed rule, we establish
interim final values using the existing process. MedPAC also encouraged
us to work with the CPT Editorial Panel and the RUC to better
disseminate information about coding and payment recommendations that
might be used for interim values as far in advance as possible. Several
commenters who do not currently participate in the development of RUC
recommendations suggested that we require the RUC to make its
operations more transparent. Most of the commenters that supported the
proposal also suggested making at least some modifications to the
proposal. Some commenters indicated there was no need for a change from
the current process. Another commenter stated ``CMS's proposal is
overly complex, potentially burdensome, and goes well beyond the
principal request of the medical specialty societies and Congress--that
is, for CMS to publish reimbursement changes for misvalued codes in the
proposed rule, as opposed to waiting until the final rule.''
Response: We appreciate the many comments in support of our
proposal to be more transparent in our ratesetting process by including
proposed changes in inputs for new, revised, and potentially misvalued
codes in the PFS proposed rules each year. We received only minimal
comments on the other alternatives we presented, and only one comment
suggesting that the current process was ideal and should be maintained.
Thus, we are finalizing the proposal, with the modifications discussed
below, to change our process for establishing values for new, revised,
and potentially misvalued codes each year by proposing values for them
in the proposed rule. We note that the CPT Editorial Panel and the RUC
have made significant efforts in recent years to make their processes
more transparent, such as making minutes of meetings publicly
available. We encourage them to continue these efforts and also to
consider ways that all physicians, practitioners and other suppliers
paid under the PFS are aware of issues that are being considered by the
RUC, and have an opportunity to provide input. With regard to comments
suggesting that we propose values for some codes in the proposed rule
and establish values for others as interim final in the final rule with
comment period, as we discussed in making the proposal, we believe this
type of system has several flaws. Most significantly, since the PFS is
a budget neutral system, proposals are more meaningful when they can be
considered in relation to all codes being revalued in a year in order
to allow public comment on the entire fee schedule at one time.
Additionally, we believe it is difficult to justify the presence or
absence of an opportunity for public comment in advance of our adopting
and using new values and inputs for services when the outcome
essentially depends upon when we receive RUC recommendations.
Comment: Commenters expressed mixed opinions on when the new
process should begin. The AMA, the RUC, and most medical specialties
opposed the proposed CY 2016 implementation and asked that it be
delayed until CY 2017. Commenters supporting a delay suggested that
much work had already been done for the CY 2016 coding cycle in
anticipation that these codes could be used for CY 2016, and stated it
seems unfair to now delay valuing these codes because the process is
being changed. These commenters also suggested that by delaying until
CY 2017, the CPT Editorial Panel and the RUC would have time to adjust
their agendas and workload so as to provide more recommendations in
time for the proposed rule. By contrast, several commenters, including
those with major code revisions for CY 2015, such as codes for
radiation therapy and upper gastrointestinal procedures, suggested that
we should implement the new process immediately, and thus, delay
implementation of the new code sets and values so that they could be
issued as proposals in the CY 2016 proposed rule. Although each of the
commenters took some unique positions in supporting a delay, they
emphasized the importance of the opportunity to comment on our specific
proposals for valuation as a major consideration for the delay. A few
other commenters also suggested that the benefit of the opportunity for
public comment prior to changing values warrants immediate
implementation. Some commenters supported a CY 2016 implementation date
as we proposed. A small group of commenters suggested an interim
approach under which, for CY 2016, we would publish ``some, but not
all, values'' in the proposed rule and use the interim final approach
for others.
Response: After reviewing the comments, we understand that the
implementation of a new process such as this one will affect
stakeholders in differing ways. As we consider the most appropriate
time frame for implementation, we believe that flexibility in
implementation offers the optimal solution. Accordingly, we are
delaying the adoption of two new codes sets (radiation therapy and
lower gastrointestinal endoscopies) until CY 2016 as requested by
affected stakeholders so that those most affected by these significant
changes have the opportunity to comment on our proposals for valuing
these codes sets before they are implemented. (See section II.G.3 of
this final rule.)
Similarly, as requested by the AMA and most other medical specialty
societies, we are delaying the complete implementation of this process
so that those who have requested new codes and modifications in
existing codes with the expectation that they would be valued under the
PFS for CY 2016 will not be negatively affected by timing of this
change. We note that the AMA has been working to develop timeframes
that would allow a much higher percentage of codes to be addressed in
the proposed rule, and has shared with us some plans to achieve this
goal. We appreciate AMA's efforts and are confident that with the
finalization of this process, the CPT Editorial Panel and the RUC will
be able to adjust their timelines and processes so that most, if
[[Page 67608]]
not all, of the annual coding changes and valuation recommendations can
be addressed in the proposed rule prior to the effective date of the
coding changes. This delay in implementation will provide additional
time for these bodies to adjust their agendas and the timing of their
recommendations to CMS to more appropriately align with the new
process. As suggested by some commenters, we will use CY 2016 as a
transition year. In the PFS proposed rule for CY 2016, we will propose
values for the new, revised and potentially misvalued codes for which
we receive the RUC recommendations in time for inclusion in the CY 2016
proposed rule. We will also include proposals for the two code sets
delayed from CY 2015 in the CY 2016 proposed rule, as discussed above.
For those new, revised, and potentially misvalued codes for which we do
not receive RUC recommendations in time for inclusion in the proposed
rule, we anticipate establishing interim final values for them for CY
2016, consistent with the current process. Beginning with valuations
for CY 2017, the new process will be applicable to all codes. In other
words, beginning with rulemaking for CY 2017, we will propose values
for the vast majority of new, revised, and potentially misvalued codes
and consider public comments before establishing final values for the
codes; use G-codes as necessary in order to facilitate continued
payment for certain services for which we do not receive RUC
recommendations in time to propose values; and adopt interim final
values in the case of wholly new services for which there are no
predecessor codes or values and for which we do not receive RUC
recommendations in time to propose values. Consistent with this policy,
we are finalizing our proposed regulatory change to Sec. 414.24 with
the addition of the phrase ``For valuations for calendar year 2017 and
beyond,'' to paragraph (b) to reflect the implementation for all CY
2017 valuations.''
Comment: Commenters also addressed the January 15th deadline for
valuations to be considered for the proposed rule. The AMA recommended
a deadline of 30 days after the RUC's January meeting to allow time to
submit complete recommendations for the proposed rule. Many others
supported this, with some commenters suggesting a variety of dates
between January 31st and April. Commenters suggested using an April
deadline so that we could include the recommendations from the April
RUC meeting in the proposed rule.
Response: In proposing a deadline for inclusion in the proposed
rule, we attempted to strike a balance that allows CMS adequate time
for CMS to do a thorough job in vetting recommendations and formulating
proposals, and allows the RUC as much time as possible to complete its
activities. Review of RUC recommendations and application of the PFS
methodology to particular codes requires significant time to complete.
With new statutory requirements being implemented in CY 2017, such as
those requiring multi-year transitions of certain changes in values and
modification to PFS payments if specified targets are not met, we
believe we will need more time to complete the process of formulating
proposals. We believe that we need to establish a consistent deadline
for receipt of RUC recommendations in order to allow all stakeholders
and CMS to plan appropriately. To balance competing priorities, we are
finalizing a deadline of February 10th. Our ability to complete our
work in this more limited time will depend in large part on the volume
of recommendations handled at the last RUC meeting and when we receive
those recommendations. We are seeking the RUC's assistance in
minimizing the recommendations that we receive after the beginning of
the year.
Comment: The majority of commenters opposed the use of G-codes,
primarily citing the administrative burden of having to use a separate
set of codes for Medicare claims. One commenter called the G-code
proposal ``unworkable.'' In addition, MedPAC objected to the principal
of attempting to maintain rates that are known to be misvalued. Those
supporting the use of G-codes generally recognized the administrative
burden, but believed the importance of the opportunity for public
comment on proposed values before they take effect outweighed the
administrative inconvenience. Commenters urged us to minimize the use
of G-codes.
Response: We recognize the commenters' concerns with the use of G-
codes. We agree that it is preferable to use CPT codes whenever
possible. Under our finalized process, the use of G-codes for the
purpose of holding over current coding and payment policies should not
be necessary, generally, as long as we receive RUC recommendations for
all new, revised and potentially misvalued codes before February 10th
of the prior year. However, we need to preserve our ability to
establish a proxy for current coding and values in situations where we
receive the RUC recommendations too late or, for some other reason,
encounter serious difficulty developing proposed values for revised
code sets. In the proposed rule, we sought input as to ways to achieve
this without using G-codes. The only suggestion offered by commenters
was to value such codes on an interim final basis. As we discuss above,
we believe the program and its stakeholders are better served by
delaying revaluations for one year while we used the notice and comment
process to obtain public comments in advance. The comments on this
proposal were overall overwhelming supportive of this point of view.
Accordingly, we are not foreclosing the possibility of using G-codes
for this purpose when warranted by the circumstances. However, we are
cognizant of the difficulties created by the use of G-codes and will
seek to minimize their use. We also note that the RUC and stakeholders
can assist us in minimizing the use of G-codes by taking steps to
insure that we receive RUC recommendations as early as possible.
5. Refinement Panel
As discussed in the 1993 PFS final rule with comment period (57 FR
55938), we adopted a refinement panel process to assist us in reviewing
the public comments on CPT codes with interim final work RVUs for a
year and in developing final work values for the subsequent year. We
decided the panel would be comprised of a multispecialty group of
physicians who would review and discuss the work involved in each
procedure under review, and then each panel member would individually
rate the work of the procedure. We believed establishing the panel with
a multispecialty group would balance the interests of the specialty
societies who commented on the work RVUs with the budgetary and
redistributive effects that could occur if we accepted extensive
increases in work RVUs across a broad range of services.
Following enactment of section 1848(c)(2)(K) of the Act, which
required the Secretary periodically to review potentially misvalued
codes and make appropriate adjustments to the RVUs, we reassessed the
refinement panel process. As detailed in the CY 2011 PFS final rule
with comment period (75 FR 73306), we continued using the established
refinement panel process with some modifications.
As we considered making changes to the process for valuing codes,
we reassessed the role that the refinement panel process plays in the
code valuation process. We noted that the current refinement panel
process is tied to interim final values. It provides an opportunity for
stakeholders to provide
[[Page 67609]]
new clinical information that was not available at the time of the RUC
valuation that might affect work RVU values that are adopted in the
interim final value process. We noted that if our proposal to modify
the valuation process for new, revised, and potentially misvalued codes
is adopted, there would no longer be interim final values except for
very few codes that describe totally new services. Thus, we proposed
eliminating the refinement panel process.
We also noted that by using the proposed process for new, revised,
and potentially misvalued codes, we believed the consideration of
additional clinical information and any other issues associated with
the CMS proposed values could be addressed through the notice and
comment process. Similarly, prior to CY 2012 when we consolidated the
five-year valuation, changes made as part of the five-year review
process were addressed in the proposed rule and those codes were
generally not subject to the refinement process. The notice and comment
process would provide stakeholders with complete information on the
basis and rationale for our proposed inputs and any relating coding
policies. We also noted that an increasing number of requests for
refinement do not include new clinical information that would justify a
change in the work RVUs and that was not available at the time of the
RUC meeting, in accordance with the current criteria for refinement.
Thus, we did not believe the elimination of the refinement panel
process would negatively affect the code valuation process. We believe
the proposed process, which includes a full notice and comment
procedure before values are used for purposes of payment, offers
stakeholders a better mechanism for providing any additional data for
our consideration and discussing any concerns with our proposed values
than the current refinement process
Comment: We received many comments on our proposal to eliminate the
refinement panel, but most addressed problems with the existing
refinement process and suggested improvements and alternatives rather
than reasons not to eliminate the refinement panel. Concerns with the
refinement panel process included that CMS imposed too high a standard
for referring codes to refinement and that CMS decreasingly changed
values based upon the refinement panel results. Some noted that
organizations with limited resources are disadvantaged compared to
those with significant resources to overturn any CMS interim final
values without a refinement process. In addition, some commenters
stated that elimination of the refinement panel runs contrary to the
transparency that CMS is trying to achieve. Many discussed their
previous understanding that the refinement panel was essentially an
appeals process for interim final values.
Commenters supported ``a fair, objective, and consistently applied
appeals process that would be open to any commenting organization.''
Commenters expressed concern that the elimination of the refinement
panel without a replacement mechanism ``indicates that CMS will no
longer seek the independent advice of contractor medical officers and
practicing physicians and will solely rely on Agency staff to determine
if the comment is persuasive in modifying a proposed value. The lack of
any perceived organized appeal process will likely lead to a fragmented
lobbying effort, rather than an objective review process.''
MedPAC suggested that we use a panel with membership limited to
those without a financial stake in the process, such as contractor
medical directors, experts in medical economics and technology
diffusion, private payer representatives, and a mix of physicians and
other health professionals not directly affected by the RVUs in
question. It also suggested user fees to provide the resources needed
or such a refinement panel.
Response: We acknowledge the commenters' concerns and believe that
some of the dissatisfaction with the current refinement panel mechanism
stems from the expectation that it constitutes an appeals process. We
do not agree. We believe the purpose of the refinement panel is to give
us additional information to consider in exercising our responsibility
to establish appropriate RVUs for Medicare services. Like many of the
commenters, we believe the refinement panel is not achieving its
purpose. Rather than providing us with additional information to assist
us in establishing work RVUs, most often the refinement panel
discussion reiterates the issues raised and information discussed at
the RUC. Since we had access to this information at the time interim
final values were established, it seems unlikely that a repeat
discussion of the same issues would lead us to change valuations based
upon information that already had been carefully considered. We remain
concerned about the amount of resources devoted to refinement panel
activities as compared to the benefit received. However, in light of
the significant concerns raised by commenters, we are not finalizing
our proposal to eliminate the refinement panel. We will use the
refinement panel for consideration of interim final rates for CY 2015
under the existing rules. We will also explore ways to address the many
concerns that we and stakeholders have about the refinement panel
process and whether the change in process eliminates the need for a
refinement panel.
We are also finalizing our proposed change to the regulation at
Sec. 414.24 with the addition of the phrase ``For valuations for
calendar year 2017 and beyond,'' to paragraph (b) to reflect
implementation of the revised process for all valuations beginning with
those for CY 2017.
G. Establishing RVUs for CY 2015
1. Methodology
We conducted a review of each code identified in this section and
reviewed the current work RVU, if one exists, the RUC-recommended work
RVUs, intensity, and time to furnish the preservice, intraservice, and
postservice activities, as well as other components of the service that
contribute to the value. Our review generally includes, but is not
limited to, a review of information provided by the RUC, Health Care
Professionals Advisory Committee (HCPAC), and other public commenters,
medical literature, and comparative databases, as well as a comparison
with other codes within the Medicare PFS, consultation with other
physicians and health care professionals within CMS and the federal
government. We also assessed the methodology and data used to develop
the recommendations submitted to us by the RUC and other public
commenters and the rationale for the recommendations. In the CY 2011
PFS final rule with comment period (75 FR 73328 through 73329), we
discussed a variety of methodologies and approaches used to develop
work RVUs, including survey data, building blocks, crosswalk to key
reference or similar codes, and magnitude estimation. More information
on these issues is available in that rule. When referring to a survey,
unless otherwise noted, we mean the surveys conducted by specialty
societies as part of the formal RUC process. The building block
methodology is used to construct, or deconstruct, the work RVU for a
CPT code based on component pieces of the code. Components used in the
building block approach may include preservice, intraservice, or
postservice time and post-procedure visits. When referring to a bundled
CPT code, the components could be the CPT
[[Page 67610]]
codes that make up the bundled code. Magnitude estimation refers to a
methodology for valuing physician work that determines the appropriate
work RVU for a service by gauging the total amount of physician work
for that service relative to the physician work for similar service
across the PFS without explicitly valuing the components of that work.
The PFS incorporates cross-specialty and cross-organ system
relativity. Valuing services requires an assessment of relative value
and takes into account the clinical intensity and time required to
furnish a service. In selecting which methodological approach will best
determine the appropriate value for a service, we consider the current
and recommended work and time values, as well as the intensity of the
service, all relative to other services.
Several years ago, to aid in the development of preservice time
recommendations for new and revised CPT codes, the RUC created
standardized preservice time packages. The packages include preservice
evaluation time, preservice positioning time, and preservice scrub,
dress and wait time. Currently there are six preservice time packages
for services typically furnished in the facility setting, reflecting
the different combinations of straightforward or difficult procedure,
straightforward or difficult patient, and without or with sedation/
anesthesia. Currently, there are three preservice time packages for
services typically furnished in the nonfacility setting, reflecting
procedures without and with sedation/anesthesia care. We have developed
several standard building block methodologies to appropriately value
services when they have common billing patterns. In cases where a
service is typically furnished to a beneficiary on the same day as an
evaluation and management (E/M) service, we believe that there is
overlap between the two services in some of the activities furnished
during the preservice evaluation and postservice time. We believe that
at least one-third of the physician time in both the preservice
evaluation and postservice period is duplicative of work furnished
during the E/M visit. Accordingly, in cases where we believe that the
RUC has not adequately accounted for the overlapping activities in the
recommended work RVU and/or times, we adjust the work RVU and/or times
to account for the overlap. The work RVU for a service is the product
of the time involved in furnishing the service times the intensity of
the work. Preservice evaluation time and postservice time both have a
long-established intensity of work per unit of time (IWPUT) of 0.0224,
which means that 1 minute of preservice evaluation or postservice time
equates to 0.0224 of a work RVU. Therefore, in many cases when we
remove 2 minutes of preservice time and 2 minutes of postservice time
from a procedure to account for the overlap with the same day E/M
service, we also remove a work RVU of 0.09 (4 minutes x 0.0224 IWPUT)
if we do not believe the overlap in time has already been accounted for
in the work RVU. The RUC has recognized this valuation policy and, in
many cases, addresses the overlap in time and work when a service is
typically provided on the same day as an E/M service. The RVUs and
other payment information for all CY 2015 payable codes are available
in Addendum B. The RVUs and other payment information for all codes
subject to public comment are available in Addendum C. Both addenda are
available on the CMS Web site under downloads for the CY 2015 PFS final
rule with comment period at https://www.cms.gov/physicianfeesched/downloads/. The time values for all CY 2015 codes are listed in a file
called ``CY 2015 PFS Physician Time,'' available on the CMS Web site
under downloads for the CY 2015 PFS final rule with comment period at
https://www.cms.gov/physicianfeesched/downloads/.
2. Addressing CY 2014 Interim Final RVUs
In this section, we are responding to the public comments received
on specific interim final values established in the CY 2014 PFS final
rule with comment period and discussing the final values that we are
establishing for CY 2015. The final CY 2015 work, PE, and MP RVUs are
in Addendum B of a file called ``CY 2015 PFS Addenda,'' available on
the CMS Web site under downloads for the CY 2015 PFS final rule with
comment period at https://www.cms.gov/physicianfeesched/PFS-Federal-Regulation-Notices.html/. The direct PE inputs are listed in a file
called ``CY 2015 PFS Direct PE Inputs,'' available on the CMS Web site
under downloads for the CY 2015 PFS final rule with comment period at
https://www.cms.gov/physicianfeesched/PFS-Federal-Regulation-Notices.html/.
a. Finalizing CY 2014 Interim Final Work RVUs for CY 2015
(i) Refinement Panel
(1) Refinement Panel Process
As discussed in the 1993 PFS final rule with comment period (57 FR
55938), we adopted a refinement panel process soon after implementing
the fee schedule to assist us in reviewing the public comments on CPT
codes with interim final work RVUs and in developing final work values
for the subsequent year. We decided the panel would be comprised of a
multispecialty group of physicians who would review and discuss the
work involved in each procedure under review, and then each panel
member would individually rate the work of the procedure. We believed a
multispecialty group would balance the interests of the specialty
societies who commented on the work RVUs with the budgetary and
redistributive effects that could occur if we accepted extensive
increases in work RVUs across a broad range of services. Depending on
the number and range of codes that are subject to refinement in a given
year, we establish refinement panels with representatives from four
groups: Clinicians representing the specialty identified with the
procedures in question; physicians with practices in related
specialties; primary care physicians; and contractor medical directors
(CMDs). Typical panels have included 8 to 10 physicians across the four
groups.
Following the addition of section 1848(c)(2)(K) to the Act, which
requires the Secretary periodically to review potentially misvalued
codes and make appropriate adjustments to the RVUs, we reassessed the
refinement panel process. As detailed in the CY 2011 PFS final rule
with comment period (75 FR 73306), we believed that the refinement
panel process might provide an opportunity to review and discuss the
proposed and interim final work RVUs with a clinically diverse group of
experts, who could provide informed recommendations following the
discussion. Therefore, we indicated that we would continue the
refinement process, but with administrative modification and
clarification. We also noted that we would continue using the
established panel composition that includes representatives from the
four groups--clinicians representing the specialty identified with the
procedures in question, physicians with practices in related
specialties, primary care physicians, and CMDs.
At that time, we made a change in how we calculated refinement
panel results. The basis of the refinement panel process is that,
following discussion of the information but without an attempt to reach
a consensus, each member of the panel submits an independent rating to
CMS. Historically, the refinement panel's recommendation to change a
work value or to retain the interim final value had
[[Page 67611]]
hinged solely on the outcome of a statistical test on the ratings (an
F-test of panel ratings among the groups of participants). Over time,
we found the statistical test used to evaluate the RVU ratings of
individual panel members became less reliable as the physicians in each
group tended to select a previously discussed value, rather than
developing a unique value, thereby reducing the observed variability
needed to conduct a robust statistical test. In addition, reliance on
values developed using the F-test also occasionally resulted in rank
order anomalies among services (that is, a more complex procedure is
assigned lower RVUs than a less complex procedure). As a result, we
eliminated the use of the statistical F-test and replaced it with the
median work value of the individual panel members' ratings. We stated
that this approach would simplify the refinement process
administratively, while providing a result that reflects the summary
opinion of the panel members based on a commonly used measure of
central tendency that is not significantly affected by outlier values.
We also clarified that we have the final authority to set the work
RVUs, including making adjustments to the work RVUs resulting from the
refinement process, and that we will make such adjustments if warranted
by policy concerns (75 FR 73307).
We remind readers that the refinement panels are not intended to
review the work RVUs for every code for which we did not accept the
RUC-recommended work RVUs. Rather, refinement panels are designed for
situations where there is new clinical information available that might
provide a reason for a change in work values and where a multispecialty
panel of physicians might provide input that would assist us in
establishing work RVUs. To facilitate the selection of services for the
refinement panels, commenters seeking consideration by a refinement
panel should specifically state in their public comments that they are
requesting refinement panel review. Furthermore, we have asked
commenters requesting refinement panel review to submit any new
clinical information concerning the work required to furnish a service
so that we can consider whether the new information warrants referral
to the refinement panel (57 FR 55917).
We note that most of the information presented during the last
several refinement panel discussions has been duplicative of the
information provided to the RUC during its development of
recommendations and considered by CMS in establishing values. As
detailed above, we consider information and recommendations from the
RUC when assigning proposed and interim final RVUs to services. Thus,
if the only information that a commenter has to present is information
already considered by the RUC, referral to a refinement panel is not
appropriate. We request that commenters seeking refinement panel review
of work RVUs submit supporting information that has not already been
considered by the RUC in developing recommendations or by CMS in
assigning proposed and interim final work RVUs. We can make best use of
our resources, as well as those of the specialties and physician
volunteers involved, by avoiding duplicative consideration of
information by the RUC, CMS, and a refinement panel. To achieve this
goal, CMS will continue to critically evaluate the need to refer codes
to refinement panels in future years, specifically considering any new
information provided by commenters.
(2) CY 2014 Interim Final Work RVUs Considered by the Refinement Panel
We referred to the CY 2014 refinement panel 19 CPT codes with CY
2014 interim final work values for which we received a request for
refinement that met the requirements described above. For these 19 CPT
codes, all commenters requested increased work RVUs. For ease of
discussion, we will be referring to these services as ``refinement
codes.'' Consistent with the process described above, we convened a
multi-specialty panel of physicians to assist us in the review of the
information submitted to support increased work RVUs. The panel was
moderated by our physician advisors, and consisted of the following
voting members:
One to two clinicians representing the commenting
organization.
One to two primary care clinicians nominated by the
American Academy of Family Physicians and the American College of
Physicians.
Four Contractor Medical Directors (CMDs).
One to two clinicians with practices in related
specialties, who were expected to have knowledge of the services under
review.
The panel process was designed to capture each participant's
independent judgment and his or her clinical experience which informed
and drove the discussion of the refinement code during the refinement
panel proceedings. Following the discussion, each voting participant
rated the work of the refinement code(s) and submitted those ratings to
CMS directly and confidentially. We note that not all voting
participants voted for every CPT code. There was no attempt to achieve
consensus among the panel members. As finalized in the CY 2011 PFS
final rule with comment period (75 FR 73307), we calculated the median
value for each service based upon the individual ratings that were
submitted to CMS by panel participants.
Table 14 presents information on the work RVUs for the refinement
codes, including the refinement panel ratings and the final CY 2015
work RVUs. In section II.G.2.a.ii., we discuss the CY 2015 work RVUs
assigned each of the individual refinement codes.
Table 14--Codes Reviewed by the 2014 Multi-Specialty Refinement Panel
----------------------------------------------------------------------------------------------------------------
CY 2014 RUC Refinement
HCPCS Code Descriptor interim final recommended panel median CY 2015 work
work RVU work RVU rating RVU
----------------------------------------------------------------------------------------------------------------
19081.......... Biopsy of breast accessed 3.29 3.29 3.40 3.29
through the skin with
stereotactic guidance.
19082.......... Biopsy of breast accessed 1.65 1.65 1.78 1.65
through the skin with
stereotactic guidance.
19083.......... Biopsy of breast accessed 3.10 3.10 3.10 3.10
through the skin with
ultrasound guidance.
19084.......... Biopsy of breast accessed 1.55 1.55 1.55 1.55
through the skin with
ultrasound guidance.
19085.......... Biopsy of breast accessed 3.64 3.64 3.64 3.64
through the skin with MRI
guidance.
19086.......... Biopsy of breast accessed 1.82 1.82 1.82 1.82
through the skin with MRI
guidance.
[[Page 67612]]
19281.......... Placement of breast 2.00 2.00 2.00 2.00
localization devices accessed
through the skin with
mammographic guidance.
19282.......... Placement of breast 1.00 1.00 1.00 1.00
localization devices accessed
through the skin with
mammographic guidance.
19283.......... Placement of breast 2.00 2.00 2.00 2.00
localization devices accessed
through the skin with
stereotactic guidance.
19284.......... Placement of breast 1.00 1.00 1.00 1.00
localization devices accessed
through the skin with
stereotactic guidance.
19285.......... Placement of breast 1.70 1.70 1.70 1.70
localization devices accessed
through the skin with
ultrasound guidance.
19286.......... Placement of breast 0.85 0.85 0.85 0.85
localization devices accessed
through the skin with
ultrasound guidance.
19287.......... Placement of breast 2.55 3.02 3.02 2.55
localization devices accessed
through the skin with MRI
guidance.
19288.......... Placement of breast 1.28 1.51 1.51 1.28
localization devices accessed
through the skin with MRI
guidance.
43204.......... Injection of dilated esophageal 2.40 2.89 2.77 2.40
veins using an endoscope.
43205.......... Tying of esophageal veins using 2.51 3.00 2.88 2.51
an endoscope.
43213.......... Dilation of esophagus using an 4.73 5.00 5.00 4.73
endoscope.
43233.......... Balloon dilation of esophagus, 4.05 4.45 4.26 4.26
stomach, and/or upper small
bowel using an endoscope.
43255.......... Control of bleeding of 3.66 4.20 4.20 3.66
esophagus, stomach, and/or
upper small bowel using an
endoscope.
----------------------------------------------------------------------------------------------------------------
(ii) Code-Specific Issues
For each code with an interim final work value, Table 15 lists the
CY 2014 interim final work RVU and the CY 2015 work RVU and indicates
whether we are finalizing the CY 2015 work RVU. For codes without a
work RVU, the table includes a PFS procedure status indicator. A list
of the PFS procedure status indicators can be found in Addendum A. If
the CY 2015 Action column indicates that the CY 2015 values are interim
final, we will accept public comments on these values during the public
comment period for this final rule with comment period. A comprehensive
list of all values for which public comments are being solicited is
contained in Addendum C to the CY 2015 PFS final rule with comment
period. A comprehensive list of all CY 2015 RVUs is in Addendum B to
this final rule with comment period. All Addenda to PFS final rule are
available on the CMS Web site under downloads at https://www.cms.gov/physicianfeesched/PFSFederalRegulationNotices.html/. The time values
for all codes are listed in a file called ``CY 2015 PFS Work Time,''
available on the CMS Web site under downloads for the CY 2015 PFS final
rule with comment period at https://www.cms.gov/physicianfeesched/downloads/.
BILLING CODE 4120-01-P
[[Page 67613]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.000
[[Page 67614]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.001
[[Page 67615]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.002
[[Page 67616]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.003
[[Page 67617]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.004
[[Page 67618]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.005
[[Page 67619]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.006
[[Page 67620]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.007
[[Page 67621]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.008
[[Page 67622]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.009
[[Page 67623]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.010
[[Page 67624]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.011
[[Page 67625]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.012
[[Page 67626]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.013
[[Page 67627]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.014
[[Page 67628]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.015
[[Page 67629]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.016
[[Page 67630]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.017
[[Page 67631]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.018
BILLING CODE 4120-01-C
In the following section, we discuss each code for which we
received a comment on the CY 2014 interim final work value or work time
during the comment period for the CY 2014 final rule with comment
period or for which we are modifying the CY 2014 interim final work
RVU, work time or procedure status indicator for CY 2015. If a code in
Table 15 is not discussed in this section, we did not receive any
comments on that code and are finalizing the interim final work RVU and
time without modification for CY 2015.
(1) Mohs Surgery (CPT Codes 17311 and 17313)
As detailed in the CY 2014 PFS final rule with comment period, we
maintained the CY 2013 work RVUs for CPT codes 17311 and 17313 codes,
based upon the RUC-recommended work RVUs.
Comment: We received a comment that was supportive of the interim
final work RVU.
Response: We thank the commenter for their support and are
finalizing the CY 2014 interim final values for CY 2015.
(2) Breast Biopsy (CPT Codes 19081, 19082, 19083, 19084, 19085, 19086,
19281, 19282, 19283, 19284, 19285, 19286, 19287, and 19288)
For CY 2014, the CPT Editorial Panel created 14 new codes, CPT
codes 19081 through 19288, to describe breast biopsy and placement of
breast localization devices, and the RUC recommended work RVUs for each
of these codes. In the 2014 final rule with comment period, we
established interim final values for all of these codes as recommended
by the RUC except for CPT code 19287 and its add-on CPT code, 19288,
which are used for magnetic resonance (MR) guidance. We expressed
concern that for CPT code 19287 the RUC-recommended work RVUs were too
high in relation to those of other marker placement codes, and refined
it to a lower value. Since we had adopted the RUC recommendation that
all the add-on codes in this family have work RVUs equal to 50 percent
of the base code's work RVU, our refinement of CPT code 19287 resulted
in a refinement of CPT code 19288 also. We also changed the
intraservice time of CPT code 19286, an add-on code, from 19 minutes to
15 minutes since we believed the intraservice time of an add-on code
should not be higher than its base code and the base code for CPT code
19286, has an intraservice time of 15 minutes.
Comment: Several commenters disagreed with the new CPT coding
structure for breast biopsy and placement of breast localization
devices because, unlike the predecessor structure, it fails to
distinguish between the two types of biopsy devices--standard core
needle and vacuum assisted. One commenter suggested that the payment
should be higher when services are vacuum assisted, and suggested that
CMS create a modifier to report when these services are furnished using
a vacuum assisted biopsy or create a series of G-codes that distinguish
between standard core needle biopsy and vacuum assisted biopsy.
Response: We prefer to use the CPT coding structure unless a
programmatic need suggests that an alternative coding structure is
preferable. In this case, we believe that we can pay appropriately for
these services using the new CPT coding structure. To the extent that
the commenters think the CPT coding system is not ideal for these
services, we believe the CPT Editorial Panel is the appropriate forum
for this concern. The commenters are mistaken regarding how the inputs
for these codes were determined as they are based upon the typical
service being vacuum assisted.
Comment: Several commenters disagreed with the interim final work
RVUs we established for CPT codes 19287 and 19288, stating that the
higher RUC-recommended RVUs were more appropriate and would maintain
relativity within the family. The commenters stated that these services
have longer intraservice time than other codes in the marker placement
family, are of high intensity, produce high patient and family anxiety,
and have higher malpractice costs. One commenter requested that the
entire breast biopsy code family be referred to refinement. Other
commenters requested refinement panel review of selected codes within
this family.
Response: Based upon this request, we referred this family of codes
to the CY 2014 multi-specialty refinement panel for further review.
Prior to CY
[[Page 67632]]
2014, breast biopsies and marker placements were billed using a single
code. In addition, the appropriate image guidance code was separately
billed. Prior to CY 2014, there were individual guidance codes for the
different types of guidance including MR and stereotactic guidance.
For CY 2013, the MR guidance code, CPT code 77032, had a lower work
RVU than the stereotactic guidance code, CPT code 77031. Combining the
values for the marker placement or biopsy codes with the guidance codes
should not, in our view, result in a change in the rank order of the
guidance. Accordingly, we do not believe the bundled code that includes
MR guidance should now be valued significantly higher than one that
includes the stereotactic guidance. Also, the refinement panel
discussions did not provide new clinical information. Therefore, we
continue to believe the CY 2014 interim final values are appropriate
for CPT codes 19287 and 19288, and are finalizing them for CY 2015.
Comment: Commenters stated that the RUC-recommended intraservice
time of 19 minutes for CPT code 19286, which is an add-on code, was
incorrect and that the code should have the same intraservice time as
its base code (15 minutes) rather than the 14 minutes assigned by CMS.
The commenter said that this was consistent with the other base code/
add-on relationships across the family.
Response: We agree and are finalizing the intraservice time for CPT
code 19286 at 15 minutes.
Comment: In response to our request for confirmation that a post
procedure mammogram is typically furnished with a breast marker
placement procedure, commenters agreed that it was. However, they
disagreed with our assertion that if it was typical it should be
bundled with the appropriate breast marker procedures. Commenters said
that it should be a separately reportable service because it requires
additional work not captured by the codes in this family.
Response: We thank commenters for their feedback. We are not
bundling post procedure mammograms with the appropriate breast marker
codes at this time, but will consider whether as a services that
typically occur together they should be bundled.
(3) Hip and Knee Replacement (CPT Codes 27130, 27446 and 27447)
In the CY 2014 final rule with comment period we established
interim final values for three CPT codes for hip and knee replacements
that had previously been identified as potentially misvalued codes
under the CMS high expenditure procedural code screen. For CY 2014, we
established the RUC-recommended work value of 17.48 as interim final
work RVUs for CPT code 27446. As we explained in the CY 2014 final rule
with comment period, we established interim final work RVUs for CPT
codes 27130 and 27447 that varied from those recommended by the RUC
based upon information that we received from the relevant specialty
societies. We noted that the information presented by the specialty
societies and the RUC raised concerns regarding the appropriate
valuation of these services, especially related to the use of the best
data source for determining the intraservice time involved in
furnishing PFS services. Specifically, there was significant variation
between the time values estimated through a survey versus those
collected through specialty databases. We characterized our concerns
saying, ``The divergent recommendations from the specialty societies
and the RUC regarding the accuracy of the estimates of time for these
services, including both the source of time estimates for the procedure
itself as well as the inpatient and outpatient visits included in the
global periods for these codes, lead us to take a cautious approach in
valuing these services.''
With regard to the specific valuations, we agreed with the RUC's
recommendation to value CPT codes 27130 and 27447 equally. We explained
that we modified the RUC-recommended work RVUs for these two codes to
reflect the visits in the global period as recommended by the specialty
societies, resulting in a 1.12 work RVU increase from the RUC-
recommended value for each code. Accordingly, we assigned CPT codes
27130 and 27447 an interim final work RVU of 20.72. We sought public
comment regarding, not only the appropriate work RVUs for these
services, but also the most appropriate reconciliation for the
conflicting information regarding time values for these services as
presented to us by the physician community. We also sought public
comment on the use of specialty databases as compared to surveys for
determining time values, potential sources of objective data regarding
procedure times, and levels of visits furnished during the global
periods for the services described by these codes.
Comment: The RUC submitted comments explaining how it reached its
recommendations for these codes and that it followed its process
consistently in developing its recommendations on these codes. All
those who commented specifically on the interim final work RVUs for
these codes objected to the interim final work RVUs--some citing
potential access problems. Commenters suggested that we use more
reliable time data. Commenters suggested that valuation should be based
on actual time data, which demonstrates that the time for this code has
not changed since the last valuation; and thus the work RVUs should not
decrease from the CY 2013 values. Among the commenters' suggestions
were using data from the Function and Outcomes Research for Comparative
Effectiveness in Total Joint Replacement (FORCE-TJR), which includes
data on more than 15,000 total lower extremity joint arthroplasty
procedures, including time in/time out data for at least half of the
procedures, and working with the specialty societies to explore the
best data collection methods. A commenter suggested restoring the CY
2013 work RVUs until additional time data are available. Another
commenter suggested valuing these services utilizing a reverse building
block methodology resulting in work RVU of 21.18 for CPT codes 27130
and 22.11 for CPT code 27447. A commenter stated that the hip and knee
replacement codes should be valued differently since they are
clinically different procedures. Two commenters expressed concern
regarding the use of a final rule to establish interim values for
established hip and knee procedures due to the lack of opportunity it
provides stakeholders to analyze and comment on reductions prior to
implementation.
Response: In the CY 2014 final rule with comment period, we noted
concerns about the time data used in valuing these services and
requested additional input from stakeholders regarding using other
sources of data beyond the surveys typically used by the RUC. We do not
believe that we received the kind of information and the level of
detail about the other types of data suggested by commenters that we
would need to be able to use routinely in valuing procedures. We will
continue to explore the use of other data on time. As we discuss in
section II.B. we have engaged contractors to assist us in exploring
alternative data sources to use in determining the times associated
with particular services. At this time, we are not convinced that data
from another source would result in an improved value for these
services. Nor did we find the reasons given for modifying the interim
final work values established in CY 2014. The interim final values are
based upon the best data we have available and preserve appropriate
relativity with other codes.
[[Page 67633]]
Accordingly, we are finalizing the interim final values for these
procedures.
(4) Transcatheter Placement Intravascular Stent (CPT Code 37236, 37237,
37238, and 37239)
For CY 2014, we established the RUC-recommended work RVUs for newly
created CPT codes 37236, 37237, and 37238 as the interim final values.
We disagreed with the RUC-recommended work RVU for CPT code 37239,
which is the add-on code to CPT code 37238, for the placement of an
intravascular stent in each additional vein. As we described in the CY
2014 final rule with comment period we believe that the work for
placement of an additional stent in a vein should bear the same
relationship to the work of placing an initial stent in the vein as the
placement of an additional stent in an artery to the placement of the
initial stent in an artery.
Comment: Many commenters indicated that our valuation of CPT code
37239 was inappropriate. They indicated that instead we should use the
RUC's recommended work RVU of 3.34 for this code since the procedure is
more intense and requires more physician work than would result from
the comparison made by CMS. One commenter requested that CPT code 37239
be referred to the refinement panel.
Response: After re-review, we continue to believe that the ratio of
the work of the placement of the initial stent to the placement of
additional stents is the same whether the stents are placed in an
artery or a vein, and accordingly the appropriate ratio is found in the
RUC-recommended work RVUs of CPT codes 37236 and 37237, the comparable
codes for the arteries. For that reason, we are finalizing our CY 2014
interim final values. Additionally, we did not refer these codes for
refinement panel review because the criteria for refinement panel
review were not met.
(5) Embolization and Occlusion Procedures (CPT Codes 37242 and 37243)
For CY 2014, we established interim final work RVUs for these two
codes based upon the survey's 25th percentile. As we discussed in the
CY 2014 interim final rule with comment period, we believed that the
RUC-recommended work RVU for CPT code 37242 did not adequately take
into account the substantial decrease in intraservice time. We
indicated that we believed that the survey's 25th percentile work RVU
of 10.05 was more consistent with the decreases in intraservice time
since its last valuation and more appropriately reflected the work of
the procedure. Similarly, we did not believe that the RUC-recommended
work RVU for CPT code 37243 adequately considered the substantial
decrease in intraservice time for the procedure; and we also use the
survey's 25th percentile for CPT code 37243.
Comment: Many commenters disagreed with our interim final valuation
of 37242, including one who recommended a work RVU of 11.98. One
commenter also believed the work RVU assigned to CPT code 37243 was
inappropriate and recommended instead a work RVU of 14.00. Commenters
requested that the family of codes be referred for refinement.
Response: After consideration of the comments, we continue to
believe that work RVUs should reflect the decreases in intraservice
time that have occurred since the last valuation. As a result, we
continue to believe that our CY 2014 interim final values are most
appropriate and are finalizing them for CY 2015. Additionally, we did
not refer these codes for refinement panel review because the criteria
for refinement panel review were not met.
(6) Rigid Transoral Esophagoscopy (CPT Codes 43191, 43192, 43193,
43194, 43195 and 43196)
We established CY 2014 interim final work RVUs for the rigid
transoral esophagoscopy codes using a ratio of 1 RVU per 10 minutes of
intraservice time, resulting in a RVU of 2.00 for CPT code 43191, 3.00
for CPT code 43193, 3.00 for CPT code 43194, 3.00 for CPT code 43195,
and 3.30 for CPT code 43196. As we detailed in the CY 2014 final rule
with comment period, the surveys showed that this ratio was reflected
for about half of the rigid transoral esophagoscopy codes.
Additionally, we noted that this ratio was further supported by the
relationship between the CY 2013 work value of 1.59 RVUs for CPT code
43200 (Esophagoscopy, rigid or flexible; diagnostic, with or without
collection of specimen(s) by brushing or washing (separate procedure))
and its intraservice time of 15 minutes. For CPT code 43192, the 1 work
RVU per 10 minutes ratio resulted in a value that was less than the
survey low, and thus did not appear to be appropriate for this
procedure. Therefore, we established a CY 2014 interim final work RVU
for CPT code 43192 of 2.45 based upon the survey low.
Comment: Multiple commenters objected to the interim final work
RVUs assigned to CPT codes 43191-43196, and expressed dissatisfaction
with CMS's explanation for the valuations. The commenters specifically
noted that CMS did not account for the difference in intensity between
flexible and rigid scopes now that there are separate codes for these
procedures. The commenters also suggested that the reduction in time in
the RUC recommendations for codes 43191, 43193, 43195, and 43196 was
also based on data from procedures with flexible scopes. The commenters
also stated that our valuation of services based upon 1 work RVU per 10
minutes of intraservice time was inappropriate and was based on the
survey low, which is an anomalous outlier. The commenters suggested the
following work RVUs based upon the RUC recommended values: 2.78 For CPT
code 43191, 3.21 for CPT code 43192, 3.36 for CPT code 43193, 3.99 for
CPT code 43194, 3.21 for CPT code 43195 and 3.36 or CPT code 43196.
Finally, the commenters asked that all these codes be referred to a
refinement panel for reconsideration.
Response: After consideration of the comments, we agree that
modification of the CY 2014 interim final values is appropriate. Based
upon the information provided in comments and further investigation, we
believe that greater intensity is involved in furnishing rigid than
flexible transoral esophagoscopy. Accordingly, rather than assigning 1
work RVU per 10 minutes of intraservice time as we did for the CY 2014
interim final, we are assigning a final work RVU to the base code, CPT
code 41391, of 2.49. This work RVU is based on increasing the work RVU
of the previous comparable code (1.59) to reflect the percentage
increase in time for the CY 2014 code. For the remaining rigid
esophagoscopy codes, we developed RVUs by starting with the RVUs for
the corresponding flexible esophagoscopy codes, and increasing those
values by adding the difference between the base flexible esophagoscopy
and the base rigid esophagoscopy codes to arrive at final RVUs. We are
establishing a final work RVU of 2.79 to CPT code 43192, 2.79 to CPT
code 43193, 3.51 to CPT code 43194, 3.07 to CPT code 43195, and 3.31 to
CPT code 43196. These codes were not referred to refinement because the
request did not meet the criteria for referral.
(7) Flexible Transnasal Esophagoscopy (CPT Codes 43197 and 43198)
We established CY 2014 interim final work RVUs of 1.48 for CPT code
43197 and 1.78 for CPT code 43198. As detailed in the CY 2014 final
rule with comment period, we removed 2 minutes
[[Page 67634]]
of the pre-scrub, dress and wait preservice time from the calculation
of the work RVUs that we established for CY 2014 for CPT codes 43200
and 43202 because we believed that unlike the transoral codes, which
they correspond to, the transnasal services are not typically furnished
with moderate sedation.
Comment: Multiple commenters objected to the work RVUs for these
codes and in particular to CMS basing its valuation on the fact that
these codes typically do not involve moderate sedation. Although the
commenters agreed that these codes typically do not involve moderate
sedation, they said that procedures involving local/topical anesthesia
often take more work than those involving general sedation due to the
difficulties of furnishing services to a conscious and often anxious
patient. Some also noted that it ignores the time necessary to apply
local/topical anesthesia and wait for it to take effect. A commenter
urged CMS to establish values based upon the RUC recommendations.
Commenters requested that these codes be referred for refinement.
Response: After consideration of the comments, we agree that the
work RVUs for these codes should not be reduced because moderate
sedation is not typically used. Accordingly, we agree with the RUC
recommendation to assign the same work RVUs to these codes as to CPT
code 43200 (Esophagoscopy, flexible, transoral; diagnostic, including
collection of specimen(s) by brushing or washing when performed) and
43202 (Esophagoscopy, flexible, transoral; with biopsy, single or
multiple) the comparable transoral codes. We are finalizing work RVUs
of 1.52 and 1.82 for CPT codes 43197 and 43198, respectively. We did
not refer these codes to refinement because the request did not meet
the criteria for refinement panel review.
(8) Flexible Transoral Esophagoscopy, (CPT Codes 43200, 43202, 43204,
43205, 43211, 43212, 43213, 43214, 43215, 43227, 43229, 43231, and
43232)
We established CY 2014 interim final work RVUs for the flexible
transoral esophagoscopy family, which are detailed in Table 15. As we
described in the CY 2014 final rule with comment period, to establish
work values for these codes we used a variety of methodologies as did
the RUC. The methodologies used by CMS And the RUC include basing
values on the surveys (either medians or 25th percentiles),
crosswalking values to other codes, using the building block
methodology, and valuing a family of codes based on the incremental
differences in the work RVUs between the codes being valued and another
family of codes. As we did for the rigid transoral esophagoscopy codes,
in addition to the methodologies used by the RUC, we also reduced the
work RVUs for particular codes in direct proportion to the reduction in
times that were recommended by the RUC. Using these methodologies, we
assigned the RUC-recommended work RVUs for five codes in this family;
for the other eight codes we used these same methodologies but because
of different values for a base code or variation in the crosswalk
selected we obtained different values.
Comment: Commenters objected to the interim final RVUs we assigned
for CPT code 43200, the base code for flexible transoral esophagoscopy,
because they did not believe the work RVU for the code should be less
than they were as of CY 2013 when there was a single code to report
both flexible and rigid esophagoscopy services. Commenters also
disagreed with the way we used standard methodologies to value many of
these codes, including using the ratio of 1 work RVU per 10 minutes of
intraservice time to CPT code 43200. Commenters requested that we
accept the RUC values for all the flexible transoral esophagoscopy
codes and asked that we refer all these codes to the refinement panel.
Response: Although refinement was requested for all of the flexible
transoral esophagoscopy codes, we found that the codes (CPT codes
43204, 43205 and 43233) met the refinement criteria, and those were
referred to the refinement panel. After consideration of the comments
and the refinement panel results, we are revising the work RVUs for
many of the codes in this family.
For CPT code 43200, which is the base code for flexible transoral
esophagoscopy, we agree with commenters that another methodology is
preferable to applying the work RVU ratio of 1 RVU per 10 minutes of
intraservice time. In revaluing this service, we subtracted 0.07 to
account for the 3 minute decrease in postservice time since the last
valuation from the CY 2013 work RVU for the predecessor base code,
which resulted in a work RVU of 1.52. We are finalizing this work RVU.
The CY 2014 interim final work RVUs for CPT codes 43201, 43202,
43204, 43205 and 43215 were all based upon methodologies using the work
RVU of the base code, 43200. As we are establishing a final value for
CPT code 43200 that is higher than the CY 2014 interim final value, we
are also adjusting the work RVUs for the other codes based upon the new
work RVU for CPT code 43200. We are finalizing a work RVU of 1.82 for
43201, 1.82 for 43202, 2.43 for 43204, 2.54 for 43205, and 2.54 for
43215.
CPT codes 43204 and 43205 were considered by the refinement panel.
The refinement panel median for each of these codes was 2.77 and 2.88,
respectively. The refinement panel discussion reiterated the
information presented to the RUC and in the comments in response to the
CY 2014 final rule with comment period, such as that the typical
patient for these codes are sicker and thus the work is more intense.
Because we do not agree with commenters' contention that higher work
RVUs are warranted since these codes involve the sicker patients or
that our methodology for calculating the interim final RVUs was
inappropriate, we are establishing final values determined using these
methodologies. However, due to the change in the base code, CPT code
43200, as discussed in the previous paragraph the final values for
these codes are higher than the interim final values.
In the CY 2014 final rule with comment period, we assigned an
interim final work RVU of 4.21 to CPT code 43211 by using a comparable
esophagogastroduodenoscopy (EGD) code and subtracting the difference in
work between the base esophagoscopy and base EGD codes. After
consideration of the comments that indicated the interim final work RVU
of 4.21 was too low, we believe this code should instead be crosswalked
to CPT code 31636 (Bronchoscopy bronch stents), which we believe is a
comparable service with comparable intensity. It has the same
intraservice time and slightly higher total time. As a result we are
finalizing a work RVU of 4.30.
As we noted in the CY 2014 final rule with comment period, we
crosswalked the interim final work RVU for CPT 43212 to that of CPT
code 43214. Since we are increasing the work RVU for CPT code 43214, we
are also increasing the work RVU for CPT code 43212, which is
consistent with comments that we had undervalued this procedure.
As we detailed in the CY 2014 final rule with comment period, we
based the work RVU of 4.73 for CPT code 43213 on the value of CPT code
43220, increased proportionately to reflect the longer intraservice
time of CPT code 43213. The refinement panel median was 5.00 for this
code. No new information was presented at the refinement panel. We
continue to believe that 4.73 is the appropriate work RVU and are
finalizing it.
[[Page 67635]]
Based upon the information presented by commenters about the
typical patient and the advanced skills required for the procedure, we
are changing our method of valuing CPT code 43214. We believe it should
be crosswalked to CPT 52214 (cystoscopy), which we believe is similar
in intensity. This results in a final work RVU of 3.50 as compared to
an interim final of 3.38. This refinement also supports the belief made
by commenters that the work of CPT code 43214 is greater than the
interim final work RVU. Therefore, we are finalizing a work RVU of 3.50
for CPT code 43214.
For CPT code 43227, we modified the CY 2013 work RVU to reflect the
percentage decrease in intraservice time of 36 minutes to 30 minutes in
the RUC recommendation to establish a CY 2014 interim final value of
2.99. The commenters stated that the survey validates the RUC
recommendation of 3.26 and that the drop in intraservice time that upon
which we based our change in the work RVU was inappropriate since the
intraservice time had not really changed. They contend that the change
was from moving the time for moderate sedation from intraservice to
preservice. We disagree. We have no information from the RUC that leads
us to believe that when the pre-service packages were developed several
years ago and moderate sedation was explicitly recognized as a pre-
service item that the RUC also intended CMS to assume that the
intraservice times were no longer correct. We believe that our proposed
valuation methodology is correct and thus are finalizing a work RUV of
2.99.
Commenters, disagreeing with our crosswalk of CPT code 43229 to CPT
code 43232, stated that the two codes were not comparable. We disagree.
We continue to believe this crosswalk is appropriate as the times and
intensities are quite similar. We note that the RUC also bases
crosswalks on the comparability of time and intensity of codes and not
on the clinical similarity of work. Thus, we will continue this
crosswalk. However, as discussed below, we are refining the interim
final value of CPT code 43232 to 3.59 and thus are finalizing the work
RVU of 3.59 for CPT code 43229.
For CPT code 43231, we added the work of an endobronchial
ultrasound (EBUS) to the work of the base esophagoscopy code to arrive
at our interim final value. The commenters disagreed with our approach,
stating that the EBUS code is an add-on code and as such does not have
pre- and postservice work. We agree that pre- and postservice work is
not included in the EBUS code nor should it be for the ultrasound
portion of the examination of esophagus. Therefore, we are finalizing a
work RVU of 2.90.
For CPT code 43232, the commenters stated our interim final value
is too low and that the work involved in this code is appropriately
reflected in the RUC recommendation. They objected to our basing the
work RVU for 43232 on the difference between the RUC-recommended values
for this code and CPT code 43231. We learned from the comments that the
typical patient for this service has advanced cancer and agree that our
interim final value may not represent the full extent of the work
involved in this procedure. Therefore, we are crosswalking this code to
CPT code 36595 (Mechanical removal of pericatheter obstructive material
(eg, fibrin sheath) from central venous device via separate venous
access), which has identical intraservice time, slightly less total
time, and a slightly higher intensity and are finalizing a work RVU of
3.59.
(10) Esophagogastroduodenoscopy (EGD) (CPT Codes 43233, 43235, 43236,
43237, 43238, 43239, 43242, 43244, 43246, 43247, 43249, 43253, 43254,
43255, 43257, 43259, 43266, and 43270.
We established interim final work RVUs for various EGD codes in the
CY 2014 final rule with comment period. In this section, we discuss the
18 EGD codes on which we received comments disagreeing with or making
recommendations for changes in our interim final values. As we detailed
in the CY 2014 final rule with comment period, we valued many of these
codes by adding the additional work of an EGD to the comparable
esophagoscopy (ESO) code. We determined the additional work of an EGD
by subtracting the work RVU of CPT code 43200, the base ESO code, from
the work of CPT code 43235, the base EGD code. For example, CPT code
43233 is an identical procedure to CPT code 43214 except that it uses
EGD rather than ESO. We valued it by adding the additional work of EGD
to the work RVU of CPT code 43214, resulting in an interim final work
RVU of 4.05. We valued the additional work the same way the RUC did in
its recommendations. The following EGD codes were valued in the same
way using the code in parentheses as the corresponding ESO code: 43233
(43214), 43236 (43201), 43237 (43231), 43238 (43232), 43247 (43215),
43254 (43211), 43255 (43227), 43266 (43212), and 43270 (43229). In
valuing CPT codes 43235, we agreed with the RUC recommended work RVU
difference between this EGD base code and the esophagoscopy base code,
CPT 43200 but applied the difference to our CY 2014 RVU values. In a
similar fashion, in valuing CPT code 43242 we agreed with the RUC
recommended methodology of which took the increment between CPT code
43238 and CPT code 43237 but we applied the difference to our CY 2014
values. In order to value other EGD codes, we crosswalked the services
to similar procedures; specifically for CY 2014 we crosswalked CPT
codes 43239 to 43236, 43246 to 43255, 43253 to 43242 and 43257 to
43238. We valued CPT codes 43244 and 43249 through acceptance of the
RUC work RVU recommendation. Lastly, we valued CPT code 43259 by
adjusting the CY 2013 work RVU to account for the CY 2014 RUC
recommended reduction in total time.
Comment: For all codes, commenters objected to our work RVUs and
said that our reductions from the RUC recommendations were based on a
decrease in intraservice time that did not reflect a change in the time
required to furnish the procedures but rather only a change in which
part of the procedure the RUC includes the moderate sedation time.
Commenters disagree with our valuing CPT code 43233 based on the value
of CPT code 43214, saying that CPT code 43233 is more intense due to
the risk of perforation, and that the achalasia patients are at high
risk and poor candidates for surgery. Commenters disagreed with our
methodology for valuing CPT code 43235, and suggested that we use the
RUC crosswalk to CPT code 31579, contending that the slight reductions
in pre- and post-service times are consistent with the slight drop in
the RUC-recommended RVU. For CPT code 43237, commenters also noted a
rank order anomaly because the interim final work RVU for this code is
the same as for CPT code 43251. Commenters said that the robust survey
data on CPT code 43238 should override CMS decisions. With regard to
CPT code 43239, commenters suggest that the survey is wrong and further
point to the fact that our valuation results in the same value for CPT
code 43239 as the base EGD code, which they state is not appropriate
due to the additional work in CPT code 43239. Commenters disagreed with
our value for CPT code 43242 stating that we inappropriately valued CPT
code 43259, which we used in calculating the work RVUs for CPT code
43242. Commenters objected to our value of CPT code 43246 because they
disagree with the work RVU for the code that it is crosswalked to, CPT
code 43255. Commenters urged us to modify
[[Page 67636]]
our work RVU for CPT code 43247 to equal the RUC recommendation. For
CPT code 43253, commenters did not disagree with the valuation
approach, but disagreed with the valuation we had assigned to the base
code, CPT code 43259, which affected the valuation of CPT code 43253.
Comments indicated that they did not understand how the value of CPT
code 43254 was derived. Commenters indicated that they disagreed with
the reduction in the work in CPT code 43255 due to a decrease in time.
They also cited that this was an emergency procedure in unstable
patients and that it was more difficult to control bleeding in the
stomach than in the esophagus. For CPT code 43257, commenters disagreed
with our crosswalk to CPT code 43238 indicating that CPT code 43257 was
more intense than CPT code 43238. Commenters acknowledged that reduced
times should result in reduced work, but disagreed with our
proportional reduction approach. Commenters agreed with our approach to
valuing CPT code 43266, but disagreed with the valuation of the CPT
code 43212, that we used as the base. With regard to CPT code 43270,
commenters disagreed with using CPT code 43229 as the base.
Response: For each of these codes, commenters were concerned that
we did not accept the RUC-recommended values. Their common reasoning
for urging us to accept the RUC-recommended values was that moderate
sedation time had been removed from intraservice time and that these
intraservice time changes should not result in a change in the RUC-
recommended RVU. However, for CPT codes 43233, 43236, 43237, 43238,
43247, 43254, 43255, 43266, and 43270, we used the standard methodology
described above for valuing EGD codes and did not base our values on
the time change. Thus, any refinements to the RUC recommendations for
the EGD codes are solely due to refinements in the ESO codes. We
discussed our valuations of these codes in the previous section. Since
we have finalized most of the ESO codes at higher levels than the CY
2014 interim final values, we are making corresponding increases in the
EGD codes. Therefore, we are finalizing these codes at the following
work RVUs: 43233 at 4.17, 43235 at 2.19, 43236 at 2.49, 43237 at 3.57,
43238 at 4.26, 43247 at 3.21, 43254 at 4.97, 43255 at 3.66, 43266 at
4.17, and 43270 at 4.26.
CPT code 43233 was referred to the refinement panel and received a
median work RVU of 4.26. As outlined above, we are finalizing a work
RVU of 4.17 for CPT code 43233 at 4.17, which is higher than our
interim value of 4.05, but consistent with our valuation of the other
EGD codes. We do not believe that the comments provided at the
refinement panel justify adoption of the higher median value.
The interim final work value of CPT code 43239 was crosswalked to
the work RVU of CPT code 43236. Since we increased the final work RVU
from the interim final for this code, the final work RUV of CPT code
43239 increases to 2.49.
(11) Endoscopic Retrograde Cholangiopancreatography (ERCP) (CPT Codes
43263, 43274, 43276, 43277 and 43278)
In the CY 2014 final rule with comment period we established
interim final work RVUs for several ERCP codes due to coding revisions.
For all those codes not discussed in this section, we are finalizing
the interim final work RVUs. For CPT code 43263, we established an
interim final work RVU based upon a crosswalk to CPT code 43262. As we
detailed in the CY 2014 final rule with comment period, we valued CPT
codes 43274, 43276, and 43278 using the same formula that the RUC used
in determining its recommendations, but substituting our interim final
work RVUs for codes used in the formula for the RUC-recommended values.
CPT code 43277 was valued using the survey 25th percentile.
Comment: Commenters objected to our valuation of CPT 43263 based
upon a crosswalk to CPT code 43262, saying that CPT 43263 is more
intense and has greater risks than CPT code 43262. Commenters also
indicated that we underestimated the intensity of CPT code 43276
indicating that CPT code 43276 typically involves replacing stents that
are overgrown with cancerous tissues. They also said that we
underestimated the intensity of CPT coded 43274 and 43277. Commenters
further took issue with our valuing CPT code 43277 based upon the
survey when most codes in this family were valued based upon the
incremental formula. Commenters stated that CPT code 43278 is valued
incorrectly because we did not correctly value CPT code 43229, which is
used in the formula we used to value CPT code 43278.
Response: After consideration of the comments, we continue to
believe that CPT code 43263 is the appropriate crosswalk for CPT code
43262 and we are finalizing a work RVU of 6.60 for that code. With
regard to CPT code 43274, we continue to believe the formula described
in the CY 2014 final rule with comment period is the appropriate
methodology. We are finalizing a work RVU of 8.58 for CPT code 43274
using the final values for the codes used in the formula and thus
increasing the work RVU from the interim final value of 8.48.
Similarly, we are finalizing a work RVU of 8.94 for CPT code 43276
based upon the formula described in the CY 2014 final rule with comment
period adjusted for changes in the final work RVUs for values used in
the formula. For CPT code 43277, we continue to believe the survey 25th
percentile is appropriate. This valuation is supported by a drop in the
intraservice time from the code it replaces. Thus, we are finalizing
the interim final work RVU of 7.00. For CPT code 43278, we continue to
believe use of the RUC formula for this code is most appropriate, and
we are adjusting the work RVU to reflect final work RVUs for values
used in the formula. The final work RVU for CPT code 43278 is 8.
(12) Spinal Injections (CPT Codes 62310, 62311, 62318 and 62319)
We proposed new work RVUs for these codes in the PFS proposed rule.
(79 FR 40338-40339). See section II.B.3 for a discussion of the
valuation of these codes, and a summary of public comments and our
responses.
(13) Laminectomy (CPT Codes 63045, 63046, 63047 and 63048)
We established interim final work RVUs for CPT codes 63047 and
63048 for CY 2014. As we indicated in the CY 2014 final rule with
comment period, we had identified CPT code 63047 as potentially
misvalued through the high expenditure procedure code screen and the
RUC included a recommendation for CPT code 63048. We noted that, to
appropriately value these codes, we need to consider the other two
codes in this family: CPT codes 63045 (Laminectomy, facetectomy and
foraminotomy (unilateral or bilateral with decompression of spinal
cord, cauda equina and/or nerve root[s], [eg, spinal or lateral recess
stenosis]), single vertebral segment; cervical) and 63046 (Laminectomy,
facetectomy and foraminotomy (unilateral or bilateral with
decompression of spinal cord, cauda equina and/or nerve root[s], [eg,
spinal or lateral recess stenosis]), single vertebral segment;
thoracic). Although we did not receive recommendations for CPT codes
63045 and 63046, we established CY 2014 interim final work RVUs for CPT
codes 63047 and 63048 of 15.37 and 3.47, respectively, based upon the
RUC recommendations. We noted that we expected to review these values
in concert with the RUC
[[Page 67637]]
recommendations for CPT codes 63045 and 63046 when we received them.
Comment: Commenters questioned our determination that CPT codes
63047, 63048, 63045 and 63046 constituted a family, noting that CPT
codes 63045 and 63046 require different work. Commenters questioned the
value of resurveying this set of codes as a family since CPT codes
63045 and 63046 constitute a small percentage of the total volume of
these codes. The survey of CPT codes 63047 and 63048 did not reveal
significant change in the values of the codes, and the work involved in
resurveying would be burdensome for those involved. One commenter urged
us to withdraw our request to survey these codes.
Response: We continue to believe that it is appropriate to value a
family of codes together in order to maintain relativity. We also
continue to believe that CPT codes 63045 and 63046 are indeed in the
same family as CPT codes 63047 and 63048 due to similarity of service.
We have received new RUC recommendations for CPT code 63045 and 63046,
but did not receive them in time to include in this rule. As a result,
we will finalize the interim work values for CPT codes 63047 and 63048
for CY 2015.
(14) Chemodenervation of Muscles (CPT Codes 64616, 64617, 64642, 64643,
64644, and 64645)
We assigned refined interim final work RVU values of 1.53 to CPT
code 64616 and 1.90 to CPT code 64617. As detailed in the CY 2014 final
rule with comment period, we refined the RUC-recommended work RVUs of
1.79 for CPT code 64616 and 2.06 for CPT code 64617 to reflect the
deletion of an outpatient visit that was included in the predecessor
code, CPT code 64613 (chemodenervation of muscle(s); neck muscle(s)
(eg, for spasmodic torticollis, spasmodic dysphonia)). We also
explained that since CPT code 64617, chemodenervation of the larynx,
includes EMG guidance when furnished we determined the interim final
work RVU by adding the work RVU for CPT code 95874 (Needle
electromyography for guidance in conjunction with chemodenervation
(List separately in addition to code for primary procedure)) to the CY
2013 work RVU for CPT 64616.
For CY 2014, we assigned interim final work RVUs for CPT code 64643
and CPT code 64645 of 1.22 and 1.39, respectively. As we explained in
the CY 2014 final rule with comment period, we refined the RUC-
recommended work RVUs for these add-on codes by subtracting the RVUs to
account for 19 minutes of pre-service time and the decrease in time for
furnishing the add-on service. Additionally, we based the global period
for these codes on the predecessor code, CPT code 64614
(chemodenervation of muscle(s); extremity and/or trunk muscle(s) (eg,
for dystonia, cerebral palsy, multiple sclerosis)), which was deleted
for CY 2014. Therefore, we assigned 10-day global periods to the
services.
Comment: Most commenters disagreed with the CY 2014 interim final
work RVU valuations for CPT codes 64616, 64643, and 64645. One
commenter stated that the work RVU for the predecessor code, CPT code
64614, did not take into account the full level of intensity, time, and
work that it takes to perform the service. This commenter also
disagreed with the times for this service. Several commenters disagreed
with the valuation of CPT code 64616 saying that we ignored the RUC
recommendation which was based on survey data and RUC deliberations and
asked that we value the code based upon the RUC recommendation. Several
commenters disagreed with the valuations for CPT codes 64643 and 64645
saying that CMS did not explain our valuation, ignored the fact that
the RUC discounted the add-on codes based on the pre- and post-service
time and did not articulate any basis for our valuation decision.
Several commenters requested refinement of the codes in the
chemodenervation family.
Response: After consideration of the comments we are finalizing the
interim final work RVUs and time for these codes. We continue to
believe that our valuations for this family take into account the full
level of intensity, time, and work that are required to furnish these
services. Additionally, we disagree with commenters that we did not
explain our valuation of CPT codes 64643 and 64645. In the CY 2014
final rule with comment period, we detail and thoroughly explain the
methodology utilized to value CPT codes 64643 and 64645. Additionally,
the request for refinement panel review was not granted as the criteria
for refinement were not met.
(15) Impacted Cerumen (CPT Code 69210)
After it was identified as a potentially misvalued code pursuant to
the CMS high expenditure screen, CPT code 69210, which describes
removal of impacted cerumen, was revised from being applicable to ``1
or both ears'' to a unilateral code effective January 1, 2014. For
Medicare purposes we limited the code to billing once whether it was
furnished unilaterally or bilaterally because we believed the procedure
would typically be furnished in both ears as the physiologic processes
that create cerumen impaction likely would affect both ears. Similarly,
we continued the CY 2013 value as our interim final CY 2014 value since
for Medicare purposes the service was unchanged.
Comment: Commenters requested that we allow CPT code 69210 to be
billed twice when it is furnished bilaterally, consistent with code
descriptor. Commenters stated that our assumption regarding the
physiologic processes that create cerumen was flawed and requested we
provide a clinical rationale and/or literature to support our claim.
Lastly, the commenters requested guidance from the agency as to how
best deal with this CPT code; specifically, if it should be sent to CPT
for clarification or if not, that we provide further guidance as to how
this procedure should be billed using the new code.
Response: We continue to believe that the procedure will be
furnished in both ears as the physiologic processes that create cerumen
impaction likely would affect both ears. As a result, we will continue
to allow only one unit of CPT 69210 to be billed when furnished
bilaterally and are finalizing our CY 2014 interim final work RVU for
this service.
(16) Magnetic Resonance Imaging (MRI) Brain (CPT Codes 77001, 77002,
and 77003)
As detailed in the CY 2014 final rule with comment period, we
agreed with the RUC-recommended values for CPT codes 77001, 77002 and
77003 but were concerned that the recommended intraservice times for
all three codes was generally higher than the procedure codes with
which they were typically billed. We sought additional public comment
and input from the RUC and other stakeholders regarding the appropriate
relationship between the intraservice time associated with fluoroscopic
guidance and the intraservice time of the procedure codes with which
they are typically billed.
Comment: Some commenters disagreed with the concern expressed by
CMS that the intraservice time for codes 77001, 77002 and 77003 is
higher than the codes alongside which they are typically billed, as the
commenters believed that the combinations being used to support this
concern were not appropriate, and they requested additional examples to
support its concern. The commenters believed that the concerns CMS
expressed are unfounded and that we should assign work RVUs of 0.38,
0.54, and 0.60 for
[[Page 67638]]
CPT code 77001, 77002, and 77003, respectively.
Response: We continue to have concerns regarding the appropriate
relationship between the intraservice time associated with fluoroscopic
guidance and the intraservice time of the procedure codes with which
they are typically billed and will continue to study this issue. We are
finalizing the CY 2014 interim final values for CY 2015.
(17) Immunohistochemistry (CPT Codes 88342 and 88343 and HCPCS Codes
G0461 and G0462)
These codes were revised for CY 2015. For discussion of valuation
for CY 2015, see section II.G.3.b.
(18) Optical Endomicroscopy (Code 88375)
As detailed in the CY 2014 final rule with comment period, we
believed that the typical optical endomicroscopy case would involve
only the endoscopist, and CPT codes 43206 and 43253 were valued to
reflect this. Accordingly, we believed a separate payment for CPT code
88375 would result in double payment for a portion of the overall
optical endomicroscopy service. Therefore, we assigned a PFS procedure
status of I (Not valid for Medicare purposes. Medicare uses another
code for the reporting of and the payment for these services) to CPT
code 88375.
Comment: Multiple commenters objected to CMS's decision to assign a
PFS status indicator of ``I'' to code 88375, stating that the code
already includes distinctions that would prevent a physician from
billing the code when it would double count work. The commenters urge
CMS to assign CPT code 88375 a Medicare status of A (Active Code), and
to immediately publish RVUs associated with the service.
Response: In our re-review of this procedure and consideration of
the information provided by commenters, we believe the coding is
adequate to avoid double payment for a portion of the service.
Accordingly, we assigned a Medicare status indicator of A (Active). To
value this service, we based the RVUs on those assigned to CPT code
88329, adjusted for the difference in intraservice time between the two
codes. We are assigning a final work RVU of 0.91 for CPT code 88375 for
CY 2015.
(19) Speech Language (CPT Codes 92521, 92522, 92523 and 92524)
In CY 2014, we assigned CY 2014 interim final work RVUs of 1.75 and
1.50 for CPT codes 92521 and 92522, respectively, as the HCPAC
recommended. For CPT code 92523, we disagreed with the HCPAC-
recommended work RVU of 3.36. We believed that the appropriate value
for 60 minutes of work for the speech evaluation codes was reflected in
CPT code 92522, for which the HCPAC recommended 1.50 RVUs. Because the
intraservice time for CPT code 92523 was twice that for CPT code 92522,
we assigned a work RVU of 3.0 to CPT code 92523. Similarly, since CPT
codes 92524 and 92522 had identical intraservice time recommendations
and similar descriptions of work we believed that the work RVU for CPT
code 92524 should be the same as the work RVU for CPT code 95922.
Therefore, we assigned a work RVU of 1.50 to CPT code 92524.
Comment: Commenters disagreed with the interim final work RVUs
assigned to CPT codes 92523 and 92524, saying they based on inaccurate
assumptions. Commenters stated that survey respondents appropriately
took time and effort into account when valuing CPT code 92523 but had
difficulty using a time-based reference code to value the RVU of an
untimed code like CPT code 92523. Commenters noted that the HCPAC
acknowledged that the work of the second hour involved in CPT code
92523 is indeed more intense than the first hour. Additionally,
commenters stated that the work RVU reduction of CPT code 92524 was
arbitrary because it was based solely on intraservice time and failed
to recognize the more difficult aspects of performing the service
compared to that of CPT code 92522. Commenters requested
reconsideration of CPT codes 92523 and 92524 through refinement panel
review.
Response: We believe that our interim final work RVU is most
appropriate for these services. In the HCPAC recommendation for CPT
code 92523 the affected specialty society stated that its survey
results were faulty for this CPT code because those surveyed did not
consider all the work necessary to perform the service. The commenters
did not provide any information that demonstrates that our valuations
fail to fully account for the intensity, work, and time required to
perform these services. Therefore, we are finalizing our CY 2014
interim final values for CY 2015. We did not refer these codes to
refinement because the request did not meet the criteria for
refinement.
(20) Percutaneous Transcatheter Closure (CPT Code 93582)
As detailed in the CY 2014 final rule with comment period, we
reviewed new CPT code 93582. Although the RUC compared this code to CPT
code 92941 (percutaneous transluminal revascularization of acute total/
subtotal occlusion during acute myocardial infarction, coronary artery
or coronary), which has a work RVU of 12.56 and 70 minutes of
intraservice time, it recommended a work RVU of 14.00, the survey's
25th percentile. We agreed with the RUC that CPT code 92941 is an
appropriate comparison code and believed that due to the similarity in
intensity and time that the codes should be valued with the same work
RVU. Therefore, we assigned an interim final work RVU of 12.56 to CPT
code 93582.
Comment: One commenter disagreed with the work RVU valuation of CPT
code 93582 because they believed it did not accurately reflect the
intensity of the procedure, particularly in treating infants. The
commenter stated that the RUC concluded that a 55 percent work
differential exists between performing this service on a child versus
an adult--a fact that they stated supports the higher work RVU
recommended by the RUC. As a result, the commenter suggests we assign
the RUC-recommended work RVU to CPT code 93582. A commenter requested
referral to the refinement panel.
Response: We continue to believe that CPT code 92941 is an
appropriate comparison code to CPT code 93582 due to similarity in
intensity and time and, as a result, the codes should be valued with
the same work RVU. Therefore, we are finalizing our CY 2014 interim
final work RVU of 12.56 to CPT code 93582 for CY 2015. We did not refer
this code to refinement because the request did not meet the criteria
for refinement.
(21) Duplex Scans (CPT Codes 93925, 93926, 93880 and 93882)
For CY 2014 we maintained the CY 2013 RVUs for CPT codes 93880 and
93882. We were concerned that the RUC-recommended values for CPT codes
93880 and 93882, as well as our final values for CPT codes 93925
(Duplex scan of lower extremity arteries or arterial bypass grafts;
complete bilateral study) and 93926 (Duplex scan of lower extremity
arteries or arterial bypass grafts; unilateral or limited study), did
not maintain the appropriate relativity within the family and referred
the entire family to the RUC to assess relativity among the codes and
then recommend appropriate work RVUs. We also requested that the RUC
consider CPT codes 93886 (Transcranial Doppler study of the
intracranial arteries; complete study) and 93888 (Transcranial Doppler
study of the
[[Page 67639]]
intracranial arteries; limited study) in conjunction with the duplex
scan codes to assess the relativity between and among the codes.
Comment: One commenter questioned why we did not include all duplex
scan codes we determined to be part of the family in our original
request to the RUC. Another commenter opposed our valuation approach
and stated that we should not redefine the codes in this family and
that we should reject the RUC recommendations.
Response: The valuations for CPT codes 93880, 93882, 93925, 93926,
93886 and 93888 are included in this year's valuations in section
II.G.3.b
(22) Interprofessional Telephone/Internet Consultative Services (CPT
Codes 99446, 99447, 99448 and 99449)
In CY 2014 we assigned CPT codes 99446, 99447, 99448, and 99449 a
PFS procedure status indicator of B (Bundled code. Payments for covered
services are always bundled into payment for other services, which are
not specified. If RVUs are shown, they are not used for Medicare
payment). If these services are covered, payment for them is subsumed
by the payment for the services to which they are bundled (for example,
a telephone call from a hospital nurse regarding care of a patient)
because Medicare pays for telephone consultations regarding beneficiary
services as a part of other services furnished to the beneficiary.
Comment: A commenter expressed concern that the services covered by
codes 99446-99449 were bundled together, and that no RVUs were
published for these codes. The commenter observed that CMS compares the
services to contact between nurses and patients in justifying its
decision to bundle the services in with other work, and stated that
this comparison is inappropriate to use regarding consultation between
physicians. The commenter also stated that these services are vital in
providing specific specialty expertise in areas where timely face-to-
face service is not a viable option. The commenter urged that the
status of these services be changed to ``Active,'' or at least ``Non-
covered,'' and that the RUC-recommended values for these services be
published.
Response: Medicare pays for telephone consultations regarding
beneficiary services as part of other services furnished to a
beneficiary. As a result, we continue to believe that CPT codes 99446-
99449 are bundled; and we are finalizing the PFS procedure status
indicator of B for these codes for CY 2015.
b. Finalizing CY 2014 Interim Direct PE Inputs
i. Background and Methodology
In this section, we address interim final direct PE inputs as
presented in the CY 2014 PFS final rule with comment period and
displayed in the final CY 2014 direct PE database available on the CMS
Web site under the downloads at https://www.cms.gov/PhysicianFeeSched/PFSFRN/list.asp#TopOfPage.
On an annual basis, the RUC provides CMS with recommendations
regarding PE inputs for new, revised, and potentially misvalued codes.
We review the RUC-recommended direct PE inputs on a code-by-code basis.
When we determine that the RUC recommendations appropriately estimate
the direct PE inputs (clinical labor, disposable supplies, and medical
equipment) required for the typical service and reflect our payment
policies, we use those direct PE inputs to value a service. If not, we
refine the PE inputs to better reflect our estimate of the PE resources
required for the service. We also confirm whether CPT codes should have
facility and/or nonfacility direct PE inputs and refine the inputs
accordingly.
In the CY 2014 PFS final rule with comment period (78 FR 74242), we
addressed the general nature of some of our common refinements to the
RUC-recommended direct PE inputs, as well as the reasons for
refinements to particular inputs. In the following sections, we respond
to the comments we received regarding common refinements we made based
on established principles or policies. Following those discussions, we
summarize and respond to comments received regarding other refinements
to particular codes.
We note that the interim final direct PE inputs for CY 2014 that
are being finalized for CY 2015 are displayed in the final CY 2015
direct PE input database, available on the CMS Web site under the
downloads for the CY 2015 PFS final rule at www.cms.gov/PhysicianFeeSched/. The inputs displayed there have also been used in
developing the CY 2015 PE RVUs as displayed in Addendum B of this final
rule with comment period.
Comment: Commenters indicated that it would be helpful to have
additional information about the specific rationale used in developing
refinements, and specifically requested that CMS provide more
information regarding how CMS makes the determination of whether an
item is typical.
Response: We continually seek ways to increase opportunity for
public comment. In response to comments received, we have provided more
detailed explanations about refinements made for the CY 2015 interim
final direct PE inputs. We recognize that we make assumptions about
what is typical, and note that we welcome objective data that provides
information about the typical case. We prefer that this information be
submitted through the notice and comment rulemaking process. We also
refer interested stakeholders to section II.F. of this final rule with
comment period, in which we provide extensive discussion of the changes
to the process that we are finalizing for valuing new, revised, and
potentially misvalued codes.
ii. Common Refinements
(1) Equipment Time
Prior to CY 2010, the RUC did not generally provide CMS with
recommendations regarding equipment time inputs. In CY 2010, in the
interest of ensuring the greatest possible degree of accuracy in
allocating equipment minutes, we requested that the RUC provide
equipment times along with the other direct PE recommendations, and we
provided the RUC with general guidelines regarding appropriate
equipment time inputs. We continue to appreciate the RUC's willingness
to provide us with these additional inputs as part of its PE
recommendations.
In general, the equipment time inputs correspond to the service
period portion of the clinical labor times. We have clarified this
principle, indicating that we consider equipment time as the times
within the intra-service period when a clinician is using the piece of
equipment plus any additional time that the piece of equipment is not
available for use for another patient due to its use during the
designated procedure. For services in which we allocate cleaning time
to portable equipment items, because the equipment does not need to be
cleaned in the room that contains the remaining equipment items, we do
not include that time for the remaining equipment items as they are
available for use for other patients during that time. In addition,
when a piece of equipment is typically used during any additional
visits included in the global period for a service, the equipment time
would also reflect that use.
We believe that certain highly technical pieces of equipment and
equipment rooms are less likely to be used during all of the pre-
service or post-service tasks performed by clinical labor staff on the
day of the procedure
[[Page 67640]]
(the clinical labor service period) and are typically available for
other patients even when one member of clinical staff may be occupied
with a pre-service or post-service task related to the procedure.
Some commenters have repeatedly objected to our rationale for
refinement of equipment minutes on this basis. We acknowledge the
comments we received reiterating those objections to this rationale and
refer readers to our extensive discussion in response to those
objections in the CY 2012 PFS final rule with comment period (76 FR
73182). In the following paragraphs, we address new comments on this
policy.
Comment: A commenter indicated that CMS removed minutes assigned to
vascular ultrasound rooms for activities that CMS does not believe take
place in the room, but CMS did not provide factual support for this
assumption. The commenter further stated that CMS did not articulate
the connection between the relevant data that the Administrative
Procedures Act (APA) requires CMS to consider and the conclusion that
CMS reached. The commenter indicated that they conducted a survey of a
significant number of providers, in which most providers indicated that
they performed these pre-service tasks in the room.
Response: We note that we would welcome comments that include
vetted survey results, especially where the data are included.
Statements regarding the existence of data to support commenters'
assertions do not provide us with information to support conclusions
based on the data. We acknowledge that we make assumptions about we
believe to be typical. If there are data that support or refute these
assumptions, we would be interested in reviewing that information. We
would be most interested in reviewing survey data that address multiple
points of our assumptions regarding high-cost equipment, including how
many procedures are furnished in a day, how often the equipment is
being used, and other such information.
Comment: A commenter stated that CMS should publish, on a quarterly
basis, refinements to the equipment times, rather than waiting until
the final rule to publish these changes.
Response: We appreciate the commenter's concern about our making
available timely information about refinements to practice expense
inputs. We note that since we do not review and make refinements to
practice expense inputs on a quarterly basis, we do not have
information to publish on a quarterly basis. Rather, we have reviewed
and refined practice expense recommendations from the RUC on an annual
basis for the subset of codes for which recommendations have been
provided to us. Because we have received many requests from
stakeholders to publish our refinements as proposals in the proposed
rule rather than in the final rule, we are finalizing a change in the
process in which changes to RVUs and direct PE inputs will be included
in the proposed rule rather than first appearing in the final rule with
comment period. We refer readers to section II.F. of this final rule
with comment period for further information about this change. We
believe that this process will address commenters' concerns about
having an opportunity to review these changes prior to the publishing
of the final rule.
Comment: Several commenters asked that CMS identify what
constitutes a highly technical piece of equipment.
Response: As we have previously indicated, during our review of all
recommended direct PE inputs, we consider such items as the degree of
specificity of a piece of equipment, which may influence whether the
equipment item is likely to be stored in the same room in which the
clinical staff greets and gowns, obtains vitals, or provides education
to a patient prior to the procedure itself. We would expect that items
that are highly specific to particular procedures would be moved
between rooms for those procedures. We also consider the level of
portability (including the level of difficulty involved in cleaning the
equipment item) to determine whether an item could be easily
transferred between rooms before or after a given procedure. Items that
are portable would also be expected to be moved between rooms. We also
examine the prices for the particular equipment items to determine
whether the equipment is likely to be located in the same room used for
all the tasks undertaken by clinical staff prior to and following the
procedure. We believe that highly expensive equipment would not be kept
in a location that does not allow for its maximum utilization. For each
service, on a case-by-case basis, we look at the description provided
in the RUC recommendation and consider the overlap of the equipment
item's level of specificity, portability, and cost; and, consistent
with the review of other recommended direct PE inputs, we make the
determination of whether the recommended equipment items are highly
technical. We note that it is not practical to ensure that all of the
existing equipment time in the database is allocated accordingly, but
as we review any recommendations received from the RUC, we make this
determination. To provide stakeholders with examples of the types of
equipment items that are and are not considered highly technical, we
have listed several items below and indicated whether they are highly
technical.
Table 16--Classification of Highly Technical Equipment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Highly technical Not highly technical
--------------------------------------------------------------------------------------------------------------------------------------------------------
Item CMS code Price Item CMS code Price
--------------------------------------------------------------------------------------------------------------------------------------------------------
room, CT.............................. EL007.................... $1,284,000.00 Light, exam............. EQ168................... $1,630.12
accelerator, 6-18 MV.................. ER010.................... 1,832,941.00 Table, exam............. EF023................... 1,338.17
gamma camera system, single-dual head ER097.................... 600,272.00 Chair, medical recliner. EF009................... 829.03
SPECT CT.
--------------------------------------------------------------------------------------------------------------------------------------------------------
(2) Standard Tasks and Minutes for Clinical Labor Tasks
In general, the pre-service, service period, and post-service
clinical labor minutes associated with clinical labor inputs in the
direct PE input database reflect the sum of particular tasks described
in the information that accompanies the recommended direct PE inputs,
commonly called the ``PE worksheets.'' For most of these described
tasks, there are a standardized number of minutes, depending on the
type of procedure, its typical setting, its global period, and the
other procedures with which it is typically reported. The RUC sometimes
recommends a number of minutes either greater than or less than the
time typically allotted for certain tasks. In those cases, CMS staff
reviews the deviations from the standards to determine their
appropriateness. When we do not accept
[[Page 67641]]
the RUC-recommended exceptions, we refine the interim final direct PE
inputs to match the standard times for those tasks. In addition, in
cases when a service is typically billed with an E/M, we remove the
pre-service clinical labor tasks to avoid duplicative inputs and to
reflect the resource costs of furnishing the typical service.
In general, clinical labor tasks fall into one of the categories on
the PE worksheets. In cases where tasks cannot be attributed to an
existing category, the tasks are labeled ``other clinical activity.''
In these instances, CMS staff reviews these tasks to determine whether
they are similar to tasks delineated for other services under the PFS.
For those tasks that do not meet this criterion, we do not accept those
clinical labor tasks as direct inputs.
(3) Equipment Minutes for Film Equipment Inputs
In section II.A. of this final rule with comment period, we
finalize our proposal to accept the RUC recommendation to remove inputs
associated with film technology that are associated with imaging
services. We acknowledge comments received regarding the minutes
allocated to equipment items associated with film technology; we will
not address those comments below, because subsequent to the publication
of the CY 2014 final rule with comment period, as discussed in section
II.A. of this final rule with comment period, we finalized our proposal
to remove these inputs from the Direct PE database, and thus the
comments are no longer relevant.
(4) Standard Inputs for Moderate Sedation
In establishing interim final direct PE inputs for services that
contain the standard moderate sedation input package, we refined the
RUC's recommendation by removing the stretcher (EF018) and adjusting
the standard moderate sedation equipment inputs to conform to the
standard moderate sedation equipment times. These procedures are listed
in Table 17.
Comment: Commenters objected to our refinement of the standard
moderate sedation equipment input times to conform to the moderate
sedation equipment standard times, since it decreased the time
allocated to these equipment items.
Response: We note that for moderate sedation procedures, the
equipment time is tied to the RN time rather than to the entire service
period. Specifically, this time includes 2 minutes for sedate/apply
anesthesia, 100 percent of physician intraservice time, and 60 minutes
of post-procedure time for every 15 minutes of RN monitoring time. The
times included in Table 17 reflect this standard. We note that for all
procedures in Table 17 the times allocated to the equipment items that
were interim final for 2014 were already consistent with the moderate
sedation standard equipment times, with the exception of CPT code
37238, which was mistakenly allocated 257 minutes, when the correct
time is actually 242 minutes.
Comment: Commenters indicated that for office endoscopic
procedures, the stretcher is typically used throughout the entire
procedure, as well as during post-procedure monitoring. Other
commenters indicated that the stretcher is required during the moderate
sedation recovery time. The commenters requested that we include the
stretcher for those procedures, and that we reduce the increased time
allocated to the power table.
Response: In section II.A. of this final rule with comment period,
we finalized our proposal to modify the standard moderate sedation
input package to include a stretcher for the same length of time as the
other equipment items in the moderate sedation package. We indicated
that the revised package would be applied to relevant codes as we
review them through future notice and comment rulemaking. We have
therefore refined those inputs to incorporate the stretcher for these
codes listed in Table 17. Since we are incorporating the stretcher, we
have removed the power table for procedures in which a power table was
previously included. We will hold these procedures as interim final for
CY 2015 due to the insertion of the stretcher and removal of the power
table.
We are therefore finalizing the PE inputs for the procedures
containing the standard moderate sedation inputs, with the additional
refinements of including the stretcher for all of these procedures,
removing the power table for the codes noted in Table 17 as containing
a power table, and adjusting the equipment time for CPT code 37238. We
note that these changes are displayed in the final CY 2015 direct PE
input database, available on the CMS Web site under the downloads for
the CY 2015 PFS final rule at www.cms.gov/PhysicianFeeSched/.
Table 17--CPT Codes With Stretcher Added
----------------------------------------------------------------------------------------------------------------
Moderate
CPT Code Short descriptor sedation Contained power table?
----------------------------------------------------------------------------------------------------------------
10030............................ Guide cathet fluid drainage 152
36245............................ Ins cath abd/l-ext art 1st. 167
37236............................ Open/perq place stent 1st.. 332
37238............................ Open/perq place stent same. 242
37241............................ Vasc embolize/occlude 272
venous.
37242............................ Vasc embolize/occlude 342
artery.
37243............................ Vasc embolize/occlude organ 362
37244............................ Vasc embolize/occlude bleed 332
43200............................ Esophagoscopy flexible 77 Yes.
brush.
43201............................ Esoph scope w/submucous inj 80 Yes.
43202............................ Esophagoscopy flex biopsy.. 82 Yes.
43206............................ Esoph optical 92 Yes.
endomicroscopy.
43213............................ Esophagoscopy retro balloon 107 Yes.
43215............................ Esophagoscopy flex remove 82 Yes.
fb.
43216............................ Esophagoscopy lesion 84 Yes.
removal.
43217............................ Esophagoscopy snare les 92 Yes.
remv.
43220............................ Esophagoscopy balloon <30mm 82 Yes.
43226............................ Esoph endoscopy dilation... 87 Yes.
43227............................ Esophagoscopy control bleed 92 Yes.
43229............................ Esophagoscopy lesion ablate 107 Yes.
43231............................ Esophagoscop ultrasound 107 Yes.
exam.
[[Page 67642]]
43232............................ Esophagoscopy w/us needle 122 Yes.
bx.
43235............................ Egd diagnostic brush wash.. 77 Yes.
43236............................ Uppr gi scope w/submuc inj. 82 Yes.
43239............................ Egd biopsy single/multiple. 77 Yes.
43245............................ Egd dilate stricture....... 85 Yes.
43247............................ Egd remove foreign body.... 92 Yes.
43248............................ Egd guide wire insertion... 82 Yes.
43249............................ Esoph egd dilation <30 mm.. 82 Yes.
43250............................ Egd cautery tumor polyp.... 82 Yes.
43251............................ Egd remove lesion snare.... 82 Yes.
43252............................ Egd optical endomicroscopy. 92 Yes.
43255............................ Egd control bleeding any... 92 Yes.
43270............................ Egd lesion ablation........ 107 Yes.
43450............................ Dilate esophagus 1/mult 77 Yes.
pass.
43453............................ Dilate esophagus........... 87 Yes.
49405............................ Image cath fluid colxn visc 162
49406............................ Image cath fluid peri/retro 162
49407............................ Image cath fluid trns/vgnl. 167
----------------------------------------------------------------------------------------------------------------
(5) Recommended PE Inputs Not Used in the Calculation of Practice
Expense Relative Value Units
In preparing the Direct Practice Expense Input database for CY
2014, we noted that in some cases, there were recommended inputs in the
database that were not used in the calculation of the PE RVUs. In cases
where inputs are included for a particular service in a particular
setting, but that service is not priced in that setting, the inputs are
not used. In the documentation files for the CY 2014 final rule, we
stated, ``In previous years, we have displayed recommended inputs even
when these inputs are not used in the calculation of the practice
expense relative value units. We note that we are no longer displaying
such inputs in these public use files since they are not used in the
calculation of the practice expense relative value units that appear in
the final rule.''
Comment: Some commenters objected to our removing practice expense
inputs for services that were not reviewed for CY 2014.
Response: As indicated in the documentation files, the inputs
removed were not used in the calculation of the PE RVUs. Therefore,
their removal has no impact on the PE RVUs for these services or the
payment for services. We remind readers that, from our perspective, the
sole purpose of the Direct PE database is to establish PE RVUs. We
believe it is more transparent for these inputs to not appear in the
Direct Practice Expense Input database when they do not contribute to
the PE RVU calculation for the relevant services.
iii. Code-Specific Direct PE Inputs
We note that we received many comments objecting to refinements
made based on ``CMS clinical review'' (including our determination that
certain recommended PE inputs were duplicative of others already
included with the service), statutory requirements, or established
principles and policies under the PFS. We note that for many of our
refinements, the specialty societies that represent the practitioners
who furnish the service objected to most of these refinements for the
general reasons described above or for the reasons we respond to in the
``background and methodology'' portion of this section, or stated that
they supported the RUC recommended PE inputs. Below, we respond to
comments in which commenters address specific CPT/HCPCS codes and
explain their objections to our refinements by providing us with new
information supporting the inclusion of the items and/or times
requested. When discussing these refinements, rather than listing all
refinements made for each service, we discuss only the specific
refinements for which commenters provided supporting information. We
indicate the presence of other refinements by noting ``among other
refinements'' after delineating the specific refinements for a
particular service or group of services. For those comments that stated
that an item was ``necessary for the service'' and provided no
additional rationale or information, we conducted further review to
determine whether the inputs as refined were appropriate and concluded
that the inputs as refined were indeed appropriate. We also note that
in many cases, commenters objected to our indication that items were
duplicative, stating that they did not know where the duplication
existed. In future rulemaking, we do not intend to respond to comments
where the commenters dispute the duplicative nature of inputs unless
commenters specifically explain why the relevant items are not
duplicative with the identical items included in a room, kit, pack, or
tray. We expect that commenters will review the components of the room,
kit, pack, or tray included for that procedure prior to commenting that
the item is not duplicative. Finally, we note that in some cases we
made proposals related to comments received in response to the CY 2014
final rule with comment period. In cases where we have addressed the
concerns of commenters in the proposed rule, we do not respond to
comments here as well.
(1) Cross-Family Comments
Comment: We received comments regarding refinements to equipment
times for many procedures for which commenters indicated that the
equipment time for the procedure should include the time that the
equipment is unavailable for other patients, including while preparing
equipment, positioning the patient, assisting the physician, and
cleaning the room. Commenters also requested that we indicate which
clinical labor tasks should be included in calculating the equipment
time for highly technical equipment.
Response: As stated above, we agree with commenters that the
equipment time should include the times within the intra-service period
when a clinician is using the piece of equipment plus any
[[Page 67643]]
additional time the piece of equipment is not available for use for
another patient due to its use during the designated procedure. We
believe that some of these commenters are suggesting that we should
allocate the full number of clinical labor minutes included in the
service period to the equipment items. However, as we have explained,
the clinical labor service period includes minutes based on some
clinical labor tasks associated with pre- and post-service activities
that we do not believe typically preclude equipment items from being
used in furnishing services to other patients because these activities
typically occur in other rooms. The equipment times allocated to the
CPT codes in Table 18 already include the full intraservice time the
equipment is typically used in furnishing the service, plus additional
minutes to reflect time that the equipment is unavailable for use in
furnishing services to other patients. In response to commenters
request for clarification, Table 19 lists the standard clinical labor
tasks to be included in the calculation of time allocated to highly
technical equipment. We note that in some cases, some specialized
intraservice clinical labor tasks are also included in the equipment
time calculations; we have not detailed every possible case in this
table.
Table 18--Equipment Inputs That Include Appropriate Clinical Labor Tasks
About Which Comments Were Received
------------------------------------------------------------------------
CPT Code Equipment Items
------------------------------------------------------------------------
70551..................................... EL008
70552..................................... EL008
70553..................................... EL008
93880..................................... EL016
93882..................................... EL016
------------------------------------------------------------------------
Table 19--Clinical Labor Tasks Included in Calculation of Equipment Time
for Highly Technical Equipment
------------------------------------------------------------------------
-------------------------------------------------------------------------
Clinical Labor Task
Prepare room, equipment, supplies
Prepare and position patient
Assist physician in performing procedure and/or Acquire images
Clean room/equipment by physician staff
Technologist QC's images in PACS, checking for all images, reformats,
and dose page
------------------------------------------------------------------------
Comment: We received comments regarding refinements to clinical
labor times for several procedures, in which commenters indicated that
CMS reduced the clinical labor minutes inappropriately for tasks
related to film inputs, since the recommended minutes were based on the
PEAC surveyed times. Tasks included ``Process images, complete data
sheet, present images and data to the interpreting physician'' and
``Retrieve prior appropriate imaging exams.''
Response: The surveyed times referenced by the commenters refer to
the clinical labor tasks associated with film technology. In reviewing
the times associated with these clinical labor tasks, we noted that it
would be consistent with our policy finalized in this rule to adjust
the times associated with clinical labor tasks for all interim final
codes to be consistent with the RUC recommendations regarding clinical
labor tasks for digital technology. We are making the associated
changes and holding these direct PE inputs interim final for 2015.
These clinical labor tasks associated with film and digital inputs are
presented side-by-side, along with the range of typical times, in Table
20. The specific interim final codes and their time changes are listed
in Table 21.
Table 20--Clinical Labor Tasks Associated with Digital Technology
----------------------------------------------------------------------------------------------------------------
Clinical labor task: film Typical Clinical labor task: Typical
Service period inputs minutes digital inputs minutes
----------------------------------------------------------------------------------------------------------------
Pre-Service................... Retrieve prior appropriate 4 to 7...... Availability of prior 2
imaging exams and hang images confirmed. 2
for MD review, verify Patient clinical
orders, review the chart information and
to incorporate relevant questionnaire reviewed by
clinical information and technologist, order from
confirm contrast protocol physician confirmed and
with interpreting MD/ exam protocoled by
Retrieve Prior Image for radiologist.
Comparison.
Service Period: Post-Service.. Process Images, complete 4 to 20..... Technologist QC's images 2
data sheet, present in PACS, checking for all 2
images and data to the images, reformats, and 1
interpreting physician/ dose page.
Process films, hang films Review examination with
and review study with interpreting MD.
interpreting MD prior to Exam documents scanned
patient discharge. into PACS. Exam completed
in RIS system to generate
billing process and to
populate images into
Radiologist work queue.
----------------------------------------------------------------------------------------------------------------
Table 21--Interim Final Codes with Adjusted Clinical Labor Times Due to Film-to-Digital Migration
----------------------------------------------------------------------------------------------------------------
Total film
CPT code CMS code task time Total digital Time change
(2014) task time
----------------------------------------------------------------------------------------------------------------
19081................................. L043A................... 8 9 1
19082................................. L043A................... 5 5 0
19083................................. L051B................... 8 9 1
19084................................. L051B................... 5 * 5 0
19085................................. L047A................... 8 9 1
19086................................. L047A................... 5 * 5 0
19281................................. L043A................... 8 9 1
19282................................. L043A................... 5 * 5 0
19283................................. L043A................... 8 9 1
19284................................. L043A................... 5 * 5 0
19285................................. L051B................... 8 9 1
19286................................. L051B................... 5 * 5 0
19287................................. L047A................... 8 9 1
[[Page 67644]]
19288................................. L047A................... 5 * 5 0
19281................................. L043A................... 5 5 0
19282................................. L043A................... 5 5 0
70450................................. L046A................... 10 9 -1
70460................................. L046A................... 11 9 -2
70470................................. L046A................... 13 9 -4
70551................................. L047A................... 6 9 2
70552................................. L047A................... 8 9 0
70553................................. L047A................... 8 9 0
72141................................. L047A................... 14 9 -5
72142................................. L047A................... 16 9 -7
72156................................. L047A................... 18 9 -9
72146................................. L047A................... 14 9 -5
72147................................. L047A................... 16 9 -7
72157................................. L047A................... 18 9 -9
72148................................. L047A................... 14 9 -5
72149................................. L047A................... 16 9 -7
72158................................. L047A................... 18 9 -9
74174................................. L046A................... 27 9 -22
----------------------------------------------------------------------------------------------------------------
* Add-on codes are allocated fewer minutes for these activities.
(2) Code-Specific Comments
(a) Destruction of Premalignant Lesions (CPT Codes 17000, 17003, 17004)
In establishing interim final direct PE inputs for CY 2014, CMS
accepted the RUC's recommendations for supply item LMX 4% anesthetic
cream (SH092).
Comment: Commenters indicated that the quantity of cream units in
CPT code 17003 created a rank order anomaly with CPT codes 17000 and
17004, and that the inclusion of 3 grams was incorrect. Instead, 1 gram
should have been included in CPT code 17003.
Response: We agree with the commenters that the quantity of SH092
in 17003 should be 1 gram. However, we also note that CPT code 17000
should also contain a quantity of 1 gram in order to avoid the rank
order anomaly. After consideration of the comments received, we are
finalizing the CY 2014 interim final direct PE inputs for CPT codes
17000, 17003, and 17004, with the additional refinement of changing the
quantity of SH092 to 1 for CPT codes 17000 and 17003.
(b) Breast Biopsy (CPT Codes 19081, 19082, 19083, 19084, 19085, 19086,
19281, 19282, 19283, 19284, 19285, 19286, 19287, and 19288)
In establishing interim final direct PE inputs for CY 2014, CMS
refined the RUC's recommendations for CPT codes 19085, 19086, 19287,
and 19288 by removing several new PE inputs, including items called
``20MM handpiece--MR,'' ``vacuum line assembly,'' ``introducer
localization set (trocar),'' and ``tissue filter,'' since we concluded
that these items served redundant clinical purposes with other biopsy
supplies already included in the PE inputs for these codes. We also
removed three new equipment items, described as ``breast biopsy
software,'' ``breast biopsy device (coil),'' and ``lateral grid,''
because we determined that these items served clinical functions to
items already included in the MR room.
Comment: Commenters indicated that the vacuum assisted breast
biopsy requires an assisted biopsy needle system, and tubing must be
run from the biopsy device to the biopsy control unit. Commenters also
discussed supply items ``introducer localization set (trocar)'' and
``tissue filter,'' stating that the trocar is used to target the biopsy
on the correct lesion, and the tissue filter is necessary to remove the
collected core samples from the collection chamber. Commenters
described the importance of the ``breast biopsy device (coil), '' which
is used to move one breast out of the way and the ``breast biopsy
software,'' which is required to make the necessary calculations to
target and biopsy the lesions. Finally, commenters stated that the
lateral grid is necessary to place the trocar correctly.
Response: The equipment item ``breast biopsy device w-system
(Mammotome)'' (EQ074) is described as ``an all-in-one platform designed
for use under ultrasound, MRI, stereotactic and 3D image guidance'' and
is used with supply item ``Mammotome probe'' (SD094). Therefore, the
supply items ``20 MM handpiece,'' ``vacuum line assembly,'' ``tissue
filter,'' and ``trocar,'' are duplicative of items already included in
this procedure. We do note that we have used the invoice to create a
price for equipment item ``Breast biopsy device (coil)'' (EQ371) at a
price of $12,238. After consideration of the comments received, we are
finalizing the CY 2014 interim final direct PE inputs for CPT codes
19085, 19086, 19287, and 19288 as established with the additional
refinement of incorporating the equipment item ``Breast biopsy device
(coil)'' (EQ371).
Comment: A commenter noted that the new breast biopsy codes do not
distinguish between the type of biopsy device used for the procedure,
and that the cost of using the vacuum-assisted biopsy device (including
a Mammotome probe, a Mammotome probe guide, and tubing and vacuum for
the Mammotome device) is nearly eight times the cost of the equipment
and supplies required to perform a standard (mechanical) core needle
biopsy. The commenter noted that vacuum-assisted biopsy devices are
predominantly used in stereotactic and MRI-guided breast biopsy
procedures and 50 percent of the time in ultrasound-guided breast
biopsy procedures.
Response: For a discussion about the change in coding, we refer
readers to section II.F. of this final rule with comment period, where
we finalize the work RVUs for interim final 2014 codes. With regard to
the direct PE inputs for these services, we note that we include direct
PE inputs based on the typical case, and since, as the commenter
[[Page 67645]]
points out, the vacuum-assisted biopsy devices are typically used, we
include these items as direct PE inputs.
In reviewing the breast biopsy codes, we noted that we
inadvertently included supply and equipment items related to breast
biopsies in CPT codes 19283, 19284, 19285, 19286, 19087, and 19088,
which are procedures that describe the placement of a localization
device, not a biopsy. We will therefore remove the items listed in
Table 22, which are currently included as direct PE inputs for these
procedures. After consideration of the comments received, we are
finalizing the CY 2014 interim final direct PE inputs for CPT codes
19081, 19082, 19083, 19084, 19085, 19086, 19281, 19282, 19283, 19284,
19285, 19286, 19287, and 19288 as established, with the additional
refinements noted above.
Table 22--Supply and Equipment Items Inadvertently Included in
Localization Device Placement Breast Biopsy Codes
------------------------------------------------------------------------
CPT SD034 SC022 EQ074
------------------------------------------------------------------------
19283.................................. X ......... X
19284.................................. X ......... X
19285.................................. ......... ......... X
19286.................................. ......... ......... X
19087.................................. X X X
19088.................................. X X X
------------------------------------------------------------------------
(c) Nasal/Sinus Endoscopy (CPT Codes 31237, 31238)
In establishing interim final direct PE inputs for CY 2014, CMS
refined the RUC's recommendations for CPT codes 31237 and 31238 by
refining the nurse blend (L037D) clinical labor time associated with
task ``Monitor pt. following service/check tubes, monitors, drains''
from 15 minutes to 5 minutes.
Comment: Commenters stated that CMS should maintain consistency in
the direct PE inputs across services by allocating the standard 15
minutes for every hour of post-procedure monitoring time. Commenters
indicated that monitoring after these procedures is critical, since the
risk of recurrent bleeding is high and patients may become lightheaded.
Response: There are two types of post-procedure monitoring time; a
standard 15 minutes per hour of post-procedure monitoring time for
moderate sedation, and a standard 15 minutes per hour of post-procedure
monitoring time unrelated to moderate sedation. We understand the
commenter's position to mean that there is 60 minutes of post-procedure
monitoring required for these services (in accordance with the 15
minutes of RN time per 60 minutes of monitoring). Because these
procedures previously included 5 minutes of post-procedure monitoring
time, we do not have a reason to believe that the monitoring time would
have increased by 55 minutes. Should commenters believe this is the
case, we invite commenters to provide information to justify this
change. In cases where the specialty society is recommending post-
procedure monitoring unrelated to moderate sedation, it is important
that the recommendation clearly indicates the reason for the monitoring
and the relationship between the clinical staff time and the monitoring
time. After consideration of the comments received, we are finalizing
the CY 2014 interim final direct PE inputs for CPT codes 31237 and
31238 as established.
(d) Implantation and Removal of Patient Activated Cardiac Event
Recorder (CPT Codes 33282 and 33284)
In the CY 2013 final rule with comment period, in response to
nomination of CPT codes 33282 and 33284 as potentially misvalued codes,
we indicated that we did not consider the absence of pricing in a
particular setting as an indicator of potentially misvalued codes.
However, we requested that the RUC review these codes, including the
work RVUs, for appropriate nonfacility and facility inputs.
Comment: A commenter expressed disappointment that CMS did not
price these services in the nonfacility setting but did not provide
further information about this decision.
Response: We received recommendations from the RUC for CPT codes
33282 and 33284 that did not include nonfacility inputs. Stakeholders
who are interested in providing information about the direct PE inputs
used in furnishing these services are welcome to submit this
information to us; information about the level of information we seek
is available to stakeholders in the sample PE worksheet available on
the CMS Web site under downloads at https://www.cms.gov/PhysicianFeeSched/PFSFRN/list.asp#TopOfPage. We encourage commenters to
submit the best data available on the appropriate inputs for these
services.
(e) Transcatheter Placement of Intravascular Stent (CPT Codes 37236,
37237)
In establishing interim final direct PE inputs for CY 2014, CMS
refined the RUC's recommendations for CPT codes 37236 and 37237 by
including supply item ``catheter, balloon, PTA'' (SD152) as a proxy for
``balloon expandable'' because we believed that was an appropriate
proxy. The invoices provided with the recommendation did not indicate
the items on the PE worksheet with which they were associated.
Comment: The specialty society representing practitioners who
furnish these services indicated that the item ``balloon expandable''
actually referred to a ``balloon implantable stent,'' and that the
invoices provided were associated with that item.
Response: We acknowledge the specialty society's clarification of
the RUC recommendation. We will add item ``balloon implantable stent''
at a price of $1,500, and remove the proxy item SD152. We note that
when line items on the invoices provided are not clearly labeled, it is
often difficult for us to determine how to relate the items on the PE
spreadsheet with the items on the invoices. For specialty societies to
ensure that the requested items are considered for inclusion in the
relevant procedure codes, it is important that invoices accompany the
RUC recommendations and the line items associated with items on the PE
spreadsheet are clearly labeled.
After consideration of the comments received, we are finalizing the
CY 2014 interim final direct PE inputs for CPT codes 37236 and 37237 as
established with the additional refinement of including ``balloon
implantable stent'' and removing ``catheter, balloon, PTA'' (SD152).
(f) Esophagoscopy (CPT Codes 43197 and 43198)
In establishing interim final direct PE inputs for CY 2014, CMS
refined the RUC's recommendations for CPT codes 43197 and 43198 to
remove the Medical/Technical Assistant (L026A) time associated with
clinical labor task ``Clean Surgical Instrument Package,'' since no
surgical instrument package is included in the service, and to remove
the endoscopic biopsy forceps (SD066) from CPT code 43198, among other
refinements.
Comment: Commenters acknowledged that the procedure did not contain
a surgical instrument package, but stated that the time was still
necessary for cleaning equipment, such as the nasal speculum, bayonette
forceps, and biopsy forceps.
Response: In general, as a matter of relativity throughout the PFS,
the time allocated for the standard clinical labor task ``Clean room/
equipment following procedure'' encompasses time for cleaning all
equipment items. The only exceptions to this rule are for equipment
items that are tied to specific clinical
[[Page 67646]]
labor tasks, such as cleaning the surgical instrument pack or cleaning
a scope. We do not believe it would serve relativity to separately
break out time to clean various different types of equipment.
For the biopsy forceps, we indicated in the final rule with comment
period that the information included with the RUC recommendation
suggested that the biopsy forceps was reusable (as suggested by the
cleaning time mentioned in this comment). As such, we have created a
new equipment item based on the invoice provided with the
recommendation and assigned 46 minutes to this equipment item. However,
since we did not receive a paid invoice with this item, we will price
it at $0 until we receive a paid invoice.
After consideration of the comments received, we are finalizing the
CY 2014 interim final direct PE inputs for CPT codes 43197 and 43198 as
established, with the additional refinement of including 46 minutes for
the reusable biopsy forceps.
(g) Esophagoscopy/Esophagoscopy Gastroscopy Duodenoscopy (EGD) (CPT
Codes 43200, 43201. 43202, 43206, 43215, 43216, 43217, 43220, 43226,
43227, 43231, 43232, 43235, 43236, 43239, 43245, 43247, 43248, 43248,
43250, 43251, 43252, 43255, 43270)
In establishing interim final direct PE inputs for CY 2014, CMS
refined the RUC's recommendations for CPT codes 43200, 43201. 43202,
43206, 43215, 43216, 43217, 43220, 43226, 43227, 43231, 43232, 43235,
43236, 43239, 43245, 43247, 43248, 43248, 43250, 43251, 43252, 43255,
and 43270 by refining the quantity of item ``canister, suction''
(SD009) from 2 to 1.
Comment: Commenters indicated that, for patient safety reasons, one
suction canister is needed for the mouth, and another for the scope for
patient safety reasons. Other stakeholders, specifically, several
specialty societies with whom we met during the comment period,
informed us that one suction canister is sufficient and typical for
these services.
Response: We are persuaded by the information provided by the
medical specialty societies during the comment period who indicated
that one suction canister is typical.
In establishing interim final direct PE inputs for CY 2014, CMS
refined the RUC's recommendations for CPT codes 43201 by removing
needle, micropigmentation (tattoo) (SC079), as the needle required for
this procedure needs to go through an endoscope, and no invoice was
provided for this item.
Comment: Commenters indicated that the tattoo needle was required
to mark the site for injection.
Response: We did not receive an invoice for the tattoo needle and
have no information about this item. We are also unable to include this
item in the PE calculations without a method to price it. We do not
believe that we have a reasonable proxy at this time. If we receive
invoices for this item, we will be able to include it in the direct PE
input database.
In establishing interim final direct PE inputs for CY 2014, CMS
refined the RUC's recommendations for CPT codes 43201, 43220, 43226,
and 43231 by removing supply item ``cup, biopsy-specimen non-sterile
4oz'' (SL035).
Comment: Commenters indicated that the endoscopy base code, 43200,
is included in all of these procedures. Since the biopsy cup is
included in the endoscopy base code, it should be included for these
codes as well.
Response: We agree with commenters that it is appropriate to
include this supply item for these procedures. We will include the
supply item ``cup, biopsy-specimen non-sterile 4oz'' in the direct PE
inputs for these procedures.
In establishing interim final direct PE inputs for CY 2014, CMS
refined the RUC's recommendations for CPT code 43220 by substituting
supply item ``SD019'' as a proxy for ``SD025.''
Comment: Commenters requested that we include ``endoscopic balloon,
dilation'' (SD287) rather than a proxy, as this supply item is now
included in the database.
Response: After receiving clarification regarding this request, we
agree with commenters that SD287 is an appropriate supply input for
this procedure. Therefore, we will include SD287 for CPT code 43220.
In establishing interim final direct PE inputs for CY 2014, CMS
refined the RUC's recommendations for CPT codes 43220, 43249, and 43270
by removing supply item ``guidewire, STIFF'' (SD090), among other
refinements.
Comment: Commenters indicated that the guidewire is required to
safely straddle tumors for which there is impaired visibility and an
inability to pass the scope through.
Response: We agree with commenters that it would be appropriate to
include supply item ``guidewire--STIFF'' in these procedures. We will
include the supply item ``guidewire--STIFF'' in the direct PE inputs
for these procedures.
After consideration of the comments received, we are finalizing the
CY 2014 interim final direct PE inputs for codes 43200, 43201. 43202,
43206, 43215, 43216, 43217, 43220, 43226, 43227, 43231, 43232, 43235,
43236, 43239, 43245, 43247, 43248, 43248, 43250, 43251, 43252, 43255,
and 43270 as established, with the additional refinements of including
the supply items noted above.
(h) Dilation of Esophagus (CPT Codes 43450, 43453)
In establishing interim final direct PE inputs for CY 2014, CMS
refined the RUC's recommendations for CPT codes 43450 and 43453 by
removing equipment item ``endoscope disinfector, rigid or fiberoptic,
w-cart'' (ES005), and not creating a new item ``mobile stand, vital
signs monitor,'' and other refinements.
Comment: Commenters stated that the endoscope disinfector is a
necessary part of all endoscopic procedures for sanitary and safety
reasons, and that it should be restored for all gastrointestinal
endoscopy codes. Commenters also noted that the mobile stand is the
standard method of monitoring that must be moved along with the
patient.
Response: Since these are non-endoscopic dilation codes, there is
no scope to clean, and thus the endoscope disinfector is unnecessary.
The standard inputs for moderate sedation as recommended by the RUC
were included in this procedure; the mobile stand overlaps with the
standard moderate sedation input items. After consideration of the
comments received, we are finalizing the CY 2014 interim final direct
PE inputs for codes CPT codes 43450 and 43453 as established.
(i) Spinal Injections (CPT Codes 62310, 62311, 62318, 62319)
In establishing interim final direct PE inputs for CY 2014, CMS
accepted the RUC recommendations for CPT codes 62310, 62311, 62318, and
62319. Based on comments received, we made a proposal to maintain the
CY 2014 direct PE inputs for CY 2015 while the codes are reexamined for
bundling. We are finalizing this proposal, so while we acknowledge
comments received on these codes, we will not respond to these comments
as the interim final inputs to which the comments relate will not be
used for 2015.
(j) Percutaneous Implantation of Neurostimulator (CPT Code 63650)
In establishing interim final direct PE inputs for CY 2014, CMS
refined the RUC's recommendations for CPT code time by removing the
time associated with clinical labor task ``Clean Surgical Instrument
Package'' and removing supply item ``pack, cleaning, surgical
instruments'' (SA043) since no surgical
[[Page 67647]]
instrument package is included in the service.
Comment: Commenters indicated that clinical staff time is critical
for the safety and efficiency of the procedure, and that the surgical
instrument cleaning package is necessary to ensure proper adherence of
the electrodes.
Response: In general, as a matter of relativity throughout the PFS,
the time allocated for the standard clinical labor task ``Clean room/
equipment following procedure'' encompasses time for cleaning all
equipment items. The only exceptions to this rule are for equipment
items which are tied to specific clinical labor tasks, such as cleaning
the surgical instrument pack or cleaning a scope. We do not believe it
would serve relativity to separately break out time to clean various
different types of equipment. After consideration of the comments
received, we are finalizing the CY 2014 interim final direct PE inputs
for CPT code 63650 as established.
(k) Chemodenervation (CPT Codes 64616, 64642, 64644, 64646, 64647)
In establishing interim final direct PE inputs for CY 2014, CMS
refined the RUC's recommendations for CPT codes 64616, 64642, 64644,
64646, and 64647 by reducing the minutes allocated to ``table, exam''
(EF023) and removing the time associated with clinical labor task
``Complete botox log,'' as well as reducing the L037D time for clinical
labor ``assist physician performing procedure'' for CPT code 64616,
among other refinements.
Comment: One commenter opposed our adjusting the minutes allocated
to the exam table. Commenters stated that the reference code, 64615,
included three minutes of clinical labor time for ``complete botox
log,'' and requested that they be included since they are in the
reference code. One commenter asked whether CMS planned to remove the
minutes from the reference code as well. Other commenters indicated
that as with most injections, it is necessary to document various
elements of information for safety purposes.
Response: Upon reviewing the time allocated to the exam table, we
noted that our standard equipment policy is to allocate the entire
service period for equipment that is not highly technical. Therefore,
we will allocate minutes for the entire service period for the exam
table, as follows: 28 minutes for 64616, 44 minutes for 64642, 49
minutes for 64644, 44 minutes for 64646, and 49 minutes for 64647. We
appreciate commenters pointing out the three minutes of time
inadvertently allocated for ``complete botox log'' in the reference
code, 64615, and will consider this issue in future rulemaking. We note
that one of the benefits of having information stored in the direct PE
database at the clinical labor task level is that it allows us to make
comparisons of codes under review to existing codes in the PE database.
This will help us ensure greater consistency in our refinements. As
commenters point out, various injections are documented in logs, rather
than medical records. The use of a different location for documentation
is not a reason to allocate additional clinical labor time for a
particular service.
Comment: One commenter supported our adjustment of ``assist
physician'' time from 7 minutes to 5 minutes. Another commenter
disagreed with the refinement and requested that CMS explain how
physician time was calculated, while a different commenter stated that
the ``assist physician'' time should be 28 minutes.
Response: Upon reviewing the work time and the time allocated for
assist physician, we determined that 7 minutes is actually appropriate
for the assist physician task.
After consideration of the comments received, we are finalizing the
CY 2014 interim final direct PE inputs for CPT codes 64616, 64642,
64644, 64646, and 64647 as established, with the additional refinement
of adjusting the minutes for the exam table as indicated above and
adding 2 minutes of clinical labor for the ``assist physician'' task
for 64616.
(l) MRI Brain (CPT Codes 70551, 70552, 70553)
In establishing interim final direct PE inputs for CY 2014, CMS
refined the RUC's recommendations for CPT codes 70551, 70552, and 70553
by adjusting the time for clinical labor task ``assist physician in
performing procedure/acquire images,'' removing 2 minutes of clinical
labor time for clinical labor task ``escort patient from exam room due
to magnetic sensitivity,'' removing supply items ``gauze,sterile 2in x
2in'' (SG053), ``tape, phix strips (for nasal catheter)'' (SG089),
``povidone swabsticks (3 pack uou'' (SJ043), and ``swab-pad, alcohol''
(SJ 053) from CPT codes 70552 and 70553, among other refinements.
Comment: Commenters indicated that the times associated with
clinical labor task ``assist physician in performing procedure/acquire
images'' reflected the PEAC surveyed times, and they had no reason to
believe that the time had decreased since the PEAC review.
Response: As indicated in the PFS CY 2014 final rule with comment
period (78 FR 74345), the procedure time for these services was last
reviewed in 2002. We noted that we believe there should be no
significant difference between the time to acquire images for an MRI of
the brain and an MRI of the spine, and that, rather than rely on very
old survey data, it would be appropriate to crosswalk the time
associated with the MRI of the spine to the MRI of the brain. We
continue to believe that this time is more accurate than that of the
survey data.
Comment: Commenters noted that the clinical labor task ``escort
patient from exam room due to magnetic sensitivity'' is a necessary
activity for patient safety.
Response: Upon review of this clinical labor task, we noted that
this task was included in the PE worksheets from when these codes were
previously reviewed in 2002. Therefore, since this activity does not
reflect a newly added clinical labor task, we agree with commenters
that it would be appropriate to include 2 minutes for this clinical
labor task.
Comment: Commenters stated that the supplies removed from CPT codes
70552 and 70553 were necessary supplies for the service, and that the
specialty society incorrectly included supply item ``tape, phix strips
(for nasal catheter)'' (SG089), when the correct supply item was
``tape, surgical paper 1in (Micropore)'' (SG079).
Response: We note that these supplies were removed because they
were already contained in the supply item ``kit, IV starter'' (SA019).
Table 23 shows the items contained in the IV starter kit and the
corresponding supply items removed due to redundancy.
Table 23--Items Removed for Redundancy and Parallel Items Included in IV Starter Kit
----------------------------------------------------------------------------------------------------------------
Items in IV starter kit Corresponding items removed for redundancy
----------------------------------------------------------------------------------------------------------------
1 tourniquet................................. .................................................................
1 PVP ointment............................... povidone swabsticks (3 pack uou)
1 PVP prep pad............................... swab-pad, alcohol
[[Page 67648]]
2 gauze sponges.............................. gauze, sterile 2in x 2in
1 bandage (1''x3'').......................... .................................................................
1 sm roll surgical tape...................... tape, surgical paper 1in
1 pr gloves.................................. .................................................................
1 underpad 2ft x 3ft (Chux).................. .................................................................
----------------------------------------------------------------------------------------------------------------
After consideration of the comments received, we are finalizing the
CY 2014 interim final direct PE inputs for CPT codes 70551, 70552, and
70553, with the additional refinement of including 2 minutes of
clinical labor time as noted above.
(m) MRI Spine (CPT Codes 72141, 72142, 72146, 72147, 72149, 72156,
72157, 72158)
In establishing interim final direct PE inputs for CY 2014, CMS
refined the RUC's recommendations for CPT codes 72141, 72142, 72146,
72147, 72149, 72156, 72157, and 72158 by removing 2 minutes of clinical
labor time for clinical labor task ``escort patient from exam room due
to magnetic sensitivity,'' and other refinements.
Comment: Commenters noted that the clinical labor task ``escort
patient from exam room due to magnetic sensitivity'' is a necessary
activity for patient safety.
Response: Upon review of this clinical labor task, we noted that
this task was included in the PE worksheets from when these codes were
previously reviewed in 2002. Therefore, since this activity does not
reflect a newly added clinical labor task, we agree with commenters
that it would be appropriate to include 2 minutes for this clinical
labor task.
Comment: A commenter noted that CMS did not include a contrast
imaging pack, which includes supplies necessary for contrast enhanced
studies.
Response: In section II.B. of this final rule with comment period,
we finalized our policy to add a contrast imaging pack to be used for
imaging services with contrast. Therefore, we will include the contrast
supply pack (CMS code SA114) for CPT codes 72142, 74147, 72149, 72156,
72157, and 72158.
After consideration of the comments received, we are finalizing the
CY 2014 interim final direct PE inputs for CPT codes 72141, 72142,
72146, 72147, 72149, 72156, 72157, and 72158, with the additional
refinement of including 2 minutes of clinical labor time and including
the supply pack for the services noted above.
(n) Selective Catheter Placement (CPT Code 75726)
In establishing interim final direct PE inputs for CY 2014, when
reviewing CPT code 36245, which was identified through a misvalued code
screen of codes reported together more than 75 percent of the time, we
noted that it was frequently billed with 75726. We then noted that
these two services had identical time for ``assist physician in
performing procedure,'' and since the time for 36245 was reduced from
73 to 45 minutes, refined the clinical labor time for 75726 to
correspond to this change.
Comment: Commenters indicated that the 73 minutes reflected the
PEAC surveyed times, and that these activities are imaging-related, and
in addition to the time and activities inherent in the accompanying
surgical base code.
Response: As indicated elsewhere in this section, we note that the
PEAC survey data are very old, and that refinements based on more
updated information are appropriate. We continue to believe that it is
appropriate for the intraservice times for 36245 and 75726 to continue
to correspond to one another, as they are frequently furnished
together. After consideration of the comments received, we are
finalizing the CY 2014 interim final direct PE inputs for CPT code
75726 as established.
(o) Radiation Treatment Delivery (CPT Codes 77373, 77422, 77423)
In establishing interim final direct PE inputs for CY 2014, CMS
refined the RUC's recommendations for CPT code 77373 by refining the
equipment time for ``pulse oximeter w-printer'' (EQ211) and ``SRS
system, SBRT, six systems, average'' (ER083) to conform to established
equipment policies.
Comment: Commenters stated that the times should be maintained at
104 minutes, rather than being reduced to 86 minutes, and indicated the
clinical labor task lines that should be included in the calculations.
Response: Upon reviewing the equipment times associated with this
procedure, we agree with commenters that the time allocated for the
equipment should include the time associated with the indicated
clinical labor tasks for these equipment items. After consideration of
the comments received, we are finalizing the CY 2014 interim final
direct PE inputs for CPT code 77373 as established, with the additional
refinement of adjusting the equipment times to 104 minutes as noted
above.
For CY 2014, we also eliminated several anomalous supply inputs
included in the direct PE database, which affected 77422 and 77423,
among other services.
Comment: Commenters indicated that upon reviewing the inputs for
these services, they noted that the Record and Verify System and the
laser targeting system were missing in both of these services, despite
being in the original 2005 recommendation.
Response: We appreciate the commenters' attention to detail.
However, as indicated elsewhere, we do not believe that the record and
verify system is medical equipment used in furnishing the technical
component of the service. We refer readers to our discussion of this
issue in the PFS 2014 Final rule with Comment period (78 FR 74317).
Further, since these codes have not been reviewed in many years, we do
not know if the laser targeting system continues to be an appropriate
input for these services. Therefore, we request that the RUC examine
the inputs for these services to ensure their accuracy.
(p) Hyperthermia (CPT Code 77600)
In establishing interim final direct PE inputs for CY 2014, CMS
refined the RUC's recommendations for CPT code 77600 by refining the
time allocated to equipment item ``hyperthermia system, ultrasound,
external'' (ER035) and removing the time associated with clinical labor
task ``clean scope,'' among other refinements.
Comment: Commenters indicated that the appropriate lines were not
used to calculate the recommended equipment times, including cleaning
the scope and check dressing.
Response: Upon reviewing the comments, we re-examined the equipment
time calculation and
[[Page 67649]]
continue to believe that the time allocated to this equipment item is
appropriate. We note that there is no scope used in this procedure, so
time to clean the scope is unnecessary. After consideration of the
comments received, we are finalizing the CY 2014 interim final direct
PE inputs for CPT code 77600 as established.
(q) High Dose Rate Brachytherapy (CPT Codes 77785, 77586, 77787)
In establishing interim final direct PE inputs for CY 2014, CMS
refined the RUC's recommendations for CPT codes 77785, 77786, and 77787
to remove ``Emergency service container--safety kit,'' as we consider
it an indirect PE.
Comment: Commenters noted that the emergency container is a safety
device used when a source must be retrieved manually. Commenters
indicated that it is a mobile item and that the service cannot be
provided unless it is in the room, and thus it is a direct PE, since it
is directly assumed by a physician in the course of providing the
service. Commenters asked that we reclassify this item as a direct
input.
Response: In our clinical review, we reviewed the work vignettes
for these procedures, which did not include the use of the ``emergency
service container--safety kit'' as a part of the procedure. Although we
acknowledge that the emergency service container safety kit needs to be
readily available during the procedure, we note that ``standby''
equipment, or items that are not used in the typical case, are
considered indirect costs. For further discussion of this issue, we
refer readers to our discussion of ``standby'' equipment in the CY 2001
PFS proposed rule (65 FR 44187).
When reviewing the interim final direct PE inputs for these
services, we noted that the specialty societies conducted a survey of
the technicians, which revealed higher procedure times than the current
procedure times. However, since the RUC indicated that they did not
have ``compelling evidence,'' the specialty society did not request the
higher procedure times. We believe that if the specialty society
believes that the code is undervalued relative to the expert panel
value, and there is no indication that the survey was flawed, the
specialty society should recommend the use of the surveyed procedure
times. In doing so, the specialty society would give CMS the
opportunity to consider the information provided alongside the RUC
recommended times. We believe that surveys of technicians have the
potential to be more accurate, rather than less accurate, than those of
physicians, as the technicians do not have incentives to increase the
surveyed time. We suggest that rather than attempting to insert items
that are not standard in the PE methodology, that specialty societies
make a strong, data-driven case, for why the survey times are correct.
Comment: A commenter noted that there have been significant
reductions to these CPT codes over the last several years, and urged
CMS to phase in the reductions over time should the reductions be
deemed appropriate after review of the methodology and data.
Response: We note that reductions to CPT codes are made on the
basis that they are potentially misvalued. We do not typically
transition such reductions. However, the Protecting Access to Medicare
Act (PAMA) requires that beginning in 2017, CMS transition code-level
reductions of greater than or equal to 20 percent in a given year;
therefore, beginning in 2017, such reductions will be transitioned.
After consideration of the comments received, we are finalizing the
CY 2014 interim final direct PE inputs for CPT codes 77785, 77786, and
77787 as established.
(r) Cytopathology (CPT Code 88112)
In establishing interim final direct PE inputs for CY 2014, CMS
refined the RUC's recommendations for CPT code 88112 by removing the
clinical labor time associated with several clinical labor tasks,
including ``Order, restock, and distribute specimen containers with
requisition forms,'' ``Perform screening function (where applicable),''
``Confirm patient ID, organize work, verify and review history,'' and
``Enter screening diagnosis in laboratory information system, complete
workload recording logs, manage any relevant utilization review/quality
assurance activities and regulatory compliance documentation and
assemble and deliver slides with paperwork to pathologist.''
Comment: Commenters pointed out that CPT code 88112 was
inadvertently listed in Table 28 in the CY 2014 final rule with comment
period as being unrefined by CMS. Commenters also opposed the
reductions in clinical labor time, and noted that the PE subcommittee
thoroughly reviewed these inputs.
Response: We apologize for the inadvertent inclusion of CPT code
88112 in Table 28 of the CY 2014 final rule with comment period. We re-
examined the clinical labor tasks in light of the comments received and
noted that the clinical labor task ``Order, restock, and distribute
specimen containers with requisition forms'' is not a clinical labor
task associated with furnishing a service to a particular patient, and
is therefore allocated in the indirect practice expense. Clinical labor
task ``Perform screening function (where applicable)'' is not a task
completed in the typical service, and is therefore not included.
Further, clinical labor task ``Confirm patient ID, organize work,
verify and review history'' is subsumed within clinical labor task
``Remove slide from coverslipper; confirm patient ID, organize work,
send slides to cytotech for screening''; including both would therefore
be duplicative. Clinical labor task ``Enter screening diagnosis in
laboratory information system, complete workload recording logs, manage
any relevant utilization review/quality assurance activities and
regulatory compliance documentation and assemble and deliver slides
with paperwork to pathologist'' involves quality assurance activities.
We refer readers to the CY 2014 PFS final rule with comment period (78
FR 74308) for a discussion regarding quality assurance activities.
After consideration of the comments received, we are finalizing the CY
2014 interim final direct PE inputs for CPT code 88112.
Comment: One commenter noted that the refinements to the PE inputs
for CPT code 88112 resulted in a rank-order anomaly, as CPT code 88108
has higher PE RVUs than CPT code 88112, while CPT code 88108 is a less
complex service than CPT code 88112. Specifically, commenters stated
that it is illogical for a cytology specimen processing technique that
involves an additional step that requires materially more resources to
have an RVU that is less than an associated technique that requires
fewer resources, and expressed concerns about the potential for
misreporting.
Response: We appreciate this commenter bringing this rank order
anomaly to our attention. As indicated in section II.B. of this final
rule with comment period, we are referring this code to the RUC as
potentially misvalued based on the information received from the
commenter.
(s) Duplex Scans (CPT Codes 93880 and 93882)
In establishing interim final direct PE inputs for CY 2014, CMS
refined the RUC's recommendations for CPT codes 93880 and 93882 by
removing the equipment time allocated for equipment items ``video SVHS
VCR (medical grade)'' (ED034) and ``video printer, color (Sony medical
grade)'' (ED036), and refining the equipment time for ``computer
desktop, w-monitor''
[[Page 67650]]
(ED021) from 68 to 51 minutes, among other refinements.
Comment: Commenters indicated that these items are not redundant
and asked that CMS explain which items encompass ED034 and ED036.
Commenters also stated that the desktop computer is used for the entire
intraservice period. Commenters also stated that the refinements were
expressed as a final decision effective January 1, 2014.
Response: The equipment item ``room, vascular ultrasound'' (EL016)
contains ``room, ultrasound general'' (EL015), which contains both
``video SVHS VCR (medical grade)'' and ``digital printer (Sony
UPD21).'' We also note that the RUC has reviewed these codes again for
2015; we refer readers to section II.F. of this rule for further
discussion, including the new interim final inputs established for
2015. We further note that contrary to the commenters' assertion, the
refinements made were indeed effective January 1, 2014, but were not
final decisions; rather, they were interim final for 2014 and subject
to public comment.
(t) Electroencephalogram (CPT Codes 95816, 95819, 95822)
In establishing interim final direct PE inputs for CY 2014, CMS
refined the RUC's recommendations for CPT codes 95816, 95819, and 95822
by refining the equipment time allocated to equipment item ``EEG,
digital, testing system (computer hardware, software & camera)''
(EQ330), among other refinements.
Comment: Commenters indicated that various staff activities are
performed on the computer and requested that we restore the time
previously removed.
Response: Upon reviewing comments regarding the equipment time, we
agree with commenters that we should allocate the entire service period
for EQ330, since it is not highly technical equipment. After
consideration of the comments received, we are finalizing the CY 2014
interim final direct PE inputs for CPT codes 95816, 95819, and 95822 as
established, with the additional refinement of assigning the
intraservice time to EQ330.
(u) Anogenital Examination With Colposcopic Magnification in Childhood
for Suspected Trauma (CPT Code 99170)
In establishing interim final direct PE inputs for CY 2014, CMS
refined the RUC's recommendations for CPT codes, we accepted the RUC's
recommendation to include a new clinical labor type called ``child life
specialist.''
Comment: One commenter supported the inclusion of clinical labor
staff time for the child life specialist.
Response: We appreciate the commenter's support for this decision.
After consideration of the comments received, we are finalizing the CY
2014 interim final direct PE inputs for CPT code 99170 as established.
(v) Immunohistochemistry (HCPCS Codes G0461 and G0462)
In establishing interim final direct PE inputs for CY 2014, CMS
refined the RUC's recommendations for CPT codes 88342 and 88343 by
creating G-codes G0461 and G0462 and refining the inputs for these
services. We acknowledge comments regarding the refinements CMS made to
these inputs, as well as comments indicating that the direct practice
expense inputs for these procedures implied that the reporting would be
different than the reporting implied by the code descriptors. We note
that the RUC has subsequently reviewed CPT codes 88342 and 88343 again
and we present the interim final values for 2015 in this final rule
with comment period. Therefore, we will not address specific comments
regarding G0461 and G0462 except, as discussed below, as they pertain
to errors identified with regard to the pricing of supplies.
Comment: Commenters alerted us to an error in the calculation of
the supply price for SL483 and SL486. Commenters pointed out that the
price for SL483 is $22.56/ml, rather than the .00256/ml that was listed
in the database, and based on the unit of measure established in the
direct PE inputs database for SL486, which costs $65.63 for 250 tests,
the per test quantity should be 1, rather than 0.004.
Response: We agree with commenters that these prices were
calculated incorrectly and have made the adjustments to the direct PE
database.
c. Finalizing CY 2014 Interim Malpractice Crosswalks for CY 2015
In accordance with our malpractice methodology, we adjusted the
malpractice RVUs for the CY 2014 new/revised/potentially misvalued
codes for the difference in work RVUs (or, if greater, the clinical
labor portion of the PE RVUs) between the source codes and the new/
revised codes to reflect the specific risk-of-service for the new/
revised codes. The interim final malpractice crosswalks were listed in
Table 30 of the CY 2014 PFS final rule with comment period.
We received only one comment on our CY 2014 interim final cross
walks. As detailed in the CY 2014 final rule with comment period, we
assigned malpractice crosswalk of CPT code 31575 (Laryngoscopy,
flexible fiberoptic; diagnostic) to CPT codes 43191-43195 and CPT code
31638 (Bronchoscopy, rigid or flexible, including fluoroscopic
guidance, when performed; with revision of tracheal or bronchial stent
inserted at previous session (includes tracheal/bronchial dilation as
required)) to CPT code 43196.
Comment: A commenter said that the established PLI crosswalk, CPT
code 31575, for CPT code 43191-43196 is not appropriate because the
latter services have a life-threatening risk to patients and the same
is not true for CPT code 31575. The commenter recommends instead that
we utilize the RUC recommended crosswalk of bronchoscopy, rigid or
flexible codes (CPT codes 31622 (Bronchoscopy, rigid or flexible,
including fluoroscopic guidance, when performed; diagnostic, with cell
washing, when performed (separate procedure)) for CPT code 43191, 31625
(Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when
performed; with bronchial or endobronchial biopsy(s), single or
multiple sites) for CPT code 43192, 43193, and 43195, and 31638
(Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when
performed; with revision of tracheal or bronchial stent inserted at
previous session (includes tracheal/bronchial dilation as required))
for CPT codes 43194 and 43196.
Response: We continue to believe that our assigned CY 2014
malpractice crosswalks best define the malpractice risk associated with
CPT codes 43191-43196. Therefore, we are finalizing our CY 2014 interim
final crosswalks.
We received no comments on the CY 2014 interim final malpractice
crosswalks and are finalizing them without modification for CY 2015.
The malpractice RVUs for these services are reflected in Addendum B
of this CY 2014 PFS final rule with comment period. Since we are
finalizing a five-year review of MP RVUs in this final rule with
comment period, the MP RVUs assigned to this codes will also be
affected by the updates due to this review. For details on the review,
see section II.C.
d. Other New, Revised or Potentially Misvalued Codes with CY 2014
Interim Final RVUs Not Specifically Discussed in the CY 2015 Final Rule
With Comment Period
For all other new, revised, or potentially misvalued codes with CY
2014 interim final RVUs that are not
[[Page 67651]]
specifically discussed in this CY 2015 PFS final rule with comment
period, we are finalizing for CY 2015, without modification, the CY
2014 interim final or CY 2014 proposed work RVUs, malpractice
crosswalks, and direct PE inputs. Unless otherwise indicated, we agreed
with the time values recommended by the RUC or HCPAC for all codes
addressed in this section. The time values for all codes are listed in
a file called ``CY 2014 PFS Work Time,'' available on the CMS Web site
under downloads for the CY 2015 PFS final rule with comment period at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
3. Establishing CY 2015 RVUs
a. Finalizing CY 2015 Proposed RVUs
In the CY 2015 proposed rule, we proposed CY 2015 work values for
several codes. Table 24 contains a list of these codes and the final CY
2015 work RVUs. For more information on these codes and the
establishment of the values, see section II.Bof this final rule with
comment period.
Table 24--CY 2015 Final Work RVUS for Codes With Proposed Work RVUs
----------------------------------------------------------------------------------------------------------------
Proposed CY
HCPCS code Long descriptor CY 2014 WRVU 2015 work CY 2015 work
RVU RVU
----------------------------------------------------------------------------------------------------------------
G0389.............. Ultrasound, B-scan and/or real time with image 0.58 0.58 0.58
documentation; for abdominal aortic aneurysm
(AAA) screening.
G0416.............. Surgical pathology, gross and microscopic 3.09 3.09 3.09
examination for prostate needle biopsies, any
method;.
G0473.............. Face-to-face behavioral counseling for obesity, (1) N/A 0.25
group (2-10), 30 minutes.
62310.............. Injection(s), of diagnostic or therapeutic 1.18 1.91 1.91
substance(s) (including anesthetic,
antispasmodic, opioid, steroid, other solution),
not including neurolytic substances, including
needle or catheter placement, includes contrast
for localization when performed, epidural or
subarachnoid; cervical or thoracic.
62311.............. Injection(s), of diagnostic or therapeutic 1.17 1.54 1.54
substance(s) (including anesthetic,
antispasmodic, opioid, steroid, other solution),
not including neurolytic substances, including
needle or catheter placement, includes contrast
for localization when performed, epidural or
subarachnoid; lumbar or sacral (caudal).
62318.............. Injection(s), including indwelling catheter 1.54 2.04 2.04
placement, continuous infusion or intermittent
bolus, of diagnostic or therapeutic substance(s)
(including anesthetic, antispasmodic, opioid,
steroid, other solution), not including
neurolytic substances, includes contrast for
localization when performed, epidural or
subarachnoid; cervical or thoracic).
62319.............. Injection(s), including indwelling catheter 1.50 1.87 1.87
placement, continuous infusion or intermittent
bolus, of diagnostic or therapeutic substance(s)
(including anesthetic, antispasmodic, opioid,
steroid, other solution), not including
neurolytic substances, includes contrast for
localization when performed, epidural or
subarachnoid; lumbar or sacral (caudal).
77055.............. mammography; unilateral,......................... .70 .70 .70
77056.............. mammography; bilateral........................... .87 .87 .87
77057.............. screening mammography, bilateral (2-view film .70 .70 .70
study of each breast).
99490.............. Chronic care management services, at least 20 New .61 .61
minutes of clinical staff time directed by a
physician or other qualified health care
professional, per calendar month, with the
following required elements: multiple (two or
more) chronic conditions expected to last at
least 12 months, or until the death of the
patient; chronic conditions place the patient at
significant risk of death, acute exacerbation/
decompensation, or functional decline;
comprehensive care plan established,
implemented, revised, or monitored.
----------------------------------------------------------------------------------------------------------------
\1\ New.
b. Establishing CY 2015 Interim Final Work RVUs
Table 25 contains the CY 2015 interim final work RVUs for all codes
for which we received RUC recommendations for CY 2015 and G-codes with
interim final values for CY 2015. These values are subject to public
comment. The column labeled ``CMS Time Refinement'' indicates whether
CMS refined the time values recommended by the RUC or HCPAC.
This section discusses codes for which the interim final work RVU
or time values assigned for CY 2015 vary from those recommended by the
RUC or for which we do not have RUC recommendations.
Table 25--CY 2015 Interim Final Work RVUS for New/Revised or Potentially Misvalued Codes
----------------------------------------------------------------------------------------------------------------
RUC/HCPAC
HCPCS Code Long descriptor CY 2014 WRVU recommended CY 2015 CMS time
work RVU work RVU refinement
----------------------------------------------------------------------------------------------------------------
11980..... Subcutaneous hormone pellet implantation 1.48 1.10 1.10 No
(implantation of estradiol and/or
testosterone pellets beneath the skin).
20604..... Arthrocentesis, aspiration and/or (\1\) 0.89 0.89 No
injection, small joint or bursa (eg,
fingers, toes); with ultrasound
guidance, with permanent recording and
reporting.
[[Page 67652]]
20606..... Arthrocentesis, aspiration and/or (\1\) 1.00 1.00 No
injection, intermediate joint or bursa
(eg, temporomandibular,
acromioclavicular, wrist, elbow or
ankle, olecranon bursa); with
ultrasound guidance, with permanent
recording and reporting.
20611..... Arthrocentesis, aspiration and/or (\1\) 1.10 1.10 No
injection, major joint or bursa (eg,
shoulder, hip, knee, subacromial
bursa); with ultrasound guidance, with
permanent recording and reporting.
20983..... Ablation therapy for reduction or (\1\) 7.13 7.13 No
eradication of 1 or more bone tumors
(eg, metastasis) including adjacent
soft tissue when involved by tumor
extension, percutaneous, including
imaging guidance when performed;
cryoablation.
21811..... Open treatment of rib fracture(s) with (\1\) 19.55 10.79 Yes
internal fixation, includes
thoracoscopic visualization when
performed, unilateral; 1-3 ribs.
21812..... Open treatment of rib fracture(s) with (\1\) 25.00 13.00 Yes
internal fixation, includes
thoracoscopic visualization when
performed, unilateral; 4-6 ribs.
21813..... Open treatment of rib fracture(s) with (\1\) 35.00 17.61 Yes
internal fixation, includes
thoracoscopic visualization when
performed, unilateral; 7 or more ribs.
22510..... Percutaneous vertebroplasty (bone biopsy (\1\) 8.15 8.15 No
included when performed), 1 vertebral
body, unilateral or bilateral
injection, inclusive of all imaging
guidance; cervicothoracic.
22511..... Percutaneous vertebroplasty (bone biopsy (\1\) 8.05 7.58 No
included when performed), 1 vertebral
body, unilateral or bilateral
injection, inclusive of all imaging
guidance; lumbosacral.
22512..... Percutaneous vertebroplasty (bone biopsy (\1\) 4.00 4.00 No
included when performed), 1 vertebral
body, unilateral or bilateral
injection, inclusive of all imaging
guidance; each additional
cervicothoracic or lumbosacral
vertebral body (list separately in
addition to code for primary procedure).
22513..... Percutaneous vertebral augmentation, (\1\) 8.90 8.90 No
including cavity creation (fracture
reduction and bone biopsy included when
performed) using mechanical device (eg,
kyphoplasty), 1 vertebral body,
unilateral or bilateral cannulation,
inclusive of all imaging guidance;
thoracic.
22514..... Percutaneous vertebral augmentation, (\1\) 8.24 8.24 No
including cavity creation (fracture
reduction and bone biopsy included when
performed) using mechanical device (eg,
kyphoplasty), 1 vertebral body,
unilateral or bilateral cannulation,
inclusive of all imaging guidance;
lumbar.
22515..... Percutaneous vertebral augmentation, (\1\) 4.00 4.00 No
including cavity creation (fracture
reduction and bone biopsy included when
performed) using mechanical device (eg,
kyphoplasty), 1 vertebral body,
unilateral or bilateral cannulation,
inclusive of all imaging guidance; each
additional thoracic or lumbar vertebral
body (list separately in addition to
code for primary procedure).
22856..... Total disc arthroplasty (artificial 24.05 24.05 24.05 No
disc), anterior approach, including
discectomy with end plate preparation
(includes osteophytectomy for nerve
root or spinal cord decompression and
microdissection); single interspace,
cervical.
22858..... Total disc arthroplasty (artificial (\1\) 8.40 8.40 No
disc), anterior approach, including
discectomy with end plate preparation
(includes osteophytectomy for nerve
root or spinal cord decompression and
microdissection); second level,
cervical (list separately in addition
to code for primary procedure).
27279..... Arthrodesis, sacroiliac joint, (\1\) 9.03 9.03 No
percutaneous or minimally invasive
(indirect visualization), with image
guidance, includes obtaining bone graft
when performed, and placement of
transfixing device.
29200..... Strapping; thorax....................... 0.65 0.39 0.39 No
29240..... Strapping; shoulder (eg, velpeau)....... 0.71 0.39 0.39 No
29260..... Strapping; elbow or wrist............... 0.55 0.39 0.39 No
29280..... Strapping; hand or finger............... 0.51 0.39 0.39 No
29520..... Strapping; hip.......................... 0.54 0.39 0.39 No
29530..... Strapping; knee......................... 0.57 0.39 0.39 No
31620..... Endobronchial ultrasound (ebus) during 1.40 1.50 1.40 No
bronchoscopic diagnostic or therapeutic
intervention(s) (list separately in
addition to code for primary
procedure[s]).
33215..... Repositioning of previously implanted 4.92 4.92 4.92 No
transvenous pacemaker or implantable
defibrillator (right atrial or right
ventricular) electrode.
33216..... Insertion of a single transvenous 5.87 5.87 5.87 No
electrode, permanent pacemaker or
implantable defibrillator.
33217..... Insertion of 2 transvenous electrodes, 5.84 5.84 5.84 No
permanent pacemaker or implantable
defibrillator.
[[Page 67653]]
33218..... Repair of single transvenous electrode, 6.07 6.07 6.07 No
permanent pacemaker or implantable
defibrillator.
33220..... Repair of 2 transvenous electrodes for 6.15 6.15 6.15 No
permanent pacemaker or implantable
defibrillator.
33223..... Relocation of skin pocket for 6.55 6.55 6.55 No
implantable defibrillator.
33224..... Insertion of pacing electrode, cardiac 9.04 9.04 9.04 No
venous system, for left ventricular
pacing, with attachment to previously
placed pacemaker or implantable
defibrillator pulse generator
(including revision of pocket, removal,
insertion, and/or replacement of
existing generator).
33225..... Insertion of pacing electrode, cardiac 8.33 8.33 8.33 No
venous system, for left ventricular
pacing, at time of insertion of
implantable defibrillator or pacemaker
pulse generator (eg, for upgrade to
dual chamber system) (list separately
in addition to code for primary
procedure).
33240..... Insertion of implantable defibrillator 6.05 6.05 6.05 No
pulse generator only; with existing
single lead.
33241..... Removal of implantable defibrillator 3.29 3.29 3.29 No
pulse generator only.
33243..... Removal of single or dual chamber 23.57 23.57 23.57 No
implantable defibrillator electrode(s);
by thoracotomy.
33244..... Removal of single or dual chamber 13.99 13.99 13.99 No
implantable defibrillator electrode(s);
by transvenous extraction.
33249..... Insertion or replacement of permanent 15.17 15.17 15.17 No
implantable defibrillator system, with
transvenous lead(s), single or dual
chamber.
33262..... Removal of implantable defibrillator 6.06 6.06 6.06 No
pulse generator with replacement of
implantable defibrillator pulse
generator; single lead system.
33263..... Removal of implantable defibrillator 6.33 6.33 6.33 No
pulse generator with replacement of
implantable defibrillator pulse
generator; dual lead system.
33270..... Insertion or replacement of permanent (\1\) 9.10 9.10 No
subcutaneous implantable defibrillator
system, with subcutaneous electrode,
including defibrillation threshold
evaluation, induction of arrhythmia,
evaluation of sensing for arrhythmia
termination, and programming or
reprogramming of sensing or therapeutic
parameters, when performed.
33271..... Insertion of subcutaneous implantable (\1\) 7.50 7.50 No
defibrillator electrode.
33272..... Removal of subcutaneous implantable (\1\) 5.42 5.42 No
defibrillator electrode.
33273..... Repositioning of previously implanted (\1\) 6.50 6.50 No
subcutaneous implantable defibrillator
electrode.
33418..... Transcatheter mitral valve repair, (\1\) 32.25 32.25 No
percutaneous approach, including
transseptal puncture when performed;
initial prosthesis.
33419..... Transcatheter mitral valve repair, (\1\) 7.93 7.93 No
percutaneous approach, including
transseptal puncture when performed;
additional prosthesis(es) during same
session (list separately in addition to
code for primary procedure).
33946..... Extracorporeal membrane oxygenation (\1\) 6.00 6.00 No
(ecmo)/extracorporeal life support
(ecls) provided by physician;
initiation, veno-venous.
33947..... Extracorporeal membrane oxygenation (\1\) 6.63 6.63 No
(ecmo)/extracorporeal life support
(ecls) provided by physician;
initiation, veno-arterial.
33949..... Extracorporeal membrane oxygenation (\1\) 4.60 4.60 No
(ecmo)/extracorporeal life support
(ecls) provided by physician; daily
management, each day, veno-arterial.
33951..... Extracorporeal membrane oxygenation (\1\) 8.15 8.15 No
(ecmo)/extracorporeal life support
(ecls) provided by physician; insertion
of peripheral (arterial and/or venous)
cannula(e), percutaneous, birth through
5 years of age (includes fluoroscopic
guidance, when performed).
33952..... Extracorporeal membrane oxygenation (\1\) 8.43 8.15 No
(ecmo)/extracorporeal life support
(ecls) provided by physician; insertion
of peripheral (arterial and/or venous)
cannula(e), percutaneous, 6 years and
older (includes fluoroscopic guidance,
when performed).
33953..... Extracorporeal membrane oxygenation (\1\) 9.83 9.11 No
(ecmo)/extracorporeal life support
(ecls) provided by physician; insertion
of peripheral (arterial and/or venous)
cannula(e), open, birth through 5 years
of age.
33954..... Extracorporeal membrane oxygenation (\1\) 9.43 9.11 No
(ecmo)/extracorporeal life support
(ecls) provided by physician; insertion
of peripheral (arterial and/or venous)
cannula(e), open, 6 years and older.
33955..... Extracorporeal membrane oxygenation (\1\) 16.00 16.00 No
(ecmo)/extracorporeal life support
(ecls) provided by physician; insertion
of central cannula(e) by sternotomy or
thoracotomy, birth through 5 years of
age.
33956..... Extracorporeal membrane oxygenation (\1\) 16.00 16.00 No
(ecmo)/extracorporeal life support
(ecls) provided by physician; insertion
of central cannula(e) by sternotomy or
thoracotomy, 6 years and older.
[[Page 67654]]
33957..... Extracorporeal membrane oxygenation (\1\) 4.00 3.51 No
(ecmo)/extracorporeal life support
(ecls) provided by physician;
reposition peripheral (arterial and/or
venous) cannula(e), percutaneous, birth
through 5 years of age (includes
fluoroscopic guidance, when performed).
33958..... Extracorporeal membrane oxygenation (\1\) 4.05 3.51 No
(ecmo)/extracorporeal life support
(ecls) provided by physician;
reposition peripheral (arterial and/or
venous) cannula(e), percutaneous, 6
years and older (includes fluoroscopic
guidance, when performed).
33959..... Extracorporeal membrane oxygenation (\1\) 4.69 4.47 No
(ecmo)/extracorporeal life support
(ecls) provided by physician;
reposition peripheral (arterial and/or
venous) cannula(e), open, birth through
5 years of age (includes fluoroscopic
guidance, when performed).
33962..... Extracorporeal membrane oxygenation (\1\) 4.73 4.47 No
(ecmo)/extracorporeal life support
(ecls) provided by physician;
reposition peripheral (arterial and/or
venous) cannula(e), open, 6 years and
older (includes fluoroscopic guidance,
when performed).
33963..... Extracorporeal membrane oxygenation (\1\) 9.00 9.00 No
(ecmo)/extracorporeal life support
(ecls) provided by physician;
reposition of central cannula(e) by
sternotomy or thoracotomy, birth
through 5 years of age (includes
fluoroscopic guidance, when performed).
33964..... Extracorporeal membrane oxygenation (\1\) 9.50 9.50 No
(ecmo)/extracorporeal life support
(ecls) provided by physician;
reposition central cannula(e) by
sternotomy or thoracotomy, 6 years and
older (includes fluoroscopic guidance,
when performed).
33965..... Extracorporeal membrane oxygenation (\1\) 3.51 3.51 No
(ecmo)/extracorporeal life support
(ecls) provided by physician; removal
of peripheral (arterial and/or venous)
cannula(e), percutaneous, birth through
5 years of age.
33966..... Extracorporeal membrane oxygenation (\1\) 4.50 4.50 No
(ecmo)/extracorporeal life support
(ecls) provided by physician; removal
of peripheral (arterial and/or venous)
cannula(e), percutaneous, 6 years and
older.
33969..... Extracorporeal membrane oxygenation (\1\) 6.00 5.22 No
(ecmo)/extracorporeal life support
(ecls) provided by physician; removal
of peripheral (arterial and/or venous)
cannula(e), open, birth through 5 years
of age.
33984..... Extracorporeal membrane oxygenation (\1\) 6.38 5.46 No
(ecmo)/extracorporeal life support
(ecls) provided by physician; removal
of peripheral (arterial and/or venous)
cannula(e), open, 6 years and older.
33985..... Extracorporeal membrane oxygenation (\1\) 9.89 9.89 No
(ecmo)/extracorporeal life support
(ecls) provided by physician; removal
of central cannula(e) by sternotomy or
thoracotomy, birth through 5 years of
age.
33986..... Extracorporeal membrane oxygenation (\1\) 10.00 10.00 No
(ecmo)/extracorporeal life support
(ecls) provided by physician; removal
of central cannula(e) by sternotomy or
thoracotomy, 6 years and older.
33987..... Arterial exposure with creation of graft (\1\) 4.04 4.04 No
conduit (eg, chimney graft) to
facilitate arterial perfusion for ecmo/
ecls (list separately in addition to
code for primary procedure).
33988..... Insertion of left heart vent by thoracic (\1\) 15.00 15.00 No
incision (eg, sternotomy, thoracotomy)
for ecmo/ecls.
33989..... Removal of left heart vent by thoracic (\1\) 9.50 9.50 No
incision (eg, sternotomy, thoracotomy)
for ecmo/ecls.
34839..... Physician planning of a patient-specific (\1\) C B N/A
fenestrated visceral aortic endograft
requiring a minimum of 90 minutes of
physician time.
34841..... Endovascular repair of visceral aorta C C C N/A
(eg, aneurysm, pseudoaneurysm,
dissection, penetrating ulcer,
intramural hematoma, or traumatic
disruption) by deployment of a
fenestrated visceral aortic endograft
and all associated radiological
supervision and interpretation,
including target zone angioplasty, when
performed; including one visceral
artery endoprosthesis (superior
mesenteric, celiac or renal artery).
34842..... Endovascular repair of visceral aorta C C C N/A
(eg, aneurysm, pseudoaneurysm,
dissection, penetrating ulcer,
intramural hematoma, or traumatic
disruption) by deployment of a
fenestrated visceral aortic endograft
and all associated radiological
supervision and interpretation,
including target zone angioplasty, when
performed; including two visceral
artery endoprostheses (superior
mesenteric, celiac and/or renal
artery[s]).
[[Page 67655]]
34843..... Endovascular repair of visceral aorta C C C N/A
(eg, aneurysm, pseudoaneurysm,
dissection, penetrating ulcer,
intramural hematoma, or traumatic
disruption) by deployment of a
fenestrated visceral aortic endograft
and all associated radiological
supervision and interpretation,
including target zone angioplasty, when
performed; including three visceral
artery endoprostheses (superior
mesenteric, celiac and/or renal
artery[s]).
34844..... Endovascular repair of visceral aorta C C C N/A
(eg, aneurysm, pseudoaneurysm,
dissection, penetrating ulcer,
intramural hematoma, or traumatic
disruption) by deployment of a
fenestrated visceral aortic endograft
and all associated radiological
supervision and interpretation,
including target zone angioplasty, when
performed; including four or more
visceral artery endoprostheses
(superior mesenteric, celiac and/or
renal artery[s]).
34845..... Endovascular repair of visceral aorta C C C N/A
and infrarenal abdominal aorta (eg,
aneurysm, pseudoaneurysm, dissection,
penetrating ulcer, intramural hematoma,
or traumatic disruption) with a
fenestrated visceral aortic endograft
and concomitant unibody or modular
infrarenal aortic endograft and all
associated radiological supervision and
interpretation, including target zone
angioplasty, when performed; including
one visceral artery endoprosthesis
(superior mesenteric, celiac or renal
artery).
34846..... Endovascular repair of visceral aorta C C C N/A
and infrarenal abdominal aorta (eg,
aneurysm, pseudoaneurysm, dissection,
penetrating ulcer, intramural hematoma,
or traumatic disruption) with a
fenestrated visceral aortic endograft
and concomitant unibody or modular
infrarenal aortic endograft and all
associated radiological supervision and
interpretation, including target zone
angioplasty, when performed; including
two visceral artery endoprostheses
(superior mesenteric, celiac and/or
renal artery[s]).
34847..... Endovascular repair of visceral aorta C C C N/A
and infrarenal abdominal aorta (eg,
aneurysm, pseudoaneurysm, dissection,
penetrating ulcer, intramural hematoma,
or traumatic disruption) with a
fenestrated visceral aortic endograft
and concomitant unibody or modular
infrarenal aortic endograft and all
associated radiological supervision and
interpretation, including target zone
angioplasty, when performed; including
three visceral artery endoprostheses
(superior mesenteric, celiac and/or
renal artery[s]).
34848..... Endovascular repair of visceral aorta C C C N/A
and infrarenal abdominal aorta (eg,
aneurysm, pseudoaneurysm, dissection,
penetrating ulcer, intramural hematoma,
or traumatic disruption) with a
fenestrated visceral aortic endograft
and concomitant unibody or modular
infrarenal aortic endograft and all
associated radiological supervision and
interpretation, including target zone
angioplasty, when performed; including
four or more visceral artery
endoprostheses (superior mesenteric,
celiac and/or renal artery[s]).
36475..... Endovenous ablation therapy of 6.72 5.30 5.30 No
incompetent vein, extremity, inclusive
of all imaging guidance and monitoring,
percutaneous, radiofrequency; first
vein treated.
36476..... Endovenous ablation therapy of 3.38 2.65 2.65 No
incompetent vein, extremity, inclusive
of all imaging guidance and monitoring,
percutaneous, radiofrequency; second
and subsequent veins treated in a
single extremity, each through separate
access sites (list separately in
addition to code for primary procedure).
36478..... Endovenous ablation therapy of 6.72 5.30 5.30 No
incompetent vein, extremity, inclusive
of all imaging guidance and monitoring,
percutaneous, laser; first vein treated.
36479..... Endovenous ablation therapy of 3.38 2.65 2.65 No
incompetent vein, extremity, inclusive
of all imaging guidance and monitoring,
percutaneous, laser; second and
subsequent veins treated in a single
extremity, each through separate access
sites (list separately in addition to
code for primary procedure).
36818..... Arteriovenous anastomosis, open; by 11.89 13.00 12.39 No
upper arm cephalic vein transposition.
36819..... Arteriovenous anastomosis, open; by 13.29 15.00 13.29 No
upper arm basilic vein transposition.
36820..... Arteriovenous anastomosis, open; by 14.47 13.99 13.07 No
forearm vein transposition.
36821..... Arteriovenous anastomosis, open; direct, 12.11 11.90 11.90 No
any site (eg, cimino type) (separate
procedure).
[[Page 67656]]
36825..... Creation of arteriovenous fistula by 14.17 15.93 14.17 No
other than direct arteriovenous
anastomosis (separate procedure);
autogenous graft.
36830..... Creation of arteriovenous fistula by 12.03 11.90 12.03 No
other than direct arteriovenous
anastomosis (separate procedure);
nonautogenous graft (eg, biological
collagen, thermoplastic graft).
36831..... Thrombectomy, open, arteriovenous 8.04 11.00 11.00 Yes
fistula without revision, autogenous or
nonautogenous dialysis graft (separate
procedure).
36832..... Revision, open, arteriovenous fistula; 10.53 13.50 13.50 Yes
without thrombectomy, autogenous or
nonautogenous dialysis graft (separate
procedure).
36833..... Revision, open, arteriovenous fistula; 11.98 14.50 14.50 Yes
with thrombectomy, autogenous or
nonautogenous dialysis graft (separate
procedure).
37218..... Transcatheter placement of intravascular (\1\) 15.00 15.00 No
stent(s), intrathoracic common carotid
artery or innominate artery, open or
percutaneous antegrade approach,
including angioplasty, when performed,
and radiological supervision and
interpretation.
43180..... Esophagoscopy, rigid, transoral with (\1\) 9.03 9.03 No
diverticulectomy of hypopharynx or
cervical esophagus (eg, zenker's
diverticulum), with cricopharyngeal
myotomy, includes use of telescope or
operating microscope and repair, when
performed.
44381..... Ileoscopy, through stoma; with (\1\) 1.48 I N/A
transendoscopic balloon dilation.
44384..... Ileoscopy, through stoma; with placement (\1\) 3.11 I N/A
of endoscopic stent (includes pre- and
post-dilation and guide wire passage,
when performed).
44401..... Colonoscopy through stoma; with ablation (\1\) 4.44 I N/A
of tumor(s), polyp(s), or other
lesion(s) (includes pre- and post-
dilation and guide wire passage, when
performed).
44402..... Colonoscopy through stoma; with (\1\) 4.96 I N/A
endoscopic stent placement (including
pre- and post-dilation and guide wire
passage, when performed).
44403..... Colonoscopy through stoma; with (\1\) 5.81 I N/A
endoscopic mucosal resection.
44404..... Colonoscopy through stoma; with directed (\1\) 3.13 I N/A
submucosal injection(s), any substance.
44405..... Colonoscopy through stoma; with (\1\) 3.33 I N/A
transendoscopic balloon dilation.
44406..... Colonoscopy through stoma; with (\1\) 4.41 I N/A
endoscopic ultrasound examination,
limited to the sigmoid, descending,
transverse, or ascending colon and
cecum and adjacent structures.
44407..... Colonoscopy through stoma; with (\1\) 5.06 I N/A
transendoscopic ultrasound guided
intramural or transmural fine needle
aspiration/biopsy(s), includes
endoscopic ultrasound examination
limited to the sigmoid, descending,
transverse, or ascending colon and
cecum and adjacent structures.
44408..... Colonoscopy through stoma; with (\1\) 4.24 I N/A
decompression (for pathologic
distention) (eg, volvulus, megacolon),
including placement of decompression
tube, when performed.
45346..... Sigmoidoscopy, flexible; with ablation (\1\) 2.97 I N/A
of tumor(s), polyp(s), or other
lesion(s) (includes pre- and post-
dilation and guide wire passage, when
performed).
45347..... Sigmoidoscopy, flexible; with placement (\1\) 2.98 I N/A
of endoscopic stent (includes pre- and
post-dilation and guide wire passage,
when performed).
45349..... Sigmoidoscopy, flexible; with endoscopic (\1\) 3.83 I N/A
mucosal resection.
45350..... Sigmoidoscopy, flexible; with band (\1\) 1.78 I N/A
ligation(s) (eg, hemorrhoids).
45388..... Colonoscopy, flexible; with ablation of (\1\) 4.98 I N/A
tumor(s), polyp(s), or other lesion(s)
(includes pre- and post-dilation and
guide wire passage, when performed).
45389..... Colonoscopy, flexible; with endoscopic (\1\) 5.50 I N/A
stent placement (includes pre- and post-
dilation and guide wire passage, when
performed).
45390..... Colonoscopy, flexible; with endoscopic (\1\) 6.35 I N/A
mucosal resection.
45393..... Colonoscopy, flexible; with (\1\) 4.78 I N/A
decompression (for pathologic
distention) (eg, volvulus, megacolon),
including placement of decompression
tube, when performed.
45398..... Colonoscopy, flexible; with band (\1\) 4.30 ............ N/A
ligation(s) (eg, hemorrhoids).
45399..... Unlisted procedure, colon............... (\1\) None I N/A
46601..... Anoscopy; diagnostic, with high- (\1\) 1.60 I N/A
resolution magnification (hra) (eg,
colposcope, operating microscope) and
chemical agent enhancement, including
collection of specimen(s) by brushing
or washing, when performed.
46607..... Anoscopy; with high-resolution (\1\) 2.20 I N/A
magnification (hra) (eg, colposcope,
operating microscope) and chemical
agent enhancement, with biopsy, single
or multiple.
47383..... Ablation, 1 or more liver tumor(s), (\1\) 9.13 9.13 No
percutaneous, cryoablation.
[[Page 67657]]
52441..... Cystourethroscopy, with insertion of (\1\) 4.50 4.50 No
permanent adjustable transprostatic
implant; single implant.
52442..... Cystourethroscopy, with insertion of (\1\) 1.20 1.20 No
permanent adjustable transprostatic
implant; each additional permanent
adjustable transprostatic implant (list
separately in addition to code for
primary procedure).
55840..... Prostatectomy, retropubic radical, with 24.63 21.36 21.36 No
or without nerve sparing;.
55842..... Prostatectomy, retropubic radical, with 26.49 24.16 21.36 No
or without nerve sparing; with lymph
node biopsy(s) (limited pelvic
lymphadenectomy).
55845..... Prostatectomy, retropubic radical, with 30.67 29.07 25.18 No
or without nerve sparing; with
bilateral pelvic lymphadenectomy,
including external iliac, hypogastric,
and obturator nodes.
58541..... Laparoscopy, surgical, supracervical 14.70 12.29 12.29 No
hysterectomy, for uterus 250 g or less;.
58542..... Laparoscopy, surgical, supracervical 16.56 14.16 14.16 No
hysterectomy, for uterus 250 g or less;
with removal of tube(s) and/or ovary(s).
58543..... Laparoscopy, surgical, supracervical 16.87 14.39 14.39 No
hysterectomy, for uterus greater than
250 g;.
58544..... Laparoscopy, surgical, supracervical 18.37 15.60 15.60 No
hysterectomy, for uterus greater than
250 g; with removal of tube(s) and/or
ovary(s).
58570..... Laparoscopy, surgical, with total 15.88 13.36 13.36 No
hysterectomy, for uterus 250 g or less;.
58571..... Laparoscopy, surgical, with total 17.69 15.00 15.00 No
hysterectomy, for uterus 250 g or less;
with removal of tube(s) and/or ovary(s).
58572..... Laparoscopy, surgical, with total 20.09 17.71 17.71 No
hysterectomy, for uterus greater than
250 g;.
58573..... Laparoscopy, surgical, with total 23.11 20.79 20.79 No
hysterectomy, for uterus greater than
250 g; with removal of tube(s) and/or
ovary(s).
62284..... Injection procedure for myelography and/ 1.54 1.54 1.54 No
or computed tomography, lumbar (other
than c1-c2 and posterior fossa).
62302..... Myelography via lumbar injection, (\1\) 2.29 2.29 No
including radiological supervision and
interpretation; cervical.
62303..... Myelography via lumbar injection, (\1\) 2.29 2.29 No
including radiological supervision and
interpretation; thoracic.
62304..... Myelography via lumbar injection, (\1\) 2.25 2.25 No
including radiological supervision and
interpretation; lumbosacral.
62305..... Myelography via lumbar injection, (\1\) 2.35 2.35 No
including radiological supervision and
interpretation; 2 or more regions (eg,
lumbar/thoracic, cervical/thoracic,
lumbar/cervical, lumbar/thoracic/
cervical).
64486..... Transversus abdominis plane (tap) block (\1\) 1.27 1.27 No
(abdominal plane block, rectus sheath
block) unilateral; by injection(s)
(includes imaging guidance, when
performed).
64487..... Transversus abdominis plane (tap) block (\1\) 1.48 1.48 No
(abdominal plane block, rectus sheath
block) unilateral; by continuous
infusion(s) (includes imaging guidance,
when performed).
64488..... Transversus abdominis plane (tap) block (\1\) 1.60 1.60 No
(abdominal plane block, rectus sheath
block) bilateral; by injections
(includes imaging guidance, when
performed).
64489..... Transversus abdominis plane (tap) block (\1\) 1.80 1.80 No
(abdominal plane block, rectus sheath
block) bilateral; by continuous
infusions (includes imaging guidance,
when performed).
64561..... Percutaneous implantation of 7.15 5.44 5.44 No
neurostimulator electrode array; sacral
nerve (transforaminal placement)
including image guidance, if performed.
66179..... Aqueous shunt to extraocular equatorial (\1\) 14.00 14.00 No
plate reservoir, external approach;
without graft.
66180..... Aqueous shunt to extraocular equatorial 16.30 15.00 15.00 No
plate reservoir, external approach;
with graft.
66184..... Revision of aqueous shunt to extraocular (\1\) 9.58 9.58 No
equatorial plate reservoir; without
graft.
66185..... Revision of aqueous shunt to extraocular 9.58 10.58 10.58 No
equatorial plate reservoir; with graft.
67036..... Vitrectomy, mechanical, pars plana 13.32 12.13 12.13 No
approach;.
67039..... Vitrectomy, mechanical, pars plana 16.74 13.20 13.20 No
approach; with focal endolaser
photocoagulation.
67040..... Vitrectomy, mechanical, pars plana 19.61 14.50 14.50 No
approach; with endolaser panretinal
photocoagulation.
67041..... Vitrectomy, mechanical, pars plana 19.25 16.33 16.33 No
approach; with removal of preretinal
cellular membrane (eg, macular pucker).
[[Page 67658]]
67042..... Vitrectomy, mechanical, pars plana 22.38 16.33 16.33 No
approach; with removal of internal
limiting membrane of retina (eg, for
repair of macular hole, diabetic
macular edema), includes, if performed,
intraocular tamponade (ie, air, gas or
silicone oil).
67043..... Vitrectomy, mechanical, pars plana 23.24 17.40 17.40 No
approach; with removal of subretinal
membrane (eg, choroidal
neovascularization), includes, if
performed, intraocular tamponade (ie,
air, gas or silicone oil) and laser
photocoagulation.
67255..... Scleral reinforcement (separate 10.17 10.17 8.38 No
procedure); with graft.
70486..... Computed tomography, maxillofacial area; 1.14 0.85 0.85 No
without contrast material.
70487..... Computed tomography, maxillofacial area; 1.30 1.17 1.13 No
with contrast material(s).
70488..... Computed tomography, maxillofacial area; 1.42 1.30 1.27 No
without contrast material, followed by
contrast material(s) and further
sections.
70496..... Computed tomographic angiography, head, 1.75 1.75 1.75 No
with contrast material(s), including
noncontrast images, if performed, and
image postprocessing.
70498..... Computed tomographic angiography, neck, 1.75 1.75 1.75 No
with contrast material(s), including
noncontrast images, if performed, and
image postprocessing.
71275..... Computed tomographic angiography, chest 1.92 1.82 1.82 No
(noncoronary), with contrast
material(s), including noncontrast
images, if performed, and image
postprocessing.
72191..... Computed tomographic angiography, 1.81 1.81 1.81 No
pelvis, with contrast material(s),
including noncontrast images, if
performed, and image postprocessing.
72240..... Myelography, cervical, radiological 0.91 0.91 0.91 No
supervision and interpretation.
72255..... Myelography, thoracic, radiological 0.91 0.91 0.91 No
supervision and interpretation.
72265..... Myelography, lumbosacral, radiological 0.83 0.83 0.83 No
supervision and interpretation.
72270..... Myelography, 2 or more regions (eg, 1.33 1.33 1.33 No
lumbar/thoracic, cervical/thoracic,
lumbar/cervical, lumbar/thoracic/
cervical), radiological supervision and
interpretation.
74174..... Computed tomographic angiography, 2.20 2.20 2.20 No
abdomen and pelvis, with contrast
material(s), including noncontrast
images, if performed, and image
postprocessing.
74175..... Computed tomographic angiography, 1.90 1.82 1.82 No
abdomen, with contrast material(s),
including noncontrast images, if
performed, and image postprocessing.
74230..... Swallowing function, with 0.53 0.53 0.53 No
cineradiography/videoradiography.
76641..... Ultrasound, breast, unilateral, real (\1\) 0.73 0.73 No
time with image documentation,
including axilla when performed;
complete.
76642..... Ultrasound, breast, unilateral, real (\1\) 0.68 0.68 No
time with image documentation,
including axilla when performed;
limited.
76700..... Ultrasound, abdominal, real time with 0.81 0.81 0.81 No
image documentation; complete.
76705..... Ultrasound, abdominal, real time with 0.59 0.59 0.59 No
image documentation; limited (eg,
single organ, quadrant, follow-up).
76770..... Ultrasound, retroperitoneal (eg, renal, 0.74 0.74 0.74 No
aorta, nodes), real time with image
documentation; complete.
76775..... Ultrasound, retroperitoneal (eg, renal, 0.58 0.58 0.58 No
aorta, nodes), real time with image
documentation; limited.
76856..... Ultrasound, pelvic (nonobstetric), real 0.69 0.69 0.69 No
time with image documentation; complete.
76857..... Ultrasound, pelvic (nonobstetric), real 0.38 0.50 0.50 No
time with image documentation; limited
or follow-up (eg, for follicles).
76930..... Ultrasonic guidance for 0.67 0.67 0.67 No
pericardiocentesis, imaging supervision
and interpretation.
76932..... Ultrasonic guidance for endomyocardial C 0.85 0.85 No
biopsy, imaging supervision and
interpretation.
76942..... Ultrasonic guidance for needle placement 0.67 0.67 0.67 No
(eg, biopsy, aspiration, injection,
localization device), imaging
supervision and interpretation.
76948..... Ultrasonic guidance for aspiration of 0.38 0.92 0.92 No
ova, imaging supervision and
interpretation.
77061..... Digital breast tomosynthesis; unilateral (\1\) 0.70 I N/A
77062..... Digital breast tomosynthesis; bilateral. (\1\) 0.90 I N/A
77063..... Screening digital breast tomosynthesis, (\1\) 0.60 0.60 No
bilateral (list separately in addition
to code for primary procedure).
77080..... Dual-energy x-ray absorptiometry (dxa), 0.20 0.20 0.20 No
bone density study, 1 or more sites;
axial skeleton (eg, hips, pelvis,
spine).
77085..... Dual-energy x-ray absorptiometry (dxa), (\1\) 0.30 0.30 No
bone density study, 1 or more sites;
axial skeleton (eg, hips, pelvis,
spine), including vertebral fracture
assessment.
[[Page 67659]]
77086..... Vertebral fracture assessment via dual- (\1\) 0.17 0.17 No
energy x-ray absorptiometry (dxa).
77300..... Basic radiation dosimetry calculation, 0.62 0.62 0.62 No
central axis depth dose calculation,
tdf, nsd, gap calculation, off axis
factor, tissue inhomogeneity factors,
calculation of non-ionizing radiation
surface and depth dose, as required
during course of treatment, only when
prescribed by the treating physician.
77306..... Teletherapy isodose plan; simple (1 or 2 (\1\) 1.40 1.40 No
unmodified ports directed to a single
area of interest), includes basic
dosimetry calculation(s).
77307..... Teletherapy isodose plan; complex (\1\) 2.90 2.90 No
(multiple treatment areas, tangential
ports, the use of wedges, blocking,
rotational beam, or special beam
considerations), includes basic
dosimetry calculation(s).
77316..... Brachytherapy isodose plan; simple (\1\) 1.50 1.40 No
(calculation[s] made from 1 to 4
sources, or remote afterloading
brachytherapy, 1 channel), includes
basic dosimetry calculation(s).
77317..... Brachytherapy isodose plan; intermediate (\1\) 1.83 1.83 No
(calculation[s] made from 5 to 10
sources, or remote afterloading
brachytherapy, 2-12 channels), includes
basic dosimetry calculation(s).
77318..... Brachytherapy isodose plan; complex (\1\) 2.90 2.90 No
(calculation[s] made from over 10
sources, or remote afterloading
brachytherapy, over 12 channels),
includes basic dosimetry calculation(s).
77385..... Intensity modulated radiation treatment (\1\) ............ I N/A
delivery (imrt), includes guidance and
tracking, when performed; simple.
77386..... Intensity modulated radiation treatment (\1\) ............ I N/A
delivery (imrt), includes guidance and
tracking, when performed; complex.
77387..... Guidance for localization of target (\1\) 0.58 I N/A
volume for delivery of radiation
treatment delivery, includes
intrafraction tracking, when performed.
77402..... Radiation treatment delivery, >1 mev; 0.00 ............ I N/A
simple.
77407..... Radiation treatment delivery, >1 mev; 0.00 ............ I N/A
intermediate.
77412..... Radiation treatment delivery, >1 mev; 0.00 ............ I N/A
complex.
88341..... Immunohistochemistry or (\1\) 0.65 0.42 No
immunocytochemistry, per specimen; each
additional single antibody stain
procedure (list separately in addition
to code for primary procedure).
88342..... Immunohistochemistry or I 0.70 0.70 No
immunocytochemistry, per specimen;
initial single antibody stain procedure.
88344..... Immunohistochemistry or (\1\) 0.77 0.77 No
immunocytochemistry, per specimen; each
multiplex antibody stain procedure.
88356..... Morphometric analysis; nerve............ 3.02 2.80 2.80 No
88364..... In situ hybridization (eg, fish), per (\1\) 0.88 0.53 No
specimen; each additional single probe
stain procedure (list separately in
addition to code for primary procedure).
88365..... In situ hybridization (eg, fish), per 1.20 0.88 0.88 No
specimen; initial single probe stain
procedure.
88366..... In situ hybridization (eg, fish), per (\1\) 1.24 1.24 No
specimen; each multiplex probe stain
procedure.
88367..... Morphometric analysis, in situ 1.30 0.86 0.73 No
hybridization (quantitative or semi-
quantitative), using computer-assisted
technology, per specimen; initial
single probe stain procedure.
88368..... Morphometric analysis, in situ 1.40 0.88 0.88 No
hybridization (quantitative or semi-
quantitative), manual, per specimen;
initial single probe stain procedure.
88369..... Morphometric analysis, in situ (\1\) 0.88 0.53 No
hybridization (quantitative or semi-
quantitative), manual, per specimen;
each additional single probe stain
procedure (list separately in addition
to code for primary procedure).
88373..... Morphometric analysis, in situ (\1\) 0.86 0.43 No
hybridization (quantitative or semi-
quantitative), using computer-assisted
technology, per specimen; each
additional single probe stain procedure
(list separately in addition to code
for primary procedure).
88374..... Morphometric analysis, in situ (\1\) 1.04 0.93 No
hybridization (quantitative or semi-
quantitative), using computer-assisted
technology, per specimen; each
multiplex probe stain procedure.
88377..... Morphometric analysis, in situ (\1\) 1.40 1.40 No
hybridization (quantitative or semi-
quantitative), manual, per specimen;
each multiplex probe stain procedure.
88380..... Microdissection (ie, sample preparation 1.56 1.14 1.14 No
of microscopically identified target);
laser capture.
88381..... Microdissection (ie, sample preparation 1.18 0.53 0.53 No
of microscopically identified target);
manual.
91200..... Liver elastography, mechanically induced (\1\) 0.30 0.30 No
shear wave (eg, vibration), without
imaging, with interpretation and report.
[[Page 67660]]
92145..... Corneal hysteresis determination, by air (\1\) 0.17 0.17 No
impulse stimulation, unilateral or
bilateral, with interpretation and
report.
92540..... Basic vestibular evaluation, includes 1.50 1.50 1.50 No
spontaneous nystagmus test with
eccentric gaze fixation nystagmus, with
recording, positional nystagmus test,
minimum of 4 positions, with recording,
optokinetic nystagmus test,
bidirectional foveal and peripheral
stimulation, with recording, and
oscillating tracking test, with
recording.
92541..... Spontaneous nystagmus test, including 0.40 0.40 0.40 No
gaze and fixation nystagmus, with
recording.
92542..... Positional nystagmus test, minimum of 4 0.33 0.48 0.48 No
positions, with recording.
92543..... Caloric vestibular test, each irrigation 0.10 0.35 0.10 No
(binaural, bithermal stimulation
constitutes 4 tests), with recording.
92544..... Optokinetic nystagmus test, 0.26 0.27 0.27 No
bidirectional, foveal or peripheral
stimulation, with recording.
92545..... Oscillating tracking test, with 0.23 0.27 0.27 No
recording.
93260..... Programming device evaluation (in (\1\) 0.85 0.85 No
person) with iterative adjustment of
the implantable device to test the
function of the device and select
optimal permanent programmed values
with analysis, review and report by a
physician or other qualified health
care professional; implantable
subcutaneous lead defibrillator system.
93261..... Interrogation device evaluation (in (\1\) 0.74 0.74 No
person) with analysis, review and
report by a physician or other
qualified health care professional,
includes connection, recording and
disconnection per patient encounter;
implantable subcutaneous lead
defibrillator system.
93282..... Programming device evaluation (in 0.85 0.85 0.85 No
person) with iterative adjustment of
the implantable device to test the
function of the device and select
optimal permanent programmed values
with analysis, review and report by a
physician or other qualified health
care professional; single lead
transvenous implantable defibrillator
system.
93283..... Programming device evaluation (in 1.15 1.15 1.15 No
person) with iterative adjustment of
the implantable device to test the
function of the device and select
optimal permanent programmed values
with analysis, review and report by a
physician or other qualified health
care professional; dual lead
transvenous implantable defibrillator
system.
93284..... Programming device evaluation (in 1.25 1.25 1.25 No
person) with iterative adjustment of
the implantable device to test the
function of the device and select
optimal permanent programmed values
with analysis, review and report by a
physician or other qualified health
care professional; multiple lead
transvenous implantable defibrillator
system.
93287..... Peri-procedural device evaluation (in 0.45 0.45 0.45 No
person) and programming of device
system parameters before or after a
surgery, procedure, or test with
analysis, review and report by a
physician or other qualified health
care professional; single, dual, or
multiple lead implantable defibrillator
system.
93289..... Interrogation device evaluation (in 0.92 0.92 0.92 No
person) with analysis, review and
report by a physician or other
qualified health care professional,
includes connection, recording and
disconnection per patient encounter;
single, dual, or multiple lead
transvenous implantable defibrillator
system, including analysis of heart
rhythm derived data elements.
93312..... Echocardiography, transesophageal, real- 2.20 3.18 2.55 No
time with image documentation (2d)
(with or without m-mode recording);
including probe placement, image
acquisition, interpretation and report.
93313..... Echocardiography, transesophageal, real- 0.95 1.00 0.51 No
time with image documentation (2d)
(with or without m-mode recording);
placement of transesophageal probe only.
93314..... Echocardiography, transesophageal, real- 1.25 2.80 2.10 Yes
time with image documentation (2d)
(with or without m-mode recording);
image acquisition, interpretation and
report only.
93315..... Transesophageal echocardiography for C 3.29 2.94 No
congenital cardiac anomalies; including
probe placement, image acquisition,
interpretation and report.
93316..... Transesophageal echocardiography for 0.95 1.50 0.85 No
congenital cardiac anomalies; placement
of transesophageal probe only.
93317..... Transesophageal echocardiography for C 3.00 2.09 Yes
congenital cardiac anomalies; image
acquisition, interpretation and report
only.
[[Page 67661]]
93318..... Echocardiography, transesophageal (tee) C 2.40 2.40 No
for monitoring purposes, including
probe placement, real time 2-
dimensional image acquisition and
interpretation leading to ongoing
(continuous) assessment of (dynamically
changing) cardiac pumping function and
to therapeutic measures on an immediate
time basis.
93320..... Doppler echocardiography, pulsed wave 0.38 0.38 0.38 No
and/or continuous wave with spectral
display (list separately in addition to
codes for echocardiographic imaging);
complete.
93321..... Doppler echocardiography, pulsed wave 0.15 0.15 0.15 No
and/or continuous wave with spectral
display (list separately in addition to
codes for echocardiographic imaging);
follow-up or limited study (list
separately in addition to codes for
echocardiographic imaging).
93325..... Doppler echocardiography color flow 0.07 0.07 0.07 No
velocity mapping (list separately in
addition to codes for echocardiography).
93355..... Echocardiography, transesophageal (tee) (\1\) 4.66 4.66 No
for guidance of a transcatheter
intracardiac or great vessel(s)
structural intervention(s) (eg, tavr,
transcathether pulmonary valve
replacement, mitral valve repair,
paravalvular regurgitation repair, left
atrial appendage occlusion/closure,
ventricular septal defect closure)
(peri- and intra-procedural), real-time
image acquisition and documentation,
guidance with quantitative
measurements, probe manipulation,
interpretation, and report, including
diagnostic transesophageal
echocardiography and, when performed,
administration of ultrasound contrast,
doppler, color flow, and 3d.
93644..... Electrophysiologic evaluation of (\1\) 3.65 3.29 No
subcutaneous implantable defibrillator
(includes defibrillation threshold
evaluation, induction of arrhythmia,
evaluation of sensing for arrhythmia
termination, and programming or
reprogramming of sensing or therapeutic
parameters).
93880..... Duplex scan of extracranial arteries; 0.60 0.80 0.80 No
complete bilateral study.
93882..... Duplex scan of extracranial arteries; 0.40 0.50 0.50 No
unilateral or limited study.
93886..... Transcranial doppler study of the 0.94 1.00 0.91 No
intracranial arteries; complete study.
93888..... Transcranial doppler study of the 0.62 0.70 0.50 No
intracranial arteries; limited study.
93895..... Quantitative carotid intima media (\1\) 0.55 N No
thickness and carotid atheroma
evaluation, bilateral.
93925..... Duplex scan of lower extremity arteries 0.80 0.80 0.80 No
or arterial bypass grafts; complete
bilateral study.
93926..... Duplex scan of lower extremity arteries 0.50 0.60 0.50 No
or arterial bypass grafts; unilateral
or limited study.
93930..... Duplex scan of upper extremity arteries 0.46 0.80 0.80 No
or arterial bypass grafts; complete
bilateral study.
93931..... Duplex scan of upper extremity arteries 0.31 0.50 0.50 No
or arterial bypass grafts; unilateral
or limited study.
93970..... Duplex scan of extremity veins including 0.70 0.70 0.70 No
responses to compression and other
maneuvers; complete bilateral study.
93971..... Duplex scan of extremity veins including 0.45 0.45 0.45 No
responses to compression and other
maneuvers; unilateral or limited study.
93975..... Duplex scan of arterial inflow and 1.80 1.30 1.16 No
venous outflow of abdominal, pelvic,
scrotal contents and/or retroperitoneal
organs; complete study.
93976..... Duplex scan of arterial inflow and 1.21 1.00 0.80 No
venous outflow of abdominal, pelvic,
scrotal contents and/or retroperitoneal
organs; limited study.
93978..... Duplex scan of aorta, inferior vena 0.65 0.97 0.80 No
cava, iliac vasculature, or bypass
grafts; complete study.
93979..... Duplex scan of aorta, inferior vena 0.44 0.70 0.50 No
cava, iliac vasculature, or bypass
grafts; unilateral or limited study.
93990..... Duplex scan of hemodialysis access 0.25 0.60 0.50 No
(including arterial inflow, body of
access and venous outflow).
95971..... Electronic analysis of implanted 0.78 0.78 0.78 No
neurostimulator pulse generator system
(eg, rate, pulse amplitude, pulse
duration, configuration of wave form,
battery status, electrode
selectability, output modulation,
cycling, impedance and patient
compliance measurements); simple spinal
cord, or peripheral (ie, peripheral
nerve, sacral nerve, neuromuscular)
neurostimulator pulse generator/
transmitter, with intraoperative or
subsequent programming.
[[Page 67662]]
95972..... Electronic analysis of implanted 1.50 0.90 0.80 No
neurostimulator pulse generator system
(eg, rate, pulse amplitude, pulse
duration, configuration of wave form,
battery status, electrode
selectability, output modulation,
cycling, impedance and patient
compliance measurements); complex
spinal cord, or peripheral (ie,
peripheral nerve, sacral nerve,
neuromuscular) (except cranial nerve)
neurostimulator pulse generator/
transmitter, with intraoperative or
subsequent programming, up to 1 hour.
95973..... Electronic analysis of implanted 0.92 NA 0.49 No
neurostimulator pulse generator system
(eg, rate, pulse amplitude, pulse
duration, configuration of wave form,
battery status, electrode
selectability, output modulation,
cycling, impedance and patient
compliance measurements); complex
spinal cord, or peripheral (ie,
peripheral nerve, sacral nerve,
neuromuscular) (except cranial nerve)
neurostimulator pulse generator/
transmitter, with intraoperative or
subsequent programming, each additional
30 minutes after first hour (list
separately in addition to code for
primary procedure).
97605..... Negative pressure wound therapy (eg, 0.55 0.55 0.55 No
vacuum assisted drainage collection),
utilizing durable medical equipment
(dme), including topical
application(s), wound assessment, and
instruction(s) for ongoing care, per
session; total wound(s) surface area
less than or equal to 50 square
centimeters.
97606..... Negative pressure wound therapy (eg, 0.60 0.60 0.60 No
vacuum assisted drainage collection),
utilizing durable medical equipment
(dme), including topical
application(s), wound assessment, and
instruction(s) for ongoing care, per
session; total wound(s) surface area
greater than 50 square centimeters.
97607..... Negative pressure wound therapy, (eg, (\1\) 0.41 C ................
vacuum assisted drainage collection),
utilizing disposable, non-durable
medical equipment including provision
of exudate management collection
system, topical application(s), wound
assessment, and instructions for
ongoing care, per session; total
wound(s) surface area less than or
equal to 50 square centimeters.
97608..... Negative pressure wound therapy, (eg, (\1\) 0.46 C Yes
vacuum assisted drainage collection),
utilizing disposable, non-durable
medical equipment including provision
of exudate management collection
system, topical application(s), wound
assessment, and instructions for
ongoing care, per session; total
wound(s) surface area greater than 50
square centimeters.
97610..... Low frequency, non-contact, non-thermal C 0.35 0.35 No
ultrasound, including topical
application(s), when performed, wound
assessment, and instruction(s) for
ongoing care, per day.
99183..... Physician or other qualified health care 2.34 2.11 2.11 No
professional attendance and supervision
of hyperbaric oxygen therapy, per
session.
99184..... Initiation of selective head or total (\1\) 4.50 4.50 No
body hypothermia in the critically ill
neonate, includes appropriate patient
selection by review of clinical,
imaging and laboratory data,
confirmation of esophageal temperature
probe location, evaluation of amplitude
eeg, supervision of controlled
hypothermia, and assessment of patient
tolerance of cooling.
99188..... Application of topical fluoride varnish (\1\) 0.20 N N/A
by a physician or other qualified
health care professional.
99487..... Complex chronic care management 1.00 1.00 B N/A
services, with the following required
elements: multiple (two or more)
chronic conditions expected to last at
least 12 months, or until the death of
the patient; chronic conditions place
the patient at significant risk of
death, acute exacerbation/
decompensation, or functional decline;
establishment or substantial revision
of a comprehensive care plan; moderate
or high complexity medical decision
making; 60 minutes of clinical staff
time directed by a physician or other
qualified health care professional, per
calendar month.
99497..... Advance care planning including the (\1\) 1.50 I N/A
explanation and discussion of advance
directives such as standard forms (with
completion of such forms, when
performed), by the physician or other
qualified health care professional;
first 30 minutes, face-to-face with the
patient, family member(s), and/or
surrogate.
[[Page 67663]]
99498..... Advance care planning including the (\1\) 1.40 I N/A
explanation and discussion of advance
directives such as standard forms (with
completion of such forms, when
performed), by the physician or other
qualified health care professional;
each additional 30 minutes (list
separately in addition to code for
primary procedure).
G0279..... Diagnostic digital breast tomosynthesis, (\1\) N/A 0.60 N/A
unilateral or bilateral (list
separately in addition to G0204 or
G0206).
----------------------------------------------------------------------------------------------------------------
\1\ New.
i. Code Specific Issues
(1) Internal Fixation of Rib Fracture (CPT Codes 21811, 21812 and
21813)
For CY 2015, the CPT Editorial Panel deleted CPT code 21810
(Treatment of rib fracture requiring external fixation (flail chest))
and replaced it with three CPT codes 21811, 21812 and 21813, to report
internal fixation of rib fracture. The RUC recommended valuing these
three codes as 90-day global services. For the reasons we articulate in
section II.B.4 of this final rule with comment period about the
difficulties in accurately valuing codes as 90-day global services, we
believe that the valuation of these codes should be as 0-day global
services. In addition, we believe this is particularly appropriate for
these codes because the number of RUC-recommended inpatient and
outpatient visits included in the postservice time seems higher than
would likely occur. The vignette for CPT code 21811 describes an
elderly patient who falls and experiences three rib fractures that
require internal fixation. The seven visits included in the postservice
time for this code seem high since the vignette does not describe a
very ill patient. The vignettes for CPT codes 21812 and 21813 describe
patients experiencing significant rib fractures in car accidents that
require internal fixation. We believe that in these scenarios, injuries
beyond rib fractures are likely, and as a result, we believe it is
likely that multiple practitioners would be involved in providing post-
operative care. If other practitioners would furnish care in the post-
surgery period, we believe the ten and thirteen postservice visits
included in CPT codes 21812 and 21813 would likely not occur. By
valuing these codes as 0-day globals, we do not need to address these
issues because the surgeon will be able to bill separately for the
postoperative services that are furnished after the day of the
procedure.
To value these services as 0-day global codes, we subtracted the
work RVUs related to the postoperative services from the total work
RVU. We are establishing CY 2015 interim work RVUs of 10.79 for CPT
code 21811, of 13.00 for CPT code 21812, and of 17.61 for CPT code
21813. We also refined the RUC recommended time by subtracting the time
associated with the postoperative visits. By removing the work and time
associated with visits in the postoperative period, the remaining work
and time reflect the work and time of services furnished on the day of
surgery.
(2) Percutaneous Vertebroplasty and Augmentation (CPT Codes 22510,
22511, 22512, 22513, 22514 and 22515)
For CY 2015, the CPT Editorial Panel replaced the eight existing
percutaneous vertebroplasty with six new codes, CPT codes 22510-22515,
which include the percutaneous vertebroplasty and the image guidance
together. We are establishing the RUC-recommended work values as
interim final for CY 2015 for all of the codes in this family except
CPT code 22511.
Unlike other codes in this family for which the RUC-recommended
work RVU was based on the 25th percentile in the survey, the RUC
established its recommended work value for CPT code 22511 by
crosswalking this service to CPT code 39400 (Mediastinoscopy, includes
biopsy(ies), when performed), which has a work RVU of 8.05. Because the
level of work performed by a physician in the two services differs, we
do not agree that this crosswalk is appropriate. Instead, we believe a
more appropriate analogy is found in the difference between the work
values for the predecessor codes for CPT codes 22510 and 22511, CPT
codes 22520 (Percutaneous vertebroplasty (bone biopsy included when
performed), 1 vertebral body, unilateral or bilateral injection;
thoracic) and 22521 (Percutaneous vertebroplasty (bone biopsy included
when performed), 1 vertebral body, unilateral or bilateral injection;
thoracic; lumbar). Accordingly, we are applying the difference in the
current work RVUs for CPT codes 22520 and 22521 to the work RVU that we
are establishing for CPT code 22510. We believe this increment
establishes the appropriate rank order in this family and thus are
assigning an interim final work RVU of 7.58 for CPT code 22511, which
is 0.57 work RVUs lower than the CY 2015 work RVU for CPT code 22510.
(3) Endobronchial Ultrasound (EBUS) (CPT Code 31620)
For CY 2015, the RUC reviewed CPT code 31620 because it was
identified through the High Volume Growth Services, which are those
services for which Medicare utilization increased by at least 100
percent from 2006 to 2011. CPT code 31620 is an add-on code to CPT code
31629 (Bronchoscopy, rigid or flexible, including fluoroscopic
guidance, when performed; with transbronchial needle aspiration
biopsy(s), trachea, main stem and/or lobar bronchus(i)).
Medicare data show that 82 percent of the time when EBUS is billed
it is billed with CPT code 31629. Given this relationship, we believe
that CPT code 31620 should be bundled with CPT code 31629. The
specialty societies maintain that EBUS is distinct from bronchoscopy
with biopsy because the intraservice work of EBUS occurs between the
two components of the base code, bronchoscopy and biopsy. However,
based upon the discussion at the RUC meeting, we believe that the
biopsy actually occurs during the EBUS and the biopsy is actually
performed through the EBUS scope. Thus, we do not believe the EBUS code
descriptor accurately describes the service nor is it possible to
accurately value this service when the descriptor is inaccurate.
Therefore, for CY 2015 we are maintaining the CY 2014 work RVU for
[[Page 67664]]
CPT code 31620. We understand that the RUC will review this code for CY
2016.
(4) Extracorporeal Membrane Oxygenation (ECMO)/Extracorporeal Life
Support (ECLS) (CPT Codes 33946, 33947, 33948, 33949, 33951-33959,
33962-33966, 33969, 33984-33989)
In the CY 2014 PFS final rule with comment period, CPT codes 33960
(Prolonged extracorporeal circulation for cardiopulmonary
insufficiency; initial day) and 33961 (Prolonged extracorporeal
circulation for cardiopulmonary insufficiency; each subsequent day)
were identified as potentially misvalued codes. Specifically, the
services were originally valued when they were primarily provided to
premature neonates; but the services are now typically used in treating
adults with severe influenza, pneumonia, and respiratory distress
syndrome. For CY 2015, CPT codes 33960 and 33961 were deleted and
replaced with 25 new codes to describe this treatment. We are assigning
the RUC-recommended work values as interim final for CY 2015 for all of
the codes in this family except CPT codes 33952, 33953, 33954, 33957,
33958 and 33959, 33962, 33969, and 33984.
We accepted the RUC-recommended work RVU of 8.15 for CPT code
33951, which describes an ECMO peripheral cannula(e) insertion for
individuals up to 5 years of age. The RUC recommended a work RVU of
8.43 for CPT code 33952, which describes the same procedure for
individuals 6 years and older. We do not believe this difference in the
age of the patient increases the work of the service from the younger
patient. The fact that the RUC-recommended intraservice time is
identical for both codes supports our view that the work RVU should be
the same for both codes. Therefore, for CY 2015, we are establishing an
interim final work RVUs of 8.15 for CPT code 33952, the same as we
established for CPT 33951 based upon the RUC-recommendation for the
younger patient.
The RUC recommended work RVUs of 9.83 and 9.43 for CPT codes 33953
and 33954, respectively. For the same reasons discussed above, we are
establishing the same work values for the code for treatment of
patients from birth through 5 years of age and the code for treatment
of patients 6 years and older. To determine the value for these codes,
we adjusted the work RVU of the equivalent percutaneous codes, CPT code
33951 (Extracorporeal membrane oxygenation (ECMO)/extracorporeal life
support (ECLS) provided by physician; insertion of peripheral (arterial
and/or venous) cannula(e), percutaneous, birth through 5 years of age
(includes fluoroscopic guidance, when performed)) and CPT code 33952
(Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support
(ECLS) provided by physician; insertion of peripheral (arterial and/or
venous) cannula(e), percutaneous, 6 years and older (includes
fluoroscopic guidance, when performed)), to reflect the greater work of
the open procedure codes, CPT codes 33953 (Extracorporeal membrane
oxygenation (ECMO)/extracorporeal life support (ECLS) provided by
physician; insertion of peripheral (arterial and/or venous) cannula(e),
open birth, through 5 years of age) and 33954 (Extracorporeal membrane
oxygenation (ECMO)/extracorporeal life support (ECLS) provided by
physician; insertion of peripheral (arterial and/or venous) cannula(e),
open, 6 years and older). To measure the difference in work between
these two sets of codes we applied the 0.96 RVU differential between
the percutaneous arterial CPT code 33620 (Application of right and left
pulmonary artery bands (for example, hybrid approach stage 1)) and the
open arterial CPT code 36625 (Arterial catheterization or cannulation
for sampling, monitoring or transfusion (separate procedure); cutdown)
codes. This measure allows us to establish the difference in work
between the sets of codes based upon the difference in intensity.
Accordingly, we are assigning an interim final work RVU to CPT codes
33953 and 33954 of 9.11.
Unlike other codes in this family for which the RUC-recommended
work value was based upon the 25th percentile of the survey, for CPT
codes 33957 and 33958 the RUC recommended a work RVU of 4.00 and 4.05,
respectively, based upon the survey median. We believe that, like other
services in this family, these codes should be valued based upon the
25th percentile values of the survey because those values best describe
the work involved in these procedures and results in the appropriate
relativity amongst the codes in the family. Therefore, for CY 2015 we
are assigning an interim final work RVU of 3.51 for CPT codes 33957 and
33958.
We believe the RUC-recommended work RVUs of 4.69 and 4.73 for CPT
codes 33959 and 33962 respectively, overstate the work involved in the
services. As we discussed above for CPT codes 33953 and 33954, we
believe the differential between the percutaneous arterial and open
arterial CPT codes more appropriately reflects the work involved in
these services. Accordingly we are establishing a CY 2015 interim final
work RVU of 4.47 for CPT codes 33959 and 33962.
After researching comparable codes, we believe the RUC-recommended
work RVUs of 6.00 and 6.38 for CPT codes 33969 and 33984, respectively,
overstates the work involved in the procedures. For the same reasons
and following the same valuation methodology utilized above, we added
the differential between the percutaneous arterial and arterial cutdown
codes, 0.96 RVU, to the CY 2015 interim final work RVU of 4.50 for CPT
code 33966, which is the percutaneous counterpart of CPT code 33984.
This results in a work RVU of 5.46 for CPT code 33984. Because CPT code
33969 has 2 minutes less intraservice time than CPT code 33984
(Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support
(ECLS) provided by physician; removal of peripheral (arterial and/or
venous) cannula(e), open, 6 years and older), we adjusted the work RVU
of CPT code 33984 for the decrease in time to get a work RVU of 5.22
for CPT code 33969 (Extracorporeal membrane oxygenation (ECMO)/
extracorporeal life support (ECLS) provided by physician; removal of
peripheral (arterial and/or venous) cannula(e), open, birth through 5
years of age). Therefore, for CY 2015 we are establishing an interim
final work RVU of 5.46 to CPT code 33984 and 5.22 to CPT code 33969.
(5) Fenestrated Endovascular Repair (FEVAR) Endograft Planning (CPT
Code 34839)
For CY 2015, CPT code 34839 was created to report the planning that
occurs prior to the work included in the global period for a FEVAR. The
RUC recommended that we contractor price this service as the RUC survey
response rate was too low to provide the basis for an appropriate
valuation. In general, we prefer that planning be bundled with the
underlying service, and we have no reason to believe bundling is not
appropriate in this case. Accordingly, we are assigning a PFS procedure
status indicator of B (Bundled Code) to CPT code 34839.
(6) AV Anastomosis (CPT Codes 36818, 36819, 36820, 36821, 36825, 36830,
36831, 36832, and 36833)
In the CY 2013 PFS final rule with comment period, the AV
anastomosis family of services were determined to be potentially
misvalued due to rank order anomalies, including CPT codes 36818-36821
and CPT codes 36825-36830. The RUC recommendations that we received
[[Page 67665]]
in response also included CPT codes 36831-36833. We are assigning the
RUC-recommended work RVUs as CY 2015 interim final values for CPT codes
36821, 36831, 36832 and 36833. For CPT code 36831, 36832, and 36833, we
are refining to remove the additional 10 minutes of preservice
evaluation time. The RUC added 10 minutes of additional pre-service
time to these codes for determining the best source of access. These
three codes are revision/repair codes and as such do not need the
additional time to determine the access source. For CPT code 36818, the
RUC recommended an approximately 12 percent increase in work RVU but a
total time increase of approximately 4.2 percent. We are assigning a CY
2015 interim final work RVU of 12.39, which reflects a 4.2 percent
increase from the current value based upon the increase in total time.
For CPT code 36819, the RUC-recommended intraservice and total
times are only minimally different than the current times. Even though
the intraservice and total times decreased minimally, the RUC increased
the work RVU. We believe that the small decrease in total time, 2
percent, suggest that the current work RUV is appropriate. Therefore,
we are assigning a CY 2015 interim final work RVU of 13.29, which is
the current work value.
The RUC recommended a work value of 13.99 for CPT code 36820. The
RUC recommended that the postservice time of CPT code 36820 be reduced
by removing visits. Specifically, a CPT code 99231 and one-half of a
CPT code 99238 were removed from the service, which would equal 1.40
RVU. We do not believe that this reduction was accounted for in the
RUC-recommended work RVU. To account for this reduction in visits, we
are establishing a CY 2015 interim final work RVU of 13.07 for CPT
36820 which reflects a 1.40 work RVU reduction in the current work RVU.
For CPT code 36825, the RUC-recommended intraservice and total
times are only minimally different than the current times. However, the
RUC increased the work RVU. We do not believe the work RVU should be
increased without corresponding time changes. Therefore, we believe the
appropriate CY 2015 interim final work RVU is the current work value of
14.17. For CPT code 36830, the RUC-recommended intraservice and total
times are only minimally different than the current times. However, the
RUC decreased the work RVU. We do not believe the work RVU should be
decreased without corresponding time changes. Therefore, we are
establishing a CY 2015 interim final work RVU of 12.03, which is equal
to the current work RVU.
Furthermore, we refined the total time values as follows: 238
minutes for CPT code 36831, 266 minutes for CPT code 36832, and 296
minutes for CPT code 36833.
(7) Illeoscopy, Pouchoscopy, Colonoscopy through Stoma, Flexible
Sigmoidoscopy and Colonoscopy (CPT Codes 44380, 44381, 44382, 44383,
44384, 44385, 44386, 44388, 44389, 44390, 44391, 44392, 44393, 44394,
44397, 44401, 44402, 44403, 44404, 44405, 44406, 44407, 44408, 44799,
45330, 45331, 45332, 45333, 45334, 45335, 45337, 45338, 45346, 45340,
45341, 45342, 45345, 45347, 45349, 45350, 45378, 45379, 45380, 45381,
45382, 45383, 45388, 45384, 45385, 45386, 45387, 45389, 45390, 45391,
45392, 45393, 45398, 45399, 0226T, 46601, 0227T, and 46607 and HCPCS
Codes G6018, G6019, G6020, G6021, G6022, G6023, G6024, G6025, G6027,
G6028)
CPT revised the lower gastrointestinal endoscopy code set for CY
2015 following identification of some of the codes as potentially
misvalued and the affected specialty society's contention that this
code set did not allow for accurate reporting of services based upon
the current practice. The RUC subsequently provided recommendations to
CMS for valuing these services. In comments on the proposed rule,
stakeholders noted our proposal to begin including proposed values for
new, revised and potentially misvalued codes in the proposed rule.
Commenters suggested that, rather than implementing this new process in
CY 2016, we should implement it immediately and thus defer the
valuation of the new GI code set until CY 2016. They indicated that the
opportunity to comment prior to implementation of the new values was
important for these codes, many of which have high utilization. In
addition, in this final rule with comment period we discuss the need to
modify how moderate sedation is reported and valued. Since the
valuation of most codes in this code set includes moderate sedation,
stakeholders suggested that we revalue these codes in conjunction with
any changes in reporting and valuation of moderate sedation.
We agree with the commenters. In light of the substantial nature of
this code revision and its relationship to the policies on moderate
sedation, we are delaying revaluation of these codes until CY 2016 when
we will be able to include proposals in the proposed rule for their
valuation, along with consideration of policies for moderate sedation.
Accordingly for CY 2015, we are maintaining the inputs for the lower
gastrointestinal endoscopy codes at the CY 2014 levels. (Note: Due to
budget neutrality adjustments and other system-wide changes, the
payment rates may change.) Since the code set is changing for CY 2015,
including the deletion of some of the CY 2014 codes, we are creating G-
codes as necessary to allow practitioners to report services to CMS in
the same way in CY 2015 that they did in CY 2014 and to maintain
payment under the PFS based on the same inputs. All payment policies
applicable to the CY 2014 CPT codes will apply to the replacement G-
codes. The new and revised CY 2015 CPT codes for lower gastrointestinal
endoscopy that will not be recognized by Medicare for CY 2015 are
denoted with an ``I'' (Not valid for Medicare purposes) in Table 26.
The chart below lists the G-codes that we are creating and the CY 2014
CPT codes that they are replacing.
Table 26--Lower Gastrointestinal Endoscopy G-Codes Replacing CY 2015 CPT Codes
----------------------------------------------------------------------------------------------------------------
CY 2014 CPT code \1\ CY 2015 HCPCS code Long descriptor
----------------------------------------------------------------------------------------------------------------
44383................... G6018................... Ileoscopy, through stoma; with transendoscopic stent
placement (includes predilation).
44393................... G6019................... Colonoscopy through stoma; with ablation of tumor(s),
polp(s), or other lesion(s) not amenable to removal by hot
biopsy forceps, bipolar cautery or snare technique.
44397................... G6020................... Colonoscopy through stoma; with transendoscopic stent
placement (includes predilation).
44799................... G6021................... Unlisted procedure, intestine.
45339................... G6022................... Sigmoidoscopy, flexible; with ablation of tumor(s),
polyp(s), or other lesions(s)not amenable to removal by hot
biopsy forceps, bipolar cautery or snare technique.
[[Page 67666]]
45345................... G6023................... Sigmoidoscopy, flexible; with transenoscopic stent placement
(includes predilation).
45383................... G6024................... Colonoscopy, flexible, proximal to splenic flexure; with
ablation of tumor(s), polyp(s), or other lesion(s) not
amenable to removal by hot biopsy forceps, bipolar cautery
or snare technique.
45387................... G6025................... Colonoscopy, flexible, proximal to splenic flexure; with
transendoscopic stent placement (includes predilation).
0226T................... G6027................... Anoscopy, high resolution (HRA) (with magnification and
chemical agent enhancement); diagnostic, including
collection of specimen(s) by brushing or washing when
performed.
0227T................... G6028................... Anoscopy, high resolution (HRA) (with magnification and
chemical agent enhancement); with biopsy(ies).
----------------------------------------------------------------------------------------------------------------
\1\ This chart only contains CY 2014 codes for which a HCPCS code is being used for CY 2015. Addendum B contains
a complete list of CPT and HCPCS codes being recognized by Medicare under the PFS for CY 20115.
(8) Prostatectomy (CPT Codes 55842 and 55845)
In the CY 2014 PFS final rule with comment period, we finalized CPT
codes 55842 and 55845 as potentially misvalued codes. For CY 2015, the
RUC provided recommendations for these services of 29.07 and 24.16,
respectively. We disagreed with the RUC-recommended crosswalk for CPT
code 55842. To value CPT code 55842, we are crosswalking it to CPT code
55840 (Prostatectomy, retropubic radical, with or without nerve
sparing) due to their identical times. Therefore, we are establishing
an interim final work RVU of 21.36.
For CPT code 55845, we are establishing a work RVU of 25.18 based
upon the 25th percentile of the survey. This work RVU results in an 18
percent decrease from the current work RVU, which we believe reflects
the changes since the last valuation, based upon a 20 percent decrease
in intraservice time and the 29 percent decrease in total time.
(9) Aqueous Shunt (CPT Code 66179, 66180, 66184, 66185, and 67255)
After identifying CPT code 66180 through the Harvard-Valued Annual
Allowed Charges Greater than $10 million screen, the RUC recommended
work RVUs for the aqueous shunt family for CY 2015. We are establishing
the RUC-recommended work RVUs as interim final for all codes in this
family except CPT code 67255. The RUC recommended maintaining the CY
2014 work RVU of 10.17 for CPT 67255. However, we believe maintaining
this value would be inconsistent with the RUC-recommended decreases in
total time for the service. As a result, we reduced the work RVU by the
same percentage that the RUC recommended a reduction in total time,
which results in a CY 2015 interim final work RVU of 8.38 for CPT code
67255.
(10) Computed Tomography (CT)--Maxillofacial (CPT Codes 70486, 70487
and 70488)
The RUC's Relativity Assessment Workgroup identified CPT code 70486
for review through the CMS/Other Source--Utilization over 250,000
screen. The involved specialty societies expanded the survey to include
CPT codes 70487 and 70488, all of which involve maxillofacial CTs. We
are establishing the RUC-recommended work RVU of 0.85 as the CY 2015
interim final value for CPT code 70486, which is without contrast
material. The RUC established this recommendation by crosswalking this
code to the equivalent code in the CT for the head or brain, CPT code
70450 (Computed tomography, head or brain without contrast). We agree
with that method and in order to maintain rank order within and across
CT families, we crosswalked CPT code 70487, which is with contrast
material(s), to the CPT code 70460, which is the equivalent code in the
head or brain family and CPT code 70488, which is without contrast
materials followed by contrast material(s) and further sections to CPT
code 70470, which is the equivalent code in the head or brain family.
Therefore, for CY 2015 we are establishing interim final work RVUs of
1.13 for CPT code 70487 and 1.27 for CPT code 70488.
(11) Breast Ultrasound (CPT Codes 76641 and 76642)
For CY 2015, the CPT Editorial Panel replaced CPT code 76645
(Ultrasound, breast(s) (unilateral or bilateral), real time with image
documentation) with two codes, CPT codes 76641 (Ultrasound, breast,
unilateral, real time with image documentation, including axilla when
performed; complete) and 76642 (Ultrasound, breast, unilateral, real
time with image documentation, including axilla when performed;
limited). The difference between the new codes is that one is for
complete breast ultrasound procedures and the other is for limited. We
are assigning the RUC-recommended work RVUs of 0.73 and 0.68 to CPT
codes 76641 and 76642, respectively, as interim final. One difference
between the predecessor code and the new ones is that while the
predecessor code was used to report unilateral or bilateral breast
ultrasounds, the new codes are unilateral ones. To appropriately adjust
payment when bilateral procedures are furnished under the PFS, payments
are adjusted to 150 percent of the unilateral payment when a service
has a bilateral payment indicator assigned. We are assigning a
bilateral payment indicator to these codes.
(12) Radiation Therapy Codes (CPT Codes 76950, 77014, 77421, 77387,
77401, 77402, 77403, 77404, 77406, 77407, 77408, 77409, 77411, 77412,
77413, 77414, 77416, 77418, 77385, 77386, 0073T, and 0197T and HCPCS
Codes G6001, G6002, G6003, G6004, G6005, G6006, G6007, G6008, G6009,
G6010, G6011, G6012, G6013, G6014, G6015, G6016 and G6017)
CPT revised the radiation therapy code set for CY 2015 following
identification of some of the codes as potentially misvalued and the
affected specialty society's contention that the provision of radiation
therapy could not be accurately reported under the existing code set.
The RUC subsequently provided recommendations to CMS for valuing these
services. Some stakeholders approached CMS with concerns about these
codes being revalued as interim final in the final rule with comment
period, noting that these codes account for the vast majority of
Medicare payment for radiation therapy centers. They noted our proposal
to begin including proposals to value new, revised and potentially
misvalued codes in the proposed rule, and suggested that these code
valuations should be delayed to CY 2016 so that they could be addressed
under this new process. This would provide affected
[[Page 67667]]
stakeholders the opportunity to comment prior to the valuations being
effective. They also noted that since they do not participate in the
RUC, they did not have the opportunity to provide input to the
recommendations nor will they have information about the RUC
recommendations until CMS makes this information available in the final
rule with comment period.
In response to comments and in light of the substantial nature of
this code revision, we are delaying revaluation of these codes until CY
2016. The coding changes for CY 2015 involve significant changes in how
radiation therapy services and associated image guidance are reported.
There is substantial work to be done to assure the new valuations for
these codes accurately reflect the coding changes. Accordingly we are
delaying the use of the revised radiation therapy code set until CY
2016 when we will be able to include proposals in the proposed rule for
their valuation. We are maintaining the inputs for radiation therapy
codes at the CY 2014 levels. (Note: Due to budget neutrality
adjustments and other system-wide changes, the payment rates may
change.) Since the code set has changed and some of the CY 2014 codes
are being deleted, we are creating G-codes as necessary to allow
practitioners to continue to report services to CMS in CY 2015 as they
did in CY 2014 and for payments to be made in the same way. All payment
policies applicable to the CY 2014 CPT codes will apply to the
replacement G-codes. The new and revised CY 2015 CPT codes that will
not be recognized by Medicare for CY 2015 are denoted with an ``I''
(Not valid for Medicare purposes) on Table 27. The chart below lists
the G-codes that we are creating and the CY 2014 CPT codes that they
are replacing.
Additionally, we would like to note that changes to the prefatory
text modify the services that are appropriately billed with CPT code
77401, which is used to report superficial radiation therapy. This
change effectively means that CPT code 77401 is now bundled with many
other procedures supporting superficial radiation therapy. However, the
RUC did not review superficial radiation therapy procedures, and
therefore, did not assess whether changes in its valuation were
appropriate in light of this bundling. Stakeholders have suggested to
us that the change to the prefatory text prohibits them from billing
for codes that were previously frequently billed in addition to this
code and as a result there will be a significant reduction in their
payments.'' We are interested in information on whether the new code
set combined with modifications in prefatory text allows for
appropriate reporting of the services associated with superficial
radiation and whether the payment continues to reflect the relative
resources required to furnish superficial radiation therapy services.
Table 27--Radiation Therapy G-Codes Replacing CY 2015 CPT Codes
----------------------------------------------------------------------------------------------------------------
CY 2014 CPT code \2\ CY 2015 HCPCS code Long descriptor
----------------------------------------------------------------------------------------------------------------
76950................... G6001................... Ultrasonic guidance for placement of radiation therapy
fields.
77421................... G6002................... Stereoscopic X-ray guidance for localization of target
volume for the delivery of radiation therapy.
77402................... G6003................... Radiation treatment delivery, single treatment area, single
port or parallel opposed ports, simple blocks or no blocks:
up to 5MeV.
77403................... G6004................... Radiation treatment delivery, single treatment area, single
port or parallel opposed ports, simple blocks or no blocks:
6-10MeV.
77404................... G6005................... Radiation treatment delivery, single treatment area, single
port or parallel opposed ports, simple blocks or no blocks:
11-19MeV.
77406................... G6006................... Radiation treatment delivery, single treatment area, single
port or parallel opposed ports, simple blocks or no blocks:
20 MeV or greater.
77407................... G6007................... Radiation treatment delivery, 2 separate treatment areas, 3
or more ports on a single treatment area, use of multiple
blocks; up to 5MeV.
77408................... G6008................... Radiation treatment delivery, 2 separate treatment areas, 3
or more ports on a single treatment area, use of multiple
blocks; 6-10MeV.
77409................... G6009................... Radiation treatment delivery, 2 separate treatment areas, 3
or more ports on a single treatment area, use of multiple
blocks; 11-19MeV.
77411................... G6010................... Radiation treatment delivery, 2 separate treatment areas, 3
or more ports on a single treatment area, use of multiple
blocks; 20 MeV or greater.
77412................... G6011................... Radiation treatment delivery, 3 or more separate treatment
areas, custom blocking, tangential ports, wedges,
rotational beam, compensators, electron beam; up to 5MeV.
77413................... G6012................... Radiation treatment delivery, 3 or more separate treatment
areas, custom blocking, tangential ports, wedges,
rotational beam, compensators, electron beam; 6-10MeV.
77414................... G6013................... Radiation treatment delivery, 3 or more separate treatment
areas, custom blocking, tangential ports, wedges,
rotational beam, compensators, electron beam; 11-19MeV.
77416................... G6014................... Radiation treatment delivery, 3 or more separate treatment
areas, custom blocking, tangential ports, wedges,
rotational beam, compensators, electron beam; 20MeV or
greater.
77418................... G6015................... Intensity modulated treatment delivery, single or multiple
fields/arcs, via narrow spatially and temporally modulated
beams, binary, dynamic MLC, per treatment session.
0073T................... G6016................... Compensator-based beam modulation treatment delivery of
inverse planned treatment using 3 or more high resolution
(milled or cast) compensator, convergent beam modulated
fields, per treatment session.
0197T................... G6017................... Intra-fraction localization and tracking of target or
patient motion during delivery of radiation therapy (eg, 3D
positional tracking, gating, 3D surface tracking), each
fraction of treatment.
----------------------------------------------------------------------------------------------------------------
[[Page 67668]]
(13) Breast Tomosynthesis (CPT codes 77061, 77062, and 77063)
For CY 2015, the CPT Editorial Panel created three codes to
describe digital breast tomosynthesis services: 77061 (Digital breast
tomosynthesis; unilateral), 77062 (Digital breast tomosynthesis;
bilateral) and 77063 (Screening digital breast tomosynthesis, bilateral
(List separately in addition to code for primary procedure) and we
received RUC recommendations for these codes. Currently, these services
are reported to Medicare using G0202, G0204, and G0206, which describe
the equivalent procedures using any digital technology (2-D or 3-D). In
addition, film mammography is reported to Medicare using CPT codes
77055, 77056 and 77057).
---------------------------------------------------------------------------
\2\ This chart only contains CY 2014 codes for which a HCPCS
code is being used for CY 2015. Addendum B contains a complete list
of CPT and HCPCS codes being recognized by Medicare under the PFS
for CY 2015.
---------------------------------------------------------------------------
In the proposed rule, based upon our belief that digital
mammography is now typical, we proposed to replace the G-codes that
currently describe all digital mammography services under Medicare with
the CPT codes, to value the CPT codes for CY 2015 based upon the
current G-code values, and to include the CPT codes on the potentially
misvalued code list since the resources involved in furnishing these
services had not been evaluated in more than a decade. Having
reassessed the proposal in light of the new codes and RUC
recommendations for tomosynthesis and the comments received upon our
proposal, we are finalizing a modified proposal. For a discussion of
our proposal, a summary of the comments we received, and our policy for
CY 2015, see section II.B.4.
With regard to screening mammography, the CPT coding system now has
an add-on CPT code for tomosynthesis. This coding scheme is consistent
with the FDA requiring a 2-D mammography when tomosynthesis is used for
screening purposes. Accordingly, we will recognize CPT code 77063 to be
reported, when tomosynthesis is used in addition to 2-D mammography.
Since CPT code 77063 is an add-on code, and does not have an equivalent
CY 2014 code, we believe it is appropriate to value it on an interim
final basis in advance of receiving the RUC recommendations for other
mammography services. We are assigning it a CY 2015 interim final work
RVU of 0.60 as recommended by the RUC.
Whenever feasible, it is our strong preference to value entire
families together in order to avoid rank order anomalies. In this final
rule with comment period, we are including the codes for digital
mammography on the potentially misvalued code list, which currently
includes tomosynthesis as well as 2-D mammography. Accordingly, we will
wait to value the new diagnostic mammography tomosynthesis codes until
we have received recommendations from the RUC for all mammography
services. In the interim, we are assigning a PFS indicator of ``I'' to
77061 and 77062. Those furnishing diagnostic mammography using
tomosynthesis will continue to report G0204 and G0206 as appropriate.
In addition, we are creating a new code, G-2079 (Diagnostic digital
breast tomosynthesis, unilateral or bilateral (List separately in
addition to G0204 or G0206)) as an add-on code that should be reported
in addition to the relevant 2-D diagnostic mammography G-code to
recognize the additional resources involved in furnishing diagnostic
breast tomosynthesis. We will assign it the same inputs as CPT code
77063 because we believe it describes a similar service.
(14) Isodose Calculation with Isodose Planning Bundle (CPT Code 77316)
For CY 2015, the CPT Editorial Panel replaced six CPT codes (77305,
77310, 77315, 77326, 77327, and 77328) with five new CPT codes to
bundle basic dosimetry calculation(s) with teletherapy and
brachytherapy isodose planning. We are establishing the RUC-recommended
work RVUs for CY 2015 for all of the codes in this family except CPT
code 77316. We disagree with the RUC-recommended crosswalk for this
service because we do not believe it is an appropriate match in work.
The RUC crosswalked CPT code 77318 to CPT code 77307, both of which are
complex isodose planning codes in the same family. We believe that the
RUC should have crosswalked CPT code 77316, a simple isodose planning
code, to the corresponding simple isodose planning code in the same
family, CPT code 77306. Therefore, for CY 2015 we are establishing an
interim final work RVU of 1.40 for CPT code 77316.
(15) Immunohistochemistry (CPT codes 88341, 88342, and 88344; HCPCS
codes G0461 and G0462)
In the CY 2014 PFS final rule with comment period (78 FR 74341), we
assigned a status indicator of I (Not valid for Medicare purposes) to
CPT codes 88341, 88342, and 88343 and instead created two G-codes,
G0461 and G0462, to report immunohistochemistry services. We did this
in part to avoid creating incentives for overutilization. For CY 2015,
the CPT coding was revised with the creation of two new CPT codes,
88341 and 88344, the revision of CPT code 88342 and the deletion of CPT
code 88343. We believe that the revised coding structure addresses the
concerns that we had with the CY 2014 coding regarding the creation of
incentives and overutilization. Accordingly, we are deleting the G-
codes and assigning interim final values for these CPT codes for CY
2015. We are establishing the RUC-recommended work RVUs as interim
final for CY 2015 for CPT codes 88342 and 88344.
In the past for similar procedures in this family, the RUC
recommended a work RVU for the add-on code that was 60 percent of the
base code. For example, the RUC-recommended work RVU for CPT code 88334
(Pathology consultation during surgery; cytologic examination (for
example, touch prep, squash prep), each additional site (List
separately in addition to code for primary procedure)) is 60 percent of
the work RVU of the base CPT code 88333 (Pathology consultation during
surgery; cytologic examination (for example, touch prep, squash prep),
initial site). Similarly, the RUC-recommended work RVU for CPT code
88177 (Cytopathology, evaluation of fine needle aspirate; immediate
cytohistologic study to determine adequacy for diagnosis, each separate
additional evaluation episode, same site (List separately in addition
to code for primary procedure)) is 60 percent of the recommended value
for the base CPT code 88172 (Cytopathology, evaluation of fine needle
aspirate; immediate cytohistologic study to determine adequacy for
diagnosis, first evaluation episode, each site). We believe that the
relative resources involved in furnishing an add-on service in this
family would be reflected appropriately using the same 60 percent
metric. To value CPT code 88341, we calculated 60 percent of the work
RVU of the base CPT code 88342, which has a work RVU of 0.70; resulting
in a work RVU of 0.42 for CPT code 88341.
(16) Morphometric Analysis In Situ Hybridization for Gene
Rearrangement(s) (CPT Codes 88364, 88365, 88366, 88368, 88369, 88373,
and 88374 and 88377)
For CY 2014, the in situ hybridization procedures, CPT codes 88365,
88367 and 88368, were revised to specify ``each separately identifiable
probe per block;'' three new add-on codes (CPT codes 88364, 88373,
88369) were created to specify ``each additional
[[Page 67669]]
separately identifiable probe per slide;'' and three new codes were
created to specify ``each multiplex probe stain procedure.'' We are
establishing the RUC-recommended work RVUs as interim final for CY 2015
for CPT codes 88365, 88366, 88368, and 88377.
CPT code 88367 is the computer assisted version of morphometric
analysis, analogous to 88368 which is the manual version. We have
accepted the RUC recommended work RVU of 0.88 for 88368 which has 30
minutes of intraservice time. CPT code 88367 only has 25 minutes of
intraservice time and we do not believe that the RUC recommended work
RVU of 0.86 adequately reflects that change in time. We believe that
the ratio of the intraservice times (25/30) applied to the work RVU
(0.88) adequately reflects the difference in work. Therefore, we are
assigning an interim final work RVU to CPT code 88367 of 0.73.
Similarly, CPT code 88374 is the computer assisted version of CPT
code 88377 but with a drop in intraservice time from 45 minutes to 30
minutes. We believe applying this ratio to the work RUV of 88377 more
accurately reflects the work. Therefore, we are assigning an interim
final work RVU to CPT code 88374 of 0.93.
As discussed in the previous section, some of the add-on codes in
this family had RUC-recommended work RVUs that were 60 percent of the
work RVU of the base procedure and we applied that reduction to 88341.
We believe this accurately reflects the resources used in furnishing
these add-on codes. Accordingly, we used this methodology to establish
interim final work RVUs of 0.53 for code 88364 (60 percent of the work
RVU of CPT code 88365); 0.53 for CPT code 88369 (60 percent of the work
RVU of CPT code 88368); and 0.43 for CPT code 88373 (60 percent of the
work RVU of CPT code 88367).
(17) Electro-oculography (EOG VNG) CPT Codes 92270, 92540, 92541,
92542, 92544, 92543, and 92545)
After the RUC identified CPT code 92543 as potentially misvalued
through the CMS-Other Source--Utilization over 250,000 screen, CPT
revised the parentheticals for this code for CY 2015. We received RUC
recommendations for CY 2015 for this code and other codes in the
family. We are assigning the RUC-recommended work values for CPT codes
92270, 92540, 92541, 92542, 92544, and 92545. For CPT code 92543,
however, we have been informed by the RUC that survey respondents may
not have understood the revised code description for CPT code 92543,
and thus the survey data may be unreliable. As a result, we believe the
most accurate information upon which to base work RVUs for CPT code
92543 is its existing work RVU. Therefore, we are establishing a work
RVU of 0.10 for CPT code 92543 as interim final for CY 2015.
(18) Interventional Transesophageal Echocardiography (TEE) (CPT Codes
93312, 93313, 93314, 93315, 93316, 93317, 93318, 93355, and 93644)
For CY 2015, CPT code 93355 was created to describe transesophageal
echocardiography during interventional cardiac procedures. The RUC
provided recommendations for CPT code 93355, and for CPT codes 93312-
93318 in order to ensure intra-family relativity. We are establishing
the RUC-recommended work RVU of 2.40 as interim final for CY 2015 for
CPT code 93318 and 4.66 for CPT code 93355.
The RUC based the work RVU for CPT code 93312 upon a crosswalk to
CPT code 43247 (Esophagogastroduodenoscopy, flexible, transoral; with
removal of foreign body). This code has significant differences from
CPT code 93312. We have been unable to identify a CPT code with 30
minutes of intraservice time and 60 minutes of total time with a work
RVU higher than 2.55. We believe this service is more similar to CPT
code 75573 (Computed tomography, heart, with contrast material, for
evaluation of cardiac structure and morphology in the setting of
congenital heart disease (including 3D image postprocessing, assessment
of LV cardiac function, RV structure and function and evaluation of
venous structures, if performed) since it has similar work, time and
the same global period. Based upon this crosswalk, we are assigning CPT
code 93312 a CY 2015 interim final work RVU of 2.55.
Due to CPT descriptor for CPT code 93315, we believe that the
appropriate work for this service is reflected in the combined work of
CPT codes 93316 and 93317, resulting in a CY 2015 interim final work
RVU of 2.94.
For CPT codes 93313, 93314, 93316 and 93317, we are assigning CY
2015 interim final work RVUs based upon the 25th percentile values from
the survey: 0.51 for CPT code 93313, 2.10 for CPT code 93314, 2.94 for
CPT code 93315, 0.85 for CPT code 93316, 2.09 for CPT code 93317, and
4.66 for CPT code 93355. Each of these codes had a significant drop in
intraservice time since the last valuation and RUC recommendations for
higher work RVUs. As we have stated in the absence of information
showing a change in intensity, we believe meaningful changes in time
should be reflected in the work RVUs. For these codes, we believe the
25th percentile survey values better describe the work and time
involved in these procedures than the RUC recommendations and also help
maintain appropriate relativity in the family. Additionally, we are
refining the preservice and intraservice times for CPT codes 93314 and
93317 to 10 and 20 minutes, respectively, to maintain relativity among
the interim final work RVUs and times.
(19) Subcutaneous Implantable Defibrillator Procedures (CPT Codes
33270, 33271, 33272, 33272, 93260, 93261 and 93644)
For CY 2015, the CPT Editorial Panel added the word ``implantable''
to the descriptors for several codes in this family and created several
new codes, CPT codes 33270, 33271, 33272, 33272, 93260, 93261 and
93644. We received RUC recommendations for the new and revised codes.
We are establishing the RUC-recommended work RVUs for all of the codes
in this family except CPT code 93644. This code has an intraservice
time of 20 minutes and a total time of 84 minutes. We disagree with the
RUC-recommended crosswalk for CPT code 93644 which has an intraservice
time of 29 minutes and a total time of 115 minutes and believe that a
crosswalk to CPT code 32551 would be better as that code's intraservice
time is 20 minutes and the total time is 83 minutes. Therefore, we are
establishing a CY 2015 interim final work RVU of 3.29 for CPT code
93644.
(20) Duplex Scans (CPT Codes 93886, 93888, 93926, 93975, 93976, 93977,
93978, and 93979)
In the CY 2013 PFS final rule with comment period, we requested
that the RUC assess the relativity among the entire family of duplex
scans codes and recommend appropriate work RVUs. CMS also requested
that the RUC consider CPT codes 93886, Transcranial Doppler study of
the intracranial arteries; complete study, and 93888, Transcranial
Doppler study of the intracranial arteries; limited study, in
conjunction with the duplex scan codes in order to assess the
relativity between and among those codes. The RUC reviewed this entire
family of codes and provided recommendations for CY 2015. For CY 2015,
we are establishing the RUC-recommended work RVUs as interim final for
all of the codes in the family except CPT codes 93886, 93888, 93926,
93975, 93976, 93977, 93978, and 93979.
For several codes in this family with 10 minutes of intraservice
time, the RUC recommended 0.50 work RVUs. We
[[Page 67670]]
believe that this relationship between intraservice time and work RVU
accurately reflects the time and intensity involved, and should be used
for the majority of the codes in the family. As a result, for CPT codes
93926, 93979, and 93888, which all have 10 minutes of intraservice
time, we are assigning an interim final work RVU of 0.50.
For several codes in this family with 15 minutes of intraservice
time, the RUC recommended work RVUs based upon the survey 25th
percentile. We find this to appropriately reflect the work involved.
Accordingly, for CPT codes 93975, 93976, and 93978, which all have 15
minutes of intraservice time, we are disagreeing with the RUC work RVU
recommendations and assigning the 25th percentile of the survey as CY
2015 interim final values. Therefore, for CY 2015 we are establishing
the following interim final work RVUs: 1.16 for CPT code 93975, 0.80
for CPT code 93976, 0.80 for CPT code 93978 and 0.50 for CPT code
93979. Lastly, we believe that the RUC recommendation for CPT code
93886 overvalues the work involved. We accepted the RUC recommendation
for CPT code 93880 of 0.80 with an intraservice time of 15 minutes. CPT
code 93886 has an intraservice time of 17 minutes. Applying the work
RVU to time ratio of CPT code 93880 to the intraservice time of CPT
code 93886 (results in our interim final value of 0.91 for CPT code
93886.
(21) Carotid Intima-Media Thickness Ultrasound (CPT Code 93895)
For CY 2015, a new code, CPT code 93895, describes the work of
using carotid ultrasound to measure atherosclerosis and quantify the
intima-media thickness. After review of this code, we determined that
it is used only for screening and therefore, we are assigning a PFS
procedure status indicator of N (Noncovered service) to CPT code 93895.
(22) Doppler Flow Testing (CPT Code 93990)
For CY 2015, the RUC provided a recommendation for CPT code 93990
which had been identified through the High Volume Growth Services where
Medicare utilization increased by at least 100 percent from 2006 to
2011. The RUC recommended a work RVU of 0.60 for this service. Due to
the similarity of this service to duplex scans, we are establishing
RVUs for CPT code 93990 that are consistent with duplex scans with 10
minutes of intraservice time; which we discussed above in section
E.4.18. We assigned it an interim final work RVU of 0.50.
(23) Electronic analysis of implanted neurostimulator (CPT Codes 95971
and 95972)
For CY 2015, the RUC reviewed CPT codes 95971 and 95972 because
they were identified by the High Volume Growth Services screen which
identifies services in which Medicare utilization increased by at least
100 percent from 2006 to 2011 screen. It is unclear to us why CPT code
95973, the add-on code to CPT code 95972, was not also surveyed. We are
valuing CPT code 95971 based upon the RUC recommended work RVU of 0.78.
For CPT code 95972, we do not believe that the RUC recommended
change in work RVU from 1.50 to 0.90 reflects the much more significant
change in intraservice time from 60 minutes to 23 minutes. Therefore,
we used a building block methodology to develop a work RUV of 0.80.
Even though the RUC did not survey 95973, we believe we should
review it as part of this family. Not having a survey or RUC
recommendations, we believe that the percent decrease in the work RVU
from the base code 95972 should apply to this code. Therefore, we are
establishing an interim final work RVU of 0.49 for CPT code 95973.
We note that the descriptor for CPT code 95972 was changed from ``.
. . first hour'' to ``. . .up to one hour.'' We note that for Medicare
purposes this code should only be billed when a majority of an hour is
completed. We would also note that the add-on code should only be
reported after a full 60 minutes of service is furnished.
The lack of a survey for CPT code 95973 along with the confusing
descriptor language and intraservice time suggest the need for this
family to be returned to CPT for clarification of the descriptor and
then to the RUC for resurvey.
(24) Negative Pressure Wound Therapy (CPT Codes 97607, and 97608, and
HCPCS codes G0456 and G0457)
Prior to CY 2013, the codes used to report negative pressure wound
therapy were CPT codes 97605 and 97606, both of which were typically
reported in conjunction with durable medical equipment that was paid
separately. In the CY 2013 final rule with comment period, we created
two HCPCS codes to provide a payment mechanism for negative pressure
wound therapy services furnished to beneficiaries using equipment that
is not paid for as durable medical equipment: G0456 (Negative pressure
wound therapy, (for example, vacuum assisted drainage collection) using
a mechanically-powered device, not durable medical equipment, including
provision of cartridge and dressing(s), topical application(s), wound
assessment, and instructions for ongoing care, per session; total
wound(s) surface area less than or equal to 50 square centimeters) and
G0457 (Negative pressure wound therapy, (for example, vacuum assisted
drainage collection) using a mechanically-powered device, not durable
medical equipment, including provision of cartridge and dressing(s),
topical application(s), wound assessment, and instructions for ongoing
care, per session; total wound(s) surface area greater than 50 sq cm).
For CY 2015, two new codes, CPT codes 97607 and 97608, were created
to describe negative pressure wound therapy with the use of a
disposable system. In addition, CPT codes 97605 and 97606 were revised
to specify the use of durable medical equipment. Based upon these the
revised coding scheme for negative pressure wound therapy, we are
deleting the G-codes. We are contractor pricing these codes for CY
2015. CPT codes 97607 and 97608 will be designated ``Sometimes
Therapy'' on our Therapy Code List, which is consistent with the G-
codes. The Therapy Code List is available at https://www.cms.gov/Medicare/Billing/TherapyServices/?redirect=/therapyservices.''
(25) Application of Topical Fluoride Varnish (CPT Code 99188)
CPT Code 99188 is a new code for CY 2015 that describes the
application of topical fluoride varnish to teeth. Since this code
describes a service that involves the care of teeth, it is excluded
from coverage under Medicare by section 1862(a)(12) of the Act, which
provides ``items and services in connection with the care, treatment,
filling, removal, or replacement of teeth, or structures directly
supporting the teeth are excluded from coverage.'' Accordingly, we are
assigning a PFS procedure status indicator of N (Noncovered service) to
CPT code 99188.
(26) Advance Care Planning (CPT codes 99497 and 99498)
For CY 2015, the CPT Editorial Panel created two new codes
describing advance care planning services: CPT code 99497 (Advance care
planning including the explanation and discussion of advance directives
such as standard forms (with completion of such forms, when performed),
by the physician or other qualified health professional; first 30
minutes, face-to-face with the patient, family member(s)
[[Page 67671]]
and/or surrogate); and an add-CPT code 99498 (Advance care planning
including the explanation and discussion of advance directives such as
standard forms (with completion of such forms, when performed), by the
physician or other qualified health professional; each additional 30
minutes (List separately in addition to code for primary procedure)).
For CY 2015, we are assigning a PFS status indicator of ``I'' (Not
valid for Medicare purposes. Medicare uses another code for the
reporting and payment of these services.) to CPT codes 99497 and 99498
for CY 2015. However, we will consider whether to pay for CPT codes
99497 and 99498 after we have had the opportunity to go through notice
and comment rulemaking.
c. Establishing Interim Final Direct PE RVUs for CY 2015
i. Background and Methodology
The RUC provides CMS with recommendations regarding direct PE
inputs, including clinical labor, disposable supplies, and medical
equipment, for new, revised, and potentially misvalued codes. We review
the RUC-recommended direct PE inputs on a code-by-code basis, including
the recommended facility PE inputs and/or nonfacility PE inputs. This
review is informed by both our clinical assessment of the typical
resource requirements for furnishing the service and our intention to
maintain the principles of accuracy and relativity in the database. We
determine whether we agree with the RUC's recommended direct PE inputs
for a service or, if we disagree, we refine the PE inputs to represent
inputs that better reflect our estimate of the PE resources required to
furnish the service in the facility and/or nonfacility settings. We
also confirm that CPT codes should have facility and/or nonfacility
direct PE inputs and make changes based on our clinical judgment and
any PFS payment policies that would apply to the code.
We have accepted for CY 2015, as interim final and without
refinement, the direct PE inputs based on the recommendations submitted
by the RUC for the codes listed in Table 28. For the remainder of the
RUC's direct PE recommendations, we have accepted the PE
recommendations submitted by the RUC as interim final, but with
refinements. These codes and the refinements to their direct PE inputs
are listed in Table 31.
We note that the final CY 2015 PFS direct PE input database
reflects the refined direct PE inputs that we are adopting on an
interim final basis for CY 2015. That database is available under
downloads for the CY 2015 PFS final rule with comment period on the CMS
Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. We also
note that the PE RVUs displayed in Addenda B and C reflect the interim
final values and policies described in this section. All PE RVUs
adopted on an interim final basis for CY 2015 are included in Addendum
C and are open for comment in this final rule with comment period.
Table 28--CY 2015 Interim Final Codes With Direct PE Input
Recommendations Accepted Without Refinement
------------------------------------------------------------------------
HCPCS Short Descriptor
------------------------------------------------------------------------
11980............................. Implant hormone pellet(s)
22512............................. Vertebroplasty addl inject
22515............................. Perq vertebral augmentation
22856............................. Cerv artific diskectomy
27280............................. Fusion of sacroiliac joint
31620............................. Endobronchial us add-on
33270............................. Ins/rep subq defibrillator
33271............................. Insj subq impltbl dfb elctrd
33272............................. Rmvl of subq defibrillator
33273............................. Repos prev impltbl subq dfb
33951............................. Ecmo/ecls insj prph cannula
33952............................. Ecmo/ecls insj prph cannula
33953............................. Ecmo/ecls insj prph cannula
33954............................. Ecmo/ecls insj prph cannula
33955............................. Ecmo/ecls insj ctr cannula
33956............................. Ecmo/ecls insj ctr cannula
33957............................. Ecmo/ecls repos perph cnula
33958............................. Ecmo/ecls repos perph cnula
33959............................. Ecmo/ecls repos perph cnula
33962............................. Ecmo/ecls repos perph cnula
33963............................. Ecmo/ecls repos perph cnula
33964............................. Ecmo/ecls repos perph cnula
33969............................. Ecmo/ecls rmvl perph cannula
33984............................. Ecmo/ecls rmvl prph cannula
33985............................. Ecmo/ecls rmvl ctr cannula
33986............................. Ecmo/ecls rmvl ctr cannula
33988............................. Insertion of left heart vent
33989............................. Removal of left heart vent
36818............................. Av fuse uppr arm cephalic
36819............................. Av fuse uppr arm basilic
36820............................. Av fusion/forearm vein
36821............................. Av fusion direct any site
36825............................. Artery-vein autograft
36830............................. Artery-vein nonautograft
36831............................. Open thrombect av fistula
36832............................. Av fistula revision open
36833............................. Av fistula revision
37218............................. Stent placemt ante carotid
43180............................. Esophagoscopy rigid trnso
52441............................. Cystourethro w/implant
55840............................. Extensive prostate surgery
55842............................. Extensive prostate surgery
55845............................. Extensive prostate surgery
58541............................. Lsh uterus 250 g or less
58542............................. Lsh w/t/o ut 250 g or less
58543............................. Lsh uterus above 250 g
58544............................. Lsh w/t/o uterus above 250 g
58570............................. Tlh uterus 250 g or less
58571............................. Tlh w/t/o 250 g or less
58572............................. Tlh uterus over 250 g
58573............................. Tlh w/t/o uterus over 250 g
64486............................. Tap block unil by injection
64487............................. Tap block uni by infusion
64488............................. Tap block bi injection
64489............................. Tap block bi by infusion
66179............................. Aqueous shunt eye w/o graft
66180............................. Aqueous shunt eye w/graft
66184............................. Revision of aqueous shunt
66185............................. Revise aqueous shunt eye
67036............................. Removal of inner eye fluid
67039............................. Laser treatment of retina
67040............................. Laser treatment of retina
67041............................. Vit for macular pucker
67042............................. Vit for macular hole
67043............................. Vit for membrane dissect
67255............................. Reinforce/graft eye wall
70496............................. Ct angiography head
70498............................. Ct angiography neck
76770............................. Us exam abdo back wall comp
76775............................. Us exam abdo back wall lim
76856............................. Us exam pelvic complete
76857............................. Us exam pelvic limited
77080............................. Dxa bone density axial
77316............................. Brachytx isodose plan simple
77317............................. Brachytx isodose intermed
77318............................. Brachytx isodose complex
88348............................. Electron microscopy
88356............................. Analysis nerve
91200............................. Liver elastography
92145............................. Corneal hysteresis deter
92541............................. Spontaneous nystagmus test
92542............................. Positional nystagmus test
92544............................. Optokinetic nystagmus test
92545............................. Oscillating tracking test
93260............................. Prgrmg dev eval impltbl sys
93261............................. Interrogate subq defib
93644............................. Electrophysiology evaluation
97610............................. Low frequency non-thermal us
------------------------------------------------------------------------
ii. Common Refinements
Table 31 details our refinements of the RUC's direct PE
recommendations at the code-specific level. In this section, we discuss
the general nature of some common refinements and the reasons for
particular refinements.
(a) Changes in Physician Time
Some direct PE inputs are directly affected by revisions in work
time described in section II.E.3.a. of this final rule with comment
period. We note that for many codes, changes in the intraservice
portions of the work time and changes in the number or level of
postoperative visits included in the global periods result in
corresponding changes to direct PE inputs. We also note that, for a
significant number of services, especially diagnostic tests, the
procedure time assumptions used in determining direct PE inputs are
distinct from, and therefore not dependent on, work intraservice time
assumptions. For these services, we do not make refinements to the
direct PE
[[Page 67672]]
inputs based on changes to estimated work intraservice times.
Changes in Intraservice Work Time in the Nonfacility Setting. For
most codes valued in the nonfacility setting, a portion of the clinical
labor time allocated to the intraservice period reflects minutes
assigned for assisting the practitioner with the procedure. To the
extent that we are refining the times associated with the intraservice
portion of such procedures, we have adjusted the corresponding
intraservice clinical labor minutes in the nonfacility setting.
For equipment associated with the intraservice period in the
nonfacility setting, we generally allocate time based on the typical
number of minutes a piece of equipment is being used, and therefore,
not available for use with another patient during that period. In
general, we allocate these minutes based on the description of typical
clinical labor activities. To the extent that we are making changes in
the clinical labor times associated with the intraservice portion of
procedures, we have adjusted the corresponding equipment minutes
associated with the codes.
Changes in the Number or Level of Postoperative Office Visits in
the Global Period. For codes valued with postservice office visits
during a global period, most of the clinical labor time allocated to
the postservice period reflects a standard number of minutes allocated
for each of those visits. To the extent that we are refining the number
or level of postoperative visits, we have modified the clinical staff
time in the postservice period to reflect the change. We note that
until the global periods are transitioned, consistent with other
policies finalized in this rule, we will make these refinements. For
codes valued with postservice office visits during a global period, we
allocate standard equipment for each of those visits. To the extent
that we are making a change in the number or level of postoperative
visits associated with a code, we have adjusted the corresponding
equipment minutes. For codes valued with postservice office visits
during a global period, a certain number of supply items are allocated
for each of those office visits. To the extent that we are making a
change in the number of postoperative visits, we have adjusted the
corresponding supply item quantities associated with the codes. We note
that many supply items associated with postservice office visits are
allocated for each office visit (for example, a minimum multi-specialty
visit pack (SA048) in the CY 2015 direct PE input database). For these
supply items, the quantities in the direct PE input database should
reflect the number of office visits associated with the code's global
period. However, some supply items are associated with postservice
office visits but are only allocated once during the global period
because they are typically used during only one of the postservice
office visits (for example, pack, post-op incision care (suture)
(SA054) in the direct PE input database). For these supply items, the
quantities in the direct PE input database reflect that single
quantity.
These refinements are reflected in the final CY 2015 PFS direct PE
input database and detailed in Table 31.
(b) Equipment Minutes
In general, the equipment time inputs reflect the sum of the times
within the intraservice period when a clinician is using the piece of
equipment, plus any additional time the piece of equipment is not
available for use for another patient due to its use during the
designated procedure. In cases where equipment times included time for
clinical labor activities in the pre-service period, we have refined
these times to remove the minutes associated with these tasks, since
the pre-service period ends ``when patient enters office/facility for
surgery/procedure.'' Although some services include equipment that is
typically unavailable during the entire clinical labor service period,
certain highly technical pieces of equipment and equipment rooms are
less likely to be used by a clinician for all tasks associated with a
service, and therefore, are typically available for other patients
during the preservice and postservice components of the service period.
We adjust those equipment times accordingly. We refer interested
stakeholders to our extensive discussion of these policies in the CY
2012 PFS final rule with comment period (76 FR 73182-73183) and in
section II.G.2.b. of this final rule with comment period. We are
refining the CY 2015 RUC direct PE recommendations to conform to these
equipment time policies. These refinements are reflected in the final
CY 2015 PFS direct PE input database and detailed in Table 31.
(c) Moderate Sedation Inputs
In the CY 2012 PFS final rule (76 FR 73043-73049), we finalized a
standard package of direct PE inputs for services where moderate
sedation is considered inherent in the procedure. In section II.A. of
this final rule with comment period, we finalized a refinement to the
standard package to include a stretcher for the same length of time as
the other equipment items in the standard package. We are refining the
CY 2015 RUC direct PE recommendations to conform to these policies.
This includes the removal of a power table where it was included during
the intraservice period, as the stretcher takes the place of the table.
These refinements are reflected in the final CY 2015 PFS direct PE
input database and detailed in Table 31.
(d) Standard Minutes for Clinical Labor Tasks
In general, the preservice, intraservice period, and postservice
clinical labor minutes associated with clinical labor inputs in the
direct PE input database reflect the sum of particular tasks described
in the information that accompanies the recommended direct PE inputs on
``PE worksheets.'' For most of these described tasks, there are a
standardized number of minutes, depending on the type of procedure, its
typical setting, its global period, and the other procedures with which
it is typically reported. At times, the RUC recommends a number of
minutes either greater than or less than the time typically allotted
for certain tasks. In those cases, CMS reviews the deviations from the
standards to assess whether they are clinically appropriate. Where the
RUC-recommended exceptions are not accepted, we refine the interim
final direct PE inputs to match the standard times for those tasks. In
addition, in cases when a service is typically billed with an E/M or
other evaluation service, we remove the preservice clinical labor tasks
so that the inputs are not duplicative and reflect the resource costs
of furnishing the typical service.
In some cases the RUC recommendations include additional minutes
described by a category called ``other clinical activity,'' or through
the addition of clinical labor tasks that are different from those
previously included as standard. In these instances, CMS reviews the
tasks as described in the recommendation to determine whether they are
already incorporated into the total number of minutes based on the
standard tasks. Additionally, CMS reviews these tasks in the context of
the kinds of tasks delineated for other services under the PFS. For
those tasks that are duplicative or not separately incorporated for
other services, we do not accept those additional clinical labor tasks
as direct inputs. For example, as we have previously discussed (78 FR
74308), we believe that quality assurance documentation tasks for
services across the PFS are already accounted for in the overall
estimate of clinical labor time. We do not believe that it would serve
the relativity of the direct PE input database were additional minutes
added for each clinical task that
[[Page 67673]]
could be discretely described for every code. These refinements are
reflected in the final CY 2015 PFS direct PE input database and
detailed in Table 31.
(e) New Supply and Equipment Items
The RUC generally recommends the use of supply and equipment items
that already exist in the direct PE input database for new, revised,
and potentially misvalued codes. Some recommendations include supply or
equipment items that are not currently in the direct PE input database.
In these cases, the RUC has historically recommended a new item be
created and has facilitated CMS's pricing of that item by working with
the specialty societies to provide sales invoices to us.
We received invoices for several new supply and equipment items for
CY 2015. We have accepted the majority of these items and added them to
the direct PE input database. Tables 29 and 30 detail the invoices
received for new and existing items in the direct PE database. As
discussed in section II.A. of this final rule with comment period, we
encourage stakeholders to review the prices associated with these new
and existing items to determine whether these prices appear reasonable.
Where prices appear unreasonable, we encourage stakeholders to provide
invoices that provide more accurate pricing for these items in the
direct PE database. We remind stakeholders that due to the budget
neutral nature of the PFS, increased prices for any items in the direct
PE database decrease the pool of PE RVUs available to all other PFS
services. Tables 29 and 30 also include the number of invoices received
as well as the number of nonfacility allowed services for procedures
that use these equipment items. In cases where large numbers of allowed
services exist, we question pricing the item based upon a single
invoice. We are concerned that the single invoice may not be reflective
of typical costs for these items and encourage stakeholders to provide
additional invoices.
In some cases we cannot adequately price a newly recommended item
due to inadequate information. In some cases, no supporting information
regarding the price of the item has been included in the recommendation
to create a new item. In other cases, the supporting information does
not demonstrate that the item has been purchased at the listed price
(for example, price quotes instead of paid invoices). In cases where
the information provided allowed us to identify clinically appropriate
proxy items, we have used existing items as proxies for the newly
recommended items. In other cases, we have included the item in the
direct PE input database without an associated price. Although
including the item without an associated price means that the item does
not contribute to the calculation of the PE RVU for particular
services, it facilitates our ability to incorporate a price once we are
able to do so.
Table 29--Invoices Received for New Direct PE Inputs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Non-facility allowed
services for HCPCS codes
CPT/HCPCS codes Item name CMS code Average price No. of using this item (or
invoices projected services for
new CPT codes*)
--------------------------------------------------------------------------------------------------------------------------------------------------------
20604, 20606, 20611.................... ultrasound transmission SJ089 $1.71.......................... 1 748248*
gel, sterile.
(single use)..............
22512.................................. 10g IVAS drill............ SD292 139.33......................... 1 99*
22512.................................. 10g cannulae.............. SD293 86.11.......................... 1 99*
29200, 29240, 29260, 29280, 29520, foam underwrap............ SG097 0.0043 per inch................ 1 415513
29530, 29540, 29550.
29200, 29240, 29260, 29280, 29520, rigid strapping tape (15 SG098 0.018 per inch................. 1 415513
29530, 29540, 29550. yards).
29200, 29240, 29260, 29280, 29520, skin prep barrier wipes... SM029 0.20........................... 1 415513
29530, 29540, 29550.
31620.................................. Flexible dual-channeled EQ361 160,260.06..................... 6 107
EBUS bronchoscope, with
radial probe.
31620.................................. Video system, Ultrasound ER099 13,379.57...................... 6 107
(processor, digital
capture, monitor,
printer, cart).
31620.................................. EBUS, single use SC10145.82......................... 5 107
aspiration needle, 21 g.
31620.................................. Balloon for Bronchosopy SD294 28.68.......................... 4 107
Fiberscope.
52441, 52442........................... Urolift Implant and SD291 775.00......................... 10 12*
implantation device.
64486, 64488........................... ultrasound needle......... SC1012.81.......................... 4 46851*
64487, 64489........................... continuous peripehral SA116 23.69.......................... 1 802*
nerve block tray.
77063.................................. multimodality software.... ED051 11,570.00...................... 12 297529*
88341.................................. Anti CD45 Monoclonal SL495 3.61 per test.................. 1 917673*
Antibody.
88344.................................. 34 Beta E12............... SL496 4.27 per test.................. 1 51591*
88348.................................. Digital Printer........... ED048 774.89......................... 1 641
88348.................................. Carbon Coater............. EQ366 22,540.08...................... 1 641
88348.................................. Diamond Milling Tool...... EQ365 1,714.00....................... 1 641
88356, 88348........................... Electron Microscopy Tissue EP115 13,119.00...................... 2 19134
processor.
88356, 88348........................... Block face milling machine EQ363 18,139.00...................... 1 19134
88356, 88348........................... Glass Knife Breaker....... EQ364 9,585.14....................... 1 19134
88364.................................. CMV DNA Probe Cocktail.... SL500 0.10 per ul.................... 1 3376*
88341, 88342, 88344, 88364, 88365, Universal Detection Kit... SA117 4.00........................... 1 1380597
88367, 88368, 88369, 88373.
88365.................................. EBER positive control SL507 20.15.......................... 1 8440
slide.
88365.................................. (EBER) DNA Probe Cocktail. SL497 8.57 per test.................. 2 8440
[[Page 67674]]
88365, 88366, 88367, 88368, 88374, VP-2000 Processor......... EP116 30,800.00...................... 1 228243
88377.
88367, 88368........................... Kappa Probe Cocktails..... SL498 0.10 per ul.................... 1 36634
88369, 88373........................... Lambda Probe Cocktail..... SL499 0.10 per ul.................... 1 24423*
88380, 88381........................... Surface Decontaminant (DNA SL494 0.07 per ml.................... 1 6649
Away).
91200.................................. Fibroscan................. ER101 124,950.00..................... 1 87*
92145.................................. Ocular Response Analyzer.. EQ360 12,000.00...................... 3 Unknown
92541, 92542, 92544, 92545............. VNG Recording System...... EQ367 29,607.50...................... 2 101139
93702.................................. BIS monitoring system EQ359 3,316.93....................... 1 Unknown
(bioimpedance
spectroscopy).
93702.................................. electrode, BIS SD290 28.33.......................... 1 Unknown
(bioimpedance
spectroscopy).
96127.................................. Beck Youth Inventory, SK119 1.96 per booklet............... 1 Unknown
Second Edition (BYI-II);
Combination Inventory
Booklet.
97610.................................. MIST Therapy System....... EQ372 28,000.00...................... 2 2*
97610.................................. MIST Therapy Cart......... EQ368 1,250.00....................... 1 2*
97610.................................. kit, low frequency SA119 63.33.......................... 3 2*
ultrasound wound therapy
(MIST).
99188.................................. CavityShield 5% Varnish SH106 0.91........................... 1 Unknown
.25mL.
G0277.................................. HBOT air break breathing EQ362 986.00......................... 1 153044*
apparatus demand system
(hoses, masks, penetrator
and demand valve).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 30--Invoices Received for Existing Direct PE Inputs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Non-facility
allowed
CPT/HCPCS codes Item name CMS code Current price Updated price % Change No. of services for
invoices HCPCS codes
using this item
--------------------------------------------------------------------------------------------------------------------------------------------------------
20983, 47383..... cryosurgery EQ302 missing.................... $37,500.00................. ............ 2 22 *
system (for
tumor ablation).
20983, 47383..... gas, argon...... SD227 $0.25 per cubic foot....... 0.32 per cubic foot........ 28 1 22 *
20983, 47383..... gas, helium..... SD079 0.25 per cubic foot........ 0.57 per cubic foot........ 128 1 22 *
31627............ system, EQ326 137,800.00................. 189,327.66................. 37 4 37
navigational
bronchoscopy
(superDimension
).
31627............ kit, locatable SA097 995.00..................... 1,063.67................... 7 3 37
guide, ext.
working
channel, w-b-
scope adapter.
64561............ kit, SA022 305.00..................... 420.00..................... 38 1 8229
percutaneous
neuro test
stimulation.
88348............ camera, digital ED006 41,000.00.................. 82,000.00.................. 100 1 641
system, for
electron
microscopy.
88348, 88356..... microtome, ultra ER043 25,950.00.................. 34,379.00.................. 32 1 19134
G0277............ HBOT (hyperbaric EQ131 125,000.00................. 127,017.98................. 2 1 153044 *
oxygen therapy)
monochamber,
incl. gurney
and integrated
grounding
assembly.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* New procedure--Projected volume.
[[Page 67675]]
(f) Recommended Items That Are Not Direct PE Inputs
In some cases, the recommended direct PE inputs included items that
are not clinical labor, disposable supplies, or medical equipment
resources. We have addressed these kinds of recommendations in previous
rulemaking and in sections II.G.2.b. and II.B.4.a. of this final rule
with comment period. Refinements to adjust for these recommended inputs
are reflected in the final CY 2015 PFS direct PE input database and
detailed in Table 31.
(g) Film-to-Digital Migration
As discussed in section II.A.3 of this final rule with comment
period, we are finalizing our policy to remove equipment and supply
inputs associated with film technology from the direct PE database.
Since the recommendations we received for 2015 were prepared before the
transition occurred, in some cases, the RUC recommendations included
film inputs. Where recommendations included these inputs, we have
removed these inputs and replaced them with ``PACS workstation proxy''
as described in section II.A.3 of this final rule with comment period.
Since the film-to-digital transition results from our acceptance of a
RUC recommendation, we do not consider the removal of these items to be
refinements of RUC recommendations, and therefore do not include them
in Table 31.
(h) Pre-Service and Post-Service Tasks for Add-On Codes
In general, we believe that certain pre-service and post-service
tasks are not repeated for services reported using add-on codes. In
some cases, we also believe that the time for certain equipment items
are not duplicated for add-on codes. In these cases, we removed the
time associated with those tasks and/or equipment items from those
codes. These refinements appear in Table 31.
iii. Code-Specific Refinements
(a) Rib Fractures (CPT Codes 21811, 21812, and 21813)
For the newly created rib fracture codes, which are frequently
furnished as emergency surgeries, the RUC did not include time for the
standard pre-service activities ``Provide pre-service education/obtain
consent'' and ``Follow-up phone calls & prescriptions.'' However, the
RUC recommendation included time for pre-service activities ``Complete
pre-service diagnostic & referral forms,'' ``Coordinate pre-surgery
services'', and ``Schedule space and equipment in facility.'' Since
these codes would typically be provided as emergency surgeries, we
question whether these tasks would typically be performed.
We reviewed other emergency procedures in the PFS to determine
whether pre-service clinical labor activities were typically included
in the PE worksheets. We found that the recommendations for these
procedures were inconsistent. Therefore, we will not remove the time
allocated for these clinical labor activities at this time. However, we
believe that for emergency procedures, none of the pre-service tasks
listed above would typically be performed. We seek comment to clarify
this issue, and plan to consider this issue in future rulemaking.
As discussed earlier in this section of this final rule with
comment period, we have valued CPT codes 21811, 21812, and 21813 as 0-
day globals. We have therefore removed direct PE inputs associated with
the postoperative visits.
(b) Percutaneous Vertebroplasty and Augmentation (CPT Codes 22510,
22511, 22512, 22513, 22514, and 22515)
The RUC recommendation regarding add-on CPT code 22512
(Percutaneous vertebroplasty (bone biopsy included when performed), 1
vertebral body, unilateral or bilateral injection, inclusive of all
imaging guidance, each additional cervicothoracic or lumbosacral
vertebral body)) included new supply item ``10g IVAS drill.'' We note
that the recommendations for the base codes did not contain this supply
item, and the vertebroplasty kit does not appear to contain this drill
either. We do not understand why the drill would be required for the
add-on code when it is not required for the base code. Therefore, we
will not include supply item ``10g IVAS drill'' in CPT code 22512 at
this time.
(c) Endobronchial Ultrasound (EBUS) (CPT Code 31620)
As indicated earlier in this section of this final rule with
comment period, we are maintaining the CY 2014 work RVU for CPT code
31620 in light of our concerns regarding coding structure. As such, we
are maintaining the CY 2014 direct PE inputs for 31620 as well.
(d) Breast Tomosynthesis (CPT Codes 77061, 77062, and 77063)
For CY 2015, the CPT Editorial Panel created three codes to
describe digital breast tomosynthesis services: 77061(Digital breast
tomosynthesis; unilateral), 77062 (Digital breast tomosynthesis;
bilateral) and 77063 (Screening digital breast tomosynthesis, bilateral
(List separately in addition to code for primary procedure)). For these
newly created codes, the RUC recommended creating a new equipment item,
``room, breast tomosynthesis'', at a price of $667,669, as well as a
list of items contained in the room. We believe that several of the
items included in the room are not appropriately characterized as
direct costs. We also believe that the creation of rooms sometimes
causes confusion when items in the room are also included as stand-
alone PE inputs, as specialty societies do not consider the items
included in the room when preparing the PE worksheets. Further, we
believe that the prices for the rooms sometimes result in less
transparency, as prices for items within the room tend to remain static
over time. Therefore, we are not creating this new equipment item, but
will instead include the individual equipment items that we believe are
appropriately characterized as direct costs.
The price for the digital breast tomosynthesis unit indicated on
the invoice received by the RUC was $498,412. We received many invoices
for this equipment item with an average price of $381,380. Therefore,
we will create a new equipment item ``DBT unit'', at a price of
$381,380.
The RUC also recommended including a new equipment item, ``PACS
cache'', for these procedures. We do not believe that digital storage
constitutes a direct cost, as it is not individually allocable to an
individual patient for a particular service. . Therefore, we will not
add this new equipment item to the direct PE database.
(e) Radiation Treatment (CPT Codes 77385, 77386, 77387, 77402, 77407,
77412)
For CY 2015, the CPT Editorial Panel revised the set of codes that
describe radiation treatment delivery services. These revisions
included the addition and deletion of several codes and the development
of new guidelines and coding instructions. Due to the significant code
restructuring and potential for changes in payment, some specialty
societies representing providers of radiation treatment services have
requested that we delay implementation of the new code set. We believe
that given the large scale of the changes in this code set
restructuring, in the context of our upcoming revised process for
valuing new, revised, and potentially misvalued codes, it is prudent to
propose the values for the revised code set in the CY 2016 rule
[[Page 67676]]
with opportunity for public comment prior to establishing payment
rates.
(f) Immunohistochemistry (CPT Codes 88341, 88342, and 88344)
The RUC recommended including supply item ``UltraView Universal DAB
Detection Kit'' (SL488) for CPT codes 88341, 88342, and 88344, which is
priced at $10.49 per kit, and ``UltraView Universal Alkaline
Phosphatase Red Detection Kit'', which is priced at $20.64. We noted
that for other similar services, CPT codes 88364, 88365, 88367, 88368,
88369, and 88373, the RUC recommended including supply item ``Universal
Detection Kit'' (SA117), which is priced at $4.00 per kit. After
reviewing information about these two kits, we believe that functions
provided by SL488 and SL489 are also provided by SA117. The
recommendations did not explain why the more expensive kit was
necessary for 88341, 88342, and 88344 when the less expensive kit was
sufficient for CPT codes 88364, 88365, 88367, 88368, 88369, and 88373.
Absent any rationale for the use of the more expensive kit, we are
including SA117 for 88341, 88342, and 88344 in place of SL488.
(g) Electron Microscopy (CPT Code 88348)
The RUC recommended including a new supply item, ``diamond milling
tool'', for use with CPT code 88348. However, upon reviewing the
invoice, we believe that ``diamond milling tool'' is more appropriately
characterized as equipment. We have therefore created an equipment item
for this tool, as listed in Table 29.
(h) Morphometric Analysis (CPT Codes 88364, 88365, 88366, 88367, 88373,
88374, 88377, 88368, and 88369)
The CPT Editorial Panel revised the in situ hybridization codes
(88365, 88367, and 88368) and created three new add-on codes for
reporting each additional separately identifiable probe per slide. The
RUC reviewed CPT codes 88365, 88367, and 88368, among other services in
this family, in October 2013 and recommended direct inputs for these
procedures, including supply item ``kit, FISH paraffin pretreatment''
(SL195), with quantities of 1 unit for CPT code 88365, 0.75 units for
CPT code 88367, and 1 unit for CPT code 88368.
After the CY 2014 PFS final rule with comment period was published,
the specialty societies determined that additional clarification was
necessary, and requested that the CPT Editorial Panel review the entire
family again. The CPT editorial panel added three new codes for ``each
multiplex probe stain procedure.'' The specialty societies then
resurveyed these procedures. The RUC reviewed the entire family at the
April 2014 meeting and recommended supply item SL195 with a quantity of
2 units for CPT code 88365, 1.4 units for CPT code 88367, and 2 units
for CPT code 88368. These quantities are double what the RUC
recommended to us in October 2013, which was 1 unit for CPT code 88365,
0.75 units for CPT code 88367, and one unit for CPT code 88368. Without
an explanation for this significant change, we are including SL195 with
the following quantities: 1 unit for CPT code 88365, 0.75 units for CPT
code 88367, and 1 unit for CPT code 88368. Similarly, for add-on
services CPT codes 88364, 88366, 88369, 88373, 88374, and 88377, more
than one unit of SL195 was included. We believe that the unit of the
kit should be consistent between the base code and the add-on code. We
will therefore include 1 unit of SL195 for CPT codes 88364, 88366,
88369, and 88377, and 0.75 units for CPT codes 88373 and 88374. We are
also interested in learning more about why a partial kit would be used
in furnishing the typical service.
CPT codes 88374 and 88377, which are add-on codes, contain more
than one unit of supply item ``kit, HER-2/neu DNA Probe'' (SL196).
Because these codes describe a service that includes a single specimen
with one stain, we do not understand why more than one kit would be
required. We have therefore included a unit of 1 for SL196 in CPT codes
88374 and 88377.
We also believe that the units of positive control slides and
negative control slides should be consistent throughout this entire
family. We note that CPT codes 88367, 88373, and 88374 included a
recommended 0.2 units of positive and/or negative control slide; supply
items SL118 and SL119 for CPT code 88367, supply items SL120 and SL121
for CPT code 88373, and supply items SL184 and SL185 for CPT code
88374.) However, for CPT codes 88368, 88369, and 88377, the
recommendation included 0.5 units of the positive and/or negative
control slide (supply item SL112 for CPT codes 88368 and 88369, and
supply items SL184 and SL185 for CPT code 88377). No rationale was
provided for why a greater quantity of the control slide would be
required. Therefore, we will include 0.2 units of positive and/or
negative control slides, as appropriate, to maintain consistency
throughout this family of codes.
As with the positive and negative control slides, we believe that
the number of units of supply item SL498 (``Kappa probe cocktails'')
and SL499 (Lambda probe cocktails'') should be consistent across
procedures. The recommendations for CPT codes 88367 and 88373 contain
28 ul of SL498 for 88367 and 27 ul of SL499 for 88373. Therefore, to
maintain consistency, we refined the units of SL498 for CPT code 88368
and SL499 for CPT code 88369 to 28 ul.
The RUC recommended a quantity of 1.6 for SL497 ``(EBER) DNA Probe
Cocktail'' for CPT code 88365. Since this procedure describes a single
stain, and the stain needs to be added to the positive control slide
and the specimen slide, we believe that a quantity of 2 is more
appropriate. We have therefore included 2 units of SL497 for CPT code
88365.
The RUC recommendation also included a new equipment item ``VP-2000
processor'' (EP116). Among the purposes of this equipment item is to
reduce the amount of technician time needed to complete the clinical
labor task. However, in the recommendations we received, rather than
the clinical labor time for these codes decreasing with the addition of
this new equipment item, the RUC recommended increased clinical labor
times associated with this task for CPT codes 88365, 88366, 88368, and
88377 increased. We are unable to reconcile as typical the new
equipment item, which is intended to reduce technician time, with the
increased technician time for this same clinical labor task. Therefore,
we will not allocate time for equipment item ``VP-2000 processor''
(EP116) in CPT codes 88365, 88366, 88368, and 88377.
(h) Microdissection (CPT Codes 88380 and 88381)
In reviewing the RUC recommendations for CPT code 88380, the work
vignette indicated that the microdissection is performed by the
pathologist. However, the PE worksheet also included several subtasks
of ``Microdissect each stained slide sequentially while reviewing H and
E stained slide'' that are performed by the cytotechnologist. Since we
do not believe that both the pathologist and the cytotechnologist are
completing these tasks, we have refined out the lines associated with
the specific tasks we believe are completed by the pathologist. Table
31 details our refinements to the clinical labor tasks.
(j) Interventional Transesophageal Echocardiography (TEE) (CPT Codes
93312 and 93314)
CPT code 93314 describes a service in which the acquisition and
interpretation of images is furnished by a different practitioner than
the placement of the
[[Page 67677]]
probe. CPT code 93312 includes all services encompassed by CPT code
93314 and included a recommendation for 30 minutes of assist physician
time. We do not believe that CPT code 93314 should have more clinical
labor than CPT code 93312, which is the more extensive code. We have
therefore refined this time to 30 minutes, which is the same as the
time allocated to 93312. We also note that the time allocated to
equipment item ``room, ultrasound, vascular'' (EL016) was affected by
this refinement.
(k) Hyperbaric Oxygen Therapy (HBOT) (HCPCS Code G0277)
We received a RUC recommendation for CPT code 99183 (Physician or
other qualified health care professional attendance and supervision of
hyperbaric oxygen therapy, per session), which included significant
increases to the direct PE inputs, which assumes a treatment time of
120 minutes. Currently, CPT code 99183 is used for both the
professional attendance and supervision and the actual treatment
delivery. Stakeholders have pointed out that although we include the PE
inputs for treatment delivery in this code, the descriptor describes
only attendance and supervision. We note that under the OPPS, the
treatment is reported using separate treatment code C1300 (Hyperbaric
oxygen under pressure, full body chamber, per 30 minute interval).
After considering this issue, we believe the OPPS approach would also
be appropriate for the PFS. We are therefore creating a G-code to
report the treatment delivery and to maintain consistency with the OPPS
coding. We will use the same descriptor as previously used for OPPS
code C1300 for a timed 30-minute code, which can then be used across
settings. To value this G-code, we used the RUC recommended direct PE
inputs for 99183 and adjusted them to align with the 30 minute
treatment interval.
In reviewing the recommended direct PE inputs, we observed that the
quantity of oxygen increased significantly relative to the previous
value. To better understand this change, we reviewed the instruction
manual for the most commonly used HBOT chamber, which provide guidance
regarding the quantity of Oxygen used. Based on our review, we
determined that 12,000, rather than 47,000, was the typical number of
units. Therefore, in aligning the direct PE inputs as described above,
we first adjusted the units of oxygen to 12,000 for the recommended 120
minute time, and subsequently adjusted it to align with the 30 minute
G-code.
(l) EOG VNG (CPT code 92543)
As described earlier in this section of this final rule with
comment period, we are maintaining the CY 2014 work RVU for CPT code
92543 due to possible confusion among survey respondents. Similarly, we
are also maintaining the CY 2014 direct PE inputs for 92543.
These refinements, as well as other applicable standard and common
refinements for these codes, are reflected in the final CY 2015 PFS
direct PE input database and detailed in Table 31.
BILLING CODE 4120-01-P
[[Page 67678]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.019
[[Page 67679]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.020
[[Page 67680]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.021
[[Page 67681]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.022
[[Page 67682]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.023
[[Page 67683]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.024
[[Page 67684]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.025
[[Page 67685]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.026
[[Page 67686]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.027
[[Page 67687]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.028
[[Page 67688]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.029
[[Page 67689]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.030
[[Page 67690]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.031
[[Page 67691]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.032
[[Page 67692]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.033
[[Page 67693]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.034
[[Page 67694]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.035
[[Page 67695]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.036
[[Page 67696]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.037
[[Page 67697]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.038
[[Page 67698]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.039
[[Page 67699]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.040
[[Page 67700]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.041
[[Page 67701]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.042
[[Page 67702]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.043
[[Page 67703]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.044
[[Page 67704]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.045
[[Page 67705]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.046
[[Page 67706]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.047
[[Page 67707]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.048
[[Page 67708]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.049
[[Page 67709]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.050
[[Page 67710]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.051
[[Page 67711]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.052
[[Page 67712]]
BILLING CODE 4120-01-C
iii. Procedures Subject to the Cap on Imaging Codes Defined by Section
5102(b) of the DRA
We are proposing to add the new codes to the list of procedures
subject to the DRA cap, effective January 1, 2015. The codes are:
(76641 (Ultrasound breast complete), 76642 (Ultrasound breast limited),
77085 (Dxa bone density study), 77086 (Fracture assessment via dxa),
77387 (Guidance for radiaj tx dlvr), G6001 (Stereoscopic x-ray
guidance), and G6002 (Echo guidance radiotherapy). These codes, which
are new for CY 2015, replace codes deleted for CY 2015 that were
subject to the cap, and meet the definition of imaging under section
5102(b) of the DRA. These codes are being added on an interim final
basis and are open to public comment in this final rule with comment
period.
d. Establishing CY 2015 Interim Final Malpractice RVUs
According to our malpractice methodology discussed in section II.C,
we are assigning malpractice RVUs for CY 2015 new, revised, and
potentially misvalued codes by utilizing a crosswalk to a source code
with a similar malpractice risk. We have reviewed the RUC recommended
malpractice source code crosswalks for CY 2015 new, revised, and
potentially misvalued codes, and we are accepting all of them on an
interim final basis for CY 2015. For G-codes that we are creating, we
are also assigning source code crosswalks to similar codes.
Table 32 lists the CY 2015 HCPCS codes and their respective source
codes used to set the interim final CY 2015 MP RVUs. The MP RVUs for
these services are reflected in Addendum B of this CY 2015 PFS final
rule with comment period.
BILLING CODE 4120-01-P
[[Page 67713]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.053
[[Page 67714]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.054
[[Page 67715]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.055
BILLING CODE 4120-01-C
H. Chronic Care Management (CCM)
As we discussed in the CY 2013 PFS final rule with comment period,
we are committed to supporting primary care and we have increasingly
recognized care management as one of the critical components of primary
care that contributes to better health for individuals and reduced
expenditure growth (77 FR 68978). Accordingly, we have prioritized the
development and implementation of a series of initiatives designed to
improve payment for, and encourage long-term investment in, care
management services. These initiatives include the following programs
and demonstrations:
The Medicare Shared Savings Program (described in
``Medicare Program; Medicare Shared Savings Program: Accountable Care
Organizations; Final Rule,'' which appeared in the November 2, 2011
Federal Register (76 FR 67802)).
The testing of the Pioneer ACO model, designed for
experienced health care organizations (described on the Centers for
Medicare and Medicaid Innovation's (Innovation Center's) Web site at
https://innovation.cms.gov/initiatives/Pioneer-ACO-Model/).
The testing of the Advance Payment ACO model, designed to
support organizations participating in the Medicare Shared Savings
Program (described on the Innovation Center's Web site at https://innovation.cms.gov/initiatives/Advance-Payment-ACO-Model/).
The Primary Care Incentive Payment (PCIP) Program
(described on the CMS Web site at www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/PCIP-2011-Payments.pdf).
The patient-centered medical home model in the Multi-payer
Advanced Primary Care Practice (MAPCP) Demonstration designed to test
whether the quality and coordination of health care services are
improved by making advanced primary care practices more broadly
available (described on the CMS Web site at www.cms.gov/Medicare/Demonstration-Projects/DemoProjectsEvalRpts/downloads/mapcpdemo_Factsheet.pdf).
The Federally Qualified Health Center (FQHC) Advanced
Primary Care Practice demonstration (described on the CMS Web site at
https://www.cms.gov/Medicare/Demonstration-Projects/DemoProjectsEvalRpts/Downloads/FQHC_APCP_Demo_FAQsOct2011.pdf and the
Innovation Center's Web site at www.innovations.cms.gov/initiatives/FQHCs/).
The Comprehensive Primary Care (CPC) initiative (described
on the Innovation Center's Web site at https://innovations.cms.gov/initiatives/Comprehensive-Primary-Care-Initiative/). The CPC
initiative is a multi-payer initiative fostering collaboration between
public and private health care payers to strengthen primary care in
certain markets across the country.
In addition, HHS leads a broad initiative focused on optimizing
health and quality of life for individuals with multiple chronic
conditions. HHS's Strategic Framework on Multiple Chronic Conditions
outlines specific objectives and strategies for HHS and private sector
partners centered on strengthening the health care and public health
systems; empowering the individual to use self-care management with the
assistance of a healthcare provider who can assess the patient's health
literacy level; equipping care providers with tools, information, and
other interventions; and supporting targeted research about individuals
with multiple chronic conditions and effective interventions. Further
information on this initiative is available on the HHS Web site at
https://www.hhs.gov/ash/initiatives/mcc/.
In coordination with all of these initiatives, we also have
continued to explore potential refinements to the PFS that would
appropriately value care management within Medicare's statutory
structure for fee-for-service physician payment and quality reporting.
For example, in the CY 2013 PFS final rule with comment period, we
adopted a policy to pay separately for care management involving the
transition of a beneficiary from care furnished by a treating physician
during a hospital stay to care furnished by the beneficiary's primary
physician in the community (77 FR 68978 through 68993).
In the CY 2014 PFS final rule with comment period, we finalized a
policy to pay separately for care management services furnished to
Medicare beneficiaries with two or more chronic
[[Page 67716]]
conditions beginning in CY 2015 (78 FR 74414).
1. Valuation of CCM Services--GXXX1
CCM is a unique PFS service designed to pay separately for non-
face-to-face care coordination services furnished to Medicare
beneficiaries with multiple chronic conditions. (See 78 FR 74414 for a
more thorough discussion of the beneficiaries for whom this service may
be billed and the scope of service elements.) In the CY 2014 PFS final
rule with comment period, we indicated that, to recognize the
additional resources required to furnish CCM services to patients with
multiple chronic conditions, we were creating the following code to use
for reporting this service (78 FR 74422):
GXXX1 Chronic care management services furnished to
patients with multiple (two or more) chronic conditions expected to
last at least 12 months, or until the death of the patient, that place
the patient at significant risk of death, acute exacerbation/
decompensation, or functional decline; 20 minutes or more; per 30 days.
Although this service is unique in that it was created to
separately pay for care management services, other codes include care
management components. To value CCM, we compared it to other codes that
involve care management. In doing so, we concluded that the CCM
services were similar in work (time and intensity) to that of the non-
face-to-face portion of the lower level code for transitional care
management (TCM) services (CPT code 99495 (Transitional Care Management
Services with the following required elements: Communication (direct
contact, telephone, electronic) with the patient and/or caregiver
within 2 business days of discharge Medical decision making of at least
moderate complexity during the service period face-to-face visit,
within 14 calendar days of discharge)). Accordingly, we based the
proposed inputs on the non-face-to-face portion of CPT code 99495.
Specifically, we proposed a work RVU for GXXX1 of 0.61, which is
the portion of the work RVU for CPT code 99495 that remains after
subtracting the work attributable to the face-to-face visit. (CPT code
99214 (Office/outpatient visit est) was used to value CPT code 99495,
which has a work RVU of 1.50). Similarly, we proposed a work time of 15
minutes for HCPCS code GXXX1 for CY 2015 based on the time attributable
to the non-face-to-face portion of CPT 99495.
For direct PE inputs, we proposed 20 minutes of clinical labor
time. As established in the CY 2014 PFS final rule with comment period,
in order to bill for this code, at least 20 minutes of CCM services
must be furnished during the 30-day billing interval (78 FR 74422).
Based upon input from stakeholders and the nature of care management
services, we believed that many aspects of this service will be
provided by clinical staff, and thus, clinical staff would be involved
in the typical service for the full 20 minutes. CPT code 99495 has 45
minutes of non-face-to-face clinical labor time and we assumed the
typical case for CCM would involve 20 minutes based upon the code
descriptor and a broad eligible population that would require limited
monthly services. The proposed CY 2015 direct PE input database
reflected the input of 20 minutes of clinical labor time and is
available on the CMS Web site under the supporting data files for the
CY 2015 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The resulting proposed PE RVUs were 0.57 for CCM
furnished in non-facility locations and 0.26 for CCM furnished in a
facility.
The proposed MP RVU of 0.04 was calculated using the weighted risk
factors for the specialties that we believed would furnish this
service. We believed the proposed malpractice risk factor would
appropriately reflect the relative malpractice risk associated with
furnishing CCM services.
We received many public comments on our proposed valuation. In
general, the commenters commended CMS for ongoing recognition of the
value of non-face-to-face time expended by physicians and staff to
improve outcomes for beneficiaries with chronic conditions, and the
proposal to pay separately for the non-face-to-face services. However,
the commenters generally believed the proposed valuation for CCM
services underestimated the resources involved with complex
beneficiaries, and recommended various alternatives for valuing the
services. We summarize these comments in the following paragraphs.
Comment: Several commenters noted that the CPT Editorial Panel
created a new code for CY 2015 that is extremely similar to the G-code
we developed to report these services. These commenters suggested that
we use the new CPT code 99490 (Chronic care management services, at
least 20 minutes of clinical staff time directed by a physician or
other qualified health care professional, per calendar month, with the
following required elements:
Multiple (two or more) chronic conditions expected to last
at least 12 months, or until the death of the patient;
Chronic conditions place the patient at significant risk
of death, acute exacerbation/decompensation, or functional decline;
Comprehensive care plan established, implemented, revised,
or monitored).
Many of these commenters expressed a preference for the ``per
calendar month'' used in the CPT descriptor to the ``per 30 days'' used
in the G-code. The commenters said a calendar month rather than 30 days
would be less complex administratively.
Response: It is our preference to use CPT codes unless Medicare has
a programmatic need that is not met by the CPT coding structure.
Accordingly, in the CY 2014 final rule with comment period we indicated
that we would consider using a CPT code if one was created that
reflected the service we were describing with the G-code. We believe
that the new CPT code 99490 appropriately describes CCM services for
Medicare beneficiaries.
We had used 30 days rather than a calendar month as the service
period for the G-code so that the number of days in the service period
would not vary based upon when CCM services were initiated for a given
period. For example, if the services were initiated near the end of a
calendar month, using the CPT code's period of ``per calendar month''
would make it harder for the practitioner to meet the required minimum
time for the month and be able to bill CMM for that month.
However, after learning about the administrative difficulties that
the 30-day period would create, we believe that the calendar month
creates a reasonable period. Accordingly, we will adopt CPT code 99490
for Medicare CCM services, effective January 1, 2015 instead of the G
code.
Comment: Several commenters suggested alternative approaches to the
use of codes that describe CCM services. For example, one commenter
said that the code should be for one year, with average of 20 minutes
per month across the year. Another commenter was concerned about how
the 20 minutes of care per month per patient will be calculated,
because some patients (those whose condition is less well controlled)
will demand more attention and care than average patients, while those
whose condition is well controlled might require very little attention.
This commenter suggested that a reasonable solution would be for the
care minutes per patient per month to be calculated as an average
across a number of CCM
[[Page 67717]]
patients. The commenter added that for patients entering and exiting
mid-month, the average minutes of care could be calculated on a pro
rata basis which adjusts for the partial months they are eligible for
CCM services. Several other commenters said that CMS should use a
capitated payment methodology for CCM services in the long run, but
supported CCM services using the CPT codes as valued by the RUC as a
short-term transitional strategy until CMS is able to expand the per
beneficiary per month care management fee under CMS's primary care
demonstration initiatives to all physicians. Others commented similarly
that the long-term goal is capitated payments like the demonstrations/
models that better encourage population-based health management and
reducing utilization.
Several commenters submitted recommendations for valuation based on
their experience in CMS's Patient-Centered Medical Home multipayer
initiative. Assuming CCM services are furnished by a care manager
receiving an annual salary of $150,000, and taking into account a
commonly accepted patient to care manager ratio of 1:150, these
commenters believed that under the proposed payment rate, the average
service time possible would be a ceiling of 23 minutes (not a floor of
20 minutes). Based on one tracking study of care manager activity in
minutes per patient per month, they believed complex care management
would require 42 minutes of face-to-face and non-face-to-face time per
month. Assuming the same care manger salary and patient load, the
commenters asserted that the monthly payment amount necessary to
provide this amount of care would be $83 per beneficiary per month.
Response: Our proposal to pay separately for these services is part
of a broader series of potential refinements to the PFS that
appropriately value care management within Medicare's statutory
structure for fee-for-service physician payment. We do not have
statutory authority to base payment under the PFS on a recurring per
beneficiary per month basis. The PFS is limited to a fee-for-service
model at present, and as such we do not use capitated payment for
services that may or may not be furnished in a given month. We refer
the commenter and other interested stakeholders to the preceding
paragraphs that describe a broader set of initiatives that are designed
to improve payment for, and encourage long-term investment in, care
management services, including a variety of CMS and HHS programs and
demonstrations.
Comment: Many commenters recommended a higher valuation for CCM
services than was proposed, with some commenters providing specific
suggestions as to changes in inputs and others simply asserting that a
higher payment was appropriate or necessary to achieve access or the
desired benefit. One commenter recommended a payment of $75 but did not
provide supporting information. Several other commenters recommended
that CMS adopt the RUC-recommended values for CPT code 99490 (work time
of 30 minutes, work RVU of 1.0, and 60 minutes of clinical labor time).
Several commenters believed CMS should adopt the work, PE and MP RVUs
for CPT code 99495, with one commenter suggesting that CMS crosswalk
the PE and MP RVU from the TCM code and not just the work RVU from the
code in order to equalize payment for the CCM code with a per
beneficiary per month payment that is made for similar services through
a state Medicaid program. Another commenter pointed out that the
proposed combined MP and PE RVU of 0.61 for CCM is significantly lower
than for the following similar services that cannot be billed during
same period with CCM: HCPCS code G0181 (Home Healthcare Oversight)
which has a combined MP and PE RVU of 1.28; HCPCS code G0182 (Hospice
Care Plan Oversight) which has a combined MP and PE RVU of 1.30; CPT
code 99339 (Care Plan Oversight Services) which has a combined MP and
PE RVU of 0.94; and CPT code 99358 (Prolonged Services without Direct
Patient Contact) which has a combined MP and PE RVU of 0.98.
Several commenters suggested that CMS's comparison with TCM, CPT
code 99495, was not an appropriate comparison. One commenter asked what
codes other than CPT code 99495 CMS considered as similar to CCM for
purposes of CCM valuation. This commenter believed the time and
intensity required for the non-face-to-face portion of CPT code 99495
is not the same as for CCM services.
Several commenters suggested that CMS should develop PE RVUs for
the service using alternative methodologies than for other PFS
services. For example, several commenters stated that CMS should adjust
the PE RVUs to account for major infrastructure and other costs
required for CCM, especially health information technology, computer
equipment, 24/7 beneficiary access, extensive documentation, nursing
staff and other overhead costs. One commenter believed the proposed
RVUs accounted for personnel costs but not the practice expense for
health information technology, workforce retooling, and analytics.
We received many public comments on the appropriate work time and
direct PE inputs for clinical staff time. Most suggested that the
proposed inputs for time were too low and recommended using the RUC-
recommended values (work time of 30 minutes and 60 minutes of clinical
labor time). Regarding clinical labor time, some commenters believed
the proposed 20 minutes of clinical labor was too low, being the 25th
percentile for work time in the RUC survey, and they noted the
significantly higher time reported in response to the RUC survey of 60
minutes of clinical labor time. Another commenter said that assuming 20
minutes of service time per month as typical significantly undervalues
the service and questioned how CMS arrived at that number. Regarding
the work time, several commenters addressed the work RVU, recommending
that the proposed RVU be adjusted upwards but did not specify by how
much. Several commenters noted that the RUC recommendation of 1.0 work
RVU for CPT codes 99490 and 99487 (Cmplx chron care w/o pt visit) is
based on median survey work times of 30 minutes and 26 minutes,
respectively, for these CCM codes. (The long descriptor for CPT code
99487 is, Complex chronic care management services, with the following
required elements:
Multiple (two or more) chronic conditions expected to last
at least 12 months, or until the death of the patient;
Chronic conditions place the patient at significant risk
of death, acute exacerbation/decompensation, or functional decline;
Establishment or substantial revision of a comprehensive
care plan;
Moderate or high complexity medical decision making;
60 minutes of clinical staff time directed by a physician
or other qualified health care professional, per calendar month).
However several commenters did not object to the proposed valuation
for GXXX1 and recommended that CMS monitor payment adequacy and
appropriate valuation once the code is implemented.
Response: After consideration of the various comments on the work
RVUs, we continue to believe that the most appropriate mechanism for
determining the appropriate work RVU for this service is by using the
non-face-to-face portion of the lower level TCM code, CPT code 99495.
We continue to believe
[[Page 67718]]
that the work and intensity for CCM services furnished to the eligible
beneficiaries is comparable to the work and intensity involved in
furnishing the non-face-to-face portion of the service described by CPT
code 99495. Therefore, we believe that using CPT code 99495 as the
comparison code assures appropriate relativity with other similar
services. The services suggested by the commenters as comparable to the
CCM code require significantly more time. CPT code 99358 is for an hour
of non-face-to-face time and has a work time of 60 minutes. CPT code
99339 has a work time of 40 minutes and is furnished to a significantly
different patient population (those in a domiciliary or rest home).
HCPCS codes G0181 and G0182 have work time of almost 60 minutes and
also are furnished to significantly different patient populations.
We appreciate commenters' concerns regarding the various kinds of
practice expense and malpractice liability costs that practices incur
as they manage beneficiaries requiring CCM services. However, we
continue to believe that our established PE and MP methodology used to
value the wide ranges of services across the PFS assures that we have
the appropriate relativity in our payments.
Although many commenters recommended that we use the time from the
RUC survey of 60 minutes of clinical labor and 30 minutes of work time,
we believe that since CCM is a new separately billable service, the
survey data may be less reliable as the practitioners would have no
experience with the code. Since at least 20 minutes of services are
required to be furnished in order to report the service and our
information, including comments, suggests that many beneficiaries who
meet Medicare's criteria for CCM services would not need more than the
minimum required minutes of service, we believe 60 minutes would
overestimate the typical number of clinical labor minutes during one
month for the typical eligible beneficiary. Accordingly, we are
finalizing our proposed work and clinical labor times.
Comment: A number of commenters recommended that coinsurance should
not apply to CCM services. These commenters were concerned that the $8
estimated coinsurance amount in the proposed rule would hinder
beneficiary access. Several commenters believed that CCM is a
preventive service that should be exempt from beneficiary cost sharing.
They noted that cost-sharing will make it challenging to reach the 20
minutes required for billing, because beneficiaries will delay care
until face-to-face is necessary.
Response: CCM services do not fall into any of the statutory
preventive services benefit categories of the Act. The Secretary has
the authority to add ``additional preventive services'' that, among
other things, have been assigned an ``A'' or ``B'' rating by the United
States Preventive Services Task Force, but CCM has not earned such a
rating. Since CCM does not meet the criteria, we cannot designate it as
an additional preventive service under section 1861(s)(2)(BB) of the
Act. Further, we do not have other statutory authority that would allow
us to waive the applicable coinsurance for CCM services. As discussed
in the CY 2014 PFS final rule with comment period (78 FR 74424), in
order to assure that beneficiaries are aware of the coinsurance for
this non-face-to-face service, we are requiring that providers explain
to beneficiaries the cost-sharing obligation involved in receiving CCM
services and obtain their consent prior to furnishing the service.
Practitioners should explain that a likely benefit of agreeing to
receive CCM services is that although cost-sharing applies to these
services, CCM services may help them avoid the need for more costly
face to face services that entail greater cost-sharing.
Comment: Most of the commenters were concerned that the proposed
payment would not be adequate for beneficiaries with complex needs who
would benefit the most from CCM services. Most of the commenters
recommended that we adopt more than one code to provide differential
payment for more and less complex beneficiaries, using CPT CCM codes,
G-code(s) or some combination thereof. Many commenters distinguished
between beneficiaries that require significantly different clinical
resources--those needing ``complex chronic care management'' and those
needing only ``standard chronic care or disease management.'' Some
commenters asserted that there is a disconnect between the code
descriptor for GXXX1 and the Medicare CCM scope of service, such that
ambiguity in the descriptor will result in use of GXXX1 to treat a very
broad spectrum of beneficiaries inconsistent with the scope of service
that the commenters believed was consistent with beneficiaries with
more complex needs. They believed the proposed payment amount is
appropriate for beneficiaries on needing only standard chronic care
management, but would significantly underpay for beneficiaries
requiring complex chronic care management.
Many commenters recommended that CMS adopt the three CPT codes
describing chronic care management. In addition to the CPT code that is
similar to the G-code described above (CPT code 99490), there are two
additional complex chronic care coordination codes (a base code and an
add-on code). Since CY 2013 when the complex chronic care coordination
codes became available, CMS has bundled these codes. The base code is
CPT code 99487 (Cmplx chron care w/o pt visit), and the add-on is CPT
code 99489 (Complex chronic care coordination services; each additional
30 minutes of clinical staff time directed by a physician or other
qualified health care professional, per calendar month (list separately
in addition to code for primary procedure).
Other commenters recommended using two codes to describe CCM for
different patient populations, or a base code and an add-on code to
describe CCM for a single patient population. Some commenters
recommended adoption of GXXX1 or CPT code 99490, plus CPT code 99487
along with the RUC-recommended values, to describe CCM for the two
distinct populations that require different services. These commenters
stated that there is no ``typical'' patient that characterizes both
groups of patients, and that a large number of eligible beneficiaries
(those having 2 or more chronic conditions) have serious mental health
and/or substance abuse disorders and would benefit greatly from CCM
services). Other commenters recommended using two G-codes, one being an
add-on code for each additional 20 minutes or other time spent caring
for a beneficiary with more complex needs. One commenter urged CMS to
adopt an add-on code for time increments over 60 minutes. Several
commenters recommended a cap on additional minutes, particularly if CMS
finalizes an applicable beneficiary coinsurance for CCM services. One
commenter recommended that we finalize the proposed valuation for
GXXX1, also recognize CPT code 99490 (Chron care mgmt srvc 20 min) with
a higher payment amount, and then collect data on the impacts of
differential payment amounts.
Other commenters recommended that CMS adopt CPT code 99487 (Cmplx
chron care w/o pt visit) with the scope of services for GXXX1. One
commenter recommended that CMS redefine its requirements and the scope
of services for GXXX1 to be more consistent with chronic disease
management, using CPT code 99487. The commenter believed we should
adopt CPT code 99487 with the RUC-recommended valuation. One commenter
more generally
[[Page 67719]]
recommended that CMS adopt a higher intensity code for patients
requiring 45-60 minutes or more of clinical staff time for assessment,
medication management, care planning, coordination, education and
advocacy.
Response: At this time, we believe that Medicare beneficiaries with
two or more chronic conditions as defined under the CCM code can
benefit from care management and want to make this service available to
all such beneficiaries. Like all services, we recognize that some
beneficiaries will need more services and some less, and thus we pay
based upon the typical service. However all scope of service elements
apply for delivery of CCM services to any eligible Medicare
beneficiary. We will evaluate the utilization of this service to
evaluate what types of beneficiaries receive the service described by
this CPT code, what types of practitioners are reporting it, and
consider any changes in payment that may be warranted in the coming
years. We are maintaining the status indicator ``B'' (Bundled) for CY
2015 for the complex care coordination codes, CPT codes 99487 and
99489.
Comment: Several commenters requested that CMS create codes
specific to remote patient biometric monitoring (recording vital signs
and other physiological data and transmitting real-time data to
physicians). Several commenters requested codes specific to or
inclusive of certain hematology, nephrology, endocrine and allergy/
immunology conditions, such as chronic kidney disease, end-stage renal
disease, diabetes and severe asthma. One commenter recommended that CMS
delay implementation of this service for CY 2015 and propose for CY
2016 specific complex chronic care codes for each of the major chronic
diseases, especially diabetes.
Response: We are not convinced that the care management services
are sufficiently unique based upon the beneficiary's specific chronic
conditions to warrant separate codes, especially given the beneficiary
must have at least two chronic conditions. As noted above, we will be
monitoring this service and will consider making changes if they appear
warranted.
After consideration of the comments received on this proposal, we
are finalizing the proposal with the following modification. Rather
than creating a G-code we are adopting the new CPT code, 99490, to
describe CCM services effective January 1, 2015. We intend to evaluate
this service closely to assess whether the service is targeted to the
right population and whether the payment is appropriate for the
services being furnished. As part of our evaluation, we will consider
the whether this new service meets the care coordination needs of
Medicare beneficiaries and if not how best to address the unmet needs.
2. CCM and TCM Services Furnished Incident to a Physician's Service
Under General Physician Supervision
In the CY 2014 PFS final rule with comment period (78 FR 74425
through 74427), we discussed how the policies relating to services
furnished incident to a practitioner's professional services apply to
CCM services. (In this discussion, the term practitioner means both
physicians and NPPs who are permitted to bill for services furnished
incident to their own professional services.) Specifically, we
addressed the policy for counting clinical staff time for services
furnished incident to the billing practitioner's services toward the
minimum amount of service time required to bill for CCM services.
We established an exception to the usual rules that apply to
services furnished incident to the services of a billing practitioner.
Generally, under the ``incident to'' rules, practitioners may bill for
services furnished incident to their own services if the services meet
the requirements specified in our regulations at Sec. 410.26. One of
these requirements is that the ``incident to'' services must be
furnished under direct supervision, which means that the supervising
practitioner must be present in the office suite and be immediately
available to provide assistance and direction throughout the service
(but does not mean that the supervising practitioner must be present in
the room where the service is furnished). We noted in last year's PFS
final rule with comment period that, because one of the required
elements of the CCM service is beneficiary access to the practice 24-
hours-a-day, 7-days-a-week, to address the beneficiary's chronic care
needs (78 FR 74426), we expect the beneficiary to be provided with a
means to make timely contact with health care providers in the practice
whenever necessary to address chronic care needs regardless of the time
of day or day of the week. In those cases when the need for contact
arises outside normal business hours, it is likely that the
beneficiary's initial contact would be with clinical staff employed by
the practice (for example, a nurse) and not necessarily with a
practitioner. Under these circumstances, it would be unlikely that a
practitioner would be available to provide direct supervision of the
service.
Therefore, in the CY 2014 PFS final rule with comment period, we
created an exception to the generally applicable requirement that
``incident to'' services must be furnished under direct supervision.
Specifically, we finalized a policy to require only general, rather
than direct, supervision when CCM services are furnished incident to a
practitioner's services outside of the practice's normal business hours
by clinical staff who are direct employees of the practitioner or
practice. We explained that, given the potential risk to beneficiaries
that the exception to direct supervision could create, we believed that
it was appropriate to design the exception as narrowly as possible (78
FR 74426). The direct employment requirement was intended to balance
the less stringent general supervision requirement by ensuring that
there is a direct oversight relationship between the supervising
practitioner and the clinical staff personnel who provide after-hours
services.
In the CY 2015 PFS proposed rule, we proposed to revise the policy
that we adopted in the CY 2014 PFS final rule with comment period. We
also proposed to amend our regulations to codify the requirements for
CCM and TCM services furnished incident to a practitioner's services.
Specifically, we proposed to remove the requirement that, in order to
count the time spent by clinical staff providing aspects of CCM
services toward the CCM time requirement, the clinical staff person
must be a direct employee of the practitioner or the practitioner's
practice. (We note that the existing requirement that these services be
provided by clinical staff, specifically, rather than by other
auxiliary personnel is an element of the service for both CCM and TCM
services, rather than a requirement imposed by the ``incident to''
rules themselves.) We also proposed to remove the restriction that
services provided by clinical staff under general (rather than direct)
supervision may be counted only if they are provided outside of the
practice's normal business hours. Under our proposed revised policy,
then, the time spent by clinical staff providing aspects of CCM
services can be counted toward the CCM time requirement at any time,
provided that the clinical staff are under the general supervision of a
practitioner and all other requirements of the ``incident to''
regulations at Sec. 410.26 are met.
We proposed to revise these aspects of the policy for several
reasons. First, one of the required elements of the CCM service is the
availability of a means for the beneficiary to make contact with
[[Page 67720]]
health care practitioners in the practice to address a beneficiary's
urgent chronic care needs (78 FR 74418 through 74419). Other elements
within the scope of CCM services are similarly required to be furnished
by practitioners or clinical staff. We believe that these elements of
the CCM scope of service require the presence of an organizational
infrastructure sufficient to adequately support CCM services,
irrespective of the nature of the employment or contractual
relationship between the clinical staff and the practitioner or
practice. We also believe that the elements of the CCM scope of
service, such as the requirement of a care plan, ensure a close
relationship between a practitioner furnishing ongoing care for a
beneficiary and clinical staff providing aspects of CCM services under
general supervision; and that this close working relationship is
sufficient to render a requirement of a direct employment relationship
or direct supervision unnecessary. Under our proposal, CCM services
could be furnished ``incident to'' if the services are provided by
clinical staff under general supervision of a practitioner whether or
not they are direct employees of the practitioner or practice that is
billing for the service; but the clinical staff must meet the other
requirements for auxiliary personnel including those at Sec.
410.26(a)(1). Other than the exception to permit general supervision
for clinical staff, the same requirements apply to CCM services
furnished incident to a practitioner's professional services as apply
to other ``incident to'' services. Furthermore, since last year's final
rule, we have had many consultations with physicians and others about
the organizational structures and other factors that contribute to
effective provision of CCM services. These consultations have convinced
us that, for purposes of clinical staff providing aspects of CCM
services, it does not matter whether the practitioner is directly
available to supervise because the nature of the services are such that
they can be, and frequently are, provided outside of normal business
hours or while the physician is away from the office during normal
business hours. This is because, unlike most other services to which
the ``incident to'' rules apply, the CCM services are intrinsically
non-face-to-face care coordination services.
In conjunction with this proposed revision to the requirements for
CCM services provided by clinical staff incident to the services of a
practitioner, we also proposed to adopt the same requirements for
equivalent purposes in relation to TCM services. As in the case of CCM,
TCM explicitly includes separate payment for services that are not
necessarily furnished face-to-face, such as coordination with other
providers and follow-up with beneficiaries. It would also not be
uncommon for auxiliary personnel to provide elements of the TCM
services when the physician was not in the office. Generally, we
believe that it is appropriate to treat separately billable care
coordination services similarly whether in the form of CCM or TCM. We
also believe that it would be appropriate to apply the same ``incident
to'' rules that we are proposing for CCM services to TCM services. We
did not propose to extend this policy to the required face-to-face
portion of TCM. Rather, the required face-to-face portion of the
service must still be furnished under direct supervision.
Therefore, we proposed to revise our regulation at Sec. 410.26,
which sets out the applicable requirements for ``incident to''
services, to permit TCM and CCM services provided by clinical staff
incident to the services of a practitioner to be furnished under the
general supervision of a physician or other practitioner. As with other
``incident to'' services, the physician (or other practitioner)
supervising the auxiliary personnel need not be the same physician (or
other practitioner) upon whose professional service the ``incident to''
service is based. We note that all other ``incident to'' requirements
continue to apply and that the usual documentation of services provided
must be included in the medical record.
Commenters uniformly supported our proposal to revise our
regulation at Sec. 410.26, which sets out the applicable requirements
for ``incident to'' services, to permit TCM and CCM services provided
by clinical staff incident to the services of a practitioner to be
furnished under the general supervision of a physician or other
practitioner. Under the revised regulation, then, the time spent by
clinical staff providing aspects of TCM and CCM services can be counted
toward the TCM or CCM time requirement at any time, provided that the
clinical staff are under the general supervision of a practitioner and
all requirements of the revised ``incident to'' regulations at Sec.
410.26 are met.
Comment: One commenter requested guidance concerning whether (as
has been the case with E/M codes) activities billed under ``incident
to'' will not be able to also be billed under the CCM code.
Response: The purpose of our proposal was to allow elements of CCM
services that are furnished by clinical staff incident to a
practitioner's professional services (under the ``incident to''
regulations) to be included and reported as CCM services. We are not
entirely clear what the commenter is asking, but the time spent
furnishing CCM services can only be counted once and for only one
purpose, and each discrete service can be billed only once. Although we
and our contractors provide many educational materials, practitioners
who furnish Medicare covered items and services are responsible for
learning how to appropriately bill each service.
Comment: One commenter urged us to revise the terminology by which
we define the CCM and TCM services to reflect non-hierarchical
interdisciplinary team care, rather than relying on an incident-to
structure that obscures the actual provider of direct patient care.
This commenter expressed concern about loss of benefits to clinicians
under contract with a practice, rather than being employed by the
practice. Another commenter similarly expressed concern that the
expanded authorization for ``general supervision'' rather than ``direct
supervision'' would provide an even greater incentive for physicians to
require that any E/M service provided by an Advanced Practice
Registered Nurse (APRN) in their practice be billed as ``incident to''
a physician's service. This could reduce transparency in billing data
and diminish accountability for services for Part B beneficiaries.
Response: We do not entirely understand the basis for these
concerns. We have accommodated numerous requests to include contracted
employees within the scope of the ``incident to'' rules for purposes of
counting time toward the TCM and CCM requirements. We have not
otherwise proposed to revise the ``incident to'' and other regulations
within which practitioners operate as they make decisions about whether
to contract or directly employ clinical staff, or about how to bill for
services provided. Although they are important within the context of
the new TCM and CCM services, we believe that the revisions to our
``incident to'' regulation that are adopted in this final rule, are
peripheral in the context of the overall employment and billing
practices of physicians and group practices.
After consideration of the comments, we are finalizing our proposal
to revise our regulation at Sec. 410.26, which sets out the applicable
requirements for ``incident to'' services, to permit the CCM and non-
face-to-face portion of the TCM services provided by clinical staff
incident to the services of a practitioner
[[Page 67721]]
to be furnished under the general supervision of a physician or other
practitioner.
3. Scope of Services and Standards for CCM Services
In the CY 2014 final rule with comment period (78 FR 74414 through
74428), we defined the elements of the scope of service for CCM that
are required for a practitioner to bill Medicare for the CCM service.
In addition, we indicated that we intended to develop standards for
practices that furnish CCM services to ensure that the practitioners
who bill for these services have the capability to fully furnish them
(78 FR 74415, 74418). At that time, we anticipated that we would
propose these standards in the CY 2015 PFS proposed rule. We actively
sought input toward development of these standards by soliciting public
comments on the CY 2014 PFS final rule with comment period, through
outreach to stakeholders in meetings, by convening a Technical Expert
Panel, and by collaborating with federal partners such as the Office of
the Assistant Secretary for Planning and Evaluation, the Office of the
Assistant Secretary for Health, the Office of the National Coordinator
for Health Information Technology (ONC), and the Health Resources and
Services Administration. Our goal is to recognize the trend toward
practice transformation and overall improved quality of care, while
preventing unwanted and unnecessary care.
As we worked to develop appropriate practice standards that would
meet this goal, we consistently found that many of the standards we
thought were important overlapped in significant ways with the scope of
service or with the billing requirements for the CCM services that had
been finalized in the CY 2014 final rule with comment period. In cases
where the standards we identified were not unique to CCM requirements,
we found that the standards overlapped with other Medicare requirements
or other federal requirements that apply generally to health care
practitioners. Based upon the feedback we received, we sought to avoid
duplicating other requirements or, worse, imposing conflicting
requirements on practitioners that would furnish CCM services. Given
the standards and requirements that are already in place for health
care practitioners and applicable to those who furnish and bill for CCM
services, we decided not to propose an additional set of standards that
would have to be met in order for practitioners to furnish and bill for
CCM services. Instead of proposing a new set of standards applicable to
only CCM services, we decided to emphasize that certain requirements
are inherent in the elements of the existing scope of service for CCM
services, and clarify that these must be met in order to bill for CCM
services. The CCM scope of service elements finalized in the CY 2014
PFS final rule (78 FR 74414 through 74428) are as follows.
The provision of 24-hour-a-day, 7-day-a-week access to
address the patient's acute chronic care needs. To accomplish this, the
patient must be provided with a means to make timely contact with
health care providers in the practice to address the patient's urgent
chronic care needs regardless of the time of day or day of the week.
Continuity of care with a designated practitioner or
member of the care team with whom the patient is able to get successive
routine appointments.
Care management for chronic conditions including
systematic assessment of the patient's medical, functional, and
psychosocial needs; system-based approaches to ensure timely receipt of
all recommended preventive care services; medication reconciliation
with review of adherence and potential interactions; and oversight of
patient self-management of medications.
In consultation with the patient, any caregiver and other
key practitioners treating the patient, the practitioner furnishing CCM
services must create a patient-centered care plan document to assure
that care is provided in a way that is congruent with patient choices
and values. The care plan is based on a physical, mental, cognitive,
psychosocial, functional and environmental (re)assessment and an
inventory of resources and supports. It is a comprehensive plan of care
for all health issues, and typically includes, but is not limited to,
the following elements: problem list, expected outcome and prognosis,
measurable treatment goals, symptom management, planned interventions,
medication management, community/social services ordered, how the
services of agencies and specialists unconnected to the billing
practice will be directed/coordinated, identify the individuals
responsible for each intervention, requirements for periodic review
and, when applicable, revision of the care plan. A full list of
problems, medications and medication allergies in the EHR must inform
the care plan, care coordination and ongoing clinical care.
Management of care transitions within health care,
including referrals to other clinicians, follow-up after the patient's
visit to an emergency department, and follow-up after discharges from
hospitals, skilled nursing facilities, or other health care facilities.
The practice must facilitate communication of relevant patient
information through electronic exchange of a summary care record with
other health care providers regarding these transitions. The practice
must also have qualified personnel who are available to deliver
transitional care services to the patient in a timely way so as to
reduce the need for repeat visits to emergency departments and
readmissions to hospitals, skilled nursing facilities or other health
care facilities.
Coordination with home and community based clinical
service providers required to support the patient's psychosocial needs
and functional deficits. Communication to and from home and community
based providers regarding these patient needs must be documented in the
patient's medical record.
Enhanced opportunities for the beneficiary and any
relevant caregiver to communicate with the practitioner regarding the
beneficiary's care through, not only telephone access, but also through
the use of secure messaging, internet or other asynchronous non face-
to-face consultation methods.
Similarly, we reminded stakeholders of the following additional
billing requirements established in the CY 2014 final rule with comment
period (in the following list, we have changed the service period from
the 2015 proposed 30-day period to the final 2015 service period of one
calendar month):
Inform the beneficiary about the availability of the CCM
services from the practitioner and obtain his or her written agreement
to have the services provided, including the beneficiary's
authorization for the electronic communication of the patient's medical
information with other treating providers as part of care coordination.
Document in the beneficiary's medical record that all
elements of the CCM service were explained and offered to the
beneficiary, and note the beneficiary's decision to accept or decline
the service.
Provide the beneficiary a written or electronic copy of
the care plan and document in the electronic medical record that the
care plan was provided to the beneficiary.
Inform the beneficiary of the right to stop the CCM
services at any time (effective at the end of a calendar month) and the
effect of a revocation of the agreement to receive CCM services.
Inform the beneficiary that only one practitioner can
furnish and be paid for
[[Page 67722]]
these services during the calendar month service period.
In one area, electronic health records (EHRs), we were concerned
that the existing elements of the CCM service could leave some gaps in
assuring that beneficiaries consistently receive care management
services that offer the benefits of advanced primary care as it was
envisioned when this service was created. It is clear that effective
care management can be accomplished only through regular monitoring of
the patient's health status, needs, and services, and through frequent
communication and exchange of information with the patient and among
the various health care practitioners and providers treating the
patient. After gathering input from stakeholders through the CY 2014
rulemaking cycle, for 2015 we proposed a new scope of service element
that would require use of a certified EHR and electronic care planning
to furnish CCM services. We believed that requiring those who furnish
CCM services to utilize EHR technology that has been certified by a
certifying body authorized by the National Coordinator for Health
Information Technology was necessary to ensure that key patient
information is stored, shared and reconciled among the many
practitioners and providers involved in managing the patient's chronic
conditions, otherwise care could not be coordinated and managed.
Requiring a certified EHR would enable members of the interdisciplinary
care team to have immediate access to the most updated information
informing the care plan. Therefore we proposed that the billing
practitioner must utilize EHR technology certified by a certifying body
authorized by the National Coordinator for Health Information
Technology to an edition of the EHR certification criteria identified
in the then-applicable version of 45 CFR part 170. We proposed that at
a minimum, the practice must utilize EHR technology that meets the
certification criteria adopted at 45 CFR 170.314(a)(3), 170.314(a)(4),
170.314(a)(5), 170.314(a)(6), 170.314(a)(7) and 170.314(e)(2)
pertaining to the capture of demographics, problem lists, medications,
and other key elements related to the ultimate creation of an
electronic summary care record. These sections of the regulation
comprise the certification criteria for specific core technology
capabilities (structured recording of demographics, problems,
medications, medication allergies, and the creation of a structured
clinical summary) for the 2014 edition. Under the proposal,
practitioners furnishing CCM services beginning in CY 2015 would be
required to utilize an EHR certified to at least these 2014 edition
certification criteria. Given these 2014 edition criteria, the EHR
technology would be certified to capture data and ultimately produce
summary records according to the HL7 Consolidated Clinical Document
Architecture standard (see 45 CFR 170.205(a)(3)).
In addition, when any of the CCM scope of service elements refers
to a health or medical record, we proposed to require use of an EHR
certified to at least the 2014 edition certification criteria to
fulfill the scope of service element in relation to the health or
medical record. As finalized in the CY 2014 PFS final rule, the scope
of service elements that reference a health or medical record are:
A full list of problems, medications and medication
allergies in the EHR must inform the care plan, care coordination and
ongoing clinical care.
Communication to and from home and community based
providers regarding the patient's psychosocial needs and functional
deficits must be documented in the patient's medical record.
Inform the beneficiary of the availability of CCM services
and obtain his or her written agreement to have the services provided,
including authorization for the electronic communication of his or her
medical information with other treating providers. Document in the
beneficiary's medical record that all of the CCM services were
explained and offered, and note the beneficiary's decision to accept or
decline these services.
Provide the beneficiary a written or electronic copy of
the care plan and document in the electronic medical record that the
care plan was provided to the beneficiary.
Regarding the care plan in particular, we believed that requiring
practitioners furnishing CCM services to maintain and share an
electronic care plan would alleviate the errors that can occur when
care plans are not systematically reconciled. To ensure that practices
offering CCM services meet these needs, we proposed that CCM services
must be furnished with the use of an EHR or other health IT or health
information exchange platform that includes an electronic care plan
that is accessible to all practitioners within the practice, including
being accessible to those who are furnishing care outside of normal
business hours, and that is available to be shared electronically with
care team members outside of the practice. This was a more limited
proposal compared to our CY 2014 proposal that we did not finalize that
would have required members of the chronic care team who are involved
in the after-hours care of the patient to have access to the
beneficiary's full electronic medical record (78 FR 74416 through
74417).
Regarding the clinical summary, we proposed to require technology
certified to the 2014 edition for the electronic creation of the
clinical summary, formatted according to the standard adopted at 45 CFR
170.205(a)(3), but we did not specify that this format must be used for
the exchange of beneficiary information (79 FR 40367). For instance, we
did not propose that practitioners billing for CCM services must adopt
certified technology related to the exchange of a summary care record
such as the transmission standard related to Direct Project Transport
in 45 CFR 170.314(b)(2)(ii).
We indicated that we believed our proposed new scope of service
element for a certified EHR and electronic care planning would ensure
that practitioners billing for CCM could fully furnish the services,
allow practitioners to innovate around the systems that they use to
furnish these services, and avoid overburdening small practices. We
indicated that we believed that allowing flexibility as to how
practitioners capture, update, and share care plan information was
important at this stage given the maturity of current EHR standards and
other electronic tools in use in the market today for care planning.
In addition to seeking comment on this new proposed scope of
service element, we sought comment on any changes to the scope of
service or billing requirements for CCM services that may be necessary
to ensure that the practitioners who bill for these services have the
capability to furnish them and that we can appropriately monitor
billing for these services. With the addition of the electronic health
information technology element that we proposed, we believed that the
elements of the scope of service for CCM services, when combined with
other important federal health and safety regulations, would provide
sufficient assurance that practitioners billing for CCM could fully
furnish the services, and that Medicare beneficiaries receiving CCM
would receive appropriate services. However we expressed special
interest in receiving public feedback regarding any meaningful elements
of the CCM service or beneficiary protections that may be missing from
the scope of service elements and billing requirements.
The following paragraphs summarize the comments we received
regarding
[[Page 67723]]
these elements of the scope of service for CCM services and our
responses.
Comment: Some commenters were disappointed that CMS did not propose
an additional set of standards. The commenters expressed concern that
there would not be sufficient accountability for high quality CCM
services. Some commenters recommended further development of standards
such as inclusion of evidence-based self-management programs offered by
community organizations, quality measures that engage patients and
demonstrate improved outcomes, or a best practices guide to assist the
physician community with implementation. However, many commenters
opposed further standards, and agreed with CMS that additional
standards would largely overlap with other Medicare requirements or
were already reflected in the scope of service elements.
Response: We appreciate the commenters' concerns about ensuring
quality of care. We continue to believe that with the addition of the
EHR element, the required scope of service elements are sufficient for
ensuring high quality CCM services in 2015. We note that section III.K
of this final rule with comment period addresses quality measures for
physicians' services, and stakeholders may submit suggestions for
quality measures related to CCM in response to this section of the
regulation.
Comment: Many commenters expressed broad support for our EHR
proposal. The commenters commended the strong emphasis on data sharing
and requirements for a robust EHR as vital to successful care
coordination and continuity of care. Several commenters did not believe
the proposal would pose a significant administrative burden. One
commenter noted that use of an EHR would help practitioners to document
the time spent furnishing CCM services.
Although commenters supported adoption of certified EHR technology
(CEHRT) generally, many were concerned that an insufficient number of
physicians have adopted CEHRT with the functionalities we proposed for
CCM, especially interoperability with other providers. The commenters
were also concerned that physicians practicing in rural or economically
depressed areas would not have the resources to implement such
technology and would be disqualified from furnishing separately
billable CCM services. Many believed the proposal was laudable but
premature, recommending that CMS delay adoption of the 2014 EHR
certification criteria for CCM services by 3 to 4 years when they will
be more widely adopted, or phase in the 2014 certification criteria
over 2 years as a requirement for 2017. Several commenters recommended
that we finalize our proposal but provide hardship exceptions for
certain smaller or rural practices to enable them to bill separately
for CCM services in the absence of an interoperable EHR in certain
circumstances, provide financial incentives, or allow other flexibility
around the requirements for physicians who cannot meet them at this
time. One commenter supported the proposal but suggested we allow
aspects of CCM services to be furnished using fax and secure messaging
technology if physicians encounter challenges with interoperability.
Until EHR systems are interoperable, some commenters suggested allowing
practitioners to attest that all requirements for billing CCM were met
using CEHRT or an alternative technology, or to attest that all members
of the care team have timely access (24/7 access in ``real time'' or
``near real time'') to the most updated information regarding the care
plan through either electronic or non-electronic means, with ongoing
efforts to implement interoperable EHRs. The commenters stated many
practices are making patient information accessible in a timely manner
to the entire care team, but have not yet fully implemented an
interoperable EHR with other providers. Several commenters were
concerned about the ability of current EHR technologies to share
information across different providers and EHR systems. Commenters
requested that CMS ensure that no certified EHR contains technological
or business impediments to data sharing across disparate technology
platforms used by multiple providers trying to coordinate care. In
addition, many commenters were concerned about access to CCM services,
and recommended that CMS prioritize access over adoption of CEHRT.
Several commenters stated that not all types of physicians have access
to an EHR that meets the needs of their specialty.
A number of commenters stated that CCM could be (and already is)
effectively provided without any EHR or a without a certified EHR, and
recommended that CMS rescind the proposal or make the EHR requirement
optional. These commenters disagreed with the requirement that CCM
services must be furnished with use of a certified EHR, information
technology (IT) platform or exchange platform that includes a care
plan, with some stating that certified EHR systems have not
demonstrated improvements in the management of chronic conditions,
especially complex cases, and suggested postponing the care plan and
other EHR requirements until they are proven effective and adopted by
most providers. Others stated that an EHR was necessary and that CMS
should require an EHR that promotes communication among various
professional on the care team, includes the patient as part of the
team, and enables clinical monitoring and effective care planning.
Commenters indicated that many physicians accomplish this through
generating or receiving electronic discharge summaries, clinical
documentation, and patient-centered plans of care, but are not using
certified technologies to carry out these functions and should not be
penalized.
One commenter stated that only about half of all physicians had an
EHR system with advanced functionalities in 2013, many current systems
were not designed with interoperability in mind and transition costs
are high. The commenter believed the proposed payment amount would not
sufficiently cover the cost of purchasing or upgrading an EHR system,
and requiring a certified EHR would limit the number of eligible
physicians without significantly adding value to CCM services. Another
commenter stated that only 1,000 physicians and other eligible health
professionals have achieved Stage 2 of Meaningful Use of certified EHR
technology, compared with more than 300,000 physicians and eligible
professionals who have achieved Stage 1.
Response: We continue to believe that it is necessary to require
the use of EHR technology that has been certified under the ONC Health
IT Certification Program as requisite for receiving separate payment
for CCM services, to ensure that practitioners have adequate
capabilities to allow members of the interdisciplinary care team to
have timely access to the most updated information informing the care
plan. We agree with commenters that health IT tools are most effective
when there are no technological or business impediments to data
sharing, or disparate technology platforms used by multiple providers
trying to coordinate care, and that we should ensure common
functionalities as much as possible across providers. However, we also
agree with commenters who expressed concern that requiring the most
recent edition of EHR certification criteria could be an impediment to
the broad utilization of the CCM service. In response to comments, we
are modifying our proposal regarding which
[[Page 67724]]
edition of certified EHR technology will be required, in order to allow
more flexibility as practitioners transition to the use of certified
EHR technology. Accordingly, we are modifying our proposal to specify
that the CCM service must be furnished using, at a minimum, the
edition(s) of certification criteria that is acceptable for purposes of
the EHR Incentive Programs as of December 31st of the calendar year
preceding each PFS payment year (hereinafter ``CCM certified
technology'') to meet the final core technology capabilities
(structured recording of demographics, problems, medications,
medication allergies, and the creation of a structured clinical
summary). Practitioners must also use this CCM certified technology to
fulfill the CCM scope of service requirements whenever the requirements
reference a health or medical record. This will ensure that
requirements for CCM billing under the PFS are consistent throughout
each PFS payment year and are automatically updated annually according
to the certification criteria required for the EHR Incentive Programs.
For CCM payment in CY 2015, this policy will allow practitioners to use
EHR technology certified to either the 2011 or 2014 edition(s) of
certification criteria to meet the final core capabilities for CCM and
to fulfill the CCM scope of service requirements whenever the
requirements reference a health or medical record. We are finalizing
the separate provision we proposed for the electronic care plan scope
of service element without modification as discussed below. We remind
stakeholders that for all electronic sharing of beneficiary information
under our final CCM policies, HIPAA standards apply in the usual
manner.
Comment: Several commenters questioned the relationship between the
Meaningful Use criteria and the proposed EHR scope of service element
for CCM. One commenter stated that none of the requirements for EHR
capability for payment of CCM services should be tied to or related to
Meaningful Use, because many of the Meaningful Use requirements do not
apply to CCM. Another commenter supported what they understood to be
our proposal, to require billing physicians to adopt an EHR and utilize
it to meet the most recent standard for Meaningful Use. However, the
commenter noted (similar to the previous commenter) that the current
functionalities and standards for EHR technology required for
Meaningful Use are not entirely aligned with the functionalities
required for CCM, for example the commenter believed that the
electronic care plan need only be shared 10 percent of the time to meet
Meaningful Use measures, but that CCM would require it to be available
24/7 and to all practitioners. The commenter expressed concern that
practitioners might not be able to furnish CCM as envisioned by CMS due
to discrepancies with the Meaningful Use criteria, and urged CMS to
adopt interoperability standards for Meaningful Use that would enable
successful care coordination models. Another commenter recommended that
enforcement of the proposed EHR requirement be coterminous with the
enforcement of Meaningful Use Stage 2 to ensure practices have the
ability to comply.
Response: Although we understand why some commenters would like for
the requirements for the EHR Incentive Programs and the EHR scope of
service element for CCM to be identical, we do not believe that is
entirely possible because of the different nature and purpose of the
respective EHR specifications. In many respects they are not comparable
requirements. For example, the PFS sets payment requirements
prospectively for a given calendar year, while the EHR Incentive
Program may change requirements mid-year. In addition, many of the
Meaningful Use measures are not relevant for the provision of CCM and
we believe we should only require practitioners to adopt the certified
technology that is relevant to the scope of CCM services. In their
attempts to meet Meaningful Use criteria for a given year,
practitioners are required to use technology certified to a specific
edition(s) of certification criteria to meet the CEHRT definition, and
as we discussed above we are aligning the edition required to bill CCM
with the edition(s) required for Meaningful Use each year. However, it
is conceivable that a practitioner could use CCM certified technology
to provide and be paid for CCM in a given calendar year that will not
be sufficient for achieving Meaningful Use in that same year because
CCM must be furnished using at least the edition(s) of certified EHR
technology required for the EHR Incentive Programs as of December 31st
of the prior calendar year. Also, it is possible that a practitioner
could use technology certified to an edition that qualifies for CCM
payment that could also be used to achieve Meaningful Use for a given
calendar year, but still not meet the objectives and associated
measures of a particular stage of Meaningful Use that are required to
qualify for an EHR Incentive payment or avoid a downward adjustment to
payments. As the commenters noted, the Meaningful Use measures are not
all relevant to the provision of CCM services, and the practitioner may
not have sufficient certified technology to support all the necessary
or relevant Meaningful Use objectives and measures under the EHR
Incentive Programs. Certified technology is used in different ways to
meet the requirements of each program. We believe that the policy we
are finalizing here aligns the CCM scope of service element to the
extent appropriate with the EHR Incentive Programs to achieve maximum
consistency.
Comment: Several commenters asked us to clarify the requirement for
the electronic care plan in relationship to the overall requirement for
a certified EHR and in relationship to the 24/7 access requirement. The
commenters stated they were not sure whether these proposals were
independent provisions or impacted one another. The commenters stated
that if CMS intended these as independent provisions, the agency should
identify objective criteria to evaluate whether a particular health IT
product has adequate capabilities to meet the separate requirement for
the electronic care plan. The commenters stated they were not sure
whether the electronic care plan would require a certified EHR, or
whether there would be an exception to use of CEHRT for the care plan.
The commenters recommended flexibility in how practitioners and
providers capture, develop, update and share care plan information. One
commenter recommended that if practitioners must attest to use of a
qualifying electronic care plan, CMS should only require a simple yes/
no response to minimize billing impediments. One commenter asked us to
clarify the required elements of the care plan in relation to different
EHR systems.
In addition, several commenters requested that we clarify whether
the care plan must be electronically accessible 24/7 to all providers
treating the patient's chronic conditions, those within the billing
practice, or those within the billing practice who are communicating
with the patient after hours. The commenters noted that providers other
than the billing practitioner may not use the same certified EHR, so it
would be unreasonable to expect the same care plan and other relevant
information to be accessible to all providers at all times. Other
commenters believed we proposed flexibility around the certified EHR
requirement in relation to the
[[Page 67725]]
electronic care plan, and supported this proposed flexibility.
Response: Regarding the care plan, we proposed that CCM services
must be furnished with the use of an EHR or other health IT or health
information exchange platform (not necessarily a certified EHR) that
includes an electronic care plan that is accessible at all times to the
practitioners within the practice, including those who are furnishing
CCM outside of normal business hours. By practitioners ``within the
practice,'' we mean any practitioners furnishing CCM services whose
minutes count towards a given practice's time requirement for reporting
the CCM billing code.
In addition, we proposed that the electronic care plan must be
available to be shared electronically with care team members outside
the practice (who are not billing for CCM). We sought to convey that
practitioners could satisfy these requirements related to the care plan
without using the certified EHR technology. We specified that the
certified EHR technology is only required to accomplish activities
described in the scope of service elements that specifically mention a
medical record or EHR. We said that a full list of problems,
medications and medication allergies in the certified EHR (which would
follow structured recording formats) must inform the care plan, not
that the care plan itself must be created or transmitted among
providers using certified EHR technology. We note that this was a
limited proposal compared to our CY 2014 proposal that we did not
finalize that would have required members of the chronic care team who
are involved in the after-hours care of the patient to have access to
the patient's full electronic medical record instead of just the care
plan (78 FR 74416 through 74417).
Through separate requirements for the electronic care plan and the
certified EHR, our intent was to require practitioners to use some form
of electronic technology tool or service in fulfilling the care plan
element (other than facsimile transmission), recognizing that certified
EHR technology is limited in its ability to support electronic care
planning at this time, and that practitioners must have flexibility to
use a wide range of tools and services beyond certified EHR technology
now available in the market to support electronic care planning. We
intended that all care team members furnishing CCM services that are
billed by a given practice (contributing to the minimum time required
for billing) must have access to the electronic care plan at all times
when furnishing CCM services. However, the electronic care plan would
not have to be available at all times to other non-billing practices,
recognizing that other practices may not be using compatible electronic
technology or participating in a health information exchange.
We are finalizing the electronic care plan and 24/7 access elements
as proposed, clarifying that to satisfy the care plan scope of service
element, practitioners must electronically capture care plan
information and make this information available to all care team
members furnishing CCM services that are billed by a given practice
(counting towards the minimum monthly service time), even when
furnishing CCM outside of normal business hours. In addition,
practitioners must electronically share care plan information as
appropriate with other providers and practitioners who are furnishing
care to the patient. We are not requiring that practitioners use a
specific electronic technology to meet the requirement for 24/7 access
to the care plan or its transmission, only that they use an electronic
technology other than facsimile. For instance, practices may satisfy
the 24/7 care plan access requirement through remote access to an EHR,
web-based access to a care management application, or web-based access
to a health information exchange service that captures and maintains
care plan information. Likewise, we are not requiring that
practitioners use a specific electronic technology to meet the
requirement to share care plan information electronically with other
practitioners and providers who are not billing for CCM. For instance,
practitioners may meet this sharing requirement through the use of
secure messaging or participation in a health information exchange with
those practitioners and providers, although they may not use facsimile
transmission.
While we are not requiring that practitioners use a specific
electronic technology at this time (other than not allowing facsimile),
we may revisit this requirement as standards-based exchange of care
plan information becomes more widely available in the future. We remind
stakeholders that for all electronic sharing of beneficiary information
under our final CCM policies, HIPAA standards apply in the usual
manner.
Comment: Several commenters asked us to clarify the relationship
between the certified EHR proposal and the summary record exchange
requirement. Commenters believed that CMS had cited specific regulatory
provisions around exchange in the proposed rule (identified by the
commenter as a Summary Record Exchange (SRE) capability tag, referring
to a designation used to identify those products on the Certified
Health IT Product List maintained by ONC offering technology certified
to criteria around the exchange of summary care records) and should
consider alternatives. The commenters were not clear as to whether they
objected to what they believed to be the proposed format or the
transmission method of the summary record exchange.
Response: In the CY 2014 PFS final rule with comment period, as
part of the care transitions management scope of service element, we
indicated that the practice must be able to facilitate the
communication of relevant patient information through electronic
exchange of a summary care record with other health care providers (78
FR 74418). We did not specify a standard for the ``summary care
record'' that providers must exchange electronically, nor did we
specify a method by which providers must facilitate the communication
of beneficiary information, such as use of certified EHR technology. In
the CY 2015 PFS proposed rule (79 FR 40367), we proposed that the
practitioner must utilize EHR technology certified by a certifying body
authorized by the National Coordinator for Health Information
Technology to an edition of the EHR certification criteria identified
in the then-applicable version of 45 CFR part 170. Under one of the
specific certification criteria cited, we proposed that practitioners
must use technology that meets the criterion adopted at Sec.
170.314(e)(2), which would ensure that they produce summary records
formatted according to the standard adopted at Sec. 170.205(a)(3).
However, we did not propose that this formatting standard must be used
for the exchange of patient information, only that in furnishing CCM
services, practitioners must format their summaries according to this
standard. We did not propose that providers billing for CCM services
must adopt any certified technology for the exchange of a summary care
record, such as the transmission standard related to Direct Project
Transport in Sec. 170.314(b)(2)(ii). We recognized that providers are
currently exchanging patient information to support transitions of care
in a variety of meaningful ways beyond the methods specified with 2014
edition certified technology, with the exception of faxing which would
not meet the proposed scope of service requirement. The 2014
[[Page 67726]]
edition sets specific requirements for transmission or exchange of the
summary record that technology must meet for certification, and we
expected that only some practitioners could adopt and use such
technology in CY 2015. Therefore we did not constrain practitioners to
the exchange functionality in the 2014 edition if they utilized an
alternative electronic tool.
As discussed above, our final policy will allow practitioners
billing the PFS for CCM services to use the edition(s) of certification
criteria that is acceptable for the EHR Incentive Programs as of
December 31st of each calendar year preceding each PFS payment year to
meet the final core technology capabilities (structured recording of
demographics, problems, medications, medication allergies, and the
creation of a structured clinical summary). (Also practitioners must
use this CCM certified technology to fulfill the CCM scope of service
requirements whenever the requirements reference a health or medical
record). Under this final policy, practitioners must format their
structured clinical summaries according to, at a minimum, the standard
that is acceptable for the EHR Incentive Programs as of December 31st
of the calendar year preceding each PFS payment year.
We are finalizing our proposal that practitioners must communicate
relevant patient information through electronic exchange of a summary
care record to support transitions of care, with a clarification that
practitioners do not have to use any specific content exchange standard
in CY 2015. We did not propose and are not finalizing a requirement to
use a specific tool or service to communicate beneficiary information,
as long as providers do so electronically. We note however that faxing
will not fulfill this requirement for exchange of the summary care
record. We did not propose to modify our view, discussed in the CY 2014
PFS final rule with comment period, that practitioners furnishing and
billing for CCM services must be able to support care transitions
through the electronic exchange of beneficiary information in a summary
care record (78 FR 74418). While certain 2014 edition certification
criteria address a content standard and transmission method for
exchange of a summary record, we continue to expect that only some
practitioners could adopt and use such technology. Moreover, we
recognize that providers are currently exchanging patient information
to support transitions of care in a variety of meaningful ways beyond
the methods specified in 2014 edition certification criteria. We
continue to believe that at least for CY 2015, we should allow
flexibility in the selection of the electronic tool or service that is
used to transmit beneficiary information in support of care
transitions, as long as practitioners electronically share beneficiary
information to support transitions of care. Finally we remind
stakeholders that for all electronic sharing of beneficiary information
under our final CCM policies, HIPAA standards apply in the usual
manner.
Comment: Several commenters expressed concern about requiring a
certified EHR for billing CCM. The commenters were concerned that CMS
would not allow the use of non-certified technologies that may be more
innovative and effective than certified technologies. Commenters
requested that we clarify whether only the certified EHR (and no other
electronic tool) could be used to conduct CCM services, for example the
use of enhanced communication methods other than telephone. One
commenter stated that many times the practice will be using the
certified EHR system to carry out such activities, and there are strong
Meaningful Use incentives to employ the certified EHR for these
activities. However, a practice may also have other capabilities and
tools that would support elements of the CCM services. These commenters
asked us to clarify whether the requirement to utilize certified EHR
technology is a literal statement that only certified EHR technology
may be used in furnishing the scope of service elements for CCM
services.
Response: We continue to believe that health IT tools are most
effective when there are no technological or business impediments to
data sharing, or disparate technology platforms used by multiple
practitioners trying to coordinate care. For the separately billable
CCM service, we believe it is necessary to establish as part of the
scope of the service a certified EHR that allows for the data capture,
accessibility and sharing capabilities necessary to furnish the
service. Therefore, we are finalizing our proposal to require use of
CCM certified technology to meet the final core technology capabilities
(structured recording of demographics, problems, medications,
medication allergies, and the creation of a structured clinical
summary). In addition, whenever a scope of service element references a
health or medical record, CCM certified technology must be used to
fulfill that scope of service element in relation to the health or
medical record. We have listed above the current scope of service
elements that include a reference to a health or medical record. If
both CCM certified technology and other methods are available to the
practitioner to fulfill the final core technology capabilities for CCM
(structured recording of demographics, problems, medications,
medication allergies, and the creation of a structured clinical
summary) or the CCM scope of service elements referencing a the health
or medical record, practitioners may only use the certified capability.
We remind stakeholders that for all electronic sharing of beneficiary
information under our final CCM policies, HIPAA standards apply in the
usual manner.
Comment: One commenter recommended that we adopt the following
additional 2014 EHR certification criteria:
Patient List Creation (45 CFR 170.314(a)(14)), which would
support the required element of service for preventive services and
routine appointments, and could help provide registry types of
functions for the practice to use in managing patients who have agreed
to participate in the chronic care management service.
Patient-Specific Education Resources (Sec.
170.314(a)(15)), which would help assure the ability to provide the
patient with relevant educational materials about their chronic disease
conditions.
Clinical Reconciliation (Sec. 170.314(b)(4)), which would
serve support the medication reconciliation requirement and the
requirement to review patient adherence to their medication regime.
View/Download/Transmit to a 3rd Party (Sec.
170.314(e)(1)), which would enable patients to access their own
electronic health record and have access to information related to
their care at their own convenience.
Secure Messaging, Ambulatory Setting Only (Sec.
170.314(e)(3)).
Response: Some of these 2014 certification criteria are not
relevant (have no corollary) in the 2011 certification criteria, so we
would not require them because practitioners are not required to use
the 2014 edition in CY 2015. In addition, we are requiring that
providers use certified EHR technology to fulfill a limited number of
the scope of service elements (summarized in Table 33). We are
requiring the certified technology only for certain foundational
elements, and believe we should avoid making the EHR requirement for
CCM unnecessarily complex at this time. While we agree that the other
features of certified EHR products mentioned by the commenter would
certainly help many practitioners fulfill the other elements of the CCM
[[Page 67727]]
service, practitioners may be using tools other than certified
technology that are adequate for the required task(s), for example,
registry tools for patient list creation, educational resources,
patient portals, third party reconciliation services, and secure
messaging systems.
Comment: We received many comments on the scope of service elements
other than the EHR, some requesting that we implement additional
standards. A few commenters said CMS should consider adding a
requirement for use of community based providers through a home visit
at least once every 12 months to assess the home environment and the
need for community based resources, or that CMS should include home and
domiciliary care, group visits and community based care. Several
commenters wanted us to include ``remote patient monitoring'' or
``patient generated health data'' in the scope of services, such as
daily remote monitoring of physiology and biometrics. Several
commenters recommended additional tools for patient self-management
education and training, or ``patient activation'' tools. One commenter
recommended we require a patient experience survey to assess the
patient's perspective regarding the CCM services they receive. Several
commenters believed we should expand the medication management and
medication reconciliation element to include more comprehensive
medication management and more clearly define ``review of adherence''
to the medication regimen.
Response: Other than the scope of service element for EHR and other
electronic technology, we do not believe additional changes to the
scope of service elements for CCM are warranted at this time. We are
requiring certified EHR technology for certain foundational or ``core''
elements, including structured recording of medications and medication
allergies. As finalized in the scope of service in the CY 2014 PFS
final rule with comment period we are also requiring medication
reconciliation with review of adherence and potential interactions, and
oversight of patient self-management of medications. We believe it
would be overly burdensome, especially given the broad eligible
beneficiary population and final RVU inputs, to include more specific
requirements related to medication management, especially when greater
specificity is likely not necessary to ensure adequate care. The CCM
services are by definition non-face-to-face services; therefore we are
not including a requirement for home or domiciliary visits or community
based care (although there is a requirement related to coordinating
home and community based care). Practitioners who engage in remote
monitoring of patient physiological data of eligible beneficiaries may
count the time they spend reviewing the reported data towards the
monthly minimum time for billing the CCM code, but cannot include the
entire time the beneficiary spends under monitoring or wearing a
monitoring device. If we believe changes to the scope of service
elements are warranted in the future, we will propose them through
notice and comment rulemaking taking the comments we received to date
into consideration.
Comment: We received many comments on the scope of service elements
other than the EHR, requesting that CMS implement fewer standards. Some
commenters believed that other than the ``incident to'' provisions, the
scope of service elements are administratively burdensome and it will
be difficult for physicians to adequately document that they have
fulfilled the requirements. Several commenters did not believe it was
necessary to require written beneficiary consent. Others asked that CMS
develop model beneficiary consent forms.
Response: We understand the commenters' concerns about adequate
documentation, although this issue is not unique to CCM services. We
believe the additional scope of service element for the EHR and
electronic sharing of the care plan and clinical summary record will
create an electronic ``footprint'' that will facilitate documentation,
including documentation of the minimum monthly amount of time spent in
providing CCM services.
Regarding beneficiary consent, we believe written beneficiary
consent and its documentation in the medical record is necessary
because we are requiring practices to share beneficiaries' protected
health information both within and outside of the billing practice in
the course of furnishing CCM services and because beneficiaries will be
required to pay coinsurance on non-face-to-face services. We do not
believe the content or nature of the required consent is so complex
that we should develop model formats. If we believe changes to the
scope of service elements are warranted in the future, we will propose
them through notice and comment rulemaking taking the comments we
received to date into consideration.
In summary, we are finalizing our proposal for the CCM scope of
service element for EHR technology as proposed, with the following
modification. We are including as an element of the separately billable
CCM service the use of, at a minimum, technology certified to the
edition(s) of certification criteria that is acceptable for the EHR
Incentive Programs as of December 31st of the calendar year prior to
the PFS payment year (CCM certified technology), to meet the final core
EHR capabilities (structured recording of demographics, problems,
medications, medication allergies and the creation of a structured
clinical summary record) and to fulfill all activities within the final
scope of service elements that reference a health or medical record.
For CCM payment in CY 2015, this policy will allow practitioners to use
EHR technology certified to either the 2011 or 2014 edition(s) of
certification criteria. The final scope of service elements that refer
to a health or medical record, and that must be fulfilled using the CCM
certified technology, are summarized in Table 33 and include the
following:
A full list of problems, medications and medication
allergies in the EHR must inform the care plan, care coordination and
ongoing clinical care.
Communication to and from home and community based
providers regarding the patient's psychosocial needs and functional
deficits must be documented in the patient's medical record.
Inform the beneficiary of the availability of CCM services
and obtain his or her written agreement to have the services provided,
including authorization for the electronic communication of his or her
medical information with other treating providers. Document in the
beneficiary's medical record that all of the CCM services were
explained and offered, and note the beneficiary's decision to accept or
decline these services.
Provide the beneficiary a written or electronic copy of
the care plan and document in the electronic medical record that the
care plan was provided to the beneficiary.
We are finalizing our proposal regarding the electronic care plan
scope of service element without modification. To satisfy this element,
practitioners must at least electronically capture care plan
information; make this information available on a 24/7 basis to all
practitioners within the practice who are furnishing CCM services whose
time counts towards the time requirement for the practice to bill the
CCM code; and share care plan information electronically (other than by
facsimile) as appropriate with other practitioners
[[Page 67728]]
and providers who are furnishing care to the beneficiary. We are not
requiring practitioners to use a specific electronic solution to
furnish the care plan element of the CCM service, only that the method
must be electronic and cannot include facsimile transmission.
Similarly, we are not requiring practitioners to use a specific
tool or service to communicate clinical summaries in managing care
transitions, as long as practitioners transmit the clinical summaries
electronically, with the exception of faxing which will not fulfill the
requirement for exchange of a summary care record. However
practitioners must format their clinical summaries according to, at a
minimum, the standard that is acceptable for the EHR Incentive Programs
as of December 31st of the calendar year preceding each PFS payment
year.
We remind stakeholders that for all electronic sharing of
beneficiary information under our final CCM policies, HIPAA standards
apply in the usual manner. We summarize the final requirements for the
CCM scope of service elements and billing requirements for CY 2015 and
their relationship to the final EHR requirements in Table 33.
Table 33--Summary of Final CCM Scope of Service Elements and Billing
Requirements for CY 2015
------------------------------------------------------------------------
Certified EHR or other
CCM Scope of service element/billing electronic technology
requirement requirement
------------------------------------------------------------------------
Structured recording of demographics, Structured recording of
problems, medications, medication demographics, problems,
allergies, and the creation of a medications, medication
structured clinical summary record. A allergies, and creation of
full list of problems, medications and structured clinical summary
medication allergies in the EHR must records using CCM certified
inform the care plan, care technology.
coordination and ongoing clinical care.
Access to care management services 24/7 None.
(providing the beneficiary with a
means to make timely contact with
health care providers in the practice
to address his or her urgent chronic
care needs regardless of the time of
day or day of the week).
Continuity of care with a designated None.
practitioner or member of the care
team with whom the beneficiary is able
to get successive routine appointments.
Care management for chronic conditions None.
including systematic assessment of the
beneficiary's medical, functional, and
psychosocial needs; system-based
approaches to ensure timely receipt of
all recommended preventive care
services; medication reconciliation
with review of adherence and potential
interactions; and oversight of
beneficiary self-management of
medications.
Creation of a patient-centered care Must at least electronically
plan based on a physical, mental, capture care plan information;
cognitive, psychosocial, functional make this information
and environmental (re)assessment and available on a 24/7 basis to
an inventory of resources and all practitioners within the
supports; a comprehensive care plan practice whose time counts
for all health issues. Share the care towards the time requirement
plan as appropriate with other for the practice to bill the
practitioners and providers. CCM code; and share care plan
information electronically
(other than by fax) as
appropriate with other
practitioners and providers.
Provide the beneficiary with a written Document provision of the care
or electronic copy of the care plan plan as required to the
and document its provision in the beneficiary in the EHR using
electronic medical record. CCM certified technology.
Management of care transitions between Format clinical
and among health care providers and summaries according to CCM
settings, including referrals to other certified technology.
clinicians; follow-up after an Not required to use a
emergency department visit; and follow- specific tool or service to
up after discharges from hospitals, exchange/transmit clinical
skilled nursing facilities or other summaries, as long as they are
health care facilities. transmitted electronically
(other than by fax).
Coordination with home and community Communication to and from home
based clinical service providers. and community based providers
regarding the patient's
psychosocial needs and
functional deficits must be
documented in the patient's
medical record using CCM
certified technology.
Enhanced opportunities for the None.
beneficiary and any caregiver to
communicate with the practitioner
regarding the beneficiary's care
through not only telephone access, but
also through the use of secure
messaging, internet or other
asynchronous non face-to-face
consultation methods.
Beneficiary consent--Inform the Document the beneficiary's
beneficiary of the availability of CCM written consent and
services and obtain his or her written authorization in the EHR using
agreement to have the services CCM certified technology.
provided, including authorization for
the electronic communication of his or
her medical information with other
treating providers. Document in the
beneficiary's medical record that all
of the CCM services were explained and
offered, and note the beneficiary's
decision to accept or decline these
services.
Beneficiary consent--Inform the None.
beneficiary of the right to stop the
CCM services at any time (effective at
the end of the calendar month) and the
effect of a revocation of the
agreement on CCM services.
Beneficiary consent--Inform the None.
beneficiary that only one practitioner
can furnish and be paid for these
services during a calendar month.
------------------------------------------------------------------------
[[Page 67729]]
4. Payment of CCM Services in CMS Models and Demonstrations
As discussed in section II.G., several CMS models and
demonstrations address payment for care management services. The Multi-
payer Advanced Primary Care Practice (MAPCP) Demonstration and the
Comprehensive Primary Care (CPC) Initiative both include payments for
care management services that closely overlap with the scope of service
for the new chronic care management services code. In these two
initiatives, primary care practices are receiving per beneficiary per
month payments for care management services furnished to Medicare fee-
for-service beneficiaries attributed to their practices. We proposed
that practitioners participating in one of these two models may not
bill Medicare for CCM services furnished to any beneficiary attributed
to the practice for purposes of participating in one of these
initiatives, as we believe the payment for CCM services would be a
duplicative payment for substantially the same services for which
payment is made through the per beneficiary per month payment. However,
we proposed that these practitioners may bill Medicare for CCM services
furnished to eligible beneficiaries who are not attributed to the
practice for the purpose of the practice's participation as part of one
of these initiatives. As the Innovation Center implements new models or
demonstrations that include payments for care management services, or
as changes take place that affect existing models or demonstrations, we
will address potential overlaps with the CCM service and seek to
implement appropriate reimbursement policies. We solicited comments on
this proposal. We also solicited comments on the extent to which these
services may not actually be duplicative and, if so, how our
reimbursement policy could be tailored to address those situations.
We received several comments that either supported or did not
oppose our proposed policy regarding the payment of CCM services in CMS
models and demonstrations that also pay for care management services.
The following is a summary of the other comments we received
regarding our proposals on reimbursement policies.
Comment: Two commenters requested that we reconsider our proposed
policy to exclude demonstration practitioners from billing for CCM
services to ensure that these practitioners are not disadvantaged
relative to those practitioners who do not participate in
demonstrations or models.
Response: Our proposed policy does not exclude practitioners
participating in demonstrations or models from billing for CCM
services. To reiterate, practitioners participating in demonstrations
or models may bill Medicare for CCM services for beneficiaries who are
not attributed to the practices for purposes of participating in either
the MAPCP or CPC. For beneficiaries who are not attributed to the
practice, no care management payment is made under the MAPCP or CPC
models. If the beneficiary otherwise meets the criteria for CCM
services, the practitioner may furnish and bill Medicare for CCM.
However, Medicare will not pay practitioners participating in MAPCP or
CPC for CCM services furnished to beneficiaries attributed to the
practice for the purpose of the practice's participation in either
these models. We believe we have created a pathway to enable
practitioners participating in CPC or MAPCP to bill Medicare for the
CCM services, as not all beneficiaries treated in a practice will be
attributed to the practice.
Comment: We received two comments expressing concern for confusion
that might occur regarding the interaction of CCM services and the CPC
model.
Response: We acknowledge that the Innovation Center will need to
engage in extensive communications efforts with practitioners
participating in either CPC or MAPCP to inform them of our policies
regarding billing for CCM services.
Comment: One individual commented that payment for CCM ``should not
be constrained'' by the payment in a demonstration. The commenter also
said, ``The two payments are completely unrelated and are made for
different purposes to very different physician practices. Also, we do
not believe it is possible to know with certainty whether there is
overlap between a fee[hyphen]for[hyphen]service chronic care management
payment and a payment for care coordination in a demonstration.''
Response: The proposed policy aims not to constrain practitioners
voluntarily participating in Innovation Center models and
demonstrations, specifically CPC and MAPCP, by allowing them to bill
Medicare for CCM services furnished to beneficiaries for whom they are
not receiving payments as part of these initiatives. We expect the
practitioners participating in these initiatives will be eligible to
bill the CCM service for some beneficiaries, as there is overlap
between elements of the CCM service and the models. For example, the
CPC model requires practitioners to use electronic health records that
have been certified by the National Coordinator for Health Information
Technology, provide patients with 24/7 access to the practice, ensure
continuity of care with a designated practitioner or care team for each
patient, provide care management that includes a systematic assessment
of patient needs, use patient-centered care plans, and give enhanced
opportunities for patient and caregiver communications. Similarly, the
MAPCP demonstration is testing the patient-centered medical home model,
which focuses on care management, continuity of care, and care
coordination. All practitioners, who are voluntarily participating in
these initiatives, receive quarterly reports indicating which
beneficiaries have been attributed to their practices. After reviewing
and comparing the features of the CPC and MAPCP models with the CCM
service, we continue to be convinced that there is overlap. The CCM
service provides appropriate payment for care management and care
coordination furnished to beneficiaries with multiple chronic
conditions within the current fee-for-service Medicare program, while
Innovation Center models and demonstrations test alternative payment
methods that promote less reliance on a fee-for-service funding stream
and support primary care delivery transformation at the practice level
to identify potential future alternative approaches to payment.
In response to these comments, we will engage in extensive
communications explaining to practices participating in CMMI models and
demonstrations, specifically the CPC and MAPCP initiatives, the
policies related to care management payments under these initiatives
and the CCM service. We continue to believe the payment for CCM
services would be a duplicative payment for substantially the same
services included in the per beneficiary per month payment under the
CPC and MAPCP models. Therefore, we are finalizing our proposed policy
that CMS will not pay practitioners participating in one of these two
initiatives for CCM services furnished to any beneficiary attributed by
the initiative to the practice. These practitioners may bill Medicare
for CCM services furnished to eligible beneficiaries who are not
attributed by the initiative to the practice. As the Innovation Center
implements new models or demonstrations that include payments for care
management services, or as changes take place that affect existing
models or demonstrations, we will address potential overlaps with the
[[Page 67730]]
CCM service and seek to implement appropriate payment policies.
I. Outpatient Therapy Caps for CY 2015
Section 1833(g) of the Act requires application of annual, per
beneficiary, limitations on the amount of expenses that can be
considered as incurred expenses for outpatient therapy services under
Medicare Part B, commonly referred to as ``therapy caps.'' There is one
therapy cap for outpatient occupational therapy (OT) services and
another separate therapy cap for physical therapy (PT) and speech-
language pathology (SLP) services combined.
The therapy caps apply to outpatient therapy services furnished in
all settings, including the once-exempt outpatient hospital setting
(effective October 1, 2012) and critical access hospitals (effective
January 1, 2014).
The therapy cap amounts under section 1833(g) of the Act are
updated each year based on the Medicare Economic Index (MEI).
Specifically, the annual caps are calculated by updating the previous
year's cap by the MEI for the upcoming calendar year and rounding to
the nearest $10.00. Increasing the CY 2014 therapy cap of $1,920 by the
CY 2015 MEI of 0.8 percent and rounding to the nearest $10.00 results
in a CY 2015 therapy cap amount of $1,940.
An exceptions process for the therapy caps has been in effect since
January 1, 2006. Originally required by section 5107 of the Deficit
Reduction Act of 2005 (DRA), which amended section 1833(g)(5) of the
Act, the exceptions process for the therapy caps has been extended
multiple times through subsequent legislation (MIEA-TRHCA, MMSEA,
MIPPA, the Affordable Care Act, MMEA, TPTCCA, MCTRJCA, ATRA and PAMA).
The Agency's current authority to provide an exceptions process for
therapy caps expires on March 31, 2015.
After expenses incurred for the beneficiary's outpatient therapy
services for the year have exceeded one or both of the therapy caps,
therapy suppliers and providers use the KX modifier on claims for
subsequent services to request an exception to the therapy caps. By use
of the KX modifier, the therapist is attesting that the services above
the therapy caps are reasonable and necessary and that there is
documentation of medical necessity for the services in the
beneficiary's medical record.
Under section 1833(g)(5)(C) of the Act, we are required to apply a
manual medical review process to therapy claims when a beneficiary's
incurred expenses for outpatient therapy services exceed a threshold
amount of $3,700. There are two separate thresholds of $3,700, just as
there are two separate therapy caps, one for OT services and one for PT
and SLP services combined, and incurred expenses are counted towards
the thresholds in the same manner as the caps. The statutorily required
manual medical review expires March 31, 2015, consistent with the
expiration of the Agency's authority to provide an exceptions process
for the therapy caps. For information on the manual medical review
process, go to www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medical-Review/TherapyCap.html.
J. Definition of Colorectal Cancer Screening Tests
As discussed in the proposed rule (79 FR 40368), section 1861(pp)
of the Act defines ``colorectal cancer screening tests'' and, under
section 1861(pp)(1)(C), a ``screening colonoscopy'' is one of the
recognized procedures. Among other things, section 1861(pp)(1)(D) of
the Act authorizes the Secretary to modify the tests and procedures
covered under this subsection, ``with such frequency and payment
limits, as the Secretary determines appropriate,'' in consultation with
appropriate organizations. The current definition of ``colorectal
cancer screening tests'' at Sec. 410.37(a)(1) includes ``screening
colonoscopies.'' Until recently, the prevailing practice for screening
colonoscopies has been moderate sedation provided intravenously by the
endoscopist, without resort to separately provided anesthesia.\3\ Based
on this prevailing practice, payment for moderate sedation has
accordingly been bundled into the payment for the colorectal cancer
screening tests, (for example, G0104, G0105). For these procedures,
because moderate sedation is bundled into the payment, the same
physician cannot also report a sedation code. An anesthesia service can
be billed by a second physician.
---------------------------------------------------------------------------
\3\ Faulx, A. L. et al. (2005). The changing landscape of
practice patterns regarding unsedated colonoscopy and propofol use:
A national web survey. Gastrointestinal Endoscopy, 62. 9-15.
---------------------------------------------------------------------------
However, a recent study in The Journal of the American Medical
Association (JAMA) cited an increase in the percentage of colonoscopies
and upper endoscopy procedures furnished using an anesthesia
professional, from 13.5 percent in 2003 to 30.2 percent in 2009 within
the Medicare population, with a similar increase in the commercially-
insured population.\4\ A 2010 study projected that the percentage of
this class of procedures involving an anesthesia professional would
grow to 53.4 percent by 2015.\5\ These studies suggest that the
prevailing practice for endoscopies in general and screening
colonoscopies in particular is undergoing a transition, and that
anesthesia separately provided by an anesthesia professional is
becoming the prevalent practice. In preparation for the proposed rule,
we reviewed these studies and analyzed Medicare claims data. We saw the
same trend in screening colonoscopies for Medicare beneficiaries with
53 percent of the screening colonoscopies for Medicare claims submitted
in 2013 had a separate anesthesia claim reported.
---------------------------------------------------------------------------
\4\ Liu H, Waxman DA, Main R, Mattke S. Utilization of
Anesthesia Services during Outpatient Endoscopies and Colonoscopies
and Associated Spending in 2003-2009. (2012). JAMA, 307(11):1178-
1184.
\5\ Inadomi, J. M. et al. (2010). Projected increased growth
rate of anesthesia professional-delivered sedation for colonoscopy
and EGD in the United States: 2009 to 2015. Gastrointestinal
Endoscopy, 72, 580-586.
---------------------------------------------------------------------------
In light of these developments, we expressed our concern in the
proposed rule that the mere reference to ``screening colonoscopies'' in
the definition of ``colorectal cancer screening tests'' has become
inadequate. Indeed, we were convinced that the growing prevalence of
separately provided anesthesia services in conjunction with screening
colonoscopies reflects a change in practice patterns. Therefore,
consistent with the authority delegated by section 1861(pp)(1)(D) of
the Act, we proposed to revise the definition of ``colorectal cancer
screening tests'' to adequately reflect these new patterns.
Specifically, we proposed to revise the definition of ``colorectal
cancer screening tests'' at Sec. 410.37(a)(1)(iii) to include
anesthesia that is separately furnished in conjunction with screening
colonoscopies (79 FR 40369).
We also stated that our proposal to revise the definition of
``colorectal cancer screening tests'' in this manner would further
reduce our beneficiaries' cost-sharing obligations under Part B.
Screening colonoscopies have been recommended with a grade of A by the
United States Preventive Services Task Force (USPSTF) and Sec.
410.152(l)(5) provides that Medicare Part B pays 100 percent of the
Medicare payment amount established under the PFS for colorectal cancer
screening tests except for barium enemas (which do not have a grade A
or B recommendation from the USPSTF). This regulation is based on
section 1833(a)(1) of the Act, as amended by section 4104 of the
Affordable Care Act, which requires 100
[[Page 67731]]
percent Medicare payment of the fee schedule amount for those
``preventive services'' that are appropriate for the individual and are
recommended with a grade of A or B by the USPSTF. Section 4104 of the
Affordable Care Act amended section 1833(a)(1) of the Act to
effectively waive any Part B coinsurance that would otherwise apply for
certain recommended preventive services, including screening
colonoscopies For additional discussion of the impact of section 4104
of the Affordable Care Act, and our prior rulemaking based on this
provision see the CY 2011 PFS final rule with comment period (75 FR
73412 through 73431). We also noted that under Sec. 410.160(b)(7)
colorectal cancer screening tests are not subject to the Part B annual
deductible and do not count toward meeting that deductible.
In implementing the amendments made by section 4104 of the
Affordable Care Act, we did not provide at that time for waiving the
Part B deductible and coinsurance for covered anesthesia services
separately furnished in conjunction with screening colonoscopies. At
that time, we believed that our payment for the screening colonoscopy,
which included payment for moderate sedation services, reflected the
typical screening colonoscopy. Under the current regulations, Medicare
beneficiaries who receive anesthesia from a different professional than
the one furnishing the screening colonoscopy would be incurring costs
for the coinsurance and deductible under Part B for those separate
services. With the changes in the standard of care and shifting
practice patterns toward increased use of anesthesia in conjunction
with screening colonoscopy, beneficiaries who receive covered
anesthesia services from a different professional than the one
furnishing the colonoscopy would incur costs for any coinsurance and
any unmet part of the deductible for this component of the service.
However, our proposed revision to the definition of ``colorectal cancer
screening tests'' would lead to Medicare paying 100 percent of the fee
schedule amounts for screening colonoscopies, including any portion
attributable to anesthesia services furnished by a separate
practitioner in conjunction with such tests, under Sec. 410.152(l)(5).
Similarly, this revision would also mean that expenses incurred for a
screening colonoscopy, and the anesthesia services furnished in
conjunction with such tests, will not be subject to the Part B
deductible and will not count toward meeting that deductible under
Sec. 410.160(b)(7). We believe the proposal encourages more
beneficiaries to obtain a screening colonoscopy, which is consistent
with the intent of the statutory provision to waive Medicare cost-
sharing for certain recommended preventive services, and is consistent
with the authority delegated to the Secretary in section 1861(pp)(1)(D)
of the Act.
In light of the changing practice patterns for screening
colonoscopies, continuing to require Medicare beneficiaries to bear the
deductible and coinsurance expenses for separately billed anesthesia
services furnished and covered by Medicare in conjunction with
screening colonoscopies could become a significant barrier to these
essential preventive services. As we noted when we implemented the
provisions of the Affordable Care Act waiving the Part B deductible and
coinsurance for these preventive services, the goal of these provisions
was to eliminate financial barriers so that beneficiaries would not be
deterred from receiving them (75 FR 73412). Therefore, we proposed to
exercise our authority under section 1861(pp)(1)(D) of the Act to
revise the definition of colorectal cancer screening tests to encourage
beneficiaries to seek these services by extending the waiver of
coinsurance and deductible to anesthesia or sedation services furnished
in conjunction with a screening colonoscopy.
We noted in the proposed rule (79 FR 40370) that, in implementing
these proposed revisions to the regulations, it would be necessary to
establish a modifier for use when billing the relevant anesthesia codes
for services that are furnished in conjunction with a screening
colonoscopy, and thus, qualify for the waiver of the Part B deductible
and coinsurance. Therefore, we noted that we would provide appropriate
and timely information on this new modifier and its proper use so that
physicians will be able to bill correctly for these services when the
revised regulations become effective. We also noted that the valuation
of colonoscopy codes, which include moderate sedation, would be subject
to the same proposed review as other codes that include moderate
sedation, as discussed in section II.B.6 of this final rule with
comment period.
The following is a summary of the comments received on this
proposal.
Comment: The majority of commenters strongly supported finalizing
our proposal to revise the definition of ``colorectal cancer screening
tests'' at Sec. 410.37(a)(1)(iii) to include anesthesia that is
furnished in conjunction with screening colonoscopies. However, one
commenter expressed concern about the timing of the proposal, and
specifically that it leaves little time for implementation in CY 2015.
Therefore, the commenter recommended that the proposal should be
considered for implementation in CY 2016.
Response: We appreciate the support for our proposal and are
finalizing it as proposed. Specifically, we are revising the definition
of ``colorectal cancer screening tests'' at Sec. 410.37(a)(1)(iii) to
include anesthesia that is furnished in conjunction with screening
colonoscopies. We disagree with the recommendation to delay
implementation until CY 2016. The proposed implementation on January
1st following the finalization of the policy in the final rule follows
the usual PFS schedule for implementation of payment changes. We are
not aware of a reason for deviating from the usual schedule for this
policy. Therefore, we are implementing this final rule, effective
January 1, 2015.
Comment: Many commenters urged us to extend our proposed revision,
by identifying a way under our existing authority to redefine
colorectal cancer screening to include screening colonoscopy with
removal of polyp, abnormal growth, or tissue during the screening
encounter. Commenters stated that there is already substantial
confusion among beneficiaries about why colonoscopy with polyp removal
requires payment of coinsurance, while colonoscopy without polyp
removal does not. The commenters maintained that our proposal to
include anesthesia that is separately furnished in conjunction with
screening colonoscopies within the definition of screening colonoscopy
would only cause additional confusion, unless screening colonoscopies
with removal of polyp, along with any anesthesia separately furnished
in conjunction with such procedures, are also included within the
definition. Because our proposal rule did not seek to make changes to
our policies with respect to diagnostic colonoscopies, the commenters
were concerned that, beneficiaries may be liable for part B coinsurance
for both diagnostic colonoscopy and any anesthesia furnished in
conjunction with the colonoscopy when a polyp is removed. Commenters
also stated that extending our proposal in this manner would be good
public policy, because it would reduce the disincentives to this
essential preventive service posed by possible liability for
coinsurance if a polyp is discovered and removed during a screening
colonoscopy. The commenters
[[Page 67732]]
also emphasized that further extending the definition in this way would
remove an inconsistency between Medicare policy and the new
requirements for private health plans that prohibit the imposition of
cost sharing when a polyp is removed under the Affordable Care Act.
Response: We understand the commenters' concerns, however, we do
not have the authority to adopt the recommended revisions by
regulation.
Our authority is limited by the language of the Medicare Act.
Specifically, section 1834(d)(3)(D) of the Act states that, ``[i]f
during the course of such a screening colonoscopy, a lesion or growth
is detected which results in a biopsy or removal of the lesion or
growth, payment under this part shall not be made for the screening
colonoscopy but shall be made for the procedure classified as a
colonoscopy with such biopsy or removal.'' As a result of this
statutory provision, when an anticipated screening colonoscopy ends up
involving a biopsy or polyp removal, Medicare cannot pay for this
procedure as a screening colonoscopy. In these circumstances, Medicare
pays 80 percent of the diagnostic colonoscopy procedure and the
beneficiary is responsible for paying Part B coinsurance. Under the
statute, when a polyp or other growth is removed, beneficiaries are
responsible for Part B coinsurance for the diagnostic colonoscopy, and
similarly, any Part B coinsurance for any covered anesthesia.
Comment: Commenters stated that the proposal was not clear on how
the deductible will be treated in the case of anesthesia services when
a polyp or other tissue is removed during a screening colonoscopy.
Response: Section 1833(b)(1) of the Act, as amended by section
4104(c) of the Affordable Care Act, waives the Part B deductible for
``colorectal screening tests regardless of the code billed for the
establishment of a diagnosis as a result of the test, or the removal of
tissue or other matter or other procedure that is furnished in
connection with, as a result of, and in the same clinical encounter as
a screening test.'' We explained this provision in the CY 2011 PFS
final rule with comment period (75 FR 73431). We apply this policy to
any surgical service furnished on the same date as a planned colorectal
cancer screening test. Our regulations at Sec. 410.152(l)(5) already
require Medicare Part B to pay 100 percent of the Medicare payment
amount for colorectal cancer screening tests (excluding barium enema).
The statutory waiver of deductible will apply to the anesthesia
services furnished in conjunction with a colorectal cancer screening
test even when a polyp or other tissue is removed during a colonoscopy.
As in the case of the physician furnishing the colonoscopy service, the
anesthesia professional reporting the anesthesia in conjunction with
the colonoscopy where a polyp is removed would also report the PT
modifier.
Comment: Commenters urged CMS to provide guidance as to whether CPT
code 00810 (Anesthesia for lower intestinal endoscopic procedures,
endoscope introduced distal to duodenum) would be billed with a
modifier to indicate whether the procedure was screening or not.
Response: Effective January 1, 2015, beneficiary coinsurance and
deductible do not apply to the following anesthesia claim lines billed
when furnished in conjunction with screening colonoscopy services and
billed with the appropriate modifier (33): 00810 (Anesthesia for lower
intestinal endoscopic procedures, endoscope introduced distal to
duodenum). Anesthesia professionals who furnish a separately payable
anesthesia service in conjunction with a colorectal cancer screening
test should include the 33 modifier on the claim line with the
anesthesia service. As noted above in situations that begin as a
colorectal cancer screening test, but for which another service such as
colonoscopy with polyp removal is actually furnished, the anesthesia
professional should report a PT modifier on the claim line rather than
the 33 modifier.
Comment: Several commenters recommended that we not only finalize
the revised definition of ``colorectal cancer screening tests,'' but
also take steps to ensure that our Medicare Administrative Contractors
(MACs) are not inappropriately taking actions that have the effect of
nullifying some or much of the intended benefit of this policy change.
Specifically, these commenters requested that we prevent the current
efforts by one or more Medicare contractors to limit Medicare coverage
for anesthesia services furnished during a screening colonoscopy by an
anesthesia professional. Another commenter urged us to clarify that
this proposed expanded definition of colorectal cancer screening to
include anesthesia services should not be construed to override or
preempt existing or planned coverage policies on the appropriate use of
these services by MACs.
Response: This final rule with comment period establishes national
policy and takes precedence over any local coverage policy that limits
Medicare coverage for anesthesia services furnished during a screening
colonoscopy by an anesthesia professional.
K. Payment of Secondary Interpretation of Images
In general, Medicare makes one payment for the professional
component of an imaging service for each technical component (TC)
service that is furnished. Under ``unusual circumstances,'' physicians
can bill for a secondary interpretation using modifier -77, for
instance, when an emergency room physician conducts an x-ray, provides
an interpretation, identified a questionable finding, and subsequently
requests a second interpretation from a radiologist to inform treatment
decisions. In all cases, a ``professional component'' (PC)
interpretation service should only be billed for a full interpretation
and report, rather than a ``review,'' which is paid for as part of an
E/M payment.
In recent years, technological advances such as the integration of
picture and archiving communications systems across health systems,
growth in image sharing networks and health information exchange
platforms through which providers can share images, and consumer-
mediated exchange of images, have greatly increased physicians' access
to existing diagnostic-quality radiology images. Accessing and
utilizing these images to inform the diagnosis and record an
interpretation in the medical record may allow physicians to avoid
ordering duplicative tests.
We solicited comments on the appropriateness of more routine
billing for secondary interpretations, although we did not propose to
make any changes to the treatment of these services in 2015. We wanted
to determine whether there were an expanded set of circumstances under
which more routine Medicare payment for a second PC for radiology
services would be appropriate, and whether such a policy would be
likely to reduce the incidence of duplicative advanced imaging studies.
To achieve that goal, we solicited comments on the following: the
circumstances under which physicians are currently conducting secondary
interpretations and whether they are seeking payment for these
interpretations; whether more routine payment for secondary
interpretations should be restricted to certain high-cost advanced
diagnostic imaging services; considerations for valuing secondary
interpretation services; the settings in which secondary
interpretations chiefly occur; and considerations for
[[Page 67733]]
operationalizing more routine payment of secondary interpretations in a
manner that would minimize burden on providers and others.
Comment: Many commenters responded to our secondary interpretation
solicitation. In addition to comments on the merits of the proposals,
commenters also provided helpful information about how to implement
this policy. Commenters offered diverse opinions on the time period for
which an existing image would be pertinent in support of a secondary
interpretation. Most commenters were in agreement that cost savings
would be derived from the implementation of a secondary interpretation
policy but there was no consensus as to the amount of such savings.
Moreover, many commenters pointed out that they were already furnishing
secondary interpretations and would appreciate adoption of a policy
that would allow them to receive payment for these services.
Response: We thank all the commenters for their input. Any changes
to our current policy on allowing physicians to more routinely bill for
secondary interpretations of images will be addressed in future
rulemaking.
L. Conditions Regarding Permissible Practice Types for Therapists in
Private Practice
Section 1861(p) of the Act defines outpatient therapy services to
include physical therapy (PT), occupational therapy (OT), and speech-
language pathology (SLP) services furnished by qualified occupational
therapists, physical therapists, and speech-language pathologists in
their offices and in the homes of beneficiaries. The regulations at
Sec. Sec. 410.59(c), 410.60(c), and 410.62(c) set forth special
provisions for services furnished by therapists in private practice,
including basic qualifications necessary to qualify as a supplier of
OT, PT, and SLP services, respectively. As part of these basic
qualifications, the current regulatory language includes descriptions
of the various practice types for therapists' private practices. Based
on our review of these three sections of our regulations, we became
concerned that the language is not as clear as it could be--especially
with regard to the relevance of whether a practice is incorporated. The
regulations appear to make distinctions between unincorporated and
incorporated practices, and some practice types are listed twice.
Accordingly, we proposed changes to the regulatory language to remove
unnecessary distinctions and redundancies within the regulations for
OT, PT, and SLP. We noted that these changes are for clarification
only, and do not reflect any change in our current policy.
To consistently specify the permissible practice types (a solo
practice, partnership, or group practice; or as an employee of one of
these) for suppliers of outpatient therapy services in private practice
(specifically for occupational therapists, physical therapists and
speech-language pathologists), we proposed to replace the regulatory
text at Sec. 410.59(c)(1)(ii)(A) through (E), Sec.
410.60(c)(1)(ii)(A) through (E), and Sec. 410.62(c)(1)(ii)(A) through
(E) and to replace it with language listing the permissible practice
types without limitations for incorporated or unincorporated.
Comment: We received comments from two therapist membership
associations supporting our proposed changes to the regulations. Both
commenters agree that the proposed language more consistently and
accurately reflects the permissible practice types for therapists in
private practice.
Another commenter representing a membership association of
rehabilitation physicians told us that, rather than clarifying or
simplifying the existing regulations, the proposed language is more
ambiguous. The commenter urged us to clarify that our proposed language
would continue to allow therapists in private practice to be employed
by physician groups as specified in current provisions.
Response: We appreciate the commenters' support for our proposal.
With regard to the commenter that expressed concern about the clarity
of the proposed regulation text as to whether therapists in private
practice can be employed by a physician group, we acknowledge that the
current regulation explicitly permits that practice arrangement.
However, we believe that our proposed language describing the practice
arrangements of private practice therapists-a solo practice,
partnership, or group practice; or as an employee of one of these-
clearly continues to permit therapists to practice as an employee of a
physician group, whether or not incorporated. We believe the reference
in the proposed regulation to ``group practice'' is sufficiently broad
to encompass a physician group, and thus permits therapists in private
practice to practice as employees of these groups, where permissible
under state law.
Therefore, we are finalizing our proposed changes to the
regulations for permissible practice types for therapists in private
practice at Sec. 410.59(c)(1)(ii)(A) through (E), Sec.
410.60(c)(1)(ii)(A) through (E), and Sec. 410.62(c)(1)(ii)(A)
through(E).
M. Payments for Practitioners Managing Patients on Home Dialysis
In the CY 2005 PFS final rule with comment period (69 FR 66357
through 66359), we established criteria for furnishing outpatient per
diem ESRD-related services in partial month scenarios. We specified
that use of per diem ESRD-related services is intended to accommodate
unusual circumstances when the outpatient ESRD-related services would
not be paid for under the monthly capitation payment (MCP), and that
use of the per diem services is limited to the circumstances listed
below.
Transient patients--Patients traveling away from home
(less than full month);
Home dialysis patients (less than full month);
Partial month where there were one or more face-to-face
visits without the comprehensive visit and either the patient was
hospitalized before a complete assessment was furnished, dialysis
stopped due to death, or the patient received a kidney transplant.
Patients who have a permanent change in their MCP
physician during the month.
Additionally, we provided billing guidelines for partial month
scenarios in the Medicare claims processing manual, publication 100-04,
chapter 8, section 140.2.1. For center-based patients, we specified
that if the MCP practitioner furnishes a complete assessment of the
ESRD beneficiary, the MCP practitioner should bill for the full MCP
service that reflects the number of visits furnished during the month.
However, we did not extend this policy to home dialysis (less than a
full month) because the home dialysis MCP service did not include a
specific frequency of required patient visits. In other words, unlike
the ESRD MCP service for center-based patients, a visit was not
required for the home dialysis MCP service as a condition of payment.
In the CY 2011 PFS final rule with comment period (75 FR 73295
through 73296), we changed our policy for the home dialysis MCP service
to require the MCP practitioner to furnish at least one face-to-face
patient visit per month as a condition of payment. However, we
inadvertently did not modify our billing guidelines for home dialysis
(less than a full month) to be consistent with partial month scenarios
for center-based dialysis patients. As discussed in the CY
[[Page 67734]]
2015 proposed rule (79 FR 40371) stakeholders have recently brought
this inconsistency to our attention. After reviewing this issue, we
proposed to allow the MCP physician or practitioner to bill for the age
appropriate home dialysis MCP service (as described by HCPCS codes
90963 through 90966) for the home dialysis (less than a full month)
scenario if the MCP practitioner furnishes a complete monthly
assessment of the ESRD beneficiary and at least one face-to-face
patient visit. For example, if a home dialysis patient was hospitalized
during the month and at least one face-to-face outpatient visit and
complete monthly assessment was furnished, the MCP practitioner should
bill for the full home dialysis MCP service. We explained that this
proposed change to home dialysis (less than a full month) would provide
consistency with our policy for partial month scenarios pertaining to
patients dialyzing in a dialysis center. We also stated that if this
proposal is adopted, we would modify the Medicare Claims Processing
Manual to reflect the revised billing guidelines for home dialysis in
the less than a full month scenario.
A summary of the comments on this proposal and our response is
provided below.
Comment: Several stakeholders strongly supported our proposed
change for practitioners managing patients on home dialysis.
Specifically, the commenters stated that the proposed change in policy
for the home dialysis MCP service is necessary to appropriately align
practitioner payment for managing home dialysis patients with center
based patients, and encouraged us to finalize the change in policy as
proposed. One commenter explained that the current policy for home
dialysis less than a full month requires the nephrologist to ``separate
out the time their home dialysis patients spend in the hospital and
bill for outpatient services at a daily rate instead of the full
capitated payment.'' The same commenter stated that ``properly aligning
physician payments for managing home dialysis patients (with managing
center based dialysis patients) may enable more patients to consider
dialyzing at home, when appropriate.''
Response: We agree with the commenters and will finalize our
proposed policy change for home dialysis. We will allow the MCP
practitioner to bill for the home dialysis MCP service for the home
dialysis (less than a full month) scenario if the MCP practitioner
furnishes a complete monthly assessment of the ESRD beneficiary and at
least one face-to-face patient visit during the month.
N. Allowed Expenditures for Physicians' Services and the Sustainable
Growth Rate
1. Medicare Sustainable Growth Rate (SGR)
The SGR is an annual growth rate that applies to physicians'
services paid by Medicare. The use of the SGR is intended to control
growth in aggregate Medicare expenditures for physicians' services.
Payments for services are not withheld if the percentage increase in
actual expenditures exceeds the SGR. Rather, the PFS update, as
specified in section 1848(d)(4) of the Act, is adjusted based on a
comparison of allowed expenditures (determined using the SGR) and
actual expenditures. If actual expenditures exceed allowed
expenditures, the update is reduced. If actual expenditures are less
than allowed expenditures, the update is increased.
Section 1848(f)(2) of the Act specifies that the SGR for a year
(beginning with CY 2001) is equal to the product of the following four
factors:
(1) The estimated change in fees for physicians' services;
(2) The estimated change in the average number of Medicare fee-for-
service beneficiaries;
(3) The estimated projected growth in real Gross Domestic Product
per capita; and
(4) The estimated change in expenditures due to changes in statute
or regulations.
In general, section 1848(f)(3) of the Act requires us to determine
the SGRs for 3 different time periods, using the best data available as
of September 1 of each year. Under section 1848(f)(3) of the Act,
(beginning with the FY and CY 2000 SGRs) the SGR is estimated and
subsequently revised twice based on later data. (The Act also provides
for adjustments to be made to the SGRs for FY 1998 and FY 1999. See the
February 28, 2003 Federal Register (68 FR 9567) for a discussion of
these SGRs). Under section 1848(f)(3)(C)(ii) of the Act, there are no
further revisions to the SGR once it has been estimated and
subsequently revised in each of the 2 years following the preliminary
estimate. In this final rule with comment, we are making our
preliminary estimate of the CY 2015 SGR, a revision to the CY 2014 SGR,
and our final revision to the CY 2013 SGR.
a. Physicians' Services
Section 1848(f)(4)(A) of the Act defines the scope of physicians'
services covered by the SGR. The statute indicates that ``the term
`physicians' services' includes other items and services (such as
clinical diagnostic laboratory tests and radiology services), specified
by the Secretary, that are commonly performed or furnished by a
physician or in a physician's office, but does not include services
furnished to a Medicare+Choice plan enrollee.''
We published a definition of physicians' services for use in the
SGR in the November 1, 2001 Federal Register (66 FR 55316). We defined
physicians' services to include many of the medical and other health
services listed in section 1861(s) of the Act. Since that time, the
statute has been amended to add new Medicare benefits. As the statute
changed, we modified the definition of physicians' services for the SGR
to include the additional benefits added to the statute that meet the
criteria specified in section 1848(f)(4)(A).
As discussed in the CY 2010 PFS final rule with comment period (74
FR 61961), the statute provides the Secretary with clear discretion to
decide whether physician-administered drugs should be included or
excluded from the definition of ``physicians' services.'' Exercising
this discretion, we removed physician-administered drugs from the
definition of physicians' services in section 1848(f)(4)(A) of the Act
for purposes of computing the SGR and the levels of allowed
expenditures and actual expenditures beginning with CY 2010, and for
all subsequent years. Furthermore, in order to effectuate fully the
Secretary's policy decision to remove drugs from the definition of
physicians' services, we removed physician-administered drugs from the
calculation of allowed and actual expenditures for all prior years.
Thus, for purposes of determining allowed expenditures, actual
expenditures for all years, and SGRs beginning with CY 2010 and for all
subsequent years, we specified that physicians' services include the
following medical and other health services if bills for the items and
services are processed and paid by Medicare carriers (and those paid
through intermediaries where specified) or the equivalent services
processed by the Medicare Administrative Contractors:
Physicians' services.
Services and supplies furnished incident to physicians'
services, except for the expenditures for ``drugs and biologicals which
are not usually self-administered by the patient.''
Outpatient physical therapy services and outpatient
occupational therapy services,
[[Page 67735]]
Services of PAs, certified registered nurse anesthetists,
certified nurse midwives, clinical psychologists, clinical social
workers, nurse practitioners, and certified nurse specialists.
Screening tests for prostate cancer, colorectal cancer,
and glaucoma.
Screening mammography, screening pap smears, and screening
pelvic exams.
Diabetes outpatient self-management training (DSMT)
services.
Medical Nutrition Therapy (MNT) services.
Diagnostic x-ray tests, diagnostic laboratory tests, and
other diagnostic tests (including outpatient diagnostic laboratory
tests paid through intermediaries).
X-ray, radium, and radioactive isotope therapy.
Surgical dressings, splints, casts, and other devices used
for the reduction of fractures and dislocations.
Bone mass measurements.
An initial preventive physical exam.
Cardiovascular screening blood tests.
Diabetes screening tests.
Telehealth services.
Physician work and resources to establish and document the
need for a power mobility device.
Additional preventive services.
Pulmonary rehabilitation.
Cardiac rehabilitation.
Intensive cardiac rehabilitation.
Kidney disease education (KDE) services.
Personalized prevention plan services
b. Preliminary Estimate of the SGR for 2015
We first estimated the CY 2015 SGR in March 2014, and we made the
estimate available to the MedPAC and on our Web site. Table 34 shows
the March 2014 estimate and our current estimates of the factors
included in the 2015 SGR. Our March 2014 estimate of the SGR was -3.6
percent. Our current estimate of the 2015 SGR is -13.7 percent. The
majority of the difference between the March estimate and our current
estimate of the CY 2015 SGR is explained by adjustments to reflect
intervening legislative changes that occurred after our March estimate
was prepared. Subsequent to the display of the March 2014 estimate,
section 101 of the Protecting Access to Medicare Act (PAMA) of 2014
continued a 0.5 percent update to the PFS conversion factor from April
1, 2014, through December 31, 2014 (relative to the 2013 conversion
factor), in place of the 24.1 percent reduction that would have
occurred under the SGR system on April 1, 2014. In addition, section
101 of PAMA also provides for a 0.0 percent update for services
furnished on or after January 1, 2015, through March 31, 2015. While
PAMA averted the large reduction in PFS rates scheduled to occur on
April 1, 2014, there will be a large reduction in PFS rates on April 1,
2015, as a result of the expiration of the temporary 0.0 percent
update. The law and regulation factor of the current estimate of the
SGR is now a much larger reduction than previously estimated to account
for the current law reduction in PFS rates scheduled to occur on April
1, 2015. We will provide more detail on the change in each of these
factors below.
Table 34--CY 2015 SGR Calculation
------------------------------------------------------------------------
Statutory factors March estimate Current estimate
------------------------------------------------------------------------
Fees............................ 1.1 percent 0.7 percent
(1.011). (1.007).
Enrollment...................... 4.0 percent 3.9 percent
(1.040). (1.039).
Real Per Capita GDP............. 0.8 percent 0.7 percent
(1.008). (1.007).
Law and Regulation.............. -9.0 percent -18.1 percent
(0.910). (0.819).
------------------------------------------------------------------------
Total....................... -3.6 percent -13.7 percent
(0.964). (0.863).
------------------------------------------------------------------------
Note: Consistent with section 1848(f)(2) of the Act, the statutory
factors are multiplied, not added, to produce the total (that is,
1.007 x 1.039 x 1.007 x 0.819 = 0.863). A more detailed explanation of
each figure is provided in section II.N.1.e. of this final rule with
comment period.
c. Revised Sustainable Growth Rate for CY 2014
Our current estimate of the CY 2014 SGR is -0.8 percent. Table 35
shows our preliminary estimate of the CY 2014 SGR, which was published
in the CY 2014 PFS final rule with comment period, and our current
estimate. The majority of the difference between the preliminary
estimate and our current estimate of the CY 2014 SGR is explained by
adjustments to reflect intervening legislative changes that have
occurred since publication of the CY 2014 PFS final rule with comment
period. The PFS update reduction that would have occurred on April 1,
2014 was averted by PAMA, which has resulted in a much higher
legislative factor than our estimate of the 2014 SGR in CY 2014 PFS
final rule with comment period. We will provide more detail on the
change in each of these factors below.
Table 35--CY 2014 SGR Calculation
------------------------------------------------------------------------
Estimate from CY
Statutory factors 2014 final rule Current estimate
------------------------------------------------------------------------
Fees............................ 0.6 percent 0.7 Percent
(1.006). (1.007).
Enrollment...................... 2.2 percent 0.2 Percent
(1.022). (1.002).
Real Per Capita GDP............. 0.8 percent 0.7 Percent
(1.008). (1.007).
Law and Regulation.............. -19.6 percent -2.4 Percent
(0.804). (0.976).
------------------------------------------------------------------------
Total....................... -16.7 percent -0.8 Percent
(0.833). (0.992).
------------------------------------------------------------------------
Note: Consistent with section 1848(f)(2) of the Act, the statutory
factors are multiplied, not added, to produce the total (that is,
1.007 x 1.002 x 1.007 x 0.976 = 0.992). A more detailed explanation of
each figure is provided in section II.N.1.e. of this final rule with
comment period.
[[Page 67736]]
d. Final Sustainable Growth Rate for CY 2013
The SGR for CY 2013 is 1.3 percent. Table 36 shows our preliminary
estimate of the CY 2013 SGR from the CY 2013 PFS final rule with
comment period, our revised estimate from the CY 2014 PFS final rule
with comment period, and the final figures determined using the best
available data as of September 1, 2014. We will provide more detail on
the change in each of these factors below.
Table 36--CY 2013 SGR Calculation
----------------------------------------------------------------------------------------------------------------
Estimate from CY 2013 Estimate from CY 2014
Statutory factors final rule final rule Final
----------------------------------------------------------------------------------------------------------------
Fees................................. 0.3 percent (1.003).... 0.4 percent (1.004).... 0.4 Percent (1.004).
Enrollment........................... 3.6 percent (1.036).... 1.0 percent (1.010).... 0.5 Percent (1.005).
Real Per Capita GDP.................. 0.7 percent (1.007).... 0.9 percent (1.009).... 0.9 Percent (1.009).
Law and Regulation................... -23.3 percent (0.767).. -.05 percent (.995).... -0.5 Percent (0.995).
----------------------------------------------------------------------------------------------------------------
Total............................ -19.7 percent (0.803... 1.8 percent (1.018).... 1.3 Percent (1.013).
----------------------------------------------------------------------------------------------------------------
Note: Consistent with section 1848(f)(2) of the Act, the statutory factors are multiplied, not added, to produce
the total (that is, 1.004 x 1.005 x 1.009 x 0.995 = 1.013). A more detailed explanation of each figure is
provided in section II.N.1.e. of this final rule with comment period.
e. Calculation of CYs 2015, 2014, and 2013 SGRs
(1) Detail on the CY 2015 SGR
All of the figures used to determine the CY 2015 SGR are estimates
that will be revised based on subsequent data. Any differences between
these estimates and the actual measurement of these figures will be
included in future revisions of the SGR and allowed expenditures and
incorporated into subsequent PFS updates.
(a) Factor 1--Changes in Fees for Physicians' Services (Before Applying
Legislative Adjustments) for CY 2015
This factor is calculated as a weighted average of the CY 2015
changes in fees for the different types of services included in the
definition of physicians' services for the SGR. Medical and other
health services paid using the PFS are estimated to account for
approximately 89.6 percent of total allowed charges included in the SGR
in CY 2015 and are updated using the percent change in the MEI. As
discussed in section A of this final rule with comment period, the
percent change in the MEI for CY 2015 is 0.8 percent. Diagnostic
laboratory tests are estimated to represent approximately 10.4 percent
of Medicare allowed charges included in the SGR for CY 2015. Medicare
payments for these tests are updated by the Consumer Price Index for
Urban Areas (CPI-U), which is 2.1 percent for CY 2015. Section
1833(h)(2)(A)(iv) of the Act requires that the CPI-U update applied to
clinical laboratory tests be reduced by a multi-factor productivity
adjustment (MFP adjustment) and, for each of years 2011 through 2015,
by 1.75 percentage points (percentage adjustment). The MFP adjustment
will not apply in a year where the CPI-U is zero or a percentage
decrease. Further, the application of the MFP adjustment shall not
result in an adjustment to the fee schedule of less than zero for a
year. However, the application of the percentage adjustment may result
in an adjustment to the fee schedule being less than zero for a year
and may result in payment rates for a year being less than such payment
rates for the preceding year. The applicable productivity adjustment
for CY 2015 is -0.6 percent. Adjusting the CPI-U update by the
productivity adjustment results in a 1.5 percent (2.1 percent (CPI-U)
minus 0.6 percent (MFP adjustment)) update for CY 2015. Additionally,
the percentage reduction of 1.75 percent is applied for CYs 2011
through 2015, as discussed previously. Therefore, for CY 2015,
diagnostic laboratory tests will receive an update of -0.3 percent.
Table 37 shows the weighted average of the MEI and laboratory price
changes for CY 2015.
Table 37--Weighted-Average of the MEI and Laboratory Price Changes for
CY 2015
------------------------------------------------------------------------
Weight Update
------------------------------------------------------------------------
Physician..................................... 0.896 0.8%
Laboratory.................................... 0.104 -0.3%
Weighted-average.............................. 1.000 0.7%
------------------------------------------------------------------------
We estimate that the weighted average increase in fees for
physicians' services in CY 2015 under the SGR (before applying any
legislative adjustments) will be 0.7 percent.
(b) Factor 2--Percentage Change in the Average Number of Part B
Enrollees from CY 2014 to CY 2015
This factor is our estimate of the percent change in the average
number of fee-for-service enrollees from CY 2014 to CY 2015. Services
provided to Medicare Advantage (MA) plan enrollees are outside the
scope of the SGR and are excluded from this estimate. We estimate that
the average number of Medicare Part B fee-for-service enrollees will
increase by 3.9 percent from CY 2014 to CY 2015. Table 38 illustrates
how this figure was determined.
Table 38--Average Number of Medicare Part B Fee-For-Service Enrollees
from CY 2014 to CY 2015 (Excluding Beneficiaries Enrolled in MA Plans)
------------------------------------------------------------------------
CY 2014 CY 2015
------------------------------------------------------------------------
Overall......................... 49.350 million.... 50.794 million.
Medicare Advantage (MA)......... 16.237 million.... 16.389 million.
Net............................. 33.113 million.... 34.405 million.
Percent Increase................ 0.2 percent....... 3.9 percent.
------------------------------------------------------------------------
An important factor affecting fee-for-service enrollment is
beneficiary enrollment in MA plans. Because it is difficult to estimate
the size of the MA enrollee population before the start of a CY, at
this time we do not know how actual enrollment in MA plans will compare
to current estimates. For this reason, the estimate may change
substantially as actual Medicare fee-for-service enrollment for CY 2015
becomes known.
(c) Factor 3--Estimated Real Gross Domestic Product Per Capita Growth
in CY 2015
We estimate that the growth in real GDP per capita from CY 2014 to
CY 2015 will be 0.7 percent (based on the annual growth in the 10-year
moving average of real GDP per capita 2006 through 2015). Our past
experience indicates that there have also been changes in estimates of
real GDP per capita growth made before the year begins and the actual
change in real
[[Page 67737]]
GDP per capita growth computed after the year is complete. Thus, it is
possible that this figure will change as actual information on economic
performance becomes available to us in CY 2015.
(d) Factor 4--Percentage Change in Expenditures for Physicians'
Services Resulting From Changes in Statute or Regulations in CY 2015
Compared With CY 2014
The statutory and regulatory provisions that will affect
expenditures for CY 2015 relative to CY 2014 are estimated to have an
impact on expenditures of -18.1 percent. This is primarily due to
payment reductions for eligible professionals that are not meaningful
users of health information technology, the estimated reduction in PFS
rates that will occur on April 1, 2015 absent a change in law, and
expiration of the work GPCI floor.
(2) Detail on the CY 2014 SGR
A more detailed discussion of our revised estimates of the four
elements of the CY 2014 SGR follows.
(a) Factor 1--Changes in Fees for Physicians' Services (Before Applying
Legislative Adjustments) for CY 2014
This factor was calculated as a weighted-average of the CY 2014
changes in fees that apply for the different types of services included
in the definition of physicians' services for the SGR in CY 2014.
We estimate that services paid using the PFS account for
approximately 91.1 percent of total allowed charges included in the SGR
in CY 2014. These services were updated using the CY 2014 percent
change in the MEI of 0.8 percent. We estimate that diagnostic
laboratory tests represent approximately 8.9 percent of total allowed
charges included in the SGR in CY 2014. For CY 2014, diagnostic
laboratory tests received an update of -0.8 percent.
Table 39 shows the weighted-average of the MEI and laboratory price
changes for CY 2014.
Table 39--Weighted-Average of the MEI, and Laboratory Price Changes for
CY 2014
------------------------------------------------------------------------
Weight Update
------------------------------------------------------------------------
Physician..................................... 0.911 0.8
Laboratory.................................... 0.089 -0.8
Weighted-average.............................. 1.000 0.7
------------------------------------------------------------------------
After considering the elements described in Table 39, we estimate
that the weighted-average increase in fees for physicians' services in
CY 2014 under the SGR was 0.7 percent. Our estimate of this factor in
the CY 2014 PFS final rule with comment period was 0.6 percent (78 FR
74393).
(b) Factor 2--Percentage Change in the Average Number of Part B
Enrollees from CY 2013 to CY 2014
We estimate that the average number of Medicare Part B fee-for-
service enrollees (excluding beneficiaries enrolled in Medicare
Advantage plans) increased by 0.2 percent in CY 2014. Table 40
illustrates how we determined this figure.
Table 40--Average Number of Medicare Part B Fee-For-Service Enrollees
from CY 2013 to CY 2014 (Excluding Beneficiaries Enrolled in MA Plans)
------------------------------------------------------------------------
CY 2013 CY 2014
------------------------------------------------------------------------
Overall......................... 47.878 million.... 49.350 million.
Medicare Advantage (MA)......... 14.842 million.... 16.237 million.
Net............................. 33.036 million.... 33.113 million.
Percent Increase................ 0.5 percent....... 0.2 percent.
------------------------------------------------------------------------
Our estimate of the 0.2 percent change in the number of fee-for-
service enrollees, net of Medicare Advantage enrollment for CY 2014
compared to CY 2013, is different than our estimate of an increase of
2.2 percent in the CY 2014 PFS final rule with comment period (78 FR
74393). While our current projection based on data from 8 months of CY
2014 differs from our estimate of 2.2 percent when we had no actual
data, it is still possible that our final estimate of this figure will
be different once we have complete information on CY 2014 fee-for-
service enrollment.
(c) Factor 3--Estimated Real GDP Per Capita Growth in CY 2014
We estimate that the growth in real GDP per capita will be 0.7
percent for CY 2014 (based on the annual growth in the 10-year moving
average of real GDP per capita (2005 through 2014)). Our past
experience indicates that there have also been differences between our
estimates of real per capita GDP growth made prior to the year's end
and the actual change in this factor. Thus, it is possible that this
figure will change further as complete actual information on CY 2014
economic performance becomes available to us in CY 2015.
(d) Factor 4--Percentage Change in Expenditures for Physicians'
Services Resulting From Changes in Statute or Regulations in CY 2014
Compared With CY 2013
The statutory and regulatory provisions that affected expenditures
in CY 2014 relative to CY 2013 are estimated to have an impact on
expenditures of -2.4 percent. This impact is due to many different
legislative or regulatory provisions affecting spending in 2014
relative to 2013 including a 0.5 percent update for PFS services in
2014.
(3) Detail on the CY 2013 SGR
A more detailed discussion of our final revised estimates of the
four elements of the CY 2013 SGR follows.
(a) Factor 1--Changes in Fees for Physicians' Services for CY 2013
This factor was calculated as a weighted average of the CY 2013
changes in fees that apply for the different types of services included
in the definition of physicians' services for the SGR in CY 2013.
We estimate that services paid under the PFS account for
approximately 90.1 percent of total allowed charges included in the SGR
in CY 2013. These services were updated using the CY 2013 percent
change in the MEI of 0.8 percent. We estimate that diagnostic
laboratory tests represent approximately 9.9 percent of total allowed
charges included in the SGR in CY 2013. For CY 2013, diagnostic
laboratory tests received an update of -3.0 percent.
Table 41 shows the weighted-average of the MEI and laboratory price
changes for CY 2013.
Table 41--Weighted-Average of the MEI, Laboratory, and Drug Price
Changes for 2013
------------------------------------------------------------------------
Weight Update
------------------------------------------------------------------------
Physician..................................... 0.901 0.8
Laboratory.................................... 0.099 -3.0
Weighted-average.............................. 1.00 0.4
------------------------------------------------------------------------
After considering the elements described in Table 41, we estimate
that the weighted-average increase in fees for physicians' services in
CY 2013 under the SGR (before applying any legislative adjustments) was
0.4 percent. This figure is a final one based on complete data for CY
2013.
[[Page 67738]]
(b) Factor 2--Percentage Change in the Average Number of Part B
Enrollees From CY 2012 to CY 2013
We estimate the change in the number of fee-for-service enrollees
(excluding beneficiaries enrolled in MA plans) from CY 2012 to CY 2013
was 0.5 percent. Our calculation of this factor is based on complete
data from CY 2013. Table 42 illustrates the calculation of this factor.
Table 42--Average Number of Medicare Part B Fee-for-Service Enrollees
From CY 2012 to CY 2013 (Excluding Beneficiaries Enrolled in MA Plans)
------------------------------------------------------------------------
CY 2012 CY 2013
------------------------------------------------------------------------
Overall......................... 46.468 million.... 47.878 million.
Medicare Advantage (MA)......... 13.587 million.... 14.842 million.
Net............................. 32.881 million.... 33.036 million.
Percent Change.................. .................. 0.5 percent.
------------------------------------------------------------------------
(c) Factor 3--Estimated Real GDP Per Capita Growth in CY 2013
We estimate that the growth in real per capita GDP was 0.9 percent
in CY 2013 (based on the annual growth in the 10-year moving average of
real GDP per capita (2004 through 2013)). This figure is a final one
based on complete data for CY 2013.
(d) Factor 4--Percentage Change in Expenditures for Physicians'
Services Resulting From Changes in Statute or Regulations in CY 2013
Compared With CY 2012
Our final estimate for the net impact on expenditures from the
statutory and regulatory provisions that affect expenditures in CY 2013
relative to CY 2012 is -0.5 percent. This impact is due to many
different legislative or regulatory provisions affecting spending in
2013 relative to 2012, including provisions of the American Taxpayer
Relief Act in 2013.
2. The Update Adjustment Factor (UAF)
Section 1848(d) of the Act provides that the PFS update is equal to
the product of the MEI and the UAF. The UAF is applied to make actual
and target expenditures (referred to in the statute as ``allowed
expenditures'') equal. As discussed previously, allowed expenditures
are equal to actual expenditures in a base period updated each year by
the SGR. The SGR sets the annual rate of growth in allowed expenditures
and is determined by a formula specified in section 1848(f) of the Act.
We note that the conversion factor for the time period from January 1,
2015 through March 31, 2015 will reflect a 0.0 percent update based on
section 101 of PAMA. Beginning on April 1, 2015 through December 31,
2015, the standard calculation of the PFS CF under the SGR formula
would apply.
The calculation of the UAF is not affected by sequestration.
Pursuant to 2 U.S.C. 906(d)(6), ``The Secretary of Health and Human
Services shall not take into account any reductions in payment amounts
which have been or may be effected under [sequestration], for purposes
of computing any adjustments to payment rates under such title XVIII.''
Therefore, allowed charges, which are unaffected by sequestration, were
used to calculate physician expenditures in lieu of Medicare payments
plus beneficiary cost-sharing. As a result, neither actual expenditures
nor allowed expenditures were adjusted to reflect the impact of
sequestration.
a. Calculation Under Current Law
Under section 1848(d)(4)(B) of the Act, the UAF for a year
beginning with CY 2001 is equal to the sum of the following--
Prior Year Adjustment Component. An amount determined by--
++ Computing the difference (which may be positive or negative)
between the amount of the allowed expenditures for physicians' services
for the prior year (the year prior to the year for which the update is
being determined) and the amount of the actual expenditures for those
services for that year;
++ Dividing that difference by the amount of the actual
expenditures for those services for that year; and
++ Multiplying that quotient by 0.75.
Cumulative Adjustment Component. An amount determined by--
++ Computing the difference (which may be positive or negative)
between the amount of the allowed expenditures for physicians' services
from April 1, 1996, through the end of the prior year and the amount of
the actual expenditures for those services during that period;
++ Dividing that difference by actual expenditures for those
services for the prior year as increased by the SGR for the year for
which the UAF is to be determined; and
++ Multiplying that quotient by 0.33.
Section 1848(d)(4)(E) of the Act requires the Secretary to
recalculate allowed expenditures consistent with section 1848(f)(3) of
the Act. As discussed previously, section 1848(f)(3) specifies that the
SGR (and, in turn, allowed expenditures) for the upcoming CY (CY 2015
in this case), the current CY (that is, CY 2014) and the preceding CY
(that is, CY 2013) are to be determined on the basis of the best data
available as of September 1 of the current year. Allowed expenditures
for a year generally are estimated initially and subsequently revised
twice. The second revision occurs after the CY has ended (that is, we
are making the second revision to CY 2013 allowed expenditures in this
final rule with comment).
Table 43 shows the historical SGRs corresponding to each period
through CY 2015.
[[Page 67739]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.059
Consistent with section 1848(d)(4)(E) of the Act, Table 43 includes
our second revision of allowed expenditures for CY 2013, a
recalculation of allowed expenditures for CY 2014, and our initial
estimate of allowed expenditures for CY 2015. To determine the UAF for
CY 2015, the statute requires that we use allowed and actual
expenditures from April 1, 1996 through December 31, 2014 and the CY
2015 SGR. Consistent with section 1848(d)(4)(E) of the Act, we will be
making revisions to the CY 2014 and CY 2015 SGRs and CY 2014 and CY
2015 allowed expenditures. Because we have incomplete actual
expenditure data for CY 2014, we are using an estimate for this period.
Any difference between current estimates and final figures will be
taken into account in determining the UAF for future years.
We are using figures from EE10 in the following statutory formula:
[[Page 67740]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.060
Section 1848(d)(4)(D) of the Act indicates that the UAF determined
under section 1848(d)(4)(B) of the Act for a year may not be less than
-0.07 or greater than 0.03. Since 0.049 (4.9 percent) is greater than
0.03, the UAF for CY 2015 will be 3 percent.
Section 1848(d)(4)(A)(ii) of the Act indicates that 1.0 should be
added to the UAF determined under section 1848(d)(4)(B) of the Act.
Thus, adding 1.0 to 0.03 makes the UAF equal to 1.03.
3. Percentage Change in the MEI for CY 2015
The MEI is required by section 1842(b)(3) of the Act, which states
that prevailing charge levels beginning after June 30, 1973, may not
exceed the level from the previous year except to the extent that the
Secretary finds, on the basis of appropriate economic index data, that
the higher level is justified by year-to-year economic changes. The
current form of the MEI was detailed in the CY 2014 PFS final rule (78
FR 74264), which revised and reclassified certain cost categories,
price proxies, and expense categories.
The MEI measures the weighted-average annual price change for
various inputs needed to produce physicians' services. The MEI is a
fixed-weight input price index, with an adjustment for the change in
economy-wide multifactor productivity. This index, which has CY 2006
base year weights, is comprised of two broad categories: (1)
Physician's own time; and (2) physician's practice expense (PE).
The physician's compensation (own time) component represents the
net income portion of business receipts and primarily reflects the
input of the physician's own time into the production of physicians'
services in physicians' offices. This category consists of two
subcomponents: (1) Wages and salaries; and (2) fringe benefits.
The physician's practice expense (PE) category represents
nonphysician inputs used in the production of services in physicians'
offices. This category consists of wages and salaries and fringe
benefits for nonphysician staff (who cannot bill independently) and
other nonlabor inputs. The physician's PE component also includes the
following categories of nonlabor inputs: office expenses; medical
materials and supplies; professional liability insurance; medical
equipment; medical materials and supplies; and other professional
expenses.
Table 44 lists the MEI cost categories with associated weights and
percent changes for price proxies for the CY 2015 update. The CY 2015
non-productivity adjusted MEI update is 1.7 percent and reflects a 1.9
percent increase in physician's own time and a 1.5 percent increase in
physician's PE. Within the physician's PE, the largest increase
occurred in postage, which increased 5.4 percent.
For CY 2015, the increase in the MEI is 0.8 percent, which reflects
an increase in the non-productivity adjusted MEI of 1.7 percent and a
productivity adjustment of 0.9 percent (which is based on the 10-year
moving average of economy-wide private nonfarm business multifactor
productivity). The BLS is the agency that publishes the official
measure of private non-farm business MFP. Please see https://www.bls.gov/mfp, which is the link to the BLS historical published data
on the measure of MFP.
Table 44--Increase in the Medicare Economic Index Update for CY 2015 \1\
------------------------------------------------------------------------
2006 revised cost
Revised cost category weight (percent) CY15 update
\2\ (percent)
------------------------------------------------------------------------
MEI Total, productivity adjusted... 100.000 0.8
Productivity: 10-year moving \5\ N/A 0.9
average of MFP \1\................
[[Page 67741]]
MEI Total, without productivity 100.000 1.7
adjustment........................
Physician Compensation \3\......... 50.866 1.9
Wages and Salaries............. 43.641 1.9
Benefits....................... 7.225 2.0
Practice Expense................... 49.134 1.5
Non-physician compensation..... 16.553 1.8
Non-physician wages............ 11.885 1.8
Non-health, non-physician 7.249 2.0
wages.....................
Professional & Related..... 0.800 1.9
Management................. 1.529 2.2
Clerical................... 4.720 1.9
Services................... 0.200 1.2
Health related, non-physician 4.636 1.5
wages.........................
Non-physician benefits......... 4.668 1.9
Other Practice Expense......... 32.581 1.4
Utilities.................. 1.266 4.0
Miscellaneous Office 2.478 1.0
Expenses..................
Chemicals.................. 0.723 -1.1
Paper...................... 0.656 3.3
Rubber & Plastics.......... 0.598 1.0
All other products......... 0.500 1.7
Telephone...................... 1.501 0.0
Postage........................ 0.898 5.4
All Other Professional Services 8.095 1.7
Professional, Scientific, 2.592 1.8
and Tech. Services........
Administrative and support 3.052 1.9
& waste...................
All Other Services......... 2.451 1.2
Capital........................ 10.310 1.8
Fixed...................... 8.957 1.9
Moveable................... 1.353 0.8
Professional Liability 4.295 -0.1
Insurance \4\.................
Medical Equipment.............. 1.978 -0.3
Medical supplies............... 1.760 -0.2
------------------------------------------------------------------------
\1\ The forecasts are based upon the latest available Bureau of Labor
Statistics data on the 10-year average of BLS private nonfarm business
multifactor productivity published on July 9, 2014. (https://www.bls.gov/news.release/prod3.nr0.htm).
\2\ The weights shown for the MEI components are the 2006 base-year
weights, which may not sum to subtotals or totals because of rounding.
The MEI is a fixed-weight, Laspeyres-type input price index whose
category weights indicate the distribution of expenditures among the
inputs to physicians' services for CY 2006. To determine the MEI level
for a given year, the price proxy level for each component is
multiplied by its 2006 weight. The sum of these products (weights
multiplied by the price index levels) over all cost categories yields
the composite MEI level for a given year. The annual percent change in
the MEI levels is an estimate of price change over time for a fixed
market basket of inputs to physicians' services.
\3\ The measures of Productivity, Employment Cost Indexes, as well as
the various Producer and Consumer Price Indexes can be found on the
Bureau of Labor Statistics Web site at https://stats.bls.gov.
\4\ Derived from a CMS survey of several major commercial insurers.
\5\ Productivity is factored into the MEI categories as an adjustment;
therefore, no explicit weight exists for productivity in the MEI.
4. Physician and Anesthesia Fee Schedule Conversion Factors for CY 2015
The CY 2015 PFS CF for January 1, 2015 through March 31, 2015 is
$35.8013. The CY 2015 PFS CF for April 1, 2015 through December 31,
2015 is $28.2239. The CY 2015 national average anesthesia CF for
January 1, 2015 through March 31, 2015 is $22.5550. The CY 2015
national average anesthesia CF for April 1, 2015 through December 31,
2015 is $17.7913.
a. PFS Update and Conversion Factors
(1) CY 2014 PFS Update
The formula for calculating the PFS update is set forth in section
1848(d)(4)(A) of the Act. In general, the PFS update is determined by
multiplying the CF for the previous year by the percentage increase in
the MEI less productivity times the UAF, which is calculated as
specified under section 1848(d)(4)(B) of the Act.
(2) CY 2015 PFS Conversion Factors
Generally, the PFS CF for a year is calculated in accordance with
section 1848(d)(1)(A) of the Act by multiplying the previous year's CF
by the PFS update.
We note section 101 of the Medicare Improvements and Extension Act,
Division B of the Tax Relief and Health Care Act of 2006 (MIEA-TRHCA)
provided a 1-year increase in the CY 2007 CF and specified that the CF
for CY 2008 must be computed as if the 1-year increase had never
applied.
Section 101 of the Medicare, Medicaid, and SCHIP Extension Act of
2007 (MMSEA) provided a 6-month increase in the CY 2008 CF, from
January 1, 2008, through June 30, 2008, and specified that the CF for
the remaining portion of CY 2008 and the CFs for CY 2009 and subsequent
years must be computed as if the 6-month increase had never applied.
Section 131 of the MIPPA extended the increase in the CY 2008 CF
that applied during the first half of the year to the entire year,
provided for a 1.1 percent increase to the CY 2009 CF, and specified
that the CFs for CY 2010 and subsequent years must be computed as if
the increases for CYs 2007, 2008, and 2009 had never applied.
Section 1011(a) of the DODAA and section 5 of the TEA specified a
zero
[[Page 67742]]
percent update for CY 2010, effective January 1, 2010 through March 31,
2010.
Section 4 of the Continuing Extension Act of 2010 (CEA) extended
the zero percent update for CY 2010 through May 31, 2010.
Subsequently, section 101(a)(2) of the PACMBPRA provided for a 2.2
percent update to the CF, effective from June 1, 2010 to November 30,
2010.
Section 2 of the Physician Payment and Therapy Relief Act of 2010
(Pub. L. 111-286) extended the 2.2 percent update through the end of CY
2010.
Section 101 of the MMEA provided a zero percent update for CY 2011,
effective January 1, 2011 through December 31, 2011, and specified that
the CFs for CY 2012 and subsequent years must be computed as if the
increases in previous years had never applied.
Section 301 of the Temporary Payroll Tax Cut Continuation Act of
2011 (TPTCCA) provided a zero percent update effective January 1, 2012
through February 29, 2012, and specified that the CFs for subsequent
time periods must be computed as if the increases in previous years had
never applied.
Section 3003 of the Middle Class Tax Relief and Job Creation Act of
2012 (Job Creation Act) provided a zero percent update effective March
1, 2012 through December 31, 2012, and specified that the CFs for
subsequent time periods must be computed as if the increases in
previous years had never applied.
Section 601 of the American Taxpayer Relief Act (ATRA) of 2012
(Pub. L. 112-240) provided a zero percent update for CY 2013, effective
January 1, 2013 through December 31, 2013, and specified that the CFs
for subsequent time periods must be computed as if the increases in
previous years had not been applied.
Section 1101 of the Pathway for SGR Reform Act of 2013 (Pub. L.
113-67) provided a 0.5 percent update to the PFS CF, effective January
1, 2014 through March 31, 2014 and specified that the CFs for
subsequent time periods must be computed as if the increases in
previous years had not been applied.
Section 101 of the Protecting Access to Medicare Act of 2014 (Pub.
L. 113-93) (PAMA) extended this 0.5 percent update through December 31,
2014. Section 101 of the PAMA also provides a 0.0 percent update for
services furnished on or after January 1, 2015, through March 31, 2015,
and specified that the CFs for subsequent time periods must be computed
as if the increases in previous years had not been applied.
Therefore, under current law, the CF that would be in effect in CY
2014 had the prior increases specified above not applied is $27.2006.
In addition, when calculating the PFS CF for a year, section
1848(c)(2)(B)(ii)(II) of the Act requires that increases or decreases
in RVUs may not cause the amount of expenditures for the year to differ
more than $20 million from what it would have been in the absence of
these changes. If this threshold is exceeded, we must make adjustments
to preserve budget neutrality. We estimate that CY 2015 RVU changes
would result in an increase in Medicare physician expenditures of more
than $20 million. Accordingly, we are decreasing the CF by 0.06 percent
to offset this estimated increase in Medicare physician expenditures
due to the CY 2015 RVU changes.
For January 1, 2015 through March 31, 2015, the PFS update will be
0.0 percent consistent with section 101 of PAMA. After applying the
budget neutrality adjustment described above, the conversion factor for
January 1, 2015 through March 31, 2015 will be $35.8013.
After March 31, 2015 the standard calculation of the PFS CF under
the SGR formula would apply. Therefore, from April 1, 2015 through
December 31, 2015 the conversion factor would be $28.2239. This final
rule with comment period announces a reduction to payment rates for
physicians' services of 21.2 percent during this time period in CY 2015
under the SGR formula.
By law, we are required to make these reductions in accordance with
section 1848(d) and (f) of the Act, and these reductions can only be
averted by an Act of Congress. While Congress has provided temporary
relief from these reductions every year since 2003, a long-term
solution is critical. We will continue to work with Congress to fix
this untenable situation so doctors and beneficiaries no longer have to
worry about the stability and adequacy of payments from Medicare under
the PFS.
We illustrate the calculation of the CY 2015 PFS CF in Table 45.
Table 45--Calculation of the CY 2015 PFS CF
------------------------------------------------------------------------
------------------------------------------------------------------------
January 1, 2015 through March 31, 2015
------------------------------------------------------------------------
Conversion Factor in effect in CY .................... $35.8228
2014.
Update............................ 0.0 percent (1.00)..
CY 2015 RVU Budget Neutrality -0.06 percent
Adjustment. (0.9994).
CY 2015 Conversion Factor (1/1/ .................... $35.8013
2015 through 3/31/2015).
------------------------------------------------------------------------
April 1, 2015 through December 31, 2015
------------------------------------------------------------------------
Conversion Factor in effect in CY .................... $35.8228
2014.
CY 2014 Conversion Factor had .................... $27.2006
statutory increases not applied.
CY 2015 Medicare Economic Index... 0.8 percent (1.008).
CY 2015 Update Adjustment Factor.. -3.0 percent (1.03).
CY 2015 RVU Budget Neutrality -0.06 percent
Adjustment. (0.9994).
CY 2015 Conversion Factor (4/1/ .................... $28.2239
2015 through 12/31/2015).
Percent Change in Conversion .................... -21.2%
Factor on 4/1/2015 (relative to
the CY 2014 CF).
Percent Change in Update (without .................... -20.9%
budget neutrality adjustment) on
4/1/2015 (relative to the CY 2014
CF).
------------------------------------------------------------------------
We note payment for services under the PFS will be calculated as
follows:
Payment = [(Work RVU x Work GPCI) + (PE RVU x PE GPCI) + (Malpractice
RVU x Malpractice GPCI)] x CF.
b. Anesthesia Conversion Factors
We calculate the anesthesia CFs as indicated in Table 46.
Anesthesia services do not have RVUs like other PFS services.
Therefore, we account for any necessary RVU adjustments through an
adjustment to the anesthesia CF to simulate changes to RVUs. More
specifically, if there is an adjustment to the work, PE, or malpractice
RVUs, these adjustments are applied to the respective shares of the
anesthesia CF as
[[Page 67743]]
these shares are proxies for the work, PE, and malpractice RVUs for
anesthesia services. Information regarding the anesthesia work, PE, and
malpractice shares can be found at the following: https://www.cms.gov/center/anesth.asp.
The anesthesia CF in effect in CY 2014 is $22.6765. Section 101 of
PAMA provides for a 0.0 percent update from January 1, 2015 through
March 31, 2015. After applying the 0.9994 budget neutrality factor
described above, the anesthesia CF in effect from January 1, 2015
through March 31, 2015 will be $22.5550.
The table below includes adjustments to the anesthesia CF that are
analogous to the physician fee schedule CF with other adjustments that
are specific to anesthesia. In order to calculate the CY 2015
anesthesia CF for April 1, 2015 through December 31, 2015, the statute
requires us to calculate the CFs for all previous years as if the
various legislative changes to the CFs for those years had not
occurred. The resulting CF is then adjusted for the update (the MEI,
less multi-factor productivity and increased by the UAF). The national
average CF is then adjusted for anesthesia specific work, practice
expense and malpractice factors that must be applied to the anesthesia
CF as the anesthesia fee schedule does not have RVUs. Accordingly,
under current law, the anesthesia CF in effect in CY 2015 for the time
period from April 1, 2015 through December 31, 2015 is $17.7913. We
illustrate the calculation of the CY 2015 anesthesia CFs in Table 45.
Table 46--Calculation of the CY 2015 Anesthesia CF
------------------------------------------------------------------------
------------------------------------------------------------------------
January 1, 2015 through March 31, 2015
------------------------------------------------------------------------
CY 2014 National Average .................... $22.6765
Anesthesia CF.
Update............................ 0.0 percent (1.00)..
CY 2015 RVU Budget Neutrality 0.0006 percent
Adjustment. (0.9994).
CY 2015 Anesthesia Fee Schedule 0.005 percent
Practice Expense Adjustment. (.99524).
CY 2015 National Average .................... $22.5550
Anesthesia CF (1/1/2015 through 3/
31/2015).
------------------------------------------------------------------------
April 1, 2015 through December 31, 2015
------------------------------------------------------------------------
2014 National Average Anesthesia .................... $22.6765
Conversion Factor in effect in CY
2015.
2014 National Anesthesia .................... $17.2283
Conversion Factor had Statutory
Increases Not Applied.
CY 2015 Medicare Economic Index... 0.8 percent (1.008).
CY 2015 Update Adjustment Factor.. 3.0 percent (0.9994)
CY 2015 Budget Neutrality Work and -0.06 percent
Malpractice Adjustment. (0.9994).
CY 2015 Anesthesia Fee Schedule 0.005 percent
Practice Expense Adjustment. (.99524).
CY 2015 Anesthesia Conversion .................... $17.7913
Factor (4/1/2015 through 12/31/
2015).
Percent Change from 2014 to 2015 .................... -21.5%
(4/1/2015 through 12/31/2015).
------------------------------------------------------------------------
III. Other Provisions of the Final Rule With Comment Period Regulation
A. Ambulance Extender Provisions
1. Amendment to Section 1834(l)(13) of the Act
Section 146(a) of the MIPPA amended section 1834(l)(13)(A) of the
Act to specify that, effective for ground ambulance services furnished
on or after July 1, 2008 and before January 1, 2010, the ambulance fee
schedule amounts for ground ambulance services shall be increased as
follows:
For covered ground ambulance transports that originate in
a rural area or in a rural census tract of a metropolitan statistical
area, the fee schedule amounts shall be increased by 3 percent.
For covered ground ambulance transports that do not
originate in a rural area or in a rural census tract of a metropolitan
statistical area, the fee schedule amounts shall be increased by 2
percent.
The payment add-ons under section 1834(l)(13)(A) of the Act have
been extended several times. Recently, section 1104(a) of the Pathway
for SGR Reform Act of 2013, enacted on December 26, 2013, as Division B
(Medicare and Other Health Provisions) of Pub L. 113-67, amended
section 1834(l)(13)(A) of the Act to extend the payment add-ons
described above through March 31, 2014. Subsequently, section 104(a) of
the Protecting Access to Medicare Act of 2014 (Pub. L. 113-93, enacted
on April 1, 2014) amended section 1834(l)(13)(A) of the Act to extend
the payment add-ons again through March 31, 2015. Thus, these payment
add-ons also apply to covered ground ambulance transports furnished
before April 1, 2015. (For a discussion of past legislation extending
section 1834(l)(13) of the Act, please see the CY 2014 PFS final rule
(78 FR 74438 through 74439)).
These statutory requirements are self-implementing. A plain reading
of the statute requires only a ministerial application of the mandated
rate increase, and does not require any substantive exercise of
discretion on the part of the Secretary. In the CY 2015 PFS proposed
rule (79 FR 40372), we proposed to revise Sec. 414.610(c)(1)(ii) to
conform the regulations to these statutory requirements. We received
one comment regarding this proposal. A summary of the comment we
received and our response are set forth below.
Comment: One commenter supported the implementation of the
ambulance payment add-ons. The commenter also agreed that these
provisions are self-implementing.
Response: We thank the commenter for their support of these
provisions.
After consideration of the public comment received, we are
finalizing our proposal to revise Sec. 414.610(c)(1)(ii) to conform
the regulations to these statutory requirements.
2. Amendment to Section 1834(l)(12) of the Act
Section 414(c) of the Medicare Prescription Drug, Improvement and
Modernization Act of 2003 (Pub. L. 108-173, enacted on December 8,
2003) (MMA) added section 1834(l)(12) to the Act, which specified that
in the case of ground ambulance services furnished on or after July 1,
2004, and before January 1, 2010, for which transportation originates
in a qualified rural area (as described in the statute), the Secretary
shall provide for a percent increase in the base rate of the fee
schedule for such transports. The statute requires this percent
increase to be based on the Secretary's estimate of the average cost
per trip for such services (not taking into account mileage) in the
lowest quartile of all rural county populations as compared to the
average cost per trip
[[Page 67744]]
for such services (not taking into account mileage) in the highest
quartile of rural county populations. Using the methodology specified
in the July 1, 2004 interim final rule (69 FR 40288), we determined
that this percent increase was equal to 22.6 percent. As required by
the MMA, this payment increase was applied to ground ambulance
transports that originated in a ``qualified rural area''; that is, to
transports that originated in a rural area included in those areas
comprising the lowest 25th percentile of all rural populations arrayed
by population density. For this purpose, rural areas included Goldsmith
areas (a type of rural census tract). This rural bonus is sometimes
referred to as the ``Super Rural Bonus'' and the qualified rural areas
(also known as ``super rural'' areas) are identified during the claims
adjudicative process via the use of a data field included on the CMS-
supplied ZIP code File.
The Super Rural Bonus under section 1834(l)(12) of the Act has been
extended several times. Recently, section 1104(b) of the Pathway for
SGR Reform Act of 2013, enacted on December 26, 2013, as Division B
(Medicare and Other Health Provisions) of Pub. L. 113-67, amended
section 1834(l)(12)(A) of the Act to extend this rural bonus through
March 31, 2014. Subsequently, section 104(b) of the Protecting Access
to Medicare Act of 2014 (Pub. L. 113-93, enacted on April 1, 2014)
amended section 1834(l)(12)(A) of the Act to extend this rural bonus
again through March 31, 2015. Therefore, we are continuing to apply the
22.6 percent rural bonus described above (in the same manner as in
previous years) to ground ambulance services with dates of service
before April 1, 2015 where transportation originates in a qualified
rural area. (For a discussion of past legislation extending section
1834(l)(12) of the Act, please see the CY 2014 PFS final rule (78 FR
74439 through 74440)).
These statutory provisions are self-implementing. Together, these
statutory provisions require a 15-month extension of this rural bonus
(which was previously established by the Secretary) through March 31,
2015, and do not require any substantive exercise of discretion on the
part of the Secretary. In the CY 2015 PFS proposed rule (79 FR 40372),
we proposed to revise Sec. 414.610(c)(5)(ii) to conform the
regulations to these statutory requirements. We received one comment
regarding this proposal. A summary of the comment we received and our
response are set forth below.
Comment: One commenter supported the implementation of the percent
increase in the base rate of the fee schedule for transports in areas
defined as super rural. The commenter also agreed with CMS that these
provisions are self-implementing.
Response: We thank the commenter for their support of these
provisions.
After consideration of the public comment received, we are
finalizing our proposal to revise Sec. 414.610(c)(5)(ii) to conform
the regulations to these statutory requirements.
B. Changes in Geographic Area Delineations for Ambulance Payment
1. Background
Under the ambulance fee schedule, the Medicare program pays for
ambulance transportation services for Medicare beneficiaries when other
means of transportation are contraindicated by the beneficiary's
medical condition, and all other coverage requirements are met.
Ambulance services are classified into different levels of ground
(including water) and air ambulance services based on the medically
necessary treatment provided during transport.
These services include the following levels of service:
For Ground--
++ Basic Life Support (BLS) (emergency and non-emergency)
++ Advanced Life Support, Level 1 (ALS1) (emergency and non-
emergency)
++ Advanced Life Support, Level 2 (ALS2)
++ Paramedic ALS Intercept (PI)
++ Specialty Care Transport (SCT)
For Air--
++ Fixed Wing Air Ambulance (FW)
++ Rotary Wing Air Ambulance (RW)
a. Statutory Coverage of Ambulance Services
Under sections 1834(l) and 1861(s)(7) of the Act, Medicare Part B
(Supplemental Medical Insurance) covers and pays for ambulance
services, to the extent prescribed in regulations, when the use of
other methods of transportation would be contraindicated by the
beneficiary's medical condition.
The House Ways and Means Committee and Senate Finance Committee
Reports that accompanied the 1965 Social Security Amendments suggest
that the Congress intended that--
The ambulance benefit cover transportation services only
if other means of transportation are contraindicated by the
beneficiary's medical condition; and
Only ambulance service to local facilities be covered
unless necessary services are not available locally, in which case,
transportation to the nearest facility furnishing those services is
covered (H.R. Rep. No. 213, 89th Cong., 1st Sess. 37 and Rep. No. 404,
89th Cong., 1st Sess. Pt 1, 43 (1965)).
The reports indicate that transportation may also be provided from
one hospital to another, to the beneficiary's home, or to an extended
care facility.
b. Medicare Regulations for Ambulance Services
Our regulations relating to ambulance services are set forth at 42
CFR part 410, subpart B and 42 CFR part 414, subpart H. Section
410.10(i) lists ambulance services as one of the covered medical and
other health services under Medicare Part B. Therefore, ambulance
services are subject to basic conditions and limitations set forth at
Sec. 410.12 and to specific conditions and limitations included at
Sec. 410.40 and Sec. 410.41. Part 414, subpart H, describes how
payment is made for ambulance services covered by Medicare.
2. Provisions of the Final Rule
Historically, the Medicare ambulance fee schedule has used the same
geographic area designations as the acute care hospital inpatient
prospective payment system (IPPS) and other Medicare payment systems to
take into account appropriate urban and rural differences. This
promotes consistency across the Medicare program, and it provides for
use of consistent geographic standards for Medicare payment purposes.
The current geographic areas used under the ambulance fee schedule
are based on OMB standards published on December 27, 2000 (65 FR 82228
through 82238), Census 2000 data, and Census Bureau population
estimates for 2007 and 2008 (OMB Bulletin No. 10-02). For a discussion
of OMB's delineation of Core-Based Statistical Areas (CBSAs) and our
implementation of the CBSA definitions under the ambulance fee
schedule, we refer readers to the preamble of the CY 2007 Ambulance Fee
Schedule proposed rule (71 FR 30358 through 30361) and the CY 2007 PFS
final rule (71 FR 69712 through 69716). On February 28, 2013, OMB
issued OMB Bulletin No. 13-01, which established revised delineations
for Metropolitan Statistical Areas (MSAs), Micropolitan Statistical
Areas, and Combined Statistical Areas, and provided guidance on the use
of the delineations of these statistical areas. A copy of this bulletin
may be obtained at https://www.whitehouse.gov/sites/default/files/omb/bulletins/2013/b-13-01.pdf. According to OMB, ``[t]his
[[Page 67745]]
bulletin provides the delineations of all Metropolitan Statistical
Areas, Metropolitan Divisions, Micropolitan Statistical Areas, Combined
Statistical Areas, and New England City and Town Areas in the United
States and Puerto Rico based on the standards published on June 28,
2010, in the Federal Register (75 FR 37246-37252) and Census Bureau
data.'' OMB defines an MSA as a CBSA associated with at least one
urbanized area that has a population of at least 50,000, and a
Micropolitan Statistical Area (referred to in this discussion as a
Micropolitan Area) as a CBSA associated with at least one urban cluster
that has a population of at least 10,000 but less than 50,000 (75 FR
37252). Counties that do not qualify for inclusion in a CBSA are deemed
``Outside CBSAs.'' We note that, when referencing the new OMB
geographic boundaries of statistical areas, we are using the term
``delineations'' consistent with OMB's use of the term (75 FR 37249).
Although the revisions OMB published on February 28, 2013 are not
as sweeping as the changes made when we adopted the CBSA geographic
designations for CY 2007, the February 28, 2013 OMB bulletin does
contain a number of significant changes. For example, we stated in the
CY 2015 PFS proposed rule (79 FR 40373) that if we adopt the revised
OMB delineations, there would be new CBSAs, urban counties that would
become rural, rural counties that would become urban, and existing
CBSAs that would be split apart. We have reviewed our findings and
impacts relating to the new OMB delineations, and find no compelling
reason to further delay implementation. We stated in the proposed rule
that we believe it is important for the ambulance fee schedule to use
the latest labor market area delineations available as soon as
reasonably possible to maintain a more accurate and up-to-date payment
system that reflects the reality of population shifts.
Additionally, in the FY 2015 IPPS proposed rule (79 FR 28055), we
also proposed to adopt OMB's revised delineations to identify urban
areas and rural areas for purposes of the IPPS wage index. This
proposal was finalized in the FY 2015 IPPS final rule (79 FR 49952).
For the reasons discussed above, we believe it would be appropriate to
adopt the same geographic area delineations for use under the ambulance
fee schedule as are used under the IPPS and other Medicare payment
systems. Thus, we proposed to implement the new OMB delineations as
described in the February 28, 2013 OMB Bulletin No. 13-01 beginning in
CY 2015 to more accurately identify urban and rural areas for ambulance
fee schedule payment purposes. We believe that the updated OMB
delineations more realistically reflect rural and urban populations,
and that the use of such delineations under the ambulance fee schedule
would result in more accurate payment. Under the ambulance fee
schedule, consistent with our current definitions of urban and rural
areas (Sec. 414.605), MSAs would continue to be recognized as urban
areas, while Micropolitan and other areas outside MSAs, and rural
census tracts within MSAs (as discussed below), would be recognized as
rural areas.
In addition to the OMB's statistical area delineations, the current
geographic areas used in the ambulance fee schedule also are based on
rural census tracts determined under the most recent version of the
Goldsmith Modification. These rural census tracts are considered rural
areas under the ambulance fee schedule (see Sec. 414.605). For certain
rural add-ons, section 1834(l) of the Act requires that we use the most
recent version of the Goldsmith Modification to determine rural census
tracts within MSAs. In the CY 2007 PFS final rule (71 FR 69714 through
69716), we adopted the most recent (at that time) version of the
Goldsmith Modification, designated as Rural-Urban Commuting Area (RUCA)
codes. RUCA codes use urbanization, population density, and daily
commuting data to categorize every census tract in the country. For a
discussion about RUCA codes, we refer the reader to the CY 2007 PFS
final rule (71 FR 69714 through 69716). As stated previously, on
February 28, 2013, OMB issued OMB Bulletin No. 13-01, which established
revised delineations for Metropolitan Statistical Areas, Micropolitan
Statistical Areas, and Combined Statistical Areas, and provided
guidance on the use of the delineations of these statistical areas.
Several modifications of the RUCA codes were necessary to take into
account updated commuting data and the revised OMB delineations. We
refer readers to the U.S. Department of Agriculture's Economic Research
Service Web site for a detailed listing of updated RUCA codes found at
https://www.ers.usda.gov/data-products/rural-urban-commuting-area-codes.aspx. The updated RUCA code definitions were introduced in late
2013 and are based on data from the 2010 decennial census and the 2006-
10 American Community Survey. We proposed to adopt the most recent
modifications of the RUCA codes beginning in CY 2015, to recognize
levels of rurality in census tracts located in every county across the
nation, for purposes of payment under the ambulance fee schedule. In
the CY 2015 PFS proposed rule (79 FR 40373), we stated that if we adopt
the most recent RUCA codes, many counties that are designated as urban
at the county level based on population would have rural census tracts
within them that would be recognized as rural areas through our use of
RUCA codes.
As we stated in the CY 2015 PFS proposed rule (79 FR 40373 through
40374), the 2010 Primary RUCA codes are as follows:
(1) Metropolitan area core: primary flow with an urbanized area
(UA).
(2) Metropolitan area high commuting: primary flow 30 percent or
more to a UA.
(3) Metropolitan area low commuting: primary flow 10 to 30 percent
to a UA.
(4) Micropolitan area core: primary flow within an Urban Cluster of
10,000 to 49,999 (large UC).
(5) Micropolitan high commuting: primary flow 30 percent or more to
a large UC.
(6) Micropolitan low commuting: primary flow 10 to 30 percent to a
large UC.
(7) Small town core: primary flow within an Urban Cluster of 2,500
to 9,999 (small UC).
(8) Small town high commuting: primary flow 30 percent or more to a
small UC.
(9) Small town low commuting: primary flow 10 to 30 percent to a
small UC.
(10) Rural areas: primary flow to a tract outside a UA or UC.
Based on this classification, and consistent with our current
policy (71 FR 69715), we proposed to continue to designate any census
tracts falling at or above RUCA level 4.0 as rural areas for purposes
of payment for ambulance services under the ambulance fee schedule. As
discussed in the CY 2007 PFS final rule (71 FR 69715), the Office of
Rural Health Policy within the Health Resources and Services
Administration (HRSA) determines eligibility for its rural grant
programs through the use of the RUCA code methodology. Under this
methodology, HRSA designates any census tract that falls in RUCA level
4.0 or higher as a rural census tract. In addition to designating any
census tracts falling at or above RUCA level 4.0 as rural areas, under
the updated RUCA code definitions, HRSA has also designated as rural
census tracts those census tracts with RUCA codes 2 or 3 that are at
least 400 square miles in area with a population density of no more
than 35 people. We refer readers to
[[Page 67746]]
HRSA's Web site: ftp://ftp.hrsa.gov/ruralhealth/Eligibility2005.pdf for
additional information. Consistent with the HRSA guidelines discussed
above, we proposed, beginning in CY 2015, to designate as rural areas
(1) those census tracts that fall at or above RUCA level 4.0, and (2)
those census tracts that fall within RUCA levels 2 or 3 that are at
least 400 square miles in area with a population density of no more
than 35 people. We stated in the CY 2015 PFS proposed rule (79 FR
40374) that we continue to believe that HRSA's guidelines accurately
identify rural census tracts throughout the country, and thus would be
appropriate to apply for ambulance payment purposes. We invited
comments on this proposal.
We stated in the CY 2015 PFS proposed rule (79 FR 40374) that the
adoption of the most current OMB delineations and the updated RUCA
codes would affect whether certain areas are recognized as rural or
urban. The distinction between urban and rural is important for
ambulance payment purposes because urban and rural transports are paid
differently. The determination of whether a transport is urban or rural
is based on the point of pick-up for the transport, and thus a
transport is paid differently depending on whether the point of pick-up
is in an urban or a rural area. During claims processing, a geographic
designation of urban, rural, or super rural is assigned to each claim
for an ambulance transport based on the point of pick-up ZIP code that
is indicated on the claim.
Currently, section 1834(l)(12) of the Act (as amended by section
104(b) of the PAMA) specifies that, for services furnished during the
period July 1, 2004 through March 31, 2015, the payment amount for the
ground ambulance base rate is increased by a ``percent increase''
(Super Rural Bonus) where the ambulance transport originates in a
``qualified rural area,'' which is a rural area that we determine to be
in the lowest 25th percentile of all rural populations arrayed by
population density (also known as a ``super rural area''). We implement
this Super Rural Bonus in Sec. 414.610(c)(5)(ii). We stated in the CY
2015 PFS proposed rule (79 FR 40374) that adoption of the revised OMB
delineations and the updated RUCA codes would have no negative impact
on ambulance transports in super rural areas, as none of the current
super rural areas would lose their status due to the revised OMB
delineations and the updated RUCA codes.
As we stated in the CY 2015 PFS proposed rule (79 FR 40374), the
adoption of the new OMB delineations and the updated RUCA codes would
affect whether or not transports would be eligible for other rural
adjustments under the ambulance fee schedule statute and regulations.
For ground ambulance transports where the point of pick-up is in a
rural area, the mileage rate is increased by 50 percent for each of the
first 17 miles (Sec. 414.610(c)(5)(i)). For air ambulance services
where the point of pick-up is in a rural area, the total payment (base
rate and mileage rate) is increased by 50 percent (Sec.
414.610(c)(5)(i)). Furthermore, under section 1834(l)(13) of the Act
(as amended by section 104(a) of the PAMA), for ground ambulance
transports furnished through March 31, 2015, transports originating in
rural areas are paid based on a rate (both base rate and mileage rate)
that is 3 percent higher than otherwise is applicable. (See also Sec.
414.610(c)(1)(ii)).
We stated in the CY 2015 PFS proposed rule (79 FR 40374) that if we
adopt OMB's revised delineations and the updated RUCA codes, ambulance
providers and suppliers that pick up Medicare beneficiaries in areas
that would be Micropolitan or otherwise outside of MSAs based on OMB's
revised delineations or in a rural census tract of an MSA based on the
updated RUCA codes (but are currently within urban areas) may
experience increases in payment for such transports because they may be
eligible for the rural adjustment factors discussed above, while those
ambulance providers and suppliers that pick up Medicare beneficiaries
in areas that would be urban based on OMB's revised delineations and
the updated RUCA codes (but are currently in Micropolitan Areas or
otherwise outside of MSAs, or in a rural census tract of an MSA) may
experience decreases in payment for such transports because they would
no longer be eligible for the rural adjustment factors discussed above.
The use of the revised OMB delineations and the updated RUCA codes
would mean the recognition of new urban and rural boundaries based on
the population migration that occurred over a 10-year period, between
2000 and 2010. In the CY 2015 PFS proposed rule (79 FR 40374), we
stated that, based on the latest United States Postal Service (USPS)
ZIP code file, there are a total of 42,914 ZIP codes in the U.S. We
stated in the proposed rule that the geographic designations for
approximately 99.48 percent of ZIP codes would be unchanged by OMB's
revised delineations and the updated RUCA codes, and that a similar
number of ZIP codes would change from rural to urban (122, or 0.28
percent) as would change from urban to rural (100, or 0.23 percent). We
stated in the proposed rule that, in general, it was expected that
ambulance providers and suppliers in 100 ZIP codes within 11 states may
experience payment increases if we adopt the revised OMB delineations
and the updated RUCA codes, as these areas would be redesignated from
urban to rural. We stated that the state of Ohio would have the most
ZIP codes changing from urban to rural with a total of 40, or 2.69
percent. We also stated in the CY 2015 PFS proposed rule that ambulance
providers and suppliers in 122 ZIP codes within 22 states may
experience payment decreases if we adopt the revised OMB delineations
and the updated RUCA codes, as these areas would be redesignated from
rural to urban. We stated that the state of West Virginia would have
the most ZIP codes changing from rural to urban (17, or 1.82 percent),
while Connecticut would have the greatest percentage of ZIP codes
changing from rural to urban (15 ZIP codes, or 3.37 percent). Our
findings were illustrated in Table 17 of the CY 2015 PFS proposed rule
(79 FR 40375).
We stated in the CY 2015 PFS proposed rule (79 FR 40375 and 40376)
that we believe the most current OMB statistical area delineations,
coupled with the updated RUCA codes, more accurately reflect the
contemporary urban and rural nature of areas across the country, and
that use of the most current OMB delineations and RUCA codes under the
ambulance fee schedule would enhance the accuracy of ambulance fee
schedule payments. We solicited comments on our proposal to implement
the new OMB delineations and the updated RUCA codes as discussed above
beginning in CY 2015, for purposes of payment under the Medicare
ambulance fee schedule.
We received four comments from two associations representing
ambulance service providers and suppliers and two ambulance suppliers
on our proposal to implement the new OMB delineations and the updated
RUCA codes for purposes of payment under the Medicare ambulance fee
schedule. Those comments are summarized below along with our responses.
Comment: All of the commenters agreed with CMS that it is
appropriate to adjust the geographic area designations periodically so
that the ambulance fee schedule reflects population shifts.
Response: We appreciate the support of the commenters.
Comment: Commenters expressed concern that the analysis of the
proposed modification in the CY 2015 PFS proposed rule did not describe
the actual impact of the proposed change
[[Page 67747]]
because it did not take into account the most recent modifications to
the RUCA codes. When these codes are applied, the commenters stated
that there would be substantially more ZIP codes that would shift. The
commenters estimated that more than 1,500 ZIP codes would shift from
rural to urban and about three times the number of ZIP codes identified
in the proposed rule would change from urban to rural. The commenters
also stated that some ZIP codes would no longer have super rural
status.
Response: The commenters are correct that the analysis published in
the CY 2015 PFS proposed rule (see Table 17 (79 FR 40375)) presented
the impact of the revised OMB delineations only and did not include the
impact of the updated RUCA codes. We did not receive the ZIP code
approximation of the 2010 RUCA codes file in time to be included in our
analysis in the proposed rule.
We have completed an updated analysis of both the revised OMB
delineations and the updated RUCA codes. Based on the latest United
States Postal Service (USPS) ZIP code file, there are a total of 42,918
ZIP codes in the U.S. Based on our updated analysis, we have concluded
that the geographic designations for approximately 92.02 percent of ZIP
codes would be unchanged by OMB's revised delineations and the updated
RUCA codes. There are more ZIP codes that would change from rural to
urban (3,038 or 7.08 percent) than from urban to rural (387 or 0.90
percent). The differences in the data provided in the proposed rule
compared to the final rule are due to inclusion of the updated RUCA
codes. In general, it is expected that ambulance providers and
suppliers in 387 ZIP codes within 41 states, may experience payment
increases under the revised OMB delineations and the updated RUCA
codes, as these areas have been redesignated from urban to rural. The
state of California has the most ZIP codes changing from urban to rural
with a total of 43, or 1.58 percent. Ambulance providers and suppliers
in 3,038 ZIP codes within 46 states and Puerto Rico may experience
payment decreases under the revised OMB delineations and the updated
RUCA codes, as these areas have been redesignated from rural to urban.
The state of Pennsylvania has the most ZIP codes changing from rural to
urban (293, or 13.06 percent), while West Virginia has the greatest
percentage of ZIP codes changing from rural to urban (269 ZIP codes, or
28.74 percent). Our findings are illustrated in Table 47.
BILLING CODE 4120-01-P
[[Page 67748]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.062
[[Page 67749]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.063
BILLING CODE 4120-01-C
As discussed above, in the CY 2015 PFS proposed rule (79 FR 40374),
we proposed to designate as rural those census tracts that fall in RUCA
codes 2 or 3 that are at least 400 square miles in area with a
population density of no more than 35 people. However, upon further
analysis, we have determined that it is not feasible to implement this
proposal. Payment under the ambulance fee schedule is based on the ZIP
codes; therefore, if the ZIP code is predominantly metropolitan but has
some rural census tracts, we do not split the ZIP code areas to
distinguish further granularity to provide different payments within
the same ZIP code. We believe that payment for all ambulance
transportation services at the ZIP code level provides a consistent
payment system. Therefore, such census tracts were not considered rural
areas in the updated analysis set forth above.
For more detail on the impact of these changes, in addition to
Table 47, the following files are available through the Internet on the
AFS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AmbulanceFeeSchedule/: ZIP codes by state that
changed from urban to rural, ZIP codes by state that changed from rural
to urban, list of ZIP codes with RUCA code designations, and a complete
list of ZIP codes identifying their designation as super rural, rural
or urban.
As reflected in Table 47, our findings are generally consistent
with the commenters' findings that more than 1,500 ZIP codes would
change from rural to urban (our updated analysis indicates that 3,038
ZIP codes are changing), and that about three times the number of ZIP
codes identified in the proposed rule (100) would change from urban to
rural (our updated analysis indicates 387 ZIP codes are changing).
As we stated in the proposed rule (79 FR 40374), none of the
current super rural areas will lose their super rural status upon
implementation of the revised OMB delineations and the updated RUCA
codes.
Comment: One commenter suggested that we delay the implementation
of the adjustment until CY 2016 to allow CMS sufficient time to publish
the changes in
[[Page 67750]]
rural and urban status and allow all interested parties to provide
comments on the proposal. In addition to delaying implementation, the
commenter suggested implementing a 4-year transition that would phase-
in the payment reduction over a specified period for those ZIP codes
losing rural status.
Other commenters requested that the implementation of the
geographic adjustments outlined in the proposed rule be delayed until
such time as the data is available to complete a full and accurate
analysis of the ZIP codes affected and the financial impact to
industry. Absent such a delay, the commenters stated that the final
rule must clarify, in a complete and transparent manner, the accuracy
of the analysis used in the proposed rule.
Response: We believe that ambulance providers and suppliers had
sufficient notice of and opportunity to comment on the proposed
adoption of the revised OMB delineations and the updated RUCA codes
under the ambulance fee schedule, and thus we do not believe a delay in
implementation is warranted. In the proposed rule, we proposed to adopt
the revised OMB delineations as set forth in OMB Bulletin No. 13-01 and
the updated RUCA codes for purposes of payment under the ambulance fee
schedule consistent with the policy we implemented in CY 2007 (see the
CY 2007 PFS final rule (71 FR 69713 through 69716)). We explained in
the proposed rule that the adoption of the revised OMB delineations and
updated RUCA codes would affect the urban/rural designation of certain
areas, and thus would affect whether transports in certain areas would
be eligible for rural adjustments under the ambulance fee schedule. In
addition, OMB Bulletin No. 13-01was available on February 28, 2013, and
contained additional information regarding the changes in OMB
geographic area delineations. As discussed above, the ZIP code analysis
set forth in the proposed rule reflected the impact of the revised OMB
delineations. The 2010 RUCA codes and definitions were available on
December 31, 2013 on the U.S. Department of Agriculture's Economic
Research Service's Web site, which provided ambulance providers and
suppliers with additional information regarding changes to the level of
rurality in census tracts. Furthermore, section 1834(l) requires that
we use the most recent modification of the Goldsmith Modification to
determine rural census tracts for purposes of certain rural add-ons,
and our established policy, as set forth in Sec. 414.605, is that
rural areas include rural census tracts as determined under the most
recent version of the Goldsmith modification.
As discussed above and in the CY 2015 PFS proposed rule, we believe
the most current OMB statistical area delineations, coupled with the
updated RUCA codes, more accurately reflect the contemporary urban and
rural nature of areas across the country, and thus we believe the use
of the most current OMB delineations and RUCA codes under the ambulance
fee schedule will enhance the accuracy of ambulance fee schedule
payments. We believe that it is important to use the most current OMB
delineations and RUCA codes available as soon as reasonably possible to
maintain a more accurate and up-to-date payment system that reflects
the reality of population shifts. Because we believe the revised OMB
delineations and updated RUCA codes more accurately identify urban and
rural areas and enhance the accuracy of the Medicare ambulance fee
schedule, we do not believe a delay in implementation or a transition
period would be appropriate. Areas that lose their rural status and
become urban have become urban because of recent population shifts. We
believe it is important to base payment on the most accurate and up-to-
date geographic area delineations available. Furthermore, we believe a
delay would disadvantage the ambulance providers or suppliers
experiencing payment increases based on these updated and more accurate
OMB delineations and RUCA codes.
Finally, given the relatively small percentage of ZIP codes
affected by the revised OMB delineations and updated RUCA codes (a
total of 3,425 ZIP codes changing their urban/rural status out of
42,918 ZIP codes, or 7.98 percent), we do not believe that a delay is
warranted. As commenters requested, we have included in Table 47 our
updated analysis of the impact of adopting the revised OMB delineations
and the updated RUCA codes.
Comment: One commenter recommended that if any ZIP codes would lose
their super rural status as a result of the proposed adoption of the
revised OMB delineations and the updated RUCA codes, then CMS should
grandfather the current super rural ZIP codes. Another commenter stated
that the ambulance providers must have verification from CMS that the
super rural ZIP codes will not be affected by the changes described in
the proposed rule in advance of their implementation in the final rule.
Response: As we stated previously, the adoption of the OMB's
revised delineations and the updated RUCA codes will have no negative
impact on ambulance transports in super rural areas, as none of the
current super rural areas will lose their status upon implementation of
the revised OMB delineations and the updated RUCA codes. Current areas
designated as super rural areas will continue to be eligible for the
super rural bonus.
After consideration of the public comments received, and for the
reasons discussed above, we are finalizing our proposals to adopt,
beginning in CY 2015, the revised OMB delineations as set forth in
OMB's February 28, 2013 bulletin (No. 13-01) and the most recent
modifications of the RUCA codes for purposes of payment under the
ambulance fee schedule. As we proposed, using the updated RUCA codes
definitions, we will continue to designate any census tracts falling at
or above RUCA level 4.0 as rural areas. However, as discussed above, we
are not finalizing our proposal to designate as rural those census
tracts that fall within RUCA codes 2 or 3 that are at least 400 square
miles in area with a population density of no more than 35 people.
Finally, as discussed above, none of the current super rural areas will
lose their super rural status upon implementation of the revised OMB
delineations and the updated RUCA codes.
C. Clinical Laboratory Fee Schedule
In the CY 2014 PFS final rule with comment period (78 FR 74440
through 74445, 74820), we finalized a process under which we would
reexamine the payment amounts for test codes on the Clinical Laboratory
Fee Schedule (CLFS) for possible payment revision based on
technological changes beginning with the CY 2015 proposed rule, and we
codified this process at Sec. 414.511. After we finalized this
process, the Congress enacted the PAMA. Section 216 of the PAMA creates
new section 1834A of the Act, which requires us to implement a new
Medicare payment system for clinical diagnostic laboratory tests based
on private payor rates. Section 216 of the PAMA also rescinds the
statutory authority in section 1833(h)(2)(A)(i) of the Act for
adjustments based on technological changes for tests furnished on or
after April 1, 2014 (PAMA's enactment date). As a result of these
provisions, we did not propose any revisions to payment amounts for
test codes on the CLFS based on technological changes, and we proposed
to remove Sec. 414.511.
We did not receive any public comments on this proposal. Therefore,
we are finalizing our proposal to remove Sec. 414.511. In addition, we
will establish through rulemaking the parameters for
[[Page 67751]]
the collection of private payor rate information and other requirements
to implement section 216 of the PAMA.
D. Removal of Employment Requirements for Services Furnished ``Incident
to'' Rural Health Clinics (RHC) and Federally Qualified Health Center
(FQHC) Visits
1. Background
Rural Health Clinics (RHCs) and Federally Qualified Health Centers
(FQHCs) furnish physicians' services; services and supplies ``incident
to'' the services of physicians: Nurse practitioner (NP), physician
assistant (PA), certified nurse-midwife (CNM), clinical psychologist
(CP), and clinical social worker (CSW) services; and services and
supplies incident to the services of NPs, PAs, CNMs, CPs, and CSWs.
They may also furnish diabetes self-management training and medical
nutrition therapy (DSMT/MNT), transitional care management services,
and in some cases, visiting nurse services furnished by a registered
professional nurse or a licensed practical nurse. (For additional
information on coverage requirements for services furnished in RHCs and
FQHCs, see Chapter 13 of the CMS Benefit Policy Manual.)
In the May 2, 2014 final rule with comment period entitled
``Prospective Payment System for Federally Qualified Health Centers;
Changes to Contracting Policies for Rural Health Clinics; and Changes
to Clinical Laboratory Improvement Amendments of 1988 Enforcement
Actions for Proficiency Testing Referral'' (79 FR 25436), we removed
the regulatory requirements that NPs, PAs, CNMs, CSWs, and CPs
furnishing services in a RHC must be employees of the RHC. RHCs are now
allowed to contract with NPs, PAs, CNMs, CSWs, and CPs, as long as at
least one NP or PA is employed by the RHC, as required under clause
(iii) in the first sentence of the flush material following
subparagraph (K) of section 1861(aa)(2) of the Act.
Services furnished in RHCs and FQHCs by nurses, medical assistants,
and other auxiliary personnel are considered ``incident to'' a RHC or
FQHC visit furnished by a RHC or FQHC practitioner. Sections
405.2413(a)(6), 405.2415(a)(6), and 405.2452(a)(6) currently state that
services furnished incident to an RHC or FQHC visit must be furnished
by an employee of the RHC or FQHC. Since there is no separate benefit
under Medicare law that specifically authorizes payment to nurses,
medical assistants, and other auxiliary personnel for their
professional services, they cannot bill the program directly and
receive payment for their services, and can only be remunerated when
furnishing services to Medicare patients in an ``incident to''
capacity.
To provide RHCs and FQHCs with as much flexibility as possible to
meet their staffing needs, we proposed to revise Sec. 405.2413(a)(5),
Sec. 405.2415(a)(5) and Sec. 405.2452(a)(5) and delete Sec.
405.2413(a)(6), Sec. 405.2415(a)(6) and Sec. 405.2452(a)(6) to remove
the requirement that services furnished incident to an RHC or FQHC
visit must be furnished by an employee of the RHC or FQHC, in order to
allow nurses, medical assistants, and other auxiliary personnel to
furnish ``incident to'' services under contract in RHCs and FQHCs. We
believe that removing the requirements will provide RHCs and FQHCs with
additional flexibility without adversely impacting the quality or
continuity of care.
We received 23 comments on our proposal. The following is a summary
of the comments received.
Comment: Most commenters were strongly in favor of removing these
employment requirements. Several commenters stated that this
flexibility will assist RHCs and FQHCs in increasing access to care,
enable them to recruit highly qualified health professionals, and fill
temporary staffing voids without adversely impacting the quality of
care. Some commenters expressed concerns about maintaining professional
standards, and others were concerned about the potential loss of
benefits for contracted staff.
A few commenters stated that they support removal of the employment
requirement, provided that RHC and FQHC auxiliary personnel are held to
the same high professional standards for the quality of care,
regardless of whether they are working under contract or as employees.
Commenters also added that all members of a physician-led health care
team should be enabled to perform medical interventions that they are
capable of performing according to their education, training,
licensure, and experience.
Response: The proposal to remove the requirement that auxiliary
workers in RHCs and FQHCs be employees of the RHC or FQHC does not
change either their professional standards of care or their scope of
practice. Nurses, medical assistants, and other auxiliary personnel are
expected to maintain their professional standards of care and furnish
services in adherence to their scope of practice, regardless of whether
they are employed or contracted by the RHC or FQHC.
Comment: Some commenters stated that although they understand the
need for greater staffing flexibility, they were concerned about the
potential loss of benefit packages to individuals that are contracted
and not employed. The commenters questioned whether the issue was
investigated or vetted, and how RHCs and FQHCs would compensate for
this loss of compensation for individuals providing incident to
services under contract rather than as an employee.
Response: We appreciate the concern that these commenters raised
regarding the potential loss of benefit packages for contracted
individuals; however, we do not regulate employment agreements or
benefit packages for individuals working at RHCs and FQHCs.
After consideration of the public comments, we are finalizing this
provision as proposed.
E. Access to Identifiable Data for the Center for Medicare and Medicaid
Innovation Models
1. Background and Statutory Authority
Section 3021 of the Affordable Care Act amended the Social Security
Act to include a new section 1115A, which established the Center for
Medicare and Medicaid Innovation (Innovation Center). Section 1115A
tasks the Innovation Center with testing innovative payment and service
delivery models that could reduce program expenditures while preserving
and/or enhancing the quality of care furnished to individuals under
titles XVIII, XIX, and XXI of the Act. The Secretary is also required
to conduct an evaluation of each model tested.
Evaluations will typically include quantitative and qualitative
methods to assess the impact of the model on quality of care and health
care expenditures. To comply with the statutory requirement to evaluate
all models conducted under section 1115A of the Act, we will conduct
rigorous quantitative analyses of the impact of the model test on
health care expenditures, as well as an assessment of measures of the
quality of care furnished under the model test. Evaluations will also
include qualitative analyses to capture the qualitative differences
between model participants, and to form the context within which to
interpret the quantitative findings. Through the qualitative analyses,
we will assess the experiences and perceptions of model participants,
providers, and individuals affected by the model.
In the evaluations we use advanced statistical methods to measure
[[Page 67752]]
effectiveness. Our methods are intended to provide results that meet a
high standard of evidence, even when randomization is not feasible. To
successfully carry out evaluations of Innovation Center models, we must
be able to determine specifically which individuals are receiving
services from or are the subject of the intervention being tested by
the entity participating in the model test. Identification of such
individuals is necessary for a variety of purposes, including the
construction of control groups against which model performance can be
compared. In addition, to determine whether the observed impacts are
due to the model being tested and not due to differences between the
intervention and comparison groups, our evaluations will have to
account for potential confounding factors at the individual level,
which will require the ability to identify every individual associated
with the model test, control or comparison groups, and the details of
the intervention at the individual level.
Evaluations will need to consider such factors as outcomes,
clinical quality, adverse effects, access, utilization, patient and
provider satisfaction, sustainability, potential for the model to be
applied on a broader scale, and total cost of care. Individuals
receiving services from or who are the subjects of the intervention
will be compared to clinically, socio-demographically, and
geographically similar matched individuals along various process,
outcome, and patient-reported measures. Research questions in a typical
evaluation will include, but are not limited to, the following:
Clinical Quality:
++ Did the model improve or have a negative impact on clinical
process measures, such as adherence to evidence-based guidelines? If
so, how, how much, and for which individuals?
++ Did the model improve or have a negative impact on clinical
outcome measures, such as mortality rates, and the incidence and
prevalence of chronic conditions? If so, how, how much, and for which
individuals?
++ Did the model improve or have a negative impact on access to
care? If so, how, how much, and for which individuals?
++ Did the model improve or have a negative impact on care
coordination among providers? If so, how, how much, and for which
individuals?
++ Did the model improve or have a negative impact on medication
management? If so, how, how much, and for which individuals?
Patient Experience:
++ Did the model improve or have a negative impact on patient-
provider communication? If so, how, how much, and for which
individuals?
++ Did the model improve or have a negative impact on patient
experiences of care, quality of life, or functional status? If so, how,
how much, and for which individuals?
Utilization/Expenditures:
++ Did the model result in decreased utilization of emergency
department visits, hospitalizations, and readmissions? If so how, how
much, and for which individuals?
++ Did the model result in increased utilization of physician or
pharmacy services? If so how, how much, and for which individuals?
++ Did the model result in decreased total cost of care? Were
changes in total costs of care driven by changes in utilization for
specific types of settings or health care services? What specific
aspects of the model led to these changes? Were any savings due to
improper cost-shifting to the Medicaid program?
To carry out this research we must have access to patient records
not generally available to us. As such, we proposed to exercise our
authority in section 1115A(b)(4)(B) of the Act to establish
requirements for states and other entities participating in the testing
of past, present, and future models under section 1115A of the Act to
collect and report information that we have determined is necessary to
monitor and evaluate such models. Thus, we proposed to require model
participants, and providers and suppliers working under the models
operated by such participants, to produce such individually
identifiable health information and such other information as the
Secretary identifies as being necessary to conduct the statutorily
mandated research described above. Such research will include the
monitoring and evaluation of such models. Further, we view engagement
with other payers, both public and private, as a critical driver of the
success of these models. CMS programs constitute only a share of any
provider's revenue. Therefore, efforts to improve quality and reduce
cost are more likely to be successful if efforts are aligned across
payers. Section 1115A of the Act specifically allows the Secretary of
Health and Human Services to consider, in selecting which models to
choose for testing, ``whether the model demonstrates effective linkage
with other public sector or private sector payers.'' Multi-payer
models, such as but not limited to the Comprehensive Primary Care
model, will conduct quality measurement across all patients regardless
of payer in order to maximize alignment and increase efficiency.
Construction of multi-payer quality measures requires the ability to
identify all individuals subject to the model test regardless of payer.
In addition, section 1115A also permits the Secretary to consider
models that allow states to test and evaluate systems of all-payer
payment reform for the medical care of residents of the state,
including dual eligible individuals. Under the State Innovation Model
(SIM), the Innovation Center is testing the ability for state
governments to accelerate transformation. The premise of the SIM
initiative is to support Governor-sponsored, multi-payer models that
are focused on public and private sector collaboration to transform the
state's payment and delivery system. States have policy and regulatory
authorities, as well as ongoing relationships with private payers,
health plans, and providers that can accelerate delivery system reform.
SIM models must impact the preponderance of care in the state and are
expected to work with public and private payers to create multi-payer
alignment. The evaluation of SIM will include all populations and
payers involved in the state initiative, which in many cases includes
private payers. The absence of identifiable data from private payers
would result in considerable limitations on the level of evaluation
conducted. Therefore, under this authority, we also proposed to require
the submission of identifiable health and utilization information for
patients of private payers treated by providers/suppliers participating
in the testing of a model under section 1115A of the Act when an
explicit purpose of the model test is to engage private sector payers.
This regulation will provide clear legal authority for Health Insurance
Portability and Accountability Act (HIPAA) Covered Entities to disclose
any required protected health information. Identifiable data submitted
by entities participating in the testing of models under section 1115A
of the Act will meet CMS Acceptable Risks Safeguards (ARS) guidelines.
When data is expected to be exchanged over the internet, such exchange
will also meet all E-Gov requirements. In accordance with the
requirements of the Privacy Act of 1974, upon receipt by CMS or its
contractors, these data will be covered under a CMS-established system
of records (System No. 09-70-0591), which serves as the Master system
for all demonstrations, evaluations, and research studies administered
by the Innovation Center. These data will be
[[Page 67753]]
stored until the evaluation is complete and all necessary policy
deliberations have been finalized.
2. Provisions of the Proposed Regulations
Wherever possible, evaluations will make use of claims, assessment,
and enrollment data available through CMS' existing administrative
systems. However, evaluations will generally also need to include
additional data not available through existing CMS administrative
systems. As such, depending on the particular project, CMS or its
contractor will require the production of the minimum data necessary to
carry out the statutorily mandated research work described in section
E.1. of this final rule with comment period. Such data may include the
identities of the patients served under the model, relevant clinical
details about the services furnished and outcomes achieved, and any
confounding factors that might influence the evaluation results
achieved through the delivery of such services. For illustrative
purposes, below are examples of some of the types of information that
could be required to carry out an evaluation, and for which the
evaluator would need patient-level identifiers.
Utilization data not otherwise available through existing
Centers for Medicare & Medicaid Services (CMS) systems.
Beneficiary, patient, participant, family, and provider
experiences.
Beneficiary, patient, participant, and provider rosters
with identifiers that allow linkages across time and datasets.
Beneficiary, patient, participant, and family socio-
demographic and ethnic characteristics.
Care management details, such as details regarding the
provision of services, payments or goods to beneficiaries, patients,
participants, families, or other providers.
Beneficiary, patient, and participant functional status
and assessment data.
Beneficiary, patient, and participant health behaviors.
Clinical data, such as, but not limited to lab values and
information from EHRs.
Beneficiary, patient, participant quality data not
otherwise available through claims.
Other data relevant to identified outcomes--for example,
participant employment status, participant educational degrees pursued/
achieved, and income.
We invited public comment on this proposal to mandate the
production of the individually identifiable information necessary to
conduct the statutorily mandated research under section 1115A of the
Act.
In addition, we proposed a new subpart K in part 403 to implement
section 1115A of the Act.
The following is a summary of the comments we received regarding
our proposal to mandate the production of the individually identifiable
information necessary to conduct the statutorily mandated research
under section 1115A of the Act.
Comment: Commenters consistently recognized the need to evaluate
Innovation Center models as an important component of the effort to
test new payment and service delivery models. Further, several
commenters supported the need for rigorous evaluations that include
control groups. One commenter further recommended the Innovation Center
make the aggregated de-identified data from evaluations available to
external researchers. Although supportive of the need to evaluate
Innovation Center models, several commenters stated the Innovation
Center had not sufficiently justified the need for individually
identifiable patient information, and suggested aggregate or de-
identified data should be sufficient. One commenter suggested the
submission of performance rates, patient outcomes information, and/or
composite scores for participating providers instead of individual
patient-level data. The commenter further stated that CMS should not
have access to proprietary patient-level data in registries. Some of
the commenters stated CMS should publish its evaluation methodologies
and solicit feedback from independent research experts as to the need
for patient-level data.
Response: We appreciate the commenters' support for rigorous
evaluations, and understand the desire for access to the aggregate de-
identified data from these evaluations. We always make our data
available in accordance with applicable law, HHS and CMS policies, and,
where relevant, the availability of funding. Such laws include HIPAA,
the Privacy Act, the Trade Secrets Act and the Freedom of Information
Act. With respect to comments recommending the use of aggregate or de-
identified data instead of individually identifiable data, as we
discussed in the preamble of the proposed rule, we believe individually
identifiable data is necessary. As noted in this final rule with
comment and in the preamble of our proposed rule, evaluations will need
to consider such factors as outcomes, clinical quality, adverse
effects, access, utilization, patient and provider satisfaction,
sustainability, potential for the model to be applied on a broader
scale, and total cost of care. Furthermore, individuals receiving
services from or who are the subjects of the intervention will be
compared to clinically, socio-demographically, and geographically
similar matched individuals along various process, outcome, and
patient-reported measures. Many of these assessments will require
person-level data. We will make use of aggregate information on system
performance through the use of provider submitted aggregate performance
rates for selected measures, patient outcomes information, and/or
composite scores. However, without the ability to identify specifically
which beneficiaries are receiving services as a result of the model,
the evaluation analyses could include individuals not even subject to
the intervention, and therefore, there would be a very real possibility
that positive impacts of the model may be diluted and unobservable.
While aggregate data could be limited to the target population,
identification of which individuals are within the target population of
the model, are receiving items and services under the model, or are
subject to the interventions being tested under the model will also
allow the evaluators to construct matched comparison groups that look
as similar as possible to the intervention group. The absence of a
well-matched comparison group, which can only be achieved when
individually identifiable characteristics are known, could result in
impact estimates that are inaccurate because these impact estimates
could be due to differences between the intervention group and the
comparison group and not the intervention itself. Further, while we
will need to know the identifiers of beneficiaries that are the subject
of the model test, the submission of other patient-level data from
proprietary registries would be limited to data necessary to conduct a
credible evaluation. Data on individuals are also needed to assess
differential impacts among subgroups of beneficiaries to identify who
benefits most from the intervention. We agree it is important to seek
expert opinion on the structure of our assessment methods, and so these
models are developed in concert with and run through our evaluation
contractors, which are independent research firms and academic
institutions. Where needed, these contractors also reach out to
technical expert panels for added guidance. As a result, the design and
implementation of
[[Page 67754]]
these assessments are informed by those with expertise in health
services research, economics, statistics, program evaluation,
epidemiology, and public health.
Comment: Although generally supportive of the need for rigorous
evaluations, some commenters worried that any requirement to provide
individually identifiable data for monitoring and/or assessment
purposes would impose an undue administrative burden on model
participants, and could lead to the need to submit large (and,
potentially, overbroad) amounts of individually identifiable patient-
level data. A few commenters suggested that the Innovation Center
should first look to other federal government sources before requesting
data from model participants. Several commenters noted that it would be
costly to produce patient-level data for models with a multi-payer
focus, and others stated additional payment should be made to model
participants to offset the cost of data reporting. Further, it was
suggested that CMS estimate the potential burden and cost on physicians
and other providers, and if found to be burdensome, give physicians the
right to opt out of producing information that may not be available due
to cost limitations or other administrative barriers, such as barriers
to producing data stored in electronic health records.
Response: We agree that our determination of what data are
necessary to evaluate a model should be made taking into consideration
the burden and cost associated with collecting and reporting such data,
including the complexities associated with abstracting data from
electronic health records. We further agree that in making such
determinations, we should take advantage of all existing federal data
systems, wherever possible so that we may minimize the amount of data
that we must obtain from model participants. Our regulation will only
require that model participants collect and report data as is necessary
for monitoring or evaluation; thus, if we do not need the data, we
would not seek to collect it from model participants.
Reimbursement may be considered for future models, but if adopted,
any such reimbursement, and any conditions for such reimbursement,
would be prominently noted in the solicitation or modifications to
model agreements. To the extent feasible, we also agree that it is
important for potential model participants to understand the data
collection requirements before the model begins, so that they may take
these requirements into consideration. We do not agree, though, that
model participants should be given the opportunity to opt out of
producing the required information, as this would undermine the
evaluation and skew results.
With respect to the specific data needed for evaluation purposes,
in many models, the evaluators will be able to determine who the
individuals are that are the subjects of the model test without the
need to obtain identifiers from the model participants. In those cases,
there is a beneficiary-specific payment under the model and the
evaluator can use our existing administrative data systems to identify
which beneficiaries are in the model. In this last example, although we
may not need to obtain the identifiers, we may still need to obtain
other person-level data, such as clinical information. In other models,
where a specific beneficiary-level payment is not being made, the
evaluation contractor will not have an ability to identify the
individuals targeted by the model participants. In this latter
circumstance, the participants will need to provide the identifiers
that would then be used by the evaluator to link to existing
administrative data systems. Although the exact data needs will vary by
model, in some cases we would determine that only the identifiers (such
as, but not limited to, the Medicare Health Insurance Claim number) are
required. In other circumstances, it is possible the evaluators will
need other data, such as clinical data not otherwise available in
claims to properly account for severity of disease. In this manner we
will limit data demands, and the attendant costs, to the data necessary
to accomplish the required monitoring and assessment.
Comment: Some commenters stated the requirement could result in
requests for data from providers tangentially involved in an Innovation
Center project to report any data the agency decides it needs. A few
commenters further stated the Innovation Center should ensure that all
participating entities seek patient authorizations to use their records
for the purpose of evaluating the model.
Response: Section 1115A(b)(4) of the Act authorizes us to establish
requirements for ``States and other entities participating in the
testing of models'' to collect and report data necessary for monitoring
and evaluating the models. Our regulation, therefore, establishes this
requirement only with respect to model participants. We consider model
participants to include any party that has agreed to participate in, or
that receives payment from us under, a model we are testing. In
response to the comment suggesting that the Innovation Center ensure
that all participating entities seek patient authorizations to use
their records for the purpose of evaluating the model, we decline to
impose such a requirement in implementing section 1115A(b)(4) of the
Act, and we refer such entities to their own legal counsel for advice
on whether any form of consent would be required by other applicable
law.
Comment: Some commenters stated the Innovation Center should
publish and be transparent about what the exact data reporting and
collection requirements would be so that participants would have notice
of what data they would be required to collect. Commenters stated that
without a notice and comment period as part of the model test, there
will be no opportunity for stakeholders to weigh in with their
perspective of what constitutes the minimum necessary information to
achieve the evaluation goals. A few commenters stated the Innovation
Center should first determine the specific data elements that are
required for evaluation purposes for the existing programs and this
information should be shared with participants who should, at minimum,
be given an opportunity to provide comment on the required inputs for
which they will be responsible as part of the evaluation. These
commenters also stated the Innovation Center should develop such
requirements in advance of the program start for participants to allow
them an opportunity to provide feedback and weigh the information as
part of their decision to participate in the model.
Response: We agree it is important to restrict data requests to the
data necessary to conduct credible monitoring and evaluation. We
frequently provide stakeholders the opportunity to weigh in on what
data they believe would be necessary to evaluate a model, generally
through webinars that we conduct during model development and
implementation. Further, in order for potential model participants to
understand the likely data reporting requirements, to the extent
feasible, these requirements are incorporated into the solicitation
process. However, we decline to adopt a requirement to undertake a
notice and comment process as part of our determination of what data
are necessary for monitoring or evaluation because we believe the
process already in place allows for model participant feedback. We also
disagree with commenters who recommend that we make the determination
and specify the particular data elements that will be required for
monitoring and evaluation prior to the start of the model. It is not
[[Page 67755]]
always possible at that early stage of the model to know precisely what
data elements will be necessary. However, we will strive to provide as
much relevant detail as possible about data collection and reporting
requirements in any solicitation process and in any ongoing
communications with potential participants, and we will continue to
take any comments received into account in determining our data needs.
Comment: A few commenters stated that CMS has not provided
sufficient assurances that providers, in responding to these data
requests, would be protected or deemed to be in compliance with the
HIPAA requirements for the use and disclosure of protected health
information (PHI). These commenters stated the Innovation Center
reference to requiring reporting of individually identifiable patient-
level data raises significant privacy concerns for providers who would
be required to report such data. These commenters stated HIPAA requires
that providers limit the use and disclosure of personal health
information to the minimum necessary to accomplish the intended purpose
of the disclosure. These commenters stated the Innovation Center
requests for such data must be in compliance with providers' HIPAA
obligations. As such, some commenters stated CMS should work with the
Office for Civil Rights (OCR) to ensure providers reporting data as
part of an evaluation are doing so consistent with their HIPAA
obligations. These commenters stated it is HHS's Office for Civil
Rights (OCR)--not CMS--that ultimately determines whether a particular
provider is properly compliant and not subject to penalties. These same
commenters suggested that the Innovation Center should work with OCR to
issue OCR guidance stating that providers reporting data as part of an
evaluation are doing so consistent with their HIPAA obligations. Some
commenters stated CMS should consider the necessary data elements on a
program-by-program basis rather than establishing a blanket approval,
or at minimum limit the scope of the approved data requirements and
uses, and should provide clear instructions and other educational
resources to ensure that collection and reporting of the data complies
with the HIPAA Privacy and Security rules.
Response: We appreciate the concerns expressed about compliance
with the HIPAA requirements and the recommendation to work with OCR.
However, we respectfully disagree that sufficient assurances have not
been provided. The disclosure would be required by a regulation, so it
would be ``required by law'' under HIPAA. See 45 CFR 164.512(a) and the
definition of ``required by law'' at 45 CFR 164.103. A HIPAA covered
entity is permitted to disclose protected health information as
required by law under these provisions so long as the disclosure
complies with and is limited to the relevant requirements of the law. A
separate minimum data necessary determination is not required under the
HIPAA Privacy Rule for required by law disclosures under 45 CFR
164.512(a). See 45 CFR 164.502(b)(2). Although a separate minimum data
necessary determination is not required, as a policy matter and
consistent with the statutory authority under 1115A(b)(4), CMS will
only require that data we determine is necessary for evaluation and
monitoring of Innovation Center models.
Comment: Several commenters stated that collection of beneficiary-
level health information raises significant security concerns. Although
supportive of sharing relevant and medically necessary patient
information, one commenter raised a particular concern that some data
could be sensitive information related to mental health or substance
abuse. Some commenters stated CMS should adopt safeguards against
inappropriate use or disclosure of patient identifiable data.
Response: We agree that it is critical to abide by rigorous
security standards, and we take patient privacy seriously. As CMMI is
part of Fee-for-Service Medicare, a Health Care Component that is
subject to the HIPAA requirements, providers' and suppliers' data will
generally be subject to the same HIPAA privacy and security
requirements as that data was subject to in the hands of the providers
and suppliers from which it came. Furthermore, if stored in a manner
searchable by individual identifiers, it will also be subject to the
Privacy Act of 1974.
As HIPAA Business Associates, this data will be equally well
protected when held by one of our evaluation contractors. In addition,
the disclosure of substance abuse records will, where applicable, also
be subject to the Part 2 regulations.
Comment: One commenter stated CMS should not use these data for
purposes other than those articulated in the proposed rule, and that
the assessments should comply with the applicable statutory
requirements, meaning that: (1) The assessments should take into
account all of the factors outlined under section 1115A(b)(4) of the
Act (that is, quality of care, including patient-level outcomes and
patient-centeredness criteria); (2) the assessments should be made
publicly available; and (3) CMS should pursue notice-and-comment
rulemaking before any of the CMS demonstrations are expanded based on
these assessments, as required by section 1115A(c) of the Act.
Response: We agree that evaluations should assess quality of care,
and the patient-de-identified results should be made publicly
available, as required by section 1115A(b)(4) of the Act. We would
pursue model expansion according to the terms of the statute.
After consideration of the public comments we received, we are
finalizing our proposal to mandate the production of the individually
identifiable information necessary to conduct the statutorily mandated
research under section 1115A of the Act. We are accepting the
recommendations made by commenters to minimize participant burden, seek
input from providers, and use independent researchers. In addition, we
are finalizing our proposal to add a new subpart K in part 403 to
implement section 1115A of the Act without modification.
F. Local Coverage Determination Process for Clinical Diagnostic
Laboratory Testing
The CY 2015 proposed rule (79 FR 40378 through 40380), section
III.F., included discussion of a proposal to modify the existing
process used by the Medicare Administrative Contractors (MACs) in
developing local coverage determinations (LCDs) for clinical diagnostic
laboratory tests. Briefly, the proposal would have expedited the
timeline for LCD development for clinical diagnostic laboratory test
LCDs by reducing the calendar days for some of the steps and by making
optional or eliminating other steps within the current process. A
detailed discussion of the proposal is available in section III.F. of
the CY 2015 PFS Proposed Rule.
We would like to thank the numerous public commenters for their
time in submitting thoughtful comments to the agency on this issue.
Comments were received from individual members of the public, insurers,
drug manufacturers, medical specialty societies, laboratory groups and
individual laboratories. The commenters focused their comments on the
following issues: The proposal to reduce the draft LCD public comment
period to 30 days; the proposal for a meeting of the Carrier Advisory
Committee to be optional; the proposal to remove the requirement for a
public meeting; and the proposal to eliminate the 45-day notice period
prior to final
[[Page 67756]]
LCDs becoming effective. In addition, commenters were concerned about
the proposed changes in light of section 216 of the Protecting Access
to Medicare Act of 2014 (PAMA), titled ``Improving Medicare Policies
for Clinical Diagnostic Laboratory Tests.'' The comments received have
given the agency much to consider prior to moving forward with any
changes to the LCD process; therefore, we will not finalize any changes
to the LCD process in this final rule. We will explore the possibility
of future notice-and-comment rulemaking on this issue.
G. Private Contracting/Opt-Out
1. Background
Effective January 1, 1998, section 1802(b) of the Act permits
certain physicians and practitioners to opt-out of Medicare if certain
conditions are met, and to furnish through private contracts services
that would otherwise be covered by Medicare. For those physicians and
practitioners who opt-out of Medicare in accordance with section
1802(b) of the Act, the mandatory claims submission and limiting charge
rules of section 1848(g) of the Act would not apply. As a result, if
the conditions necessary for an effective opt-out are met, physicians
and practitioners are permitted to privately contract with Medicare
beneficiaries and to charge them without regard to Medicare's limiting
charge rules. Regulations governing the requirements and procedures for
private contracts appear at 42 CFR part 405, subpart D.
a. Opt-Out Determinations (Sec. 405.450)
The private contracting regulation at Sec. 405.450 describes
certain opt-out determinations made by Medicare, and the process that
physicians, practitioners, and beneficiaries may use to appeal those
determinations. Section 405.450(a) describes the process available for
physicians or practitioners to appeal Medicare enrollment
determinations related to opting out of the program, and Sec.
405.450(b) describes the process available to challenge payment
determinations related to claims for services furnished by physicians
who have opted out. Both provisions refer to Sec. 405.803, the Part B
claims appeals process that was in place at the time the opt-out
regulations were issued (November 2, 1998). When those regulations were
issued, a process for a physician or practitioner to appeal enrollment
related decisions had not been implemented in regulation. Thus, to
ensure an appeals process was available to physicians and practitioners
for opt-out related issues, we chose to utilize the existing claims
appeals process in Sec. 405.803 for both enrollment and claims related
appeals.
In May 16, 2012 Federal Register (77 FR 29002), we published a
final rule entitled ``Medicare and Medicaid Program; Regulatory
Provisions to Promote Program Efficiency, Transparency and Burden
Reduction.'' In that final rule, we deleted the provisions relating to
initial determinations, appeals, and reopenings of Medicare Part A and
Part B claims, and relating to determinations and appeals regarding an
individual's entitlement to benefits under Medicare Part A and Part B,
which were contained in part 405, subparts G and H (including Sec.
405.803) because these provisions were obsolete and had been replaced
by the regulations at part 405, subpart I. We inadvertently neglected
to revise the cross-reference in Sec. 405.450(a) and (b) of the
private contracting regulations to direct appeals of opt-out
determinations through the current appeal process. However, it is
important to note that our policy regarding the appeal of opt-out
determinations did not change when the appeal regulations at part 405,
subpart I were finalized.
The procedures set forth in current part 498 establish the appeals
procedures regarding decisions made by Medicare that affect enrollment
in the program. We believe this process, and not the appeal process in
part 405, subpart I, is the appropriate channel for physicians and
practitioners to challenge an enrollment related opt-out decision made
by Medicare. There are now two different sets of appeal regulations for
initial determinations; and the appeal of enrollment related opt-out
determinations is more like the types of determinations now addressed
under part 498 than those under part 405, subpart I. Specifically, the
appeal process under part 405, subpart I focuses on reviews of
determinations regarding beneficiary entitlement to Medicare and claims
for benefits for particular services. The appeal process under part 498
is focused on the review of determinations regarding the participation
or enrollment status of providers and suppliers. Enrollment related
opt-out determinations involve only the status of particular physician
or practitioners under Medicare, and do not involve beneficiary
eligibility or claims for specific services. As such, the appeal
process under part 498 is better suited for the review of enrollment
related opt-out determinations.
However, we do not believe the enrollment appeals process
established in part 498 is the appropriate mechanism for challenging
payment decisions on claims for services furnished by a physician and
practitioner who has opted out of the program. Appeals for such claims
should continue to follow the appeals procedures now set forth in part
405 subpart I.
b. Definitions, Requirements of the Opt Out Affidavit, Effects of
Opting Out of Medicare, Application to Medicare Advantage Contracts
(Sec. Sec. 405.400, 405.420(e), 405.425(a), and 405.455)
Section 405.400 sets forth certain definitions for purposes of the
private contracting regulations. Among the defined terms is ``Emergency
care services'' which means services furnished to an individual for
treatment of an ``emergency medical condition'' as that term is defined
in Sec. 422.2. The cross-referenced regulation at Sec. 422.2 included
within the definition of emergency care services was deleted on June
29, 2000 (65 FR 40314) and at that time we inadvertently neglected to
revise that cross-reference. The cross-reference within the definition
of emergency care services should have been amended at that time to
cite the definition of ``emergency services'' in Sec. 424.101.
The private contracting regulations at Sec. 405.420(e), Sec.
405.425(a) and Sec. 405.455 all use the term Medicare+Choice when
referring to Part C plans. However, we no longer use the term
Medicare+Choice when referring to Part C plans; instead the plans are
referred to as Medicare Advantage plans. When part 422 of the
regulations was updated on January 28, 2005 (70 FR 4741), we
inadvertently neglected to revise Sec. 405.420(e), Sec. 405.425(a)
and Sec. 405.455 to replace the term Medicare+Choice with Medicare
Advantage plan.
2. Provisions of the Proposed Regulation
For the reasons discussed above, we proposed that a determination
described in Sec. 405.450(a) (relating to the status of opt-out or
private contracts) is an initial determination for purposes of Sec.
498.3(b), and a physician or practitioner who is dissatisfied with a
Medicare determination under Sec. 405.450(a) may utilize the
enrollment appeals process currently available for providers and
suppliers in part 498. In addition, we proposed that a determination
described in Sec. 405.450(b) (that payment cannot be made to a
beneficiary for services furnished by a physician or practitioner who
has opted out) is an initial determination for the purposes of Sec.
405.924 and may be challenged through the existing claims appeals
procedures in part 405 subpart I. Accordingly, we proposed that the
cross
[[Page 67757]]
reference to Sec. 405.803 in Sec. 405.450(a) be replaced with a cross
reference to Sec. 498.3(b). We also proposed that the cross reference
to Sec. 405.803 in Sec. 405.450(b) be replaced with a cross reference
to Sec. 405.924. We also proposed corresponding edits to Sec.
498.3(b) and Sec. 405.924 to note that the determinations under Sec.
405.450(a) and (b), respectively, are initial determinations.
For the reasons discussed above, we also proposed that the
definition of Emergency care services at Sec. 405.400 be revised to
cite the definition of Emergency services in Sec. 424.101 and that all
references to Medicare+Choice in Sec. 405.420(e), Sec. 405.425(a) and
Sec. 405.455 be replaced with the term ``Medicare Advantage.''
The following is a summary of the comments we received regarding
our proposals.
Comment: Commenters requested that physicians and practitioners be
allowed to opt out of Medicare indefinitely instead of submitting a new
affidavit every 2 years.
Response: These comments are outside the scope of this rule as they
are not related to the proposed changes to the opt-out regulations.
Nevertheless, we note that section 1802(b)(3)(B)(ii) of the Act
specifies that the opt-out affidavit must provide that the ``physician
or practitioner will not submit any claim under this title for any item
or service provided to any medicare beneficiary. . . during the 2-year
period beginning on the date the affidavit is signed.'' As such, the
longest interval for which an opt-out can be effective is 2 years. We
have no authority to modify that statutory requirement.
Because we did not receive any comments on our proposals, we are
finalizing the rule as proposed.
H. Solicitation of Comments on the Payment Policy for Substitute
Physician Billing Arrangements
1. Background
In accordance with section 1842(b)(6) of the Act, no payment under
Medicare Part B may be made to anyone other than to the beneficiary to
whom a service was furnished or to the physician or other person who
furnished the service. However, there are certain limited exceptions to
this general prohibition. For example, section 1842(b)(6)(D) of the Act
describes an exception for substitute physician billing arrangements,
which states that ``payment may be made to a physician for physicians'
services (and services furnished incident to such services) furnished
by a second physician to patients of the first physician if (i) the
first physician is unavailable to provide the services; (ii) the
services are furnished pursuant to an arrangement between the two
physicians that (I) is informal and reciprocal, or (II) involves per
diem or other fee-for-time compensation for such services; (iii) the
services are not provided by the second physician over a continuous
period of more than 60 days or are provided over a longer continuous
period during all of which the first physician has been called or
ordered to active duty as a member of a reserve component of the Armed
Forces; and (iv) the claim form submitted to the [Medicare
Administrative contractor (MAC)] for such services includes the second
physician's unique identifier . . . and indicates that the claim meets
the requirements of this subparagraph for payment to the first
physician.'' Section 1842(b)(6) of the Act is self-implementing and we
have not interpreted the statutory provisions through regulations.
In practice, section 1842(b)(6)(D) of the Act generally allows for
two types of substitute physician billing arrangements: (1) An informal
reciprocal arrangement where doctor A substitutes for doctor B on an
occasional basis and doctor B substitutes for doctor A on an occasional
basis; and (2) an arrangement where the services of the substitute
physician are paid for on a per diem basis or according to the amount
of time worked. Substitute physicians in the second type of arrangement
are sometimes referred to as ``locum tenens'' physicians. It is our
understanding that locum tenens physicians are substitute physicians
who often do not have a practice of their own, are geographically
mobile, and work on an as-needed basis as independent contractors. They
are utilized by physician practices, hospitals, and health care
entities enrolled in Part B as Medicare suppliers to cover for
physicians who are absent for reasons such as illness, pregnancy,
vacation, or continuing medical education. Also, we have heard
anecdotally that locum tenens physicians are used to fill staffing
needs (for example, in physician shortage areas) or, on a temporary
basis, to replace physicians who have permanently left a medical group
or employer.
We are concerned about the operational and program integrity issues
that result from the use of substitute physicians to fill staffing
needs or to replace a physician who has permanently left a medical
group or employer. For example, although our Medicare enrollment rules
require physicians and physician groups or organizations to notify us
promptly of any enrollment changes (including reassignment changes)
(see Sec. 424.516(d)), processing delays or miscommunication between
the departing physician and his or her former medical group or employer
regarding which party would report the change to Medicare could result
in the Provider Transaction Access Number (PTAN) that links the
departed physician and his or her former medical group remaining
``open'' or ``attached'' for a period of time. During such period, both
the departed physician and the departed physician's former medical
group might bill Medicare under the departed physician's National
Provider Identifier (NPI) for furnished services. This could occur
where a substitute physician is furnishing services in place of the
departed physician in the departed physician's former medical group,
while the departed physician is also furnishing services to
beneficiaries following departure from the former group. Operationally,
either or both types of claims could be rejected or denied, even though
the claims filed by the departed physician were billed appropriately.
Moreover, the continued use of a departed physician's NPI to bill for
services furnished to beneficiaries by a substitute physician raises
program integrity issues, particularly if the departed physician is
unaware of his or her former medical group or employer's actions.
Finally, as noted above, section 1842(b)(6)(D)(iv) of the Act
requires that the claim form submitted to the MAC include the
substitute physician's unique identifier. Currently, the unique
identifier used to identify a physician is the physician's NPI. Prior
to the implementation of the NPI, the Unique Physician Identification
Number (UPIN) was used. Because a substitute physician's NPI is not
captured on the CMS-1500 claim form or on the appropriate electronic
claim, physicians and other entities that furnish services to
beneficiaries through the use of a substitute physician are required to
enter a modifier on the CMS-1500 claim form or on the appropriate
electronic claim indicating that the services were furnished by a
substitute physician; and to keep a record of each service provided by
the substitute physician, associated with the substitute physician's
UPIN or NPI; and to make this record available to the MAC upon request.
(See Medicare Claims
[[Page 67758]]
Processing Manual (Pub. 100-4), Chapter 1, Sections 30.2.10 and
30.2.11) However, having a NPI or UPIN does not necessarily mean that
the substitute physician is enrolled in the Medicare program. Without
being enrolled in Medicare, we do not know whether the substitute
physician has the proper credentials to furnish the services being
billed under section 1842(b)(6)(D) of the Act or if the substitute
physician is sanctioned or excluded from Medicare. The importance of
enrollment and the resulting transparency afforded the Medicare program
and its beneficiaries was recognized by the Congress when it included
in the Affordable Care Act a requirement that physicians and other
eligible non-physician practitioners (NPPs) enroll in the Medicare
program if they wish to order or refer certain items or services for
Medicare beneficiaries. This includes those physicians and other
eligible NPPs who do not and will not submit claims to a Medicare
contractor for the services they furnish. We solicited comments
regarding how to achieve similar transparency in the context of
substitute physician billing arrangements for the identity of the
individual actually furnishing the service to a beneficiary.
2. Analysis of Comments
To help inform our decision whether and, if so, how to address the
issues discussed in section III.H.1., and whether to adopt regulations
interpreting section 1842(b)(6)(D) of the Act, we solicited comments on
the policy for substitute physician billing arrangements. We noted that
any regulations would be proposed in a future rulemaking with
opportunity for public comment. Through this solicitation, we hoped to
understand better current industry practices for the use of substitute
physicians and the impact that policy changes limiting the use of
substitute physicians might have on beneficiary access to physician
services.
We received a few comments on the issues raised in this
solicitation. We thank the commenters for their input, and we will
carefully consider their comments in any future rulemaking on this
subject.
I. Reports of Payments or Other Transfers of Value to Covered
Recipients
1. Background
In the February 8, 2013 Federal Register (78 FR 9458), we published
the ``Transparency Reports and Reporting of Physician Ownership or
Investment Interests'' final rule which implemented section 1128G of
the Social Security Act (``Act''), as added by section 6002 of the
Affordable Care Act. Under section 1128G(a)(1) of the Act,
manufacturers of covered drugs, devices, biologicals, and medical
supplies (applicable manufacturers) are required to submit on an annual
basis information about certain payments or other transfers of value
made to physicians and teaching hospitals (collectively called covered
recipients) during the course of the preceding calendar year. Section
1128G(a)(2) of the Act requires applicable manufacturers and applicable
group purchasing organizations (GPOs) to disclose any ownership or
investment interests in such entities held by physicians or their
immediate family members, as well as information on any payments or
other transfers of value provided to such physician owners or
investors. The implementing regulations are at 42 CFR part 402, subpart
A, and part 403, subpart I. We have organized these reporting
requirements under the ``Open Payments'' program.
The Open Payments program creates transparency around the nature
and extent of relationships that exist between drug, device,
biologicals and medical supply manufacturers, and physicians and
teaching hospitals (covered recipients and physician owner or
investors). The implementing regulations, which describe procedures for
applicable manufacturers and applicable GPOs to submit electronic
reports detailing payments or other transfers of value and ownership or
investment interests provided to covered recipients and physician
owners or investors, are codified at Sec. 403.908.
Since the publication and implementation of the February 8, 2013
final rule, various stakeholders have provided feedback to CMS
regarding certain aspects of these reporting requirements.
Specifically, Sec. 403.904(g)(1) excludes the reporting of payments
associated with certain continuing education events, and Sec.
403.904(c)(8) requires reporting of the marketed name for drugs and
biologicals but makes reporting the marketed name of devices or medical
supplies optional. We proposed a change to Sec. 403.904(g) to correct
an unintended consequence of the current regulatory text. Additionally,
at Sec. 403.904(c)(8), we proposed to make the reporting requirements
consistent by requiring the reporting of the marketed name for drugs,
devices, biologicals, or medical supplies which are associated with a
payment or other transfer of value.
Additionally, at Sec. 403.902, we proposed to remove the
definition of a ``covered device'' because we believe it is duplicative
of the definition of ``covered drug, device, biological or medical
supply'' which is codified in the same section. We also proposed to
require the reporting of the following distinct forms of payment:
stock; stock option; or any other ownership interests specified in
Sec. 403.904(d)(3) to collect more specific data regarding the forms
of payment.
2. Continuing Education Exclusion (Sec. 403.904(g)(1))
In the February 8, 2013 final rule, many commenters recommended
that accredited or certified continuing education payments to speakers
should not be reported because there are safeguards already in place,
and they are not direct payments to a covered recipient. In the final
rule preamble, we noted that ``industry support for accredited or
certified continuing education is a unique relationship'' (78 FR 9492).
Section 403.904(g)(1) states that payments or other transfers of value
provided as compensation for speaking at a continuing education program
need not be reported if the following three conditions are met:
The event at which the covered recipient is speaking must
meet the accreditation or certification requirements and standards for
continuing education for one of the following organizations: the
Accreditation Council for Continuing Medical Education (ACCME); the
American Academy of Family Physicians (AAFP); the American Dental
Association's Continuing Education Recognition Program (ADA CERP); the
American Medical Association (AMA); or the American Osteopathic
Association (AOA).
The applicable manufacturer does not pay the covered
recipient speaker directly.
The applicable manufacturer does not select the covered
recipient speaker or provide the third party (such as a continuing
education vendor) with a distinct, identifiable set of individuals to
be considered as speakers for the continuing education program.
Since the implementation of Sec. 403.904(g)(1), other accrediting
organizations have requested that payments made to speakers at their
events also be exempted from reporting. These organizations have stated
that they follow the same accreditation standards as the organizations
specified in Sec. 403.904(g)(1)(i). Other stakeholders have
recommended that the exemption be removed in its entirety stating
[[Page 67759]]
removal of the exclusion will allow for consistent reporting for
compensation provided to physician speakers at all continuing education
events, as well as transparency regarding compensation paid to
physician speakers. Many stakeholders raised concerns that the
reporting requirements are inconsistent because certain continuing
education payments are reportable, while others are not. CMS' apparent
endorsement or support to organizations sponsoring continuing education
events was an unintended consequence of the final rule.
After consideration of these comments, we proposed to remove the
language in Sec. 403.904(g) in its entirety, in part because it is
redundant with the exclusion in Sec. 403.904(i)(1). That provision
excludes indirect payments or other transfers of value where the
applicable manufacturer is ``unaware'' of, that is, ``does not know,''
the identity of the covered recipient during the reporting year or by
the end of the second quarter of the following reporting year. When an
applicable manufacturer or applicable GPO provides funding to a
continuing education provider, but does not either select or pay the
covered recipient speaker directly, or provide the continuing education
provider with a distinct, identifiable set of covered recipients to be
considered as speakers for the continuing education program, CMS will
consider those payments to be excluded from reporting under Sec.
403.904(i)(1). This approach is consistent with our discussion in the
preamble to the final rule, in which we explained that if an applicable
manufacturer conveys ``full discretion'' to the continuing education
provider, those payments are outside the scope of the rule (78 FR
9492). In contrast, for example, when an applicable manufacturer
conditions its financial sponsorship of a continuing education event on
the participation of particular covered recipients, or pays a covered
recipient directly for speaking at such an event, those payments are
subject to disclosure.
We considered two alternative approaches to address this issue.
First, we explored expanding the list of organizations in Sec.
403.904(g)(1)(i) by name; however, we believe that this approach might
imply CMS's endorsement of the named continuing education providers
over others. Second, we considered expansion of the organizations in
Sec. 403.904(g)(1)(i) by articulating accreditation or certification
standards that would allow a CME program to qualify for the exclusion.
This approach is not easily implemented because it would require
evaluating both the language of the standards, as well as the
enforcement of the standards of any organization professing to meet the
criteria. We solicited comments on both alternatives presented,
including commenters' suggestions about what standards, if any, CMS
should incorporate.
The following is summary of the comments we received regarding both
alternatives presented, and what standards, if any, CMS should
incorporate.
Comment: We received numerous comments addressing our proposal to
remove the exclusion for compensation for speaking at a continuing
education program. Some comments were in support to remove the
exclusion stating it is an important step toward ensuring transparency.
Supporting comments also agreed removing the exclusion will level the
playing field with the medical education community. Numerous commenters
questioned our proposal to remove the exclusion for compensation for
speaking at a continuing education program. Commenters provided
background regarding accrediting continuing education organizations
stating that creating continuing education accreditation standards is a
function of professional self-regulation and additional government
regulation is not necessary.
Many commenters recommend modifying the indirect payment exclusion
currently at Sec. 403.904(i)(1) to specify a continuing education
indirect payment should be excluded if the manufacturer did not know
the identity of the covered recipient before providing the payment to a
third party, such as a continuing education organization. This differs
from the current indirect payment exclusion language which states the
payment is excluded if the manufacturer did not know the identity of
the covered recipient during the reporting year or by the end of the
second quarter of the following reporting year. Commenters stated it is
not practical for a manufacturer to not know the identity of a
physician speaker receiving compensation for speaking at a continuing
education event during the reporting year or by the end of the second
quarter of the following reporting year because manufacturers could
learn the identities of physician speakers through brochures, programs
and other publications. Therefore, commenters assert that the indirect
payment exclusion is not applicable to exclude compensation provided to
physicians at a continuing education event and recommend the indirect
payment exclusion is modified to accommodate indirect payments provided
to a physician covered recipient through a continuing medical education
organization.
Additionally, commenters suggested an alternative approach where
CMS would adopt established criteria, such as the Standards for
Commercial Support: Standards to Ensure Independence in CME Activities,
in order to have payments provided to physicians at continuing
education events excluded. Similar criteria suggested by commenters to
modify the exclusion were: does not pay covered speakers or attendees
directly, does not select covered recipient speakers or provide a third
party with a distinct, identifiable set of individuals to be considered
as speakers or attendees for the continuing education program, and does
not control the continuing education program content.
Response: We appreciate commenters support to remove the exclusion
for compensation for speaking at a continuing education program. We
appreciate the comments stating that continuing medical education
accrediting organizations is a function of professional self-
regulation. We believe creating consistent reporting requirements for
all continuing education events, by removing the language in Sec.
403.904(g) in its entirety, will provide enhanced regulatory clarity
for stakeholders. Manufacturers reporting compensation paid to
physician speakers may opt to distinguish if the payment was provided
at an accredited or certified continuing education program versus an
unaccredited or non-certified continuing education program by selecting
the appropriate nature of payment category at Sec. 403.904(e).
We understand commenters concern regarding learning the identity of
the physician during the reporting year or by the end of the second
quarter of the following reporting year. In the situation of an
applicable manufacturer providing an indirect payment through a
continuing education organization and learning the identity of the
physician covered recipient in the allotted timeframe (during the
reporting year or by the end of the second quarter of the following
reporting year) the indirect payment would not meet the criteria of the
indirect payment exclusion and would need to be reported. However,
payments or other transfers of value, including payments made to
physician covered recipients for purposes of attending or speaking at
continuing education events, which do not meet the definition of an
indirect payment, as
[[Page 67760]]
defined at Sec. 403.902, are not reportable. For example, if an
applicable manufacturer or applicable GPO provides funding to support a
continuing education event but does not require, instruct, direct, or
otherwise cause the continuing education event provider to provide the
payment or other transfer or value in whole or in part to a covered
recipient, the applicable manufacturer or applicable GPO is not
required to report the payment or other transfer of value. The payment
is not reportable regardless if the applicable manufacturer or
applicable GPO learns the identity of the covered recipient during the
reporting year or by the end of the second quarter of the following
reporting year because the payment or other transfer of value did not
meet the definition of an indirect payment. This approach is also
consistent with our statement at (78 FR 9490), where we explained that
``if an applicable manufacturer provided an unrestricted donation to a
physician professional organization to use at the organization's
discretion, and the organization chose to use the donation to make
grants to physicians, those grants would not constitute `indirect
payments' because the applicable manufacturer did not require,
instruct, or direct the organization to use the donation for grants to
physicians.'' Therefore, because such payments are not indirect
payments, we do not need to create an additional exclusion specific to
continuing education indirect payments by modifying the indirect
payment exclusion at Sec. 403.904(i)(1).
Comment: Many commenters interpreted the removal of physician
speaker compensation at continuing education events would also remove
the reporting exclusion for attendees at accredited or certified
continuing education events whose fees have been subsidized through the
continuing medical education organization by an applicable
manufacturers.
Response: We did not intend to remove the exclusion regarding
subsidized fees provided to physician attendees by manufacturers at
continuing education events. However, we intend for physician speaker
compensation and physician attendees fees which have been subsidized
through the continuing medical education organization by an applicable
manufacturer to be reported unless the payment meets the indirect
payment exclusion at Sec. 403.904(i)(1). This allows for consistent
reporting for physician attendees and speakers at continuing education
events. We will provide sub-regulatory guidance specifying tuition fees
provided to physician attendees that have been generally subsidized at
continuing education events by manufacturers are not expected to be
reported. However, if a manufacturer does instruct, direct, or
otherwise cause the subsidized tuition fee for a continuing education
event to go to a specific physician attendee, the payment will not be
excluded, since the indirect payment exclusion only applies if the
manufacturer did not know the identity of the physician attendee.
Comment: Many commenters interpreted the proposed removal ofSec.
403.904(g) to expand the exclusion to account for continuing education
programs accredited or certified for nurses, optometrists, pharmacists,
and others.
Response: We appreciate the comments, but the removal ofSec.
403.904(g) was not intended to expand the exclusion. The intent is to
allow for consistent reporting for compensation provided to physician
speakers at all continuing education events, as well as transparency
regarding compensation paid to physician speakers.
Comment: A few commenters requested CMS provide clear and realistic
timeframes regarding payments related to continuing education events to
allow manufacturers to provide sponsor notice as it considers proposals
to eliminate the current CME exclusion.
Response: We agree with commenters that manufacturers may need
additional time to comply with reporting requirements; therefore, we
are finalizing data collection requirements that would begin January 1,
2016 according to this final rule for applicable manufacturers.
3. Reporting of Marketed Name (Sec. 403.904(c)(8))
Section 1128G(a)(1)(A)(vii) of the Act requires applicable
manufacturers to report the name of the covered drug, device,
biological or medical supply associated with that payment, if the
payment is related to ``marketing, education, or research'' of a
particular covered drug, device, biological, or medical supply. Section
403.904(c)(8)(i) requires applicable manufacturers to report the
marketed name for each drug or biological related to a payment or other
transfer of value. At Sec. 403.904(c)(8)(ii), we require an applicable
manufacturer of devices or medical supplies to report one of the
following: the marketed name; product category; or therapeutic area. In
the February 8, 2013, final rule, we provided applicable manufactures
with flexibility when it was determined that the marketed name for all
devices and medical supplies may not be useful for the general
audience. We did not define product categories or therapeutic areas in
Sec. 403.904(c). However, since implementation of the February 8, 2013
final rule and the development of the Open Payments system, we have
determined that aligning the reporting requirements for marketed name
across drugs, biologics, devices and medical supplies will make the
data fields consistent within the system, and also enhance consumer's
use of the data.
Accordingly, we proposed to revise Sec. 403.904(c)(8) to require
applicable manufacturers to report the marketed name for all covered
drugs, devices, biologicals or medical supplies. We believe this would
facilitate consistent reporting for the consumers and researchers using
the data displayed publicly on the Open Payments. Manufacturers would
still have the option to report product category or therapeutic area,
in addition to reporting the market name, for devices and medical
supplies.
Comment: We received a few comments regarding revising reporting
requirements at Sec. 403.904(c)(8). These comments mainly stated that
the marketed name for a device or medical supply is not useful for the
public because the public is not familiar with device or medical supply
marketed names. We also received a few comments that supported
requiring the reporting of marketed name for devices and medical
supplies. Supporting commenters believe that reporting marketed name
for all products will allow the public (including researchers and
consumers) to search the data via the Open Payments public Web site for
a specific device or medical supply. Commenters also stated that
reporting marketed name for non-covered products is not required by the
statute and therefore manufacturers should not be required to report
marketed names for non-covered products. Additionally, some comments
indicated reporting marketed name for devices and medical supplies for
research payments is not practical because there is not a marketed name
for every device or medical supply associated with research payments;
rather there may only be a connection to an associated research study.
A few commenters addressed that manufacturers will have an increased
burden to modify reporting systems to accommodate reporting marketed
name for devices and medical supplies.
Response: We appreciate the comments supporting our proposed
revisions requiring reporting marketed name for devices and medical
supplies.
[[Page 67761]]
We have finalized a modified approach to accommodate concerns regarding
reporting related covered drug, device, biological or medical supply
information. We agree manufacturers should not be required to report
marketed names for non-covered products; therefore, we are finalizing
the proposal that reporting marketed names for non-covered drugs,
devices, biologicals, or medical supplies will continue to be optional.
We also agree a payment or other transfer of value associated with a
research payment regarding a device or medical supply may not have a
marketed name. Therefore, we are finalizing the proposal that
manufacturers will continue to have an option to report either a device
or medical supply marketed name, therapeutic area or product category
when reporting research payments.
After consideration of comments received, we agree that displaying
therapeutic areas or product categories are useful for the public
reviewing data on the Open Payments public Web site because the public
is not familiar with marketed names for devices and medical supplies.
We agree therapeutic areas and products categories are more
recognizable by the public. Yet, reporting marketed names for all
covered products is necessary to achieve consistent reporting and to
have the ability to aggregate all payments or other transfers of value
associated with a specific device or medical supply. Therefore to
achieve consistent reporting by manufacturers, we will require
manufacturers to report marketed name and therapeutic area or product
category for all covered drugs, devices, biologicals or medical
supplies. We also agree with commenters that complying with this
reporting requirement will require a change in manufacturers' reporting
systems; therefore, data collection for this reporting requirement
would begin January 1, 2016.
4. Reporting of Stock, Stock Option, or Any Other Ownership Interest
Section 403.904(d)(3) requires the reporting of stock, stock
option, or any other ownership interest. We proposed to require
applicable manufacturers to report such payments as distinct
categories. This will enable us to collect more specific data regarding
the forms of payment made by applicable manufacturers. After issuing
the February 8, 2013 final rule and the development of the Open
Payments system, we determined that this specificity will increase the
ease of data aggregation within the system, and also enhance consumer's
use of the data. We solicited comments on the extent to which users of
this data set find this disaggregation to be useful, and whether this
change presents operational or other issues on the part of applicable
manufacturers.
The following is summary of the comments we received regarding the
extent to which users of this data set find this disaggregation to be
useful, requiring reporting of marketed name for covered devices and
medical supplies, and whether this change presents operational or other
issues on the part of applicable manufacturers.
Comment: Commenters agreed that requiring reporting of stock, stock
option or any other ownership interest in distinct categories is
useful.
Response: We agree the disaggregation of reporting stock, stock
option or any other ownership interest in distinct categories.
Therefore, we have finalized this provision as proposed, which requires
reporting stock, stock option, or any other ownership interest form of
payment or other transfer of value in distinct categories.
J. Physician Compare Web Site
1. Background and Statutory Authority
Section 10331(a)(1) of the Affordable Care Act, requires that, by
no later than January 1, 2011, we develop a Physician Compare Internet
Web site with information on physicians enrolled in the Medicare
program under section 1866(j) of the Act, as well as information on
other eligible professionals (EPs) who participate in the Physician
Quality Reporting System (PQRS) under section 1848 of the Act.
CMS launched the first phase of Physician Compare on December 30,
2010 (https://www.medicare.gov/physiciancompare). In the initial phase,
we posted the names of EPs that satisfactorily submitted quality data
for the 2009 PQRS, as required by section 1848(m)(5)(G) of the Act.
Section 10331(a)(2) of the Affordable Care Act also requires that,
no later than January 1, 2013, and for reporting periods that began no
earlier than January 1, 2012, we implement a plan for making publicly
available through Physician Compare information on physician
performance that provides comparable information on quality and patient
experience measures. We met this requirement in advance of January 1,
2013, as outlined below, and plan to continue addressing elements of
the plan through rulemaking.
To the extent that scientifically sound measures are developed and
are available, we are required to include, to the extent practicable,
the following types of measures for public reporting:
Measures collected under the Physician Quality Reporting
System (PQRS).
An assessment of patient health outcomes and functional
status of patients.
An assessment of the continuity and coordination of care
and care transitions, including episodes of care and risk-adjusted
resource use.
An assessment of efficiency.
An assessment of patient experience and patient,
caregiver, and family engagement.
An assessment of the safety, effectiveness, and timeliness
of care.
Other information as determined appropriate by the
Secretary.
As required under section 10331(b) of the Affordable Care Act, in
developing and implementing the plan, we must include, to the extent
practicable, the following:
Processes to ensure that data made public are
statistically valid, reliable, and accurate, including risk adjustment
mechanisms used by the Secretary.
Processes for physicians and eligible professionals whose
information is being publicly reported to have a reasonable
opportunity, as determined by the Secretary, to review their results
before posting to Physician Compare. We have established a 30-day
preview period for all measurement performance data that will allow
physicians and other EPs to view their data as it will appear on the
Web site in advance of publication on Physician Compare (77 FR 69166
and 78 FR 74450). Details of the preview process will be communicated
directly to those with measures to preview and will also be published
on the Physician Compare Initiative page (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/physician-compare-initiative/) in advance of the preview period.
Processes to ensure the data published on Physician
Compare provides a robust and accurate portrayal of a physician's
performance.
Data that reflects the care provided to all patients seen
by physicians, under both the Medicare program and, to the extent
applicable, other payers, to the extent such information would provide
a more accurate portrayal of physician performance.
Processes to ensure appropriate attribution of care when
multiple physicians and other providers are involved in the care of the
patient.
Processes to ensure timely statistical performance
feedback is
[[Page 67762]]
provided to physicians concerning the data published on Physician
Compare.
Implementation of computer and data infrastructure and
systems used to support valid, reliable and accurate reporting
activities.
Section 10331(d) of the Affordable Care Act requires us to consider
input from multi-stakeholder groups, consistent with sections
1890(b)(7) and 1890A of the Act, when selecting quality measures for
Physician Compare. We also continue to get general input from
stakeholders on Physician Compare through a variety of means, including
rulemaking and different forms of stakeholder outreach (for example,
Town Hall meetings, Open Door Forums, webinars, education and outreach,
Technical Expert Panels, etc.). In developing the plan for making
information on physician performance publicly available through
Physician Compare, section 10331(e) of the Affordable Care Act requires
the Secretary, as the Secretary determines appropriate, to consider the
plan to transition to value-based purchasing for physicians and other
practitioners that was developed under section 131(d) of the MIPPA.
Under section 10331(f) of the Affordable Care Act, we are required
to submit a report to the Congress by January 1, 2015, on Physician
Compare development, and include information on the efforts and plans
to collect and publish data on physician quality and efficiency and on
patient experience of care in support of value-based purchasing and
consumer choice. Section 10331(g) of the Affordable Care Act provides
that any time before that date, we may continue to expand the
information made available on Physician Compare.
We believe section 10331 of the Affordable Care Act supports our
overarching goals of providing consumers with quality of care
information that will help them make informed decisions about their
health care, while encouraging clinicians to improve the quality of
care they provide to their patients. In accordance with section 10331
of the Affordable Care Act, we plan to publicly report physician
performance information on Physician Compare.
2. Public Reporting of Performance and Other Data
Since the initial launch of the Web site, we have continued to
build on and improve Physician Compare. On June 27, 2013, we launched a
full redesign of Physician Compare bringing significant improvements
including a complete overhaul of the underlying database and a new
Intelligent Search feature, addressing two of our stakeholders' primary
critiques of the site--the accuracy and currency of the database and
the limitations of the search function--and considerably improving Web
site functionality and usability. Provider Enrollment, Chain, and
Ownership System (PECOS), as the sole source of verified Medicare
professional information, is the primary source of administrative
information on Physician Compare. With the redesign, however, we
incorporated the use of Medicare Fee-For-Service claims information to
verify the information in PECOS to help ensure only the most current
and accurate information is included on the site. For example, claims
information is used to determine which of the active and approved
practice locations in PECOS are where the professional is currently
providing services. Claims information helps confirm that only the most
current group practice affiliations are included on the site. Our use
of claims also helps ensure that we are posting on Physician Compare
the most current and accurate information available about the
professionals for Medicare consumers.
We received several comments about the enhancements made to the
Physician Compare Web site and the data currently on the Web site.
Comment: Several commenters noted the improvements made to the
Physician Compare Web site, including the additional labeling,
improvements to the ``Is this you?'' link, the reordering of the search
results, the Intelligent Search functionality, the use of claims data
to verify professionals' demographic information, denoting board
certified physicians with contextual text, and explanations and
disclaimers about each of the federal quality reporting programs
included on the Web site. Commenters also noted an appreciation for the
transparency and easy-to-use, comprehensive information available on
the site to aid consumers in making informed health care decisions.
Some commenters provided suggestions for future Physician Compare
enhancements. A few commenters suggested continued improvements to the
Intelligent Search functionality to better find health care
professionals other than physicians and additional specialty labels for
Advanced Practice Registered Nurses (APRNs) and allied health
professionals.
Response: We appreciate the commenters' feedback and the continued
support for the Physician Compare Web site. We are committed to
continuing to improve the site and its functionality to ensure it is a
useful resource for Medicare consumers, including information that can
help these consumers make informed health care decisions. We also
appreciate the recommendations regarding other health care
professionals, and we will evaluate these recommendations for potential
future inclusion. Also, we are continually working to improve and
enhance the Intelligent Search functionality.
Comment: Some commenters expressed concerns about the accuracy of
data such as demographic information, specialty classification, and
hospital affiliation. Several commenters urged CMS to address these
concerns prior to posting additional quality measure performance
information on the Web site. Other commenters requested we implement a
streamlined process by which professionals can confirm or correct their
information in a timely manner. One commenter urged CMS to ensure that
updates made in PECOS are reflected on Physician Compare within 30
days, while another commenter cautioned against using PECOS for
updating information. Several commenters suggested continuing to work
with stakeholders, particularly health care professionals, and/or
providing educational material regarding how to keep data current to
ensure the accuracy of the Web site.
Response: We appreciate the commenters' feedback regarding concerns
over the accuracy of the information currently available on Physician
Compare. We are committed to including accurate and up-to-date
information on Physician Compare and continue to work to make
improvements to the information presented.
The underlying database on Physician Compare is generated from
PECOS, as well as Fee-For-Service (FFS) claims, and it is therefore
critical that physicians, other health care professionals, and group
practices ensure that their information is up-to-date and as complete
as possible in the national PECOS database. Currently, the most
immediate way to address inaccurate PECOS data on Physician Compare is
by updating information via Internet-based PECOS at https://pecos.cms.hhs.gov/pecos/login.do. Please note that the specialties as
reported on Physician Compare are those specialties reported to
Medicare when a physician or other health care professional enrolls in
Medicare and are limited to the specialties noted on the 855i
Enrollment Form. All addresses listed on Physician Compare must be
entered in and verified in PECOS.
[[Page 67763]]
There is a lag between when an edit is made in PECOS and when that
edit is processed by the Medicare Administrative Contractor (MAC) and
available in the PECOS data pulled for Physician Compare. This time is
necessary for data verification but unfortunately results in a delay
updating information. We are continually working to find ways to
minimize this delay.
To update information not found in PECOS, such as hospital
affiliation and foreign language, professionals and group practices
should contact the Physician Compare support team directly at
PhysicianCompare@Westat.com. Information regarding how to keep your
information current can also be found on the Physician Compare
Initiative page on CMS.gov (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/physician-compare-initiative/).
Although we appreciate the concerns raised around the PECOS data
included on Physician Compare, it is necessary to continue the use of
the PECOS data as it is the sole, verified source of Medicare
information. However, we are aware of its limitations. For these
reasons, we have instituted the use of claims information and are
continuing to work to find ways to further improve the data. The data
are significantly better today than they were prior to the 2013
redesign and continues to improve. We strongly encourage all
professionals and group practices listed on the site to regularly check
their data and to contact the support team with any questions or
concerns.
Currently, Web site users can view information about approved
Medicare professionals such as name, primary and secondary specialties,
practice locations, group affiliations, hospital affiliations that link
to the hospital's profile on Hospital Compare as available, Medicare
Assignment status, education, languages spoken, and American Board of
Medical Specialties (ABMS) board certification information. In
addition, for group practices, users can also view group practice
names, specialties, practice locations, Medicare assignment status, and
affiliated professionals.
We post on the Web site the names of individual EPs who
satisfactorily report under PQRS, as well as those EPs who are
successful electronic prescribers under the Medicare Electronic
Prescribing (eRx) Incentive Program. Physician Compare contains a link
to a downloadable database of all information on Physician Compare
(https://data.medicare.gov/data/physician-compare), including
information on this quality program participation. In addition, there
is a section on each Medicare professional's profile page indicating
with a green check mark the quality programs under which the EP
satisfactorily or successfully reported. We proposed (79 FR 40386) to
continue to include this information annually in the year following the
year it is reported (for example, 2015 PQRS reporting will be included
on the Web site in 2016). We did not receive any comments on this
proposal. We are finalizing this proposal at this time, and therefore,
will include satisfactory 2015 PQRS reporters on the Web site in 2016.
The eRx Incentive Program ends in 2014 so those data will not be
available in 2015 or beyond.
With the Physician Compare redesign, we added a quality programs
section to each group practice profile page in order to indicate which
group practices are satisfactorily reporting in the Group Practice
Reporting Option (GPRO) under PQRS or are successful electronic
prescribers under the eRx Incentive Program. We have also included a
notation and check mark for individuals that successfully participate
in the Medicare EHR Incentive Program, as authorized by section
1848(o)(3)(D) of the Act. We proposed (79 FR 40386) to continue to
include this information annually in the year following the year it is
reported (for example, 2015 data will be included on the Web site in
2016).
We did not receive any comments regarding our proposal regarding
this PQRS GPRO. We are finalizing the proposal to include a notation
for satisfactory PQRS GPRO reporters. As noted above, the eRx Incentive
Program is ending in 2014, and therefore, there will not be data for
this program in 2015 or beyond. We did receive comments regarding
including a notation for individuals that successfully participate in
the Medicare EHR Incentive Program.
Comment: Two commenters urged CMS to reconsider its decision to
publicly report participation in the Medicare EHR Incentive Program due
to ongoing issues related to the program--including unresolved
challenges related to vendor certification delays, concerns about the
relevancy to consumers, and limited ability to implement core measures.
One commenter suggested including a disclaimer next to the indicator
explaining these barriers and clarifying that successful participation
in the EHR Incentive Program is only one of various ways to demonstrate
an investment in higher quality care.
Response: We appreciate the commenters' feedback, and we will take
the suggestions provided regarding a disclaimer into consideration for
possible future enhancements. We also appreciate the concerns raised
about the program, specifically around vendor certification and core
measures. However, despite those potential limitations, a number of
professionals and groups are successfully taking part at this time and
we believe it is important to continue to recognize them. Also,
consumers find this information interesting and helpful. This is only
one of multiple quality programs included on Physician Compare that we
find important to highlight. As a result, we are going to finalize our
proposal to continue including an indicator for participation in the
EHR Incentive Program on the Web site.
We previously finalized a decision to publicly report the names of
those EPs who report the 2014 PQRS Cardiovascular Prevention measures
group in support of Million Hearts on Physician Compare in 2015, by
including a check mark in the quality programs section of the profile
page (78 FR 74450). We proposed (79 FR 40386) to also continue to
include this information annually in the year following the year it is
reported (for example, 2015 data will be included on Physician Compare
in 2016).
Comment: Some commenters supported our proposal to publicly report
and include an indicator for EPs who report the 2015 PQRS
Cardiovascular Prevention measures group in support of Million Hearts.
Commenters noted that Million Hearts is an important initiative for
supporting cardiovascular health.
Response: We appreciate the commenters' support. We agree that
Million Hearts is an important initiative that is improving outcomes
for cardiovascular health. However, we are finalizing the removal of
the Cardiovascular Prevention measure group from the PQRS program given
that the two cholesterol control measures included in the measure group
are no longer clinically relevant, and therefore, the measure group no
longer meets the necessary threshold for PQRS of six measures and will
no longer be available for reporting under the program. With the
removal of the 2 cholesterol control measures, the remaining measures
from the original Cardiovascular Prevention measure group are:
Ischemic Vascular Disease (IVD): Use of Aspirin or Another
Antithrombotic.
Preventive Care and Screening: Tobacco Use.
[[Page 67764]]
Controlling High Blood Pressure.
Preventive Care and Screening: Screening for High Blood
Pressure and Follow-Up Documented.
All of these measures are available as individual measures under
PQRS. Given that the Cardiovascular Prevention measure group is being
eliminated from the PQRS, but that the remaining measures identified
above will be available for individual reporting, we are modifying our
final policy with regard to our proposal to support Million Hearts on
Physician Compare. Specifically, we are finalizing that any EP that
satisfactorily reports all four of the individual measures noted above
will receive a green check mark indicating support for Million Hearts.
A key strategy of the Million Hearts initiative is to reduce the number
of heart attacks and strokes, and the program has found that reporting
these quality measures is a first step toward performance improvement.
We are committed to supporting this initiative, and even though the
measure group is no longer available under PQRS, we think it is
important to continue recognizing those individual EPs who are
reporting these quality measures as individual measures. Even though
the individual measures require that a potentially higher number of
patients are reported on--50 percent of patients that meet the sample
requirements versus just 20 patients for the measure group--we believe
this does not increase burden on reporters because as currently
available claims data show, significantly more EPs are already
reporting these measures as individual PQRS measures versus as part of
the Cardiovascular Prevention measures group. Ensuring these
professionals are recognized for reporting these measures is important
in ensuring we are continuing support for this important program
despite the measure group no longer being available for reporting.
Finally, we will also indicate with a green check mark those
individuals who have earned the 2014 PQRS Maintenance of Certification
Incentive (Additional Incentive) on the Web site in 2015 (78 FR 74450).
Comment: Several commenters supported publicly reporting earners of
the PQRS Maintenance of Certification (MOC) program Additional
Incentive, as well as ABMS Board Certification data, while other
commenters are concerned that ABMS data are not complete or only
include some specialists. Multiple commenters suggested including other
Boards' certifications and MOC programs, contextual certification
process information, and the certifying Board's identification.
Response: We appreciate the commenters' feedback and support for
including ABMS and PQRS MOC information on Physician Compare. We also
understand the concerns that not all specialties are presented by the
ABMS data and will review the recommendations made to include
additional certification and MOC program information on the Web site
for possible inclusion in the future.
We continue to implement our plan for a phased approach to public
reporting performance information on Physician Compare. The first phase
of this plan was finalized with the CY 2012 PFS final rule with comment
period (76 FR 73419-73420), where we established that PQRS GPRO
measures collected through the GPRO Web Interface for 2012 would be
publicly reported on Physician Compare. The plan was expanded with the
CY 2013 PFS final rule with comment period (77 FR 69166), where we
established that the specific GPRO Web Interface measures that would be
posted on Physician Compare would include the PQRS GPRO measures for
Diabetes Mellitus (DM) and Coronary Artery Disease (CAD), and we noted
that we would report composite measures for these measure groups in
2014, if technically feasible.\6\ The 2012 PQRS GPRO measures were
publicly reported on Physician Compare in February 2014. Data reported
in 2013 on the GPRO DM and GPRO CAD measures and composites collected
via the GPRO Web Interface that meet the minimum sample size of 20
patients and prove to be statistically valid and reliable will be
publicly reported on Physician Compare in December CY 2014, if
technically feasible. If the minimum threshold is not met for a
particular measure, or the measure is otherwise deemed not to be
suitable for public reporting, the group's performance rate on that
measure will not be publicly reported. We will only publish on
Physician Compare those measures that are statistically valid and
reliable, and therefore, most likely to help consumers make informed
decisions about the Medicare professionals they choose to meet their
health care needs.
---------------------------------------------------------------------------
\6\ By ``technically feasible'' we mean that there are no
operational constraints inhibiting us from moving forward on a given
public reporting objective. Operational constraints include delays
and/or issues related to data collection which render a set of
quality data unavailable in the timeframe necessary for public
reporting.
---------------------------------------------------------------------------
Measures must be based on reliable and valid data elements to be
useful to consumers and thus included on Physician Compare. A reliable
data element is consistently measuring the same thing regardless of
when or where it is collected, while a valid data element is measuring
what it is meant to measure. To address the reliability of performance
scores, we will measure the extent to which differences in each quality
measure are due to actual differences in clinician performance versus
variation that arises from measurement error. Statistically,
reliability depends on performance variation for a measure across
clinicians (``signal''), the random variation in performance for a
measure within a clinician's panel of attributed beneficiaries
(``noise''), and the number of beneficiaries attributed to the
clinician. High reliability for a measure suggests that comparisons of
relative performance across clinicians are likely to be stable over
different performance periods and that the performance of one clinician
on the quality measure can confidently be distinguished from another.
Potential reliability values range from zero to one, where one (highest
possible reliability) means that all variation in the measure's rates
is the result of variation in differences in performance, while zero
(lowest possible reliability) means that all variation is a result of
measurement error. Reliability testing methods included in the CMS
Measures Management System Blueprint (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/MeasuresManagementSystemBlueprint.html) include test-retest reliability
and analysis of variance (ANOVA). Reliability tests endorsed by the NQF
include the beta-binomial model test.
The validity of a measure refers to the ability to record or
quantify what it claims to measure. To analyze validity, we can
investigate the extent to which each quality measure is correlated with
related, previously validated, measures. We can assess both concurrent
and predictive validity. Predictive validity is most appropriate for
process measures or intermediate outcome measures, in which a cause-
and-effect relationship is hypothesized between the measure in question
and a validated outcome measure. Therefore, the measure in question is
computed first, and the validated measure is computed using data from a
later period. To examine concurrent validity, the measure in question
and a previously validated measure are computed using contemporaneous
data. In this context, the previously validated measure should measure
a health outcome related to the outcome of interest.
Comment: Many commenters supported only publishing on Physician
[[Page 67765]]
Compare those measures that are statistically valid and reliable.
Several commenters urged CMS to carefully assess if all GPRO measure
data is sufficiently reliable and valid for public reporting before
posting the data. One commenter recommended removing any measures
deemed unreliable or inaccurate. One commenter recommended a one-year
delay in public reporting of all new measures to enable professionals
to accurately report the measures and to account for measure testing
and validity.
One commenter requested CMS publish the results of validity and
reliability studies, as well as the methodology for choosing measures
prior to posting on Physician Compare. Another commenter is concerned
that measures related to patient behavior, preferences, or abilities do
not provide a statistically valid portrayal of a health care
professional's performance and should not be published unless the data
is appropriately risk adjusted. Several other commenters also strongly
urged CMS to move forward with expanding its risk adjustment
methodology.
Response: We appreciate the commenters' feedback, and understand
the concerns raised. As required under section 10331(b) of the
Affordable Care Act, in developing and implementing the plan to include
performance data on Physician Compare, we must include, to the extent
practicable, processes to ensure that the data posted on the Web site
are statistically valid, reliable, and accurate, including risk
adjustment mechanisms used by the Secretary. We understand that this
information is complex and are committed to providing data on Physician
Compare that are useful to beneficiaries in assisting them in making
informed health care decisions, while being accurate, valid, reliable,
and complete. We will closely evaluate all quality measures under
consideration for public reporting on the Web site to ensure they are
meeting these standards. We will also only post data that meet the
established standards of reliability and validity regardless of
threshold, and regardless of measure type. Should we find a measure
meeting the minimum threshold to be invalid or unreliable for any
reason, the measure will not be reported. We are also making changes in
light of the concerns about first year measures. We will not publicly
post measures that are in their first year given the concerns raised
about their validity, reliability, accuracy, and comparability. After a
measure's first year in the program, CMS will evaluate the measure to
see if and when the measure is suitable for pubic reporting. Also, we
will continue to analyze the measure data to ensure that risk
adjustment concerns are taken into consideration. All data are analyzed
and reviewed by our Technical Expert Panel (TEP). A summary of the TEP
recommendations is made public on the Physician Compare Initiative page
(https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/physician-compare-initiative/Informational-Materials.html)
when available.
In the November 2011 Medicare Shared Savings Program final rule (76
FR 67948), we noted that because Accountable Care Organization (ACO)
providers/suppliers that are EPs are considered to be a group practice
for purposes of qualifying for a PQRS incentive under the Shared
Savings Program, we would publicly report ACO performance on quality
measures on Physician Compare in the same way as we report performance
on quality measures for PQRS GPRO group practices. Public reporting of
performance on these measures is presented at the ACO level only. The
first sub-set of ACO measures was also published on the Web site in
February 2014. ACO measures can be viewed by following the link for
Accountable Care Organization (ACO) Quality Data on the homepage of the
Physician Compare Web site (https://medicare.gov/physiciancompare/aco/search.html).
As part of our public reporting plan for Physician Compare, in the
CY 2013 PFS final rule with comment period (77 FR 69166 and 69167), we
also finalized the decision to publicly report Clinician and Group
Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) data
for group practices of 100 or more eligible professionals reporting
data in 2013 under the GPRO and for ACOs participating in the Shared
Savings Program, if technically feasible. We anticipate posting these
data on Physician Compare in late 2014, if available.
We continued to expand our plan for public reporting data on
Physician Compare in the CY 2014 PFS final rule with comment period (78
FR 74449). In that final rule we finalized a decision that all measures
collected through the GPRO Web Interface for groups of two or more EPs
participating in 2014 under the PQRS GPRO and for ACOs participating in
the Medicare Shared Savings Program would be available for public
reporting in CY 2015. As with all measures we finalized with regard to
Physician Compare, these data would include measure performance rates
for measures reported that meet the minimum sample size of 20 patients
and prove to be statistically valid and reliable. We also finalized a
30-day preview period prior to publication of quality data on Physician
Compare. This will allow group practices to view their data as it will
appear on Physician Compare before it is publicly reported. We decided
that we will detail the process for the 30-day preview and provide a
detailed timeline and instructions for preview in advance of the start
of the preview period. ACOs will be able to view their quality data
that will be publicly reported on Physician Compare through the ACO
Quality Reports, which will be made available to ACOs for review at
least 30 days prior to the start of public reporting on Physician
Compare.
We also finalized a decision to publicly report in CY 2015 on
Physician Compare performance on certain measures that group practices
report via registries and EHRs in 2014 for the PQRS GPRO (78 FR 74451).
Specifically, we finalized making available for public reporting
performance on 16 registry measures and 13 EHR measures (78 FR 74451).
These measures are consistent with the measures available for public
reporting via the Web Interface. We will indicate the mechanism by
which these data were collected and only those data deemed
statistically comparable, valid, and reliable would be published on the
site.
We also finalized publicly reporting patient experience survey-
based measures from the CG-CAHPS measures for groups of 100 or more
eligible professionals who participate in PQRS GPRO, regardless of GPRO
submission method, and for Shared Savings Program ACOs reporting
through the GPRO Web Interface or other CMS-approved tool or interface
(78 FR 74452). For 2014 data, we finalized publicly reporting data for
the 12 summary survey measures also finalized for groups of 25 to 99
for PQRS reporting requirements (78 FR 74452). These summary survey
measures would be available for public reporting group practices of 100
or more EPs participating in PQRS GPRO, as well as group practices of
25 to 99 EPs when collected via any certified CAHPS vendor regardless
of PQRS participation, as technically feasible. For ACOs participating
in the Shared Savings Program, the patient experience measures that are
included in the Patient/Caregiver Experience domain of the Quality
Performance Standard under the Shared Savings Program (78 FR 74452)
will be available for public reporting in 2015.
For 2014, we also finalized publicly reporting 2014 PQRS measure
data
[[Page 67766]]
reported by individual EPs in late CY 2015 for individual PQRS quality
measures specifically identified in the final rule with comment period,
if technically feasible. Specifically, we finalized to make available
for public reporting 20 individual measures collected through a
registry, EHR, or claims (78 FR 74453-74454). These are measures that
are in line with those measures reported by groups via the GPRO Web
Interface.
Finally, in support of the HHS-wide Million Hearts Initiative, we
finalized a decision to publicly report, no earlier than CY 2015,
performance rates on measures in the PQRS Cardiovascular Prevention
measures group at the individual EP level for data collected in 2014
for the PQRS (78 FR 74454). See Table 48 for a summary of our final
policies for public reporting data on Physician Compare.
[[Page 67767]]
[GRAPHIC] [TIFF OMITTED] TR13NO14.064
[[Page 67768]]
3. Final Policies for Public Data Disclosure on Physician Compare in
2015 and 2016
We are continuing the expansion of public reporting on Physician
Compare by making an even broader set of quality measures available for
publication on the Web site. We started the phased approach with a
small number of possible PQRS GPRO Web Interface measures for 2012 and
have been steadily building on this to provide Medicare consumers with
more information to help them make informed health care decisions. As a
result, we proposed (79 FR 40388) to increase the measures available
for public reporting in the CY 2015 proposed PFS rule.
Comment: Although multiple commenters supported continuing the
phased approach to public reporting of quality data, a number of
commenters are concerned with the aggressive timeline for publicly
reporting performance data. Several commenters supported a more gradual
approach to public reporting to evaluate the public response to data
prior to widespread implementation, ensure accuracy, and present data
in a format that is easy to understand, meaningful, and actionable for
both patients and health care professionals. A few commenters were
unsure if CMS conducted analysis of consumer use of the site and urged
CMS to do so. Other commenters opposed the extensive expansion until
existing Web site problems are addressed.
Response: We appreciate the commenters' feedback, and we appreciate
the concerns raised. However, we believe that public reporting of
quality data has been a measured, phased approach which started with
the publication of just five 2012 PQRS GPRO measures collected via the
Web Interface for 66 group practices and 141 ACOs (76 FR 73417) and
continues with a similarly limited set of 2013 PQRS GPRO Web Interface
measures (77 FR 69166). We started to build on this plan with the 2014
Physician Fee Schedule (PFS) final rule (78 FR 74446). This rule made
additional PQRS GPRO measures available for public reporting, including
a subset of measures reported via Registry and EHR, as well as a sub-
set of 20 individual EP PQRS measures. Therefore, the proposals put
forth this year are just the next step in the process to realize goals
for authorization of Physician Compare. We are confident that taking
this phased approach has afforded us the opportunity to prepare for
this significant expansion.
Throughout this process, we have been engaging with consumers and
stakeholders and regularly testing the site and the information to be
included to ensure it is accurately presented and understood. We are
also continually working to improve the Web site and the administrative
and demographic information included. We continue to encourage
physicians, other health care professionals, and group practices to
ensure their information is updated in PECOS so that we can ensure the
most accurate information is available on Physician Compare. We also
encourage individuals and groups to reach out to the Physician Compare
support team at PhysicianCompare@Westat.com for any questions or
concerns regarding the information included on the Web site.
We proposed (79 FR 40388) to expand public reporting of group-level
measures by making all 2015 PQRS GPRO measure sets across group
reporting mechanisms--GPRO Web Interface, registry, and EHR--available
for public reporting on Physician Compare in CY 2016 for groups of 2 or
more EPs, as appropriate by reporting mechanism.\7\ Similarly, we also
proposed that all measures reported by Shared Savings Program ACOs
would be available for public reporting on Physician Compare. As with
all quality measures proposed for inclusion on Physician Compare, we
noted that only measures that prove to be valid, reliable, and accurate
upon analysis and review at the conclusion of data collection would be
included on the Web site.
---------------------------------------------------------------------------
\7\ Tables Q1-Q27 detail proposed changes to available PQRS
measures. Additional information on PQRS measures can be found on
the CMS.gov PQRS Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/.
---------------------------------------------------------------------------
Comment: Commenters were both positive and negative in regard to
our proposal to expand the group-level measures available for public
reporting to all measures reported under 2015 PQRS GPRO. Commenters in
support of the proposal noted group-level measures are a robust
indication of care team quality and helpful to consumers. Some
commenters opposed the expansion and cited concerns with the accuracy
of current data as well as measure fidelity. One commenter encouraged
CMS to ensure that GPRO quality data is accurately labeled and
accessible through the group entry only to ensure it is clear what the
quality measure represents. One commenter asked for clarification on
the availability of the PQRS GPRO Web Interface reporting option for
groups of two or more EPs.
Response: We appreciate the commenters' feedback on our proposal to
report all 2015 PQRS measures reported via the Web Interface, EHR, and
Registry for group practices of 2 or more EPs participating in the PQRS
GPRO. As noted, Physician Compare will only publicly report those
measures evaluated to be comparable, reliable, and valid. Also, we will
continue to work to ensure that measures are labeled accurately and
accompanied by explanations that are both true to the measure
specifications and accurately understood by health care consumers,
while adhering to HHS plain language guidelines. Measure data accuracy
is of paramount importance to CMS. The measure data currently available
on Physician Compare was previewed by those group practices that
currently have 2012 PQRS GPRO data available on Physician Compare prior
to publication with no concerns raised regarding accuracy. Since being
published, no group practices with GPRO data have raised concerns
regarding the accuracy of the measure data available. To confirm, the
Web Interface reporting option will remain limited to groups of 25 or
more EPs. Smaller groups, groups of 2 to 24 EPs, can report under the
PQRS via EHR or Registry. We also clarify that group-level data is only
published at the group level--included on the group practice profile
page--on Physician Compare. And, in response to comments that raised
concern about measures reported in the first year, we have decided that
we will not publicly report a measure that is in its first year. By
first year we mean a measure that is newly available for reporting
under PQRS.
We also received comments specifically about EHR measures.
Comment: Commenters were opposed to publicly reporting EHR
measures, citing that it is too soon to publicly post performance data
from eCQMs without additional work to verify the validity and accuracy
of the measure results. One commenter suggested that new quality
measures could be piloted by health care professionals prior to
requiring their use within a federal program. One commenter strongly
encouraged developing a tutorial that allows the public to better
understand this data.
Response: We appreciate the commenters' feedback regarding
including measures collected via EHRs. Group practices will have the
ability to report measures via an EHR prior the 2015 data collection.
Therefore, this reporting mechanism will not be in its first year of
use at this time. As a result, we do not believe it is too soon to
report these quality measures. As noted, only comparable, valid,
reliable, and accurate
[[Page 67769]]
data will be included on Physician Compare. All measures slated for
public reporting will be consumer tested to ensure they are accurately
understood prior to publication. If concerns surface from this testing,
we will evaluate if the requirements for public reporting are not
suitably met and if the measure or measures in question should be
suppressed and not publicly reported to ensure only those measures that
are valid, reliable, and accurate and inform quality choice are
included on the site.
Given the value of these group-level data, and the successful
publication of such data to date, we are finalizing our proposal to
report all 2015 PQRS measures for all reporting options for group
practices of 2 or more EPs participating in PQRS GPRO, and all 2015
measures reported by ACOs. Consistent with this final policy, we are
making a conforming change to the regulation at Sec. 425.308(e) to
provide that all quality measures reported by ACOs will be reported on
Physician Compare in the same way as for group practices that report
under the PQRS.
We also proposed (79 FR 40389) that measures must meet the public
reporting criteria of a minimum sample size of 20 patients.
Comment: Several commenters supported the proposed minimum sample
size of 20 patients. However, the majority of commenters believed a
patient threshold of 20 is too low to be statistically valid, which
commenters claim may result in inaccurate quality scores based on one
outlier. Commenters recommended CMS use a higher threshold to ensure
validity. Several commenters also urged CMS to test measures and
composites with 20 patients and to provide an opportunity for public
comment and to review reliability and validity.
Response: We appreciate the commenters' feedback and understand the
concerns raised regarding the 20 patient minimum sample size. However,
we believe this threshold of 20 patients is a large enough sample to
protect patient privacy for reporting on the Web site, and aligns with
the reliability threshold previously finalized for the Value-Based
Modifier (VM) (77 FR 69166). As we continue to work to align quality
initiatives and minimize reporting burden on physicians and other
health care professionals, we are finalizing a patient sample size of
20 patients.
We proposed to include an indicator of which reporting mechanism
was used and to only include on the site measures deemed statistically
comparable.\8\ We received several comments regarding data
comparability, generally.
---------------------------------------------------------------------------
\8\ By statistically comparable, CMS means that the quality
measures are analyzed and proven to measure the same phenomena in
the same way regardless of the mechanism through which they were
collected.
---------------------------------------------------------------------------
Comment: Some commenters expressed concern with the comparability
of measures reported through different reporting mechanisms and
requested notation specifying the measure differences. One commenter
supported only publicly reporting measures with specifications
consistent across all reporting mechanisms, while another commenter
recommended that CMS group results by the data collection methodology
to improve comparability.
Response: Though we understand concerns regarding including
measures collected via different mechanisms, CMS is conducting analyses
to ensure that these measures align across different reporting
mechanisms. This analysis is done on a measure per measure basis. For
example, if a measure is reported via claims, then the measure
specifications would be aligned with a measure being reported via EHR
as long as it stays consistent with the original measure intent. Only
those measures that are proven to be comparable and most suitable for
public reporting will be included on Physician Compare and made
publicly available. Therefore, we are finalizing our proposal to report
data from the available reporting mechanisms and to include a notation
indicating which reporting mechanism was used.
We proposed (79 FR 40389) to publicly report all measures submitted
and reviewed and found to be statistically valid and reliable in the
Physician Compare downloadable file. However, we proposed that not all
of these measures necessarily would be included on the Physician
Compare profile pages. As we noted, consumer testing has shown profile
pages with too much information and/or measures that are not well
understood by consumers can negatively impact a consumer's ability to
make informed decisions. Our analysis of the collected measure data,
along with consumer testing and stakeholder feedback, will determine
specifically which measures are published on profile pages on the Web
site. Statistical analyses will ensure the measures included are
statistically valid and reliable and comparable across data collection
mechanisms. Stakeholder feedback will ensure all measures meet current
clinical standards. CMS will continue to reach out to stakeholders in
the professional community, such as specialty societies, to ensure that
the measures under consideration for public reporting remain clinically
relevant and accurate. When measures are finalized significantly in
advance of moment they are collected, it is possible that clinical
guidelines can change rendering a measure no longer relevant.
Publishing that measure can lead to consumer confusion regarding what
best practices their health care professional should be subscribing to.
As we noted in the proposed rule (79 FR 40389), the primary goal of
Physician Compare is to help consumers make informed health care
decisions. If a consumer does not properly interpret a quality measure
and thus misunderstands what the quality score represents, the consumer
cannot use this information to make an informed decision. Through
concept testing, CMS will test with consumers how well they understand
each measure under consideration for public reporting. If a measure is
not consistently understood and/or if consumers do not understand the
relevance of the measure to their health care decision making process,
CMS will not include the measure on the Physician Compare profile page
as inclusion will not aid informed decision making. Finally, consumer
testing will help ensure the measures included on the profile pages are
accurately understood and relevant to consumers, thus helping them make
informed decisions. This will be done to ensure that the information
included on Physician Compare is consumer friendly and consumer
focused.
Comment: Several commenters supported the proposal to have all 2015
measures available for download with only a select group of measures on
the Web site. One commenter further emphasized CMS should create
consistent formatting with Hospital Compare downloadable files.
Response: We appreciate the commenters' feedback and support for
this proposal. We are finalizing the proposal to include all measures
in a downloadable file and limiting the measures available on Physician
Compare profile pages to those measures that not only meet the
requirements of public reporting such as validity, reliability,
accuracy, and comparability, but that also are accurately understood
and interpreted by consumers as evidenced via consumer testing. This
will ensure that the measures presented on Physician Compare help them
make informed health care decisions without overwhelming them with too
much information. We will also take into future consideration the
[[Page 67770]]
recommendation regarding the Hospital Compare file.
We also received comments regarding stakeholder involvement and
consumer testing.
Comment: Commenters encouraged continued involvement of measure
developers and stakeholders in the public reporting development
process. Several commenters appreciated the continued collaboration
with specialty societies via town hall meetings and other mechanisms.
Several commenters advocated for more transparency by providing the
opportunity for the public to comment on the deliberations of the
Physician Compare TEP; regular engagement with interested stakeholders;
and increased communication about the measure consideration process,
including methods and interpretation of performance. Some commenters
appreciated that CMS will continue to reach out to stakeholders in the
professional community to ensure that the measures under consideration
for public reporting remain clinically relevant and accurate. One
commenter suggested an opportunity for stakeholder associations to
participate in the 30-day measure preview process.
Response: We appreciate the commenters' feedback regarding
stakeholder outreach and involvement in Physician Compare. As we noted,
section 10331(d) of the Affordable Care Act requires that the Secretary
take into consideration input provided by multi-stakeholder groups,
consistent with sections 1890(b)(7) and 1890A of the Act, as added by
section 3014 of the Act, in selecting quality measures for use on
Physician Compare. We also are dedicated to providing opportunities for
stakeholders to provide input. We will continue to identify the best
ways to accomplish this. We will also review all recommendations
provided for future consideration.
Comment: Many commenters supported consumer testing to ensure only
meaningful measures are included on the site. One commenter suggested
CMS first focus on communicating validated and meaningful information
in a user-friendly way. One commenter urged CMS to consult a broader
array of stakeholders during concept testing, while another commenter
specified the inclusion of health care professionals. Some commenters
requested that CMS share with professional associations or measure
developers any information obtained through consumer concept testing. A
few commenters asked for more details on concept testing plans, while
another recommended CMS use concept testing for the information
currently on the Physician Compare. One commenter emphasized testing
must occur prior to placing these additional measures on the Web site
in late 2016. One commenter believed health care professionals must be
aware of what measures will be reported to the Physician Compare Web
site before the reporting period begins.
Response: We appreciate the commenters' feedback. We will continue
to conduct consumer testing in terms of both usability testing--to
ensure the site is easy to navigate and functioning appropriately--and
concept testing--to ensure users understand the information included on
the Web site and that information included resonates with health care
consumers. We are continually working to test the information planned
for public reporting with consumers. We regularly test the information
currently on the Web site with site users. We are planning concept
testing of the measures being finalized in this rule prior to
publication in 2016 and we will work to ensure that valid, reliable,
and meaningful information is included on the Web site. This testing
ensures that the best information is shared and that it is shared in a
way that is correctly interpreted.
We will also engage stakeholders for feedback, including input from
the public, consumers, and health care professionals, as appropriate
and feasible through such opportunities as Town Halls, Listening
Sessions, Open Door Forums, and Webinars. We will review feedback for
future consideration. Although we establish in rulemaking the subset of
measures available for posting on the Physician Compare Web site, at
this time, however, it is not possible for us to provide stakeholders
with the exact list of measures that will be included on the Web site
prior to our analysis of the reported data to know which measures meet
the criteria we specified previously for public reporting.
As is the case for all measures published on Physician Compare,
group practices will be given a 30-day preview period to view their
measures as they will appear on Physician Compare prior to the measures
being published. As in previous years, we will detail the process for
the 30-day preview and provide a detailed timeline and instructions for
preview in advance of the start of the preview period. ACOs will be
able to view their quality data that will be publicly reported on
Physician Compare through the ACO Quality Reports, which will be made
available to ACOs for review at least 30 days prior to the start of
public reporting on Physician Compare.
Comment: Several commenters were in support of the 30-day preview
period prior to publication of quality data. Many commenters urged CMS
to also allow group practices, ACOs, and EPs the opportunity to correct
and/or appeal any errors found in the performance information before it
is posted on the Web site. Several commenters recommended CMS postpone
posting information if a group practice or EP files an appeal and flags
their demographic data or quality information as problematic. Other
commenters noted that a 30-day preview period is insufficient and
requested that CMS extend the period to 60 or 90 days. One commenter
believed the preview period should match the PQRS committee's measure
review timeline of 9 months. Some commenters sought clarification on
how CMS plans to notify EPs of the preview period and requested more
detail about correcting errors found during the preview period.
Response: We appreciate the commenters' feedback regarding the 30-
day preview period for quality measures on Physician Compare. Detailed
instructions regarding how to preview measure data, the time frame for
the measure preview, and directions for how to address any concerns or
get additional help during this process is shared at the start of the
preview period with all groups and individuals that have data to
preview. If an error is found in the measure display during this 30-day
preview, the directions explain how to contact the Physician Compare
team by both phone and email to have concerns addressed. Errors will be
corrected prior to publication. If measure data has been collected and
the measure has been deemed suitable for pubic reporting, the data will
be published. This 30-day period is in line with the preview period
provided for other public reporting programs such as Hospital Compare.
To date, our experience with this preview period for group practices
demonstrates that 30 days is sufficient time to allow for preview to be
conducted. It is important that quality data be shared with the public
as soon as possible so it is as current and relevant as possible when
published. To avoid further delaying this publication we will maintain
the 30-day preview period.
Group practices and EPs with available data for public reporting
will be informed via email when the preview period is going to take
place. Group practices and EPs will be provided instructions for
previewing data and information for on how to request help
[[Page 67771]]
or have questions answered. Additionally, information regarding the
preview period will be included on the Physician Compare Initiative
page on CMS.gov. As noted, ACOs will preview their data via their ACO
Quality Reports, which will be sent at least 30 days before data are
publicly reported. There is no preview period for demographic data.
These data are currently publicly available. If a group practice or EP
has questions about their demographic data, they should contact the
Physician Compare support team at PhysicianCompare@Westat.com.
In addition to making all 2015 PQRS GPRO measures available for
public reporting, we solicited comment (78 FR 40389) on creating
composites using 2015 data and publishing composite scores in 2016 by
grouping measures based on the PQRS GPRO measure groups, if technically
feasible. We indicated we would analyze the data collected in 2015 and
conduct psychometric and statistical analyses, looking at how the
measures best fit together and how accurately they are measuring the
composite concept, to create composites for certain PQRS GPRO measure
groups, including but not limited to:
Care Coordination/Patient Safety (CARE) Measures
Coronary Artery Disease (CAD) Disease Module
Diabetes Mellitus (DM) Disease Module
Preventive (PREV) Care Measures
In particular, we would analyze the component measures that make up
each of these measure groups to see if a statistically viable composite
can be constructed with the data reported for 2015. Composite scores
have proven to be beneficial in providing consumers a better way to
understand quality measure data, as composites provide a more concise,
easy to understand picture of physician quality.
Comment: Commenters were both positive and negative in regard to
our request for information on publicly reporting composite scores.
Some commenters stated composites should only be publicly reported if
statistically reliable, risk adjusted, or medically meaningful, and
should be scientifically or consumer tested prior to public display. A
few commenters also suggested NQF endorsement of individual components
and composites before finalizing any composites. Several commenters
strongly urged CMS to seek input from relevant specialty societies,
measure developers, consumers, and other stakeholders on the
construction and display of the composites. A few commenters opposed
public reporting of composites, but suggested providing physicians the
composite scores confidentially through the QRURs. Several commenters
noted concerns about the proposal to create composites given the
variability in the methodologies, difficulty validating the results,
and use of stand-alone measures developed to be reported individually.
One commenter suggested stand-alone measures are preferable to
composites in relatively small and heterogeneous measure sets. A few
commenters suggested posting additional information about composite
measures on Physician Compare clarifying that composite groups are not
readily available at this time for all measure groups. One commenter
urged CMS to retain more comprehensive information about the measures
within each composite measure in the downloadable file. One commenter
does not specifically support the Oncology Composite Score on Physician
Compare.
Response: We appreciate the commenters' feedback on this request
for information. We will be carefully reviewing all concerns raised and
recommendations made as we continue to evaluate options for including
composites in future rulemaking. This concept was put forth merely to
seek comment and no formal proposal was made, so we are not finalizing
any decisions regarding composite scores at this time. However, given
that we received feedback from stakeholders indicating such composite
scores are desired, we plan to analyze the data once it is collected to
establish the best possible composite, which would help consumers use
these quality data to make informed health care decisions, and will
consider proposing such composites in future rulemaking.
Similar to composite scores, benchmarks are also important to
ensuring that the quality data published on Physician Compare are
accurately interpreted and appropriately understood. A benchmark will
allow consumers to more easily evaluate the information published by
providing a point of comparison between groups. We continue to receive
requests from all stakeholders, but especially consumers, to add this
information to Physician Compare. As a result, we proposed (79 FR
40389) to publicly report on Physician Compare in 2016 benchmarks for
2015 PQRS GPRO data using the same methodology currently used under the
Shared Savings Program. This ACO benchmark methodology was previously
finalized in the November 2011 Shared Savings Program final rule (76 FR
67898), as amended in the CY 2014 PFS final rule with comment period
(78 FR 74759). Details on this methodology can be found on CMS.gov at
https://cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/MSSP-QM-Benchmarks.pdf. We proposed to
follow this methodology using the 2014 PQRS GPRO data.
We proposed to calculate benchmarks using data at the group
practice TIN level for all EPs who have at least 20 cases in the
denominator. A benchmark per this methodology is the performance rate a
group practice must achieve to earn the corresponding quality points
for each measure. Benchmarks would be established for each percentile,
starting with the 30th percentile (corresponding to the minimum
attainment level) and ending with the 90th percentile (corresponding to
the maximum attainment level). A quality scoring point system would
then be determined. Quality scoring would be based on the group
practice's actual level of performance on each measure. A group
practice would earn quality points on a sliding scale based on level of
performance: performance below the minimum attainment level (the 30th
percentile) for a measure would receive zero points for that measure;
performance at or above the 90th percentile of the performance
benchmark would earn the maximum points available for the measure. The
total points earned for measures in each measure group would be summed
and divided by the total points available for that measure group to
produce an overall measure group score of the percentage of points
earned versus points available. The percentage score for each measure
group would be averaged together to generate a final overall quality
score for each group practice. The goal of including such benchmarks
would be to help consumers see how each group practice performs on each
measure, measure group, and overall in relation to other group
practices.
Comment: Many commenters supported the use of benchmarks to help
consumers make informed health care decisions. However, several
commenters did not support the calculation of an overall quality score,
as they believe it will result in the unfair comparison of all group
practices. Additional commenters noted that benchmarks using
percentiles will be difficult for consumers to understand and
encouraged consumer testing to remedy this problem. Some commenters
noted appropriate methodology is needed when potential data constraints
impact the calculation of benchmarks. Several commenters also asked for
[[Page 67772]]
clarification on the impact of exception rates on quality scores and
how benchmarks will be displayed, noting the risk of arbitrary
thresholds potentially exaggerating minor performance differences. A
commenter asked for the opportunity to review sample data prior to
supporting the proposed methodology, while another noted that
benchmarks need to be set prior to the beginning of the new measurement
period. One commenter sought clarification on whether the benchmarking
methodology would be the same as the methodology applied under the
Value-Modifier. Several commenters urged CMS to use consistent
benchmarking across its programs to promote consistency and minimize
confusion. One commenter cautioned the use of benchmarks, noting it can
lead to an incomplete and potentially misleading indicator of quality.
Response: We appreciate the commenters' feedback on our proposal to
include on Physician Compare a benchmark for 2015 PQRS GPRO measures
(and measures reported by individual EPs) measures based on the current
Shared Savings Program benchmark methodology. Although we agree
benchmarks can add great value for consumers, we understand the many
concerns raised. As a result, we have made a decision not to finalize
this proposal at this time. We want to be sure to discuss more
thoroughly potential benchmarking methodologies with our stakeholders
prior to finalizing the proposal. We also want to evaluate other
programs' methodologies, including the Value Modifier, to work toward
better alignment across programs. We therefore feel it would be best to
forgo finalizing a methodology at this time in favor of a stronger,
potentially better aligned methodology that can be included in future
rulemaking.
Understanding the value consumers place on patient experience data
and the commitment to reporting these data on Physician Compare, we
proposed (79 FR 40390) publicly reporting in CY 2016 patient experience
data from 2015 for all group practices of two or more EPs, who meet the
specified sample size requirements and collect data via a CMS-specified
certified CAHPS vendor. The patient experience data available are
specifically the CAHPS for PQRS and CAHPS for ACO measures, which
include the CG-CAHPS core measures. For group practices, we proposed to
make available for public reporting these 12 summary survey measures:
Getting Timely Care, Appointments, and Information.
How Well Providers Communicate.
Patient's Rating of Provider.
Access to Specialists.
Health Promotion & Education.
Shared Decision Making.
Health Status/Functional Status.
Courteous and Helpful Office Staff.
Care Coordination.
Between Visit Communication.
Helping You to Take Medication as Directed.
