Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Pricing Data Release; Medicare Advantage and Part D Medical Low Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model, 46161-46476 [2016-16097]
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Vol. 81
Friday,
No. 136
July 15, 2016
Part II
Department of Health and Human Services
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 411, et al.
Medicare Program; Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage
Pricing Data Release; Medicare Advantage and Part D Medical Low Ratio
Data Release; Medicare Advantage Provider Network Requirements;
Expansion of Medicare Diabetes Prevention Program Model; Proposed
Rules
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Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 405, 410, 411, 414, 417,
422, 423, 424, 425, and 460
[CMS–1654–P]
RIN 0938–AS81
Medicare Program; Revisions to
Payment Policies Under the Physician
Fee Schedule and Other Revisions to
Part B for CY 2017; Medicare
Advantage Pricing Data Release;
Medicare Advantage and Part D
Medical Low Ratio Data Release;
Medicare Advantage Provider Network
Requirements; Expansion of Medicare
Diabetes Prevention Program Model
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
AGENCY:
This major proposed rule
addresses changes to the physician fee
schedule and other Medicare Part B
payment policies, such as changes to the
Value Modifier, 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. This proposed
rule also includes proposals related to
the Medicare Shared Saving Program,
and the release of certain pricing data
from Medicare Advantage bids and
medical loss ratio reports from Medicare
health and drug plans. In addition, this
rule proposes to expand the Medicare
Diabetes Prevention Program model.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on September 6, 2016.
ADDRESSES: In commenting, please refer
to file code CMS–1654–P. 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–1654–P, P.O. Box 8013, Baltimore,
MD 21244–8013.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
SUMMARY:
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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–1654–P, 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:
Jessica Bruton, (410) 786–5991 for
issues related to any physician payment
issues not identified below.
Gail Addis, (410) 786–4522, for issues
related to diabetes self-management
training.
Jaime Hermansen, (410) 786–2064, for
issues related to moderate sedation
coding and anesthesia services.
Jessica Bruton, (410) 786–5991, for
issues related to identification of
potentially misvalued services.
Roberta Epps, (410) 786–4503, for
issues related to PAMA section 218(a)
policy and the transition from
traditional x-ray imaging to digital
radiography.
Ken Marsalek, (410) 786–4502, for
issues related to telehealth services.
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Ann Marshall, (410) 786–3059, for
primary care issues related to chronic
care management (CCM), burden
reduction and evaluation and
management services.
Emily Yoder, (410) 786–1804, for
primary care issues related to resource
intensive services and other primary
care issues.
Lindsey Baldwin, (410) 786–1694, for
primary care issues related to behavioral
health integration services.
Geri Mondowney, (410) 786–4584,
and Donta Henson, (410) 786–1947, for
issues related to geographic practice
cost indices.
Michael Soracoe, (410) 786–6312, for
issues related to the target and phase-in
provisions, the practice expense
methodology, impacts, conversion
factor, and the valuation of surgical
procedures.
Pamela West, (410) 786–2302, for
issues related to therapy.
Patrick Sartini, (410) 786–9252, for
issues related to malpractice RVUs,
radiation treatment, mammography and
other imaging services.
Kathy Bryant, (410) 786–3448, for
issues related to collecting data on
resources used in furnishing global
services.
Donta Henson, (410) 786–1947, for
issues related to pathology and
ophthalmology services.
Corinne Axelrod, (410) 786–5620, for
issues related to rural health clinics or
federally qualified health centers for
comprehensive care management
services furnished incident to.
Simone Dennis (410) 786–8409, for
issues related to FQHC-specific market
basket.
JoAnna Baldwin (410) 786–7205, or
Sarah Fulton (410) 786–2749, for issues
related to appropriate use criteria for
advanced diagnostic imaging services.
Erin Skinner (410) 786–0157, for
issues related to open payments.
Sean O’Grady (410) 786–2259, or Julie
Uebersax (410) 786–9284, for issues
related to release of pricing data from
Medicare Advantage bids and release of
medical loss ratio data submitted by
Medicare Advantage organizations and
Part D sponsors.
Sara Vitolo (410) 786–5714, for issues
related to prohibition on billing
qualified Medicare beneficiary
individuals for Medicare cost-sharing.
Michelle Peterman (410) 786–2591,
for issues on the technical correction for
PQRS.
Katie Mucklow (410) 786–0537 or
John Spiegel (410) 786–1909, for issues
related to Provider Enrollment Medicare
Advantage Program.
Jen Zhu (410) 786–3725, Carlye Burd
(410) 786–1972, or Nina Brown (410)
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786–6103, for issues related to Medicare
Diabetes Prevention Program model
expansion.
Rabia Khan or Terri Postma, (410)
786–8084 or ACO@cms.hhs.gov, for
issues related to Medicare Shared
Savings Program.
Sabrina Ahmed (410) 786–7499, or
Fiona Larbi (410) 786–7224, for issues
related to Value-based Payment
Modifier and Physician Feedback
Program.
Lisa Ohrin Wilson (410) 786–8852, or
Gabriel Scott (410) 786–3928, for issues
related to physician self-referral
updates.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
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.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
Table of Contents
I. Executive Summary and Background
A. Executive Summary
B. Background
II. Provisions of the Proposed Rule for PFS
A. Determination of Practice Expense
Relative Value Units (PE RVUs)
B. Determination of Malpractice Relative
Value Units (MRVUs)
C. Medicare Telehealth Services
D. Potentially Misvalued Services Under
the Physician Fee Schedule
1. Background
2. Progress in Identifying and Reviewing
Potentially Misvalued Codes
3. Validating RVUs of Potentially
Misvalued Codes
4. CY 2017 Identification and Review of
Potentially Misvalued Services
5. Valuing Services That Include Moderate
Sedation as an Inherent Part of
Furnishing the Procedure
6. Collecting Data on Resources Used in
Furnishing Global Services
E. Improving Payment Accuracy for
Primary Care, Care Management
Services, and Patient-Centered Services
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F. Improving Payment Accuracy for
Preventive Services: Diabetes SelfManagement Training (DSMT)
G. Target for Relative Value Adjustments
for Misvalued Services
H. Phase-In of Significant RVU Reductions
I. Geographic Practice Cost Indices (GPCIs)
J. Payment Incentive for the Transition
From Traditional X-Ray Imaging to
Digital Radiography and Other Imaging
Services
K. Procedures Subject to the Multiple
Procedure Payment Reduction (MPPR)
and the OPPS Cap
L. Valuation of Specific Codes
III. Other Provisions of the Proposed Rule for
PFS
A. Chronic Care Management (CCM) and
Transitional Care Management (TCM)
Supervision Requirements in Rural
Health Clinics (RHCs) and Federally
Qualified Health Centers (FQHCs)
B. FQHC-Specific Market Basket
C. Appropriate Use Criteria for Advanced
Diagnostic Imaging Services
D. Reports of Payments or Other Transfers
of Value to Covered Recipients:
Solicitation of Public Comments
E. Release of Part C Medicare Advantage
Bid Pricing Data and Part C and Part D
Medical Loss Ratio (MLR) Data
F. Prohibition on Billing Qualified
Medicare Beneficiary Individuals for
Medicare Cost-Sharing
G. Recoupment or Offset of Payments to
Providers Sharing the Same Taxpayer
Identification Number
H. Accountable Care Organization (ACO)
Participants Who Report Physician
Quality Reporting System (PQRS)
Quality Measures Separately
I. Medicare Advantage Provider Enrollment
J. Proposed Expansion of the Diabetes
Prevention Program (DPP) Model
K. Medicare Shared Savings Program
L. Value-Based Payment Modifier and
Physician Feedback Program
M. Physician Self-referral Updates
IV. Collection of Information Requirements
V. Response to Comments
VI. Regulatory Impact Analysis
Regulations Text
Acronyms
In addition, because of the many
organizations and terms to which we
refer by acronym in this proposed rule,
we are listing these acronyms and their
corresponding terms in alphabetical
order below:
A1c—Hemoglobin A1c
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)
AWV—Annual wellness visit
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)
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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
CoA—Certificate of Accreditation
CoC—Certificate of Compliance
CoR—Certificate of Registration
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 2015
American Medical Association. All rights
reserved.)
CQM—Clinical quality measure
CSW—Clinical social worker
CT—Computed tomography
CW—Certificate of Waiver
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
ED—Emergency Department
EHR—Electronic health record
E/M—Evaluation and management
EMT—Emergency Medical Technician
EP—Eligible professional
eRx—Electronic prescribing
ESRD—End-stage renal disease
FAR—Federal Acquisition Regulations
FDA—Food and Drug Administration
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
IPPE—Initial preventive physical exam
IPPS—Inpatient Prospective Payment System
IQR—Inpatient Quality Reporting
ISO—Insurance service office
IT—Information technology
IWPUT—Intensity of work per unit of time
LCD—Local coverage determination
MA—Medicare Advantage
MAC—Medicare Administrative Contractor
MACRA—Medicare Access and CHIP
Reauthorization Act of 2015 (Pub. L. 114–
10)
MAP—Measure Applications Partnership
MAPCP—Multi-payer Advanced Primary
Care Practice
MAV—Measure application validity
[process]
MCP—Monthly capitation payment
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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
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
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
PPM—Provider-Performed Microscopy
PQRS—Physician Quality Reporting System
PPIS—Physician Practice Expense
Information Survey
PT—Physical therapy
PT—Proficiency Testing
PT/INR—Prothrombin Time/International
Normalized Ratio
PY—Performance year
QA—Quality Assessment
QC—Quality Control
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
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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 proposed rule are
available through the Internet on the
CMS Web site at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFSFederal-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 2017 PFS
Proposed Rule, refer to item CMS–1654–
P. 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 Jessica
Bruton at (410) 786–5991.
CPT (Current Procedural Terminology)
Copyright Notice
Throughout this proposed rule, we
use CPT codes and descriptions to refer
to a variety of services. We note that
CPT codes and descriptions are
copyright 2015 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 proposed rule proposes to
revise payment polices under the
Medicare Physician Fee Schedule (PFS)
and make other policy changes related
to Medicare Part B payment. These
changes would be applicable to services
furnished in CY 2017. In addition, this
proposed rule includes proposals
related to: the Medicare Shared Savings
Program and release of pricing data
submitted to CMS by Medicare
Advantage (MA) organizations; and
medical loss ratio reports submitted by
MA plans and Part D plans. These
additional proposals are addressed in
section III. of this proposed rule.
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2. Summary of the Major Provisions
The statute 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 statute 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 paid under the PFS,
incorporating geographic adjustments to
reflect the variations in the costs of
furnishing services in different
geographic areas. In this major proposed
rule, we are proposing to establish RVUs
for CY 2017 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 proposed rule
includes discussions and proposals
regarding:
• Potentially Misvalued PFS Codes.
• Telehealth Services.
• Establishing Values for New, Revised,
and Misvalued Codes.
• Target for Relative Value Adjustments
for Misvalued Services.
• Phase-in of Significant RVU Reductions.
• Chronic Care Management (CCM) and
Transitional Care Management (TCM)
Supervision Requirements in Rural Health
Clinics (RHCs) and Federally Qualified
Health Centers (FQHCs).
• FQHC-Specific Market Basket.
• Appropriate Use Criteria for Advanced
Diagnostic Imaging Services.
• Reports of Payments or Other Transfers
of Value to Covered Recipients: Solicitation
of Public Comments.
• Release of Part C Medicare Advantage
Bid Pricing Data and Part C and Part D
Medical Loss Ratio (MLR) Data.
• Prohibition on Billing Qualified
Medicare Beneficiary Individuals for
Medicare Cost-Sharing.
• Recoupment or Offset of Payments to
Providers Sharing the Same Taxpayer
Identification Number.
• Accountable Care Organization (ACO)
Participants Who Report Physician Quality
Reporting System (PQRS) Quality Measures
Separately.
• Medicare Advantage Provider
Enrollment.
• Proposed Expansion of the Diabetes
Prevention Program (DPP) Model.
• Medicare Shared Savings Program.
• Value-Based Payment Modifier and the
Physician Feedback Program.
• Physician Self-referral Updates.
3. Summary of Costs and Benefits
The statute requires that annual
adjustments to PFS RVUs may not cause
annual estimated expenditures to differ
by more than $20 million from what
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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 changes
proposed in this proposed rule would
affect the specialty distribution of
Medicare expenditures. When
considering the combined impact of
proposed work, PE, and MP RVU
changes, the projected payment impacts
would be small for most specialties;
however, the impact would be larger for
a few specialties.
We have determined that this major
proposed rule is economically
significant. For a detailed discussion of
the economic impacts, see section VI. of
this proposed rule.
B. Background
Since January 1, 1992, Medicare has
paid for physicians’ services under
section 1848 of the Social Security Act
(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 major
proposed rule, 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
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
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
cooperative agreement with the
Department of Health and Human
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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. 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.
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
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46165
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 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
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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.
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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.B.2. of this
proposed rule.
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.
In addition to the five-year reviews,
beginning for CY 2009, CMS and the
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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
proposed rule, in accordance with
section 1848(c)(2)(B)(ii)(II) of the Act, if
revisions to the RVUs cause
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
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
work, PE, and MP in an area compared
to the national average costs for each
component.
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 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.
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 ensure
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
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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
Section 220(d) of the Protecting
Access to Medicare Act of 2014 (Pub. L.
113–93, enacted on April 1, 2014)
(PAMA) added a new subparagraph (O)
to section 1848(c)(2) of the Act to
establish an annual target for reductions
in PFS expenditures resulting from
adjustments to relative values of
misvalued codes. If the estimated net
reduction in expenditures for a year is
equal to or greater than the target for
that year, the provision specifies that
reduced expenditures attributable to
such adjustments shall be redistributed
in a budget-neutral manner within the
PFS. The provision specifies that the
amount by which such reduced
expenditures exceed the target for a
given year shall be treated as a
reduction in expenditures for the
subsequent year for purposes of
determining whether the target for the
subsequent year has been met. The
provision also specifies that an amount
equal to the difference between the
target and the estimated net reduction in
expenditures, called the target recapture
amount, shall not be taken into account
when applying the budget neutrality
requirements specified in section
1848(c)(2)(B)(ii)(II) of the Act. The
PAMA amendments originally made the
target provisions applicable for CYs
2017 through 2020 and set the target for
reduced expenditures at 0.5 percent of
estimated expenditures under the PFS
for each of those 4 years.
Subsequently, section 202 of the
Achieving a Better Life Experience Act
of 2014 (Division B of Pub. L. 113–295,
enacted December 19, 2014) (ABLE)
accelerated the application of the target,
amending section 1848(c)(2)(O) of the
Act to specify that target provisions
apply for CYs 2016, 2017, and 2018; and
setting a 1 percent target for reduced
expenditures for CY 2016 and a 0.5
percent target for CYs 2017 and 2018.
The implementation of the target
legislation was finalized in the CY 2016
PFS final rule with comment period,
and proposed revisions are discussed in
section II.G. of this proposed rule.
Section 1848(c)(7) of the Act, as
added by section 220(e) of the PAMA,
specified that for services that are not
new or revised codes, if the total RVUs
for a service for a year would otherwise
be decreased by an estimated 20 percent
or more as compared to the total RVUs
for the previous year, the applicable
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adjustments in work, PE, and MP RVUs
shall be phased in over a 2-year period.
Section 220(e) of the PAMA required
the phase-in of RVU reductions of 20
percent or more to begin for 2017.
Section 1848(c)(7) of the Act was later
amended by section 202 of the ABLE
Act to require instead that the phase-in
must begin in CY 2016. The
implementation of the phase-in
legislation was finalized in the CY 2016
PFS final rule with comment period and
proposed revisions in this year’s
rulemaking are discussed in section
II.H. of this proposed rule.
II. Provisions of the Proposed Rule for
PFS
A. Determination of 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
physicians’ 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.
2. Practice Expense Methodology
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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
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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
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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 Medicare Economic Index
(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
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). We have incorporated the
available utilization data for
interventional cardiology, which
became a recognized Medicare specialty
during 2014. We finalized the use of a
proxy PE/HR value for interventional
cardiology in the CY 2016 final rule
with comment period (80 FR 70892), as
there are no PPIS data for this specialty,
by crosswalking the PE/HR for from
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Cardiology, since the specialties furnish
similar services in the Medicare claims
data.
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.
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(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 proposed rule
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
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 used 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.
That is, 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 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 added the greater of the
work RVUs or clinical labor portion of
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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 incorporated 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.
(3) 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. 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.
For this reason, 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.
(4) Services With Technical
Components (TCs) and Professional
Components (PCs)
Diagnostic services are generally
composed 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
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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.)
(5) 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). We also direct interested readers
to the file called ‘‘Calculation of PE
RVUs under Methodology for Selected
Codes’’ which is available on our Web
site under downloads for the CY 2017
PFS proposed rule at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-Notices.html. This file
contains a table that illustrates the
calculation of PE RVUs as described
below for individual PFS codes.
(a) 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.
(b) 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.
Step 2: Calculate the aggregate pool of
direct PE costs for the current year. We
set the aggregate pool of PE costs equal
to the product of the ratio of the current
aggregate PE RVUs to current aggregate
work RVUs and the proposed aggregate
work RVUs.
Step 3: Calculate the aggregate pool of
direct PE costs for use in ratesetting.
This is the product of the aggregate
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
factor 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
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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.
(c) 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.
We use an average of the 3 most
recent years of available Medicare
claims data to determine the specialty
mix assigned to each code. As we stated
in the CY 2016 final rule with comment
period (80 FR 70894), we believe that
the 3-year average will mitigate the need
to use dominant or expected specialty
instead of the claims data. Because we
are incorporating CY 2015 claims data
for use in the CY 2017 proposed rates,
we believe that the proposed PE RVUs
associated with the CY 2017 PFS
proposed rule provide a first
opportunity to determine whether
service-level overrides of claims data are
necessary. Currently, in the
development of PE RVUs we apply only
the overrides that also apply to the MP
RVU calculation. Since the proposed PE
RVUs include a new year of claims into
the 3 year average for the first time, we
are seeking comment on the proposed
CY 2017 PFS rates and whether or not
the incorporation of a new year of
utilization data into a three year average
mitigates the need for alternative
service-level overrides such as a claimsbased approach (dominant specialty) or
stakeholder-recommended approach
(expected specialty) in the development
of PE (and MP) RVUs for low-volume
codes. Prior year RVUs are available at
several locations on the PFS Web site
located at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/.
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 labor PE RVUs; and
the work RVUs.
For most services the indirect
allocator is: Indirect PE percentage *
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(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 the download file called
‘‘Calculation of PE RVUs under
Methodology for Selected Codes’’, 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
the result of step 8 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
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46169
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.
(d) Calculate the Final PE RVUs
Step 18: Add the direct PE RVUs from
Step 5 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 sum of steps 5 and 17 of
to the proposed aggregate work RVUs
scaled by the ratio of current aggregate
PE and work RVUs. This adjustment
ensures that all PE RVUs in the PFS
account for the fact that certain
specialties are excluded from the
calculation of PE RVUs but included in
maintaining overall PFS budget
neutrality. (See ‘‘Specialties excluded
from ratesetting calculation’’ later in
this section.)
(e) 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.
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TABLE 1—SPECIALTIES EXCLUDED FROM RATESETTING CALCULATION
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
relatively low PFS utilization to the
associated specialties.
• Physical therapy utilization:
Crosswalk the utilization associated
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
Description
Volume adjustment
80, 81, 82 ....................
AS ...............................
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
Modifier
16% .....................................................
14% (85% * 16%) ...............................
or LT and RT .........
................................
................................
................................
................................
Assistant at Surgery ............................
Assistant at Surgery—Physician Assistant.
Bilateral Surgery .................................
Multiple Procedure ..............................
Reduced Services ...............................
Discontinued Procedure ......................
Intraoperative Care only .....................
55 ................................
Postoperative Care only .....................
50
51
52
53
54
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Time adjustment
Intraoperative portion.
Intraoperative portion.
150% ................................................... 150% of work time.
50% ..................................................... Intraoperative portion.
50% ..................................................... 50%.
50% ..................................................... 50%.
Preoperative + Intraoperative Percent- Preoperative + Intraoperative portion.
ages on the payment files used by
Medicare contractors to process
Medicare claims.
Postoperative Percentage on the pay- Postoperative portion.
ment files used by Medicare contractors to process Medicare claims.
Fmt 4701
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46171
TABLE 2—APPLICATION OF PAYMENT MODIFIERS TO UTILIZATION FILES—Continued
Modifier
Description
Volume adjustment
62 ................................
66 ................................
Co-surgeons ........................................
Team Surgeons ..................................
62.5% ..................................................
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
(MPPRs). 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 we
use the average allowed charge when
simulating RVUs; therefore, the RVUs as
calculated already reflect the payments
as adjusted by modifiers, and no volume
adjustments are necessary. However, a
time adjustment of 33 percent is made
only for medical direction of two to four
cases since that is the only situation
where a single practitioner is involved
with multiple beneficiaries
concurrently, so that counting each
service without regard to the overlap
with other services would overstate the
amount of time spent by the practitioner
furnishing these services.
• Work RVUs: The setup file contains
the work RVUs from this proposed rule.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
(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)
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.
Stakeholders have often suggested
that particular equipment items are used
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less frequently than 50 percent of the
time in the typical setting and that CMS
should reduce the equipment utilization
rate based on these recommendations.
We appreciate and share stakeholders’
interest in using the most accurate
assumption regarding the equipment
utilization rate for particular equipment
items. However, we believe that absent
robust, objective, auditable data
regarding the use of particular items, the
50 percent assumption is the most
appropriate within the relative value
system. We welcome the submission of
data that illustrates an alternative rate.
Maintenance: This factor for
maintenance was proposed and
finalized during rulemaking for CY 1998
PFS (62 FR 33164).
We continue to investigate potential
avenues for determining equipment
maintenance costs across a broad range
of equipment items.
Interest Rate: In the CY 2013 PFS final
rule with comment period (77 FR
68902), we updated the interest rates
used in 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.) We
are not proposing any changes to these
interest rates for CY 2017.
Time adjustment
50%.
33%.
PhysicianFeeSched/PFS-FederalRegulation-Notices.html.
(1) PE Inputs for Digital Imaging
Services
Prior to the CY 2015 PFS rulemaking
cycle, the RUC provided a
recommendation regarding the PE
inputs for digital imaging services.
Specifically, the RUC recommended
that we remove supply and equipment
items associated with film technology
from a previously specified list of codes
since these items were no longer typical
resource inputs. The RUC also
recommended that the Picture
Archiving and Communication System
(PACS) equipment be included for these
imaging services since these items had
been become typically used in
furnishing imaging services. However,
since we did not receive any invoices
for the PACS system prior to that year’s
proposed rule, we were unable to
determine the appropriate pricing to use
for the inputs. For CY 2015, we
finalized our proposal to remove the
film supply and equipment items, and
to create a new equipment item as a
proxy for the PACS workstation as a
direct expense (79 FR 67561–67563).
We used the price associated with
ED021 (computer, desktop, w-monitor)
to price the new item, ED050 (PACS
Workstation Proxy), pending receipt of
invoices to facilitate pricing specific to
the PACS workstation. Subsequent to
establishing payment rates for CY 2015,
we received information from several
TABLE 3—SBA MAXIMUM INTEREST
stakeholders regarding pricing for items
RATES
related to the digital acquisition and
Useful life Interest rate storage of images. We received invoices
Price
from one stakeholder that facilitated a
(years)
(%)
proposed price update for the PACS
<$25K ...................
<7
7.50 workstation in the CY 2016 PFS
$25K to $50K ........
<7
6.50 proposed rule, and we updated the price
>$50K ...................
<7
5.50 for the PACS workstation to $5,557 in
<$25K ...................
7+
8.00 the CY 2016 PFS final rule with
$25K to $50K ........
7+
7.00
comment period (80 FR 70899).
>$50K ...................
7+
6.00
In addition to the workstation used by
the clinical staff acquiring the images
d. Proposed Changes to Direct PE Inputs
and furnishing the TC of the services, a
for Specific Services
stakeholder also submitted more
This section focuses on specific PE
detailed information regarding a
inputs. The direct PE inputs are
workstation used by the practitioner
included in the CY 2017 direct PE input interpreting the image in furnishing the
database, which is available on our Web PC of many of these services.
site under downloads for the CY 2017
As we stated in the CY 2015 PFS final
PFS proposed rule at https://
rule with comment period (79 FR
www.cms.gov/Medicare/Medicare-Fee67563), we generally believe that
for-Service-Payment/
workstations used by these practitioners
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Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
are more accurately considered indirect
costs associated with the PC of the
service. However, we understand that
the professional workstations for
interpretation of digital images are
similar in principle to some of the
previous film inputs incorporated into
the global and technical components of
the codes, such as the view box
equipment. Given that the majority of
these services are reported globally in
the nonfacility setting, we believe it is
appropriate to include these costs as
direct inputs for the associated HCPCS
codes. Based on our established
methodology in which single codes with
professional and technical components
are constructed by assigning work RVUs
exclusively to the professional
component and direct PE inputs
exclusively to the technical
components, these costs would be
incorporated into the PE RVUs of the
global and technical component of the
HCPCS code.
We stated in the CY 2016 PFS final
rule with comment period that the costs
of the professional workstation may be
analogous to costs related to the use of
film previously incorporated as direct
PE inputs for these services. We also
solicited comments on whether
including the professional workstation
as a direct PE input for these codes
would be appropriate, given that the
resulting PE RVUs would be assigned to
the global and technical components of
the codes. Commenters responded by
indicating their approval of the concept
of a professional PACS workstation used
for interpretation of digital images. We
received invoices for the pricing of a
professional PACS workstation, as well
as additional invoices for the pricing of
a mammography-specific version of the
professional PACS workstation. The
RUC also included these new
equipment items in its
recommendations for the CY 2017 PFS
rulemaking cycle.
Based on our analysis of submitted
invoices, we are proposing to price the
professional PACS workstation (ED053)
at $14,616.93. We are not proposing a
change in price for the current technical
PACS workstation (ED050), which will
remain at a price of $5,557.00.
The price of the professional PACS
workstation is based upon individual
invoices submitted for the cost of a PC
Tower ($1531.52), a pair of 3 MP
monitors ($10,500.00 in total), a
keyboard and mouse ($84.95), a UPS
power backup devices for TNP
($1098.00), and a switch for PACS
monitors/workstations ($1402.46).
We are proposing to add the
professional PACS workstation to many
CPT codes in the 70000 series that use
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the current technical PACS workstation
(ED050) and include professional work
for which such a workstation would be
used. We are not proposing to add the
equipment item to add-on codes since
the base codes would include minutes
for the item. We are also not proposing
to add the item to codes that are
therapeutic in nature, as the
professional PACS workstation is
intended for use in diagnostic services.
We are therefore not proposing to add
the item to codes in the Radiation
Therapy section (77261 through 77799)
or the Nuclear Medicine Cardiology
section (78414–78499). We also are not
proposing to add the item to image
guidance codes where the dominant
provider is not a radiologist (77002,
77011, 77071, 77077, and 77081)
according to the most recent year of
claims data, since we believe a single
workstation would be more typical in
those cases. We have identified
approximately 426 codes to which we
are proposing to add a professional
PACS workstation. Please see Table 4
for the full list of affected codes.
For the professional PACS
workstation, we are proposing to assign
equipment time equal to the intraservice
work time plus half of the preservice
work time associated with the codes,
since the work time generally reflects
the time associated with the
professional interpretation. We are
proposing half of the preservice work
time for the professional PACS
workstation, as we do not believe that
the practitioner would typically spend
all of the preservice work period using
the equipment. For older codes that do
not have a breakdown of physician work
time by service period, and only have an
overall physician work time, we are
proposing to use half the total work time
as an approximation of the intraservice
work time plus one half of the
preservice work time. In our review of
services that contained an existing
PACS workstation and had a breakdown
of physician work time, we found that
half of the total time was a reasonable
approximation for the value of
intraservice work time plus one half of
preservice work time where no such
breakdown existed. We also considered
using an equipment time formula of the
physician intraservice time plus 1
minute (as a stand-in for the physician
preservice work time). We are seeking
public comment on the most accurate
equipment time formula for the
professional PACS workstation.
We are seeking public comment on
the proposed list of codes that would
incorporate either the professional
PACS workstation. We are interested in
public comment on the codes for which
PO 00000
Frm 00012
Fmt 4701
Sfmt 4702
a professional PACS workstation should
be included, and whether one of these
professional workstations should be
included for codes outside the 70000
series. In cases within the 70000 series
where radiologists are not the typical
specialty reporting the code, such as
CPT codes 77002 and 77011, we are
asking whether it would be appropriate
to add one of the professional PACS
workstations to these services.
TABLE 4—CODES WITH PROFESSIONAL
PACS WORKSTATION IN THE PROPOSED DIRECT PE INPUT DATABASE
HCPCS
70015
70030
70100
70110
70120
70130
70134
70140
70150
70160
70190
70200
70210
70220
70240
70250
70260
70300
70310
70320
70328
70330
70332
70336
70350
70355
70360
70370
70371
70380
70390
70450
70460
70470
70480
70481
70482
70490
70491
70492
70540
70542
70543
70544
70545
70546
70547
70548
70549
70551
70552
70553
70554
71010
71015
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15JYP2
ED053
minutes
12
3
3
4
3
4
4
3
4
3
3
4
3
4
3
4
7
2
3
3
3
22
6
20
3
5
3
4
9
3
5
12
15
18
13
13
14
13
13
14
14
19
19
13
18
18
13
20
25
21
23
28
43
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Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
46173
TABLE 4—CODES WITH PROFESSIONAL TABLE 4—CODES WITH PROFESSIONAL TABLE 4—CODES WITH PROFESSIONAL
PACS WORKSTATION IN THE PROPACS WORKSTATION IN THE PROPACS WORKSTATION IN THE PROPOSED DIRECT PE INPUT DATAPOSED DIRECT PE INPUT DATAPOSED DIRECT PE INPUT DATABASE—Continued
BASE—Continued
BASE—Continued
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
HCPCS
71020
71021
71022
71023
71030
71034
71035
71100
71101
71110
71111
71120
71130
71250
71260
71270
71275
71550
71551
71552
71555
72020
72040
72050
72052
72070
72072
72074
72080
72081
72082
72083
72084
72100
72110
72114
72120
72125
72126
72127
72128
72129
72130
72131
72132
72133
72141
72142
72146
72147
72148
72149
72156
72157
72158
72159
72170
72190
72191
72192
72193
72194
72195
72196
72197
72198
72200
ED053
minutes
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4
4
5
4
5
3
5
4
4
5
3
3
18
17
13
28
15
30
28
33
3
4
6
6
4
3
3
3
6
7
8
9
4
6
6
4
18
12
12
18
12
12
18
12
12
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23
26
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26
28
28
28
31
5
3
28
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12
12
30
26
30
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ED053
minutes
HCPCS
72202
72220
72240
72255
72265
72270
72275
72285
72295
73000
73010
73020
73030
73040
73050
73060
73070
73080
73085
73090
73092
73100
73110
73115
73120
73130
73140
73200
73201
73202
73206
73218
73219
73220
73221
73222
73223
73225
73501
73502
73503
73521
73522
73523
73525
73551
73552
73560
73564
73565
73580
73590
73592
73600
73610
73615
73620
73630
73650
73660
73700
73701
73702
73706
73718
73719
73720
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3
3
19
18
18
23
36
9
9
3
3
3
5
6
3
4
3
4
6
3
3
4
4
6
4
4
3
18
11
12
35
25
25
30
23
23
35
31
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5
6
5
6
7
6
4
5
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6
4
6
4
3
4
4
6
4
4
3
3
18
11
12
35
20
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30
73721
73722
73723
73725
74000
74010
74020
74022
74150
74160
74170
74174
74175
74176
74177
74178
74181
74182
74183
74185
74210
74220
74230
74240
74241
74245
74246
74247
74249
74250
74251
74260
74261
74262
74263
74270
74280
74283
74290
74400
74410
74415
74430
74440
74455
74485
74710
74712
74740
75557
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minutes
23
24
32
33
4
3
4
4
14
17
21
33
28
25
28
33
15
28
35
33
5
5
12
7
7
9
7
18
9
5
33
6
43
48
42
7
23
19
4
18
6
6
4
5
4
6
4
68
5
45
58
50
66
13
25
38
35
6
11
11
13
50
13
20
11
13
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TABLE 4—CODES WITH PROFESSIONAL TABLE 4—CODES WITH PROFESSIONAL TABLE 4—CODES WITH PROFESSIONAL
PACS WORKSTATION IN THE PROPACS WORKSTATION IN THE PROPACS WORKSTATION IN THE PROPOSED DIRECT PE INPUT DATAPOSED DIRECT PE INPUT DATAPOSED DIRECT PE INPUT DATABASE—Continued
BASE—Continued
BASE—Continued
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
HCPCS
75731
75733
75736
75741
75743
75746
75756
75791
75809
75820
75822
75825
75827
75831
75833
75840
75842
75860
75870
75872
75880
75885
75887
75889
75891
75893
75901
75902
75962
75966
75978
75984
75989
76000
76010
76080
76098
76100
76101
76102
76120
76376
76380
76390
76506
76536
76604
76700
76705
76770
76775
76776
76800
76801
76805
76811
76813
76815
76816
76817
76818
76819
76820
76821
76825
76826
76830
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minutes
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(2) Standardization of Clinical Labor
Tasks
As we noted in the CY 2015 PFS rule
(79 FR 67640–67641), we continue to
work on revisions to the direct PE input
database to provide the number of
clinical labor minutes assigned for each
task for every code in the database
instead of only including the number of
clinical labor minutes for the preservice,
service, and postservice periods for each
code. In addition to increasing the
transparency of the information used to
set PE RVUs, this improvement would
allow us to compare clinical labor times
for activities associated with services
across the PFS, which we believe is
important to maintaining the relativity
of the direct PE inputs. This information
would facilitate the identification of the
usual numbers of minutes for clinical
labor tasks and the identification of
exceptions to the usual values. It would
also allow for greater transparency and
consistency in the assignment of
equipment minutes based on clinical
labor times. Finally, we believe that the
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information can be useful in
maintaining standard times for
particular clinical labor tasks that can be
applied consistently to many codes as
they are valued over several years,
similar in principle to the use of
physician preservice time packages. We
believe such standards would provide
greater consistency among codes that
share the same clinical labor tasks and
could improve relativity of values
among codes. For example, as medical
practice and technologies change over
time, changes in the standards could be
updated at once for all codes with the
applicable clinical labor tasks, instead
of waiting for individual codes to be
reviewed.
In the following paragraphs, we
address a series of issues related to
clinical labor tasks, particularly relevant
to services currently being reviewed
under the misvalued code initiative.
(a) Clinical Labor Tasks Associated With
Digital Imaging
In the CY 2015 PFS rule, we noted
that the RUC recommendation regarding
inputs for digital imaging services
indicated that, as each code is reviewed
under the misvalued code initiative, the
clinical labor tasks associated with
digital technology (instead of film)
would need to be addressed. When we
reviewed that recommendation, we did
not have the capability of assigning
standard clinical labor times for the
hundreds of individual codes since the
direct PE input database did not
previously allow for comprehensive
adjustments for clinical labor times
based on particular clinical labor tasks.
Therefore, consistent with the
recommendation, we proposed to
remove film-based supply and
equipment items but maintain clinical
labor minutes that were assigned based
on film technology.
As noted in the paragraphs above, we
continue to improve the direct PE input
database by specifying for each code the
46175
minutes associated with each clinical
labor task. Once completed, this work
would allow adjustments to be made to
minutes assigned to particular clinical
labor tasks related to digital technology
that occur in multiple codes, consistent
with the changes that were made to
individual supply and equipment items.
In the meantime, we believe it would be
appropriate to establish standard times
for clinical labor tasks associated with
all digital imaging services for purposes
of reviewing individual services at
present, and for possible broad-based
standardization once the changes to the
direct PE input database facilitate our
ability to adjust time across services.
During the CY 2016 PFS rulemaking
cycle, we proposed appropriate
standard minutes for five different
clinical labor tasks associated with
services that use digital imaging
technology. In the CY 2016 PFS final
rule with comment period (80 FR
70901), we finalized appropriate
standard minutes for four of those five
activities, which are listed in Table 5.
TABLE 5—CLINICAL LABOR TASKS ASSOCIATED WITH DIGITAL IMAGING TECHNOLOGY
Typical
minutes
Clinical labor task
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
Availability of prior images confirmed ......................................................................................................................................................
Patient clinical information and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by
radiologist .............................................................................................................................................................................................
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 ............................................................................................................................................................................
We did not finalize standard minutes
for the activity ‘‘Technologist QC’s
images in PACS, checking for all
images, reformats, and dose page.’’ We
agreed with commenters that this task
may require a variable length of time
depending on the number of images to
be reviewed. We stated that it may be
appropriate to establish several different
standard times for this clinical labor
task for a low/medium/high quantity of
images to be reviewed, in the same
fashion that the clinical labor assigned
to clean a surgical instrument package
has two different standard times
depending on the use of a basic pack (10
minutes) or a medium pack (30
minutes). We solicited public comment
and feedback on this subject, with the
anticipation of including a proposal in
the CY 2017 proposed rule.
We received many comments
suggesting that this clinical labor
activity should not have a standard time
value. Commenters stated that the
number of minutes varies significantly
for different imaging modalities; and the
time is not simply based on the quantity
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of images to be reviewed, but also the
complexity of the images. The
commenters recommended that time for
this clinical labor activity should be
assigned on a code by code basis. We
agree with the commenters that the
amount of clinical labor needed to
check images in a PACS workstation
may vary depending on the service.
However, we do not believe that this
precludes the possibility of establishing
standards for clinical labor tasks as we
have done in the past by creating
multiple standard times, for example,
those assigned to cleaning different
kinds of scopes. We continue to believe
that the use of clinical labor standards
provides greater consistency among
codes that share the same clinical labor
tasks and can improve relativity of
values among codes. We are proposing
to establish a range of appropriate
standard minutes for the clinical labor
activity Technologist QCs images in
PACS, checking for all images,
reformats, and dose page. These
standard minutes will be applied to new
and revised codes that make use of this
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clinical labor activity when they are
reviewed by us for valuation. We are
proposing 2 minutes as the standard for
the simple case, 3 minutes as the
standard for the intermediate case, and
4 minutes as the standard for the
complex case. We are proposing the
simple case of 2 minutes as the standard
for the typical procedure code involving
routine use of imaging. These values are
based upon a review of the existing
minutes assigned for this clinical labor
activity; we have determined that 2
minutes is the duration for most
services and a small number of codes
with more complex forms of digital
imaging have higher values. We are
proposing to use 2 minutes for services
involving routine x-rays (simple), 3
minutes for services involving CTs and
MRIs (intermediate), and 4 minutes for
the most highly complex services which
would exceed these more typical cases.
We are soliciting comments regarding
the most accurate category—simple,
intermediate, or complex for existing
codes, and in particular what criteria
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might be used to identify complex cases
systematically.
(b) Pathology Clinical Labor Tasks
As with the clinical labor tasks
associated with digital imaging, many of
the currently assigned times for the
specialized clinical labor tasks
associated with pathology services are
not consistent across codes. In
reviewing past RUC recommendations
for pathology services, we have not
identified information that supports the
judgment that the same tasks take
significantly more or less time
depending on the individual service for
which they are performed, especially
given the high degree of specificity with
which the tasks are described. We
continue to believe that, in general, a
clinical labor task will tend to take the
same amount of time to perform as the
same clinical labor task when it is
performed in a clinically similar service.
Therefore, we developed standard
times for clinical labor tasks that we
have used in finalizing direct PE inputs
in recent years, starting in the CY 2012
PFS final rule with comment period (76
FR 73213). These times were based on
our review and assessment of the
current times included for these clinical
labor tasks in the direct PE input
database. We proposed in the CY 2016
PFS proposed rule to establish standard
times for a list of 17 clinical labor tasks
related to pathology services, and
solicited public feedback regarding our
proposed standards. Many commenters
stated in response to our proposal that
they did not support the standardization
of clinical labor activities across
pathology services. Commenters stated
that establishing a single standard time
for each clinical labor task was
infeasible due to the differences in batch
size or number of blocks across different
pathology procedures. Several
commenters indicated that it might be
possible to standardize across codes
with the same batch sizes, and urged us
to consider pathology-specific details,
such as batch size and block number, in
the creation of any future standard times
for clinical labor tasks related to
pathology services.
As we stated in the CY 2016 PFS
proposed rule, we developed the
proposed standard times based on our
review and assessment of the current
times included for these clinical labor
tasks in the direct PE input database.
We believe that, generally speaking,
clinical labor tasks with the same
description are comparable across
different pathology procedures. We
believe this to be true based on the
comparability of clinical labor tasks in
non-pathology services, as well as the
high degree of specificity with which
most pathology tasks are described
relative to clinical labor tasks associated
with other PFS services. We concurred
with commenters that accurate clinical
labor times for pathology codes may be
dependent on the number of blocks or
batch size typically used for each
individual service. However, we also
believe that it is appropriate and
feasible to establish ‘‘per block’’
standards or standards varied by batch
size assumptions for many clinical labor
activities that would be comparable
across a wide range of individual
services. We have received detailed
information regarding batch size and
number of blocks during review of
individual pathology services on an
intermittent basis in the past. We
requested regular submission of these
details on the PE worksheets supplied
by the RUC as part of the review process
for pathology services, as a means to
assist in the determination of the most
accurate direct PE inputs.
We also stated our belief that many of
the clinical labor activities for which we
proposed to establish standard times
were tasks that do not depend on
number of blocks or batch size. Clinical
labor activities such as ‘‘Clean room/
equipment following procedure’’ and
‘‘Dispose of remaining specimens’’
would typically remain standard across
different services without varying by
block number or batch size, with the
understanding that additional time may
be required above the standard value for
a clinical labor task that is part of an
unusually complex or difficult service.
As a result, we ultimately finalized
standard times for 6 of the 17 proposed
clinical labor activities in the CY 2016
final rule with comment period (80 FR
70902). We have listed the finalized
standard times in Table 6. We are
currently proposing no further action on
the remaining 11 clinical labor activities
pending further action by the RUC (see
below).
TABLE 6—STANDARD TIMES FOR CLINICAL LABOR TASKS ASSOCIATED WITH PATHOLOGY SERVICES
Standard clinical
labor time
(minutes)
Clinical labor task
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
Accession specimen/prepare for examination ...............................................................................................................................
Assemble and deliver slides with paperwork to pathologists ........................................................................................................
Assemble other light microscopy slides, open nerve biopsy slides, and clinical history, and present to pathologist to prepare
clinical pathologic interpretation .................................................................................................................................................
Clean room/equipment following procedure (including any equipment maintenance that must be done after the procedure) ...
Dispose of remaining specimens, spent chemicals/other consumables, and hazardous waste ..................................................
Prepare, pack and transport specimens and records for in-house storage and external storage (where applicable) ................
We remain committed to the process
of establishing standard clinical labor
times for tasks associated with
pathology services. This may include
establishing standards on a per-block or
per-batch basis, as we indicated during
the previous rulemaking cycle.
However, we are aware that the PE
Subcommittee of the RUC is currently
working to standardize the pathology
clinical labor activities they use in
making their recommendations. We
believe the RUC’s efforts to narrow the
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19:43 Jul 14, 2016
Jkt 238001
current list of several hundred
pathology clinical labor tasks to a more
manageable number through the
consolidation of duplicative or highly
similar activities into a single
description may serve PFS relativity and
facilitate greater transparency in PFS
ratesetting. We also believe that the
RUC’s standardization of pathology
clinical labor tasks would facilitate our
capacity to establish standard times for
pathology clinical labor tasks in future
rulemaking. Therefore, we are not
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proposing any additional change to
clinical labor tasks associated with
pathology services at this time.
(3) Equipment Recommendations for
Scope Systems
During our routine reviews of direct
PE input recommendations, we have
regularly found unexplained
inconsistencies involving the use of
scopes and the video systems associated
with them. Some of the scopes include
video systems bundled into the
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equipment item, some of them include
scope accessories as part of their price,
and some of them are standalone scopes
with no other equipment included. It is
not always clear which equipment items
related to scopes fall into which of these
categories. We have also frequently
found anomalies in the equipment
recommendations, with equipment
items that consist of a scope and video
system bundle recommended along with
a separate scope video system. Based on
our review, the variations do not appear
to be consistent with the different code
descriptions.
To promote appropriate relativity
among the services and facilitate the
transparency of our review process,
during review of recommended direct
PE inputs for the CY 2017 PFS proposed
rule, we developed a structure that
separates the scope and the associated
video system as distinct equipment
items for each code. Under this
approach, we are proposing standalone
prices for each scope, and separate
prices for the video systems that are
used with scopes. We would define the
scope video system as including: (1) A
monitor; (2) a processor; (3) a form of
digital capture; (4) a cart; and (5) a
printer. We believe that these
equipment components represent the
typical case for a scope video system.
Our model for this system is the ‘‘video
system, endoscopy (processor, digital
capture, monitor, printer, cart)’’
equipment item (ES031), which we are
proposing to re-price as part of this
separate pricing approach. We obtained
current pricing invoices for the
endoscopy video system as part of our
investigation of these issues involving
scopes, which we are proposing to use
for this re-pricing. We understand that
there may be other accessories
associated with the use of scopes; we
are proposing to separately price any
scope accessories, and individually
evaluate their inclusion or exclusion as
direct PE inputs for particular codes as
usual under our current policy based on
whether they are typically used in
furnishing the services described by the
particular codes.
We are also proposing standardizing
refinements to the way scopes have
been defined in the direct PE input
database. We believe that there are four
general types of scopes: Non-video
scopes; flexible scopes; semi-rigid
scopes, and rigid scopes. Flexible
scopes, semi-rigid scopes, and rigid
scopes would typically be paired with
one of the video scope systems, while
the non-video scopes would not. The
flexible scopes can be further divided
into diagnostic (or non-channeled) and
therapeutic (or channeled) scopes. We
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19:43 Jul 14, 2016
Jkt 238001
are proposing to identify for each
anatomical application: (1) A rigid
scope; (2) a semi-rigid scope; (3) a nonvideo flexible scope; (4) a nonchanneled flexible video scope; and (5)
a channeled flexible video scope. We
are proposing to classify the existing
scopes in our direct PE database under
this classification system, to improve
the transparency of our review process
and improve appropriate relativity
among the services. We plan to propose
input prices for these equipment items
through future rulemaking.
We have proposed these changes only
for the reviewed codes that make use of
scopes; this applies to the codes in the
Flexible Laryngoscopy family (CPT
codes 31575, 31576, 31577, 31578,
315X1, 315X2, 315X3, 31579) (see
section II.L) and the Laryngoplasty
family (CPT codes 31580, 31584, 31587,
315Y1, 315Y2, 315Y3, 315Y4, 315Y5,
315Y6) (see section II.L) along with
updated prices for the equipment items
related to scopes utilized by these
services. We are also soliciting comment
on this separate pricing structure for
scopes, scope video systems, and scope
accessories, which we could consider
proposing to apply to other PFS codes
in future rulemaking.
(4) Technical Corrections to Direct PE
Input Database
Subsequent to the publication of the
CY 2016 PFS final rule with comment
period, stakeholders alerted us to
several clerical inconsistencies in the
direct PE database. We propose to
correct these inconsistencies as
described below and reflected in the CY
2017 direct PE input database displayed
on our Web site under downloads for
the CY 2017 PFS proposed rule at
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-Notices.html.
For CY 2017, we are proposing the
following technical corrections:
• For CPT codes 72081–72084, a
stakeholder informed us that the
equipment time for the PACS
workstation (ED050) should be equal to
the clinical labor during the service
period; the equipment time formula we
used for these codes for CY 2016
erroneously included 4 minutes of
preservice clinical labor. We agree with
the stakeholder that the PACS
workstation should use the standard
equipment time formula for a PACS
workstation for these codes. As a result,
we are proposing to refine the ED050
equipment time to 21 minutes for CPT
code 72081, 36 minutes for CPT code
72082, 44 minutes for CPT code 72083,
and 53 minutes for CPT code 72084 to
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46177
reflect the clinical labor time associated
with these codes. This same commenter
also indicated that a number of clinical
labor activities had been entered in the
database in the incorrect service period
for CPT codes 37215, 50432, 50694, and
72081. These clinical labor activities
were incorrectly listed in the
‘‘postservice’’ period instead of the
‘‘service post’’ period. We are proposing
to make these technical corrections as
well so that the minutes are assigned to
the appropriate service period within
the direct PE input database.
• Another stakeholder alerted us that
Ileoscopy codes 44380, 44381 and
44382 did not include the direct PE
input equipment item called the Gomco
suction machine (EQ235) and indicated
that this omission appeared to be
inadvertent. We agree that it was. We
have included the item EQ235 in the
proposed direct PE input database for
CPT code 44380 at a time of 29 minutes,
for CPT code 44381 at a time of 39
minutes, and to CPT code 44382 at a
time of 34 minutes.
The PE RVUs displayed in Addendum
B on our Web site were calculated with
the inputs displayed in the CY 2017
direct PE input database.
(5) Restoration of Inputs
Several of the PE worksheets included
in the RUC recommendations for CY
2016 contained time for the equipment
item ‘‘xenon light source’’ (EQ167).
Because there appeared to be two
special light sources already present
(the fiberoptic headlight and the
endoscope itself) in the services for
which this equipment item was
recommended by the RUC, we believed
that the use of only one of these light
sources would be typical and removed
the xenon light equipment time. In the
CY 2016 PFS final rule with comment
period, we restored the xenon light
(EQ167) and removed the fiberoptic
headlight (EQ170) with the same
number of equipment minutes for CPT
codes 30300, 31295, 31296, 31297, and
92511.
We received comments expressing
approval for the restoration of the xenon
light. However, the commenters also
stated that the two light sources were
not duplicative, but rather, both a
headlight and a xenon light source are
required concurrently for
otolaryngology procedures when scopes
are utilized. The commenters requested
that the fiberoptic headlight be restored
to these codes.
We agree with the commenters that
the use of both light sources would be
typical for these procedures. We are
therefore proposing to add the fiberoptic
headlight (EQ170) to CPT codes 30300,
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31295, 31296, 31297, and 92511 at the
same number of equipment minutes as
the xenon light (EQ167).
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(6) Updates to Prices for Existing Direct
PE 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. For CY 2017, we are
proposing the following price updates
for existing direct PE inputs:
Several commenters wrote to discuss
the price of the Antibody Estrogen
Receptor monoclonal (SL493). We
received information including three
invoices with new pricing information
regarding the SL493 supply. We are
proposing to use this information to
propose for the supply item SL493 a
price of $14.00 per test, which is the
average price based on the invoices that
we received in total for the item.
We are also proposing to update the
price for two supplies in response to the
submission of new invoices. The
proposed price for ‘‘antigen, venom’’
supply (SH009) reflects an increase from
$16.67 to $20.14 per milliliter, and the
proposed price for ‘‘antigen, venom, trivespid’’ supply (SH010) reflects an
increase from $30.22 to $44.05 per
milliliter.
We routinely accept public
submission of invoices as part of our
process for developing payment rates for
new, revised, and potentially misvalued
codes. Often these invoices are
submitted in conjunction with the RUC
recommended values for the codes. For
CY 2017, we note that some
stakeholders have submitted invoices
for new, revised, or potentially
misvalued codes since the February
deadline established for code valuation
recommendations. To be included a
given year’s proposed rule, we generally
need to receive invoices by the same
February deadline. Of course, we will
consider invoices submitted as public
comments during the comment period
following the publication of the
proposed rule, and will consider any
invoices received after February and/or
outside of the public comment process
as part of our established annual process
for requests to update supply and
equipment prices.
B. Determination of Malpractice
Relative Value Units (RVUs)
1. Overview
Section 1848(c) of the Act requires
that each service paid under the PFS be
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composed of three components: Work,
PE, and malpractice expense (MP). As
required by section 1848(c)(2)(C)(iii) 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. In the CY 2015
PFS final rule with comment period, we
implemented the third review and
update of MP RVUs. For a
comprehensive discussion of the third
review and update of MP RVUs see the
CY 2015 proposed rule (79 FR 40349
through 40355) and final rule with
comment period (79 FR 67591 through
67596).
To determine MP RVUs for individual
PFS services, our MP methodology uses
three primary kinds of data: Specialtylevel risk factors based on the collection
of specialty-specific MP premium data
that represent the actual expense
incurred by practitioners to obtain MP
insurance; Medicare claims data to
determine service level risk factors
based on a weighted average risk factors
of the specialties that furnish each
service, and the higher of the work RVU
or clinical labor RVU to adjust the
service level risk factor for the intensity
and complexity of the service. Prior to
CY 2016, MP RVUs were only updated
once every 5 years, except in the case
of new and revised codes.
As explained in the CY 2011 PFS final
rule with comment period (75 FR
73208), MP RVUs for new and revised
codes effective before the next 5-year
review of MP RVUs were determined
either by a direct crosswalk from a
similar source code or by a modified
crosswalk to account for differences in
work RVUs between the new/revised
code and the source code. For the
modified crosswalk approach, we adjust
(or scale) the MP RVU for the new/
revised code to reflect the difference in
work RVU between the source code and
the new/revised work RVU (or, if
greater, the difference in the clinical
labor portion of the fully implemented
PE RVU) for the new code. For example,
if the proposed work RVU for a revised
code were 10 percent higher than the
work RVU for its source code, the MP
RVU for the revised code would be
increased by 10 percent over the source
code MP RVU. Under this approach the
same risk factor is applied for the new/
revised code and source code, but the
work RVU for the new/revised code is
used to adjust the MP RVUs for risk.
In the CY 2016 PFS final rule with
comment period (80 FR 70906 through
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70910), we finalized a policy to begin
conducting annual MP RVU updates to
reflect changes in the mix of
practitioners providing services (using
Medicare claims data), and to adjust MP
RVUs for risk for intensity and
complexity (using the work RVU or
clinical labor RVU). We also finalized a
policy to modify the specialty mix
assignment methodology (for both MP
and PE RVU calculations) to use an
average of the 3 most recent years of
data instead of a single year of data. We
stated that under this approach, the
specialty-specific risk factors would
continue to be updated through notice
and comment rulemaking every 5 years
using updated premium data, but would
remain unchanged between the 5-year
reviews.
For CY 2016, we did not propose to
discontinue our current approach for
determining MP RVUs for new/revised
codes. For the new and revised codes
for which we proposed work RVUs and
PE inputs, we also published the
proposed MP crosswalks used to
determine their MP RVUs. We address
comments regarding valuation of new
and revised codes in section II.L of this
proposed rule, which makes clear the
codes with interim final values for CY
2016 have newly proposed values for
CY 2017, all of which are again open for
comment. The MP crosswalks for new
and revised codes with interim final
values were established in the CY 2016
PFS final rule with comment period; we
will respond to comments regarding
these interim final values in the CY
2017 PFS final rule.
2. Updating Specialty Specific Risk
Factors
The proposed CY 2017 GPCI update
(eighth update), discussed in section II.E
of this proposed rule, reflects updated
MP premium data, collected for the
purpose of proposing updates to the MP
GPCIs. While we could use the updated
MP premium data obtained for the
purposes of the proposed eighth GPCI
update to propose updates to the
specialty risk factors used in the
calculation of MP RVUs, this would not
be consistent with the policy we
previously finalized in the CY 2016 PFS
final rule with comment period. In that
rule, we indicated that the specialtyspecific risk factors would continue to
be updated through notice and comment
rulemaking every 5 years using updated
premium data, but would remain
unchanged between the 5-year reviews.
Additionally, consistent with the
statutory requirement at section
1848(e)(1)(C) of the Act, only 1⁄2 of the
adjustment to MP GPCIs would be
applied for CY 2017 based on the new
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MP premium data. As such, we do not
think it would be appropriate to propose
to update the specialty risk factors for
CY 2017 based on the updated MP
premium data that is reflected in the
proposed CY 2017 GPCI update.
Therefore, we are not currently
proposing to update the specialty-risk
factors based on the new premium data
collected for the purposes of the 3-year
GPCI update for CY 2017 at this time.
However, we seek comment on whether
we should consider doing so, perhaps as
early as for 2018, prior to the fourth
review and update of MP RVUs that
must occur no later than CY 2020.
C. Medicare Telehealth Services
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1. Billing and Payment for Telehealth
Services
Several conditions must be met for
Medicare to make payments for
telehealth services under the PFS. The
service must be on the list of Medicare
telehealth services and meet all of the
following additional requirements:
• The service must be furnished via
an interactive telecommunications
system.
• The service must be furnished by a
physician or other authorized
practitioner.
• The service must be furnished to an
eligible telehealth individual.
• The individual receiving the service
must be located in a telehealth
originating site.
When all of these conditions are met,
Medicare pays a facility fee to the
originating site and makes a 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
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two-way, real-time interactive
communication between the patient and
distant site physician or practitioner.
Telephones, facsimile machines, and
stand-alone 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 § 410.78(a)(1),
asynchronous store-and-forward is the
transmission of medical information
from an originating site for review by
the distant site physician or practitioner
at a later time.
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 is an individual
enrolled under Part B who receives a
telehealth service furnished at a
telehealth 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 MACs 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
facility 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
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46179
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
area (MSA).
Historically, we have defined rural
HPSAs to be those located outside of
MSAs. Effective January 1, 2014, we
modified the regulations regarding
originating sites to define rural HPSAs
as those located in rural census tracts as
determined by the Office of Federal
Rural Health Policy (FORHP) 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 https://
www.cms.gov/Medicare/MedicareGeneral-Information/Telehealth/
index.html.
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
status for an originating site would be
established and maintained on an
annual basis, consistent with other
telehealth payment policies (78 FR
74400). Geographic status 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
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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 who is present 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. 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 telehealth services, see
the CMS Web site at https://www.cms.
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gov/Medicare/Medicare-GeneralInformation/Telehealth/.
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 2016
will be considered for the CY 2018
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, requesters 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 https://www.
cms.gov/Medicare/Medicare-GeneralInformation/Telehealth/.
3. Submitted Requests To Add Services
to the List of Telehealth Services for CY
2017
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 for 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, but also
expedite our ability to identify codes for
the telehealth list that resemble those
services already on this list.
We received several requests in CY
2015 to add various services as
Medicare telehealth services effective
for CY 2017. The following presents a
discussion of these requests, and our
proposals for additions to the CY 2017
telehealth list. Of the requests received,
we found that four services were
sufficiently similar to ESRD-related
services currently on the telehealth list
to qualify on a category 1 basis.
Therefore, we propose to add the
following services to the telehealth list
on a category 1 basis for CY 2017:
• CPT codes 90967 (End-stage renal
disease (ESRD) related services for
dialysis less than a full month of
service, per day; for patients younger
than 2 years of age; 90968 (End-stage
renal disease (ESRD) related services for
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dialysis less than a full month of
service, per day; for patients 2–11 years
of age; 90969 (End-stage renal disease
(ESRD) related services for dialysis less
than a full month of service, per day; for
patients 12–19 years of age); and 90970
(End-stage renal disease (ESRD) related
services for dialysis less than a full
month of service, per day; for patients
20 years of age and older).
As we indicated in the CY 2015 final
rule (80 FR 41783) for the ESRD-related
services (CPT codes 90963–90966)
added to the telehealth list for CY 2016,
the required clinical examination of the
catheter access site must be furnished
face-to-face ‘‘hands on’’ (without the use
of an interactive telecommunications
system) by a physician, CNS, NP, or PA.
This requirement also applies to CPT
codes 90967–90970.
While we did not receive a specific
request, we also propose to add two
advance care planning services to the
telehealth list. We have determined that
these services are similar to the annual
wellness visits (HCPCS codes G0438 &
G0439) currently on the telehealth list:
• CPT codes 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 care
professional; first 30 minutes, face-toface with the patient, family member(s),
or surrogate); and 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 care
professional; each additional 30 minutes
(list separately in addition to code for
primary procedure)).
We also received requests to add
services to the telehealth list that do not
meet our criteria for Medicare telehealth
services. We are not proposing to add
the following procedures for the reasons
noted:
a. Observation Care: CPT codes—
• 99217 (observation care discharge
day management (this code is to be
utilized to report all services provided
to a patient on discharge from
‘‘observation status’’ if the discharge is
on other than the initial date of
‘‘observation status.’’ To report services
to a patient designated as ‘‘observation
status’’ or ‘‘inpatient status’’ and
discharged on the same date, use the
codes for observation or inpatient care
services [including admission and
discharge services, 99234–99236 as
appropriate.]));
• 99218 (initial observation care, per
day, for the evaluation and management
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of a patient which requires these three
key components: A detailed or
comprehensive history; a detailed or
comprehensive examination; and
medical decision making that is
straightforward or of low complexity.
Counseling and coordination of care
with other physicians, other qualified
health care professionals, or agencies
are provided consistent with the nature
of the problem(s) and the patient’s and
family’s needs. Usually, the problem(s)
requiring admission to ‘‘observation
status’’ are of low severity. Typically, 30
minutes are spent at the bedside and on
the patient’s hospital floor or unit);
• 99219 (initial observation care, per
day, for the evaluation and management
of a patient, which requires these three
key components: A comprehensive
history; a comprehensive examination;
and medical decision making of
moderate complexity. Counseling and
coordination of care with other
physicians, other qualified health care
professionals, or agencies are provided
consistent with the nature of the
problem(s) and the patient’s and
family’s needs. Usually, the problem(s)
requiring admission to ‘‘observation
status’’ are of moderate severity.
Typically, 50 minutes are spent at the
bedside and on the patient’s hospital
floor or unit);
• 99220 (initial observation care, per
day, for the evaluation and management
of a patient, which requires these three
key components: A comprehensive
history; a comprehensive examination;
and medical decision making of high
complexity. Counseling and
coordination of care with other
physicians, other qualified health care
professionals, or agencies are provided
consistent with the nature of the
problem(s) and the patient’s and
family’s needs. Usually, the problem(s)
requiring admission to ‘‘observation
status’’ are of high severity. Typically,
70 minutes are spent at the bedside and
on the patient’s hospital floor or unit);
• 99224 (subsequent observation care,
per day, for the evaluation and
management of a patient, which
requires at least two of these three key
components: Problem focused interval
history; problem focused examination;
medical decision making that is
straightforward or of low complexity.
Counseling and coordination of care
with other physicians, other qualified
health care professionals, or agencies
are provided consistent with the nature
of the problem(s) and the patient’s and
family’s needs. Usually, the patient is
stable, recovering, or improving.
Typically, 15 minutes are spent at the
bedside and on the patient’s hospital
floor or unit);
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• 99225 (subsequent observation care,
per day, for the evaluation and
management of a patient, which
requires at least two of these three key
components: An expanded problem
focused interval history; an expanded
problem focused examination; medical
decision making of moderate
complexity. Counseling and
coordination of care with other
physicians, other qualified health care
professionals, or agencies are provided
consistent with the nature of the
problem(s) and the patient’s and
family’s needs. Usually, the patient is
responding inadequately to therapy or
has developed a minor complication.
Typically, 25 minutes are spent at the
bedside and on the patient’s hospital
floor or unit);
• 99226 (subsequent observation care,
per day, for the evaluation and
management of a patient, which
requires at least two of these three key
components: A detailed interval history;
a detailed examination; medical
decision making of high complexity.
Counseling and coordination of care
with other physicians, other qualified
health care professionals, or agencies
are provided consistent with the nature
of the problem(s) and the patient’s and
family’s needs. Usually, the patient is
unstable or has developed a significant
complication or a significant new
problem. Typically, 35 minutes are
spent at the bedside and on the patient’s
hospital floor or unit);
• 99234 (observation or inpatient
hospital care, for the evaluation and
management of a patient including
admission and discharge on the same
date, which requires these three key
components: A detailed or
comprehensive history; a detailed or
comprehensive examination; and
medical decision making that is
straightforward or of low complexity.
Counseling and coordination of care
with other physicians, other qualified
health care professionals, or agencies
are provided consistent with the nature
of the problem(s) and the patient’s and
family’s needs. Usually the presenting
problem(s) requiring admission are of
low severity. Typically, 40 minutes are
spent at the bedside and on the patient’s
hospital floor or unit);
• 99235 (observation or inpatient
hospital care, for the evaluation and
management of a patient including
admission and discharge on the same
date, which requires these three key
components: A comprehensive history;
a comprehensive examination; and
medical decision making of moderate
complexity. Counseling and
coordination of care with other
physicians, other qualified health care
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professionals, or agencies are provided
consistent with the nature of the
problem(s) and the patient’s and
family’s needs. Usually the presenting
problem(s) requiring admission are of
moderate severity. Typically, 50
minutes are spent at the bedside and on
the patient’s hospital floor or unit);
• 99236 (observation or inpatient
hospital care, for the evaluation and
management of a patient including
admission and discharge on the same
date, which requires these three key
components: A comprehensive history;
a comprehensive examination; and
medical decision making of high
complexity. Counseling and
coordination of care with other
physicians, other qualified health care
professionals, or agencies are provided
consistent with the nature of the
problem(s) and the patient’s and
family’s needs. Usually the presenting
problem(s) requiring admission are of
high severity. Typically, 55 minutes are
spent at the bedside and on the patient’s
hospital floor or unit);
The request to add these observation
services referenced various studies
supporting the use of observation units.
The studies indicated that observation
units provide safe, cost effective care to
patients that need ongoing evaluation
and treatment beyond the emergency
department visit by having reduced
hospital admissions, shorter lengths of
stay, increased safety and reduced cost.
Additional studies cited indicated that
observation units reduce the work load
on emergency department physicians,
and reduce emergency department
overcrowding.
In the CY 2005 PFS proposed rule (69
FR 47510), we considered a request but
did not propose to add the observation
CPT codes 99217–99220 to the list of
Medicare telehealth services on a
category two basis for the reasons
described in that rule. The most recent
request did not include any information
that would cause us to question the
previous evaluation under the category
one criterion, which has not changed,
regarding the significant differences in
patient acuity between these services
and services on the telehealth list. (69
FR 66277) While the request included
evidence of the general benefits of
observation units, it did not include
specific information demonstrating that
the services described by these codes
provided clinical benefit when
furnished via telehealth, which is
necessary for us to consider these codes
on a category two basis. Therefore, we
are not proposing to add these services
to the list of approved telehealth
services.
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b. Emergency Department Visits: CPT
Codes—
• 99281 (emergency department visit
for the evaluation and management of a
patient, which requires these three key
components: A problem focused history;
a problem focused examination; and
straightforward medical decision
making. Counseling and coordination of
care with other physicians, other
qualified health care professionals, or
agencies are provided consistent with
the nature of the problem(s) and the
patient’s and family’s needs. Usually,
the presenting problem(s) are selflimited or minor);
• 99282 (emergency department visit
for the evaluation and management of a
patient, which requires these three key
components: An expanded problem
focused history; an expanded problem
focused examination; and medical
decision making of low complexity.
Counseling and coordination of care
with other physicians, other qualified
health care professionals, or agencies
are provided consistent with the nature
of the problem(s) and the patient’s and
family’s needs. Usually, the presenting
problem(s) are of low to moderate
severity);
• 99283 (emergency department visit
for the evaluation and management of a
patient, which requires these three key
components: An expanded problem
focused history; an expanded problem
focused examination; and medical
decision making of moderate
complexity. Counseling and
coordination of care with other
physicians, other qualified health care
professionals, or agencies are provided
consistent with the nature of the
problem(s) and the patient’s and
family’s needs. Usually, the presenting
problem(s) are of moderate severity);
• 99284 (emergency department visit
for the evaluation and management of a
patient, which requires these three key
components: A detailed history; a
detailed examination; and medical
decision making of moderate
complexity. Counseling and
coordination of care with other
physicians, other qualified health care
professionals, or agencies are provided
consistent with the nature of the
problem(s) and the patient’s and
family’s needs. Usually, the presenting
problem(s) are of high severity, and
require urgent evaluation by the
physician, or other qualified health care
professionals but do not pose an
immediate significant threat to life or
physiologic function); and
• 99285 (emergency department visit
for the evaluation and management of a
patient, which requires these three key
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components within the constraints
imposed by the urgency of the patient’s
clinical condition and mental status: A
comprehensive history; a
comprehensive examination; and
medical decision making of high
complexity. Counseling and
coordination of care with other
physicians, other qualified health care
professionals, or agencies are provided
consistent with the nature of the
problem(s) and the patient’s and
family’s needs. Usually, the presenting
problem(s) are of high severity and pose
an immediate significant threat to life or
physiologic function).
In the CY 2005 PFS proposed rule (69
FR 47510), we considered a request but
did not propose to add the emergency
department visit CPT codes 99281–
99285 to the list of Medicare telehealth
services for the reasons described in that
rule.
The current request to add the
emergency department E/M services
stated that the codes are similar to
outpatient visit codes (CPT codes
99201–99215) that have been on the
telehealth list since CY 2002. As we
noted in the CY 2005 PFS final rule,
while the acuity of some patients in the
emergency department might be the
same as in a physician’s office; we
believe that, in general, more acutely ill
patients are more likely to be seen in the
emergency department, and that
difference is part of the reason there are
separate codes describing evaluation
and management visits in the
Emergency Department setting. The
practice of emergency medicine often
requires frequent and fast-paced patient
reassessments, rapid physician
interventions, and sometimes the
continuous physician interaction with
ancillary staff and consultants. This
work is distinctly different from the
pace, intensity, and acuity associated
with visits that occur in the office or
outpatient setting. Therefore, we are not
proposing to add these services to the
list of approved telehealth services on a
category one basis.
The requester did not provide any
studies supporting the clinical benefit of
managing emergency department
patients with telehealth which is
necessary for us to consider these codes
on a category two basis. Therefore, we
are not proposing to add these services
to the list of approved telehealth
services on a category two basis.
Many requesters of additions to the
telehealth list urged us to consider the
potential value of telehealth for
providing beneficiaries access to needed
expertise. We note that if clinical
guidance or advice is needed in the
emergency department setting, a
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consultation may be requested from an
appropriate source, including
consultations that are currently
included on the list of telehealth
services.
c. Critical Care Evaluation and
Management: CPT Codes—
• 99291 (critical care, evaluation and
management of the critically ill or
critically injured patient; first 30–74
minutes); and 99292 (critical care,
evaluation and management of the
critically ill or critically injured patient;
each additional 30 minutes (list
separately in addition to code for
primary service).
We previously considered and
rejected adding these codes to the list of
Medicare telehealth services in the CY
2009 PFS final rule (74 FR 69744) on a
category 1 basis because, due to the
acuity of critically ill patients, we did
not believe critical care services are
similar to any services on the current
list of Medicare telehealth services. In
that rule, we said that critical care
services must be evaluated as category
2 services. Because we considered
critical care services under category 2,
we needed to evaluate whether these are
services for which telehealth can be an
adequate substitute for a face-to-face
encounter, based on the category 2
criteria at the time of that request. We
had no evidence suggesting that the use
of telehealth could be a reasonable
surrogate for the face-to-face delivery of
this type of care.
The American Telemedicine
Association (ATA) submitted a new
request for CY 2016 that cited several
studies to support adding these services
on a category 2 basis. To qualify under
category 2, we would need evidence
that the service furnished via telehealth
is still described accurately by the
requested code and produces a clinical
benefit for the patient via telehealth.
However, in reviewing the information
provided by the ATA and a study titled,
‘‘Impact of an Intensive Care Unit
Telemedicine Program on Patient
Outcomes in an Integrated Health Care
System,’’ published July 2014 in JAMA
Internal Medicine, which found no
evidence that the implementation of
ICU telemedicine significantly reduced
mortality rates or hospital length of stay,
which could be indicators of clinical
benefit. Therefore, we stated that we do
not believe that the submitted evidence
demonstrates a clinical benefit to
patients. Therefore, we did not propose
to add these services on a category 2
basis to the list of Medicare telehealth
services for CY 2016 (80 FR 71061).
This year, requesters cited additional
studies to support adding critical care
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services on a category 2 basis. Eight of
the studies dealt with telestroke and one
with teleneurology. Telestroke is an
approach that allows a neurologist to
provide remote treatment to vascular
stroke victims. Teleneurology offers
consultations for neurological problems
from a remote location. It may be
initiated by a physician or a patient, for
conditions such as headaches,
dementia, strokes, multiple sclerosis
and epilepsy.
However, according to the literature,
the management of stroke via telehealth
requires more than a single practitioner
and is distinct from the work described
by the E/M codes. One additional study
cited involved pediatric patients, while
another noted that the Department of
Defense has used telehealth to provide
critical care services to hospitals in
Guam for many years. Another reference
study indicated that consulting
intensivists thought that telemedicine
consultations were superior to
telephone consultations. In all of these
cases, we believe the evidence
demonstrates that interaction between
these patients and distant site
practitioners can have clinical benefit.
However, we do not agree that the kinds
of services described in the study are
those that are included in the critical
care E/M codes. We note that CPT
guidance makes clear that a variety of
other services are bundled into the
payment rates for critical care, including
gastric intubations and vascular access
procedures among others We do not
believe these kinds of services are
furnished via telehealth. Public
comments, included cited studies, can
be viewed at https://
www.regulations.gov/
#!documentDetail;D=CMS-2015-00810002. Therefore, we are not proposing to
add these services to the list of Medicare
telehealth services for CY 2017.
However, we are persuaded by the
requests that we recognize the potential
benefit of critical care consultation
services that are furnished remotely. We
note that there are currently codes on
the telehealth list that could be reported
when consultation services are
furnished to critically ill patients. But in
consideration of these public requests,
we recognize that there may be greater
resource costs involved in furnishing
these services relative to the existing
telehealth consultation codes. We also
agree with the requesters that there may
be potential benefits of remote care by
specialists for these patients. For these
reasons, we think it would be advisable
to create a coding distinction between
telehealth consultations for critically ill
patients relative to telehealth
consultations for other hospital patients.
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Such a coding distinction would allow
us to recognize the additional resource
costs in terms of time and intensity
involved in furnishing such services
under the conditions where remote,
intensive consultation is required to
provide access to appropriate care for
the critically ill patient. We recognize
that the current set of codes may not
adequately describe such services
because current E/M coding presumes
that the services are occurring inperson, in which case the expert care
would be furnished in a manner
described by the current codes for
critical care.
Therefore, we are proposing to make
payment through new codes, initial and
subsequent, used to describe critical
care consultations furnished via
telehealth. This coding would provide a
mechanism to report an intensive
telehealth consultation service, initial or
subsequent, for the critically ill patient
under the circumstance when a
qualified health care professional has
in-person responsibility for the patient
but the patient benefits from additional
services from a distant-site consultant
specially trained in providing critical
care services. We propose limiting these
services to once per day per patient.
Like the other telehealth consultations,
these services would be valued relative
to existing E/M services (see Section
II.L.2.b for proposed code valuations).
More details on the new coding
(GTTT1 and GTTT2) and proposed
valuation for these services are
discussed in section II.L. of this
proposed rule and the proposed RVUs
for this service are included in
Addendum B of this proposed rule. Like
the other telehealth consultation codes,
we are proposing that these services
would be added to the telehealth list
and would be subject to the geographic
and other statutory restrictions that
apply to telehealth services.
We request comment on this proposal,
specifically as to whether the use of new
coding would create a helpful
distinction between telehealth
consultations for critically ill patients
relative to telehealth consultations for
other hospital patients. We are also
specifically interested in comments on
how these services would be
distinguished from existing critical care
services and examples of different
scenarios when each code would be
appropriate. Such comments will help
us to refine provider communication
materials.
d. Psychological Testing: CPT Codes—
• 96101 (psychological testing
(includes psychodiagnostic assessment
of emotionality, intellectual abilities,
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personality and psychopathology, e.g.,
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, e.g.,
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
(e.g., 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
(e.g., 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).
Requesters indicated that there is
nothing in the Minnesota Multiphasic
Personality Inventory (MMPI), the
Rorschach inkblot test, the Wechsler
Adult Intelligence Scale (WAIS), the
Halstead-Reitan Neuropsychological
Battery and Allied Procedures, or the
Wisconsin Card Sorting Test (WCST),
that cannot be done via telehealth nor
is different than neurological tests done
for Parkinson’s disease, seizure
medication side effects, gait assessment,
nor any of the many neurological
examinations done via telehealth with
the approved outpatient office visit and
inpatient visit CPT codes currently on
the telehealth list. As an example,
requesters indicated that the MPPI is
administered by a computer, which
generates a report that is interpreted by
the clinical psychologist, and that the
test requires no interaction between the
clinician and the patient.
We previously considered the request
to add these codes to the Medicare
telehealth list in the CY 2015 final rule
(79 FR 67600). We decided not to add
these codes, indicating that these
services are not similar to other services
on the telehealth list because they
require close observation of how a
patient responds. We noted that the
requesters did not submit evidence
supporting the clinical benefit of
furnishing these services via telehealth
so that we could evaluate them on a
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category 2 basis. While we acknowledge
that requesters believe that some of
these tests require minimal, if any,
interaction between the clinician and
patient, we disagree. We continue to
believe that successful completion of
the tests listed as examples in these
codes require the clinical psychologist
to closely observe the patient’s
response, which cannot be performed
via telehealth. Some patient responses,
for example, sweating and fine tremors,
may be missed when the patient and
examiner are not in the same room.
Therefore, we are not proposing to add
these services to the list of Medicare
telehealth services for CY 2017.
e. Physical and Occupational Therapy
and Speech-Language Pathology
Services: CPT Codes—
• 92507 (treatment of speech,
language, voice, communication, and
auditory processing disorder;
individual); and, 92508 (treatment of
speech, language, voice,
communication, and auditory
processing disorder; group, 2 or more
individuals); 92521 (evaluation of
speech fluency (e.g., stuttering,
cluttering)); 92522 (evaluation of speech
sound production (e.g., articulation,
phonological process, apraxia,
dysarthria)); 92523 (evaluation of
speech sound production (e.g.,
articulation, phonological process,
apraxia, dysarthria); with evaluation of
language comprehension and expression
(e.g., receptive and expressive
language)); 92524 (behavioral and
qualitative analysis of voice and
resonance); (evaluation of oral and
pharyngeal swallowing function); 92526
(treatment of swallowing dysfunction or
oral function for feeding); 92610
(evaluation of oral and pharyngeal
swallowing function); CPT codes 97001
(physical therapy evaluation); 97002
(physical therapy re-evaluation); 97003
(occupational therapy evaluation);
97004 (occupational therapy reevaluation); 97110 (therapeutic
procedure, 1 or more areas, each 15
minutes; therapeutic exercises to
develop strength and endurance, range
of motion and flexibility); 97112
(therapeutic procedure, 1 or more areas,
each 15 minutes; neuromuscular
reeducation of movement, balance,
coordination, kinesthetic sense, posture,
or proprioception for sitting or standing
activities); 97116 (therapeutic
procedure, 1 or more areas, each 15
minutes; gait training (includes stair
climbing)); 97532 (development of
cognitive skills to improve attention,
memory, problem solving (includes
compensatory training), direct (one-onone) patient contact, each 15 minutes);
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97533 (sensory integrative techniques to
enhance sensory processing and
promote adaptive responses to
environmental demands, direct (one-onone) patient contact, each 15 minutes);
97535 (self-care/home management
training (e.g., activities of daily living
(adl) and compensatory training, meal
preparation, safety procedures, and
instructions in use of assistive
technology devices/adaptive equipment)
direct one-on-one contact, each 15
minutes); 97537 (community/work
reintegration training (e.g., shopping,
transportation, money management,
avocational activities or work
environment/modification analysis,
work task analysis, use of assistive
technology device/adaptive equipment),
direct one-on-one contact, each 15
minutes); 97542 (wheelchair
management (e.g., assessment, fitting,
training), each 15 minutes); 97750
(physical performance test or
measurement (e.g., musculoskeletal,
functional capacity), with written
report, each 15 minutes); 97755
(assistive technology assessment (e.g., to
restore, augment or compensate for
existing function, optimize functional
tasks and maximize environmental
accessibility), direct one-on-one contact,
with written report, each 15 minutes);
97760 Orthotic(s) management and
training (including assessment and
fitting when not otherwise reported),
upper extremity(s), lower extremity(s)
and/or trunk, each 15 minutes); 97761
(prosthetic training, upper and lower
extremity(s), each 15 minutes); and
97762 (checkout for orthotic/prosthetic
use, established patient, each 15
minutes).
The statute defines who is an
authorized practitioner of telehealth
services. Physical therapists,
occupational therapists and speechlanguage pathologists are not authorized
practitioners of telehealth under section
1834(m)(4)(E) of the Act, as defined in
section 1842(b)(18)(C) of the Act.
Because the above services are
predominantly furnished by physical
therapists, occupational therapists and
speech-language pathologists, we do not
believe it would be appropriate to add
them to the list of telehealth services at
this time. One requester suggested that
we can add telehealth practitioners
without legislation, as evidenced by the
addition of nutritional professionals.
However, we do not believe we have
such authority and note that nutritional
professionals are included as
practitioners in the definition at section
1834(b)(18)(C)(vi) of the Act, and thus,
are within the statutory definition of
telehealth practitioners. Therefore, we
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are not proposing to add these services
to the list of Medicare telehealth
services for CY 2017.
In summary, we propose to add the
following codes to the list of Medicare
telehealth services beginning in CY
2017 on a category 1 basis:
• ESRD-related services 90967
through 90970. The required clinical
examination of the catheter access site
must be furnished face-to-face ‘‘hands
on’’ (without the use of an interactive
telecommunications system) by a
physician, CNS, NP, or PA.
• Advance care planning (CPT codes
99497 and 99498).
• Telehealth Consultations for a
Patient Requiring Critical Care Services
(GTTT1 and GTTT2)
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 2018, these requests must be
submitted and received by December 31,
2016. 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 https://
www.cms.gov/Medicare/MedicareGeneral-Information/Telehealth/
index.html.
4. Place of Service (POS) Code for
Telehealth Services
CMS has received multiple requests
from various stakeholders to establish a
POS code to identify services furnished
via telehealth. These requests have
come from other payers, but may also be
related to confusion concerning whether
to use the POS where the distant site
physician is located or the POS where
the patient is located. The process for
establishing POS codes, is managed by
the POS Workgroup within CMS, is
available for use by all payers, and is
not contingent upon Medicare PFS
rulemaking. However, if such a POS
code were to be created, in order to
make it valid for use in Medicare, we
would have to determine the
appropriate payment rules associated
with the code. Therefore, we are
proposing how a POS code for
telehealth would be used under the PFS
with the expectation that, if such a code
is available, it would be used as early as
January 1, 2017. We propose that the
physicians or practitioners furnishing
telehealth services would be required to
report the telehealth POS code to
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indicate that the billed service is
furnished as a telehealth service from a
distant site.
Our proposed requirement for
physicians and practitioners to use the
telehealth POS code to report that
telehealth services were furnished from
a distant site would improve payment
accuracy and consistency in telehealth
claims submission. Currently, for
services furnished via telehealth, we
have instructed practitioners to report
the POS code that would have been
reported had the service been furnished
in person. However, some practitioners
use the POS where they are located
when the service is furnished, while
others use the POS corresponding to the
patient’s location.
Under the PFS, the POS code
determines whether a service is paid
using the facility or non-facility practice
expense relative value units (PE RVUs).
The facility rate is paid when a service
is furnished in a location where
Medicare is making a separate facility
payment to an entity other than the
physician or practitioner that is
intended to reflect the facility costs
associated with the service (clinical
staff, supplies and equipment). We note
that in accordance with section
1834(m)(2)(B) of the Act, the payment
amount for the telehealth facility fee
paid to the originating site is a national
fee, paid without geographic or site of
service adjustments that generally are
made for payments to different kinds of
Medicare providers and suppliers. In
the case of telehealth services, we
believe that facility costs (clinical staff,
supplies, and equipment) associated
with the provision of the service would
generally be incurred by the originating
site, where the patient is located, and
not by the practitioner at the distant
site. And, by statute, the Medicare pays
a fee to the site that hosts the patient.
This is analogous to the circumstances
under which the facility PE RVUs are
used to pay for services under the PFS.
Therefore, we are proposing to use the
facility PE RVUs to pay for telehealth
services reported by physicians or
practitioners with the telehealth POS
code. We note that there are only three
codes on the telehealth list with a
difference greater than 1.0 PE RVUs
between the facility PE RVUs and the
non-facility PE RVUs. The remainder of
the physician payments for telehealth
services would be unchanged by this
proposal. We do not anticipate that this
proposal would result in a significant
change in the total payment for the
majority of services on the telehealth
list. Moreover, many practitioners
already use a facility POS when billing
for telehealth services (those that report
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the POS of the originating site where the
beneficiary is located). The proposed
policy to use the telehealth POS code
for telehealth services would not affect
payment for telehealth services for these
practitioners.
The POS code for telehealth would
not apply to originating sites billing the
facility fee. Originating sites are not
furnishing a service via telehealth since
the patient is physically present in the
facility. Accordingly, the originating site
would continue to use the POS code
that applies to the type of facility where
the patient is located.
We are also proposing a change to our
regulation at § 414.22(b)(5)(i)(A) that
addresses the PE RVUs used in different
settings. These proposed revisions
would improve clarity regarding our
current and proposed policies.
Specifically, we are proposing to amend
this section to specify that the facility
PE RVUs are paid for practitioner
services furnished via telehealth under
§ 410.78. In addition, we are proposing
a change to resolve any potential
ambiguity and clarify that payment
under the PFS is made at the facility
rate (facility PE RVUs) when services
are furnished in a hospital but for which
the hospital is not being paid. Finally,
to streamline the existing regulation, we
are also proposing to delete § 414.32 of
our regulation that refers to the
calculating of payments for certain
services prior to 2002.
This proposed change is aligned with
regulatory changes being proposed in
the ‘‘Medicare Program: Hospital
Outpatient Prospective Payment and
Ambulatory Surgical Center Payment
Systems and Quality Reporting
Programs; Organ Procurement
Organization Reporting and
Communication; Transplant Outcome
Measures and Documentation
Requirements; Electronic Health Record
(EHR) Incentive Programs; Payment to
Certain Off-Campus Provider-Based
Departments’’ proposed rule to
implement section 603 of the Bipartisan
Budget Act of 2015. In that proposed
rule, we discuss payment rates for
services furnished to patients in offcampus provider-based departments.
D. Potentially Misvalued Services Under
the Physician Fee Schedule
1. 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
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and to review and make appropriate
adjustments to the relative values for
those services. Section 1848(c)(2)(L) to
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 II.B. of this
proposed rule, 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 System
(PQRS) 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 for our review. 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 and requires us to
take into account the results of
consultations with organizations
representing physicians who provide
the services. 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 (https://www.medpac.gov/
documents/reports/Mar06_
EntireReport.pdf?sfvrsn=0), MedPAC
discussed the importance of
appropriately valuing physicians’
services, noting that misvalued services
can distort the market for physicians’
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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 (https://
www.medpac.gov/documents/reports/
march-2009-report-to-congressmedicare-payment-policy.pdf?sfvrsn=0),
in the intervening years since MedPAC
made the initial recommendations, CMS
and the RUC have taken several steps to
improve the review process. Also,
section 1848(c)(2)(K)(ii) of the Act
augments our efforts by directing the
Secretary to specifically examine, as
determined appropriate, potentially
misvalued services in the following
categories:
• Codes that have experienced the
fastest growth.
• Codes that have experienced
substantial changes in practice
expenses.
• Codes that describe new
technologies or services within an
appropriate time period (such as 3
years) after the relative values are
initially established for such codes.
• Codes which are 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 that have not been subject to
review since implementation of the fee
schedule.
• Codes that account for the majority
of spending under the physician fee
schedule.
• Codes for services that have
experienced a substantial change in the
hospital length of stay or procedure
time.
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• 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 practice expense
relative value units.
• Codes with high cost supplies.
• Codes as determined appropriate by
the Secretary.
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 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.
2. 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
in these areas over the upcoming 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
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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 1,671 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 PFS
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 PFS 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 (76 FR
32410), we requested recommendations
from the RUC to aid in our review of
Harvard-valued codes with annual
utilization of greater than 30,000. In the
CY 2013 PFS final rule with comment
period, we identified specific Harvardvalued 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
PFS 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 2016 PFS final rule with
comment period, we finalized for
review a list of potentially misvalued
services, which included eight codes in
the neurostimulators analysisprogramming family (CPT 95970–
95982). We also finalized as potentially
misvalued 103 codes identified through
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our screen of high expenditure services
across specialties.
3. 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 to be 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.
A summary of the comments along with
our responses are included in the CY
2011 PFS final rule with comment
period (75 FR 73217) and the CY 2012
PFS final rule with comment period
(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 develop empirical time estimates
based on data collected from several
health systems with multispecialty
group practices. The Urban Institute
collected data by directly observing the
delivery of services and through the use
of electronic health records for services
selected by the contractor in
consultation with CMS and is using this
data to produce objective time
estimates. We expect the final Urban
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Institute report will be made available
on the CMS Web site later this summer.
The second contract is with the RAND
Corporation, which used 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 consulted with a
technical expert panel on model design
issues and the test results. The RAND
report is available under downloads on
the Web site for the CY 2015 PFS Final
Rule with Comment Period at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-Notices-Items/CMS–1612–
FC.html.
After posting RAND’s report on the
models and results on our Web site, we
received comments indicating that the
models did not adequately address
global surgery services due to the lack
of available data on included visits.
Therefore, we modified the RAND
contract to include the development of
G-codes that could be used to collect
data about post-surgical follow-up visits
on Medicare claims to meet the
requirements in section 1848(c)(8)(B) of
the Act regarding collection of data on
global services. Our proposals related to
this data collection requirement are
discussed in section II.D.6. Also, the
data from this project would provide
information that would allow the time
for these services to be included in the
model for validating RVUs.
4. CY 2017 Identification and Review of
Potentially Misvalued Services
a. 0-day Global Services That Are
Typically Billed With an Evaluation and
Management (E/M) Service With
Modifier 25
Because routine E/M is included in
the valuation of codes with 0-, 10-, and
90-day global periods, Medicare only
makes separate payment for E/M
services that are provided in excess of
those considered included in the global
procedure. In such cases, the physician
would report the additional E/M service
with Modifier 25, which is defined as a
significant, separately identifiable E/M
service performed by the same
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46187
physician on the day of a procedure
above and beyond other services
provided or beyond the usual preservice
and postservice care associated with the
procedure that was performed. Modifier
25 allows physicians to be paid for
E/M services that would otherwise be
denied as bundled.
In reviewing misvalued codes, both
CMS and the RUC have often
considered how frequently particular
codes are reported with E/M codes to
account for potential overlap in
resources. Some stakeholders have
expressed concern with this policy
especially with regard to the valuation
of 0-day global services that are
typically billed with a separate E/M
service with the use of Modifier 25. For
example, when we established our
valuation of the osteopathic
manipulation services, described by
CPT codes 98925–98929, we did so with
the understanding that these codes are
usually reported with E/M codes.
Medicare claims data for CY 2015
show that 19 percent of the codes that
describe 0-day global services were
billed over 50 percent of the time with
an E/M with Modifier 25. Since routine
E/M is included in the valuation of
0-day global services, we believe that
the routine billing of separate E/M
services may indicate a possible
problem with the valuation of the
bundle, which is intended to include all
the routine care associated with the
service.
We believe that reviewing the
procedure codes typically billed with an
E/M with Modifier 25 as potentially
misvalued may be one avenue to
improve valuation of these services. To
develop the CY 2017 proposed list of
potentially misvalued services in this
category, we identified 0-day global
codes billed with an E/M 50 percent of
the time or more, on the same day of
service, with the same physician and
same beneficiary. To prioritize review of
these potentially misvalued services, we
are identifying the codes that have not
been reviewed in the last 5 years, and
with greater than 20,000 allowed
services. Table 7 lists the 83 codes that
meet these review criteria and we are
proposing these as potentially
misvalued for CY 2017. We request
public input on additional ways to
address appropriate valuations for all
services that are typically billed with an
E/M with Modifier 25.
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TABLE 7—0-DAY GLOBAL SERVICES THAT ARE TYPICALLY BILLED WITH AN EVALUATION AND MANAGEMENT (E/M)
SERVICE WITH MODIFIER 25
HCPCS
11000
11100
11300
11301
11302
11305
11306
11307
11310
11311
11312
11740
11755
11900
11901
12001
12002
12004
12011
12013
17250
20526
20550
20551
20552
20553
20600
20604
Long descriptor
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
20605 .................
20606 .................
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20610 .................
20611 .................
20612
29105
29125
29515
29540
29550
30901
30903
31231
31238
31500
31575
31579
31645
32551
32554
40490
43760
45300
46600
51701
51702
51703
56605
57150
57160
58100
64405
64418
64455
65205
65210
65222
67515
67810
67820
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
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Removal of inflamed or infected skin, up to 10% of body surface.
Biopsy of single growth of skin or tissue.
Shaving of 0.5 centimeters or less skin growth of the trunk, arms, or legs.
Shaving of 0.6 centimeters to 1.0 centimeters skin growth of the trunk, arms, or legs.
Shaving of 1.1 to 2.0 centimeters skin growth of the trunk, arms, or legs.
Shaving of 0.5 centimeters or less skin growth of scalp, neck, hands, feet, or genitals.
Shaving of 0.6 centimeters to 1.0 centimeters skin growth of scalp, neck, hands, feet, or genitals.
Shaving of 1.1 to 2.0 centimeters skin growth of scalp, neck, hands, feet, or genitals.
Shaving of 0.5 centimeters or less skin growth of face, ears, eyelids, nose, lips, or mouth.
Shaving of 0.6 centimeters to 1.0 centimeters skin growth of face, ears, eyelids, nose, lips, or mouth.
Shaving of 1.1 to 2.0 centimeters skin growth of face, ears, eyelids, nose, lips, or mouth.
Removal of blood accumulation between nail and nail bed.
Biopsy of finger or toe nail.
Injection of up to 7 skin growths.
Injection of more than 7 skin growths.
Repair of wound (2.5 centimeters or less) of the scalp, neck, underarms, trunk, arms or legs.
Repair of wound (2.6 to 7.5 centimeters) of the scalp, neck, underarms, genitals, trunk, arms or legs.
Repair of wound (7.6 to 12.5 centimeters) of the scalp, neck, underarms, genitals, trunk, arms or legs.
Repair of wound (2.5 centimeters or less) of the face, ears, eyelids, nose, lips, or mucous membranes.
Repair of wound (2.6 to 5.0 centimeters) of the face, ears, eyelids, nose, lips, or mucous membranes.
Application of chemical agent to excessive wound tissue.
Injection of carpal tunnel.
Injections of tendon sheath, ligament, or muscle membrane.
Injections of tendon attachment to bone.
Injections of trigger points in 1 or 2 muscles.
Injections of trigger points in 3 or more muscles.
Aspiration or injection of small joint or joint capsule.
Arthrocentesis, aspiration or injection, small joint or bursa (e.g., fingers, toes); with ultrasound guidance, with permanent recording and reporting.
Aspiration or injection of medium joint or joint capsule.
Arthrocentesis, aspiration or injection, intermediate joint or bursa (e.g., temporomandibular, acromioclavicular, wrist, elbow or
ankle, olecranon bursa); with ultrasound guidance, with permanent recording and reporting.
Aspiration or injection of large joint or joint capsule.
Arthrocentesis, aspiration or injection, major joint or bursa (e.g., shoulder, hip, knee, subacromial bursa); with ultrasound
guidance, with permanent recording and reporting.
Aspiration or injection of cysts.
Application of long arm splint (shoulder to hand).
Application of non-moveable, short arm splint (forearm to hand).
Application of short leg splint (calf to foot).
Strapping of ankle or foot.
Strapping of toes.
Simple control of nose bleed.
Complex control of nose bleed.
Diagnostic examination of nasal passages using an endoscope.
Control of nasal bleeding using an endoscope.
Emergent insertion of breathing tube into windpipe cartilage using an endoscope.
Diagnostic examination of voice box using flexible endoscope.
Examination to assess movement of vocal cord flaps using an endoscope.
Aspiration of lung secretions from lung airways using an endoscope.
Removal of fluid from between lung and chest cavity, open procedure.
Removal of fluid from chest cavity.
Biopsy of lip.
Change of stomach feeding, accessed through the skin.
Diagnostic examination of rectum and large bowel using an endoscope.
Diagnostic examination of the anus using an endoscope.
Insertion of temporary bladder catheter.
Insertion of indwelling bladder catheter.
Insertion of indwelling bladder catheter.
Biopsy of external female genitals.
Irrigation of vagina or application of drug to treat infection.
Fitting and insertion of vaginal support device.
Biopsy of uterine lining.
Injection of anesthetic agent, greater occipital nerve.
Injection of anesthetic agent, collar bone nerve.
Injections of anesthetic or steroid drug into nerve of foot.
Removal of foreign body in external eye, conjunctiva.
Removal of foreign body in external eye, conjunctiva or sclera.
Removal of foreign body, external eye, cornea with slit lamp examination.
Injection of medication or substance into membrane covering eyeball.
Biopsy of eyelid.
Removal of eyelashes by forceps.
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TABLE 7—0-DAY GLOBAL SERVICES THAT ARE TYPICALLY BILLED WITH AN EVALUATION AND MANAGEMENT (E/M)
SERVICE WITH MODIFIER 25—Continued
HCPCS
68200
69100
69200
69210
69220
92511
92941
92950
98925
98926
98927
98928
98929
G0168
G0268
Long descriptor
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
Injection into conjunctiva.
Biopsy of ear.
Removal of foreign body from ear canal.
Removal of impact ear wax, one ear.
Removal of skin debris and drainage of mastoid cavity.
Examination of the nose and throat using an endoscope.
Insertion of stent, removal of plaque or balloon dilation of coronary vessel during heart attack, accessed through the skin.
Attempt to restart heart and lungs.
Osteopathic manipulative treatment to 1–2 body regions.
Osteopathic manipulative treatment to 3–4 body regions.
Osteopathic manipulative treatment to 5–6 body regions.
Osteopathic manipulative treatment to 7–8 body regions.
Osteopathic manipulative treatment to 9–10 body regions.
Wound closure utilizing tissue adhesive(s) only.
Removal of impacted cerumen (one or both ears) by physician on same date of service as audiologic function testing.
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b. End-Stage Renal Disease Home
Dialysis Services (CPT Codes 90963
Through 90970)
In the CY 2004 PFS final rule with
comment period (68 FR 63216), we
established new Level II HCPCS G-codes
for end-stage renal disease (ESRD)
services and established payment for
those codes through monthly capitation
payment (MCP) rates. For ESRD centerbased patients, payment for the G-codes
varied based on the age of the
beneficiary and the number of face-toface visits furnished each month (for
example, 1 visit, 2–3 visits and 4 or
more visits). We believed that many
physicians would provide 4 or more
visits to center-based ESRD patients and
a small proportion will provide 2–3
visits or only one visit per month.
Under the MCP methodology, to receive
the highest payment, a physician would
have to provide at least four ESRDrelated visits per month. However,
payment for home dialysis MCP services
only varied by the age of beneficiary.
Although we did not initially specify a
frequency of required visits for home
dialysis MCP services, we stated that we
expect physicians to provide clinically
appropriate care to manage the home
dialysis patient.
The CPT Editorial Panel created new
CPT codes to replace the G-codes for
monthly ESRD-related services, and we
accepted the new codes for use under
the PFS in CY 2009. The CPT codes
created were 90963–90966 for monthly
ESRD-related services for home dialysis
patient and CPT codes 90967–90970 for
dialysis with less than a full month of
services.
In a GAO report titled ‘‘END-STAGE
RENAL DISEASE Medicare Payment
Refinements Could Promote Increased
Use of Home Dialysis’’ dated October
2015, https://www.gao.gov/products/
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GAO-16-125, the GAO stated that
experts and stakeholders they
interviewed indicated that home
dialysis could be clinically appropriate
for at least half of patients. Also, at a
meeting in 2013, the chief medical
officers of 14 dialysis facility chains
jointly estimated that a realistic target
for home dialysis would be 25 percent
of dialysis patients. The GAO noted that
CMS data showed that about 10 percent
of adult Medicare dialysis patients use
home dialysis as of March 2015.
In the report, the GAO noted that
CMS intended for the existing payment
structure to create an incentive for
physicians to prescribe home dialysis,
because the monthly payment rate for
managing the dialysis care of home
patients, which requires a single inperson visit, was approximately equal to
the rate for managing and providing two
to three visits to ESRD center-based
patients. However, GAO found that, in
2013, the rate of $237 for managing
home patients was lower than the
average payment of $266 and maximum
payment of $282 for managing ESRD
center-based patients. The GAO stated
that this difference in payment rates
may discourage physicians from
prescribing home dialysis.
Physician associations and other
physicians GAO interviewed stated that
the visits with home patients are often
longer and more comprehensive than incenter visits; this is in part because
physicians may conduct visits with
individual home patients in a private
setting, but they may be able to more
easily visit multiple in-center patients
on a single day as they receive dialysis.
The physician associations GAO
interviewed also said that they may
spend a similar amount of time outside
of visits to manage the care of home
patients and that they are required to
provide at least one visit per month to
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perform a complete assessment of the
patient.
It is important to note that, as stated
in the CY 2011 PFS final rule with
comment period (75 FR 73296), we
believe that furnishing monthly face-toface visits is an important component of
high quality medical care for ESRD
patients being dialyzed at home and
generally would be consistent with the
current standards of medical practice.
However, we also acknowledged that
extenuating circumstances may arise
that make it difficult for the MCP
physician (or NPP) to furnish a visit to
a home dialysis patient every month.
Therefore, we allow Medicare
contractors the discretion to waive the
requirement for a monthly face-to-face
visit for the home dialysis MCP service
on a case-by-case basis, for example,
when the MCP physician’s (or NPP’s)
notes indicate that the MCP physician
(or NPP) actively and adequately
managed the care of the home dialysis
patient throughout the month.
The GAO recommended, and we
agreed, that CMS examine Medicare
policies for monthly payments to
physicians to manage the care of
dialysis patients and revise them if
necessary to ensure that these policies
are consistent with our goal of
encouraging the use of home dialysis
among patients for whom it is
appropriate. Therefore, we are
proposing to identify CPT codes 90963
through 90970 as potentially misvalued
codes based on the volume of claims
submitted for these services relative to
those submitted for facility ESRD
services.
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c. Direct PE Input Discrepancies
i. Appropriate Direct PE Inputs Involved
in Procedures Involving Endoscopes
Stakeholders have raised concerns
about potential inconsistencies with the
inputs and the prices related to
endoscopic procedures in the direct PE
database. Upon review, we noted that
there are 45 different pieces of
endoscope related-equipment and 25
different pieces of endoscope relatedsupplies that are currently associated
with these services. Relative to other
kinds of equipment items in the direct
PE input, these items are much more
varied and used for many fewer
services. Given the frequency with
which individual codes can be reviewed
and the importance of standardizing
inputs for purposes of maintaining
relativity across PFS services, we
believe that this unusual degree of
variation is likely to result in code
misvaluation. To facilitate efficient
review of this particular kind of
misvaluation, and because we believe
that stakeholders will prefer the
opportunity to contribute to such
standardization, we request that
stakeholders like the RUC review and
make recommendations on the
appropriate endoscopic equipment and
supplies typically provided in all
endoscopic procedures for each
anatomical body region, along with their
appropriate prices.
ii. Appropriate Direct PE Inputs in the
Facility Post-Service Period When PostOperative Visits Are Excluded
We identified a potential
inconsistency in instances where there
are direct PE inputs included in the
facility postservice period even though
post-operative visit is not included in a
service. We identified 13 codes that are
affected by this issue and we are unclear
if the discrepancy is caused by
inaccurate direct PE inputs or
inaccurate post-operative data in the
work time file. We request that
stakeholders including the RUC review
these discrepancies and provide their
recommendations on the appropriate
direct PE inputs for the codes listed in
Table 8.
TABLE 8—CODES THAT HAVE DIRECT PE INPUTS IN THE FACILITY POSTSERVICE PERIOD WHEN POST-OPERATIVE VISITS
ARE EXCLUDED
CPT Code
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21077
21079
21080
21081
21082
21083
21084
28636
28666
43652
46900
47570
66986
...........................
...........................
...........................
...........................
...........................
...........................
...........................
...........................
...........................
...........................
...........................
...........................
...........................
Long descriptor
Impression and preparation of eye socket prosthesis.
Impression and custom preparation of temporary oral prosthesis.
Impression and custom preparation of permanent oral prosthesis.
Impression and custom preparation of lower jaw bone prosthesis.
Impression and custom preparation of prosthesis for roof of mouth enlargement.
Impression and custom preparation of roof of mouth prosthesis.
Impression and custom preparation of speech aid prosthesis.
Insertion of hardware to foot bone dislocation with manipulation, accessed through the skin.
Insertion of hardware to toe joint dislocation with manipulation, accessed through the skin.
Incision of vagus nerves of stomach using an endoscope.
Chemical destruction of anal growths.
Connection of gall bladder to bowel using an endoscope.
Exchange of lens prosthesis.
d. Insertion and Removal of Drug
Delivery Implants—CPT Codes 11981
and 11983
Stakeholders have urged CMS to
create new coding describing the
insertion and removal of drug delivery
implants for buprenorphine
hydrochloride, formulated as a 4 rod, 80
mg, long acting subdermal drug implant
for the treatment of opioid addiction.
These stakeholders have suggested that
current coding that describes insertion
and removal of drug delivery implants
is too broad and that new coding is
needed to account for specific
additional resource costs associated
with particular treatment. We are
identifying existing CPT codes 11981
(Insertion, non-biodegradable drug
delivery implant), 11982 (Removal, nonbiodegradable drug delivery implant),
and 11983 (Removal with reinsertion,
non-biodegradable drug delivery
implant) as potentially misvalued codes
and are seeking comment and
information regarding whether the
current resource inputs in work and
practice expense for these codes
appropriately account for variations in
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the service relative to which devices
and related drugs are inserted and
removed.
5. Valuing Services That Include
Moderate Sedation as an Inherent Part
of Furnishing the Procedure
The CPT manual identifies more than
400 diagnostic and therapeutic
procedures (listed in Appendix G) for
which the CPT Editorial Committee has
determined that moderate sedation is an
inherent part of furnishing the
procedure. In developing RVUs for these
services, we include the resource costs
associated with moderate sedation in
the valuation since the CPT codes
include moderate sedation as an
inherent part of the procedure.
Therefore, only the procedure code is
currently reported when furnishing the
service. Endoscopic procedures
constitute a significant portion of the
services identified in Appendix G. In
the CY 2015 PFS proposed rule (79 FR
40349), we noted that it appeared that
practice patterns for endoscopic
procedures were changing, with
anesthesia increasingly being separately
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reported for these procedures, meaning
that the resource costs associated with
sedation were no longer incurred by the
practitioner reporting the Appendix G
procedure. We indicated that, in order
to reflect apparent changes in medical
practice, we were considering
establishing a uniform approach to the
appropriate valuation of all Appendix G
services for which moderate sedation is
no longer inherent, rather than
addressing the issue at the procedure
level as individual codes are revalued.
We solicited public comment on
approaches to the appropriate valuation
of these services.
In the CY 2016 PFS proposed rule (80
FR 41707), we again solicited public
comment and recommendations on
approaches to address the appropriate
valuation of moderate sedation related
to Appendix G services. In response to
our comment solicitation, the CPT
Editorial Panel created CPT codes for
separately reporting moderate sedation
services in association with the
elimination of Appendix G from the
CPT Manual for CY 2017. This coding
change would provide for payment for
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moderate sedation services only in cases
where it is furnished. In addition to
providing recommended values for the
new codes used to separately report
moderate sedation, the RUC has also
provided a methodology for revaluing
all services previously identified in
Appendix G, without moderate
sedation, in order to make appropriate
corresponding adjustments for the
procedural services. The RUC
recommended this methodology to
address moderate sedation valuation
generally instead of recommending that
it be addressed as individual codes are
reviewed. The RUC’s recommended
methodology would remove work RVUs
for moderate sedation from Appendix G
codes based on a code-level assessment
of whether the procedures are typically
performed on straightforward patients
or more difficult patients. Based on its
recommended methodology, the RUC is
recommending removal of fewer RVUs
from each of the procedural services
than it recommends for valuing the
moderate sedation services. If we were
to use the RUC-recommended values for
both the moderate sedation codes and
the Appendix G procedural codes
without refinement, overall payments
for these procedures, when moderate
sedation is furnished, would increase
relative to the current payment.
We direct readers to section II.L. of
this proposed rule, which includes more
details regarding our proposed valuation
of the new moderate sedation codes and
our proposed uniform methodology for
revaluation of the procedural codes
previously identified in Appendix G.
We believe that the RVUs assigned
under the PFS should reflect the overall
resource costs of PFS services,
regardless of how many codes are used
to report the services. Therefore, our
proposed methodology for valuation of
Appendix G procedural services would
maintain current resource assumptions
for the procedures when furnished with
moderate sedation and redistribute the
RVUs associated with moderate
sedation (previously included in
Appendix G procedural codes) to other
PFS services. We believe that our
proposed uniform methodology for
revaluation of Appendix G services
without moderate sedation is consistent
with our general principle that the
overall resource costs for the procedures
do not change based solely on changes
in coding.
We also note that stakeholders
presented information to CMS regarding
specialty group survey data for
physician work. The stakeholders
shared survey results for physician work
involved in furnishing moderate
sedation that demonstrated a significant
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bimodal distribution between
procedural services furnished by
gastroenterologists (GI) and procedural
services furnished by other specialties.
Since we believe that gastroenterologists
furnish the highest volume of services
previously identified in Appendix G,
and services primarily furnished by
gastroenterologists prompted the
concerns that led to our identification of
changes in medical practice and
potentially duplicative payment for
these codes, we have addressed the
variations between the GI and other
specialties in our review of the new
moderate sedation CPT codes and their
recommended values. We again direct
readers to section II.L. of this proposed
rule where we discuss our proposal to
augment the new CPT codes for
moderate sedation with an endoscopyspecific moderate sedation code, as well
as proposed valuations reflecting the
differences in the physician survey data
between GI and other specialties.
6. Collecting Data on Resources Used in
Furnishing Global Services
a. Background
(1) Current Payment Policy for Global
Packages
Under the PFS, certain services, such
as surgery, are valued and paid for as
part of global packages that include the
procedure and the services typically
furnished in the periods immediately
before and after the procedure. For each
of these global packages, 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 packages
include the surgical procedure and the
pre-operative and post-operative
services furnished by the physician on
the day of the service. The 10-day global
packages include these services and, in
addition, visits related to the procedure
during the 10 days following the day of
the procedure. The 90-day global
packages include the same services as
the 0-day global codes plus the preoperative services furnished one day
prior to the procedure and postoperative services during the 90 days
immediately following the day of the
procedure. Section 40.1 of Chapter 12 of
the Claims Processing Manual (Pub.
100–04) defines the global surgical
package to include the following
services related to the surgery when
furnished during the global period by
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the same physician or another
practitioner in the same group practice:
• Pre-operative Visits: Pre-operative
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 post-operative period of the surgery
because of complications that do not
require additional trips to the operating
room;
• Post-operative Visits: Follow-up
visits during the post-operative period
of the surgery that are related to
recovery from the surgery;
• Post-surgical 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.
In the CY 2015 PFS proposed and
final rules we extensively discussed the
problems with accurate valuation of 10and 90-day global packages. Our
concerns included the fact that we do
not use actual data on services
furnished in order to update the rates,
questions regarding the accuracy of our
current assumptions about typical
services, whether we will be able to
adjust values on a regular basis to reflect
changes in the practice of medicine and
health care delivery, and how our global
payment policies affect what services
are actually furnished (79 FR 67582
through 67585). In finalizing a policy to
transform all 10-day and 90-day global
codes to 0-day global codes in CY 2017
and CY 2018, respectively, to improve
the accuracy of valuation and payment
for the various components of global
packages, including pre- and postoperative visits and the procedure itself,
we stated that we were adopting this
policy because we believe it is critical
that PFS payment rates be based upon
RVUs that reflect the resource costs of
furnishing the services. We also stated
our belief that transforming all 10- and
90-day global codes to 0-day global
packages would:
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• Increase the accuracy of PFS
payment by setting payment rates for
individual services that more closely
reflect the typical resources used in
furnishing the procedures;
• Avoid potentially duplicative or
unwarranted payments when a
beneficiary receives post-operative care
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 packages;
and
• Facilitate the availability of more
accurate data for new payment models
and quality research.
(2) Data Collection and Revaluation of
Global Packages Required by MACRA
Section 523(a) of the Medicare Access
and CHIP Reauthorization Act of 2015
(MACRA) (Pub. L. 114–10, enacted
April 16, 2015) prohibits the Secretary
from implementing the policy,
described above, that would have
transformed all 10-day and 90-day
global surgery packages to 0-day global
packages.
Section 1848(c)(8)(B) of the Act,
which was also added by section 523(a)
of the MACRA, requires us to collect
data to value surgical services. Section
1848(c)(8)(B)(i) of the Act requires us to
develop, through rulemaking, a process
to gather information needed to value
surgical services from a representative
sample of physicians, and requires that
the data collection begin no later than
January 1, 2017. The collected
information must include the number
and level of medical visits furnished
during the global period and other items
and services related to the surgery and
furnished during the global period, as
appropriate. This information must be
reported on claims at the end of the
global period or in another manner
specified by the Secretary. Section
1848(c)(8)(B)(ii) of the Act requires that,
every 4 years, we reassess the value of
this collected information; and allows
us to discontinue the collection of this
information if the Secretary determines
that we have adequate information from
other sources to accurately value global
surgical services. Section
1848(c)(8)(B)(iii) of the Act specifies
that the Inspector General shall audit a
sample of the collected information to
verify its accuracy. Section 1848(c)(9) of
the Act (added by section 523(b) of the
MACRA) authorizes the Secretary,
through rulemaking, to delay up to 5
percent of the PFS payment for services
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for which a physician is required to
report information under section
1848(c)(8)(B)(i) of the Act until the
required information is reported.
Section 1848(c)(8)(C) of the Act,
which was also added by section 523(a)
of the MACRA, requires that, beginning
in CY 2019, we must use the
information collected as appropriate,
along with other available data, to
improve the accuracy of valuation of
surgical services under the PFS.
(3) Public Input
As noted above, section 1848(c)(8)(C)
of the Act mandates that we use the
collected data to improve the accuracy
of valuation of surgery services
beginning in 2019. We described in the
CY 2015 PFS final rule (79 FR 67582
through 67591) the limitations and
difficulties involved in the appropriate
valuation of the global packages,
especially when the resources and the
related values assigned to the
component services are not defined. To
gain input from stakeholders on
implementation of this data collection,
we sought comment on various aspects
of this task in the CY 2016 proposed
rule (80 FR 41707 through 41708). We
solicited comments from the public
regarding the kinds of auditable,
objective data (including the number
and type of visits and other services
furnished during the post-operative
period by the practitioner furnishing the
procedure) needed to increase the
accuracy of the values for surgical
services. We also solicited comment on
the most efficient means of acquiring
these data as accurately and efficiently
as possible. For example, we sought
information on the extent to which
individual practitioners or practices
may currently maintain their own data
on services, including those furnished
during the post-operative period, and
how we might collect and objectively
evaluate those data for use in increasing
the accuracy of the values beginning in
CY 2019.
We received many comments
regarding potential methods of valuing
the individual components of the global
surgical package. A large number of
comments expressed strong support for
our proposal to hold an open door
forum or town hall meetings with the
public. Toward this end, we held a
national listening session on January 20,
2016. Prior to the listening session, the
topics for which guidance was being
sought were sent electronically to those
who registered for the session and made
available on our Web site. The topics
were:
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• Mechanisms for capturing the types
of services typically furnished during
the global period.
• Determining the representative
sample for the claims-based data
collection.
• Determining whether we should
collect data on all surgical services or,
if not, which services should be
sampled.
• Potential for designing data
collection elements to interface with
existing infrastructure used to track
follow-up visits within the global
period.
• Consideration of use of 5 percent
withhold until required information is
furnished.
The 658 participants in the national
listening session provided valuable
information on this task. A written
transcript and an audio recording of this
session are available at https://
www.cms.gov/Outreach-and-Education/
Outreach/NPC/National-Provider-Callsand-Events-Items/2016-01-20MACRA.html.
We considered both the comments
submitted on the CY 2016 PFS proposed
rule and the input provided at the
listening session as we developed this
proposal for data collection. When
relevant, we discuss this stakeholder
input below without distinguishing
between comments on the proposed rule
and input provided at the national
listening session.
b. Data Collection Required To
Accurately Value Global Packages
Resource-based valuation of
individual physicians’ services is a
critical foundation for Medicare
payment to physicians. It is essential
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 make appropriate
payment and preserve relativity among
services. For global surgical packages,
this requires using objective data on all
of the resources used to furnish the
services that are included in the
package. Not having such data for some
components may significantly skew
relativity and create unwarranted
payment disparities within the PFS.
The current valuations for many
services valued as global packages are
based upon the total package as a unit
rather than by determining the resources
used in furnishing the procedure and
each additional service/visit and
summing the results. As a result, we do
not have the same level of information
about the components of global
packages as we do for other services. To
value global packages accurately and
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relative to other procedures, we need
accurate information about the
resources—work, PEs and malpractice—
used in furnishing the procedure,
similar to what is used to determine
RVUs for all services. In addition we
need the same information on the postoperative services furnished in the
global period (and pre-operative
services the day before for 90-day global
packages). Public comments about our
proposal to value all global services as
0-day global services and pay separately
for additional post-operative services
when furnished indicated that there
were no reliable data available on the
value of the underlying procedure that
did not also incorporate the value of the
post-operative services, reinforcing our
view that more data are needed across
the board.
While we believe that most of the
services furnished in the global period
are visits for follow-up care, we do not
have accurate information on the
number and level of visits typically
furnished because those billing for
global services are not required to
submit claims for post-operative visits.
A May 2012 Office of Inspector General
(OIG) report, entitled Cardiovascular
Global Surgery Fees Often Did Not
Reflect the Number of Evaluation and
Management Services Provided (https://
oig.hhs.gov/oas/reports/region5/
50900054.pdf) found that for 202 of the
300 sampled cardiovascular global
surgeries, the Medicare payment rates
were based on a number of visits that
did not reflect the actual number of
services provided. Specifically,
physicians provided fewer services than
the visits included in the payment
calculation for 132 global surgery
services and provided more services
than were included in the payment
calculations for 70 services. Similar
results were found in OIG reports
entitled ‘‘Musculoskeletal Global
Surgery Fees Often Did Not Reflect The
Number Of Evaluation And
Management Services Provided’’ (https://
oig.hhs.gov/oas/reports/region5/
50900053.asp) and ‘‘Review of Cataract
Global Surgeries and Related Evaluation
and Management Services, Wisconsin
Physicians Service Insurance
Corporation Calendar Year 2003, March
2007’’ (https://oig.hhs.gov/oas/reports/
region5/50600040.pdf).
Claims data plays a major role in PFS
rate-setting. Specifically, Medicare
claims data is a primary driver in the
allocation of indirect PE RVUs and MP
RVUs across the codes used by
particular specialties, and in making
overall budget neutrality and relativity
adjustments. In most cases, a claim must
be filed for all visits. Such claims
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provide information such as the place of
service, the type and, if relevant, the
level of the service, the date of the
service, and the specialty of the
practitioner furnishing the services.
Because we have not required claims
reporting of visits included in global
surgical packages, we do not have any
of this information for the services
bundled in the package.
In addition to the lack of information
about the number and level of visits
actually furnished, the current global
valuations rely on crosswalks to E/M
visits, based upon the assumption that
the resources, including work, used in
furnishing pre- and post-operative visits
are similar to those used in furnishing
E/M visits. We are unaware of any
studies or surveys that verify this
assertion. Although we generally value
global packages using the same direct
PE inputs as are used for the E/M
services, for services for which the RUC
recommendations include specific PE
inputs in addition to those typically
included for E/M services, we generally
use the additional inputs in the global
package valuation. Of note, when a visit
included in a global package would use
fewer resources than a comparable E/M
service, the RUC generally does not
include recommendations to decrease
the PE inputs of the visit included in the
global package, and we have not
generally made comparable reductions.
Another inconsistency with our current
global package valuation approach is
that even though we effectively assume
that the E/M codes are appropriate for
valuing pre- and post-operative services,
the indirect PE inputs used for
calculating payments for global services
are based upon the specialty mix
furnishing the global service, not the
specialty mix of the physicians
furnishing the E/M services, resulting in
a different valuation for the E/M
services contained in global packages
than for separately billable E/M
services. There is a critical need to
obtain complete information if we are to
value global packages accurately and in
a way that preserves relativity across the
fee schedule.
To meet the requirement under
section 1848(c)(8)(B)(i) of the Act, we
develop, through rulemaking, a process
to gather information needed to value
surgical services. Therefore, we are
proposing a rigorous data collection
effort that we believe would provide us
the data needed to accurately value the
4,200 codes with a 10- or 90-day global
period. Using our authority under
sections 1848(c)(2)(M) and (c)(8)(B)(i) of
the Act, we propose to gather the data
needed to determine how to best
structure global packages with post-
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operative care that is typically delivered
days, weeks or months after the
procedure and whether there are some
procedures for which accurate valuation
for packaged post-operative care is not
possible. Finally, we believe these data
would provide useful information to
assess the resources used in furnishing
pre- and post-operative care. To
accurately do so, we need to know the
volume and costs of the resources
typically used. Although it may not be
possible to gather all the necessary data
and to complete the analysis required to
re-value all of the codes currently
valued as 10- or 90-day global packages
by January 1, 2019, we believe the
proposed data collection would provide
the foundation for such valuations and
would allow us to re-value, as
appropriate, the surgical services on a
flow basis, starting in rulemaking for CY
2019.
We are proposing a three-pronged
approach to collect timely and accurate
data on the frequency of, and inputs
involved in furnishing, global services
including the procedure and the preoperative visits, post-operative visits,
and other services for which payment is
included in the global surgical payment.
By analyzing these data, we would not
only have the most comprehensive
information available on the resources
used in furnishing these services, but
also would be able to determine the
appropriate packages for such services.
Specifically, the effort would include:
• Comprehensive claims-based
reporting about the number and level of
pre- and post-operative visits furnished
for 10- and 90-day global services.
• A survey of a representative sample
of practitioners about the activities
involved in and the resources used in
providing a number of pre- and postoperative visits during a specified,
recent period of time, such as two
weeks.
• A more in-depth study, including
direct observation of the pre- and postoperative care delivered in a small
number of sites, including some ACOs.
This work is critical to understanding
and characterizing the work and other
resources involved in furnishing
services throughout the current global
periods assigned to specific surgical
procedures. The information collected
and analyzed through the activities
would be the first comprehensive look
at the volume and level of services in a
global period, and the activities and
inputs involved in furnishing global
services. The data from these activities
would ultimately inform our revaluation
of global surgical packages.
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(1) Statutory Authority for Data
Collection
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As described above, section
1848(c)(8)(B)(i) of the Act requires us to
develop, through rulemaking, a process
to gather information needed to value
surgical services from a representative
sample of physicians. The statute
requires that the collected information
include the number and level of medical
visits furnished during the global period
and other items and services related to
the surgery and furnished during the
global period, as appropriate.
In addition, section 1848(c)(2)(M) of
the Act, which was added to the Act by
section 220 of the PAMA, authorizes the
Secretary to collect or obtain
information on resources directly or
indirectly related to furnishing services
for which payment is made under the
PFS. Such information may be collected
or obtained from any eligible
professional or any other source.
Information may be collected or
obtained from surveys of physicians,
other suppliers, providers of services,
manufacturers, and vendors. That
section also authorizes the Secretary to
collect information through any other
mechanism determined appropriate.
When using information gathered under
this authority, the statute requires the
Secretary to disclose the information
source and discuss the use of such
information in the determination of
relative values through notice and
comment rulemaking.
As described above, to gain all the
information that is needed to determine
the appropriate packages for global
services and to revalue those services,
we need to conduct a comprehensive
study on the resources used in
furnishing such services. Through such
a study, we would have much more
robust data to use in valuation than has
been typically available. We anticipate
that such efforts would inform how to
more regularly collect data on the
resources used in furnishing physicians’
services. To the extent that such
mechanisms prove valuable, they may
be used to collect data for valuing other
services. To achieve this significant data
collection, we are proposing to collect
data under the authority of both section
1848(c)(8)(B) and (c)(2)(M) of the Act.
(2) Claims-Based Data Collection
This section describes our proposal
for claims-based data collection that
would be applicable to 10- and 90-day
global services furnished on or after
January 1, 2017, including who would
be required to report, what they would
be required to report, and how reports
would be submitted.
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(a) Information To Be Reported
A key element of claims-based
reporting is using codes that
appropriately reflect the services
furnished. In response to the comment
solicitation in the CY 2016 PFS
proposed rule and in the January 2016
listening session, we received numerous
recommendations for the information to
be reported on claims. The most
frequently recommended approach was
for practitioners to report the existing
CPT code for follow-up visits included
in the surgical package (CPT 99024—
Postoperative follow-up visit, normally
included in the surgical package, to
indicate that an E/M service was
performed during a postoperative period
for a reason(s) related to the original
procedure). Others suggested using this
code for outpatient visits and using
length of stay data for estimating the
number of inpatient visits during the
global period. In response to our
concerns that CPT code 99024 would
provide only the number of visits and
not the level of visits as required by the
statute, one commenter suggested using
modifiers in conjunction with CPT code
99024 to indicate the level of the visit
furnished. Others recommended using
existing CPT codes for E/M visits to
report post-operative care. One
commenter suggested that CMS analyze
data from a sample of large systems and
practices that are using electronic health
records that require entry of some CPT
code for every visit to capture the
number of post-operative visits. After
noting that the documentation
requirements and PEs required for postoperative visits differ from those of E/
M visits outside the global period, one
commenter encouraged us to develop a
separate series of codes to capture the
work of the post-operative services and
to measure, not just estimate, the
number and complexity of visits during
the global period.
Other commenters opposed the use of
a new set of codes or the use of
modifiers to report post-operative visits.
Commenters also noted several issues
for us to consider in developing data
collection mechanisms, including that
many post-operative services do not
have CPT codes to bill separately, that
surgeons perform a wide range of
collaborative care services, and that
patient factors, including disease
severity and comorbidities, influence
what post-operative care is furnished.
To assist us in determining
appropriate coding for claims-based
reporting, we added a task to the RAND
contract for developing a model to
validate the RVUs in the PFS, which
was awarded in response to a
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requirement in the Affordable Care Act.
Comments that we received on RAND’s
report suggested the models did not
adequately address global surgery
services due to the lack of available data
on included visits. Therefore, we
modified the RAND contract to include
the development of G-codes that could
be used to collect data about postsurgical follow-up visits on Medicare
claims for valuing global services under
MACRA and so that this time could be
included in the model for validating
RVUs.
To inform its work, RAND conducted
interviews with surgeons and other
physicians/non-physician practitioners
(NPP) who provide post-operative care.
A technical expert panel (TEP),
convened by RAND, reviewed the
findings of the interviews and provided
input on how to best capture care
provided in the post-operative period on
claims.
In summarizing the input from the
interviews and the TEP, RAND
indicated that several considerations
were important in developing a claimsbased method for capturing postoperative services. First, a simple
system to facilitate reporting was
needed. Since it was reported that a
majority of post-operative visits are
straightforward, RAND found that a key
for any proposed system is identifying
the smaller number of complex postoperative visits. Another consideration
for RAND was not using the existing
CPT E/M structure to capture
postoperative care because of concerns
that E/M codes are inadequately
designed to capture the full scope of
post-operative care and that using such
codes might create confusion. Another
consideration was that the TEP was
most enthusiastic about a set of codes
that used site of care, time, and
complexity to report visits. RAND also
believed it was important to
distinguish—particularly in the
inpatient setting—between
circumstances where a surgeon is
providing primary versus secondary
management of a patient. Finally, a
mechanism for reporting the
postoperative care occurs outside of inperson visits and by clinical staff was
needed. RAND noted that in the
inpatient setting in particular, surgeons
spend considerable time reviewing test
results and coordinating care with other
practitioners.
After reviewing various approaches,
RAND recommended a set of timebased, post-operative visit codes that
could be used for reporting care
provided during the post-operative
period.
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The recommended codes are
distinguished by the setting of care and
whether they are furnished by a
physician/NPP or by clinical staff. All
codes are intended to be reported in 10minute increments. A copy of the report
is available available on the CMS Web
site under downloads for the CY 2017
PFS proposed rule with comment
period at https://www.cms.gov/
physicianfeesched/downloads/.
Based upon the work done by RAND,
we are proposing the following codes be
used for reporting on claims the services
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actually furnished but not paid
separately because they are part of
global packages. No separate payment
would be made for these codes.
TABLE 9—PROPOSED GLOBAL SERVICE CODES
Inpatient .......................................................
Office or Other Outpatient ...........................
GXXX1
GXXX2
GXXX3
GXXX4
Via Phone or Internet ..................................
GXXX5
GXXX6
GXXX7
GXXX8
(i) Coding for Inpatient Global Service
Visits
Our coding proposal includes three
codes for reporting inpatient pre- and
post-operative visits that distinguish the
intensity involved in furnishing the
services. The typical inpatient visit
would be reported using HCPCS code
GXXX1, Inpatient visit, typical, per 10
minutes, included in surgical package.
The activities listed in Table 10 are
those that RAND recommended to be
reported as a typical visit. Under our
proposal, visits that involve any
combination or number of the services
listed in Table 10 would be reported
using GXXX1. Based on the findings
from the interviews and the TEP, RAND
reports that the vast majority of
inpatient post-operative visits would be
expected to be reported using GXXX1.
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TABLE 10—ACTIVITIES INCLUDED IN
TYPICAL VISIT (GXXX1 & GXXX5)
Review vitals, laboratory or pathology results,
imaging, progress notes
Take interim patient history and evaluate
post-operative progress
Assess bowel function
Conduct patient examination with a specific
focus on incisions and wounds, post-surgical pain, complications, fluid and diet intake
Manage medications (for example, wean pain
medications)
Remove stitches, sutures, and staples
Change dressings
Counsel patient and family in person or via
phone
Write progress notes, post-operative orders,
prescriptions, and discharge summary
Contact/coordinate care with referring physician or other clinical staff
Complete forms or other paperwork
Inpatient pre- and post-operative
visits that are more complex than
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Inpatient visit, typical, per 10 minutes, included in surgical package.
Inpatient visit, complex, per 10 minutes, included in surgical package.
Inpatient visit, critical illness, per 10 minutes, included in surgical package.
Office or other outpatient visit, clinical staff, per 10 minutes, included in surgical package.
Office or other outpatient visit, typical, per 10 minutes, included in surgical package.
Office or other outpatient visit, complex, per 10 minutes, included in surgical package.
Patient interactions via electronic means by physician/NPP, per 10 minutes, included
in surgical package.
Patient interactions via electronic means by clinical staff, per 10 minutes, included in
surgical package.
typical visits but do not qualify as
critical illness visits would be coded
using GXXX2 (Inpatient visit, complex,
per 10 minutes, included in surgical
package). To report this code, the
practitioner would be required to
furnish services beyond those included
in a typical visit and have
documentation that indicates what
services were provided that exceeded
those included in a typical visit. Some
circumstances that might merit the use
of the complex visit code are secondary
management of a critically ill patient
where another provider such as an
intensivist is providing the primary
management, primary management of a
particularly complex patient such as a
patient with numerous comorbidities or
high likelihood of significant decline or
death, management of a significant
complication, or complex procedures
outside of the operating room (For
example, significant debridement at the
bedside).
The highest level of inpatient pre- and
post-operative visits, critical illness
visits (GXXX3—Inpatient visit, critical
illness, per 10 minutes, included in
surgical package) would be reported
when the physician is providing
primary management of the patient at a
level of care that would be reported
using critical care codes if it occurred
outside of the global period. This
involves acute impairment of one or
more vital organ systems such that there
is a high probability of imminent or life
threatening deterioration in the patient’s
condition.
Similar to how time is now counted
for the existing CPT critical care codes,
all time spent engaged in work directly
related to the individual patient’s care
would count toward the time reported
with the inpatient visit codes; this
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includes time spent at the immediate
bedside or elsewhere on the floor or
unit, such as time spent with the patient
and family members, reviewing test
results or imaging studies, discussing
care with other staff, and documenting
care.
(ii) Coding for Office and Other
Outpatient Global Services Visits
Our proposal includes three codes
that would be used for reporting postoperative visits in the office or other
outpatient settings. For these three
codes, time would be defined as the
face-to-face time with patient, which
reflects the current rules for time-based
outpatient codes.
Under our proposal, GXXX4 (Office or
other outpatient visit, clinical staff, per
10 minutes, included in surgical
package) would be used for visits in
which the clinical care is provided by
clinical staff.
GXXX5 (Office or other outpatient
visit, typical, per 10 minutes, included
in surgical package) would be used for
reporting any combination of activities
in Table 10. Based on the findings from
the interviews and the TEP, RAND
reports that the vast majority of office or
other outpatient visits would be
expected to be reported using the
GXXX5 code.
Accordingly, we would expect the
office or other outpatient visit code,
complex, GXXX6 (Office or other
outpatient visit, complex, per 10
minutes, included in surgical package),
to be used infrequently. Examples of
when it might be used include
management of a particularly complex
patient such as a patient with numerous
comorbidities or high likelihood of
dying, management of a significant
complication, or management or
discussion of a complex diagnosis (For
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example, new cancer diagnosis, high
risk of mortality). Practitioners would
include documentation in the medical
record as to what services were
provided that exceeded those included
in a typical visit.
Only face-to-face time spent by the
practitioner with the patient and their
family members would count toward
the time reported with the office visit
codes. Therefore, even though the codes
for both inpatient and outpatient
settings use the same time increment,
the services that are included differ by
setting, consistent with the variation in
existing coding conventions.
(iii) Coding for Services Furnished Via
Electronic Means
Services that are provided via phone,
the internet, or other electronic means
outside the context of a face-to-face visit
would be reported using GXXX7 when
furnished by a practitioner and GXXX8
when furnished by clinical staff. We are
proposing that practitioners would not
report these services if they are
furnished the day before, the day of, or
the day after a visit as we believe these
would be included in the pre- and postservice activities in the typical visit.
However, we are proposing that these
codes be used to report non-face-to-face
services provided by clinical staff prior
to the primary procedure since global
surgery codes are typically valued with
assumptions regarding pre-service
clinical labor time. Given that some
practitioners have indicated that
services they furnish commonly include
activities outside the face-to-face
service, we believe it is important to
capture information about those
activities in both the pre- and postservice periods. We believe these
requirements to report on clinical labor
time are consistent with and no more
burdensome than those used to report
clinical labor time associated with
chronic care management services,
which similarly describe care that takes
place over more than one patient
encounter.
In addition, for services furnished via
interactive telecommunications that
meet the requirements of a Medicare
telehealth service visit, the appropriate
global service G-code for the services
should be reported with the GT modifier
to indicate that the service was
furnished ‘‘via interactive audio and
video telecommunications systems.’’
(iv) Benefits of G-Codes
One commenter indicated that the
documentation requirements and PEs
for post-operative visits differ from
those of other E/M visits, and
encouraged us to develop a separate
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series of codes to capture the work of
the post-operative services and to
measure, not just estimate, the number
and complexity of visits during the
global period. Others opposed the use of
a new set of codes or the use of
modifiers to collect information on postoperative visits. After considering the
RAND report, the comments and other
stakeholder input that we have received,
and our needs for data to fulfill our
statutory mandate and to value surgical
services appropriately, we are proposing
this new set of codes because we believe
it provides us the most robust data upon
which to determine the most
appropriate way and amounts to pay for
PFS surgical services. We believe that
the codes being proposed would
provide data of the kind that can
reasonably collected through claims
data and that reflect what we believe are
key issues in the post-operative care
where the service is provided, who
furnishes the service, its relative
complexity, and the time involved in
the service.
We seek public comments about all
aspects of these codes, including the
nature of the services described, the
time increment, and any other areas of
interest to stakeholders. We are
particularly interested in any pre- or
post-operative services furnished that
could not be appropriately captured by
these codes. Although RAND developed
this set of codes to collect data on postoperative services, we are proposing to
also use such codes to collect data on
pre-operative services. We are seeking
comments on whether the codes
discussed above are appropriate for
collecting data on pre-operative services
or whether additional codes should be
added to distinguish in the data
collected the resources used for preoperative services from those used for
post-operative services. We also seek
comment on any activities that should
be added to the list of activities in Table
10 to reflect typical pre-operative visit
activities.
(v) Alternative Approach to Coding
As noted above, many stakeholders
expressed strong support for the use of
CPT code 99024 (Postoperative followup visit, normally included in the
surgical package, to indicate that an
evaluation and management service was
performed during a postoperative period
for a reason(s) related to the original
procedure) to collect data on postoperative care. Stakeholders suggest that
practitioners are familiar with this
existing CPT code and the burden on
practitioners would be minimized by
only having to report that a visit
occurred, not the level of the visit. We
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do not believe that this code alone
would provide the information that we
need for valuing surgical services nor do
we believe it alone can meet the
statutory requirement that we collect
data on the number and level of visits
because it does not provide any
information beyond the number of
visits. Although we are proposing to use
the G-codes detailed above to measure
pre- and post-operative visits, given the
strong support that many stakeholders
have for the use of CPT code 99024, we
are soliciting comments specifically on
how we could use this code to capture
the statutorily required data on the
number and level of visits and the data
that we would need to value global
services in the future.
Some have suggested using CPT code
99024 with modifiers to indicate to
which of the existing levels of E/M
codes the visit corresponds. As outlined
in the RAND report, E/M visits may not
accurately capture what drives greater
complexity in post-operative visits. E/M
billing requirements are built upon
complexity in elements such as medical
history, review of systems, family
history, social history, and how many
organ systems are examined. In the
context of a post-operative visit, many
of these elements may be irrelevant.
RAND also noted that there was
significant concern from interviewees
and the expert panel about
documentation that is required for
reporting E/M codes. Specifically, they
argued that documentation
requirements for surgeons to support the
relevant E/M visit code would place
undue administrative burden on
surgeons. RAND reported that many
surgeons currently use minimal
documentation when they provide a
postoperative visit. Moreover, to value
surgical packages accurately we need to
understand the activities involved in
furnishing post-operative care and as
discussed above, we lack information
that would demonstrate that activities
involved in post-operative care are
similar to those in E/M services. In
addition, the use of modifiers to report
levels of services is more difficult to
operationalize than using unique
HCPCS codes. However, we would be
interested in whether, and if so, why,
practitioners would find it easier to
report CPT code 99024 with modifiers
corresponding to the proposed G-code
levels rather than the new G-codes, as
proposed. We are also seeking comment
on whether practitioners would find it
difficult to use this for pre-operative
visits since the CPT code descriptor
specifically defines it as a ‘‘postoperative follow-up’’ service.
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We are also seeking comment on
whether time of visits could alone be a
proxy for the level of visit. If pre- and
post-operative care varies only by the
time the practitioner spends care so that
time could be a proxy for complexity of
the service, then we could use the
reporting of CPT code 99024 in 10minute increments to meet the statutory
requirement of collecting claims-based
data on the number and level of visits.
In addition to comments on whether
time is an accurate proxy for level of
visit, we are seeking comment on the
feasibility and desirability of reporting
CPT 99024 in 10-minute increments.
c. Reporting of Claims
We propose that the G-codes detailed
above would be reported for services
related to and within 10- and 90-day
global periods for procedures furnished
on or after January 1, 2017. Services
related to the procedure furnished
following recovery and otherwise
within the relevant global period would
be required to be reported. These codes
would be included on claims filed
through the usual process. Through this
mechanism, we would collect all of the
information reported on a claim for
services, including information about
the practitioner, service furnished, date
of service, and the units of service. By
not imposing special reporting
requirements on the reporting of these
codes, we intend to allow practitioners
the flexibility to report the services on
a rolling basis as they are furnished or
to report all of the services on one claim
once all have been furnished, as long as
the filed claims meet the requirements
for filing claims. As with all other
claims, we would expect the patient’s
medical record to include
documentation of the services
furnished. Documentation that would be
expected is an indication that a visit
occurred or a service was furnished and
sufficient information to determine that
the appropriate G-code was reported.
We are not proposing any special
requirements for inclusion of additional
data on claims that could be used for
linking the post-operative care
furnished to a particular service. To use
the data reported on post-operative
visits for analysis and valuation, we will
link the data reported on post-operative
care to the related procedure using date
of service, practitioner, beneficiary, and
diagnosis. We believe this approach to
matching will allow us to accurately
link the preponderance of G-codes to
the related procedure. However, we
solicit comment on the extent to which
post-operative care may not be
appropriately linked to related
procedures whether we should consider
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using additional variables to link these
aspects of the care, and whether
additional data should be required to be
reported to enable a higher percentage
of matching.
d. Special Provisions for Teaching
Physicians
We are seeking comment on whether
special provisions are needed to capture
the pre- and post-operative services
provided by residents in teaching
settings. If the surgeon is present for the
key portion of the visit, should the
surgeon report the joint time spent by
the resident and surgeon with the
patient? If the surgeon is not present for
the key portion of the visit, should the
resident report the service? If we value
services without accounting for services
provided by residents that would
otherwise be furnished by the surgeon
in non-teaching settings, subsequent
valuations based upon the data we
collect may underestimate the resources
used, particularly for the types of
surgeries typically furnished in teaching
facilities. However, there is also a risk
of overvaluing services if the reporting
includes services that are provided by
residents when those services would
otherwise be furnished by a physician
other than the surgeon, such as a
hospitalist or intensivist, and as such,
should not be valued in the global
package.
e. Who Reports
In both the comments on the CY 2016
proposed rule and in the national
listening session, there was a great deal
of discussion regarding the challenges
that we are likely to encounter in
obtaining adequate data to support
appropriate valuation. Some indicated
that a broad sample and significant
cooperation from physicians would be
necessary to understand what is
happening as part of the global surgical
package. One commenter suggested that
determining a representative sample
would be difficult and, due to the
variability related to the patient
characteristics, it would be easier to
have all practitioners report. Many
suggested that we conduct an extensive
analysis across surgical specialties with
a sample that is representative of the
entire physician community and covers
the broad spectrum of the various types
of physician practice to avoid problems
that biased or inadequate data collection
would cause. Suggestions of factors to
account for in selecting a sample
include specialty, practice size
(including solo practices), practice
setting, volume of claims, urban, rural,
type of surgery, and type of health care
delivery systems. Another commenter
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pointed out that small sample sizes may
lead to unreliable data. On the other
hand, some commenters stated that
requiring all practitioners to report this
information is unreasonable and would
be an insurmountable burden. A
participant acknowledged that it would
be difficult for practitioners to report on
only certain procedures, while another
stated that this would not be an
administrative burden.
After considering the input of
stakeholders, we are proposing that any
practitioner who furnishes a procedure
that is a 10- or 90-day global report the
pre- and post-operative services
furnished on a claim using the codes
proposed above. We agree with
stakeholders that it is necessary to
obtain data from a broad, representative
sample across specialties, geographic
location, and practice size, practice
model, patient acuity, and differing
practice patterns. However, as we
struggled to develop a sampling
approach that would result in
statistically reliable and valid data, it
became apparent that we do not have
adequate information about how postoperative care is delivered, how it varies
and, more specifically, what drives
variation in post-operative care. In its
work to develop the coding used for its
study, RAND found a range of opinions
on what drives variation in postoperative care. (The report is available
on the CMS Web site under downloads
for the CY 2017 PFS proposed rule with
comment period at https://www.cms.gov/
physicianfeesched/downloads/.)
Without information on what drives
variation in pre- and post-operative
care, we would have to speculate about
the factors upon which to base a sample
or assume that the variation in such care
results from the same variables as are
frequently identified for explaining
variation in health care and clinical
practice. In addition, we have concerns
about whether a sample could provide
sufficient volume to value accurately
the global package, except in the case of
a few high-volume procedures.
In addition to concerns about
achieving an appropriate, sufficient, and
unbiased representative sample of
practitioners, we have significant
operational concerns with collecting
data from a limited sample of
practitioners or on a limited sample of
services. These include how to gain
sufficient information on practitioners
to sufficiently stratify the sample, how
to identify the practitioners who must
report, determining which services, and
for those who practice in multiple
settings and/or with multiple groups in
which settings the practitioner would
report. Establishing the rules to govern
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which post-operative care should be
reported for which procedures would be
challenging for us to develop for a
random sample and difficult for
physicians to apply.
With the limited time between the
issuance of the CY 2017 PFS final rule
with comment period and the beginning
of reporting on January 1st, it would be
challenging to make sure that affected
practitioners are aware of the
requirement to report and have an
ability to determine which postoperative care to report. If, instead, we
require all practitioners to report, we
can take a uniform approach to
notifying practitioners. The national
medical and coding organizations are
routinely relied upon by practitioners
for information on new coding and
billing requirements and play a major
role in the expeditious adoption of new
coding or billing requirements.
Similarly, adjustments to software used
for medical records and coding are
made by national organizations. We
have concerns that if this requirement is
only applied to a small segment of
practitioners that these organizations
will not be able to ensure that the
affected practitioners are aware and
easily able to comply with the
requirements.
The more robust the reported data, the
more accurate our ultimate valuations
can be. Given the importance of data on
visits in accurate valuations for global
packages, we believe that collecting data
on all pre- and post-operative visits in
the global period is the best way to
accurately value surgical procedures
with global packages.
We recognize that reporting of all preand post-operative visits would require
submission of additional claims by
those practitioners furnishing global
services, but we believe the benefits of
accurate data for valuation of services
merits the imposition of this
requirement. By using the claims system
to report the data, we believe the
additional burden is minimized.
Stakeholders have reported that many
practitioners are already required by
their practice or health care system to
report a code for each visit for internal
control purposes and some of these
systems already submit claims for these
services, which are denied. For these
practices, the additional burden would
be minimal. We believe that requiring
only some physicians to report this
information, or requiring reporting for
only some services, could actually be
more burdensome to physicians than
requiring this information from all
physicians on all services because of the
additional steps necessary to determine
whether a report is required for a
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particular service and adopting a
mechanism to assure that data is
collected and reported when required.
Moreover, we believe the challenges
with implementing a limited approach
at the practice level as compared to a
requirement for all global services
would result in less reliable data being
reported.
As we analyze the data collected and
make decisions about valuations, we
would reassess the data needed and
what should be required from whom.
Under section 1848(c)(8)(B)(ii) of the
Act, we are required to reassess every 4
years whether continued collection of
these data is needed. However, we can
modify through rulemaking what data is
collected at any time, as appropriate. By
collecting data on all procedures with a
10- or 90-day global package, we would
have the information to assess whether
the post-operative care furnished varies
by factors such as specialty, geography,
practice setting, and practice size, and
thus, the information needed for a
selection of a representative sample. By
initially collecting information from all
practitioners that furnish surgical
services, we believe we would be able
to reduce required reporting in the
future if we find that adequate
information can be obtained by selective
reporting. Without the broader set of
data we would not be able to evaluate
the variability of pre- and post-operative
care in order to identify a useful
targeted data collection.
While section 1848(c)(8)(B) of the Act
requires us to collect data from a
representative sample of physicians on
the number and level of visits provided
during the global period, it does not
prohibit us from collecting data from a
broad set of physicians. In addition,
section 1848(c)(2)(M) of the Act
authorizes the collection of data from a
wide range of physicians. Given the
benefits of more robust data, including
avoiding sample bias, obtaining more
accurate data, and facilitating
operational simplicity, we believe
collecting data on all post-operative care
initially is the best way to undertake an
accurate valuation of surgical services in
the future.
(1) Survey of Practitioners
We agree with commenters that we
need more information than is currently
provided on claims and that we should
utilize a number of different data
sources and collection approaches to
collect the data needed to assess and
revalue global surgery services. In
addition to the claims-based reporting,
we are proposing to survey a large,
representative sample of practitioners
and their clinical staff in which
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respondents would report information
about approximately 20 discrete preoperative and post-operative visits and
other global services like care
coordination and patient training. The
proposed survey would produce data on
a large sample of pre-operative and postoperative visits and is being designed so
that we could analyze the data collected
in conjunction with the claims-based
data that we would be collecting. We
expect to obtain data from
approximately 5,000 practitioners.
We have contracted with RAND to
develop and, if our proposal is finalized,
conduct this survey. RAND would also
assist us in analyzing data collected
under this survey and the claims-based
data. While the primary data collection
would be via a survey instrument,
RAND would conduct semi-structured
interviews and direct observations of
data in a small number of pilot sites to
inform survey design, validate survey
results, and collect information that is
not conducive to survey-based
reporting.
Our proposed sampling approach
would sample practitioners rather than
for procedures or visits to streamline
survey data collection and minimize
respondent burden. Specifically, we
propose to representative and random
sample from a frame of providers who
billed Medicare for more than a
minimum threshold of surgical
procedures with a 10- or 90-day global
period (for example, 200 procedures) in
the most recent available prior year of
claims data. We expect to survey
approximately 5,000 practitioners,
stratified by specialty, geography, and
practice type. Based upon preliminary
analysis we believe this number of
participants will allow us to collect
information on post-operative care
following the full range of CPT level-2
surgical procedure code groups. A
smaller sample size would reduce the
precision of estimates from the survey
and more importantly risk missing
important differences in post-operative
care for specific specialties or following
different types of surgical procedures.
We expect a response rate in excess of
50 percent.
We are not proposing that
respondents report on the entire period
of post-operative care for individual
patients, as a 90-day follow-up window
(for surgeries currently with a 90-day
global period) is too long to implement
practically in this study setting and
would be more burdensome to
practitioners. Instead, we propose to
collect information on a range of
different post-operative services
resulting from surgeries furnished by
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the in-sample practitioner prior to or
during a fixed reporting period.
Each sampled practitioner will be
assigned to a specified and brief (for
example, 2-week) reporting period.
Given the proposed overall data
collection period, the selected sample of
providers will be randomly divided into
6 subsets within each specialty, each of
which will be assigned to a specified
reporting period. Practitioners will be
asked to describe 20 post-operative
visits furnished to Medicare
beneficiaries or other patients during
the reporting period. The information
collected through the survey
instrument, which will be developed
based upon direct observation and
discussions in a small number of pilot
sites, will include contextual
information to describe the background
for the post-operative care, including,
for example:
• Procedure codes(s) and date of
service for procedure upon which the
global period is based.
• Procedure place of service (type).
• Whether or not there were
complications during or after the
procedure.
• The number in sequence of the
follow-up visit (for example, the first
visit after the procedure).
The survey instrument will also
collect information on the visit in
question including, for example:
• Which level of visit using the
finalized no-pay codes.
• Specific pre-service, face-to-face,
and post-service activities furnished
during the visit.
• Times for each activity.
• Identify who performed each
activity (physician or other
practitioner).
• PE components used during the
visit, for example supplies like surgical
dressings and clinical staff time.
Finally, the instrument will ask
respondents to report other prior or
anticipated care furnished to the patient
by the practice outside of the context of
a post-operative visit, for example nonface-to-face services.
The survey approach will
complement the claims data collection
by collecting detailed information on
the activities, time, intensity, and
resources involved in delivering global
services. The resulting visit-level survey
data would allow us to explore in detail
the variation in activities, time,
intensity, and resources associated with
global services within and between
physicians and procedures, and would
help to validate the information
gathered through claims. A summary of
the work that RAND would be doing is
available on the CMS Web site under
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downloads for the CY 2017 PFS
proposed rule with comment period at
https://www.cms.gov/physicianfeesched/
downloads/.
(2) Required Participation in Data
Collection
Using the authority we are provided
under sections 1848(c)(8) and
1848(c)(2)(M) of the Act, we are
proposing to require all practitioners
who furnish a 10- or 90-day global
service to submit a claim(s) providing
information on all services furnished
within the relevant global service period
in the form and manner described
below, beginning with surgical or
procedural services furnished on or after
January 1, 2017. We are also proposing
to require participation by practitioners
selected for the broad-based survey
through which we are proposing to
gather additional data needed to value
surgical services, such as the clinical
labor and equipment involved that
cannot be efficiently collected on claim
(see below).
Given the importance of the proposed
survey effort, making sure that we get
valid data is critical. By eliminating the
bias that would be associated with using
only data reported voluntarily, we
believe we will get more accurate and
representative data. In addition to the
potential bias inherent in voluntary
surveys, we are concerned that relying
on voluntary data reporting would limit
the adequacy of the volume of data we
obtain, will require more effort to recruit
participation, and may make it
impossible to obtain data for valuation
for CY 2019 as required by the statute.
Based on our previous experience
with requesting voluntary cooperation
in data collection activity, voluntary
participation poses a significant
challenge in data collection.
Specifically, the Urban Institute’s work
(under contract with us) to validate
work RVUs by conducting direct
observation of the time it took to furnish
certain elements of services paid under
the physician fee schedule provides
evidence of this challenge. (See https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/PhysicianFee
Sched/Downloads/RVUs-ValidationUrban-Interim-Report.pdf for an interim
report that describes challenges in
securing participation in voluntary data
collection.) Similarly, we routinely
request invoices on equipment and
supplies that are used in furnishing
services and often receive no more than
one invoice. These experiences support
the idea that mandatory participation in
data collection activities is essential if
we are to collect valid and unbiased
data.
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Section 1848(a)(9) of the Act
authorizes us, through rulemaking, to
withhold payment of up to 5 percent of
the payment for services on which the
practitioner is required to report under
section 1848(c)(8)(B)(i) of the Act until
the practitioner has completed the
required reporting. Some commenters
opposed the imposition of this payment
withhold, and others said it was too
large of a penalty. While we believe this
is a way to encourage practitioners to
report on claims the information we
propose to require on care that is
furnished in the global period, we are
not proposing to implement this option
at this time. We believe that requiring
physicians to report the information on
claims, combined with the incentive to
report complete information so that we
can make appropriate revisions when
we revalue payments for global surgical
services, would result in compliance
with the reporting requirements.
However, we note that if we find that
compliance with required claims-based
reporting is not acceptable, we would
consider in future rulemaking imposing
up to a 5 percent payment withhold as
authorized by the statute.
Consistent with the requirements of
section 1848(c)(2)(M) of the Act, should
the data collected under this
requirement be used to determine RVUs,
we will disclose the information source
and discuss the use of such information
in such determination of relative values
through future notice and comment
rulemaking.
(3) Data Collection From Accountable
Care Organizations (ACOs)
We are particularly interested in
knowing whether physicians and
practices affiliated with ACOs expend
greater time and effort in providing
post-operative global services in keeping
with their goal of improving care
coordination for their assigned
beneficiaries. ACOs are organizations in
which practitioners and hospitals
voluntarily come together to provide
high-quality and coordinated care for
their patients. Because such
organizations share in the savings
realized by Medicare, their incentive is
to minimize post-operative visits while
maintaining high quality post-operative
care for patients. In addition, we believe
that such organizations offer us the
opportunity to gain more in-depth
information about delivery of surgical
services.
We propose to collect primary data on
the activities and resources involved in
delivering services in and around
surgical events in the ACO context by
surveying a small number of ACOs
(Pioneer and Next Generation ACOs).
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Similar to the approach of the more
general practitioner survey, this effort
would begin with an initial phase of
primary data collection using a range of
methodologies in a small number of
ACOs; development, piloting, and
validation of an additional survey
module specific to ACOs. A survey of
practitioners participating in
approximately 4 to 6 ACOs using the
survey instrument along with the
additional ACO-specific module will be
used to collect data from on pre- and
post-operative visits.
(4) Conclusion
We recognize that the some of the
data collection activity proposed here
varies greatly from how the data is
currently gathered to support PFS
valuations for global surgery services.
However, we believe the proposed
claims-based data collection is generally
consistent with how claims data is
reported for other kinds of services paid
under the PFS. We believe that the
authority and requirements included in
the statute through the MACRA and
PAMA were intended to expand and
enhance data that might be available to
enhance the accuracy of PFS payments.
Because these are new approaches to
collecting data and in an area—global
surgery—where very little data has
previously been collected, we cannot
describe exactly how this information
would be used in valuing services. What
is clear is that the claims-based data
would provide information parallel to
the kinds of claims-data used in
developing RVUs for other PFS services
and that by collecting these data, we
would know far more than we do now
about how post-operative care is
delivered and gain insight to support
appropriate packaging and valuation.
We would include any revaluation
proposals based on these data in
subsequent notice and comment
rulemaking.
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E. Improving Payment Accuracy for
Primary Care, Care Management, and
Patient-Centered Services
1. Overview
In recent years, we have undertaken
ongoing efforts to support primary care
and patient-centered care management
within the PFS as part of HHS’ broader
efforts to achieve better care, smarter
spending and healthier people through
delivery system reform. We have
recognized the need to improve
payment accuracy for primary care and
patient-centered care management over
several years, especially beginning in
the CY 2012 PFS proposed rule (76 FR
42793) and continuing in each
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subsequent year of rulemaking. In the
CY 2012 proposed rule, we
acknowledged the limitations of the
current code set that describes
evaluation & management (E/M)
services within the PFS. For example, E/
M services represent a high proportion
of PFS expenditures but have not been
recently revalued to account for
significant changes in the disease
burden of the Medicare patient
population and changes in health care
practice that are underway, to meet the
current population’s health care needs.
These trends in the Medicare
population and health care practice
have been widely recognized in the
provider community and by health
services researchers and policymakers
alike.1 We believe the focus of the
health care system has shifted to
delivery system reforms, such as
patient-centered medical homes,
clinical practice improvement, and
increased investment in primary and
comprehensive care management/
coordination services for chronic and
other conditions. This shift requires
centralized management of patient
needs and extensive care coordination
among practitioners and providers
(often on a non-face-to-face basis across
an extended period of time). In contrast,
the current CPT code set is designed
with an overall orientation to pay for
discrete services and procedural care as
opposed to ongoing primary care, care
management and coordination, and
cognitive services. It includes thousands
of separately paid, individual codes,
most of which describe highly
specialized procedures and diagnostic
tests, while there are relatively few
codes that describe care management
and cognitive services. Further, in the
past, we have not recognized as
separately payable many existing CPT
codes that describe care management
and cognitive services, viewing them as
bundled and paid as part of other
services including the broadly drawn E/
M codes that describe face-to-face visits
billed by physicians and practitioners in
all specialties.
This has resulted in minimal service
variation for ongoing primary care, care
management and coordination, and
1 See, for example, https://content.healthaffairs.
org/content/25/5/w378.full; https://www.common
wealthfund.org/publications/issue-briefs/2008/feb/
how-disease-burden-influences-medicationpatterns-for-medicare-beneficiaries—implicationsfor-polic; https://www.hhs.gov/ash/about-ash/
multiple-chronic-conditions/; https://
www.nejm.org/doi/full/10.1056/NEJMp1600999#
t=article; https://www.pcpcc.org/about; https://
www.cms.gov/Medicare/Quality-Initiatives-PatientAssessment-Instruments/Value-Based-Programs/
MACRA-MIPS-and-APMs/MACRA-MIPS-andAPMs.html.
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cognitive services relative to other PFS
services, and in potential misvaluation
of E/M services under the PFS (76 FR
42793). Some stakeholders believe that
there is substantial misvaluation of
physician work within the PFS, and that
the current service codes fail to capture
the range and intensity of
nonprocedural physician activities (E/M
services) and the ‘‘cognitive’’ work of
certain specialties (https://www.nejm.
org/doi/full/10.1056/NEJMp1600999#
t=article).
Recognizing the inverse for specialties
that furnish other kinds of services,
MedPAC has noted that the PFS allows
some specialties to more easily increase
the volume of services they provide
(and therefore their revenue from
Medicare) relative to other specialties,
particularly those that spend most of
their time providing E/M services.
(MedPAC March 2015 Report to the
Congress, available at https://
www.medpac.gov/-documents-/reports).
We agree with this analysis, and we
recognize that the current set of E/M
codes limits Medicare’s ability under
the PFS to appropriately recognize the
relative resource costs of primary care,
care management/coordination and
cognitive services relative to specialized
procedures and diagnostic tests.
In recent years, we have been engaged
in an ongoing incremental effort to
update and improve the relative value of
primary care, care management/
coordination, and cognitive services
within the PFS by identifying gaps in
appropriate payment and coding. These
efforts include changes in payment and
coding for a broad range of PFS services.
This effort is particularly vital in the
context of the forthcoming transition to
the Merit-Based Incentive Payment
System (MIPS) and Alternative Payment
Models (APMs) incentives under The
Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA)
(Pub. L. 114–10, enacted April 16,
2015), since MIPS and many APMs will
adopt and build on PFS coding, RVUs
and PFS payment as their foundation.
In CY 2013, we began by focusing on
post-discharge care management and
transition of beneficiaries back into the
community, establishing new codes to
pay separately for transitional care
management (TCM) services. Next we
finalized new coding and separate
payment beginning in CY 2015 for
chronic care management (CCM)
services provided by clinical staff. Most
recently, in the CY 2016 PFS proposed
rule (80 FR 41708 through 41711), we
solicited public comments on three
additional policy areas of consideration:
(1) Improving payment for the
professional work of care management
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services through coding that would
more accurately describe and value the
work of primary care and other
cognitive specialties for complex
patients (for example, monthly timed
services including care coordination,
patient/caregiver education, medication
management, assessment and
integration of data, care planning); (2)
establishing separate payment for
collaborative care, particularly, how we
might better value and pay for robust
inter-professional consultation, between
primary care physicians and
psychiatrists (developing codes to
describe and provide payment for the
evidence-based psychiatric collaborative
care model (CoCM), and between
primary care physicians and other (nonmental health) specialists; and (3)
assessing whether current PFS payment
for CCM services is adequate and
whether we should reduce the
administrative burden associated with
furnishing and billing these services.
In the CY 2016 PFS final rule with
comment period (80 FR 70919 through
70921), we summarized the many
public comments we received in
response to last year’s comment
solicitation. Instead of the specific
policies we sought comment on, several
commenters recommended an overhaul
and complete revaluation of the E/M
codes through a major research
initiative akin to that undertaken when
the PFS was first established. Many
other commenters recommended that,
until a major research initiative could be
conducted to fully address the
deficiencies in the current E/M code set,
CMS should make separate payment
under Medicare for a number of existing
CPT codes to improve payment in the
areas in which we solicited comments,
including the codes used to describe
complex CCM services (CPT codes
99487 and 99489). Other commenters
also suggested that care management
services may be beneficial to a number
of other patient populations in addition
to those transitioning into the
community from an inpatient setting
and those with multiple chronic
conditions.
Also in response to our CY 2016
comment solicitation, the AMA
restructured its existing CPT/RUC
workgroup on these issues and
convened the relevant individual
specialty societies to develop new CPT
coding that would address these issues.
We understand that these efforts are
ongoing, and that at this time, two sets
of new codes are scheduled to be
included in the CY 2018 CPT code set
in response to our 2016 comment
solicitation. One is a set of new codes
describing services furnished under the
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psychiatric CoCM and the other is a
code for assessment and care planning
services for patients with cognitive
impairment. Several stakeholders have
urged us to facilitate Medicare payment
for these and other new primary care,
care management, and cognitive
services sooner than CY 2018 by
proposing payment using G-codes for
CY 2017.
In response to our comment
solicitation in the CY 2016 proposed
rule, MedPAC commented that the PFS
is an ill-suited payment mechanism for
primary care and cognitive care
generally. MedPAC recommended that
Congress replace the expired Primary
Care Incentive Payment (PCIP) with a
capitated payment mechanism and
expressed preference for codes like CCM
that are beneficiary-centered and do not
pay for each distinct care coordination
activity.
Finally, many public commenters
recommended a number of
modifications to the current CCM
payment rules. According to many
commenters, current payment does not
cover the cost of furnishing these
services, and therefore, the codes are
underutilized. As referenced in section
II.E.3 on improving access and payment
for CCM services, our assessment of
claims data for CY 2015 for CPT code
99490 suggests that CCM services may
be underutilized relative to the intended
eligible patient population.
After considering the commenters’
perspective and recommendations, as
well as monitoring the ongoing efforts at
the AMA/RUC and CPT to respond with
new/revised coding, for CY 2017 we are
proposing a number of changes to
coding and payment policies under the
PFS. These proposals are intended to
accomplish the following:
• Improve payment for care
management services provided in the
care of beneficiaries with behavioral
health conditions (including services for
substance use disorder treatment)
through new coding, including three
codes used to describe services
furnished as part of the psychiatric
CoCM and one to address behavioral
health integration more broadly.
• Improve payment for cognition and
functional assessment, and care
planning for beneficiaries with cognitive
impairment.
• Adjust payment for routine visits
furnished to beneficiaries whose care
requires additional resources due to
their mobility-related disabilities.
• Recognize for Medicare payment
the additional CPT codes within the
Chronic Care Management family (for
Complex CCM services) and adjust
payment for the visit during which CCM
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services are initiated (the initiating CCM
visit) to reflect resources associated with
the assessment for, and development of,
a new care plan.
• Recognize for Medicare payment
CPT codes for non-face-to-face
Prolonged E/M services by the
physician (or other billing practitioner)
that are currently bundled, and increase
payment rates for face-to-face prolonged
E/M services by the physician (or other
billing practitioner) based on existing
RUC recommended values.
We are aware that CPT has approved
a code to describe assessment and care
planning for patients with cognitive
impairment; however, it will not be
ready in time for valuation in CY 2017.
Therefore, we are proposing to make
payment using a G-code (GPPP6—see
below) for this service in 2017. We are
also aware that CPT has approved three
codes that describe services furnished
consistent with the psychiatric CoCM,
but that they will also not be ready in
time for valuation in CY 2017. We
discuss these services in more detail in
the next section of this proposed rule.
To facilitate separate payment for these
services furnished to Medicare
beneficiaries during CY 2017, we are
proposing to make payment through the
use of three G-codes (GPPP1, GPPP2,
and GPPP3—see below) that parallel the
new CPT codes, as well as a fourth Gcode (GPPPX—see below) to describe
services furnished using a broader
application of behavioral health
integration in the primary care setting.
We intend for these to be temporary
codes (for perhaps only one year) and
will consider whether to adopt and
establish values for the new CPT codes
under our standard process, presumably
for CY 2018. While we recognize that
there may be overlap in the patient
populations for the proposed new Gcodes, we note that time spent by a
practitioner or clinical staff cannot be
counted more than once for any code (or
assigned to more than one patient),
consistent with PFS coding
conventions.
Proposed payment for services
described by new coding are as follows
(please note that the descriptions
included for GPPP1, GPPP2, and GPPP3
are from Current Procedural
Terminology (CPT®) Copyright 2016
American Medical Association (and will
be effective as part of CPT codes January
1, 2018). All rights reserved):
• GPPP1: Initial psychiatric
collaborative care management, first 70
minutes in the first calendar month of
behavioral health care manager
activities, in consultation with a
psychiatric consultant, and directed by
the treating physician or other qualified
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health care professional, with the
following required elements:
++ Outreach to and engagement in
treatment of a patient directed by the
treating physician or other qualified
health care professional;
++ Initial assessment of the patient,
including administration of validated
rating scales, with the development of
an individualized treatment plan;
++ Review by the psychiatric
consultant with modifications of the
plan if recommended;
++ Entering patient in a registry and
tracking patient follow-up and progress
using the registry, with appropriate
documentation, and participation in
weekly caseload consultation with the
psychiatric consultant; and
++ Provision of brief interventions
using evidence-based techniques such
as behavioral activation, motivational
interviewing, and other focused
treatment strategies.
• GPPP2: Subsequent psychiatric
collaborative care management, first 60
minutes in a subsequent month of
behavioral health care manager
activities, in consultation with a
psychiatric consultant, and directed by
the treating physician or other qualified
health care professional, with the
following required elements:
++ Tracking patient follow-up and
progress using the registry, with
appropriate documentation;
++ Participation in weekly caseload
consultation with the psychiatric
consultant;
++ Ongoing collaboration with and
coordination of the patient’s mental
health care with the treating physician
or other qualified health care
professional and any other treating
mental health providers;
++ Additional review of progress and
recommendations for changes in
treatment, as indicated, including
medications, based on
recommendations provided by the
psychiatric consultant;
++ Provision of brief interventions
using evidence-based techniques such
as behavioral activation, motivational
interviewing, and other focused
treatment strategies;
++ Monitoring of patient outcomes
using validated rating scales; and
relapse prevention planning with
patients as they achieve remission of
symptoms and/or other treatment goals
and are prepared for discharge from
active treatment.
• GPPP3: Initial or subsequent
psychiatric collaborative care
management, each additional 30
minutes in a calendar month of
behavioral health care manager
activities, in consultation with a
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psychiatric consultant, and directed by
the treating physician or other qualified
health care professional (List separately
in addition to code for primary
procedure) (Use GPPP3 in conjunction
with GPPP1, GPPP2).
• GPPPX: Care management services
for behavioral health conditions, at least
20 minutes of clinical staff time,
directed by a physician or other
qualified health care professional time,
per calendar month.
• GPPP6: Cognition and functional
assessment using standardized
instruments with development of
recorded care plan for the patient with
cognitive impairment, history obtained
from patient and/or caregiver, by the
physician or other qualified health care
professional in office or other outpatient
setting or home or domiciliary or rest
home.
• GPPP7: Comprehensive assessment
of and care planning by the physician or
other qualified health care professional
for patients requiring chronic care
management services, including
assessment during the provision of a
face-to-face service (billed separately
from monthly care management
services) (Add-on code, list separately
in addition to primary service).
• GDDD1: Resource-intensive
services for patients for whom the use
of specialized mobility-assistive
technology (such as adjustable height
chairs or tables, patient lifts, and
adjustable padded leg supports) is
medically necessary and used during
the provision of an office/outpatient
evaluation and management visit (Addon code, list separately in addition to
primary procedure).
Additionally, we are aware that other
codes are being developed through the
CPT process. We have noted with
interest that the CPT Editorial Panel and
AMA/RUC restructured the former
Chronic Care Coordination Workgroup
to establish a new Emerging CPT and
RUC Issues Workgroup that we hope
will continue to consider the issues
raised in this section of our CY 2017
proposed rule. We are continuing to
consider possible additional codes for
CCM services that would describe the
time of the physician or other billing
practitioner. We also remain interested
in whether there should be changes
under the PFS to reflect additional
models of inter-professional
collaboration for health conditions, in
addition to those we are proposing for
behavioral health integration.
For additional details on the coding
and proposed valuation related to these
proposals, see section II.L of this
proposed rule for Valuation of Specific
Codes. We note that the development of
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coding for these and other kinds of
services across the PFS is typically an
iterative process that responds to
changes in medical practice and may be
best refined over several years, with PFS
rulemaking and the development of CPT
codes as important parts of that process.
Thus, we anticipate continuing the
multi-year process of implementing
initiatives designed to improve payment
for, and recognize long-term investment
in, primary care, care management and
cognitive services, and patient-centered
services.
2. Non-Face-To-Face Prolonged
Evaluation & Management (E/M)
Services
In public comments to the CY 2016
PFS proposed rule, many commenters
recommended that CMS should
establish separate payment for non-faceto-face prolonged E/M service codes that
we currently consider to be ‘‘bundled’’
under the PFS (CPT codes 99358,
99359). The CPT descriptors are:
• CPT code 99358 (Prolonged
evaluation and management service
before and/or after direct patient care,
first hour); and
• CPT code 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).
Commenters believed that separate
payment for these existing CPT codes
would provide a means for physicians
and other billing practitioners to receive
payment that more appropriately
accounts for time that they spend
providing non-face-to-face care. We
agree that these codes would provide a
means to recognize the additional
resource costs of physicians and other
practitioners when they spend an
extraordinary amount of time outside
the in-person office visit caring for the
individual needs of their patients. And
we believe that doing so in the context
of the ongoing changes in health care
practice to meet the current
population’s health care needs would be
beneficial for Medicare beneficiaries
and consistent with our overarching
goals related to patient-centered care.
These non-face-to-face prolonged
service codes are broadly described
(although they include only time spent
personally by the physician or other
billing practitioner) and have a
relatively high time threshold (the time
counted must be beyond the usual
service time for the primary or
companion E/M code that is also billed).
We believe this makes them sufficiently
distinct from the other codes we
propose to pay in CY 2017 as part of our
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primary care/care management/
cognitive care initiative described in
this section of our proposed rule.
Accordingly, beginning in CY 2017 we
propose to recognize CPT codes 99358
and 99359 for separate payment under
the PFS. We note that time could not be
counted more than once towards the
provision of CPT codes 99358 or 99359
and any other PFS service. See section
II.L for a discussion of our proposed
valuation of CPT codes 99358 and
99359.
We propose to require the services to
be furnished on the same day by the
same physician or other billing
practitioner as the companion E/M
code. However, in reviewing the CPT
guidance for CPT codes 99358 and
99359, we noted that CPT codes 99358
and 99359 should not be reported
during the same service period as
complex CCM services (CPT codes
99487, 99489) or TCM services (CPT
codes 99495, 99496). One reason for
excluding TCM and complex CCM
services from concurrent billing would
be that, like prolonged services, TCM
and complex CCM services include
substantial non-face-to-face work by the
billing physician or other practitioner
(an E/M visit and/or medical decisionmaking of moderate or high
complexity). However, the CPT
prolonged service with patient contact
codes are billable on the same day an E/
M service is furnished, and the CPT
prolonged service codes without direct
patient contact are services furnished
during a single day that are directly
related to a discrete face-to-face service.
In contrast, TCM and CCM codes are
billed monthly and focused on a broader
episode of patient care. We are seeking
public input on the intersection of the
prolonged service codes with CCM and
TCM services. We are also seeking
public comment on the potential
intersection of the prolonged service
CPT codes 99358 and 99359 with
proposed code GPPP7 (Comprehensive
assessment of and care planning for
patients requiring CCM services).
Specifically, we are seeking comment
regarding how distinctions among these
services can be clearly delineated,
including how the prolonged time can
be clearly distinguished from typical
pre- and post-service time, which is
continued to be bundled with other
codes. For all of these services, we have
concerns that there may potentially be
program integrity risks as the same nonface-to-face activities could be
undertaken to meet the billing
requirements for any of the above. We
are seeking public comment to help us
identify the full extent of program
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integrity considerations, as well as
options for mitigating program integrity
risks associated with these and other
potentially overlapping codes.
3. Establishing Separate Payment for
Behavioral Health Integration (BHI)
a. Psychiatric Collaborative Care Model
(CoCM)
In the CY 2016 PFS final rule with
comment period (80 FR 70920), we
stated that we believed the care and
management for Medicare beneficiaries
with behavioral health conditions may
include extensive discussion,
information sharing and planning
between a primary care physician and a
specialist. We refer to this practice
broadly as ‘‘Behavioral Health
Integration’’ (BHI). In CY 2016
rulemaking, we described that in recent
years, many randomized controlled
trials have established an evidence base
for an approach to caring for patients
with behavioral health conditions called
the psychiatric Collaborative Care
Model (CoCM). A specific model for
BHI, CoCM typically is provided by a
primary care team, consisting of a
primary care provider and a care
manager who works in collaboration
with a psychiatric consultant, such as a
psychiatrist. Care is directed by the
primary care team and includes
structured care management with
regular assessments of clinical status
using validated tools and modification
of treatment as appropriate. The
psychiatric consultant provides regular
consultations to the primary care team
to review the clinical status and care of
patients and to make recommendations.
As we previously noted, several
resources have been published that
describe the psychiatric CoCM in greater
detail and assess the impact of the
model, including pieces from the
University of Washington (https://
aims.uw.edu/), the Institute for Clinical
and Economic Review (https://icerreview.org/announcements/icer-reportpresents-evidence-based-guidance-tosupport-integration-of-behavioralhealth-into-primary-care/), and the
Cochrane Collaboration (https://
www.cochrane.org/CD006525/
DEPRESSN_collaborative-careforpeople-with-depression-and-anxiety).
Because this particular kind of
collaborative care model has been tested
and documented in medical literature,
we expressed that we were particularly
interested in comments on how coding
under the PFS might facilitate
appropriate valuation of the services
furnished under the model. We also
solicited comments to assist us in
considering refinements to coding and
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payment to address this model in
particular relative to current coding and
payment policies, as well as information
related to various requirements and
aspects of these services.
After consideration of the comments,
we are proposing to begin making
separate payment for services furnished
using the psychiatric CoCM beginning
January 1, 2017. We are aware that CPT,
recognizing the need for new coding for
services under this model of care, has
approved three codes to describe
psychiatric collaborative care that is
consistent with this model, but the
codes will not be ready in time for
valuation in CY 2017. Current CPT
coding does not accurately describe or
facilitate appropriate payment for the
treatment of Medicare beneficiaries
under this model of care. For example,
under current Medicare payment policy,
there is no payment made specifically
for regular monitoring of patients using
validated clinical rating scales or for
regular psychiatric caseload review and
consultation that does not involve faceto-face contact with the patient. We
believe that these resources are directly
involved in furnishing ongoing care
management services to specific
patients with specific needs, but they
are not appropriately recognized under
current coding and payment
mechanisms. Because PFS valuation is
based on the relative resource costs of
the PFS services furnished to Medicare
beneficiaries, we believe that
appropriate coding for these services for
CY 2017 will facilitate accurate payment
for these and other PFS services.
Therefore, we are proposing separate
payment for services under the
psychiatric CoCM using three new Gcodes, as detailed above: GPPP1, GPPP2,
and GPPP3, which would parallel the
CPT codes that are being created to
report these services. We intend for
these to be temporary codes (for perhaps
only one year) and will consider
whether to adopt and establish values
for the new CPT codes under our
standard process, presumably for CY
2018.
Services in the psychiatric CoCM are
provided under the direction of a
treating physician or other qualified
health care professional during a
calendar month. These services are
provided when a patient has a
diagnosed psychiatric disorder that
requires a behavioral health care
assessment; establishing, implementing,
revising, or monitoring a care plan; and
provision of brief interventions. The
diagnosis may be either pre-existing or
made by the billing practitioner. These
services are reported by the treating
physician or other qualified health care
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professional and include the services of
the treating physician or other qualified
health care professional, the behavioral
health care manager (see description
below) who furnishes services incident
to services of the treating physician or
other qualified health care professional,
and the psychiatric consultant (see
description below) whose consultative
services are furnished incident to
services of the treating physician or
other qualified health care professional.
Patients who are appropriate candidates
to participate in the psychiatric CoCM
may have newly diagnosed conditions,
need help in engaging in treatment,
have not responded to standard care
delivered in a non-psychiatric setting, or
require further assessment and
engagement prior to consideration of
referral to a psychiatric care setting.
Patients are treated under this model for
an episode of care, defined as beginning
when the behavioral health care
manager engages in care of the patient
under the appropriate supervision of the
treating physician and ending with:
• The attainment of targeted
treatment goals, which typically results
in the discontinuation of care
management services and continuation
of usual follow-up with the treating
physician or other qualified healthcare
professional; or
• Failure to attain targeted treatment
goals culminating in referral to a
psychiatric care provider for ongoing
treatment; or
• Lack of continued engagement with
no psychiatric collaborative care
management services provided over a
consecutive six month calendar period
(break in episode).
A new episode of care starts after a
break in episode of six calendar months
or more.
The treating physician or other
qualified health care professional
directs the behavioral health care
manager and continues to oversee the
patient’s care, including prescribing
medications, providing treatments for
medical conditions, and making
referrals to specialty care when needed.
Medically necessary E/M and other
services may be reported separately by
the treating physician or other qualified
health care professional, or other
physicians or practitioners, during the
same calendar month. Time spent by the
treating physician or other qualified
health care professional on activities for
services reported separately may not be
included in the services reported using
GPPP1, GPPP2, and GPPP3. The
behavioral health care manager under
this model of care is a member of the
treating physician or other qualified
health care professional’s clinical staff
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with formal education or specialized
training in behavioral health (which
could include a range of disciplines, for
example, social work, nursing, and
psychology) who provides care
management services, as well as an
assessment of needs, including the
administration of validated rating
scales,2 the development of a care plan,
provision of brief interventions, ongoing
collaboration with the treating
physician or other qualified health care
professional, maintenance of a registry,3
all in consultation with a psychiatric
consultant. The behavioral health care
manager furnishes these services both
face-to-face and non-face-to-face, and
consults with the psychiatric consultant
minimally on a weekly basis. We would
expect that the behavioral health care
manager would be on-site at the location
where the treating physician or other
qualified health care professional
furnishes services to the beneficiary.
The behavioral health care manager
may or may not be a professional who
meets all the requirements to
independently furnish and report
services to Medicare. If otherwise
eligible, then that individual may report
separate services furnished a beneficiary
receiving the services described by
GPPP1, GPPP2, GPPP3, and GPPPX in
the same calendar month. These could
include: psychiatric evaluation (90791,
90792), psychotherapy (90832, 90833,
90834, 90836, 90837, 90838),
psychotherapy for crisis (90839, 90840),
family psychotherapy (90846, 90847),
multiple family group psychotherapy
(90849), group psychotherapy (90853),
smoking and tobacco use cessation
counseling (99406, 90407), and alcohol
or substance abuse structured screening
and brief intervention services (99408,
99409). Time spent by the behavioral
health care manager on activities for
services reported separately may not be
included in the services reported using
time applied to GPPP1, GPPP2, and
GPPP3.
The psychiatric consultant involved
in the ‘‘incident to’’ care furnished
under this model is a medical
professional trained in psychiatry and
qualified to prescribe the full range of
medications. The psychiatric consultant
advises and makes recommendations, as
needed, for psychiatric and other
medical care, including psychiatric and
other medical diagnoses, treatment
strategies including appropriate
therapies, medication management,
2 For example, see https://aims.uw.edu/resourcelibrary/measurement-based-treatment-target.
3 For example, see https://aims.uw.edu/
collaborative-care/implementation-guide/planclinical-practice-change/identify-population-based.
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medical management of complications
associated with treatment of psychiatric
disorders, and referral for specialty
services, that are communicated to the
treating physician or other qualified
health care professional, typically
through the behavioral health care
manager. The psychiatric consultant
does not typically see the patient or
prescribe medications, except in rare
circumstances, but can and should
facilitate a referral to a psychiatric care
provider when clinically indicated.
In the event that the psychiatric
consultant furnishes services to the
beneficiary directly in the calendar
month described by other codes, such as
E/M services or psychiatric evaluation
(90791, 90792), the services may be
reported separately by the psychiatric
consultant. Time spent by the
psychiatric consultant on activities for
services reported separately may not be
included in the services reported using
GPPP1, GPPP2, and GPPP3.
We also note that, although the
psychiatric CoCM has been studied
extensively in the setting of specific
behavioral health conditions (for
example, depression), we received
persuasive comments last year
recommending that we not specify
particular diagnoses required for use of
the codes for several reasons, including
that: there may be overlap in behavioral
health conditions; there are concerns
that there could be modification of
diagnoses to fit within payment rules
which could skew the accuracy of
submitted diagnosis code data; and for
many patients for whom specialty care
is not available, or who choose for other
reasons to remain in primary care,
primary care treatment will be more
effective if it is provided within a model
of integrated care that includes care
management and psychiatric
consultation.
(1) General Behavioral Health
Integration (BHI)
We recognize that the psychiatric
CoCM is prescriptive and that much of
its demonstrated success may be
attributable to adherence to a set of
elements and guidelines of care as
described in the preceding paragraphs.
Therefore, we are proposing the use of
these codes to pay accurately for this
specific model of care for the benefit of
Medicare beneficiaries, given its widespread adoption and recognized
effectiveness. However, we note that
PFS coding, in general, does not dictate
how physicians practice medicine and
believe that it should, instead, reflect
the practice of medicine. We also
recognize that there are primary care
practices that are incurring, or may
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incur, resource costs inherent to
treatment of patients with similar
conditions based on other models of
BHI that may benefit beneficiaries with
behavioral health conditions (see, for
example, the approach described at
https://www.integration.samhsa.gov/
integrated-care-models.) These models
of care include resource costs associated
with care managers and consultants that
are not accurately characterized by the
descriptions in the preceding
paragraphs. However, these costs are
also not included as direct PE inputs in
other PFS services, such as E/M codes.
In its comment regarding the psychiatric
CoCM, MedPAC noted its preference for
beneficiary-centered treatment that
would allow for flexibility in addressing
patient needs, rather than approaches
that are tied to a particular model of
care. MedPAC also urged CMS not to
make separate payment for each care
management activity.
Therefore, to recognize the resource
costs associated with furnishing
behavioral health care management
services to Medicare beneficiaries under
related but different models of care
without paying for each activity
separately, we are also proposing to
make payment using a new G-code that
describes care management for
beneficiaries with diagnosed behavioral
health conditions under a broader
application of integration in the primary
care setting. We believe that for this
subset of Medicare beneficiaries, the
resources associated with medically
necessary care management services are
not otherwise adequately reflected
under the PFS. The proposed code is
GPPPX (Care management services for
behavioral health conditions, at least 20
minutes of clinical staff time, directed
by a physician or other qualified health
care professional time, per calendar
month). We note that we expect this
coding to be refined over time as we
receive more information about other
behavioral health care models being
used and how they are implemented.
We are seeking stakeholder input on
whether we should consider requiring a
longer duration of time for this code or
an add-on to the code that would allow,
for example, additional 20 minute
increments. In addition, while we
recognize that services inherent to
models of BHI provided under this code
may range in resource costs, we hope
that appropriate payment for these
services will lead to appropriate use of
BHI models of care, which, in turn, will
inform further refinement of the
valuation in the future. For additional
information on proposed valuation of
these codes, see section II.L of this
proposed rule.
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(2) Initiating Visit for Proposed BHI
Codes (GPPP1, GPPP2, GPPP3, and
GPPPX)
Similar to CCM services (see section
II.E.4), we propose to require an
initiating visit for the BHI codes (both
the psychiatric CoCM model and the
general BHI code), that would be
billable separately from the services
themselves. We propose that the same
services that can serve as the initiating
visit for CCM services (see section II.E.3
of this proposed rule) can serve as the
initiating visit for the proposed BHI
codes. The initiating visit would
establish the beneficiary’s relationship
with the billing practitioner (most
aspects of the BHI services would be
furnished incident to the billing
practitioner’s professional services),
ensure the billing treating physician or
other qualified health care professional
assesses the patient prior to initiating
other care management processes, and
provides an opportunity to obtain
beneficiary consent (discussed below).
We welcome public comment on the
types of services that are appropriate for
an initiating visit for the BHI codes, and
within what timeframe the initiating
visit should be conducted prior to
furnishing BHI services.
consultant, and that, as part of the
consent, the beneficiary is informed that
there is beneficiary cost-sharing,
including potential deductible and
coinsurance amounts, for both in-person
and non-face-to-face services that are
provided. We welcome stakeholder
comments on this proposal.
We recognize that special informed
consent can also be helpful in cases
when a particular service is limited to
being billed by a single practitioner for
a particular beneficiary. We do not
believe that there are circumstances
where it would reasonable for multiple
practitioners to be reporting these codes
during the same month. However, we
are not proposing a formal limit at this
time. We are seeking comment on
whether such a limitation would be
beneficial or whether there are
circumstances under which a
beneficiary might reasonably receive
BHI services from more than one
practitioner during a given month.
In recent months, many stakeholders
have advised that we should waive the
applicable Part B coinsurance for
services such as those included in our
proposed BHI codes. However, we
currently lack statutory authority to
waive the coinsurance for services such
as these.
(3) Beneficiary Consent
Commenters to the CY 2016 PFS
proposed rule indicated that they did
not believe a specific patient consent for
BHI services is necessary and, in fact,
that requiring special informed consent
for these services may reduce access due
to stigma associated with behavioral
health conditions. Instead, the
commenters recommended requiring a
more general consent prior to initiating
these services whereby the beneficiary
gives the initiating physician or
practitioner permission to consult with
relevant specialists, which would
include conferring with a psychiatric
consultant. Accordingly, we propose to
require a general beneficiary consent to
consult with relevant specialists prior to
initiating these services, recognizing
that applicable rules continue to apply
regarding privacy. The proposed general
consent would encompass conferring
with a psychiatric consultant when
furnishing the psychiatric CoCM codes
(GPPP1, GPPP2, and GPPP3) or the
broader BHI code (GPPPX). Similar to
the proposed beneficiary consent
process for CCM services (see section
II.E.4 of this proposed rule), we propose
that the billing practitioner must
document in the beneficiary’s medical
record that the beneficiary’s consent
was obtained to consult with relevant
specialists including a psychiatric
4. Reducing Administrative Burden and
Improving Payment Accuracy for
Chronic Care Management (CCM)
Services
Beginning in CY 2015, we
implemented separate payment for
chronic care management (CCM)
services under CPT code 99490 (Chronic
care management services, at least 20
minutes of clinical staff time directed by
a physician or other qualified health
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.
We finalized a proposal to make
separate payment for CCM services as
one initiative in a series of initiatives
designed to improve payment for, and
encourage long-term investment in, care
management services (79 FR 67715). In
particular, we sought to address an issue
raised to us by the physician
community, which asserted that the care
management included in many of the
existing E/M services, such as office
visits, does not adequately describe the
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typical non-face-to-face care
management work required by certain
categories of beneficiaries (78 FR
43337). We began to re-examine how
Medicare should pay under the PFS for
non-face-to-face care management
services that were bundled into the PFS
payment for face-to-face E/M visits,
being included in the pre- and postencounter work (78 FR 43337). In
proposing separate payment for CCM,
we acknowledged that, even though we
had previously considered non-face-toface care management services as
bundled into the payment for face-toface E/M visits, the E/M office/
outpatient visit CPT codes may not
reflect all the services and resources
required to furnish comprehensive,
coordinated care management for
certain categories of beneficiaries. We
stated that we believed that the
resources required to furnish complex
chronic care management services to
beneficiaries with multiple (that is, two
or more) chronic conditions were not
adequately reflected in the existing E/M
codes. Medical practice and patient
complexity required physicians, other
practitioners and their clinical staff to
spend increasing amounts of time and
effort managing the care of comorbid
beneficiaries outside of face-to-face E/M
visits, for example complex and
multidisciplinary care modalities that
involve regular physician development
and/or revision of care plans;
subsequent report of patient status;
review of laboratory and other studies;
communication with other health care
professionals not employed in the same
practice who are involved in the
patient’s care; integration of new
information into the care plan; and/or
adjustments of medical therapy.
Therefore, in the CY 2014 PFS final
rule with comment period, we
established a separate payment under
the PFS for CPT code 99490 (78 FR
43341 through 43342). We sought to
include a relatively broad eligible
patient population within the code
descriptor, established a moderate
payment amount, and established
bundled payment for concurrently new
CPT codes that were reserved for
beneficiaries requiring ‘‘complex’’ CCM
services (base CPT code 99487 and its
add-on code 99489) (79 FR 67716
through 67719). We stated that we
would evaluate the services reported
under CPT code 99490 to assess
whether the service is targeted to the
right population and whether the
payment amount is appropriate (79 FR
67719). We remind stakeholders that
CMS did not limit the eligible
population to any particular list of
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chronic conditions other than the
language in the CPT code descriptor.
Accordingly, one or more of the chronic
conditions being managed through CCM
services could be chronic mental health
or behavioral health conditions or
chronic cognitive disorders, as long as
the chronic conditions meet the
eligibility language in the CPT code
descriptor for CCM services and the
billing practitioner meets all of
Medicare’s requirements to bill the code
including comprehensive, patientcentered care planning for all health
conditions (see Table 11).
In finalizing separate payment for
CPT code 99490, we considered
whether we should develop standards to
ensure that physicians and other
practitioners billing the service would
have the capability to fully furnish the
service (79 FR 67721). We sought to
make certain that the new PFS code(s)
would provide beneficiary access to
appropriate care management services
that are characteristic of advanced
primary care, such as patient support for
chronic diseases to achieve health goals;
24/7 patient access to care and health
information; receipt of preventive care;
patient, family and caregiver
engagement; and timely coordination of
care through electronic health
information exchange. Accordingly, we
established a set of scope of service
elements and payment rules in addition
to or in lieu of those established in CPT
guidance (in the CPT code descriptor
and CPT prefatory language), that the
physician or nonphysician practitioner
must satisfy to fully furnish CCM
services and report CPT code 99490 (78
FR 74414 through 74427, 79 FR 67715
through 67730, and 80 FR 14854). We
established requirements to furnish a
preceding qualifying visit, obtain
advance written beneficiary consent,
use certified electronic health record
(EHR) technology to furnish certain
elements of the service, share the care
plan and clinical summaries
electronically, document specified
activities, and other items summarized
in Table 11. For the CCM service
elements for which we required use of
a certified EHR, the billing practitioner
must use, at a minimum, technology
meeting 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. (For
the CY 2017 PFS payment year, this
would mean technology meeting the
2014 edition of certification criteria).
These elements and requirements for
separately payable CCM services are
extensive and generally exceed those
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required for payment of codes
describing procedures, diagnostic tests,
or other E/M services under the PFS. In
addition, both CPT guidance and our
rules specify that only a single
practitioner who assumes the care
management role for a given beneficiary
can bill CPT code 99490 per service
period (calendar month). Because the
new CCM service closely overlapped
with several Medicare demonstration
models of advanced primary care (the
Multi-Payer Advanced Primary Care
Practice (MAPCP) demonstration and
the Comprehensive Primary Care
Initiative (CPCI)), we provided that
practitioners participating in one of
these two initiatives could not be paid
for CCM services furnished to a
beneficiary attributed by the initiative to
their practice (79 FR 67729).
Given the non-face-to-face nature of
CCM services, we also sought to ensure
that beneficiaries would receive
advance notice that Part B cost sharing
applies since we currently have no
legislative authority to ‘‘waive’’ cost
sharing for this service. Also since only
one practitioner can bill for CCM each
service period, we believed the
beneficiary notice requirement would
help prevent duplicate payment to
multiple practitioners.
Since the establishment of CPT code
99490 for separate payment of CCM
services, in a number of forums and in
public comments to the CY 2016 PFS
final rule (80 FR 70921), many
practitioners have stated that the service
elements and billing requirements are
burdensome, redundant and prevent
them from being able to provide the
services to beneficiaries who could
benefit from them. Stakeholders have
stated that CPT 99490 is underutilized
because it is underpaid relative to the
resources involved in furnishing the
services, especially given the extensive
Medicare rules for payment, and they
have suggested a number of potential
changes to our current payment rules.
Stakeholders continue to believe that
many of the CCM payment rules are
duplicative of other statutory and
regulatory provisions, and to
recommend that we reduce the rules
and expand CCM coding and payment
to distinguish among different levels of
patient complexity. We also note that
section 103 of the MACRA requires
CMS to assess and report to Congress
(no later than December 31, 2017) on
access to CCM services by underserved
rural and racial and ethnic minority
populations and to conduct an
outreach/education campaign that is
underway.
Our assessment of claims data for CY
2015 for CPT code 99490 suggests that
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CCM services may indeed be
underutilized considering the number of
eligible Medicare beneficiaries. Our
analysis of Medicare claims data
indicates that for CY 2015,
approximately 275,000 unique Medicare
beneficiaries received the service an
average of 3 times each, totaling $37
million in allowed charges. Since CPT
code 99490 describes a minimum of 20
minutes of clinical staff time spent
furnishing CCM services during a month
and does not have a time limit, and
since we currently do not separately pay
the other codes in the CCM family of
CPT codes (which would provide us
with utilization data on the number of
patients requiring longer service times
during a billing period), we do not know
how often patients required more than
20 minutes of CCM services per month.
We also do not know their relative
complexity, other than meeting the
acuity criteria in the CPT code
descriptor. We also have no way to
know the relative complexity of the
CCM services furnished to beneficiaries.
In light of this stakeholder feedback
and our mandate under MACRA section
103 to encourage and report on access
to CCM services, we are proposing
several changes in the payment rules for
CCM services. Our primary goal and
statutory mandate is to pay as accurately
as possible for services furnished to
Medicare beneficiaries based on the
relative resources required to furnish
PFS services, including CCM services.
In so doing, we also expect to facilitate
beneficiaries’ access to reasonable and
necessary CCM services that improve
health outcomes. First, for CY 2017 we
are proposing to more appropriately
recognize and pay for the other codes in
the CPT family of CCM services (CPT
codes 99487 and 99489 describing
complex CCM), consistent with our
general practice to price services
according to their relative ranking
within a given family of services. We
direct the reader to section II.L of this
proposed rule for a discussion of
proposed valuation for base CPT code
99487 and its add-on CPT code 99489.
The CPT code descriptors are:
• CPT code 99487—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;
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++ 60 minutes of clinical staff time
directed by a physician or other
qualified health care professional, per
calendar month.
• CPT code 99489—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).
As CPT provides, less than 60
minutes of clinical staff time in the
service period could not be reported
separately, and similarly, less than 30
minutes in addition to the first 60
minutes of complex CCM in a service
period could not be reported. We would
require 60 minutes of services for
reporting CPT code 99487 and 30
additional minutes for each unit of CPT
code 99489.
We propose to adopt the CPT
provision that CPT codes 99487, 99489,
99490 may only be reported once per
service period (calendar month) and
only by the single practitioner who
assumes the care management role with
a particular beneficiary for the service
period. That is, a given beneficiary
would be classified as eligible to receive
either complex or non-complex CCM
during a given service period (calendar
month), not both, and only one
professional claim could be submitted
to the PFS for CCM for that service
period by one practitioner.
Except for differences in the CPT code
descriptors, we propose to require the
same CCM service elements for CPT
codes 99487, 99489 and 99490. In other
words, all the requirements in Table 11
would apply whether the code being
billed for the service period is CPT code
99487 (plus 99489 if applicable) or CPT
code 99490. These three codes would
differ in the amount of clinical staff
service time provided; the complexity of
medical decision-making as defined in
the E/M guidelines (determined by the
problems addressed by the reporting
practitioner during the month); and the
nature of care planning that was
performed (establishment or substantial
revision of the care plan for complex
CCM versus establishment,
implementation, revision or monitoring
of the care plan for non-complex CCM).
Billing practitioners could consider
identifying beneficiaries who require
complex CCM services using criteria
suggested in CPT guidance (such as
number of illnesses, number of
medications or repeat admissions or
emergency department visits) or the
profile of typical patients in the CPT
prefatory language, but these would not
comprise Medicare conditions of
eligibility for complex CCM.
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We are proposing several changes to
our current scope of service elements for
CCM, and are proposing that the same
scope of service elements, as amended,
would apply to all codes used to report
CCM services beginning in 2017 (i.e.,
CPT codes 99487, 99489 and 99490). In
particular, we are proposing changes in
the requirements for the initiating visit,
24/7 access to care and continuity of
care, format and sharing of the care plan
and clinical summaries, beneficiary
receipt of the care plan, beneficiary
consent, and documentation. In Table
11, we summarize the current scope of
service elements and payment rules for
CCM and indicate whether we are
proposing to retain, remove or revise
each element.
a. Initiating Visit
As provided in the CY 2014 PFS final
rule with comment period (78 FR
74425) and subregulatory guidance
(available at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/
Downloads/Payment_for_CCM_
Services_FAQ.pdf), CCM must be
initiated by the billing practitioner
during a ‘‘comprehensive’’ E/M visit,
annual wellness visit (AWV) or initial
preventive physical exam (IPPE). This
face-to-face, initiating visit is not part of
the CCM service and can be separately
billed to the PFS, but is required before
CCM services can be provided directly
or under other arrangements. The billing
practitioner must discuss CCM with the
patient at this visit. While informed
patient consent does not have to be
obtained during this visit, the visit is an
opportunity to obtain the required
consent. The face-to-face visit included
in transitional care management (TCM)
services (CPT 99495 and 99496)
qualifies as a ‘‘comprehensive’’ visit for
CCM initiation. Levels 2 through 5 E/M
visits (CPT 99212 through 99215) also
qualify; CMS does not require the
practice to initiate CCM during a level
4 or 5 E/M visit. However CPT codes
that do not involve a face-to-face visit by
the billing practitioner or are not
separately payable by Medicare (such as
CPT 99211, anticoagulant management,
online services, telephone and other E/
M services) do not qualify as initiating
visits. If the practitioner furnishes a
‘‘comprehensive’’ E/M, AWV, or IPPE
and does not discuss CCM with the
patient at that visit, that visit cannot
count as the initiating visit for CCM.
We continue to believe that we should
require an initiating visit in advance of
furnishing CCM services, separate from
the services themselves, because a faceto-face visit establishes the beneficiary’s
relationship with the billing practitioner
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(most aspects of the CCM services are
furnished incident to the billing
practitioner’s professional services). The
initiating visit also ensures collection of
comprehensive health information to
inform the care plan. We continue to
believe that the types of face-to-face
services that qualify as an initiating visit
for CCM are appropriate. We are not
proposing to change the kinds of visits
that can qualify as initiating CCM visits.
However we are proposing to require
the initiating visit only for new patients
or patients not seen within one year
instead of for all beneficiaries receiving
CCM services. We believe this will
allow practitioners with existing
relationships with patients who have
been seen relatively recently to initiate
CCM services without furnishing a
potentially unnecessary E/M visit. We
are seeking public comment on whether
a period of time shorter than one year
would be more appropriate.
We are also proposing for CY 2017 to
create a new add-on G-code that would
improve payment for visits that qualify
as initiating visits for CCM services. The
code would be billable for beneficiaries
who require extensive face-to-face
assessment and care planning by the
billing practitioner (as opposed to
clinical staff), through an add-on code to
the initiating visit, GPPP7
(Comprehensive assessment of and care
planning by the physician or other
qualified health care professional for
patients requiring chronic care
management services (billed separately
from monthly care management
services) (Add-on code, list separately
in addition to primary service). We
propose that when the billing
practitioner initiating CCM personally
performs extensive assessment and care
planning outside of the usual effort
described by the billed E/M code (or
AWV or IPPE code), the practitioner
could bill GPPP7 in addition to the E/
M code for the initiating visit (or in
addition to the AWV or IPPE), and in
addition to the CCM CPT code 99490 (or
proposed 99487 and 99489) if all
requirements to bill for CCM services
are also met. See section II.L for
proposed valuation of GPPP7.
The code GPPP7 would account
specifically for additional work of the
billing practitioner in personally
performing a face-to-face assessment of
a beneficiary requiring CCM services,
and personally performing CCM care
planning (the care planning could be
face-to-face and/or non-face-to-face) that
is not already reflected in the initiating
visit itself (nor in the monthly CCM
service code). We believe GPPP7 might
be particularly appropriate to bill when
the initiating visit is a less complex visit
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(such as a level 2 or 3 E/M visit),
although GPPP7 could be billed along
with higher level visits if the billing
practitioner’s effort and time exceeded
the usual effort described by the
initiating visit code. It could also be
appropriate to bill GPPP7 when the
initiating visit addresses problems
unrelated to CCM, and the billing
practitioner does not consider the CCMrelated work he or she performs in
determining what level of initiating visit
to bill. We believe that this proposal
will more appropriately recognize the
relative resource costs for the work of
the billing practitioner in initiating CCM
services, specifically for extensive work
assessing the beneficiary and
establishing the CCM care plan that is
reasonable and necessary, and that is
not accounted for in the billed initiating
visit or in the unit of the CCM service
itself that is billed for a given service
period. In addition, we believe this
proposal will help ensure that the
billing practitioner personally performs
and meaningfully contributes to the
establishment of the CCM care plan
when the patient’s complexity warrants
it.
Consistent with general coding
guidance, the work that is reported
under GPPP7 (including time) could not
also be reported under or counted
towards the reporting of any other billed
code, including any of the monthly
CCM services codes. The care plan that
the practitioner must create in order to
bill GPPP7 would be subject to the same
requirements as the care plan included
in the monthly CCM services, namely it
must be an electronic 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. This would distinguish it from
the more limited care plan included in
the BHI codes GPPP1, GPPP2, GPPP3 or
GPPPX which focus on behavioral
health issues, or the care plan included
in GPPP6 which focuses on cognitive
status. We are seeking public input on
potential overlap among these codes
and further clinical input as to how the
assessments and care planning that is
included in them would differ.
Finally, although not part of our
proposals for 2017, we have noted with
interest a recent CPT coding proposal
for a code that would potentially
identify and separately pay for monthly
CCM work that is personally performed
by the billing physician or other
practitioner. We will continue to follow
any CPT developments in this area.
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b. 24/7 Access to Care and Continuity of
Care
We propose several revisions to the
scope of service elements of 24/7 Access
to care and Continuity of Care. We
continue to believe these elements are
important aspects of CCM services, but
that it would be appropriate to improve
alignment with CPT provisions and
remove the requirement for the care
plan to be available remotely to
individuals providing CCM services
after hours. Studies have shown that
after-hours care is best implemented as
part of a larger practice approach to
access and continuity (see for example,
the peer-review article available at
https://www.ncbi.nlm.nih.gov/pmc/
articles/PMC3475839/). There is
substantial local variation in how 24/7
access and continuity of care are
achieved, depending on the contractual
relationships among practitioners and
providers in a particular geographic area
and other factors. Care models include
various contractual relationships
between physician practices and afterhours clinics, urgent care centers and
emergency departments; extended
primary care office hours; physician
call-sharing; telephone triage systems;
and health information technology such
as shared EHRs and systematic
notification procedures (https://
www.ncbi.nlm.nih.gov/pmc/articles/
PMC3475839/). Some or all of these may
be used to provide access to urgent care
on a 24/7 basis while maintaining
information continuity between
providers.
We recognize that some models of
care require more significant investment
in practice infrastructure than others,
for example resources in staffing or
health information technology. In
addition, we believe there is room to
reduce the administrative complexity of
our current payment rules for CCM
services to accommodate a range of
potential care models. In re-examining
what should be included in the CCM
scope of service elements for 24/7
Access to Care and Continuity of Care,
we believe the CPT language adequately
and more appropriately describes the
services that should, at a minimum, be
included in these service elements.
Therefore, we propose to adopt the CPT
language for these two elements. For 24/
7 Access to Care, the scope of service
element would be to provide 24/7
access to physicians or other qualified
health care professionals or clinical staff
including providing patients/caregivers
with a means to make contact with
health care professionals in the practice
to address urgent needs regardless of the
time of day or day of week. We believe
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the CPT language more accurately
reflects the potential role of clinical staff
or call-sharing services in addressing
after-hours care needs than our current
language does. In addition, the 24/7
access would be for ‘‘urgent’’ needs
rather than ‘‘urgent chronic care needs,’’
because we believe after-hours services
typically would and should address any
urgent needs and not only those
explicitly related to the beneficiary’s
chronic conditions.
We recognize that health information
systems that include remote access to
the care plan or the full EHR after hours,
or a feedback loop that communicates
back to the primary care physician and
others involved in the beneficiary’s care
regarding after-hours care or advice
provided, are extremely helpful (https://
www.ncbi.nlm.nih.gov/pmc/articles/
PMC3475839/#CR25). They help ensure
that the beneficiary receives necessary
follow up, particularly if he or she is
referred to the emergency department,
and follow up after an emergency
department visit is required under the
CCM element of Management of Care
Transitions. Accordingly, we continue
to support and encourage the use of
interoperable EHRs or remote access to
the care plan in providing the CCM
service elements of 24/7 Access to Care,
Continuity of Care, and Management of
Care Transitions. However, adoption of
such technology would be optimal not
only for CCM services, but also for a
number of other PFS services and
procedures (including various other care
management services), and we have not
required adoption of any certified or
non-certified health information
technology as a condition of payment
for any other PFS service. We note that
there are incentives under other
Medicare programs to adopt such
information technology, and are
concerned that imposing EHR-related
requirements at the service level as a
condition of PFS payment could create
disparities between these services and
others under the fee schedule. Lastly,
we recognize that not all after-hours
care warrants follow-up or a feedback
loop with the practitioner managing the
beneficiary’s care overall, and that
under particular circumstances feedback
loops can be achieved through oral,
telephone or other less sophisticated
communication methods. Therefore at
this time, we propose to remove the
requirement that the individuals
providing CCM after hours must have
access to the electronic care plan. This
proposal reflects our understanding that
flexibility in how practices can provide
the requisite 24/7 access to care, as well
as continuity of care and management of
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care transitions, for their CCM patients
can facilitate appropriate access to these
services for Medicare beneficiaries. This
proposal is not intended to undermine
the significance of standardized
communication methods as part of
effective care. Instead, we recognize that
other CMS initiatives may be better
mechanisms to incentivize increased
interoperability of health information
systems than conditions of payment
assigned to particular services under the
PFS. We also anticipate that improved
accuracy of payment for care
management services and reduced
administrative burden associated with
billing for them will contribute to
practitioners’ capacity to invest in the
best tools for managing the care of
Medicare beneficiaries.
For Continuity of Care, we currently
require the ability to obtain successive
routine appointments ‘‘with the
practitioner or a designated member of
the care team,’’ while CPT only
references successive routine
appointments ‘‘with a designated
member of the care team.’’ We do not
believe there is any practical difference
between these two phrases and therefore
are proposing to omit the words
‘‘practitioner or’’ from our requirement.
The billing practitioner is a member of
the CCM care team, so the CPT language
already allows for successive routine
appointments either with the billing
practitioner or another appropriate
member of the CCM care team.
c. Electronic Care Plan
Based on review of extensive public
comment and stakeholder feedback, we
have come to believe that we should not
require individuals providing the
beneficiary with the required 24/7
access to care for urgent needs to have
access to the care plan as a condition of
CCM payment. As discussed above, we
believe that in general, provision of
effective after-hours care of the
beneficiary would require access to the
care plan, if not the full EHR. However,
we have heard from rural and other
practices that remote access to the care
plan is not always necessary or possible
because urgent care needs after-hours
are often referred to a practitioner or
care team member who established the
care plan or is familiar with the
beneficiary. In some instances, the care
plan does not need to be available in
order to address urgent patient needs
after business hours. In addition, we
have not required the use of any
certified or non-certified health
information technology in the provision
of any other PFS services (including
various other care management
services). We are concerned that
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imposing EHR-related requirements at
the service level as a condition of PFS
payment could distort the relative
valuation of services priced under the
fee schedule. Therefore, we propose to
change the CCM service element to
require timely electronic sharing of care
plan information within and outside the
billing practice, but not necessarily on
a 24/7 basis, and to allow transmission
of the care plan by fax.
We acknowledge that it is best for
practitioners and providers to have
access to care plan information any time
they are providing services to
beneficiaries who require CCM services.
This proposal is not intended to
undermine the significance of electronic
communication methods other than fax
transmission in providing effective,
continuous care. On the contrary, we
believe that fax transmission, while
commonly used, is much less efficient
and secure than other methods of
communicating patient health
information, and we encourage
practitioners to adopt and use electronic
technologies other than fax for
transmission and exchange of the CCM
care plan. We continue to believe the
best means of exchange of all relevant
patient health information is through
standardized electronic means.
However, we recognize that other CMS
initiatives may be better mechanisms to
incentivize increased interoperability of
health information systems than
conditions of payment assigned to
particular services under the PFS. We
believe our proposal would still allow
timely availability of health information
within and outside the practice for
purposes of providing CCM, and would
simplify the rules governing provision
of the service and improve access to the
service. These proposed revisions
would better align the service with
appropriate CPT prefatory language,
which may reduce unnecessary
administrative complexity for
practitioners in navigating the
differences between CPT guidance and
Medicare rules.
d. Clinical Summaries
The CCM scope of service element
Management of Care Transitions
includes a requirement for the creation
and electronic transmission and
exchange of continuity of care
documents referred to as ‘‘clinical
summaries’’ (see Table 11). We
patterned our requirements regarding
clinical summaries after the EHR
Incentive Program requirement that an
eligible professional who transitions
their patient to another setting of care or
provider of care, or refers their patient
to another provider of care, should
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provide a summary care record for each
transition of care or referral. This
clinical summary includes
demographics, the medication list,
medication allergy list, problem list, and
a number of other data elements if the
practitioner knows them. As a condition
of CCM payment, we required
standardized content for clinical
summaries (that they must be created/
formatted according to certified EHR
technology). For the exchange/transport
function, we did not require the use of
a specific tool or service to exchange/
transmit clinical summaries, as long as
they are transmitted electronically (this
can include fax only when the receiving
practitioner or provider can only receive
by fax).
Based on review of extensive public
comment and stakeholder feedback, we
have come to believe that we should not
require the use of any specific electronic
technology in managing a beneficiary’s
care transitions as a condition of
payment for CCM services. Instead we
are proposing more simply to require
the billing practitioner to create and
exchange/transmit continuity of care
document(s) timely with other
practitioners and providers. To avoid
confusion with the requirements of the
EHR Incentive Programs, and since we
would no longer require standardized
content for the CCM continuity of care
document(s), we would refer to them as
continuity of care documents instead of
clinical summaries. We would no longer
specify how the billing practitioner
must transport or exchange these
document(s), as long as it is done timely
and consistent with the Care Transitions
Management scope of service element.
We welcome public input on how we
should refer to these document(s),
noting that CPT does not provide model
language specific to CCM services. The
proposed term ‘‘continuity of care
document(s)’’ draws on CPT prefatory
language for TCM services, which CPT
provides may include ‘‘obtaining and
reviewing the discharge information (for
example, discharge summary, as
available, or continuity of care
document).’’
Again, this proposal is not intended to
undermine the significance of a
standardized, electronic format and
means of exchange (other than fax) of all
relevant patient health information, for
achieving timely, seamless care across
settings especially after discharge from
a facility. On the contrary, we believe
that fax transmission, while commonly
used, is much less efficient and secure
than other methods of communicating
patient health information, and we
encourage practitioners to adopt and use
electronic technologies other than fax
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for transmission and exchange of
continuity of care documents in
providing CCM services. We continue to
believe the best means of exchange of all
relevant patient health information is
through standardized electronic means.
However, as we discussed above
regarding the CCM care plan, we have
not applied similar requirements to
other PFS services specifically
(including various other care
management services) and have
concerns about how doing so may create
disparities between these services and
others under the PFS. We also recognize
that other CMS initiatives may be better
mechanisms to incentivize increased
interoperability of health information
systems than conditions of payment
assigned to particular services under the
PFS. However, we also anticipate that
our proposals will contribute to
practitioners’ capacity to invest in the
best tools for managing the care of
Medicare beneficiaries.
e. Beneficiary Receipt of Care Plan
We propose to simplify the current
requirement to provide the beneficiary
with a written or electronic copy of the
care plan, by instead adopting the CPT
language specifying more simply that a
copy of the care plan must be given to
the patient or caregiver. While we
believe beneficiaries should and must
be provided a copy of the care plan, and
that practitioners may choose to provide
the care plan in hard copy or electronic
form in accordance with patient
preferences, we do not believe it is
necessary to specify the format of the
care plan that must be provided as a
condition of CCM payment.
Additionally, we recognize that there
may be times that sharing the care plan
with the caregiver (in a manner
consistent with applicable privacy and
security rules and regulations) may be
appropriate.
f. Beneficiary Consent
We continue to believe that obtaining
advance beneficiary consent to receive
CCM services is important to ensure the
beneficiary is informed, educated about
CCM services, and is aware of
applicable cost sharing. We also believe
that querying the beneficiary about
whether another practitioner is already
providing CCM services helps to reduce
the potential for duplicate provision or
billing of the services. However, we
believe the consent process could be
simplified, and that it should be left to
the practitioner and the beneficiary to
decide the best way to establish consent.
Therefore, we propose to continue to
require billing practitioners to inform
the beneficiary of the currently required
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information (that is, inform the
beneficiary of the availability of CCM
services; inform the beneficiary that
only one practitioner can furnish and be
paid for these services during a calendar
month; and inform the beneficiary of the
right to stop the CCM services at any
time (effective at the end of the calendar
month)). However, we propose to
specify that the practitioner could
document in the beneficiary’s medical
record that this information was
explained and note whether the
beneficiary accepted or declined CCM
services instead of obtaining a written
agreement.
We also propose to remove the
language requiring beneficiary
authorization for the electronic
communication of his or her medical
information with other treating
providers as a condition of payment for
CCM services, because under the Health
Insurance Portability and
Accountability Act (HIPAA) Privacy
Rule (45 CFR 164.506), a covered entity
is permitted to use or disclose protected
health information for purposes of
treatment without patient authorization.
Moreover, if such disclosure is
electronic, the HIPAA Security Rule
requires secure transmission (45 CFR
164.312(e)). In previous regulations we
have reminded practitioners that for all
electronic sharing of beneficiary
information in the provision of CCM
services, HIPAA Privacy and Security
Rule standards apply in the usual
manner (79 FR 67728).
g. Documentation
We have heard from practitioners that
the requirements to document certain
information in a certified EHR format
are redundant because the CCM billing
rules already require documentation of
core clinical information in a certified
EHR format. Specifically, we already
require structured recording of
demographics, problems, medications
and medication allergies, and the
creation of a clinical summary record,
using a qualifying certified EHR; and
that a full list of problems, medications
and medication allergies in the EHR
must inform the care plan, care
coordination and ongoing clinical care.
Therefore, we propose to no longer
require the use of a qualifying certified
EHR to document communication to
and from home- and community-based
providers regarding the patient’s
psychosocial needs and functional
deficits and to document beneficiary
consent. We would continue to require
documentation in the medical record of
beneficiary consent (discussed above)
and of communication to and from
home- and community-based providers
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regarding the patient’s psychosocial
needs and functional deficits.
In summary, we believe our proposed
changes would retain elements of the
CCM service that are most characteristic
of the changes in medical practice
toward advanced primary care, while
eliminating redundancy, simplifying
provision of the services, and improving
access without compromising quality of
care and beneficiary privacy or advance
notice and consent. We also anticipate
that improved accuracy of payment for
care management services and reduced
administrative burden associated with
billing for these services will contribute
to practitioners’ capacity to invest in the
best tools for managing the care of
Medicare beneficiaries.
g. CCM Requirements for Rural Health
Clinics (RHCs) and Federally Qualified
Health Centers (FQHCs)
RHCs and FQHCs have been
authorized to bill for CCM services since
January 1, 2016, and are paid based on
the Medicare PFS national average nonfacility payment rate when CPT code
99490 is billed alone or with other
payable services on a RHC or FQHC
claim. The RHC and FQHC
requirements for billing CCM services
have generally followed the
requirements for practitioners billing
under the PFS, with some adaptations
based on the RHC and FQHC payment
methodologies.
To assure that CCM requirements for
RHCs and FQHCs are not more
burdensome than those for practitioners
billing under the PFS, we are proposing
revisions for CCM services furnished by
RHCs and FQHCs similar to the
revisions proposed under the section
above entitled, ‘‘Reducing
Administrative Burden and Improving
Payment Accuracy for Chronic Care
Management (CCM) Services’’ for RHCs
and FQHCs. Specifically, we propose to:
• Require that CCM be initiated
during an AWV, IPPE, or
comprehensive E/M visit only for new
patients or patients not seen within one
year. This would replace the
requirement that CCM could only be
initiated during an AWV, IPPE, or
comprehensive E/M visit where CCM
services were discussed.
• Require 24/7 access to a RHC or
FQHC practitioner or auxiliary staff
with a means to make contact with a
RHC or FQHC practitioner to address
urgent health care needs regardless of
the time of day or day of week. This
would replace the requirement that
CCM services be available 24/7 with
health care practitioners in the RHC or
FQHC who have access to the patient’s
electronic care plan to address his or her
urgent chronic care needs, regardless of
the time of day or day of the week.
• Require timely electronic sharing of
care plan information within and
outside the RHC or FQHC, but not
necessarily on a 24/7 basis, and allow
transmission of the care plan by fax.
This would replace the requirement that
the electronic care plan be available on
a 24/7 basis to all practitioners within
the RHC or FQHC whose time counts
towards the time requirement for the
practice to bill the CCM code, and
removes the restriction on allowing the
care plan to be faxed.
• Require that in managing care
transitions, the RHC or FQHC creates,
exchanges, and transmits continuity of
care document(s) in a timely manner
with other practitioners and providers.
This would replace the requirements
that clinical summaries must be created
and formatted according to certified
EHR technology, and the requirement
for electronic exchange of clinical
summaries by a means other than fax.
• Require that a copy of the care plan
be given to the patient or caregiver. This
would remove the description of the
format (written or electronic) and allows
the care plan to be provided to the
caregiver when appropriate (and in a
manner consistent with applicable
46211
privacy and security rules and
regulations).
• Require that the RHC or FQHC
practitioner documents in the
beneficiary’s medical record that all the
elements of beneficiary consent (for
example, that the beneficiary was
informed of the availability of CCM
services; only one practitioner can
furnish and be paid for these services
during a calendar month; the
beneficiary may stop the CCM services
at any time, effective at the end of the
calendar month, etc.) were provided,
and whether the beneficiary accepted or
declined CCM services. This would
replace the requirement that RHCs and
FQHCs obtain a written agreement that
these elements were discussed, and
removes the requirement that the
beneficiary provide authorization for the
electronic communication of his or her
medical information with other treating
providers as a condition of payment for
CCM services.
• Require that communication to and
from home- and community-based
providers regarding the patient’s
psychosocial needs and functional
deficits be documented in the patient’s
medical record. This would replace the
requirement to document this patient
health information in a certified EHR
format.
We note that we are not proposing an
additional payment adjustment for
patients who require extensive
assessment and care planning as part of
the initiating visit, as payments for RHC
and FQHC services are not adjusted for
length or complexity of the visit.
We believe these proposed changes
would keep the CCM requirements for
RHCs and FQHCs consistent with the
CCM requirements for practitioners
billing under the PFS, simplify the
provision of CCM services by RHCs and
FQHCs, and improve access to these
services without compromising quality
of care, beneficiary privacy, or advance
notice and consent.
TABLE 11—CHRONIC CARE MANAGEMENT (CCM) SCOPE OF SERVICE ELEMENTS AND BILLING REQUIREMENTS
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
CCM Scope of service element/billing requirement
Propose to
retain
Propose to
remove
Proposed revision
Initiating Visit—Initiation during an AWV, IPPE, or
face-to-face E/M visit for all patients (Level 4 or 5
visit not required).
Structured Recording of Patient Information Using
Certified EHR Technology—Structured recording of
demographics, problems, medications, medication
allergies, and the creation of a structured clinical
summary record, using certified EHR technology. A
full list of problems, medications and medication allergies in the EHR must inform the care plan, care
coordination and ongoing clinical care.
........................
........................
........................
........................
Initiation during an AWV, IPPE, or face-to-face E/M
visit (Level 4 or 5 visit not required) for new patients or patients not seen within 1 year.
Structured Recording of Patient Information Using
Certified EHR Technology—Structured recording of
demographics, problems, medications and medication allergies using certified EHR technology. A full
list of problems, medications and medication allergies in the EHR must inform the care plan, care coordination and ongoing clinical care.
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TABLE 11—CHRONIC CARE MANAGEMENT (CCM) SCOPE OF SERVICE ELEMENTS AND BILLING REQUIREMENTS—
Continued
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
CCM Scope of service element/billing requirement
Propose to
retain
Propose to
remove
Proposed revision
24/7 Access to Care—Access to care management
services 24/7 (providing the beneficiary with a
means to make timely contact with health care
practitioners in the practice who have access to the
patient’s electronic care plan to address his or her
urgent chronic care needs regardless of the time of
day or day of the week).
Continuity of Care—Continuity of care with a designated practitioner or member of the care team
with whom the beneficiary is able to get successive
routine appointments.
Comprehensive Care Management—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.
Electronic Comprehensive Care Plan—Creation of an
electronic 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.
Electronic Sharing of Care Plan—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 (by fax in extenuating circumstance)
as appropriate with other practitioners and providers.
Beneficiary Receipt of Care Plan—Provide the beneficiary with a written or electronic copy of the care
plan.
Documentation of care plan provision to beneficiary—
Document provision of the care plan as required to
the beneficiary using certified EHR technology.
Management of Care Transitions .................................
• 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.
• Format clinical summaries according to certified
EHR technology (content standard).
• Not required to use a specific tool or service to exchange/transmit clinical summaries, as long as they
are transmitted electronically (by fax in extenuating
circumstance).
Home- and Community-Based Care Coordination—
Coordination with home and community based clinical service providers.
Documentation of Home- and Community-Based Care
Coordination—Communication to and from homeand community-based providers regarding the patient’s psychosocial needs and functional deficits
must be documented in the patient’s medical record
using certified EHR technology.
........................
........................
Provide 24/7 access to physicians or other qualified
health professionals or clinical staff including providing patients/caregivers with a means to make
contact with health care professionals in the practice to address urgent needs regardless of the time
of day or day of week.
........................
........................
Continuity of care with a designated member of the
care team with whom the beneficiary is able to
schedule successive routine appointments.
X
........................
X
........................
........................
........................
Must at least electronically capture care plan information, and make this information available timely
within and outside the billing practice as appropriate. Share care plan information electronically
(can include fax) and timely within and outside the
billing practice to individuals involved in the beneficiary’s care.
........................
........................
A copy of the plan of care must be given to the patient or caregiver.
........................
X
........................
........................
X
........................
........................
........................
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Management of Care Transitions
• 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.
• Create and exchange/transmit continuity of care
document(s) timely with other practitioners and providers.
Communication to and from home- and communitybased providers regarding the patient’s psychosocial needs and functional deficits must be documented in the patient’s medical record.
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46213
TABLE 11—CHRONIC CARE MANAGEMENT (CCM) SCOPE OF SERVICE ELEMENTS AND BILLING REQUIREMENTS—
Continued
CCM Scope of service element/billing requirement
Propose to
retain
Propose to
remove
Enhanced Communication Opportunities—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-faceto-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.
• 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.
• Inform the beneficiary that only one practitioner can
furnish and be paid for these services during a calendar month.
• Document the beneficiary’s written consent and authorization using certified EHR technology.
X
........................
........................
........................
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
5. Assessment and Care Planning for
Patients With Cognitive Impairment
For CY 2017 we are proposing a Gcode that would provide separate
payment to recognize the work of a
physician (or other appropriate billing
practitioner) in assessing and creating a
care plan for beneficiaries with
cognitive impairment, GPPP6 (Cognition
and functional assessment using
standardized instruments with
development of recorded care plan for
the patient with cognitive impairment,
history obtained from patient and/or
caregiver, in office or other outpatient
setting or home or domiciliary or rest
home). We understand that a similar
code was recently approved by the CPT
Editorial Panel and is scheduled to be
included in the CY 2018 CPT code set.
We intend for GPPP6 to be a temporary
code (perhaps for only one-year) and
will consider whether to adopt and
establish relative value units for the new
CPT code under our standard process,
presumably for CY 2018.
We reviewed the list of service
elements that were proposed at CPT,
and are proposing the following as
required service elements of GPPP6:
• Cognition-focused evaluation
including a pertinent history and
examination.
• Medical decision making of
moderate or high complexity (defined
by the E/M guidelines).
• Functional assessment (for
example, Basic and Instrumental
Activities of Daily Living), including
decision-making capacity.
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Proposed revision
• Inform the beneficiary of the availability of CCM
services.
• Inform the beneficiary that only one practitioner can
furnish and be paid for these services during a calendar month.
• Inform the beneficiary of the right to stop the CCM
services at any time (effective at the end of the calendar month).
• Document in the beneficiary’s medical record that
the required information was explained and whether
the beneficiary accepted or declined the services.
• Use of standardized instruments to
stage dementia.
• Medication reconciliation and
review for high-risk medications, if
applicable.
• Evaluation for neuropsychiatric and
behavioral symptoms, including
depression, including use of
standardized instrument(s).
• Evaluation of safety (for example,
home), including motor vehicle
operation, if applicable.
• Identification of caregiver(s),
caregiver knowledge, caregiver needs,
social supports, and the willingness of
caregiver to take on caregiving tasks.
• Advance care planning and
addressing palliative care needs, if
applicable and consistent with
beneficiary preference.
• Creation of a care plan, including
initial plans to address any
neuropsychiatric symptoms and referral
to community resources as needed (for
example, adult day programs, support
groups); care plan shared with the
patient and/or caregiver with initial
education and support.
The proposed valuation of GPPP6
(discussed in section II.E.1) assumes
that this code would include services
that are personally performed by the
physician (or other appropriate billing
practitioner) and would significantly
overlap with services described by
certain E/M visit codes, advance care
planning services, and certain
psychological or psychiatric service
codes that are currently separately
payable under the PFS. Accordingly, we
propose that GPPP6 must be furnished
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by the physician (or other appropriate
billing practitioner) and could not be
billed on the same date of service as
CPT codes 90785 (Psytx complex
interactive), 90791 (Psych diagnostic
evaluation), 90792 (Psych diag eval w/
med srvcs), 96103 (Psycho testing
admin by comp), 96120 (Neuropsych tst
admin w/comp), 96127 (Brief
emotional/behav assmt), 99201–99215
(Office/outpatient visits new), 99324–
99337 (Domicil/r-home visits new pat),
99341–99350 (Home visits new patient),
99366–99368 (Team conf w/pat by hc
prof), 99497 (Advncd care plan 30 min),
99498 (Advncd care plan addl 30 min)),
since these codes all reflect face-to-face
services provided by the physician or
other billing practitioner for related
services that are separately payable. In
addition, we are proposing to prohibit
billing of GPPP6 with other care
planning services, such as care plan
oversight services (CPT code 99374),
home health care and hospice
supervision (G0181, G0182), or our
proposed add-on code for
comprehensive assessment and care
planning by the billing practitioner for
patients requiring CCM services
(GPPP7). We are seeking comment on
whether there are circumstances where
multiple care planning codes could be
furnished without significant overlap.
We propose to specify that GPPP6 may
serve as a companion or primary E/M
code to the prolonged service codes
(those that are currently separately paid,
and those we propose to separately pay
beginning in 2017), but are interested in
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public input on whether there is any
overlap among these services. We are
seeking comment on how to best
delineate the post-service work for
GPPP6 from the work necessary to
provide the prolonged services code.
We do not believe the services
described by GPPP6 would significantly
overlap with proposed or current
medically necessary CCM services (CPT
codes 99487, 99489, 99490); TCM
services (99495, 99496); or the proposed
behavioral health integration service
codes (GPPP1, GPPP2, GPPP3, GPPPX).
Therefore we propose that GPPP6 could
be billed on the same date-of-service or
within the same service period as these
codes (CPT codes 99487, 99489, 99490,
99495, 99496, GPPP1, GPPP2, GPPP3,
GPPPX). There may be overlap in the
patient population eligible to receive
these services and the population
eligible to receive the services described
by GPPP6, but we believe there would
be sufficient differences in the nature
and extent of the assessments,
interventions and care planning, as well
as the qualifications of individuals
providing the services, to allow
concurrent billing for services that are
medically reasonable and necessary. We
welcome public comment on potential
overlap between GPPP6 and existing
PFS billing codes, as well as the other
primary care/cognitive services
addressed in this section of the
proposed rule.
6. Improving Payment Accuracy for Care
of People With Disabilities
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
a. Background
People with disabilities face
significant challenges accessing the
health care system. Medicare
beneficiaries who are under age 65 with
disabilities are three times more likely
to report having difficulties finding a
doctor who accepts Medicare than
beneficiaries age 65 and older.4 When
able to find a Medicare participating
physician, people with disabilities
report worse experiences than people
without disabilities on many quality
measures, including those related to
patient-centered care and patient safety
based on data from the National
Healthcare Disparities Report, produced
by the Agency for Healthcare Research
and Quality (AHRQ).5 The reasons for
4 The Henry J Kaiser Family Foundation. 2010.
‘‘Medicare and Nonelderly People with
Disabilities.’’
5 National Healthcare Disparities Report, 2013.
May 2014. Agency for Healthcare Research and
Quality, Rockville, MD. The National Healthcare
Disparities Report summarizes health care quality
and access among various racial, ethnic, and
income groups and other priority populations, such
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these access and quality disparities are
multifaceted and may include a range of
payment challenges, accessibility issues
with equipment and facilities,
communication obstacles, and
sometimes lack of practitioner
understanding of how to assess and
fully address the needs and preferences
of people with disabilities. The Equity
Plan for Improving Quality in Medicare,
released last fall by CMS, highlights
many challenges in achieving better
outcomes for people with disabilities.
One way to help improve access to
high-quality physicians’ services for
people with disabilities is to ensure
Medicare Physician Fee Schedule
payments are based on the accurate
relative resource costs of services
furnished to people with disabilities.
As described in section I.B. of this
proposed rule, PFS payments are
required to be based on the relative
resources involved in furnishing a
service. To determine the relative
resources required to furnish a service
described by a specific HCPCS code,
CMS considers the ‘‘typical’’ Medicare
service described by that code, and
identifies the resources involved in that
scenario. This approach assumes that
while practitioners might incur greater
or fewer costs in furnishing any specific
service to any particular beneficiary,
RVUs are allocated appropriately based
on a ‘‘typical’’ Medicare case-mix.
For HCPCS codes that describe
narrowly-defined procedures and tests,
PFS payment rates based on the typical
resources may be accurate for most
kinds of practitioners and many
beneficiaries, because the granularity of
coding corresponds with practitioners’
use of resources based on the specific
medical needs of their patients.
However, the HCPCS codes that
describe the office/outpatient E/M
services are broadly defined, so the
typical service billed using one of those
HCPCS codes matches a much smaller
percentage of all the services billed
using that HCPCS code. Medicare
payment rates for these kinds of services
under the PFS do not vary by the
population being served, or by the
particular practitioner furnishing the
services. Payment for these kinds of
service vary only based on the
delineations among the level of visits,
despite the reality that adequately
serving certain patients requires much
greater resources in ways that are
generally not reflected in the described
differentiation between visit levels.
For example, the same codes and rates
are used to pay for routine care of all
as residents of rural areas and people with
disabilities.
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patients, including furnishing care to
patients with disabilities that often
require greater resources relating to
equipment, clinical staff, and physician
time relative to the resource costs
associated with providing the same kind
of care to other Medicare beneficiaries.
Thus, the payment rate for the code may
not accurately reflect the resources
involved in providing the service to
certain categories of beneficiaries. For
these reasons, the resources involved in
furnishing care, including and
especially routine care of both acute and
chronic illness, to beneficiaries with
disabilities may be routinely and
systematically underestimated under
PFS payment made on the basis of the
broadly described visit codes. This
effectively reduces overall payment
relative to resource needs for
practitioners who more frequently serve
such patients, which could negatively
impact access or quality of care for
beneficiaries with disabilities.
b. Establishing a HCPCS G-Code To
Improve Payment Accuracy for Care of
People With Mobility-Related
Disabilities
We estimate that about 7 percent of all
Medicare beneficiaries have a
potentially disabling mobility-related
diagnosis (the Medicare-only prevalence
is 5.5 percent and the prevalence for
Medicare-Medicaid dual eligible
beneficiaries is 11 percent), using 2010
Medicare (and for dual eligible
beneficiaries, Medicaid) claims data.
When a beneficiary with a mobilityrelated disability goes to a physician or
other practitioner’s office for an E/M
visit, the resources associated with
providing the visit can exceed the
resources required for the typical E/M
visit. An E/M visit for a patient with a
mobility-related disability can require
more physician and clinical staff time to
provide appropriate care because the
patient may require skilled assistance
throughout the visit to carefully move
and adjust his/her body. Furthermore,
an E/M visit for a patient with a
mobility-related disability commonly
requires specialized equipment such as
a wheel chair accessible scale, floor and
overhead lifts, a movable exam table,
padded leg supports, a stretcher and
transfer board. The current E/M visit
payment rates, based on an assumption
of ‘‘typical’’ resources involved in
furnishing an E/M visit to a ‘‘typical’’
patient, do not accurately reflect these
additional resources associated with
furnishing appropriate care to many
beneficiaries with mobility-related
disabilities.
When furnishing E/M services to
beneficiaries with mobility-related
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disabilities, practitioners face difficult
choices in deciding whether to take the
extra time necessary and invest in the
required specialized equipment for
these visits even though the payment
rate for the service does not account for
either expense; potentially providing
less than optimal care for a beneficiary
whose needs exceed the standard
appointment block of time in the
standard equipped exam room reflected
in the current E/M visit payment rate; or
declining to accept appointments
altogether for beneficiaries who require
additional time and specialized
equipment.
Each of these scenarios is potentially
problematic. The first two scenarios
suggest that the quality of care for this
beneficiary population might be
compromised by assumptions under the
PFS regarding relative resource costs in
furnishing services to this population.
The third scenario reflects an obvious
access problem for these beneficiaries.
To improve payment accuracy and help
ameliorate potential disparity in access
and quality for beneficiaries with
mobility-related disabilities, we propose
to create a new add-on G-code, effective
for CY 2017, to describe the additional
services furnished in conjunction with
E/M services to beneficiaries with
disabilities that impair their mobility:
• GDDD1: Resource-intensive
services for patients for whom the use
of specialized mobility-assistive
technology (such as adjustable height
chairs or tables, patient lifts, and
adjustable padded leg supports) is
medically necessary and used during
the provision of an office/outpatient
evaluation and management service
visit (Add-on code, list separately in
addition to primary procedure).
Effective January 1, 2017, we propose
that this add-on code could be billed
with new and established patient office/
outpatient E/M codes (CPT codes 99201
through 99205, and 99212 through
99215), as well as transitional care
management codes (CPT codes 99495
and 99496), when the additional
resources described by the code are
medically necessary and used in the
provision of care. In addition to seeking
comment on this proposal, we are also
seeking comment on other HCPCS codes
that may be appropriate base codes for
this proposed add-on code, including
those describing preventive visits and
services. We remind potential
commenters that the rationale for this
proposal is based in large part on the
broad use and lack of granularity in
coding for E/M services relative to other
PFS services in conjunction with the
additional resources used.
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The proposed inputs and valuation
for this code are detailed in section II.L
of this proposed rule.
c. Soliciting Comment on Other Coding
Changes To Improve Payment Accuracy
for Care of People With Disabilities
When furnishing care to a beneficiary
with a mobility-related disability, the
current E/M visit payment rates may not
fully reflect the associated resource
costs that are being incurred by
practitioners. We recognize that there
are other populations for which
payment adjustment may be
appropriate. Our proposal regarding
beneficiaries with mobility-related
disabilities reflects the discrete nature of
the additional resource costs for this
population, the clear lack of
differentiation in resource costs
regarding particular kinds of frequentlyfurnished services, and the broad
recognition of access problems. We
recognize that some physician practices
may frequently furnish services to
particular populations for which the
relative resource costs are similarly
systemically undervalued and we seek
comment regarding other circumstances
where these dynamics can be discretely
observed.
7. Supervision for Requirements for
Non-Face-to-Face Care Management
Services
Our current regulations in § 410.26(b)
provide for an exception to allow
general supervision of CCM services
(and similarly, for the non-face-to-face
portion of TCM services), because these
are non-face-to-face care management/
care coordination services that would
commonly be provided by clinical staff
when the billing practitioner, and
hence, the supervising physician, is not
physically present; and the CPT codes
are comprised solely (or largely) of nonface-to-face services provided by
clinical staff. A number of codes that we
are proposing to establish for separate
payment in CY 2017 under our initiative
to improve payment accuracy for
primary care and care management are
similar to CCM services in that a critical
element of the services is non-face-toface care management/care coordination
services provided by clinical staff when
the billing practitioner may not be
physically present. Accordingly, we are
proposing to amend § 410.26(a)(3) and
§ 410.26 (b) to better define general
supervision and to allow general
supervision not only for CCM services
and the non-face-to-face portion of TCM
services, but also for proposed codes
GPPP1, GPPP2, GPPP3, GPPPX, CPT
code 99487, and CPT code 99489.
Instead of adding each of these
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46215
proposed codes requiring general
supervision to the regulation text on an
individual basis, we propose to revise
our regulation under paragraph (b)(1) of
§ 410.26 to allow general supervision of
the non-face-to-face portion of
designated care management services,
and we would designate the applicable
services through notice and comment
rulemaking.
F. Improving Payment Accuracy for
Services: Diabetes Self-Management
Training (DSMT)
Section 1861(s)(2)(S) of the Act
specifies that medical and other health
services include DSMT services as
defined in section 1861(qq) of the Act.
DSMT services are intended to educate
beneficiaries in the successful selfmanagement of diabetes. DSMT
includes, as applicable, instructions in
self-monitoring of blood glucose;
education about diet and exercise; an
insulin treatment plan developed
specifically for the patient who is
insulin-dependent; and motivation for
patients to use the new skills for selfmanagement (see § 410.144(a)(5)).
DSMT services are reported under
HCPCS codes G0108 (Diabetes
outpatient self-management training
services, individual, per 30 minutes)
and G0109 (Diabetes outpatient selfmanagement training services, group
session (2 or more), per 30 minutes).
The benefit, as specified at § 410.141,
consists of 1 hour of individual and 9
hours of group training unless special
circumstances warrant more individual
training or no group session is available
within 2 months of the date the training
is ordered.
Section 1861(qq) of the Act specifies
that DMST services are furnished by a
certified provider, defined as a
physician or other individual or entity
that also provides, in addition to DSMT,
other items or services for which
payment may be made under Medicare.
The physician, individual or entity that
furnishes the training also must meet
certain quality standards. The
physician, individual or entity can meet
standards established by us or standards
originally established by the National
Diabetes Advisory Board and
subsequently revised by organizations
who participated in their establishment,
or can be recognized by an organization
that represents individuals with
diabetes as meeting standards for
furnishing the services.
We require that all those who furnish
DSMT services be accredited as meeting
quality standards by a CMS-approved
national accreditation organization
(NAO). In accordance with § 410.144, a
CMS-approved NAO may accredit an
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individual, physician or entity to meet
one of three sets of DSMT quality
standards: CMS quality standards; the
National Standards for Diabetes SelfManagement Education Programs
(National Standards); or the standards of
an NAO that represents individuals
with diabetes that meet or exceed our
quality standards. Currently, we
recognize the American Diabetes
Association and the American
Association of Diabetes Educators as
approved NAOs, both of whom follow
National Standards. Medicare payment
for outpatient DSMT services is made in
accordance with § 414.63.
An article titled ‘‘Use of Medicare’s
Diabetes Self-Management Training
Benefit’’ was published in the Health
Education Behavior on January 23,
2015. The article noted that only 5
percent of Medicare beneficiaries with
newly diagnosed diabetes used DSMT
services. The article recommended that
future research identify barriers to
DSMT access.
We understand there are a number of
issues that may contribute to the low
utilization of these services. Some of the
issues that have been brought to our
attention by the DSMT community and
NAOs are:
• Concerns that claims have been
rejected or denied because of confusion
about the credentials of the individuals
who furnish DSMT services. In entities
following the National Standards, the
credentials of the educators actually
providing the training are determined
by the NAO and are not to be
determined by the Medicare
Administrative Contractor. Many
individuals who actually furnish DSMT
services, such as registered nurses and
pharmacists, do not qualify to enroll in
Medicare as certified providers, as that
term is defined at section 1861(qq)(2)(A)
of the Act, and codified in our
regulations at § 410.140 as approved
entit(ies).
• Questions about when individual
(rather than group) DSMT services are
available. As noted above, the benefit
consists of 1 hour of individual and 9
hours of group training unless special
circumstances warrant more individual
training or no group session is available
within 2 months of the date the training
is ordered. The special circumstances
are when the beneficiary’s physician or
qualified NPP documents in the
beneficiary’s medical record that the
beneficiary has special needs resulting
from conditions such as severe vision,
hearing, or language limitations that
would hinder effective participation in
a group training session. In all cases,
however, the physician or NPP must
order individual training.
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• Concerns that the Medicare Benefit
Policy Manual, Chapter 15, section 300
does not clarify the settings and
locations in which DSMT services may
be provided. As a result, some providers
(and perhaps some Medicare
contractors) are confused. In regard to
this issue, we note that a forthcoming
manual update will reiterate the
guidance we provided to the DSMT
community, including the NAOs, in a
response to their letter requesting
clarification regarding the settings and
locations in which DSMT services can
be provided. The manual update will
clarify that: (a) In the case of DSMT
services furnished by an entity that
submits professional claims to the A/B
Medicare Administrative Contractor
(MAC), such as a physician’s office or
an RD’s practice, DSMT services may be
furnished at alternate locations used by
the entity as a practice location; and (b)
when the DSMT services are furnished
by an entity that is a hospital outpatient
department (HOPD), these DSMT
services must be furnished in the
hospital (including a provider-based
department) and cannot be furnished at
alternate non-hospital locations. We
plan to address and clarify the above
issues through Medicare program
instructions as appropriate. We also
recognize the possibility that Medicare
payment for these services may not fully
reflect the resources required to provide
them and this may be contributing to
relatively low utilization. There may
also be other barriers to access of which
we are not aware. We are seeking public
comment on such barriers to help us
identify and address them. We also seek
comment and information on whether
Medicare payment for these services is
accurate. In particular, we would
appreciate information on the time and
intensity of services provided, and on
the services and supplies that should be
included in the calculation of practice
expenses. We will consider this
information to determine whether to
propose an update to resource inputs
used to develop payment rates for these
services in future rulemaking.
G. Target for Relative Value
Adjustments for Misvalued Services
Section 1848(c)(2)(O) of the Act
establishes an annual target for
reductions in PFS expenditures
resulting from adjustments to relative
values of misvalued codes. Under
section 1848(c)(2)(O)(ii) of the Act, if the
estimated net reduction in expenditures
for a year as a result of adjustments to
the relative values for misvalued codes
is equal to or greater than the target for
that year, reduced expenditures
attributable to such adjustments shall be
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redistributed in a budget-neutral
manner within the PFS in accordance
with the existing budget neutrality
requirement under section
1848(c)(2)(B)(ii)(II) of the Act. The
provision also specifies that the amount
by which such reduced expenditures
exceeds the target for a given year shall
be treated as a net reduction in
expenditures for the succeeding year,
for purposes of determining whether the
target has been met for that subsequent
year. Section 1848(c)(2)(O)(iv) of the Act
defines a target recapture amount as the
difference between the target for the
year and the estimated net reduction in
expenditures under the PFS resulting
from adjustments to RVUs for misvalued
codes. Section 1848(c)(2)(O)(iii) of the
Act specifies that, if the estimated net
reduction in PFS expenditures for the
year is less than the target for the year,
an amount equal to the target recapture
amount shall not be taken into account
when applying the budget neutrality
requirements specified in section
1848(c)(2)(B)(ii)(II) of the Act. Under
section 1848(c)(2)(O)(v) of the Act, the
target that applies to calendar years
(CYs) 2017 and 2018 is calculated as 0.5
percent of the estimated amount of
expenditures under the PFS for the year.
In CY 2016 PFS rulemaking, we
proposed and finalized a methodology
to implement this statutory provision.
Because the annual target is
calculated by measuring changes from
one year to the next, for CY 2016, we
considered how to account for changes
in values that are best measured over 3
years, instead of 2 years. As we
described in the CY 2016 final rule with
comment period (80 FR 70932), our
general valuation process for potentially
misvalued, new, and revised codes was
to establish values on an interim final
basis for a year in the PFS final rule
with comment period. Then, during the
60-day period following the publication
of the final rule with comment period,
we would accept public comment about
those valuations. In the final rule with
comment period for the subsequent
year, we would consider and respond to
public comments received on the
interim final values, and make any
appropriate adjustments to values based
on those comments. Under that process
for revaluing new, revised, and
misvalued codes, we believe the overall
change in valuation for many codes
would best measured across values for
3 years: Between the original value in
the first year; the interim final value in
the second year; and the finalized value
in the third year. However, the target
calculation for a year would only be
comparing changes in RVUs between 2
years and not among 3 years, so the
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contribution of a particular change
towards the target for any single year
would be measured against only the
preceding year without regard to the
overall change that takes place over 3
years.
For recent years, interim final values
for misvalued codes (year 2) have
generally reflected reductions relative to
original values (year 1), and for most
codes, the interim final values (year 2)
are maintained and finalized (year 3).
However, when values for particular
codes have changed between the interim
final (year 2) and final values (year 3)
based on public comment, the general
tendency has been that codes increase
in the final value (year 3) relative to the
interim final value (year 2), even in
cases where the final value (year 3)
represents a decrease from the original
value (year 1). Therefore, for these
codes, the year 2 changes compared to
year 1 would risk over-representing the
overall reduction, while the year 3 to
year 2 changes would represent an
increase in value. We noted that if there
were similar targets in every PFS year,
and a similar number of misvalued code
changes made on an interim final basis,
the incongruence in measuring what is
really a 3-year change in 2-year
increments might not be particularly
problematic since each year’s
calculation would presumably include a
similar number of codes measured
between years 1 and 2 and years 2 and
3.
However, including changes that take
place over 3 years generated challenges
in calculating the target for CY 2016.
Because there was no target for CY 2015,
any reductions that occurred on an
interim final basis for CY 2015 were not
counted toward achievement of a target.
If we had then included any upward
adjustments made to these codes based
on public comment as ‘‘misvalued
code’’ changes for CY 2016, we would
effectively be counting the service-level
increases for 2016 (year 3) relative to
2015 (year 2) against achievement of the
target without any consideration to the
service-level changes relative to 2014
(year 1), even in cases where the overall
change in valuation was negative.
Therefore, we proposed and finalized
the decision to exclude code-level input
changes for CY 2015 interim final values
from the calculation of the CY 2016
misvalued code target since the
misvalued change occurred over
multiple years, including years not
applicable to the misvalued code target
provision.
For the CY 2017 final rule with
comment period, we will be finalizing
values (year 3) for codes that were
interim final in CY 2016 (year 2). Unlike
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codes that were interim final for CY
2015, the codes that are interim final for
CY 2016 were included as misvalued
codes and will fall within the range of
years for which the misvalued code
target provision applies. Thus, overall
changes in values for these codes would
be measured in the target across 3 full
years: The original value in the first year
(CY 2015); the interim final value in the
second year (CY 2016); and the finalized
value in the third year (CY 2017). The
changes in valuation for these CY 2016
interim final codes were previously
measured and counted towards the
target during their initial change in
valuation between years 1 and 2.
As such, we are proposing to include
changes in values of the CY 2016
interim final codes toward the CY 2017
misvalued code target. We believe that
this is consistent with the approach that
we finalized in last year’s final rule with
comment period. The changes in values
of CY 2015 interim final codes were not
counted towards the misvalued code
target in CY 2016 since the valuation
change occurred over multiple years,
including years not applicable to the
misvalued code target provision.
However, both of the changes in
valuation for the CY 2016 interim final
codes, from year 1 to year 2 (CY 2015
to CY 2016) and from year 2 to year 3
(CY 2016 to CY 2017), have taken place
during years that occur within the
misvalued code target provision. We
therefore believe that any adjustments
made to these codes based on public
comment should be considered towards
the achievement of the target for CY
2017, just as any changes in valuation
for these same CY 2016 interim final
codes previously counted towards the
achievement of the target for CY 2016.
We seek public comments regarding
this proposal. We also remind
commenters that we have revised our
process for revaluing new, revised and
misvalued codes so that we will be
proposing and finalizing values for most
of the misvalued codes during a single
calendar year. After this year, there will
be far fewer instances of interim final
codes and changes that are best
measured over 3 years far.
We refer readers to the regulatory
impact analysis section of this proposed
rule for our estimate of the proposed net
reduction in expenditures relative to the
0.5 percent target for CY 2017, and the
resulting adjustment required to be
made to the conversion factor.
Additionally, we refer readers to the
public use file that provides a
comprehensive description of how the
target is calculated as well as the
estimated impact by code family on the
CMS Web site under the supporting data
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files for the CY 2017 PFS proposed rule
at https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
PhysicianFeeSched/.
H. Phase-In of Significant RVU
Reductions
Section 1848(c)(7) of the Act specifies
that for services that are not new or
revised codes, if the total RVUs for a
service for a year would otherwise be
decreased by an estimated 20 percent or
more as compared to the total RVUs for
the previous year, the applicable
adjustments in work, PE, and MP RVUs
shall be phased in over a 2-year period.
In the CY 2016 PFS rulemaking, we
proposed and finalized a methodology
to implement this statutory provision.
To determine which services are
described by new or revised codes for
purposes of the phase-in provision, we
apply the phase-in to all services that
are described by the same, unrevised
code in both the current and update
year, and exclude codes that describe
different services in the current and
update year.
Because the phase-in of significant
reductions in RVUs falls within the
budget neutrality requirements specified
in section 1848(c)(2)(B)(ii)(II) of the Act,
we estimate the total RVUs for a service
prior to the budget-neutrality
redistributions that result from
implementing phase-in values. In
implementing the phase-in, we consider
a 19 percent reduction as the maximum
1-year reduction for any service not
described by a new or revised code.
This approach limits the year one
reduction for the service to the
maximum allowed amount (that is, 19
percent), and then phases in the
remainder of the reduction.
The statute provides that the
applicable adjustments in work, PE, and
MP RVUs shall be phased in over a 2year period when the RVU reduction for
a code for a year is estimated to be equal
to or greater than 20 percent. Since CY
2016 was the first year in which we
applied the phase-in transition, CY 2017
will be the first year in which a single
code could be subject to RVU reductions
greater than 20 percent for 2 consecutive
years.
Under our finalized policy, the only
codes that are not subject to the phasein are those that are new or revised,
which we defined as those services that
are not described by the same,
unrevised code in both the current and
update year, or by the same codes that
describe different services in the current
and update year. Since CY 2016 was the
first year for which the phase-in
provision applied, we did not address
how we would handle codes with
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values that had been partially phased in
during the first year, but that have a
remaining phase-in reduction of 20
percent or greater.
The significant majority of codes with
reductions in RVUs that are greater than
20 percent in year one would not be
likely to meet the 20 percent threshold
in a consecutive year. However, in a few
cases, significant changes (for example,
in the input costs included in the
valuation of a service) could produce
reductions of 20 percent or greater in
consecutive years.
We believe that a consistent
methodology regarding the phase-in
transition should be applied to these
cases. We propose to reconsider in each
year, for all codes that are not new or
revised codes and including codes that
were assigned a phase-in value in the
previous year, whether the total RVUs
for the service would otherwise be
decreased by an estimated 20 percent or
more as compared to the total RVUs for
the previous year. Under this proposed
policy, the 19 percent reduction in total
RVUs would continue to be the
maximum one-year reduction for all
codes (except those considered new and
revised), including those codes with
phase-in values in the previous year. In
other words, for purposes of the 20
percent threshold, every service is
evaluated anew each year, and any
applicable phase-in is limited to a
decrease of 19 percent. For example, if
we were to adopt a 50 percent reduction
in total RVUs for an individual service,
the reduction in any particular year
would be limited to a decrease of 19
percent in total RVUs. Because we do
not set rates 2 years in advance, the
phase-in transition continues to apply
until the year-to-year reduction for a
given code does not meet the 20 percent
threshold.
We are soliciting comments regarding
this proposal.
The list of codes proposed to be
subject to the phase-in and the
associated proposed RVUs that result
from this methodology are available on
the CMS Web site under downloads for
the CY 2017 PFS proposed rule at
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-Notices.html.
I. 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
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to the national average for each of the
three fee schedule components (that is,
work, PE, and malpractice (MP)). The
PFS localities are discussed in section
II.E.3. of this proposed rule. 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, 2015. Section
201 of the MACRA amended the statute
to extend the 1.0 floor for the work
GPCIs through CY 2017 (that is, for
services furnished no later than
December 31, 2017).
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 GPCI
adjustment, the adjustment to be
applied in the first year of the next
adjustment shall be half of the
adjustment that otherwise would be
made. Therefore, since the previous
GPCI update was implemented in CY
2014 and CY 2015, we are proposing to
phase in 1/2 of the latest GPCI
adjustment in CY 2017.
We have completed a review of the
GPCIs and are proposing new GPCIs in
this proposed rule. We also calculate a
geographic adjustment factor (GAF) for
each PFS locality. The GAFs are a
weighted composite of each area’s work,
PE and malpractice expense GPCIs
using the national GPCI cost share
weights. While we do not actually use
GAFs in computing the fee schedule
payment for a specific service, they are
useful in comparing overall areas costs
and payments. The actual effect on
payment for any actual service would
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 noted above, section 201 of the
MACRA extended the 1.0 work GPCI
floor for services furnished through
December 31, 2017. Therefore, the
proposed CY 2017 work GPCIs and
summarized GAFs reflect the 1.0 work
floor. Additionally, as required by
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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 2017. See
Addenda D and E to this proposed rule
for the proposed CY 2017 GPCIs and
summarized GAFs available on the CMS
Web site under the supporting
documents section of the CY 2017 PFS
proposed rule located at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/.
2. GPCI Update
The proposed updated GPCI values
were calculated by a contractor. There
are three GPCIs (work, PE, and MP), and
all GPCIs are calculated through
comparison to a national average for
each. Additionally, each of the three
GPCIs relies on its own data source(s)
and methodology for calculating its
value as described below. Additional
information on the CY 2017 GPCI
update may be found in our contractor’s
draft report, ‘‘Draft Report on the CY
2017 Update of the Geographic Practice
Cost Index for the Medicare Physician
Fee Schedule,’’ which is available on
our Web site. It is located under the
supporting documents section for the
CY 2017 PFS proposed rule located at
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
PhysicianFeeSched/.
a. Work GPCIs
The work GPCIs are designed to
reflect the relative costs of physician
labor by Medicare PFS locality. As
required by statute, the work GPCI
reflects one quarter of the relative wage
differences for each locality compared
to the national average.
To calculate the work GPCIs, we use
wage data for seven professional
specialty occupation categories,
adjusted to reflect one-quarter of the
relative cost differences for each locality
compared to the national average, as a
proxy for physicians’ wages. Physicians’
wages are not included in the
occupation categories used in
calculating the work GPCI because
Medicare payments are a key
determinant of physicians’ earnings.
Including physician wage data in
calculating the work GPCIs would
potentially introduce some circularity to
the adjustment since Medicare
payments typically contribute to or
influence physician wages. That is,
including physicians’ wages in the
physician work GPCIs would, in effect,
make the indices, to some extent,
dependent upon Medicare payments.
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The work GPCI updates in CYs 2001,
2003, 2005, and 2008 were based on
professional earnings data from the 2000
Census. However, for the CY 2011 GPCI
update (75 FR 73252), the 2000 data
were outdated and wage and earnings
data were not available from the more
recent Census because the ‘‘long form’’
was discontinued. Therefore, we used
the median hourly earnings from the
2006 through 2008 Bureau of Labor
Statistics (BLS) Occupational
Employment Statistics (OES) wage data
as a replacement for the 2000 Census
data. The BLS OES data meet several
criteria that we consider to be important
for selecting a data source for purposes
of calculating the GPCIs. For example,
the BLS OES wage and employment
data are derived from a large sample
size of approximately 200,000
establishments of varying sizes
nationwide from every metropolitan
area and can be easily accessible to the
public at no cost. Additionally, the BLS
OES is updated regularly, and includes
a comprehensive set of occupations and
industries (for example, 800
occupations in 450 industries). For the
CY 2014 GPCI update, we used updated
BLS OES data (2009 through 2011) as a
replacement for the 2006 through 2008
data to compute the work GPCIs.
Because of its reliability, public
availability, level of detail, and national
scope, we believe the BLS OES
continues to be the most appropriate
source of wage and employment data for
use in calculating the work GPCIs (and
as discussed in section II.E.2.b the
employee wage component and
purchased services component of the PE
GPCI). Therefore, for the proposed CY
2017 GPCI update, we used updated
BLS OES data (2011 through 2014) as a
replacement for the 2009 through 2011
data to compute the work GPCIs.
b. Practice Expense GPCIs
The PE GPCIs are designed to measure
the relative cost difference in the mix of
goods and services comprising practice
expenses (not including malpractice
expenses) among the PFS localities as
compared to the national average of
these costs. Whereas the physician work
GPCIs (and as discussed later in this
section, the MP GPCIs) are comprised of
a single index, the PE GPCIs are
comprised of four component indices
(employee wages; purchased services;
office rent; and equipment, supplies and
other miscellaneous expenses). The
employee wage index component
measures geographic variation in the
cost of the kinds of skilled and
unskilled labor that would be directly
employed by a physician practice.
Although the employee wage index
adjusts for geographic variation in the
cost of labor employed directly by
physician practices, it does not account
for geographic variation in the cost of
services that typically would be
purchased from other entities, such as
law firms, accounting firms, information
technology consultants, building service
managers, or any other third-party
vendor. The purchased services index
component of the PE GPCI (which is a
separate index from employee wages)
measures geographic variation in the
cost of contracted services that
physician practices would typically
buy. (For more information on the
development of the purchased service
index, we refer readers to the CY 2012
PFS final rule with comment period (76
FR 73084 through 73085)). The office
rent index component of the PE GPCI
measures relative geographic variation
in the cost of typical physician office
rents. For the medical equipment,
supplies, and miscellaneous expenses
component, we believe there is a
national market for these items such
that there is not significant geographic
variation in costs. Therefore, the
equipment, supplies and other
miscellaneous expense cost index
component of the PE GPCI is given a
value of 1.000 for each PFS locality.
For the previous update to the GPCIs
(implemented in CY 2014) we used
2009 through 2011 BLS OES data to
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calculate the employee wage and
purchased services indices for the PE
GPCI. As discussed in section II.E.2.a.,
because of its reliability, public
availability, level of detail, and national
scope, we continue to believe the BLS
OES is the most appropriate data source
for collecting wage and employment
data. Therefore, in calculating the
proposed CY 2017 GPCI update, we
used updated BLS OES data (2011
through 2014) as a replacement for the
2009 through 2011 data for purposes of
calculating the employee wage
component and purchased service index
of the PE GPCI.
c. Malpractice Expense (MP) GPCIs
The MP GPCIs measure the relative
cost differences among PFS localities for
the purchase of professional liability
insurance (PLI). The MP GPCIs are
calculated based on insurer rate filings
of premium data for $1 million to $3
million mature claims-made policies
(policies for claims made rather than
services furnished during the policy
term). For the CY 2014 GPCI update
(seventh update) we used 2011 and
2012 malpractice premium data (78 FR
74382). The proposed CY 2017 MP GPCI
update reflects 2014 and 2015 premium
data. Additionally, the proposed CY
2017 MP GPCI update reflects several
proposed technical refinements to the
MP GPCI methodology as discussed
later in section 5.
d. GPCI Cost Share Weights
For the proposed CY 2017 GPCIs, we
are continuing to use the current cost
share weights for determining the PE
GPCI values and locality GAFs. We refer
readers to the CY 2014 PFS final rule
with comment period (78 FR 74382
through 74383), for further discussion
regarding the 2006-based MEI cost share
weights revised in CY 2014 that were
also finalized for use in the CY 2014
(seventh) GPCI update.
The proposed GPCI cost share weights
for CY 2017 are displayed in Table 12.
TABLE 12—PROPOSED COST SHARE WEIGHTS FOR CY 2017 GPCI UPDATE
Current cost
share weight
(%)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
Expense category
Work .........................................................................................................................................................................
Practice Expense .....................................................................................................................................................
—Employee Compensation ..............................................................................................................................
—Office Rent ....................................................................................................................................................
—Purchased Services ......................................................................................................................................
—Equipment, Supplies, Other ..........................................................................................................................
Malpractice Insurance ..............................................................................................................................................
Total ..................................................................................................................................................................
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E:\FR\FM\15JYP2.SGM
15JYP2
50.866
44.839
16.553
10.223
8.095
9.968
4.295
100.000
Proposed CY
2017 cost
share weight
(%)
50.866
44.839
16.553
10.223
8.095
9.968
4.295
100.000
46220
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
e. PE GPCI Floor for Frontier States
Section 10324(c) of the Affordable
Care Act added a new subparagraph (I)
under section 1848(e)(1) of the Act to
establish a 1.0 PE GPCI floor for
physicians’ services furnished in
frontier states effective January 1, 2011.
In accordance with section 1848(e)(1)(I)
of the Act, beginning in CY 2011, we
applied a 1.0 PE GPCI floor for
physicians’ services furnished in states
determined to be frontier states. In
general, a frontier state is one in which
at least 50 percent of the counties are
‘‘frontier counties,’’ which are those that
have a population per square mile of
less than 6. For more information on the
criteria used to define a frontier state,
we refer readers to the FY 2011
Inpatient Prospective Payment System
(IPPS) final rule (75 FR 50160 through
50161). There are no changes in the
states identified as Frontier States for
the CY 2017 proposed rule. The
qualifying states are: Montana,
Wyoming, North Dakota, South Dakota,
and Nevada. In accordance with statute,
we would apply a 1.0 PE GPCI floor for
these states in CY 2017.
f. Proposed GPCI Update
As explained above in the background
section, the periodic review and
adjustment of GPCIs is mandated by
section 1848(e)(1)(C) of the Act. At each
update, the proposed GPCIs are
published in the PFS proposed rule to
provide an opportunity for public
comment and further revisions in
response to comments prior to
implementation. The proposed CY 2017
updated GPCIs for the first and second
year of the 2-year transition, along with
the GAFs, are displayed in Addenda D
and E to this proposed rule available on
our Web site under the supporting
documents section of the CY 2017 PFS
proposed rule Web page at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
3. Payment Locality Discussion
a. Background
The current PFS locality structure was
developed and implemented in 1997.
There are currently 89 total PFS
localities; 34 localities are statewide
areas (that is, only one locality for the
entire state). There are 52 localities in
the other 16 states, with 10 states having
2 localities, 2 states having 3 localities,
1 state having 4 localities, and 3 states
having 5 or more localities. The
combined District of Columbia,
Maryland, and Virginia suburbs; Puerto
Rico; and the Virgin Islands are the
remaining three localities of the total of
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89 localities. The development of the
current locality structure is described in
detail in the CY 1997 PFS proposed rule
(61 FR 34615) and the subsequent final
rule with comment period (61 FR
59494). We note that the localities
generally represent a grouping of one or
more constituent counties.
Prior to 1992, Medicare payments for
physicians’ services were made under
the reasonable charge system. Payments
were based on the charging patterns of
physicians. This resulted in large
differences in payment for physicians’
services among types of services,
geographic payment areas, and
physician specialties. Recognizing this,
the Congress replaced the reasonable
charge system with the Medicare PFS in
the Omnibus Budget Reconciliation Act
(OBRA) of 1989, and the PFS went into
effect January 1, 1992. Payments under
the PFS are based on the relative
resources involved with furnishing
services, and are adjusted to account for
geographic variations in resource costs
as measured by the GPCIs.
Payment localities originally were
established under the reasonable charge
system by local Medicare carriers based
on their knowledge of local physician
charging patterns and economic
conditions. These localities changed
little between the inception of Medicare
in 1967 and the beginning of the PFS in
1992. Shortly after the PFS took effect,
we undertook a study in 1994 that
culminated in a comprehensive locality
revision that was implemented in 1997
(61 FR 59494).
The revised locality structure reduced
the number of localities from 210 to the
current 89, and the number of statewide
localities increased from 22 to 34. The
revised localities were based on locality
resource cost differences as reflected by
the GPCIs. For a full discussion of the
methodology, see the CY 1997 PFS final
rule with comment period (61 FR
59494). The current 89 fee schedule
areas are defined alternatively by state
boundaries (for example, Wisconsin),
metropolitan areas (for example,
Metropolitan St. Louis, MO), portions of
a metropolitan area (for example,
Manhattan), or rest-of-state areas that
exclude metropolitan areas (for
example, Rest of Missouri). This locality
configuration is used to calculate the
GPCIs that are in turn used to calculate
payments for physicians’ services under
the PFS.
As stated in the CY 2011 PFS final
rule with comment period (75 FR
73261), changes to the PFS locality
structure would generally result in
changes that are budget neutral within
a state. For many years, before making
any locality changes, we have sought
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Sfmt 4702
consensus from among the professionals
whose payments would be affected. In
recent years, we have also considered
more comprehensive changes to locality
configuration. In 2008, we issued a draft
comprehensive report detailing four
different locality configuration options
(https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
PhysicianFeeSched/downloads/
ReviewOfAltGPCIs.pdf). We refer
readers to the CY 2014 PFS final rule
with comment period for further
discussion regarding that report, as well
as a discussion about the Institute of
Medicine’s empirical study of the
Medicare GAFs established under
sections 1848(e) (PFS GPCI) and
1886(d)(3)(E) (IPPS wage index) of the
Act.
b. California Locality Update to the Fee
Schedule Areas Used for Payment
Under Section 220(h) of the Protecting
Access to Medicare Act
(1) General Discussion and Legislative
Change
Section 220(h) of the PAMA added a
new section 1848(e)(6) to the Act, that
modifies the fee schedule areas used for
payment purposes in California
beginning in CY 2017.
Currently, the fee schedule areas used
for payment in California are based on
the revised locality structure that was
implemented in 1997 as previously
discussed. Beginning in CY 2017,
section 1848(e)(6)(A)(i) of the Act
requires that the fee schedule areas used
for payment in California must be
Metropolitan Statistical Areas (MSAs) as
defined by the Office of Management
and Budget (OMB) as of December 31 of
the previous year; and section
1848(e)(6)(A)(ii) of the Act requires that
all areas not located in an MSA must be
treated as a single rest-of-state fee
schedule area. The resulting
modifications to California’s locality
structure would increase its number of
localities from 9 under the current
locality structure to 27 under the MSAbased locality structure.
However, section 1848(e)(6)(D) of the
Act defines transition areas as the fee
schedule areas for 2013 that were the
rest-of-state locality, and locality 3,
which was comprised of Marin county,
Napa county, and Solano county.
Section 1848(e)(6)(B) specifies that the
GPCI values used for payment in a
transition area are to be phased in over
6 years, from 2017 through 2021, using
a weighted sum of the GPCIs calculated
under the new MSA-based locality
structure and the GPCIs calculated
under the current PFS locality structure.
That is, the GPCI values applicable for
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areas that are now in MSAs, which are
only some of the counties in the 2013
California rest-of state locality and
locality 3.
Additionally, section 1848(e)(6)(C) of
the Act establishes a hold harmless for
transition areas beginning with CY 2017
whereby the applicable GPCI values for
a year under the new MSA-based
locality structure may not be less than
what they would have been for the year
under the current locality structure.
There are a total of 58 counties in
California, 50 of which are in transition
areas as defined in section 1848(e)(6)(D)
of the Act. Therefore, 50 counties in
California are subject to the hold
harmless provision. The other 8
counties, which are metropolitan
counties that are not defined as
transition areas, are not held harmless
for the impact of the new MSA-based
locality structure, and may therefore
potentially experience slight decreases
in their GPCI values as a result of the
provisions in section 1848(e)(6) of the
Act, insofar as the locality in which they
are located now newly includes data
from adjacent counties that decreases
their GPCI values relative to those that
these areas during this transition period
are a blend of what the GPCI values
would have been under the current
locality structure, and what the GPCI
values would be under the MSA-based
locality structure. For example, in the
first year, CY 2017, the applicable GPCI
values for counties that were previously
in rest-of-state or locality 3 and are now
in MSAs are a blend of 1/6 of the GPCI
value calculated for the year under the
MSA-based locality structure, and 5/6 of
the GPCI value calculated for the year
under the current locality structure. The
proportions shift by 1/6 in each
subsequent year so that, by CY 2021, the
applicable GPCI values for counties
within transition areas are a blend of 5/
6 of the GPCI value for the year under
the MSA-based locality structure, and 1/
6 of the GPCI value for the year under
the current locality structure. Beginning
in CY 2022, the applicable GPCI values
for counties in transition areas are the
values calculated under the new MSAbased locality structure. For the sake of
clarity, we reiterate that this
incremental phase-in is only applicable
to those counties that are in transition
would have applied had the new data
not been incorporated. Therefore, the
GPCIs for these eight counties under the
MSA-based locality structure may be
less than they would have been under
the current GPCI structure. The eight
counties that are not within transition
areas are: Orange; Los Angeles;
Alameda; Contra Costa; San Francisco;
San Mateo; Santa Clara; and Ventura
counties.
We emphasize that while transition
areas are held harmless from the impact
of the GPCI changes using the new
MSA-based locality structure, because
we are proposing other updates for CY
2017 as part of the eighth GPCI update,
including the use of updated data,
transition areas would still be subject to
impacts resulting from those other
updates. Table 13 illustrates using
GAFs, for CY 2017, the isolated impact
of the MSA-based locality changes and
hold-harmless for transition areas
required by section 1848(e)(6) of the
Act, the impact of the proposed use of
updated data for GPCIs, and the
combined impact of both of these
proposed changes.
TABLE 13—IMPACT ON CALIFORNIA GAFS AS A RESULT OF SECTION 1848(e)(6) OF THE ACT AND PROPOSED UPDATED
DATA BY FEE SCHEDULE AREA
[Sorted alphabetically by locality name]
Transition
area
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
Medicare fee schedule area
Bakersfield .......................................
Chico ................................................
El Centro ..........................................
Fresno ..............................................
Hanford-Corcoran ............................
Los Angeles-Long Beach-Anaheim
(Los Angeles County) ...................
Los Angeles-Long Beach-Anaheim
(Orange County) ...........................
Madera .............................................
Merced .............................................
Modesto ...........................................
Napa .................................................
Oxnard-Thousand Oaks-Ventura .....
Redding ............................................
Rest Of California ............................
Riverside-San Bernardino-Ontario ...
Sacramento-Roseville-Arden-Arcade
Salinas .............................................
San Diego-Carlsbad .........................
San
Francisco-Oakland-Hayward
(Alameda/Contra Costa County) ..
San
Francisco-Oakland-Hayward
(Marin County) ..............................
San
Francisco-Oakland-Hayward
(San Francisco County) ...............
San
Francisco-Oakland-Hayward
(San Mateo County) .....................
San Jose-Sunnyvale-Santa Clara
(San Benito County) .....................
San Jose-Sunnyvale-Santa Clara
(Santa Clara County) ...................
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2016
GAF
2017 GAF w/o
1848(e)(6)
% Change due
to new GPCI
data
2017 GAF w/
1848(e)(6)
% Change due
to 1848(e)(6)
Combined impact of PAMA
and new GPCI
data (%)
1
1
1
1
1
1.04
1.04
1.04
1.04
1.04
1.031
1.031
1.031
1.031
1.031
¥0.50
¥0.50
¥0.50
¥0.50
¥0.50
1.031
1.031
1.031
1.031
1.031
0.00
0.00
0.00
0.00
0.00
¥0.50
¥0.50
¥0.50
¥0.50
¥0.50
0
1.09
1.09
¥0.20
1.091
0.10
¥0.10
0
1
1
1
1
0
1
1
1
1
1
1
1.09
1.04
1.04
1.04
1.14
1.09
1.04
1.04
1.04
1.04
1.04
1.04
1.104
1.031
1.031
1.031
1.128
1.083
1.031
1.031
1.031
1.031
1.031
1.031
1.10
¥0.50
¥0.50
¥0.50
¥0.80
¥0.60
¥0.50
¥0.50
¥0.50
¥0.50
¥0.50
¥0.50
1.101
1.031
1.031
1.031
1.128
1.083
1.031
1.031
1.032
1.031
1.033
1.035
¥0.30
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.10
0.00
0.20
0.40
0.80
¥0.50
¥0.50
¥0.50
¥0.80
¥0.60
¥0.50
¥0.50
¥0.40
¥0.50
¥0.30
¥0.10
0
1.18
1.125
¥4.80
1.142
1.50
¥3.40
1
1.14
1.128
¥0.80
1.129
0.10
¥0.70
0
1.18
1.194
1.00
1.175
¥1.60
¥0.60
0
1.18
1.187
0.40
1.171
¥1.30
¥0.90
1
1.04
1.031
¥0.50
1.053
2.10
1.60
0
1.18
1.176
0.10
1.175
¥0.10
0.00
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TABLE 13—IMPACT ON CALIFORNIA GAFS AS A RESULT OF SECTION 1848(e)(6) OF THE ACT AND PROPOSED UPDATED
DATA BY FEE SCHEDULE AREA—Continued
[Sorted alphabetically by locality name]
Transition
area
Medicare fee schedule area
San Luis Obispo-Paso Robles-Arroyo Grande .................................
Santa Cruz-Watsonville ...................
Santa Maria-Santa Barbara .............
Santa Rosa ......................................
Stockton-Lodi ...................................
Vallejo-Fairfield ................................
Visalia-Porterville .............................
Yuba City .........................................
1
1
1
1
1
1
1
1
Additionally, for the purposes of
calculating budget neutrality and
consistent with the PFS budget
neutrality requirements as specified
under section 1848(c)(2)(B)(ii)(II) of the
Act, we are proposing to start by
calculating the national GPCIs as if the
current localities are still applicable
nationwide; then for the purposes of
payment in California, we will override
the GPCI values with the values that are
applicable for California consistent with
the requirements of section 1848(e)(6) of
the Act. This approach is consistent
with the implementation of the GPCI
floor provisions that have previously
been implemented—that is, as an afterthe-fact adjustment that is implemented
for purposes of payment after both the
GPCIs and PFS budget neutrality have
already been calculated.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
(2) Proposed Operational Considerations
As discussed above, under section
1848(e)(6) of the Act, counties that were
previously in the rest-of-state locality or
locality 3 and are now in MSAs would
have their GPCI values under the new
MSA-based locality structure phased in
gradually, in increments of one-sixth
over 6 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 GPCI 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. While section 1848(e)(6)(B) of the
Act establishes a blended phase-in for
the MSA-based GPCI values, it does not
explicitly state whether or how that
provision is to be reconciled with the
requirement at section 1848(e)(1)(C) of
the Act. We believe that since section
1848(e)(6)(A) of the Act requires that we
must make the change to MSA-based fee
schedule areas for California GPCIs
notwithstanding the preceding
provisions of section 1848(e) of the Act,
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GAF
2017 GAF w/o
1848(e)(6)
% Change due
to new GPCI
data
1.031
1.031
1.031
1.031
1.031
1.128
1.031
1.031
¥0.50
¥0.50
¥0.50
¥0.50
¥0.50
¥0.80
¥0.50
¥0.50
1.04
1.04
1.04
1.04
1.04
1.14
1.04
1.04
and subject to the succeeding provisions
of section 1848(e)(6) of the Act, that
applying the two-year phase-in
specified by the preceding provisions
simultaneously with the six-year phasein would undermine the incremental 6year phase-in specified in section
1848(e)(6)(B) of the Act. Therefore, we
are proposing that the requirement at
section 1848(e)(1)(C) of the Act to phase
in 1⁄2 of the adjustment in year 1 of the
GPCI update would not apply to
counties that were previously in the
rest-of-state or locality 3 and are now in
MSAs, and therefore, are subject to the
blended phase-in as described above.
Since section 1848(e)(6)(B) of the Act
provides for a gradual phase in of the
GPCI values under the new MSA-based
locality structure, specifically in onesixth increments over 6 years, if we
were to also apply the requirement to
phase in 1/2 of the adjustment in year
1 of the GPCI update then the first year
increment would effectively be onetwelfth. We note that this issue is only
of concern if more than 1 year has
elapsed since the previous GPCI update,
and would only be applicable through
CY 2021 since, beginning in CY 2022,
the GPCI values for such areas in an
MSA would be fully based on the values
calculated under the new MSA-based
locality structure for California.
As previously stated, the resulting
modifications to California’s locality
structure increase its number of
localities from 9 under the current
locality structure to 27 under the MSAbased locality structure. However, both
the current localities and the MSAbased localities are comprised of various
component counties, and in some
localities only some of the component
counties are subject to the blended
phase-in and hold harmless provisions
required by section 1848(e)(6)(B) and (C)
of the Act. Therefore, the application of
these provisions may produce differing
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2017 GAF w/
1848(e)(6)
1.031
1.042
1.036
1.037
1.031
1.128
1.031
1.031
% Change due
to 1848(e)(6)
Combined impact of PAMA
and new GPCI
data (%)
0.00
1.10
0.50
0.60
0.00
0.00
0.00
0.00
¥0.50
0.60
0.00
0.10
¥0.50
¥0.80
¥0.50
¥0.50
GPCI values among counties within the
same fee schedule area under the MSAbased locality structure. For example,
the MSA-based San Jose-SunnyvaleSanta Clara locality, is comprised of 2
constituent counties—San Benito
county, and Santa Clara county. San
Benito County is in a transition area
(2013 rest-of-state), while Santa Clara
county is not. Hence, although the
counties are in the same MSA, the
requirements of section 1848(e)(6)(B)
and (C) of the Act may produce differing
GPCI values for each county. To address
this issue, we propose to assign a
unique locality number to the counties
that would be impacted in the
aforementioned manner. As a result,
although the modifications to
California’s locality structure increase
the number of localities from 9 under
the current locality structure to 27
under the MSA-based locality structure,
for purposes of payment, the actual
number of localities under the MSAbased locality structure would be 32 to
account for instances where unique
locality numbers are needed as
described above. Additionally, while
the fee schedule area names are
consistent with the MSAs designated by
OMB, we are proposing to maintain 2digit locality numbers to correspond to
the existing fee schedule areas. Pursuant
to the implementation of the new MSAbased locality structure for California,
the total number of PFS localities would
increase from 89 to 112. Table 14
displays the current fee schedule areas
in California, and Table 15 displays the
MSA-based fee schedule areas in
California required by section 1848(e)(6)
of the Act. Additional information on
the California locality update may be
found in our contractor’s draft report,
‘‘Draft Report on the CY 2017 Update of
the Geographic Practice Cost Index for
the Medicare Physician Fee Schedule,’’
which is available on the CMS Web site.
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It is located under the supporting
documents section of the CY 2017 PFS
proposed rule located at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/PhysicianFee
Sched/.
TABLE 14—CURRENT FEE SCHEDULE
AREAS IN CALIFORNIA
TABLE 14—CURRENT FEE SCHEDULE
AREAS IN CALIFORNIA—Continued
[Sorted alphabetically by locality name]
[Sorted alphabetically by locality name]
Locality
number
Fee schedule
area
26 ...........
Anaheim/Santa
Ana.
Los Angeles ....
Marin/Napa/Solano.
Oakland/Berkley.
18 ...........
03 ...........
07 ...........
Counties
Orange
Los Angeles
Marin, Napa,
And Solano
Alameda And
Contra Costa
Locality
number
05
06
09
17
99
Fee schedule
area
...........
...........
...........
...........
...........
Counties
San Francisco
San Mateo .......
Santa Clara .....
Ventura ............
Rest Of State ..
San Francisco
San Mateo
Santa Clara
Ventura
All Other Counties
TABLE 15—MSA-BASED FEE SCHEDULE AREAS IN CALIFORNIA
[Sorted alphabetically by locality name]
Current
locality
number
...........
...........
...........
...........
...........
...........
54
55
71
56
57
18
26 ...........
99 ...........
99 ...........
99 ...........
3 .............
17 ...........
99 ...........
99 ...........
99 ...........
99 ...........
26
58
59
60
51
17
61
75
62
63
99 ...........
99 ...........
7 .............
64
72
7
3 .............
5 .............
52
5
6 .............
99 ...........
9 .............
6
65
9
99 ...........
99 ...........
99 ...........
99 ...........
99 ...........
3 .............
99 ...........
99 ...........
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
99
99
99
99
99
18
Proposed new
locality
number
73
66
74
67
73
53
69
70
Counties
Bakersfield, CA .....................................................................
Chico, CA ..............................................................................
El Centro, CA ........................................................................
Fresno, CA ............................................................................
Hanford-Corcoran, CA ..........................................................
Los Angeles-Long Beach-Anaheim, CA (Los Angeles
County).
Los Angeles-Long Beach-Anaheim, CA (Orange County) ...
Madera, CA ...........................................................................
Merced, CA ...........................................................................
Modesto, CA .........................................................................
Napa, CA ..............................................................................
Oxnard-Thousand Oaks-Ventura, CA ...................................
Redding, CA ..........................................................................
REST OF STATE ..................................................................
Riverside-San Bernardino-Ontario, CA .................................
Sacramento—Roseville—Arden-Arcade, CA ........................
Kern .......................................................
Butte ......................................................
Imperial ..................................................
Fresno ...................................................
Kings .....................................................
Los Angeles ..........................................
YES.
YES.
YES.
YES.
YES.
NO.
Orange ..................................................
Madera ..................................................
Merced ..................................................
Stanislaus ..............................................
Napa ......................................................
Ventura ..................................................
Shasta ...................................................
All Other Counties .................................
Riverside, and San Bernardino .............
El Dorado, Placer, Sacramento, and
Yolo.
Monterey ...............................................
San Diego .............................................
Alameda, Contra Costa .........................
NO.
YES.
YES.
YES.
YES.
NO.
YES.
YES.
YES.
YES.
Marin .....................................................
San Francisco .......................................
YES.
NO.
San Mateo .............................................
San Benito .............................................
Santa Clara ...........................................
NO.
YES.
NO.
San Luis Obispo ....................................
Santa Cruz ............................................
Santa Barbara .......................................
Sonoma .................................................
San Joaquin ..........................................
Solano ...................................................
Tulare ....................................................
Sutter, and Yuba ...................................
YES.
YES.
YES.
YES.
YES.
YES.
YES.
YES.
Salinas, CA ...........................................................................
San Diego-Carlsbad, CA .......................................................
San Francisco-Oakland-Hayward, CA (Alameda County/
Contra Costa County).
San Francisco-Oakland-Hayward, CA (Marin County) .........
San Francisco-Oakland-Hayward, CA (San Francisco
County).
San Francisco-Oakland-Hayward, CA (San Mateo County)
San Jose-Sunnyvale-Santa Clara, CA (San Benito County)
San Jose-Sunnyvale-Santa Clara, CA (Santa Clara County).
San Luis Obispo-Paso Robles-Arroyo Grande, CA ..............
Santa Cruz-Watsonville, CA .................................................
Santa Maria-Santa Barbara, CA ...........................................
Santa Rosa, CA ....................................................................
Stockton-Lodi, CA .................................................................
Vallejo-Fairfield, CA ..............................................................
Visalia-Porterville, CA ...........................................................
Yuba City, CA .......................................................................
4. Proposed Update to the Methodology
for Calculating GPCIs in the U.S.
Territories
In calculating GPCIs within U.S.
states, we use county-level wage data
from the Bureau of Labor Statistics
(BLS) Occupational Employment
Statistics Survey (OES), county-level
residential rent data from the American
Community Survey (ACS), and
malpractice insurance premium data
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area
Fee schedule area (MSA name)
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from state departments of insurance. In
calculating GPCIs for the U.S. territories,
we currently use three distinct
methodologies—one for Puerto Rico,
another for the Virgin Islands, and a
third for the Pacific Islands (Guam,
American Samoa, and Northern
Marianas Islands). These three
methodologies were adopted at different
times based primarily on the data that
were available at the time they were
adopted. At present, because Puerto
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YES.
YES.
NO.
Rico is the only territory where countylevel BLS OES, county-level ACS, and
malpractice premium data are available,
it is the only territory for which we use
territory-specific data to calculate
GPCIs. For the Virgin Islands, because
county-level wage and rent data are not
available, and insufficient malpractice
premium data are available, CMS has set
the work, PE, and MP GPCI values for
the Virgin Islands payment locality at
the national average of 1.0 even though,
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like Puerto Rico, the Virgin Islands is its
own locality and county-level BLS OES
data are available for the Virgin Islands.
For the U.S. territories in the Pacific
Ocean, we currently crosswalk GPCIs
from the Hawaii locality for each of the
three GPCIs, and incorporate no local
data from these territories into the GPCI
calculations even though county-level
BLS OES data does exist for Guam, but
not for American Samoa or the Northern
Mariana Islands.
As noted above, currently Puerto Rico
is the only territory for which we
calculate GPCIs using the territoryspecific information relative to data
from the U.S. States. For several years
stakeholders in Puerto Rico have raised
concerns regarding the applicability of
the proxy data in Puerto Rico relative to
their applicability in the U.S. states. We
believe that these concerns may be
consistent across island territories, but
lack of available, appropriate data has
made it difficult to quantify such
variation in costs. For example, some
stakeholders previously indicated that
shipping and transportation expenses
increase the cost of acquiring medical
equipment and supplies in islands and
territories relative to the mainland.
While we have previously attempted to
locate data sources specific to
geographic variation in such shipping
costs, we found no comprehensive
national data source for this information
(we refer readers to 78 FR 74387
through 74388 for the detailed
discussion of this issue). Therefore, we
have not been able to quantify variation
in costs specific to island territories in
the calculation of the GPCIs.
For all the island territories other than
Puerto Rico, the lack of comprehensive
data about unique costs for island
territories has had minimal impact on
GPCIs because we have used either the
Hawaii GPCIs (for the Pacific territories)
or used the unadjusted national
averages (for the Virgin Islands). In an
effort to provide greater consistency in
the calculation of GPCIs given the lack
of comprehensive data regarding the
validity of applying the proxy data used
in the States in accurately accounting
for variability of costs for these island
territories, we are proposing to treat the
Caribbean Island territories (the Virgin
Islands and Puerto Rico) in a consistent
manner. We propose to do so by
assigning the national average of 1.0 to
each GPCI index for both Puerto Rico
and the Virgin Islands. We are not
proposing any changes to the GPCI
methodology for the Pacific Island
territories (Guam, American Samoa, and
Northern Marianas Islands) where we
already consistently assign the Hawaii
GPCI values for each of the three GPCIs.
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Additional information on the Proposed
Update to the Methodology for
Calculating GPCIs in the U.S. Territories
may be found in our contractor’s draft
report, ‘‘Draft Report on the CY 2017
Update of the Geographic Practice Cost
Index for the Medicare Physician Fee
Schedule,’’ which is available on our
Web site. It is located under the
supporting documents section of the CY
2017 PFS proposed rule located at
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
PhysicianFeeSched/.
5. Proposed Refinement to the MP GPCI
Methodology
In the process of calculating MP
GPCIs for the purposes of this proposed
rule, we identified several technical
refinements to the methodology that
yield improvements over the current
method. We are also proposing
refinements that conform to our
proposed methodology for calculating
the GPCIs for the U.S. Territories
described above. Specifically, we are
proposing modifications to the
methodology to account for missing data
used in the calculation of the MP GPCI.
Under the methodology used in the CY
2014 GPCI update (78 FR 74380 through
74391), we first calculated the average
premiums by insurer and specialty, then
imputed premium values for specialties
for which we did not have specific data,
before adjusting the specialty-specific
premium data by market share weights.
We are proposing to revise our
methodology to instead calculate the
average premiums for each specialty
using issuer market share for only
available companies. This proposed
methodological improvement would
reduce potential bias resulting from
large amounts of imputation, an issue
that is prevalent for insurers that only
write policies for ancillary specialties
for which premiums tend to be low. The
current method would impute the low
premiums for ancillary specialties
across the remaining specialties, and
generally greater imputation leads to
less accuracy. Additional information
on the MP GPCI methodology, and the
proposed refinement to the MP GPCI
methodology may be found in our
contractor’s draft report, ‘‘Draft Report
on the CY 2017 Update of the
Geographic Practice Cost Index for the
Medicare Physician Fee Schedule,’’
which is available on our Web site. It is
located under the supporting documents
section of the CY 2017 PFS proposed
rule located at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/
index.html.
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J. Payment Incentive for the Transition
From Traditional X-Ray Imaging to
Digital Radiography and Other Imaging
Services
Section 502(a)(1) of the Consolidated
Appropriations Act of 2016 (H.R. 2029)
amended section 1848(b) of the Act by
establishing new paragraph (b)(9).
Effective for services furnished
beginning January 1, 2017, section
1848(b)(9)(A) of the Act reduces by 20
percent the payment amounts under the
PFS for the technical component (TC)
(including the TC portion of a global
service) of imaging services that are Xrays taken using film. The reduction is
made prior to any other adjustment
under this section and without
application of this new paragraph.
Section 1848(b)(9)(B) of the Act
provides for a 7 percent reduction in
payments for imaging services made
under the PFS that are X-rays (including
the X-ray component of a packaged
service) taken using computed radiology
furnished during CY 2018, 2019, 2020,
2021, or 2022, and for a 10 percent
reduction for such imaging services
taken using computed radiology
furnished during CY 2023 or a
subsequent year. Computed radiology
technology is defined for purposes of
this paragraph as cassette-based
imaging, which utilizes an imaging plate
to create the image involved. Section
1848(b)(9) of the Act also requires
implementation of the reductions in
payment for X-rays through appropriate
mechanisms, which can include the use
of modifiers. In accordance with section
1848(c)(2)(B)(v)(X), the adjustments
under section 1848(b)(9)(A) of the Act
are exempt from budget neutrality.
In this section of the rule, we discuss
the proposed implementation of the
reduction in payment for X-rays taken
using film provided for in section
1848(b)(9)(A) of the Act. Because the
required reductions in PFS payment for
imaging services (including the imaging
portion of a service) that are X-rays
taken using computed radiography
technology does not apply for CY 2017,
we will address implementation of
section 1848(b)(9)(B) of the Act in future
rulemaking.
To implement the provisions of
sections 1848(b)(9)(A) of the Act relating
to the PFS payment reduction for X-rays
taken using film that are furnished
during CY 2017 or subsequent years, in
this proposed rule, we are proposing to
establish a new modifier (modifier
‘‘XX’’) to be used on claims, as allowed
under the section 1848(b)(9)(D) of the
Act. The list of CY 2017 applicable
HCPCS codes describing imaging
services that are X-ray services are on
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the CMS Web site under downloads for
the CY 2017 PFS proposed rule with
comment period at https://www.cms.gov/
physicianfeesched/downloads/. We are
proposing that, beginning January 1,
2017, this modifier would be required
on claims for X-rays that are taken using
film. The modifier would be required on
claims for the technical component of
the X-ray service, including when the
service is billed globally, since the PFS
payment adjustment is made to the
technical component regardless of
whether it is billed globally or
separately using the –TC modifier. The
use of this proposed modifier to indicate
an X-ray taken using film would result
in a 20-percent reduction for the
technical component of the X-ray
service, as specified under section
1848(b)(9)(A) of the Act that would be
exempt from budget neutrality as
specified under section
1848(c)(2)(B)(v)(X) of the Act.
K. Procedures Subject to the Multiple
Procedure Payment Reduction (MPPR)
and the OPPS Cap
Effective January 1, 2012, we
implemented an MPPR of 25 percent on
the professional component (PC) of
advanced imaging services. The
reduction applies when multiple
imaging procedures are furnished by the
same physician (or physician in the
same group practice) to the same
patient, in the same session, on the
same day. Full payment is made for the
PC of the highest priced procedure.
Payment for the PC of subsequent
services is reduced by 25 percent.
Section 502(a)(2)(A) of the
Consolidated Appropriations Act, 2016
(Pub. L. 114–113, enacted on December
18, 2015) added a new section
1848(b)(10) of the Act which revises the
payment reduction from 25 percent to 5
percent, effective January 1, 2017.
Section 502(a)(2)(B) added a new
subclause at section 1848(c)(2)(B)(v)(XI)
which exempts the reduced
expenditures attributable to the revised
5 percent MMPR on the PC of imaging
from the PFS budget neutrality
provision. We propose to implement
these provisions for services furnished
on or after January 1, 2017. We refer
readers to section VI.C of this proposed
rule regarding the necessary adjustment
to the proposed PFS conversion factor to
account for the mandated exemption
from PFS budget neutrality.
We note that the lists of services for
the upcoming calendar year that are
subject to the MPPR on diagnostic
cardiovascular services, diagnostic
imaging services, diagnostic
ophthalmology services, and therapy
services; and the list of procedures that
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meet the definition of imaging under
section 5102(b) of the DRA, and
therefore, are subject to the OPPS cap,
are displayed in the public use files for
the PFS proposed and final rules for
each year. The public use files for CY
2017 are available on our Web site
under downloads for the CY 2017 PFS
proposed rule with comment period at
https://www.cms.gov/Medicare-Fee-forService-Payment/PhysicianFeeSched/
PFSFederal-Regulation-Notices.html.
L. Valuation of Specific Codes
1. Background: Process for 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 make sure 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 5-year review
process, which resulted in revised work
RVUs for CY 1997, CY 2002, CY 2007,
and CY 2012, and revised PE RVUs in
CY 2001, CY 2006, and CY 2011. Under
the 5-year review process, revisions in
RVUs were proposed and finalized via
rulemaking. In addition to the 5-year
reviews, beginning with CY 2009, CMS
and the RUC have identified a number
of potentially misvalued codes each
year using various identification
screens, as discussed in section II.B.5. of
this proposed rule. Historically, when
we received RUC recommendations, our
process had been to establish interim
final RVUs for the potentially misvalued
codes, new codes, and any other codes
for which there were coding changes in
the final rule with comment period for
a year. Then, during the 60-day period
following the publication of the final
rule with comment period, we accepted
public comment about those valuations.
For services furnished during the
calendar year following the publication
of interim final rates, we paid for
services based upon the interim final
values established in the final rule with
comment period. In the final rule with
comment period for the subsequent
year, we considered and responded to
public comments received on the
interim final values, and typically made
any appropriate adjustments and
finalized those values.
In the CY 2015 PFS final rule with
comment period, we finalized a new
process for establishing values for new,
revised and potentially misvalued
codes. Under the new process, we
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46225
include proposed values for these
services in the proposed rule, rather
than establishing them as interim final
in the final rule with comment period.
Beginning with this CY 2017 proposed
rule, the new process will be applicable
to all codes, except for new codes that
describe truly new services. For CY
2017, we are proposing new values in
this proposed rule for the vast majority
of new, revised, and potentially
misvalued codes for which we received
complete RUC recommendations by
February 10, 2016. To complete the
transition to this new process, for codes
where we established interim final
values in the CY 2016 PFS final rule
with comment period, we reviewed the
comments received during the 60-day
public comment period following
release of the CY 2016 PFS final rule
with comment period, and are reproposing values for those codes in this
CY 2017 proposed rule.
We will consider public comments
received during the 60-day public
comment period for this proposed rule
before establishing final values in the
final rule with comment period, and
adopt interim final values only in the
case of wholly new services for which
there are no predecessor codes or values
and for which we do not receive
recommendations in time to propose
values. Recommendations regarding any
new or revised codes received after
February 10th will be considered in the
next year’s proposed rule (that is, CY
2018 PFS rulemaking).
2. Methodology for Proposing Work
RVUs
We conduct a review of each code
identified in this section and review the
current work RVU (if any), RUCrecommended work RVU, intensity,
time to furnish the preservice,
intraservice, and postservice activities,
as well as other components of the
service that contribute to the value. Our
review of recommended work RVUs and
time inputs generally includes, but is
not limited to, a review of information
provided by the RUC, HCPAC (Health
Care Professionals Advisory
Committee), and other public
commenters, medical literature, and
comparative databases, as well as a
comparison with other codes within the
PFS, consultation with other physicians
and health care professionals within
CMS and the federal government, as
well as Medicare claims data. 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
the recommendations. In the CY 2011
PFS final rule with comment period (75
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FR 73328 through 73329), we discussed
a variety of methodologies and
approaches used to develop work RVUs,
including survey data, building blocks,
crosswalks to key reference or similar
codes, and magnitude estimation (see
the CY 2011 PFS final rule with
comment period for more information).
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 building block
components could be the CPT codes
that make up the bundled code and the
inputs associated with those codes.
Magnitude estimation refers to a
methodology for valuing work that
determines the appropriate work RVU
for a service by gauging the total amount
of work for that service relative to the
work for a similar service across the PFS
without explicitly valuing the
components of that work. In addition to
these methodologies, we have
frequently utilized an incremental
methodology in which we value a code
based upon its incremental difference
between another code or another family
of codes. The statute specifically defines
the work component as the resources in
time and intensity required in
furnishing the service. Also, the
published literature on valuing work
has recognized the key role of time in
overall work. For particular codes, we
refine the work RVUs in direct
proportion to the changes in the best
information regarding the time
resources involved in furnishing
particular services, either considering
the total time or the intraservice time.
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
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without and with sedation/anesthesia
care.
We have developed several standard
building block methodologies to value
services appropriately when they have
common billing patterns. In cases where
a service is typically furnished to a
beneficiary on the same day as an 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. Our longstanding adjustments
have reflected a broad assumption that
at least one-third of the work 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 multiplied by the intensity of
the work. Preservice evaluation time
and postservice time both have a longestablished 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, now
addresses the overlap in time and work
when a service is typically furnished on
the same day as an E/M service.
We note that many commenters and
stakeholders have expressed concerns
with our ongoing adjustment of work
RVUs based on changes in the best
information we have regarding the time
resources involved in furnishing
individual services. We are particularly
concerned with the RUC’s and various
specialty societies’ objections to our
approach given the significance of their
recommendations to our process for
valuing services and since much of the
information we have used to make the
adjustments is derived from their survey
process. As explained in the CY 2016
PFS final rule with comment period (80
FR 70933), we recognize that adjusting
work RVUs for changes is not always a
straightforward process, so we apply
various methodologies to identify
several potential work values for
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individual codes. However, we want to
reiterate that we are statutorily obligated
to consider both time and intensity in
establishing work RVUs for PFS
services.
We have observed that for many codes
reviewed by the RUC, final
recommended work RVUs appear to be
incongruous with recommended
assumptions regarding the resource
costs in time. This is the case for a
significant portion of codes for which
we have recently established or
proposed work RVUs that are based on
refinements to the RUC-recommended
values. When we have adjusted work
RVUs to account for significant changes
in time, we begin by looking at the
change in the time in the context of the
RUC-recommended work RVU. When
the recommended work RVUs do not
appear to account for significant
changes in time, we employ the
different approaches to identify
potential values that reconcile the
recommended work RVUs with the
recommended time values. Many of
these methodologies, such as survey
data, building blocks, crosswalks to key
reference or similar codes, and
magnitude estimation have long been
used in developing work RVUs under
the PFS. In addition to these we
sometimes use the relationship between
the old time values and the new time
values for particular services to identify
alternative work RVUs based on changes
in time components.
In so doing, rather than ignoring the
RUC-recommended value, we are using
the recommended values as a starting
reference and then applying one of these
several methodologies to account for the
reductions in time that we believe have
not otherwise been reflected in the RUC
recommended value. When we believe
that such changes in time have already
been accounted for in the RUC
recommendation, then we do not make
such adjustments. Likewise, we do not
arbitrarily apply time ratios to current
work RVUs to calculate proposed work
RVUs. We use the ratios to identify
potential work RVUs and consider these
work RVUs as potential options relative
to the values developed through other
options.
We want to make it clear that we are
not implying that the decrease in time
as reflected in survey values must
equate to a one-to-one or linear decrease
in newly valued work RVUs. Instead,
we believe that since the two
components of work are time and
intensity that absent an obvious or
explicitly stated rationale for why the
relative intensity of a given procedure
has increased, that significant decreases
in time should be reflected in decreases
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to work RVUs. If the RUC
recommendation has appeared to
disregard or dismiss the changes in
time, without a persuasive explanation
of why such a change should not be
accounted for in the overall work of the
service, then we generally use one of the
aforementioned referenced
methodologies to identify potential
work RVUs, including the
methodologies intended to account for
the changes in the resources involved in
furnishing the procedure.
Several commenters, including the
RUC, in general have objected to our use
of these methodologies and deemed our
actions in adjusting the recommended
work RVUs as inappropriate. We
received several specific comments
regarding this issue in response to the
CY 2016 PFS final rule with comment
period, those comments are summarized
below.
Comment: Several commenters,
including the RUC, stated that our
methodology for adjusting work RVUs
appears to be contrary to the statute.
Response: We disagree with these
comments. Since section 1848(c)(1)(A)
of the Act explicitly identifies time as
one of the two types of resources that
encompass the work component of the
PFS payment, we do not believe that our
use of the aforementioned
methodologies to adjust the work RVU
to account for the changes in time,
which is one of the resources involved,
is inconsistent with the statutory
requirements related to the maintenance
of work RVUs, and we have regularly
used these and other methodologies in
developing values for PFS services. 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. In our review of RUC
recommended values, we have observed
that the RUC also uses a variety of
methodologies to develop work RVUs
for individual codes, and subsequently
validates the results of these approaches
through magnitude estimation or
crosswalk to established values for other
codes.
Comment: Several commenters,
including the RUC, stated that we could
not take one element of the services that
has changed such as intra-service time,
and apply an overall ratio for reduction
to the work RVU based on changes to
time, as that renders the value no longer
resource-based in comparison to the
RUC-recommended values.
Response: We disagree with the
commenters. We continue to believe
that the use of time ratios is one of
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several reasonable methods for
identifying potential work RVUs for
particular PFS services, particularly
when the alternative values do not
account for information that suggests
the amount of time involved in
furnishing the service has changed
significantly. We reiterate that,
consistent with the statute, we are
required to value the work RVU based
on the relative resources involved in
furnishing the service, which include
time and intensity. When our review of
recommended values determines that
changes in the resource of time have
been unaccounted for in a
recommended RVU, then we believe we
have the obligation to account for that
change in establishing work RVUs since
the statute explicitly identifies time as
one of the two elements of the work
RVUs. We recognize that it would not be
appropriate to develop work RVUs
solely based on time given that intensity
is also an element of work, but in
applying the time ratios we are using
derived intensity measures based on
current work RVUs for individual
procedures. Were we to disregard
intensity altogether, the work RVUs for
all services would be developed based
solely on time values and that is
definitively not the case. Furthermore,
we reiterate that we use time ratios to
identify potential work RVUs, and then
use other methods (including estimates
of work from CMS medical personnel
and crosswalks to key reference or
similar codes) to validate these RVUs.
We also disagree with several
commenters’ implications that a work
RVU developed through such estimation
methods is only resource-based through
the RUC process.
Comment: Several commenters,
including the RUC, stated that our
inconsistent use of the time ratio
methodology has rendered it ineffective
for valuation purposes and that by
choosing the starting base work value
and/or physician time at random, we are
essentially reverse engineering the work
value we want under the guise of a
standard algorithm.
Response: We do not choose a starting
base work value and/or physician time
at random as suggested by the
commenters. We use the RUC
recommended values or the existing
values as the base values; essentially,
we are taking one of those values and
applying adjustments to account for the
change in time that based on our
analysis of the RUC recommendation,
we determine has not been properly
accounted for to determine an
appropriate work RVU. In
circumstances where adjustments to
time and the corresponding work RVU
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are relatively congruent or persuasively
explained, our tendency has been to use
those values as recommended. Where
the RUC recommendations do not
account for changes in time, we have
made changes to RUC-recommended
values to account for the changes in
time.
Comment: Commenters, including the
RUC, also stated that the use of time
ratio methodologies distills the
valuation of the service into a basic
formula with the only variable being
either the new total physician time or
the new intra-service physician time,
and that these methodologies are based
on the incorrect assumption that the per
minute physician work intensity
established is permanent regardless of
when the service was last valued. Other
commenters have suggested that
previous assumed times are inaccurate.
Response: We agree with commenters
that per minute intensity for a given
service may change over time. If we
believed that the per-minute intensity
for a given service were immutable, then
a reverse-building block approach to
revaluation based on new time data
could be appropriate. However, we have
not applied such an approach
specifically because we agree that the
per-minute intensity of work is not
necessarily static over time or even
necessarily during the course of a
procedure. Instead, we utilize time
ratios to identify potential values that
account for changes in time and
compare these values to other PFS
services for estimates of overall work.
When the values we develop reflect a
similar derived intensity, we agree that
our values are the result of our
assessment that the relative intensity of
a given service has remained similar.
Regarding the validity of comparing
new times to the old times, we, too,
hope that time estimates have improved
over many years especially when many
years have elapsed since the last time
the service in question was valued.
However, we also believe that our
operating assumption regarding the
validity of the pre-existing values as a
point of comparison is critical to the
integrity of the relative value system as
currently constructed. Pre-existing times
are a very important element in the
allocation of indirect PE RVUs by
specialty, and had the previously
recommended times been
overestimated, the specialties that
furnish such services would be
benefitting from these times in the
allocation of indirect PE RVUs. As long
time observers of the RUC process, we
also recognize that the material the RUC
uses to develop overall work
recommendations includes the data
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from the surveys about time. We have
previously stated concerns regarding the
validity of much of the RUC survey
data. However, we believe additional
kinds of concern would be warranted if
the RUC itself were operating under the
assumption that its pre-existing data
were typically inaccurate.
We understand stakeholders’
concerns regarding how best to consider
changes in time in improving the
accuracy of work RVUs and have
considered all of the issues raised by
commenters. In conjunction with our
review of recommended code values for
CY 2017, we conducted a preliminary
analysis to identify general tendencies
in the relationship between changes in
time and changes in work RVUs for CY
2014 and CY 2015. We looked at
services for which there were no coding
changes to simplify the analysis. The
intent of this preliminary analysis was
to examine commenters’ beliefs that
CMS is only considering time when
making refinements to RUC
recommended work values. For CY
2014, we found that in the aggregate, the
average difference between the RUC
recommended intraservice time and
existing intraservice time was ¥17
percent, but the average difference
between the RUC recommended work
RVU and existing work RVU was only
¥4 percent. However, the average
difference between the CMS refined
work RVU and existing work RVU was
¥7 percent. For CY 2015, the average
difference between the RUC
recommended intraservice time and
existing intraservice time was ¥17
percent, but the average difference
between the RUC recommended work
RVU and existing work RVU was 1
percent, and the average difference
between the CMS refined work RVU and
existing work RVU was ¥6 percent.
This preliminary analysis demonstrates
that we are not making refinements
solely in consideration of time, if that
were the case, the changes in the work
RVU values that we adopted would be
comparable to the changes in the time
that we adopted, but that is not the case.
We believe that we should account for
efficiencies in time when the
recommended work RVU does not
account for those efficiencies, otherwise
relativity across the PFS can be
significantly skewed over periods of
time. For example, if when a code is
first valued, a physician was previously
able to do only 5 procedures per day,
but due to new technologies, the same
physician can now do 10 procedures per
day, resource costs in time have
empirically been lessened, and we
believe that relative reduction in
resources involved in furnishing that
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service should be accounted for in the
assignment of work RVUs for that
service, since the statute explicitly
identifies time as one of the two
components of work. Of course, if more
resource intensive technology has
allowed for the increased efficiency in
furnishing the procedure, then the
nonfacility PE RVUs for the service
should also be adjusted to account for
this change. Additionally, we believe it
may be that the intensity per minute of
the procedure may have changed with
the greater efficiency in time. Again,
that is why we do not generally reduce
work RVUs in strict proportion to
changes in time. We understand that
intensity is not entirely linear, and that
data related to time as obtained in the
RUC survey instrument may improve
over time, and that the number of
survey respondents may improve over
time. However, we also understand time
as a tangible resource cost in furnishing
PFS services, and a cost that by statute,
is one of the two kinds of resources to
be considered as part of the work RVU.
Therefore, we are interested in
receiving comments on whether, within
the statutory confines, there are
alternative suggestions as to how
changes in time should be accounted for
when it is evident that the survey data
and/or the RUC recommendation
regarding the overall work RVU does
not reflect significant changes in the
resource costs of time for codes
describing PFS services. We are also
seeking comment on potential
alternatives, including the application
of the reverse building block
methodology, to making the adjustments
that would recognize overall estimates
of work in the context of changes in the
resource of time for particular services.
Table 16 contains a list of codes for
which we are proposing work RVUs;
this includes all RUC recommendations
received by February 10, 2016, and
codes for which we established interim
final values in the CY 2016 PFS final
rule with comment period. When the
proposed work RVUs vary from those
recommended by the RUC or for which
we do not have RUC recommendations,
we address those codes in the portions
of this section that are dedicated to
particular codes. The proposed work
RVUs and other payment information
for all proposed CY 2017 payable codes
are available in Addendum B.
Addendum B is available on the CMS
Web site under downloads for the CY
2017 PFS proposed rule with comment
period at https://www.cms.gov/
physicianfeesched/downloads/. The
proposed time values for all CY 2017
codes are listed in a file called ‘‘CY 2017
PFS Proposed Work Time,’’ available on
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the CMS Web site under downloads for
the CY 2017 PFS proposed rule with
comment period at https://www.cms.gov/
physicianfeesched/downloads/.
3. Methodology for Proposing the Direct
PE Inputs To Develop PE RVUs
a. Background
On an annual basis, the RUC provides
us with recommendations regarding PE
inputs for new, revised, and potentially
misvalued codes. We review the RUCrecommended direct PE inputs on a
code by code basis. Like our review of
recommended work RVUs, our review
of recommended direct PE inputs
generally includes, but is not limited to,
a review of information provided by the
RUC, HCPAC, and other public
commenters, medical literature, and
comparative databases, as well as a
comparison with other codes within the
PFS, consultation with physicians and
health care professionals within CMS
and the federal government, as well as
Medicare claims data. 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
the recommendations. 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, consistent with the principles of
relativity, and reflect our payment
policies, we use those direct PE inputs
to value a service. If not, we refine the
recommended 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.
Our review and refinement of RUCrecommended direct PE inputs includes
many refinements that are common
across codes as well as refinements that
are specific to particular services. Table
16 details our proposed refinements of
the RUC’s direct PE recommendations at
the code-specific level. In this proposed
rule, we address several refinements
that are common across codes, and
refinements to particular codes are
addressed in the portions of this section
that are dedicated to particular codes.
We note that for each refinement, we
indicate the proposed impact on direct
costs for that service. We note that, on
average, in any case where the impact
on the direct cost for a particular
refinement is $0.32 or less, the
refinement has no impact on the
proposed PE RVUs. This calculation
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(2) Equipment Time
cleaning time to portable equipment
items, because the portable equipment
does not need to be cleaned in the room
where the service is furnished, we do
not include that cleaning time for the
remaining equipment items, as those
items and the room are both available
for use for other patients during that
time. In addition, when a piece of
equipment is typically used during
follow-up post- operative 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 preservice or
postservice tasks performed by clinical
labor staff on the day of the procedure
(the clinical labor service period) and
are typically available for other patients
even when one member of the clinical
staff may be occupied with a preservice
or postservice task related to the
procedure. We also note that we believe
these same assumptions would apply to
inexpensive equipment items that are
used in conjunction with and located in
a room with non-portable highly
technical equipment items since any
items in the room in question would be
available if the room is not being
occupied by a particular patient. For
additional information, we refer readers
to our discussion of these issues in the
CY 2012 PFS final rule with comment
period (76 FR 73182) and the CY 2015
PFS final rule with comment period (79
FR 67639).
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 over several
years of rulemaking, indicating that we
consider equipment time as the time
within the intraservice 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
those services for which we allocate
(3) Standard Tasks and Minutes for
Clinical Labor Tasks
In general, the preservice,
intraservice, 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 RUC-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, we review
the deviations from the standards and
any rationale provided for the
deviations. When we do not accept the
RUC-recommended exceptions, we
refine the proposed direct PE inputs to
conform to the standard times for those
tasks. In addition, in cases when a
service is typically billed with an E/M
considers both the impact on the direct
portion of the PE RVU, as well as the
impact on the indirect allocator for the
average service. We also note that nearly
half of the proposed refinements listed
in Table 16 result in changes under the
$0.32 threshold and are unlikely to
result in a change to the proposed
RVUs.
We also note that the proposed direct
PE inputs for CY 2017 are displayed in
the proposed CY 2017 direct PE input
database, available on the CMS Web site
under the downloads for the CY 2017
proposed rule at www.cms.gov/
PhysicianFeeSched/. The inputs
displayed there have also been used in
developing the proposed CY 2017 PE
RVUs as displayed in Addendum B.
b. Common Refinements
(1) Changes in Work Time
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Some direct PE inputs are directly
affected by revisions in work time.
Specifically, changes in the intraservice
portions of the work time and changes
in the number or level of postoperative
visits associated with the global periods
result in corresponding changes to
direct PE inputs. The direct PE input
recommendations generally correspond
to the work time values associated with
services. We believe that inadvertent
discrepancies between work time values
and direct PE inputs should be refined
or adjusted in the establishment of
proposed direct PE inputs to resolve the
discrepancies.
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service, we remove the preservice
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.’’ We believe that continual
addition of new and distinct clinical
labor tasks each time a code is reviewed
under the misvalued code initiative is
likely to degrade relativity between
newly reviewed services and those with
already existing inputs. This is because
codes more recently reviewed would be
more likely to have a greater number of
clinical labor tasks as a result of the
general tendency to increase the number
of clinical labor tasks. To mitigate the
potential negative impact of these
additions, we review these tasks to
determine whether they are fully
distinct from existing clinical labor
tasks, typically included for other
clinically similar services under the
PFS, and thoroughly explained in the
recommendation. For those tasks that do
not meet these criteria, we do not accept
these newly recommended clinical labor
tasks.
(4) Recommended Items That Are Not
Direct PE Inputs
In some cases, the PE worksheets
included with the RUC
recommendations include items that are
not clinical labor, disposable supplies,
or medical equipment or that cannot be
allocated to individual services or
patients. We have addressed these kinds
of recommendations in previous
rulemaking (78 FR 74242), and we do
not use items included in these
recommendations as direct PE inputs in
the calculation of PE RVUs.
(5) 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, however, include
supply or equipment items that are not
currently in the direct PE input
database. In these cases, the RUC has
historically recommended that a new
item be created and has facilitated our
pricing of that item by working with the
specialty societies to provide us copies
of sales invoices. For CY 2017, we
received invoices for several new
supply and equipment items. Tables 16
and 17 detail the invoices received for
new and existing items in the direct PE
database. As discussed in section II.A.
of this proposed rule with comment
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period, we encourage stakeholders to
review the prices associated with these
new and existing items to determine
whether these prices appear to be
accurate. Where prices appear
inaccurate, we encourage stakeholders
to provide invoices or other information
to improve the accuracy of pricing for
these items in the direct PE database
during the 60-day public comment
period for this proposed rule. We expect
that invoices received outside of the
public comment period would be
submitted by February 10th of the
following year for consideration in
future rulemaking, similar to our new
process for consideration of RUC
recommendations.
We remind stakeholders that due to
the relativity inherent in the
development of RVUs, reductions in
existing prices for any items in the
direct PE database increase the pool of
direct PE RVUs available to all other
PFS services. Tables 16 and 17 also
include the number of invoices
received, as well as the number of
nonfacility allowed services for
procedures that use these equipment
items. We provide the nonfacility
allowed services so that stakeholders
will note the impact the particular price
might have on PE relativity, as well as
to identify items that are used
frequently, since we believe that
stakeholders are more likely to have
better pricing information for items used
more frequently. A single invoice may
not be reflective of typical costs and we
encourage stakeholders to provide
additional invoices so that we might
identify and use accurate prices in the
development of PE RVUs.
In some cases, we do not use the price
listed on the invoice that accompanies
the recommendation because we
identify publicly available alternative
prices or information that suggests a
different price is more accurate. In these
cases, we include this in the discussion
of these codes. In other cases, we cannot
adequately price a newly recommended
item due to inadequate information.
Sometimes, no supporting information
regarding the price of the item has been
included in the recommendation. In
other cases, the supporting information
does not demonstrate that the item has
been purchased at the listed price (for
example, vendor price quotes instead of
paid invoices). In cases where the
information provided on the item allows
us to identify clinically appropriate
proxy items, we might use existing
items as proxies for the newly
recommended items. In other cases, we
have included the item in the direct PE
input database without any associated
price. Although including the item
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without an associated price means that
the item does not contribute to the
calculation of the proposed PE RVU for
particular services, it facilitates our
ability to incorporate a price once we
obtain information and are able to do so.
(6) Service Period Clinical Labor Time
in the Facility Setting
Generally speaking, our proposed
inputs do not include clinical labor
minutes assigned to the service because
the cost of clinical labor during the
service period for a procedure in the
facility setting is not considered a
resource cost to the practitioner since
Medicare makes separate payment to the
facility for these costs. We address
proposed code-specific refinements to
clinical labor in the individual code
sections.
(7) Procedures Subject to the Multiple
Procedure Payment Reduction (MPPR)
and the OPPS Cap
We note that the public use files for
the PFS proposed and final rules for
each year display both the services
subject to the MPPR lists on diagnostic
cardiovascular services, diagnostic
imaging services, diagnostic
ophthalmology services and therapy
services and the list of procedures that
meet the definition of imaging under
section 1848(b)(4)(B) of the Act, and
therefore, are subject to the OPPS cap
for the upcoming calendar year. The
public use files for CY 2017 are
available on the CMS Web site under
downloads for the CY 2017 PFS
proposed rule with comment period at
https://www.cms.gov/Medicare-Fee-forService-Payment/PhysicianFeeSched/
PFSFederal-Regulation-Notices.html.
4. Specialty-Mix Assumptions for
Proposed Malpractice RVUs
The proposed CY 2017 malpractice
crosswalk table is displayed in the
public use files for the PFS proposed
and final rules. The public use files for
CY 2017 are available on the CMS Web
site under downloads for the CY 2017
PFS proposed rule with comment
period at https://www.cms.gov/MedicareFee-for-Service-Payment/
PhysicianFeeSched/PFSFederalRegulation-Notices.html. The table lists
the CY 2017 HCPCS codes and their
respective source codes used to set the
proposed CY 2017 MP RVUs where the
source code for this calculation deviates
from the source code for the utilization
otherwise used for purposes of PFS
ratesetting. The proposed MP RVUs for
all PFS services and the utilization
crosswalk used to identify the source
codes for all other PFS codes are
reflected in Addendum B on the CMS
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Web site at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/.
5. Valuation of Specific Codes
a. CY 2017 Proposed Codes That Were
Also CY 2016 Proposed Codes
(1) Soft Tissue Localization (CPT Codes
10035 and 10036)
In the CY 2016 PFS final rule with
comment period, we established the
RUC-recommended work value as
interim final for CPT codes 10035 and
10036. We also made standard
refinements to remove duplicative
clinical labor and utilize standard
equipment time formulas for the PACS
workstation proxy (ED050).
Comment: A commenter stated that
the clinical labor task ‘‘Review/read Xray, lab, and pathology reports’’ occurs
during the preservice period, and it is a
separate activity than ‘‘Review
examination with interpreting MD’’,
which occurs during the service period.
Response: We continue to believe that
this clinical labor is duplicative with
the clinical labor for Review
examination with interpreting MD
because we believe that these two
descriptors detail the same clinical labor
activity taking place, rather than two
separate and distinct tasks. We are
proposing to maintain our previous
refinement to 0 minutes for this clinical
labor task for CPT codes 10035 and
10036.
We are also proposing to maintain the
interim final work RVUs for CPT codes
10035 and 10036.
(2) Repair Flexor Tendon (CPT Codes
26356, 26357, and 26358)
In the CY 2016 PFS final rule with
comment period, we established an
interim final work RVU of 9.56 for CPT
code 26356 after considering both its
similarity in time to CPT code 25607
(Open treatment of distal radial extraarticular fracture) and the recommended
reduction in time relative to the current
times assumed for this procedure. We
established an interim final work RVU
of 10.53 for CPT code 26357 based on
a direct crosswalk from CPT code 27654
(Repair, secondary, Achilles tendon,
with or without graft), as we believed
that this work RVU better reflected the
changes in time for this procedure. For
the last code in the family, we
established an interim final work RVU
of 12.13 for CPT code 26358, based on
the RUC recommended increment of
1.60 work RVUs relative to CPT code
26357.
Comment: We received several
comments regarding the interim final
work values for this family of codes.
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One commenter stated that it was
inappropriate to use time ratios to
evaluate CPT code 26356 as it was last
valued in 1995, noting that there was an
anomalous relationship between the
current work RVU and the imputed time
components in the RUC database. This
commenter also pointed out that when
the previous time was developed,
fabrication of a splint was considered to
be part of the intraservice work, while
in the current survey instrument, the
fabrication of the splint is considered to
be part of the postservice work since it
is a dressing. This commenter urged
CMS to adopt the RUC
recommendations. A different
commenter agreed that the CMS
crosswalk to CPT code 25607 was an
appropriate crosswalk for CPT code
26356 and supported the CMS work
RVU of 9.56.
Response: We appreciate the support
from the commenter. We continue to
believe that our crosswalk for this code
is an appropriate choice, due to our
estimate of overall work between CPT
code 26356 and CPT code 25607. We
appreciate the commenters’ concerns
regarding the time ratio methodologies
and have responded to these concerns
about our methodology in section II.L.2
of this proposed rule. Although we note
the commenter’s statement about how
the service period in which fabrication
of a splint takes place may have evolved
over time, we do not agree that this task
would be responsible for a decrease in
intraservice survey time, as the
postservice survey time for CPT code
26356 remained unchanged at 30
minutes. If the decrease in intraservice
time had been due to the shift of
splinting from the intraservice period to
the postservice period, then we would
have expected to see an increase in the
postservice period minutes. However,
they remained exactly the same in the
physician survey for CPT 26356. As we
wrote earlier in this section, we believe
in the validity of using pre-existing time
values as a point of comparison, and we
believe that we should account for
efficiencies in time when the
recommended work RVU does not
account for those efficiencies. After
consideration of comments received, we
are proposing to maintain CPT code
26356 at its current work RVU of 9.56
for CY 2017.
Comment: Several commenters
disagreed with the work RVU for CPT
code 26357. One commenter stated that
the CMS crosswalk to CPT code 27654
had less total time and resulted in an
inappropriately lower intensity. This
commenter urged CMS to adopt the
RUC-recommended work value.
Another commenter stated that a better
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crosswalk for CPT code 26357 would be
CPT code 25608 (Open treatment of
distal radial intra-articular fracture or
epiphyseal separation), the next code in
the same upper extremity family that
CMS used for the initial crosswalk. This
commenter stated that the CMS
crosswalk for CPT code 26357 created a
rank order anomaly in terms of intensity
within this family, and that the
commenter’s suggested crosswalk would
create two pairs of matched codes,
survey CPT codes 26356/26357 with
crosswalk CPT codes 25607/25608.
Response: We appreciate the
suggested crosswalk from the
commenters, and we agree that the
choice of the initial CMS crosswalk
creates a rank order anomaly within the
family in terms of intensity. As a result,
after consideration of comments
received, we are proposing to instead
value CPT code 26357 at the 25th
percentile survey work RVU of 11.00 for
CY 2017. This valuation corrects the
anomalous intensity within the Repair
Flexor Tendon family of codes, and
preserves the RUC-recommended
increment between CPT codes 26356
and 26357.
Comment: The commenters agreed
that the RUC-recommended increment
of 1.60 was appropriate for the work
RVU of CPT code 26358 when added to
the work RVU of CPT code 26357.
However, commenters stated that this
increment of 1.60 should be added to
the RUC-recommended work value for
CPT code 26357, and not the CMS
refined value from the CY 2016 PFS
final rule with comment period.
Response: We also continue to believe
that the increment of 1.60 is appropriate
for the work RVU of CPT code 26358.
After consideration of comments
received, we are therefore proposing to
set the work RVU for this code at 12.60
for CY 2017, based on the increment of
1.60 from CPT code 26357’s proposed
work RVU of 11.00.
We are proposing to maintain the
current direct PE inputs for all three
codes.
(3) Esophagogastric Fundoplasty TransOral Approach (CPT Code 43210)
For CY 2016, the CPT Editorial Panel
established CPT code 43210 to describe
trans-oral esophagogastric fundoplasty.
The RUC recommended a work RVU of
9.00 for CPT code 43210. We noted our
determination that a work RVU of 7.75,
which corresponds to the 25th
percentile survey result, more
accurately reflects the resources used in
furnishing the service associated with
CPT code 43210. Therefore, for CY 2016
we established an interim final work
RVU of 7.75 for CPT code 43210.
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Comment: A few commenters urged
CMS to accept the RUC-recommended
work RVU of 9.00 for CPT code 43210.
The commenters believed that the RUCrecommended value compared well
with the key reference service, CPT code
43276 (Endoscopic retrograde
cholangiopancreatography (ERCP); with
removal and exchange of stent(s), biliary
or pancreatic duct, including pre- and
post-dilation and guide wire passage,
when performed, including
sphincterotomy, when performed, each
stent exchanged), which has a work
RVU of 8.94 and an intraservice time of
60 minutes. Commenters believed that
due to similar intra-service times and
intensities, that CPT code 43210 should
be valued nearly identically to CPT code
43276. Some commenters also stated
that to maintain relativity within the
upper GI code families, CPT code 43210
should not have a lower work RVU than
CPT code 43276, especially since the
majority of survey participants
indicated that CPT code 43210 is
‘‘somewhat more’’ complex than CPT
code 43276. Additionally, one
commenter noted that an EGD
(Esophagogastroduodenoscopy) is used
twice during this service, before and
after fundoplication. They stated that
because this is a multi-stage procedure,
other EGD codes are not comparable.
The commenter also pointed out that
this technology has a small number of
users and urged us to accept the RUCrecommended work RVU of 9.00 until
there is increased volume and then
reassess in 2 years. Commenters also
requested refinement panel
consideration for this service.
Response: Per the commenters’
request, we referred this code to the CY
2016 multi-specialty refinement panel
for further review. The result of the
panel was a recommendation that we
accept the RUC-recommended value of
9.00 work RVUs. However, since there
are four ERCP codes with 60 minutes of
intraservice time, three of which have
work RVUs of less than 7.00 and only
one of the four codes has a work RVU
higher than 7.75 RVUs (8.94), based on
our estimate of overall work for this
service, we continue to believe that the
25th percentile of the survey most
accurately reflects the relative resource
costs associated with CPT code 43210.
Therefore, for CY 2017 we are proposing
a work RVU of 7.75 for CPT code 43210.
(4) Percutaneous Biliary Procedures
Bundling (CPT Codes 47531, 47532,
47533, 47534, 47535, 47536, 47537,
47538, 47539, 47540, 47541, 47542,
47543, and 47544)
These codes were revalued with new
recommendations at the October 2015
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RUC meeting; we will discuss the CY
2016 interim final comments alongside
the new recommendations. Please see
section II.L for a discussion of the CY
2017 proposed code values.
(5) Percutaneous Image Guided
Sclerotherapy (CPT Code 49185)
For CY 2016, we established an
interim final work RVU of 2.35 for CPT
code 49185 based on a crosswalk from
CPT code 62305 (Myelography via
lumbar injection, including radiological
supervision and interpretation; 2 or
more regions (e.g., lumbar/thoracic,
cervical/thoracic, lumbar/cervical,
lumbar/thoracic/cervical)); which we
believed accurately reflected the time
and intensity involved in furnishing
CPT code 49185. We also requested
stakeholder input on the price of supply
item SH062 (sclerosing solution) as the
volume of the solution in this procedure
(300 mL) is much higher than other CPT
codes utilizing SH062 (between 1 and
10 mL).
Comment: Commenters disagreed
with our proposed crosswalk of CPT
code 49185 from CPT code 62305.
Commenters believed that the RUCrecommended crosswalk from CPT code
31622 (Bronchoscopy, rigid or flexible,
including fluoroscopic guidance, when
performed; diagnostic, with cell
washing, when performed (separate
procedure)) was a more appropriate
comparison due to similarity in service.
Commenters requested that CPT code
49185 be referred to the refinement
panel.
Response: The requests did not meet
the requirements related to new clinical
information for referral to the
refinement panel. After review of the
comments, we continue to believe that
a crosswalk of CPT code 49185 from the
value for CPT code 62305 is most
appropriate due to similarities in overall
work. Therefore, we are proposing a
work RVU of 2.35 for CPT code 49185
for CY 2017 and seek additional
rationale for why a different work RVU
or crosswalk would more accurately
reflect the resources involved in
furnishing this service.
Comment: A commenter stated that
the procedure described by CPT code
49185 involved a separate clinical labor
staff type. Due to the inclusion of this
additional individual, the L037D
clinical labor and additional gloves
were appropriate to include in the
procedure.
Response: The commenter did not
provide any evidence for this claim. We
continue to believe that this additional
use of clinical staff would not be typical
for CPT code 49185. This procedure
does not involve moderate sedation, and
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therefore, we do not believe that there
would be a typical need for a third staff
member. As a result, we are proposing
to maintain our direct PE refinements
from the CY 2016 PFS final rule with
comment period.
Additionally, we did not receive any
information regarding SH062 that
supports maintaining an input of 300
mL, and as noted above, this level far
exceeds the volume associated with
other CPT codes; therefore, we are
proposing to refine the direct practice
expense inputs for SH062 from 300 mL
to 10 mL, which is the highest level
associated with other CPT codes
utilizing SH062.
(6) Genitourinary Procedures (CPT
Codes 50606, 50705, and 50706)
In the CY 2016 PFS final rule with
comment period, we established as
interim final the RUC-recommended
work RVUs for all three codes. We did
not receive any comments on the work
values for these codes, and we are
proposing to maintain all three at their
current work RVUs.
The RUC recommended the inclusion
of ‘‘room, angiography’’ (EL011) for this
family of codes. As we discussed in the
CY 2016 PFS final rule with comment
period, we did not believe that an
angiography room would be used in the
typical case for these procedures, and
we therefore replaced the recommended
equipment item ‘‘room, angiography’’
with equipment item ‘‘room,
radiographic-fluoroscopic’’ (EL014) for
all three codes on an interim final basis.
We also stated our belief that since the
predecessor procedure codes generally
did not include an angiography room
and we did not have a reason to believe
that the procedure would have shifted
to an angiography room in the course of
this coding change, we did not believe
that the use of an angiography room
would be typical for these procedures.
Comment: Several commenters
disagreed with the CMS substitution of
the fluoroscopic room in place of the
angiography room. The commenters
stated that all three of these procedures
were previously reported using CPT
code 53899 (Unlisted procedure, urinary
system) which does not have any PE
inputs, and the RUC recommendations
included as a reference CPT code 50387
(Removal and replacement of externally
accessible transnephric ureteral stent),
which includes an angiography room.
The commenters suggested that CPT
code 50387 was an example of a
predecessor code that included the use
of an angiography room, along with
other codes that are being bundled
together to create the new Genitourinary
codes.
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Response: We do not agree with the
commenter’s implication that because
CPT code 50387 was an appropriate
reference code for use in valuation, that
it necessarily would have previously
been used to describe services that are
now reported under CPT codes 50606,
50705, or 50706. Our perspective is
consistent with the RUC-recommended
utilization crosswalk for the three new
codes, which did not suggest that the
services were previously reported using
50706. We do not believe that use of one
particular code for reference in
developing values for another
necessarily means that the all of the
same equipment would be used for both
services.
We do not believe that these codes
describe the same clinical work either.
CPT code 50387 is for the ‘‘Removal and
replacement of externally accessible
transnephric ureteral stent’’ while CPT
code 50606 describes an ‘‘Endoluminal
biopsy of ureter and/or renal pelvis’’,
CPT code 50705 refers to ‘‘Ureteral
embolization or occlusion’’, and CPT
code 50706 details ‘‘Balloon dilation,
ureteral stricture.’’ Additionally, the
codes do not have the same global
periods, which makes comparisons
between CPT code 50387 and CPT codes
506060, 50705, and 50706 even more
difficult. We note that despite the
commenter’s claim that CPT code 50387
was provided as a reference for these
procedures, 50387 is not in fact listed as
a reference for any of these three codes,
or mentioned at all in the codes’
respective summary of
recommendations. However, we
acknowledge that among the procedures
that are provided as references, many of
them include the use of an angiography
room, such as CPT code 36227
(Selective catheter placement, external
carotid artery) and CPT code 37233
(Revascularization, endovascular, open
or percutaneous, tibial/peroneal artery,
unilateral, each additional vessel).
Therefore, we agree that the use of the
angiography room in these procedures,
or at least some of its component parts,
may be warranted.
Comment: A commenter stated that
the substitution of the fluoroscopic
room for the angiography room was
clinically unjustified. The commenter
stated that the angiography room was
needed for these procedures to carry out
3-axis rotational imaging (so as to avoid
rolling the patient), ensure sterility, and
avoid unacceptable radiation exposure
to physicians, their staff, and their
patients. The commenter indicated that
the only piece of equipment listed in the
angiography room that would not be
typically utilized for these procedures is
the Provis Injector. All of the other
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items are used for these Genitourinary
procedures. The commenter urged CMS
to restore the angiography room to these
procedures.
Response: We agree that it is
important to provide equipment that is
medically reasonable and necessary.
Our concern with the use of the
angiography room for these codes is that
we do not believe all of the equipment
would be typically necessary to furnish
the procedure. For example, the
commenter agreed that the Provis
Injector would not be required for these
Genitourinary codes. Therefore, we are
proposing to remove the angiography
room from these three procedures and
add in its place the component parts
that make up the room. Table 16 details
these components:
TABLE 16—ANGIOGRAPHY ROOM
(EL011) COMPONENTS
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100 KW at 100 kV (DIN6822) generator
C-arm single plane system, ceiling mounted,
integrated multispace
T motorized rotation, multiple operating
modes
real-time digital imaging
40 cm image intensifier at 40/28/20/14cm
30 × 38 image intensifier dynamic flat panel
detector
floor-mounted patient table with floating tabletop designed for angiographic exams
and interventions (with peistepping for
image intensifiers 13in+)
18 in TFT monitor
network interface (DICOM)
Careposition: Radiation free positioning of
collimators
Carewatch: Acquisition and monitoring of
configurable dose area product
Carefilter: Cu-prefiltration
DICOM HIS/RIS
Control room interface
Injector, Provis
Shields, lower body and mavig
Leonardo software
Fujitsu-Siemens high performance computers
Color monitors
Singo modules for dynamic replay and full
format images
Prepared for internal networking and Siemens remote servicing, both hardware and
software
We will include all of the above
components except the Provis Injector,
as commenters have indicated that its
use would not be typical for these
procedures. We welcome additional
comment regarding if these or other
components are typically used in these
Genitourinary procedures. We currently
lack pricing information for these
components; we are therefore proposing
to include each of these components in
the direct PE input database at a price
of $0.00 and we are soliciting invoices
from the public for their costs so that we
may be able to price these items for use
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in developing final PE RVUs for CY
2017
We also note that we believe that this
issue illustrates a potentially broad
problem with our use of equipment
‘‘rooms’’ in the direct PE input database.
For most services, we only include
equipment items that are used and
unavailable for other uses due to their
use during the services described by a
particular code. However, for items
included in equipment ‘‘rooms,’’ we
allocate costs regardless of whether the
individual items that comprise the room
are actually used in the particular
service.
To maintain relativity among different
kinds of procedures, we are interested
in obtaining more information
specifying the exact resources used in
furnishing services described by
different codes. We hope to address this
subject in greater detail in future
rulemaking.
(7) Laparoscopic Radical Prostatectomy
(CPT code 55866)
In the CY 2016 PFS final rule with
comment period, we established an
interim final work RVU of 21.36 for CPT
code 55866 based on a direct crosswalk
to CPT code 55840 (Prostatectomy,
retropubic radical, with or without
nerve sparing). We stated that we
believed these codes were medically
similar procedures with nearly identical
time values, and we did not believe that
the difference in intensity between CPT
code 55840 and CPT code 55866 was
significant enough to warrant the RUCrecommended difference of 5.50 work
RVUs. We also compared CPT code
55866 to the work RVU of 25.18 for CPT
code 55845, and stated our belief that,
in general, a laparoscopic procedure
would not require greater resources than
an open procedure.
Comment: Several commenters
disagreed with the statement that a
laparoscopic procedure, such as CPT
code 55866, would generally require
fewer resources than an open procedure,
such as CPT code 55840. Commenters
stated that developing the skill
necessary to perform a minimally
invasive laparoscopic surgery requires a
greater degree of experience and
specialized training than that required
to perform an open prostatectomy.
Commenters indicated that this level of
practitioner skill should be reflected in
the work RVU for the procedure, as
intensity is based in part upon skill,
mental effort, and psychological stress.
Response: We agree with the
commenters that skill and technique as
well as mental effort and psychological
stress on the part of the practitioner
contribute to the overall intensity of the
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46233
furnishing a given service, and
therefore, are one of the two
components in determining code-level
work RVUs. However, we do not believe
that relative increases in requisite skill
or technique can be considered alone.
Although the development of new
technology (such as robotic assistance)
may create a greater burden of
knowledge on the part of the
practitioner, it can also make
procedures faster, safer, and easier to
perform. This means that there may be
reductions in time for such a procedure
(which is the other component of the
work RVU), but also that the mental
effort and psychological stress for a
given procedure may be mitigated by
the improvements in safety. Therefore,
we do not agree that a newer procedure
that includes additional technology and
requires greater training would
inherently be valued at a higher rate
than an older and potentially more
invasive procedure.
Comment: A commenter stated that
CPT code 55866 describes two very
different procedures in one code. The
descriptor for the code states ‘‘includes
robotic assistance when performed’’,
and the procedure is performed
differently depending on whether or not
the robotic assistance is included. The
commenter indicated that the vast
majority of radical prostatectomies are
performed with the robot, and although
the outcomes are the same in both cases,
the procedures are completely different.
Response: We agree with the
commenter that the descriptor includes
the possibility for confusion, especially
on the part of the survey respondents.
Valuing this code based on the typical
case is difficult when the procedure
differs depending on the inclusion or
exclusion of robotic assistance. We
would recommend that valuation might
be improved if the CPT Editorial Panel
were to consider further revisions to this
code to describe the two cases of
laparoscopic radical prostatectomy:
With and without robotic assistance.
Comment: One commenter stated that
the application of the phase-in
transition for facility-only codes like
CPT code 55866 would have a
particularly egregious impact in the
second year of the transition. The
commenter urged CMS to ensure that its
implementation of the phase-in
transition does not undermine the
protections created by the statute.
Response: Please see Sections II.G and
II.H or a discussion of the phase-in
transition and its implementation in its
second year.
Comment: Several commenters
requested that CMS refer CPT code
55866 to the refinement panel for
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review. At the refinement panel, the
presenters brought up new evidence in
the form of a study published in 2016
describing discharge data for radical
laparoscopic prostatectomies. The
presenters stated that there were many
more people included in this study as
opposed to the 30 respondents in the
survey data, and that on average the
robotic procedure took 90 minutes
longer than the open procedure. The
additional time needed to perform the
procedure, as indicated by this new
study’s results, was presented as a new
rationale as to why CMS should accept
the RUC-recommended work RVU.
Response: CPT code 55866 was
referred to the CY 2016 Multi-Specialty
Refinement Panel per the request of
commenters. The outcome of the
refinement panel was a median work
RVU of 26.80, the same value as the
RUC recommended in the previous
rulemaking cycle. After consideration of
the comments and the results of the
refinement panel, we are proposing for
CY 2017 to maintain the interim final
work RVU of 21.36 for CPT code 55866.
We are interested in the results of the
study mentioned at the refinement
panel, and we will consider
incorporating this data into the
valuation of this code, including, if
appropriate, adjustments to the work
times used in PFS ratesetting. We are
also seeking that the study be submitted
through the public comment process so
that we can allow it proper
consideration along with other
information submitted by the public,
rather than using the results of a single
study to propose valuations. We are also
curious about the time values regarding
the duration of CPT code 55866. One of
the members of the refinement panel
stated that on average the robotic
procedure took 90 minutes longer than
the open procedure. This is not what
was indicated by the survey data from
the RUC recommendations, which had
the two procedures valued at virtually
identical times (same intraservice time,
6 minutes difference total time). We are
therefore seeking comment on whether
the times included in this study are
more accurate than the time reflected in
the RUC surveys.
(8) Intracranial Endovascular
Intervention (CPT codes 61645, 61650,
and 61651)
For CY 2016, we established interim
final work RVUs of 15.00 for CPT code
61645, 10.00 for CPT code 61650 and
4.25 for CPT code 61651. The RUCrecommended values for CPT codes
61645, 61650 and 61651 were 17.00,
12.00 and 5.50, respectively. We valued
CPT code 61645 by applying the ratio
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between the RUC-recommended
reference code’s, CPT 37231
(revascularization, endovascular, open
or percutaneous, tibial, peroneal artery,
unilateral, initial vessel; with
transluminal stent placement(s) and
atherectomy, includes angioplasty
within the same vessel, when
performed), work and time to CPT code
61645. We valued CPT code 61650
based on a crosswalk to CPT code 37221
(revascularization, endovascular, open
or percutaneous, iliac artery, unilateral,
initial vessel; with transluminal stent
placement(s), includes angioplasty
within the same vessel, when
performed), due to similar intensity and
intraservice time. We valued CPT code
61651 based on a crosswalk to CPT code
37223 (revascularization, endovascular,
open or percutaneous, iliac artery, each
additional ipsilateral iliac vessel; with
transluminal stent placement(s),
includes angioplasty within the same
vessel, when performed (list separately
in addition to the code for primary
procedure, due to similar intraservice
time and intensity.
Both CPT codes 61645 and 61650
included postservice work time
associated with CPT code 99233
(Subsequent hospital care, per day, for
the evaluation and management of a
patient, which requires at least 2 of
these 3 key components: A detailed
interval history; A detailed examination;
Medical decision making of high
complexity. Counseling and/or
coordination of care with other
physicians, other qualified health care
professionals, or agencies are provided
consistent with the nature of the
problem(s) and the patient’s and/or
family’s needs. Usually, the patient is
unstable or has developed a significant
complication or a significant new
problem. Typically, 35 minutes are
spent at the bedside and on the patient’s
hospital floor or unit). In the CY 2016
PFS final rule with comment period, we
stated that we believe that for the
typical patient, these services would be
considered hospital outpatient services,
not inpatient services. As a result the
intraservice time of the hospital
observation care service was valued in
the immediate postservice time. We
refined the work time for CPT code
61645 by removing 55 minutes of work
time associated with CPT code 99233,
and added 30 minutes of time from CPT
code 99233 to the immediate
postservice. Therefore the total time for
CPT code 61645 was reduced to 241
minutes and the immediate postservice
time increased to 83 minutes. We also
removed the inpatient visit from CPT
code 61650, which reduced the total
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time to 206 minutes and increased the
postservice time to 75 minutes.
Comment: Commenters disagreed
with our categorization of these codes as
outpatient only, and therefore, subject to
the 23-hour outpatient policy.
Commenters stated that according to
Medicare claims data, the predecessor
codes were performed primarily on an
inpatient basis. Additionally,
commenters pointed out that the new
codes would typically be performed on
acute stroke patients. Commenters also
said as the new codes are inpatientonly, the CMS reductions in work and
time based on the assumption of
outpatient status are flawed; as a result,
commenters suggested we accept the
RUC-recommended values. Commenters
also requested that these codes be
referred to the refinement panel.
Response: We valued CPT codes
61645, 61650, and 61651 based on
comparisons to reference CPT codes
37231, 37221, and 37223, respectively.
We continue to believe that these codes
are appropriate comparisons based on
intensity and intra-service time because
no persuasive information was
presented at the refinement panel that
indicated that these comparisons are not
appropriate. Therefore we are proposing
an RVU of 15.00 for CPT code 61645,
10.00 for CPT code 61650, and 4.25 for
CPT code 61651. We are also proposing
time inputs based on our refinements of
the RUC recommendations, including
removing the time associated with
hospital inpatient visit CPT code 99233
from the intraservice work time, and
adding 30 minutes to the immediate
postservice time for both CPT codes
61645 and 61650.
We are also seeking comment on the
inclusion of post-operative visits in a 0day global. Both CPT codes 61645 are 0day global codes, and the refinements
described above reflect changes to more
appropriate value these codes as 0-day
codes. We do not believe that 0-day
globals codes should include postoperative visits; rather, if global codes
require post-operative visits, they are
more appropriately assigned 10- or 90day global periods based on our current
criteria. Our policy has been to remove
the visit from the post-operative period
and the associated minutes from the
total time while adding 30 minutes to
the immediate postservice period
without necessarily making an
adjustment to the work RVU (see the CY
2010 PFS proposed rule, 74 FR 33557;
also see the CY 2011 PFS proposed rule,
75 FR 40072).
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(9) Paravertebral Block Injection (CPT
codes 64461, 64462, and 64463)
(10) Implantation of Neuroelectrodes
(CPT codes 64553 and 64555)
In CY 2015, the CPT Editorial Panel
created three new codes to describe
paravertebral block injections at single
or multiple levels, as well as for
continuous infusion for the
administration of local anesthetic for
post-operative pain control and thoracic
and abdominal wall analgesia. For the
CY 2016 PFS final rule with comment
period, we established the RUCrecommended work RVUs, 1.75 and
1.10, as interim final for CPT codes
64461 and 64462, respectively.
For CPT code 64463, we utilized a
direct crosswalk from three other
injection codes (CPT codes 64416
(Injection, anesthetic agent; brachial
plexus, continuous infusion by catheter
(including catheter placement), 64446
(Injection, anesthetic agent; sciatic
nerve, continuous infusion by catheter
(including catheter placement), and
64449 (Injection, anesthetic agent;
lumbar plexus, posterior approach,
continuous infusion by catheter
(including catheter placement)) which
all had a work RVU of 1.81 as we
believed this crosswalk more accurately
reflected the work involved in
furnishing this service.
Comment: The RUC stated that CPT
code 64463 is more comparable to CPT
code 64483 (Injection(s), anesthetic
agent and/or steroid, transforaminal
epidural, with imaging guidance
(fluoroscopy or CT); lumbar or sacral,
single), which has a work RVU of 1.90
and requires the same physician work
and time to perform. The RUC
recommended we accept the 25th
percentile survey work RVU of 1.90.
Another commenter stated that our
value for CPT code 64463 was
inappropriate since imaging guidance is
not part of our comparison codes. The
commenter advocated for us to accept
the survey respondent’s selection of
CPT code 64483 as the most appropriate
comparison code and assign a work
RVU of 1.90.
Response: After reviewing and
considering the comments, we continue
to believe that CPT codes 64416, 64446,
and 64449, all of which have 20 minutes
of intraservice time, are better
crosswalks to CPT code 64463, which
also has 20 minutes of intraservice time
and a similar total time. In contrast, the
crosswalk code recommended by
commenters, CPT 64483, only has 15
minutes of intraservice time. Therefore,
we are proposing a work RVU of 1.81 for
CPT code 64463 for CY 2017.
The RUC identified CPT codes 64553
and 64555 as a site of service anomaly
during the CY 2016 PFS rulemaking
cycle. In the Medicare claims data, these
services were typically reported in the
nonfacility setting, yet the survey data
was predicated on a facility-based
procedure. We agreed with the RUC that
these two codes should be referred to
the CPT Editorial Panel to better define
the services, in particular to investigate
the possibility of establishing one code
to describe temporary or testing
implantation and another code to
describe permanent implantation. We
maintained the CY 2015 work RVUs and
direct PE inputs for these two codes on
an interim basis until receiving updated
recommendations from CPT and the
RUC.
Comment: A commenter requested
that CMS allow practitioners to bill the
MACs separately for a percutaneous
electrode kit (SA022) for CPT code
64555. The commenter stated that
without allowing for a separate payment
for the percutaneous electrode kit, the
payment for the procedure would be
insufficient to cover the physician’s
costs.
Response: We agree that CPT codes
64553 and 64555 as currently
constructed are potentially misvalued
codes, which is why we are maintaining
the CY 2015 work RVUs and direct PE
inputs on an interim basis. We believe
that the disposable supplies furnished
incident to the procedure are paid
through the nonfacility PE RVUs. The
percutaneous electrode kit (SA022) was
not previously included in the direct PE
inputs for either of these two services,
and since we are proposing to maintain
current direct PE inputs pending
additional recommendations, we do not
agree that disposable supplies should be
separately payable. We are proposing to
maintain the interim final work RVUs
and direct PE inputs for these two
codes, and we look forward to reviewing
recommendations regarding these
procedures again for future rulemaking.
Additionally, we were alerted to a
discrepancy regarding the times for
these codes in the CY 2016 work time
file. Our proposed CY 2017 work time
file addresses this discrepancy by
reflecting the RUC recommended times
of 155 minutes for CPT code 64553 and
140 minutes for CPT code 64555.
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(11) Ocular Reconstruction Transplant
(CPT code 65780)
In CY 2015, the RUC identified CPT
code 65780 as potentially misvalued
through a misvalued code screen for 90-
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46235
day global services that included more
than 6 office visits. The RUC
recommended a direct work RVU
crosswalk from CPT code 27829 (Open
treatment of distal tibiofibular joint
(syndesmosis) disruption, includes
internal fixation, when performed).
After examining comparable codes, we
determined the RUC-recommended
work RVU of 8.80 for CPT code 65780
would likely overstate the work
involved in the procedure given the
change in intraservice and total times
compared to the previous values. We
believed that the ratio of the total times
(230/316) applied to the work RVU
(10.73) more accurately reflected the
work involved in this procedure.
Therefore, we established an interim
final work RVU of 7.81 for CPT code
65780.
Comment: The RUC and other
commenters disagreed with our interim
final values based on objections to our
use of time ratios in developing work
RVUs for PFS services.
Response: We appreciate the
commenters’ concerns and have
responded to these concerns about our
methodology in section II.L of this
proposed rule. After review of the
comments, we continue to consider the
work RVU of 7.81 to accurately
represent the work involved in CPT
code 65780. We believe this service is
similar in overall intensity to CPT code
27766 (Open treatment of medial
malleolus fracture, includes internal
fixation, when performed) that has a
work RVU of 7.89 and a total time that
more closely approximates that of CPT
code 65780. Therefore, we are proposing
a work RVU of 7.81 for CPT code 65780
for CY 2017.
(12) Trabeculoplasty by Laser Surgery
(CPT code 65855)
In CY 2015, the RUC identified CPT
code 65855 as potentially misvalued
through the review of 10-day global
services with more than 1.5
postoperative visits. The RUC noted that
the code was changed from a 90-day to
a 10-day global period when it was last
valued in 2000. However, the descriptor
was not updated to reflect that change.
CPT code 65855 describes multiple laser
applications to the trabecular meshwork
through a contact lens to reduce
intraocular pressure. The current
practice is to perform only one
treatment session during a 10-day
period and then wait for the effect on
the intraocular pressure. The descriptor
for CPT code 65855 has been revised
and removes the language ‘‘1 or more
sessions’’ to clarify this change in
practice.
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The RUC recommended a work RVU
of 3.00 for CPT code 65855. While the
RUC-recommended value represents a
reduction from the CY 2015 work RVU
of 3.99, we stated that significant
reductions in the intraservice time, the
total time, and the change in the office
visits represent a more significant
change in the work resources involved
in furnishing the typical service. The
intraservice and total times were
decreased by approximately 33 percent
while the elimination of two postoperative visits (CPT code 99212) alone
would reduce the overall work RVU by
at least 24 percent under the reverse
building block method. However, the
RUC-recommended work RVU only
represents a 25 percent reduction
relative to the previous value. To
identify potential work RVUs for this
service, we calculated an intraservice
time ratio between the CY 2015
intraservice time, 15 minutes, and the
RUC-recommended intraservice time, 10
minutes, and applied this ratio to the
current work RVU of 3.99 to arrive at a
work RVU of 2.66 for CPT code 65855,
which we established as interim final
for CY 2016.
Comment: A few commenters,
including the RUC, provided
explanations as to how the RUC
recommendation had already accounted
for the reduction in physician intraservice time and post-operative visits.
Some commenters disagreed with CMS’
interim final values based on objections
to CMS’ use of time ratios in developing
work RVUs for PFS services.
Response: We appreciate the
commenters’ concerns regarding the
time ratio methodologies and have
responded to these concerns about our
methodology in section II.H.2 of this
proposed rule. After considering the
explanations provided by commenters
through public comments describing the
RUC’s methodologies in more detail, we
agree that the proposed value did not
accurately reflect the physician work
involved in furnishing the service.
Therefore, for CY 2017 we are proposing
the RUC-recommended work RVU value
of 3.00 for CPT code 65855.
(13) Glaucoma Surgery (CPT codes
66170 and 66172)
The RUC identified CPT codes 66170
and 66172 as potentially misvalued
through a screen for 90-day global codes
that included more than 6 office visits).
We believed the RUC-recommended
work RVU of 13.94 for CPT code 66170
did not accurately account for the
reductions in time. Specifically, the
survey results indicated reductions of
25 percent in intraservice time and 28
percent in total time. These reductions
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suggested that the RUC-recommended
work RVU for CPT code 66170
overstated the work involved in
furnishing the service, since the
recommended value only represented a
reduction of approximately seven
percent. We believed that applying the
intraservice time ratio, the ratio between
the CY 2015 intraservice time, 60
minutes, and the RUC-recommended
intraservice time, 45 minutes, applied to
the current work RVU, 15.02, resulted in
a more appropriate work RVU.
Therefore, for CY 2016, we established
an interim final work RVU of 11.27 for
CPT code 66170.
For CPT code 66172, the RUC
recommended a work RVU of 14.81.
After comparing the RUC-recommended
work RVU for this code to the work
RVU for similar codes (for example, CPT
code 44900 (Incision and drainage of
appendiceal abscess, open) and CPT
code 52647 (Laser coagulation of
prostate, including control of
postoperative bleeding, complete
(vasectomy, meatotomy,
cystourethroscopy, urethral calibration
and/or dilation, and internal
urethrotomy are included if
performed))), we believed the RUCrecommended work RVU of 14.81
overstated the work involved in this
procedure. For the same reasons and
following the same valuation
methodology utilized above, we applied
the intraservice time ratio between the
CY 2015 intraservice time and the
survey intraservice time, 60/90, to the
CY 2015 work RVU of 18.86. This
resulted in a work RVU of 12.57 for CPT
code 66172. Therefore, for CY 2016, we
established an interim final work RVU
of 12.57 for CPT code 66172.
Comment: Several commenters,
including the RUC, disagreed with our
interim final values based on objections
to our use of time ratios in developing
work RVUs for PFS services.
Commenters also requested CMS refer
CPT codes 66170 and 66172 to the
refinement panel.
Response: We appreciate the
commenters’ concerns regarding the
time ratio methodologies and have
responded to these concerns in section
II.H.2 of this proposed rule. CPT codes
66170 and 66172 were referred to the
CY 2016 multi-specialty refinement
panel per commenters’ request. The
outcome of the refinement panel was a
median of 13.94 RVUs for CPT code
66170 and 14.84 RVUs for CPT code
66172. Due to the new information
presented to the refinement panel
regarding the level of intensity required
to perform millimeter incisions in the
eye, we agree with the assessment of the
refinement panel and therefore, for CY
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2017 we are proposing a work RVU of
13.94 for CPT code 66170 and 14.84 for
CPT code 66172.
(14) Retinal Detachment Repair (CPT
codes 67107, 67108, 67110, and 67113)
CPT codes 67107, 67108, 67110 and
67113 were identified as potentially
misvalued through a screen for 90-day
global post-operative visits. The RUC
recommended a work RVU of 16.00 for
CPT code 67107, which corresponded to
the 25th percentile of the survey. While
the RUC recommendation represented a
five percent reduction from the current
work RVU of 16.71, we believed the
RUC recommendation still overvalued
the service given the 15 percent
reduction in intraservice time and 25
percent reduction in total time. We used
the intraservice time ratio between the
existing and new time values to identify
an interim final work RVU of 14.06. We
believed this value accurately reflected
the work involved in this service and
was comparable to other codes that have
the same global period and similar
intraservice time and total time. For CY
2016, we established an interim final
work RVU of 14.06 for CPT code 67107.
For CPT code 67108, the RUC
recommended a work RVU of 17.13
based on the 25th percentile of the
survey, which reflected a 25 percent
reduction from the current work RVU.
The survey results reflected a 53 percent
reduction in intraservice time and a 42
percent reduction in total time. We
believe the RUC-recommended work
RVU overestimated the work, given the
significant reductions in intraservice
time and total time and does not
maintain relativity among the codes in
this family. To determine the
appropriate value for this code and
maintain relativity within the family,
we preserved the 1.13 work RVU
increment recommended by the RUC
between this code and CPT code 67107
and applied that increment to the
interim final work RVU of 14.06 for CPT
code 67107. Therefore, we established
an interim final work RVU of 15.19 for
CPT code 67108.
For CPT code 67110, the RUC
recommended maintaining the current
work RVU of 10.25. To maintain
appropriate relativity with the work
RVUs established for the other services
within this family, we used the RUCrecommended ¥5.75 RVU differential
between CPT code 67107 and CPT code
67110 to establish the CY 2016 interim
final work RVU of 8.31 for CPT code
67110. For CPT code 67113, the RUC
recommended and we established an
interim final work RVU of 19.00 based
on the 25th percentile of the survey.
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Comment: Several commenters,
including the RUC, disagreed with our
interim final values based on objections
to our use of time ratios in developing
work RVUs for PFS services. Some
commenters also stated that by using
some RUC-recommended increments
and rejecting others, we have not only
established inconsistencies within the
family of codes, but potentially opened
up anomalies across a wide range of
services. The RUC also expressed
disagreement with using the
recommended work RVU increments
without using the recommended work
RVU. Some commenters also stated the
new IWPUT values for these three
services are inappropriately low and
pointed to the derived per minute
intensity of 0.064 for CPT code 67110 as
particularly problematic.
Response: We appreciate the
commenters’ concerns regarding the
time ratio methodologies and have
responded to these concerns in section
II.H.2 of this proposed rule. We disagree
with the statement about
inconsistencies as the codes in this
family are valued relative to one another
based on the times and level of
physician work required for each code.
Also, we generally do not agree that a
low IWPUT itself indicates overall
misvaluation as the validity of the
IWPUT as a measure of intensity
depends on the accuracy of the
assumptions regarding the number,
level, and work RVUs attributable to
visits for services in the post-operative
global period for individual services.
For example, a service with an
unrealistic number or level of postoperative visits may have a very low
derived intensity for the intra-service
time.
CPT codes 67107, 67108, and 67110
were referred to the CY 2016 multispecialty refinement panel per
commenters’ request. The outcome of
the refinement panel was a median of
16.00, 17.13, and 10.25 work RVUs;
respectively. After consideration of the
comments and the results of the
refinement panel, we are proposing a
work RVU of 16.00, 17.13, and 10.25 for
CPT codes 67107, 67108, and 66110,
respectively, for CY 2017.
(15) Fetal MRI (CPT Codes 74712 and
74713)
For CY 2016, we established the RUCrecommended work RVU of 3.00 as
interim final for CPT code 74712. We
established an interim final work RVU
of 1.78 for CPT code 74713 based on a
refinement of the RUC-recommended
work RVU of 1.85 using the ratio of
work to time for both codes. This
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proposed value also corresponds to the
25th percentile survey result.
Comment: Commenters stated that the
work RVU of 1.78 for CPT code 74713
did not reflect the higher intensity
inherent in the procedure’s typical
patient. The commenter explained that
the typical patient is pregnant with
twins and has a higher likelihood of
complications related to congenital
anomalies, as well as of ischemic brain
injury with twin gestations. The
commenter further stated that twin
gestations are more difficult to image.
Commenters requested that CPT code
74713 be referred to the multispecialty
refinement panel.
Response: CPT code 74713 was
referred to the CY 2016 multispecialty
refinement panel. After considering the
comments and the results of the
refinement panel, we agree with
commenters that an RVU of 1.78
underestimates the work for CPT code
74713. Therefore, we propose a work
RVU of 1.85 for the service for CY 2017.
(16) Interstitial Radiation Source Codes
(CPT Codes 77778 and 77790)
In CY 2016 PFS final rule with
comment period, we established an
interim final value for CPT code 77790
without a work RVU, consistent with
the RUC’s recommendation. We did not
use the RUC-recommended work RVU
to establish the interim final values for
CPT code 77778. We stated that the
specialty society survey included a
work time that was significantly higher
than the RUC-recommended work time
without a commensurate change in
RVU. For CY 2016, we established the
25th percentile work RVU survey result
of 8.00 as interim final for CPT code
77778.
Comment: Commenters agreed that
the preservice survey times and the
RUC-recommended survey times were
inconsistent and explained that this
inconsistency resulted from the RUC’s
use of preservice packages in
developing recommendations. In
addition, commenters stated that
because the work associated with CPT
code 77790 (including pre-time
supervision, handling, and loading of
radiation seeds into needles) was
bundled into CPT code 77778, that the
additional work should be reflected in
the RVU for CPT code 77778.
Commenters encouraged us to accept
the RUC-recommended work RVU of
8.78 and requested that CPT code 77778
be referred to the refinement panel.
Response: We did not refer CPT code
77778 to the CY 2016 multispecialty
refinement panel because commenters
did not provide new clinical
information. We continue to believe
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46237
that, based on the reduction in total
work time, an RVU of 8.00 accurately
reflects the work involved in furnishing
CPT code 77778. Therefore for CY 2017,
we are proposing a work RVU of 8.00 for
CPT code 77778 and 0 work RVUs for
CPT code 77790. We are also seeking
comment on whether we should use
time values based on preservice
packages if the recommended work
value is based on time values that are
significantly different than those
ultimately recommended.
(17) Colon Transit Imaging (CPT Codes
78264, 78265, and 78266)
In establishing CY 2016 interim final
values, we accepted the RUCrecommended work RVUs for CPT
codes 78265 and 78266. We believed
that the RUC-recommended RVU of 0.80
overestimated the work involved in
furnishing CPT code 78264 and as a
result, we established an interim final
work RVU of 0.74 based on a crosswalk
to CPT code 78226 (hepatobiliary
system imaging, including gallbladder
when present), due to similar
intraservice times and intensities.
Comment: Commenters did not
support our interim final work RVU for
CPT code 78264. Commenters disagreed
with our assessment of CPT code 78264
as having a higher work RVU and
shorter intraservice time relative to the
other codes in the family. One
commenter stated that a difference of
two minutes in intraservice time was
insignificant and should not be used as
a rationale for revaluing. Another
commenter stated that we should have
maintained the RUC-recommended
crosswalk of CPT code 78264 to CPT
code 78227 (Hepatobiliary system
imaging, including gallbladder when
present; with pharmacologic
intervention, including quantitative
measurement(s) when performed) due to
similarities in service, work and
intensity. Based on these concerns,
commenters requested that CPT code
78264 be referred to the refinement
panel.
Response: CPT code 78264 was
referred to the CY 2016 multi-specialty
refinement panel for further review. We
calculate the refinement panel results as
the median of each vote. That result for
CPT code 78264 was 0.79 RVUs. After
consideration of the comments and the
refinement panel results, we agree that
0.79 accurately captures the overall
work involved in furnishing this service
and are proposing a value of 0.79 for
CPT code 78264.
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(18) Cytopathology Fluids, Washings or
Brushings and Cytopathology Smears,
Screening, and Interpretation (CPT
Codes 88104, 88106, 88108, 88112,
88160, 88161, and 88162)
In the CY 2016 PFS final rule with
comment period, we made a series of
refinements to the recommended direct
PE inputs for this family of codes. We
removed the equipment time for the
solvent recycling system (EP038) and
the associated clinical labor described
by the tasks ‘‘Recycle xylene from
stainer’’ and ‘‘Order, restock, and
distribute specimen containers and or
slides with requisition forms’’ due to
our belief that these were forms of
indirect PE. This refinement applied to
all seven codes in the family. We also
noticed what appeared to be an error in
the quantity of non-sterile gloves
(SB022), impermeable staff gowns
(SB027), and eye shields (SM016)
assigned to CPT codes 88108 and 88112.
The recommended value of these
supplies was a quantity of 0.2, which
we believed was intended to be a
quantity of 2. We therefore refined the
value of these supplies to 2 for CPT
codes 88108 and 88112.
Comment: Several commenters
disagreed with our characterization of
the solvent recycling system and its
associated clinical labor tasks as
indirect PE. Commenters stated that the
solvent recycling system costs are direct
expenses since they are based on the
amount of recycled solvent allocated to
each specimen, with solvents allocated
to specific specimens based on batch
size. They indicated that the related
clinical labor tasks are also forms of
direct PE as they are also based on the
amount of recycled solvent allocated to
each specimen. The time for these tasks
varies based on the batch size, which
varies by procedure.
Response: We maintain our
previously stated belief that these are
forms of indirect PE, as they are not
allocated to any individual service. We
have defined direct PE inputs as clinical
labor, medical supplies, or medical
equipment that are individually
allocable to a particular patient for a
particular service. We continue to
believe that a solvent recycling system
would be in general use for a lab
practice, and that the associated clinical
labor tasks for ordering and restocking
specimen containers can be more
accurately described as administrative
activities. We are proposing to maintain
these refinements from the previous
rulemaking cycle for CPT codes 88104–
88162.
Comment: A commenter indicated
that we did not account for the batch
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size when considering the supply
quantities for CPT codes 88108 and
88112. The commenter indicated that
the practice expense inputs should be
assumed to have a batch size of five for
these two codes, and therefore, no edits
should be made. The commenter
requested that we restore the quantity of
0.2 for the gloves, gowns, and eye
shields associated with these
procedures. This did not apply to the
other codes on the submitted
spreadsheet, which had a batch size of
one.
Response: We appreciate the
assistance of the commenter in
clarifying the batch size for these
procedures. As a result, we are
proposing to refine the supply quantity
of the non-sterile gloves (SB022),
impermeable staff gowns (SB027), and
eye shields (SM016) back to the RUCrecommended value of 0.2 for CPT
codes 88108 and 88112.
(19) Immunohistochemistry (CPT Codes
88341, 88342, 88344, and 88350)
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 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. In the past
for similar procedures in this family, the
RUC recommended a work RVU for the
add-on code (CPT code 88364) that was
60 percent of the base code (CPT code
88365). In the CY 2015 PFS final rule
with comment period, we stated that the
relative resources involved in furnishing
an add-on service in this family would
be reflected appropriately using the
same 60 percent metric and
subsequently established an interim
final work RVU of 0.42 for CPT code
88341, which was 60 percent of the
work RVU of the base CPT code 88342
(0.70). In the CY 2016 PFS proposed
rule, we revised the add-on codes from
60 percent to 76 percent of the base
code and subsequently revalued CPT
code 88341 at 0.53 work RVUs.
However, we inadvertently published
work RVUs for CPT code 88341 in
Addendum B without explicitly
discussing it in the preamble text. In the
CY 2016 PFS final rule with comment
period, we maintained CPT code
88341’s CY 2015 work RVU of 0.53 as
interim final for CY 2016 and requested
public comment. Also, in the CY 2016
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PFS final rule with comment period, we
established an interim final value of
0.70 work RVUs for CPT codes 88342
and 88344.
Comment: Several commenters
expressed their opposition to a standard
discount for the physician work
involved in pathology add-on services
and urged us to accept the RUCrecommend value of 0.65 RVUs for CPT
code 88341.
Response: We appreciate commenters’
concerns regarding a standard discount;
however, we believe that it is reasonable
to estimate work RVUs for a base and an
add-on code, and to recognize
efficiencies between them, by looking at
how similar efficiencies are reflected in
work RVUs for other PFS services. Also
we note that the intravascular codes for
which we initially established our base/
add-on code relationship for CPT codes
88346 and 88350 were deleted in CY
2016 and replaced with two new codes;
CPT codes 37252 and 37253. The
relationship between 37252 and 37253
represents a 20 percent discount for the
add-on code as the base CPT code 37252
has a work RVU of 1.80 and 37523 and
work RVU of 1.44. As CPT codes 37252
and 37253 replaced the codes on which
our discounts for base and add-on codes
were based (please see the CY 2016 PFS
final rule with comment period (80 FR
70972) for a detailed discussion) we
believed it would be appropriate to
maintain the same 20 percent
relationship for 88346 and 88350.
Therefore, for CY 2017, we are
proposing a work RVU of 0.56 for CPT
code 88341, which represents 80
percent of 0.70, the work RVU of the
base code.
For CY 2016, we finalized a work
RVU of 0.56 for CPT code 88350 which
represented 76 percent of 0.74, the RVU
for the base code. To maintain
consistency within this code family, we
are proposing to revalue CPT code
88350 using the 20 percent discount
discussed above. To value CPT code
88350, we multiplied the work RVU of
CPT code 88346, 0.74, by 80 percent,
and then subtracted the product from
0.74, resulting in a work RVU of 0.59 for
CPT code 88350. Therefore, for CY
2017, we are proposing a work RVU of
0.59 for CPT code 88350.
A stakeholder has suggested to us that
an error was made in the
implementation of direct PE inputs for
code 88341 and several other related
codes. This stakeholder stated that
when CMS reclassified equipment code
EP112 (Benchmark ULTRA automated
slide preparation system) and EP113 (EBar II Barcode Slide Label System) into
a single equipment item, with a price of
$150,000 using equipment code EP112,
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the equipment minutes assigned to the
E-Bar II Barcode Slide Label System
should have been added into the new
EP112 equipment time. The stakeholder
requested that these minutes should be
added into the EP112 equipment time;
for example, 1 additional minute should
be added to CPT code 88341 for a total
of 16 minutes.
We appreciate the additional
information, and are soliciting
additional information on this topic
through public comment on this
proposed rule to assess whether it
would be appropriate to add the former
EP113 minutes into EP112. We are
specifically seeking comment from other
stakeholders, including the RUC, since
the assigned number of minutes was
originally based on a RUC
recommendation. This information
would be potentially relevant for CPT
codes 88341 (Immunohistochemistry or
immunocytochemistry, per specimen;
each additional single antibody stain
procedure), 88342
(Immunohistochemistry or
immunocytochemistry, per specimen;
initial single antibody stain procedure),
88344 (Immunohistochemistry or
immunocytochemistry, per specimen;
each multiplex antibody stain
procedure), 88360 (Morphometric
analysis, tumor immunohistochemistry,
quantitative or semiquantitative, per
specimen, each single antibody stain
procedure; manual), and 88361
(Morphometric analysis, tumor
immunohistochemistry, quantitative or
semiquantitative, per specimen, each
single antibody stain procedure; using
computer-assisted technology).
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(20) Morphometric Analysis (CPT Codes
88364, 88365, 88367, 88368, 88369 and
88373)
For CY 2015, the CPT editorial panel
revised the code descriptors for the in
situ hybridization procedures, CPT
codes 88365, 88367 and 88368, to
specify ‘‘each separately identifiable
probe per block.’’ Additionally, three
new add-on codes (CPT codes 88364,
88369, 88373,) were created to specify
‘‘each additional separately identifiable
probe per slide.’’ Some of the add-on
codes in this family had RUCrecommended work RVUs that were 60
percent of the work RVU of the base
procedure. We believed this accurately
reflected the resources used in
furnishing these add-on codes and
subsequently established 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
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percent of the work RVU of CPT code
88367).
For CY 2016, the RUC re-reviewed
these services due to the specialty
society’s initially low survey response
rate. In our review of these codes, we
noticed that the latest RUC
recommendation was identical to the
RUC recommendation provided for CY
2015. Therefore, we proposed to retain
the CY 2015 work RVUs and work time
for CPT codes 88367 and 88368 for CY
2016. For CPT code 88365 we finalized
a work RVU of 0.88.
For CPT codes 88364 and 88369, we
increased the work RVUs of these addon codes from 0.53 to 0.67, which
reflected 76 percent of the work RVUs
of the base procedures for these
services. However, we inadvertently
omitted the rationale for this revision to
the work RVUs in the proposed rule.
Consequently, we maintained the CY
2015 interim final values of the work
RVU of 0.67 for CPT codes 88464 and
88369 and sought comment on these
values for CY 2016. For CPT code 88373
we finalized a work RVU of 0.43.
Comment: A few commenters stated
their objection to our use of a standard
discount for pathology add-on services
and for suggesting that each service is
separate and unique. Commenters also
stated there should be no comparison of
intravascular ultrasound services to
morphometric analysis,
immunohistochemistry,
immunofluorescence, or any pathology
service.
Response: In reviewing the RUCrecommended base/add-on
relationships between several pathology
codes, we continue to believe the base/
add-on code time relationships for
pathology services are appropriate and
have not been presented with any
compelling evidence that conflicts with
the RUC-recommended relationships.
However, as we stated above, the
intravascular codes we initially
examined in revaluing CPT codes 88364
and 88369 were deleted in CY 2016 and
replaced with CPT codes 37252 and
37253. For the reasons stated above we
continue to believe this 20 percent
discount relationship between the base
and add-on code accurately reflects the
work involved in furnishing these
services.
Therefore, for CY 2017, we are
proposing a work RVU of 0.70 for CPT
codes 88364 and 88369 which
represents a 20 percent discount from
the base code. As the relationship
between the base code and add-on code
now represents a 20 percent difference
we are proposing to revalue CPT code
88373 at 0.58 work RVUs. Therefore, for
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46239
CY 2017 we are proposing a work RVU
of 0.58 for CPT code 88373.
(21) Liver Elastography (CPT Code
91200)
For CY 2016, we received a RUC
recommendation of 0.27 RVU for CPT
code 91200. After careful review of the
recommendation, we established the
RUC-recommended work RVU and
direct PE inputs as interim final for CY
2016.
Comment: A few commenters
requested that we reconsider the level of
payment assigned to this service when
furnished in a non-facility setting,
stating that the code met the definition
for the potentially misvalued code list
as there is a significant difference in
payment between sites of service. The
commenters also asked us to reconsider
the assigned 50 percent utilization rate
for the FibroScan equipment in this
procedure as the current utilization rate
would translate to over 50 procedures
per week. Instead, the commenters
suggested the typical number of
procedures done per week ranges
between 15 and 25 and requested we
adopt a 25 percent utilization rate
which corresponds to that number of
procedures.
Response: We refer commenters to the
CY 2016 final rule with comment period
(80 FR 71057–71058) where we
discussed and addressed the
comparison of the PFS payment amount
to the OPPS payment amount for CPT
91200. For the commenter’s statement
about the utilization rate, we have
previously addressed the accuracy of
these default assumptions as they apply
to particular equipment resources and
particular services. In the CY 2008 PFS
proposed rule (72 FR 38132), we
discussed the 50 percent utilization
assumption and acknowledged that the
default 50 percent usage assumption is
unlikely to capture the actual usage
rates for all equipment. However, we
stated that we did not believe that we
had strong empirical evidence to
support any alternative approaches. We
indicated that we would continue to
monitor the appropriateness of the
equipment utilization assumption, and
evaluate whether changes should be
proposed in light of the data available.
The commenters did not provide any
verifiable data suggesting a lower
utilization rate. Therefore, for CY 2017
we are proposing a work RVU of 0.27 for
CPT code 91200, consistent with the CY
2016 interim final value, and we
continue to explore and seek comments
regarding publicly available data
sources to identify the most accurate
equipment utilization rate assumptions
possible. We also note that following the
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publication of the CY 2016 PFS final
rule with comment period (80 FR
70886) there was an inconsistency in
the Work Time file published on the
CMS Web site. For CPT code 91200 the
RUC recommended 16 minutes total
service time whereas our file reflected
18 minutes total time for the service. For
CY 2017, we are proposing to update the
Work Time file to reflect the RUC’s
recommendation, which is 16 minutes
for CPT code 91200.
b. CY 2017 Proposed Codes
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
(1) Anesthesia Services Furnished in
Conjunction with Lower
Gastrointestinal (GI) Procedures (CPT
Codes 00740 and 00810)
The anesthesia procedure CPT codes
00740 and 00810 are used for anesthesia
furnished in conjunction with lower
gastrointestinal (GI) procedures. In the
CY 2016 PFS proposed rule (80 FR
41686), we discussed that in reviewing
Medicare claims data, a separate
anesthesia service is now reported more
than 50 percent of the time that several
types of colonoscopy procedures are
reported. We discussed that given the
significant change in the relative
frequency with which anesthesia codes
are reported with colonoscopy services,
we believe the relative values of the
anesthesia services should be
reexamined. We proposed to identify
CPT codes 00740 and 00810 as
potentially misvalued and sought public
comment regarding valuation for these
services.
The RUC recommended maintaining
the base unit value of 5 as an interim
base value for both CPT code 00740 and
00810 on an interim basis, due to their
concerns about the specialty society
surveys. The RUC suggested that the
typical patient vignettes used in the
surveys for both CPT codes 00740 and
00810 were not representative of current
typical practice and recommended that
the codes be resurveyed with updated
vignettes. We agree that it is premature
to propose any changes to the valuation
of CPT codes 00740 and 00810, but
continue to believe that these services
are potentially misvalued and look
forward to receiving input from
interested parties and specialty societies
for consideration during future notice
and comment rulemaking.
(2) Removal of Nail Plate (CPT Code
11730)
We identified CPT code 11730
(Avulsion of nail plate, partial or
complete, simple; single) through a
screen of high expenditures by
specialty. The HCPAC recommended a
work RVU of 1.10. We believe the
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recommendation for this service
overestimates the work involved in
performing this procedure, specifically
given the decrease in physician
intraservice and total time concurrently
recommended by the HCPAC. We
believe that a work RVU of 1.05, which
corresponds to the 25th percentile of the
survey results, more accurately
represents the time and intensity of
furnishing the service. To further
support the validity of the use of the
25th percentile of the survey, a work
RVU of 1.05, we identified two
crosswalk CPT codes, 20606
(Arthrocentesis, aspiration and/or
injection, intermediate joint or bursa),
with a work RVU of 1.00, and 50389
(Removal of nephrostomy tube,
requiring fluoroscopic guidance) with a
work RVU of 1.10, both of which have
identical intraservice times, similar total
times and similar intensity. We note
that our proposed work RVU of 1.05 for
CPT code 11730 falls halfway between
the work RVUs for these two crosswalkcodes. CPT Code 11730 may be reported
with add-on CPT code 11732 to report
performance of the same procedure for
each additional nail plate procedure.
Since CPT code 11732 was not
reviewed by the HCPAC for CY 2017,
we are proposing a new work value to
maintain the consistency of this add-on
code with the base code, CPT code
11730. We are proposing to remove 2
minutes from the physician intraservice
time to maintain consistency with the
HCPAC-recommended reduction of 2
minutes from the physician intraservice
time period for the base code. We are
using a crosswalk from the value for
CPT code 77001 (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)), which has
similar physician intraservice and total
time values; therefore, we are proposing
a work RVU of 0.38 for CPT code 11732.
As further support for this proposal, we
note that this proposed RVU reduction
is similar to the value obtained by
subtracting the incremental difference
in the current and recommended work
RVUs for the base code from the current
value of CPT code 11732.
We are proposing to use the HCPACrecommended direct PE inputs for CPT
code 11730. We are proposing to apply
some of HCPAC-recommended
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refinements for CPT code 11730
to11732, including the removal of the
penrose drain (0.25in x 4in), lidocaine
1%–2% inj (Xylocaine), applicator
(cotton-tipped, sterile) and silver
sulfadiazene cream (Silvadene), as well
as the reduction of the swab-pad,
alcohol from 2 to 1. In addition, we are
proposing not to include the
recommended the supply items ‘‘needle,
30g, and syringe, 10–12ml’’ since other
similar items are present, and we think
inclusion of these additional supply
items would be duplicative. For clinical
labor, we are proposing to assign 8
minutes to ‘‘Assist physician in
performing procedure’’ for to maintain a
reduction that is proportionate to that
recommended for 11730. For the supply
item ‘‘ethyl chloride spray,’’ we believe
that the listed input price of $4.40 per
ounce overestimates the cost of this
supply item, and we are seeking
comment on the accuracy of this supply
item price. Finally, we are adding two
equipment items as was done in the
base code, basic instrument pack and
mayo stand, and are proposing to adjust
the times for all pieces of equipment to
8 minutes to reflect the clinical service
period time.
(3) Bone Biopsy Excisional (CPT Code
20245)
In CY 2014, CPT code 20245 was
identified by the RUC’s 10-Day Global
Post-Operative Visits Screen.
For CY 2017, the RUC recommended
a value of 6.50 work RVUs for CPT code
20245, including a change in global
period from 10- to 0- days. We disagree
with this value given the significant
reductions in the intraservice time, total
time, and the change in the office visits
assuming the change in global period.
The intraservice and total times were
decreased by approximately 33 and 53
percent respectively; while the
elimination of three post-operative visits
(one CPT code 99214 and two CPT code
99213 visits) alone would reduce the
overall work RVU by at least 38 percent
under the reverse building block
methodology. We also note that the
RUC-recommended work RVU of 6.50
only represents a 27 percent reduction
relative to the previous work RVU of
8.95. To develop a work RVU for this
service, we used a crosswalk from CPT
code 19298 (Placement of radiotherapy
after loading brachytherapy catheters
(multiple tube and button type) into the
breast for interstitial radioelement
application following (at the time of or
subsequent to) partial mastectomy,
includes imaging guidance), since we
believe the codes share similar intensity
and total time and the same intraservice
time of 60 minutes. Therefore, for CY
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2017, we are proposing a work RVU of
6.00 for CPT code 20245.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
(4) Insertion of Spinal Stability
Distractive Device (CPT Codes 228X1,
228X2, 228X4, and 228X5)
For CY 2016, the CPT Editorial Panel
converted two Category III codes to
Category I codes describing the insertion
of an interlaminar/interspinous process
stability device (CPT codes 228X1 and
228X4) and developed two
corresponding add-on codes (CPT codes
228X2 and 228X5). The RUC
recommended a work RVU of 15.00 for
CPT code 228X1, 4.00 for CPT code
228X2, 7.39 for CPT code 228X4, and
2.34 for CPT code 228X5.
We believe that the RUC
recommendations for CPT codes 228X1
and 228X4 overestimate the work
involved in furnishing these services.
We believe that a crosswalk to CPT code
36832 (Revision, open, arteriovenous
fistula; without thrombectomy,
autogenous or nonautogenous dialysis
graft (separate procedure)) which has a
work RVU of 13.50 is an accurate
comparison. CPT code 36832 is similar
in total time, work intensity, and
number of visits to 228X1. This is
supported by the ratio between total
time and work in the key reference
service, CPT code 63047 (Laminectomy,
facetectomy and foraminotomy
(unilateral or bilateral with
decompression of spinal cord, cauda
equina and/or nerve root[s], [e.g., spinal
or lateral recess stenosis]), single
vertebral segment; lumbar). Therefore,
we are proposing a work RVU of 13.50
for CPT code 228X1. For CPT code
228X4, we believe that CPT code 29881
(Arthroscopy, knee, surgical; with
meniscectomy (medial OR lateral,
including any meniscal shaving)
including debridement/shaving of
articular cartilage (chondroplasty), same
or separate compartment(s), when
performed) is an appropriate crosswalk
based on clinical similarity as well as
intensity and total time. CPT code
29881 has an RVU of 7.03; therefore, we
are proposing a work RVU of 7.03 for
CPT code 228X4. We are proposing to
accept the RUC-recommended work
RVU for CPT codes 228X2 and 228X5
without refinement.
(5) Biomechanical Device Insertion (CPT
Codes 22X81, 22X82, and 22X83)
For CY 2016, the CPT Editorial Panel
established three new category I add-on
codes and deleted one code to provide
a more detailed description of the
placement and attachment of
biomechanical spinal devices. For CPT
code 22X81, the RUC recommended a
work RVU of 4.88. For CPT code 22X82,
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and CPT code 22X83, the recommended
work RVUs are 5.50 and 6.00,
respectively.
In reviewing the code descriptors,
descriptions of work and vignettes
associated with CPT codes 22X82 and
22X83, we determined that the two
procedures, in addition to having
identical work time, contain many
clinical similarities and do not have
quantifiable differences in overall
intensity. Therefore, we are proposing
the RUC-recommended work RVU of
5.50 for both CPT code 22X82 and CPT
code 228X3. We believe that the RUCrecommended work RVU for CPT code
22X81 overestimates the work in the
procedure relative to the other codes in
the family. We are proposing a work
RVU of 4.25 for CPT code 228X1 based
a crosswalk from CPT code 37237
(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)), which is similar in
time and intensity to the work described
by CPT code 22X81.
(6) Closed Treatment of Pelvic Ring
Fracture (CPT Codes 271X1 and 271X2)
For CY 2017, the CPT Editorial Panel
deleted CPT codes 27193 and 27194 and
replaced them with two new codes,
271X1 and 271X2, and the RUC
recommended a work RVU of 5.50 for
CPT code 27193, and a work RVU of
9.00 for CPT code 271X2 to describe
closed treatment of pelvic ring fracture.
We are proposing to change the global
period for these services from 90 days
to 0 days because these codes typically
represent emergent procedures with
which injuries beyond pelvic ring
fractures are likely to occur; we believe
it is typical that multiple practitioners
would be involved in providing postoperative care and it is likely that a
practitioner furnishing a different
procedure is more likely to be providing
the primary post-operative care. If other
practitioners are typically furnishing
care in the post-surgery period, we
believe that the six postservice visits
included in CPT code 271X1, and the
seven included in 271X2, would likely
not occur. This is similar to our CY 2016
review and valuation of CPT codes
21811 (Open treatment of rib fracture(s)
with internal fixation, includes
thoracoscopic visualization when
performed, unilateral; 1–3 ribs), 21812
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46241
(Open treatment of rib fracture(s) with
internal fixation, includes thoracoscopic
visualization when performed,
unilateral; 4–6 ribs), and 21813 (Open
treatment of rib fracture(s) with internal
fixation, includes thoracoscopic
visualization when performed,
unilateral; 7 or more ribs). In our
valuation of those codes, we determined
that a 0-day, rather than a 90-day global
period was preferable, in part because
those codes describe rib fractures that
would typically occur along with other
injuries, and the patient would likely
already be receiving post-operative care
because of the other injuries. We believe
that the same rationale applies here. To
establish a work RVU for 271X1, we are
crosswalking this code to CPT code
65800 (Paracentesis of anterior chamber
of eye (separate procedure); with
removal of aqueous), due to its identical
intraservice time and similar total time,
after removing the work associated with
postoperative visits, and its similar level
of intensity. Therefore, we are proposing
a work RVU of 1.53 for CPT code 271X1.
For 271X2, we are crosswalking to CPT
code 93452 (Left heart catheterization
including intraprocedural injection(s)
for left ventriculography, imaging
supervision and interpretation, when
performed) which has an identical
intraservice time and similar total time
after removing the work associated with
postoperative visits from 271X2. We are
proposing a work RVU of 4.75 for code
271X2.
(7) Bunionectomy (CPT Codes 28289,
282X1, 28292, 28296, 282X2, 28297,
28298, and 28299)
The RUC identified CPT Code 28293
as a 90-day global service with more
than 6 office visits and CPT codes
28290–28299 as part of the family of
services. In October 2015, the CPT
Editorial Panel created two new CPT
codes (282X1, 282X2), deleted CPT
codes 28290, 28293, 28294 and revised
CPT codes 28289, 28292, 28296, 28297,
28298 and 28299 based on the rationale
that more accurate descriptions of the
services needed to be developed.
For CPT codes 28289, 28292, 28296,
28297, 28298, and 28299 the RUC
recommended and we are proposing
work RVUs of 6.90, 7.44, 8.25, 9.29,
7.75, and 9.29 respectively. For CPT
code 282X1, the RUC recommended a
work RVU of 8.01 based on the 25th
percentile of the survey. We believe the
recommendation for this service
overestimates the overall work involved
in performing this procedure given the
decrease in intraservice time, total time,
and post-operative visits when
compared to deleted predecessor CPT
code 28293. Due to similarity in
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intraservice and total times, we believe
a direct crosswalk of the work RVUs for
CPT code 65780 (Ocular surface
reconstruction; amniotic membrane
transplantation, multiple layers), to CPT
code 282X1 more accurately reflects the
time and intensity of furnishing the
service. Therefore, for CY 2017, we are
proposing a work RVU of 7.81 for CPT
code 282X1.
For CPT code 282X2, the RUC
recommended a work RVU of 8.57 based
on the 25th percentile of the survey. We
believe the recommendation for this
service overestimates the work involved
in performing this procedure given the
similarity in the intensity of the services
and identical intraservice and total
times as CPT code 28296. Therefore, we
propose a direct RVU crosswalk from
CPT code 28296 to CPT code 282X2. For
CY 2017, we are proposing a work RVU
of 8.25 for CPT code 282X2.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
(8) Endotracheal Intubation (CPT Code
31500)
In the CY 2016 PFS final rule with
comment period (80 FR 70914), we
identified CPT code 31500 as
potentially misvalued. The specialty
societies surveyed this code, and after
reviewing the survey responses,
including increases in time, the RUC
recommended an increase in work
RVUs to 3.00 for CPT code 31500. After
reviewing the RUC’s recommendation,
we are proposing a work RVU of 2.66,
based on a direct crosswalk to CPT code
65855, which has similar intensity and
service times as reflected in the survey
data reported by the specialty groups.
(9) Closure of Left Atrial Appendage
With Endocardial Implant (CPT Code
333X3)
The CPT Editorial Panel deleted
category III code 0281T (Percutaneous
transcatheter closure of the left atrial
appendage with implant, including
fluoroscopy, transseptal puncture,
catheter placement(s), left atrial
angiography, left atrial appendage
angiography, radiological supervision
and interpretation) and created new
CPT code 333X3 to describe
percutaneous transcatheter closure of
the left atrial appendage with implant.
The RUC recommended a work RVU of
14.00, which is the 25th percentile
survey result. After reviewing that
recommendation, we are proposing a
work RVU of 13.00 for CPT code 333X3,
which is the minimum survey result.
Based on our clinical judgment and that
the key reference codes discussed in the
RUC recommendations have higher
intraservice and total service times than
the median survey results for CPT code
333X3, we believe a work RVU of 13.00
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more accurately represents the work
value for this service.
(10) Valvuloplasty (CPT Codes 334X1
and 334X2)
The CPT Editorial Committee created
new codes to describe valvuloplasty
procedures and deleted existing CPT
code 33400 (Valvuloplasty, aortic valve;
open, with cardiopulmonary bypass).
New CPT code 334X1 represents a
simple valvuloplasty procedure and
new CPT code 334X2 describes a more
complex valvuloplasty procedure. We
are proposing to use the RUCrecommended values for CPT code
334X1. For CPT code 334X2, the RUC
recommended a work RVU of 44.00, the
25th percentile survey result. The RUC
estimated that approximately 70 percent
of the services previously reported using
CPT code 33400 would have been
reported using CPT code 334X2 with 30
percent reported using new CPT code
334X1. Therefore, the typical service
previously reported with 33400 ought to
now be reported with 334X2. Compared
to deleted CPT code 33400, the survey
results for CPT 334X2 showed the
median intraservice time to be similar
but total service time to be decreased.
Therefore, we do not believe the
increase recommended by the RUC is
warranted, and we are proposing a work
RVU of 41.50 for CPT code 334X2. This
is the current value of CPT code 33400,
and given that the typical service should
remain consistent between the two
codes, we believe the work RVU should
remain consistent as well.
(11) Dialysis Circuit (CPT Codes 369X1,
369X2, 369X3, 369X4, 369X5, 369X6,
369X7, 369X8, 369X9)
In January 2015, a CPT/RUC
workgroup identified the following CPT
codes as being frequently reported
together in various combinations: 35475
(Transluminal balloon angioplasty,
percutaneous; brachiocephalic trunk or
branches, each vessel), 35476
(Transluminal balloon angioplasty,
percutaneous; venous), 36147
(Introduction of needle and/or catheter,
arteriovenous shunt created for dialysis
(graft/fistula); initial access with
complete radiological evaluation of
dialysis access, including fluoroscopy,
image documentation and report), 36148
(Introduction of needle and/or catheter,
arteriovenous shunt created for dialysis
(graft/fistula); additional access for
therapeutic intervention), 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,
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including radiological supervision and
interpretation and including all
angioplasty within the same vessel,
when performed; initial artery), 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),
75791 (Angiography, arteriovenous
shunt (e.g., dialysis patient fistula/graft),
complete evaluation of dialysis access,
including fluoroscopy, image
documentation and report (includes
injections of contrast and all necessary
imaging from the arterial anastomosis
and adjacent artery through entire
venous outflow including the inferior or
superior vena cava), radiological
supervision and interpretation), 75962
(Transluminal balloon angioplasty,
peripheral artery other than renal, or
other visceral artery, iliac or lower
extremity, radiological supervision and
interpretation), and 75968
(Transluminal balloon angioplasty, each
additional visceral artery, radiological
supervision and interpretation). These
codes are frequently reported together
for both dialysis circuit services and
transluminal angioplasty services. At
the October 2015 CPT Editorial Panel
meeting, the panel approved the
creation of nine new codes and deletion
of four existing codes used to describe
bundled dialysis circuit intervention
services, and the creation of four new
codes and deletion of 13 existing codes
used to describe bundled percutaneous
transluminal angioplasty services (see
discussion of the latter code family in
the next section). The Dialysis Circuit
family of codes overlaps with the Open
and Percutaneous Transluminal
Angioplasty family of codes (CPT codes
372X1–372X4), as they are both being
constructed from the same set of
frequently reported together codes. We
reviewed these two families of codes
concurrently to maintain relativity
between these clinically similar
procedures based upon the same
collection of deleted codes.
For CPT code 369X1, we are
proposing a work RVU of 2.82 instead
of the RUC-recommended work RVU of
3.36. When we compared CPT code
369X1 against other codes in the RUC
database, we found that the RUCrecommended work RVU of 3.36 would
be the highest value in the database
among the 32 0-day global codes with
25 minutes of intraservice time.
Generally speaking, we are particularly
skeptical of RUC-recommended values
for newly ‘‘bundled’’ codes that appear
not to recognize the full resource
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overlap between predecessor codes.
Since the recommended values would
establish a new highest value when
compared to other services with similar
time, we believe it likely that the
recommended value for the new code
does not reflect the efficiencies in time.
Of course, were the compelling
evidence for this valuation
accompanying the recommendation, we
would consider such information. We
also note that the reference code
selected by the survey participants, CPT
code 36200 (Introduction of catheter,
aorta), has a higher intraservice time
and total time, but a lower work RVU
of 3.02. We believe that there are more
accurate CPT codes that can serve as a
reference for CPT code 369X1. As a
result, we are proposing to crosswalk
CPT code 369X1 to CPT code 44388
(Colonoscopy through stoma;
diagnostic). CPT code 44388 has a work
RVU of 2.82, and we believe it is a more
accurate crosswalk for valuation due to
its similar overall intensity and shared
intraservice time of 25 minutes with
369X1 and similar total time of 65
minutes.
We are proposing a work RVU of 4.24
for CPT code 369X2 instead of the RUCrecommended work RVU of 4.83. The
RUC-recommended work RVU is based
upon a direct crosswalk to CPT code
43253 (Esophagogastroduodenoscopy,
flexible, transoral) which shares the
same 40 minutes of intraservice time
with CPT code 369X2. However, CPT
code 43253 has significantly longer total
time than CPT code 369X2, 104 minutes
against 86 minutes, which we believe
reduces its utility for comparison. We
are instead proposing to crosswalk the
work RVU for CPT code 369X2 from
CPT code 44408 (Colonoscopy through
stoma), which has a work RVU of 4.24.
In addition to our assessment that the
two codes share similar intensities, CPT
code 44408 also shares 40 minutes of
intraservice time with CPT code 369X2
but has only 95 minutes of total time
and matches the duration of the
procedure under review more closely
than the RUC-recommended crosswalk
to CPT code 43253. We also note that
the RUC-recommended work increment
between CPT codes 369X1 and 369X2
was 1.47, and by proposing a work RVU
of 4.24 for CPT code 369X2, we
maintain a very similar increment of
1.42. As a result, we are proposing a
work RVU of 4.24 for CPT code 369X2,
based on this direct crosswalk to CPT
code 44408.
For CPT code 369X3, we are
proposing a work RVU of 5.85 instead
of the RUC-recommended work RVU of
6.39. The RUC-recommended value is
based on a direct crosswalk to CPT code
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52282 (Cystourethroscopy, with
insertion of permanent urethral stent).
Like the previous pair of RUCrecommended crosswalk codes, CPT
code 52282 shares the same intraservice
time of 50 minutes with CPT code
369X3, but has substantially longer total
time (120 minutes against 96 minutes)
which we believe limits its utility as a
crosswalk. We are proposing a work
RVU of 5.85 based on maintaining the
RUC-recommended work RVU
increment of 3.03 as compared to CPT
code 369X1 (proposed at a work RVU of
2.82), the base code for this family of
related procedures. We also point to
CPT code 44403 (Colonoscopy through
stoma; with endoscopic mucosal
resection) as a reference point for this
value. CPT code 44403 has a work RVU
of 5.60, but also lower intraservice time
(45 minutes as compared to 50 minutes)
and total time (92 minutes as compared
to 96 minutes) in relation to CPT code
369X3, suggesting that a work RVU a bit
higher than 5.60 would be an accurate
valuation. Therefore, we are proposing a
work RVU of 5.85 for CPT code 369X3,
based on an increment of 3.03 from the
work RVU of CPT code 369X1.
We are proposing a work RVU of 6.73
instead of the RUC-recommended work
RVU of 7.50 for CPT code 369X4. Our
proposed value comes from a direct
crosswalk from CPT code 43264
(Endoscopic retrograde
cholangiopancreatography), which
shares the same intraservice time of 60
minutes with CPT code 369X4 and has
a higher total time. We also looked to
the intraservice time ratio between CPT
codes 369X1 and 369X4; this works out
to 60 minutes divided by 25 minutes,
for a ratio of 2.4, and a suggested work
RVU of 6.77 (derived from 2.4 times
CPT code 369X1’s work RVU of 2.82).
This indicates that our proposed work
RVU of 6.73 maintains relativity within
the Dialysis Circuit family. As a result,
we are proposing a work RVU of 6.73 for
CPT code 369X4, based on a direct
crosswalk to CPT code 43264.
We are proposing a work RVU of 8.46
instead of the RUC-recommended work
RVU of 9.00 for CPT code 369X5. We
looked at the intraservice time ratio
between CPT codes 369X1 and 369X5 as
one potential method for valuation,
which is a 1:3 ratio (25 minutes against
75 minutes) for this case. This means
that one potential value for CPT code
369X5 would be triple the work RVU of
CPT code 369X1, or 2.82 times 3, which
results in a work RVU of 8.46. We also
investigated preserving the RUCrecommended work RVU increment
between CPT code 369X1 and 369X5,
which was an increase of 5.64. When
this increment is added to the work
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RVU of 2.82 for CPT code 369X1, it also
resulted in a work RVU of 8.46 for CPT
code 369X5. Therefore, we are
proposing a work RVU of 8.46 for CPT
code 369X5, based on both the
intraservice time ratio with CPT code
369X1 and the RUC-recommended work
increment with the same code.
For CPT code 369X6, we are
proposing a work RVU of 9.88 instead
of the RUC-recommended work RVU of
10.42. We based the proposed value
upon the RUC-recommended work RVU
increment between CPT codes 369X1
and 369X6, which is 7.06. When added
to the work RVU of 2.82 for CPT code
369X1, the work RVU for CPT code
369X6 would be 9.88. We are
supporting this value through the use of
two crosswalks that both share the same
90 minutes of intraservice time with
369X6. These are CPT code 31546
(Laryngoscopy, direct, with submucosal
removal of non-neoplastic lesion(s) of
vocal cord) at a work RVU of 9.73 and
CPT code 61623 (Endovascular
temporary balloon arterial occlusion,
head or neck) at a work RVU of 9.95.
The final three codes in the Dialysis
Circuit family are all add-on codes,
which make comparisons difficult to the
global 0-day codes that make up the rest
of the family. We are proposing a work
RVU of 2.48 instead of the RUCrecommended work RVU of 3.00 for
CPT code 369X7. Due to the difficulty
of comparing CPT code 369X7 with the
non-add-on codes in the rest of the
Dialysis Circuit family, we looked
instead to compare the value to the addon codes in the Open and Percutaneous
Transluminal Angioplasty family of
codes (CPT codes 372X1–372X4). As we
stated previously, both of these groups
of new codes are being constructed from
the same set of frequently reported
together codes. We reviewed these two
families of codes together to maintain
relativity across the two families, and so
that we could compare codes that
shared the same global period.
We are proposing the RUCrecommended work RVUs for all four
codes in the Open and Percutaneous
Transluminal Angioplasty family of
codes. As a result, we compared CPT
code 369X7 with the RUCrecommended work RVU of 2.97 for
CPT code 372X4, which is also an addon code. These procedures should be
clinically very similar, since both of
them are performing percutaneous
transluminal angioplasty on a central
vein, and both of them are add-on
procedures. We looked at the
intraservice time ratio between these
two codes, which was a comparison
between 25 minutes for CPT code 369X7
against 30 minutes for CPT code 372X4.
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This produces a ratio of 0.83, and a
proposed work RVU of 2.48 for CPT
code 369X7 when multiplied with the
RUC-recommended work RVU of 2.97
for CPT code 372X4. We note as well
that the intensity was markedly higher
for CPT code 369X7 as compared to CPT
code 372X4 when using the RUCrecommended work values, which did
not make sense since CPT code 369X7
would typically be a clinically less
intense procedure. Using the
intraservice time ratio results in the two
codes having exactly the same intensity.
As a result, we are therefore proposing
a work RVU of 2.48 for CPT code 369X7,
based on this intraservice time ratio
with the RUC-recommended work RVU
of CPT code 372X4.
For CPT code 369X8, we disagree
with the RUC-recommended work RVU
of 4.25, and we are instead proposing a
work RVU of 3.73. We do not consider
the RUC work value of 4.25 to be
accurate for CPT code 369X8, as this
was higher than our proposed work
value for CPT code 369X2 (4.24), and
we do not believe that an add-on code
should typically have a higher work
value than a similar non-add-on code
with the same intraservice time. We
identified two appropriate crosswalks
for valuing CPT code 369X8: CPT code
93462 (Left heart catheterization by
transseptal puncture through intact
septum or by transapical puncture) and
CPT code 37222 (Revascularization,
endovascular, open or percutaneous,
iliac artery). Both of these codes share
the same intraservice time as CPT code
369X8, and both of them also have the
same work RVU of 3.73, which results
in these codes also sharing the same
intensity since they are all add-on
codes. We are therefore proposing a
work value of 3.73 for CPT code 369X8,
based on a direct crosswalk to CPT
codes 93462 and 37222.
Finally, we are proposing a work RVU
of 3.48 for CPT code 369X9 instead of
the RUC-recommended work RVU of
4.12. The RUC recommended value
comes from a direct crosswalk from CPT
code 38746 (Thoracic
lymphadenectomy by thoracotomy). We
compared the RUC-recommended work
RVU for this procedure to other add-on
codes with 30 minutes of intraservice
time and found that the recommended
work RVU of 4.12 would overestimate
the overall intensity of this service
relative to those with similar times. In
reviewing the range of these codes, we
believe that a more appropriate
crosswalk is to CPT code 61797
(Stereotactic radiosurgery (particle
beam, gamma ray, or linear accelerator))
at a work RVU of 3.48. We believe that
this value is more accurate when
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compared to other add-on procedures
with 30 minutes of intraservice time
across the PFS. As a result, we are
proposing a work RVU of 3.48 for CPT
code 369X9 based on a direct crosswalk
from CPT code 61797.
We are proposing to use the RUCrecommended direct PE inputs for these
nine codes with several refinements. We
are not proposing to include the
recommended additional preservice
clinical labor for CPT codes 369X4,
369X5, and 369X6. The preservice work
description is identical for all six of the
global 0-day codes in this family; there
is no justification given in the RUC
recommendations as to why the second
three codes need additional clinical
labor time beyond the minimal
preservice clinical labor assigned to the
first three codes. We do not believe that
the additional staff time would be
typical. Patient care already would have
been coordinated ahead of time in the
typical case, and the need for
unscheduled dialysis or other unusual
circumstances would be discussed prior
to the day of the procedure. We are
therefore proposing to refine the
preservice clinical labor for CPT codes
369X4, 369X5, and 369X6 to match the
preservice clinical labor of CPT codes
369X1, 369X2, and 369X3.
We are proposing to refine the L037D
clinical labor for ‘‘Prepare and position
patient/monitor patient/set up IV’’ from
5 minutes to 3 minutes for CPT codes
369X1–369X6. The RUC
recommendation included a written
justification for additional clinical labor
time beyond the standard 2 minutes for
this activity, stating that the extra time
is needed to prepare the patient’s arm
for the procedure. We agree that extra
time may be needed for this activity as
compared to the default standard of 2
minutes; however, we are assigning 1
extra minute for preparing the patient’s
arm, resulting in a total of 3 minutes for
this task. We do not believe that 3 extra
minutes would be typically needed for
arm positioning.
We are proposing to remove the ‘‘kit,
for percutaneous thrombolytic device
(Trerotola)’’ supply (SA015) from CPT
codes 369X4, 369X5, and 369X6. We
believe that this thrombolytic device kit
and the ‘‘catheter, thrombectomyFogarty’’ (SD032) provide essentially the
same supply, and the use of only one of
them would be typical in these
procedures. We believe that each of
these supplies can be used individually
for thrombectomy procedures. We are
proposing to remove the SA015 supply
and retain the SD032 supply, and we
seek additional comment and
information regarding the use of these
two supplies.
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We are also proposing to remove the
recommended supply item ‘‘covered
stent (VIABAHN, Gore)’’ (SD254) and
replace it with the ‘‘stent, vascular,
deployment system, Cordis SMART’’
(SA103) for CPT codes 369X3 and
369X6. The Cordis SMART vascular
stent was previously used in the past for
CPT code 37238, which is the deleted
code for transcatheter placement of an
intravascular stent that CPT codes
369X3 and 369X6 are replacing. We do
not have a stated rationale as to the need
for this supply substitution, and
therefore, we do not believe it would be
appropriate to replace the current items
with a significantly higher-priced item
without additional information.
We are also proposing to refine the
quantity of the ‘‘Hemostatic patch’’
(SG095) from 2 to 1 for CPT codes
369X4, 369X5, and 369X6. This supply
was not included in any of the deleted
base codes out of which the new codes
are being constructed, and while we
agree that the use of a single hemostatic
patch has become common clinical
practice, we do not agree that CPT codes
369X4–369X6 would typically require a
second patch. As a result, we are
proposing to refine the SG095 supply
quantity from 2 to 1 for CPT codes
369X4–369X6, which also matches the
supply quantity for CPT codes 369X1–
369X3.
Included in the RUC recommendation
for the Dialysis Circuit family of codes
were a series of invoices for a
‘‘ChloraPrep applicator (26 ml)’’ supply.
We are soliciting comments regarding
whether the Betadine solution has been
replaced by a Chloraprep solution in the
typical case for these procedures. We
are also soliciting comments regarding
whether the ‘‘ChloraPrep applicator (26
ml)’’ detailed on the submitted invoices
is the same supply as the SH098
‘‘chlorhexidine 4.0% (Hibiclens)’’
applicator currently in the direct PE
database.
Finally, we are also interested in
soliciting comments about the use of
guidewires for these procedures. We are
requesting feedback about which
guidewires would be typically used for
these procedures, and which guidewires
are no longer clinically necessary.
(12) Open and Percutaneous
Transluminal Angioplasty (CPT Codes
372X1, 372X2, 372X3, and 372X4)
In January 2015, a CPT/RUC
workgroup identified the following CPT
codes as being frequently reported
together in various combinations: 35475
(Transluminal balloon angioplasty,
percutaneous; brachiocephalic trunk or
branches, each vessel), 35476
(Transluminal balloon angioplasty,
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percutaneous; venous), 36147
(Introduction of needle and/or catheter,
arteriovenous shunt created for dialysis
(graft/fistula); initial access with
complete radiological evaluation of
dialysis access, including fluoroscopy,
image documentation and report), 36148
(Introduction of needle and/or catheter,
arteriovenous shunt created for dialysis
(graft/fistula); additional access for
therapeutic intervention), 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), 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),
75791 (Angiography, arteriovenous
shunt (e.g., dialysis patient fistula/graft),
complete evaluation of dialysis access,
including fluoroscopy, image
documentation and report (includes
injections of contrast and all necessary
imaging from the arterial anastomosis
and adjacent artery through entire
venous outflow including the inferior or
superior vena cava), radiological
supervision and interpretation), 75962
(Transluminal balloon angioplasty,
peripheral artery other than renal, or
other visceral artery, iliac or lower
extremity, radiological supervision and
interpretation), and 75968
(Transluminal balloon angioplasty, each
additional visceral artery, radiological
supervision and interpretation). At the
October 2015 CPT Editorial Panel
meeting, the panel approved the
creation of four new codes and deletion
of 13 existing codes used to describe
bundled percutaneous transluminal
angioplasty services. The Open and
Percutaneous Transluminal Angioplasty
family of codes overlaps with the
Dialysis Circuit family of codes (CPT
codes 369X1–369X9), as they are both
being constructed from the same set of
frequently reported together codes. We
reviewed these two families of codes
concurrently to maintain relativity
between these clinically similar
procedures based upon the same
collection of deleted codes. After
consideration of these materials, we are
proposing to accept the RUCrecommended work RVU for CPT codes
372X1, 372X2, 372X3, and 372X4.
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For the clinical labor direct PE inputs,
we are proposing to use the RUCrecommend inputs with several
refinements. Our proposed inputs refine
the recommended clinical labor time for
‘‘Prepare and position patient/monitor
patient/set up IV’’ from 5 minutes to 3
minutes for CPT codes 372X1 and
372X3. The RUC recommendation
included a written justification for
additional clinical labor time beyond
the standard 2 minutes for this activity,
stating that the extra time was needed
to move leads out of X-ray field, check
that X-ray is not obstructed and that
there is no risk of collision of X-ray
equipment with patient. As we wrote for
the same clinical labor activity in the
Dialysis Circuit family, we agree that
extra time may be needed for this
activity as compared to the default
standard of 2 minutes; however, we are
assigning 1 extra minute for the
additional positioning tasks, resulting in
a total of 3 minutes for this task. We do
not believe that 3 extra minutes would
be typically needed for preparation of
the X-ray. The equipment times for the
angiography room (EL011) and the
PACS workstation (ED050) have been
refined to reflect this change in clinical
labor.
We are proposing to remove the
‘‘drape, sterile, femoral’’ supply (SB009)
and replace it with a ‘‘drape, sterile,
fenestrated 16in x 29in’’ supply (SB011)
for CPT codes 372X1 and 372X3. The
two base codes out of which these new
codes are being constructed, CPT codes
35471 and 35476, both made use of the
SB011 fenestrated sterile drape supply,
and there was no rationale provided for
the switch to the SB009 femoral sterile
drape in the two new codes. We are
seeking comment on the use of sterile
drapes for these procedures, and what
rationale there is to support the use of
the SB009 femoral sterile drape as
typical for these new procedures.
(13) Percutaneous Biliary Procedures
Bundling (CPT Codes 47531, 47532,
47533, 47534, 47535, 47536, 47537,
47538, 47539, 47540, 47541, 47542,
47543, and 47544)
This group of fourteen codes was
reviewed by the RUC at the April 2015
meeting. We established interim final
values for this group of codes during the
CY 2016 PFS rulemaking cycle, and
subsequently received updated RUC
recommendations from the October
2015 meeting for the CY 2017 PFS
rulemaking cycle. Our proposals for
these codes incorporate both the
updated RUC recommendations, as well
as public comments received as part of
the interim final status of these
procedures.
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We received several comments
regarding the CMS refinements to the
work values for this family of codes in
the CY 2016 final rule with comment
period. The relevance of many of these
comments has been diminished by the
new series of RUC recommendations for
work values that we received as a result
of the October 2015 meeting. Given that
we are proposing the updated RUCrecommended work RVUs for CPT
codes 47531, 47532, 47533, 47534,
47535, 47536, 47537, 47538, 47539,
47540, 47542, 47543, and 47544, we
seek additional comments relative to
these proposed values. We agree that the
second round of physician surveys
conducted for the October 2015 RUC
meeting more accurately captured the
work and time required to perform these
procedures. The one exception is CPT
code 47541; the survey times for this
procedure were identical as conducted
for the April and October 2015 RUC
meetings, yet the RUC recommendation
increased from a work RVU of 5.61 in
April to a work RVU of 7.00 in October.
Given that the time values for the
procedure remained unchanged
between the two surveys, we do not
understand why the work RVU would
have increased by nearly 1.50 in the
intervening months. Since this code also
has an identical intraservice time (60
minutes) and total time (121 minutes) as
CPT code 47533, we do not agree that
it should be valued at a substantially
higher rate compared to a medically
similar procedure within the same code
family. We are therefore proposing to
crosswalk the work value of CPT code
47541 to the work value of CPT code
47533, and we are proposing a work
RVU of 5.63 for both procedures.
We also note that many of the codes
in the Percutaneous Biliary Procedures
family were previously included in
Appendix G, and were valued under the
assumption that moderate sedation was
typically performed on the patient. As
part of the initiative to pay separately
for moderate sedation when it is
performed, we are removing a portion of
the work RVU and preservice work time
from CPT codes 47532, 47533, 47534,
47535, 47536, 47538, 47539, 47540, and
47541. For example, we are proposing
that CPT code 47541 undergoes a 0.25
reduction in its work RVU from 5.63 to
5.38, and a 10 minute reduction in its
preservice work time from 33 minutes to
23 minutes, to reflect the work that will
now be reported separately using the
new moderate sedation codes. CPT
codes 47542, 47533, and 47544 are also
included in the moderate sedation
initiative; however, as add-on codes,
they are not subject to alterations in
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their work RVUs or work times since the
moderate sedation code with work
RVUs and work time (991X2) will only
be billed once for each base-code and
not additionally with the add-on codes.
These changes are reflected in
Appendix B and the work time file
posted to the Web; see section II.D for
more details.
For the direct PE inputs, we are
proposing to remove the L051A clinical
labor for ‘‘Sedate/apply anesthesia’’ and
the L037D for ‘‘Assist Physician in
Performing Procedure’’ for CPT codes
47531 and 47537. As we wrote in last
year’s final rule with comment period
(80 FR 71053), we believe that this
clinical labor describes activities
associated with moderate sedation, and
moderate sedation is not typical for
these procedures. We are also proposing
to refine the L037D clinical labor for
‘‘Clean room/equipment by physician
staff’’ from 6 minutes to 3 minutes for
all of the codes in this family. Three
minutes is the standard for this clinical
labor activity, and we continue to
maintain that the need for additional
clinical labor time for this cleaning
activity would not be typical for these
procedures.
Comment: One commenter disagreed
with our refinement to replace supply
item ‘‘catheter, balloon, PTA’’ (SD152)
with supply item ‘‘catheter, balloon
ureteral (Dowd)’’ (SD150). The
commenter stated that a Dowd catheter
is designed and FDA approved for use
in the prostatic urethra by retrograde
placement through the penile urethra,
and it is not designed for use in an
antegrade ureteral dilation procedure.
The commenter stated that this
replacement is inappropriate. The
updated RUC recommendations for this
family of codes also restored the balloon
PTA catheter.
Response: We are proposing again to
replace the recommended supply item
‘‘catheter, balloon, PTA’’ (SD152) with
supply item ‘‘catheter, balloon ureteral
(Dowd)’’ (SD150). We believe that the
use of this ureteral balloon catheter,
which is specifically designed for
catheter and image guidance
procedures, would be more typical than
the use of a PTA balloon catheter. While
we recognize that the Dowd catheter is
not FDA approved, it is our
understanding that the PTA balloon
catheter has also not been FDA
approved for use in these procedures.
We are uncertain if the commenter was
requesting that we should no longer
include catheters that lack FDA
approval in the direct PE database; this
would preclude the use of most of the
catheters in our direct PE database. We
welcome additional comment on the use
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of FDA approved catheters; in the
meantime, we will continue our longstanding practice of using the catheters
in the direct PE database without
explicit regard to FDA approval in
particular procedures.
We are also proposing to remove the
recommended supply item ‘‘stone
basket’’ (SD315) from CPT code 47543
and add it to CPT code 47544. Based on
the code descriptors, we believe that the
stone basket was intended to be
included in CPT code 47544 and was
erroneously listed under CPT code
47543. We are soliciting comments from
the public to help clarify this issue.
We note again that many of the codes
in the Percutaneous Biliary Procedures
family were previously included in
Appendix G, and as part of the initiative
to pay separately for moderate sedation
when performed, we are removing some
of the recommended direct PE inputs
related to moderate sedation from CPT
codes 47532, 47533, 47534, 47535,
47536, 47538, 47539, 47540, and 47541.
We are removing the L051A clinical
labor time for ‘‘Sedate/apply
anesthesia’’, ‘‘Assist Physician in
Performing Procedure (CS)’’, and
‘‘Monitor pt. following moderate
sedation’’. We are also removing the
conscious sedation pack (SA044)
supply, and some or all of the
equipment time for the stretcher
(EF018), the mobile instrument table
(EF027), the 3-channel ECG (EQ011),
and the IV infusion pump (EQ032).
These changes are reflected in the
public use files posted to the web; see
section II.D for more details.
(14) Flexible Laryngoscopy (CPT Codes
31575, 31576, 31577, 31578, 317X1,
317X2, 317X3, and 31579)
After we identified CPT codes 31575
and 31579 as potentially misvalued in
(80 FR 70912–70914) the RUC referred
the entire flexible laryngoscopy family
of codes back to CPT for revision and
the addition of several codes
representing new technology within this
family of services. At the May 2015 CPT
meeting, the Editorial Panel added three
new codes to describe laryngoscopy
with ablation or destruction of lesion
and therapeutic injection. Based on the
survey results, the time resources
involved in furnishing the procedures
described by this code family
experienced a significant reduction in
the intraservice period, yet the
recommended work RVUs were not
similarly reduced. Therefore, in
reviewing the recommended values for
this family of codes we looked for a
rationale for increased intensity and
absent such rationale, propose to adjust
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the recommend work RVUs to account
for significant changes in time.
For CPT code 31575, we disagree with
the RUC-recommended work RVU of
1.00, and we are instead proposing a
work RVU of 0.94. We looked at the
total time ratio for CPT code 31575,
which is decreasing from 28 minutes to
24 minutes, and applied this ratio of
0.86 times the current work RVU of 1.10
to derive our proposed work RVU of
0.94. We are supporting this value for
CPT code 31575 through a crosswalk to
CPT code 64405 (Injection, anesthetic
agent; greater occipital nerve), which
shares 5 minutes of intraservice time
and also has a work RVU of 0.94.
We agree with the RUC that CPT code
31575 serves as the base code for the
rest of the Flexible Laryngoscopy
family. As a result, we are proposing to
maintain the same RUC-recommended
increments for the rest of the codes in
this family, measuring the increments
from CPT code 31575’s refined work
RVU of 0.94 instead of the RUCrecommended work RVU of 1.00. This
means that each of the work RVUs for
the codes in the rest of the family has
decreased by 0.06 when compared to
the RUC-recommended value. We are
therefore proposing a work RVU of 1.89
for CPT code 31576, a work RVU of 2.19
for CPT code 31577, a work RVU of 2.43
for CPT code 31578, a work RVU of 3.01
for CPT code 317X1, a work RVU of 2.43
for CPT code 317X2, a work RVU of 2.43
for CPT code 317X3, and a work RVU
of 1.88 for CPT code 31579.
Amongst the direct PE inputs, we are
proposing to refine the clinical labor
time for ‘‘Obtain vital signs’’ for CPT
codes 31577 and 31579 from 3 minutes
to 2 minutes. We believe that this extra
clinical labor time is duplicative, as
these codes are typically performed
with a same day E/M service. Each
procedure is only allotted a maximum
of 5 minutes for obtaining vital signs,
and since 3 minutes are already
included in the E/M code, we are
proposing to reduce the time to 2
minutes for these services. Similarly, we
are proposing to remove the 3 minutes
of clinical labor time for ‘‘Clean room/
equipment by physician staff’’ from CPT
codes 31575, 31577, and 31579. These
procedures are typically reported with a
same day E/M service, making the
clinical labor minutes for cleaning the
room in these procedure codes
duplicative of the time already included
in the E/M codes.
For CPT code 317X1, we are
proposing to remove the ‘‘laser tip,
diffuser fiber’’ supply (SF030) and
replace it with the ‘‘laser tip, bare
(single use)’’ supply (SF029) already
present in our direct PE database. We
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believe that the invoice for SF030
submitted with the RUC
recommendation is not current enough
to establish a new price for this supply;
as a result, we are substituting the
SF029 supply for this input. We
welcome the submission of new
invoices to accurately price the diffuser
fiber with laser tip.
We are also proposing to make
significant changes to the prices of
several of the supplies and equipment
related to Flexible Laryngoscopy, as
well as to the prices of scopes more
broadly. We are proposing to set the
price of the disposable biopsy forceps
supply (SD318) at $26.84, based on the
submission of an invoice with a price of
$536.81 for a unit size of 20. In our
search for additional information
regarding scope inputs, we obtained a
quote from a vendor listing the current
price for several equipment items
related to the use of scopes. Since we
believe that the prices in vendor quotes
would typically be equal to or higher
than prices actually paid by
practitioners, we are updating the prices
in our direct PE database to reflect this
new information. As part of this
process, we are proposing to increase
the price of the ‘‘light source, xenon’’
(EQ167) from $6,723.33 to $7,000 to
reflect current pricing information. We
are also proposing to adjust the price of
the ‘‘fiberscope, flexible,
rhinolaryngoscopy’’ (ES020) from
$6,301.93 to $4,250.00.
In accordance with the wider
proposal that we are making involving
the use of scope equipment, we are
proposing to separate the scopes used in
these procedures from the scope video
systems. In the course of researching
different kinds of scopes, we obtained
vendor pricing for two different types of
scopes used in these procedures. We are
proposing to price the
‘‘rhinolaryngoscope, flexible, video,
non-channeled’’ (ES063) at $8,000 and
the ‘‘rhinolaryngoscope, flexible, video,
channeled’’ (ES064) at $9,000 in
accordance with our vendor quotes. We
are proposing to use the non-channeled
scope for CPT codes 31575, 31579, and
317X3 and the channeled scope for CPT
codes 31576, 31577, 31578, 317X1, and
317X2 in accordance with the RUCrecommended video systems that
stipulated channeled versus nonchanneled scope procedures.
We believe that the ‘‘Video-flexible
laryngoscope system’’ listed in the
recommendations is not a new form of
equipment, but rather constitutes a
version of the existing ‘‘video system,
endoscopy’’ equipment (ES031). We are
not adding a new equipment item to our
direct PE database; instead, we are
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proposing to use the submitted invoices
to update the price of the ES031
endoscopy video system. As the
equipment code for ES031 indicates, we
are proposing to define the endoscopy
video system as containing a processor,
digital capture, monitor, printer, and
cart. We are proposing to price ES031 at
$15,045.00; this reflects a price of
$2,000.00 for the monitor, $9,000.00 for
the processor, $1,750.00 for the cart, and
$2,295.00 for the printer. These prices
were obtained from our vendor invoice,
with the exception of the printer, which
is a crosswalk to the ‘‘video printer,
color (Sony medical grade)’’ equipment
(ED036).
We do not agree that there is a need
for multiple different video systems for
this collection of Flexible Laryngoscopy
codes based on our understanding of the
clinical differences among the codes. In
keeping with this understanding, we are
proposing to use the same existing
‘‘video system, endoscopy’’ equipment
(ES031) for the remaining codes in the
family that included RUC
recommendations for new equipment
items named ‘‘Video-flexible channeled
laryngoscope system’’ and ‘‘Videoflexible laryngoscope stroboscopy
system.’’ For CPT codes 31576, 31577,
31578, 317X1, and 317X2, we are
proposing to replace the Video-flexible
channeled laryngoscope system with the
existing endoscopy video system
(ES031) along with a channeled flexible
video rhinolaryngoscope (ES064). For
CPT code 31579, we are proposing to
rename the RUC-recommended ‘‘Videoflexible laryngoscope stroboscopy
system’’ to the shortened ‘‘stroboscopy
system’’ (ES065) and assign it a price of
$19,100.00. This reflects the price of the
StrobeLED Stroboscopy system included
on the submitted invoice. We are
proposing to treat the stroboscopy
system as a scope accessory, which will
be included along with the ‘‘video
system, endoscopy’’ equipment (ES031)
and the ‘‘rhinolaryngoscope, flexible,
video, non-channeled’’ (ES063) for CPT
code 31579. When the price of the
scope, the scope video system, and the
stroboscopy system are summed
together, the total proposed equipment
price is $42,145.00.
We are proposing to refine the
recommended equipment times for
several equipment items to conform to
changes in clinical labor time. These
are: The fiberoptic headlight (EQ170),
the suction and pressure cabinet
(EQ234), the reclining exam chair with
headrest (EF008), and the basic
instrument pack (EQ137). We are
proposing to use the standard
equipment time formula for scope
accessories for the endoscopy video
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system (ES031) and the stroboscopy
scope accessory system (ES065). We are
also proposing to refine the equipment
time for the channeled and nonchanneled flexible video
rhinolaryngoscopes to use the standard
equipment time formula for scopes. For
this latter pair of two new equipment
items, this proposal results in small
increases to their respective equipment
times.
(15) Laryngoplasty (CPT Codes 31580,
31584, 31587, and 315X1–315X6)
CPT code 31588 (Laryngoplasty, not
otherwise specified (e.g., for burns,
reconstruction after partial
laryngectomy) was identified as
potentially misvalued based on the
RUC’s 90-Day Global Post-Operative
Visits screen. When this code family
was reviewed by the RUC, it was
determined that some codes in the
family required revision to reflect the
typical patient before a survey could be
conducted and the code family was
referred to the CPT Editorial Panel for
revision. At the October 2015 CPT
Editorial Panel meeting, the CPT
Editorial Panel approved the creation of
six new codes, revision of three codes,
and deletion of three codes. For CPT
codes 31580, 31587, 315X1, 315X2,
315X3, 315X4, and 315X6, CMS is
proposing the RUC-recommended work
RVUs.
For CPT code 31584, the RUC
recommended a work RVU of 20.00. We
believe that the 25th percentile of the
survey, which is a work RVU of 17.58,
better represents the time and intensity
involved with furnishing this service
based on a comparison with and
assessment of the overall intensity of
other codes with similar instraservice
and total time. This value is also
supported by a crosswalk code of CPT
code 42844 (Radical resection of tonsil,
tonsillar pillars, and/or retromolar
trigone; closure with local flap (e.g.,
tongue, buccal)), which has identical
intraservice time and identical total
time. Therefore, we are proposing a
work value of 17.58 RVUs for CPT code
31584.
For CPT code 315X5, the RUC
recommended a work value of 15.60
RVUs. We believe that the 25th
percentile of the survey, which is a
work RVU of 13.56, better represents the
time and intensity involved with
furnishing this service based on a
comparison of the overall intensity of
other codes with similar instraservice
and total time. The 25th percentile of
the survey is additionally bracketed by
two crosswalk codes that we estimate
have slightly lower and slighter higher
overall intensities, CPT code 36819
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(Arteriovenous anastomosis, open; by
upper arm basilic vein transposition),
which has a work RVU of 13.29, and
CPT code 49654 (Laparoscopy, surgical,
repair, incisional hernia (includes mesh
insertion, when performed); reducible),
which has a work RVU of 13.76; both of
these codes have identical intraservice
time and similar total time. Therefore,
we are proposing a work RVU of 13.56
for CPT code 315X5.
Additionally, the RUC forwarded
invoices provided by a medical
specialty society for the video-flexible
laryngoscope system used in these
services. As discussed in section II.A of
this proposed rule, we have proposed
changes to the items included in
equipment item ES031 (video system,
endoscopy). Consistent with those
proposed changes, we are proposing to
add a Nasolaryngoscope, nonchanneled, to the list of equipment
items used for CPT codes 31580, 31584,
31587, and 315X1–315X6, along with
the modified equipment item ES031.
(16) Mechanochemical Vein Ablation
(MOCA) (CPT Codes 364X1 and 364X2)
At the October 2015 CPT meeting, the
CPT Editorial Panel established two
Category I codes for reporting venous
mechanochemical ablation, CPT codes
364X1 and 364X2. We are proposing the
RUC-recommended work RVU of 3.50
for CPT code 364X1. For CPT code
364X2 we believe that the RUCrecommended work RVU of 2.25 does
not accurately reflect the typical work
involved in furnishing this procedure.
The specialty society survey
recommended that this add-on code has
half the work of the base code, CPT code
364X1. This value is supported by the
ratio between work and time in the key
reference service, CPT code 36476
(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)). Therefore, we
are proposing a work RVU of 1.75 for
CPT code 364X2.
The RUC-recommended direct
practice expense inputs for CPT codes
364X1 and 364X2 included inputs for
an ultrasound room (EL015). Based on
the clinical nature of these procedures,
we do not believe that an ultrasound
room would typically be used to furnish
these procedures. We are proposing to
remove inputs for the ultrasound room
and put in a portable ultrasound
(EQ250), power table (EF031), and light
(EF014). The RUC also recommended
that the ultrasound machine be
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allocated clinical staff time based on the
PACS workstation formula. We do not
believe that an ultrasound machine
would be used like a PACS workstation,
as images are generated and reviewed in
real time. Therefore, we are proposing to
remove all inputs associated with the
PACS workstation.
(17) Esophageal Sphincter
Augmentation (CPT Codes 432X1 and
432X2)
In October 2015, the CPT Editorial
Panel created two new codes to describe
laparoscopic implantation and removal
of a magnetic bead sphincter
augmentation device used for treatment
of gastroesophageal reflux disease
(GERD). The RUC noted that the
specialty societies conducted a targeted
survey of the 145 physicians who have
been trained to furnish these services
and who are the only physicians who
have performed these procedures. They
noted that only 18 non-conflicted
survey responses were received despite
efforts to follow up and that nine
physicians had no experience in the
past 12 months with the procedure. The
RUC agreed with the specialty society
that the expertise of those responding
was sufficient to consider the survey,
however, neither entity used the survey
results as the as the primary basis for
their recommended value.
For CPT code 432X1, the RUC
recommended a work RVU of 10.13. We
compared this code to CPT code 43180
(Esophagoscopy, rigid, transoral with
diverticulectomy of hypopharynx or
cervical esophagus (e.g., Zenker’s
diverticulum), with cricopharyngeal
myotomy, includes use of telescope or
operating microscope and repair, when
performed), which has a work RVU of
9.03 and has identical intraservice time
and similar total time. We believe the
overall intensity of these procedures is
similar, therefore, we are proposing a
work RVU of 9.03 for CPT code 432X1.
For CPT code 432X2, the RUC
recommended a work RVU of 10.47. To
value this code, we used the increment
between the RUC-recommended work
RVU for this code and CPT code 432X1
(0.34 RVUs) to develop our proposed
work RVU of 9.37 for CPT code 432X2.
(18) Electromyography Studies (CPT
Code 51784)
We identified CPT code 51784 as
potentially misvalued through a screen
of high expenditure by specialty. This
family also includes CPT code 51785
(Needle electromyography studies
(EMG) of anal or urethral sphincter, any
technique) but was not included in this
survey. Both services have 0-day global
periods. The RUC recommended a work
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RVU of 0.75 for CPT code 51784. We
believe that this service is more
accurately valued without a global
period, since that is more consistent
with other diagnostic services, and
specifically, with all the other
diagnostic electromyography services.
We are proposing a change to the global
period from 0-day to no global period,
and we are proposing the RUCrecommended work RVU of 0.75 for CY
2017. We are also proposing to change
the global period for CPT code 51785
from 0-day to no global period, to be
consistent with 51784. Additionally, we
are proposing to add CPT code 51785 to
the list of potentially misvalued codes
to update the value of the service
considering the change in global period,
and to maintain consistency with 51784.
(19) Cystourethroscopy (CPT Code
52000)
In the CY 2016 PFS final rule with
comment period, CMS identified CPT
code 52000 through the screen for high
expenditure services by specialty
screen. The RUC-recommended work
RVUs of 1.75 for CPT code 52000 is
larger than the work RVUs for all 0-day
global codes with 10 minutes of
intraservice time and we do not believe
that the overall intensity of this service
is greater than all of the other codes.
Instead, we believe the overall work
compares for this code compares
favorably to CPT code 58100
(Endometrial sampling (biopsy) with or
without endocervical sampling (biopsy),
without cervical dilation, any method
(separate procedure)), which has a work
RVU of 1.53, and has identical
intraservice time and similar total time.
Therefore, we are using a direct
crosswalk to CPT code 58100 and are
proposing a work RVU of 1.53 for CPT
code 52000.
(20) Biopsy of Prostate (CPT Code
55700)
In the CY 2016 PFS final rule with
comment period, CMS identified CPT
code 55700 as potentially misvalued
based on the high expenditure by
specialty screen.
The RUC subsequently reviewed this
code for physician work and practice
expense and recommended a work RVU
of 2.50 based on the 25th percentile of
the survey. We believe the RUCrecommended work RVU overestimates
the work involved in furnishing this
service given the reduction in total
service time; specifically, the reduction
in preservice and postservice times. The
RUC recommendation also appears
overvalued when compared to similar 0day global services with 15 minutes of
intraservice time and comparable total
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times. To develop a proposed work
RVU, we crosswalked the work RVUs
for this code from CPT code 69801
(Labyrinthotomy, with perfusion of
vestibuloactive drug(s), transcanal),
noting similar levels of intensity, similar
total times, and identical intraservice
times. Therefore, we are proposing a
work RVU of 2.06 for CPT code 55700.
As part of the recommended direct PE
inputs for CPT code 55700, the RUC
recommended inclusion of a new
equipment item, Biopsy Guide, but we
have not received any invoices to price
this item. Given our longstanding
difficulties in acquiring accurate pricing
information for equipment items, we are
seeking invoices and public comment
for pricing this equipment prior to
adding this new equipment item code.
(21) Hysteroscopy (CPT Codes 58555–
58563)
In the CY 2016 PFS proposed rule, we
proposed CPT code 58558 as a
potentially misvalued code based on the
screen for high expenditure by specialty
screen. This code was reviewed at the
January 2016 RUC meeting and CPT
codes 58559–58563 were included in
the review as part of the family.
For CPT code 58555, the RUC
recommended a work RVU of 3.07. We
believe that the 25th percentile of the
survey, a work RVU of 2.65, more
accurately reflects the resources
involved in furnishing this service. This
value is bracketed by two crosswalk
codes, CPT code 43191 (Esophagoscopy,
rigid, transoral; diagnostic, including
collection of specimen(s) by brushing or
washing when performed (separate
procedure)), which has a work RVU of
2.49, and CPT code 31295 (Nasal/sinus
endoscopy, surgical; with dilation of
maxillary sinus ostium (e.g., balloon
dilation), transnasal or via canine fossa),
which has a work RVU of 2.70.
Compared with CPT code 58555, CPT
codes 43191 and 31295 have identical
intraservice times and similar total
times. Therefore, we are proposing a
work RVU of 2.65 for CPT code 58555.
For CPT code 58558, the RUC
recommended a work RVU of 4.37.
However, we believe that a direct
crosswalk from CPT code 36221 (Nonselective catheter placement, thoracic
aorta, with angiography of the
extracranial carotid, vertebral, and/or
intracranial vessels, unilateral or
bilateral, and all associated radiological
supervision and interpretation, includes
angiography of the cervicocerebral arch,
when performed), which has a work
RVU of 4.17, and which has identical
intraservice time and very similar total
time, more accurately reflects the time
and intensity of furnishing this service.
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This value is additionally supported by
using an increment between this code
and the base code for this family, CPT
code 58555. The increment between the
RUC-recommended values for these two
codes is 1.3. That increment added to
the proposed work RVU of 2.65 for the
base code, CPT code 58555, results in a
work RVU of 3.95. Therefore, we are
proposing a work value of 4.17 RVUs for
CPT code 58558.
For CPT code 58559, the RUC
recommended a work RVU of 5.54.
However, we believe that a direct
crosswalk of the work RVUs for CPT
code 52315 (Cystourethroscopy, with
removal of foreign body, calculus, or
ureteral stent from urethra or bladder
(separate procedure); complicated),
which has a work RVU of 5.20 and
which has a similar (slightly higher)
intraservice time and similar total time
as compared with CPT code 58589 more
accurately reflects the time and
intensity of furnishing this service. This
value is additionally supported by using
an increment between CPT code 58559
and the base code for this family, CPT
code 58555. The increment between the
RUC recommended values for the two
codes is 2.47. That increment added to
the proposed value for the base code,
CPT code 58555 (2.65), results in a work
RVU of 5.12. Therefore, we are
proposing a work RVU of 5.20 for CPT
code 58559.
For CPT code 58560, the RUC
recommended a work RVU of 6.15.
However, we believe that a direct
crosswalk of the work RVUs for CPT
code 52351 (Cystourethroscopy, with
ureteroscopy and/or pyeloscopy;
diagnostic), which has a work RVU of
5.75 and which has more intraservice
time and very similar total time, more
accurately reflects the time and
intensity of furnishing this service. This
value is additionally supported by using
an increment between CPT code 58560
and the base code for this family, CPT
code 58555. The increment between the
RUC recommended values for the two
codes is 3.08. That increment added to
the proposed value for the base code,
CPT code 58555 (2.65), results in a work
RVU of 5.73. Therefore, we are
proposing a work RVU of 5.75 for CPT
code 58560.
For CPT code 58561, the RUC
recommended a work RVU of 7.00.
However, we believe that a direct
crosswalk of the work RVUs for CPT
code 35475 (Transluminal balloon
angioplasty, percutaneous;
brachiocephalic trunk or branches, each
vessel), which has a work RVU of 6.60
and which has similar intraservice and
total times, more accurately reflects the
time and intensity of furnishing this
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service. This value is additionally
supported by using an increment
between CPT code 58561 and the base
code for this family, CPT code 58555.
The increment between the RUC
recommended values for the two codes
is 3.93. That increment added to the
proposed value for the base code, CPT
code 58555 (2.65), results in a work
RVU of 6.58. Therefore, we are
proposing a work RVU of 6.60 for CPT
code 58561.
For CPT code 58562, the RUC
recommended a work RVU of 4.17.
However, we believe that a direct
crosswalk of the work RVUs for CPT
code 15277 (Application of skin
substitute graft to face, scalp, eyelids,
mouth, neck, ears, orbits, genitalia,
hands, feet, and/or multiple digits, total
wound surface area greater than or equal
to 100 sq cm; first 100 sq cm wound
surface area, or 1% of body area of
infants and children), which has a work
RVU of 4.00 and which has identical
intraservice time and similar total time,
more accurately reflects the time and
intensity of furnishing this service. The
RUC also used this code as one of its
supporting codes for its
recommendation. This value is
additionally supported by using an
increment between CPT code 58562 and
the base code for this family, CPT code
58555. The increment between the RUC
recommended values for the two codes
is 1.10. That increment added to the
proposed value for the base code, CPT
code 58555 (2.65), results in a work
RVU of 3.75. Therefore, we are
proposing a work RVU of 4.00 for CPT
code 58562.
For CPT code 58563, the RUC
recommended a work RVU of 4.62.
However, we believe that a direct
crosswalk of the work RVUs for CPT
code 33962 (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)), which has a work
RVU of 4.47 and which has identical
intraservice time and similar total time,
more accurately reflects the resources
involved in furnishing this service. This
value is additionally supported by using
an increment between CPT code 58563
and the base code for this family, CPT
code 58555. The increment between the
RUC recommended values for the two
codes is 1.55. That increment added to
the proposed value for the base code,
CPT code 58555 (2.65), results in a work
RVU of 4.20. We note that CPT code
58563 has the same instraservice time
and the same total time as CPT code
58558; however, we agree that the
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intensity would be slightly higher for
this service. Therefore, we are proposing
a work RVU of 4.47 for CPT code 58562.
The RUC submitted invoices for two
new equipment items used in furnishing
CPT code 58558, the Hysteroscopic
Fluid Management System and the
Hysteroscopic Resection System. We are
proposing to use these invoice prices for
the Hysteroscopic Fluid Management
System, which totaled $14,698.38. The
Hysteroscopic Resection System
included the price of the hysteroscope
as well as other items necessary for
tissue removal. However, we generally
price endoscopes separately and not as
a part of a system. In order to maintain
consistency, we are proposing not to
include the hysteroscope from the
Resection System. Instead, we are
proposing to update the equipment item
‘‘endoscope, rigid, hysteroscopy’’
(ES009) with the invoice price,
$6,207.50. We are not proposing to
include the sterilization tray from the
Hysteroscopic Resection System
because we believe this tray has
generally been characterized as an
indirect expense. For the Hysteroscopic
Resection System, we are proposing to
include the Hysteroscopic tissue
remover ($18,375), the sheath
($1,097.25), and the calibration device
($300), and creating a new equipment
item code, priced at $19,857.50 in the
proposed direct PE input database. We
did not propose to include the
calibration device since the submitted
price was not documented with a paid
invoice.
(22) Epidural Injections (CPT Codes
623X5, 623X6, 623X7, 623X8, 623X9,
62X10, 62X11, and 62X12)
We are proposing the RUCrecommended work RVU for all eight of
the codes in this family.
We are proposing to remove the 10–
12ml syringes (SC051) and the RK
epidural needle (SC038) from all eight
of the codes in this family. These
supplies are duplicative, as they are
included in the epidural tray (SA064).
As an alternative, we could remove the
epidural tray and replace it with the
individual supply components used in
each procedure; we are seeking public
comment on either the inclusion of the
epidural tray or its individual
components for this family of codes.
(23) Endoscopic Decompression of
Spinal Cord (CPT code 630X1)
For CY 2016, the CPT Editorial Panel
created CPT code 630X1 to describe the
endoscopic decompression of neural
elements. The RUC recommended a
work RVU of 10.47 based on a crosswalk
to CPT code 47562 (Laparoscopy,
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surgical; cholecystectomy) with a higher
intraservice time than reflected in the
survey data. Since we believe CPT codes
630X1 and 47562 are similar in
intensity, we believe using the same
work RVU as the crosswalk code
overestimates the work involved in
furnishing CPT code 630X1. Reference
CPT code 49507 (Repair initial inguinal
hernia, age 5 years or older; incarcerated
or strangulated) has a work RVU of 9.09
and has similar intensity and an
identical intraservice time compared to
CPT code 630X1. Therefore, we are
proposing a work RVU of 9.09 for CPT
code 630X1.
(24) Retinal Detachment Repair (CPT
Codes 67101 and 67105)
For CY 2015, the CPT Editorial Panel
made several changes to CPT codes
67101 and 67105. These changes
include revising the code descriptors to
exclude ‘‘diathermy’’ and ‘‘with or
without drainage of subretinal fluid’’
and removing the reference to ‘‘1 or
more sessions’’. The recommended
global period has also changed from 90
days to 10 days.
For CPT code 67101 we propose the
RUC recommendation of 3.50 work
RVUs, which was based on the 25th
percentile of the survey. For CPT code
67105, the RUC recommended a work
RVU of 3.84 based on the 25th
percentile of the survey. The RUC also
stated that CPT code 67105 was a more
intense procedure, and therefore, should
have a higher work RVU than CPT code
67101. Currently, CPT code 67101 has a
higher work RVU than CPT code 67105
and according to the surveys the
intraservice and total times remain
higher for CPT code 67101. It was not
clearly explained and we do not
understand why the RUC believes that
CPT code 67105 is more work than CPT
code 67101. Therefore we are not
proposing the RUC-recommended work
value of 3.50 for CPT code 67105. We
do not find evidence that CPT code
67105 is more intense than CPT code
67101 and accordingly propose a new
value for CPT code 67105. To value CPT
code 67105 we used the RVU ratio
between 67101 and 67105. We divided
the current work RVU of CPT code
67105 (8.53), by the current work RVU
of CPT code 67101 (8.80) and multiplied
the quotient by the RUC-recommended
work RVU for CPT code 67101 (3.50) to
arrive at a product of 3.39 work RVUs.
Therefore, for CY 2017 we are
proposing a work RVU of 3.39 for CPT
code 67105.
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(25) Abdominal Aortic Ultrasound
Screening (CPT Code 767X1)
For CY 2017, the CPT Editorial Panel
created a new code, CPT 767X1, to
describe abdominal aortic ultrasound
screening, currently described by
HCPCS G-code G0389. The specialties
that surveyed CPT code 767X1 for the
RUC were vascular surgery and
radiology, and the direct practice
expense inputs recommended by the
RUC included an ultrasound room.
Based on an analysis of Medicare claims
data, the dominant specialties
furnishing the service are family
practice and internal medicine. We
believe that these specialties may more
typically use a portable ultrasound
device rather than an ultrasound room.
Therefore, we are proposing to accept
the RUC-recommended work value of
0.55, and the RUC-recommended PE
inputs for this service, but we are
seeking comment regarding whether or
not it would be more accurate to
substitute a portable ultrasound device
or possibly a hand-held device for an
ultrasound room for CPT code 767X1.
We note that while the phase-in of
significant reductions in RVUs
ordinarily would not apply to new
codes, we believe that it would be
appropriate to consider this change from
a G-code to a CPT code to be
fundamentally similar to an editorial
coding change since the service is not
described differently, and therefore, we
propose to apply the phase-in to this
service by comparing the previous value
of the G-code to the value for the new
CPT code.
(26) Fluoroscopic Guidance (CPT Codes
77001, 77002, and 77003)
In the CY 2015 PFS final rule with
comment period, CMS indicated that
while CPT codes 77002 and 77003 had
been previously classified as standalone codes without global periods, we
believe their vignettes and CPT Manual
parentheticals are consistent with an
add-on code as has been established for
CPT code 77001. Therefore, the global
periods for CPT codes 77002 and 77003
now reflect an add-on code global
period with modifications to the
vignettes and parentheticals.
For CPT code 77001, we are
proposing the RUC-recommended work
RVU of 0.38. The RUC-recommended
work RVUs for CPT codes 77002 and
77003 do not appear to account for the
significant decrease in total times for
these codes relative to the current total
times. We note that these three codes
describe remarkably similar services
and have identical intraservice and total
times. Based on the identical times and
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notable similarity for all three of these
codes, we are proposing a work RVU of
0.38 for all three codes.
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(27) Radiation Treatment Devices (CPT
Codes 77332, 77333, and 77334)
We identified CPT codes 77332,
77333, and 77334 through the high
expenditures by specialty screen. These
services represent an incremental
increase of complexity from the simple
to the intermediate to the complex in
design of radiation treatment devices.
The RUC recommended no change from
the current work RVUs for these codes,
which are currently 0.54 for CPT code
77332, 0.84 for CPT code 77333 and
1.24 for CPT code 77334. We believe the
recommended work RVUs overstate the
work involved in furnishing these
services, as they do not sufficiently
reflect the degree to which the RUC
concurrently recommended a decrease
in intraservice or total time. For CPT
code 77332, we believe the RUC
recommendation to maintain its current
value despite a 34 percent decrease in
total time appears to ignore the change
in time. Therefore, we are proposing a
value for this code based on a crosswalk
from the value from CPT code 93287
(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)), due
to its identical intraservice time, similar
total time, and similar level of intensity.
We are therefore proposing a work RVU
of 0.45 for CPT code 77332. We are
further supporting this valuation with
HCPAC code 97760 (Orthotic(s)
management and training (including
assessment and fitting when not
otherwise reported) upper extremity(s),
lower extremity(s) and/or trunk, each 15
minutes), which has similar physician
time and intensity measurements and a
work RVU of 0.45. As these codes are
designed to reflect an incremental
increase in work value from simple, to
intermediate, and complex device
designs, we used an incremental
difference methodology to value CPT
codes 77333 and 77334. We are
proposing a work RVU of 0.75 for CPT
code 77333, maintaining its
recommended increment from CPT code
77332, For CPT code 77334, we are
proposing a work RVU of 1.15 which
maintains its increment from CPT code
77332.
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(28) Special Radiation Treatment (CPT
Code 77470)
We identified CPT code 77470
through the high expenditure charges by
specialty. We are proposing the RUCrecommended work RVU of 2.03.
However, we believe the description of
service and vignette describe different
and unrelated treatments being
performed by the physician and clinical
staff for a typical patient, and this
presents a disparity between the work
RVUs and PE RVUs. We seek public
comment on information that would
clarify this apparent disparity to help
determine appropriate PE inputs. In
addition, we seek comment to
determine if creating two G-codes, one
which describes the work portion of this
service, and one which describes the PE
portion, may be a potentially more
accurate method of valuing and paying
for the service or services described by
this code.
(29) Flow Cytometry Interpretation (CPT
Codes 88184, 88185, 88187, 88188, and
88189)
The Flow Cytometry Interpretation
family of codes is split into a pair of
codes used to describe the technical
component of flow cytometry (CPT
codes 88184 and 88185), which do not
have a work component, and a trio of
codes (CPT codes 88187, 88188, and
88189) which do not have direct
practice expense inputs, as they are
professional component only services.
CPT codes 88184 and 88185 were
reviewed by the RUC in April 2014, and
their CMS refined values were included
in the CY 2016 PFS final rule with
comment period. The full family of
codes was reviewed again at the January
2016 RUC meeting, and new
recommendations were submitted to
CMS as part of the CY 2017 PFS
rulemaking cycle.
We are proposing the RUCrecommended work RVU of 0.74 for
CPT code 88187, and the RUCrecommended work RVU of 1.70 for
CPT code 88189. For CPT code 88188,
we are proposing a work RVU of 1.20
instead of the RUC-recommended work
RVU of 1.40. We arrived at this value by
noticing that there were no comparable
codes with no global period in the RUC
database with intraservice time and total
time of 30 minutes that had a work RVU
higher than 1.20. The RUCrecommended work RVU of 1.40 would
go beyond the current maximum value
and establish a new high, which is not
consistent with our estimation of the
overall intensity of this service relative
to the others. As a result, we believe it
is more accurate to crosswalk CPT code
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88188 to the work value of the code
with the current highest value, which is
CPT code 88120 (Cytopathology, in situ
hybridization (for example, FISH),
urinary tract specimen with
morphometric analysis, 3–5 molecular
probes) at a work RVU of 1.20. We
believe that CPT code 88120 is
crosswalk comparable code since it
shares the identical intraservice time
and total time of 30 minutes with CPT
code 88188.
We also noted that the survey
increment between CPT codes 88187
and 88188 at the RUC-recommended
25th percentile was 0.40 (between work
RVUs of 1.00 and 1.40), and this
increment of 0.40 when added to CPT
code 88187’s work RVU of 0.74 would
arrive at a value of 1.14. In addition, the
total time for CPT code 88188 decreases
from 43 minutes to 30 minutes, which
is a ratio of 0.70, and when this time
ratio is multiplied by CPT code 88188’s
previous work value of 1.69, the result
would be a new work RVU of 1.18. With
this information in mind, we are
proposing a work RVU of 1.20 for CPT
code 88188 as a result of a direct
crosswalk to CPT code 88120.
For CPT codes 88184 and 88185,
which describe the technical component
of flow cytometry, we are proposing to
use the RUC-recommended inputs with
a series of refinements. However, we
believe that the coding for these two
procedures may inhibit accurate
valuation. CPT code 88184 describes the
first marker for flow cytometry, while
CPT code 88185 is an add-on code that
describes each additional marker. We
believe that it may be more accurate to
have a single CPT code that describes
the technical component of flow
cytometry on a per patient case basis, as
these two procedures are always
performed together and it is difficult to
determine the clinical labor, supplies,
and equipment used in the typical case
under the current coding structure. We
are soliciting comments regarding the
public interest in consolidating these
two procedures into a single code used
to describe the technical component of
flow cytometry.
Absent such a change in coding, we
are proposing to refine the clinical labor
time for ‘‘Instrument start-up, quality
control functions, calibration,
centrifugation, maintaining specimen
tracking, logs and labeling’’ from 15
minutes to 13 minutes for CPT code
88184. We maintain that 13 minutes for
this activity, which is the current time
value, would be typical for the
procedure, as CPT code 88182 also uses
13 minutes for the identical clinical
labor task. We are also proposing to
refine the L054A clinical labor for
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‘‘Load specimen into flow cytometer,
run specimen, monitor data acquisition,
and data modeling, and unload flow
cytometer’’ from 10 minutes to 7
minutes using the same rationale, a
comparison to CPT code 88182.
We are proposing to maintain the
clinical labor for ‘‘Print out histograms,
assemble materials with paperwork to
pathologists Review histograms and
gating with pathologist’’ for CPT code
88184 at 2 minutes, as opposed to the
RUC-recommended 5 minutes. A
clinical labor time of 2 minutes is
standard for this activity; we disagree
with the RUC rationale that reviewing
histograms and gating with the
pathologist in this procedure is not
similar to other codes. We also note that
the review of histograms with a
pathologist is not even described by
CPT code 88184, which again refers to
the technical component of flow
cytometry, not the professional
component. We are also proposing to
refine the L033A clinical labor time for
‘‘Clean room/equipment following
procedure’’ from 2 minutes to 1 minute
for CPT code 88184. We have
established 1 minute in previous
rulemaking (80 FR 70902) as the
standard time for this clinical labor
activity in the laboratory setting.
We are proposing to maintain our
removal of the clinical labor time for
‘‘Enter data into laboratory information
system, multiparameter analyses and
field data entry, complete quality
assurance documentation’’ for both CPT
code 88182 and CPT code 88184. As we
stated in last year’s final rule with
comment period (80 FR 70979), we have
not recognized the laboratory
information system as an equipment
item that can be allocated to an
individual service. We continue to
believe that this is a form of indirect PE,
and therefore, we do not recognize the
laboratory information system as a
direct PE input, and we not consider
this task as typically performed by
clinical labor on a per-service basis.
We are proposing to maintain the
quantity of the ‘‘lysing reagent’’ supply
(SL089) at 2 ml for CPT code 88185, as
opposed to the RUC-recommended
quantity of 3 ml. In our discussions with
pathology specialists who perform flow
cytometry, we were informed that the
use of 50–55 ml of the lysing reagent
would be typical for an entire patient
case. The RUC recommendation
similarly suggested a quantity of 46 ml
or 48 ml per patient case. We were also
told that the most typical number of
markers used for flow cytometry is 24,
consisting of 1 service of CPT code
88184 and 23 services of CPT code
88185. An investigation of our claims
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data confirmed this information,
indicating that 24 markers is the most
frequent per patient case for flow
cytometry, and the use of more than 20
markers is typical. We believe that this
data supports our refinement of the
lysing reagent from a quantity of 3 ml
to a quantity of 2 ml for CPT code
88185, which is also the current value
for the procedure and the RUCrecommended value from the previous
set of recommendations. For the typical
case of 24 markers, our value would
produce a total lysing reagent quantity
of 51 ml (5 ml from the single service
of CPT code 88184 and 46 ml from the
23 services of CPT code 88185), which
matches with the amount required for a
total per patient case. If we were to
adopt the RUC recommendation, the
total lysing reagent quantity would be
74 ml, which is well in excess of what
we believe to be typical for these
procedures.
We are also proposing to refine the
quantity of the ‘‘antibody, flow
cytometry’’ supply (SL186) from
quantity 1.6 to quantity 1, which is also
the current value for the supply and the
RUC-recommended value from the
previous set of recommendations. We
do not agree that more than one
antibody would be typically used for
each marker. We are reaffirming the
previous RUC recommendation, and
maintaining the current quantity of 1
antibody for each marker.
We are not proposing the
recommended additional time for the
‘‘printer, dye sublimation (photo,
color)’’ equipment (ED031). We are
proposing to maintain the equipment
time at 2 minutes for CPT code 88184,
and at 1 minute for CPT code 88185. As
we stated in the CY 2016 PFS final rule
with comment period (80 FR 70979), we
are proposing to assign equipment time
for the dye sublimation printer to match
the clinical labor time for ‘‘Print out
histograms, assemble materials with
paperwork to pathologists.’’ We do not
believe that it would be typical for the
printer to be in use longer than it takes
to accomplish this clinical labor task.
(30) Mammography—Computer Aided
Detection Bundling (CPT Codes 770X1,
770X2 and 770X3)
Section 104 of the Medicare,
Medicaid, and SCHIP Benefits
Improvement and Protection Act of
2000 (BIPA) (Pub. L. 106–554) required
us to create separate codes with higher
payment amounts for digital
mammography compared to film
mammography, which was the
technology considered to be typical at
the time. In addition, the statute
required additional payment to be made
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when computer-aided detection (CAD)
was used.
In CY 2002, we began valuing digital
mammography services using three Gcodes, G0202, G0204, and G0206 to
describe screening mammography,
unilateral diagnostic mammography,
and bilateral diagnostic mammography,
respectively. CMS implemented the
requirements of BIPA section 104(d)(1),
which applied to tests furnished in
2001, by using the work RVUs of the
parallel CPT codes, but establishing a
fixed PE RVU rather than using PE
RVUs developed under the standard PE
methodology. The fixed amount of PE
RVUs for these codes has generally
remained unchanged since
implementation of the G-codes that
specifically described digital imaging.
Most mammography services under
Medicare have since been billed with
these G-codes when digital
mammography was used, and with CPT
codes 77055, 77056, and 77057 when
film mammography was used. The use
of CAD has been reported with CPT
codes 77051 and 77052. For CY 2017,
the CPT Editorial Panel deleted CPT
codes 77051, 77052, 77055, 77056,
77057 and created three new CPT codes,
770X1, 770X2, and 770X3, to describe
mammography services bundled with
CAD. For CY 2017, the RUC
recommended a work RVU of 0.81 for
CPT code 770X1, a work RVU of 1.00 for
CPT code 770X2, and a work RVU of
0.76 for CPT code 770X3, as well as new
PE inputs for use in developing
resource-based PE RVUs based on our
standard methodologies. The RUC has
recommended these inputs and only
one medical specialty society has
provided us with a set of single invoices
to price the equipment used in
furnishing these services.
We have reviewed these coding
changes and recommended changes to
valuation for CY 2017. The revised CPT
coding mitigates the need for both
separate G-codes and the CAD add-on
codes. Based upon these coding changes
and the recommended input values,
overall Medicare payment for
mammography services would be
drastically reduced. This is especially
the case for the technical component of
these services, which could possibly be
reduced up to 50 percent relative to the
PE RVUs currently used for payment for
these services.
Based on our initial review of the
recommended inputs for the new codes,
we believe that these changes would
likely result in values more closely
related to the relative resources
involved in furnishing these services.
However, we recognize that these
services, particularly the preventive
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screenings, are of particular importance
to the Medicare program and the health
of the Medicare beneficiaries. We are
concerned that making drastic changes
in coding and payment for these
services could be disruptive in ways
that could affect beneficiary access to
necessary services. We also recognize
that unlike almost any other highvolume PFS service, the RVUs used for
payment for many years have not been
developed through the generally
applicable PFS methodologies, and
instead reflect the statutory directive
under section 104 of the BIPA.
Similarly, we recognize that the changes
in both coding and valuation are
significant changes for those who
provide these services. Therefore,
instead of proposing to simultaneously
adopt the revised CPT coding and
drastic reductions in overall payment
rates, we believe it is advisable to adopt
the new coding, including the
elimination of separate billing for CAD,
for CY 2017 without proposing
immediate implementation of the
recommended resource inputs. We
anticipate that we will consider the
recommended inputs, including the
pricing of the required equipment, as
carefully as possible prior to proposing
revised PE values through subsequent
rulemaking.
Therefore, for CPT codes 770X1,
770X2, and 770X3, we are proposing to
accept the RUC-recommended work
RVUs, but to crosswalk the PE RVUs for
the technical component of the current
corresponding G-codes, as we seek
further pricing information for these
equipment items.
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In addition to seeking comment on
this proposal, we are also seeking
comment on rates for these services in
the commercial market to help us
understand the potential impacts of any
future proposed revisions to PFS
payment rates.
Finally, we note that by adopting the
new coding for CY 2017, any
subsequent significant reduction in
RVUs (greater than 20 percent) for the
codes would be subject to the statutory
phase-in under section 1848(c)(7).
To help us examine the resource
inputs for these services, we are seeking
public comment on the list of items
recommended as equipment inputs for
mammography services. We also invite
commenters to provide any invoices
that would help with future pricing of
these items.
TABLE 17—RECOMMENDED EQUIPMENT ITEMS FOR MAMMOGRAPHY SERVICES
#
Item description
1 ................
1
Mammography unit and in-room console itself.
2 ................
2D Selenia Dimensions Mammography System.
Mammo Accreditation Phantom ........
1
3 ................
4 ................
Phantom Case ..................................
Paddle Storage Rack ........................
1
3
5 ................
Needle Localization Kit .....................
1
6 ................
1
1
1
CAD server, and also used for post-processing.
License required for using CAD. This is a one-time fee.
9 ................
10 ..............
Advanced Workflow Manager System.
Cenova 2D Tower System ................
Image Checker CAD (9.4) License
for One FFDM.
Film Digitizing System .......................
Mammography Chair .........................
Required for MQSA. The phantom is currently valued into the existing
mammography room.
Protects expensive required phantom from damage.
It requires 3 racks to hold and prevent damage to all of the paddles that
are part of the typical standard mammography system.
Needed for a full functioning mammography room. Allows for the performance of needle localizations. Input is not separately in the PE for the
mammography guided procedure codes, 19281–19282, as a fully functioning mammography room is needed for those procedures.
Workflow system connecting mammography room and workstations.
1
1
11 ..............
Laser Imager Printer .........................
1
12 ..............
13 ..............
Barcode Scanner ..............................
MRS V7 SQL Reporting System ......
1
1
14 ..............
Worksheet Printing Module ...............
1
15 ..............
16 ..............
Site License .......................................
Additional Concurrent User License
1
3
17 ..............
Densitometer .....................................
1
Digitizes analog films to digital for comparison purposes.
A special chair needed for patients who cannot stand to safely have their
mammogram performed.
Prints high resolution copies of the mammograms to send to surgeons
and oncologists, and to use in the OR.
Allows selection of individual patient file for interpretation.
MQSA requires that the facility develop and maintain a database that
tracks recall rates from screening, true and false positive and true and
false negative rates, sensitivity, specificity, and cancer detection rate. A
reporting system is required to build the required database and produce
the federally required quality audit. Components below needed for the
reporting system. The reporting system is currently valued into the existing mammography room.
Database reports are required for federal tracking purposes. This is used
to generate reports for MQSA.
License for site to use the reporting system. This is a one-time fee.
Licenses for radiologists to use the reporting system. A minimum of three
additional licenses is typical.
Required for MQSA.
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7 ................
8 ................
Quantity
We also received specialty society
recommendations for a new Equipment
Item, a physician PACS mammography
workstation. We note that we discuss
physician PACS workstation in section
II.A of this rule. The items that comprise
the physician PACS mammography
workstation are listed in Table 18. We
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Purpose
are requesting public comment as to the
appropriateness of this list and if some
items are indirect expenses or belong in
other codes. We also invite commenters
to provide any invoices that would help
with future pricing of these items.
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TABLE 18—PHYSICIAN PACS
MAMMOGRAPHY WORKSTATION
PC Tower.
Monitors 5 MP (mammo) (x2).
3rd & 4th monitor (for speech recognition,
etc.).
Admin Monitor (the extra working monitor).
Keyboard & Mouse.
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recommended direct PE inputs from the
TABLE 18—PHYSICIAN PACS MAMMOGRAPHY WORKSTATION—Contin- January 2016 meeting, the labor,
supplies, and equipment inputs related
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We also note that for CY 2015, the
CPT Editorial Panel created CPT codes
77061, 77062, and 77063 to describe
unilateral, bilateral, and screening
digital breast tomosynthesis,
respectively. CPT code 77063 is an addon code to 77057, the CPT code for
screening mammography. To be
consistent with our use of G codes for
digital mammography, we did not
implement two of these three CPT codes
for Medicare purposes. We only adopted
CPT code 77063 an add-on code to
G0202. Instead of adopting stand-alone
codes 77061 and 77062, we created a
new code, G0279 Diagnostic digital
breast tomosynthesis, as an add-on code
to the diagnostic digital mammography
codes G0204 and G0206 and assigned it
values based on CPT code 77063.
Pending revaluation of the
mammography codes using direct PE
inputs, we propose to maintain the
current coding structure for digital
breast tomosynthesis with the technical
change that G0279 be reported with
770X1 or 770X2 as the replacement
codes for G0204 and G0206.
(31) Microslide Consultation (CPT
Codes 88321, 88323, and 88325)
CPT codes 88321, 88323, and 88325
were reviewed by the RUC in April 2014
for their direct PE inputs only, and the
CMS refined values were included in
the CY 2016 PFS final rule with
comment period. The family of codes
was reviewed again at the January 2016
RUC meeting for both work values and
direct PE inputs, and new
recommendations were submitted to
CMS as part of the CY 2017 PFS
rulemaking cycle.
In the CY 2016 PFS final rule with
comment period, we finalized our
proposal to remove many of the inputs
for clinical labor, supplies, and
equipment for CPT code 88325. The
descriptor for this code did not state
that slide preparation was taking place,
and therefore, we refined the labor,
supplies, and equipment inputs to align
with the inputs recommended for CPT
code 88321, which also does not
include the preparation of slides. After
further discussion with pathologists and
consideration of comments received, we
have been persuaded that slide
preparation does take place in
conjunction with the service described
by CPT code 88325. In the RUC-
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to slide preparation were added once
again to CPT code 88325. We are
proposing to accept these restorations
related to slide preparation without
refinement.
Regarding the clinical labor direct PE
inputs, we are proposing to assign 1
minute of L037B clinical labor for
‘‘Complete workload recording logs.
Collate slides and paperwork. Deliver to
pathologist’’ for CPT codes 88323 and
88325. We are maintaining this at the
current value for CPT code 88323, and
adding this 1 minute to CPT code 88325
based on our new understanding that
slide preparation is undertaken as part
of the service described by this code.
We are proposing to remove the clinical
labor for ‘‘Assemble and deliver slides
with paperwork to pathologists’’ from
all three codes, as we believe this
clinical labor is redundant with the
labor assigned for ‘‘Complete workload
recording logs.’’ We are similarly
proposing to remove the clinical labor
for ‘‘Clean equipment while performing
service’’ from CPT codes 88323 and
88325, as we believe it to be redundant
with the clinical labor assigned for
‘‘Clean room/equipment following
procedure.’’
We are proposing to maintain the
quantity of the ‘‘stain, hematoxylin’’
supply (SL135) at 16 ml for CPT codes
88323 and 88325, as opposed to the
RUC-recommended quantity of 32 ml.
The RUC recommendation stated that
the hematoxylin supply does not
include eosin and should not be
redundant; the stains are not mixed
together, but are instead sequential. The
recommendation also made a
comparison to the use of the
hematoxylin supply quantity in CPT
code 88305. However, we note that CPT
code 88305 does not include 8 ml of
eosin stain (SL201), but instead 8 gm of
eosin solution (SL063), and these are
not the same supply. Therefore we do
not agree that a direct comparison of the
supply quantities is the most accurate
way to value these procedures. For CPT
codes 88323 and 88325, we continue to
note that the prior supply inputs for
these procedures had quantity 2.4 of the
eosin solution (SL063) and quantity 4.8
of the hematoxylin stain (SL135); in
other words, a 1:2 ratio between the
eosin and hematoxylin. We are
proposing to maintain that 1:2 ratio with
8 ml of the eosin stain (SL201) and 16
ml of the hematoxylin stain (SL135).
We are also proposing to update the
use of the eosin solution (sometimes
listed as ‘‘eosin y’’) in our supply
database. We believe that the eosin
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solution supply (SL063), which is
measured in grams, reflects an older
process of creating eosin stains by hand.
This is in contrast to the eosin stain
supply (SL201), which is measured in
milliliters, and can be ordered in a state
that is ready for staining immediately.
We do not believe that the use of eosin
solution would reflect typical lab
practice today, with the readily
availability for purchase of inexpensive
eosin staining materials. We also note
that in the CY 2016 PFS final rule with
comment period, we removed 8 gm of
the eosin solution and replaced it with
8 ml of the eosin stain, and this
substitution was accepted without
further change in the most recent set of
RUC recommendations. As a result, we
are proposing to update the price of the
eosin stain supply from $0.044 per ml
to $0.068 per ml to reflect the current
cost of the supply. We are also
proposing to use CPT codes 88323 and
88325 as a model, and replace the use
of eosin solution with an equal quantity
of eosin stain for the rest of the codes
that make use of this supply. This
applies to 15 other CPT codes: 88302
(Level II—Surgical pathology, gross and
microscopic examination), 88304 (Level
III—Surgical pathology, gross and
microscopic examination), 88305 (Level
IV—Surgical pathology, gross and
microscopic examination), 88307 (Level
V—Surgical pathology, gross and
microscopic examination), 88309 (Level
VI—Surgical pathology, gross and
microscopic examination), 88364 (In
situ hybridization (e.g., FISH), per
specimen; each additional single probe
stain procedure), 88365 (In situ
hybridization (e.g., FISH), per specimen;
initial single probe stain procedure),
88366 (In situ hybridization (e.g., FISH),
per specimen; each multiplex probe
stain procedure), 88367 (Morphometric
analysis, in situ hybridization
(quantitative or semi-quantitative),
using computer-assisted technology, per
specimen; initial single probe stain
procedure), 88368 (Morphometric
analysis, in situ hybridization
(quantitative or semi-quantitative),
manual, per specimen; initial single
probe stain procedure), 88369
(Morphometric analysis, in situ
hybridization (quantitative or semiquantitative), manual, per specimen;
each additional single probe stain
procedure), 88373 (Morphometric
analysis, in situ hybridization
(quantitative or semi-quantitative),
using computer-assisted technology, per
specimen; each additional single probe
stain procedure), 88374 (Morphometric
analysis, in situ hybridization
(quantitative or semi-quantitative),
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using computer-assisted technology, per
specimen; each multiplex probe stain
procedure), 88377 (Morphometric
analysis, in situ hybridization
(quantitative or semi-quantitative),
manual, per specimen; each multiplex
probe stain procedure), and G0416
(Surgical pathology, gross and
microscopic examinations, for prostate
needle biopsy, any method).
(32) Closure of Paravalvular Leak (CPT
Codes 935X1, 935X2, and 935X3)
The CPT Editorial Committee
developed three new codes (two base
codes and one add-on code) to describe
paravalvular leak closure procedures
that were previously reported using an
unlisted code. The RUC recommended a
work RVU of 17.97 for CPT code 935X2.
We are proposing a work RVU of 14.50
for CPT code 935X2, a direct crosswalk
from CPT code 37227. We believe that
a direct crosswalk to CPT code 37227
accurately reflects the time and
intensity described in CPT code 935X2
since CPT code 37227 also describes a
transcatheter procedure with similar
service times.
To maintain relativity among the
codes in this family, we are proposing
refinements to the recommended work
RVUs for CPT code 935X1. The RUC
noted the additional work associated
with CPT code 935X1 compared to CPT
code 935X2 was due to the addition of
a transseptal puncture to access the
mitral valve. The RUC identified a work
RVU of 3.73 for a transseptal puncture.
Therefore, for CPT code 935X1, we are
proposing a work RVU of 18.23 arrived
at by using our proposed work RVU for
CPT code 935X2 (14.50) and adding the
value of a transseptal puncture (3.73).
CPT code 935X3 is an add-on code
used to report placement of additional
occlusion devices for percutaneous
transcatheter paravalvular leak closure,
performed in conjunction with either an
initial mitral or aortic paravalvular leak
closure. The RUC recommended a work
RVU of 8.00 for this code. We
considered applying the relative
increment between CPT codes 935X1
and 935X2, however, we believe that a
direct crosswalk to CPT code 35572,
with a work RVU of 6.81, more
accurately reflects the time and
intensity of furnishing the service.
Therefore, for CPT code 935X3, we are
proposing a work RVU of 6.81.
(33) Electroencephalogram (EEG) (CPT
Codes 95812, 95813, and 95957)
In February 2016, the RUC submitted
recommendations for work and direct
PE inputs for CPT codes 95812, 95813,
and 95957. We are proposing to use the
RUC-recommended physician work and
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direct PE inputs for CPT code 95957 and
to use the RUC-recommended work
RVUs for CPT codes 95812 and 95813.
In the CY 2016 PFS final rule with
comment period (80 FR 70886), we
finalized direct PE input refinements for
several clinical labor times for CPT
codes 95812 and 95813. The RUC’s
February 2016 PE summary of
recommendations indicated that the
specialty society expert panel disagreed
with CMS’ refinements to clinical labor
time for these two codes. The RUC
recommended 62 minutes for clinical
labor task ‘‘perform procedure’’ for CPT
code 95812 and 96 minutes for the same
clinical labor task for CPT code 95813,
similar to the values recommended by
the RUC in April 2014.
We are proposing to maintain the
CMS-refined CY 2016 PE inputs for
clinical labor task ‘‘perform procedure’’
for CPT codes 95812 (50 minutes) and
95813 (80 minutes). The PE summary of
recommendations state that CPT code
95812 requires 50 minutes of clinical
labor time for EEG recording, and CPT
code 95813 requires 80 minutes of
clinical labor time for the same clinical
labor task.
(34) Parent, Caregiver-Focused Health
Risk Assessment (CPT Code 961X0)
In October 2015, the CPT Editorial
Panel created two new PE-only codes,
961X0 (Administration of patientfocused health risk assessment
instrument (e.g., health hazard
appraisal) with scoring and
documentation, per standardized
instrument) and 961X1 (Administration
of caregiver-focused health risk
assessment instrument (e.g., depression
inventory) for the benefit of the patient,
with scoring and documentation, per
standardized instrument). For CPT code
961X0, we are proposing the RUCrecommended direct PE inputs. For CPT
code 961X1, the service is furnished to
a patient who may not be a Medicare
beneficiary and thus we do not believe
would be eligible for Medicare payment.
We are proposing to assign a procedure
status of I (Not valid for Medicare
purposes) for CPT code 961X1.
We note that we believe that this code
describes a service that is frequently
reasonable and necessary in the
treatment of illness or injury, such as
when there has been a change in health
status. However, when the service
described by CPT code 961X0 is
explicitly included in another service
being furnished, such as the Annual
Wellness Visit (AWV), this code should
not be billed separately, much like other
codes that describe services included in
codes with broader descriptions. We
also note that this service should not be
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billed separately if furnished as a
preventive service as it would describe
a non-covered service. However, we are
also seeking comment on whether this
service may be better categorized as an
add-on code and welcome stakeholder
input regarding whether or not there are
circumstances when this service might
be furnished as a stand-alone service.
(35) Reflectance Confocal Microscopy
(CPT Codes 96931, 96932, 96933, 96934,
96935, and 96936)
For CY 2015, the CPT Editorial panel
established six new Category I codes to
describe reflectance confocal
microscopy (RCM) for imaging of skin.
For CPT codes 96931 and 96933, the
specialty society and the RUC agreed
that the physician work required for
both codes were identical, and
therefore, should be valued the same.
The RUC recommended a work RVU of
0.80 for CPT codes 96931 and 96933
based on the 25th percentile of the
survey. Based on the similarity of the
services being performed in CPT codes
96931 and 96933 and the identical intraservice times of 96931, 96933 and
88305, the key reference code from the
survey, we believe a direct crosswalk
from CPT code 88305 to 96931 and
96933 would more accurately reflect the
work involved in furnishing the
procedure. Therefore, for CY 2017 we
are proposing a value of 0.75 RVUs for
CPT codes 96931 and 96933. In
addition, we are removing 3 minutes of
preservice time in CPT codes 96931 and
96933 since it is not included in CPT
code 88305 and as a result, we do not
believe it is appropriate in CPT codes
96931 and 96933 either.
For CPT codes 96934 and 96936 the
specialty society and the RUC agreed
that the physician work required for
both codes were identical, and
therefore, should be valued the same. In
its recommendation, the RUC stated that
it believed the survey respondents
somewhat overestimated the work for
CPT code 96934 with the 25th
percentile yielding a work RVU of 0.79.
Consequently, the RUC reviewed the
survey results from CPT code 96936 and
agreed that the 25th percentile work
RVU of 0.76 accurately accounted for
the work involved for the service.
Therefore, the RUC recommended a
work RVU of 0.76 for CPT codes 96934
and 96936.
We believe that the incremental
difference between the RUCrecommended values for the base and
add-on codes accurately captures the
difference in work between the code
pairs. However, because we valued the
base codes differently than the RUC, we
are proposing values for the add-on
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codes that maintain the RUC’s 0.04
increment instead of the RUCrecommended values. Therefore we are
proposing a work RVU of 0.71 for CPT
codes 96934 and 96936.
We are also proposing to reduce the
preservice clinical labor for Patient
clinical information and questionnaire
reviewed by technologist, order from
physician confirmed and exam
protocoled by physician CPT codes
96934 and 93936 as this work is
performed in the two CPT base codes
93931 and 93933. The service period
clinical labor for ‘‘Prepare and position
patient/monitor patient/set up IV’’ was
reduced from 2 to 1 minute for CPT
codes 93934 and 93936 since we believe
that less positioning time is needed with
subsequent lesions. The service period
clinical labor for ‘‘Other Clinical
Activity—Review imaging with
interpreting physician’’ was refined to
zero minutes for CPT codes 96933 and
96936 as these are interpretation and
report only codes and not image
acquisition.
(36) Evaluative Procedures for Physical
Therapy and Occupational Therapy
(CPT Codes 97X61, 97X62, 97X63,
97X64, 97X65, 97X66, 97X67, 97X68)
For CY 2017, the CPT Editorial Panel
deleted four CPT codes (97001, 97002,
97003, and 97004) and created eight
new CPT codes (97X61–97X68) to
describe the evaluative procedures
furnished by physical therapists and
occupational therapists. There are three
new codes, stratified by complexity, to
replace a single code, 97001, for
physical therapy (PT) evaluation, three
new codes, also stratified by
complexity, to replace a single code,
97003, for occupational therapy (OT)
evaluation, and one new code each to
replace the reevaluation codes for
physical and occupational therapy—
97002 and 97004. Table 19 includes the
long descriptors and the required
components of each of the eight new
CPT codes for the PT and OT services.
The CPT Editorial Panel’s creation of
the new codes for PT and OT evaluative
procedures grew out of a CPT
workgroup that was originally convened
in January 2012 when contemplating
major revision of the Physical Medicine
and Rehabilitation CPT section of codes
in response to our nomination of
therapy codes as potentially misvalued
codes, including CPT code 97001 (and,
as a result, all four codes in the family)
in the CY 2012 PFS proposed rule.
In reviewing the eight new CPT codes
for evaluative procedures, the HCPAC
forwarded recommendations for work
RVUs and direct PE inputs for each
code. Currently, CPT codes 97001 and
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97003 both have a work RVU of 1.20,
and CPT codes 97002 and 97004 both
have a work RVU of 0.60. These CPT
codes have reflected the same work
RVUs since CY 1998 when we accepted
the HCPAC values during CY 1998
rulemaking.
i. Valuation of Evaluation Codes
The HCPAC submitted work RVU
recommendations for each of the six
new PT and OT evaluation codes. These
recommendations are intended to be
work neutral relative to the valuation for
the previous single evaluation code for
PT and OT, respectively. However, that
assessment for each family of codes is
dependent on the accuracy of the
utilization forecast for the different
complexity levels within the PT or OT
family. As used in this section, work
neutrality is distinct from the budget
neutrality that is applied broadly in the
PFS. Specifically, work neutrality is
intended to reflect that despite changes
in coding, the overall amount of work
RVUs for a set of services is held
constant from one year to the next. For
example, if a service is reported using
a single code with a work RVU of 2.0
for one year but that same service would
be reported using two codes, one for
‘‘simple’’ and another for ‘‘complex’’ in
the subsequent year valued at 1.0 and
3.0 respectively, work neutrality could
only be attained if exactly half the
services were reported using each of the
two new codes. If more than half of the
services were reported using the
‘‘simple’’ code, then there would be
fewer overall work RVUs. If more than
half of the services were reported using
the ‘‘complex’’ code, then there would
be more overall work RVUs. Therefore,
work neutrality can only be assessed
with an understanding of the relative
frequency of how often particular codes
will be reported.
The HCPAC recommended a work
RVU of 0.75 for CPT code 97X61, a work
RVU of 1.18 for CPT code 97X62, and
a work RVU of 1.5 for CPT code 97X63.
The PT specialty society projected that
the moderate complexity evaluation
code would be reported 50 percent of
the time because it is the typical
evaluation, and the CPT codes for the
low and high complexity evaluations
are each expected to be billed 25
percent of the time. The HCPACrecommended work RVU of 1.18 for
CPT code 97X62 represents the survey
median with 30 minutes of intraservice
time, 10 minutes of preservice time, and
15 minutes postservice time. The
HCPAC notes this work value is
appropriately ranked between levels 2
and 3 of the E/M office visit codes for
new patients.
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The HCPAC recommended a work
RVU of 0.88 for CPT code 97X65, a work
RVU of 1.20 for CPT code 97X66, and
a work RVU of 1.70 for CPT code 97X67.
For the OT codes, work neutrality
would be achieved only with a
projected utilization in which the lowcomplexity evaluation is billed 50
percent of the time; the moderatecomplexity evaluation is billed 40
percent of the time, and the highcomplexity evaluation only billed 10
percent of the time. For purposes of
calculating work neutrality, the HCPAC
recommended assuming that the lowcomplexity code will be most frequently
reported even though the HCPACrecommended work RVU of 1.20 and 45
minutes of intraservice time for
moderate complexity code is identical
to that of the current OT evaluation
code. The HCPAC believes that the work
RVU of 1.20 is appropriately ranked
between 99202 and 99203, levels 2 and
3 for E/M office visits for new
outpatients.
ii. Valuation of Evaluation Codes and
Discussion of PAMA
In our review of the HCPAC
recommendations, we noted the work
neutrality and the inherent reliance on
the utilization assumptions. We
considered the three complexity levels
for the PT evaluations and the three
complexity levels for the OT
evaluations; and we also considered the
evaluation services described by the
codes as a whole. The varying work
RVUs and the dependence on utilization
for each complexity level to ensure
work neutrality in the PT and OT code
families make it difficult for us evaluate
the HCPAC’s recommended values or to
predict with a high degree of certainty
whether physical and occupational
therapists will actually bill for these
services at the same rate forecast by
their respective specialty societies.
We are concerned that the coding
stratification in the PT and OT
evaluation codes may result in upcoding
incentives, especially while physical
and occupational therapists gain
familiarity and expertise in the
differential coding of the new PT and
OT evaluation codes that now include
the typical face-to-face times and new
required components that are not
enumerated in the current codes. We are
also concerned that stratified payment
rates may provide, in some cases, a
payment incentive to therapists to
upcode to a higher complexity level
than was actually furnished to receive a
higher payment.
We understand that there may be
multiple reasons for the CPT Editorial
Panel to stratify coding for OT and PT
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evaluation codes based on complexity.
We also note that the codes will be used
by payers in addition to Medicare, and
other payers may have direct interest in
making such differential payment based
on complexity of OT and PT evaluation.
Given our concerns regarding
appropriate valuation, work neutrality,
and potential upcoding, however, we do
not believe that making different
payment based on the reported
complexity for these services is, at
current, advantageous for Medicare or
Medicare beneficiaries.
Given the advantages inherent and
public interest in using CPT codes once
they become part of the code set, we are
proposing to adopt the new CPT codes
for use in Medicare for CY 2017.
However, given our concerns about
appropriate pricing and payment for the
stratified services, we are proposing to
price the services described by these
stratified codes as a group instead of
individually. To do that, we are
proposing to utilize the authority in
section 220(f) of the Protecting Access to
Medicare Act (PAMA), which revised
section 1848(c)(2)(C) of the Act to
authorize the Secretary to determine
RVUs for groups of services, rather than
determining RVUs at the individual
service level. We believe that using this
authority instead of proposing to make
payment based on Medicare G-codes
will preserve consistency in the code set
across payers, thus lessening burden on
providers, while retaining flexibilities
that are beneficial to Medicare.
We propose a work RVU of 1.20 for
both the PT and the OT evaluation
groups of services. We are proposing
this work RVU because we believe it
best represents the typical PT and OT
evaluation. This is the value
recommended by the HCPAC for the OT
moderate-complexity evaluation and
nearly the same work RVU for
corresponding PT evaluation (1.18).
Additionally, 1.20 work RVUs is the
long-standing value for the current
evaluation codes, 97001 and 97003, and,
thus, assures work neutrality without
reliance on particular assumptions
about utilization, which we believe was
the intent of the HCPAC
recommendation.
Because we are proposing to use the
same work RVU for the six evaluation
codes, we are not addressing any
additional concerns about the
utilization assumptions recommended
to us. By proposing the same work
values for each code in the family, there
will be no ratesetting impact to work
neutrality. As such, we are not revising
the utilization crosswalks as projected
by the respective therapy specialties to
achieve work neutrality. However, were
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we to value each code in the PT or OT
evaluation families individually, we
would seek objective data from
stakeholders to support the utilization
crosswalks, particularly those for the OT
family in which the low-level
complexity evaluation is depicted as
typical and the high-complexity is
projected to be billed infrequently at 10
percent of the overall number of OT
evaluations.
We are proposing to use the direct PE
inputs forwarded by the HCPAC (with
the refinements described below) for the
typical PT evaluation and also for the
typical OT evaluation in the
development of PE RVUs for the PT and
OT codes as a group of services. For the
PT codes, we are proposing to use the
recommended inputs for the moderatecomplexity code for the direct PE inputs
of all three codes based on its
assumption as the typical service. Our
proposed direct PE inputs reflect the
recommended values minus 2 minutes
of physical therapist assistant (PTA)
time in the service period because we
believe that PTA tasks to administer
certain assessment tools are
appropriately included as part of the
physical therapist’s work and the time
of the PTA to explain and/or score selfreported outcome measures is not
separately included in the clinical labor
of other codes. We are proposing to
include the recommended four sheets of
laser paper without an association to a
specific equipment item, but we are
seeking comment regarding the paper’s
use.
For the OT evaluation codes, we
considered proposing to use the direct
PE inputs for the low-complexity
evaluation because the OT specialty
organization believes it represents the
typical OT evaluation service with a
projected 50 percent utilization rate.
However, we propose to use the
moderate-level direct inputs instead,
because the direct PE for this level is
based on a vignette that is valued with
the same intraservice time, 45 minutes,
as the current code, CPT code 97003.
Consequently, we propose to use the
recommended direct PE inputs for the
moderate-complexity code for use in
developing PE RVUs for this group of
services.
Our proposed direct PE inputs reflect
the recommended values minus 2
minutes of occupational therapist
assistant (OTA) time in the service
period because we believe that OTA
tasks to administer certain assessment
tools are appropriately included as part
of the occupational therapist’s work and
the time of the OTA to explain and/or
score self-reported outcome measures is
not separately included in the clinical
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labor of other codes. We also rounded
up the recommended 6.8 minutes to 7
minutes to represent the time the OTA
assists the occupational therapist during
the intraservice time period. For the
Vision Kit equipment item, our
proposed price reflects the submitted
invoice that clearly defined a kit.
iii. Valuation of Reevaluation Codes
The recommendations the HCPAC
sent to us for the PT and OT
reevaluation codes are not work neutral.
For the new PT reevaluation code, CPT
code 97X64, the HCPAC recommended
a work RVU of 0.75 compared to the
work RVU of 0.60 for CPT code 97002.
This recommended work RVU falls
between the 25th percentile of the
survey and the survey’s median value
and was based on a direct crosswalk to
CPT code 95992 for canalith
repositioning with 20 minutes
intraservice time and 10 minutes
immediate postservice time. The
HCPAC supported this 0.15 work RVU
increase based on an anomalous
relationship between PT services and E/
M office visit codes for established
patients, noting that physician E/M
codes have historically been used as a
relative comparison. The HCPAC stated
its 0.75 work RVU recommendation for
code 97X64 appropriately ranks it
between the key reference codes for this
service 99212 and 99213, levels 2 and
3 E/M office-visit codes for established
patients.
The HCPAC provided a work RVU of
0.80 for the OT reevaluation code, CPT
code 97X68, based on the 25th
percentile of the survey, which
represents an increase over the current
work RVU of 0.60 for CPT code 97004.
This work value includes 30 minutes of
intraservice time, 5 minutes preservice
time, and 10 minutes immediate
postservice time. The HCPAC noted that
the increase in work compared to the PT
reevaluation code (0.75) is because the
occupational therapist spends more
time observing and assessing the patient
and, in general, the OT patient typically
has more functional and cognitive
disabilities. The HCPAC
recommendation notes that the 0.80
work RVU recommendation
appropriately ranks it between the level
1 and 2 E/M office-visit codes for new
patients.
The HCPAC’s recommended increases
to work RVUs for the PT and OT
reevaluation codes are not work neutral.
We are unclear why the HCPAC did not
maintain work neutrality for the OT and
PT reevaluation codes since maintaining
work neutrality was important to the
establishment of the six new evaluation
codes. We are proposing to maintain the
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overall work RVUs for these services by
proposing 0.60 work RVUs for CPT
codes 97X64 and 97X68, consistent with
the work RVUs for the deleted
reevaluation codes. We are seeking
comments from stakeholders on
whether there are reasons that the
reevaluation codes should be revalued
without regard to work neutrality
particularly given the HCPAC’s interest
in preserving work neutrality for the
new evaluation codes.
We are proposing the HCPACrecommended direct PE inputs for CPT
code 97X64 with a reduction in time for
the PTA by 1 minute (from 5 to 4) in the
service period– the line for ‘‘Other
Clinical Activity’’—because the time to
explain and score the self-reported
outcome measure (for example,
Oswestry) is not separately included in
the clinical labor of other codes.
We are proposing the HCPACrecommended direct PE inputs for CPT
code 97X68 with a reduction in time for
the OTA by 1 minute (from 3 to 2) in
the service period—the line for ‘‘Other
Clinical Activity’’—for the same reason
we reduced the corresponding line for
PTAs—because the time to explain and
score any patient-self-administered
functional and/or other standardized
outcome measure is not separately
included in the clinical labor of other
codes.
Because the new CPT code
descriptors contain new coding
requirements for each complexity level,
we seek comment from the PT and OT
specialty organizations as well as other
stakeholders to clarify how therapists
will be educated to distinguish the
required complexity level components
and the selection of the number of
elements that impact the plan of care.
For example, for the OT codes, we
invite comment on how to define
performance deficits, what process the
occupational therapist uses to identify
the number of these performance
deficits that result in activity
limitations, and performance factors
needed for each complexity level. For
the PT codes, we would like more
information about how the physical
therapist differentiates the number of
personal factors that actually affect the
plan of care. We would also be
interested in understanding more about
how the physical therapist selects the
number of elements from any of the
body structures and functions, activity
limitations, and/or participation
restrictions to make sure there is no
duplication during the physical
therapist’s examination of body systems.
iv. Always Therapy Codes
It is also important to note that CMS
defines the codes for these evaluative
services as ‘‘always therapy.’’ This
means that they always represent
therapy services regardless of who
performs them and always require a
therapy modifier, GP or GO, to signify
that the services are furnished under a
PT or OT plan of care, respectively.
These codes will also be subject to the
therapy MPPR and to statutory therapy
caps.
TABLE 19—CPT LONG DESCRIPTORS FOR PHYSICAL MEDICINE AND REHABILITATION
New CPT code
CPT long descriptors for physical medicine and rehabilitation
97X61 ...............
Physical therapy evaluation: Low complexity, requiring these components:
• A history with no personal factors and/or comorbidities that impact the plan of care;
• An examination of body system(s) using standardized tests and measures addressing 1–2 elements from any of the following: Body structures and functions, activity limitations, and/or participation restrictions;
• A clinical presentation with stable and/or uncomplicated characteristics; and
• Clinical decision making of low complexity using standardized patient assessment instrument and/or measurable assessment of functional outcome.
Typically, 20 minutes are spent face-to-face with the patient and/or family.
Physical therapy evaluation: Moderate complexity, requiring these components:
• A history of present problem with 1–2 personal factors and/or comorbidities that impact the plan of care;
• An examination of body systems using standardized tests and measures in addressing a total of 3 or more elements from
any of the following: Body structures and functions, activity limitations, and/or participation restrictions;
• An evolving clinical presentation with changing characteristics; and
• Clinical decision making of moderate complexity using standardized patient assessment instrument and/or measurable assessment of functional outcome.
Typically, 30 minutes are spent face-to-face with the patient and/or family.
Physical therapy evaluation: High complexity, requiring these components:
• A history of present problem with 3 or more personal factors and/or comorbidities that impact the plan of care;
• An examination of body systems using standardized tests and measures addressing a total of 4 or more elements from any
of the following: Body structures and functions, activity limitations, and/or participation restrictions;
• A clinical presentation with unstable and unpredictable characteristics; and
• Clinical decision making of high complexity using standardized patient assessment instrument and/or measurable assessment of functional outcome.
Typically, 45 minutes are spent face-to-face with the patient and/or family.
Reevaluation of physical therapy established plan of care, requiring these components:
• An examination including a review of history and use of standardized tests and measures is required; and
• Revised plan of care using a standardized patient assessment instrument and/or measurable assessment of functional outcome
Typically, 20 minutes are spent face-to-face with the patient and/or family.
Occupational therapy evaluation, low complexity, requiring these components:
• An occupational profile and medical and therapy history, which includes a brief history including review of medical and/or
therapy records relating to the presenting problem;
• An assessment(s) that identifies 1–3 performance deficits (i.e., relating to physical, cognitive, or psychosocial skills) that result in activity limitations and/or participation restrictions; and
• Clinical decision making of low complexity, which includes an analysis of the occupational profile, analysis of data from
problem-focused assessment(s), and consideration of a limited number of treatment options. Patient presents with no
comorbidities that affect occupational performance. Modification of tasks or assistance (e.g., physical or verbal) with assessment(s) is not necessary to enable completion of evaluation component.
Typically, 30 minutes are spent face-to-face with the patient and/or family.
97X62 ...............
97X63 ...............
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
97X64 ...............
97X65 ...............
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TABLE 19—CPT LONG DESCRIPTORS FOR PHYSICAL MEDICINE AND REHABILITATION—Continued
New CPT code
CPT long descriptors for physical medicine and rehabilitation
97X66 ...............
Occupational therapy evaluation, moderate complexity, requiring these components:
• An occupational profile and medical and therapy history, which includes an expanded review of medical and/or therapy
records and additional review of physical, cognitive, or psychosocial history related to current functional performance;
• An assessment(s) that identifies 3–5 performance deficits (i.e., relating to physical, cognitive, or psychosocial skills) that result in activity limitations and/or participation restrictions; and
• Clinical decision making of moderate analytic complexity, which includes an analysis of the occupational profile, analysis of
data from detailed assessment(s), and consideration of several treatment options. Patient may present with comorbidities
that affect occupational performance. Minimal to moderate modification of tasks or assistance (e.g., physical or verbal) with
assessment(s) is necessary to enable patient to complete evaluation component.
Typically, 45 minutes are spent face-to-face with the patient and/or family.
Occupational therapy evaluation, high complexity, requiring these components:
• An occupational profile and medical and therapy history, which includes review of medical and/or therapy records and extensive additional review of physical, cognitive, or psychosocial history related to current functional performance;
• An assessment(s) that identify 5 or more performance deficits (i.e., relating to physical, cognitive, or psychosocial skills)
that result in activity limitations and/or participation restrictions; and
• A clinical decision-making is of high analytic complexity, which includes an analysis of the patient profile, analysis of data
from comprehensive assessment(s), and consideration of multiple treatment options. Patient presents with comorbidities
that affect occupational performance. Significant modification of tasks or assistance (e.g., physical or verbal) with assessment(s) is necessary to enable patient to complete evaluation component.
Typically, 60 minutes are spent face-to-face with the patient and/or family.
Reevaluation of occupational therapy established plan of care, requiring these components:
• An assessment of changes in patient functional or medical status with revised plan of care;
• An update to the initial occupational profile to reflect changes in condition or environment that affect future interventions
and/or goals; and
• A revised plan of care. A formal reevaluation is performed when there is a documented change in functional status or a significant change to the plan of care is required.
Typically, 30 minutes are spent face-to-face with the patient and/or family.
97X67 ...............
97X68 ...............
v. Potentially Misvalued Therapy Codes
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
Since 2010, in addition to the codes
for evaluative services, CMS has
periodically added codes that represent
therapy services to the list of potentially
misvalued codes. The current list of 10
therapy codes was based on the
statutory category ‘‘codes that account
for the majority of spending under the
physician fee schedule,’’ as specified in
section 1848(c)(2)(K)(ii)(VII) of the Act.
We understand that the therapy
specialty organizations have pursued
the development of coding changes
through the CPT process for these
modality and procedures services.
While we understand that, in some
cases, it may take several years to
develop appropriate coding revisions,
we are, in the meantime, seeking
information regarding appropriate
valuation for the existing codes. See
Table 20.
TABLE 20—POTENTIALLY MISVALUED
CODES IDENTIFIED THROUGH HIGH
EXPENDITURE
BY
SPECIALTY
SCREEN
HCPCS
code
97032
97035
97110
97112
97113
97116
97140
97530
97535
G0283
Short descriptor
Electrical stimulation.
Ultrasound therapy.
Therapeutic exercises.
Neuromuscular reeducation.
Aquatic therapy/exercises.
Gait training therapy.
Manual therapy 1/regions.
Therapeutic activities.
Self care mngment training.
Elec stim other than wound.
(37) Proposed Valuation of Services
Where Moderate Sedation Is an Inherent
Part of the Procedure and Proposed
Valuation of Moderate Sedation
Services (CPT Codes 991X1, 991X2,
991X3, 991X4, 991X5, and 991X6; and
HCPCS Code GMMM1)
In the CY 2015 PFS proposed rule (79
FR 40349), we noted that it appeared
that practice patterns for endoscopic
procedures were changing. Anesthesia
services are increasingly being
separately reported for endoscopic
procedures, meaning that resource costs
associated with sedation were no longer
incurred by the practitioner reporting
the procedure. Subsequently, in the CY
2016 PFS proposed rule (80 FR 41707),
we sought public comment and
recommendations on approaches to
address the appropriate valuation of
moderate sedation related to the
approximately 400 diagnostic and
therapeutic procedures for which the
CPT Editorial Committee has
determined that moderate sedation is an
inherent part of furnishing the service.
The CPT Editorial Committee created
separate codes for reporting of moderate
sedation services.
TABLE 21—MODERATE SEDATION CODES AND DESCRIPTORS
CPT/HCPCS
code
Descriptor
991X1 ................
Moderate sedation services provided by the same physician or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of the patient’s level of consciousness and physiological status; initial 15 minutes of intra-service
time, patient younger than 5 years of age.
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TABLE 21—MODERATE SEDATION CODES AND DESCRIPTORS—Continued
CPT/HCPCS
code
Descriptor
991X2 ................
Moderate sedation services provided by the same physician or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of the patient’s level of consciousness and physiological status; initial 15 minutes of intra-service
time, patient age 5 years or older.
Moderate sedation services provided by a physician or other qualified health care professional other than the physician or
other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports; initial
15 minutes of intra-service time, patient younger than 5 years of age.
Moderate sedation services provided by a physician or other qualified health care professional other than the physician or
other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports; initial
15 minutes of intra-service time, patient age 5 years or older.
Moderate sedation services provided by the same physician or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of the patient’s level of consciousness and physiological status; each additional 15 minutes of intraservice time (List separately in addition to code for primary service).
Moderate sedation services provided by a physician or other qualified health care professional other than the physician or
other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports; each
additional 15 minutes intra-service time (List separately in addition to code for primary service).
991X3 ................
991X4 ................
991X5 ................
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
991X6 ................
For the newly created moderate
sedation CPT codes, we are proposing to
use the RUC-recommended work RVUs
for CPT codes 991X1, 991X2, 991X3,
and 991X6. CPT codes 991X1 and
991X2 make a distinction between
moderate sedation services furnished to
patients younger than 5 years of age and
patients 5 years or older, with CPT
codes 991X3 and 991X4 making a
similar distinction. The RUC
recommendations include a work RVU
increment of 0.25 between CPT code
991X1 and 991X2. For CPT code 991X4,
we are proposing a work RVU of 1.65 to
maintain the 0.25 increment relative to
CPT code 991X3 (a RUC-recommended
work RVU of 1.90) and maintain
relativity among the CPT codes in this
family. We are proposing to use the
RUC-recommended direct PE inputs for
all six codes.
When moderate sedation is reported
for Medicare beneficiaries, we expect
that it would most frequently reported
using the code that describes moderate
sedation furnished by the same person
who also performs the primary
procedure for patients 5 years of age or
older. Under the new coding structure,
these services would be reported using
CPT code 991X2. Stakeholders have
presented information that illustrates
that the specialty group survey data
regarding the work involved in
furnishing the moderate sedation
described by CPT code 991X2 showed a
significant bimodal distribution
between procedural services furnished
by gastroenterologists (GI) and those
services furnished by other specialties.
The GI societies’ survey data reported a
median valuation of 0.10 work RVUs for
moderate sedation furnished by the
same person furnishing the base
procedure; all other specialty groups
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19:43 Jul 14, 2016
Jkt 238001
(combined) reported a median valuation
of 0.25 work RVUs. Given the
significant volume of moderate sedation
furnished by GI practitioners and the
significant difference in RVUs reported
in the survey data, we are proposing to
make payment using a gastrointestinal
(GI) endoscopy-specific moderate
sedation code GMMM1 that would be
used in lieu of the new CPT moderate
sedation coding used more broadly:
GMMM1: Moderate sedation services
provided by the same physician or other
qualified health care professional
performing a gastrointestinal
endoscopic service (excluding biliary
procedures) that sedation supports,
requiring the presence of an
independent trained observer to assist
in the monitoring of the patient’s level
of consciousness and physiological
status; initial 15 minutes of intra-service
time; patient age 5 years or older.
We are proposing to value GMMM1 at
0.10 work RVUs based on the median
survey result for GI respondents in the
survey data. We are proposing that
when moderate sedation services are
furnished by the same practitioner
reporting the GI endoscopy procedure,
practitioners would report the sedation
services using GMMM1 instead of
991X2. In all other cases, we propose
that practitioners would report
moderate sedation using one of the new
moderate sedation CPT codes consistent
with CPT guidance. This would include
the full range of codes for those
furnishing moderate sedation with the
remaining (non-GI endoscopy) base
procedures as well as for the other
circumstances during which moderate
sedation is furnished along with a GI
endoscopy (for example, to a patient
under 5 years of age or for a biliary
procedure, the endoscopist furnishing
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moderate sedation should not use
GMMM1, but instead use the
appropriate CPT code; see Table 22 for
more information about when GMMM1
should be used in lieu of the newly
created moderate sedation CPT codes).
In addition to providing
recommended values for the new codes
used to separately report moderate
sedation, the RUC has provided
recommendations that value the
procedural services without moderate
sedation. However, the RUC
recommends removing fewer RVUs from
the procedures than it recommends for
valuing the sedation services. In other
words, the RUC is recommending that
overall payments for these procedures
should be increased now that
practitioners will be required to report
the sedation services that were
previously included as inherent parts of
the procedures. We believe that if we
were to use the RUC recommendations
for re-valuation of the procedural
services without refinement, the RVUs
currently attributable to the redundant
payment for sedation services when
anesthesia is separately reported would
be used exclusively to increase overall
payment for these services. We refer
readers to Section II.D.5. of this
proposed rule, which includes a more
extensive discussion of our general
principle that overall resource costs for
the procedures including moderate
sedation do not inherently change based
solely on changes in coding.
To account for the separate billing of
moderate sedation services, we are
proposing to maintain current values for
the procedure codes less the work RVUs
associated with the most frequently
reported corresponding moderate
sedation code so that practitioners
furnishing the moderate sedation
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services previously considered to be
inherent in the procedure will have no
change in overall work RVUs. Since we
are proposing 0.10 work RVUs for
moderate sedation for the GI endoscopy
procedures, this means we are
proposing a corresponding .10 reduction
in work RVUs for these procedures. For
all other Appendix G procedures that
currently include moderate sedation as
an inherent part of the procedure, we
are proposing to remove 0.25 work
RVUs from the current values.
Table 22 lists the existing work RVUs
for each applicable service and our
proposed refined work RVU using the
proposed revaluation methodology
described above. Additionally, the table
identifies the GI endoscopic services for
which we are proposing that GMMM1
would be used to report moderate
sedation services. This information will
be made available and maintained in the
‘‘downloads’’ section of the PFS Web
site at https://www.cms.gov/Medicare/
Medicare-Feefor-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-Notices.html.
TABLE 22—PROPOSED VALUATIONS
FOR ENDOSCOPY SERVICES MINUS
MODERATE SEDATION
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
HCPCS
10030
19298
20982
20983
22510
22511
22512
22513
22514
22515
22526
22527
31615
31622
31623
31624
31625
31626
31627
31628
31629
31632
31633
31634
31635
31645
31646
31647
31648
31649
31651
31652
31653
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
VerDate Sep<11>2014
CY 2016
work
RVU
CY 2017
proposed
work
RVU
3.00
6.00
7.27
7.13
8.15
7.58
4.00
8.90
8.24
4.00
6.10
3.03
2.09
2.78
2.88
2.88
3.36
4.16
2.00
3.80
4.00
1.03
1.32
4.00
3.67
3.16
2.72
4.40
4.20
1.44
1.58
4.71
5.21
2.75
5.75
7.02
6.88
7.90
7.33
4.00
8.65
7.99
4.00
5.85
3.03
1.84
2.53
2.63
2.63
3.11
3.91
2.00
3.55
3.75
1.03
1.32
3.75
3.42
2.91
2.47
4.15
3.95
1.44
1.58
4.46
4.96
19:43 Jul 14, 2016
Use
GMMM1
to report
moderate
sedation
(Y/N)
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
Jkt 238001
TABLE 22—PROPOSED VALUATIONS
FOR ENDOSCOPY SERVICES MINUS
MODERATE SEDATION—Continued
HCPCS
31654
31660
31661
31725
32405
32550
32551
32553
33010
33011
33206
33207
33208
33210
33211
33212
33213
33214
33216
33217
33218
33220
33221
33222
33223
33227
33228
33229
33230
33231
33233
33234
33235
33240
33241
33244
33249
33262
33263
33264
33282
33284
33990
33991
33992
33993
35471
35472
35475
35476
36010
36140
36147
36148
36200
36221
36222
36223
36224
36225
36226
36227
36228
36245
36246
PO 00000
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
Frm 00101
Use
GMMM1
to report
moderate
sedation
(Y/N)
CY 2016
work
RVU
CY 2017
proposed
work
RVU
1.40
4.25
4.50
1.96
1.93
4.17
3.29
3.80
2.24
2.24
7.39
8.05
8.77
3.30
3.39
5.26
5.53
7.84
5.87
5.84
6.07
6.15
5.80
5.10
6.55
5.50
5.77
6.04
6.32
6.59
3.39
7.91
10.15
6.05
3.29
13.99
15.17
6.06
6.33
6.60
3.50
3.00
8.15
11.88
4.00
3.51
10.05
6.90
6.60
5.10
2.43
2.01
3.72
1.00
3.02
4.17
5.53
6.00
6.50
6.00
6.50
2.09
4.25
4.90
5.27
1.40
4.00
4.25
1.71
1.68
3.92
3.04
3.55
1.99
1.99
7.14
7.80
8.52
3.05
3.14
5.01
5.28
7.59
5.62
5.59
5.82
5.90
5.55
4.85
6.30
5.25
5.52
5.79
6.07
6.34
3.14
7.66
9.90
5.80
3.04
13.74
14.92
5.81
6.08
6.35
3.25
2.75
7.90
11.63
3.75
3.26
9.80
6.65
6.35
4.85
2.18
1.76
3.47
1.00
2.77
3.92
5.28
5.75
6.25
5.75
6.25
2.09
4.25
4.65
5.02
Fmt 4701
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N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
TABLE 22—PROPOSED VALUATIONS
FOR ENDOSCOPY SERVICES MINUS
MODERATE SEDATION—Continued
HCPCS
36247
36248
36251
36252
36253
36254
36481
36555
36557
36558
36560
36561
36563
36565
36566
36568
36570
36571
36576
36578
36581
36582
36583
36585
36590
36870
37183
37184
37185
37186
37187
37188
37191
37192
37193
37197
37211
37212
37213
37214
37215
37216
37218
37220
37221
37222
37223
37224
37225
37226
37227
37228
37229
37230
37231
37232
37233
37234
37235
37236
37237
37238
37239
37241
37242
E:\FR\FM\15JYP2.SGM
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
15JYP2
CY 2016
work
RVU
CY 2017
proposed
work
RVU
6.29
1.01
5.35
6.99
7.55
8.15
6.98
2.68
5.14
4.84
6.29
6.04
6.24
6.04
6.54
1.92
5.36
5.34
3.24
3.54
3.48
5.24
5.29
4.84
3.35
5.20
7.99
8.66
3.28
4.92
8.03
5.71
4.71
7.35
7.35
6.29
8.00
7.06
5.00
2.74
18.00
0.00
15.00
8.15
10.00
3.73
4.25
9.00
12.00
10.49
14.50
11.00
14.05
13.80
15.00
4.00
6.50
5.50
7.80
9.00
4.25
6.29
2.97
9.00
10.05
6.04
1.01
5.10
6.74
7.30
7.90
6.73
2.43
4.89
4.59
6.04
5.79
5.99
5.79
6.29
1.67
5.11
5.09
2.99
3.29
3.23
4.99
5.04
4.59
3.10
4.95
7.74
8.41
3.28
4.92
7.78
5.46
4.46
7.10
7.10
6.04
7.75
6.81
4.75
2.49
17.75
0.00
14.75
7.90
9.75
3.73
4.25
8.75
11.75
10.24
14.25
10.75
13.80
13.55
14.75
4.00
6.50
5.50
7.80
8.75
4.25
6.04
2.97
8.75
9.80
Use
GMMM1
to report
moderate
sedation
(Y/N)
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
46262
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
TABLE 22—PROPOSED VALUATIONS
FOR ENDOSCOPY SERVICES MINUS
MODERATE SEDATION—Continued
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
HCPCS
37243
37244
37252
37253
43200
43201
43202
43204
43205
43206
43211
43212
43213
43214
43215
43216
43217
43220
43226
43227
43229
43231
43232
43233
43235
43236
43237
43238
43239
43240
43241
43242
43243
43244
43245
43246
43247
43248
43249
43250
43251
43252
43253
43254
43255
43257
43259
43260
43261
43262
43263
43264
43265
43266
43270
43273
43274
43275
43276
43277
43278
43450
43453
44360
44361
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
VerDate Sep<11>2014
CY 2016
work
RVU
CY 2017
proposed
work
RVU
11.99
14.00
1.80
1.44
1.52
1.82
1.82
2.43
2.54
2.39
4.30
3.50
4.73
3.50
2.54
2.40
2.90
2.10
2.34
2.99
3.59
2.90
3.69
4.17
2.19
2.49
3.57
4.26
2.49
7.25
2.59
4.83
4.37
4.50
3.18
3.66
3.21
3.01
2.77
3.07
3.57
3.06
4.83
4.97
3.66
4.25
4.14
5.95
6.25
6.60
6.60
6.73
8.03
4.17
4.26
2.24
8.58
6.96
8.94
7.00
8.02
1.38
1.51
2.59
2.87
11.74
13.75
1.80
1.44
1.42
1.72
1.72
2.33
2.44
2.29
4.20
3.40
4.63
3.40
2.44
2.30
2.80
2.00
2.24
2.89
3.49
2.80
3.59
4.07
2.09
2.39
3.47
4.16
2.39
7.15
2.49
4.73
4.27
4.40
3.08
3.56
3.11
2.91
2.67
2.97
3.47
2.96
4.73
4.87
3.56
4.15
4.04
5.70
6.00
6.35
6.35
6.48
7.78
3.92
4.01
2.24
8.33
6.71
8.69
6.75
7.77
1.13
1.26
2.49
2.77
19:43 Jul 14, 2016
TABLE 22—PROPOSED VALUATIONS
FOR ENDOSCOPY SERVICES MINUS
MODERATE SEDATION—Continued
Use
GMMM1
to report
moderate
sedation
(Y/N)
HCPCS
N
N
N
N
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
Y
Y
44363 ......
44364 ......
44365 ......
44366 ......
44369 ......
44370 ......
44372 ......
44373 ......
44376 ......
44377 ......
44378 ......
44379 ......
44380 ......
44381 ......
44382 ......
44384 ......
44385 ......
44386 ......
44388 ......
44388–53
44389 ......
44390 ......
44391 ......
44392 ......
44394 ......
44401 ......
44402 ......
44403 ......
44404 ......
44405 ......
44406 ......
44407 ......
44408 ......
44500 ......
45303 ......
45305 ......
45307 ......
45308 ......
45309 ......
45315 ......
45317 ......
45320 ......
45321 ......
45327 ......
45332 ......
45333 ......
45334 ......
45335 ......
45337 ......
45338 ......
45340 ......
45341 ......
45342 ......
45346 ......
45347 ......
45349 ......
45350 ......
45378 ......
45378–53
45379 ......
45380 ......
45381 ......
45382 ......
45384 ......
45385 ......
Jkt 238001
PO 00000
Frm 00102
Use
GMMM1
to report
moderate
sedation
(Y/N)
CY 2016
work
RVU
CY 2017
proposed
work
RVU
3.49
3.73
3.31
4.40
4.51
4.79
4.40
3.49
5.25
5.52
7.12
7.46
0.97
1.48
1.27
2.95
1.30
1.60
2.82
1.41
3.12
3.84
4.22
3.63
4.13
4.44
4.80
5.60
3.12
3.33
4.20
5.06
4.24
0.49
1.50
1.25
1.70
1.40
1.50
1.80
2.00
1.78
1.75
2.00
1.86
1.65
2.10
1.14
2.20
2.15
1.35
2.22
3.08
2.91
2.82
3.62
1.78
3.36
1.68
4.38
3.66
3.66
4.76
4.17
4.67
3.39
3.63
3.21
4.30
4.41
4.69
4.30
3.39
5.15
5.42
7.02
7.36
0.87
1.38
1.17
2.85
1.20
1.50
2.72
1.36
3.02
3.74
4.12
3.53
4.03
4.34
4.70
5.50
3.02
3.23
4.10
4.96
4.14
0.39
1.40
1.15
1.60
1.30
1.40
1.70
1.90
1.68
1.65
1.90
1.76
1.55
2.00
1.04
2.10
2.05
1.25
2.12
2.98
2.81
2.72
3.52
1.68
3.26
1.63
4.28
3.56
3.56
4.66
4.07
4.57
Fmt 4701
Sfmt 4702
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
TABLE 22—PROPOSED VALUATIONS
FOR ENDOSCOPY SERVICES MINUS
MODERATE SEDATION—Continued
HCPCS
45386
45388
45389
45390
45391
45392
45393
45398
47000
47382
47383
47532
47533
47534
47535
47536
47538
47539
47540
47541
47542
47543
47544
49405
49406
49407
49411
49418
49440
49441
49442
49446
50200
50382
50384
50385
50386
50387
50430
50432
50433
50434
50592
50593
50606
50693
50694
50695
50705
50706
57155
66720
69300
77371
77600
77605
77610
77615
92920
92921
92924
92925
92928
92929
92933
E:\FR\FM\15JYP2.SGM
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
15JYP2
CY 2016
work
RVU
CY 2017
proposed
work
RVU
3.87
4.98
5.34
6.14
4.74
5.60
4.78
4.30
1.90
15.22
9.13
4.25
6.00
8.03
4.50
2.88
6.60
9.00
10.75
5.61
2.50
3.07
4.29
4.25
4.25
4.50
3.82
4.21
4.18
4.77
4.00
3.31
2.63
5.50
5.00
4.44
3.30
2.00
3.15
4.25
5.30
4.00
6.80
9.13
3.16
4.21
5.50
7.05
4.03
3.80
5.40
5.00
6.69
0.00
1.56
2.09
1.56
2.09
10.10
0.00
11.99
0.00
11.21
0.00
12.54
3.77
4.88
5.24
6.04
4.64
5.50
4.68
4.20
1.65
14.97
8.88
4.25
5.38
7.60
3.95
2.61
4.75
8.75
9.03
5.38
2.85
3.00
3.28
4.00
4.00
4.25
3.57
3.96
3.93
4.52
3.75
3.06
2.38
5.25
4.75
4.19
3.05
1.75
2.90
4.00
5.05
3.75
6.55
8.88
3.16
3.96
5.25
6.80
4.03
3.80
5.15
4.75
6.44
0.00
1.31
1.84
1.31
1.84
9.85
0.00
11.74
0.00
10.96
0.00
12.29
Use
GMMM1
to report
moderate
sedation
(Y/N)
Y
Y
Y
Y
Y
Y
Y
Y
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
TABLE 22—PROPOSED VALUATIONS
FOR ENDOSCOPY SERVICES MINUS
MODERATE SEDATION—Continued
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
HCPCS
92934
92937
92938
92941
92943
92944
92953
92960
92961
92973
92974
92975
92978
92979
92986
92987
93312
93313
93314
93315
93316
93317
93318
93451
93452
93453
93454
93455
93456
93457
93458
93459
93460
93461
93462
93463
93464
93505
93530
93561
93562
93563
93564
93565
93566
93567
93568
93571
93572
93582
93583
93609
93613
93615
93616
93618
93619
93620
93621
93622
93624
93640
93641
93642
93644
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
......
VerDate Sep<11>2014
CY 2016
work
RVU
CY 2017
proposed
work
RVU
0.00
11.20
0.00
12.56
12.56
0.00
0.23
2.25
4.59
3.28
3.00
7.24
0.00
0.00
22.85
23.63
2.55
0.51
2.10
2.94
0.85
2.09
2.40
2.72
4.75
6.24
4.79
5.54
6.15
6.89
5.85
6.60
7.35
8.10
3.73
2.00
1.80
4.37
4.22
0.50
0.16
1.11
1.13
0.86
0.86
0.97
0.88
0.00
0.00
12.56
14.00
0.00
6.99
0.99
1.49
4.25
7.31
11.57
0.00
0.00
4.80
3.51
5.92
4.88
3.29
0.00
10.95
0.00
12.31
12.31
0.00
0.01
2.00
4.34
3.28
3.00
6.99
0.00
0.00
22.60
23.38
2.30
0.26
1.85
2.69
0.60
1.84
2.15
2.47
4.50
5.99
4.54
5.29
5.90
6.64
5.60
6.35
7.10
7.85
3.73
2.00
1.80
4.12
3.97
0.25
0.01
1.11
1.13
0.86
0.86
0.97
0.88
0.00
0.00
12.31
13.75
0.00
6.99
0.74
1.24
4.00
7.06
11.32
0.00
0.00
4.55
3.26
5.67
4.63
3.04
19:43 Jul 14, 2016
Use
GMMM1
to report
moderate
sedation
(Y/N)
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
Jkt 238001
TABLE 22—PROPOSED VALUATIONS
FOR ENDOSCOPY SERVICES MINUS
MODERATE SEDATION—Continued
HCPCS
93650 ......
93653 ......
93654 ......
93655 ......
93656 ......
93657 ......
94011 ......
94012 ......
94013 ......
96440 ......
G0105 .....
G0105–53
G0121 .....
G0121–53
G0341 .....
Use
GMMM1
to report
moderate
sedation
(Y/N)
CY 2016
work
RVU
CY 2017
proposed
work
RVU
10.49
15.00
20.00
7.50
20.02
7.50
2.00
3.10
0.66
2.37
3.36
1.68
3.36
1.68
6.98
10.24
14.75
19.75
7.50
19.77
7.50
1.75
2.85
0.41
2.12
3.26
1.63
3.26
1.63
6.98
N
N
N
N
N
N
N
N
N
N
Y
Y
Y
Y
N
(38) Prolonged Evaluation and
Management Services (CPT Codes
99354, 99358, and 99359)
We previously received RUC
recommendations for face-to-face and
non-face-to-face prolonged E/M
services. In response to the CY 2016 PFS
proposed rule, in which we sought
comment about improving payment
accuracy for cognitive services,
commenters suggested that we consider
making separate payment for CPT codes
99358 and 99359. As reflected in section
II.E, we are proposing to make separate
payment for these services.
We are also proposing values for
services in this family of codes based on
the RUC-recommended values,
including for CPT code 99354, which
would increase the current work RVU to
2.33. Likewise, we are proposing to
adopt the RUC-recommended work
values of 2.10 for CPT code 99358 and
of 1.00 for CPT code 99359.
46263
(40) Prostate Biopsy, Any Method
(HCPCS Code G0416)
The College of American Pathologists
and the American Society of
Cytopathology formed an expert panel
to make recommendations at the
October 2015 RUC meeting to determine
an appropriate work RVU for HCPCS
code G0416, as they felt that the survey
results were invalid. The panel made
several arguments to the RUC in
recommending for a higher work RVU
under the RUC’s ‘‘compelling evidence’’
standard. These arguments were: (1)
That incorrect assumptions were made
in previous valuations; (2) the value of
HCPCS code G0416 remained constant
while the code descriptors changed over
the years; and (3) the ‘‘anomalous
relationship’’ between HCPCS code
G0416 and CPT code 88305 (Level IV—
Surgical pathology, gross and
microscopic examination). The expert
panel recommended a work RVU of 4.00
based on a crosswalk from CPT code
38240 (Hematopoietic progenitor cell
(HPC); allogeneic transplantation per
donor). The RUC agreed.
We believe HCPCS code G0416
should not be valued as a direct
crosswalk from CPT code 38240. Instead
we believe CPT code 88305 is the basis
for HCPCS code G0416, and therefore,
HCPCS code G0416 should be valued as
such. To value HCPCS code G0416, we
used the intra-service time ratio
between HCPCS code G0416 and CPT
code 88305 to arrive at a work RVU of
3.60. To further support this method, we
note that the IWPUT for HCPCS code
G0416 with a work RVU of 3.60 is the
same as CPT code 88305. Using the RUC
recommended RVU of 4.00 results in a
higher IWPUT, and we do not believe
there is a difference in work intensity
between these codes. Therefore for CY
2017, we are proposing a work RVU of
3.60 for HCPCS code G0416.
(39) Complex Chronic Care Management
Services (CPT Codes 99487 and 99489)
(41) Behavioral Health Integration:
Psychiatric Collaborative Care Model
(HCPCS Codes GPPP1, GPPP2, and
GPPP3) and General Behavioral Health
Integration (HCPCS Code GPPPX)
We received RUC recommendations
for CPT codes 99487 and 99489
following the October 2012 RUC
meeting. For CY 2017, we are proposing
to change the procedure status for CPT
codes 99487 and 99489 from B
(bundled) to A (active), see II.E, and are
proposing to adopt the RUCrecommended values for work, 1.00
work RVUs for CPT code 99487 and
0.50 work RVUs for CPT code 99489, as
well as direct PE inputs consistent with
the RUC recommendations.
For CY 2017, we are proposing to
establish and make separate Medicare
payment using four new HCPCS Gcodes, GPPP1 (Initial psychiatric
collaborative care management, first 70
minutes in the first calendar month of
behavioral health care manager
activities, in consultation with a
psychiatric consultant, and directed by
the treating physician or other qualified
health care professional), GPPP2
(Subsequent psychiatric collaborative
care management, first 60 minutes in a
subsequent month of behavioral health
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care manager activities, in consultation
with a psychiatric consultant, and
directed by the treating physician or
other qualified health care professional),
GPPP3 (Initial or subsequent psychiatric
collaborative care management, each
additional 30 minutes in a calendar
month of behavioral health care
manager activities, in consultation with
a psychiatric consultant, and directed
by the treating physician or other
qualified health care professional), and
GPPPX (Care management services for
behavioral health conditions, at least 20
minutes of clinical staff time, directed
by a physician or other qualified health
care professional time, per calendar
month) for collaborative care and care
management for beneficiaries with
behavioral health conditions, as detailed
in section II.E of this proposed rule. To
value HCPCS codes GPPP1, GPPP2, and
GPPP3, we are proposing to base the
portion of the work RVU that accounts
for the work of the treating physician or
other qualified health care professional
on a direct crosswalk to the proposed
work values for the complex CCM
codes, CPT codes 99487 and 99489. To
value the portion of the work RVU that
accounts for the psychiatric consultant,
we are estimating ten minutes of
psychiatric consultant time per patient
per month and a value of 0.42 work
RVUs, based on the per minute work
RVUs for the highest volume codes
typically billed by psychiatrists. Since
the behavioral health care manager in
the services described by HCPCS codes
GPPP1, GPPP2, and GPPP3 should have
academic with specialized training in
behavioral health, we are proposing a
new clinical labor type for the
behavioral health care manager, L057B,
at $0.57 per minute, based on the rates
for genetic counselors in the direct PE
input database. We are seeking
comment on all aspects of these
proposed valuations.
To value HCPCS code GPPPX, we are
proposing a work value based on a
direct crosswalk from CPT code 99490
(Chronic care management services), a
work value of 0.61 RVUs. We recognize
that the services described by CPT code
99490 are distinct from those furnished
under the CoCM and we believe that
these alsovary based on different kinds
of BHI care. We note that there are
relatively few existing codes that
describe these kinds of services over a
calendar month. We also believe that
the resources associated with 99490
may vary based on the ways different
practitioners implement the service.
Until we have more information about
how these services are typically
furnished, we believe valuation based
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on the minimum resources would be
most appropriate. To account for the
care manager minutes in the direct PE
inputs for HCPCS code GPPPX, we are
proposing to use clinical labor type
L045C, which is the labor type for social
workers/psychologists and has a rate of
$0.45 per minute.
(42) Resource-Intensive Services
(HCPCS Code GDDD1)
As discussed in section II.E, we are
proposing to establish payment for
services furnished to patients with
mobility-related disabilities, through a
new add-on G-code, to be billable with
office/outpatient E/M and TCM codes.
Based on our analysis of the resources
typically involved in furnishing office
visits to patients with these needs
(especially including the typical
additional practitioner and staff time),
we believe that the physician work and
time for HCPCS code GDDD1 is most
accurately valued through a direct
crosswalk from CPT code 99212 (Level
2 office or other outpatient visit for the
evaluation and management of an
established patient). Therefore, we are
proposing a work RVU of 0.48 and a
physician time of 16 minutes for HCPCS
code GDDD1. We are seeking comment
on whether these work and time values
accurately capture the additional
physician work typically involved in
furnishing services to patients with
mobility impairments.
We believe that a direct crosswalk to
the clinical staff-time associated with
CPT code 99212, which is 27 minutes of
LN/LPN/MTA (L037D) accurately
represents the additional clinical staff
time required to furnish an outpatient
office visit or TCM to a patient with a
mobility-related disability. We are also
proposing to include as direct practice
expense inputs 27 minutes for a
stretcher (EF018) and a high/low table
(EF028), and 27 minutes for new
equipment inputs associated with the
following: A patient lift system,
wheelchair accessible scale, and padded
leg support positioning system. These
items are included in the CY 2017
proposed direct PE input database. We
are seeking comments on whether these
inputs are appropriate, and whether any
additional inputs are typically used in
treating patients with mobilityimpairments.
(43) Comprehensive Assessment and
Care Planning for Patients With
Cognitive Impairment (HCPCS Code
GPPP6)
For CY 2017, we are proposing to
create and pay separately for new
HCPCS code GPPP6 (Cognition and
functional assessment using
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standardized instruments with
development of recorded care plan for
the patient with cognitive impairment,
history face-to-face obtained from
patient and/or caregiver, in office or
other outpatient setting or home or
domiciliary or rest home), see II.E for
further discussion. Based on similarities
between work intensity and time, we
believe that the physician work and
time for this code would be accurately
valued by combining the work RVUs
from CPT code 99204 (Level 4 office or
other outpatient visit for the evaluation
and management of a new patient) and
half the work RVUs for HCPCS code
G0181 (Physician supervision of a
patient receiving Medicare-covered
services furnished by a participating
home health agency (patient not
present) requiring complex and
multidisciplinary care modalities
involving regular physician
development and/or revision of care
plans, review of subsequent reports of
patient status, review of laboratory and
other studies, communication
(including telephone calls) with other
health care professionals involved in the
patient’s care, integration of new
information into the medical treatment
plan and/or adjustment of medical
therapy, within a calendar month, 30
minutes or more). Therefore, we are
proposing a work RVU of 3.30. For
direct practice expense inputs we are
proposing 70 total minutes of time for
RN/LPN/MTA (L037D). We believe this
is typical based on information from
several specialty societies representing
practitioners who typically furnish this
service and report, it, when appropriate,
using E/M codes. We are seeking
comment on these valuation
assumptions and would welcome
additional information on the work and
direct practice expense associated with
furnishing this service.
(44) Comprehensive Assessment and
Care Planning for Patients Requiring
Chronic Care Management (HCPCS
Code GPPP7)
For CY 2017 we are proposing to
make payment for the resource costs of
comprehensive assessment and care
planning for patients requiring CCM
services through HCPCS code GPPP7 as
an add-on code to be billed with the
initiating visit for CCM for patients that
require extensive assessment and care
planning (see section II.E). In valuing
this code, we believe that a crosswalk to
half the work and time values of HCPCS
code G0181 (Physician supervision of a
patient receiving Medicare-covered
services provided by a participating
home health agency (patient not
present) requiring complex and
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multidisciplinary care modalities
involving regular physician
development and/or revision of care
plans, review of subsequent reports of
patient status, review of laboratory and
other studies, communication
(including telephone calls) with other
health care professionals involved in the
patient’s care, integration of new
information into the medical treatment
plan and/or adjustment of medical
therapy, within a calendar month, 30
minutes or more) accurately accounts
for the time and intensity of the work
associated with furnishing this service
over and above the work accounted for
as part of the separately billed initiating
visit. Therefore, we are proposing a
work RVU of 0.87 and 29 minutes of
physician time. We are also proposing
36 minutes for a RN/LPN/MTA (L037D)
as the only direct PE input for this
service.
(45) Telehealth Consultation for a
Patient Requiring Critical Care Services
(HCPCS Codes GTTT1 and GTTT2)
As discussed in section II.C, we are
proposing use of HCPCS G-codes,
GTTT1 (Telehealth consultation, critical
care, physicians typically spend 60
minutes communicating with the
patient via telehealth (initial) and
GTTT2 (Telehealth consultation, critical
care, physicians typically spend 50
minutes communicating with the
patient via telehealth (subsequent)), to
report telehealth consultations for a
patient requiring critical care services.
We note that due to limited coding
granularity for high-intensity cognitive
services, in the PFS, we do not believe
there is an intuitive crosswalk code for
ideal estimation of the work and time
values for GTTT1. In general, we believe
that the overall work for GTTT1 is not
as much as 99291 (Critical care,
evaluation and management of the
critically ill or critically injured patient;
first 30–74 minutes) but that the service
involves more work than G0427
(Telehealth consultation, emergency
department or initial inpatient, typically
70 minutes or more communicating
with the patient via telehealth). We
believe that GTTT1 is most accurately
valued by a crosswalk to the work RVU
and physician intra-service time of
38240 (Hematopoietic progenitor cell
(HPC); allogeneic transplantation per
donor) can therefore serve as an
appropriate crosswalk. Therefore we are
proposing a work RVU of 4.0 and are
seeking comment on the accuracy of
these assumptions. We do not believe
that direct PE inputs would typically be
involved with furnishing this service
from the distant site. For GTTT2 we are
proposing a work RVU of 3.86 based on
a crosswalk from G0427. We believe that
G0427 has similar overall work intensity
to GTTT2 and has a similar intraservice
time. We also believe that no direct PE
inputs would typically be associated
with furnishing this service from the
distant site.
TABLE 23—PROPOSED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES
HCPCS
Descriptor
Current work
RVU
00740 ...........
Anesthesia for upper gastrointestinal endoscopic procedures, endoscope introduced proximal to duodenum.
Anesthesia for lower intestinal endoscopic procedures, endoscope introduced distal to duodenum.
Placement of soft tissue localization device(s) (e.g., clip,
metallic pellet, wire/needle, radioactive seeds),
percutaneous, including imaging guidance; first lesion.
Placement of soft tissue localization device(s) (e.g., clip,
metallic pellet, wire/needle, radioactive seeds),
percutaneous, including imaging guidance; each additional lesion.
Avulsion of nail plate, partial or complete, simple; single ....
Avulsion of nail plate, partial or complete, simple; each additional nail plate.
Biopsy, bone, open; deep (e.g., humerus, ischium, femur)
Injection(s); single tendon sheath, or ligament, aponeurosis
(e.g., plantar ‘‘fascia’’).
Injection(s); single or multiple trigger point(s), 1 or 2 muscle(s).
Injection(s); single or multiple trigger point(s), 3 or more
muscles.
Insertion of interlaminar/interspinous process stabilization/
distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; single level.
Insertion of interlaminar/interspinous process stabilization/
distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; second level.
Insertion of interlaminar/interspinous process stabilization/
distraction device, without open decompression or fusion, including image guidance when performed, lumbar;
single level.
Insertion of interlaminar/interspinous process stabilization/
distraction device, without open decompression or fusion, including image guidance when performed, lumbar;
second level.
0.00 ................
0.00
0.00
No.
0.00 ................
0.00
0.00
No.
1.70 ................
........................
1.70
No.
0.85 ................
........................
0.85
No.
1.10 ................
0.44 ................
1.10
0.44
1.05
0.38
No.
Yes.
8.95 ................
0.75 ................
6.50
0.75
6.00
0.75
No.
No.
0.66 ................
0.66
0.66
No.
0.75 ................
0.75
0.75
No.
NEW ..............
15.00
13.50
No.
NEW ..............
4.00
4.00
No.
NEW ..............
7.39
7.03
No.
NEW ..............
2.34
2.34
No.
00810 ...........
10035 ...........
10036 ...........
11730 ...........
11732 ...........
20245 ...........
20550 ...........
20552 ...........
20553 ...........
228X1 ...........
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228X2 ...........
228X4 ...........
228X5 ...........
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TABLE 23—PROPOSED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued
HCPCS
Descriptor
Current work
RVU
22X81 ...........
Insertion of interbody biomechanical device(s) (e.g., synthetic cage, mesh) with integral anterior instrumentation
for device anchoring (e.g., screws, flanges) when performed to intervertebral disc space in conjunction with
interbody arthrodesis, each interspace.
Insertion of intervertebral biomechanical device(s) (e.g.,
synthetic cage, mesh) with integral anterior instrumentation for device anchoring (e.g., screws, flanges) when
performed to vertebral corpectomy(ies) (vertebral body
resection, partial or complete) defect, in conjunction with
interbody arthrodesis, each contiguous defect.
Insertion of intervertebral biomechanical device(s) (e.g.,
synthetic
cage,
mesh,
methylmethacrylate)
to
intervertebral disc space or vertebral body defect without
interbody arthrodesis, each contiguous defect.
Repair or advancement, flexor tendon, in zone 2 digital
flexor tendon sheath (e.g., no man’s land); primary, without free graft, each tendon.
Repair or advancement, flexor tendon, in zone 2 digital
flexor tendon sheath (e.g., no man’s land); secondary,
without free graft, each tendon.
Repair or advancement, flexor tendon, in zone 2 digital
flexor tendon sheath (e.g., no man’s land); secondary,
with free graft (includes obtaining graft), each tendon.
Closed treatment of posterior pelvic ring fracture(s), dislocation(s), diastasis or subluxation of the ilium, sacroiliac joint, and/or sacrum, with or without anterior pelvic
ring fracture(s) and/or dislocation(s) of the pubic symphysis and/or superior/inferior rami, unilateral or bilateral;
without manipulation.
Closed treatment of posterior pelvic ring fracture(s), dislocation(s), diastasis or subluxation of the ilium, sacroiliac joint, and/or sacrum, with or without anterior pelvic
ring fracture(s) and/or dislocation(s) of the pubic symphysis and/or superior/inferior rami, unilateral or bilateral;
with manipulation, requiring more than local anesthesia
(i.e., general anesthesia, moderate sedation, spinal/epidural).
Hallux rigidus correction with cheilectomy, debridement
and capsular release of the first metatarsophalangeal
joint.
Correction, hallux valgus (bunion), with or without
sesamoidectomy; Keller, McBride, or Mayo type procedure.
Correction, hallux valgus (bunion), with or without
sesamoidectomy; with metatarsal osteotomy (e.g., Mitchell, Chevron, or concentric type procedures).
Correction, hallux valgus (bunion), with or without
sesamoidectomy; Lapidus-type procedure.
Correction, hallux valgus (bunion), with or without
sesamoidectomy; by phalanx osteotomy.
Correction, hallux valgus (bunion), with or without
sesamoidectomy; by double osteotomy.
Hallux rigidus correction with cheilectomy, debridement
and capsular release of the first metatarsophalangeal
joint; with implant.
Correction,
hallux
valgus
(bunionectomy),
with
sesamoidectomy, when performed; with proximal metatarsal osteotomy, any method.
Intubation, endotracheal, emergency procedure ..................
Laryngoscopy, flexible fiberoptic; diagnostic ........................
Laryngoscopy, flexible fiberoptic; with biopsy ......................
Laryngoscopy, flexible fiberoptic; with removal of foreign
body.
Laryngoscopy, flexible fiberoptic; with removal of lesion .....
Laryngoscopy, flexible or rigid fiberoptic, with stroboscopy
Laryngoscopy, flexible; with ablation or destruction of lesion(s) with laser, unilateral.
NEW ..............
4.88
4.25
No.
NEW ..............
5.50
5.50
No.
NEW ..............
6.00
5.50
No.
9.56 ................
........................
9.56
No.
10.53 ..............
........................
11.00
No.
12.13 ..............
........................
12.60
No.
NEW ..............
5.50
1.53
Yes.
NEW ..............
9.00
4.75
Yes.
8.31 ................
6.90
6.90
No.
9.05 ................
7.44
7.44
No.
8.35 ................
8.25
8.25
No.
9.43 ................
9.29
9.29
No.
8.13 ................
7.75
7.75
No.
11.57 ..............
9.29
9.29
No.
NEW ..............
8.01
7.81
No.
NEW ..............
8.57
8.25
No.
2.33
1.10
1.97
2.47
................
................
................
................
3.00
1.00
1.95
2.25
2.66
0.94
1.89
2.19
No.
No.
No.
No.
2.84 ................
2.26 ................
NEW ..............
2.49
1.94
3.07
2.43
1.88
3.01
No.
No.
No.
22X82 ...........
22X83 ...........
26356 ...........
26357 ...........
26358 ...........
271X1 ...........
271X2 ...........
28289 ...........
28292 ...........
28296 ...........
28297 ...........
28298 ...........
28299 ...........
282X1 ...........
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282X2 ...........
31500
31575
31576
31577
...........
...........
...........
...........
31578 ...........
31579 ...........
317X1 ...........
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TABLE 23—PROPOSED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued
HCPCS
Descriptor
Current work
RVU
317X2 ...........
Laryngoscopy, flexible; with therapeutic injection(s) (e.g.,
chemodenervation agent or corticosteroid, injected
percutaneous, transoral, or via endoscope channel), unilateral.
Laryngoscopy, flexible; with injection(s) for augmentation
(e.g., percutaneous, transoral), unilateral.
Laryngoplasty; for laryngeal web, 2-stage, with keel insertion and removal.
Laryngoplasty; with open reduction of fracture ....................
Laryngoplasty, cricoid split ...................................................
Laryngoplasty; for laryngeal stenosis, with graft, without indwelling stent placement, younger than 12 years of age.
Laryngoplasty; for laryngeal stenosis, with graft, without indwelling stent placement, age 12 years or older.
Laryngoplasty; for laryngeal stenosis, with graft, with indwelling stent placement, younger than 12 years of age.
Laryngoplasty; for laryngeal stenosis, with graft, with indwelling stent placement, age 12 years or older.
Laryngoplasty, medialization; unilateral ...............................
Cricotracheal resection .........................................................
Percutaneous transcatheter closure of the left atrial appendage with endocardial implant, including fluoroscopy,
transseptal puncture, catheter placement(s), left atrial
angiography, left atrial appendage angiography, when
performed, and radiological supervision and interpretation.
Valvuloplasty, aortic valve, open, with cardiopulmonary bypass; simple (i.e., valvotomy, debridement, debulking
and/or simple commissural resuspension).
Valvuloplasty, aortic valve, open, with cardiopulmonary bypass; complex (e.g., leaflet extension, leaflet resection,
leaflet reconstruction or annuloplasty).
Partial exchange transfusion, blood, plasma or crystalloid
necessitating the skill of a physician or other qualified
health care professional, newborn.
Push transfusion, blood, 2 years or younger .......................
Exchange transfusion, blood; newborn ................................
Exchange transfusion, blood; other than newborn ..............
Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring,
percutaneous, mechanochemical; first vein treated.
Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring,
percutaneous, mechanochemical; subsequent vein(s)
treated in a single extremity, each through separate access sites.
Introduction of needle(s) and/or catheter(s), dialysis circuit,
with diagnostic angiography of the dialysis circuit, including all direct puncture(s) and catheter placement(s), injection(s) of contrast, all necessary imaging from the arterial anastomosis and adjacent artery through entire venous outflow including the inferior or superior vena cava,
fluoroscopic guidance, radiologic supervision and interpretation and image documentation and report.
Introduction of needle(s) and/or catheter(s), dialysis circuit,
with diagnostic angiography of the dialysis circuit, including all direct puncture(s) and catheter placement(s), injection(s) of contrast, all necessary imaging from the arterial anastomosis and adjacent artery through entire venous outflow including the inferior or superior vena cava,
fluoroscopic guidance, radiologic supervision and interpretation and image documentation and report; with
transluminal balloon angioplasty, peripheral dialysis segment, including all imaging and radiological supervision
and interpretation necessary to perform the angioplasty.
NEW ..............
2.49
2.43
No.
NEW ..............
2.49
2.43
No.
14.66 ..............
14.60
14.60
No.
20.47 ..............
15.27 ..............
NEW ..............
20.00
15.27
21.50
17.58
15.27
21.50
No.
No.
No.
NEW ..............
20.50
20.50
No.
NEW ..............
22.00
22.00
No.
NEW ..............
22.00
22.00
No.
NEW ..............
NEW ..............
NEW ..............
15.60
25.00
14.00
13.56
25.00
13.00
No.
No.
No.
NEW ..............
35.00
35.00
No.
NEW ..............
44.00
41.50
No.
NEW ..............
2.00
2.00
No.
1.03 ................
2.23 ................
2.43 ................
NEW ..............
1.03
3.50
2.43
3.50
1.03
3.50
2.43
3.50
No.
No.
No.
No.
NEW ..............
2.25
1.75
No.
NEW ..............
3.36
2.82
No.
NEW ..............
4.83
4.24
No.
317X3 ...........
31580 ...........
31584 ...........
31587 ...........
315X1 ...........
315X2 ...........
315X3 ...........
315X4 ...........
315X5 ...........
315X6 ...........
333X3 ...........
334X1 ...........
334X2 ...........
364X1 ...........
36440
36450
36455
36X41
...........
...........
...........
...........
364X2 ...........
369X1 ...........
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369X2 ...........
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TABLE 23—PROPOSED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued
HCPCS
Descriptor
Current work
RVU
369X3 ...........
Introduction of needle(s) and/or catheter(s), dialysis circuit,
with diagnostic angiography of the dialysis circuit, including all direct puncture(s) and catheter placement(s), injection(s) of contrast, all necessary imaging from the arterial anastomosis and adjacent artery through entire venous outflow including the inferior or superior vena cava,
fluoroscopic guidance, radiologic supervision and interpretation and image documentation and report; with
transcatheter placement of intravascular stent(s) peripheral dialysis segment, including all imaging and radiological supervision and interpretation necessary to perform the stenting, and all angioplasty within the peripheral dialysis segment.
Percutaneous transluminal mechanical thrombectomy and/
or infusion for thrombolysis, dialysis circuit, any method,
including all imaging and radiological supervision and interpretation, diagnostic angiography, fluoroscopic guidance, catheter placement(s), and intraprocedural pharmacological thrombolytic injection(s).
Percutaneous transluminal mechanical thrombectomy and/
or infusion for thrombolysis, dialysis circuit, any method,
including all imaging and radiological supervision and interpretation, diagnostic angiography, fluoroscopic guidance, catheter placement(s), and intraprocedural pharmacological thrombolytic injection(s); with transluminal
balloon angioplasty, peripheral dialysis segment, including all imaging and radiological supervision and interpretation necessary to perform the angioplasty.
Percutaneous transluminal mechanical thrombectomy and/
or infusion for thrombolysis, dialysis circuit, any method,
including all imaging and radiological supervision and interpretation, diagnostic angiography, fluoroscopic guidance, catheter placement(s), and intraprocedural pharmacological thrombolytic injection(s); with transcatheter
placement of an intravascular stent(s), peripheral dialysis
segment, including all imaging and radiological supervision and interpretation to perform the stenting and all
angioplasty within the peripheral dialysis circuit.
Transluminal balloon angioplasty, central dialysis segment,
performed through dialysis circuit, including all imaging
and radiological supervision and interpretation required
to perform the angioplasty.
Transcatheter placement of an intravascular stent(s), central dialysis segment, performed through dialysis circuit,
including all imaging and radiological supervision and interpretation required to perform the stenting, and all
angioplasty in the central dialysis segment.
Dialysis circuit permanent vascular embolization or occlusion (including main circuit or any accessory veins),
endovascular, including all imaging and radiological supervision and interpretation necessary to complete the
intervention.
Transluminal balloon angioplasty (except lower extremity
artery(s) for occlusive disease, intracranial, coronary,
pulmonary, or dialysis circuit), open or percutaneous, including all imaging and radiological supervision and interpretation necessary to perform the angioplasty within
the same artery; initial artery.
Transluminal balloon angioplasty (except lower extremity
artery(s) for occlusive disease, intracranial, coronary,
pulmonary, or dialysis circuit), open or percutaneous, including all imaging and radiological supervision and interpretation necessary to perform the angioplasty within
the same artery; each additional artery.
Transluminal balloon angioplasty (except dialysis circuit),
open or percutaneous, including all imaging and radiological supervision and interpretation necessary to perform the angioplasty within the same vein; initial vein.
NEW ..............
6.39
5.85
No.
NEW ..............
7.50
6.73
No.
NEW ..............
9.00
8.46
No.
NEW ..............
10.42
9.88
No.
NEW ..............
3.00
2.48
No.
NEW ..............
4.25
3.73
No.
NEW ..............
4.12
3.48
No.
NEW ..............
7.00
7.00
No.
NEW ..............
3.50
3.50
No.
NEW ..............
6.00
6.00
No.
369X4 ...........
369X5 ...........
369X6 ...........
369X7 ...........
369X8 ...........
369X9 ...........
372X1 ...........
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
372X2 ...........
372X3 ...........
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TABLE 23—PROPOSED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued
HCPCS
Descriptor
Current work
RVU
372X4 ...........
Transluminal balloon angioplasty (except dialysis circuit),
open or percutaneous, including all imaging and radiological supervision and interpretation necessary to perform the angioplasty within the same vein; each additional vein.
Submucosal ablation of the tongue base, radiofrequency, 1
or more sites, per session.
Esophagogastroduodenoscopy, flexible, transoral; with
esophagogastric fundoplasty, partial or complete, includes duodenoscopy when performed.
Laparoscopy, surgical, esophageal sphincter augmentation
procedure, placement of sphincter augmentation device
(i.e., magnetic band), including cruroplasty when performed.
Removal of esophageal sphincter augmentation device .....
Injection procedure for cholangiography, percutaneous,
complete diagnostic procedure including imaging guidance (e.g., ultrasound and/or fluoroscopy) and all associated radiological supervision and interpretation; existing
access.
Injection procedure for cholangiography, percutaneous,
complete diagnostic procedure including imaging guidance (e.g., ultrasound and/or fluoroscopy) and all associated radiological supervision and interpretation; new access (e.g., percutaneous transhepatic cholangiogram).
Placement of biliary drainage catheter, percutaneous, including diagnostic cholangiography when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy),
and all associated radiological supervision and interpretation; external.
Placement of biliary drainage catheter, percutaneous, including diagnostic cholangiography when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy),
and all associated radiological supervision and interpretation; internal-external.
Conversion of external biliary drainage catheter to internalexternal biliary drainage catheter, percutaneous, including diagnostic cholangiography when performed, imaging
guidance (e.g., fluoroscopy), and all associated radiological supervision and interpretation.
Exchange of biliary drainage catheter (e.g., external, internal-external, or conversion of internal-external to external
only),
percutaneous,
including
diagnostic
cholangiography when performed, imaging guidance
(e.g., fluoroscopy), and all associated radiological supervision and interpretation.
Removal of biliary drainage catheter, percutaneous, requiring fluoroscopic guidance (e.g., with concurrent indwelling biliary stents), including diagnostic cholangiography
when performed, imaging guidance (e.g., fluoroscopy),
and all associated radiological supervision and interpretation.
Placement of stent(s) into a bile duct, percutaneous, including diagnostic cholangiography, imaging guidance
(e.g., fluoroscopy and/or ultrasound), balloon dilation,
catheter exchange(s) and catheter removal(s) when performed, and all associated radiological supervision and
interpretation, each stent; existing access.
Placement of stent(s) into a bile duct, percutaneous, including diagnostic cholangiography, imaging guidance
(e.g., fluoroscopy and/or ultrasound), balloon dilation,
catheter exchange(s) and catheter removal(s) when performed, and all associated radiological supervision and
interpretation, each stent; new access, without placement of separate biliary drainage catheter.
NEW ..............
2.97
2.97
No.
3.50 ................
........................
3.50
No.
7.75 ................
........................
7.75
No.
NEW ..............
10.13
9.03
No.
NEW ..............
1.80 ................
10.47
1.30
9.37
1.30
No.
No.
4.25 ................
4.32
4.25
No.
6.00 ................
5.45
5.38
No.
8.03 ................
7.67
7.60
No.
4.50 ................
4.02
3.95
No.
2.88 ................
2.68
2.61
No.
1.83 ................
1.84
1.84
No.
6.60 ................
4.82
4.75
No.
9.00 ................
8.82
8.75
No.
41530 ...........
43210 ...........
432X1 ...........
432X2 ...........
47531 ...........
47532 ...........
47533 ...........
47534 ...........
47535 ...........
47536 ...........
47537 ...........
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
47538 ...........
47539 ...........
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TABLE 23—PROPOSED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued
HCPCS
Descriptor
Current work
RVU
47540 ...........
Placement of stent(s) into a bile duct, percutaneous, including diagnostic cholangiography, imaging guidance
(e.g., fluoroscopy and/or ultrasound), balloon dilation,
catheter exchange(s) and catheter removal(s) when performed, and all associated radiological supervision and
interpretation, each stent; new access, with placement of
separate biliary drainage catheter (e.g., external or internal-external).
Placement of access through the biliary tree and into small
bowel to assist with an endoscopic biliary procedure
(e.g., rendezvous procedure), percutaneous, including
diagnostic cholangiography when performed, imaging
guidance (e.g., ultrasound and/or fluoroscopy), and all
associated radiological supervision and interpretation,
new access.
Balloon dilation of biliary duct(s) or of ampulla
(sphincteroplasty), percutaneous, including imaging guidance (e.g., fluoroscopy), and all associated radiological
supervision and interpretation, each duct.
Endoluminal biopsy(ies) of biliary tree, percutaneous, any
method(s) (e.g., brush, forceps, and/or needle), including
imaging guidance (e.g., fluoroscopy), and all associated
radiological supervision and interpretation, single or multiple.
Removal of calculi/debris from biliary duct(s) and/or gallbladder, percutaneous, including destruction of calculi by
any method (e.g., mechanical, electrohydraulic,
lithotripsy) when performed, imaging guidance (e.g., fluoroscopy), and all associated radiological supervision and
interpretation.
Sclerotherapy of a fluid collection (e.g., lymphocele, cyst,
or seroma), percutaneous, including contrast injection(s),
sclerosant injection(s), diagnostic study, imaging guidance (e.g., ultrasound, fluoroscopy) and radiological supervision and interpretation when performed.
Endoluminal biopsy of ureter and/or renal pelvis, nonendoscopic, including imaging guidance (e.g., ultrasound
and/or fluoroscopy) and all associated radiological supervision and interpretation.
Ureteral embolization or occlusion, including imaging guidance (e.g., ultrasound and/or fluoroscopy) and all associated radiological supervision and interpretation.
Balloon dilation, ureteral stricture, including imaging guidance (e.g., ultrasound and/or fluoroscopy) and all associated radiological supervision and interpretation.
Bladder irrigation, simple, lavage and/or instillation .............
Insertion of non-indwelling bladder catheter (e.g., straight
catheterization for residual urine).
Insertion of temporary indwelling bladder catheter; simple
(e.g., Foley).
Insertion of temporary indwelling bladder catheter; complicated (e.g., altered anatomy, fractured catheter/balloon).
Bladder instillation of anticarcinogenic agent (including retention time).
Electromyography studies (EMG) of anal or urethral
sphincter, other than needle, any technique.
Cystourethroscopy (separate procedure) .............................
Biopsy, prostate; needle or punch, single or multiple, any
approach.
Laparoscopy, surgical prostatectomy, retropubic radical, including nerve sparing, includes robotic assistance, when
performed.
Hysteroscopy, diagnostic (separate procedure) ...................
Hysteroscopy, surgical; with sampling (biopsy) of endometrium and/or polypectomy, with or without D & C.
Hysteroscopy, surgical; with lysis of intrauterine adhesions
(any method).
Hysteroscopy, surgical; with division or resection of intrauterine septum (any method).
Hysteroscopy, surgical; with removal of leiomyomata .........
10.75 ..............
9.10
9.03
No.
5.61 ................
6.82
5.38
No.
2.50 ................
2.85
2.85
No.
3.07 ................
3.00
3.00
No.
4.29 ................
3.28
3.28
No.
2.35 ................
........................
2.35
No.
3.16 ................
........................
3.16
No.
4.03 ................
........................
4.03
No.
3.80 ................
........................
3.80
No.
0.88 ................
0.50 ................
0.60
0.50
0.60
0.50
No.
No.
0.50 ................
0.50
0.50
No.
1.47 ................
1.47
1.47
No.
1.50 ................
0.87
0.87
No.
1.53 ................
0.75
0.75
No.
2.23 ................
2.58 ................
1.75
2.50
1.53
2.06
No.
No.
21.36 ..............
........................
21.36
No.
3.33 ................
4.74 ................
3.07
4.37
2.65
4.17
No.
No.
6.16 ................
5.54
5.20
No.
6.99 ................
6.15
5.75
No.
9.99 ................
7.00
6.60
No.
47541 ...........
47542 ...........
47543 ...........
47544 ...........
49185 ...........
50606 ...........
50705 ...........
50706 ...........
51700 ...........
51701 ...........
51702 ...........
51703 ...........
51720 ...........
51784 ...........
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
52000 ...........
55700 ...........
55866 ...........
58555 ...........
58558 ...........
58559 ...........
58560 ...........
58561 ...........
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TABLE 23—PROPOSED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued
HCPCS
Descriptor
Current work
RVU
58562 ...........
Hysteroscopy, surgical; with removal of impacted foreign
body.
Hysteroscopy, surgical; with endometrial ablation (e.g.,
endometrial
resection,
electrosurgical
ablation,
thermoablation).
Laparoscopy, surgical, ablation of uterine fibroid(s) including intraoperative ultrasound guidance and monitoring,
radiofrequency.
Balloon dilatation of intracranial vasospasm, percutaneous;
initial vessel.
Balloon dilatation of intracranial vasospasm, percutaneous;
each additional vessel in same vascular family.
Balloon dilatation of intracranial vasospasm, percutaneous;
each additional vessel in different vascular family.
Percutaneous
arterial
transluminal
mechanical
thrombectomy and/or infusion for thrombolysis,
intracranial,
any
method,
including
diagnostic
angiography, fluoroscopic guidance, catheter placement,
and intraprocedural pharmacological thrombolytic injection(s).
Endovascular intracranial prolonged administration of pharmacologic agent(s) other than for thrombolysis, arterial,
including catheter placement, diagnostic angiography,
and imaging guidance; initial vascular territory.
Endovascular intracranial prolonged administration of pharmacologic agent(s) other than for thrombolysis, arterial,
including catheter placement, diagnostic angiography,
and imaging guidance; each additional vascular territory.
Injection(s), of diagnostic or therapeutic substance(s) (e.g.,
anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, cervical or thoracic; without imaging guidance.
Injection(s), of diagnostic or therapeutic substance(s) (e.g.,
anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, cervical or thoracic; with imaging guidance
(i.e., fluoroscopy or CT).
Injection(s), of diagnostic or therapeutic substance(s) (e.g.,
anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); without imaging
guidance.
Injection(s), of diagnostic or therapeutic substance(s) (e.g.,
anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); with imaging guidance (ie, fluoroscopy or CT).
Injection(s), including indwelling catheter placement, continuous infusion or intermittent bolus, of diagnostic or
therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including
neurolytic substances, interlaminar epidural or subarachnoid, cervical or thoracic; without imaging guidance.
Injection(s), including indwelling catheter placement, continuous infusion or intermittent bolus, of diagnostic or
therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including
neurolytic substances, interlaminar epidural or subarachnoid, cervical or thoracic; with imaging guidance (ie, fluoroscopy or CT).
5.20 ................
4.17
4.00
No.
6.16 ................
4.62
4.47
No.
NEW ..............
14.08
14.08
No.
N ....................
N
N
No.
N ....................
N
N
No.
N ....................
N
N
No.
15.00 ..............
........................
15.00
No.
10.00 ..............
........................
10.00
No.
4.25 ................
........................
4.25
No.
NEW ..............
1.80
1.80
No.
NEW ..............
1.95
1.95
No.
NEW ..............
1.55
1.55
No.
NEW ..............
1.80
1.80
No.
NEW ..............
1.89
1.89
No.
NEW ..............
2.20
2.20
No.
58563 ...........
585X1 ...........
61640 ...........
61641 ...........
61642 ...........
61645 ...........
61650 ...........
61651 ...........
623X5 ...........
623X6 ...........
623X7 ...........
623X8 ...........
623X9 ...........
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
62X10 ...........
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TABLE 23—PROPOSED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued
HCPCS
Descriptor
Current work
RVU
62X11 ...........
Injection(s), including indwelling catheter placement, continuous infusion or intermittent bolus, of diagnostic or
therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including
neurolytic substances, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); without imaging guidance.
Injection(s), including indwelling catheter placement, continuous infusion or intermittent bolus, of diagnostic or
therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including
neurolytic substances, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); with imaging guidance
(ie, fluoroscopy or CT).
Endoscopic decompression of spinal cord, nerve root(s),
including laminotomy, partial facetectomy, foraminotomy,
discectomy and/or excision of herniated intervertebral
disc; 1 interspace, lumbar.
Paravertebral block (PVB) (paraspinous block), thoracic;
single injection site (includes imaging guidance, when
performed).
Paravertebral block (PVB) (paraspinous block), thoracic;
second and any additional injection site(s) (includes imaging guidance, when performed).
Paravertebral block (PVB) (paraspinous block), thoracic;
continuous infusion by catheter (includes imaging guidance, when performed).
Percutaneous implantation of neurostimulator electrode
array; cranial nerve.
Percutaneous implantation of neurostimulator electrode
array; peripheral nerve (excludes sacral nerve).
Posterior tibial neurostimulation, percutaneous needle electrode, single treatment, includes programming.
Placement of amniotic membrane on the ocular surface;
without sutures.
Placement of amniotic membrane on the ocular surface;
single layer, sutured.
Ocular surface reconstruction; amniotic membrane transplantation, multiple layers.
Trabeculoplasty by laser surgery .........................................
Fistulization of sclera for glaucoma; trabeculectomy ab
externo in absence of previous surgery.
Fistulization of sclera for glaucoma; trabeculectomy ab
externo with scarring from previous ocular surgery or
trauma (includes injection of antifibrotic agents).
Repair of retinal detachment, 1 or more sessions;
cryotherapy or diathermy, including drainage of subretinal fluid, when performed.
Repair of retinal detachment, 1 or more sessions;
photocoagulation, including drainage of subretinal fluid,
when performed.
Repair of retinal detachment; scleral buckling (such as lamellar scleral dissection, imbrication or encircling procedure), including, when performed, implant, cryotherapy,
photocoagulation, and drainage of subretinal fluid.
Repair of retinal detachment; with vitrectomy, any method,
including, when performed, air or gas tamponade, focal
endolaser photocoagulation, cryotherapy, drainage of
subretinal fluid, scleral buckling, and/or removal of lens
by same technique.
Repair of retinal detachment; by injection of air or other
gas (e.g., pneumatic retinopexy).
Repair of complex retinal detachment (e.g., proliferative
vitreoretinopathy, stage C–1 or greater, diabetic traction
retinal detachment, retinopathy of prematurity, retinal
tear of greater than 90 degrees), with vitrectomy and
membrane peeling, including, when performed, air, gas,
or silicone oil tamponade, cryotherapy, endolaser
photocoagulation, drainage of subretinal fluid, scleral
buckling, and/or removal of lens.
NEW ..............
1.78
1.78
No.
NEW ..............
1.90
1.90
No.
NEW ..............
10.47
9.09
No.
1.75 ................
........................
1.75
No.
1.10 ................
........................
1.10
No.
1.81 ................
........................
1.81
No.
2.36 ................
........................
2.36
Yes.
2.32 ................
........................
2.32
Yes.
0.60 ................
........................
0.60
No.
1.00 ................
........................
1.00
No.
2.50 ................
........................
2.50
No.
7.81 ................
........................
7.81
No.
2.66 ................
11.27 ..............
........................
........................
2.77
11.27
No.
No.
12.57 ..............
........................
12.57
No.
8.80 ................
3.50
3.50
No.
8.53 ................
3.84
3.39
No.
14.06 ..............
........................
14.06
No.
15.19 ..............
........................
15.19
No.
8.31 ................
........................
8.31
No.
19.00 ..............
........................
19.00
No.
62X12 ...........
630X1 ...........
64461 ...........
64462 ...........
64463 ...........
64553 ...........
64555 ...........
64566 ...........
65778 ...........
65779 ...........
65780 ...........
65855 ...........
66170 ...........
66172 ...........
67101 ...........
67105 ...........
67107 ...........
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
67108 ...........
67110 ...........
67113 ...........
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TABLE 23—PROPOSED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued
HCPCS
Descriptor
Current work
RVU
RUC work
RVU
67227 ...........
Destruction of extensive or progressive retinopathy (e.g.,
diabetic retinopathy), cryotherapy, diathermy.
Treatment of extensive or progressive retinopathy (e.g., diabetic retinopathy), photocoagulation.
Magnetic resonance (e.g., proton) imaging, orbit, face,
and/or neck; without contrast material(s).
Magnetic resonance (e.g., proton) imaging, orbit, face,
and/or neck; with contrast material(s).
Magnetic resonance (e.g., proton) imaging, orbit, face,
and/or neck; without contrast material(s), followed by
contrast material(s) and further sequences.
Radiologic examination, pelvis; 1 or 2 views .......................
Radiologic examination, hip, unilateral, with pelvis when
performed; 1 view.
Radiologic examination, hip, unilateral, with pelvis when
performed; 2–3 views.
Radiologic examination, hip, unilateral, with pelvis when
performed; minimum of 4 views.
Radiologic examination, hips, bilateral, with pelvis when
performed; 2 views.
Radiologic examination, hips, bilateral, with pelvis when
performed; 3–4 views.
Radiologic examination, hips, bilateral, with pelvis when
performed; minimum of 5 views.
Radiologic examination, femur; 1 view ................................
Radiologic examination, femur; minimum 2 views ...............
Magnetic resonance (e.g., proton) imaging, fetal, including
placental and maternal pelvic imaging when performed;
single or first gestation.
Magnetic resonance (e.g., proton) imaging, fetal, including
placental and maternal pelvic imaging when performed;
each additional gestation.
Ultrasound, abdominal aorta, real time with image documentation, screening study for abdominal aortic aneurysm.
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).
Fluoroscopic guidance for needle placement (e.g., 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).
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).
Fluoroscopic guidance for needle placement (e.g., 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).
Treatment devices, design and construction; simple (simple block, simple bolus).
Treatment devices, design and construction; intermediate
(multiple blocks, stents, bite blocks, special bolus).
Treatment devices, design and construction; complex (irregular blocks, special shields, compensators, wedges,
molds or casts).
Special treatment procedure (e.g., total body irradiation,
hemibody radiation, per oral or endocavitary irradiation).
3.50 ................
........................
3.50
No.
4.39 ................
........................
4.39
No.
1.35 ................
1.35
1.35
No.
1.62 ................
1.62
1.62
No.
2.15 ................
2.15
2.15
No.
0.17 ................
0.18 ................
........................
........................
0.17
0.18
No.
No.
0.22 ................
........................
0.22
No.
0.27 ................
........................
0.27
No.
0.22 ................
........................
0.22
No.
0.29 ................
........................
0.29
No.
0.31 ................
........................
0.31
No.
0.16 ................
0.18 ................
3.00 ................
........................
........................
........................
0.16
0.18
3.00
No.
No.
No.
1.78 ................
........................
1.85
No.
NEW ..............
0.55
0.55
No.
0.38 ................
0.38
0.38
No.
0.54 ................
0.54
0.38
No.
0.60 ................
0.60
0.38
No.
NEW ..............
0.81
0.81
No.
NEW ..............
1.00
1.00
No.
NEW ..............
0.76
0.76
No.
0.54 ................
0.54
0.45
No.
0.84 ................
0.84
0.75
No.
1.24 ................
1.24
1.15
No.
2.09 ................
2.03
2.03
No.
67228 ...........
70540 ...........
70542 ...........
70543 ...........
72170 ...........
73501 ...........
73502 ...........
73503 ...........
73521 ...........
73522 ...........
73523 ...........
73551 ...........
73552 ...........
74712 ...........
74713 ...........
767X1 ...........
77001 ...........
77002 ...........
77003 ...........
770X1 ...........
770X2 ...........
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
770X3 ...........
77332 ...........
77333 ...........
77334 ...........
77470 ...........
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TABLE 23—PROPOSED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued
HCPCS
Descriptor
Current work
RVU
RUC work
RVU
77778 ...........
Interstitial radiation source application, complex, includes
supervision, handling, loading of radiation source, when
performed.
Supervision, handling, loading of radiation source ..............
Gastric emptying imaging study (e.g., solid, liquid, or both)
Gastric emptying imaging study (e.g., solid, liquid, or both);
with small bowel transit.
Gastric emptying imaging study (e.g., solid, liquid, or both);
with small bowel and colon transit, multiple days.
Cytopathology, fluids, washings or brushings, except cervical or vaginal; smears with interpretation.
Cytopathology, fluids, washings or brushings, except cervical or vaginal; simple filter method with interpretation.
Cytopathology, concentration technique, smears and interpretation (e.g., Saccomanno technique).
Cytopathology, selective cellular enhancement technique
with interpretation (e.g., liquid based slide preparation
method), except cervical or vaginal.
Cytopathology, smears, any other source; screening and
interpretation.
Cytopathology, smears, any other source; preparation,
screening and interpretation.
Cytopathology, smears, any other source; extended study
involving over 5 slides and/or multiple stains.
Flow cytometry, cell surface, cytoplasmic, or nuclear marker, technical component only; first marker.
Flow cytometry, cell surface, cytoplasmic, or nuclear marker, technical component only; each additional marker.
Flow cytometry, interpretation; 2 to 8 markers ....................
Flow cytometry, interpretation; 9 to 15 markers ..................
Flow cytometry, interpretation; 16 or more markers ............
Consultation and report on referred slides prepared elsewhere.
Consultation and report on referred material requiring preparation of slides.
Consultation, comprehensive, with review of records and
specimens, with report on referred material.
Immunohistochemistry or immunocytochemistry, per specimen; each additional single antibody stain procedure
(List separately in addition to code for primary procedure).
In situ hybridization (e.g., FISH), per specimen; each additional single probe stain procedure.
Morphometric analysis, in situ hybridization (quantitative or
semi-quantitative), manual, per specimen; each additional single probe stain procedure.
Gastrointestinal tract imaging, intraluminal (e.g., capsule
endoscopy), esophagus through ileum, with interpretation and report.
Gastrointestinal tract imaging, intraluminal (e.g., capsule
endoscopy), esophagus with interpretation and report.
Liver elastography, mechanically induced shear wave (e.g.,
vibration), without imaging, with interpretation and report.
Scanning computerized ophthalmic diagnostic imaging, anterior segment, with interpretation and report, unilateral
or bilateral.
Scanning computerized ophthalmic diagnostic imaging,
posterior segment, with interpretation and report, unilateral or bilateral; optic nerve.
Scanning computerized ophthalmic diagnostic imaging,
posterior segment, with interpretation and report, unilateral or bilateral; retina.
Fluorescein angiography (includes multiframe imaging)
with interpretation and report.
Indocyanine-green angiography (includes multiframe imaging) with interpretation and report.
Fundus photography with interpretation and report .............
Fluorescein
angiography
and
indocyanine-green
angiography (includes multiframe imaging) performed at
the same patient encounter with interpretation and report, unilateral or bilateral.
8.00 ................
........................
8.00
No.
0.00 ................
0.74 ................
0.98 ................
........................
........................
........................
0.00
0.74
0.98
No.
No.
No.
1.08 ................
........................
1.08
No.
0.56 ................
........................
0.56
No.
0.37 ................
........................
0.37
No.
0.44 ................
........................
0.44
No.
0.56 ................
........................
0.56
No.
0.50 ................
........................
0.50
No.
0.50 ................
........................
0.50
No.
0.76 ................
........................
0.76
No.
0.00 ................
0.00
0.00
No.
0.00 ................
0.00
0.00
No.
1.36
1.69
2.23
1.63
................
................
................
................
0.74
1.40
1.70
1.63
0.74
1.20
1.70
1.63
No.
No.
No.
No.
1.83 ................
1.83
1.83
No.
2.50 ................
2.85
2.85
No.
0.53 ................
........................
0.56
No.
0.67 ................
........................
0.70
No.
0.67 ................
........................
0.67
No.
3.64 ................
2.49
2.49
No.
1.00 ................
1.00
1.00
No.
0.27 ................
........................
0.27
No.
0.35 ................
0.30
0.30
No.
0.50 ................
0.40
0.40
No.
0.50 ................
0.45
0.45
No.
0.81 ................
0.75
0.75
No.
1.10 ................
0.80
0.80
No.
0.44 ................
NEW ..............
0.40
0.95
0.40
0.95
No.
No.
77790 ...........
78264 ...........
78265 ...........
78266 ...........
88104 ...........
88106 ...........
88108 ...........
88112 ...........
88160 ...........
88161 ...........
88162 ...........
88184 ...........
88185 ...........
88187
88188
88189
88321
...........
...........
...........
...........
88323 ...........
88325 ...........
88341 ...........
88364 ...........
88369 ...........
91110 ...........
91111 ...........
91200 ...........
92132 ...........
92133 ...........
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
92134 ...........
92235 ...........
92240 ...........
92250 ...........
922X4 ...........
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TABLE 23—PROPOSED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued
HCPCS
Descriptor
Current work
RVU
RUC work
RVU
93050 ...........
Arterial pressure waveform analysis for assessment of
central arterial pressures, includes obtaining waveform(s), digitization and application of nonlinear mathematical transformations to determine central arterial
pressures and augmentation index, with interpretation
and report, upper extremity artery, non-invasive.
Percutaneous transcatheter closure of paravalvular leak;
initial occlusion device, mitral valve.
Percutaneous transcatheter closure of paravalvular leak;
initial occlusion device, aortic valve.
Percutaneous transcatheter closure of paravalvular leak;
each additional occlusion device (list separately in addition to code for primary service).
Professional services for the supervision of preparation
and provision of antigens for allergen immunotherapy,
single dose vial(s) (specify number of vials).
Professional services for the supervision of preparation
and provision of antigens for allergen immunotherapy;
single or multiple antigens (specify number of doses).
Electroencephalogram (EEG) extended monitoring; 41–60
minutes.
Electroencephalogram (EEG) extended monitoring; greater
than 1 hour.
Digital analysis of electroencephalogram (EEG) (e.g., for
epileptic spike analysis).
Electronic analysis of implanted neurostimulator pulse generator system (e.g., 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 (i.e., peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter,
with intraoperative or subsequent programming.
Electronic analysis of implanted neurostimulator pulse generator system (e.g., 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 (i.e, peripheral nerve, sacral nerve, neuromuscular) (except cranial nerve) neurostimulator pulse
generator/transmitter, with intraoperative or subsequent
programming.
Administration of patient-focused health risk assessment
instrument (e.g., health hazard appraisal) with scoring
and documentation, per standardized instrument.
Administration of caregiver-focused health risk assessment
instrument (e.g., depression inventory) for the benefit of
the patient, with scoring and documentation, per standardized instrument.
Reflectance confocal microscopy (RCM) for cellular and
sub-cellular imaging of skin; image acquisition and interpretation and report, first lesion.
Reflectance confocal microscopy (RCM) for cellular and
sub-cellular imaging of skin; image acquisition only, first
lesion.
Reflectance confocal microscopy (RCM) for cellular and
sub-cellular imaging of skin; interpretation and report
only, first lesion.
Reflectance confocal microscopy (RCM) for cellular and
sub-cellular imaging of skin; image acquisition and interpretation and report, each additional lesion.
Reflectance confocal microscopy (RCM) for cellular and
sub-cellular imaging of skin; image acquisition only, each
additional lesion.
Reflectance confocal microscopy (RCM) for cellular and
sub-cellular imaging of skin; interpretation and report
only, each additional lesion.
Physical therapy evaluation; low complexity ........................
Physical therapy evaluation; moderate complexity ..............
Physical therapy evaluation; high complexity ......................
Reevaluation of physical therapy established plan of care
0.17 ................
........................
0.17
No.
NEW ..............
21.70
18.23
No.
NEW ..............
17.97
14.50
No.
NEW ..............
8.00
6.81
No.
0.06 ................
0.06
0.06
No.
0.06 ................
0.06
0.06
No.
1.08 ................
1.08
1.08
No.
1.73 ................
1.63
1.63
No.
1.98 ................
1.98
1.98
No.
0.78 ................
........................
0.78
No.
0.80 ................
........................
0.80
No.
NEW ..............
0.00
0.00
No.
NEW ..............
0.00
0.00
No.
0.00 ................
0.80
0.75
No.
0.00 ................
0.00
0.00
No.
0.00 ................
0.80
0.75
No.
0.00 ................
0.76
0.71
No.
0.00 ................
0.00
0.00
No.
0.00 ................
0.76
0.71
No.
NEW
NEW
NEW
NEW
0.75
1.18
1.50
0.75
1.20
1.20
1.20
0.60
Yes.
No.
Yes.
No.
935X1 ...........
935X2 ...........
935X3 ...........
95144 ...........
95165 ...........
95812 ...........
95813 ...........
95957 ...........
95971 ...........
95972 ...........
961X0 ...........
961X1 ...........
96931 ...........
96932 ...........
96933 ...........
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
96934 ...........
96935 ...........
96936 ...........
97X61
97X62
97X63
97X64
...........
...........
...........
...........
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HCPCS
97X65
97X66
97X67
97X68
...........
...........
...........
...........
991X1 ...........
991X2 ...........
991X3 ...........
991X4 ...........
991X5 ...........
991X6 ...........
99354 ...........
99358 ...........
99359 ...........
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
99487 ...........
VerDate Sep<11>2014
Current work
RVU
Descriptor
Occupational therapy evaluation; low complexity ................
Occupational therapy evaluation; moderate complexity ......
Occupational therapy evaluation; high complexity ...............
Reevaluation of occupational therapy care/established plan
of care.
Moderate sedation services provided by the same physician or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of
the patient’s level of consciousness and physiological
status; initial 15 minutes of intra-service time, patient
younger than 5 years of age.
Moderate sedation services provided by the same physician or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of
the patient’s level of consciousness and physiological
status; initial 15 minutes of intra-service time, patient
age 5 years or older.
Moderate sedation services provided by a physician or
other qualified health care professional other than the
physician or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports; initial 15 minutes of intra-service time,
patient younger than 5 years of age.
Moderate sedation services provided by a physician or
other qualified health care professional other than the
physician or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports; initial 15 minutes of intra-service time,
patient age 5 years or older.
Moderate sedation services provided by the same physician or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of
the patient’s level of consciousness and physiological
status; each additional 15 minutes of intra-service time.
Moderate sedation services provided by a physician or
other qualified health care professional other than the
physician or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports; each additional 15 minutes intra-service
time.
Prolonged evaluation and management or psychotherapy
service(s) (beyond the typical service time of the primary
procedure) in the office or other outpatient setting requiring direct patient contact beyond the usual service; first
hour.
Prolonged evaluation and management service before and/
or after direct patient care; first hour.
Prolonged evaluation and management service before and/
or after direct patient care; each additional 30 minutes.
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.
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NEW
NEW
NEW
RUC work
RVU
CMS work
RVU
CMS time
refinement
..............
..............
..............
..............
0.88
1.20
1.70
0.80
1.20
1.20
1.20
0.60
Yes.
No.
Yes.
No.
NEW ..............
0.50
0.50
No.
NEW ..............
0.25
0.25
No.
NEW ..............
1.90
1.90
No.
NEW ..............
1.84
1.65
No.
NEW ..............
0.00
0.00
No.
NEW ..............
1.25
1.25
No.
1.77 ................
........................
2.33
No.
2.10 ................
........................
2.10
No.
1.00 ................
........................
1.00
No.
0.00 ................
........................
1.00
No.
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TABLE 23—PROPOSED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued
HCPCS
Descriptor
Current work
RVU
RUC work
RVU
99489 ...........
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; each additional 30 minutes of clinical staff time
directed by a physician or other qualified health care
professional, per calendar month.
Surgical pathology, gross and microscopic examinations,
for prostate needle biopsy, any method.
Resource-intensive services for patients for whom the use
of specialized mobility-assistive technology (such as adjustable height chairs or tables, patient lift, and adjustable padded leg supports) is medically necessary and
used during the provision of an office/outpatient E/M visit
(Add-on code, list separately in addition to primary procedure).
Moderate sedation services provided by the same physician or other qualified health care professional performing a gastrointestinal endoscopic service (excluding
biliary procedures) that the sedation supports, requiring
the presence of an independent trained observer to assist in the monitoring of the patient’s level of consciousness and physiological status; initial 15 minutes of intraservice time.
Initial psychiatric collaborative care management, first 70
minutes in the first calendar month of behavioral health
care manager activities, in consultation with a psychiatric
consultant, and directed by the treating physician or
other qualified health care professional.
Subsequent psychiatric collaborative care management,
first 60 minutes in a subsequent month of behavioral
health care manager activities, in consultation with a
psychiatric consultant, and directed by the treating physician or other qualified health care professional.
Initial or subsequent psychiatric collaborative care management, each additional 30 minutes in a calendar
month of behavioral health care manager activities, in
consultation with a psychiatric consultant, and directed
by the treating physician or other qualified health care
professional.
Cognition and functional assessment using standardized
instruments with development of recorded care plan for
the patient with cognitive impairment, history obtained
from patient and/or caregiver, in office or other outpatient setting or home or domiciliary or rest home.
Comprehensive assessment of and care planning for patients requiring chronic care management services
(billed separately from monthly care management services).
Care management services for behavioral health conditions, at least 20 minutes of clinical staff time, directed
by a physician or other qualified health care professional
time, per calendar month.
Telehealth consultation, critical care, physicians typically
spend 60 minutes communicating with the patient via
telehealth (initial).
Telehealth consultation, critical care, physicians typically
spend 50 minutes communicating with the patient via
telehealth (subsequent).
0.00 ................
........................
0.50
No.
3.09 ................
4.00
3.60
No.
NEW ..............
........................
0.48
No.
NEW ..............
........................
0.10
No.
NEW ..............
........................
1.59
No.
NEW ..............
........................
1.42
No.
NEW ..............
........................
0.71
No.
NEW ..............
........................
3.30
No.
NEW ..............
........................
0.87
No.
NEW ..............
........................
0.61
No.
NEW ..............
........................
4.00
No.
NEW ..............
........................
3.86
No.
G0416 ..........
GDDD1 .........
GMMM1 .......
GPPP1 .........
GPPP2 .........
GPPP3 .........
GPPP6 .........
GPPP7 .........
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
GPPPX .........
GTTT1 ..........
GTTT2 ..........
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TABLE 24—CY 2016 PROPOSED
CODES WITH DIRECT PE INPUT
RECOMMENDATIONS
ACCEPTED
WITHOUT REFINEMENT
HCPCS code
00740
00810
10030
11730
19298
20245
20550
20552
20553
20982
20983
22510
22511
22512
22513
22514
22515
22526
22527
228X1
228X4
28289
28292
28296
28297
28298
28299
282X1
31615
31622
31623
31624
31625
31626
31627
31628
31629
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
31632
31633
31634
31635
31645
31646
31652
...........
...........
...........
...........
...........
...........
...........
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
31653 ...........
31654
32405
32550
32553
333X3
334X1
334X2
35471
35472
35475
35476
36010
36140
36147
36148
36200
36221
36222
36223
36224
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
VerDate Sep<11>2014
Description
HCPCS code
Anesth upper gi visualize.
Anesth low intestine scope.
Guide cathet fluid drainage.
Removal of nail plate.
Place breast rad tube/caths.
Bone biopsy excisional.
Inj tendon sheath/ligament.
Inj trigger point 1/2 muscl.
Inject trigger points 3/>.
Ablate bone tumor(s) perq.
Ablate bone tumor(s) perq.
Perq cervicothoracic inject.
Perq lumbosacral injection.
Vertebroplasty addl inject.
Perq vertebral augmentation.
Perq vertebral augmentation.
Perq vertebral augmentation.
Idet single level.
Idet 1 or more levels.
Insj stablj dev w/dcmprn.
Insj stablj dev w/o dcmprn.
Repair hallux rigidus.
Correction of bunion.
Correction of bunion.
Correction of bunion.
Correction of bunion.
Correction of bunion.
Corrj halux rigdus w/implt.
Visualization of windpipe.
Dx bronchoscope/wash.
Dx bronchoscope/brush.
Dx bronchoscope/lavage.
Bronchoscopy w/biopsy(s).
Bronchoscopy w/markers.
Navigational bronchoscopy.
Bronchoscopy/lung bx each.
Bronchoscopy/needle bx
each.
Bronchoscopy/lung bx addl.
Bronchoscopy/needle bx addl.
Bronch w/balloon occlusion.
Bronchoscopy w/fb removal.
Bronchoscopy clear airways.
Bronchoscopy reclear airway.
Bronch ebus samplng 1/2
node.
Bronch ebus samplng 3/>
node.
Bronch ebus ivntj perph les.
Percut bx lung/mediastinum.
Insert pleural cath.
Ins mark thor for rt perq.
Perq clsr tcat l atr apndge.
Valvuloplasty aortic valve.
Valvuloplasty aortic valve.
Repair arterial blockage.
Repair arterial blockage.
Repair arterial blockage.
Repair venous blockage.
Place catheter in vein.
Establish access to artery.
Access av dial grft for eval.
Access av dial grft for proc.
Place catheter in aorta.
Place cath thoracic aorta.
Place cath carotid/inom art.
Place cath carotid/inom art.
Place cath carotid art.
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CODES WITH DIRECT PE INPUT
RECOMMENDATIONS
ACCEPTED
WITHOUT REFINEMENT—Continued
36225
36226
36227
36228
36245
36246
36247
36248
36251
36252
36253
36254
36481
36555
36557
36558
36560
36561
36563
36565
36566
36568
36570
36571
36576
36578
36581
36582
36583
36585
36590
36870
369X7
369X8
369X9
37183
37184
37185
37186
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
37187 ...........
37188 ...........
37191 ...........
37192 ...........
37193 ...........
37197
37220
37221
37222
37223
37224
37225
37226
37227
37228
37229
37230
37231
37232
37233
37234
37235
37236
37237
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
37238 ...........
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TABLE 24—CY 2016 PROPOSED
CODES WITH DIRECT PE INPUT
RECOMMENDATIONS
ACCEPTED
WITHOUT REFINEMENT—Continued
Description
HCPCS code
Description
Place cath subclavian art.
Place cath vertebral art.
Place cath xtrnl carotid.
Place cath intracranial art.
Ins cath abd/l-ext art 1st.
Ins cath abd/l-ext art 2nd.
Ins cath abd/l-ext art 3rd.
Ins cath abd/l-ext art addl.
Ins cath ren art 1st unilat.
Ins cath ren art 1st bilat.
Ins cath ren art 2nd+ unilat.
Ins cath ren art 2nd+ bilat.
Insertion of catheter vein.
Insert non-tunnel cv cath.
Insert tunneled cv cath.
Insert tunneled cv cath.
Insert tunneled cv cath.
Insert tunneled cv cath.
Insert tunneled cv cath.
Insert tunneled cv cath.
Insert tunneled cv cath.
Insert picc cath.
Insert picvad cath.
Insert picvad cath.
Repair tunneled cv cath.
Replace tunneled cv cath.
Replace tunneled cv cath.
Replace tunneled cv cath.
Replace tunneled cv cath.
Replace picvad cath.
Removal tunneled cv cath.
Percut thrombect av fistula.
Balo angiop ctr dialysis seg.
Stent plmt ctr dialysis seg.
Dialysis circuit embolj.
Remove hepatic shunt (tips).
Prim art m-thrmbc 1st vsl.
Prim art m-thrmbc sbsq vsl.
Sec art thrombectomy addon.
Venous mech thrombectomy.
Venous m-thrombectomy addon.
Ins endovas vena cava filtr.
Redo endovas vena cava filtr.
Rem endovas vena cava filter.
Remove intrvas foreign body.
Iliac revasc.
Iliac revasc w/stent.
Iliac revasc add-on.
Iliac revasc w/stent add-on.
Fem/popl revas w/tla.
Fem/popl revas w/ather.
Fem/popl revasc w/stent.
Fem/popl revasc stnt & ather.
Tib/per revasc w/tla.
Tib/per revasc w/ather.
Tib/per revasc w/stent.
Tib/per revasc stent & ather.
Tib/per revasc add-on.
Tibper revasc w/ather add-on.
Revsc opn/prq tib/pero stent.
Tib/per revasc stnt & ather.
Open/perq place stent 1st.
Open/perq place stent ea
add.
Open/perq place stent same.
37239 ...........
Open/perq place stent ea
add.
Vasc embolize/occlude venous.
Vasc embolize/occlude artery.
Vasc embolize/occlude organ.
Vasc embolize/occlude bleed.
Intrvasc us noncoronary 1st.
Intrvasc us noncoronary addl.
Trluml balo angiop addl art.
Trluml balo angiop addl vein.
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 <30
mm.
Esoph endoscopy dilation.
Esophagoscopy control bleed.
Esophagoscopy lesion ablate.
Esophagoscop ultrasound
exam.
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.
Laps esophgl sphnctr agmnt.
Rmvl esophgl sphnctr dev.
Dilate esophagus 1/mult pass.
Dilate esophagus.
Small bowel endoscopy br/
wa.
Small bowel endoscopy br/
wa.
Small bowel endoscopy.
Endoscopy of bowel pouch.
Endoscopy bowel pouch/biop.
Colonoscopy thru stoma spx.
Colonoscopy with biopsy.
Colonoscopy for foreign body.
Colonoscopy for bleeding.
Colonoscopy & polypectomy.
Colonoscopy w/snare.
Colonoscopy with ablation.
Colonoscopy w/injection.
Colonoscopy w/dilation.
Proctosigmoidoscopy dilate.
Proctosigmoidoscopy w/bx.
Fmt 4701
Sfmt 4702
37241 ...........
37242
37243
37244
37252
37253
372X2
372X4
43200
...........
...........
...........
...........
...........
...........
...........
...........
43201 ...........
43202 ...........
43206 ...........
43213 ...........
43215 ...........
43216 ...........
43217 ...........
43220 ...........
43226
43227
43229
43231
...........
...........
...........
...........
43232 ...........
43235
43236
43239
43245
43247
43248
43249
43250
43251
43252
43255
43270
432X1
432X2
43450
43453
44380
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
44381 ...........
44382
44385
44386
44388
44389
44390
44391
44392
44394
44401
44404
44405
45303
45305
E:\FR\FM\15JYP2.SGM
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
15JYP2
46279
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
TABLE 24—CY 2016 PROPOSED
CODES WITH DIRECT PE INPUT
RECOMMENDATIONS
ACCEPTED
WITHOUT REFINEMENT—Continued
HCPCS code
Description
45307 ...........
45308 ...........
Proctosigmoidoscopy fb.
Proctosigmoidoscopy removal.
Proctosigmoidoscopy removal.
Proctosigmoidoscopy removal.
Proctosigmoidoscopy bleed.
Proctosigmoidoscopy ablate.
Sigmoidoscopy w/fb removal.
Sigmoidoscopy & polypectomy.
Sigmoidoscopy for bleeding.
Sigmoidoscopy w/submuc inj.
Sigmoidoscopy w/tumr remove.
Sig w/tndsc balloon dilation.
Sigmoidoscopy w/ablation.
Sgmdsc w/band ligation.
Diagnostic colonoscopy.
Colonoscopy w/fb removal.
Colonoscopy and biopsy.
Colonoscopy submucous njx.
Colonoscopy w/control bleed.
Colonoscopy w/lesion removal.
Colonoscopy w/lesion removal.
Colonoscopy w/balloon dilat.
Colonoscopy w/ablation.
Colonoscopy w/band ligation.
Needle biopsy of liver.
Percut ablate liver rf.
Perq abltj lvr cryoablation.
Image cath fluid colxn visc.
Image cath fluid peri/retro.
Image cath fluid trns/vgnl.
Ins mark abd/pel for rt perq.
Insert tun ip cath perc.
Place gastrostomy tube perc.
Place duod/jej tube perc.
Place cecostomy tube perc.
Change g-tube to g-j perc.
Renal biopsy perq.
Change ureter stent percut.
Remove ureter stent percut.
Change stent via transureth.
45309 ...........
45315 ...........
45317
45320
45332
45333
...........
...........
...........
...........
45334 ...........
45335 ...........
45338 ...........
45340
45346
45350
45378
45379
45380
45381
45382
45384
...........
...........
...........
...........
...........
...........
...........
...........
...........
45385 ...........
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
45386
45388
45398
47000
47382
47383
49405
49406
49407
49411
49418
49440
49441
49442
49446
50200
50382
50384
50385
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
VerDate Sep<11>2014
19:43 Jul 14, 2016
Jkt 238001
TABLE 24—CY 2016 PROPOSED
CODES WITH DIRECT PE INPUT
RECOMMENDATIONS
ACCEPTED
WITHOUT REFINEMENT—Continued
HCPCS code
50386
50387
50430
50432
50433
50434
...........
...........
...........
...........
...........
...........
50592
50593
50693
50694
50695
51702
51703
51720
51784
55700
57155
58558
58559
58560
58561
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
58563
585X1
630X1
66720
67101
67105
69300
767X1
77332
77333
77334
77470
77600
77605
77610
77615
91110
91111
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
92132 ...........
92133 ...........
92134 ...........
PO 00000
Frm 00119
Description
Remove stent via transureth.
Change nephroureteral cath.
Njx px nfrosgrm &/urtrgrm.
Plmt nephrostomy catheter.
Plmt nephroureteral catheter.
Convert nephrostomy catheter.
Perc rf ablate renal tumor.
Perc cryo ablate renal tum.
Plmt ureteral stent prq.
Plmt ureteral stent prq.
Plmt ureteral stent prq.
Insert temp bladder cath.
Insert bladder cath complex.
Treatment of bladder lesion.
Anal/urinary muscle study.
Biopsy of prostate.
Insert uteri tandem/ovoids.
Hysteroscopy biopsy.
Hysteroscopy lysis.
Hysteroscopy resect septum.
Hysteroscopy remove
myoma.
Hysteroscopy ablation.
Laps abltj uterine fibroids.
Ndsc dcmprn 1 ntrspc lumbar.
Destruction ciliary body.
Repair detached retina.
Repair detached retina.
Revise external ear.
Us abdl aorta screen aaa.
Radiation treatment aid(s).
Radiation treatment aid(s).
Radiation treatment aid(s).
Special radiation treatment.
Hyperthermia treatment.
Hyperthermia treatment.
Hyperthermia treatment.
Hyperthermia treatment.
Gi tract capsule endoscopy.
Esophageal capsule endoscopy.
Cmptr ophth dx img ant
segmt.
Cmptr ophth img optic nerve.
Cptr ophth dx img post
segmt.
Fmt 4701
Sfmt 4702
TABLE 24—CY 2016 PROPOSED
CODES WITH DIRECT PE INPUT
RECOMMENDATIONS
ACCEPTED
WITHOUT REFINEMENT—Continued
HCPCS code
92235
92240
92250
922X4
92960
93312
93314
93451
93452
93453
93454
93455
93456
93457
93458
93459
93460
93461
93464
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
93505
93566
93567
93568
935X1
935X2
93642
93644
95144
95165
95957
961X0
961X1
96440
96931
96932
97X64
97X68
991X1
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
...........
991X2 ...........
991X5 ...........
G0341 ..........
GMMM1
E:\FR\FM\15JYP2.SGM
15JYP2
Description
Eye exam with photos.
Icg angiography.
Eye exam with photos.
Fluorescein icg angiography.
Cardioversion electric ext.
Echo transesophageal.
Echo transesophageal.
Right heart cath.
Left hrt cath w/ventrclgrphy.
R&l hrt cath w/ventriclgrphy.
Coronary artery angio s&i.
Coronary art/grft angio s&i.
R hrt coronary artery angio.
R hrt art/grft angio.
L hrt artery/ventricle angio.
L hrt art/grft angio.
R&l hrt art/ventricle angio.
R&l hrt art/ventricle angio.
Exercise w/hemodynamic
meas.
Biopsy of heart lining.
Inject r ventr/atrial angio.
Inject suprvlv aortography.
Inject pulm art hrt cath.
Perq transcath cls mitral.
Perq transcath cls aortic.
Electrophysiology evaluation.
Electrophysiology evaluation.
Antigen therapy services.
Antigen therapy services.
Eeg digital analysis.
Pt-focused hlth risk assmt.
Caregiver health risk assmt.
Chemotherapy intracavitary.
Rcm celulr subcelulr img skn.
Rcm celulr subcelulr img skn.
Pt re-eval est plan care.
Ot re-eval est plan care.
Mod sed same phys/qhp <5
yrs.
Mod sed same phys/qhp 5/
>yrs.
Mod sed oth phys/qhp 5/>yrs.
Percutaneous islet celltrans.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46280
VerDate Sep<11>2014
TABLE 25: CY 2016 Proposed Codes With Direct PE Input Recommendations Accepted With Refinement
Jkt 238001
PO 00000
Frm 00120
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
Input
Code
Input code
description
11732
Remove nail
plate add-on
Remove nail
plate add-on
EF015
mayo stand
NF
EF031
table, power
NF
7
8
Refined equipment
time to conform to
changes in clinical
labor time
$0.02
11732
Remove nail
plate add-on
EQ137
instmment pack,
basic ($500-$1499)
NF
0
8
See preamble text
$0.02
11732
Remove nail
plate add-on
EQ168
light, exam
NF
7
8
Refined equipment
time to conform to
changes in clinical
labor time
$0.00
11732
Remove nail
plate add-on
L037D
RN/LPN/MTA
NF
7
8
See preamble text
$0.37
11732
Remove nail
plate add-on
SC031
needle, 30g
NF
1
0
Add-on code.
Additional supplies
not typical; see
preamble text
-$0.34
11732
Remove nail
plate add-on
SC051
syringe 10-12ml
NF
1
0
Add-on code.
Additional supplies
not typical; see
preamble text
-$0.18
Remove nail
plate add-on
SG067
pemose drain
(0.25in x 4in)
NF
1
0
Add-on code.
Additional supplies
not typical; sec
preamble text
-$0.50
11732
Assist
physician
in
performing
procedure
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
8
See preamble tex1
$0.01
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS code
description
11732
EP15JY16.000</GPH>
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
0
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Input
Code
Input code
description
11732
Remove nail
plate add-on
SH047
lidocaine 1%-2% inj
(Xylocaine)
NF
11732
Remove nail
plate add-on
SH064
silver sulfadiazene
cream (Silvadene)
NF
0.5
0
Add-on code.
Additional supplies
not typical; see
preamble text
-$0.08
11732
Remove nail
plate add-on
SJ053
swab-pad, alcohol
NF
2
1
Add-on code.
Additional supplies
not typical; see
preamble text
-$0.01
271Xl
Clsd tx pelvic
ring fx
Clsd tx pelvic
ring fx
Clsd tx pelvic
ring fx
Clsd tx pelvic
ring fx
Diagnostic
laryngoscopy
L037D
RN/LPN/MTA
F
36
1
0
See preamble text
-$13.32
L037D
RN!LPN/MTA
F
27
2
0
See preamble texi
-$19.98
L037D
RN!LPN/MTA
F
27
1
0
See preamble text
-$9.99
L037D
RN!LPN/MTA
F
36
2
0
See preamble text
-$26.64
EF008
chair with headrest,
exam, reclining
NF
23
20
Refined equipment
time to conform to
changes in clinical
labor time
Refined equipment
time to conform to
established policies for
scope accessories
Refined equipment
time to conform to
changes in clinical
labor time
-$0.03
Jkt 238001
HCPCS code
description
PO 00000
Frm 00121
Fmt 4701
Sfmt 4725
271Xl
E:\FR\FM\15JYP2.SGM
271X2
271X2
31575
Nonfacility
(NF)/ Facility
(F)
99213
minutes
99212
minutes
99212
minutes
99213
minutes
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
0
Add-on code.
Additional supplies
not typical; see
preamble text
-$0.35
15JYP2
31575
Diagnostic
laryngoscopy
EQ167
light source, xenon
NF
0
17
31575
Diagnostic
laryngoscopy
EQ170
light, fiberoptic
headlight w-source
NF
23
20
$0.47
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
10
Labor
activity
(where
applicable)
-$0.02
46281
EP15JY16.001</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46282
VerDate Sep<11>2014
Jkt 238001
Input
Code
Input code
description
31575
Diagnostic
laryngoscopy
EQ234
suction and pressure
cabinet, ENT (SMR)
NF
31575
Diagnostic
laryngoscopy
ES031
NF
31575
Diagnostic
laryngoscopy
ES060
video system,
endoscopy
(processor, digital
capture, monitor,
printer, cart)
Video-flexible
laryngoscope system
31575
Diagnostic
laryngoscopy
ES063
31575
Diagnostic
laryngoscopy
L037D
PO 00000
HCPCS code
description
Frm 00122
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.002</GPH>
Nonfacility
(NF)/ Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
20
Refined equipment
time to conform to
changes in clinical
labor time
-$0.03
0
17
Refined equipment
time to conform to
established policies for
scope accessories
$1.01
NF
44
0
See preamble text
-$14.00
rhinolaryngoscope,
flexible, video, nonchanneled
NF
0
47
Refined equipment
time to conform to
established policies for
scopes
$2.18
RN!LPN/MTA
NF
3
0
Clinical labor task
redundant with clinical
labor task "Assist
physician in
perfonning the
procedure" (L041B)
-$1.11
Clean
mom/equip
mcntby
physician
staff
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
23
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Input
Code
Input code
description
31576
Laryngoscopy
with biopsy
EQ167
light source, xenon
NF
31576
Laryngoscopy
with biopsy
ES031
video system,
endoscopy
(processor, digital
capture, monitor,
printer, cart)
NF
31576
Laryngoscopy
with biopsy
ES061
Video-flexible
channeled
laryngoscope system
31576
Laryngoscopy
with biopsy
ES064
31577
Remove foreign
body larynx
Remove foreign
body larynx
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Refined equipment
time to conform to
established policies for
scope accessories
$0.78
0
28
Refined equipment
time to conform to
established policies for
scope accessories
$1.67
NF
55
0
See preamble text
-$21.23
rhinolaryngoscope,
flexible, video,
channeled
NF
0
55
Refined equipment
time to conform to
established policies for
scopes
$2.87
EF008
chair with headrest,
exam, reclining
NF
99
95
Refined equipment
time to conform to
changes in clinical
labor time
-$0.04
EF015
mayo stand
NF
99
95
Refined equipment
time to conform to
changes in clinical
labor time
$0.00
PO 00000
28
Frm 00123
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Jkt 238001
HCPCS code
description
31577
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)I Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
0
Labor
activity
(where
applicable)
46283
EP15JY16.003</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46284
VerDate Sep<11>2014
Input code
description
31577
Remove foreign
body larynx:
EQ137
instrument pack,
basic ($500-$1499)
NF
31577
Remove foreign
body larynx
EQ167
light source, xenon
NF
31577
Remove foreign
body larynx
EQ170
light, fiberoptic
headlight w-source
31577
Remove foreign
body laryiLx
EQ234
31577
Remove foreign
body larynx
Remove foreign
body larynx
PO 00000
Frm 00124
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
39
Refined equipment
time to conform to
changes in clinical
labor time
$0.00
0
29
Refined equipment
time to conform to
established policies for
scope accessories
$0.80
NF
99
95
Refined equipment
time to conform to
changes in clinical
labor time
-$0.03
suction and pressure
cabinet, ENT (SMR)
NF
99
95
Refined equipment
time to conform to
changes in clinical
labor time
-$0.04
ES031
video system,
endoscopy
(processor, digital
capture, monitor,
printer, cart)
NF
0
29
Refined equipment
time to conform to
established policies for
scope accessories
$1.73
ES061
Video-flexible
channeled
laryngoscope system
NF
54
0
See preamble text
-$20.84
15JYP2
EP15JY16.004</GPH>
Nonfacility
(NF)/ Facility
(F)
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Input
Code
Jkt 238001
HCPCS code
description
31577
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
40
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Jkt 238001
HCPCS code
description
Input
Code
Input code
description
31577
Remove foreign
body larynx
ES064
rhinolaryngoscope,
flexible, video,
channeled
NF
31577
Remove foreign
body larynx
L037D
RNILPN/MTA
NF
PO 00000
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
0
CMS
refine
ment
(min
or qty)
Direct
costs
change (in
dollars)
Comment
Frm 00125
Fmt 4701
Sfmt 4725
59
Refined equipment
time to conform to
established policies for
scopes
$3.08
0
Clinical labor task
redundant with clinical
labor task Assist
physician in
perfonning the
procedure" (L041B)
-$1.11
Clinical labor task
redundant with clinical
labor task 11 Assist
physician in
perfonning the
procedure" (L041B)
Refined equipment
time to conform to
established policies for
scope accessories
-$0.37
Clean
room/equip
mentby
physician
staff
3
Obtain vital
signs
3
2
II
L037D
RNILPN/MTA
NF
31578
Removal of
larynx lesion
EQ167
light source, xenon
NF
0
33
Removal of
larynx lesion
ES031
video system,
endoscopy
(processor, digital
captnre, monitor,
printer, cart)
NF
0
33
15JYP2
Remove foreign
body larynx
31578
E:\FR\FM\15JYP2.SGM
31577
Refined equipment
time to conform to
established policies for
scope accessories
$0.92
$1.97
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
Nonfacility
(NF)/ Facility
(F)
Labor
activity
(where
applicable)
46285
EP15JY16.005</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46286
VerDate Sep<11>2014
Input code
description
31578
Removal of
larynx lesion
ES061
Video-flexible
channeled
laryngoscope system
NF
31578
Removal of
larymclesion
ES064
rhinolaryngoscope,
flexible, video,
channeled
NF
0
60
Refined equipment
time to conform to
established policies for
scopes
$3.13
31579
Diagnostic
laryngoscopy
EF008
chair with headrest,
exam, reclining
NF
31
27
Refined equipment
time to conform to
changes in clinical
labor time
-$0.04
31579
Diagnostic
laryngoscopy
EF015
mayo stand
NF
31
27
Refined equipment
time to conform to
changes in clinical
labor time
$0.00
31579
Diagnostic
laryngoscopy
EQ167
light source, xenon
NF
0
24
Refined equipment
time to conform to
established policies for
scope accessories
$0.67
Diagnostic
laryngoscopy
EQ170
light, fiberoptic
headlight w-source
NF
31
27
Refined equipment
time to conform to
changes in clinical
labor time
-$0.03
Nonfacility
(NF)I Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
0
See preamble text
-$20.84
PO 00000
Frm 00126
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.006</GPH>
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Input
Code
Jkt 238001
HCPCS code
description
31579
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
54
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Jkt 238001
HCPCS code
description
Input
Code
Input code
description
31579
Diagnostic
laryngoscopy
EQ234
suction and pressure
cabinet, ENT (SMR)
NF
31579
Diagnostic
laryngoscopy
ES031
video system,
endoscopy
(processor, digital
capture, monitor,
printer, cart)
NF
31579
Diagnostic
laryngoscopy
ES063
rhinolaryngoscope,
flexible, video, nonchanneled
31579
Diagnostic
laryngoscopy
ES065
31579
Diagnostic
laryngoscopy
L037D
Nonfacility
(NF)/ Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Refined equipment
time to conform to
changes in clinical
labor time
-$0.04
0
24
Refined equipment
time to conform to
established policies for
scope accessories
$1.43
NF
0
54
Refined equipment
time to conform to
established policies for
scopes
$2.50
stroboscopy system
NF
49
44
-$0.38
RNILPN/MTA
NF
3
2
Refined equipment
time to conform to
established policies for
scope accessories
Clinical labor task
redundant with clinical
labor task "Assist
physician in
perfonning the
procedure" (L041B)
PO 00000
27
Frm 00127
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
Obtain vital
signs
-$0.37
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
31
Labor
activity
(where
applicable)
46287
EP15JY16.007</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46288
VerDate Sep<11>2014
RUC
recommen
dation or
current
value (min
or qty)
3
0
Clinical labor task
redundant with clinical
labor task "Assist
physician in
perfonuing the
procedure" (L041B)
-$1.11
CMS
refine
ment
(min
or qty)
Direct
costs
change (in
dollars)
Input
Code
Input code
description
31579
Diagnostic
laryngoscopy
L037D
RNILPN/MTA
NF
31580
Revision of
larynx
EQ137
instrument pack,
basic ($500-$1499)
F
138
129
Refined equipment
time to conform to
established policies for
surgical instrument
packs
-$0.02
31580
Revision of
larym:.
EQ167
light source, xenon
F
0
108
Equipment item
replaces another item;
see preamble text
EQ170
$3.00
31580
Revision of
larynx
EQ170
light, fiberoptic
headlight w-source
F
108
0
-$0.85
31580
Revision of
larynx
ES031
F
0
108
Revision of
larynx
ES060
video system,
endoscopy
(processor, digital
capture, monitor,
printer, cart)
Video-flexible
laryngoscope system
Equipment item
replaced by another
item; see preamble
text EQ167
Refined equipment
time to conform to
established policies for
scope accessories
F
198
0
Jkt 238001
HCPCS code
description
31580
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)I Facility
(F)
PO 00000
Clean
room/equip
mentby
physician
staff
Frm 00128
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.008</GPH>
Comment
See preamble text
$6.44
-$62.98
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
PO 00000
Input code
description
31580
Revision of
larynx
ES063
rhinolaryngoscope,
flexible, video, nonchanneled
F
31584
Treat larynx
fracture
EQ137
instrument pack,
basic ($500-$1499)
F
31584
Treat larynx
fracture
EQ167
light source, xenon
31584
Treat larynx
fracture
EQ170
31584
Treat larynx
fracture
Treat larynx
fracture
Frm 00129
Input
Code
Nonfacility
(NF)/ Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
Refined equipment
time to conform to
established policies for
scopes
$8.76
138
129
Refined equipment
time to conform to
established policies for
surgical instrument
packs
-$0.02
F
0
108
$3.00
light, fiberoptic
headlight w-source
F
108
0
ES031
video system,
endoscopy
(processor, digital
capture, monitor,
printer, cart)
F
0
108
Equipment item
replaces another item;
see preamble text
EQ170
Equipment item
replaced by another
item; see preamble
tcx.1 EQ167
Refined equipment
time to conform to
established policies for
scope accessories
ES060
Video-flexible
laryngoscope system
F
198
0
See preamble text
-$62.98
15JYP2
189
-$0.85
$6.44
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Jkt 238001
HCPCS code
description
31584
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
0
Labor
activity
(where
applicable)
46289
EP15JY16.009</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46290
VerDate Sep<11>2014
Input
Code
Input code
description
31584
Treat larynx
fracture
ES063
rhinolaryngoscope,
flexible, video, nonchanneled
F
31587
Revision of
larynx
EQ137
instmment pack,
basic ($500-$1499)
F
31587
Revision of
larynx
EQ167
light source, xenon
31587
Revision of
larynx
EQ170
31587
Revision of
larynx
Revision of
larynx
Nonfacility
(NF)/ Facility
(F)
CMS
refine
ment
(min
or qty)
189
Refined equipment
time to conform to
established policies for
scopes
$8.76
138
129
Refined equipment
time to conform to
established policies for
surgical instrument
packs
-$0.02
F
0
108
$3.00
light, fiberoptic
headlight w-source
F
108
0
ES031
video system,
endoscopy
(processor, digital
capture, monitor,
printer, cart)
F
0
108
Equipment item
replaces another item;
see preamble text
EQ170
Equipment item
replaced by another
item; see preamble
tcx.1 EQ167
Refined equipment
time to conform to
established policies for
scope accessories
ES060
Video-flexible
laryngoscope system
F
198
0
See preamble text
-$62.98
PO 00000
Frm 00130
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.010</GPH>
Comment
Direct
costs
change (in
dollars)
-$0.85
$6.44
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Jkt 238001
HCPCS code
description
31587
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
0
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Input
Code
Input code
description
31587
Revision of
larynx
ES063
rhinolaryngoscope,
flexible, video, nonchanneled
F
317Xl
Largsc w!laser
dstlj les
EQ167
light source, xenon
NF
317Xl
Largsc w!laser
dstlj les
ES031
video system,
endoscopy
(processor, digital
capture, monitor,
printer, cart)
317Xl
Largsc w/laser
dstlj les
ES061
317Xl
Largsc w!laser
dstlj les
Largsc w!laser
dstlj les
Nonfacility
(NF)I Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Refined equipment
time to conform to
established policies for
scopes
$8.76
0
38
Refined equipment
time to conform to
established policies for
scope accessories
$1.05
NF
0
38
Refined equipment
time to conform to
established policies for
scope accessories
$2.27
Video-flexible
channeled
laryngoscope system
NF
59
0
See preamble text
-$22.77
ES064
rhinolaryngoscope,
flexible, video,
channeled
NF
0
65
$3.39
SF029
laser tip, bare
(single use)
NF
0
1
Refined equipment
time to conform to
established policies for
scopes
Supply item replaces
another item; see
preamble SF030
PO 00000
189
Frm 00131
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
$150.00
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Jkt 238001
HCPCS code
description
317Xl
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
0
Labor
activity
(where
applicable)
46291
EP15JY16.011</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46292
VerDate Sep<11>2014
Jkt 238001
PO 00000
HCPCS code
description
Input
Code
Input code
description
317Xl
Largsc w/laser
dstlj les
SF030
laser tip, diffuser
fiber
NF
317X2
Largsc wither
EQ167
light source, xenon
NF
ES031
video system,
endoscopy
(processor, digital
capture, monitor,
printer, cart)
Video-flexible
channeled
laryngoscope system
ES064
EQ167
Nonfacility
(NF)I Facility
(F)
CMS
refine
ment
(min
or qty)
Frm 00132
Fmt 4701
Largsc wither
i~ection
Sfmt 4725
E:\FR\FM\15JYP2.SGM
0
Supply item replaced
by another item; see
preamble SF029
-$197.50
0
33
Refined equipment
time to conform to
established policies for
scope accessories
$0.92
NF
0
33
Refined equipment
time to conform to
established policies for
scope accessories
$1.97
NF
54
0
See preamble text
-$20.84
rhinolaryngoscope,
flexible, video,
channeled
NF
0
60
Refined equipment
time to conform to
established policies for
scopes
$3.13
light source, xenon
NF
0
33
Refined equipment
time to conform to
established policies for
scope accessories
$0.92
i~ection
317X2
317X2
Largsc wither
ES061
i~ection
317X2
Largsc wither
i~ection
15JYP2
317X3
EP15JY16.012</GPH>
Largsc winjx
augmentation
Comment
Direct
costs
change (in
dollars)
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
1
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Input
Code
Input code
description
317X3
Largsc w/njx
augmentation
ES031
video system,
endoscopy
(processor, digital
capture, monitor,
printer, cart)
NF
317X3
Largsc w/njx
augmentation
ES060
Video-flexible
laryngoscope system
NF
317X3
Largsc w/njx
augmentation
ES063
rhinolaryngoscope,
flexible, video, nonchanneled
315X1
Laryngoplasty
laryngeal sten
EQ137
315Xl
Laryngoplasty
laryngeal sten
Laryngoplasty
laryngeal sten
Nonfacility
(NF)I Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Refined equipment
time to conform to
established policies for
scope accessories
$1.97
60
0
See preamble text
-$19.09
NF
0
60
$2.78
instrument pack,
basic ($500-$1499)
F
138
129
Refined equipment
time to conform to
established policies for
scopes
Refined equipment
time to conform to
established policies for
surgical instrument
packs
EQ167
light source, xenon
F
0
108
Equipment item
replaces another item;
see preamble text
EQ170
$3.00
EQ170
light, fiberoptic
headlight w-source
F
108
0
Equipment item
replaced by another
item; see preamble
text EQ167
-$0.85
PO 00000
33
Frm 00133
Fmt 4701
Sfmt 4725
-$0.02
E:\FR\FM\15JYP2.SGM
15JYP2
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Jkt 238001
HCPCS code
description
315Xl
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
0
Labor
activity
(where
applicable)
46293
EP15JY16.013</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46294
VerDate Sep<11>2014
EQ137
Laryngoplasty
laryngeal sten
315X2
315X2
Input code
description
315Xl
Laryngoplasty
laryngeal sten
ES031
315Xl
Laryngoplasty
laryngeal sten
ES060
video system,
endoscopy
(processor, digital
capture, monitor,
printer, cart)
Video-flexible
laryngoscope system
315Xl
Laryngoplasty
laryngeal sten
ES063
315X2
Laryngoplasty
laryngeal sten
315X2
19:43 Jul 14, 2016
Input
Code
Nonfacility
(NF)I Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Jkt 238001
Refined equipment
time to conform to
established policies for
scope accessories
$6.44
198
0
See preamble text
-$62.98
F
0
189
Refined equipment
time to conform to
established policies for
scopes
$8.76
instrument pack,
basic ($500-$1499)
F
138
129
Refined equipment
time to conform to
established policies for
surgical instrument
packs
-$0.02
EQ167
light source, xenon
F
0
108
Equipment item
replaces another item;
see preamble text
EQ170
$3.00
Laryngoplasty
laryngeal sten
EQ170
light, fiberoptic
headlight w-source
F
108
0
-$0.85
Laryngoplasty
laryngeal sten
ES031
video system,
endoscopy
(processor, digital
capture, monitor,
F
0
108
Equipment item
replaced by another
item; see preamble
text EQ167
Refined equipment
time to conform to
established policies for
scope accessories
Fmt 4701
108
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.014</GPH>
$6.44
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
rhinolaryngoscope,
flexible, video, nonchanneled
HCPCS code
description
Frm 00134
F
HCPCS
code
PO 00000
F
RUC
recommen
dation or
current
value (min
or qty)
0
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
HCPCS code
description
Input
Code
Input code
description
Jkt 238001
RUC
recommen
dation or
current
value (min
or qty)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
printer, cart)
ES060
Video-flexible
laryngoscope system
F
198
0
See preamble text
-$62.98
315X2
Laryngoplasty
laryngeal sten
ES063
rhinolaryngoscope,
flexible, video, nonchanneled
F
0
189
Refined equipment
time to conform to
established policies for
scopes
$8.76
315X3
Laryngoplasty
laryngeal sten
EQ137
instrument pack,
basic ($500-$1499)
F
138
129
Refined equipment
time to conform to
established policies for
surgical instrument
packs
-$0.02
15JYP2
315X3
Laryngoplasty
laryngeal sten
EQ167
light source, xenon
F
0
108
$3.00
315X3
Laryngoplasty
laryngeal sten
EQ170
light, fiberoptic
headlight w-source
F
108
0
Equipment item
replaces another item;
see preamble text
EQ170
Equipment item
replaced by another
item; see preamble
text EQ167
Frm 00135
Laryngoplasty
laryngeal sten
E:\FR\FM\15JYP2.SGM
PO 00000
315X2
Fmt 4701
Sfmt 4725
-$0.85
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
Labor
activity
(where
applicable)
46295
EP15JY16.015</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46296
VerDate Sep<11>2014
Input code
description
315X3
Laryngoplasty
laryngeal sten
ES031
video system,
endoscopy
(processor, digital
capture, monitor,
printer, cart)
F
315X3
Laryngoplasty
laryngeal sten
ES060
Video-flexible
laryngoscope system
F
315X3
Laryngoplasty
laryngeal stcn
ES063
rhinolaryngoscope,
flexible, video, nonchanneled
315X4
Laryngoplasty
laryngeal sten
EQ137
315X4
Laryngoplasty
laryngeal sten
315X4
PO 00000
Frm 00136
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.016</GPH>
Nonfacility
(NF)/ Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
108
Refined equipment
time to conform to
established policies for
scope accessories
$6.44
198
0
See preamble text
-$62.98
F
0
189
$8.76
instrument pack,
basic ($500-$1499)
F
138
129
EQ167
light source, xenon
F
0
108
Laryngoplasty
laryngeal sten
EQ170
light, fiberoptic
headlight w-source
F
108
0
Laryngoplasty
laryngeal sten
ES031
video system,
endoscopy
(processor, digital
capture, monitor,
printer, cart)
F
0
108
Refined equipment
time to conform to
established policies for
scopes
Refined equipment
time to conform to
established policies for
surgical instrument
packs
Equipment item
replaces another item;
see preamble text
EQ170
Equipment item
replaced by another
item; see preamble
text EQ167
Refined equipment
time to conform to
established policies for
scope accessories
-$0.02
$3.00
-$0.85
$6.44
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Input
Code
Jkt 238001
HCPCS code
description
315X4
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
0
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Jkt 238001
HCPCS code
description
Input
Code
Input code
description
315X4
Laryngoplasty
laryngeal sten
Laryngoplasty
laryngeal sten
ES060
Video-flexible
laryngoscope system
rhinolaryngoscope,
flexible, video, nonchaimeled
315X4
ES063
F
F
0
189
Nonfacility
(NF)I Facility
(F)
PO 00000
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
0
See preamble text
-$62.98
Refined equipment
time to conform to
established policies for
scopes
Refined equipment
time to conform to
established policies for
surgical instrument
packs
Equipment item
replaces another item;
see preamble text
EQ170
Equipment item
replaced by another
item; see preamble
text EQ167
Refined equipment
time to conform to
established policies for
scope accessories
$8.76
EQ137
instrument pack,
basic ($500-$1499)
F
138
129
315X5
Laryngoplasty
medializatio n
EQ167
light source, xenon
F
0
108
315X5
Laryngoplasty
medializatio n
EQ170
light, fiberoptic
headlight w-source
F
108
0
315X5
Laryngoplasty
medializatio n
ES031
F
0
108
315X5
Laryngoplasty
medializatio n
Laryngoplasty
medializatio n
ES060
video system,
endoscopy
(processor, digital
capture, monitor,
printer, cart)
Video-flexible
laryngoscope system
rhinolaryngoscope,
flexible, video, nonchaimeled
F
198
0
See preamble text
-$62.98
F
0
189
$8.76
F
138
129
Refined equipment
time to conform to
established policies for
scopes
Refined equipment
time to conform to
established policies for
surgical instrument
packs
Frm 00137
Laryngoplasty
mcdializatio n
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
315X5
315X6
Cricotracheal
resection
ES063
EQ137
instrument pack,
basic ($500-$1499)
$3.00
-$0.85
$6.44
-$0.02
46297
EP15JY16.017</GPH>
-$0.02
315X5
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
198
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46298
VerDate Sep<11>2014
Jkt 238001
PO 00000
Frm 00138
Input
Code
Input code
description
315X6
Cricotracheal
resection
EQ167
light source, xenon
F
315X6
Cricotracheal
resection
EQ170
light, fiberoptic
headlight w-source
F
108
0
315X6
Cricotracheal
resection
ES031
F
0
108
315X6
Cricotracheal
resection
Cricotracheal
resection
ES060
video system,
endoscopy
(processor, digital
capture, monitor,
printer, cart)
Video-flexible
laryngoscope system
rhinolaryngoscope,
flexible, video, nonchanneled
F
198
F
Fmt 4701
HCPCS code
description
CMS
refine
ment
(min
or qty)
108
Comment
Direct
costs
change (in
dollars)
Equipment item
replaces another item;
see preamble text
EQ170
Equipment item
replaced by another
item; see preamble
text EQ167
Refined equipment
time to conform to
established policies for
scope accessories
$3.00
0
See preamble tex1
-$62.98
0
189
Refined equipment
time to conform to
established policies for
scopes
$8.76
-$0.85
$6.44
E:\FR\FM\15JYP2.SGM
364X2
Endovenous
mchnchem addon
EF014
light, surgical
NF
0
30
Equipment item
replaces another item;
see preamble text
EL015
$0.30
364X2
Endovenous
mchnchem addon
EF031
table, power
NF
0
30
Equipment item
replaces another item;
see preamble text
EL015
$0.49
15JYP2
Sfmt 4725
315X6
EP15JY16.018</GPH>
ES063
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
0
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Input code
description
364X2
Endovenous
mclmchem addon
EL015
room, ultrasound,
general
NF
364X2
Endovenous
mclmchem addon
EQ250
ultrasound unit,
portable
NF
0
30
364X2
Endovenous
mclmchem addon
SH108
So trade col
Sclerosing Agent
NF
2
1
369Xl
lntro cath
dialysis circuit
ED050
PACS Workstation
Prox-y
NF
54
52
369Xl
Intra cath
dialysis circuit
ELOll
room, angiography
NF
37
35
369Xl
Intra cath
dialysis circuit
L037D
RNILPN/MTA
NF
5
3
See preamble text
-$0.74
369X2
Intro cath
dialysis circuit
ED050
PACS Workstation
Prox-y
NF
69
67
-$0.04
Intro cath
dialysis circuit
ELOll
room, angiography
NF
52
50
Intra cath
dialysis circuit
L037D
RNILPN/MTA
NF
5
3
Refined equipment
time to conform to
changes in clinical
labor time
Refined equipment
time to conform to
changes in clinical
labor time
See preamble text
Nonfacility
(NF)I Facility
(F)
Frm 00139
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
Prepare and
position pt/
monitorpt/
setup IV
15JYP2
Prepare and
position pt/
CMS
refine
ment
(min
or qty)
0
Comment
Equipment item
replaced by another
item; see preamble
text EQ250
Equipment item
replaces another item;
see preamble text
EL015
Refined supply
quantity to what is
typical for the
procedure
Refined equipment
time to conform to
changes in clinical
labor time
Refined equipment
time to conform to
changes in clinical
labor time
Direct
costs
change (in
dollars)
-$42.05
$3.49
-$110.20
-$0.04
-$10.51
-$10.51
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
PO 00000
Input
Code
369X2
Jkt 238001
HCPCS code
description
369X2
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
30
Labor
activity
(where
applicable)
-$0.74
46299
EP15JY16.019</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46300
VerDate Sep<11>2014
HCPCS code
description
Input
Code
Input code
description
RUC
recommen
dation or
current
value (min
or qty)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Jkt 238001
monitorpt/
setup IV
Intro cath
dialysis circuit
ED050
PACS Workstation
Prox-y
NF
79
77
Refined equipment
time to conform to
changes in clinical
labor time
-$0.04
369X3
lntro cath
dialysis circuit
ELOll
room, angiography
NF
62
60
Refined equipment
time to conform to
changes in clinical
labor time
-$10.51
369X3
Intro cath
dialysis circuit
L037D
RNILPN/MTA
NF
5
3
See preamble text
-$0.74
369X3
Intro cath
dialysis circuit
SA103
NF
0
l
Intro cath
dialysis circuit
SD254
NF
l
0
Supply item replaces
another item; see
preamble SD254
Supply item replaced
by another item; see
preamble SA103
$1,645.00
369X3
stent, vascular,
deployment system,
Cordis SMART
covered stent
(VIABAHN, Gore)
369X4
Thrmbc/nfs
dialysis circuit
ED050
PACS Workstation
Prox-y
NF
89
87
-$0.04
369X4
Thrmbc/nfs
dialysis circuit
ELOll
room, angiography
NF
72
70
Refined equipment
time to conform to
changes in clinical
labor time
Refined equipment
time to conform to
changes in clinical
labor time
PO 00000
369X3
Frm 00140
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.020</GPH>
Prepare and
position pt/
monitorpt/
setup IV
-$3,768.00
-$10.51
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)I Facility
(F)
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Jkt 238001
PO 00000
HCPCS code
description
Input
Code
Input code
description
369X4
Thrmbc/nfs
dialysis circuit
L037D
RN!LPN/MTA
F
Schedule
space and
equipment
in facility
369X4
Thrmbc/nfs
dialysis circuit
L037D
RN!LPN/MTA
F
369X4
Thnnbc/nfs
dialysis circuit
L037D
RN!LPN/MTA
F
Complete
preservice
diagnostic
and referral
forms
Follow-up
phone calls
and
prcscriptio
369X4
Thrmbc/nfs
dialysis circuit
L037D
RN!LPN/MTA
NF
369X4
Thrmbc/nfs
dialysis circuit
L037D
RN!LPN/MTA
NF
Frm 00141
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
6
CMS
refine
ment
(min
or qty)
3
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
Thrmbc/nfs
dialysis circuit
L037D
RN!LPN/MTA
F
Coordinate
pre-surgery
services
-$1.11
-$1.11
0
6
0
5
3
6
3
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
-$1.11
6
3
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
-$1.11
TIS
369X4
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
See preamble text
3
TIS
Prepare and
position pt/
monitorpt/
setup IV
Follow-up
phone calls
and
prescriptio
Comment
Direct
costs
change (in
dollars)
-$2.22
-$0.74
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
Labor
activity
(where
applicable)
46301
EP15JY16.021</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46302
VerDate Sep<11>2014
RUC
recommen
dation or
current
value (min
or qty)
6
CMS
refine
ment
(min
or qty)
PO 00000
Frm 00142
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
Input
Code
Input code
description
369X4
Thrmbc/nfs
dialysis circuit
L037D
RN!LPN/MTA
NF
369X4
Thrmbc/nfs
dialysis circuit
SA015
kit, for percutaneous
thrombolytic device
(Trerotola)
NF
1
0
369X4
Thrmbc/nfs
dialysis circuit
SG095
Hemostatic patch
NF
2
1
369X5
Thrmbc/nfs
dialysis circuit
ED050
PACS Workstation
Prox-y
NF
104
102
369X5
Thrmbc/nfs
dialysis circuit
ELOll
room, angiography
NF
87
85
369X5
Thnnbc/nfs
dialysis circuit
L037D
RN!LPN/MTA
NF
6
3
Thrmbc/nfs
dialysis circuit
L037D
RN!LPN/MTA
NF
6
3
15JYP2
HCPCS code
description
369X5
Jkt 238001
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
Coordinate
pre-surgery
services
Follow-up
phone calls
and
prescriptio
3
ns
EP15JY16.022</GPH>
Coordinate
pre-surgery
services
Comment
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
Supply removed due
to redundancy when
used together with
supply SD032
Refined supply
quantity to what is
typical for the
procedure
Refined equipment
time to conform to
changes in clinical
labor time
Refined equipment
time to conform to
changes in clinical
labor time
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
Direct
costs
change (in
dollars)
-$1.11
-$487.50
-$35.75
-$0.04
-$10.51
-$1.11
-$1.11
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Input
Code
Input code
description
369X5
Thrmbc/nfs
dialysis circuit
L037D
RN!LPN/MTA
F
Schedule
space and
equipment
in facility
369X5
Thrmbc/nfs
dialysis circuit
L037D
RN!LPN/MTA
F
Follow-up
phone calls
and
prescriptio
369X5
Thrmbc/nfs
dialysis circuit
L037D
RN!LPN/MTA
F
369X5
Thrmbc/nfs
dialysis circuit
L037D
RN!LPN/MTA
F
369X5
Thrmbc/nfs
dialysis circuit
L037D
RN!LPN/MTA
NF
Thrmbc/nfs
dialysis circuit
SA015
kit, for percutaneous
thrombolytic device
(Trerotola)
NF
PO 00000
HCPCS code
description
369X5
Jkt 238001
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
6
CMS
refine
ment
(min
or qty)
3
Frm 00143
Fmt 4701
0
3
0
6
3
5
3
1
0
ns
Sfmt 4725
E:\FR\FM\15JYP2.SGM
6
Complete
preservice
diagnostic
and referral
forms
Coordinate
pre-surgery
services
15JYP2
Prepare and
position pt/
monitorpt/
setup IV
Comment
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
See preamble text
Supply removed due
to redundancy when
used together with
supply SD032
Direct
costs
change (in
dollars)
-$1.11
-$2.22
-$1.11
-$1.11
-$0.74
-$487.50
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
Labor
activity
(where
applicable)
46303
EP15JY16.023</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46304
VerDate Sep<11>2014
Input
Code
Input code
description
369X5
Thrmbc/nfs
dialysis circuit
SG095
Hemostatic patch
NF
369X6
Thrmbc/nfs
dialysis circuit
ED050
PACS Workstation
Pro.x.-y
NF
369X6
Thrmbc/nfs
dialysis circuit
EL011
room, angiography
NF
369X6
Thrmbc/nfs
dialysis circuit
L037D
RNILPN/MTA
NF
369X6
Thrmbc/nfs
dialysis circuit
L037D
RN/LPN/MTA
NF
Jkt 238001
HCPCS code
description
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Refined supply
quantity to what is
typical for the
procedure
-$35.75
119
117
-$0.04
102
100
Refined equipment
time to conform to
changes in clinical
labor time
Refined equipment
time to conform to
changes in clinical
labor time
6
3
-$1.11
6
3
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
PO 00000
1
Frm 00144
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.024</GPH>
Follow-up
phone calls
and
prescriptio
ns
Coordinate
pre-surgery
services
-$10.51
-$1.11
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)I Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
2
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
PO 00000
Input
Code
Input code
description
369X6
Thrmbc/nfs
dialysis circuit
L037D
RN!LPN/MTA
F
Schedule
space and
equipment
in facility
369X6
Thrmbc/nfs
dialysis circuit
L037D
RN!LPN/MTA
F
369X6
Thrmbc/nfs
dialysis circuit
L037D
RN!LPN/MTA
F
Complete
preservice
diagnostic
and referral
forms
Follow-up
phone calls
and
prescriptio
369X6
Thrmbc/nfs
dialysis circuit
L037D
RN!LPN/MTA
F
369X6
Thrmbc/nfs
dialysis circuit
L037D
RN!LPN/MTA
NF
369X6
Thrmbc/nfs
dialysis circuit
SA015
kit, for percutaneous
thrombolytic device
(Trerotola)
Thrmbc/nfs
dialysis circuit
SA103
stent, vascular,
deployment system,
Cordis SMART
Frm 00145
HCPCS code
description
369X6
Jkt 238001
HCPCS
code
Nonfacility
(NF)I Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
6
CMS
refine
ment
(min
or qty)
3
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
3
0
6
0
Coordinate
pre-surgery
services
6
3
Prepare and
position pt/
monitor pll
setup IV
5
3
NF
1
0
NF
0
1
ns
Comment
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
See preamble text
Supply removed due
to redundancy when
used together with
supply SD032
Supply item replaces
another item; see
preamble SD254
Direct
costs
change (in
dollars)
-$1.11
-$1.11
-$2.22
-$1.11
-$0.74
-$487.50
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
Labor
activity
(where
applicable)
$1,645.00
46305
EP15JY16.025</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46306
VerDate Sep<11>2014
Input code
description
369X6
Thrmbc/nfs
dialysis circuit
SD254
covered stcnt
(VIABAHN, Gore)
NF
369X6
Thrmbc/nfs
dialysis circuit
SG095
Hemostatic patch
NF
36X41
Endovenous
mchnchem 1st
vein
EF014
light, surgical
36X41
Endovenous
mchnchem 1st
vein
EF031
36X41
Endovenous
mchnchem 1st
vein
36X41
Nonfacility
(NF)/ Facility
(F)
CMS
refine
ment
(min
or qty)
PO 00000
Frm 00146
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
0
Supply item replaced
by another item; see
preamble SA103
-$3,768.00
2
1
Refined supply
quantity to what is
typical for the
procedure
-$35.75
NF
0
48
$0.48
table, power
NF
0
48
EL015
room, ultrasound,
general
NF
39
0
Endovenous
mchnchem 1st
vein
EQ250
ultrasound unit,
portable
NF
0
48
Equipment item
replaces another item;
see preamble tex1
EL015
Equipment item
replaces another item;
see preamble text
EL015
Equipment item
replaced by another
item; see preamble
text EQ250
Equipment item
replaces another item;
see preamble text
EL015
Endovenous
mchnchem 1st
vein
L037D
RN!LPN/MTA
NF
2
0
See preamble text
-$0.74
15JYP2
EP15JY16.026</GPH>
Comment
Direct
costs
change (in
dollars)
Prepare
room,
equipment,
supplies
$0.78
-$54.67
$5.58
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Input
Code
Jkt 238001
HCPCS code
description
36X41
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
1
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Jkt 238001
HCPCS code
description
Input
Code
Input code
description
36X41
Endovenous
mclmchem 1st
vein
L054A
Vascular
Teclmologist
NF
36X41
Endovenous
mclmchem 1st
vein
L054A
Vascular
Teclmologist
NF
36X41
Endovenous
mclmchem 1st
vein
L054A
Vascular
Teclmologist
NF
PO 00000
HCPCS
code
Frm 00147
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
Exam
documents
scanned
into U/S
machine.
Exam
completed
inRIS
system to
generate
billing
process and
to populate
images into
Radiologist
work queue
Review
examinatio
nwith
interpreting
MD
Technologi
stQCs
images in
PACS,
checking
all images,
reformats,
and dose
page
RUC
recommen
dation or
current
value (min
or qty)
1
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
0
See preamble text
-$0.54
2
0
See preamble text
-$1.08
2
0
See preamble text
-$1.08
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
Nonfacility
(NF)/ Facility
(F)
Labor
activity
(where
applicable)
46307
EP15JY16.027</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46308
VerDate Sep<11>2014
Comment
Direct
costs
change (in
dollars)
0
See preamble text
-$1.08
2
0
See preamble text
-$1.08
HCPCS code
description
Input
Code
Input code
description
36X41
Endovenous
mchnchem 1st
vein
L054A
Vascular
Teclmologist
NF
36X41
Endovenous
mchnchem 1st
vein
L054A
Vascular
Teclmologist
NF
36X41
Endovenous
mchnchem 1st
vein
SA016
kit, guidewire
introducer (MicroStick)
NF
1
0
Supply not typically
used in this service
-$23.00
36X41
Endovenous
mchnchem 1st
vein
SH108
So trade col
Sclerosing Agent
NF
2
1
Refined supply
quantity to what is
typical for the
procedure
-$110.20
Jkt 238001
HCPCS
code
PO 00000
Frm 00148
Fmt 4701
15JYP2
EP15JY16.028</GPH>
Patient
clinical
information
and
questionnai
re reviewed
by
technologis
t, order
from
physician
confirmed
and exam
protocoled
by
radiologist
Availabilit
y of prior
images
confirmed
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
CMS
refine
ment
(min
or qty)
E:\FR\FM\15JYP2.SGM
RUC
recommen
dation or
current
value (min
or qty)
2
Sfmt 4725
19:43 Jul 14, 2016
Nonfacility
(NF)I Facility
(F)
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Input
Code
Input code
description
372Xl
Trhunl balo
angiop 1st art
ED050
PACS Workstation
Prox-y
NF
372Xl
Trluml balo
angiop 1st art
ELOll
room, angiography
NF
372Xl
Trluml balo
angiop 1st art
L037D
RNILPN/MTA
NF
372Xl
Trluml balo
angiop 1st art
SB009
drape, sterile,
femoral
Trluml balo
angiop 1st art
SBOll
drape, sterile,
fenestrated 16in x
29in
Nonfacility
(NF)/ Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Refined equipment
time to conform to
changes in clinical
labor time
-$0.04
72
70
Refined equipment
time to conform to
changes in clinical
labor time
-$10.51
5
3
See preamble text
-$0.74
NF
1
0
Supply item replaced
by another item; see
preamble SBO 11
-$15.95
NF
0
1
Supply item replaces
another item; see
preamble SB009
$0.56
PO 00000
89
Frm 00149
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
Prepare and
position
patient/
monitor
patient/ set
up IV
15JYP2
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Jkt 238001
HCPCS code
description
372Xl
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
91
Labor
activity
(where
applicable)
46309
EP15JY16.029</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46310
VerDate Sep<11>2014
PO 00000
Input code
description
372X3
Trhunl balo
angiop 1st vein
ED050
PACS Workstation
Prox-y
NF
372X3
Trluml balo
angiop 1st vein
ELOll
room, angiography
NF
72
70
372X3
Trluml balo
angiop 1st vein
L037D
RNILPN/MTA
NF
5
3
372X3
Trluml balo
angiop 1st vein
SB009
drape, sterile,
femoral
NF
1
0
Supply item replaced
by another item; see
preamble
-$15.95
Trluml balo
angio p 1st vein
SBOll
drape, sterile,
fenestrated 16in x
29in
NF
0
1
Supply item replaces
another item; see
preamble
$0.56
Frm 00150
Input
Code
372X3
Jkt 238001
HCPCS code
description
Nonfacility
(NF)/ Facility
(F)
Fmt 4701
Sfmt 4725
Prepare and
position
patient/
monitor
patient/ set
up IV
CMS
refine
ment
(min
or qty)
89
Comment
Refined equipment
time to conform to
changes in clinical
labor time
Refined equipment
time to conform to
changes in clinical
labor time
See preamble text
Direct
costs
change (in
dollars)
-$0.04
-$10.51
-$0.74
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.030</GPH>
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
91
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Input code
description
47531
Injection for
cholangiogram
ED050
PACS Workstation
Prox-y
NF
47531
Injection for
cholangiogram
EF018
stretcher
NF
47531
Injection for
cholangiogram
EF027
table, instmment,
mobile
47531
II*ction for
cholangiogram
ELOll
47531
Injection for
cholangiogram
Injection for
cholangiogram
Nonfacility
(NF)I Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Refined equipment
time to conform to
established policies for
PACS Workstation
Prox-y
-$0.11
87
82
-$0.03
NF
87
82
room, angiography
NF
27
24
Refined equipment
time to conform to
established policies for
equipment with 4x
monitoring time
Refined equipment
time to conform to
established policies for
equipment with 4x
monitoring time
Refined equipment
time to conform to
changes in clinical
labor time
EQOll
ECG, 3-channel
(with Sp02, NIBP,
temp, resp)
NF
87
82
-$0.07
EQ032
IV infusion pump
NF
87
82
Refined equipment
time to conform to
established policies for
equipment with 4x
monitoring time
Refined equipment
time to conform to
established policies for
equipment with 4x
PO 00000
46
Frm 00151
Fmt 4701
Sfmt 4725
-$0.01
E:\FR\FM\15JYP2.SGM
-$15.76
15JYP2
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Input
Code
Jkt 238001
HCPCS code
description
47531
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
51
Labor
activity
(where
applicable)
-$0.03
46311
EP15JY16.031</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46312
VerDate Sep<11>2014
HCPCS code
description
Input
Code
Input code
description
RUC
recommen
dation or
current
value (min
or qty)
CMS
refine
ment
(min
or qty)
Jkt 238001
monitoring time
47531
Injection for
cholangiogram
EQ168
light, exam
NF
47531
Injection for
cholangiogram
L037D
RNILPN/MTA
NF
47531
Injection for
cholangiogram
L041B
Radiologic
Teclmologist
NF
47531
Injection for
cholangiogram
L051A
RN
NF
PO 00000
51
40
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
-$0.05
Assist
physician
in
performing
procedure
15
0
Removed clinical
labor associated with
moderate sedation;
moderate sedation not
typical for this
procedure
-$5.55
Clean
room/equip
mentby
physician
staff
Sedate/App
ly
anesthesia
6
3
Refined time to
standard for this
clinical labor task
-$1.23
2
0
Removed clinical
labor associated with
moderate sedation;
moderate sedation not
typical for this
procedure
-$1.02
Frm 00152
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.032</GPH>
Comment
Direct
costs
change (in
dollars)
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Input
Code
Input code
description
47532
Injection for
cholangiogram
ED050
PACS Workstation
Prox-y
NF
PO 00000
47532
EF018
stretcher
NF
297
187
Frm 00153
l~jection for
cholangiogram
47532
Injection for
cholangiogram
EF027
table, instmment,
mobile
NF
297
187
See preamble text MS
minutes backed out
input
-$0.16
47532
Injection for
cholangiogram
ELOll
room, angiography
NF
57
54
-$15.76
47532
Injection for
cholangiogram
EQOll
ECG, 3-channel
(with Sp02, NIBP,
temp, resp)
NF
297
187
Refined equipment
time to conform to
changes in clinical
labor time
See preamble text MS
minutes backed out
input
47532
Injection for
cholangiogram
EQ032
IV infusion pump
NF
297
187
See preamble text MS
minutes backed out
input
-$0.70
Nonfacility
(NF)I Facility
(F)
CMS
refine
ment
(min
or qty)
Jkt 238001
76
Comment
Refined equipment
time to conform to
established policies for
PACS Workstation
Prox-y
See preamble text MS
minutes backed out
input
Direct
costs
change (in
dollars)
-$0.11
-$0.56
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
-$1.53
15JYP2
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
HCPCS code
description
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
81
Labor
activity
(where
applicable)
46313
EP15JY16.033</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46314
VerDate Sep<11>2014
Input
Code
Input code
description
47532
Injection for
cholangiogram
EQ168
light, exam
NF
47532
Injection for
cholangiogram
EQ250
ultrasound unit,
portable
NF
47532
Injection for
cholangiogram
L041B
Radiologic
Technologist
NF
47532
Injection for
cholangiogram
L051A
RN
NF
Injection for
cholangiogram
L051A
RN
NF
CMS
refine
ment
(min
or qty)
70
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
-$0.05
81
70
-$1.28
Clean
mom/equip
mentby
physician
staff
6
3
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
Refined time to
standard for tllis
clinical labor task
Assist
Physician
in
Perfomling
Procedure
(CS)
Monitor pt.
following
moderate
sedation
45
0
See preamble text MS
nlinutes backed out
input
-$22.95
15
0
Sec preamble tc.ll..1 MS
nlinutes backed out
input
-$7.65
PO 00000
Frm 00154
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.034</GPH>
Comment
Direct
costs
change (in
dollars)
-$1.23
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Jkt 238001
HCPCS code
description
47532
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
81
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
RUC
recommen
dation or
current
value (min
or qty)
CMS
refine
ment
(min
or qty)
2
0
See preamble tex1 MS
minutes backed out
input
-$1.02
Direct
costs
change (in
dollars)
Input
Code
Input code
description
47532
Injection for
cholangiogram
L051A
RN
NF
47532
Injection for
cholangiogram
SA044
pack, conscious
sedation
NF
1
0
See preamble text MS
supply backed out
input
-$17.31
47533
Plmt biliary
drainage cath
ED050
PACS Workstation
Prox-y
NF
96
91
-$0.11
47533
Plmt biliary
drainage cath
EF018
stretcher
NF
312
187
Refined equipment
time to conform to
established policies for
PACS Workstation
Prox-y
See preamble text MS
minutes backed out
input
Plmt biliary
drainage cath
EF027
table, instrument,
mobile
NF
312
187
PO 00000
HCPCS code
description
47533
Jkt 238001
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
Sedate/App
ly
anesthesia
Comment
Frm 00155
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
-$0.64
15JYP2
See preamble text MS
minutes backed out
input
-$0.18
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
Labor
activity
(where
applicable)
46315
EP15JY16.035</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46316
VerDate Sep<11>2014
Input
Code
Input code
description
47533
Plmt biliary
drainage cath
ELOll
room, angiography
NF
47533
Plmt biliary
drainage cath
EQOll
ECG, 3-channel
(with Sp02, NIBP,
temp, resp)
NF
312
187
See preamble text MS
minutes backed out
input
-$1.74
47533
Plmt biliary
drainage cath
EQ032
IV infusion pump
NF
312
187
See preamble text MS
minutes backed out
input
-$0.79
47533
Plmt biliary
drainage cath
EQ168
light, exam
NF
96
85
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
-$0.05
47533
Plmt biliary
drainage cath
EQ250
ultrasound unit,
portable
NF
96
85
-$1.28
Plmt biliary
drainage cath
L041B
Radiologic
Teclmologist
NF
6
3
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
Refined time to
standard for this
clinical labor task
CMS
refine
ment
(min
or qty)
69
Refined equipment
time to conform to
changes in clinical
labor time
-$15.76
PO 00000
Frm 00156
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.036</GPH>
Clean
room/equip
mentby
physician
staff
Comment
Direct
costs
change (in
dollars)
-$1.23
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Jkt 238001
HCPCS code
description
47533
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
72
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Labor
activity
(where
applicable)
Input code
description
47533
Plmt biliary
drainage cath
L051A
RN
NF
Assist
Physician
in
Performing
Procedure
(CS)
47533
Plmt biliary
drainage cath
L051A
RN
NF
47533
Plmt biliary
drainage cath
L051A
RN
NF
Monitor pt.
following
moderate
sedation
Sedate/App
ly
anesthesia
47533
Plmt biliary
drainage cath
SA044
pack, conscious
sedation
47534
Plmt biliary
drainage cath
ED050
Plmt biliary
drainage cath
47534
Plmt biliary
drainage cath
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Sec preamble tc.'.1 MS
minutes backed out
input
-$30.60
15
0
See preamble text MS
minutes backed out
input
-$7.65
2
0
See preamble text MS
minutes backed out
input
-$1.02
NF
1
0
-$17.31
PACS Workstation
Prox-y
NF
104
99
EF018
stretcher
NF
320
187
See preamble text MS
supply backed out
input
Refined equipment
time to conform to
established policies for
PACS Workstation
Prox-y
See preamble text MS
minutes backed out
input
EF027
table, instrument,
mobile
NF
320
187
See preamble text MS
minutes backed out
input
-$0.19
PO 00000
0
Frm 00157
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Input
Code
Jkt 238001
HCPCS code
description
47534
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
60
-$0.11
15JYP2
-$0.68
46317
EP15JY16.037</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46318
VerDate Sep<11>2014
Input
Code
Input code
description
47534
Plmt biliary
drainage cath
ELOll
room, angiography
NF
47534
Plmt biliary
drainage cath
EQOll
ECG, 3-channel
(with Sp02, NIBP,
temp, resp)
NF
320
187
47534
Plmt biliary
drainage cath
EQ032
IV infusion pump
NF
320
E:\FR\FM\15JYP2.SGM
47534
Plmt biliary
drainage cath
EQ168
light, exam
NF
15JYP2
47534
Plmt biliary
drainage cath
EQ250
ultrasound unit,
portable
NF
CMS
refine
ment
(min
or qty)
Jkt 238001
PO 00000
Frm 00158
Fmt 4701
Refined equipment
time to conform to
changes in clinical
labor time
See preamble text MS
minutes backed out
input
-$15.76
187
See preamble text MS
minutes backed out
input
-$0.84
104
93
-$0.05
104
93
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
77
Sfmt 4725
EP15JY16.038</GPH>
Comment
Direct
costs
change (in
dollars)
-$1.86
-$1.28
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
HCPCS code
description
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
80
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
HCPCS code
description
Input
Code
Input code
description
47534
Plmt biliary
drainage cath
L041B
Radiologic
Teclmologist
NF
Clean
room/equip
mentby
physician
staff
47534
Plmt biliary
drainage cath
L051A
RN
NF
47534
Plmt biliary
drainage cath
L051A
RN
NF
47534
Plmt biliary
drainage cath
L051A
RN
NF
Assist
Physician
in
Performing
Procedure
(CS)
Monitor pt.
following
moderate
sedation
Sedate/App
ly
anesthesia
47534
Plmt biliary
drainage cath
SA044
pack, conscious
sedation
47535
Conversion ext
bil drg cath
ED050
PACS Workstation
Prox-y
Jkt 238001
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
6
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Refined time to
standard for this
clinica11abor task
-$1.23
68
0
See preamble text MS
minutes backed out
input
-$34.68
15
0
See preamble text MS
minutes backed out
input
-$7.65
2
0
See preamble text MS
minutes backed out
input
-$1.02
NF
1
0
See preamble text MS
supply backed out
input
-$17.31
NF
81
76
Refined equipment
time to conform to
established policies for
PACS Workstation
Prox-y
-$0.11
PO 00000
3
Frm 00159
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
Nonfacility
(NF)/ Facility
(F)
Labor
activity
(where
applicable)
46319
EP15JY16.039</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46320
VerDate Sep<11>2014
Input
Code
Input code
description
47535
Conversion ext
bil drg cath
EF018
stretcher
NF
47535
Conversion ext
bil drg cath
EF027
table, instrument,
mobile
NF
47535
Conversion ext
bil drg cath
ELOll
room, angiography
47535
Conversion ext
bil drg cath
EQOll
47535
Conversion ext
bil drg cath
Conversion ext
bil drg cath
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
See preamble tex1 MS
minutes backed out
input
-$0.56
297
187
See preamble text MS
minutes backed out
input
-$0.16
NF
57
54
-$15.76
ECG, 3-channel
(with Sp02, NIBP,
temp, resp)
NF
297
187
Refined equipment
time to conform to
changes in clinical
labor time
See preamble text MS
minutes backed out
input
EQ032
IV infusion pump
NF
297
187
See preamble text MS
minutes backed out
input
-$0.70
EQ168
light, exam
NF
81
70
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
-$0.05
PO 00000
187
Frm 00160
Fmt 4701
Sfmt 4725
-$1.53
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.040</GPH>
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Jkt 238001
HCPCS code
description
47535
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
297
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
HCPCS code
description
Input
Code
Input code
description
47535
Conversion ext
bil drg cath
L041B
Radiologic
Teclmologist
NF
47535
Conversion ext
bil drg cath
L051A
RN
NF
47535
Conversion ext
bil drg cath
L051A
RN
NF
47535
Conversion ext
bil drg cath
L051A
RN
NF
47535
Conversion ext
bil drg cath
SA044
pack, conscious
sedation
47536
Exchange biliary
drg cath
ED050
PACS Workstation
Prox-y
Jkt 238001
HCPCS
code
PO 00000
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
3
Refined time to
standard for this
clinical labor task
-$1.23
45
0
See preamble text MS
minutes backed out
input
-$22.95
15
0
See preamble text MS
minutes backed out
input
-$7.65
2
0
See preamble tex1 MS
minutes backed out
input
-$1.02
NF
1
0
See preamble text MS
supply backed out
input
-$17.31
NF
56
51
Refined equipment
time to conform to
established policies for
PACS Workstation
Prox-y
-$0.11
Frm 00161
Clean
room/equip
mentby
physician
staff
Assist
Physician
in
Performing
Procedure
(CS)
RUC
recommen
dation or
current
value (min
or qty)
6
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
Monitor pt.
following
moderate
sedation
Sedate/App
ly
anesthesia
15JYP2
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
Nonfacility
(NF)I Facility
(F)
Labor
activity
(where
applicable)
46321
EP15JY16.041</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46322
VerDate Sep<11>2014
Input
Code
Input code
description
47536
EF018
stretcher
NF
Jkt 238001
Exchange biliary
drg cath
47536
EF027
table, instrument,
mobile
NF
152
67
See preamble text MS
minutes backed out
input
-$0.12
PO 00000
Exchange biliary
drg cath
47536
Exchange biliary
drg cath
ELOll
room, angiography
NF
32
29
-$15.76
47536
Exchange biliary
drg cath
EQOll
ECG, 3-channel
(with Sp02, NIBP,
temp, resp)
NF
152
67
Refined equipment
time to conform to
changes in clinical
labor time
See preamble text MS
minutes backed out
input
47536
Exchange biliary
drg cath
EQ032
IV infusion pump
NF
152
67
See preamble text MS
minutes backed out
input
-$0.54
47536
Exchange biliary
drg cath
EQ168
light, exam
NF
56
45
-$0.05
47536
Exchange biliary
drg cath
L041B
Radiologic
Teclmologist
NF
6
3
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
Refined time to
standard for this
clinical labor task
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
67
See preamble text MS
minutes backed out
input
-$0.43
Frm 00162
Fmt 4701
-$1.19
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.042</GPH>
Clean
room/equip
mentby
physician
staff
-$1.23
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
HCPCS code
description
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
152
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
RUC
recommen
dation or
current
value (min
or qty)
20
0
See preamble text MS
minutes backed out
input
-$10.20
15
0
See preamble text MS
minutes backed out
input
-$7.65
2
0
See preamble text MS
minutes backed out
input
-$1.02
CMS
refine
ment
(min
or qty)
Direct
costs
change (in
dollars)
Input
Code
Input code
description
47536
Exchange biliary
drg cath
L051A
RN
NF
47536
Exchange biliary
drg cath
L051A
RN
NF
47536
Exchange biliary
drg cath
L051A
RN
NF
47536
Exchange biliary
drg cath
SA044
pack, conscious
sedation
NF
1
0
See preamble text MS
supply backed out
input
-$17.31
Removal biliary
drg cath
ED050
PACS Workstation
Pro.x.-y
NF
51
46
Refined equipment
time to conform to
established policies for
PACS Workstation
Pro.x.-y
-$0.11
PO 00000
HCPCS code
description
47537
Jkt 238001
HCPCS
code
Nonfacility
(NF)I Facility
(F)
Frm 00163
Fmt 4701
Sfmt 4725
Assist
Physician
in
Performing
Procedure
(CS)
Monitor pt.
following
moderate
sedation
Sedate/App
ly
anesthesia
Comment
E:\FR\FM\15JYP2.SGM
15JYP2
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
Labor
activity
(where
applicable)
46323
EP15JY16.043</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46324
VerDate Sep<11>2014
Input code
description
47537
Removal biliary
drg cath
EF018
stretcher
NF
47537
Removal biliary
drg cath
EF027
table, instrument,
mobile
NF
47537
Removal biliary
drg cath
ELOll
room, angiography
47537
Removal biliary
drg cath
EQOll
47537
Removal biliary
drg cath
Removal biliary
drg cath
CMS
refine
ment
(min
or qty)
82
Refined equipment
time to conform to
established policies for
equipment with 4x
monitoring time
-$0.03
87
82
-$0.01
NF
27
24
ECG, 3-channel
(with Sp02, NIBP,
temp, resp)
NF
87
82
Refined equipment
time to conform to
established policies for
equipment with 4x
monitoring time
Refined equipment
time to conform to
changes in clinical
labor time
Refined equipment
time to conform to
established policies for
equipment with 4x
monitoring time
EQ032
IV infusion pump
NF
87
82
-$0.03
EQ168
light, exam
NF
51
40
Refined equipment
time to conform to
established policies for
equipment with 4x
monitoring time
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
PO 00000
Frm 00164
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.044</GPH>
Comment
Direct
costs
change (in
dollars)
-$15.76
-$0.07
-$0.05
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Input
Code
Jkt 238001
HCPCS code
description
47537
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)I Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
87
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Labor
activity
(where
applicable)
Input code
description
47537
Removal biliary
drg cath
L037D
RNILPN/MTA
NF
Assist
physician
in
performing
procedure
47537
Removal biliary
drg cath
L041B
Radiologic
Teclmologist
NF
Clean
room/equip
mentby
physician
staff
47537
Removal biliary
drg cath
L051A
RN
NF
Sedate/App
ly
anesthesia
47538
Perq plmt bile
duct stent
ED050
PACS Workstation
Prox-y
Perq plmt bile
duct stent
EF018
47538
Perq plmt bile
duct stent
EF027
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Removed clinical
labor associated with
moderate sedation;
moderate sedation not
typical for tl1is
procedure
-$5.55
6
3
Refined time to
standard for tills
clinical labor task
-$1.23
2
0
-$1.02
NF
89
84
stretcher
NF
305
187
Removed clinical
labor associated with
moderate sedation;
moderate sedation not
typical for tills
procedure
Refined equipment
time to conform to
established policies for
PACS Workstation
Prox-y
See preamble text MS
minutes backed out
input
table, instrument,
mobile
NF
305
187
PO 00000
0
Frm 00165
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
-$0.60
-$0.17
46325
EP15JY16.045</GPH>
See preamble text MS
minutes backed out
input
-$0.11
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Input
Code
Jkt 238001
HCPCS code
description
47538
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)I Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
15
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46326
VerDate Sep<11>2014
Input
Code
Input code
description
47538
Perq plmt bile
duct stent
ELOll
room, angiography
NF
PO 00000
47538
Perq plmt bile
duct stent
EQOll
ECG, 3-channel
(with Sp02, NIBP,
temp, resp)
NF
305
187
Frm 00166
47538
Perq plmt bile
duct stent
EQ032
IV infusion pump
NF
305
187
Fmt 4701
47538
Perq plmt bile
duct stent
EQ168
light, exam
NF
89
78
47538
Perq plmt bile
duct stent
L041B
Radiologic
Teclmologist
NF
6
3
47538
Perq plmt bile
duct stent
L051A
RN
NF
53
47538
Perq plmt bile
duct stent
L051A
RN
NF
47538
Perq plmt bile
duct stent
L051A
RN
NF
Jkt 238001
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.046</GPH>
Clean
room/equip
mentby
physician
staff
Assist
Physician
in
Performing
Procedure
(CS)
Monitor pt.
following
moderate
sedation
Sedate/App
ly
anesthesia
CMS
refine
ment
(min
or qty)
62
Comment
Refined equipment
time to conform to
changes in clinical
labor time
See preamble text MS
minutes backed out
input
Direct
costs
change (in
dollars)
-$15.76
-$1.65
See preamble text MS
minutes backed out
input
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
Refined time to
standard for this
clinical labor task
-$0.75
0
See preamble text MS
minutes backed out
input
-$27.03
15
0
See preamble text MS
minutes backed out
input
-$7.65
2
0
See preamble text MS
minutes backed out
input
-$1.02
-$0.05
-$1.23
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
HCPCS code
description
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
65
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
Input code
description
47538
Perq plmt bile
duct stent
SA044
pack, conscious
sedation
NF
47538
SD150
catheter, balloon
ureteral (Dowd)
NF
PO 00000
Perq plmt bile
duct stent
47538
Perq plmt bile
duct stent
SD152
catheter, balloon,
PTA
47539
Perq plmt bile
duct stent
ED050
47539
Perq plmt bile
duct stent
47539
Nonfacility
(NF)I Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
See preamble text MS
supply backed out
input
-$17.31
0
2
Supply item replaces
another item; see
preamble SD152
$130.00
NF
2
0
Supply item replaced
by another item; see
preamble SD150
-$487.00
PACS Workstation
Prox-y
NF
111
106
-$0.11
EF018
stretcher
NF
327
187
Perq plmt bile
duct stent
EF027
table, instrument,
mobile
NF
327
187
Refined equipment
time to conform to
established policies for
PACS Workstation
Prox-y
See preamble text MS
minutes backed out
input
See preamble text MS
minutes backed out
input
47539
Perq plmt bile
duct stent
EL011
room, angiography
NF
87
84
Refined equipment
time to conform to
changes in clinical
labor time
-$15.76
47539
Perq plmt bile
duct stent
EQOll
NF
327
187
Perq plmt bile
duct stent
EQ032
NF
327
187
See preamble text MS
minutes backed out
input
See preamble text MS
minutes backed out
input
-$1.95
47539
ECG, 3-channel
(with Sp02, NTBP,
temp, resp)
IV infusion pump
Frm 00167
0
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
-$0.20
-$0.89
46327
EP15JY16.047</GPH>
-$0.71
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Input
Code
19:43 Jul 14, 2016
HCPCS code
description
Jkt 238001
VerDate Sep<11>2014
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
1
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46328
VerDate Sep<11>2014
Input code
description
47539
Pcrq plmt bile
duct stent
EQ168
light, exam
NF
47539
Perq plmt bile
duct stent
EQ250
ultrasound unit,
portable
NF
111
100
47539
Perq plmt bile
duct stent
L041B
Radiologic
Teclmologist
NF
6
3
47539
Perq plmt bile
duct stent
L051A
RN
NF
75
47539
Perq plmt bile
duct stent
L051A
RN
NF
47539
Perq plmt bile
duct stent
L051A
RN
NF
Perq plmt bile
duct stent
SA044
pack, conscious
sedation
NF
PO 00000
Frm 00168
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.048</GPH>
Clean
mom/equip
mentby
physician
staff
Assist
Physician
in
Performing
Procedure
(CS)
Monitor pt.
following
moderate
sedation
Sedate/App
ly
anesthesia
CMS
refine
ment
(min
or qty)
100
Comment
Direct
costs
change (in
dollars)
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
Refined time to
standard for this
clinical labor task
-$0.05
0
See preamble text MS
minutes backed out
input
-$38.25
15
0
See preamble text MS
minutes backed out
input
-$7.65
2
0
See preamble text MS
minutes backed out
input
-$1.02
1
0
See preamble tex1 MS
supply backed out
input
-$17.31
-$1.28
-$1.23
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Input
Code
Jkt 238001
HCPCS code
description
47539
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
111
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
HCPCS code
description
Input
Code
Input code
description
47539
Perq plmt bile
duct stent
SD150
catheter, balloon
ureteral (Dowd)
NF
47539
Perq plmt bile
duct stent
SD152
catheter, balloon,
PTA
NF
47540
Perq plmt bile
duct stent
ED050
PACS Workstation
Prox-y
47540
Perq plmt bile
duct stent
EF018
47540
Perq plmt bile
duct stent
47540
Nonfacility
(NF)/ Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
PO 00000
Frm 00169
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
Supply item replaces
another item; see
preamble SD152
$130.00
2
0
Supply item replaced
by another item; see
preamble SD150
-$487.00
NF
121
116
-$0.11
stretcher
NF
337
187
Refined equipment
time to conform to
established policies for
PACS Workstation
Prox-y
See preamble text MS
minutes backed out
input
EF027
table, instrument,
mobile
NF
337
187
Perq plmt bile
duct stent
EL011
room, angiography
NF
97
94
47540
Perq plmt bile
duct stent
EQ011
ECG, 3-channel
(with Sp02, NIBP,
temp, resp)
NF
337
187
47540
Jkt 238001
2
Perq plmt bile
duct stent
EQ032
IV infusion pump
NF
337
187
-$0.76
See preamble texi MS
minutes backed out
input
Refined equipment
time to conform to
changes in clinical
labor time
See preamble text MS
minutes backed out
input
-$0.21
See preamble text MS
minutes backed out
input
-$0.95
-$15.76
-$2.09
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
0
Labor
activity
(where
applicable)
46329
EP15JY16.049</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46330
VerDate Sep<11>2014
Input code
description
47540
Perq plmt bile
duct stent
EQ168
light, exam
NF
47540
Perq plmt bile
duct stent
EQ250
ultrasound unit,
portable
NF
121
110
47540
Perq plmt bile
duct stent
L041B
Radiologic
Technologist
NF
6
3
47540
Perq plmt bile
duct stent
L051A
RN
NF
85
47540
Perq plmt bile
duct stent
L051A
RN
NF
47540
Perq plmt bile
duct stent
L051A
RN
NF
Pcrq plmt bile
duct stent
SA044
pack, conscious
sedation
47540
Perq plmt bile
duct stent
SD150
catheter, balloon
ureteral (Dowd)
PO 00000
Frm 00170
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.050</GPH>
CMS
refine
ment
(min
or qty)
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
Refined time to
standard for tlus
clinical labor task
-$0.05
0
See preamble text MS
n1inutes backed out
input
-$43.35
15
0
See preamble text MS
n1inutes backed out
input
-$7.65
2
0
-$1.02
NF
1
0
NF
0
2
See preamble text MS
n1inutes backed out
input
Sec preamble tc.ll..1 MS
supply backed out
input
Supply item replaces
another item; see
preamble SD152
Clean
room/equip
mentby
physician
staff
Assist
Physician
in
Perforn1ing
Procedure
(CS)
Monitor pt.
following
moderate
sedation
Sedate/App
ly
anesthesia
110
Comment
Direct
costs
change (in
dollars)
-$1.28
-$1.23
-$17.31
$130.00
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Input
Code
Jkt 238001
HCPCS code
description
47540
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)I Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
121
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Input
Code
Input code
description
47540
Perq plmt bile
duct stent
SD152
catheter, balloon,
PTA
NF
47541
Plmt access bil
tree sm bwl
ED050
PACS Workstation
Prox-y
NF
96
91
47541
Plmt access bil
tree sm bwl
EF018
stretcher
NF
312
187
47541
Plmt access bil
tree sm bwl
EF027
table, instrument,
mobile
NF
312
187
47541
Plmt access bil
tree sm bwl
ELOll
room, angiography
NF
72
69
Refined equipment
time to conform to
changes in clinical
labor time
-$15.76
47541
Plmt access bil
tree sm bwl
EQOll
ECG, 3-channel
(with Sp02, NIBP,
temp, resp)
NF
312
187
See preamble text MS
minutes backed out
input
-$1.74
47541
Plmt access bil
tree sm bwl
EQ032
IV infusion pump
NF
312
187
See preamble text MS
minutes backed out
input
-$0.79
Plmt access bil
tree sm bwl
EQ168
light, exam
NF
96
85
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
-$0.05
Nonfacility
(NF)/ Facility
(F)
CMS
refine
ment
(min
or qty)
0
Comment
PO 00000
Frm 00171
Fmt 4701
Supply item replaced
by another item; see
preamble SD150
Refined equipment
time to conform to
established policies for
PACS Workstation
Proxy
See preamble text MS
minutes backed out
input
See preamble text MS
minutes backed out
input
Direct
costs
change (in
dollars)
-$487.00
-$0.11
-$0.64
-$0.18
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Jkt 238001
HCPCS code
description
47541
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
2
Labor
activity
(where
applicable)
46331
EP15JY16.051</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46332
VerDate Sep<11>2014
HCPCS code
description
Input
Code
Input code
description
47541
Plmt access bil
tree sm bwl
EQ250
ultrasound unit,
portable
NF
47541
Plmt access bil
tree sm bwl
L041B
Radiologic
Teclmologist
NF
47541
Plmt access bil
tree sm bwl
L051A
RN
NF
47541
Plmt access bil
tree sm bwl
L051A
RN
NF
47541
Plmt access bil
tree sm bwl
L051A
RN
NF
47541
Plmt access bil
tree sm bwl
SA044
pack, conscious
sedation
47542
Dilate biliary
duct/ampulla
ED050
PACS Workstation
Prox-y
Jkt 238001
HCPCS
code
PO 00000
Frm 00172
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.052</GPH>
Clean
room/equip
ment by
physician
staff
Assist
Physician
in
Performing
Procedure
(CS)
Monitor pt.
following
moderate
sedation
Scdatc/App
ly
anesthesia
RUC
recommen
dation or
current
value (min
or qty)
96
CMS
refine
ment
(min
or qty)
85
Comment
Direct
costs
change (in
dollars)
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
Refined time to
standard for this
clinical labor task
-$1.28
6
3
-$1.23
85
0
See preamble tex1 MS
minutes backed out
input
-$43.35
15
0
See preamble text MS
minutes backed out
input
-$7.65
2
0
Sec preamble tcx1 MS
minutes backed out
input
-$1.02
NF
1
0
See preamble text MS
supply backed out
input
-$17.31
NF
30
0
Refined equipment
time to conform to
changes in clinical
labor time
-$0.66
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
Nonfacility
(NF)/ Facility
(F)
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
Input code
description
47542
Dilate biliary
duct/ampulla
EF018
stretcher
NF
47542
EF027
table, instrument,
mobile
NF
30
0
PO 00000
Dilate biliary
duct/ampulla
47542
Dilate biliary
duct/ampulla
EQOll
ECG, 3-channel
(with Sp02, NIBP,
temp, resp)
NF
30
0
See preamble text MS
minutes backed out
input
-$0.42
Fmt 4701
47542
Dilate biliary
duct/ampulla
EQ032
IV infusion pump
NF
30
0
-$0.19
Sfmt 4725
47542
Dilate biliary
duct/ampulla
EQ168
light, exam
NF
30
0
47542
Dilate biliary
duct/ampulla
L051A
RN
NF
30
0
See preamble text MS
minutes backed out
input
Refined equipment
time to conform to
changes in clinical
labor time
See preamble te.'.1 MS
minutes backed out
input
47542
Dilate biliary
duct/ampulla
SD150
catheter, balloon
ureteral (Dowd)
NF
0
1
Supply item replaces
another item; see
preamble SD152
$65.00
47542
Dilate biliary
duct/ampulla
SD152
catheter, balloon,
PTA
NF
1
0
-$243.50
47543
Endoluminal bx
biliary tree
ED050
PACS Workstation
Prox-y
NF
30
0
Supply item replaced
by another item; see
preamble SD150
Refined equipment
time to conform to
changes in clinical
labor time
Frm 00173
E:\FR\FM\15JYP2.SGM
Assist
Physician
in
Performing
Procedure
(CS)
CMS
refine
ment
(min
or qty)
0
Comment
Sec preamble tc.'.1 MS
minutes backed out
input
See preamble text MS
minutes backed out
input
Direct
costs
change (in
dollars)
-$0.15
-$0.04
-$0.13
-$15.30
15JYP2
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Input
Code
19:43 Jul 14, 2016
HCPCS code
description
Jkt 238001
VerDate Sep<11>2014
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
30
Labor
activity
(where
applicable)
-$0.66
46333
EP15JY16.053</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46334
VerDate Sep<11>2014
47543
Endoluminal bx
biliary tree
EF018
stretcher
NF
47543
Endoluminal bx
biliary tree
EF027
table, instrument,
mobile
NF
30
0
47543
Endoluminal bx
biliary tree
EQOll
ECG, 3-channel
(with Sp02, NIBP,
temp, resp)
NF
30
47543
Endoluminal bx
biliary tree
EQ032
IV infusion pump
NF
47543
Endoluminal bx
biliary tree
EQ168
light, exam
NF
47543
Endoluminal bx
biliary tree
L051A
RN
NF
Endoluminal bx
biliary tree
SD315
Stone basket
Removal duct
glbldr calculi
ED050
PACS Workstation
Prox-y
Frm 00174
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
-$0.15
0
See preamble text MS
minutes backed out
input
-$0.42
30
0
See preamble text MS
minutes backed out
input
-$0.19
30
0
-$0.13
30
0
Refined equipment
time to conform to
changes in clinical
labor time
See preamble texi MS
minutes backed out
input
NF
1
0
See preamble text
-$417.00
NF
45
0
Refined equipment
time to conform to
changes in clinical
labor time
-$0.99
Assist
Physician
in
Performing
Procedure
(CS)
0
Comment
Direct
costs
change (in
dollars)
See preamble text MS
minutes backed out
input
See preamble text MS
minutes backed out
input
15JYP2
EP15JY16.054</GPH>
CMS
refine
ment
(min
or qty)
-$0.04
-$15.30
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Input code
description
PO 00000
Input
Code
47544
Jkt 238001
HCPCS code
description
47543
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)I Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
30
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Input code
description
47544
Removal duct
glbldr calculi
EF018
stretcher
NF
47544
Removal duct
glbldr calculi
EF027
table, instrument,
mobile
NF
47544
Removal duct
glbldr calculi
EQOll
ECG, 3-channel
(with Sp02, NIBP,
temp, resp)
47544
Removal duct
glbldr calculi
EQ032
47544
Removal duct
glbldr calculi
47544
PO 00000
Input
Code
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Frm 00175
See preamble tex1 MS
minutes backed out
input
-$0.23
45
0
See preamble text MS
minutes backed out
input
-$0.06
NF
45
0
See preamble text MS
minutes backed out
input
-$0.63
IV infusion pump
NF
45
0
See preamble text MS
minutes backed out
input
-$0.28
EQ168
light, exam
NF
45
0
Refined equipment
time to conform to
changes in clinical
labor time
-$0.19
Removal duct
glbldr calculi
L051A
RN
NF
45
0
See preamble text MS
minutes backed out
input
-$22.95
Removal duct
glbldr calculi
SD150
catheter, balloon
ureteral (Dowd)
NF
0
1
Supply item replaces
another item; see
preamble SD152
$65.00
Fmt 4701
0
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Jkt 238001
HCPCS code
description
47544
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
45
Labor
activity
(where
applicable)
Assist
Physician
in
Performing
Procedure
(CS)
46335
EP15JY16.055</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46336
VerDate Sep<11>2014
PO 00000
Frm 00176
Input code
description
47544
Removal duct
glbldr calculi
SD152
catheter, balloon,
PTA
NF
47544
Removal duct
glbldr calculi
SD315
Stone basket
NF
50606
Endoluminal bx
urtr rnl plvs
EL014
room, radiographicfluoroscopic
50606
Endoluminal bx
urtr ml plvs
EL029
50606
Endoluminal bx
urtr rnl plvs
EL030
Endoluminal bx
urtr rnl plvs
EL031
Fmt 4701
Input
Code
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.056</GPH>
Nonfacility
(NF)/ Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
0
Supply item replaced
by another item; see
preamble SD150
-$243.50
0
1
See preamble text
$417.00
NF
47
0
Equipment item
replaced by another
item; see preamble
text
-$65.48
100 KW at 100 kV
(DING822)
generator (for
angiography room)
NF
0
47
Equipment item
replaces another item;
see preamble text
EL014
$0.00
C-ann single plane
system, ceiling
mounted, integrated
mullispace (for
angiography room)
T motorized
rotation, multiple
operating modes
(for angiography
room)
NF
0
47
Equipment item
replaces another item;
see preamble text
EL014
$0.00
NF
0
47
Equipment item
replaces another item;
see preamble text
EL014
$0.00
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Jkt 238001
HCPCS code
description
50606
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
1
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Jkt 238001
50606
PO 00000
Frm 00177
HCPCS code
description
Input
Code
Input code
description
Endoluminal bx
EL032
real-time digital
imaging (for
angiography room)
NF
EL033
40 em image
intensifier at
40/28/20/14 em (for
angiography room)
NF
EL034
30 x 38 image
intensifier dynamic
flat panel detector
(for angiography
room)
EL035
floor-mounted
patient table with
floating tabletop
designed for
angiographic exams
and interventions
(with peistepping
for image
intensifiers 13 in+)
18 in TFT monitor
(for angiography
room)
urtr rnl plvs
50606
Endoluminal bx
urtr rnl plvs
50606
Endoluminal bx
urtr rnl plvs
Fmt 4701
Sfmt 4725
50606
Endoluminal bx
E:\FR\FM\15JYP2.SGM
urtr rnl plvs
15JYP2
50606
Endoluminal bx
EL036
urtr rnl plvs
50606
Endoluminal bx
urtr rnl plvs
EL037
network interface
(DICOM) (for
angiography room)
Nonfacility
(NF)/ Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
47
Equipment item
replaces another item;
see preamble text
EL014
$0.00
0
47
Equipment item
replaces another item;
see preamble text
EL014
$0.00
NF
0
47
Equipment item
replaces another item;
see preamble text
EL014
$0.00
NF
0
47
Equipment item
replaces another item;
see preamble text
EL014
$0.00
NF
0
47
Equipment item
replaces another item;
see preamble text
EL014
$0.00
NF
0
47
Equipment item
replaces another item;
sec preamble tcx.1
EL014
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
0
Labor
activity
(where
applicable)
$0.00
46337
EP15JY16.057</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46338
VerDate Sep<11>2014
Jkt 238001
50606
PO 00000
HCPCS code
description
Input
Code
Input code
description
Endoluminal bx
EL038
Careposition:
radiation free
positionong of
collimators (for
angiography room)
Care watch:
acquisition and
monitoring of
configurable dose
area product (for
angiography room)
Carefilter: Cuprefiltration (for
angiography room)
NF
NF
EL041
Endoluminal bx
$0.00
0
47
Equipment item
replaces another item;
see preamble text
EL014
$0.00
NF
0
47
Equipment item
replaces another item;
see preamble text
EL014
$0.00
DICOM HIS IRIS
(for angiography
room)
NF
0
47
Equipment item
replaces another item;
see preamble text
EL014
$0.00
EL042
Control room
interface (for
angiography room)
NF
0
47
Equipment item
replaces another item;
see preamble text
EL014
$0.00
EL043
Shields, lower body
and mavig (for
angiography room)
NF
0
47
Equipment item
replaces another item;
sec preamble tcx.1
EL014
$0.00
EL039
Frm 00178
Fmt 4701
Endoluminal bx
EL040
urtr rnl plvs
Sfmt 4725
E:\FR\FM\15JYP2.SGM
50606
urtr rnl plvs
15JYP2
50606
Endoluminal bx
urtr rnl plvs
50606
EP15JY16.058</GPH>
Endoluminal bx
Endoluminal bx
urtr ml plvs
Comment
Direct
costs
change (in
dollars)
Equipment item
replaces another item;
see preamble text
EL014
urtr rnl plvs
50606
CMS
refine
ment
(min
or qty)
47
urtr rnl plvs
50606
Nonfacility
(NF)/ Facility
(F)
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
0
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Jkt 238001
50606
PO 00000
Input
Code
Input code
description
Endoluminal bx
EL044
Leonardo software
(for angiography
room)
NF
EL045
Fujitsu-Siemens
high performance
computers (for
angiography room)
NF
EL046
Color monitors (for
angiography room)
EL047
Singo modules for
dynamic replay and
full format images
(for angiography
room)
Prepared for internal
networking and
Siemens remote
servicing, both
hardware and
software (for
angiography room)
urtr rnl plvs
50606
Endoluminal bx
urtr rnl plvs
Frm 00179
Fmt 4701
HCPCS code
description
50606
Endoluminal bx
Sfmt 4725
urtr rnl plvs
E:\FR\FM\15JYP2.SGM
50606
15JYP2
50606
Endoluminal bx
urtr rnl plvs
Endoluminal bx
urtr rnl plvs
EL048
Nonfacility
(NF)I Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
47
Equipment item
replaces another item;
see preamble text
EL014
$0.00
0
47
Equipment item
replaces another item;
see preamble text
EL014
$0.00
NF
0
47
Equipment item
replaces another item;
see preamble text
EL014
$0.00
NF
0
47
Equipment item
replaces another item;
see preamble text
EL014
$0.00
NF
0
47
Equipment item
replaces another item;
see preamble text
EL014
$0.00
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
0
Labor
activity
(where
applicable)
46339
EP15JY16.059</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46340
VerDate Sep<11>2014
Input
Code
Input code
description
50705
Ureteral
embolization/occl
EL014
room, radiographicfluoroscopic
NF
50705
Ureteral
embolization/occl
EL029
100 KW at 100 kV
(DIN6822)
generator (for
angiography room)
NF
50705
Ureteral
embolization/occl
EL030
E:\FR\FM\15JYP2.SGM
C-arm single plane
system, ceiling
mounted, integrated
multispace (for
angiography room)
50705
Ureteral
embolization/occl
EL031
15JYP2
50705
Ureteral
embolization/occl
EL032
50705
Ureteral
embolization/occl
EL033
Jkt 238001
PO 00000
Frm 00180
Fmt 4701
Sfmt 4725
EP15JY16.060</GPH>
Nonfacility
(NF)I Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
0
Equipment item
replaced by another
item; see preamble
text
-$86.37
0
62
Equipment item
replaces another item;
see preamble tex1
EL014
$0.00
NF
0
62
Equipment item
replaces another item;
see preamble text
EL014
$0.00
T motorized
rotation, multiple
operating modes
(for angiography
room)
real-time digital
imaging (for
angiography room)
NF
0
62
Equipment item
replaces another item;
see preamble text
EL014
$0.00
NF
0
62
$0.00
40 em image
intensifier at
40/28/20/14 em (for
angiography room)
NF
0
62
Equipment item
replaces another item;
see preamble text
EL014
Equipment item
replaces another item;
see preamble text
EL014
$0.00
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
HCPCS code
description
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
62
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Input code
description
50705
Ureteral
embolization/occl
EL034
NF
50705
Ureteral
embolization/occl
EL035
NF
0
62
Equipment item
replaces another item;
see preamble text
EL014
$0.00
50705
Ureteral
embolization/occl
EL036
30 x 38 image
intensifier dynamic
flat panel detector
(for angiography
room)
floor-mounted
patient table with
floating tabletop
designed for
angiographic exams
and interventions
(with pcistcpping
for image
intensifiers 13 in+)
18 in TFT monitor
(for angiography
room)
NF
0
62
Equipment item
replaces another item;
see preamble text
EL014
$0.00
50705
Ureteral
embolization/occl
EL037
network interface
(DICOM) (for
angiography room)
NF
0
62
$0.00
50705
Ureteral
embolization/occl
EL038
NF
0
62
Ureteral
embolization/occl
EL039
Careposition:
radiation free
positionong of
collimators (for
angiography room)
Care watch:
acquisition and
monitoring of
configurable dose
area product (for
angiography room)
Equipment item
replaces another item;
see preamble text
EL014
Equipment item
replaces another item;
see preamble text
EL014
NF
0
62
Equipment item
replaces another item;
see preamble texi
EL014
$0.00
Nonfacility
(NF)/ Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
62
Equipment item
replaces another item;
see preamble text
EL014
$0.00
PO 00000
Frm 00181
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
$0.00
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Input
Code
Jkt 238001
HCPCS code
description
50705
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
0
Labor
activity
(where
applicable)
46341
EP15JY16.061</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46342
VerDate Sep<11>2014
Input
Code
Input code
description
50705
Ureteral
embolization/occl
EL040
Carefilter: Cuprefiltration (for
angiography room)
NF
50705
Ureteral
embolization/occl
EL041
DICOM HIS IRIS
(for angiography
room)
NF
0
62
Equipment item
replaces another item;
see preamble text
EL014
$0.00
50705
Ureteral
embolization/occl
EL042
Control room
interface (for
angiography room)
NF
0
62
$0.00
50705
Ureteral
embolization/occl
EL043
Shields, lower body
and mavig (for
angiography room)
NF
0
62
50705
Ureteral
embolization/occl
EL044
Leonardo software
(for angiography
room)
NF
0
62
50705
Ureteral
embolization/occl
EL045
NF
0
62
Ureteral
embolization/occl
EL046
Fujitsu-Siemens
high performance
computers (for
angiography room)
Color monitors (for
angiography room)
NF
0
62
50705
Ureteral
embolization/occl
EL047
Singo modules for
dynamic replay and
full format images
(for angiography
NF
0
62
Equipment item
replaces another item;
see preamble text
EL014
Equipment item
replaces another item;
see preamble text
EL014
Equipment item
replaces another item;
see preamble text
EL014
Equipment item
replaces another item;
see preamble text
EL014
Equipment item
replaces another item;
see preamble text
EL014
Equipment item
replaces another item;
see preamble text
EL014
Nonfacility
(NF)I Facility
(F)
CMS
refine
ment
(min
or qty)
PO 00000
62
Equipment item
replaces another item;
see preamble text
EL014
$0.00
Frm 00182
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.062</GPH>
Comment
Direct
costs
change (in
dollars)
$0.00
$0.00
$0.00
$0.00
$0.00
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Jkt 238001
HCPCS code
description
50705
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
0
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
HCPCS code
description
Input
Code
Input code
description
RUC
recommen
dation or
current
value (min
or qty)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Jkt 238001
room)
EL048
50706
Balloon dilate
urtrl strix
EL014
50706
Balloon dilate
urtrl strix
EL029
50706
Balloon dilate
urtrl strix
EL030
50706
Balloon dilate
urtrl strix
EL031
Balloon dilate
urtrl strix
EL032
Frm 00183
Ureteral
embolization/occl
50706
PO 00000
50705
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
Prepared for internal
networking and
Siemens remote
servicing, both
hardware and
software (for
angiography room)
room, radiographicfluoroscopic
NF
0
62
Equipment item
replaces another item;
see preamble text
EL014
$0.00
NF
62
0
-$86.37
100 KW at 100 kV
(DIN6822)
generator (for
angiography room)
C-arm single plane
system, ceiling
mounted, integrated
multispace (for
angiography room)
T motorized
rotation, multiple
operating modes
(for angiography
room)
NF
0
62
NF
0
62
Equipment item
replaced by another
item; see preamble
text
Equipment item
replaces another item;
see preamble text
EL014
Equipment item
replaces another item;
see preamble text
EL014
NF
0
62
Equipment item
replaces another item;
see preamble text
EL014
$0.00
real-time digital
imaging (for
angiography room)
NF
0
62
Equipment item
replaces another item;
sec preamble tcx.1
EL014
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
Labor
activity
(where
applicable)
$0.00
$0.00
$0.00
46343
EP15JY16.063</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46344
VerDate Sep<11>2014
PO 00000
Frm 00184
Fmt 4701
Input code
description
50706
Balloon dilate
urtrl strix
EL033
40 em image
intensifier at
40/28/20/14 em (for
angiography room)
NF
50706
Balloon dilate
urtrl strix
EL034
NF
0
62
Equipment item
replaces another item;
see preamble texi
EL014
$0.00
50706
Balloon dilate
urtrl strix
EL035
NF
0
62
Equipment item
replaces another item;
see preamble text
EL014
$0.00
50706
Balloon dilate
urtrl strix
EL036
30 x 38 image
intensifier dynamic
flat panel detector
(for angiography
room)
floor-mounted
patient table with
floating tabletop
designed for
angiographic exams
and interventions
(with peistepping
for image
intensifiers 13in+)
18 in TFT monitor
(for angiography
room)
NF
0
62
$0.00
50706
Balloon dilate
urtrl strix
EL037
network interface
(DICOM) (for
angiography room)
NF
0
62
Balloon dilate
urtrl strix
EL038
Careposition:
radiation free
positionong of
collimators (for
angiography room)
NF
0
62
Equipment item
replaces another item;
sec preamble tcxi
EL014
Equipment item
replaces another item;
see preamble text
EL014
Equipment item
replaces another item;
see preamble text
EL014
Sfmt 4725
Input
Code
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.064</GPH>
Nonfacility
(NF)I Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
62
Equipment item
replaces another item;
see preamble text
EL014
$0.00
$0.00
$0.00
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Jkt 238001
HCPCS code
description
50706
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
0
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Input code
description
50706
Balloon dilate
urtrl strix
EL039
NF
50706
Balloon dilate
urtrl strix
EL040
Care watch:
acquisition and
monitoring of
configurable dose
area product (for
angiography room)
Carefilter: Cuprefiltration (for
angiography room)
NF
0
62
50706
Balloon dilate
urtrl strix
EL041
DICOM HIS IRIS
(for angiography
room)
NF
0
62
50706
Balloon dilate
urtrl strix
EL042
Control room
interface (for
angiography room)
NF
0
62
50706
Balloon dilate
urtrl strix
EL043
Shields, lower body
and mavig (for
angiography room)
NF
0
62
50706
Balloon dilate
urtrl strix
EL044
Leonardo software
(for angiography
room)
NF
0
62
Balloon dilate
urtrl strix
EL045
Fujitsu-Siemens
high performance
computers (for
angiography room)
NF
0
62
PO 00000
Input
Code
Nonfacility
(NF)I Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Frm 00185
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
62
Equipment item
replaces another item;
see preamble text
EL014
$0.00
Equipment item
replaces another item;
see preamble text
EL014
Equipment item
replaces another item;
see preamble text
EL014
Equipment item
replaces another item;
see preamble text
EL014
Equipment item
replaces another item;
see preamble text
EL014
Equipment item
replaces another item;
see preamble text
EL014
$0.00
Equipment item
replaces another item;
sec preamble tcx.1
EL014
$0.00
$0.00
$0.00
$0.00
$0.00
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Jkt 238001
HCPCS code
description
50706
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
0
Labor
activity
(where
applicable)
46345
EP15JY16.065</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46346
VerDate Sep<11>2014
Input
Code
Input code
description
50706
Balloon dilate
urtrl strix
EL046
Color monitors (for
angiography room)
NF
50706
Balloon dilate
urtrl strix
EL047
NF
0
62
Equipment item
replaces another item;
see preamble text
EL014
$0.00
50706
Balloon dilate
urtrl strix
EL048
NF
0
62
Equipment item
replaces another item;
see preamble text
EL014
$0.00
51700
Irrigation of
bladder
SD024
Singo modules for
dynamic replay and
full format images
(for angiography
room)
Prepared for internal
networking and
Siemens remote
servicing, both
hardware and
software (for
angiography room)
catheter, Foley
NF
0
1
Supply item replaces
another item; see
preamble SD030
$7.82
51700
Irrigation of
bladder
SD030
catheter, straight
NF
1
0
Supply item replaced
by another item; see
preamble SD024
-$1.70
51700
Irrigation of
bladder
SJ031
leg or urinary
drainage bag
NF
0
1
$3.08
Insert bladder
catheter
SD024
catheter, Foley
NF
1
0
Supply item replaces
another item; see
preamble SD030
Supply item replaced
by another item; see
preamble SD030
51701
Insert bladder
catheter
SD030
catheter, straight
NF
0
1
Supply item replaces
another item; see
preamble SD024
$1.70
PO 00000
Frm 00186
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.066</GPH>
Nonfacility
(NF)/ Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
62
Equipment item
replaces another item;
see preamble text
EL014
$0.00
-$7.82
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Jkt 238001
HCPCS code
description
51701
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
0
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Jkt 238001
PO 00000
Frm 00187
Fmt 4701
HCPCS code
description
Input
Code
Input code
description
51701
Insert bladder
catheter
SJ031
leg or urinary
drainage bag
NF
52000
Cystoscopy
EF027
table, instrument,
mobile
NF
17
22
52000
Cystoscopy
EF031
table, power
NF
17
22
52000
Cystoscopy
EQ167
light source, xenon
NF
17
22
52000
Cystoscopy
ES031
NF
17
22
Refined equipment
time to conform to
established policies for
scopes
$0.30
58555
Hysteroscopy dx
sep proc
L037D
video system,
endoscopy
(processor, digital
capture, monitor,
printer, cart)
RNILPN/MTA
0
3
Refined time to
standard for this
clinical labor task
$1.11
Nonfacility
(NF)I Facility
(F)
CMS
refine
ment
(min
or qty)
0
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
F
Conduct
phone
calls/call in
prescriptio
ns
Comment
Supply item replaced
by another item; see
preamble SD030
Refined equipment
time to conform to
established policies for
scopes
Refined equipment
time to conform to
established policies for
scopes
Refined equipment
time to conform to
established policies for
scopes
Direct
costs
change (in
dollars)
-$3.08
$0.01
$0.08
$0.14
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
1
Labor
activity
(where
applicable)
46347
EP15JY16.067</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46348
VerDate Sep<11>2014
Input
Code
Input code
description
58562
Hysteroscopy
remove fb
L037D
RNILPN/MTA
F
Jkt 238001
HCPCS code
description
Conduct
phone
calls/call in
prescriptio
RUC
recommen
dation or
current
value (min
or qty)
0
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
3
Refined time to
standard for this
clinical labor task
$1.11
IlS
PO 00000
Frm 00188
Njx interlaminar
crv/thrc
SC038
needle, epidural
(RK)
NF
1
0
Duplicative; supply is
included in conscious
sedation pack
-$10.00
623X5
Njx interlaminar
crv/thrc
SC051
syringe 10-12ml
NF
1
0
Duplicative; supply is
included in conscious
sedation pack
-$0.18
623X6
Njx interlaminar
crv/thrc
EF018
stretcher
NF
73
75
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
$0.01
623X6
Njx interlaminar
crv/thrc
EQ211
pulse oximeter wprinter
NF
73
75
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
$0.01
Fmt 4701
623X5
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.068</GPH>
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Input code
description
623X6
Njx interlaminar
crv/thrc
SC038
needle, epidural
(RK)
NF
623X6
Njx interlaminar
crv/thrc
SC051
syringe 10-12ml
NF
623X7
Njx interlaminar
lmbr/sac
SC038
needle, epidural
(RK)
623X7
Njx interlaminar
lmbr/sac
SC051
623X8
Njx interlaminar
lmbr/sac
623X8
Nonfacility
(NF)/ Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
PO 00000
Duplicative; supply is
included in conscious
sedation pack
-$10.00
2
0
Duplicative; supply is
included in conscious
sedation pack
-$0.37
NF
1
0
-$10.00
syringe 10-12ml
NF
1
0
EF018
stretcher
NF
73
75
Njx interlaminar
lmbr/sac
EQ211
pulse oximeter wprinter
NF
73
75
Njx interlaminar
lmbr/sac
SC038
needle, epidural
(RK)
NF
1
0
Duplicative; supply is
included in conscious
sedation pack
Duplicative; supply is
included in conscious
sedation pack
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
Duplicative; supply is
included in conscious
sedation pack
Frm 00189
0
Fmt 4701
Sfmt 4725
-$0.18
E:\FR\FM\15JYP2.SGM
$0.01
15JYP2
$0.01
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Input
Code
Jkt 238001
HCPCS code
description
623X8
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
1
Labor
activity
(where
applicable)
-$10.00
46349
EP15JY16.069</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46350
VerDate Sep<11>2014
Input code
description
623X8
Njx interlaminar
lmbr/sac
SC051
syringe 10-12ml
NF
623X9
Njx interlaminar
crv/thrc
SC038
needle, epidural
NF
1
0
623X9
Njx interlaminar
crv/thrc
SC051
syringe 10-121111
NF
1
0
62Xl0
Njx interlaminar
crv/thrc
EF018
stretcher
NF
73
75
E:\FR\FM\15JYP2.SGM
62Xl0
Njx interlaminar
crv/thrc
EQ211
pulse oximeter wprinter
NF
73
75
62Xl0
Njx interlaminar
crv/thrc
SC038
needle, epidural
NF
1
0
Duplicative; supply is
included in conscious
sedation pack
-$10.00
Njx interlaminar
crv/thrc
SC051
NF
2
0
Duplicative; supply is
included in conscious
sedation pack
-$0.37
CMS
refine
ment
(min
or qty)
0
Duplicative; supply is
included in conscious
sedation pack
-$0.37
Duplicative; supply is
included in conscious
sedation pack
Duplicative; supply is
included in conscious
sedation pack
-$10.00
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
$0.01
PO 00000
Frm 00190
Fmt 4701
15JYP2
62Xl0
EP15JY16.070</GPH>
(RK)
(RK)
syringe 10-121111
Comment
Direct
costs
change (in
dollars)
-$0.18
$0.01
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Input
Code
Jkt 238001
HCPCS code
description
Sfmt 4725
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
2
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Input code
description
62Xll
Njx interlaminar
lmbr/sac
SC038
needle, epidural
NF
62Xll
Njx interlaminar
lmbr/sac
SC051
syringe 10-12ml
NF
62X12
Njx interlaminar
lmbr/sac
EF018
stretcher
62X12
Njx interlaminar
lmbr/sac
EQ211
62Xl2
Njx interlaminar
lmbr/sac
Njx interlaminar
lmbr/sac
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
PO 00000
Frm 00191
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
0
Duplicative; supply is
included in conscious
sedation pack
-$10.00
1
0
Duplicative; supply is
included in conscious
sedation pack
-$0.18
NF
73
75
$0.01
pulse oximeter wprinter
NF
73
75
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
SC038
needle, epidural
(RK)
NF
1
0
Duplicative; supply is
included in conscious
sedation pack
-$10.00
SC051
syringe 10-12ml
NF
2
0
Duplicative; supply is
included in conscious
sedation pack
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Input
Code
Jkt 238001
HCPCS code
description
62X12
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
1
Labor
activity
(where
applicable)
-$0.37
(RK)
$0.01
46351
EP15JY16.071</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46352
VerDate Sep<11>2014
Input
Code
Input code
description
70540
Mri
orbit/face/neck
w/o dye
ED053
Professional P ACS
Workstation
NF
70542
Mri
orbit/face/neck
w/dye
ED053
Professional P ACS
Workstation
NF
25
23
70543
Mri orbt/fac/nck
w/o &w/dye
ED053
Professional P ACS
Workstation
NF
30
77001
Fluoroguide for
vein device
ED050
PACS Workstation
Proxy
NF
77001
Fluoroguide for
vein device
EL014
room, radiographicfluoroscopic
NF
Jkt 238001
HCPCS code
description
Nonfacility
(NF)/ Facility
(F)
CMS
refine
ment
(min
or qty)
PO 00000
Refined equipment
time to conform to
established policies for
PACS Workstation
Proxy
Refined equipment
time to conform to
established policies for
PACS Workstation
Proxy
-$0.14
28
Refined equipment
time to conform to
established policies for
PACS Workstation
Proxy
-$0.14
27
25
Refined equipment
time to conform to
changes in clinical
labor time
-$0.04
24
22
Refined equipment
time to conform to
changes in clinical
labor time
-$2.79
22
Frm 00192
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.072</GPH>
Comment
Direct
costs
change (in
dollars)
-$0.14
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
24
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
PO 00000
Frm 00193
Input
Code
Input code
description
77001
Fluoroguidc for
vein device
L041B
Radiologic
Teclmologist
NF
77002
Needle
localization by
xray
ED050
PACS Workstation
Proxy
NF
77002
Needle
localization by
xray
EL014
room, radiographicfluoroscopic
NF
77002
Needle
localization by
xray
L041B
Radiologic
Teclmologist
NF
77003
Fluoroguide for
spine inject
ED050
PACS Workstation
Proxy
Fluoroguidc for
spine inject
EL014
room, radiographicfluoroscopic
Fmt 4701
HCPCS code
description
77003
Jkt 238001
HCPCS
code
Prepare
room,
equipment,
supplies
RUC
recommen
dation or
current
value (min
or qty)
2
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
0
Add-on code.
Additional time for
clinical labor task not
typical; see preamble
text
-$0.82
27
25
-$0.04
24
22
Refined equipment
time to conform to
changes in clinical
labor time
Refined equipment
time to conform to
changes in clinical
labor time
2
0
Add-on code.
Additional time for
clinical labor task not
typical; see preamble
text
-$0.82
NF
27
25
Refined equipment
time to conform to
changes in clinical
labor time
-$0.04
NF
24
22
Refined equipment
time to conform to
changes in clinical
labor time
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
Nonfacility
(NF)I Facility
(F)
Labor
activity
(where
applicable)
-$2.79
Prepare
roon1,
equipment,
supplies
-$2.79
46353
EP15JY16.073</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46354
VerDate Sep<11>2014
HCPCS code
description
Input
Code
Input code
description
77003
Fluoroguide for
spine inject
L041B
Radiologic
Teclmologist
NF
88184
Flowcyto metryI
tc 1 marker
ED031
printer, dye
sublimation (photo,
color)
88184
Flowcytometryl
tc 1 marker
L033A
Lab Technician
NF
88184
Flowcyto metryI
tc 1 marker
L033A
Lab Teclmician
NF
Prepare
room,
equipment,
supplies
0
Add-on code.
Additional time for
clinical labor task not
typical; see preamble
text
-$0.82
5
NF
Jkt 238001
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
2
2
Refined equipment
time to conform to
changes in clinical
labor time
-$0.03
4
0
Indirect Practice
Expense input and/or
not individually
allocable to a
particular patient for a
particular service
-$1.32
2
1
Refined time to
standard for this
clinical labor task
-$0.33
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
PO 00000
Frm 00194
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.074</GPH>
Enter data
into
laboratory
information
system,
multiparam
eter
analyses
and field
data entry,
complete
quality
assurance
documentat
ion
Clean
room/equip
mcnt
following
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
Nonfacility
(NF)/ Facility
(F)
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
HCPCS code
description
Input
Code
Input code
description
Jkt 238001
PO 00000
Frm 00195
88184
Fmt 4701
Flowcyto metryI
tc 1 marker
L045A
Cytotechnologist
NF
procedure
(including
any
equipment
mainte nanc
e that must
be done
after the
procedure)
Load
specimen
into flow
cytometer,
CMS
refine
ment
(min
or qty)
10
7
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
-$1.35
5
2
Refined time to
standard for this
clinical labor task
-$1.35
nm
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
RUC
recommen
dation or
current
value (min
or qty)
88184
Flowcyto metryI
tc 1 marker
L045A
Cytotechnologist
NF
specimen,
monitor
data
acquisition,
and data
modeling,
and unload
flow
cytometer
Print out
histograms,
assemble
materials
with
paperwork
to
pathologist
s
Comment
Direct
costs
change (in
dollars)
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
Labor
activity
(where
applicable)
46355
EP15JY16.075</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46356
VerDate Sep<11>2014
Input code
description
88184
F1owcyto metryI
tc 1 marker
L045A
Cytoteclmo1ogist
NF
88184
Flowcyto metryI
tc 1 marker
SL186
antibody, flow
cytometry (each
test)
NF
88185
Flowcyto metryftc
add-on
ED031
printer, dye
sublimation (photo,
color)
NF
Flowcyto metryftc
add-on
L033A
Lab Technician
NF
PO 00000
Frm 00196
Fmt 4701
Instrument
start-up,
quality
control
functions,
calibration,
centrifugati
on,
maintainin
g specimen
tracking,
logs and
labeling
RUC
recommen
dation or
current
value (min
or qty)
15
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Sfmt 4725
E:\FR\FM\15JYP2.SGM
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
-$0.90
1.6
1
See preamble text
-$5.10
2
1
Refined equipment
time to conform to
changes in clinical
labor time
-$0.01
1
0
Indirect Practice
Expense input and/or
not individually
allocable to a
particular patient for a
particular service
-$0.33
15JYP2
13
EP15JY16.076</GPH>
Enter data
into
laboratory
information
system,
multiparam
eter
analyses
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Input
Code
Jkt 238001
HCPCS code
description
88185
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
HCPCS code
description
Input
Code
Input code
description
RUC
recommen
dation or
current
value (min
or qty)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Jkt 238001
and field
data entry,
complete
quality
assurance
documentat
ion
PO 00000
Flowcyto metryftc
add-on
SL089
lysing reagent
(FACS)
NF
3
2
See preamble text
-$4.49
88185
Flowcyto metryftc
add-on
SL186
antibody, flow
cytometry (each
test)
NF
1.6
1
See preamble text
-$5.10
88321
Micro slide
consultation
L037B
Histoteclmologist
NF
1
0
Clinical labor task
redundant with clinical
labor task
-$0.37
88323
Micro slide
consultation
L037B
Histoteclmologist
NF
0
1
See preamble text
$0.37
Frm 00197
88185
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
46357
EP15JY16.077</GPH>
Assemble
and deliver
slides with
paperwork
to
pathologist
s
Complete
workload
recording
logs.
Collate
slides and
paperwork.
Deliver to
pathologist.
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)I Facility
(F)
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46358
VerDate Sep<11>2014
Input code
description
88323
Micro slide
consultation
L037B
Histotechnologist
NF
88323
Micro slide
consultation
L037B
Histotechnologist
NF
88323
Micro slide
consultation
SL135
stain, hematoxylin
88325
Comprehensive
review of data
L037B
Histotechnologist
NF
Comprehensive
review of data
L037B
Histotechnologist
NF
Frm 00198
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.078</GPH>
Assemble
and deliver
slides with
paperwork
to
pathologist
s
Clean
equipment
while
performing
service
Assemble
and deliver
slides with
paperwork
to
pathologist
s
Clean
Equipment
while
performing
service
0
Clinica1labor task
redundant with clinical
labor task
-$0.37
1
0
Clinical labor task
redundant with clinical
labor task
-$0.37
32
NF
PO 00000
Input
Code
88325
Jkt 238001
HCPCS code
description
RUC
recommen
dation or
current
value (min
or qty)
1
16
See preamble text
-$0.70
1
0
Clinical labor task
redundant with clinical
labor task
-$0.37
1
0
Clinical labor task
redundant with clinical
labor task
-$0.37
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
RUC
recommen
dation or
current
value (min
or qty)
0
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
1
See preamble text
$0.37
Input
Code
Input code
description
88325
Comprehensive
review of data
L037B
Histotechnologist
NF
88325
Comprehensive
review of data
SL135
stain, hematoxylin
NF
32
16
See preamble text
-$0.70
95812
EEG 41-60
minutes
EF003
bedroom furniture
(hospital bed, table,
reclining chair)
NF
108
99
-$0.05
95812
EEG 41-60
minutes
EQ017
EEG, digital,
prolonged testing
system (computer
w-remote camera)
NF
108
99
95812
EEG 41-60
minutes
L047B
REEGT
NF
62
50
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
See preamble tex1
EEG over 1 hour
EF003
bedroom furniture
(hospital bed, table,
reclining chair)
NF
142
129
PO 00000
HCPCS code
description
95813
Jkt 238001
HCPCS
code
Nonfacility
(NF)I Facility
(F)
Frm 00199
Complete
workload
recording
logs.
Collate
slides and
paperwork.
Deliver to
pathologist.
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
Perform
procedure
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
-$1.32
-$5.64
-$0.08
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
Labor
activity
(where
applicable)
46359
EP15JY16.079</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46360
VerDate Sep<11>2014
RUC
recommen
dation or
current
value (min
or qty)
142
HCPCS code
description
Input
Code
Input code
description
95813
EEG over 1 hour
EQ017
EEG, digital,
prolonged testing
system (computer
w-remote camera)
NF
95813
EEG over 1 hour
L047B
REEGT
NF
Perform
procedure
96
96933
Rcmcelulr
subcelulr img skn
L042A
RNILPN
NF
Review
imaging
with
interpreting
physician
96934
Rcmcelulr
subcelulr img skn
EF031
table, power
96934
Rcmcelulr
subcelulr img skn
EQ168
96934
Rcmcelulr
subcclulr img skn
ES056
Jkt 238001
HCPCS
code
CMS
refine
ment
(min
or qty)
129
Comment
Direct
costs
change (in
dollars)
PO 00000
-$1.91
-$7.52
2
0
See preamble texi
-$0.84
NF
32
31
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
-$0.02
light, exam
NF
32
31
$0.00
reflectance confocal
imaging system
NF
32
31
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
Frm 00200
80
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
See preamble text
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.080</GPH>
-$0.37
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
Nonfacility
(NF)/ Facility
(F)
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
PO 00000
Input code
description
96934
Rcmcelulr
subcelulr img skn
L042A
RNILPN
NF
96934
Rcmcelulr
subcelulr img skn
L042A
RNILPN
NF
96934
Rcmcelulr
subcelulr img skn
L042A
RNILPN
NF
Rem celulr
subcelulr img skn
EF031
table, power
NF
Frm 00201
Input
Code
96935
Jkt 238001
HCPCS code
description
Review
imaging
with
interpreting
physician
Prepare and
position pt/
monitor pt/
set up IV
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
Patient
clinical
information
and
questimmai
re reviewed
by
technologis
t, order
from
physician
confirmed
and exam
protocoled
by
radiologist
RUC
recommen
dation or
current
value (min
or qty)
2
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
1
See preamble texi
-$0.42
2
1
-$0.42
2
0
Add-on code.
Additional time for
clinical labor task not
typical; see preamble
text
Add-on code.
Additional time for
clinical labor task not
typical; see preamble
text
32
31
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
-$0.02
-$0.84
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
Labor
activity
(where
applicable)
46361
EP15JY16.081</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46362
VerDate Sep<11>2014
PO 00000
Input
Code
Input code
description
96935
Rcmcelulr
subcelulr img skn
EQ168
light, exam
NF
96935
Rcmcelulr
subcelulr img skn
ES056
reflectance confocal
imaging system
NF
32
31
96935
Rcmcelulr
subcelulr img skn
L042A
RNILPN
NF
2
0
Rcmcelulr
subcelulr img skn
L042A
RNILPN
NF
2
1
CMS
refine
ment
(min
or qty)
31
Frm 00202
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.082</GPH>
Patient
clinical
information
and
questionnai
re reviewed
by
technologis
t, order
from
physician
confirmed
and exam
protocoled
by
radiologist
Prepare and
position pt/
monitor pt/
setup IV
Comment
Direct
costs
change (in
dollars)
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
Refined equipment
time to conform to
established policies for
non-highly technical
equipment
Add-on code.
Additional time for
clinical labor task not
typical; see preamble
text
$0.00
Add-on code.
Additional time for
clinical labor task not
typical; see preamble
text
-$0.42
-$0.37
-$0.84
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Jkt 238001
HCPCS code
description
96935
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
RUC
recommen
dation or
current
value (min
or qty)
32
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Labor
activity
(where
applicable)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
0
See preamble text
-$0.84
Refined equipment
time to conform with
other codes in the
family
Refined equipment
time to conform with
other codes in the
family
Refined equipment
time to conform with
other codes in the
family
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
$0.07
Input code
description
96935
Rcmcelulr
subcelulr img skn
L042A
RNILPN
NF
97X61
Pt evallow
complex 20 min
EF028
table, mat, hi-lo, 6 x
8 platform
NF
13
20
97X61
Pt evallow
complex 20 min
EQ219
rehab and testing
system (BTE
primus)
NF
5
10
97X61
Pt evallow
complex 20 min
EQ243
treadmill
NF
5
3
97X61
Pt evallow
complex 20 min
L023A
Physical Therapy
Aide
NF
Prepare and
position pt/
monitorpt/
setup IV
0
2
97X61
Pt evallow
complex 20 min
L039B
Physical Therapy
Assistant
NF
Obtain vital
signs
3
5
Pt evallow
complex 20 min
L039B
Physical Therapy
Assistant
NF
Assist
physical
therapist
with
exam/evalu
ation,
5
10
PO 00000
Frm 00203
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.083</GPH>
Review
imaging
with
interpreting
physician
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
$0.89
-$0.03
$0.46
$0.78
$1.95
46363
Input
Code
Jkt 238001
HCPCS code
description
97X61
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)I Facility
(F)
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
RUC
recommen
dation or
current
value (min
or qty)
2
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46364
VerDate Sep<11>2014
HCPCS code
description
Input
Code
Input code
description
Jkt 238001
97X61
Pt evallow
complex 20 min
L039B
Physical Therapy
Assistant
NF
Conduct
phone
calls/call in
prescriptio
97X61
Pt evallow
complex 20 min
L039B
Physical Therapy
Assistant
NF
97X62
Pt eval mod
complex 30 min
L039B
Physical Therapy
Assistant
NF
Obtainlreco
rd medical
and
medication
history, self
assessment
tools, and
fall
screening
forPT
review
Obtainlreco
rd medical
and
medication
history, self
assessment
tools, and
fall
screening
forPT
review
Pt eval high
complex 45 min
EF028
table, mat, hi-lo, 6 x
8 platform
NF
PO 00000
Frm 00204
0
3
5
8
10
8
See preamble text
-$0.78
30
20
Refined equipment
time to conform with
other codes in the
family
-$0.10
ns
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
obtain
records/me
asures
97X63
15JYP2
EP15JY16.084</GPH>
RUC
recommen
dation or
current
value (min
or qty)
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
$1.17
$1.17
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)I Facility
(F)
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Jkt 238001
HCPCS code
description
Input
Code
Input code
description
97X63
Pt eval high
complex 45 min
EQ148
kit, hand dexterity,
sensory, strength
NF
97X63
Pt eval high
complex 45 min
EQ20l
parallel bars,
platform mounted
NF
5
Nonfacility
(NF)/ Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Refined equipment
time to conform with
other codes in the
family
-$0.01
0
Refined equipment
time to conform with
other codes in the
family
-$0.02
PO 00000
2
Frm 00205
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
5
Labor
activity
(where
applicable)
46365
EP15JY16.085</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46366
VerDate Sep<11>2014
Input code
description
97X63
Pt eval high
complex 45 min
EQ243
treadmill
NF
97X63
Pt eval high
complex 45 min
L039B
Physical Therapy
Assistant
NF
97X63
Pt eval high
complex 45 min
L039B
Physical Therapy
Assistant
NF
97X63
Pt eval high
complex 45 min
SM022
NF
Pt re-eval est
plan care
L039B
sanitizing clothwipe (surface,
instruments,
equipment)
Physical Therapy
Assistant
PO 00000
Frm 00206
Fmt 4701
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.086</GPH>
NF
RUC
recommen
dation or
current
value (min
or qty)
0
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Obtain/reco
rd medical
and
medication
history, self
assessment
Refined equipment
time to conform with
other codes in the
family
$0.04
15
10
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
-$1.95
12
8
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
-$1.56
6
Assist
physical
therapist
with
exam/evalu
ation,
obtain
records/me
asures
Obtain/reco
rd medical
and
medication
history, self
assessment
tools, and
fall
screening
forPT
review
3
5
-$0.05
5
4
Refined supply
quantity to conform
with other codes in the
family
See preamble text
-$0.39
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
Input
Code
Jkt 238001
HCPCS code
description
97X64
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)I Facility
(F)
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
HCPCS code
description
Input
Code
Input code
description
RUC
recommen
dation or
current
value (min
or qty)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Jkt 238001
tools, and
fall
screening
forPT
review
PO 00000
Frm 00207
Ot evallow
complex 20 min
EF033
table, treatment, hilo
NF
0
10
97X65
Ot evallow
complex 20 min
EL002
environmental
module - kitchen
NF
10
11
97X65
Ot evallow
complex 20 min
EQ068
balance assessmentretraining system
(Balance Master)
NF
0
8
97X65
Ot evallow
complex 20 min
EQ143
kit, ADL
NF
8
11
Fmt 4701
97X65
Sfmt 4725
E:\FR\FM\15JYP2.SGM
Refined equipment
time to conform with
other codes in the
family
Refined equipment
time to conform with
other codes in the
family
Refined equipment
time to conform with
other codes in the
family
Refined equipment
time to conform with
other codes in the
family
$0.05
$0.11
$0.43
$0.00
15JYP2
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
Labor
activity
(where
applicable)
46367
EP15JY16.087</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46368
VerDate Sep<11>2014
Jkt 238001
HCPCS code
description
Input
Code
Input code
description
97X65
Ot evallow
complex 20 min
EQ151
kit, motor
coordination
NF
97X65
Ot evallow
complex 20 min
EQ152
kit, sensory
NF
2
Nonfacility
(NF)/ Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Refined equipment
time to conform with
other codes in the
family
$0.00
3
Refined equipment
time to conform with
other codes in the
family
$0.00
PO 00000
3
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E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.088</GPH>
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
2
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Jkt 238001
HCPCS code
description
Input
Code
Input code
description
97X65
Ot evallow
complex 20 min
ES057
environmental
module- bathroom
NF
97X65
Ot evallow
complex 20 min
ES058
kit, vision
NF
0
Nonfacility
(NF)/ Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Refined equipment
time to conform with
other codes in the
family
$0.64
3
Refined equipment
time to conform with
other codes in the
family
$0.00
PO 00000
10
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E:\FR\FM\15JYP2.SGM
15JYP2
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
0
Labor
activity
(where
applicable)
46369
EP15JY16.089</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46370
VerDate Sep<11>2014
HCPCS code
description
Input
Code
Input code
description
97X65
Ot evallow
complex 20 min
L039B
Physical Therapy
Assistant
NF
Obtain vital
signs
97X65
Ot evallow
complex 20 min
L039B
Physical Therapy
Assistant
NF
Obtain
measure me
nts
97X65
Ot evallow
complex 20 min
L039B
Physical Therapy
Assistant
NF
97X66
Oteval mod
complex 30 min
L039B
Physical Therapy
Assistant
NF
Assist
physician
in
performing
procedure
(15%)
Obtain
measure me
nts
97X67
Ot eval high
complex 45 min
EF033
table, treatment, hilo
NF
Jkt 238001
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
3
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
$0.78
4
6
$0.78
5
7
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
8
6
See preamble text
-$0.78
15
10
Refined equipment
time to conform with
other codes in the
family
-$0.03
PO 00000
5
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E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.090</GPH>
$0.78
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
Nonfacility
(NF)/ Facility
(F)
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Jkt 238001
PO 00000
Input
Code
Input code
description
97X67
Ot eval high
complex 45 min
EL002
environmental
module - kitchen
NF
97X67
Ot eval high
complex 45 min
EQ068
balance assessmentretraining system
(Balance Master)
NF
0
8
97X67
Ot eval high
complex 45 min
EQ117
evaluation system
for upper extremityhand (Greenleaf)
NF
5
4
97X67
Ot eval high
complex 45 min
EQ143
kit, ADL
NF
15
11
97X67
Ot eval high
complex 45 min
EQ185
neurobehavioral
status instrument
NF
11
0
Frm 00211
HCPCS code
description
Nonfacility
(NF)/ Facility
(F)
CMS
refine
ment
(min
or qty)
11
Comment
Fmt 4701
Sfmt 4725
Refined equipment
time to conform with
other codes in the
family
Refined equipment
time to conform with
other codes in the
family
E:\FR\FM\15JYP2.SGM
15JYP2
Refined equipment
time to conform with
other codes in the
family
Refined equipment
time to conform with
other codes in the
family
Refined equipment
time to conform with
other codes in the
family
Direct
costs
change (in
dollars)
-$0.34
$0.43
-$0.07
-$0.01
-$0.59
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
14
Labor
activity
(where
applicable)
46371
EP15JY16.091</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46372
VerDate Sep<11>2014
Jkt 238001
HCPCS code
description
Input
Code
Input code
description
97X67
Ot eval high
complex 45 min
EQ219
rehab and testing
system (BTE
primus)
NF
97X67
Ot eval high
complex 45 min
ES057
environmental
module- bathroom
NF
14
Nonfacility
(NF)/ Facility
(F)
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
Refined equipment
time to conform with
other codes in the
family
-$0.36
10
Refined equipment
time to conform with
other codes in the
family
-$0.26
PO 00000
3
Frm 00212
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E:\FR\FM\15JYP2.SGM
15JYP2
EP15JY16.092</GPH>
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
5
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Jkt 238001
HCPCS code
description
Input
Code
Input code
description
97X67
Ot eval high
complex 45 min
L039B
Physical Therapy
Assistant
NF
Obtain
measure me
nts
97X67
Ot eval high
complex 45 min
L039B
Physical Therapy
Assistant
NF
Assist
physician
in
performing
procedure
6
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
-$2.34
9
7
Refined clinical labor
time to conform with
identical labor activity
in other codes in the
family
-$0.78
CMS
refine
ment
(min
or qty)
PO 00000
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
12
Comment
Direct
costs
change (in
dollars)
Frm 00213
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E:\FR\FM\15JYP2.SGM
(15%)
15JYP2
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
Nonfacility
(NF)/ Facility
(F)
Labor
activity
(where
applicable)
46373
EP15JY16.093</GPH>
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
46374
VerDate Sep<11>2014
Jkt 238001
HCPCS code
description
Input
Code
Input code
description
97X68
Ot re-eval est
plan care
L039B
Physical Therapy
Assistant
NF
00416
Prostate biopsy,
any mthd
SL063
eosin y
NF
Obtain
measure me
nts
CMS
refine
ment
(min
or qty)
Comment
Direct
costs
change (in
dollars)
2
See preamble texi
-$0.39
0
Supply item replaced
by another item; see
preamble SL20 1
-$38.45
PO 00000
HCPCS
code
RUC
recommen
dation or
current
value (min
or qty)
3
Frm 00214
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Sfmt 4725
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EP15JY16.094</GPH>
48
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
Nonfacility
(NF)/ Facility
(F)
Labor
activity
(where
applicable)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
VerDate Sep<11>2014
Jkt 238001
PO 00000
Frm 00215
Fmt 4701
HCPCS code
description
Input
Code
Input code
description
00416
Prostate biopsy,
any mthd
SL201
stain, eosin
NF
RUC
recommen
dation or
current
value (min
or qty)
0
CMS
refine
ment
(min
or qty)
48
Comment
Supply item replaces
another item; see
preamble SL063
Direct
costs
change (in
dollars)
$3.24
Sfmt 4725
E:\FR\FM\15JYP2.SGM
15JYP2
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
19:43 Jul 14, 2016
HCPCS
code
Nonfacility
(NF)/ Facility
(F)
Labor
activity
(where
applicable)
46375
EP15JY16.095</GPH>
46376
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
TABLE 26—INVOICES RECEIVED FOR EXISTING DIRECT PE INPUTS
CPT/HCPCS codes
19030, 19081, 19082,
19281, 19282,
19283, 19284,
77053, 77054,
770X1, 770X2,
770X3.
31575, 31576, 31577,
31578, 31579,
317X1, 317X2,
317X3, 31580,
31584, 31587,
315X1, 315X2,
315X3, 315X4,
315X5, 315X6, 190+
other codes.
58555, 58562, 58563,
58565.
88323, 88355, 88380,
88381.
88360, 88361 ...............
91110 ...........................
91110, 91111 ...............
91111 ...........................
95145, 95146, 95148,
95149.
95147, 95148, 95149 ..
122 codes ....................
59 codes ......................
Item name
CMS
code
Current price
Updated price
Percent
change
Estimated
non-facility
allowed
services
for HCPCS
codes using
this item
Number of
invoices
room, digital mammography.
EL013
168,214.00
362,935.00
116
10
2,294,862
video system, endoscopy
(processor, digital capture, monitor, printer,
cart).
ES031
33,232.50
15,045.00
¥55
1
1,497,130
endoscope, rigid,
hysteroscopy.
stain, eosin ......................
ES009
4,990.50
6,207.50
24
1
672
SL201
0.04
0.07
55
5
45,393
SL493
3.19
14.00
339
4
216,208
SA005
450.00
520.00
16
1
30,464
ES029
17,000.00
12,450.00
¥27
1
30,586
SA094
450.00
472.80
5
1
122
SH009
16.67
20.14
21
4
50,772
SH010
EQ167
ES020
30.22
6,723.33
6,301.93
44.05
7,000.00
4,250.00
46
4
¥33
3
1
1
37,955
2,149,616
581,924
Antibody Estrogen Receptor monoclonal.
kit, capsule endoscopy wapplication supplies
(M2A).
video system, capsule endoscopy (software,
computer, monitor,
printer).
kit, capsule, ESO, endoscopy w-application supplies (ESO).
antigen, venom ................
antigen, venom, tri-vespid
light source, xenon ..........
fiberscope, flexible,
rhinolaryngoscopy.
TABLE 27—INVOICES RECEIVED FOR NEW DIRECT PE INPUTS
CMS
code
Number of
invoices
Item name
31575, 31579, 317X3, 31580, 31584,
31587, 315X1, 315X2, 315X3,
315X4, 315X5, 315X6.
31576, 31577, 31578, 317X1, 317X2 ..
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
CPT/HCPCS codes
rhinolaryngoscope, flexible, video, nonchanneled.
ES063
8,000.00
1
541,537
rhinolaryngoscope,
flexible,
video,
channeled.
Disposable biopsy forceps ...................
stroboscopy system .............................
Voice Augmentation Gel ......................
Claravein Kit .........................................
Sotradecol Sclerosing Agent ................
Biopsy Guide ........................................
BLADE INCSR 2.9MM .........................
Hysteroscopic fluid management system.
Hysteroscopic Resection System ........
PACS Mammography Workstation ......
Professional PACS Workstation ..........
ES064
9,000.00
1
756
SD318
ES065
SJ090
SA122
SH108
EQ375
SF059
EQ378
26.84
19,100.00
575.00
890.00
110.20
7,000.00
599.00
14,698.38
1
1
1
1
1
0
1
1
574
54,466
99
264
528
85,731
2,677
2,677
EQ379
ED054
ED053
19,857.50
103,616.47
14,616.93
1
8
9
2,677
2,274,249
32,571,650
31576, 31577, 31578 ............................
31579 ....................................................
317X3 ....................................................
36X41 ....................................................
36X41, 364X2 .......................................
55700 ....................................................
58558 ....................................................
58558 ....................................................
58558 ....................................................
770X1, 770X2, 770X3 ..........................
70540, 70542, 70543; over 400 additional codes.
VerDate Sep<11>2014
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PO 00000
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Average price
Estimated
non-facility
allowed
services
for HCPCS
codes using
this item
E:\FR\FM\15JYP2.SGM
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46377
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
TABLE 27—INVOICES RECEIVED FOR NEW DIRECT PE INPUTS—Continued
CMS
code
CPT/HCPCS codes
Item name
77332 ....................................................
77333 ....................................................
knee wedge/foot block system .............
Thermoplastic
tissue
bolus
30X30X0.3cm.
water bath, digital control .....................
Supine Breast/Lung Board ...................
Urethane Foaming Agent .....................
flow cytometry analytics software ........
antigen vial transport envelope ............
Beck Depression Inventory, Second
Edition (BDI–II).
IV infusion pump, ambulatory ..............
Imaging Tray ........................................
adhesive ruler .......................................
reflectance confocal imaging system ...
environmental module—bathroom .......
kit, vision ..............................................
patient lift system .................................
wheelchair accessible scale .................
leg positioning system ..........................
77333 ....................................................
77333, 77334 ........................................
77334 ....................................................
88184, 88185 ........................................
95144, 95165 ........................................
961X1 ....................................................
96416 ....................................................
96931, 96932 ........................................
96931, 96932 ........................................
96931, 96932, 96934, 96935 ...............
97X66, 97X67, 97X68 ..........................
97X66, 97X67 .......................................
GDDD1 .................................................
GDDD1 .................................................
GDDD1 .................................................
III. Other Provisions of the Proposed
Rule for PFS
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
A. Chronic Care Management (CCM)
and Transitional Care Management
(TCM) Supervision Requirements in
Rural Health Clinics (RHCs) and
Federally Qualified Health Centers
(FQHCs)
In the CY 2016 PFS final rule with
comment period (80 FR 71080 through
71088), we finalized policies for
payment of CCM services in RHCs and
FQHCs. Payment for CCM services in
RHCs and FQHCs was effective
beginning on January 1, 2016, for RHCs
and FQHCs that furnish a minimum of
20 minutes of qualifying CCM services
during a calendar month to patients
with multiple (two or more) chronic
conditions that are expected to last at
least 12 months or until the death of the
patient, and that would place the
patient at significant risk of death, acute
exacerbation/decompensation, or
functional decline. Payment is made
when CPT code 99490 is billed alone or
with other payable services on a RHC or
FQHC claim, and the rate is based on
the PFS national average non-facility
payment rate. The requirement that RHC
or FQHC services be furnished face-toface was waived for CCM services
furnished to a RHC or FQHC patient
because CCM services are not required
to be furnished face-to-face.
Medicare payment for TCM services
furnished by a RHC or FQHC
practitioner was effective January 1,
2013, consistent with the effective date
VerDate Sep<11>2014
19:43 Jul 14, 2016
Jkt 238001
Average price
EQ376
SD321
3,290.00
23.90
1
1
48,831
3,493
EP120
EQ377
SL519
EQ380
SK127
SK128
2,350.00
5,773.15
53.50
14,000.00
1.50
2.26
1
1
1
1
2
1
3,493
290,969
287,476
1,680,252
6,464,311
1
EQ381
SA121
SK125
ES056
ES057
ES058
EF045
EF046
EF047
2384.45
34.75
9.95
98,500.00
25,000.00
410.00
2,824.33
875.92
1,076.50
1
1
1
1
1
1
3
3
3
117,248
5
5
9
115,107
86,912
15,115,789
15,115,789
15,115,789
of payment for TCM services under the
PFS (77 FR 68978 through 68994; also,
see CMS-Pub. 100–02, Medicare Benefit
Policy Manual, chapter 13, section
110.4).
TCM services are billable only when
furnished within 30 days of the date of
the patient’s discharge from a hospital
(including outpatient observation or
partial hospitalization), skilled nursing
facility, or community mental health
center. Communication (direct contact,
telephone, or electronic) with the
patient or caregiver must commence
within 2 business days of discharge, and
a face-to-face visit must occur within 14
days of discharge for moderate
complexity decision making (CPT code
99495), or within 7 days of discharge for
high complexity decision making (CPT
code 99496). The TCM visit is billed on
the day that the TCM visit takes place,
and only one TCM visit may be paid per
beneficiary for services furnished during
that 30 day post-discharge period. If the
TCM visit occurs on the same day as
another billable visit, only one visit may
be billed. TCM and CCM cannot be
billed during the same time period for
the same patient.
In the CY 2016 PFS final rule with
comment period (80 FR 71087), we
responded to comments requesting that
we make an exception to the
supervision requirements for auxiliary
staff furnishing CCM and TCM services
incident to physician services in RHCs
and FQHCs (80 FR 71087). Auxiliary
staff in RHCs and FQHCs furnish
services incident to a RHC or FQHC
PO 00000
Frm 00217
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non-facility
allowed
services
for HCPCS
codes using
this item
Sfmt 4702
Number of
invoices
visit and include nurses, medical
assistants, and other clinical staff who
work under the direct supervision of a
RHC or FQHC practitioner. The
commenters suggested that the
regulatory language be amended to be
consistent with the provision in
§ 410.26(b)(5) for CCM and TCM
services under the PFS, which states
that services and supplies furnished
incident to CCM and TCM services can
be furnished under general supervision
of the physician (or other practitioner)
when they are provided by clinical staff.
It further specifies that 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, but only the
supervising physician (or other
practitioner) may bill Medicare for
incident to services. We responded that
due to the differences between
physician offices and RHCs and FQHCs
in their models of care and payment
structures, we believe that the direct
supervision requirement for services
furnished by auxiliary staff is
appropriate for RHCs and FQHCs, but
that we would consider changing this in
future rulemaking if RHCs and FQHCs
find that requiring direct supervision
presents a barrier to furnishing CCM
services.
Since payment for CCM in RHCs and
FQHCs began on January 1, 2016, some
RHCs and FQHCs have informed us
that, in their view, the direct
supervision requirement for auxiliary
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Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
staff has limited their ability to furnish
CCM services. Specifically, these RHCs
and FQHCs have stated that the direct
supervision requirement has prevented
them from entering into contracts with
third party companies to provide CCM
services, especially during hours that
they are not open, and that they are
unable to meet the CCM requirements
within their current staffing and budget
constraints.
To bill for CCM services, RHCs and
FQHCs must ensure that there is access
to care management services on a 24
hour a day, 7 day a week basis. This
includes providing the patient with a
means to make timely contact with RHC
or FQHC practitioners who have access
to the patient’s electronic care plan to
address his or her urgent chronic care
needs. The RHC or FQHC must ensure
the care plan is available electronically
at all times to anyone within the RHC
or FQHC who is providing CCM
services.
Once the RHC or FQHC practitioner
has initiated CCM services and the
patient has consented to receiving this
service, CCM services can be furnished
by a RHC or FQHC practitioner, or by
auxiliary personnel, as defined in
§ 410.26(a)(1), which includes nurses,
medical assistants, and other staff
working under physician supervision
who meet the requirements to provide
incident to services. Auxiliary
personnel in RHCs and FQHCs must
furnish services under direct
supervision, which requires that a RHC
or FQHC practitioner be present in the
RHC or FQHC and immediately
available to furnish assistance and
direction. The RHC or FQHC
practitioner does not need to be present
in the room when the service is
furnished.
Although many RHCs and FQHCs
prefer to furnish CCM and TCM services
utilizing existing staff, some RHCs and
FQHCs would like to contract with a
third party to furnish aspects of their
CCM and TCM services, but cannot do
so because of the direct supervision
requirement. Without the ability to
contract with a third party, these RHCs
and FQHCs have stated that they find it
difficult to meet the CCM requirements
for 24 hours a day, 7 days a week access
to services.
To enable RHCs and FQHCs to
effectively contract with third parties to
furnish aspects of CCM and TCM
services, we propose to revise
§ 405.2413(a)(5) and § 405.2415(a)(5) to
state that services and supplies
furnished incident to TCM and CCM
services can be furnished under general
supervision of a RHC or FQHC
practitioner. The proposed exception to
VerDate Sep<11>2014
19:43 Jul 14, 2016
Jkt 238001
the direct supervision requirement
would apply only to auxiliary personnel
furnishing TCM or CCM incident to
services, and would not apply to any
other RHC or FQHC services. The
proposed revisions for CCM and TCM
services and supplies furnished by
RHCs and FQHCs are consistent with
§ 410.26(b)(5), which allows CCM and
TCM services and supplies to be
furnished by clinical staff under general
supervision when billed under the PFS.
B. FQHC-Specific Market Basket
1. Background
Section 10501(i)(3)(A) of the
Affordable Care Act (Pub. L. 111–148
and Pub. L. 111–152) added section
1834(o) of the Act to establish a
payment system for the costs of FQHC
services under Medicare Part B based on
prospectively set rates. In the
Prospective Payment System (PPS) for
FQHC Final Rule published in the May
2, 2014 Federal Register (79 FR 25436),
we implemented a methodology and
payment rates for the FQHC PPS. The
FQHC PPS base payment rate was
determined using FQHC cost report and
claims data and was effective for FQHC
payments from October 1, 2014, through
December 31, 2015 (implementation
year). The adjusted base payment rate
for the implementation year was
$158.85 (79 FR 25455). When
calculating the FQHC PPS payment, the
base payment rate is multiplied by the
FQHC geographic adjustment factor
(GAF) based on the location of the
FQHC, and adjusted for new patients or
when an initial preventive physical
examination or annual wellness visit are
furnished. Beginning on October 1,
2014, FQHCs began to transition to the
FQHC PPS based on their cost reporting
periods. As of January 1, 2016, all
FQHCs are paid under the FQHC PPS.
Section 1834(o)(2)(B)(ii) of the Act
requires that the payment for the first
year after the implementation year be
increased by the percentage increase in
the MEI. Therefore, in CY 2016, the
FQHC PPS base payment rate was
increased by the MEI. The MEI was
based on 2006 data from the American
Medical Association (AMA) for selfemployed physicians and was used in
the PFS Sustainable Growth Rate (SGR)
formula to determine the conversion
factor for physician service payments.
(See the CY 2014 PFS final rule (78 FR
74264) for a complete discussion of the
2006-based MEI). Section
1834(o)(2)(B)(ii) of the Act also requires
that beginning in CY 2017, the FQHC
PPS base payment rate will be increased
by the percentage increase in a market
basket of FQHC goods and services, or
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if such an index is not available, by the
percentage increase in the MEI.
For CY 2017, we are proposing to
create a 2013-based FQHC market
basket. The proposed market basket uses
Medicare cost report (MCR) data
submitted by freestanding FQHCs. In
the following discussion, we provide an
overview of the proposed market basket
and describe the methodologies used to
determine the cost categories, cost
weights, and price proxies. In addition,
we compare the growth rates of the
proposed FQHC market basket to the
growth rates of the MEI.
2. Overview of the FQHC Market Basket
The 2013-based FQHC market basket
is a fixed-weight, Laspeyres-type price
index. A Laspeyres price index
measures the change in price, over time,
of the same mix of goods and services
purchased in the base period. Any
changes in the quantity or mix of goods
and services (that is, intensity)
purchased over time relative to a base
period are not measured.
The index itself is constructed in
three steps. First, a base period is
selected (in this proposed rule, the base
period is CY 2013), total base period
costs are estimated for a set of mutually
exclusive and exhaustive cost
categories, and the proportion of total
costs that each cost category represents
is calculated. These proportions are
called cost weights. Second, each cost
category is matched to an appropriate
price or wage variable, referred to as a
price proxy. These price proxies are
derived from publicly available
statistical series that are published on a
consistent schedule (preferably at least
on a quarterly basis). Finally, the cost
weight for each cost category is
multiplied by the established price
proxy index level. The sum of these
products (that is, the cost weights
multiplied by their price levels) for all
cost categories yields the composite
index level of the market basket for the
given time period. Repeating this step
for other periods produces a series of
market basket levels over time. Dividing
the composite index level of one period
by the composite index level for an
earlier period produces a rate of growth
in the input price index over that
timeframe.
As previously noted, the market
basket is described as a fixed-weight
index because it represents the change
in price over time of a constant mix
(quantity and intensity) of goods and
services needed to furnish FQHC
services. The effects on total costs
resulting from changes in the mix of
goods and services purchased
subsequent to the base period are not
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measured. For example, a FQHC hiring
more nurses to accommodate the needs
of patients would increase the volume
of goods and services purchased by the
FQHC, but would not be factored into
the price change measured by a fixedweight FQHC market basket. Only when
the index is rebased would changes in
the quantity and intensity be captured,
with those changes being reflected in
the cost weights. Therefore, we rebase
the market baskets periodically so that
the cost weights reflect a current mix of
goods and services purchased (FQHC
inputs) to furnish FQHC services.
3. Creating a FQHC Market Basket
In 2015, we began researching the
possibility of creating a FQHC market
basket that would be used in place of
the MEI to update the FQHC PPS base
payment rate annually. An FQHC
market basket should reflect the cost
structures of FQHCs while the MEI
reflects the cost structures of selfemployed physician offices. At the time
of implementation of the FQHC PPS, a
FQHC market basket had not been
developed, and therefore, the law
stipulated that the FQHC PPS base
payment rate be updated by the MEI for
the first year after implementation (CY
2016). In subsequent years, the FQHC
PPS base payment rate should be
annually updated by a FQHC market
basket, if available.
The MEI cost weights were derived
from data collected by the AMA on the
Physician Practice Expense Information
Survey (PPIS), since physicians, unlike
other Medicare providers, are not
required to complete and submit a
Medicare Cost Report. FQHCs submit
expense data annually on the Medicare
Cost Report form CMS–222–92 (OMB
No: 0938–0107), ‘‘Independent Rural
Health Clinic and Freestanding
Federally Qualified Health Center Cost
Report’’; therefore, we were able to
estimate relative cost weights specific to
FQHCs. We define a ‘‘major cost
weight’’ as one calculated using the
Medicare cost reports (for example,
FQHC practitioner compensation).
However, the Medicare cost report data
allows multiple methods for reporting
detailed expenses, either in detailed
cost center lines or more broadly
reported in general categories of
expenses. An alternative data source is
used to disaggregate further residual
costs that could not be classified into a
major cost category directly using only
the Medicare Cost Report data. We
estimated the cost weights for each year
2009 through 2013 and found the cost
weights from each year to be similar,
which provided confidence in the
derived cost weights.
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In summary, our research over the
past year allowed us to evaluate the
appropriateness of using freestanding
FQHC Medicare cost report data to
calculate the major cost weights for a
FQHC market basket. We believe that
the proposed methodologies described
below create a FQHC market basket that
reflects the cost structure of FQHCs.
Therefore, we believe that the use of this
proposed 2013-based FQHC market
basket to update FQHC PPS base
payment rate would more accurately
reflect the actual costs and scope of
services that FQHCs furnish compared
to the 2006-based MEI.
4. Development of Cost Categories and
Cost Weights for the Proposed 2013Based FQHC Market Basket
a. Use of Medicare Cost Report Data
The proposed 2013-based FQHC
market basket consists of eight major
cost categories, which were derived
from the CY 2013 Medicare cost reports
for freestanding FQHCs. These
categories are FQHC-Practitioner
Compensation, Other Clinical
Compensation, Non-Health
Compensation, Fringe Benefits,
Pharmaceuticals, Fixed Capital,
Moveable Capital, and an All Other
(Residual) cost category. The All Other
(Residual) cost category reflects the
costs not captured in the other seven
cost categories. The CY 2013 Medicare
cost reports include all FQHCs whose
cost reporting period began on or after
January 1, 2013, and prior to or on
December 31, 2013. We selected CY
2013 as the base year because the
Medicare cost reports for that year were
the most recent, complete set of
Medicare cost report data available for
FQHCs at the time of development of
the cost share weights and proposed
2013-based FQHC market basket. As
stated above, we compared the cost
share weights from the MCR for CY
2009 through CY 2013 and the CY 2013
weights were consistent with the
weights from prior years.
We began with all FQHCs with
reporting periods in CY 2013 (that is,
between and including January 1, 2013,
and December 31, 2013). We then
excluded FQHCs missing ‘‘total costs’’
(that is, any FQHC that did not report
expenses on Worksheet A, Column 7,
Line 62). This edit removed 83
providers from our analysis. Next, we
compared the total Medicare allowable
costs (that is, total costs eligible for
reimbursement under the FQHC PPS) to
total costs reported on the Medicare cost
report. We kept FQHCs whose
Medicare-allowable costs accounted for
60 percent or more of total costs to
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46379
remove FQHCs whose costs were
primarily driven by services not covered
under the FQHC benefit. For example,
FQHCs that reported a majority of costs
for dental services were excluded from
the sample. This edit removed 33
FQHCs from our analysis. We used the
remaining Medicare cost reports to
calculate the costs for the eight major
cost categories (FQHC Practitioner
Compensation, Other Clinical
Compensation, Non-Health
Compensation, Fringe Benefits,
Pharmaceuticals, Fixed Capital,
Moveable Capital, and All Other
(Residual) costs).
The resulting 2013-based FQHC
market basket cost weights reflect
Medicare allowable costs. We propose
to define Medicare allowable costs for
freestanding FQHC facilities as:
Worksheet A, Columns 1 and 2, cost
centers lines 1 through 51 but excluding
line 20, which is professional liability
insurance (PLI). We exclude PLI costs
from the total Medicare allowable costs
because FQHCs that receive section 330
grant funds also are eligible to apply for
medical malpractice coverage under
Federally Supported Health Centers
Assistance Act (FSHCAA) of 1992 (Pub.
L. 102–501) and FSHCAA of 1995 (Pub.
L. 104–73 amending section 224 of the
Public Health Service Act). Below we
derive the eight major cost categories.
(1) FQHC Practitioner Compensation:
A FQHC practitioner is defined as one
of the following occupations:
Physicians, NPs, PAs, CNMs, Clinical
Psychologist (CPs), and Clinical Social
Worker (CSWs). Under certain
conditions, a FQHC visit also may be
provided by qualified practitioners of
outpatient DSMT and MNT when the
FQHC meets the relevant program
requirements for provision of these
services. FQHC Practitioner
Compensation costs are derived as the
sum of compensation and other costs as
reported on Worksheet A; columns 1
and 2; lines 1, 2, 3, 6, 7, 13, 14. The
Medicare cost reports also captures
‘‘Other’’ compensation costs (the sum of
costs reported on Worksheet A; columns
1 and 2; lines 9, 10, 11, and 15). We
allocate a portion of these compensation
costs to FQHC Practitioner
compensation by multiplying this
amount by the ratio of FQHC
Practitioner compensation costs to the
sum of FQHC Practitioner compensation
costs and Other Clinical compensation
costs. We believe that the assumption of
distributing the costs proportionally is
reasonable since there is no additional
detail on the specific occupations these
compensation costs represent. We also
include a proportion of Fringe Benefit
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costs as described in section III.B.1.a.iv
of this proposed rule.
(2) Other Clinical Compensation:
Other Clinical Compensation includes
any health-related clinical staff who
does not fall under the definition of a
FQHC practitioner from paragraph (1)
(FQHC Practitioner Compensation).
Other Clinical Compensation costs are
derived as the sum of compensation and
other costs as reported on Worksheet A;
columns 1 and 2; lines 4, 5, and 8.
Similar to the FQHC Practitioner
compensation, we also allocate a
proportion of the ‘‘Other’’ Clinical
compensation costs by multiplying this
amount by the ratio of Other Clinical
Compensation costs to the sum of FQHC
Practitioner Compensation costs and
Other Clinical compensation costs.
Given the ambiguity in the costs
reported on these lines, we believe that
the assumption of distributing the costs
proportionally is reasonable since there
is no additional detail on the specific
occupations these compensation costs
represent. We also include a proportion
of Fringe Benefit costs as described in
section III.B.1.a.iv of this proposed rule.
(3) Non-Health Compensation: NonHealth Compensation includes
compensation costs for Office Staff,
Housekeeping & Maintenance, and
Pharmacy. Non-Health Compensation
costs are derived as the sum of
compensation costs as reported on
Worksheet A; column 1 only for lines 32
and 51; and Worksheet A; both columns
1 and 2 for line 38. We only use the
costs from column 1 for housekeeping
and maintenance and pharmacy since
we believe that there are considerable
costs other than compensation that
could be reported for these categories.
We use the costs from both column 1
and column 2 for office salaries (line 38)
since only salaries or compensation
should be reported on this line. We also
include a proportion of Fringe Benefit
costs as described in section III.B.1.a.iv
of this proposed rule.
(4) Fringe Benefits: Worksheet A;
columns 1 and 2; line 45 of the
Medicare cost report captures fringe
benefits and payroll tax expenses. We
proposed to estimate the fringe benefit
cost weight as the fringe benefits costs
divided by total Medicare allowable
costs. We propose to allocate the Fringe
Benefits cost weight to the three
compensation cost categories (FQHC
practitioner compensation, other
clinical compensation, and non-health
compensation) based on their relative
proportions. The fringe benefits ratio is
equal to the compensation cost weight
as a percent of the sum of the
compensation cost weights for all three
types of workers. These allocation ratios
are 46 percent, 14 percent, and 40
percent, respectively. Therefore, we
propose to allocate 46 percent of the
fringe benefits cost weight to the FQHC
practitioner cost weight, 14 percent of
the fringe benefits cost weight to the
clinical compensation cost weight, and
40 percent of the fringe benefits cost
weight to the non-health compensation
cost weight. Table 28 shows the three
compensation category cost weights
after the fringe benefit cost weight is
allocated for the proposed 2013-based
FQHC market basket.
TABLE 28—COMPENSATION CATEGORY COST WEIGHTS AFTER FRINGE BENEFITS ALLOCATION
Before fringe
benefits
allocation
(%)
Cost category
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FQHC Practitioner Compensation ...........................................................................................................................
Other Clinical Compensation ...................................................................................................................................
Non-Health Compensation ......................................................................................................................................
Fringe Benefits (distribute to comp) ........................................................................................................................
We believe that distributing the fringe
benefit expenses reported on line 45
using the provider-specific
compensation ratios is reasonable.
(5) Pharmaceuticals: Drugs and
biologicals that are not usually selfadministered, and certain Medicarecovered preventive injectable drugs are
paid incident to a FQHC visit.
Therefore, pharmaceutical costs include
the non-compensation costs reported on
Worksheet A, column 2, for the
pharmacy cost center (line 51). We note
that pharmaceutical costs are not
included in the MEI since
pharmaceutical costs are paid outside of
the PFS.
(6) Fixed Capital: Fixed capital costs
are equal to the sum of costs for rent,
interest on mortgage loans, depreciation
on buildings and fixtures, and property
tax as reported on Worksheet A;
columns 1 and 2; lines 26, 28, 30, and
33.
(7) Moveable Capital: Moveable
capital costs are equal to the sum of
costs for depreciation of medical
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equipment, office equipment, and other
equipment as reported on Worksheet A;
column 1 and 2; lines 19, 31, and 39.
(8) All Other (Residual): After
estimating the expenses for the seven
cost categories listed above, we summed
all remaining costs together for each
FQHC to come up with All Other
(Residual) costs. The costs included in
the All Other (Residual) category
include all costs reported for medical
supplies, transportation, allowable GME
pass through costs, facility insurance,
utilities, office supplies, legal,
accounting, administrative insurance,
telephone, housekeeping &
maintenance, nondescript healthcare
costs, nondescript facility costs, and
nondescript administrative costs.
Although a cost weight for these
categories could be obtained directly
from the costs reported in that cost
center’s respective line on the cost
report form, some FQHCs reported
significant costs in other (specify), or
‘‘free form,’’ lines which made it
difficult to determine the accuracy of
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26.8
8.1
23.1
10.7
After fringe
benefits
allocation
(%)
31.8
9.5
27.4
0.0
these costs. For example, some FQHCs
reported costs only in the free form lines
and not in the cost center specific lines,
while other FQHCs reported costs in
both the cost center specific lines and
the free form lines. Since a majority of
FQHCs used the free form lines, relying
solely on the costs reported in the cost
center specific lines for costs could lead
to an inaccurate cost weights in the
market basket. For example, if a FQHC
reported all other healthcare costs in
line 21 rather than breaking the
healthcare costs into the detailed cost
centers (lines 17 through 20.50), then
the cost weight for medical supplies
could be lower than it should be if we
did not allocate the costs reported in the
free form lines to medical supplies.
Section III.B.1.b explains the method
used to allocate the residual costs to
more detailed cost categories.
After we derived costs for the eight
major cost categories for each FQHC
using the Medicare cost report data as
previously described, we addressed data
outliers using the following steps. First,
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we divided the costs for each of the
eight categories by total Medicare
allowable costs for each FQHC. We then
removed those FQHCs whose derived
cost weights fell in the top and bottom
5 percent of provider specific derived
cost weights. Five percent is the
standard trim applied for all CMS
market basket cost weights. After these
outliers were removed, we summed the
costs for each category across all
remaining FQHCs. We then divided this
by the sum of total Medicare allowable
costs across all remaining FQHCs to
obtain a cost weight for the proposed
2013-based FQHC market basket for the
given category. See Table 29 for the
resulting cost weights for these major
cost categories that we obtained from
the Medicare cost reports.
46381
To further divide the ‘‘All Other’’
TABLE 29—MAJOR COST CATEGORIES
AS DERIVED FROM MEDICARE COST residual cost weight (20.1 percent)
estimated from the CY 2013 Medicare
REPORTS—Continued
cost report data into more detailed cost
categories, we propose to use the
Cost category
relative cost shares from the 2006-based
MEI for nine detailed cost categories:
Fixed Capital .........................
4.5 Utilities; Miscellaneous Office
Moveable Capital ..................
1.7 Expenses; Telephone; Postage; Medical
Non Salary Pharmaceuticals
5.1 Equipment; Medical Supplies;
All Other (Residual) ..............
20.1 Professional, Scientific, & Technical
Totals may not sum to 100.0% due to Services; Administrative & Facility
Services; and Other Services. For
rounding.
example, the Utilities cost represents 7
b. Derivation of Detailed Cost Categories
percent of the sum of the 2006-based
From the All Other (Residual) Cost
MEI ‘‘All Other’’ cost category weights;
Weight
therefore, the Utilities cost weight
The All Other Residual cost weight
would represent 7 percent of the
was derived from summing all expenses proposed 2013-based FQHC market
reported on the Medicare cost report
basket’s ‘‘All Other’’ cost category
Worksheet A, columns 1 and 2 for
(20.066 percent), yielding a ‘‘final’’
TABLE 29—MAJOR COST CATEGORIES medical supplies (line 17),
Utilities proposed cost weight of 1.4
AS DERIVED FROM MEDICARE COST transportation (line 18), allowable GME
percent in the proposed 2013-based
pass through costs (line 20.50), facility
REPORTS
LTCH market basket (7 percent * 20.1
insurance (line 27), utilities (line 29),
percent = 1.4 percent).
office supplies (line 40), legal (line 41),
2013 FQHC
Cost category
weight
Table 30 shows the cost weight for
accounting (line 42), administrative
(%)
each matching category from the 2006insurance (line 43), telephone (line 44),
based MEI, the percent each cost
non-compensation housekeeping &
FQHC Practitioner Comcategory represents of the 2006-based
maintenance (line 32, column 2 only),
pensation ...........................
26.8
MEI ‘‘All Other’’ cost weight, and the
Other Clinical Compensation
8.1 nondescript healthcare costs (lines 21–
resulting proposed 2013-based FQHC
Non-Health Compensation ...
23.1 23), nondescript facility costs (lines 34–
36), and nondescript administrative
market basket cost weights for detailed
Fringe Benefits (distribute to
compensation) ...................
10.7 costs (lines 54–56).
cost categories.
2013 FQHC
weight
(%)
TABLE 30—PROPOSED DETAILED FQHC COST CATEGORY WEIGHTS
2006-based
MEI cost
weights
(%)
Proposed FQHC detailed cost categories
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Total All Other (Residual) ............................................................................................................
Utilities .........................................................................................................................................
Miscellaneous Office Expenses ...................................................................................................
Telephone ....................................................................................................................................
Postage ........................................................................................................................................
Medical Equipment ......................................................................................................................
Medical supplies ..........................................................................................................................
Professional, Scientific, & Tech. Services ...................................................................................
Administrative & Facility Services ...............................................................................................
Other Services .............................................................................................................................
FQHCs have liberty in how and where
certain costs are reported on the
Medicare cost report form. We believe
that, given the ambiguity in how the
data are reported for these overhead cost
centers on the FQHC cost report form,
relying on the relative shares
determined from the MEI is reasonable.
We hope that future cost data from the
upcoming revised FQHC cost report
form will allow us to better estimate the
detailed cost weights for these
categories directly. All FQHCs will
report costs on the new forms for cost
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report periods for CY 2016 expenses.
For details regarding how the 2006based MEI cost categories were derived,
see the CY 2011 PFS final rule with
comment period (75 FR 73262 through
73267). The following is a description of
the types of expenses included in
detailed cost categories derived from the
All Other (Residual) cost category:
• Utilities: Includes expenses
classified in the fuel, oil and gas, water
and sewage, and electricity industries.
These types of industries are classified
in NAICS and include NAICS 2211
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17.976
1.266
2.478
1.501
0.898
1.978
1.760
2.592
3.052
2.451
Percent of the
2006-based
MEI ‘‘All
Other’’ cost
weight
(%)
Proposed
2013-based
FQHC detailed
cost weights
(%)
100.000
7.0
13.8
8.4
5.0
11.0
9.8
14.4
17.0
13.6
20.1
1.4
2.8
1.7
1.0
2.2
2.0
2.9
3.4
2.7
(Electric power generation,
transmission, and distribution), 2212
(Natural gas distribution), and 2213
(Water, sewage, and other systems).
• Miscellaneous Office Expense:
Includes expenses for office expenses
not reported in other categories,
miscellaneous expenses, included but
not limited to, paper (such as paper
towels), printing (such as toner for
printers), miscellaneous chemicals
(such as soap and hand sanitizer).
• Telephone: Includes expenses
classified in NAICS 517
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(Telecommunications) and NAICS 518
(Internet service providers), and NAICS
515 (Cable and other subscription
programming). Telephone service,
which is one component of the
Telecommunications expenses,
accounts for the majority of the
expenditures in this cost category.
• Postage: Includes expenses
classified in NAICS 491 (Postal services)
and NAICS 492 (Courier services).
• Medical Equipment Expenses:
Includes the expenses related to
maintenance contracts, and the leases or
rental of medical equipment used in
diagnosis or treatment of patients. It
would also include the expenses for any
medical equipment that was purchased
in a single year and not financed.
• Medical Supplies Expenses:
Includes the expenses related to medical
supplies such as sterile gloves, needles,
bandages, specimen containers, and
catheters. We note that the Medical
Supply cost category does not include
expenses related to pharmaceuticals
(drugs and biologicals).
• Professional, Scientific, & Technical
Services: Includes the expenses for any
professional services purchased from an
outside agency or party and could
include fees including but not limited
to, legal, marketing, professional
association memberships, licensure fees,
journal fees, continuing education.
• Administrative & Facility Services:
Includes the expenses for any
administrative and facility services
purchased from an outside agency or
party and could include fees including
but not limited to, accounting, billing,
office management services, security
services, transportation services,
landscaping, or professional car upkeep.
• Other Services: Includes other
service expenses including, but not
limited to, nonresidential maintenance
and repair, machinery repair, janitorial,
and security services.
Table 31 shows the proposed cost
categories and weights for the 2013based FQHC market basket. The
resulting cost weights include
combining the cost weights derived
from the Medicare Cost Report Data
(shown in Table 29), distributing the
fringe benefits weight across the three
compensation cost categories (shown in
Table 28), and disaggregating the
residual cost weight into detailed cost
categories (shown in Table 30).
Additionally, we compare the cost
weights of the proposed 2013-based
FQHC market basket to the cost weights
in the 2006-based MEI, where we have
grouped the cost weights from the MEI
to align with the FQHC proposed cost
categories.
TABLE 31—PROPOSED FQHC MARKET BASKET AND MEI, COST CATEGORIES, COST WEIGHTS
2013 FQHC
weight
(percent)
2006 MEI
weight
(percent)
MEI cost category
FQHC Market Basket ...................................................
Total Compensation ..............................................
FQHC Practitioner Compensation .................
Other Clinical Compensation .........................
Non-health Compensation .............................
All Other Products .................................................
Utilities ............................................................
Miscellaneous Office Expenses .....................
Telephone ......................................................
Postage ..........................................................
Medical Equipment .........................................
Medical Supplies ............................................
Professional Liability Insurance .....................
Pharmaceuticals .............................................
All Other Services ..........................................
Professional, Scientific & Technical Services
Administrative & Facility Services ..................
Other Services ...............................................
Capital ...................................................................
Fixed Capital ..................................................
Moveable Capital ...........................................
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FQHC cost category
100.0
68.7
31.7
9.5
27.4
16.1
1.4
2.8
1.7
1.0
2.2
2.0
........................
5.1
9.0
2.9
3.4
2.7
6.1
4.5
1.7
100.000
67.419
50.866
6.503
10.050
14.176
1.266
2.478
1.501
0.898
1.978
1.760
4.295
........................
8.095
2.592
3.052
2.451
10.310
8.957
1.353
MEI.
Total Compensation.
Physician Compensation.
Other Clinical Compensation.
Non-health Compensation.
All Other Products.
Utilities.
Miscellaneous Office Expenses.
Telephone.
Postage.
Medical Equipment.
Medical Supplies.
Professional Liability Insurance.
Pharmaceuticals.
All Other Services.
Professional, Scientific & Technical Services.
Administrative & Facility Services.
Other Services.
Capital.
Fixed Capital.
Moveable Capital.
Although the overall cost structure of
the MEI, the index currently used to
update the FQHC PPS base payment, is
similar to the proposed FQHC cost
structure, there are a few key
differences.
First, though total compensation costs
in the proposed FQHC market basket
and the MEI are each approximately 67–
68 percent of total costs, non-health
compensation accounts for a larger
share of compensation costs in the
FQHC setting than in the self-employed
physician office. Likewise, physician
compensation accounts for a larger
percentage of costs in the MEI than
FQHC practitioner compensation
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accounts for in the proposed FQHC
market basket.
Second, the proposed FQHC market
basket includes a cost category for
pharmaceuticals, while drug costs are
excluded from the MEI. Drug costs are
an expense in the FQHC PPS base
payment rate since drugs and
biologicals that are not usually selfadministered, and certain Medicarecovered preventive injectable drugs are
paid incident to a visit while drug costs
are reimbursed separately under the
PFS.
Third, as mentioned previously, PLI
expenditures are excluded from the
proposed FQHC market basket since
most FQHCs PLI costs are covered
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under the Federal Tort Claims Act,
while in the MEI the PLI costs are a
significant expense for self-employed
physicians. Finally, fixed capital
expenses, which include costs such as
office rent and depreciation, are about
half of the share in the FQHC market
basket as they are in the MEI.
c. Selection of Price Proxies for the
Proposed 2013-Based FQHC Market
Basket
After establishing the 2013 cost
weights for the proposed FQHC market
basket, an appropriate price proxy was
selected for each cost category. The
proposed price proxies are chosen from
a set of publicly available price indexes
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that best reflect the rate of price change
for each cost category in the FQHC
market basket. All of the proxies for the
proposed 2013-based FQHC market
basket are based on indexes published
by the Bureau of Labor Statistics (BLS)
and are grouped into one of the
following BLS categories:
• Producer Price Indexes: Producer
Price Indexes (PPIs) measure price
changes for goods sold in markets other
than the retail market. PPIs are
preferable price proxies for goods and
services that businesses purchase as
inputs. For example, we are proposing
to use a PPI for prescription drugs,
rather than the Consumer Price Index
(CPI) for prescription drugs, because
healthcare providers generally purchase
drugs directly from a wholesaler. The
PPIs that we are proposing to use
measure price changes at the final stage
of production.
• Consumer Price Indexes: CPIs
measure change in the prices of final
goods and services bought by the typical
consumer. Because they may not
represent the price encountered by a
producer, we are proposing to use CPIs
only if an appropriate PPI is not
available, or if the expenditures are
more like those faced by retail
consumers in general rather than by
purchasers of goods at the wholesale
level.
• Employment Cost Indexes:
Employment Cost Indexes (ECIs)
measure the rate of change in employee
wage rates and employer costs for
employee benefits per hour worked.
These indexes are fixed-weight indexes
and strictly measure the change in wage
rates and employee benefits per hour.
Appropriately, they are not affected by
shifts in employment mix.
We evaluate the price proxies using
the criteria of reliability, timeliness,
availability, and relevance. Reliability
indicates that the index is based on
valid statistical methods and has low
sampling variability. Timeliness implies
that the proxy is published regularly,
preferably at least once a quarter.
Availability means that the proxy is
publicly available. Finally, relevance
means that the proxy is applicable and
representative of the cost category
weight to which it is applied. We
believe the proposed PPIs, CPIs, and
ECIs selected meet these criteria.
Table 32 lists all price proxies that we
are proposing to use for the 2013-based
FQHC market basket. Below is a
detailed explanation of the price proxies
that we are proposing for each cost
category weight. We note that many of
the proxies that we are proposing for the
2013-based FQHC market basket are the
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same as those used for the 2006-based
MEI.
(1) FQHC Practitioner Compensation:
We are proposing to use the ECI for
Total Compensation for Private Industry
Workers in Professional and Related)
(BLS series code CIU2010000120000I) to
measure price growth of this category.
There is no specific ECI for physicians
and, therefore, similar to the MEI, we
are proposing to use an index that is
based on professionals that receive
advanced training. We note that the
2006-based MEI has a separate cost
category for Physician Wages and
Salaries and Physician Benefits. For
these cost categories, the MEI uses the
ECI for Wages and Salaries and ECI for
Benefits for Professional and Related
Occupations.
(2) Other Clinical Compensation: We
are proposing to use the ECI for Total
Compensation for all Civilian Workers
in Health Care and Social Assistance
(BLS series code CIU1016200000000I) to
measure the price growth of this cost
category. This cost category consists of
compensation costs for Nurses,
Laboratory Technicians, and all other
health staff not included in the FQHC
practitioner compensation category.
Based on the clinical composition of
these workers, we believe that the ECI
for health-related workers is an
appropriate proxy to measure
compensation price pressures for these
workers. The MEI uses the ECI for
Wages and Salaries and benefits for
Hospitals.
(3) Non-Health Compensation: We are
proposing to use the ECI for Total
Compensation for Private Industry
Workers in Office and Administrative
Support (BLS series code
CIU2010000220000I) to measure the
price growth of this cost category. The
Non-health compensation cost weight is
predominately attributable to
administrative and facility type
occupations, as reported in the data
from the Medicare cost reports. We note
the MEI has a composite index of four
price proxies, with the majority of the
composite index accounted for by
administrative occupations, proxied by
the ECI for Wages & Salaries of Office
and Administrative Support (Private).
(4) Utilities: We are proposing to use
the CPI for Fuel and Utilities (BLS series
code CUUR0000SAH2) to measure the
price growth of this cost category. This
is the same proxy used in the 2006based MEI.
(5) Miscellaneous Office Expenses:
We are proposing to use the CPI for All
Items Less Food and Energy (BLS series
code CUUR0000SA0L1E) to measure the
price growth of this cost category. We
believe that using the CPI for All Items
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46383
Less Food and Energy avoids double
counting of changes in food and energy
prices already captured elsewhere in the
market basket. We note the MEI does
not have a separate cost category for
miscellaneous office expenses.
(6) Telephone Services: We are
proposing to use the CPI for Telephone
Services (BLS series code
CUUR0000SEED) to measure the price
growth of this cost category. This is the
same price proxy used in the 2006based MEI.
(7) Postage: We are proposing to use
the CPI for Postage (BLS series code
CUUR0000SEEC01) to measure the price
growth of this cost category. This is the
same proxy used in the 2006-based MEI.
(8) Medical Equipment: We are
proposing to use the PPI Commodities
for Surgical and Medical Instruments
(BLS series code WPU1562) as the price
proxy for this category. This is the same
proxy used in the current 2006-based
MEI.
(9) Medical Supplies: We are
proposing to use a 50/50 blended index
comprised of the PPI Commodities for
Medical and Surgical Appliances and
Supplies (BLS series code WPU156301)
and the CPI–U for Medical Equipment
and Supplies (BLS series code
CUUR0000SEMG). The 50/50 blend is
used in all market baskets where we do
not have an accurate split available. We
believe FQHCs purchase the types of
supplies contained within these proxies,
including such items as bandages,
dressings, catheters, intravenous
equipment, syringes, and other general
disposable medical supplies, via
wholesale purchase, as well as at the
retail level. Consequently, we are
proposing to combine the two
aforementioned indexes to reflect those
modes of purchase. This is the same
proxy used in the 2006-based MEI.
(10) Pharmaceuticals: We are
proposing to use the PPI Commodities
for Pharmaceuticals for Human Use,
Prescription (BLS series code
WPUSI07003) to measure the price
growth of this cost category. We note the
MEI does not have a separate cost
category for Pharmaceuticals. This price
proxy is used to measure prices of
Pharmaceuticals in other CMS market
baskets, such as 2010-based Inpatient
Prospective Payment System and 2010based Skilled Nursing Facility market
baskets.
(11) Professional, Scientific, &
Technical Services: We are proposing to
use the ECI for Total Compensation for
Private Industry Workers in
Professional, Scientific, and Technical
Services (BLS series code
CIU2015400000000I) to measure the
price growth of this cost category. This
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is the same proxy used in the 2006based MEI.
(12) Administrative & Facility
Services: We are proposing to use the
ECI Total Compensation for Private
Industry Workers in Office and
Administrative Support (BLS series
code CIU2010000220000I) to measure
the price growth of this cost category.
This is the same price proxy used in the
2006-based MEI.
(13) Other Services: We are proposing
to use the ECI for Total Compensation
for Private Industry Workers in Service
Occupations (BLS series code
CIU2010000300000I) to measure the
price growth of this cost category. This
is the same price proxy used in the
2006-based MEI.
(14) Fixed Capital: We are proposing
to use the PPI Industry for Lessors of
Nonresidential Buildings (BLS series
code PCU531120531120) to measure the
price growth of this cost category. This
is the same price proxy used in the
2006-based MEI. We believe this is an
appropriate proxy since fixed capital
expenses in FQHCs should reflect
inflation for the rental and purchase of
business office space.
(15) Moveable Capital: We are
proposing to use the PPI Commodities
for Machinery and Equipment (series
code WPU11) to measure the price
growth of this cost category as this cost
category represents nonmedical
moveable equipment. This is the same
proxy used in the 2006-based MEI.
Table 32 lists the proposed price
proxies for each cost category in the
proposed FQHC market basket.
TABLE 32—PROPOSED COST CATEGORIES AND PRICE PROXIES FOR THE FQHC MARKET BASKET
Cost category
FQHC price proxies
FQHC Practitioner Compensation ............................................................
ECI—for Total Compensation for Private Industry Workers in Professional and Related.
ECI—for Total Compensation for all Civilian Workers in Health Care
and Social Assistance.
ECI—for Total Compensation for Private Industry Workers in Office
and Administrative Support.
CPI–U for Fuels and Utilities.
CPI–U for All Items Less Food And Energy.
CPI–U for Telephone.
CP–U for Postage.
PPI Commodities for Surgical and Medical Instruments.
Blend: PPI Commodities for Medical and Surgical Appliances and Supplies and CPI for Medical Equipment and Supplies.
PPI Commodities for Pharmaceuticals for Human Use, Prescription.
ECI—for Total Compensation for Private Industry Workers in Professional, Scientific, and Technical Services.
ECI—for Total Compensation for Private Industry Workers in Office
and Administrative Support.
ECI—for Total compensation for Private industry workers in Service
Occupations.
PPI Industry—for Lessors of nonresidential buildings.
PPI Commodities—for Machinery and Equipment.
Other Clinical Compensation ....................................................................
Non-health Compensation ........................................................................
Utilities ......................................................................................................
Miscellaneous Office Expense .................................................................
Telephone .................................................................................................
Postage .....................................................................................................
Medical Equipment ...................................................................................
Medical supplies .......................................................................................
Pharmaceuticals .......................................................................................
Professional, Scientific, and Technical Services ......................................
Administrative & Facility Services ............................................................
Other Services ..........................................................................................
Fixed Capital .............................................................................................
Moveable Capital ......................................................................................
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
d. Inclusion of Multi-Factor
Productivity in the Proposed FQHC
Market Basket
Section 1834(o)(2)(B)(ii) of the Act
describes the methods for determining
updates to FQHC PPS payment. After
the first year of implementation, the
FQHC PPS base payment rate must be
increased by the percentage increase in
the MEI. In subsequent years, the FQHC
PPS base payment rate shall be
increased by the percentage increase in
a market basket of FQHC goods and
services as established through
regulations or, if not available, the MEI
published in the PFS final rule.
The MEI published in the PFS final
rule has a productivity adjustment. The
MEI has been adjusted for changes in
productivity since its inception. In the
CY 2003 PFS final rule with comment
period (67 FR 80019), we implemented
a change in the way the MEI was
adjusted to account for changes in
productivity. The MEI used for the 2003
physician payment update incorporated
changes in the 10-year moving average
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of private nonfarm business (economywide) multifactor productivity.
Previously, the index incorporated
changes in productivity by adjusting the
labor portions of the index by the 10year moving average of private nonfarm
business (economy-wide) labor
productivity.
In 2012, we convened the MEI
Technical Panel to review all aspects of
the MEI including inputs, input
weights, price-measurement proxies,
and productivity adjustment. For more
information regarding the MEI
Technical Panel, see the CY 2014 PFS
final rule with comment period (78 FR
74264). The MEI Technical Panel was
asked to review the approach of
adjusting the MEI by the 10-year moving
average of private nonfarm business
productivity. As described in the CY
2014 PFS final rule with comment
period (78 FR 74271), the MEI Technical
Panel concluded in Finding 5.1 that
‘‘such an adjustment continues to be
appropriate. This adjustment prevents
‘double counting’ of the effects of
productivity improvements, which
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would otherwise be reflected in both (i)
the increase in compensation and other
input price proxies underlying the MEI,
and (ii) the growth in the number of
physician services performed per unit of
input resources, which results from
advances in productivity by individual
physician practices.’’
We are proposing to include a
productivity adjustment similar to the
MEI in the proposed FQHC market
basket. We believe that applying a
productivity adjustment is appropriate
because this would be consistent with
the MEI, which has an embedded
productivity adjustment. We note that
the MEI Technical Panel concluded that
a productivity adjustment is appropriate
for the MEI given the type of services
performed in physician’s offices.
Specifically, the MEI Technical Panel
report states that ‘‘The input price
increases within the MEI are reflected in
the price proxies, such as changes in
wages and benefits. Wages increase, in
part, due to the ability of workers to
increase the amount of output per unit
of input. Absent a productivity
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adjustment in the MEI, physicians
would be receiving increased payments
resulting both from their ability to
increase their individual outputs and
from the productivity gains already
reflected in the wage proxies used in the
index. The productivity adjustment
used in the MEI ensures the
productivity gains reflected in increased
outputs are not double counted, or paid
for twice. Currently, the productivity
adjustment in the MEI is based on
changes in economy-wide productivity
based on the rationale that the price
proxy for physician income reflects
changes in economy-wide wages.
Implicitly, this assumes physicians can
achieve the same level of productivity
as the average general wage earner.’’ We
believe that the services performed in
FQHC facilities are similar to those
covered by the MEI, and therefore, a
productivity adjustment is appropriate
to avoid double counting of the effects
of productivity improvements.
We propose to use the most recent
estimate of the 10-year moving average
of changes in annual private nonfarm
business (economy-wide) multifactor
productivity (MFP), which is the same
measure of MFP used in the MEI. The
BLS publishes the official measure of
private nonfarm business MFP. (See
https://www.bls.gov/mfp for the
published BLS historical MFP data). For
the final FQHC market basket update,
we propose to use the most recent
historical estimate of annual MFP as
published by the BLS. Generally, the
most recent historical MFP estimate is
lagged two years from the payment year.
Therefore, we propose to use the 2015
MFP as published by BLS in the CY2017
FQHC market basket update.
We note that MFP is derived by
subtracting the contribution of labor and
capital input growth from output
growth. Since at the time of the
proposed rule the 2015 MFP has not
been published by BLS, we rely on a
projection of MFP. The projection of
MFP is currently produced by IHS
Global Insight (IGI), a national economic
forecasting firm with which CMS
contracts to forecast the components of
the market basket and MFP. A complete
description of the MFP projection
methodology is available at https://
www.cms.gov/Research-Statistics-Dataand-Systems/Statistics-Trends-andReports/MedicareProgramRatesStats/
MarketBasketResearch.html.
Using IGI’s first quarter 2016 forecast,
the productivity adjustment for CY 2017
(the 10-year moving average of MFP for
the period ending CY 2015) is projected
to be 0.4 percent. If more recent data are
subsequently available (for example, a
more recent estimate of the market
basket and MFP adjustment), we would
use such data to determine the CY 2017
increase in the proposed FQHC market
basket in the final rule.
5. CY 2017 Proposed Market Basket
Update: Proposed CY 2017 FQHC
Market Basket Update Compared to the
MEI Update for CY 2017
For CY 2017, we are proposing to use
the proposed 2013-based FQHC market
basket increase factor to update the
FQHC PPS base payment rate.
46385
Consistent with CMS practice, we
estimated the market basket update for
the FQHC PPS based on the most recent
forecast from IGI. Identical to the MEI,
we are proposing to use the update
based on the most recent historical data
available at the time of publication of
the final rule. For example, the final CY
2017 FQHC update would be based on
the four-quarter moving-average percent
change of the FQHC market basket
through the second quarter of 2016
(based on the final rule’s statutory
publication schedule). For the proposed
rule, we do not have the second quarter
of 2016 historical data and, therefore,
we will use the most recent projection
available.
Based on IGI’s first quarter 2016
forecast with historical data through the
fourth quarter of 2015, the projected
proposed FQHC market basket increase
factor for CY 2017 would be 1.7 percent.
This reflects a 2.1-percent increase of
FQHC input prices and a 0.4-percent
adjustment for productivity. We are also
proposing that if more recent data are
subsequently available (for example, a
more recent estimate of the market
basket or MFP) we would use such data,
to determine the CY 2017 update in the
final rule.
For comparison, the 2006-based MEI
is projected to be 1.3 percent in CY
2017; this estimate is based on IGI’s first
quarter 2016 forecast (with historical
data through the fourth quarter of 2015).
Table 33 compares the proposed 2013based FQHC market basket updates and
the 2006-based MEI market basket
updates for CY 2017.
TABLE 33—FQHC MARKET BASKET AND MEI, COST CATEGORIES, COST WEIGHTS, MFP, AND CY 2017 UPDATE
CY 2017 Update
FQHC cost category
MEI cost category
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(percent)
FQHC Market Basket ...................................................
Productivity adjustment ................................................
FQHC Market Basket (unadjusted) ..............................
Total Compensation ..............................................
FQHC Practitioner Comp. ..............................
Other Clinical Compensation .........................
Non-health Compensation .............................
All Other Products .................................................
Utilities ............................................................
Miscellaneous Office Expenses .....................
Telephone ......................................................
Postage ..........................................................
Medical Equipment .........................................
Medical Supplies ............................................
Professional Liability Insurance .....................
Pharmaceuticals .............................................
All Other Services .................................................
Professional, Scientific & Technical Services
Administrative & Facility Services ..................
Other Services ...............................................
Capital ...................................................................
Fixed Capital ..................................................
Moveable Capital ...........................................
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(percent)
1.7
0.4
2.1
2.1
1.9
1.9
2.4
2.6
¥3.9
2.0
0.4
0.3
1.2
¥0.4
........................
7.8
2.0
1.5
2.4
1.9
1.6
2.1
0.1
1.3
0.4
1.7
2.0
2.0
2.0
2.4
¥0.6
¥3.9
¥1.7
0.4
0.3
1.2
¥0.4
¥0.4
........................
2.0
1.5
2.4
1.9
1.9
2.1
0.1
Frm 00225
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MEI.
Productivity adjustment.
MEI (unadjusted).
Total Compensation.
Physician Compensation.
Other Clinical Compensation.
Non-health Compensation.
All Other Products.
Utilities.
Miscellaneous Office Expenses.
Telephone.
Postage.
Medical Equipment.
Medical Supplies.
Professional Liability Insurance.
Pharmaceuticals.
All Other Services.
Professional, Scientific & Technical Services.
Administrative & Facility Services.
Other Services.
Capital.
Fixed Capital.
Moveable Capital.
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For CY 2017, the proposed 2013based FQHC market basket update (1.7
percent) is 0.4 percent higher than the
2006-based MEI (1.3 percent). The 0.4
percentage point difference stems
mostly from the inclusion of
pharmaceuticals in the proposed FQHC
market basket. Prices for
pharmaceuticals are projected to grow
7.8 percent, faster than the other
components in the market basket. This
cost category and associated price
pressures are not included in the MEI.
We propose to update the FQHC PPS
base payment rate by 1.7 percent for CY
2017 based on the proposed 2013-based
FQHC market basket. The proposed
FQHC market basket would more
accurately reflect the actual costs and
scope of services that FQHCs furnish
compared to the 2006-based MEI. We
invite public comment on all aspects of
the FQHC market basket proposals.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
C. Appropriate Use Criteria for
Advanced Diagnostic Imaging Services
Section 218(b) of the PAMA amended
Title XVIII of the Act to add section
1834(q) of the Act directing us to
establish a program to promote the use
of appropriate use criteria (AUC) for
advanced diagnostic imaging services.
The CY 2016 PFS final rule with
comment period addressed the initial
component of the new Medicare AUC
program, specifying applicable AUC. In
that rule we established evidence-based
process and transparency requirements
for the development of AUC, defined
provider-led entities (PLEs) and
established the process by which PLEs
may become qualified to develop,
modify or endorse AUC. The first list of
qualified PLEs are expected to be posted
on the CMS Web site by the end of June
2016 at which time their AUC libraries
will be considered to be specified AUC
for purposes of section 1834(q)(2)(A) of
the Act.
This rule proposes requirements and
processes for specification of qualified
clinical decision support mechanisms
(CDSMs) under the Medicare AUC
program; the initial list of priority
clinical areas; and exceptions to the
requirement that ordering professionals
consult specified applicable AUC when
ordering applicable imaging services.
1. Background
AUC present information in a manner
that links: A specific clinical condition
or presentation; one or more services;
and, an assessment of the
appropriateness of the service(s). For
purposes of this program, AUC are a set
or library of individual appropriate use
criteria. Each individual criterion is an
evidence-based guideline for a
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particular clinical scenario. Each
scenario in turn starts with a patient’s
presenting symptoms and/or condition.
Evidence-based AUC for imaging can
assist clinicians in selecting the imaging
study that is most likely to improve
health outcomes for patients based on
their individual clinical presentation.
AUC need to be integrated as
seamlessly as possible into the clinical
workflow. CDSMs are the electronic
portals through which clinicians would
access the AUC during the patient
workup. While CDSMs can be
standalone applications that require
direct entry of patient information, they
may be more effective when they
automatically incorporate information
such as specific patient characteristics,
laboratory results, and lists of co-morbid
diseases from Electronic Health Records
(EHRs) and other sources. Ideally,
practitioners would interact directly
with the CDSM through their primary
user interface, thus minimizing
interruption to the clinical workflow.
Consistent with definitions of CDSM
by the Agency for Healthcare Research
and Quality (AHRQ) (https://
www.ahrq.gov/professionals/preventionchronic-care/decision/clinical/
index.html), and the Office of the
National Coordinator for Health
Information Technology (ONC) (https://
www.healthit.gov/policy-researchersimplementers/clinical-decision-supportcds), within Health IT applications, a
CDSM is a functionality that provides
persons involved in care processes with
general and person-specific information,
intelligently filtered and organized, at
appropriate times, to enhance health
and health care.
2. Previous CDSM Experience
In the CY 2016 PFS final rule with
comment period, we included a
discussion of the Medicare Imaging
Demonstration (MID), which was
required by section 135(b) of the
MIPPA, in addition to independent
experiences of implementing AUC by
several healthcare systems and
academic medical centers. Two key
aspects of that discussion remain
relevant to the CDSM component of this
program. First, AUC, and the CDSMs
through which clinicians access AUC,
must be integrated into the clinical
workflow and facilitate, not obstruct,
evidence-based care delivery. For
instance, a CDSM external to a
provider’s primary user interface could
utilize an application program interface
(API), a set of protocols and tools
specifying how software components
should interact, to pull relevant
information into the decision support
application. By adhering to common
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interoperability standards, such as the
national standards advanced through
certified health IT (see 2015 edition of
criteria available in the Federal Register
(80 FR 62601) and described in the
Interoperability Standards Advisory at
https://www.healthit.gov/standardsadvisory), CDSMs could both ensure
integration of patient-specific data from
EHRs, and allow clinicians to optimize
the time spent using the tool.
Second, the ideal AUC is an evidencebased guide that starts with a patient’s
specific clinical condition or
presentation (symptoms) and assists the
clinician in the overall patient workup,
treatment, and follow-up. Imaging
would appear as key nodes within the
clinical management decision tree.
Other options outside of certified EHR
technology exist to access AUC through
CDSMs. Stand-alone, internet-based
CDSMs are available and, although they
will not interact with EHR data, can
nonetheless search for and present AUC
relevant to a patient’s presenting
symptoms or condition.
In communicating an appropriateness
rating to the ordering practitioner, some
CDSMs provide a scale with numeric
ratings, some output a red, yellow, or
green light while others provide a
dichotomous yes or no. At this time, we
do not believe there is one correct
approach to communicating the level of
appropriateness to the ordering
professional. However, section
1834(q)(4)(B) of the Act requires that
information be reported on the claim
form as to whether the service would or
would not adhere to the specified AUC
consulted through a particular CDSM, or
whether the AUC was not applicable to
the service. We are requesting feedback
from commenters regarding how
appropriateness ratings provided by
CDSMs could be interpreted and
recorded for the purposes of this
program.
There are different views about the
comprehensiveness of AUC that should
be accessible within CDSMs. Some
stakeholders believe that the CDSM
should contain as comprehensive a
collection of AUC as possible,
incorporating individual criteria from
across all specified AUC libraries. The
intent would be for ordering
professionals to avoid the frustration,
experienced and voiced by many
clinicians participating in the MID, of
spending time navigating the CDSM
only to find that no criterion for their
patient’s specific clinical condition
exists.
Other stakeholders believe, based on
decades of experience rolling out AUC
in the context of robust quality
improvement programs that it is best to
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start with a CDSM that contains AUC for
a few clinical areas where impact is
large and evidence is strong. This would
ensure that quality AUC are developed,
and that clinicians and entire care teams
could fully understand the AUC they
are using, including when they do not
apply to a particular patient.
As we stated in the CY 2016 PFS final
rule with comment period, we believe
there is merit to both approaches, and
it has been suggested to us that the best
approach may depend on the particular
care setting. The second, ‘‘focused’’
approach may work better for a large
health system that produces and uses its
own AUC. The first, ‘‘comprehensive’’
approach may in turn work better for a
smaller practice with broad image
ordering patterns and fewer resources
that wants to simply adopt and start
using a complete AUC system
developed elsewhere. We believe a
successful program would allow
flexibility, and under section 1834(q) of
the Act, we foresee a number of sets of
AUC developed by different PLEs, and
an array of CDSMs from which
clinicians may choose.
3. Priority Clinical Areas
We established in the CY 2016 PFS
final rule with comment period that we
would identify priority clinical areas
through rulemaking, and that these may
be used in the determination of outlier
ordering professionals (a future phase of
the Medicare AUC program). The
concept of priority clinical areas allows
us to implement an AUC program that
combines the focused and
comprehensive approaches to
implementation discussed above.
Although potentially large volumes of
AUC (as some PLEs have large libraries
of AUC) would become specified across
clinical conditions and advanced
imaging technologies, we believe this
rapid and comprehensive roll out of
specified AUC should be balanced with
a more focused approach when
identifying outlier ordering
professionals. We believe this will
provide an opportunity for physicians
and practitioners to become familiar
with AUC in identified priority clinical
areas prior to Medicare claims for those
services being part of the input for
calculating outlier ordering
professionals.
As we describe earlier, CDSMs are the
access point for ordering professionals
to consult AUC. We believe the
combination of the comprehensive and
focused approaches should be applied
to CDSM requirements as we consider a
minimum floor of AUC that must be
made available to ordering professionals
through qualified CDSMs. AUC that
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reasonably address the entire clinical
scope of priority clinical areas could
establish a minimum floor of AUC to be
included in qualified CDSMs, and the
number of priority clinical areas could
be expanded through annual rulemaking
and in consultation with physicians and
other stakeholders. This allows priority
clinical areas to roll out judiciously, and
build over time.
4. Statutory Authority
Section 218(b) of the PAMA added a
new section 1834(q) of the Act entitled,
‘‘Recognizing Appropriate Use Criteria
for Certain Imaging Services,’’ which
directs the Secretary to establish a new
program to promote the use of AUC.
Section 1834(q)(3)(A) of the Act requires
the Secretary to specify qualified
CDSMs that could be used by ordering
professionals to consult with specified
applicable AUC for applicable imaging
services.
5. Discussion of Statutory Requirements
There are four major components of
the AUC program under section 1834(q)
of the Act, each with its own
implementation date: (1) Establishment
of AUC by November 15, 2015 (section
1834(q)(2)); (2) identification of
mechanisms for consultation with AUC
by April 1, 2016 (section 1834(q)(3)); (3)
AUC consultation by ordering
professionals and reporting on AUC
consultation by furnishing professionals
by January 1, 2017 (section 1834(q)(4));
and (4) annual identification of outlier
ordering professionals for services
furnished after January 1, 2017 (section
1834(q)(5)). As we will discuss later in
this preamble, we did not identify
mechanisms for consultation by April 1,
2016 and will not have specified or
published the list of qualified CDSMs by
January 1, 2017; therefore, ordering
professionals will not be required to
consult CDSMs, and furnishing
professionals will not be able to report
information on the consultation, by this
date.
a. Establishment of AUC
In the CY 2016 PFS final rule with
comment period, we addressed the first
component under section 1834(q)(2) of
the Act—the requirements and process
for establishment and specification of
applicable AUC, along with relevant
aspects of the definitions under section
1834(q)(1) of the Act. This included
defining the term PLE and finalizing
requirements for the rigorous, evidencebased process by which a PLE would
develop AUC, upon which qualification
is based, as provided in section
1834(q)(2)(B) of the Act and in the CY
2016 PFS final rule with comment
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46387
period. Using this process, once a PLE
is qualified by CMS, the AUC that are
developed, modified or endorsed by the
qualified PLE are considered to be
specified applicable AUC under section
1834(q)(2)(A) of the Act. We defined the
term PLE to include national
professional medical societies, health
systems, hospitals, clinical practices
and collaborations of such entities such
as the High Value Healthcare
Collaborative or the National
Comprehensive Cancer Network.
Qualified PLEs may collaborate with
third parties that they believe add value
to their development of AUC, provided
such collaboration is transparent. We
expect qualified PLEs to have sufficient
infrastructure, resources, and the
relevant experience to develop and
maintain AUC according to the rigorous,
transparent, and evidence-based
processes detailed in the CY 2016 PFS
final rule with comment period.
A timeline and process was
established for PLEs to apply to become
qualified with the first list of qualified
PLEs expected to be published at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Appropriate-Use-CriteriaProgram/ by June 30, 2016.
b. Mechanism for AUC Consultation
The second major component of the
Medicare AUC program is the
specification of qualified CDSMs that
could be used by ordering professionals
for consultation with specified
applicable AUC under section
1834(q)(3) of the Act. We envision a
CDSM as an interactive tool that
communicates AUC information to the
user. Information regarding the clinical
presentation of the patient would be
incorporated into the CDSM from
another health IT system or through
data entry by the ordering professional.
At a minimum, the tool would provide
immediate feedback to the ordering
professional on the appropriateness of
one or more imaging services. Ideally,
CDSMs would be integrated within or
seamlessly interoperable with existing
health IT systems and would
automatically receive patient data from
the EHR or through an API or other
connection. Such integration would
minimize burden on practitioners and
avoid duplicate documentation. Also
useful to clinicians would be the ability
to switch between CDSMs that can
interoperate based on common
standards.
Section 1834(q)(3)(A) of the Act states
that the Secretary must specify qualified
CDSMs in consultation with physicians,
practitioners, health care technology
experts, and other stakeholders. This
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paragraph authorizes the Secretary to
specify mechanisms that could include:
CDS modules within certified EHR
technology; private sector CDSMs that
are independent of certified EHR
technology; and a CDSM established by
the Secretary. The Secretary does not
propose to establish a CDSM at this
time.
All CDSMs must meet the
requirements under section
1834(q)(3)(B) of the Act, which specifies
that a mechanism must: Make available
to the ordering professional applicable
AUC and the documentation supporting
the appropriateness of the applicable
imaging service that is ordered; where
there is more than one applicable
appropriate use criterion specified for
an applicable imaging service, indicate
the criteria it uses for the service;
determine the extent to which an
applicable imaging service that is
ordered is consistent with the
applicable AUC; generate and provide to
the ordering professional
documentation to demonstrate that the
qualified CDSM was consulted by the
ordering professional; be updated on a
timely basis to reflect revisions to the
specification of applicable AUC; meet
applicable privacy and security
standards; and perform such other
functions as specified by the Secretary
(which may include a requirement to
provide aggregate feedback to the
ordering professional). Section
1834(q)(3)(C) of the Act specifies that
the Secretary must publish an initial list
of specified mechanisms no later than
April 1, 2016, and that the Secretary
must identify on an annual basis the list
of specified qualified CDSMs.
As we explained in the CY 2016 PFS
proposed and final rules with comment
period, implementation of many aspects
of the amendments made by section
218(b) of the PAMA requires
consultation with physicians,
practitioners, and other stakeholders,
and notice and comment rulemaking.
We continue to believe the PFS calendar
year rulemaking process is the most
appropriate and administratively
feasible implementation vehicle. Given
the timing of the PFS rulemaking
process, we were not able to include
proposals in the PFS proposed rule to
begin implementation in the same year
the PAMA was enacted, as we would
have had to interpret and analyze the
new statutory language, and develop
proposed plans for implementation in
under one month. As we did prior to the
CY 2016 PFS proposed rule when we
met extensively with stakeholders to
gain insight and hear their comments
and concerns about the AUC program,
we have used the time prior to the CY
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2017 PFS proposed rule to meet with
many of the same stakeholders but also
a new group of stakeholders specifically
related to CDSMs. In addition, we are
continuing our stepwise approach to
implementing this AUC program. The
first phase of the AUC program
(specifying AUC including defining
what AUC are and specifying the
process for developing them) was
accomplished through last year’s CY
2016 PFS final rule with comment
period. For this second phase, we will
use this CY 2017 PFS rulemaking
process as the vehicle to establish
requirements for CDSMs, and the
process to specify qualified CDSMs, in
a transparent manner that allows for
stakeholder and public involvement.
Therefore, the final CDSM requirements
and process for CDSMs to become
qualified would be published in the CY
2017 PFS final rule with comment
period on or about November 1, 2016.
d. Identification of Outliers
c. AUC Consultation and Reporting
The third major component of the
AUC program is in section 1834(q)(4) of
the Act, Consultation with Applicable
Appropriate Use Criteria. This section
establishes, beginning January 1, 2017,
the requirement for an ordering
professional to consult with a qualified
CDSM when ordering an applicable
imaging service that would be furnished
in an applicable setting and paid for
under an applicable payment system;
and for the furnishing professional to
include on the Medicare claim
information about the ordering
professional’s consultation with a
qualified CDSM. The statute
distinguishes between the ordering and
furnishing professional, recognizing that
the professional who orders an
applicable imaging service is usually
not the same professional who bills
Medicare for that service when
furnished. Section 1834(q)(4)(C) of the
Act provides for certain exceptions to
the AUC consultation and reporting
requirements including in the case of
certain emergency services, inpatient
services paid under Medicare Part A,
and ordering professionals who obtain
an exception due to a significant
hardship. Section 1834(q)(4)(D) of the
Act specifies that the applicable
payment systems for the AUC
consultation and reporting requirements
are the PFS, hospital outpatient
prospective payment system, and the
ambulatory surgical center payment
systems.
Since a list of qualified CDSMs is not
yet available and will not be available
by January 1, 2017, we will not require
ordering professionals to meet this
requirement by that date.
In § 414.94(b), we propose to codify
and add language to clarify some of the
definitions provided in section 1834(q)
of the Act, as well as define terms that
were not defined in statute but for
which a definition would be helpful for
program implementation. In this
section, we provide a description of the
terms we propose to codify to facilitate
understanding and encourage public
comment on the AUC program.
We propose to define CDSM under
§ 414.94(b) as an interactive, electronic
tool for use by clinicians that
communicates AUC information to the
user and assists them in making the
most appropriate treatment decision for
a patient’s specific clinical condition. A
CDSM would incorporate specified
applicable AUC sets from which an
ordering professional could select. A
CDSM may be a module within or
available through certified EHR
technology (as defined in section
1848(o)(4) of the Act) or private sector
mechanisms independent from certified
EHR technology. If within or available
through certified EHR technology, a
qualified CDSM would incorporate
relevant patient-specific information
into the assessment of the
appropriateness of an applicable
imaging service.
As prescribed in section 1834(q) of
the Act and § 414.94(b) of our
regulations, the Medicare AUC program
imposes requirements only for
applicable imaging services furnished in
applicable settings. Further, as specified
in section 1834(q)(4)(D) of the Act, we
propose to amend our regulation at
§ 414.94(b) to state that the applicable
payment systems for the Medicare AUC
program are the PFS under section
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The fourth component of the AUC
program is in section 1834(q)(5) of the
Act, Identification of Outlier Ordering
Professionals. The identification of
outlier ordering professionals under this
paragraph facilitates a prior
authorization requirement for outlier
professionals beginning January 1, 2020,
as specified under section 1834(q)(6) of
the Act. Although we are not proposing
to implement these sections in the CY
2017 PFS proposed rule, we propose
below a list of priority clinical areas
which may serve as part of the basis for
identifying outlier ordering
professionals.
6. Proposals for Implementation
We propose to amend our regulations
at § 414.94, ‘‘Appropriate Use Criteria
for Certain Imaging Services.’’
a. Definitions
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1848(b) of the Act, the prospective
payment system for hospital outpatient
department services under section
1833(t) of the Act, and the ambulatory
surgical center payment systems under
section 1833(i) of the Act. Applicable
payment systems are relevant to
implementation of section 1834(q)(4)(B)
of the Act, entitled ‘‘Reporting by
Furnishing Professionals.’’
We remind readers that in PFS
rulemaking for CY 2016 we defined
applicable imaging service in
§ 414.94(b) as an advanced diagnostic
imaging service as defined in
1834(e)(1)(B) of the Act for which the
Secretary determines (i) One or more
applicable appropriate use criteria
apply; (ii) There are one or more
qualified clinical decision support
mechanisms listed; and (iii) One or
more of such mechanisms is available
free of charge.
b. Priority Clinical Areas
We propose to establish a new
§ 414.94(e)(5) to set forth the initial list
of priority clinical areas.
To compile this proposed list we
performed an analysis of Medicare
claims data using the CMS Chronic
Conditions Data Warehouse (CCW) as
the primary data source. The CCW
contains 100 percent of Medicare claims
for beneficiaries who are enrolled in the
fee-for-service (FFS) program. Data were
derived from the CCW’s 2014 Part B
non-institutional claim line file, which
includes Part B services furnished
during CY 2014. This is the main file
containing final action claims data for
non-institutional health care providers,
including physicians, physician
assistants, clinical social workers, nurse
practitioners, independent clinical
laboratories, and freestanding
ambulatory surgical centers. The Part B
non-institutional claim line file contains
the individual line level information
from the claim and includes Healthcare
Common Procedure Coding System
(HCPCS) code(s), diagnosis code(s)
using the International Classification of
Diseases, Ninth Revision (ICD–9),
service dates, and Medicare payment
amount. A publicly available version of
this dataset can be downloaded from the
CMS Web site at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/AppropriateUse-Criteria-Program/. We
encourage stakeholders to review this
dataset as a source that may help inform
public comments related to the
proposed priority clinical areas.
In the CY 2016 PFS final rule with
comment period, we stated that when
identifying priority clinical areas we
may consider factors such as incidence
and prevalence of disease, the volume
and variability of utilization of imaging
services, the strength of evidence for
their use, and applicability of the
clinical area to the Medicare population
and to a variety of care settings.
Using the 2014 Medicare claims data
referenced above, we ranked ICD–9
codes by the frequency with which they
were used as the primary indication for
specific imaging procedures, which in
turn were identified by the volume of
individual Current Procedural
Terminology (CPT) codes for which
payments were made in 2014. We
extracted the top 135 ICD–9 codes from
this list and formed clinically-related
categories. Next, we searched manually
through an electronic list of all ICD–9
codes to find others that would
plausibly fit into each clinical grouping.
This process required subjective clinical
judgment on whether a particular ICD–
9 code should be included in a given
clinical group. The top eight clinical
groupings (by volume of procedures) are
what we are proposing as the initial list
of priority clinical areas. The eight
clinical areas account for roughly 40
percent of part B advanced diagnostic
imaging services paid for by Medicare in
2014. We are aware that some
stakeholders have suggested beginning
the AUC program with no more than
five priority clinical areas while others
have suggested a far greater number. We
believe the proposed eight priority
clinical areas strike a reasonable balance
that allows us to focus on a significant
46389
range and volume of advanced
diagnostic imaging services.
We also considered extracting
pulmonary embolism as a separate
priority clinical area from the chest pain
grouping based on stakeholder
consultation and feedback. However, we
decided not to identify pulmonary
embolism separately, but are asking for
public comment on whether pulmonary
embolism should be included as a
stand-alone priority clinical area. Based
on our consultations with physicians,
practitioners and other stakeholders, as
required by section 218(b) of the PAMA,
we attempted to be inclusive when
grouping ICD–9 codes into cohesive
clinical areas. As an example of how we
derived the priority clinical area for low
back pain, we grouped together 10 ICD–
9 codes, incorporating six from the top
135 and four from the manual search of
all ICD–9 codes. Included in this
grouping are the ICD–9 codes for
displacement of lumbar intervertebral
disc without myelopathy (722.10),
degeneration of lumbar of lumbosacral
intervertebral disc (722.52),
intervertebral disc disorder with
myelopathy lumbar region (722.73),
post-laminectomy syndrome of lumbar
region (722.83), lumbago (724.2),
sciatica (724.3), thoracic or lumbosacral
neuritis or radiculitis unspecified
(724.4), spinal stenosis, lumbar region,
without neurogenic claudication
(724.02), lumbosacral spondylosis
without myelopathy (721.3), and
spondylosis with myelopathy lumbar
region (721.42) which resulted in
1,883,617 services. To see all of the
priority clinical area groupings of
diagnosis codes, a table is available on
the CMS Web site at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Appropriate-Use-CriteriaProgram/.
Using the above methodology, we
developed and are proposing eight
priority clinical areas. These reflect both
the significance and the high prevalence
of some of the most disruptive diseases
in the Medicare population.
TABLE 34—PROPOSED PRIORITY CLINICAL AREAS WITH CORRESPONDING CLAIMS DATA
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Proposed priority clinical area
Total services
Chest Pain (includes angina, suspected myocardial infarction, and suspected pulmonary embolism) .......................................................................
Abdominal Pain (any locations and flank pain) ...............................................
Headache, traumatic and non-traumatic .........................................................
Low back pain ..................................................................................................
Suspected stroke .............................................................................................
Altered mental status .......................................................................................
Cancer of the lung (primary or metastatic, suspected or diagnosed) .............
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% Total
services 1
4,435,240.00
2,973,331.00
2,107,868.00
1,883,617.00
1,810,514.00
1,782,794.00
1,114,303.00
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Total
payments
12
8
6
5
5
5
3
15JYP2
$ 470,395,545
235,424,592
89,382,087
180,063,352
119,574,141
83,296,007
154,872,814
% Total
payments/1
14
7
3
5
4
3
5
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TABLE 34—PROPOSED PRIORITY CLINICAL AREAS WITH CORRESPONDING CLAIMS DATA—Continued
Proposed priority clinical area
Total services
Cervical or neck pain .......................................................................................
% Total
services 1
1,045,381.00
Total
payments
3
83,899,299
% Total
payments/1
3
1
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Percentage of 2014 Part B non-institutional claim line file for advanced imaging services from Medicare claims for beneficiaries who are enrolled in the fee-for-service (FFS) program (source: CMS Chronic Conditions Data Warehouse).
CMS also engaged the CMS Alliance
to Modernize Healthcare (CAMH)
Federally Funded Research and
Development Center (FFRDC), the
MITRE Corporation (MITRE), to begin
developing efficient and effective
processes for managing current and
future health technology assessments.
MITRE generated an independent report
that presents a summary of findings
from claims data from the Medicare
population and their utilization of
advanced imaging procedures. Coupled
with our internal analysis, this report
has assisted in identification of
proposed priority clinical areas for the
Medicare AUC program for advanced
diagnostic imaging services. Analysis
and methods for this report are available
at https://www.mitre.org/publications/
technical-papers/claims-data-analysisto-define-priority-clinical-areas-foradvanced.
While this year we are proposing
priority clinical areas based on an
analysis of claims data alone, we may
use a different approach in future
rulemaking cycles. As we provided in
§ 414.94(e) of our regulations, we may
consider factors other than volume
when proposing priority clinical areas
including incidence and prevalence of
disease, variability of use of particular
imaging services, strength of evidence
supporting particular imaging services
and the applicability of a clinical area
to a variety of care settings and to the
Medicare population.
We encourage public comments on
this proposed initial list of priority
clinical areas, including
recommendations for other clinical
areas that we should include among our
list of priority clinical areas. In
particular, we are interested in
comments on the above methodology or
alternate options; whether the proposed
priority clinical areas are appropriate
including information on the extent to
which these proposed priority clinical
areas may be represented by clinical
guidelines or AUC in the future.
Furthermore, we are interested in public
comments, supported by published
information, with respect to varying
levels of evidence that exist across as
well as within priority clinical areas.
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c. CDSM Qualifications and
Requirements
We are proposing to add a new
§ 414.94(g)(1) to our regulations to
establish requirements for qualified
CDSMs. Section 1834(q)(3)(A)(iii) of the
Act provides relative flexibility for
qualified CDSMs, and states that they
may include mechanisms that are
within certified EHR technology, private
sector mechanisms that are independent
from certified EHR technology or
mechanisms that are established by the
Secretary.
We believe that, at least initially, it is
in the best interest of the program to
establish CDSM requirements that are
not prescriptive about specific IT
standards. Rather, we are proposing an
approach that focuses on the
functionality and capabilities of
qualified CDSMs. The CDSM, EHR and
health IT environments are constantly
changing and improving and we want to
allow room for growth and innovation.
However, in the future, as more
stakeholders and other entities
including the ONC, AHRQ, and relevant
standards development organizations
come to consensus regarding standards
for CDSMs, then we may consider
pointing to such standards as a
requirement for qualified CDSMs under
this program. We believe standards
would make it possible to achieve
interoperability, allowing any CDSM to
incorporate any standardized AUC and
for sets of AUC to be easily
interchangeable among various CDSMs.
We will continue to work with the ONC
and AHRQ to facilitate movement in
this direction.
Recent work under the federallysponsored Clinical Quality Framework
(CQF) initiative has successfully
developed an integrated approach that
harmonizes standards for electronic
clinical quality measurement with those
that enable shareable clinical decision
support artifacts (for example, AUC).
The CQF initiative is working to support
semantically interoperable data
exchange for (1) sending patient data to
a service for clinical decision support
guidance and receiving clinical decision
support guidance or quality
measurement results in return, and (2)
enabling a system to consume and
internally execute decision support
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artifacts. As this standard is considered
sufficiently mature for widespread
adoption, the ONC may consider it for
use in future editions of certification
criteria for health IT. While the current
regulation requires no specific standard,
the CMS and ONC are supportive of this
approach and additional information
can be found at https://hl7-fhir.github.io/
cqif/cqif.html.
Under § 414.94(g)(1), we propose to
codify in regulations the seven
requirements for qualified CDSMs set
forth in section 1834(q)(3)(B)(ii) of the
Act. The Act requires qualified CDSMs
to make available to the ordering
professional specified applicable AUC
and the supporting documentation for
the applicable imaging service ordered.
We do not interpret this requirement to
mean that every qualified CDSM must
make available every specified
applicable AUC. In the CY 2016 PFS
final rule with comment period we
allowed for the approval of massive
libraries of AUC (resulting from
approvals for qualified PLEs with
comprehensive and extensive libraries),
yet we expressed our intention to
establish priority clinical areas. While
there is a statutory requirement to
consult AUC for each applicable
imaging service, we recognize that
ordering professionals may choose to
thoroughly improve their understanding
of, and focus their internal quality
improvement (QI) programs on, those
priority clinical areas; and these areas
will in turn serve as the basis for future
outlier calculations.
Consistent with that approach, we
propose to add a requirement in
§ 414.94(g)(1)(iii) that qualified CDSMs
must make available to ordering
professionals, at a minimum, specified
applicable AUC that reasonably
encompass the entire clinical scope of
all priority clinical areas. We encourage
and expect some CDSMs, based on the
needs of the professionals they serve,
will choose to include a far more
comprehensive set of AUC going above
and beyond the minimum set as we
understand many ordering professionals
want such comprehensive access to
AUC. When this Medicare AUC program
is fully implemented, all ordering
professionals must consult specified
applicable AUC through a qualified
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CDSM for every applicable imaging
service that would be furnished in an
applicable setting and paid for under an
applicable payment system in order for
payment to be made for the service.
However, when identifying the outlier
ordering professionals who will be
subject to prior authorization beginning
in 2020, we anticipate focusing on
consultation with specified applicable
AUC within priority clinical areas rather
than the universe of specified applicable
AUC. The concept of priority clinical
areas will allow us to implement an
AUC program that combines two
approaches to implementation allowing
clinicians flexibility to either engage
with a rapid rollout of comprehensive
specified applicable AUC or adopt a
focused approach to consulting AUC.
Thus, they can choose their approach
and select a CDSM and AUC set(s) that
fit their needs and preferences, while
being sure that each qualified CDSM
will include AUC that address all
priority clinical areas.
We further propose to add a
requirement in § 414.94(g)(1)(iv) of our
regulations that qualified CDSMs must
be able to incorporate specified
applicable AUC from more than one
qualified PLE. We believe this approach
ensures that CDSMs can expand the
AUC libraries they can provide access to
in order to represent AUC across all
priority clinical areas (consistent with
the requirements under proposed
§ 414.94(g)(1)(iii)). We do not
necessarily expect that a single qualified
PLE will develop AUC addressing every
priority clinical area domain, especially
since we believe that over time and
through future rulemaking, the list of
priority clinical areas will expand and
cross additional clinical domains.
Ensuring that qualified CDSMs are not
limited in their technology to
incorporating AUC from only one
qualified PLE will help to ensure that
ordering professionals will not be in a
position of consulting a CDSM that
cannot offer them access to AUC that
address all priority clinical areas. As
stakeholders continue to advance CDSM
technology, we look forward to
standards being developed and widely
accepted so that AUC are incorporated
in a standardized format across CDSM
platforms. Increasing standardization in
this area will move the industry closer
to the goal of interoperability across
CDSMs and EHRs.
We also propose to add a requirement
in § 414.94(g)(1)(i) that specified
applicable AUC and related
documentation supporting the
appropriateness of the applicable
imaging service ordered must be made
available within the qualified CDSM.
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For example, the ordering professional
would have immediate access to the full
appropriate use criterion, citations
supporting the criterion and a summary
of key evidence supporting the criterion.
We propose to add a requirement in
§ 414.94(g)(1)(ii), consistent with section
1834(q)(3)(B)(ii)(II) of the Act, that the
qualified CDSM must clearly identify
the appropriate use criterion consulted
if the tool makes available more than
one criterion relevant to a consultation
for a patient’s specific clinical scenario.
We believe this is important since
CDSMs that choose to incorporate a
comprehensive AUC library may be
offering the ordering professional access
to AUC from multiple qualified PLEs. In
such scenarios, it is important that the
ordering professional knows which
appropriate use criterion is being
consulted and have the option to choose
one over the other if more than one
criterion applies to the scenario.
We propose to add a requirement in
§ 414.94(g)(1)(v), consistent with section
1834(q)(3)(B)(ii)(III) of the Act, that the
qualified CDSM must provide to the
ordering professional a determination,
for each consultation, of the extent to
which an applicable imaging service is
consistent with specified applicable
AUC or a determination of ‘‘not
applicable’’ when the mechanism does
not contain a criterion that would apply
to the consultation. This determination
would communicate the
appropriateness of the applicable
imaging service to the ordering
professional. In addition to this
determination, we also propose that the
CDSM provide the ordering professional
with a determination of ‘‘not
applicable’’ when the mechanism does
not contain an appropriate use criterion
applicable to that patient’s specific
clinical scenario.
We propose to add a requirement in
§ 414.94(g)(1)(vi), consistent with
section 1834(q)(3)(B)(ii)(IV) of the Act,
that the qualified CDSM must generate
and provide to the ordering professional
certification or documentation that
documents which qualified CDSM was
consulted, the name and NPI of the
ordering professional that consulted the
CDSM and whether the service ordered
would adhere to applicable AUC,
whether the service ordered would not
adhere to such criteria, or whether such
criteria was not applicable for the
service ordered. We propose to require
under § 414.94(g)(1)(vi)(A) that this
certification or documentation must be
issued each time an ordering
professional consults the qualified
CDSM. Since Medicare claims will be
filed only for services that are rendered
to beneficiaries, we will not see CDSM
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consultation information on the claim
form specific to imaging services that
are not ordered. We believe that for the
CDSM to be able to provide meaningful
feedback to ordering professionals,
information regarding consultations that
do not result in imaging is just as
important as information on
consultations that do result in an order
for advanced imaging.
Thus, we propose to require under
§ 414.94(g)(1)(vi)(B) that the
documentation or certification provided
by the qualified CDSM must include a
unique consultation identifier. This
would be a unique code issued by the
CDSM that is specific to each
consultation by an ordering
professional. This type of unique code
may serve as a platform for future
collaboration and aggregation of
consultation data across CDSMs. In
addition, at some point in the future,
this unique code may assist in more
seamlessly bringing Medicare data
together with CDSM clinical data to
maximize quality improvement in
clinical practices and to iteratively
improve the AUC itself.
We propose in § 414.94(g)(1)(vii),
consistent with section
1834(q)(3)(B)(ii)(V) of the Act, that the
specified applicable AUC content
within qualified CDSMs be updated at
least every 12 months to reflect
revisions or updates made by qualified
PLEs to their AUC sets or to an
individual appropriate use criterion. We
propose 12 months as the maximum
acceptable delay for updating content.
We believe that in most cases it will be
possible to update AUC content more
frequently than every 12 months,
particularly for cloud-based CDSMs. We
further propose in § 414.94(g)(1)(vii)(A)
that qualified CDSMs have a protocol in
place to more expeditiously remove
AUC that are determined by the
qualified PLE to be potentially
dangerous to patients and/or harmful if
followed.
In addition, we propose in
§ 414.94(g)(1)(vii)(B) that qualified
CDSMs must make available for
consultation specified applicable AUC
that address any new priority clinical
areas within 12 months of the priority
clinical area being finalized by CMS. We
believe this would allow the CDSM
sufficient time to incorporate the AUC
into the CDSM. Thus, any new priority
clinical areas finalized, for example, in
the CY 2018 PFS final rule with
comment period that would be effective
January 1, 2018, would need to be
incorporated into a qualified CDSM by
January 1, 2019. To accommodate this
time frame, we would accept a not
applicable determination from a CDSM
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for a consultation on a priority clinical
area for dates of service through the 12month period that ends, in this
example, on January 1, 2019. We note
that all qualified CDSMs that are
approved by June 30, 2017 should be
capable of supporting AUC for all
priority clinical areas that are finalized
in the CY 2017 PFS final rule with
comment period.
We propose to add a requirement in
§ 414.94(g)(1)(viii), consistent with
section 1834(q)(3)(B)(ii)(VI) of the Act,
that the qualified mechanism must meet
privacy and security standards under
applicable provisions of law. Potentially
applicable laws may include the HIPAA
Privacy and Security rules.
We propose to add a requirement in
§ 414.94(g)(1)(ix), consistent with
section 1834(q)(3)(B)(ii)(VII) of the Act,
that qualified CDSMs must provide
ordering professionals aggregate
feedback in the form of an electronic
report on an annual basis (at minimum)
regarding their consultations with
specified applicable AUC. Our intent is
to require records to be retained in a
manner consistent with the HIPAA
Security Rule. To provide such
feedback, and to make detailed
consultation information available to
ordering professionals, furnishing
professionals (when they have
authorized access to the CDSM),
auditors and CMS, we propose in
§ 414.94(g)(1)(x) that a qualified CDSM
must maintain electronic storage of
clinical, administrative and
demographic information of each
unique consult for a minimum of 6
years. We believe CDSMs could fulfill
this requirement in a number of ways,
including involving a third party in the
storage of information as well as for
providing feedback to ordering
professionals. We recognize that these
requirements represent a minimum floor
that clinicians may choose to expand
upon in their local QI programs.
In the event requirements under
§ 414.94(g)(1) are modified through
rulemaking during the course of a
qualified CDSM’s 5-year approval cycle,
we propose in § 414.94(g)(1)(xi) that the
CDSM would be required to comply
with the modification(s) within 12
months of the effective date of the
modification.
d. Process for CDSMs To Become
Qualified and Determination of NonAdherence
We propose that CDSMs must apply
to CMS to be specified as a qualified
CDSM. We propose that CDSM
developers who believe their
mechanisms meet the regulatory
requirements must submit an
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application to us that documents
adherence to each of the requirements to
be a qualified CDSM.
We propose to require in
§ 414.94(g)(2) that CDSM developers
must submit applications to CMS for
review that document adherence to each
of the CDSM requirements. Applications
to be specified as a qualified CDSM
must be submitted by January 1 of a year
in order to be reviewed within that
year’s review cycle. For example, the
first applications would be accepted
from the date of publication of the PFS
final rule until January 1, 2017. A
determination on whether the
applicants are qualified would be made
by June 30, 2017. Applications must be
submitted electronically to
ImagingAUC@cms.hhs.gov. This process
and timeline mirror the qualified PLE
application and approval process and
timeline. As we did for qualified PLEs,
we will post a list of all applicants that
we determine to be qualified CDSMs to
our Web site at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/AppropriateUse-Criteria-Program/ by
June 30. We propose that all qualified
CDSMs must reapply every 5 years and
their applications must be received by
January 1 during the 5th year that they
are qualified CDSMs. It is important to
note that, as with PLE applications, the
application for qualified CDSMs is not
a CMS form; rather it is created by the
applicant. A CDSM that is specified as
qualified for the first 5-year cycle
beginning on July 1, 2017 would be
required to submit an application for
requalification by January 1, 2022. A
determination would be made by June
30, 2022, and, if approved, the second
5-year cycle would begin on July 1,
2022.
An example of our proposed timeline
for applications and the approval cycle
is as follows:
• Year 1 = July 2017 to June 2018.
• Year 2 = July 2018 to June 2019.
• Year 3 = July 2019 to June 2020.
• Year 4 = July 2020 to June 2021.
• Year 5 = July 2021 to June 2022
(reapplication is due by January 1,
2022).
We believe it is important for us to
have the ability to remove from the list
of specified qualified CDSMs a CDSM
that we determine fails to adhere to any
of the qualification requirements,
including removal outside of the
proposed 5-year cycle. We propose to
state under § 414.94(h) that, at any time,
we may remove from the list of qualified
CDSMs a CDSM that fails to meet the
criteria to be a qualified CDSM or
consider this information during the
requalification process. Such
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determinations may be based on public
comment or our own review and we
may consult with the National
Coordinator for Health Information
Technology or her designee to assess
whether a qualified CDSM continues to
adhere to requirements.
We invite comments on how we could
streamline and strengthen the approval
process for CDSMs in future program
years. For instance, CMS may consider
a testing framework for CDSMs that
would validate adherence to specific
standards that enable seamless
incorporation of AUC across CDSMs.
e. Consultation by Ordering Professional
and Reporting by Furnishing
Professional
Although we continue to aggressively
move forward to implement this AUC
program, ordering professionals will not
be expected to consult qualified CDSMs
by January 1, 2017. At the earliest,
under this proposal, the first qualified
CDSM(s) will be specified on June 30,
2017. We anticipate that some ordering
professionals could be able to begin
consulting AUC through qualified
CDSMs very quickly as some may
already be aligned with a qualified
CDSM.
We anticipate that furnishing
professionals may begin reporting as
early as January 1, 2018. This reporting
delay is necessary to allow time for
ordering practitioners who are not
already aligned with a qualified CDSM
to research and evaluate the qualified
CDSMs so they may make an informed
decision. While there will be further
rulemaking next year, we are
announcing this date because the
agency expects physicians and other
stakeholders/regulated parties to begin
preparing themselves to begin reporting
on that date. We will adopt procedures
for capturing this information on claims
forms and the timing of the reporting
requirement through PFS rulemaking for
CY 2018.
As we expect to implement the AUC
consultation and reporting requirements
under section 1834(q)(4)(A) and (B) of
the Act on January 1, 2018, we are
interested in receiving feedback from
the public to include a discussion of
specific operational considerations that
we should take into account and
include in such rulemaking. For
example, commenters could consider
alternatives for reporting data on claims
and for seeking exceptions, as discussed
below. We also seek information on the
barriers to implementation along this
timeline that allows ordering and
furnishing professionals to be prepared
to consult AUC and report consultation
information on the claims and whether
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separate rulemaking outside of the
payment rule cycle would be preferred.
Under section 1834(q)(4)(B) of the
Act, Medicare claims for applicable
imaging services furnished in applicable
settings can only be paid under the
applicable payment systems if certain
information is included on the claim
including: Which qualified CDSM was
consulted by the ordering professional
for the service; whether the service,
based on the CDSM consultation,
adheres to specified applicable AUC,
does not adhere to specified applicable
AUC or whether no criteria in the CDSM
were applicable to the patient’s clinical
scenario; and, the national provider
identifier (NPI) of the ordering
professional. This section further allows
payment for these services only if the
claim contains such information
beginning January 1, 2017. To develop
and operationalize a meaningful
solution to collecting new AUC
consultation-related information on the
claims, we must diligently evaluate our
options taking into account the vast
number of claims impacted and the
limitations of the legacy claims
processing system. While we could have
moved more quickly to establish some
sort of AUC consultation indicator for
Medicare claims, any such indicator
would have been a relatively
meaningless token. Additionally, in the
case of advanced imaging services,
related claims are already required to
append certain HCPCS modifiers and G
codes for purposes of proper payments.
In the recent implementation of section
218(a) of the PAMA, we established a
HCPCS modifier for CT services
rendered on machines that do not meet
an equipment standard. It is important
that we understand and evaluate how
the additional requirements for AUC
reporting would impact the information
that is already required for advanced
imaging services. Moving too quickly to
satisfy the reporting requirement could
inadvertently result in technical and
operational problems that could cause
delays in payments.
Section 1834(q)(4)(C) of the Act
includes exceptions that allow claims to
be paid even though they do not include
the information about AUC consultation
by the ordering professional. We believe
that, unless a statutory exception
applies, an AUC consultation must take
place for every order for an applicable
imaging service furnished in an
applicable setting and under an
applicable payment system. We further
believe that section 1834(q)(4)(B) of the
Act accounts for the possibility that
AUC may not be available in a
particular qualified CDSM to address
every applicable imaging service that
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might be ordered; and thus, the
furnishing professional can meet the
requirement to report information on
the ordering professional’s AUC
consultation by indicating that AUC is
not applicable to the service ordered.
We are considering the mechanisms
for appending the AUC consultation
information to various types of
Medicare claims and expect to develop
requirements for appending such
information in the CY 2018 PFS
rulemaking process. Stakeholders
interested in sharing feedback related to
reporting and claims processing are
welcome to do so as part of the
comment period for this proposed rule.
We are particularly interested in
receiving feedback on, for example,
whether the information should be
collected using HCPCS level II G codes
or HCPCS modifiers. We will use this
feedback to inform CY 2018 rulemaking.
f. Exceptions To Consulting and
Reporting Requirements
Section 1834(q)(4)(C) of the Act
provides for certain exceptions to the
AUC consultation and reporting
requirements under section
1834(q)(4)(B) of the Act. First, the
statute provides for an exception under
section 1834(q)(4)(C)(i) of the Act where
an applicable imaging service is ordered
for an individual with an emergency
medical condition as defined in section
1867(e)(1) of the Act. We believe this
exception is warranted because there
can be situations in which a delay in
action would jeopardize the health or
safety of individuals. Though we believe
they occur primarily in the emergency
department, these emergent situations
could potentially arise in other settings.
Furthermore, we recognize that most
encounters in an emergency department
are not for an emergency medical
condition as defined in section
1867(e)(1) of the Act.
We propose to provide for an
exception to the AUC consultation and
reporting requirements under
§ 414.94(i)(1) for an applicable imaging
service ordered for an individual with
an emergency medical condition as
defined in section 1867(e)(1) of the Act.
For example, if a patient, originally
determined by the clinician to have an
emergency medical condition prior to
ordering an applicable imaging service,
is later determined not to have had an
emergency medical condition at that
time, the relevant claims for applicable
imaging services would still qualify for
an exception. To meet the exception for
an emergency medical condition as
defined in section 1867(e)(1) of the Act,
the clinician only needs to determine
that the medical condition manifests
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itself by acute symptoms of sufficient
severity (including severe pain) such
that the absence of immediate medical
attention could reasonably be expected
to result in: Placing the health of the
individual (or a woman’s unborn child)
in serious jeopardy; serious impairment
to bodily functions; or serious
dysfunction of any bodily organ or part.
Orders for advanced imaging services
for beneficiaries with an emergency
medical condition as defined under
section 1867(e)(1) of the Act are
excepted from the requirement to
consult AUC. We intend through the CY
2018 PFS proposed rule to propose
more details around how this exception
will be identified on the Medicare
claim.
The second exception is under section
1834(q)(4)(ii) of the Act for applicable
imaging services ordered for an
inpatient and for which payment is
made under Medicare Part A. We
propose to codify this exception in new
§ 414.94(i)(2). While we are including
this exception consistent with statute,
we note that if payment is made under
Medicare Part A, the service would not
be paid under an applicable payment
system, such that the AUC consultation
and reporting requirements under
§ 414.94 would never apply.
The third exception is under section
1834(q)(4)(iii) of the Act for applicable
imaging services ordered by an ordering
professional who the Secretary
determines, on a case-by-case basis and
subject to annual renewal, that
consultation with applicable AUC
would result in a significant hardship,
such as in the case of a professional
practicing in a rural area without
sufficient Internet access. We propose to
codify this exception in new
§ 414.94(i)(3) by specifying that ordering
professionals who are granted a
significant hardship exception for
purposes of the Medicare EHR Incentive
Program payment adjustment under
§ 495.102(d)(4)(i), (ii), or (iii)(A)(B) of
our regulations would also be granted a
significant hardship exception for
purposes of the AUC consultation
requirement. We are proposing, to the
extent technically feasible, that the year
for which the eligible professional is
excepted from the EHR Incentive
Program payment adjustment is the
same year that the ordering professional
is excepted from the requirement to
consult AUC through a qualified CDSM.
We propose not to adopt the Meaningful
Use significant hardship exception
under § 495.102(d)(4)(iv)(C) as an
exception for purposes of the AUC
consultation requirement. Therefore,
ordering professionals with a primary
specialty of anesthesiology, radiology or
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pathology will not be categorically
excepted from AUC consultation
requirements.
We believe there is substantial
overlap between the eligible
professionals that would seek a
hardship exception under the EHR
Incentive Program and those ordering
professionals that would seek a
hardship exception under the AUC
program and, as such, this proposal
would be administratively efficient.
Using an existing program is the most
efficient and expeditious manner to
implement the significant hardship
exception under the Medicare AUC
program. We also believe it is the only
administratively feasible option for a
national significant hardship
identification process that can be
implemented by January 1, 2018, though
we intend to revisit this option for years
after 2018 as the current EHR Incentive
Program payment adjustment is set to
expire after the 2018 payment year as
the Merit-Based Incentive Payment
System takes effect. In addition, below
we discuss considerations for a
supplemental process to account for
hardships for ordering professionals that
are not eligible to apply for a significant
hardship under the EHR Incentive
Program (for example, non-physician
practitioners) and ordering professionals
that incur a significant hardship outside
of the EHR Incentive Program
application deadline.
The criteria for significant hardships
under the EHR Incentive Program relate
to insufficient internet connectivity,
practicing for less than 2 years,
practicing at multiple locations with the
inability to control the availability of
Certified EHR Technology, lack of faceto-face interaction with patients or a
primary specialty designation of
anesthesiology, radiology or pathology.
We believe that most of these criteria
would be relevant to demonstrate a
significant hardship for ordering
professionals to consult AUC. Regarding
hardship exceptions for certain
specialty designations, based on
Medicare claims data for advanced
imaging services from the first 6 months
of 2014, approximately 1.2 percent of
those claims were for advanced imaging
services that had been ordered by a
professional with one of the three
primary specialty designations. While
their combined ordering volume is
small, we do not believe that categorical
exclusion of certain specialties of which
the practitioner selected as their
primary specialty designation for
Medicare enrollment would necessarily
be appropriate under the AUC program.
Since eligible professionals in these
three specialties are categorically
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excepted from the EHR Incentive
Program payment adjustment, few of
them would have applied for an
exception on the other grounds.
Therefore, we must consider another
mechanism to evaluate whether
ordering practitioners with these
medical specialties experience a
significant hardship for purposes of the
AUC program.
We understand that there are
differences between the purpose and
timing of significant hardship
exceptions for the EHR Incentive
Program and the Medicare AUC
program. Foremost, a significant
hardship under the EHR Incentive
Program is generally based on a
hardship that occurred in a prior period,
impacting meaningful EHR use that
would affect payments in a subsequent
calendar year. For example, a
professional that submits an application
in March 2017 and qualifies for the
hardship exception under the EHR
Incentive Program would be exempt
from the EHR payment adjustment for
calendar year 2018. Although significant
hardship exceptions for the EHR
payment adjustment year generally are
based on the existence of a hardship in
a prior period, we believe it would be
appropriate for these professionals to
also qualify for a significant hardship
exception for purposes of the AUC
consultation requirement during
calendar year 2018. It is also our best,
most efficient, administratively feasible
means of determining significant
hardships for ordering professionals for
CY 2018.
We also recognize the possibility that
an ordering professional could suffer a
significant hardship during the AUC
program year, and therefore, is
immediately unable to consult AUC. In
addition, while again we believe there is
significant overlap, there may be
circumstances where an ordering
professional is not considered to be an
eligible professional under the EHR
Incentive Program (for example, an
ordering professional that is not a
physician). We are seeking feedback
from commenters regarding processes
that could be put in place to
accommodate ordering professionals
with primary specialties that
categorically receive significant
hardship exceptions under the EHR
Incentive Program, real-time hardships
that arise during a year, and ordering
professionals that are not eligible to
apply using the EHR Incentive Program
significant hardship exception process
and need to seek a significant hardship
exception for the purposes of the AUC
program. We believe this would involve
only a small number of ordering
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professionals. To the extent technically
feasible, some possibilities for
implementing such hardship exceptions
may include Medicare Administrative
Contractors granting hardships on a
case-by-case basis or establishing
another mechanism to allow for selfattestation of a significant hardship for
a defined period of time (for example,
a calendar quarter or a calendar year).
We intend to propose a process in the
CY 2018 PFS proposed rule.
We invite the public to comment on
our proposal for ordering professionals
granted a hardship exception for the
EHR Incentive Program for payment
year 2018 to also be granted a hardship
exception to the Medicare AUC program
for those years. We propose that the year
the practitioner is excepted from the
EHR Incentive Program payment
adjustment is the same year that the
practitioner would be excepted from
consulting AUC.
6. Summary
Section 1834(q) of the Act includes
rapid timelines for establishing a
Medicare AUC program for advanced
diagnostic imaging services. The
number of clinicians impacted by the
scope of this program is massive as it
will apply to every physician or other
practitioner who orders or furnishes
applicable imaging services. This
crosses almost every medical specialty
and could have a particular impact on
primary care physicians since their
scope of practice can be quite broad.
We continue to believe the best
implementation approach is one that is
diligent, maximizes the opportunity for
public comment and stakeholder
engagement, and allows for adequate
advance notice to physicians and
practitioners, beneficiaries, AUC
developers, and CDSM developers. It is
for these reasons we are proposing to
continue a stepwise approach, adopted
through notice and comment
rulemaking. We propose this second
component to the program to specify
qualified CDSMs, identify the initial list
of priority clinical areas, and establish
requirements related to CDSMs, as well
as consulting and reporting exceptions.
However, we also recognize the
importance of moving expeditiously to
accomplish a fully implemented
program. Under this proposal, the first
list of qualified CDSMs will be posted
no later than June 30, 2017, allowing
ordering professionals to begin aligning
themselves with a qualified CDSM. We
anticipate that furnishing professionals
could begin reporting AUC information
starting as early as January 1, 2018, but
will provide details in CY 2018 PFS
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rulemaking for how to report that
information on claims.
In summary, we propose definitions
of terms and processes necessary to
implement the second component of the
AUC program. We invite the public to
submit comments on these proposals.
We are particularly seeking comment on
the proposed priority clinical areas and
the requirements that must be met by
CDSMs to become qualified. We believe
the proposed requirements for qualified
CDSMs will allow for flexibility so
mechanisms can continue to reflect
innovative concepts in decision support
and develop customer-driven products
to ultimately provide information to the
ordering professional in such a manner
that will maximize appropriate ordering
of advanced diagnostic imaging while
seamlessly integrating into workflow.
As the stakeholders continue to move to
a place of consensus-based standards
deemed ready for deployment, we may
become more prescriptive in future
requirements for CDSMs. We also seek
comment on the exceptions to the
requirements to consult applicable AUC
using CDSMs.
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D. Reports of Payments or Other
Transfers of Value to Covered
Recipients: Solicitation of Public
Comments
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 (Open Payments
Final Rule) which implemented section
1128G of the 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
Open Payments program creates
transparency around the nature and
extent of relationships that exist
between drug, device, biologicals and
medical supply manufacturers, and
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physicians and teaching hospitals
(covered recipients and physician
owner or investors). The implementing
regulations are at 42 CFR part 402,
subpart A, and part 403, subpart I.
In addition to the Open Payments
final rule, we issued final regulations in
the CY 2015 PFS final rule with
comment period (79 FR 67758) that
revised the Open Payments regulations.
Specifically, we: (1) Deleted of the
definition of ‘‘covered device’’; (2)
removed the continuous medical
education (CME) exclusion; (3)
expanded the marketed name reporting
requirements to biologicals and medical
supplies; and (4) required stock, stock
options, and any other ownership
interests to be reported as distinct forms
of payment.
Since the publication and
implementation of the Open Payments
Final Rule and the CY 2015 PFS,
various stakeholders have provided
feedback to us regarding aspects of the
Open Payment program. We have
identified areas in the rule that might
benefit from revision. In order to
consider the views of all stakeholders,
we are soliciting comments to inform
future rulemaking. We do not intend to
finalize any requirements related to
Open Payments directly as a result of
this proposed rule; rather, we expect to
conduct future rulemaking. We are
particularly interested in receiving
comments on the following:
• We would like to know if the nature
of payment categories as listed at
§ 403.904(e)(2) are inclusive enough to
facilitate reporting of all payments or
transfers of value to covered recipient
physicians and teaching hospitals. We
also seek feedback on further
categorization of reported research
payments.
• Although there is a 5-year record
retention requirement at § 403.912(e),
our regulations are currently silent on
how long applicable manufacturers and
applicable GPOs remain obligated to
report on past years of payments or
ownership or investment interests. We
are soliciting feedback on how many
years an applicable manufacturer or
applicable GPO should continue to
monitor and report on past program
years for Open Payments reporting
purposes.
• We are continuing to refresh all
years of program data in addition to
newly submitted payment records. We
are interested in receiving feedback on
how many years of Open Payments data
is relevant to our stakeholders to help us
determine how many years to continue
to publish and refresh annually on our
Web site. In addition, we are looking for
feedback on how many years may be
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useful or relevant to Open Payments
data users as archive files available for
download on our Web site.
• We are seeking feedback on a
requirement for all applicable
manufacturers and applicable GPOs as
defined in § 403.902 to register each
year, regardless of whether the entity
will be reporting payments or other
transfers of value, or ownership or
investment interests for the program
year. We also seek comment on
requiring applicable manufacturers and
applicable GPOs to include the reason
for not reporting any payments or other
transfers of value, or ownership or
investment interests.
• We are constantly striving to ensure
that all published Open Payments data
is valid and reliable. As part of this
effort we are seeking comment on a
requirement for applicable
manufacturers and applicable GPOs to
pre-vet payment information with
covered recipients and physicians
owners or investors before reporting to
the Open Payments system, which we
understand is an increasingly common
practice. Specifically, we would like
feedback on pre-vetting based on
threshold payment values or random
samplings of covered recipients. We are
also interested in hearing how
applicable manufacturers and
applicable GPOs are successfully prevetting payment or transfer of value
records.
• We continue to receive feedback
that the current definition of a covered
recipient teaching hospital, as defined at
§ 403.902, makes reporting payments or
transfers of value difficult for applicable
manufacturers. Section 1128G of the Act
is silent on the definition of a covered
recipient teaching hospital. We are
soliciting feedback on the specific
hurdles that the current definition
presents. Additionally we would like to
receive proposed alternative
operationally feasible definitions or
definitional elements of a covered
recipient teaching hospital.
• We have heard from stakeholders
that verifying receipt of payments or
transfers of value to teaching hospitals
is a difficult process on the recipient
end for a various number of reasons
(such as size of hospitals, number of
departments, etc.). Without context
around a payment record, teaching
hospitals have reported difficulties
verifying payments attributed to them.
This leads to payment disputes. We are
seeking feedback on adding a new nonpublic data element to assist in review
and affirmation of payment records.
Some examples might be hospital
contact name or department etc. Would
a free form text field be preferable?
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Should this field be mandatory to
facilitate review of any attributed
payments to a teaching hospital?
• Some reporting entities have
expressed interest to upload data into
the Open Payments system before the
end of the calendar year for which the
data is collected. We believe this may
increase data validity and minimize
disputes. We solicit feedback on the
benefit for applicable manufacturers and
applicable GPOs to report data to CMS
early or ongoing throughout the year.
• We recognize that some entities
may experience mergers, acquisitions,
corporate organizations and
reorganizations, and other structural
corporate changes. We seek feedback on
how we might change our reporting
requirements to ensure that industry can
properly, and easily, represent these
changes while still monitoring for
compliance with reporting
requirements.
• We have received feedback from
industry that there is confusion
surrounding requirements for reporting
ownership and investment interests.
Keeping in mind that these reporting
requirements are statutorily mandated,
we solicit feedback on operationally
feasible definitions regarding ownership
or investment interests. Specifically, we
would like feedback on the terms ‘‘value
or interest’’ and ‘‘dollar amount
invested.’’ We also solicit comments on
additional terms that may require
further clarification to facilitate
compliance with reporting
requirements.
• We solicit ideas on how to define
physician-owned distributors (PODs) for
data reporting purposes, as well as what
data elements PODs should be required
to report. We also seek feedback on
what portion of the reported data we
should share on our Web site.
• From a data collection perspective,
we welcome suggestions on ways to
streamline or make the process more
efficient, while facilitating our role in
oversight, compliance, and enforcement.
• With respect to all solicitations, we
are requesting an estimate of the time
and cost burden associated with
reporting for purposes of compliance
with the Paperwork Reduction Act.
E. Release of Part C Medicare Advantage
Bid Pricing Data and Part C and Part D
Medical Loss Ratio (MLR) Data
1. Background
As part of the annual bidding process
required under section 1854(a) of the
Act, Medicare Advantage organizations
(MAOs) submit bids for each plan they
wish to offer in the upcoming contract
year (calendar year). We refer to each of
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these bids as a Medicare Advantage
(MA) plan bid. As required by sections
1857(e)(4) and 1860D–12(b)(3)(D) of the
Act, data supporting medical loss ratios
(MLR) are submitted annually to us by
MAOs and Part D sponsors,
respectively. Using this authority, we
codified the MLR submission
requirement in the MLR final rule for
Part C and Part D published in the
Federal Register (78 FR 31284) on May
23, 2013.
We are proposing to release to the
public MA bid pricing data and Part C
and Part D MLR data on a specific
schedule and subject to specified
exclusions. We propose to add contract
terms and expand the basis and scope
of our regulations on MA bidding and
Part C and Part D MLR submission to
incorporate section 1106(a) of the Act
(42 U.S.C. 1306(a)), which authorizes
disclosure of information filed with this
agency in accordance with regulations
adopted by the agency. (See Parkridge
Hospital, Inc. v. Califano, 625 F.2d 719,
724–25 (6th Cir. 1980). A substantive
regulation issued following rulemaking
provides the legal authorization for
government officials to disclose
commercial information that would
otherwise be required to be kept
confidential in accordance with 18
U.S.C. 1905. See Chrysler Corp. v.
Brown, 441 U.S. 281, 306–08 (1979). We
note as well that under 45 CFR
401.105(a),6 we have adopted a
regulation that permits publication and
release of data that would not be exempt
from disclosure under FOIA or
prohibited from disclosure under other
law, even if a request has not been
submitted. We further note that because
we collect Part D MLR information
under section 1860D–12(b)(3)(D) of the
Act, we have the authority to use such
information for purposes of improving
public health through research on the
utilization, safety, effectiveness, quality
and efficiency of health care services.
We propose to adopt a regulation that
clearly identifies the categories of data
from submitted bids and reports of
medical loss ratios that will be released
so as to avoid repeating FOIA analyses
and reviews of each request, to
standardize the disclosure and the
procedures for disclosure, and in the
6 The regulation, which implements 42 U.S.C.
1306(a), provides that the Freedom of Information
Act rules shall be applied to every proposed
disclosure of information. If, considering the
circumstances of the disclosure, the information
would be made available in accordance with the
Freedom of Information Act rules, then the
information may be disclosed regardless of whether
the requester or beneficiary of the information has
a statutory right to request the information under
the Freedom of Information Act, 5 U.S.C. 552, or
whether a request has been made.
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interest of furthering goals related to the
MA and Part D programs.
The purposes underlying these
proposed data releases include allowing
public evaluation of the MA and Part D
programs encouraging research into
these programs and better ways to
provide health care, and reporting to the
public regarding federal expenditures
and other statistics involving these
programs. In particular, we believe that
facilitating public research using this
bid pricing data could lead to better
understanding of the costs and
utilization trends in MA and support
future policymaking for the MA
program. For example, MA bid pricing
data (which contains actual and
projected cost figures) could be used to
understand patterns of health care
utilization such as how projected and
actual costs may differ across
geographic areas and different
beneficiary populations. Release of MLR
data from the MA and Part D programs
could lead to research into how
managed care in the Medicare
population differs from and is similar to
managed care in other populations
(such as the individual and group
markets) where MLR data is also
released publicly; such research could
inform future administration of these
programs. Further, we believe that
making certain MA bid pricing data and
Part C and Part D MLR data available
publicly aligns with Presidential
initiatives to improve management and
transparency of federal information. The
President’s January 21, 2009,
Memorandum on Transparency and
Open Government (74 FR 4685)
instructed federal agencies to take
specific actions to implement increased
data transparency and access to federal
datasets. Subsequent Presidential
memoranda (including the May 23, 2012
memorandum Building a 21st Century
Digital Government and May 9, 2013
memorandum Making Open and
Machine Readable the New Default for
Government Information) further stated
the policy initiative to increase open
access to and interoperability among
such government data sets. These
memoranda demonstrate a commitment
to making information about
government activities and government
spending available to the public and
using the internet as a means of public
disclosure in order to eliminate as many
barriers as possible to public access to
such information. Our proposal would
promote accountability in the MA and
Part D programs, by making MLR
information publicly available for use
by beneficiaries who are making
enrollment choices and by allowing the
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public to see whether and how
privately-operated MA and Part D plans
administer Medicare—and
supplemental—benefits in an effective
and efficient manner. Disclosing MA
pricing data would provide the public
with insight as to how public dollars are
spent in this aspect of the Medicare
program. Further, we have received
requests under FOIA for data of the type
of the pricing data we propose to release
here and we anticipate that, as the MLR
Reports from MA and Part D plans are
submitted, we will receive requests for
those reports and that data.
These interests, however, must also be
balanced with the need to protect the
privacy of individuals, the
confidentiality of information about
Medicare beneficiaries, and the
proprietary interests of the MA and Part
D plans that submit the information.
While transparency in governmental
activities and spending is important, we
recognize that some of the information
we collect in the form of MA bid pricing
submissions and Part C and Part D MLR
reports should not be publicly
disclosed. We believe that our proposal
balances these various interests and
goals, both in carving out from the
planned and authorized releases certain
specific data, and (in the case of the MA
bid pricing data) in delaying the release
past the point of the commercial
usefulness of the data.
We are seeking to balance protection
of the proprietary interests of MAOs and
Part D sponsors with the need to
effectively and transparently administer
federal health care programs and to
encourage research into better ways to
provide health care. Further, we believe
that adopting a fixed schedule for
release of this information and
standardizing releases of this data
through this rule, will reduce the
burdens on the public, CMS, and the
submitters of the data that are associated
with individual requests for
information. Proposing a rule for these
releases provides the opportunity for a
fulsome and public dialogue that is not
always the case with individual requests
for information. We encourage
commenters to identify and explain
additional uses of the information we
propose here to release and to suggest
additional protections from release if
commenters disagree with how we have
balanced the competing interests. We
hope to receive comments from all
viewpoints to ensure that the lines for
releasing and protecting information are
appropriately drawn.
2. MA Bid Submission and Pricing Data
We make monthly prospective
payments to MAOs for providing Part C
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coverage to Medicare beneficiaries
enrolled in their MA plans. As
mandated in section 1854 of the Act,
amended by Title II of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub.
L. 108–173), our payments to MAOs for
their MA plan enrollees are based on
bids that MAOs must submit to us no
later than the first Monday in June for
the upcoming contract year. Each MA
plan bid is an estimate of the plan’s
revenue requirement to cover plan
benefits for a projected population. The
monthly aggregate bid amount for an
MA plan is composed of estimated
benefit expenses (direct medical
expenses), non-benefit expenses
(administrative expenses), and a gain/
loss margin (profit) for coverage of
original Medicare benefits, Part C
supplemental benefits (if any), and Part
D benefits (if any). We are not proposing
to release Part D bid pricing data in this
rule. Also, cost plans operated under
section 1876 and section 1833 of the
Act, Program for All Inclusive Care for
the Elderly (PACE) organizations, and
Medicare-Medicaid demonstration plans
operated under the Financial Alignment
Initiative (https://www.cms.gov/
Medicare-Medicaid-Coordination/
Medicare-and-Medicaid-Coordination/
Medicare-Medicaid-CoordinationOffice/FinancialAlignmentInitiative/
FinancialModelstoSupportStates
EffortsinCareCoordination.html) do not
submit Part C bids to us so pricing data
relating to those plans is not part of this
proposed rule.
Section 1854(a) of the Act requires
that MA bid submissions, including
coverage, cost-sharing, and pricing, be
in a form and manner specified by the
Secretary. The statute, as specified in
paragraphs (a)(1), (a)(3), and (a)(6),
requires that bids include the plan type,
the plan’s geographic service area,
projected enrollment under the plan,
bid amounts for the provision of Part C
benefits, bid amounts for Part D benefits
(if offered by the MA plan), descriptions
of beneficiary cost-sharing liability for
each type of benefit, the plan’s use of
the beneficiary rebate (if any), and the
actuarial basis for determining the bid
pricing amounts. Part C benefits include
basic benefits (that is, the benefits
available under Original Medicare Parts
A and B) and non-Medicare
supplemental benefits (both mandatory
and optional); supplemental benefits
may include benefits not available
under Original Medicare (for example,
vision and dental benefits) or the
reduction in cost-sharing obligations of
enrollees compared to Original
Medicare.
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The regulation at § 422.254 addresses
the content of the bid submission as
well but does not specify the form or
manner of the submission. We
developed standardized templates for
MAOs to populate and upload to our
Health Plan Management System
(HPMS) as the bid submission described
in the statute and regulation. These
standardized MA bid submission
templates collect the information
required under § 422.254, and organize
the information as follows:
• Plan Benefit Package (PBP)
information (describing the Part C
benefits and cost-sharing for each MA
plan);
• Service Area information
(identifying geographic areas where an
MA plan is to be offered by the MAO);
• Plan Crosswalk information
(identifying plan consolidations,
terminations, and/or service area
changes from one year to the next); and
• The MA bid pricing data for each
PBP (that is, each MA plan). MA bid
pricing data is uploaded to HPMS in a
template referred to as the MA Bid
Pricing Tool (MA BPT).
Currently, we publicly release
information on the Plan Benefit
Package, service area, and plan
crosswalks each year. These data sets
can be found on our Web site at https://
www.cms.gov/Research-Statistics-Dataand-Systems/Statistics-Trends-andReports/MCRAdvPartDEnrolData/
index.html, under the subpages
Benefits-Data, MA-Contract-ServiceArea-by-State-County, and PlanCrosswalks, respectively.
In this rule, we propose to release MA
bid pricing data, as defined at proposed
§ 422.272, which would be
implemented as a release of data housed
in the MA BPT for each MA plan subject
to specified exclusions from release
(noted in this section of the proposed
rule). The MA BPT is a standardized
Excel workbook with multiple
worksheets and special functions builtin (for example, validation features).
There are also separate BPTs used to
price two types of MA plans: Medicare
Medical Savings Account plans (the
MSA BPT); and End-Stage Renal
Disease-only special needs plans (the
ESRD–SNP BPT). The MSA BPT was
first released for calendar year (CY)
2009 bidding, and the ESRD–SNP BPT
was first released for CY 2014 bidding.
We maintain and update these three MA
BPT formats under OMB #0938–0944,
and release annual versions every April.
The MA BPT templates can be found
on our Web site at https://www.cms.gov/
Medicare/Health-Plans/
MedicareAdvtgSpecRateStats/BidForms-Instructions.html, accompanied
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by instructions on how to populate the
tool and a data dictionary for all data
elements. Information pertaining to the
MSA BPT and the ESRD–SNP BPT can
be found in the Appendices within the
general MA BPT instructions, which can
be found on the Bid-Forms Web site.
Below we describe the general
categories of MA bid pricing data
contained in the MA BPT templates,
indicating the associated BPT
worksheet. Worksheets 1 through 6 of
the MA BPT template collect
information for the development and
identification of the revenue
requirements for basic benefits and
mandatory supplemental benefits.
Optional supplemental benefits, which
enrollees may opt to purchase
separately, are addressed in a separate
worksheet. The BPT as a whole collects
the information described in
§ 422.254(b), (c) and (d) for coordinated
care and private fee-for-service plans
and in § 422.254(b) and (e) for MA–MSA
plans. The regulation describes the
required bid elements in general terms,
which we implemented and
operationalized at a detailed level in the
BPT.
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a. MA Base Period Experience and
Projection Assumptions (MA BPT
Worksheet 1)
MAOs must report base period
experience data, which is defined as
claims incurred in the calendar year 2
years prior to the contract year for
which the bid is being submitted, for
basic benefits and mandatory
supplemental benefits. For example, for
CY 2017 bids (which must be submitted
June 6, 2016), the base period data is for
CY 2015. For the historical period,
MAOs report the plan’s actual allowed
per member per month (PMPM) cost,
unit cost and utilization by service type
(for example, inpatient, outpatient, etc.);
cost sharing and net costs are also
reported. MAOs must also report actual
enrollment and revenue, as well as
expenses for claims, administration, and
gain/loss margin, for this base period.
Finally, MAOs must report the
assumptions they use to project (that is,
trend) the base period claims experience
to the contract year for which they are
bidding.
b. MA Projected Allowed Costs (MA
BPT Worksheet 2)
MAOs provide the projected allowed
PMPM costs, unit costs, and utilization
by service type for the contract year,
using the claims experience and
projection assumptions described
previously; such information
demonstrates the actuarial bases of the
bid. Allowed costs are ‘‘gross’’ costs,
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that is, before the application of any
beneficiary cost sharing. Total projected
allowed costs are reported separately for
dual eligible beneficiaries without full
Medicare cost-sharing liability versus
other beneficiaries. MAOs may also
enter manual rates and the credibility
assumptions used to blend together
manual rates with projected experience.
c. MA Projected Cost Sharing (MA BPT
Worksheet 3)
MAOs present the effective value of a
plan’s level of cost-sharing by service
type, which must include both innetwork and out-of-network cost sharing
(copays and coinsurance) and other
amounts such as plan deductibles and
the plan’s out-of-pocket maximum costsharing amount.
d. MA Projected Revenue Requirement
(MA BPT Worksheet 4)
MAOs then combine their allowed
cost data and cost sharing information
(described in sections III.E.2.b. and c. of
this proposed rule) to calculate the
plan’s projected revenue requirement,
which consists of benefit costs (direct
medical costs) net of cost-sharing, nonbenefit expenses (administrative costs),
and gain/loss margin. The plan’s
projected revenue requirement is
allocated to the following: Medicarecovered A/B services, prescription drug
coverage (if the plan is an MA–PD plan),
and non-Medicare covered services
(mandatory supplemental benefits
under the plan).7 MAOs report the
revenue requirement separately for dual
eligible beneficiaries without full
Medicare cost-sharing liability versus
other enrolled beneficiaries. They also
report administrative expenses by
category (for example, direct versus
indirect administration) and
information related to the plan’s gain/
loss (profit) margin.
MAOs have the option of reporting
enrollment, revenue and expense
information related to their plan
enrollees with End Stage Renal Disease
(ESRD) on worksheet 4; these costs are
otherwise excluded from bid
development. (We have the authority to
determine whether and when it is
appropriate to apply the bidding
methodology to ESRD MA enrollees, as
set forth at § 422.254(a)(2).) MAOs also
have the option of reporting information
7 We are not proposing to release any Part D bid
pricing data as part of this proposed rule. Therefore,
for any MA–PD bid, the Part D information
underlying the pricing of Part D benefits would be
redacted from any data release under this rule.
However, the amount of beneficiary rebate applied
to buy-down the Part D premiums if any, is
included at § 422.264(b)(2) as a use of Part C
dollars, so will be included in the MA bid pricing
data release. See section III.E.3.a.1.
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related to Medicaid revenue and
expenses for dual eligible beneficiaries.
The plan’s expected risk profile
(average risk score) is reflected in the
projected revenue requirements (costs)
for both A/B and supplemental bid
amounts. That is, the projected costs
will reflect the expected risk profile of
that plan’s population because the
utilization projections built into the
costs projected in the bid reflect the
underlying risk and need for services of
the expected enrollees for that plan.
When these projected costs are divided
by the plan’s projected risk score for a
projected enrollment, the costs become
‘‘standardized.’’ Standardized costs
have a risk score equal to one, which
means that they reflect the risk profile
of the average Medicare beneficiary.
e. MA BPT Benchmark (Worksheet 5)
The MA BPT illustrates development
of the plan-specific A/B benchmark,
based on the service area of the plan and
the county rates (or MA regional rates)
applicable to the plan; the benchmark is
identified and calculated using
information provided by the plan and
county rate information announced by
CMS. See § 422.254 and § 422.258. The
service-area level benchmark represents
the upper limit that the federal
government will pay PMPM for
coverage of A/B benefits in the defined
service area, given the plan’s quality
rating, prior to risk adjusting payments.
The service-area level benchmark for
(non-regional) plans that cover multiple
counties is a weighted average of the
projected plan enrollment and the
applicable county ratebook amounts.
For benchmark development, the
MAO reports the following: Projected
enrollment in member months per
county; projected average risk score for
the projected enrollment in each county
in the plan’s service area; and a planlevel factor for the proportion of
beneficiaries with Medicare as
Secondary Payer. Plan-level projected
member months and risk scores are
reported separately for dual eligible
beneficiaries without full Medicare costsharing liability versus other
beneficiaries.
The MA BPT is programmed to
compare the A/B bid amount from the
MAO to the benchmark to determine
whether the plan has a beneficiary
rebate (defined at § 422.266) and must
submit information required by
§ 422.254(d). If the plan A/B bid amount
is lower than the plan benchmark, a
percentage of the difference determines
the beneficiary rebate amount (where
the percentage is based on the plan’s
quality rating). If the bid is greater than
benchmark, the plan must charge a
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member premium for coverage of A/B
benefits.
f. MA Bid Summary (MA BPT
Worksheet 6)
The MA BPT presents a summary of
key figures developed in the tool,
including the bid, benchmark, projected
risk score, and rebate amount, to
support the final step of bid pricing—
development of the beneficiary
premium (if any) for the plan. To
determine the premium, MAOs indicate
how the rebate amount will be
allocated. Under § 422.266(b), the rebate
must be allocated to some combination
of MA mandatory supplemental benefits
(defined at § 422.2), which can include
buy down of original Medicare A/B
cost-sharing and offering additional
benefits not covered by original
Medicare; and buy down of the Part D
basic premium, the Part D supplemental
premium, and/or the Part B premium.
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g. Optional Supplemental Benefits (MA
BPT Worksheet 7)
MAOs may offer optional
supplemental benefits, which plan
enrollees may opt to purchase for a
separate, additional premium. MAOs
present the actuarial pricing elements
for any optional supplemental benefit
packages to be offered during the
contract year, up to a maximum of 5
packages. Not all MA plans offer
optional supplemental benefits. MAOs
report projected member months,
allowed costs PMPM, cost sharing,
administrative costs and gain/loss
margin for each optional supplemental
benefit package. MAOs also report base
period experience for optional
supplemental benefits, including
revenue, enrollment, claim expenses,
administrative expenses, and gain/loss
margin. The information is reported
separately as enrollees must make a
separate election to purchase these
benefits, and for coordinated care plans
and private fee-for-service plans they
cannot be funded by beneficiary rebates.
h. MSA BPT and ESRD–SNP BPT
Regarding the MSA BPT and ESRD–
SNP BPT, the same general
requirements apply: Submission of base
period experience data; projected
allowed costs by service type; projected
enrollee cost-sharing payments;
projected revenue requirements
(medical, administrative, and margin);
and development of the plan benchmark
against which the bid is compared.
Unique to the MSA BPT is development
of the beneficiary deposit amount for
the high-deductible plan. Unique to the
ESRD–SNP BPT are service categories
such as dialysis and nephrologist.
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i. Additional Documentation
In addition to the categories of data
noted in this section of the proposed
rule, MAOs must also submit
supporting documentation to
substantiate the actuarial basis of
pricing and an actuarial certification of
the bid for their MA BPTs, MSA BPTs,
and ESRD–SNP BPTs, as required at
§§ 422.254(b)(5) and 422.256(c)(5).
3. Proposed Regulatory Changes for
Release of MA Bid Pricing Data
We are proposing to amend our MA
regulations to provide for the release of
certain MA bid pricing data. We
propose to release to the public each
year, after the first Monday in October,
MA bid pricing data that we accepted or
approved for a contract year at least 5
years prior to the upcoming calendar
year, subject to specific exclusions
described in proposed § 422.272(c). We
believe this disclosure is consistent with
Presidential directives to make
information available to the public, and
with our goals of allowing public
evaluation of the MA program,
encouraging research into better ways to
provide health care, and reporting to the
public regarding federal expenditures
and other statistics involving this
program. For example, MA bid pricing
data (which contains actual and
projected cost figures) could be used to
understand patterns of health care
utilization such as how projected and
actual costs may differ across
geographic areas and different
beneficiary populations, which could
inform future bidding and payment
policies. Further, releasing pricing data,
particularly in conjunction with
information already released under
§ 422.504(n), will provide insight into
the use of public funds for the MA
program, providing appropriate
transparency about the administration
of the program.
We propose to codify the
requirements for release of MA bid
pricing data for MA plan bids accepted
or approved by us by adding a new
§ 422.272 to subpart F of part 422. First,
we discuss the definition of MA bid
pricing data, then our proposal to
release MA bid pricing data for MA plan
bids accepted or approved by us, and
the types of information we propose be
excluded from these data releases. Next,
we discuss the specific proposal for the
timing of the public data release.
Finally, we solicit public comment on
approaches to releasing more recent MA
bid pricing data. We also solicit
comment on our goals and purposes
stated above for the release of MA bid
pricing data.
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(a) Terminology
At § 422.272(a), we propose a
definition of MA bid pricing data to
mean the information that MAOs must
submit for the annual bid submission
for each MA plan, in a form and manner
specified by us. Specifically, we
propose that MA bid pricing data
includes the information described at
§ 422.254(a)(1) and the information
required for MSA plans at § 422.254(e).
We use § 422.254(a)(1) in our proposed
definition because it provides an
overview of the submission
requirements in our MA bidding
regulations. Specifically, § 422.254(a)(1)
references § 422.254(b), (c), and (d),
which address, respectively, general bid
requirements, information required for
coordinated care plans and private feefor-service plans, and information on
beneficiary rebates. At § 422.272(a)(2),
we propose to include in the definition
the information required for bids for
MSA plans, set forth at § 422.254(e),
which includes the amount of plan
deductible for the high-deductible plan.
By proposing to define MA bid
pricing data at § 422.272(a) using crossreferences to existing regulation at
§ 422.254(a)(1) and (e), we are proposing
in operational terms that the term
encompass all plan-specific data fields
in the MA BPT, the MSA BPT, and the
ESRD–SNP BPT, that is, the figures that
MAOs input and those that are
calculated within the BPT. The BPTs
also include data that are not planspecific, which consist of look-up tables
built-in to facilitate calculations. We do
not propose to include these look-up
tables as part of the proposed definition
of MA bid pricing data, as they are not
submitted by the MAO. These look-up
tables are hidden Excel worksheets
(which can be ‘‘unhidden’’ within
Excel), and are currently available to the
public in the BPT templates on the CMS
Web site at https://www.cms.gov/
Medicare/Health-Plans/
MedicareAdvtgSpecRateStats/BidForms-Instructions.html. Selected data
from the look-up tables are reflected in
each MA plan’s BPT. For example, there
is a look-up table in the BPTs with the
county rates for the contract year and
when the MAO enters a state-county
code, the BPT extracts the appropriate
rate amount for the county from the
look-up table and populates the
appropriate data field.
Our proposed definition of MA bid
pricing data references elements
required at § 422.254(b) and includes
information described in section III.E.2.
(MA Bid Pricing Data) of this proposed
rule: The estimated revenue required by
an MA plan for providing original
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Medicare benefits and mandatory
supplemental health care benefits, if any
(composed of direct medical costs by
service type, administrative costs and
return on investment); and the plan
pricing of enrollee cost-sharing for
original Medicare benefits and
mandatory supplemental benefits. In
addition, the definition references the
MA bid pricing data elements required
at § 422.254(c), which include more
detail about the Medicare-covered and
supplemental bid amounts such as the
actuarial bases for the bid amounts,
projected enrollment, and data specific
to regional MA plans.
Finally, we propose to define MA bid
pricing data to include elements
required at § 422.254(d), thus
incorporating a reference to the forms of
beneficiary rebate at § 422.266(b). That
is, for plans that bid below the
benchmark for their service areas, the
term would include the beneficiary
rebate amounts that are allocated in the
BPTs to the uses allowed in law:
Reduction of cost-sharing below original
Medicare levels, offering additional
benefits not covered by original
Medicare, and reduction of the Part D
basic premium, the Part D supplemental
premium, and/or the Part B premium.
Unlike the underlying components of
the Part D pricing (that is, pricing
information related to the Part D benefit
analogous to the information included
in the MA BPT), we consider
beneficiary rebate amounts that are
applied to reduce the Part D basic and
supplemental premiums to be Part C
amounts that are part of the MA bid
pricing submission, not the Part D bid
pricing submission.
(b) Release of Accepted or Approved
MA Bid Pricing Data With a 5 Year Lag
In § 422.272(b), we propose to
authorize the public release of MA bid
pricing data for the MA plan bids that
were accepted or approved by us for a
contract year under § 422.256. We
propose that the annual release will
contain MA bid pricing data from the
final list of MA plan bids accepted or
approved by us for a contract year that
is at least 5 years prior to the upcoming
calendar year.
We use the phrase ‘‘accepted or
approved’’ in the proposed regulation
text because both terms are used in
existing regulation when referring to
MA bids. We consider these words to
mean the same thing in the context of
MA bid pricing submissions, and we
use both words in proposed § 422.272(b)
to mirror existing regulation. For
example, existing § 422.256(b) states
that CMS can only accept bids that meet
the standards in that paragraph.
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However, § 422.256(b)(4)(i) and (ii) use
the phrase ‘‘CMS approves a bid. . . .’’
The phrases ‘‘decline to accept’’ and
‘‘decline to approve’’ are used at
§ 422.254(a)(5) and § 422.256(a),
respectively. In the remainder of this
preamble, we will use the term
‘‘accepted’’ to represent the phrase
‘‘accepted or approved.’’
During our annual bid review process,
we determine which MAOs must submit
one or more updated versions of the
initial MA BPT for one or more of their
MA plans, in response to questions from
our bid reviewers. In addition, as part of
the bid pricing submission process, an
MAO may have to adjust its allocation
of beneficiary rebate dollars for some or
all of its MA plans that offer Part D and
for their regional PPOs, after we
publicly release the Part D national
average bid amount and the final MA
regional plan benchmarks. Any
reallocation of rebate dollars results in
a revised MA bid, which must be
submitted to us as an updated version
of the original submission. Finally, on
occasion an MAO will withdraw an MA
plan after we have accepted the plan
bid. For these reasons, we propose that
the MA bid pricing data to be released
will only be the data found in the final
list of accepted bids; for operational
purposes, this means the final accepted
MA BPTs, MSA BPTs, and ESRD–SNP
BPTs, subject to exclusions noted in
proposed paragraph (c).
Finally, in § 422.272(b), we propose to
authorize the annual release of MA bid
pricing data for a contract year that is at
least 5 years prior to the upcoming
calendar year. We believe that 5 years is
an appropriate length of time for the MA
bid pricing data to no longer be
competitively sensitive. (The base
period data on actual expenses in the
MA BPT, MSA BPT, and ESRD–SNP
BPT is 2 years older than the data for
the bidding year—see the description of
the MA BPT category MA Base Period
Experience and Projection Assumptions
in section III.E.2. of this proposed rule.)
Since this will be an annual release,
over time the public would have the
ability to trend bid cost projections
across years, to compare actual costs
from the MA BPT with projections from
prior years, and to observe bidding
patterns over ever-longer periods of
time.
We are seeking to balance the
protection of commercially sensitive
information with our goals to effectively
administer federal health care programs,
increase data transparency regarding
federal expenditures, and encourage
research into better ways to provide
health care. We propose that a 5-year
delay renders multi-year comparisons of
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pricing trends less relevant to the
current year of MA plan pricing. The
time lag represents a buffer between the
development and implementation of
pricing strategies that can be distilled
from data multiple years for and the
observed relationship and trend from
one year to the next, thus mitigating
possible competitive disadvantage from
the proposed data disclosure. For
example, an MAO looking to enter a
new MA market is significantly less
likely to gain an unfair commercial
advantage from being able to examine
and trend 5-year-old bid pricing data
than if the MAO were able to examine
and trend more recent bid pricing data.
We solicit comment on the proposed
5 year delay for reducing competitive
disadvantages to MAOs. We solicit
comments explaining whether a shorter
period would suffice to protect MAOs
from competitive harm associated from
the disclosure of confidential
commercial information or if a longer
period is necessary to adequately
protect the information and assure the
continued submission of accurate data.
(c) Exclusions From Release
In § 422.272(c), we propose that
several types of MA bid pricing
information be excluded from the data
releases under paragraph (b). First, we
note that we are not proposing to release
Part D bid pricing data in this rule. For
this reason, the exclusion from release
at proposed § 422.272(c)(1) is
information pertaining to the Part D
prescription drug bid amount for an MA
plan offering Part D benefits,
specifically the information required for
Part D bid submission at
§ 422.254(b)(1)(ii), (c)(3)(ii), and (c)(7).
We consider this exclusion at proposed
§ 422.272(c)(1) to include the following
amounts in the MA BPT that pertain to
the Part D premiums: The Part D basic
premium before and after application of
beneficiary rebate amounts; the Part D
supplemental premium before and after
application of beneficiary rebate
amounts; the combined MA plus Part D
total plan premium; and the target Part
D basic premium.
Regarding Part D bid pricing data,
section 1860D–15(f) of the Act contains
protections for data submitted by Part D
Sponsors in accordance with section
1860D–15; these protections would
generally prohibit public release of such
data. We propose that the Part D bid
pricing elements listed in this section of
the proposed rule, which appear in the
MA bid pricing tools, would be
excluded from release. However, we
note that the Part C statute does not
establish similar protections for MA bid
pricing data, and we believe that MA
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bid pricing data is not subject to the
protections imposed by section 1860D–
15 of the Act.
Second, at § 422.272(c)(2), we propose
to exclude from release two categories of
additional information that we require
to verify the actuarial bases of the MA
plan bids. At paragraph (c)(2)(i), we
propose to exclude from release any
narrative information in the MA BPT,
MSA BPT, and ESRD SNP BPT
regarding base period factors, manual
rates, cost-sharing methodology,
optional supplemental benefits, or other
topics for which narratives are required
by us under § 422.254. These narrative
fields provide additional information to
allow us to verify the actuarial bases of
the bid, as described at § 422.256(c)(5).
For the base period narratives, MAOs
are asked to describe the source of the
base period experience data, and any
other utilization adjustment factors, unit
cost adjustment factors, and additive
adjustment factors that the MAO
applied. For projected allowed costs, the
narrative field captures descriptions of
manual rates including trending
assumptions in the manual rates. For
projected cost sharing, the narrative
fields contains a description of the
methodology for reflecting the impact of
maximum cost-sharing. Finally, for
optional supplemental benefits, there is
a general comments field. The proposed
regulation text would also exclude from
release any other narrative fields in the
BPT that we may require as the bid
submission process changes over time.
We propose to exclude these text fields
in the BPTs. MAOs may populate them
with information pertinent to more than
the individual MA plan bid in which
the narrative is included, such as
regional or national-level information
on an MAO’s approach to cost-sharing
methodology or projection factors. For
example, MAOs may provide
information on provider contracting,
such as the fee schedules. Further, these
explanations and additional information
provide insight into the exercise of
actuarial judgment in developing the
bids. We believe that it is reasonable to
treat such summary statements of MAO
methodology or strategy as information
proprietary to the MAO that should
remain protected from public
disclosure. The release of such
information (for example, fee schedules
or national pricing strategy) may
provide an unfair commercial advantage
to certain entities, such as new market
entrants, and likely would impair the
government’s ability to obtain such
information in the future, since MAOs
have greater discretion in deciding what
written information to share with us and
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would likely attempt to avoid sharing
fee schedule and pricing strategy
information.
Another category of information that
we propose to exclude from release, at
§ 422.272(c)(2)(ii), is the supporting
documentation that MAOs submit to us
to support the actuarial bases of each
MA plan bid; these materials are
collected outside of the BPT templates
so this proposed exclusion would be
operationalized by withholding from
release any materials submitted as part
of an MA bid that were not part of the
BPT worksheet submission. Supporting
documentation for each MA plan bid
can consist of multiple text,
spreadsheet, and email files. MAOs
submit the first round of supporting
documentation with the initial bid
submission. Subsequently, during the
bid review process, our reviewers may
communicate requests for additional
supporting documentation, and in
response, MAOs may submit multiple
updated versions of an MA plan’s BPT
and additional supporting
documentation. There are no standard
formats for supporting documentation.
A range of files (Word, Adobe, Excel,
and email formats) may be uploaded for
each of the MA plan bids, and there is
no way to identify clearly which data
elements in any of the supporting
documentation for an MA plan bid
applies to the final accepted version of
the bid. Supporting documentation
often links a particular plan bid to an
MAO’s broader pricing approaches,
such as financial arrangements with
providers, and we believe that such
analytical information at a regional or
national level could be commercially
sensitive information in a way that the
cost and enrollment estimates in the
BPT are not, since such strategic pricing
and contracting information could
provide an unfair commercial advantage
to certain entities, such as new market
entrants, who would not need to release
such strategic information. We also are
concerned whether release of
supporting documentation could have a
chilling effect on the scope of
information provided by MAOs for
future bidding and our ability to
accurately evaluate bids. We rely on
MAOs to provide detailed explanations
of the bids in order for CMS to fully
understand the judgment calls
underlying the assumptions reflected in
the bids. If MAOs believe that the
explanations and additional information
are not protected from disclosure, they
may provide less information and less
explanation. In order to preserve the
access we have, we are proposing to
protect this information.
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Third, at § 422.272(c)(3), we propose
to exclude from release any information
identifying Medicare beneficiaries and
other individuals. We believe that this
identifying information should be
excluded from a public data release to
protect the privacy of individuals,
including but not limited to protecting
the confidentiality of information about
Medicare beneficiaries. Regarding
Medicare beneficiaries, we propose to
exclude from release any MA bid
pricing data element that is based on
fewer than 11 Medicare beneficiaries as
we believe that this threshold
establishes the point at which
individual-level data can be discerned.
Following our longstanding data release
policy for protecting individually
identifiable information, in the event
that data fields in an MA BPT, MSA
BPT, or ESRD SNP BPT are populated
with fewer than 11 MA plan members
(or 132 member months, assuming each
individual is counted for 12 months),
we would suppress all of those data
fields in the public release file for that
MA plan bid under our proposed rule.
We are not proposing to build this
threshold into the regulation text,
however, as we believe that technology
and the ability to reverse-engineer data
to identify beneficiaries may change
over time. We may revisit this threshold
as we administer the data releases
proposed here (and in other Medicare
contexts) and will make adjustments as
necessary to ensure that we do not
disclose data that could be used to
identify beneficiaries. For example, data
fields with member months, utilizers,
and utilization per 1,000 could be
populated based on fewer than 11 MA
plan members and would be suppressed
from the release under this proposed
rule. Protection of information that
could identify Medicare beneficiaries,
particularly in the context of their
receipt of health care services, is a longstanding principle of ours in the context
of the Medicare program. Incorporating
this principle and the necessary
protection of this data into this proposal
to disclose information is appropriate.
Regarding other individuals, we
require the names and contact
information of certifying actuaries and
MA plan contacts in the MA bid
submission, that is, in certain fields in
the MA BPT, MSA BPT, and ESRD–SNP
BPT, and we also require the names and
contact information in the actuarial
certifications submitted by actuaries
who prepared the bids. We propose to
exclude this information from the
release that we propose to implement.
The actuarial certification consists of
standardized language that we
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developed for the purpose of bidding;
for example, the language notes that the
actuary is a member of the American
Academy of Actuaries, federal law and
CMS guidance regarding MA bids were
followed, the data and assumptions
used in the development of the bid are
reasonable, and Actuarial Standards of
Practice were applied. (Certifying
actuaries may choose whether to
append additional language.) We do not
believe that these bid certification
paragraphs represent information that
serves the goals for this proposed
release of MA bid pricing data (for
example, to inform research and public
evaluation of the MA program and to be
transparent about spending). In
addition, identifying specific
individuals who have worked on a bid
for an MAO appears an unnecessary
intrusion into the personal privacy of
these individuals. In sum, we propose to
not release any information identifying
individual actuaries or their associated
certification paragraphs, to protect
individual names and to not expend
resources separating names from each of
the hundreds of identical or similar
paragraphs of attestation language.
Finally, at § 422.272(c)(4), we propose
to exclude from release bid review
correspondence between us (including
our contractors) and the MAO, and
internal bid review reports (for example,
bid desk review documentation housed
in the HPMS Bid Desk Review module,
which supports the automated aspects
of bid review). First, bid review
correspondence (emails) often involves
follow-up questions requesting
clarification of supporting
documentation, so our concerns
described above regarding the release of
supporting documentation apply to bid
review correspondence. Second, it
would not be operationally feasible to
determine which set of bid review
emails between our reviewers and
MAOs and which internal bid review
reports pertain to the final accepted/
approved bid for an MA plan, which is
the data we propose to release.
(d) Timing of MA Bid Pricing Data
Release
At § 422.272(d), we propose the
timing of the release of MA bid pricing
data as provided in paragraph (b) and
limited by the exclusions in paragraph
(c). We propose that the annual release
would occur after the first Monday in
October. We selected the first Monday
in October as the date after which the
release could occur each year because
the annual bidding cycle has come to a
close at this point and we have
completed the approval of MA plan bids
for the upcoming contract year (calendar
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year). For example, after the first
Monday in October 2016, the bids for
contract year 2017 have been accepted;
thus, a public release in December 2016
or January 2017 would be a release of
the final accepted MA bid pricing data
for a contract year not more recent than
2012.
Under this example, our December
2016 release of MA bid pricing data
under this proposed rule may include
the following: (1) The accepted MA BPT
worksheets for 2012 in their entirety,
subject to the exceptions § 422.272(c);
(2) the accepted MSA BPT worksheets
for 2012 in their entirety, subject to the
same exceptions; (3) accepted MA BPTs
for 2006 through 2011, subject to the
same exceptions; and (4) MSA BPTs for
2009 through 2011 (as 2009 was the first
year this BPT was used), subject to the
same exceptions, because these years
are more than 5 years prior to 2017.
However, under the example of a
December 2016 release, we would not
release any Part C pricing data for
ESRD–SNPs because the ESRD–SNP
BPT was used for the first time for
contract year 2014; the first time that
data from accepted ESRD–SNP BPTs
could be released under this proposal is
after the first Monday in October 2018.
While we propose to authorize release
of this data after the first Monday in
October each year, we are not
committing to a specific date for each
annual release. We will provide details
on each year’s release schedule through
sub-regulatory communications. We
anticipate that as the release process
becomes more standardized over the
years, we will be able to release these
files closer to the proposed regulatory
timeline. In addition, we intend that the
first time we implement a public release
MA bid submission data, we may
release data for multiple contract years
that meet the criterion of at least 5 years
prior to the upcoming calendar year.
As mentioned in the Background
(section III.E.1), in crafting this proposal
to release MA bid pricing data, we are
seeking to balance proprietary interests
with our mission to effectively
administer federal health care programs
and increase data transparency. We are
soliciting comments on the approach we
are proposing for the public release of
MA bid pricing data based on a 5-year
lag in the data, and whether that is the
appropriate timeframe to apply to this
data release. We also seek comment on
the scope of the proposed release of BPT
worksheets and data elements. We are
particularly interested in whether of the
MA bid pricing data we are proposing
to release contains proprietary
information, and if so, are requesting
detailed explanations of good cause for
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its redaction from public availability
and suggestions for what safeguards
might be implemented to appropriately
protect those portions of the data.
Detailed explanations should contain
specific examples which show how this
information disclosure could cause
substantial competitive harm to MAOs.
Specific examples should (1) cite the
particular information proposed to be
released and explain how that
information differs from publicly
available data; (2) point to the particular
entity or entity type that could gain an
unfair competitive advantage from the
information release; and (3) fully
explain the mechanism by which the
release of that particular information
would create an unfair competitive
advantage for that particular entity.
Similarly, we are interested in
comments that our proposed scope for
release is too narrow and unnecessarily
protects data that is not confidential and
should not be protected. We are
soliciting comments and explanations
that show how the data is not
confidential, could not be used to create
unfair competitive disadvantage, and
that its release would not have a chilling
effect on the nature and scope of the
data that we currently receive from
MAOs in the bid submissions. As noted
above, we view this rulemaking as the
opportunity to solicit wide ranging
comments on this issue in order to chart
the wisest course for release of pricing
data in support of our goals.
4. Proposed Technical Change
We propose to amend § 422.250 on
the basis and scope of the MA program
to add a reference to section 1106 of the
Act. As discussed in the Background
(section E.1.), section 1106(a) of the Act
(42 U.S.C. 1306(a)) provides us the
authority to enact regulations that
would enable the agency to release
information filed with this agency.
5. Other Approaches To Release of MA
Bid Pricing Data
We are also considering whether to
release MA bid pricing data for years
more recent than the 5-year data lag
proposal. In 2011, an academic
researcher submitted a request to CMS
for certain data elements regarding the
2009 MA Base Period Experience in the
2011 MA bid pricing submissions. We
rejected the request under Exemption 4
to the FOIA, 5 U.S.C. 552(b)(4), which
exempts from disclosure trade secrets
and confidential or privileged
commercial or financial information
that is obtained from a person. In a 2013
opinion, Biles v. Dep’t of Health and
Human Services, 931 F. Supp. 2d 211
(D.D.C. 2013), the U.S. District Court for
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the District of Columbia ordered the
release of the requested bid information,
rejecting HHS’s argument that release
would cause substantial competitive
harm to the private companies that
submit bid data to CMS. The court
remarked that the HHS statements about
substantial competitive harm were
conclusory. As a result of this ruling, we
released the requested data to the
academic researcher (and the public) at
https://www.cms.gov/Medicare/HealthPlans/MedicareAdvtgSpecRateStats/
DataRequests.html. In light of this
litigation, as well as anticipated
additional requests for more recent MA
bid pricing data, we are soliciting public
comments on a range of approaches we
could implement to release data more
recent than the proposal we are
currently setting forth for consideration.
For example, we are considering
whether to release MA bid pricing data
on a shorter timeframe than the
proposed 5-year lagged timeframe,
which could be as recent as MA bid
pricing data from the previouslyconcluded MA contract year. We are
also seeking comment as to whether the
relationship between the passage of time
and commercial sensitivity of the bid
data changes more rapidly for some MA
bid pricing data elements than others. If
commenters believe this to be the case,
we are seeking the submission of
detailed analysis that sets forth which
data elements meet this standard and
why.
If unfair competitive harm is included
as a rationale for us to consider in
withholding some or all elements of
more recent MA bid pricing data from
release, either to external researchers
subject to some limitations in
redisclosure of the data or the public at
large, we seek evidence of this
competitive harm linked to particular
bid data elements, and a fulsome
discussion as to how each of the
elements identified could be used by a
competitor to directly harm a competing
MAO. See section III.E.3.d above for
detail on what a fulsome discussion
would include, in our explanation of
‘‘specific examples.’’ If there are
commercially sensitive data elements in
the MA bids, we also seek comment as
to whether there are safeguards that
might be appropriately implemented to
protect those identified data elements,
while still allowing releases of more
recent data.
Finally, we are seeking comment
regarding to whom we should release
more recent MA bid pricing data.
Specifically, should such a release be
made fully available to the public at
large, or only to researchers who have
studies approved through an application
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process and who are subject to our longstanding data sharing procedures. If we
were to release MA bid pricing data for
years more recent than the 5 year lagged
data we propose here, we also seek
comment on whether to use the existing
policies for the release of Part D
prescription drug event (PDE) data at
§ 423.505(m) and Part C encounter data
at § 422.310(f)(2). We also seek comment
on whether research results from the
analysis of MA bid pricing data should
be subject to additional restrictions,
such as a prohibition of publication of
MA bid pricing data at the plan level or
prohibitions on the identification of the
applicable MAO that submitted the
data. We seek comment on whether
external researchers should be able to
use MA bid pricing data for commercial
purposes rather than to produce
research that could be useful to us in
our administration of the Medicare
program generally. We are considering
limiting conditions of this type as
means to release as much data while
protecting what should be protected.
As discussed in section III.E.3.d
above, we are seeking comment on our
proposal that 5 years is an appropriate
length of time for the MA bid pricing
data we are proposing to release to no
longer be competitively sensitive. In
addition, in setting forth this section
III.E.5 discussion, we are also soliciting
comments on how we can best serve the
needs of the public through the sharing
of MA bid pricing data that is less than
5 years old while at the same time
addressing the concerns of MAOs that
we appropriately guard against the
potential misuse of data in ways that
would undermine protections put in
place to ensure nondisclosure of
proprietary data. The purpose of this
solicitation is to both inform our
decision-making process about the 5year threshold proposed above, as well
as to inform future policy development.
6. Background on Part C and Part D
Medical Loss Ratio Data
Section 1103 of Title I, Subpart B of
the Health Care and Education
Reconciliation Act (Pub. L. 111–152)
amends section 1857(e) of the Act to
add medical loss ratio (MLR)
requirements to Medicare Part C. An
MLR is expressed as a percentage,
generally representing the percentage of
revenue used for patient care rather than
for such other items as administrative
expenses or profit. Because section
1860D–12(b)(3)(D) of the Act
incorporates by reference the
requirements of section 1857(e) of the
Act, these MLR requirements also apply
to the Part D program. In the May 23,
2013 final rule (78 FR 31284), we
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codified the MLR requirements for
MAOs and Part D sponsors in the
regulations at part 422, subpart X, and
part 423, subpart X.
For contracts beginning in 2014 or
later, MAOs, cost plans, and Part D
sponsors are required to report their
MLRs and are subject to financial and
other penalties for a failure to meet the
statutory requirement that they have an
MLR of at least 85 percent (see
§ 422.2410 and § 423.2410). The statute
imposes several levels of sanctions for
failure to meet the 85 percent minimum
MLR requirement, including remittance
of funds to CMS, a prohibition on
enrolling new members, and ultimately
contract termination. The minimum
MLR requirement in section 1857(e)(4)
of the Act creates incentives for MAOs
and Part D sponsors to reduce
administrative costs, such as marketing
costs, profits, and other uses of the
funds earned by plan sponsors, and
helps to ensure that taxpayers and
enrolled beneficiaries receive value
from Medicare health plans.
Under the regulations at § 422.2410
and § 422.2460, with respect to MAOs,
and § 423.2410 and § 423.2460, with
respect to Part D sponsors, for each
contract year, each MAO and Part D
sponsor is required to submit a report to
us, in a timeframe and manner that we
specify, which includes the data needed
to calculate and verify the MLR and
remittance amount, if any, for each
contract. The information that MAOs
and Part D sponsors report to us
includes incurred claims for medical
services and prescription drug costs,
expenditures on activities that improve
health care quality, taxes, licensing and
regulatory fees, non-claims costs, and
revenue.
We have developed a standardized
MLR Report template, called the MLR
Report, for MAOs and Part D sponsors
to populate with the data used to
calculate the MLR and remittance
amount owed to us under § 422.2410
and § 423.2410, if any. The MLR Report
is a standardized Excel workbook with
three worksheets and special functions
built in (for example, validation
features). We maintain and update the
MLR Report data collection format
under OMB #0938–1232.
For each contract year beginning in
2014 or later, MAOs and Part D
sponsors are required to enter their MLR
data and upload their MLR Reports to
our Health Plan Management System
(HPMS). Based on the data entered by
the MAO or Part D sponsor, the Report
calculates the MLR for the contract. An
MA or Part D contract’s MLR is
increased by a credibility factor if the
contract’s experience for the contract
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year is partially credible in actuarial
terms, as provided at § 422.2440 and
§ 423.2440. Finally, we also require
MAOs and Part D sponsors to include in
their MLR Reports a detailed
description of the methods used to
allocate expenses, including how each
specific expense meets the criteria for
the expense category to which it was
assigned. The MLR Report is on our
Web site at https://www.cms.gov/
Medicare/Medicare-Advantage/PlanPayment/medicallossratio.html,
accompanied by instructions on how to
populate the Report.
Below we describe the categories of
Part C and Part D MLR data submitted
in the MLR Reports:
• Revenue. MAOs and Part D
sponsors must report revenue received
under the contract. The MLR Report
includes separate lines for MAOs and
Part D sponsors to report the amounts of
revenue received, such as beneficiary
premiums; MA plan payments (based on
A/B bids); MA rebates; Part D direct
subsidies; federal reinsurance subsidies;
Low Income Premium Subsidy
Amounts; risk corridor payments; and
MSA enrollee deposits (see
§ 422.2420(c)(1) and § 423.2420(c)(1)).
• Claims. MAOs and Part D sponsors
must report incurred claims for clinical
services and prescription drug costs,
including categories such as the
following: Direct claims paid to
providers (including under capitation
contracts with physicians) for covered
services; for an MA contract that
includes MA–PD plans, or a Part D
contract, the MLR Report must include
drug costs provided to all enrollees
under the contract; liability and reserves
for claims incurred during the contract
year; paid and accrued medical
incentive pools and bonuses; reserves
for contingent benefits and the medical
or Part D claim portion of lawsuits; MA
rebate amounts that are used to reduce
enrollees’ Part B premiums; total fraud
reduction expenses and total claim
payment recoveries as a result of fraud
reduction efforts; MSA enrollee
deposits; and direct and indirect
remuneration (see § 422.2420(b) and
§ 423.2420(b)).
• Federal and State Taxes and
Licensing or Regulatory Fees. The MLR
Report includes MAOs and Part D
sponsors’ outlays for taxes and fees,
such as federal income taxes and other
federal taxes; state income, excise,
business, and other taxes; state premium
taxes; allowable community benefit
expenditures; and licensing and
regulatory fees (see § 422.2420(c)(2) and
§ 423.2420(c)(2)).
• Health Care Quality Improvement
Expenses Incurred. MAOs and Part D
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sponsors must enter their expenditures
for health care quality improvement.
Expenditures are categorized separately
depending on the primary purpose of
the activity. Quality improvement
expenses are reported in categories such
as: (1) Expenses for improving health
outcomes through the implementation
of activities such as quality reporting,
effective case management, care
coordination, chronic disease
management, and medication and care
compliance initiatives; (2) expenses for
implementing activities to prevent
hospital readmissions; (3) expenses for
activities primarily designed to improve
patient safety, reduce medical errors,
and lower infection and mortality rates;
(4) expenses for activities primarily
designed to implement, promote, and
increase wellness and health activities;
(5) expenditures to enhance the use of
health care data to improve quality,
transparency, and outcomes and
support meaningful use of health
information technology; or (6) allowable
ICD–10 implementation costs (see
§ 422.2430(a)(1) and § 423.2430(a)(1)).
• Non-Claims Costs. MAOs and Part
D sponsors must report expenditures for
non-claims costs, such as administrative
fees, direct sales salaries and benefits,
brokerage fees and commissions,
regulatory fines and penalties, cost
containment expenses not included as
quality improvement expenses, all other
claims adjustment expenses, nonallowable community benefit
expenditures, and non-allowable ICD–
10 implementation costs (see
§ 422.2430(b) and § 423.2430(b)).
• Employer Group Waiver Plan
(EGWP) Reporting Methodology. We
only apply the MLR requirement to the
Medicare-funded portion of EGWPs.
MLR Reports submitted for MA or Part
D contracts that include EGWPs must
specify the percentage of the contract’s
total revenue that was funded by
Medicare. The MLR Report must also
identify the methodology that the MAO
or Part D sponsor used to determine the
Medicare-funded portion of the EGWP
(see § 422.2420 and § 423.2420).
• Total Member Months. MAOs and
Part D sponsors must report all member
months across all plans under the
contract (see § 422.2440 and
§ 423.2440).
• Plan-Specific Data. MAOs and Part
D sponsors enter a list of all of the plans
offered under the contract, and the
member months associated with each
plan entered. They must provide
additional details about each plan that
is listed, including whether the plan is
a Special Needs Plan for beneficiaries
who are dually eligible for both
Medicare and Medicaid (D–SNP);
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whether the plan’s defined service area
includes counties in one of the
territories; and plan-level cost and
revenue information for D–SNPs in
territories (see § 422.2420(a) and
§ 423.2420(a)).
• Medical Loss Ratio Numerator. This
is a calculated field that is the sum of
all amounts reported as claims or as
health care quality improvement
expenses in the MLR Report (see
§ 422.2420(b) and § 423.2420(b)).
• Medical Loss Ratio Denominator.
This field is calculated by taking the
contract’s total revenue and deducting
the sum of the reported licensing or
regulatory fees, federal and state taxes,
and allowable community benefit
expenditures (see § 422.2420(c) and
§ 423.2420(c)).
• Credibility Adjustment. An MAO or
Part D sponsor may add a credibility
adjustment to a contract’s MLR if the
contract’s experience is partially
credible, as determined by us (see
§ 422.2440(d) and § 423.2440(d)). If a
contract receives a credibility
adjustment (determined by the number
of total member months under the
contract), this field is populated by a
percentage that represents the
credibility adjustment factor (see
§ 422.2440(a) and § 423.2440(a)).
• Unadjusted MLR. This is a
calculated field that reflects the MLR for
an MA or Part D contract before
application of the credibility adjustment
(see § 422.2440 and § 423.2440).
• Adjusted MLR. This is a calculated
field that represents the MLR after the
application of the credibility adjustment
factor (see § 422.2440(a) and
§ 423.2440(a)).
• Remittance Amount Due to CMS for
the Contract Year. The MLR Report
includes any amounts that the MAO or
Part D sponsor must remit to us. The
MLR Report identifies the amount of the
remittance that is allocated to Parts A
and B, and the amount allocated to Part
D (see § 422.2410(c) and § 423.2410(c)).
7. Proposed Regulatory Changes for
Release of MLR Data
a. Proposed Addition of § 422.2490 and
§ 423.2490 Authorizing Release of Part C
and Part D Medical Loss Ratio Data
We are proposing to add new contract
requirements, codified in new
regulations at §§ 422.504 and 422.2490
of part 422, with respect to Part C MLR
data, and §§ 423.505 and 423.2490 of
part 423, with respect to Part D MLR
data, to authorize release to the public
by CMS of certain MLR data submitted
by MAOs and Part D sponsors. We
propose to define Part C MLR data at
§ 422.2490(a), and Part D MLR data at
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§ 423.2490(a), as the data the MAOs and
Part D sponsors submit to us in their
annual MLR Reports, as required under
existing § 422.2460 and § 423.2460. At
§ 422.2490(b) and § 423.2490(b), we
propose certain exclusions to the
definitions of Part C MLR data and Part
D MLR data, respectively. Finally, we
propose at § 422.2490(c) and
§ 423.2490(c) to release the Part C MLR
data and Part D MLR data, respectively,
for each contract for each contract year,
no earlier than 18 months after the end
of the applicable contract year.
Generally, the MLR for each MA and
Part D contract reflects the ratio of costs
(numerator) to revenues (denominator)
for all enrollees under the contract. For
an MA contract, the MLR reflects the
percentage of revenue received under
the contract spent on incurred claims
for all enrollees, prescription drug costs
for those enrollees in MA plans under
the contract offering the Part D benefit,
quality initiatives that meet the
requirements at § 422.2430, and
amounts spent to reduce Part B
premiums. The MLR for a Part D
contract reflects the percentage of
revenue received under the contract
spent on incurred claims for all
enrollees for Part D prescription drugs,
and on quality initiatives that meet the
requirements at § 423.2430. The
percentage of revenue that is used for
other items such as administration,
marketing, and profit is excluded from
the numerator of the MLR (see
§ 422.2401 and § 423.2401;
§ 422.2420(b)(4) and § 423.2420(b)(4);
§ 422.2430(b) and § 423.2430(b)).
As discussed in section III.F.1. of this
proposed rule, our proposed release of
Part C and Part D MLR data is in
keeping with Presidential initiatives to
improve federal management of
information resources by increasing data
transparency and access to federal
datasets. In proposing this release, we
are also seeking to align with current
disclosures of MLR data that issuers of
commercial health plans submit each
year as required by section 2718 of the
Public Health Service Act. We have
published similar commercial MLR data
on our Web site at https://www.cms.gov/
CCIIO/Resources/Data-Resources/
mlr.html.
The MLR data that we propose to
release will enable enrollees,
consumers, regulators, and others to see
how much of plan sponsors’ revenue is
used to pay for services, quality
improving activities, and Part B
premium rebates versus how much is
used to pay for ‘‘non-claims,’’ or
administrative expenses, incurred by
the plan sponsor. We believe that the
release of this data will facilitate public
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evaluation of the MA and Part D
programs by providing insight into the
efficiency of health insurers’ operations.
In addition, we believe that our
proposed policy for the release of
certain MLR data will provide
beneficiaries with information that can
be used to assess the relative value of
Medicare health and drug plans.
b. Exclusions From the Release of Part
C and Part D MLR Data
For the purpose of this data release
under proposed § 422.2490 and
§ 423.2490, we would exclude four
categories of information from the
release of Part C and Part D MLR data,
as described at proposed § 422.2490(b)
and § 423.2490(b), respectively. First, at
§ 422.2490(b)(1) and § 423.2490(b)(1),
we propose to exclude from release any
narrative information that MAOs and
Part D sponsors submit to support the
amounts that they include in their MLR
Reports, such as descriptions of the
methods used to allocate expenses.
MAOs and Part D sponsors are required
to describe the methods they used to
allocate expenses, including incurred
claims, quality improvement expenses,
federal and state taxes and licensing or
regulatory fees, and other non-claims
costs. A detailed description of each
expense element should be provided,
including how each specific expense
meets the criteria for the type of expense
in which it is categorized. We believe
that descriptions of expense allocation
methods should be excluded because
MAOs and Part D sponsors may be
required to provide information that is
pertinent to more than the individual
MA or Part D contract for which the
MLR Report is being submitted (see, for
example, § 422.2420(d)(1)(ii) and
§ 423.2420(d)(1)(ii), which requires that
expenditures that benefit multiple
contracts, or contracts other than those
being reported, be reported on a pro rata
share), such as an MAO’s or Part D
sponsor’s proprietary approach to
setting payment rates in contracts with
providers, or its strategies for investing
in activities that improve health quality.
We are concerned that MAOs and Part
D sponsors would be reluctant to submit
narrative descriptions that include
information that they regard as
proprietary if they know that it will be
disclosed to the public, which could
impair our ability to assess the accuracy
of their allocation methods.
Second, at § 422.2490(b)(2) and
§ 423.2490(b)(2), we propose to exclude
from release any plan-level information
that MAOs and Part D sponsors submit
in their MLR Reports. Some of the planlevel data in MAO’s and Part D
sponsors’ MLR Reports is also included
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in their plan bids as base period
experience data, such as plan IDs, plan
member months, and Medicaid per
member per month gain/loss. As
discussed in our proposal to release
certain MA bid pricing data, we believe
bid data would no longer be
competitively sensitive after 5 years;
however, we do not believe that bid data
becomes no longer competitively
sensitive within the 18-month
timeframe for our proposed release of
MLR data. Therefore, we will exclude
from our proposed release plan-level
data that is included as base period
experience data in plan bids. We also
propose to exclude the plan-level
information submitted in MLR Reports
because we do not regard it as relevant
to the purposes of our proposed release
of Part C and Part D MLR data, which
include giving the public access to data
that can be used to evaluate the
efficiency of MAOs and Part D sponsors
and providing enrollees with
information that can be used to compare
the relative value of health plans. For
example, our proposed release would
exclude MAOs’ and Part D sponsors’
responses to questions in the MLR
Report that ask whether each plan under
a contract is a Special Needs Plan for
beneficiaries who are dually eligible for
both Medicare and Medicaid (D–SNP),
or whether the plan’s defined service
area includes counties in one of the
territories.
Third, at § 422.2490(b)(3) and
§ 423.2490(b)(3), we propose to exclude
from release any information identifying
Medicare beneficiaries or other
individuals. This exclusion is proposed
for the same reason we propose to
exclude similar information from MA
bid submission data that will be
released; we believe that it is important
to protect the privacy of individuals
identified in these submissions,
particularly Medicare beneficiaries.
Protection of information that could
identify Medicare beneficiaries,
particularly in the context of their
receipt of health care services, is a longstanding principle of ours in the context
of the Medicare program. Incorporating
this principle and the necessary
protection of this data into this proposal
to disclose information is appropriate.
With respect to Medicare beneficiaries,
we propose to exclude from release any
information (that is, data elements) in
an MLR Report for a contract if the total
number of beneficiaries under the
contract is fewer than 11, as we believe
that this threshold establishes the point
at which individual-level data can be
discerned. Following our longstanding
data release policy for protecting
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individually identifiable information, if
a data field in the MLR Report for an
MA or Part D contract is calculated
based on figures associated with fewer
than 11 enrollees (or 132 member
months, assuming each individual is
counted for 12 months), we would
suppress all the data from such fields in
the public release file for that contract.
We are not proposing to build this
threshold into the regulation text,
however, as we believe that as
technology changes and the ability to
reverse-engineer data to identify
beneficiaries may change over time. We
may revisit this threshold as we
administer the data releases proposed
here (and in other Medicare contexts)
and will make adjustments as necessary
to ensure that we do not disclose data
that could be used to identify
beneficiaries.
Regarding other individuals, we
require that MAOs and Part D sponsors
provide in their MLR Reports the names
and contact information of individuals
who can answer questions about the
data submitted in an MLR Report. We
propose to exclude this information
from release. We do not believe that the
release of this information serves the
purposes of our proposed release of
certain MLR data, which are to provide
the public with data that can be used to
evaluate MA and Part D contracts’
efficiency, and to provide beneficiaries
with information that can be used to
compare the relative value of Medicare
plans. Further, release of this
identifying and contact information
appears to be an unnecessary intrusion
into information about private
individuals.
Fourth, at § 422.2490(b)(4) and
§ 423.2490(b)(4), we propose to exclude
from release any MLR review
correspondence. In the course of the
MLR review process, our reviewers may
engage in correspondence with MAOs
and Part D sponsors in order to validate
amounts included in their MLR Reports.
Such correspondence may include
requests for evidence of amounts
reported to us. Responses to these
requests could include competitivelysensitive information, such as MAOs’
and Part D sponsors’ negotiated rates of
reimbursement. Release of this
correspondence could cause MAOs to
be less forthcoming in the information
provided to CMS, which would impede
the ability of the agency to verify the
information submitted by MAOs and
Part D sponsors.
c. Timing of Release of Part C and Part
D MLR Data
We are proposing to release the MLR
data specified in this rule for each MA
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and Part D contract on an annual basis
no earlier than 18 months after the end
of the contract year to which the MLR
data applies. We are proposing to follow
the commercial MLR approach in
making the data we receive in MLR
Reports available to the public. For Part
C and Part D MLR reporting, the data is
due about 12 months after the end of the
contract year. After we receive MAOs’
and Part D sponsors’ MLR Reports, we
anticipate that it will take up to six
months for us to review and finalize the
data submitted by MAOs and Part D
sponsors.
We believe that our proposed release
of contract-level MLR data strikes the
appropriate balance between
safeguarding information that could be
commercially sensitive or proprietary
and providing enrollees of health plans,
consumers, regulators, and others with
a measure that can be used to evaluate
health insurers’ efficiency. The Part C
MLR data and Part D MLR data that we
propose to release is aggregated at the
contract level. Costs in the MLR
numerator are aggregated across
providers, beneficiaries, and sites of
service. Costs and revenues are further
aggregated across all plans under the
contract. We do not believe that there is
a realistic possibility that the MLR data
that we propose to release could be
disaggregated or reverse engineered to
reveal commercially sensitive or
proprietary information. We seek
comment on this point and on our
analysis of the commercial sensitivity of
this information.
We believe the availability of the Part
C MLR data and Part D MLR data we are
proposing to release will provide
beneficiaries a measure by which they
can compare the relative value of
Medicare products. Our proposed
release of MLR data will permit
enrollees of health plans, consumers,
regulators, and others to take into
consideration MLRs when evaluating
health insurers’ efficiency.
We also believe the availability of
MLR data will enhance the competitive
nature of the MA and Part D programs.
The proposed access to data will
support potential plan sponsors in
evaluating their participation in the Part
C and D programs and will facilitate the
entry into new markets of existing plan
sponsors. In knowing historical MLR
data, new business partners might
emerge, and better business decisions
might be made by existing partners. As
a result, we believe that releasing Part
C and Part D MLR data as proposed is
both necessary and appropriate for the
effective operation of these programs.
We seek comment on the release of
Part C MLR data and Part D MLR data
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as outlined above. We solicit comment
on whether the Part C MLR data and
Part D MLR data we propose to release
contain proprietary information, and if
so, what safeguards might be
appropriate to protect those data, such
as recommended fields to be redacted,
the minimum length of time that such
data remains commercially sensitive,
and any suggestions for publishing
aggregations of Part C MLR data and
Part D MLR data in lieu of publishing
the MLR data as submitted by MAOs
and Part D sponsors. We invite
commenters to provide analysis and
explanations to support comments that
information should be protected for a
longer—or shorter—period of time so
that we may properly evaluate our
proposal in adopting a final rule.
Analysis and explanations should (1)
cite the particular information proposed
to be released and explain how that
information differs from publicly
available data; (2) point to the particular
entity or entity type that could gain an
unfair competitive advantage from the
information release; and (3) fully
explain the mechanism by which the
release of that particular information
would create an unfair competitive
advantage for that particular entity.
We also solicit comment on whether
MLR data that is associated single-plan
contracts is more commercially
sensitive than MLR data that is
associated with contracts that include
multiple plans, and if so, whether we
should take any protective measures
when releasing the MLR data for singleplan contracts, such as redacting data
fields that could be used to identify the
contract, withholding the MLR data for
all single-plan contracts and instead
publishing a data set consisting of
figures that have been averaged across
all single-plan contracts, or by releasing
a more limited data set for single-plan
contracts.
8. Proposed Technical Changes
We are proposing to amend
§ 422.2400, which identifies the basis
and scope of the MLR regulations for
MAOs, and § 423.2400, which identifies
the basis and scope of the MLR
regulations for Part D sponsors, to add
a reference to section 1106 of the Act,
which governs the release of
information gathered in the course of
administering our programs under the
Act.
F. Prohibition on Billing Qualified
Medicare Beneficiary Individuals for
Medicare Cost-Sharing
We remind all Medicare providers
(including providers of services defined
in section 1861 of the Act and
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physicians) that federal law prohibits
them from collecting Medicare Part A
and Medicare Part B deductibles,
coinsurance, or copayments, from
beneficiaries enrolled in the Qualified
Medicare Beneficiaries (QMB) program
(a Medicaid program which helps
certain low-income individuals with
Medicare cost-sharing liability). In July
2015, we released a study finding that
confusion and inappropriate balance
billing persist notwithstanding laws
prohibiting Medicare cost-sharing
charges for QMB individuals, Access to
Care Issues Among Qualified Medicare
Beneficiaries (QMB) (‘‘Access to Care’’)
https://www.cms.gov/MedicareMedicaid-Coordination/Medicare-andMedicaid-Coordination/MedicareMedicaid-Coordination-Office/
Downloads/Access_to_Care_Issues_
Among_Qualified_Medicare_
Beneficiaries.pdf.
These findings underscore the need to
re-educate providers about proper
billing practices for QMB enrollees.
In 2013, approximately 7 million
Medicare beneficiaries were enrolled in
the QMB program. State Medicaid
programs are liable to pay Medicare
providers who serve QMB individuals
for the Medicare cost-sharing. However,
as permitted by federal law, states can
limit provider payment for Medicare
cost-sharing to the lesser of the
Medicare cost-sharing amount, or the
difference between the Medicare
payment and the Medicaid rate for the
service. Regardless, Medicare providers
must accept the Medicare payment and
Medicaid payment (if any, and
including any permissible Medicaid
cost sharing from the beneficiary) as
payment in full for services rendered to
a QMB individual. Medicare providers
who violate these billing prohibitions
are violating their Medicare Provider
Agreement and may be subject to
sanctions. (See sections 1902(n)(3);
1905(p); 1866(a)(1)(A); 1848(g)(3) of the
Act.)
Providers should take steps to educate
themselves and their staff about QMB
billing prohibitions and to exempt QMB
individuals from impermissible
Medicare cost-sharing billing and
related collection efforts. For more
information about these requirements,
steps to identify QMB patients and ways
to promote compliance, see https://
www.cms.gov/Outreach-and-Education/
Medicare-Learning-Network-MLN/
MLNMattersArticles/downloads/
se1128.pdf.
Given that original Medicare
providers may also serve Medicare
Advantage enrollees, we note that the
CY 2017 Medicare Advantage Call Letter
reiterates the billing prohibitions
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applicable to dual eligible beneficiaries
(including QMBs) enrolled in Medicare
Advantage plans and the responsibility
of plans to adopt certain measures to
protect dual eligible beneficiaries from
unauthorized charges under
§ 422.504(g). (See pages 181–183 at
https://www.cms.gov/Medicare/HealthPlans/MedicareAdvtgSpecRateStats/
Downloads/Announcement2017.pdf).
G. Recoupment or Offset of Payments to
Providers Sharing the Same Taxpayer
Identification Number
1. Overview and Background
Medicare payments to providers and
suppliers may be offset or recouped, in
whole or in part, by a Medicare
contractor if the Medicare contractor or
CMS has determined that a provider or
supplier has been overpaid. Historically,
we have used the Medicare provider
billing number or National Provider
Identifier (NPI) to recoup overpayments
from Medicare providers and suppliers
until these debts were paid in full or
eligible for referral to the Department of
Treasury (Treasury) for further
collection action under the Debt
Collection Improvement Act of 1996
and the Digital Accountability and
Transparency Act of 2014. Once an
overpayment is referred to Treasury, the
Treasury’s Debt Management Services
uses various tools to collect the debt,
including offset of federal payments
against entities that share the same
provider Taxpayer Identification
Number (TIN). Hence, Treasury has the
ability to collect our overpayments
using the provider TIN and we pay a fee
for every collection made.
On March 23, 2010, the Affordable
Care Act (ACA) was enacted. Section
6401(a)(6) of the Affordable Care Act
established a new section 1866(j)(6) of
the Act. Section 1866j(6) of the Act
allows the Secretary to make any
necessary adjustments to the payments
to an applicable provider of services or
supplier to satisfy any amount due from
an obligated provider of services or
supplier. The statute defines an
applicable provider of services or
supplier (applicable provider) as a
provider of services or supplier that has
the same taxpayer identification number
as the one assigned to the obligated
provider of services or supplier. The
statute defines the obligated provider of
services or supplier (obligated provider)
as a provider of services or supplier that
owes a past-due overpayment to the
Medicare program. For purposes of this
provision, the applicable and obligated
providers must share a TIN, but may
possess a different billing number or
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National Provider Identifier (NPI)
number than one another.
For example, a health care system
may own a number of hospital providers
and these providers may share the same
TIN while having different NPI or
Medicare billing numbers. If one of the
hospitals in this system receives a
demand letter for a Medicare
overpayment, then that hospital
(Hospital A) will be considered the
obligated provider while its sister
hospitals (Hospitals B and C) will be
considered the applicable providers.
This authority allows us to recoup the
overpayment of the obligated provider,
Hospital A, against any or all of the
applicable providers, Hospitals B and C,
with which it, Hospital A, shares a TIN.
2. Provisions of the Proposed
Regulations
If CMS or a Medicare contractor has
decided to put into effect an offset or
recoupment, then § 405.373(a) requires
the Medicare contractor to notify the
provider or supplier in writing of its
intention to fully or partially offset or
recoup payment and the reasons for the
offset or recoupment. Currently, the
written demand letter sent by the
Medicare contractor to a provider or
supplier serves as notification of the
overpayment and intention to recoup or
offset if the obligated provider, Hospital
A, fails to repay the overpayment in a
timely manner.
With the passage of section 1866(j)(6)
of the Act, the requirements in
§ 405.373(a) could be interpreted to
require the Medicare contractor to
provide notification to both the
obligated provider, Hospital A, and the
applicable provider, Hospital B, of its
intention to recoup or offset payment.
Because we don’t think it is necessary
to provide separate notice to both the
obligated provider and the applicable
provider, we propose to amend the
notice requirement in § 405.373.
Specifically, we propose to create a new
paragraph (f) in § 405.373 to state that
§ 405.373(a) does not apply in instances
where the Medicare Administrative
Contractor intends to offset or recoup
payments to the applicable provider of
services or supplier to satisfy an amount
due from an obligated provider of
services or supplier when the applicable
and obligated provider of services or
supplier share the same Taxpayer
Identification Number.
Before the effective date of this rule,
we intend to notify all potentially
affected Medicare providers of the
implementation of section 1866j(6) of
the Act through Medicare Learning
Network (MLN) or MLN Connects
Provider eNews article(s), an update to
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the current Internet Only Manual
instructions including, the Medicare
Financial Management Manual, and the
addition of clarifying language in the
demand letters issued to obligated
providers. We believe these actions
would provide adequate notice to
providers and suppliers sharing a TIN,
if they choose, provide the opportunity
to implement a tracking system of
Medicare overpayments on the
corporate level for the affected
providers. We also believe these actions
are sufficient because of Treasury’s
analogous practice of offsetting using a
TIN without furnishing notice to all
potentially affected providers and
suppliers. It has been a long standing
practice for Treasury to offset federal
payments using the TIN and Treasury
currently does not issue a notice of
intent to recoup or offset to applicable
providers and suppliers when Treasury
recoups CMS overpayments.
Additionally, in our review of
§ 405.373(a) and (b), we propose to
replace the terms intermediary and
carrier with the term Medicare
Administrative Contractor as
intermediaries and carriers no longer
exist.
H. Accountable Care Organization
(ACO) Participants Who Report
Physician Quality Reporting System
(PQRS) Quality Measures Separately
The Affordable Care Act gives the
Secretary authority to incorporate
reporting requirements and incentive
payments from certain Medicare
programs into the Shared Savings
Program, and to use alternative criteria
to determine if payments are warranted.
Specifically, section 1899(b)(3)(D) of the
Act affords the Secretary discretion to
incorporate reporting requirements and
incentive payments related to the
physician quality reporting initiative
(PQRI), under section 1848 of the Act,
including such requirements and such
payments related to electronic
prescribing, electronic health records,
and other similar initiatives under
section 1848, and permits the Secretary
to use alternative criteria than would
otherwise apply (under section 1848 of
the Act) for determining whether to
make such payments.
Current Shared Savings Program
regulations at § 425.504(c) do not allow
eligible professionals (EPs) billing
through the Taxpayer Identification
Number (TIN) of an Accountable Care
Organization (ACO) participant to
participate in PQRS outside of the
Shared Savings Program, and these EPs
and the ACO participants through
which they bill may not independently
report for purposes of the PQRS apart
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from the ACO. This policy was designed
to ease reporting burden for individual
EPs and group practices and promote
integration of providers and suppliers
within the ACO in order to help achieve
the Shared Savings Program goals of
improving quality and coordination of
care. While over 98 percent of ACOs
satisfactorily report their quality data
annually, if an ACO fails to satisfy the
PQRS reporting requirements, the
individual EPs and group practices
participating in that ACO will receive
the PQRS payment adjustment along
with the automatic VM downward
payment adjustment.
We are proposing to amend the
regulation at § 425.504 to permit EPs
that bill under the TIN of an ACO
participant to report separately for
purposes of the 2018 PQRS payment
adjustment when the ACO fails to report
on behalf of the EPs who bill under the
TIN of an ACO participant. Specifically,
we are proposing to remove the
requirement at § 425.504(c)(2) so that,
for purposes of the reporting period for
the 2018 PQRS payment adjustment
(that is, January 1, 2016, through
December 31, 2016), EPs who bill under
the TIN of an ACO participant have the
option of reporting separately as
individual EPs or group practices. If the
ACO fails to satisfactorily report on
behalf of such EPs or group practices,
we are proposing to consider this
separately reported data for purposes of
determining whether the EPs or group
practices are subject to the 2018 PQRS
payment adjustment. We are also
proposing to amend § 425.504(c)(2) to
apply only for purposes of the 2016
payment adjustment. We propose at
§ 425.504(d) the revised requirements
for the 2017 and 2018 PQRS payment
adjustment under the Shared Savings
Program. We discuss the proposed
changes for the 2017 PQRS payment
adjustment under the Shared Savings
Program in more detail later in this
section.
We note that the registration deadline
for participating in the PQRS Group
Practice Reporting Option (GPRO) is
June 30 of the applicable reporting
period. Since affected EPs are not able
to register for the PQRS GPRO by the
applicable deadline for the 2018 PQRS
payment adjustment, we propose that
such EPs would not need to register for
the PQRS GPRO for the 2018 PQRS
payment adjustment, but rather mark
the data as group data in their
submission. Thus, we are proposing to
eliminate a registration process for
groups submitting data using third party
entities. When groups submit data
utilizing third party entities, such as a
qualified registry, QCDR, direct EHR
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product, or EHR data submission
vendor, we are able to obtain group
information from the third party entity
and discern whether the data submitted
represents group submission or
individual submission once the data is
submitted. In addition, we propose that
an affected EP may utilize the secondary
reporting period either as an individual
EP using one of the registry, qualified
clinical data registry (QCDR), direct
Electronic Health Record (EHR) product,
or EHR data submission vendor
reporting options or as a group practice
using one of the registry, QCDR, direct
EHR product, or EHR data submission
vendor reporting options. We note that
this would exclude, for individual EPs,
the claims reporting option and, for
group practices, the Web Interface and
certified survey vendor reporting
options.
Furthermore, we recognize that
certain EPs are similarly situated with
regard to the 2017 PQRS payment
adjustment, which will be applied
beginning on January 1, 2017. We
believe it is appropriate and consistent
with our stated policy goals to afford
these EPs the benefit of this proposed
policy change. Accordingly, as noted
above,we are proposing to permit EPs
that bill through the TIN of an ACO
participant to report separately for
purposes of the 2017 PQRS payment
adjustment if the ACO failed to report
on behalf of the EPs who bill under the
TIN of an ACO participant. Specifically,
we are proposing to remove the
requirements at § 425.504(c)(2) so that,
for purposes of the reporting period for
the 2017 PQRS payment adjustment,
EPs who bill under the TIN of an ACO
participant have the option of reporting
separately as individual EPs or group
practices. As noted above, we are
proposing to amend § 425.504(c)(2) to
apply only for purposes of the 2016
payment adjustment. We propose at
§ 425.504(d) the revised requirements
for the 2017 and 2018 PQRS payment
adjustment under the Shared Savings
Program.
The previously established reporting
period for the 2017 PQRS payment
adjustment is January 1, 2015, through
December 31, 2015. To allow affected
EPs that participate in an ACO to report
separately for purposes of the 2017
PQRS payment adjustment, we are
proposing at § 414.90(j)(1)(ii) to
establish a secondary PQRS reporting
period for the 2017 PQRS payment
adjustment for individual EPs or group
practices who bill under the TIN of an
ACO participant if the ACO failed to
report on behalf of such individual EPs
or group practices during the previously
established reporting period for the
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2017 PQRS payment adjustment. This
option is limited to EPs that bill through
the TIN of an ACO participant in an
ACO that failed to satisfactorily report
on behalf of its EPs and would not be
available to EPs that failed to report for
purposes of PQRS outside the Shared
Savings Program.
In addition, we propose that these
affected EPs may utilize the secondary
reporting period either as an individual
EP using the registry, QCDR, direct EHR
product, or EHR data submission vendor
reporting options or as a group practice
using one of the registry, QCDR, direct
EHR product, or EHR data submission
vendor reporting options. We note that
this would exclude, for individual EPs,
the claims reporting option and, for
group practices, the Web Interface and
certified survey vendor reporting
options.
We note that the registration deadline
for the participating in the PQRS GPRO
is June 30 of the applicable reporting
period. Since the applicable deadline
for the 2017 PQRS payment adjustment
has passed, we propose that such EPs
would not need to register for the PQRS
GPRO for the 2017 PQRS payment
adjustment, but rather would be able to
report as a group practice via the
registry, QCDR, direct EHR product, or
EHR data submission vendor reporting
options. Therefore, we propose at
§ 414.90(j)(4)(v) that sections
§ 414.90(j)(8)(ii), (iii), and (iv) would
apply to affected EPs reporting as
individuals using this secondary
reporting period for the 2017 PQRS
payment adjustment. In addition, we
propose at § 414.90(j)(7)(viii) that
sections § 414.90(j)(9)(ii), (iii), and (iv)
would apply to affected EPs reporting as
group practices using this secondary
reporting period for the 2017 PQRS
payment adjustment. Further, we
propose at § 414.90(k)(4)(ii) that
§ 414.90(k)(5) would apply to affected
EPs reporting as individuals or group
practices using this secondary reporting
period for the 2017 PQRS payment
adjustment.
We are also proposing that the
secondary reporting period for the 2017
PQRS payment adjustment would
coincide with the reporting period for
the 2018 PQRS payment adjustment
(that is, January 1, 2016 through
December 31, 2016). In addition, for
operational reasons and to minimize
any additional burden on affected EPs
(who are already required to report for
CY 2016 for purposes of the 2018 PQRS
payment adjustment), we propose to
assess the individual EP or group
practice’s 2016 data using the applicable
satisfactory reporting requirements for
the 2018 PQRS payment adjustment
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(including, but not limited to, the
applicable PQRS measure set). We
invite comment on any 2018
requirements that may need to be
modified when applied for purposes of
the 2017 PQRS payment adjustment,
As a result, individual EP or group
practice 2016 data could be used with
respect to the secondary reporting
period for the 2017 payment adjustment
or for the 2018 payment adjustment or
for both payment adjustments if the
ACO in which the affected EPs
participate failed to report for purposes
of the applicable payment adjustment.
We believe this change to our program
rules is necessary for affected individual
EPs and group practices to be able to
take advantage of the additional
flexibility proposed at section III.K.1.e.
for the Shared Savings Program. If an
affected individual EP or group practice
decides to use the secondary reporting
period for the 2017 payment
adjustment, it is important to note that
this EP or group practice should expect
to receive a PQRS payment adjustment
for services furnished in 2017 until CMS
is able to determine that the EP or group
practice satisfactorily reported for
purposes of the 2017 PQRS payment
adjustment. First, we would need to
process the data submitted for 2016.
Second, we would need to determine
whether or not the individual EP or
group practice met the applicable
satisfactory reporting requirements for
the 2018 PQRS payment adjustment.
Third, we would need to update the
individual EP or group practice’s status
so that the EP or group practice stops
receiving a negative payment
adjustment on claims for services
furnished in 2017 and reprocess all
claims that were previously paid. In
addition, as discussed further in section
III.L. of this proposed rule, the EP or
group practice would also avoid the
automatic downward VM adjustment,
but would not qualify for an upward
adjustment since the ACO failed to
report.
Since EPs and group practices taking
advantage of this secondary reporting
period for the 2017 PQRS payment
adjustment will have missed the
deadline for submitting an informal
review request for the 2017 PQRS
payment adjustment, we propose the
informal review submission periods for
these EPs or group practices would
occur during the 60 days following the
release of the PQRS feedback reports for
the 2018 PQRS payment adjustment.
We request comments on these
proposals.
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46409
I. Medicare Advantage Provider
Enrollment
1. Background
a. General Overview
The Medicare program is the primary
payer of health care for approximately
54 million beneficiaries and enrollees.
Section 1802(a) of the Act permits
beneficiaries to obtain health services
from any individual or organization
qualified to participate in the Medicare
program. Providers and suppliers
furnishing items or services must
comply with all applicable Medicare
requirements stipulated in the Act and
codified in the regulations. These
requirements are meant to promote
quality care while protecting the
integrity of the program. As a major
component of our fraud prevention
activities, we have increased our efforts
to prevent unqualified individuals or
organizations from enrolling in
Medicare.
The term ‘‘provider of services’’ is
defined in section 1861 of the Act as a
hospital, a critical access hospital
(CAH), a skilled nursing facility (SNF),
a comprehensive outpatient
rehabilitation facility (CORF), a home
health agency (HHA), or a hospice. The
term ‘‘supplier’’ is defined in section
1861(d) of the Act as, unless context
otherwise requires, a physician or other
practitioner, facility or other entity
(other than a provider of services) that
furnishes items or services under title
XVIII of the Act. Other supplier
categories may include, for example,
physicians, nurse practitioners, and
physical therapists.
Providers and suppliers that fit into
these statutorily defined categories may
enroll in Medicare if they meet the
proper screening and enrollment
requirements. This proposed rule would
require MA organization providers and
suppliers to be enrolled in Medicare in
an approved status. We generally refer
to an ‘‘approved status’’ as a status
whereby a provider or supplier is
enrolled in, and is not revoked from, the
Medicare program. For example, a
provider or supplier that has submitted
an application, but has not completed
the enrollment process with their
respective Medicare Administrative
Contractor (MAC), is not enrolled in an
approved status. The submission of an
enrollment application does not deem a
provider or supplier enrolled in an
approved status. A provider or supplier
that is currently revoked from Medicare
is not in an approved status. Out-of
network or non-contract providers and
suppliers are not required to enroll in
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b. Background
To receive payment for a furnished
Medicare Part A or Part B service or
item, or to order, certify, or prescribe
certain Medicare services, items, and
drugs, a provider or supplier must
enroll in Medicare. The enrollment
process requires the provider or
supplier to complete, sign, and submit
to its assigned Medicare contractor the
appropriate Form CMS–855 enrollment
application. The CMS–855 application
form captures information about the
provider or supplier that is needed for
CMS or its contractors to screen the
provider or supplier and determine
whether the provider or supplier meets
all Medicare requirements. This
screening prior to enrollment helps to
ensure that unqualified individuals and
entities do not bill Medicare and that
the Medicare Trust Funds are
accordingly protected. Data collected
and verified during the enrollment
process generally includes, but is not
limited to: (1) Basic identifying
information (for example, legal business
name, tax identification number); (2)
state licensure information; (3) practice
locations; and (4) information regarding
ownership and management control.
We strive to further strengthen its
provider and supplier enrollment
process to prevent and deter
problematic providers and suppliers
from entering the Medicare program.
This includes, but is not limited to,
enhancing its program integrity
monitoring systems and revising its
provider and supplier enrollment
regulations in 42 CFR 424, subpart P,
and elsewhere as needed. With
authority granted by the Act, including
provisions in the Affordable Care Act
and Medicare Access and CHIP
Reauthorization Act, we have revised
our provider and supplier enrollment
regulations by issuing the following:
• In the February 2, 2011 Federal
Register (76 FR 5861), we published a
final rule with comment period titled,
‘‘Medicare, Medicaid, and Children’s
Health Insurance Programs; Additional
Screening Requirements, Application
Fees, Temporary Enrollment Moratoria,
Payment Suspensions and Compliance
Plans for Providers and Suppliers.’’ This
final rule with comment period
implemented major Affordable Care Act
provisions, including the following:
++ A requirement that institutional
providers and suppliers must submit
application fees as part of the Medicare,
Medicaid, and CHIP provider and
supplier enrollment processes.
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++ Establishment of Medicare,
Medicaid, and CHIP provider and
supplier risk-based enrollment
screening categories and corresponding
screening requirements.
++ Authority that enabled imposition
of temporary moratoria on the
enrollment of new Medicare, Medicaid,
and CHIP providers and suppliers of a
particular type (or the establishment of
new practice locations of a particular
type) in a geographic area.
• In the April 27, 2012 Federal
Register (77 FR 25284), we published a
final rule titled, ‘‘Medicare and
Medicaid Programs; Changes in
Provider and Supplier Enrollment,
Ordering and Referring, and
Documentation Requirements and
Changes in Provider Agreements.’’ The
rule implemented another major
Affordable Care Act provision and
required, among other things, that
providers and suppliers that order or
certify certain items or services be
enrolled in or validly opted-out of the
Medicare program.
++ This requirement was expanded to
include prescribers of Medicare Part D
drugs in the final rule published in the
May 23, 2014 Federal Register (79 FR
29844) titled, ‘‘Medicare Program;
Contract Year 2015 Policy and
Technical Changes to the Medicare
Advantage and the Medicare
Prescription Drug Benefit Programs.’’
Through improved processes and
systems, since March 2011 we have:
• Saved over $927 million by
revoking Medicare Part A and B
providers and suppliers that did not
comply with Medicare requirements;
• Avoided over $2.4 billion in costs
by preventing further billing from
revoked and deactivated Medicare Part
A and B providers and suppliers;
• Deactivated more than 543,163
Medicare Part A and B providers and
suppliers that did not meet Medicare
enrollment standards;
• Revoked enrollment and billing
privileges under § 424.535 for more than
34,888 Medicare Parts A and B
providers and suppliers that did not
meet Medicare enrollment standards,
and
• Denied 4,949 applications for
providers and suppliers in Medicare
Parts A and B that did not meet
Medicare enrollment standards within a
recent 12-month period.8
The public may review CMS’ Reports
to Congress each year for more
information on program integrity efforts,
8 Taken from Shantanu Agrawal, M.D. testimony
to Congress on July 22, 2015 https://
www.aging.senate.gov/imo/media/doc/
CMS%20_Agrawal_7_22_15.pdf.
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including how we calculate savings to
the Medicare and Medicaid programs.
The Department of Health and Human
Services Office of Inspector General
(OIG), Government Accountability
Office (GAO), and other federal agencies
routinely review Medicare’s provider
and supplier enrollment processes and
systems, including a recent study stating
that ‘‘as part of an overall effort to
enhance program integrity and reduce
fraud risk, effective enrollmentscreening procedures are essential to
ensure that ineligible or potentially
fraudulent providers or suppliers do not
enroll in the Medicare program.’’ (GAO–
15–448) The enrollment screening
authorities granted in the Affordable
Care Act and used to prevent and detect
ineligible or potentially fraudulent
providers and suppliers from enrolling
in the Medicare program are working to
protect beneficiaries and the Medicare
Trust Funds.
Under applicable provisions of the
Tax Equity and Fiscal Responsibility
Act (TEFRA) of 1982, Medicare began to
pay health plans on a prospective risk
basis for the first time. The Balanced
Budget Act of 1997 (BBA) modified
these provisions and established a new
Part C of the Medicare program, known
as Medicare+Choice (M+C), effective
January 1999. As part of the M+C
program, the BBA authorized us to
contract with public or private
organizations to offer a variety of health
plan options for enrollees, including
both traditional managed care plans
(such as those offered by HMOs, as
defined in section 1876 of the Act) and
new options not previously authorized.
The M+C program was renamed the
Medicare Advantage (MA) program
under Title II of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub.
L. 108–173), which was enacted on
December 8, 2003. The MMA updated
and improved the choice of plans for
enrollees under MA and changed how
benefits are established and payments
are made. Under the MMA, enrollees
may choose from additional plan
options. In addition, Title I of the MMA
established the Medicare prescription
drug benefit (Part D) program and
amended the MA program to allow most
MA plans to offer prescription drug
coverage.
All Medicare health plans, with the
exception of PACE organizations,
operating in geographic areas that we
determine to have enough qualified
providers and suppliers with which to
contract in order for enrollees to have
access to all Medicare Part A and Part
B services, must develop a network of
qualified providers and suppliers that
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meet our network adequacy standards.
As a condition of contracting with us,
the health plans’ contracted network of
providers and suppliers must be
approved by us as part of application
approval (§ 417.406). PACE
organizations must furnish
comprehensive medical, health, and
social services that integrate acute and
long-term care in at least the PACE
center, the participant’s home, or
inpatient facilities, and must ensure
accessible and adequate services to meet
the needs of its participants. Under
current guidance, Medicare health plans
may include in their networks providers
and suppliers that are not enrolled in
Medicare.
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2. Provisions of the Proposed Regulation
a. Need for Regulatory Action
This proposed rule would require
providers or suppliers that furnish
health care items or services to a
Medicare enrollee who receives his or
her Medicare benefit through an MA
organization to be enrolled in Medicare
and be in an approved status. The term
‘‘MA organization’’ refers to Medicare
Advantage plans and also MA plans that
provide drug coverage, otherwise
known as an MA–PD plan. This
proposal would create consistency with
the provider and supplier enrollment
requirements for all other Medicare
(Part A, Part B, and Part D) programs.
We believe that this proposed rule is
necessary to help ensure that Medicare
enrollees receive items or services from
providers and suppliers that are fully
compliant with the requirements for
Medicare enrollment and that are in an
approved enrollment status in Medicare.
This proposed rule would assist our
efforts to prevent fraud, waste, and
abuse and to protect Medicare enrollees
by carefully screening all providers and
suppliers, especially those that
potentially pose an elevated risk to
Medicare, to ensure that they are
qualified to furnish Medicare items and
services. Out-of network or non-contract
providers and suppliers are not required
to enroll in Medicare to meet the
requirements of this proposed rule.
We consider provider and supplier
enrollment to be the gateway to the
Medicare program and to beneficiaries.
Requiring enrollment of those that wish
to furnish Medicare items or services
gives us improved oversight of the
providers and suppliers treating
beneficiaries and the Medicare Trust
Funds dollars spent on their care.
However, Medicare does not have direct
oversight over all providers and
suppliers in MA organizations. We note
that § 422.204 requires MA
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organizations to conduct screening of
their providers. We believe that we,
through our enrollment processes, can
further ensure that only qualified
providers and suppliers treat Medicare
beneficiaries by conducting rigorous
screening and rescreening of providers
and suppliers that include, for example,
risk-based site visits and, in some cases,
fingerprint-based background checks.
We also has access to information not
available to MA organizations, making
oversight to ensure compliance with all
federal and state requirements more
robust. We also continually review
provider and supplier enrollment
information from multiple sources, such
as judicial, law enforcement, state
licensure, professional credentialing,
and other databases. In short, we collect
and carefully review and verify
information prior to the provider’s or
supplier’s enrollment and, of great
importance, continue this monitoring
throughout the period of enrollment.
Section 422.204, on the other hand,
neither requires MA organizations to,
for instance, review a provider or
supplier’s final adverse action history
(as defined in § 424.502), nor to verify
a provider or supplier’s practice
location, ownership, or general
identifying information.
We believe that MA organization
enrollees should have the same
protections against potentially
unqualified or fraudulent providers and
suppliers as those afforded to
beneficiaries under the fee-for-service
and Part D programs. Indeed, Medicare
beneficiaries and enrollees, the
Medicare Trust Funds, and the program
at large, are at risk when providers and
suppliers that have not been adequately
screened and reviewed furnish, order,
certify, or prescribe Medicare services
and items and receive Medicare
payments. For instance, a network
provider with a history of performing
medically unnecessary tests, treatments,
or procedures could threaten enrollees’
welfare, as could a physician who
routinely overprescribes dangerous
drugs. This could also result in
improper Medicare payments, harming
the Medicare Trust Funds and
taxpayers. Requiring enrollment allows
us to have proper oversight of providers
and suppliers. Under the provisions of
this proposed rule, if a provider or
supplier fails to meet our requirements
or violates federal rules and regulations,
we may revoke their enrollment, thereby
removing them from consideration as an
MA organization provider or supplier.
Information regarding a provider or
supplier’s enrollment status is housed
in our enrollment repository called the
Provider Enrollment, Chain and
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Ownership System (PECOS). A link to
that information is located on the CMS
Web site. Initial data show a large
percent of Medicare Advantage
providers and suppliers are already
enrolled in Medicare. We do not believe
that this proposed rule would have a
significant impact on MA organizations’
ability to establish networks of
contracted providers that meet CMS’
MA network requirements. However, we
are soliciting industry comment on the
potential impact of this proposed rule
on MA organizations ability to establish
or maintain an adequate networks of
providers.
We believe that preventing
questionable providers or suppliers
from participating in the MA program
and removing existing unqualified
providers and suppliers would help
ensure that fewer enrollees are exposed
to risks and potential harm, and that
taxpayer monies are spent
appropriately. Such a policy would also
help comply with the GAO’s
recommendation that we improve its
provider and supplier enrollment
processes and systems to increase the
protection of all beneficiaries and the
Medicare Trust Funds. (GAO–15–448).
The additional resources and oversight
that we provide in its processes for
enrolling providers and suppliers will
enhance and complement the screening
processes that MA organizations already
are required to perform.
b. Statutory Authority
The following are the principal legal
authorities for our proposed provisions:
• Section 1856(b) of the Act provides
that the Secretary shall establish by
regulation other standards for
Medicare+Choice organizations and
plans ‘‘consistent with, and to carry out,
this part.’’ In addition, § 1856(b) states
that these standards supersede any state
law or regulation (other than those
related to licensing or plan solvency) for
all MA organizations.
• Sections 1102 and 1871 of the Act,
which provide general authority for the
Secretary to prescribe regulations for the
efficient administration of the Medicare
program.
• Section 1866(j) of the Act, which
provides specific authority with respect
to the enrollment process for providers
and suppliers in the Medicare program.
3. Major Provisions
Given the foregoing and the need to
safeguard the Medicare program and its
enrollees, we propose several provisions
in this proposed rule.
Although existing regulations at
§ 422.204 address basic requirements for
MA provider credentialing, we propose
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in § 422.204(b)(5) to require plans to
verify that they are compliant with the
provider and supplier enrollment
requirements. We believe this addition
would help facilitate MA organizations’
compliance.
In §§ 422.222, 417.478, 460.68, and
460.32, we propose to add a
requirement that providers and
suppliers enroll in Medicare in an
approved status in order to provide
health care items or services to a
Medicare enrollee who receives his or
her Medicare benefit through an MA
organization. This requirement would
apply to network providers and
suppliers; first-tier, downstream, and
related entities (FDR); providers and
suppliers participating in the Program of
All-inclusive Care for the Elderly
(PACE); suppliers in Cost HMOs or
CMPs; providers and suppliers
participating in demonstration
programs; providers and suppliers in
pilot programs; locum tenens suppliers;
and incident-to suppliers. MA
organizations that do not ensure that
providers and suppliers comply with
the provider and supplier enrollment
requirements may be subject to
sanctions and termination. Considering
the serious risks to the Medicare
program and enrollees from fraudulent
or unqualified providers and suppliers,
we believe that these are appropriate
sanctions.
Current rules allow MA organizations
to contract with different entities to
provide services to beneficiaries. These
contracted entities are referred to as
first-tier, downstream, and related
entities or FDRs, as defined in
§ 422.500.
PACE is a Medicare and Medicaid
program that helps people meet their
health care needs in the community
instead of going to a nursing home or
other care facility, wherein a team of
health care professionals works with
participants and their families to make
sure participants get the coordinated
care they need. A participant enrolled in
PACE must receive Medicare and
Medicaid benefits solely through the
PACE organization. To ensure
consistency within our programs, we
believe that our proposed provider and
supplier enrollment requirements
should extend to this program.
Medicare Cost HMOs or CMPs are a
type of Medicare health plan available
in certain areas of the country. Some
Cost HMOs or CMPs only provide
coverage for Part B services. Cost HMOs
or CMPs do not include Part D. These
plans are either sponsored by employer
or union group health plans or offered
by companies that do not provide Part
A services.
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Demonstrations and pilot programs,
also called research studies, are special
projects that test improvements in
Medicare coverage, payment, and
quality of care. They usually operate
only for a limited time for a specific
group of people and/or are offered only
in specific areas. Providers and
suppliers in these programs would not
be exempt from the requirements of this
proposed rule.
In § 422.224, we also propose to
prohibit MA organizations from paying
individuals or entities that are excluded
by the OIG or revoked from the
Medicare program. In this proposal,
there would be a first time allowance for
payment; as part of this, the MA
organization would be required to notify
the provider or supplier and the
enrollee that no future payment shall be
made to, or on behalf of, the revoked or
excluded provider or supplier. We
believe such notification is necessary
because enrollees and beneficiaries
often do not know when their provider
or supplier is excluded by the OIG or
revoked from Medicare. We understand
that MA organizations have little or no
notice when enrollees seek out-ofnetwork providers and suppliers and
only obtain this information once an
item or service has been provided. It is
probable that some out-of-network
providers or suppliers cannot meet
Medicare enrollment requirements and
therefore may be unable to enroll. We
believe the proposals included in this
proposed rule will allow for notification
to be given to the enrollee and the
provider or supplier that no further
payments shall be made. We believe
such excluded or revoked individuals
and entities pose a significant risk to
enrollees and should not receive federal
dollars, even if payment is made
through an intermediary such as an MA
organization.
In § 422.501(c)(2), we propose to add
to language to the MA organization
application requirements requiring MA
organizations to provide documentation
that all applicable providers and
suppliers are enrolled in Medicare in an
approved status. We believe that this
would assist CMS in the MA
organization application process by
requiring MA organizations to provide
assurance that the designated providers
and suppliers are properly screened and
enrolled in Medicare.
In § 422.504(a)(6), we propose to add
language to the conditions to which an
MA organization must agree in its
contract with us. MA organizations
must agree to comply with all
applicable provider requirements in
subpart E of this part, including
provider certification requirements,
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anti-discrimination requirements,
provider participation and consultation
requirements, the prohibition on
interference with provider advice, limits
on provider indemnification, rules
governing payments to providers, and
limits on physician incentive plans. In
§ 422.504(a)(6), we propose to extend
this requirement to suppliers, not just
limit it to providers. In this same
section, we also propose to add a
requirement at for MA organizations to
comply with the provider and supplier
enrollment requirements referenced in
§ 422.222. We believe these revisions
would help facilitate the MA plan’s
compliance with § 422.222.
In §§ 422.504(i)(2)(v), 417.484, and
460.70, we propose to add provisions
that requires MA organizations, Cost
plans, and PACE organizations to
require all FDRs and contracted entities
to agree to comply with the provider
and supplier enrollment provision.
In §§ 422.510(a)(4)(xiii) and 460.50,
we propose provisions that would give
us the authority to terminate a contract
if an MA organization or PACE
organization fails to meet provider and
supplier enrollment requirements in
accordance with § 422.222 and payment
prohibitions in § 422.224. This section
is necessary to ensure plan compliance
with §§ 422.222 and 422.224 and to
provide an appropriate remedy with
respect to plans that fail to comply.
We also propose to add provisions to
§§ 422.752(a) and 460.40 that would
give us the authority to impose
sanctions if an MA organization or
PACE organizations fails to meet
provider and supplier enrollment
requirements in accordance with
§§ 422.222 and 422.224. As with
proposed § 422.510(a)(13), we believe
this section is necessary to ensure plan
compliance with §§ 422.222 and
422.224 and to furnish an appropriate
remedy regarding plans that do not
comply.
Finally, we propose to make these
provisions effective the first day of the
next plan year that begins 2 years from
the date of publication of the CY 2017
PFS final rule with comment period.
We believe this would give all
stakeholders sufficient time to prepare
for these requirements. We are unable to
impose new requirements on MA
organizations mid-year and therefore
must wait to make these rules effective.
We seek public comment on our
proposed effective date.
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J. Proposed Expansion of the Diabetes
Prevention Program (DPP) Model
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1. Background
In January 2015, the Administration
announced the vision of ‘‘Better Care,
Smarter Spending, Healthier People’’
with emphases on improving the way
providers are paid, improving and
innovating in care delivery, and sharing
information to support better decisions.
Diabetes is at epidemic levels in the
Medicare population, affecting more
than 25 percent of Americans aged 65 or
older.9 Care for Americans aged 65 and
older with diabetes accounts for roughly
$104 billion annually, and these costs
are growing; by 2050, diabetes
prevalence is projected to increase 2 to
3 fold if current trends continue.10
Fortunately, Type 2 diabetes is typically
preventable with appropriate lifestyle
changes.
A diabetes prevention program is an
evidence-based intervention targeted to
individuals with prediabetes, meaning
those who have blood sugar that is
higher than normal but not yet in the
diabetes range. The risk of progression
to Type 2 diabetes in an individual with
prediabetes is around 5–10 percent per
year, or about 5–20 times higher than in
individuals with normal blood
glucose.11 The National Diabetes
Prevention Program (DPP) administered
by the Centers for Disease Control and
Prevention (CDC), is a structured health
behavior change program delivered in
community and health care settings by
trained community health workers or
health professionals. The National DPP
consists of 16 intensive ‘‘core’’ sessions
of a CDC-approved curriculum in a
group-based setting that provides
practical training in long-term dietary
change, increased physical activity, and
problem-solving strategies for
overcoming challenges to sustaining
weight loss and a healthy lifestyle. After
the 16 core sessions, monthly
maintenance sessions help to ensure
that the participants maintain healthy
behaviors. The primary goal of the
intervention is to reduce incidence of
Type 2 diabetes by achieving at least 5
percent average weight loss among
9 Centers for Medicare and Medicaid Services.
Chronic Conditions among Medicare Beneficiaries,
Chartbook, 2012 Edition. Baltimore, MD. 2012.
10 Boyle, J.P., Thompson, T.J., Gregg, E.W.,
Barker, L.E., & Williamson, D.F. (2010). Projection
of the year 2050 burden of diabetes in the US adult
population: Dynamic modeling of incidence,
mortality, and prediabetes prevalence. Popul Health
Metr, 8(1), 29.
11 Zhang, X., Gregg, E.W., Williamson, D.F.,
Barker, L.E., Thomas, W., Bullard, K.M., & Albright,
A.L. (2010). A1C level and future risk of diabetes:
a systematic review. Diabetes Care, 33(7), 1665–
1673.
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participants. To learn more about the
National DPP please visit https://
www.cdc.gov/diabetes/prevention/
lifestyle-program/.
In 2012, the Center for Medicare &
Medicaid Innovation (the Innovation
Center) awarded a Health Care
Innovation Award (HCIA) to The Young
Men’s Christian Association (YMCA) of
the USA (Y–USA) to test whether DPP
services could be successfully furnished
by non-physician, community-based
organizations to Medicare beneficiaries
diagnosed with prediabetes and
therefore at high risk for development of
Type 2 diabetes. The HCIA model tests
are being conducted under the authority
of section 1115A of the Act (added by
section 3021 of the Affordable Care Act)
(42 U.S.C. 1315a). The statute authorizes
the Innovation Center to test innovative
health care payment and service
delivery models that have the potential
to reduce Medicare, Medicaid, and
Children’s Health Insurance Program
(CHIP) expenditures while preserving or
enhancing the quality of patient care.
Between February 2013 and June
2015, the Y–USA, in partnership with
17 local YMCAs, the Diabetes
Prevention and Control Alliance, and
seven other non-profit organizations,
enrolled a total of 7,804 Medicare
beneficiaries into the model. Enrolled
beneficiaries represented a diverse
geography across the eight states of
Arizona, Delaware, Florida, Indiana,
Minnesota, New York, Ohio, and Texas.
According to the second year
independent evaluation report of the
Y–USA Diabetes Prevention Program
model, Medicare beneficiaries
demonstrated high rates of participation
and sustained engagement in the
Diabetes Prevention Program.
Approximately 83 percent of recruited
Medicare beneficiaries attended at least
4 core sessions and approximately 63
percent completed 9 or more core
sessions. The first and second
independent evaluation reports are
available on the Innovation Center’s
Web site at https://innovation.cms.gov/
initiatives/Health-Care-InnovationAwards/.
2. Certification of the Medicare Diabetes
Prevention Program (MDPP)
CMS’ Office of the Actuary has
determined that DPP is likely to reduce
Medicare expenditures if made available
to eligible Medicare beneficiaries based
on historical evidence from evaluations
of the Y–USA DPP and other DPPs in
the CDC Diabetes Prevention
Recognition Program. In addition, to
evaluate the longer-term impact of the
program, the CMS Actuary developed a
model to estimate lifetime per
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46413
participant savings of a Medicare
beneficiary receiving DPP services.
The full CMS Actuary Report is
available at https://www.cms.gov/
Research-Statistics-Data-and-Systems/
Research/ActuarialStudies/Downloads/
Diabetes-Prevention-Certification-201603-14.pdf.
3. Requirements for Expansion
Section 1115A(c) of the Act provides
the Secretary with the authority to
expand (including implementation on a
nationwide basis) through rulemaking
the duration and scope of a model that
is being tested under section 1115A(b)
of the Act if the following findings are
made, taking into account the
evaluation of the model under section
1115A(b)(4) of the Act: (1) The Secretary
determines that the expansion is
expected to either reduce spending
without reducing quality of care or
improve the quality of patient care
without increasing spending; (2) the
CMS Chief Actuary certifies that the
expansion would reduce (or would not
result in any increase in) net program
spending; and (3) the Secretary
determines that the expansion would
not deny or limit the coverage or
provision of benefits.
• Improved Quality of Care without
Increased Spending: Weight loss is a key
indicator of success among persons
enrolled in a DPP. According to the
second year independent evaluation of
the Y–USA DPP HCIA project, those
beneficiaries who attended at least one
core session lost an average of 7.6
pounds while beneficiaries who
attended at least four core sessions lost
an average of 9 pounds. BMI was
reduced from 32.9 to 31.5 among
Medicare beneficiaries that attended at
least four core sessions. Based on these
findings and results from other DPP
evaluations demonstrating the
effectiveness of the program in
preventing diabetes onset, the Secretary
determined that expansion of the DPP
will reduce spending and improve the
quality of care.
• Impact on Medicare Spending: The
CMS Chief Actuary has certified that
expansion of the DPP would not result
in an increase of Medicare spending.
• No Alteration in Coverage or
Provision of Benefits: The DPP, if
implemented in Medicare, would
provide services in addition to existing
Medicare services, and beneficiaries
receiving DPP services would retain all
benefits covered in traditional Medicare.
Therefore, the Secretary has determined
that expansion of DPP would not deny
or limit the coverage or provision of
Medicare benefits for Medicare
beneficiaries.
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4. Proposed Expansion of Medicare
Diabetes Prevention Program
We propose to expand the duration
and scope of the DPP model test by
expanding DPP under section 1115A(c)
of the Act, and we propose to refer to
this expanded model as the Medicare
Diabetes Prevention Program (MDPP). In
this section of this proposed rule, we
propose a basic framework for the
MDPP. If finalized, we will engage in
additional rulemaking, likely within the
next year, to establish specific
requirements of the MDPP. We seek
comment on all of the proposals below
and on any other policy or operational
issues that need to be considered in
implementing this expansion. The
MDPP will become effective January 1,
2018.
• MDPP as an ‘‘Additional Preventive
Service’’ under section 1861(ddd) of the
Act: CMS Authority to to Designate
MDPP as an ‘‘Additional Preventive
Service’’: We propose to designate
MDPP services as ‘‘additional
preventive services’’ available under
Medicare Part B. Section 1861(ddd)
defines ‘‘additional preventive services’’
as services that are not preventive
services or personalized prevention plan
services (as those terms defined in
section 1861(ddd)(3)(A) and (C)) that
identify medical conditions or risk
factors and that the Secretary
determines are (A) reasonable and
necessary for the prevention or early
detection of an illness or disability; (B)
recommended with a grade of A or B by
the United States Preventive Services
Task Force (USPSTF); and (C)
appropriate for individuals entitled to
benefits under Part A or enrolled in Part
B.
We believe that MDPP services are
generally consistent with the types of
additional preventive services that are
appropriate for Medicare beneficiaries.
In particular, we believe that MDPP
services we are proposing under the
expanded MDPP model meet the
requirements of section 1861(ddd)(1)(A)
of the Act because they are specifically
designed to prevent prediabetes from
advancing into diabetes. MDPP services
do not meet the requirement in section
1861(ddd)(1)(B) of the Act that they
have received a recommendation with a
grade of A or B by the USPSTF.
However, under section 1115A(d)(1) of
the Act, the Secretary has authority to
waive certain requirements. We propose
to use this waiver authority to waive
section 1861(ddd)(1)(B) of the Act with
respect to MDPP services because they
have been recommended by the
Community Preventive Services Task
Force, which is similar to the USPSTF,
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and therefore a USPSTF
recommendation is not necessary. We
believe that MDPP services are
appropriate for individuals entitled to
benefits under part A or enrolled in Part
B, and thus meet the requirements of
section 1861(ddd)(1)(C) of the Act,
because findings from the second year
independent evaluation of the Y–USA
DPP HCIA project and results from other
DPP evaluations demonstrate
effectiveness of the program in
preventing diabetes onset and thus
improve quality of care for Medicare
beneficiaries.
Section 1861(ddd)(2) of the Act
requires the Secretary to make the
determinations required under section
1861(ddd)(1) of the Act using the
process for making national coverage
determinations (NCDs). However, we
propose to waive this requirement
because using the NCD process to
implement the MDPP would create
implementation problems, especially as
this rule proposes to create a supplier
class and this is an issue that the NCD
process does not address.
We seek comment on these proposals.
MDPP Benefit Description: We
propose MDPP to be a 12 month
program using the CDC-approved DPP
curriculum, consisting of 16 core
sessions over 16–26 weeks and the
option for monthly core maintenance
sessions over 6 months thereafter if the
beneficiary achieves and maintains a
minimum weight loss in accordance
with the CDC Diabetes Prevention
Recognition Program Standards and
Operating Procedures. CDC-approved
DPP session curriculum requirements
are detailed below.
CDC-Approved DPP Session Curriculum
Requirements
During the first 6 months (weeks 1–
26) of the DPP intervention, each of the
16 core sessions must address one of
these curriculum topics, and all topics
must be addressed by the end of the 16
sessions.
1. Welcome to the National Diabetes
Prevention Program
2. Self-Monitoring Weight and Food
Intake
3. Eating Less
4. Healthy Eating
5. Introduction to Physical Activity
(Move Those Muscles)
6. Overcoming Barriers to Physical
Activity (Being Active—A Way of
Life)
7. Balancing Calorie Intake and Output
8. Environmental Cues to Eating and
Physical Activity
9. Problem Solving
10. Strategies for Healthy Eating Out
11. Reversing Negative Thoughts
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12. Dealing with Slips in Lifestyle
Change
13. Mixing Up Your Physical Activity:
Aerobic Fitness
14. Social Cues
15. Managing Stress
16. Staying Motivated, Program Wrap
Up
The last 6 months (weeks 27–52) of
the DPP 12-month intervention must
include at least one core maintenance
session delivered in each of the 6
months (for a minimum of six sessions),
and all core maintenance sessions must
address different topics.
1. Welcome to the Second Phase of the
Program
2. Healthy Eating: Taking It One Meal at
a Time
3. Making Active Choices
4. Balance Your Thoughts for LongTerm Maintenance
5. Healthy Eating With Variety and
Balance
6. Handling Holidays, Vacations, and
Special Events
7. More Volume, Fewer Calories
(Adding Water Vegetables and
Fiber)
8. Dietary Fats
9. Stress and Time Management
10. Healthy Cooking: Tips for Food
Preparation and Recipe
Modification
11. Physical Activity Barriers
12. Preventing Relapse
13. Heart Health
14. Life With Type 2 Diabetes
15. Looking Back and Looking Forward
CDC-approved curriculum can be
found at https://www.cdc.gov/diabetes/
prevention/pdf/curriculum_toc.pdf.
We propose that the MDPP expanded
model will use the CDC-approved
curriculum. We also propose that
beneficiaries who meet the coverage
criteria that we propose below would be
able to enroll in the MDPP only once;
however, we propose that those
beneficiaries who complete the 12
month program and achieve and
maintain a required minimum level of
weight loss would be eligible for
additional monthly maintenance
sessions for as long as the weight loss
is maintained. We propose that these
ongoing maintenance sessions adhere to
the same curriculum requirements as
the core maintenance sessions. We
propose to require that each MDPP
session be at least an hour in duration.
We propose to describe the services
that would be covered under the
Medicare Diabetes Prevention Program
expanded model at § 410.79. Consistent
with our statutory authority, we will
continue to test and evaluate the
nationwide MDPP as finalized. In the
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future, we will assess whether the
nationwide implementation of the
MDPP is continuing to reduce Medicare
spending without reducing quality of
care or improve the quality of patient
care without increasing spending, and
could modify the nationwide MDPP as
appropriate. We seek comment on this
proposal.
• Enrollment of New Medicare
Suppliers:
MDPP Supplier Enrollment
Requirements: As of 2015, more than
800 organizations have preliminary or
full recognition from the CDC Diabetes
Prevention Recognition Program (DPRP)
to provide DPP services. These
organizations have served more than
40,000 participants. More than 60 health
plans provide some coverage of DPP
services.
We propose that any organization
recognized by the CDC (that is, those
with preliminary or full recognition) to
provide DPP services would be eligible
to apply for enrollment in Medicare as
a supplier beginning on or after January
1, 2017. This proposal would promote
timely enrollment of CDC-recognized
organizations before billing begins, and
would permit full implementation of the
MDPP expansion by January 1, 2018.
We propose that MDPP suppliers would
be subject to the enrollment regulations
set forth in 42 CFR part 424, subpart P.
Organizations seeking to enroll in
Medicare specifically to become MDPP
Suppliers would be subject to screening
under § 424.518. We are considering
what level of application screening is
most appropriate, and we are currently
proposing that potential MDPP
Suppliers be screened according to the
high categorical risk category defined in
§ 424.518(c) because we acknowledge
that MDPP may bring organization types
that are entirely new to Medicare. We
also believe that MDPP suppliers have
some similarities to home health
agencies because non-medical personnel
may deliver MDPP services in a nonclinical setting, such as at Y–USA. We
seek comments on this approach.
As suppliers, enrolled MDPP
organizations would be obligated to
comply with all statutes and regulations
that establish generally applicable
requirements for Medicare suppliers.
For example, there are regulations that
specify time limits for filing claims
(§ 424.44), requirements to report and
return overpayments (§ 401.305), and
procedures for suspending, offsetting or
recouping Medicare payments in certain
situations (§ 405.371).
We propose that before enrolling in
Medicare, DPP organizations must have
either preliminary or full CDC
recognition status. Organizations that
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apply for CDC recognition can attain
preliminary CDC recognition within 1
year of applying, and full upon
demonstrating program effectiveness
within 24–36 months of applying. We
propose that if an organization loses its
CDC recognition status at any point, or
withdraws from the CDC recognition
program at any point, or fails to move
from preliminary to full recognition
within 36 months of applying for CDC
recognition, the organization would be
subject to revocation of its Medicare
billing privileges for MDPP services as
provided by 42 CFR part 424, subpart P.
Under the CDC standards for
recognition, an organization that loses
its CDC recognition (and thus, under our
proposal, would no longer be able to bill
Medicare for MDPP services) must wait
12 months before reapplying for
recognition. We propose that DPP
organizations would be eligible to reenroll in Medicare as an MDPP supplier
if, after reapplying for CDC recognition,
the organization again achieves
preliminary recognition. CDC’s
standards for recognition as a DPP
organization can be found at https://
www.cdc.gov/diabetes/prevention/pdf/
dprp-standards.pdf.
We propose to permit CDC-recognized
organizations who are not already
enrolled in Medicare (on the basis of
being an existing Medicare provider or
supplier) to apply to enroll any time on
or after January 1, 2017. Existing
Medicare providers and suppliers that
wish to bill for MDPP services would
have to inform us of that intention and
satisfy all other requirements, but would
not need to enroll a second time. These
existing Medicare providers and
suppliers would be eligible to bill for
MDPP services furnished on or after
January 1, 2018. We also considered an
alternative approach where existing
Medicare providers and suppliers
would have to submit a separate
enrollment application (including any
applicable enrollment application fee)
and be separately screened to be eligible
to bill for MDPP services. We seek
comments on our approach.
Requirements for MDPP Coaches: We
propose to require personnel who
would deliver MDPP services, referred
to hereafter as ‘‘coaches’’, to obtain a
National Provider Identifier (NPI) to
help ensure the coaches meet CMS
program integrity standards. We are also
considering requiring that coaches
enroll in the Medicare program in
addition to obtaining an NPI, and we
seek comment on this approach. An
alternative policy we considered was to
require DPP organizations to collect and
submit to Medicare information on the
coaches who would deliver MDPP
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services, which could include
identifying information such as first and
last name and social security number.
However, we determined that doing so
would require CMS implement a new
process, rather than leveraging an
existing process, and increase CMS use
of social security numbers as a primary
identifier. In addition, by requiring
coaches to obtain NPIs, we align with
current process for provider enrollment
and program integrity efforts. We
propose to require MDPP suppliers to
submit the active and valid NPIs of all
coaches who would furnish MDPP
services on behalf of the MDPP supplier
as an employee or contractor. If MDPP
suppliers fail to provide active and valid
NPIs of their coaches, or if the coaches
fail to obtain or lose their active and
valid NPIs, the MDPP supplier may be
subject to compliance action or
revocation of MDPP supplier status.
Revocation of MDPP billing privileges:
We propose that all MDPP suppliers
would be required to comply with the
requirements of 42 CFR part 424. If an
MDPP supplier has its Medicare
enrollment revoked or deactivated for
reasons independent of DPRP
recognition, that supplier would lose its
ability to bill Medicare for MDPP
services but would not automatically
lose its DPRP recognition from the CDC.
We propose that existing Medicare
providers and suppliers who lose CDC
recognition would lose their Medicare
billing privileges with respect to MDPP
services, but may continue to bill for
other non-MDPP Medicare services for
which they are eligible to bill. We
propose that MDPP Suppliers that have
their Medicare billing privileges
revoked or that lose billing privileges for
MDPP may appeal these decisions in
accordance with the procedures
specified in 42 CFR part 405, subpart H,
42 CFR part 424, and 42 CFR part 498.
We propose to add a new § 424.59 to our
regulations to specify the suppliers who
would be eligible for Medicare
enrollment and billing for MDPP
services. We seek comment on this
proposal.
• Expected MDPP Reimbursement:
Expected MDPP Reimbursement
Structure: We plan to reimburse for
MDPP services at the times and in the
amounts set forth in the Table 35, with
payment tied to number of sessions
attended and achievement of a
minimum weight loss of 5 percent of
baseline weight (body weight recorded
during the beneficiary’s first core
session). MDPP suppliers would be
required to attest to beneficiary session
attendance and weight loss at the time
claims are submitted to Medicare for
payment. Each beneficiary’s attendance
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must be documented through paper or
electronic means and that each
beneficiary’s weight must be measured
and recorded every MDPP session the
beneficiary attends. MDPP suppliers
would be required to securely maintain
beneficiary attendance records and
measured weights and make them
available to CMS or its designee for
audit at any time.
TABLE 35—DPP PAYMENT MODEL
Payment per
beneficiary
(non-cumulative)
Core Sessions
1 session attended ..........................................................................................................................................................................
4 sessions attended .........................................................................................................................................................................
9 sessions attended .........................................................................................................................................................................
Achievement of minimum weight loss of 5% from baseline weight ................................................................................................
$25
50
100
160
Achievement of advanced weight loss of 9% from baseline weight ...............................................................................................
* 25
Maximum Total for Core sessions ...........................................................................................................................................
360
Maintenance Sessions (Maximum of 6 monthly sessions over 6 months in Year 1)
3 Maintenance sessions attended (with maintenance of minimum requiredweight loss from baseline) ........................................
6 Maintenance sessions attended (with maintenance of minimum required weight loss from baseline) ......................................
45
45
Maximum Total for Maintenance sessions ...............................................................................................................................
90
Maximum Total for first year .............................................................................................................................................
450
Maintenance Sessions After Year 1 (Minimum of 3 sessions attended per quarter/no maximum)
3 Maintenance sessions attended plus maintenance of minimum required weight loss from baseline .........................................
6 Maintenance sessions attended plus maintenance of minimum required weight loss from baseline .........................................
9 Maintenance sessions attended plus maintenance of minimum required weight loss from baseline .........................................
12 Maintenance sessions attended plus maintenance of minimum required weight loss from baseline .......................................
45
45
45
45
Maximum Total After First Year ...............................................................................................................................................
180
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* In addition to $160 above.
Submission of Claims for MDPP
Services: As Table 35 illustrates,
proposed payments would be heavily
weighted toward achievement of weight
loss over the first 6 months, and no
payments would be available after the
first 6 months without achievement of
the minimum weight loss. In the
proposed payment structure, claims for
payment would be submitted following
the achievement of core session
attendance, minimum weight loss,
maintenance session attendance, and
maintenance of minimum weight loss.
For example, MDPP suppliers would
not be able to submit another claim after
session one until the beneficiary has
completed four sessions, and
maintenance sessions would not qualify
for payment unless minimum weight
loss is achieved and maintained. Similar
value-based payments are being offered
by commercial insurers and accepted by
DPP organizations. We seek comment
on this payment structure. We seek
comment on whether to update payment
rates annually through an existing fee
schedule, such as the PFS, or establish
a new fee schedule for MDPP suppliers.
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• IT infrastructure and capabilities:
We propose that in order to receive
payment, MDPP suppliers would be
required to submit claims to Medicare
using standard claims forms and
procedures. Claims would be submitted
in batches that contain beneficiary
Protected Health Information (PHI) and
Personally Identifiable Information (PII),
including the Health Insurance Claim
Number (HICN). Most Medicare claims
are submitted electronically except in
limited situations. We provide a free
software package called PC–ACE Pro32
that creates a patient database and
allows organizations to electronically
submit claims to Medicare Part A and B.
We understand there are several other
electronic claims submissions software
packages available in the market for
purchase. We encourage current and
prospective DPP organizations to
investigate adopting these systems to
enhance the efficiency of claims
submission, and we seek comment on
the capacity of DPP organizations to
integrate these systems into their
workflows. If this provision is finalized,
we would provide technical assistance
to MDPP suppliers to comply with the
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Medicare claims submission standards.
We seek comment from current and
prospective DPP organizations on their
ability to transmit claims to Medicare in
a timely and secure manner.
We propose to require MDPP
suppliers to maintain a crosswalk
between the beneficiary identifiers they
submit to CMS for billing purposes and
the beneficiary identifiers they provide
CDC for the beneficiary level-clinical
data. We propose that MDPP suppliers
provide this crosswalk to the CMS
evaluator on a regular basis. We seek
comment on this approach.
We plan to propose to require MDPP
suppliers to maintain records that
document the MDPP services provided
to beneficiaries. We propose that these
records must contain detailed
documentation of the services provided,
including but not limited to the
beneficiary’s eligibility status, sessions
attended, the coach furnishing the
session attended, the date and place of
service of sessions attended, and weight.
MDPP suppliers would be required to
maintain these records within a larger
medical record, or within a medical
record that an MDPP supplier
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establishes for the purposes of
administering MDPP. Consistent with
the requirement in § 424.516(f) we
propose that these records be retained
for 7 years from the date of service and
that MDPP suppliers would provide
CMS or a Medicare contractor access to
these records upon request. We propose
to require MDPP suppliers to accurately
track payments and resolve any
discrepancies between claims and the
beneficiary record within their medical
record. We also propose that MDPP
suppliers would be required to maintain
and handle any beneficiary PII and PHI
in compliance with HIPAA, other
applicable privacy laws and CMS
standards. If this provision is finalized,
we intend to provide education and
technical assistance to DPP
organizations to mitigate the risk of data
discrepancies and audits. We seek
comment on our approach. We would
address specific recordkeeping
requirements and standards in future
rulemaking.
• MDPP Eligible beneficiaries: We
propose that coverage of MDPP services
would be available for beneficiaries who
meet the following criteria: (1) Are
enrolled in Medicare Part B; (2) have as
of the date of attendance at the first Core
Session a body mass index (BMI) of at
least 25 if not self-identified as Asian
and a BMI of at least 23 if self-identified
as Asian. The CDC standards have
defined a lower BMI for Asian
individuals based on data that show
Asians develop abnormal glucose levels
at a lower BMI; (3) have within the 12
months prior to attending the first Core
Session a hemoglobin A1c test with a
value between 5.7 and 6.4 percent, or a
fasting plasma glucose of 110–125 mg/
dL, or a 2-hour post-glucose challenge of
of 140–199 mg/dL (oral glucose
tolerance test). We use this definition of
prediabetes instead of the definition in
§ 410.18 because the 2016 American
Diabetes Association Standards of Care
includes the use of a hemoglobin A1c
test to diagnose prediabetes and the
CMS actuarial certification uses the
World Health Organization definition of
prediabetes as a fasting plasma glucose
of 110–125 mg/dL; (4) have no previous
diagnosis of Type 1 or Type 2 diabetes.
A beneficiary with previous diagnosis of
gestational diabetes is eligible for
MDPP; and (5) does not have end-stage
renal disease (ESRD).
The National DPP currently allows
community-referral such as by Y–USA
and self-referral of patients, in addition
to referral by physicians and other
health care practitioners, if the patient
presents DPP-qualifying blood test
results that the DPP organization keeps
on record. We propose to similarly
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permit beneficiaries who meet the
proposed criteria above to obtain MDPP
services by self-referral, communityreferral, or health care practitionerreferral.
We propose to establish the
beneficiary eligibility criteria at
§ 410.79. We seek comment on this
proposal.
• Program integrity: We propose all
DPP organizations that are eligible and
wish to bill Medicare would enroll as
MDPP suppliers, and thus would be
required to comply with applicable
Medicare supplier enrollment, program
integrity, and payment rules. We
recognize the potential for fraud and
abuse by filing inaccurate claims and/or
duplicative claims on beneficiaries’
sessions attended or weight loss
achieved. We also recognize
beneficiaries may move between MDPP
suppliers, and we intend to address in
future rulemaking requirements to
prevent duplication of a beneficiary’s
claims for the same services by more
than one MDPP supplier. We are also
concerned about the potential for
beneficiary inducement or coercion and
the potential program risks posed by
permitting a new type of organization to
receive payment from CMS for
providing MDPP services. We intend to
develop policies, and will propose them
in future rulemaking, to mitigate these
risks, and monitor the MDPP expansion
to ensure MDPP suppliers meet all
applicable CMS program integrity and
supplier enrollment standards. We
intend to develop system checks to
identify where CMS may need to audit
an MDPP supplier’s medical records.
We are considering ways CMS could
cross reference the data DPP
organizations are currently required to
report to the CDC to identify potential
discrepancies with data submitted to us.
We seek comment on such approaches.
Finally, MDPP suppliers would be
subject to audits and reviews performed
by CMS program integrity and/or review
or audit contractors in addition to
program-specific audits. We seek
comment on these approaches and
others to mitigate these risks and
strategies to ensure program integrity.
• Site of service: Currently, CDCrecognized DPP organizations deliver
DPP services in-person or virtually via
a telecommunications system or other
remote technology. The majority of
current DPP organizations provide DPP
services in-person, but an emerging
body of literature supports the
effectiveness of virtual sessions
delivered remotely. We propose to allow
MDPP suppliers to provide MDPP
services via remote technologies. As
part of our evaluation of the MDPP
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expansion, to the extent feasible, we
will evaluate the effectiveness of MDPP
services, particularly in relation to
virtual versus in-person services, and,
using the evaluation data, may modify
or terminate this component of the
expansion as appropriate. To permit
such evaluation, we are considering
specifying the nature of the virtual
service and the site of the service in
codes included on claims submitted for
payment, as well as collecting
information on the nature of the virtual
service and the site of service at the
beneficiary level from MDPP suppliers.
We seek comment on this approach.
Under this last example, MDPP
suppliers would be expected to
maintain this information as part of the
beneficiary level cross walk discussed
under the IT Infrastructure and
Capabilities section of this proposed
rule.
We plan to monitor administrative
claims for virtual services to identify
any unusual and/or adverse utilization
of the DPP benefit. We seek comment on
specific monitoring activities or
program integrity safeguards with
respect to virtual services, in addition to
the time period in which such enhanced
monitoring activities should occur.
We note that MDPP services provided
via a telecommunications system or
other remote technology will not be part
of the current Medicare telehealth
benefits and have no impact on how
telehealth services are defined by
Medicare. We recognize that the
provision of MDPP services by such
virtual methods may introduce
additional risks for fraud and abuse, and
if this proposal is finalized, we would
propose specific policies in future
rulemaking to mitigate these risks. We
thus seek comment on whether there are
quality or program integrity concerns
regarding the use of virtual sessions, or
whether they offer comparable or higher
quality MDPP services when compared
to in-person services. We seek comment
on strategies to strengthen program
integrity and minimize the potential for
fraud and abuse in virtual sessions.
• Learning activities: The CDC
provides technical assistance to DPP
organizations recognized by the DPRP to
improve performance. We intend to
coordinate with CDC to supplement this
technical assistance with education,
training and technical assistance on data
security, claims submission and medical
record keeping. We seek comment on
what additional technical assistance
would be needed by providers and other
organizations in order to expand the
MDPP model.
• Quality monitoring and reporting:
We seek comment on the quality metrics
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that should be reported by MDPP
suppliers in addition to the reporting
elements required on Medicare claims
submissions outlined above (attendance
and weight loss) or by the CDC
recognition program. We seek comment
specifically on what quality metrics
should be considered for public
reporting (not for payment) to guide
beneficiary choice of MDPP suppliers.
• Timing of the MDPP expansion:
Expanding the MDPP model will be a
technically and logistically complex
undertaking. One option may be to
expand the MDPP nationally in its first
year of implementation. Another option
is a ‘‘phase-in’’ approach, where the
MDPP is expanded initially for a period
of time in certain geographic markets or
regions, or is furnished by a
subpopulation of MDPP suppliers, with
the goal of addressing technical issues
prior to broader expansion. We seek
comment on expanding DPP nationally,
and specifically on what factors we
should consider in the selection of
initial MDPP suppliers.
K. Medicare Shared Savings Program
Under section 1899 of the Act, we
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
establishing the Shared Savings Program
appeared in the November 2, 2011
Federal Register (Medicare Shared
Savings Program: Accountable Care
Organizations Final Rule (76 FR 67802)
(November 2011 final rule)). A
subsequent major update to the program
rules appeared in the June 9, 2015
Federal Register (Medicare Shared
Savings Program; Accountable Care
Organizations Final Rule (80 FR 32692)
(June 2015 final rule)). A final rule
addressing changes related to the
program’s financial benchmark
methodology appeared in the June 10,
2016 Federal Register (Medicare
Program; Medicare Shared Savings
Program; Accountable Care
Organizations—Revised Benchmark
Rebasing Methodology, Facilitating
Transition to Performance-Based Risk,
and Administrative Finality of Financial
Calculations (81 FR 37950) (June 2016
final rule)). As noted below, we have
also made use of the annual PFS rules
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to address quality reporting and certain
other issues.
Additionally, on April 27, 2016, the
Department of Health and Human
Services (HHS) issued a proposed rule
to implement key provisions of the
Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA)
and establish a new Quality Payment
Program (QPP) (Medicare Program;
Merit-Based Incentive Payment System
(MIPS) and Alternative Payment Model
(APM) Incentive under the Physician
Fee Schedule, and Criteria for
Physician-Focused Payment Models (81
FR 28162) (QPP proposed rule)). The
QPP proposed rule would establish a
new program under which Medicare
would reward physicians for providing
high-quality care, instead of paying
them only for the number of tests or
procedures provided. The QPP
proposed rule addresses issues related
to APMs, such as the Medicare Shared
Savings Program, and issues related to
reporting for purposes of MIPS by
eligible clinicians (ECs) that are
participating in APMs.
Our intent in this proposed rule is to
propose further refinements to the
Shared Savings Program rules, and we
have identified several policies that we
propose to update or revise. First, we
discuss and propose policies related to
ACO quality reporting including
proposing changes to the quality
measures used to assess ACO quality
performance, changes in the
methodology used in our quality
validation audits and the way in which
the results of these audits may affect an
ACO’s sharing rate, various issues
related to alignment with policies
proposed in the QPP proposed rule, and
revisions related to the terminology
used in quality assessment such as
‘‘quality performance standard’’ and
‘‘minimum attainment level.’’ We are
also proposing conforming changes to
our regulatory text. Next, we address
several issues unrelated to quality
reporting and assessment. Specifically,
we propose to implement a process by
which beneficiaries may voluntarily
align with an ACO by designating an
ACO professional as responsible for
their overall care. We also propose to
introduce beneficiary protections
related to use of the SNF 3-Day Waiver.
Finally, we are proposing to make
technical changes to certain rules
related to merged and acquired TINs
and the minimum savings rate (MSR)
and minimum loss rate (MLR) that
would be used during financial
reconciliation for ACOs that fall below
5,000 assigned beneficiaries.
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1. ACO Quality Reporting
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
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 and
recent CY PFS final rules with comment
period (77 FR 69301 through 69304; 78
FR 74757 through 74764; 79 FR 67907
through 67931; and 80 FR 71263
through 712710), we have established
the quality performance standard that
ACOs must meet to be eligible to share
in savings that are generated. For
example, in the CY 2015 PFS final rule
with comment period, we made a
number of updates to the quality
requirements within the program, such
as updates to the quality measure set,
the addition of a quality improvement
reward, and the establishment of
benchmarks for 2 years. We made
further updates to the quality measure
set, established policies to address
outdated measures, and made
conforming changes to align with PQRS
in the CY 2016 PFS final rule with
comment period. Through these
previous rulemakings, we have worked
to improve the alignment of quality
performance measures, submission
methods, and incentives under the
Shared Savings Program and PQRS.
Currently, eligible professionals billing
through the TIN of an ACO participant
may avoid the downward PQRS
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payment adjustment when the ACO
satisfactorily reports the ACO GPRO
measures on their behalf using the CMS
web interface.
We are proposing several changes and
other revisions to our policies related to
the quality measures and quality
performance standard in this rule,
including the following:
• Changes to the measure set used in
establishing the quality performance
standard;
• Changes to the methodology used to
validate quality data submitted by the
ACO along with penalties that may
apply if the audit match rate is less than
90 percent;
• Revisions to the use of the terms
‘‘quality performance standard’’ and
‘‘minimum attainment level’’ in the
regulation text;
• Revisions related to use of flat
percentages to establish quality
benchmarks; and
• Alignment with policies proposed
in the QPP proposed rule.
a. Changes to the Quality Measure Set
Used in Establishing the Quality
Performance Standard
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(1) Background
Section 1899(b)(3)(C) of the Act states
that the Secretary shall 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 final rule, we established a quality
performance standard consisting of 33
measures across four domains,
including patient experience of care,
care coordination/patient safety,
preventive health, and at-risk
population. In subsequent PFS final
rules with comment period, we made a
number of updates to the set of
measures that make up the quality
performance standard. For example, in
the CY 2015 PFS final rule with
comment period, we added new
measures that ACOs must report, retired
measures that no longer aligned with
updated clinical guidelines, reduced the
sample size for measures reported
through the CMS web interface,
established a schedule for the phase in
of new quality measures, and
established an additional reward for
quality improvement. The revisions to
the measures set made in the CY 2016
PFS final rule with comment period,
resulted in a net increase in the quality
measure set from 33 measure to 34
measures.
Quality measures are submitted by the
ACO through the CMS web interface,
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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. The
CAHPS for ACOs patient experience of
care survey used for the Shared Savings
Program includes the core CG–CAHPS
modules, as well as some additional
modules. The measures collected
through the CMS web interface are also
used to determine whether eligible
professionals participating in an ACO
avoid the PQRS and automatic
Physician Value Modifier (VM) payment
adjustments for 2015 and subsequent
years. Currently, eligible professionals
billing through the TIN of an ACO
participant may avoid the downward
PQRS payment adjustment when the
ACO satisfactorily reports all of the
ACO GPRO measures on their behalf
using the CMS web interface. Beginning
with the 2017 VM, ACO performance on
the CMS web interface measures and all
cause readmission measure will be used
in calculating the quality component of
the VM for groups and solo practitioners
participating within an ACO (79 FR
67941 through 67947).
As we previously stated (76 FR
67872), our principal goal in selecting
quality measures for ACOs has been to
identify measures of success in the
delivery of high-quality health care at
the individual and population levels
with a focus on outcomes. We believe
endorsed measures have been tested,
validated, and clinically accepted, and
therefore, when selecting the original 33
measures, we had 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 have
also exercised our discretion to include
certain measures that we believe to be
high impact but that are not currently
endorsed, including for example,
ACO#11, which is currently titled
Percent of PCPs Who Successfully Meet
Meaningful Use Requirements.
In selecting the original measure set,
we balanced a wide variety of important
considerations. Our measure selection
emphasized prevention and
management of chronic diseases that
have a high impact on Medicare FFS
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
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46419
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.
In the CY 2015 PFS final rule with
comment period we finalized a number
of changes to the quality measures used
in establishing the quality performance
standard to better align with PQRS,
retire measures that no longer align with
updated clinical practice, and add new
outcome measures that support the CMS
Quality Strategy and National Quality
Strategy goals. In the CY 2016 PFS final
rule with comment period, in modifying
the measures set we sought to include
both process and outcome measures,
including patient experience of care (80
FR 71263 through 71268). We believe it
is important to retain a combination of
both process and outcomes measures
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.
However, as other CMS quality
reporting programs, such as PQRS,
move to more outcomes-based measures
and fewer process measures over time,
we have indicated that we might also
revise the quality performance standard
for the Shared Savings Program to
incorporate more outcomes-based
measures and fewer process measures
over time.
We are also continuing to work with
the measures community to ensure that
the specifications for the measures used
under the Shared Savings Program are
up-to-date and reduce reporting burden.
We believe that it is important to
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.
The Core Quality Measures
Collaborative was formed in 2014, as a
collaboration between CMS, providers,
and other stakeholders, with the goal of
aligning quality measures for reporting
across public and private stakeholders
in order to reduce provider reporting
burden. On February 16, 2016, the Core
Quality Measures Collaborative
recommended a core quality measure
set that aligns and simplifies quality
reporting across multiple payers
(https://www.cms.gov/Newsroom/
MediaReleaseDatabase/Press-releases/
2016-Press-releases-items/2016-0216.html) and made specific
recommendations for ACOs (https://
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asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/QualityMeasures/
Downloads/ACO-and-PCMH-PrimaryCare-Measures.pdf). We proposed to
integrate several recommendations
made by the Core Quality Measures
Collaborative into the CMS web
interface as part of the QPP proposed
rule (81 FR 28399). Groups that are
eligible to report using the CMS web
interface for purposes of reporting
quality measures to CMS for various
quality reporting initiatives such as
PQRS, the Shared Savings Program are
required to report on all measures
included in the CMS web interface. In
addition, in the QPP proposed rule, we
proposed that groups would also be
required to report on all CMS web
interface measures.
(2) Proposals
In efforts to continue to align with
other CMS initiatives and reduce
provider confusion and the burden of
reporting, we propose modifications to
the quality measure set that an ACO is
required to report. Specifically, to align
the Shared Savings Program quality
measure set with the measures
recommended by the Core Quality
Measures Collaborative and proposed
for reporting through the CMS web
interface under the QPP proposed rule,
we propose to add, and in some cases
to replace, existing quality measures
with the following:
• ACO–12 Medication Reconciliation
Post-Discharge (NQF #0097). This
measure addresses adverse drug events
(ADEs) through medication
reconciliation, which is an important
aspect of care coordination. According
to HHS’ Agency for Healthcare Research
and Quality (AHRQ), ADEs account for
nearly 700,000 emergency department
visits and 100,000 hospitalizations each
year.12 The ACO–12 Medication
Reconciliation measure was previously
in the Shared Savings Program measure
set, however, it was replaced with
ACO–39, Documentation of Current
Medications in the Medical Record (79
FR 67912 through 67914). The Core
Quality Measures Collaborative, in
coordination with providers and
stakeholders, determined the original
Medication Reconciliation measure
would be more appropriate for
alignment across quality reporting
initiatives. Based on this
recommendation, we have proposed to
require reporting of the measure through
the CMS web interface in the QPP
12 ‘‘Medication Errors.’’ AHRQ. https://
psnet.ahrq.gov/primers/primer/23/medicationerrors.
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proposed rule (81 FR 28403). In an effort
to align with the QPP proposals, we
therefore propose to replace the
Documentation of Current Medications
in the Medical Record measure (ACO–
39) by reintroducing Medication
Reconciliation (ACO–12) in the Care
Coordination/Patient Safety domain. We
note that in accordance with our policy
for newly introduced measures, this
measure would phase into pay for
performance after two years as pay for
reporting, unless the measure has been
finalized only as pay for reporting. We
propose to phase the measure into pay
for performance in accordance with the
schedule outlined in Table 36 which is
consistent with the original phase in
schedule for the measure under the
2011 final rule.
• ACO–44 Use of Imaging Studies for
Low Back Pain (NQF #0052). Imaging
utilization is an important area for
quality measurement, because of the
wide use of imaging services. This
measure reports the percentage of
patients with a primary diagnosis of low
back pain that did not have an imaging
study (for example, MRI, CT scan)
within 28 days of the diagnosis. (A
higher score indicates higher
performance). The Use of Imaging
Studies for Low Back Pain quality
measure is specified for patients 18–50
years of age. This age range could result
in smaller case sizes for some ACOs;
however, it addresses the appropriate
use of imaging for low back pain, which
is a condition that affects a high volume
of adults in the United States. We
propose adding this measure in the Care
Coordination/Patient Safety domain to
address a gap in measures related to
resource utilization and align with the
ACO measures recommended by the
Core Quality Measures Collaborative
core measure set (https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/
QualityMeasures/Downloads/ACO-andPCMH-Primary-Care-Measures.pdf). We
note the measure is also proposed in the
QPP proposed rule for measuring the
quality of care furnished by individual
and specialty ECs (81 FR 28399 and
28460 Tables A and E). If finalized, the
measure would not be reported through
the CMS web interface. Instead, it
would be calculated using Medicare
claims data without any additional
provider reporting requirement. We note
that in accordance with our policy for
newly introduced measures, this
measure would be designated as pay for
reporting in 2017 and 2018, and then
phase into pay for performance. We
propose to phase the measure into pay
for performance in accordance with the
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Fmt 4701
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schedule outlined in Table 36.
Specifically, following the initial 2 years
of pay for reporting, we propose to
phase in the measure to pay for
performance starting with PY2 of an
ACO’s first agreement period. We
believe this is reasonable because there
is no reporting burden on the part of the
ACO and because many stakeholders
have some familiarity with similar
claims-based outcomes measures.
However, given the possible small case
sizes due to the measure specifications,
we seek comment on if this measure
should be phased in to pay for
performance or whether it should
remain pay for reporting for all three
performance years.
By aligning the Shared Savings
Program measures with the Core Quality
Measures Collaborative
recommendations and proposals under
the QPP proposed rule, we hope to
reduce the burden of provider data
collection and reporting of measures
that do not align across public and
private quality reporting initiatives.
Therefore, we propose to retire or
replace the following measures in order
to reduce provider reporting burden by
reducing the number of measures that
must be reported and because these
measures do not align with the core
measure set recommendations from the
Core Quality Measures Collaborative
and the measures that we proposed for
reporting through the CMS web
interface in the QPP proposed rule:
• ACO–39 Documentation of Current
Medications in the Medical Record.
• ACO–21 Preventive Care and
Screening: Screening for High Blood
Pressure and Follow-up Documented.
• ACO–31 Heart Failure (HF): BetaBlocker Therapy for Left Ventricular
Systolic Dysfunction (LVSD).
• 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%).
In addition to our proposals above to
modify the quality measure set to align
with the Core Quality Measures
Collaborative and the proposed
modifications to the measures reported
through the CMS web interface under
the QPP proposed rule, we propose a
few additional modifications as follows:
First, we propose to retire the two
AHRQ Ambulatory Sensitive Conditions
Admission measures (ACO–9 and ACO–
10). Although ACO–9 and ACO–10
address admissions for patients with
heart failure, chronic obstructive
pulmonary disease (COPD), and asthma,
we introduced two all-cause, unplanned
admission measures for heart failure
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and multiple chronic conditions (ACO–
37 and ACO–38, respectively) in the
2015 PFS final rule (79 FR 67911–
67912). We believe ACO–37 and ACO–
38 report on a similar population with
similar conditions as ACO–9 and ACO–
10. Therefore, in order to continue our
efforts to reduce redundancies within
the Shared Savings Program measure
set, we propose to remove ACO–9 and
ACO–10 from the measure set.
Second, while we are proposing above
to remove ACO–9 and ACO–10, we
continue to believe AHRQ’s Prevention
Quality Indicator (PQI) measures are
important because they report on
inpatient hospital admissions of
patients with clinical conditions that
could potentially be prevented with
high-quality outpatient care.
Coordination of patient care and patient
access to primary care services can often
prevent complications or hospital
admissions. AHRQ’s PQI #91
Ambulatory Sensitive Condition Acute
Composite is a composite measure,
currently used in the Physician ValueBased Payment Modifier, which
includes PQIs reporting on admissions
related to dehydration, bacterial
pneumonia, and urinary tract infections
(PQIs #10, 11, and 12). Dehydration,
bacterial pneumonia, and urinary tract
infection admissions may occur as a
result of inadequate access to
ambulatory care or poorly coordinated
ambulatory care. As a result, we propose
adding ACO–43 Ambulatory Sensitive
Condition Acute Composite (AHRQ PQI
#91) to the Care Coordination/Patient
Safety domain. The measure will be
risk-adjusted for demographic variables
and comorbidities. In accordance with
our policy for newly introduced
measures, we propose that this measure
be pay for reporting for two years, and
then phase into pay for performance in
accordance with the schedule outlined
in Table 36.
Table 36 lists the Shared Savings
Program quality measure set and
summarizes our proposed measure
changes, which will be used to assess
quality performance starting with the
2017 performance year. We note that,
consistent with our rules at
§ 425.502(a)(4), all newly introduced
measures are set at the level of complete
and accurate reporting for the first two
reporting periods for which reporting of
the measures is required. Therefore, the
proposed new measures discussed
above, including the Medication
Reconciliation measure, would be pay
for reporting for the 2017 and 2018
performance years. Beginning in the
2019 performance year, these quality
measures will be assessed according to
the phase-in schedule noted in Table 36.
As a result of these proposed measure
changes, each of the four domains will
include the following number of quality
measures (See Table 37 for details.):
• Patient/Caregiver Experience of
Care—8 measures
• Care Coordination/Patient Safety—10
measures
• Preventive Health—8 measures
• At Risk Population—5 measures
(3 individual measures and a 2component diabetes composite
measure)
Table 37 provides a summary of the
number of measures by domain and the
total points and domain weights that
would be used for scoring purposes
with the proposed changes to the
quality measures.
TABLE 36—MEASURES FOR USE IN THE ESTABLISHING QUALITY PERFORMANCE STANDARD THAT ACOS MUST MEET FOR
SHARED SAVINGS
ACO
measure #
Domain
Measure title
New
measure
NQF
#/measure
steward
Pay for
performance
phase in
R—reporting
P—performance
Method of
data
submission
PY1
PY2
PY3
AIM: Better Care for Individuals
Patient/Caregiver Experience ..
ACO–1 ...........
ACO–2 ...........
ACO–3 ...........
ACO–4 ...........
ACO–5 ...........
ACO–6 ...........
ACO–7 ...........
ACO–34 .........
Care Coordination/Patient
Safety.
ACO–8 ...........
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
ACO–35 .........
ACO–36 .........
ACO–37 .........
ACO–38 .........
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CAHPS: Getting Timely Care,
Appointments, and Information.
CAHPS: How Well Your Providers Communicate. 13
CAHPS: Patients’ Rating of
Provider. 2
CAHPS: Access to Specialists
CAHPS: Health Promotion and
Education.
CAHPS: Shared Decision Making.
CAHPS: Health Status/Functional Status.
CAHPS: Stewardship of Patient
Resources.
Risk-Standardized, All Condition Readmission.
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.
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........................
N#0005 AHRQ
Survey ............
R
P
P
........................
NQF #0005
AHRQ.
NQF #0005
AHRQ.
NQF #N/A
CMS/AHRQ.
NQF #N/A
CMS/AHRQ.
NQF #N/A
CMS/AHRQ.
NQF #N/A
CMS/AHRQ.
NQF #N/A
CMS/AHRQ.
Adapted NQF
#1789 CMS.
Adapted NQF
#2510 CMS.
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
........................
NQF #TBD
CMS.
Claims ............
R
R
P
........................
NQF #TBD
CMS.
Claims ............
R
R
P
........................
NQF #TBD
CMS.
Claims ............
R
R
P
........................
........................
........................
........................
........................
........................
........................
........................
Sfmt 4702
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TABLE 36—MEASURES FOR USE IN THE ESTABLISHING QUALITY PERFORMANCE STANDARD THAT ACOS MUST MEET FOR
SHARED SAVINGS—Continued
ACO
measure #
Domain
New
measure
Measure title
NQF
#/measure
steward
Pay for
performance
phase in
R—reporting
P—performance
Method of
data
submission
PY1
ACO–43 .........
ACO–11 .........
ACO–12 .........
ACO–13 .........
ACO–44 .........
PY2
PY3
Ambulatory Sensitive Condition
Acute Composite (AHRQ
Prevention Quality Indicator
(PQI) #91).
Use of certified EHR technology.
X
AHRQ .............
Claims ............
R
P
P
X
NQF #N/A
CMS.
R
P
P
Medication Reconciliation PostDischarge.
Falls: Screening for Future Fall
Risk.
Use of Imaging Studies for Low
Back Pain.
X
NQF #0097
CMS.
NQF #0101
NCQA.
NQF #0052
NCQA.
As proposed in
the QPP
proposed
rule.
CMS Web
Interface.
CMS Web
Interface.
Claims ............
R
P
P
R
P
P
R
P
P
R
P
P
R
P
P
R
P
P
........................
X
AIM: Better Health for Populations
Preventive Health .....................
ACO–14 .........
ACO–19 .........
Preventive Care and Screening: Influenza Immunization.
Pneumonia Vaccination Status
for Older Adults.
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 ...
ACO–20 .........
Breast Cancer Screening .........
........................
ACO–42 .........
Statin Therapy for the Prevention and Treatment of Cardiovascular Disease.
Depression
Remission
at
Twelve Months.
Diabetes Composite (All or
Nothing Scoring): ACO–27:
Diabetes Mellitus: Hemoglobin A1c Poor Control.
ACO–41: Diabetes: Eye Exam
........................
ACO–15 .........
ACO–16 .........
ACO–17 .........
ACO–18 .........
Clinical Care for At Risk Population—Depression.
Clinical Care for At Risk Population—Diabetes.
ACO–40 .........
ACO–27 .........
ACO–41 .........
Clinical Care for At Risk Population—Hypertension.
Clinical Care for At Risk Population—Ischemic Vascular
Disease.
ACO–28 .........
ACO–30 .........
Hypertension (HTN): Controlling High Blood Pressure.
Ischemic Vascular Disease
(IVD): Use of Aspirin or Another Antithrombotic.
........................
NQF #0041
AMA–PCPI.
NQF #0043
NCQA.
NQF #0421
CMS.
CMS Web
Interface.
CMS Web
Interface.
CMS Web
Interface.
........................
NQF #0028
AMA–PCPI.
CMS Web
Interface.
R
P
P
........................
NQF #0418
CMS.
CMS Web
Interface.
R
P
P
........................
NQF #0034
NCQA.
NQF #2372
NCQA.
NQF #N/A
CMS.
CMS Web
Interface.
CMS Web
Interface.
CMS Web
Interface.
R
R
P
R
R
P
R
R
R
NQF #0710
MNCM.
NQF #0059
NCQA (individual component).
NQF #0055
NCQA (individual component).
NQF #0018
NCQA.
NQF #0068
NCQA.
CMS Web
Interface.
CMS Web
Interface.
R
R
R
R
P
P
CMS Web
Interface.
R
P
P
CMS Web
Interface.
CMS Web
Interface.
R
P
P
R
P
P
........................
........................
........................
........................
........................
........................
........................
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
TABLE 37—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 ...................
8
10
Preventive Health ............................................
8
Total
possible
points
8 individual survey module measures ...........
10 measures, including double-scored EHR
measure.
8 measures ....................................................
13 The quality measure title has been updated to
‘‘Providers’’ and is not only referencing ‘‘Doctors.’’
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Domain
weight
(percent)
16
22
25
25
16
25
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TABLE 37—NUMBER OF MEASURES AND TOTAL POINTS FOR EACH DOMAIN WITHIN THE QUALITY PERFORMANCE
STANDARD—Continued
Number of
individual
measures
Domain
Total measures
for scoring
purposes
Total
possible
points
Domain
weight
(percent)
At-Risk Population ..........................................
5
3 individual measures, plus a 2-component
diabetes composite measure that is scored
as one measure.
8
25
Total in all Domains .................................
31
30 ...................................................................
62
100
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
b. Improving the Process Used To
Validate ACO Quality Data Reporting
(1) Background
In the November 2011 final rule, we
finalized a proposal to retain the right
to validate the data ACOs enter into the
Web Interface (76 FR 67893 through
67894). This validation process, referred
to as the Quality Measures Validation
audit, was based on the process used in
Phase I of the Physician Group Practice
(PGP) demonstration. The policy was
finalized at § 425.500(e). In this audit
process, CMS selects a subset of Web
Interface measures, and selects a
random sample of 30 confirmed and
completely reported beneficiaries for
each measure in the subset. The ACO
provides medical records to support the
data reported in the Web Interface for
those beneficiaries. A measure-specific
audit performance rate is then
calculated using a multi-phased audit
process:
• Phase 1: Eight randomly selected
medical records for each audited
measure are reviewed to determine if
the medical record documentation
supports what was reported (that is, a
match). If all records reviewed support
what was reported, the audit ends. If
any records do not support what was
reported (that is, a mismatch), the audit
process continues in a second phase for
any measure with a mismatch
identified.
• Phase 2: The remaining 22 medical
records are reviewed for any measure
that had a mismatch identified in Phase
1. If less than 90 percent of the medical
records provided for a measure support
what was reported, the audit process
continues to Phase 3.
• Phase 3: For each measure with a
match rate less than 90 percent, CMS
provides education to the ACO about
how to correct reporting and the ACO is
given an opportunity to resubmit the
measure(s) in question.
If at the conclusion of the third phase
there is a discrepancy greater than 10
percent between the quality data
reported and the medical records
provided during the audit, the ACO will
not be given credit for meeting the
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quality target for any measure(s) for
which the mismatch rate exists.
Since publication of the initial
program rules in 2011, we have gained
experience in conducting audits and
believe that certain modifications to our
rules should be made in order to
increase the statistical rigor of the audit
methodology, streamline audit
operations, and more closely align the
Quality Measures Validation audit used
in Shared Savings Program audits with
other CMS quality program audits
including those performed in the
Physician Quality Reporting Program
and the Hospital Inpatient and
Outpatient Quality Reporting programs.
Below, we propose four improvements
to the previously described process. The
proposed changes address the number
of records to be reviewed per measure,
the number of audit phases, the
calculation of an audit match rate and
the consequences if the audit match rate
falls below 90 percent.
(2) Proposals
First, we propose to increase the
number of records audited per measure
to achieve a high level of confidence
that the true audit match rate is within
5 percentage points of the calculated
result. The November 2011 final rule
indicated that CMS would review as few
as 8 records (Phase 1 only) or as many
as 30 records (Phase 1 and 2) per
audited measure. With this phased
methodology, the total number of
records reviewed for each ACO varies
(range of 40 to 150 records per audited
ACO during the Performance Year 2014
audit). A sample size analysis found
that the number of reviewed records
needs to increase in order to provide the
desired high level of confidence that the
audited sample is representative of the
ACO’s quality reporting performance.
We note that the precise number of
records requested for review would
vary, depending on the desired
confidence level, the number of
measures audited, and the expected
match rate. Therefore, we are not
proposing a specific number of records
that would be requested for purposes of
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ACO quality validation audits in the
future. However, based on an analysis
using the poorest expected match rate,
the highest degree of confidence and an
estimated number of measures to be
audited, we do not anticipate more than
50 records will be requested per audited
measure.
Second, we propose to modify our
regulations in order to conduct the
quality validation audit in a single step
rather than the current multi-phased
process described at § 425.500(e)(2). We
propose to use a more streamlined
approach in which all records selected
for audit are reviewed in a single step
and some activities currently conducted
in phase 3 would be removed from the
audit process entirely while others
would instead be addressed at the
conclusion of the audit. During the
proposed single step, we would review
all submitted medical records and
calculate the match rate. The education
we currently provide to ACOs and the
opportunity for ACOs to explain the
mismatches that occur in Phase 3 of the
current process would continue, but
would occur at the conclusion of the
audit. Under this proposal, there would
not be an the opportunity for ACOs to
correct and resubmit data for any
measure with a >10 percent mismatch
because we have learned through our
experience with program operations that
resubmission of CMS Web Interface
measure data after the close of the CMS
Web Interface is not feasible. Instead,
we propose that an ACO’s quality score
would be affected by an audit failure as
described below, without requiring reopening of the CMS Web Interface. This
single step process would allow us to
maintain the desired level of confidence
that the true audit match rate is within
5 percentage points of the calculated
result and to complete the audit in a
more timely manner. Therefore, we
propose to remove the provision at
§ 425.500(e)(2) that requires 3 phases of
medical record review. In so doing, we
propose to redesignate § 425.500(e)(3) as
§ 425.500(e)(2).
Third, we propose to revise
§ 425.500(e)(3) in order to provide for an
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assessment of the ACO’s overall audit
match rate across all measures, instead
of assessing the ACO’s audit mismatch
rate at the measure level. Specifically,
we propose to calculate an overall audit
match rate which would be derived by
dividing the total number of audited
records that match the information
reported in the Web Interface by the
total number of records audited. This is
a change from the current audit
performance calculation methodology,
which calculates a measure specific
mismatch rate. We believe that making
this change is necessary to minimize the
number of records that must be
requested in order to achieve the
desired level of statistical certainty as
described in our first proposal in this
section. Our analysis suggests that we
would have to request a much larger
number of records (approximately 200
per measure) from the ACO during a
quality validation audit of individual
measures to achieve a 90 percent
confidence interval for each measure. In
addition, combining all records to
calculate an overall audit match rate is
less subject to variability based on the
specific subset of measures chosen for
audit each year and better aligns with
the methodology used by other CMS
quality program audits.
Fourth, we propose to revise the
redesignated provision at
§ 425.500(e)(2), to indicate that if an
ACO fails the audit (that is, has an
overall audit match rate of less than 90
percent), the ACO’s overall quality score
would be adjusted proportional to its
audit performance. Currently, our
regulation at § 425.500(e)(3) states that
if, at the conclusion of the audit process
there is a discrepancy greater than 10
percent between the quality data
reported and the medical records
provided, the ACO will not be given
credit for meeting the quality target for
any measures for which this mismatch
rate exists. In light of our proposed
modifications to the quality validation
audit process above in which we
propose to assess and validate the
ACO’s performance overall rather than
the ACO’s performance on each
measure, we believe a modification to
this requirement is necessary to reflect
an overall adjustment. Therefore, we
propose to modify the provision at
newly redesignated § 425.500(e)(2) to
state that if an ACO fails the audit (that
is, has an audit match rate of less than
90 percent), the ACO’s overall quality
score will be adjusted proportional to
the ACO’s audit performance. The
audit-adjusted quality score will be
calculated by multiplying the ACO’s
overall quality score by the ACO’s audit
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match rate. For example, if an ACO’s
quality score is 75 percent and the
ACO’s audit match rate is 80 percent,
the ACO’s audit-adjusted quality score
is 60 percent. The audit-adjusted quality
score would be the quality score that is
used to determine the percentage of any
earned savings that the ACO may share
or the percentage of any losses for
which the ACO is accountable.
Finally, we propose to add a new
requirement at § 425.500(e)(3) that in
addition to the adjustment in the ACO’s
overall quality score, any ACO that has
an audit match rate of less than 90
percent, may be required to submit a
corrective action plan (CAP) under
§ 425.216 for CMS approval. In the CAP,
the ACO may be required to explain the
cause of its audit performance and how
it plans to improve the accuracy of its
quality reporting in the future. In
addition, CMS maintains the right, as
described in § 425.500(f), to terminate or
impose other sanctions on any ACO that
does not report quality data accurately,
completely or timely.
We invite comment on the proposed
improvements to the process used to
validate ACO quality data reporting.
c. Technical Changes Related to Quality
Reporting Requirements
The Shared Savings Program quality
reporting rules were originally
established through rulemaking in the
November 2011 final rule. In this
section, we make several proposals
regarding the quality performance
standard that an ACO must meet to be
eligible to share in savings. Part of the
determination of whether an ACO has
met the quality reporting standard in
each year is dependent on the ACO
meeting the minimum attainment level
for certain measures. We discuss how
the ‘‘minimum attainment’’ requirement
has been implemented to date and
propose a modification that we believe
is more consistent with our policies for
assessing an ACO’s performance over
time. Finally, we propose to move
references to compliance actions from
§ 425.502(d)(2)(ii) to a more appropriate
provision at § 425.316(c).
First, we propose to make technical
revisions to ensure stakeholder
understanding of the definition of the
quality performance standard. The
quality performance standard is
established under Subpart F for each
performance year (§ 425.502(a)). For the
first performance year of an ACO’s first
agreement period, the quality
performance standard is defined as
complete and accurate reporting of all
quality measures. For each subsequent
performance year, quality measures
phase in to pay for performance, and
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although the ACO must continue to
report all measures completely and
accurately, the ACO will also be
assessed on performance based on the
quality performance benchmark and
minimum attainment level of certain
measures that are designated as pay for
performance. The quality performance
standard that applies to an ACO’s final
year in its first agreement period also
applies to each year of an ACO’s
subsequent agreement period
(§ 425.502(a)(3)) (79 FR 67925 through
67926). ACOs must meet or exceed the
minimum quality performance standard
in a given performance year to be
eligible to receive payments for shared
savings (§ 425.100(b)). Conversely,
failure to meet the quality performance
standard in a given performance year
makes ACOs ineligible to share in
savings, even if generated, and such
ACOs may be subject to compliance
actions.
Our intent in the November 2011 final
rule was to establish a single quality
performance standard that would apply
for each performance year in which an
ACO participates in the program.
Because the quality performance
standard changes, depending on the
performance year, the ACO may be
subject to multiple quality performance
standards over the course of its 3-year
agreement period. We recognize that
some of the language used in
subsequent revisions to our regulations
may have generated some confusion
related to this issue. For example, as
explained above, the quality
performance standard refers to the
overall standard the ACO must meet,
however, in § 425.502(a)(4), we state
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. We wish to clarify
that while there are certain standards
that must be met for each measure or in
each domain, there is one overall
quality performance standard that must
be met in each performance year by an
ACO. We propose to make conforming
changes to the regulations text to
remove references to the quality
performance standard in contexts where
it does not appear to apply to the overall
quality performance standard (see
§ 425.316(c)(2), § 425.502(a)(4), and
§ 425.502(d)(1)). We do not believe that
modifications necessarily must be made
to the regulations text in all instances
where there is a reference to multiple
quality performance standards,
however, because we recognize that the
quality performance standard varies
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depending on the performance year in
question as indicated at § 425.502(a)(1)–
(3) or, for example, where we refer to
ACOs having to meet quality
performance standards to be eligible to
share in savings (§ 425.100(b)).
Therefore, we propose to retain certain
references to multiple quality
performance standards, such as the one
found in § 425.100(b), because we
believe the use of the plural is
appropriate in certain contexts.
Second, we wish to address the
concept of the minimum attainment
level and its use in determining whether
an ACO has met the quality
performance standard. As noted above,
beginning in the second year of an
ACO’s first agreement period, the
quality performance standard is met by
complete and accurate reporting on all
measures, but also includes meeting the
minimum attainment level on ‘‘certain’’
measures. As provided at
§ 425.502(b)(1), we designate a
performance benchmark and minimum
attainment level for each measure.
Pursuant to § 425.502(b)(3), the
minimum attainment level is set at 30
percent or the 30th percentile of the
performance benchmark. In
§ 425.502(c)(1) through (c)(2), we state
that performance below the minimum
attainment level for a measure will
receive zero points for that measure and
performance equal to or greater than the
minimum attainment level for a
measure will receive points on a sliding
scale based on the level of performance.
Finally, § 425.502(d) outlines quality
performance requirements for the four
domains, stating that the ACO must
report all measures in a domain and
must score above the minimum
attainment level determined by CMS on
70 percent of the measures in each
domain. If the ACO fails to achieve the
minimum attainment level on at least 70
percent of the measures in a domain,
CMS will take compliance action.
Additionally, the ACO must achieve the
minimum attainment level for at least
one measure in each of the four domains
to be eligible to share in savings. In
guidance, we have interpreted the
quality performance requirements for
domains to apply only to pay for
performance measures because
minimum attainment applies only to
‘‘certain’’ measures according to the
definition of the quality performance
standard in § 425.502(a)(3), and we have
interpreted the reference to ‘‘certain’’
measures in § 425.502(a)(2) to mean pay
for performance measures. As a result of
this interpretation, we believe an
inconsistency in the application of the
policy goals outlined in our November
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2011 final rule has arisen. In particular,
we believe certain current policies are
inconsistent with our goal of holding
ACOs to higher quality reporting
standards over time. Specifically,
because measures are phased-in from
pay for reporting to pay for performance
over the course of an ACO’s first 3-year
agreement period, there are no pay for
performance measures during PY1 and
fewer pay for performance measures in
each domain in PY2 compared to PY3.
Thus, under our current interpretation
of the rules, it is not possible to take
compliance actions against an ACO in
its first performance year for failure to
achieve the minimum attainment level
on at least 70 percent of the measures
in a domain because there are no pay for
performance measures on which to
assess performance on a domain.
Additionally, because there are fewer
pay for performance measures in PY2
than in PY3, it is more likely that a
compliance action would be taken
against an ACO due to failure to meet
the minimum attainment level on 70
percent of the pay for performance
measures in a domain in PY2 than in
PY3. Since publication of the November
2011 final rule, we have used the annual
PFS rule to update the measures that
ACOs are required to report. Each time
a new measure is added, the measure is
designated as pay for reporting for the
first 2 years it is in use so that we can
establish a performance benchmark
prior to using it as a pay for
performance measure. This, in turn,
diminishes even further the number of
pay for performance measures available
in a domain in PY2 and PY3 or in an
ACO’s second or subsequent agreement
period, making it more likely that ACOs
would be subject to compliance action.
Based on this experience, we believe it
would be more consistent with our
policy goals to take all measures into
account when determining whether a
compliance action should be taken
against an ACO based on its quality
performance in one or more domains.
Therefore, we propose to take all
measures into account when
determining ACO performance at the
domain level for purposes of
compliance actions. Additionally, we
believe that compliance actions should
be addressed at § 425.316 rather than in
the quality reporting section, and
therefore, we propose to move the
provisions governing the specific
performance levels at which a
compliance action would be triggered
from § 425.502 to § 425.316.
Specifically, we propose the following
modifications to our regulations:
• Revise introductory text at
§ 425.502(a) to make it clear that the
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quality performance standard is the
overall standard the ACO must meet to
qualify to share in savings.
• Replace the word ‘‘certain’’ in
§ 425.502(a)(2) and (3) with ‘‘all,’’ so
that the term ‘‘minimum attainment
level’’ clearly applies to both pay for
reporting and pay for performance
measures.
• At § 425.502(a)(4), make
modifications to remove the reference to
the quality performance standard each
time it appears to avoid causing
confusion between the standards for
individual measures and the overall
quality performance standard.
• At § 425.502(b)(3), define
‘‘minimum attainment level’’ for both
pay for reporting and pay for
performance measures. We propose to
set the minimum attainment level for
pay for performance measures at the
30th percent or 30th percentile of the
quality benchmark. We propose to set
the minimum attainment level for pay
for reporting measures at the level of
complete and accurate reporting.
• At § 425.502(c)(2), we propose to
revise the regulation text to specify that
only pay for performance measures are
assessed on a sliding scale.
• At § 425.502(c)(5), we propose to
add a provision to specify that pay for
reporting measures earn the maximum
number of points for a measure when
the minimum attainment level is met.
• Finally, we propose to modify
§ 425.502(d) to refer generally to
compliance actions that may be taken
for low quality performance. We
propose to address specific levels of
quality domain performance at which
compliance action would be triggered
by modifying § 425.316(c)(1).
d. Technical Change to Application of
Flat Percentages for Quality Benchmarks
In the CY 2014 PFS final rule with
comment period (78 FR 74761–74763),
we finalized a methodology to spread
clustered measures when setting quality
benchmarks to promote a clinically
meaningful assessment of ACO quality.
Specifically, we finalized a policy that
CMS would set quality benchmarks
using flat percentages for a clustered
measure when the national FFS data
results in the 60th percentile for the
measure are equal to or greater than
80.00 percent. We noted that the
methodology would not apply to
measures whose performance rates are
calculated as ratios, for example,
measures such as the two ACO
Ambulatory Sensitive Conditions
Admissions and the All Condition
Readmission measures. Similarly, in the
CY 2015 PFS final rule with comment
period (79 FR 67925), we finalized a
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policy to address ‘‘topped out’’
measures by also setting benchmarks
using flat percentages when the 90th
percentile is equal to or greater than 95
percent. Although similar to the
‘‘cluster’’ policy finalized in the CY
2014 PFS final rule with comment
period, we included measures whose
performance rates are calculated as
ratios. We believed this policy was
appropriate because measures
calculated and reported as ratios may
become topped out and expressed our
desire to treat all topped out measures
consistently.
Since the CY 2015 PFS final rule with
comment period, we have determined
that converting measures calculated and
reported as ratios into benchmarks
expressed as percentiles and
percentages creates confusion in the
interpretation of quality results and may
yield results that are contrary to the
intended purpose of using flat
percentages. As a result, we propose no
longer applying the flat percentage
policy to performance measures
calculated as ratios, such as the
Ambulatory Sensitive Conditions
Admissions measures and the All-Cause
Readmission measure. In addition, we
propose two technical changes to
address typographical errors in
§ 425.502(a)(1), which contains a
duplicative reference to CMS, and in
§ 425.502(b)(2)(ii), which contains an
extra ‘‘t’’ at the end of ‘‘percent.’’
e. Incorporation of Other Reporting
Requirements Related to the PQRS
The Affordable Care Act gives the
Secretary authority to incorporate
reporting requirements and incentive
payments from certain Medicare
programs into the Shared Savings
Program, and to use alternative criteria
to determine if payments are warranted.
Specifically, section 1899(b)(3)(D) of the
Act affords the Secretary discretion to
incorporate reporting requirements and
incentive payments related to the
physician quality reporting initiative
(PQRI), under section 1848 of the Act,
including such requirements and such
payments related to electronic
prescribing, electronic health records,
and other similar initiatives under
section 1848, and permits the Secretary
to use alternative criteria than would
otherwise apply (under section 1848 of
the Act) for determining whether to
make such payments. Under this
authority, in the November 2011 final
rule, we incorporated certain reporting
requirements and payment rules related
to the PQRS into the Shared Savings
Program at § 425.504 for ‘‘eligible
professionals’’ (EPs) who bill under the
TIN of an ACO participant within an
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ACO. Thus, the Shared Savings Program
rules provide that EPs who bill under
the TIN of an ACO participant within an
ACO may only participate under their
ACO participant TIN as a group practice
under PQRS under the Shared Savings
Program for purposes of qualifying for a
PQRS incentive (prior to 2015) or
avoiding the payment adjustment
(starting in 2015). In other words, the
current regulations prohibit ACO
participant TINs and the EPs billing
through those TINs from participating in
PQRS outside of the Shared Savings
Program such that these entities may not
independently report for purposes of
PQRS apart from the ACO.
An ACO, reporting on behalf of its
EPs for purposes of PQRS, is required to
satisfactorily submit through the CMS
web interface all of the ACO GPRO
measures that are part of the Shared
Savings Program quality performance
standard. Under § 425.504(c), for 2016
and subsequent years, if an ACO fails to
satisfactorily report all of the ACO
GPRO measures through the CMS web
interface each EP who bills under the
TIN of an ACO participant within the
ACO will receive a downward
adjustment, as described in § 414.90(e)
for that year. The current regulations do
not provide any mechanism for these
EPs to report separately or otherwise
avoid the downward payment
adjustment if the ACO fails to
satisfactorily report on their behalf.
We stated in the November 2011 final
rule that there were two main reasons
for not allowing EPs who bill under the
TIN of an ACO participant to report
outside of their ACO for purposes of
PQRS: (1) The Shared Savings Program
is concerned with measuring the quality
of care furnished by the ACO to its
patient population as a whole, and not
that of individual ACO providers/
suppliers, and (2) allowing EPs that bill
under the TIN of an ACO participant to
earn more than one PQRS incentive goes
against the rules of traditional PQRS (76
FR 67901 through 67902).
Since publication of the November
2011 final rule, we have gained
experience with these policies and
program operations and believe it is
necessary to propose a change in policy
in order to be able to accept and use
data that is separately reported outside
the ACO by EPs billing through the TIN
of an ACO participant within an ACO
for purposes of PQRS under limited
circumstances for the final two years of
PQRS before it sunsets and is replaced
by the Quality Payment Program (QPP).
We continue to believe that in most
cases it is appropriate to assess EPs that
bill through the TIN of an ACO
participant under the PQRS as a group
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practice because as noted in the
November 2011 final rule, the Shared
Savings Program is concerned with
measuring the quality of care furnished
to an assigned population of FFS
beneficiaries by the ACO, as a whole,
and not that of individual ACO
providers/suppliers. We believe this
framework promotes clinical integration
among the ACO providers/suppliers,
which is an important aspect of the
Shared Savings Program. In addition, it
is consistent with the requirement
under § 425.108(d) that each ACO
provider/supplier must demonstrate a
meaningful commitment to the mission
of the ACO to ensure its likely success.
Because an ACO cannot be successful in
the Shared Savings Program without
satisfying the quality reporting
requirements, we believe a meaningful
commitment by ACO providers/
suppliers to the mission of the ACO
includes assisting with and engaging in
annual quality reporting through the
ACO. Further, ACO reporting reduces
burden for those in small or solo
practices, and places a focus on
population health by encouraging care
coordination by ACO providers/
suppliers to improve the health of the
broader patient population for which
they are responsible. Finally, we believe
that such group reporting is consistent
with group reporting under various
other CMS initiatives and therefore, we
do not intend to remove the requirement
that ACOs report on behalf of the EPs
who bill under the TIN of an ACO
participant. As a corollary, we would
continue to use ACO data preferentially
for purposes of assessing or determining
an EP’s quality performance for
purposes of programs such as PQRS or,
by extension, the VM.
However, we believe that when an
ACO does not satisfactorily report for
purposes of PQRS, it may be appropriate
to accept and use data that is reported
outside the ACO. For PQRS to be able
to accept and use data reported outside
the ACO, however, we must modify the
provision at § 425.504 prohibiting EPs
that bill under the TIN of an ACO
participant in an ACO to report
separately for purposes of PQRS. We are
therefore proposing to modify § 425.504
to lift the prohibition on separate
reporting for purposes of the 2017 and
2018 PQRS payment adjustment. We
believe this change to our program rules
is necessary for several reasons.
First, we believe it is necessary to
protect EPs that participate in ACOs that
fail to satisfactorily report all of the
ACO GPRO measures. Although 98
percent of ACOs successfully complete
required quality reporting annually,
there have been a few instances where
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an ACO has failed to report all of the
required measures, for example, where
an ACO has terminated its participation
in the Shared Savings Program and did
not quality report on behalf of the EPs
that bill under the TIN of an ACO
participant at the end of the
performance year as required under our
close-out procedures. In other instances,
some ACOs continued to participate in
the Shared Savings Program but failed
to complete quality reporting in a timely
manner. In these instances, the lack of
complete quality reporting by the ACO
translated into a failure for the EPs
within the ACO to receive a PQRS
incentive (or to avoid the PQRS
downward adjustment) for that year.
Second, PQRS has transitioned away
from providing incentive payments to
applying only downward payment
adjustments to payments under the
Medicare Physician Fee Schedule,
making it even more important for EPs
to ensure they comply with the
reporting requirements for PQRS. Under
the current rules, EPs who bill under the
TIN of an ACO participant within an
ACO must ultimately rely on the ACO
to report on their behalf. These EPs are
only able to encourage and facilitate
ACO reporting, but lack the ability to
ensure that the ACO satisfactorily
reports in order to prevent application
of the payment adjustment. The
proposed change to allow EPs to report
separately would provide them a
mechanism over which they have direct
control to ensure satisfactory reporting
occurs. Additionally, we note that
because there are no more payment
incentives under the PQRS, there is no
longer any concern that an EP may
inadvertently receive duplicative PQRS
incentive payments from CMS. Specific
issues and policies related to data
reported by EPs apart from an ACO for
purposes of avoiding the PQRS payment
adjustment for payment years 2017 and
2018 are addressed in section III.H. of
this proposed rule.
Third, under the VM, if the ACO
satisfactorily reports quality data on
their behalf, groups and solo
practitioners that bill under the TIN of
an ACO participant will be evaluated
under the quality tiering methodology
and could qualify for an upward
payment adjustment if the ACO
satisfactorily reports on their behalf.
However, if the ACO does not
satisfactorily report quality data as
required under § 425.504 then groups
and solo practitioners that bill under the
TIN of an ACO participant fall into
Category 2 for the VM and are subject
to a downward payment adjustment. In
section III.G. of this proposed rule, we
make proposals for how quality data
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reported by EPs billing under the TINs
of ACO participants that is reported
apart from the ACO for purposes of
avoiding the VM downward payment
adjustment for 2017 and 2018.
For the reasons noted above, we
believe it is appropriate to retain the
provisions under § 425.504 that require
the ACO to report all of the ACO GPRO
measures to satisfactorily report on
behalf of the EPs who bill under the TIN
of an ACO participant for purposes of
the PQRS payment adjustment,
however, we are proposing to modify
the provisions that prohibit EPs that bill
under the TIN of an ACO participant to
report apart from the ACO. Specifically,
we propose to add a redesignated and
revised paragraph at § 425.504(d) to
address the requirement that the ACO
report on behalf of the eligible
professionals who bill under the TIN of
an ACO participant for purposes of the
of the 2017 and 2018 PQRS payment
adjustment. Under this revised
provision the prohibition on separate
quality reporting for purposes of the
PQRS payment for 2017 and 2018
would be removed. We also propose to
make a technical change to § 425.504 to
move existing § 425.504(d) to
§ 425.504(c)(5) because the intent of this
provision was to parallel the language of
§ 425.504(b)(6) for purposes of the
payment adjustment for 2016 and
subsequent years. We reiterate our
intent that data reported by an ACO
would continue to be preferentially
used for purposes of other CMS
initiatives that rely on such data,
including the PQRS and the VM, as
discussed in sections III.I. and III.M.,
respectively. If an EP who bills under
the TIN of an ACO participant chooses
to report apart from the ACO, the EP’s
data may be used for purposes of PQRS
and VM only when complete ACO
reported data is not available.
Additionally, we note that under the
Shared Savings Program, only the
quality data reported by the ACO as
required under § 425.500 would be used
to assess the ACO’s performance under
the Shared Savings Program. In other
words, quality data submitted separately
from the ACO will not be considered
under the Shared Savings Program. We
request comments on this proposal.
f. Alignment With the Quality Payment
Program (QPP)
1. Background and Introduction to the
Quality Payment Program
The Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA)
(Pub. L. 114–10, enacted April 16,
2015), amended title XVIII of the Act to
repeal the Medicare sustainable growth
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46427
rate (SGR) and strengthen Medicare
access by improving physician
payments and making other
improvements, to reauthorize the
Children’s Health Insurance Program,
and for other purposes. The statute
established the Merit-Based Incentive
Payment System (MIPS), a new program
for certain Medicare-participating
practitioners. MIPS consolidates
components of three existing programs,
the PQRS, the Physician Value Modifier
(VM), and the Medicare Electronic
Health Record (EHR) Incentive Program
for EPs. The statute also established
incentives for participation in certain
alternative payment models (APMs). On
April 27, 2016, the Department of
Health and Human Services (HHS)
issued a proposed rule to implement
key provisions of the MACRA and
establish a new Quality Payment
Program (QPP) (Medicare Program;
Merit-Based Incentive Payment System
(MIPS) and Alternative Payment Model
(APM) Incentive under the Physician
Fee Schedule, and Criteria for
Physician-Focused Payment Models (81
FR 28162 through 28586) (the QPP
proposed rule)). The QPP proposed rule
proposes to implement a Quality
Payment Program (QPP) that replaces a
patchwork system of Medicare reporting
programs with a flexible system that
allows practitioners to choose from two
paths that link quality to payments: the
Merit-Based Incentive Payment System
(MIPS) and Advanced Alternative
Payment Models (APMs). As proposed,
MIPS and the APM incentive will
impact practitioner payments beginning
in payment year 2019 based on 2017
reporting. MIPS is a new program that
combines parts of the Physician Quality
Reporting System (PQRS), Value
Modifier (VM) and Medicare Electronic
Health Record (EHR) Incentive Program
into a single program in which eligible
clinicians (ECs) will be measured over
4 categories which include quality,
resource use, clinical practice
improvement, and advancing care
information. The QPP proposed rule
specifically addresses ECs that
participate in APMs and Advanced
APMs, such as the Shared Savings
Program. Specifically, for ECs
participating in APMs, the QPP
proposed rule proposes to:
• Establish criteria for reporting
under each of the 4 categories. For
example, the QPP proposed rule
proposes for the quality performance
category to use quality information
submitted by the ACO through the CMS
web interface to assess each EC billing
under the TIN of an ACO participant.
For assessing performance in the
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category of advancing care information
for ECs billing under the TIN of an ACO
participant, the QPP proposed rule
proposes to aggregate EC-reported data
to calculate an ACO score which is
applied to each participating EC.
• Define an Advanced APM as one
that meets several criteria including
requiring participants to use certified
EHR technology (CEHRT). As proposed
under the QPP proposed rule, only
Tracks 2 and 3 of the Shared Savings
Program have the potential to meet all
criteria necessary for designation as an
Advanced APM. As proposed, in order
to meet the CEHRT requirement, the
Medicare Shared Savings Program must
hold ACOs accountable for their
participating eligible clinicians’ use of
CEHRT by applying a penalty or reward
based on the degree of use of CEHRT
(such as the percentage of EPs that are
using CEHRT or the care coordination or
other activities they perform using
CEHRT).
We therefore reviewed the Shared
Savings Program rules and identified
several modifications to program rules
that we believe must be proposed in
order to support and align with this
effort. These proposed modifications are
discussed in more detail below and
include:
• Revisions to §§ 425.504 and
425.506 to sunset Shared Savings
Program alignment with PQRS and the
EHR Incentive Program starting with
quality reporting period 2017
(corresponding to payment year 2019).
• Addition of new paragraph
§ 425.506(e) and section § 425.508 to
align with the proposed Quality
Payment Program, including rules
addressing annual assessment of an
ACO ECs’ use of CEHRT and for ACO
reporting of certain quality measures to
satisfy the quality performance category
on behalf of the eligible clinicians who
bill under the TIN of an ACO
participant.
• Modifications to the EHR measure
title and specifications necessary to
align with the proposed QPP criteria for
determining Advanced APM status,
including scoring requirements for the
limited circumstances when the
measure is designated as pay for
reporting.
2. Proposals Related to Sunsetting PQRS
and EHR Incentive Program Alignment
and Alignment With APM Reporting
Requirements Under the Quality
Payment Program
The Shared Savings Program has
established rules at §§ 425.504 and
425.506 incorporating reporting
requirements related to PQRS and the
EHR Incentive Program. The current
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provision at § 425.504(c), addresses the
PQRS payment adjustment for 2016 and
subsequent years. Under the existing
Shared Savings Program rules, which
we propose to modify as discussed in
the immediately preceding section, EPs
who bill under the TIN of an ACO
participant within an ACO may only
participate under their ACO participant
TIN as a group practice under the PQRS
Group Practice Reporting Option for
purposes of the PQRS payment
adjustment under the Shared Savings
Program. ACOs must submit all of the
ACO GPRO measures to satisfactorily
report on behalf of their eligible
professionals for purposes of the PQRS
payment adjustment. Under the current
rules, if an ACO does not satisfactorily
report, each EP participating in the ACO
receives a payment adjustment under
PQRS. As discussed in this rule, we
have proposed to revise the rules to
allow EPs who bill under the TIN of an
ACO participant within an ACO to
report separately from their ACO for
purposes of the PQRS payment
adjustment for 2017 and 2018.
At § 425.506, we address alignment
with the EHR Incentive Program.
Specifically, at § 425.506(a), we assert
that ACOs, ACO participants, and ACO
providers/suppliers are encouraged to
develop a robust EHR infrastructure,
which aligns with our eligibility criteria
under § 425.112 that require ACOs to
define care coordination processes,
which may include the use of enabling
technologies such as CEHRT. At
§ 425.506(b) and (c) we state that the
quality measure regarding EHR adoption
is measured based on a sliding scale and
that it is weighted twice that of any
other measure for scoring purposes and
determining compliance with quality
performance requirements for domains.
To align with the EHR incentive
program we state in § 425.506(d), 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 the EP extracts
data necessary for the ACO to satisfy the
quality reporting requirements under
the Shared Savings Program from
CEHRT and when the ACO reports the
ACO GPRO measures through a CMS
web interface. EPs are responsible for
meeting the rest of the EHR incentive
program requirements apart from the
ACO.
As noted in this section of the
proposed rule, the VM, PQRS and the
EHR incentive programs are sunsetting
and the last quality reporting period
under these programs is proposed to be
2016, which would impact payments in
2018. Quality reporting under the QPP,
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as proposed, would begin in 2017 for
payment year 2019. In order to align
with the policies proposed in the QPP
proposed rule, we propose to amend
§§ 425.504 and 425.506 to indicate that
these reporting requirements apply to
ACOs and their EPs through the 2016
performance year. Specifically, at
§ 425.504(c) we propose to remove the
phrase ‘‘for 2016 and subsequent
performance years’’ each time it appears
and add in its place the phrase ‘‘for
2016.’’ As noted in section III.H. of this
rule, we propose a technical change to
redesignate paragraph (d) as paragraph
(c)(5) and then to add new paragraph (d)
to address PQRS alignment rules for the
2017 and 2018 PQRS payment
adjustment. Similarly, at § 425.506, we
propose to revise paragraph (d) to
indicate that the last reporting year for
the EHR Incentive program is 2016. As
stated in this section of the proposed
rule, the PQRS and EHR incentive
programs are sunsetting and we have
proposed that the Quality Payment
Program will begin with the 2017
reporting year, and payment
adjustments will take effect in 2019 for
eligible clinicians.
In addition, we propose to require
ACOs, on behalf of the ECs who bill
under the TIN of an ACO participant, to
report quality measures through the
CMS web interface in order to satisfy
the QPP quality performance category.
Currently, ACOs are required under
§ 425.504 to report measures on behalf
of the EPs who bill under the TIN of an
ACO participant for purposes of PQRS.
Under the QPP proposed rule, the
quality data submitted to the CMS web
interface by ACOs would satisfy the
quality performance category for ECs
participating in the ACO. Therefore, in
order to align with the QPP proposals,
we propose to add a new paragraph at
§ 425.508(a) that parallels the current
requirement at § 425.504 for reporting
on behalf of EPs who bill under the TIN
of an ACO participant for purposes of
PQRS. Specifically, we propose to
require that ACOs, on behalf of ECs who
bill under the TIN of an ACO
participant, must submit all the ACO
CMS web interface measures required
by the Shared Savings Program using a
CMS web interface, to meet reporting
requirements for the quality
performance category under MIPS. We
also propose to maintain flexibility for
EPs to report quality performance
category data separately from the ACO,
and therefore, do not propose to include
a provision that would restrict an EP
from reporting outside the ACO. The
intent is to permit flexibility in
reporting quality data. Under the Shared
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Savings Program, however, no quality
data reported apart from the ACO will
be considered for purposes of assessing
the quality performance of the ACO. We
note that the QPP proposed rule does
not address what, if any, separately
reported EC quality performance
category data might be considered,
however, we believe it is important to
retain flexibility in the event we finalize
a policy under the QPP that would
permit consideration of quality
performance category data that is
submitted separately by ECs
participating in ACOs.
3. Proposals Related to Alignment With
the Quality Payment Program (QPP)
In the QPP proposed rule (81 FR
28296) we outlined and defined the
proposed criteria for Advanced APMs,
APMs through which ECs would have
the opportunity to become Qualified
Participants as specified in section
1833(z)(3)(C) and (D) of the Act. First,
under MACRA, for an APM to be
considered an Advanced APM, it must
meet three requirements: (1) Require
participants to use certified EHR
technology; (2) provide payment for
covered professional services based on
quality measures comparable to those
used in the quality performance
category of MIPS; and (3) be either a
Medical home Model expanded under
section 1115A(c) of the Act or bear more
than an nominal amount of risk for
monetary losses. In the QPP proposed
rule, we proposed criteria for each of
these requirements (81 FR 28296). As
proposed under the QPP proposed rule,
significant distinctions between the
design of different tracks or options
within an APM mean that certain tracks
or options could meet the proposed
Advanced APM criteria while other
tracks or options may not. Because of
this, only Tracks 2 and 3 of the Shared
Savings Program would have the
potential to meet all criteria necessary
for designation as an Advanced APM.
Under the approach discussed in the
QPP proposed rule, while all ACOs
would meet the criterion for provider
payment based on quality measures
comparable to those used in the quality
performance category of MIPS, only
Tracks 2 and 3 would appear to the
meet the proposed financial risk
standard to bear more than a nominal
amount of risk for monetary losses.
For purposes of meeting the CEHRT
requirement, we proposed in the QPP
proposed rule to adopt for Advanced
APMs the definition of CEHRT that is
proposed for MIPS and the APM
incentive under § 414.1305 (see 81 FR
28299 for more detailed information).
We also noted in the QPP proposed rule
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that the statute does not specify the
number of ECs who must use CEHRT or
how CEHRT must be used in an
Advanced APM. For this reason, we
stated we believed it was reasonable to
use discretion when proposing details
on how APMs might meet criteria. In
the QPP proposed rule, we proposed
that an Advanced APM must require at
least 50 percent of ECs who are enrolled
in Medicare (or each hospital if
hospitals are the APM participants) to
use the certified health IT functions
outlined in the proposed definition of
CEHRT to document and communicate
clinical care with patients and other
health care professionals. However, we
stated we believed it was appropriate to
propose an alternative criterion for
CEHRT use for the Shared Savings
Program because, although the Shared
Savings Program requires ACOs to
encourage and promote the use of
enabling technologies (such as EHRs) to
coordinate care for assigned
beneficiaries, the Shared Savings
Program does not require a specific level
of CEHRT use for participation in the
program. Instead, the Shared Savings
Program, as noted above, includes an
assessment of EHR use as part of the
quality performance standard which
directly impacts the amount of shared
savings/shared losses generated by the
ACO. We therefore proposed an
alternative criterion available only to
the Shared Savings Program.
Specifically, we proposed that the
alternative criterion would allow the
Shared Savings Program to satisfy the
EHR criterion if it holds APM Entities
accountable for their ECs’ use of CEHRT
by applying a financial penalty or
reward based on the degree of CEHRT
use (such as the percentage of ECs that
use CEHRT or the engagement in care
coordination or other activities using
CEHRT). We noted that the current EHR
quality measure at ACO #11, as noted
above, assesses the degree to which
certain ECs in the ACO successfully
meet the requirements of the EHR
Incentive Program, which requires the
use of CEHRT by certain ECs in the
ACO, and we stated that ‘‘[s]uccessful
reporting of the measure for a
performance year gives the ACO points
toward its overall quality score, which
in turn affects the amount of shared
savings or shared losses an ACO could
earn or be liable for, respectively.’’ (81
FR 28300). Finally, we stated that we
believed the alternative criterion meets
the statutory requirement because the
‘‘proposed alternative criterion builds
on established Shared Savings Program
rules and incentives that directly tie the
level of CEHRT use to the ACO’s
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46429
financial reward which in turn has the
effect of directly incentivizing everincreasing levels of CEHRT use among
EPs.’’
In light of these QPP proposals, we
are proposing several modifications to
our program rules in order to align with
the QPP proposals.
First, we propose to modify the title
and specifications of the EHR quality
measure (ACO #11). This measure is
currently titled Percent of PCPs Who
Successfully Meet Meaningful Use
Requirements. Under the current Shared
Savings Program rules, ACOs must
report on and are held accountable for
certain measures that make up the
quality reporting standard. One of these
measures, ACO #11, assesses the degree
of CEHRT use by primary care
physicians participating in the ACO and
performance on this measure is
weighted twice that of any other
measure for scoring purposes. To
calculate this measure, CMS collects
information submitted by PCPs through
the EHR Incentive Program and
determines the rate of CEHRT use by
PCPs participating in the ACO.
Specifically, as explained in our
guidance [https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/sharedsavingsprogram/
Downloads/2015-ACO11-Percent-PCPSuccessfully-Meeting-Meaningful-UseRequirement.pdf ], the denominator is
based on all PCPs who are participating
in the ACO in the reporting year under
the Shared Savings Program and the
numerator for the measure is based on
the PCPs included in the denominator
who successfully qualify to participate
in either the Medicare or Medicaid EHR
Incentive Program in the year indicated.
Results of this measure are used in
determining the ACO’s overall quality
score which in turn determines the
ACO’s final sharing/loss rate and the
amount of shared savings earned (or
shared losses owed) by the ACO.
Additionally, under the proposed
policies included in the QPP proposed
rule, ECs participating in an ACO would
satisfy the Advancing Care Information
category by reporting meaningful use of
EHRs apart from the ACO (81 FR 28247,
Table 15). Similar to the process
currently used under the Shared
Savings Program to determine what
practitioners have met criteria for
meaningful use for the ACO #11
measure, we anticipate accessing ECreported data under the Advancing
Clinical Information category to assess
the ACO’s overall use of CEHRT.
Because the current measure only
assesses the degree of use of CEHRT by
primary care physicians participating in
the ACO, we propose to modify the EHR
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measure to align with the QPP
proposals. Specifically, we propose to
change the specifications of the EHR
measure to assess the ACO on the
degree of CEHRT use by all providers
and suppliers designated as ECs under
the QPP proposed rule that are
participating in the ACOs rather than
narrowly focusing on the degree of use
of CEHRT of only the primary care
physicians participating in the ACO. We
believe this modification to the
specifications for ACO #11 would better
align with the QPP proposals and
ensure a subset of ACOs in the Shared
Savings Program could qualify to be
Advanced APM entities. We would also
modify the title of the measure to
remove the reference to PCPs. We
believe the modification in the
specifications of ACO #11 will be
extensive and will require ECs to gain
familiarity with the reporting
requirements under the QPP proposed
rule. We therefore propose that this
measure would be considered a newly
introduced measure and set at the level
of complete and accurate reporting for
the first two reporting period for which
reporting of the measures is required
according to our rules at § 425.502(a)(4).
Therefore, the measure would be pay for
reporting for the 2017 and 2018
performance years. We further propose
to define requirements specific to this
measure for the limited circumstances
in which it is designated as pay for
reporting. Specifically, we propose to
include the requirement at
§ 425.506(e)(1) that during years in
which ACO #11 is designated as a pay
for reporting measure, in order for us to
determine that the ACO has met
requirements for complete and accurate
reporting, at least one EC as we have
proposed to define the term in the
Proposed QPP rule, participating in the
ACO must meet the reporting
requirements under the Advancing
Clinical Information category under the
QPP, as proposed under the QPP
proposed rule. We believe this proposal
would safeguard the ability of Tracks 2
and 3 to fully meet all criteria for
designation as Advanced APMs as
proposed in the QPP proposed rule by
ensuring the letter and spirit of the
statutory criteria are met, even in the
limited circumstances when ACO #11 is
designated as pay for reporting under
the Shared Savings Program. Beginning
in the 2019 performance year, ACO #11
would be assessed according to the
phase-in schedule noted in Table 36
which remains consistent with the
current phase-in schedule under which
the measure will be phased in to pay for
performance starting with PY2 of an
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ACO’s first agreement period and for all
performance years of any subsequent
agreement periods, assuming no major
changes to the measure that would
cause us to consider the measure to be
a newly introduced measure and revert
it to pay for reporting. We therefore
further propose to add § 425.506(e)(2)
reiterating our current requirement at
§ 425.506(b) that during pay for
performance years, assessment of EHR
adoption is measured based on a sliding
scale. We do not intend that our
proposal to use this measure to assess
the degree of CEHRT use by ECs
participating in the ACO for purposes of
meeting the CERHT criterion for
Advanced APMs under the QPP to
change the way we treat the measure
under pay for performance now. Similar
to the current method used by the
Shared Savings Program to calculate the
EHR measure, the data will continue to
be derived using EC reported EHR data
that is required and collected by MIPS
as proposed in the QPP proposed rule.
Additionally, the measure will remain
double weighted. We propose to retain
the existing EHR measure requirements
at § 425.506(a)–(c) and to modify
§ 425.506(d) to sunset the current EHR
reporting requirement as noted in the
prior section.
Finally, consistent with our
statements in the QPP proposed rule as
noted above, we do not believe that any
additional modifications or exceptions
to current program rules (other than the
ones proposed here, specifically, that
the measure specifications and title of
ACO #11 be modified to include all ECs
and not just PCPs, and the proposal for
how an ACO would demonstrate
complete and accurate reporting) must
be made in order to be consistent with
the spirit and intent of the statute and
the QPP proposed criteria. Rather, the
existing Shared Savings Program rules
are sufficient to meet the QPP proposed
criteria for Tracks 2 and 3 to be
designated as eligible APMs because the
EHR quality measure will always be
used to impact the amount of shared
savings or losses of an ACO, regardless
of whether it is designated as pay for
performance or pay for reporting. We
note that the EHR measure has an
especially significant impact on the
overall quality scoring for an ACO
because it is double-weighted compared
to any other measure. In spite of this, we
are considering additional options
regarding the treatment of the EHR
measure under the Shared Savings
Program in order to further enhance the
importance of this measure and its
impact on an ACO’s quality
performance score and to improve
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alignment with the intent of the policies
proposed in the QPP proposed rule.
Specifically, we are considering
whether to finalize a policy that would
require the EHR measure to be P4P in
all performance years, including the
first year of an ACO’s first agreement
period. Additionally, we are considering
whether to finalize a policy that would
require the EHR measure to remain P4P,
even when a new EHR measure is
introduced or there are significant
modifications to the specifications for
the measure. Such modifications may
require additional changes or alternative
approaches to certain current Shared
Savings Program rules related to quality
benchmarking and scoring. We
anticipate that if such modifications are
made, they would only apply to the
EHR measure and would not impact
current scoring and benchmarking rules
for other quality measures that make up
the quality performance standard. For
example, if a final policy is adopted that
requires the EHR measure to remain P4P
in the face of changes to the measure,
we anticipate that we would need to
establish a benchmark appropriate for
the measure that does not depend on
FFS or ACO generated data and
distributing points on a sliding scale
according to the benchmark because no
FFS or ACO generated data would be
available to do so in the first 2 years of
the use of the new measure. For
example, we may use a flat rate to assess
performance or create a scale that aligns
with our final QPP policies (for
example, assessing ACO performance on
a scale from 0–50 percent or 0–75
percent) and incrementally making
points available depending on level of
attainment. Additionally, we would
consider exempting the EHR measure
from ‘‘minimum attainment level’’ rules
that would normally apply to a pay for
performance measure, at least for the
first 2 years of implementation and/or
the first year of the first agreement
period since the measure would be new
to the ACO. Finally, we would consider
whether these modifications should
apply to the EHR measure only for
tracks that could meet the requirements
for designation as Advanced APMs
under the forthcoming QPP final rule;
we note that under the QPP proposed
rule, only Tracks 2 and 3 would be
designated as Advanced APMs. We seek
comment on how best to conform to the
intent and spirit of the QPP
requirements to ensure that clinicians
have assurance they are participating in
an Advanced APM. We specifically seek
comment on our proposals and the
alternatives considered.
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Finally, we note that the CMS web
interface measures, including those
proposed in the QPP proposed rule, are
consistent across CMS reporting
programs. We do not believe it is
beneficial to propose CMS web interface
measures for ACO quality reporting
separately. Therefore, to avoid
confusion and duplicative rulemaking,
we propose that any future changes to
the CMS web interface measures would
be proposed through rulemaking for the
QPP and would be applicable to ACO
quality reporting under the Shared
Savings Program.
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4. Incorporating Beneficiary Preference
Into ACO Assignment
a. Background
Under section 1899(c) of the Act,
beneficiaries are required to be assigned
to an ACO participating in the Shared
Savings Program based on the
beneficiary’s utilization of primary care
services rendered by physicians
participating in the ACO. Medicare FFS
beneficiaries do not enroll in the Shared
Savings Program, and they retain the
right to seek Medicare-covered services
from any Medicare-enrolled provider or
supplier of their choosing. No
exclusions or restrictions based on
health conditions or similar factors are
applied in the assignment of Medicare
FFS beneficiaries. Thus, a beneficiary’s
choice to receive primary care services
furnished by physicians and certain
non-physician practitioners that are
ACO professionals in the ACO,
determines the beneficiary’s assignment
to an ACO under the Shared Savings
Program. As discussed in detail in the
November 2011 Medicare Shared
Savings Program final rule (76 FR 67851
through 67870), we finalized a claimsbased hybrid approach (called
preliminary prospective assignment
with retrospective reconciliation) for
assigning beneficiaries to an ACO.
Under this approach, beneficiaries are
preliminarily assigned to an ACO at the
beginning of a performance year to help
the ACO refine its care coordination
activities, but final beneficiary
assignment is determined at the end of
each performance year based on where
beneficiaries chose to receive a plurality
of their primary care services during the
performance year. We adopted this
policy because we believe that the
methodology balances beneficiary
freedom to choose healthcare providers
under FFS Medicare with the ACO’s
desire to have information about the
FFS beneficiaries that are likely to be
assigned at the end of the performance
year. We believe this methodology
accomplishes an appropriate balance
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because ACOs have the greatest
opportunities to impact the quality and
cost of the care of beneficiaries that
choose to receive care from providers
and suppliers participating in the ACO
during the course of the year.
A beneficiary is eligible for
assignment to an ACO under § 425.402
if the beneficiary had a primary care
service with a physician who is an ACO
professional, and thus, is eligible for
assignment to the ACO under the
statutory requirement to base
assignment on ‘‘utilization of primary
care services’’ furnished by physicians
who are ACO professionals in the ACO.
The beneficiary is then assigned to the
ACO if the allowed charges for primary
care services furnished to the
beneficiary by all primary care
physicians who are ACO professionals
and non-physician ACO professionals in
the ACO are greater than the allowed
charges for such services provided by
primary care physicians, nurse
practitioners, physician assistants, and
clinical nurse specialists who are ACO
professionals in another ACO or not
affiliated with any ACO and are
identified by a Medicare-enrolled TIN.
The second step of the assignment
process considers the remainder of
beneficiaries who have received at least
one primary care service from an ACO
physician with a specialty designation
specified in § 425.402(c) , but have
received no services from a primary care
physician, nurse practitioner, physician
assistant, or clinical nurse specialist
either inside or outside the ACO. These
beneficiaries are assigned to the ACO if
the allowed charges for primary care
services furnished by physicians who
are ACO professionals in the ACO with
one of the specialty designations
specified in § 425.402(c) are greater than
the allowed charges for primary care
services furnished by physicians with
such specialty designations in another
ACO or who are not affiliated with any
ACO and are identified by a Medicareenrolled TIN. The ‘‘two step’’
assignment process simultaneously
maintains the requirement to focus on
primary care services in beneficiary
assignment, while recognizing the
necessary and appropriate role of
specialists and non-physician
practitioners in providing primary care
services, such as in areas with primary
care physician shortages. We revised
this two-step claims based methodology
in the June 2015 Final Rule as discussed
in detail in that final rule (80 FR 32743
through 32758) and finalized a policy
that would exclude services provided by
certain physician specialties from step 2
of the assignment process.
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Additionally, in the June 2015 final
rule, and in response to stakeholders,
we implemented an option for ACOs to
participate in a new two-sided
performance-based risk track, Track 3.
Under Track 3, beneficiaries are
prospectively assigned to the ACO at the
beginning of the performance year using
the same two-step methodology, based
on the most recent 12 months for which
data are available, which reflects where
beneficiaries have chosen to receive
primary care services during that
period. The ACO is held accountable for
beneficiaries that are prospectively
assigned to it for the performance year.
Under limited circumstances, a
beneficiary may be excluded from the
prospective assignment list, for
example, if the beneficiary enrolls in
Medicare Advantage or no longer lives
in the United States or U.S. territories
and possessions, based on the most
recent available data in our beneficiary
records at the end of the performance
year. A beneficiary is not excluded from
the ACO’s prospective assignment list at
the time of reconciliation because the
beneficiary chose to receive most or all
of his or her primary care during the
performance year from providers and
suppliers outside the ACO.
Additionally, no beneficiaries are added
to the ACO’s prospective assignment list
at the time of reconciliation because a
beneficiary chose to receive a plurality
of his or her primary care during the
performance year from ACO
professionals participating in the ACO.
Offering this alternative approach to
beneficiary assignment responds to
stakeholders who expressed a desire for
a prospective assignment approach.
These stakeholders believe prospective
assignment will provide more certainty
about the beneficiaries for whom the
ACO will be held accountable during
the performance year, thus enabling
ACOs to redesign their patient care
processes to more efficiently and
effectively improve care for specific FFS
beneficiaries rather than for all FFS
beneficiaries. We note, however, that
such certainty is limited because
prospectively aligned beneficiaries who
meet the exclusion criteria specified in
§ 425.401(b) during the performance
year will not be aligned to the ACO at
the end of the year; and further, as
noted, beneficiaries remain free under
FFS Medicare to choose the healthcare
providers from whom they receive
services.
Because of uncertainty inherent in
FFS Medicare where there is no
beneficiary lock-in or enrollment, both
patient advocacy groups and ACOs have
expressed interest in and support for
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enhancing claims-based assignment of
beneficiaries to ACOs by taking into
account beneficiary attestation regarding
the healthcare provider that they
consider to be responsible for
coordinating their overall care.
Stakeholders believe that incorporating
this information and giving beneficiaries
the opportunity to voluntarily ‘‘align’’
with the ACO in which their primary
healthcare provider participates will
improve the patient centeredness of the
assignment methodology. In theory,
active beneficiary acknowledgement of
the practitioner they believe to be
responsible for their overall care could
enhance engagement and the
beneficiary’s commitment to receive the
bulk of his or her primary care from the
designated practitioner. In turn, some
stakeholders believe this could reduce
year-to-year ‘‘churn’’ in beneficiary
assignment lists and, in the case of
prospective assignment, potentially
increase certainty further because the
increase in beneficiary engagement may
encourage the beneficiary to receive care
during the performance year from ACO
providers/suppliers, to the extent that
the beneficiary is aware of which
providers and suppliers participate in
the ACO. However, we note that such a
process would not obligate the
beneficiary to receive care from ACO
providers/suppliers because the
beneficiary would retain freedom under
FFS Medicare to receive services from
whichever provider or supplier the
beneficiary chooses. Thus, while taking
beneficiary attestation into account in
the assignment algorithm may improve
beneficiary engagement and therefore
reduce year-to-year ‘‘churn’’ in
beneficiary assignment of such patients,
it may not result in the sort of certainty
that some ACOs desire, particularly
with respect to where beneficiaries
choose to receive services.
To begin to address these concerns,
the Center for Medicare & Medicaid
Innovation (Innovation Center) began
conducting a test of beneficiary
attestation (which was referred to as
voluntary alignment, a term that we will
also use in the context of the Shared
Savings Program) in the Pioneer ACO
Model (see https://innovation.cms.gov/
initiatives/Pioneer-aco-model/) for the
2015 performance year.
In the Pioneer ACO Model, for a
Pioneer ACO to participate in voluntary
alignment for performance year four
(Pioneer ACO contract year 2015), the
Pioneer ACO was required to submit an
application to CMS in the summer of
performance year three (Pioneer ACO
contract year 2014) in which the ACO
explained its plan for contacting
beneficiaries. ACOs that were approved
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to participate in voluntary alignment
were limited to contacting only those
beneficiaries who appeared on the
ACO’s then current (Pioneer ACO
contract year 2014) and prior year’s
(Pioneer ACO contract year 2013)
prospective assignment lists.
The ACOs sent letters to beneficiaries
during a specified period asking the
beneficiaries to confirm whether a listed
Pioneer Provider/Supplier was their
‘‘main doctor.’’ The Innovation Center
imposed certain safeguards on the
participating ACOs to protect against
actions that could improperly influence
a beneficiary’s decision to complete the
voluntary alignment form. The ACOs
collected responses and turned them in
to CMS in fall 2014, before the start of
the 2015 performance year.
Beneficiaries who confirmed a care
relationship with the Pioneer Provider/
Supplier listed on the form, and met all
other eligibility criteria for alignment,
were prospectively aligned to the
Pioneer ACO for the upcoming
performance year, regardless of whether
or not the practitioners participating in
the Pioneer ACO rendered the plurality
of the beneficiary’s primary care
services during the alignment period.
We refer to the procedures used under
the Pioneer ACO Model as ‘‘the manual
process.’’
Because the testing of beneficiary
attestation in the Pioneer ACO Model
was just beginning at the time of the
publication of the December 2014
proposed rule, in that proposed rule we
indicated our interest in beneficiary
attestation, but did not make any
specific proposals. However, we
welcomed comments on whether it
would be appropriate to offer a
beneficiary attestation process to ACOs
participating under two-sided risk
financial arrangements under the
Shared Savings Program in the future
(79 FR 72826 through 72829). We noted
that if we were to offer a beneficiary
attestation process for ACOs in
performance-based risk tracks, we
would anticipate initially implementing
beneficiary attestation in a manner
consistent with the beneficiary
attestation process tested under the
Pioneer ACO Model (79 FR 72829).
Beneficiary and ACO participation in
and experience with voluntary
alignment under the Pioneer ACO
Model to date has been mixed. Initially,
beneficiaries often seemed confused
about the implications of attesting to a
care relationship with a Pioneer
Provider/Supplier, based on the letters
they received from Pioneer ACOs.
Beneficiaries, for example, were often
unfamiliar with the name of the Pioneer
ACO. Although most Pioneer ACOs
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initially expressed high interest in
beneficiary attestation, only half
participated. Those that did not
participate cited cost/benefit concerns.
To address concerns expressed by ACOs
and beneficiaries, the beneficiary
attestation process was updated for the
Pioneer ACO Model for PY 2016, with
letters sent to beneficiaries during the
summer of 2015. The new beneficiary
attestation process includes updated
language in the letters to beneficiaries
and the attestation form to reduce
beneficiary confusion. The letters now
include plainer language, refer to a
specific healthcare provider (in addition
to the ACO), and Pioneer Providers/
Suppliers are permitted to discuss
beneficiary attestation with beneficiaries
and respond to questions. Other
significant changes to the process
include a longer voluntary alignment
period and the ability for ACOs to
provide the letter/form to beneficiaries
via email, patient portal, or other
electronic method (in which case the
forms must be returned with a ‘‘wetink’’ signature, such as by returning the
original signed form by mail. (We
continue to view this updated process to
be a manual process.) In addition there
was a change to the voluntary alignment
eligibility criteria. For performance year
four (Pioneer ACO contract year 2015),
only those beneficiaries who were
identified on a Pioneer ACO’s
prospective alignment list from
performance year two (Pioneer ACO
contract year 2013) or performance year
three (Pioneer ACO contract year 2014)
were eligible to voluntarily align with
the Pioneer ACO for performance year
four, assuming all other eligibility
criteria were met. For performance year
five (Pioneer ACO contract year 2016),
CMS changed the criteria to allow
beneficiaries to voluntarily align into
the performance year five aligned
population if, among other
requirements, the beneficiary had at
least one paid claim for a Qualified E/
M service, as defined in section 2.4 of
Appendix C of the Pioneer ACO
Agreement, furnished by a Pioneer
Provider/Supplier on or after January 1,
2013. Based on some initial feedback,
beneficiaries appear to be wary of the
implications of designating a ‘‘main
doctor’’ but are much more amenable to
this type of information request when it
comes from their physician or other
practitioner, rather than from an ACO.
However, information is not yet
available on the impact or results of the
modifications made to the beneficiary
attestation process in the Pioneer ACO
Model. The Next Generation ACO
Model, which started operation on
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January 1, 2016, includes a beneficiary
attestation policy similar to the updated
manual process used under the Pioneer
ACO model. In order for a Medicare FFS
beneficiary to be eligible to voluntarily
align with a Next Generation ACO for
performance year two (Next Generation
ACO contract year 2017), the beneficiary
must have had at least one paid claim
for a qualified evaluation and
management service on or after January
1, 2014, with an entity that was a Next
Generation Participant during
performance year one, among other
requirements.
To date, the Innovation Center has
done limited analyses of the updated
voluntary alignment process for effects
on beneficiary engagement. Early
experience indicates that for the
participating ACOs, the number of
prospectively assigned beneficiaries per
ACO increased by 0.2 to 2.7 percent
relative to the number of beneficiaries
who would have otherwise been
assigned. However, there is not yet
enough information to determine
whether beneficiary attestation under
the manual process has had an impact
on increasing certainty that a
beneficiary will continue to choose to
receive primary care or other services
from practitioners participating in an
ACO. For example, we would like to
know how many of the beneficiaries
who ‘‘attested’’ into alignment to the
ACO continued to seek primary care
services from ACO professionals during
the performance year, which might
demonstrate increased engagement on
the part of the beneficiary. The
Innovation Center found that ACOs
were implementing the beneficiary
attestation process under the Pioneer
ACO Model as they described in their
applications, and no marketing abuses
have been observed to date.
Based on valuable experience gained
through development and testing of
beneficiary attestation processes
through the Pioneer ACO Model, the
manual process developed thus far
appears to be resource intensive and
may not significantly impact beneficiary
assignment to ACOs. We also note that
a similar manual process for sending
letters to beneficiaries to provide them
notice of their opportunity to opt out of
claims data sharing was removed from
the Shared Savings Program in the June
2015 final rule (see 80 FR 32743). This
data sharing opt out process was
removed because it was resource
intensive and cumbersome for ACOs
and CMS, and was confusing for
beneficiaries. Instead, based on
stakeholder comments, we finalized a
process to provide beneficiaries the
opportunity to decline claims data
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sharing directly by contacting the
Medicare program (through 1–800–
MEDICARE) rather than through the
ACO. This more direct process started at
the end of 2015 and so far appears to be
working well, as it has not generated the
number of complaints and concerns
raised by the initial manual process.
b. Proposals
We continue to believe that it may be
desirable to incorporate beneficiary
attestation into the assignment of
beneficiaries to ACOs participating in
the Shared Savings Program, to
supplement and enhance the current
claims-based algorithm driven
methodology as described in more detail
in this section of the proposed rule. We
agree with stakeholders that
supplementing the current assignment
process with a voluntary alignment
process that incorporates beneficiary
attestation about their ‘‘main doctor’’
could help ACOs to increase patient
engagement, improve care management
and health outcomes, and lower
expenditures for beneficiaries.
Incorporating beneficiary attestation
into the beneficiary assignment process
could further strengthen the current
claims-based, two-step assignment
process. For example, although we
defined certain HCPCS codes at § 425.20
as being ‘‘primary care services,’’ the
use of these codes may not fully capture
the extent of the primary care
relationship a beneficiary has with his
or her provider. Supplementing the
claims-based assignment algorithm with
beneficiary attestations could further
assure that beneficiaries are assigned to
ACOs based on their relationship with
providers that they believe to be truly
responsible for their overall care.
We believe that it would be
appropriate to implement, at a
minimum, a voluntary alignment
process under the Shared Savings
Program that would be similar to the
updated manual process we have
implemented under the Pioneer ACO
Model and that will be used under the
Next Generation ACO Model. However,
based on the valuable knowledge and
experience we have gained through
these Innovation Center models, we are
concerned that the manual voluntary
alignment process used for the Pioneer
ACO Model and that will be used under
the Next Generation ACO Model is
resource intensive for both ACOs and
CMS. The voluntary alignment process
under the Pioneer ACO Model requires
individual ACOs to directly obtain
information from beneficiaries by
sending them a form letter approved by
CMS that includes a copy of a CMSapproved form that the beneficiary may
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46433
complete to confirm their care
relationship with a provider or supplier
that is participating in the ACO (that is,
their ‘‘main doctor’’), whose services are
considered in the alignment process.
The ACOs then communicate these
beneficiary attestations to CMS.
However, not all beneficiaries that
submit an attestation form may be
eligible to be aligned to the ACO.
Accordingly, we must review the
submissions, and provided the
beneficiary is otherwise eligible for
alignment to the ACO, this confirmation
(or attestation) is then used to align the
beneficiary to the ACO. If we were to
implement a similar manual process
under the Shared Savings Program, we
believe it would be appropriate to limit
voluntary alignment to Track 3 ACOs
for the reasons explained later in this
section. Additionally, the timing and
requirements of the process would
prohibit beneficiaries from voluntarily
aligning to ACOs that initially join the
Shared Savings Program under Track 3
for the ACO’s first performance year
because, consistent with the coluntary
alignment process under the Pioneer
ACO and Next Generation ACO models
explained above, an ACO would only be
permitted to contact beneficiaries that
were aligned prospectively to the ACO
in the current or prior years. Thus, a
beneficiary’s designation of an ACO
professional as responsible for
coordinating their overall care would
impact an ACO’s prospective
assignment list starting in PY2,
assuming the ACO met all requirements
necessary for the incorporation of this
information during PY1, including
applying for participation in voluntary
alignment, sending letters, collecting
beneficiary preferences, and timely
submitting all required information to
CMS.
Because of the limitations of the
manual process, we have considered
ways that voluntary alignment might be
implemented in a more automated and
direct way under the Shared Savings
Program, potentially having a more
significant impact on beneficiary
engagement while reducing burdens on
ACOs, ACO participants, ACO
providers/suppliers, ACO professionals,
beneficiaries, and CMS. Automating a
process for Medicare FFS beneficiaries
to designate their ‘‘main doctor’’ or the
other healthcare provider they believe is
responsible for their overall care could
align with agency goals to provide
increased focus on patient centered
care, and improve beneficiary
engagement. We believe strengthening
primary care is critical to an effective
health care system. Automating a
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process for beneficiaries to designate
their ‘‘main doctor’’ or the healthcare
provider they believe is responsible for
their overall care could encourage
beneficiaries to partner with a
healthcare provider to better coordinate
their care, including care with
specialists, and would help to support
the continued development of a health
care system that results in healthier
people and smarter spending of our
health care dollars. Incorporating
beneficiary preferences through
voluntary alignment could also help to
increase the accuracy of the assignment
process. If a beneficiary is aligned to the
ACO in which the healthcare provider
who they believe is responsible for
coordinating their overall care is
participating, there may be an increased
probability that the beneficiary’s care
will be coordinated, resulting in smarter
spending of health care dollars,
including spending on care by
specialists.
We are therefore proposing to
implement an automated approach
under which we could determine which
healthcare provider a FFS beneficiary
believes is responsible for coordinating
their overall care (their ‘‘main doctor’’)
using information that is collected in an
automated and standardized way
directly from beneficiaries (through a
system established by us, such as
MyMedicare.Gov), rather than requiring
individual ACOs, ACO participants, or
ACO professionals to directly obtain
this information from beneficiaries
annually and then communicate these
beneficiary attestations to CMS. We
believe such an approach would be
more efficient for ACOs and their
participants, beneficiaries, and CMS.
We anticipate that, to the extent
feasible, the operational process for
beneficiaries to voluntarily align with
an ACO by designating a ‘‘main doctor’’
or primary healthcare provider would
be incorporated into existing processes.
For example, currently Medicare FFS
beneficiaries already have the ability to
obtain an account at
www.MyMedicare.gov and save
information about their ‘‘favorite’’
providers from that Web site’s Physician
Compare function, so one possibility
would be to include an additional
feature in MyMedicare.Gov that would
allow beneficiaries to indicate which of
their ‘‘favorite’’ healthcare providers
they consider to be responsible for their
overall care. Another possibility would
be to permit beneficiaries to directly
choose their ‘‘main doctor’’ through
1–800–Medicare or through Physician
Compare with a link to
MyMedicare.Gov, similar to the
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mechanism that is currently available to
select a ‘‘favorite’’ healthcare provider
through Physician Compare. We would
notify beneficiaries of this opportunity
and encourage them to designate their
primary healthcare provider and explain
how to do this through beneficiary
outreach materials such as through the
Medicare & You Handbook (see https://
www.medicare.gov/medicare-and-you/
medicare-and-you.html), the required
Shared Savings Program notifications
under § 425.312, and/or other
beneficiary outreach activities or
materials. CMS would issue, either
directly or indirectly through template
language, all written communications to
beneficiaries detailing the automated
process for voluntary alignment.
We propose to make such an
automated mechanism available for
beneficiaries to voluntarily align with
the provider or supplier that they
believe is responsible for coordinating
their overall care starting early in 2017,
making it possible for us to use
beneficiary attestations for assigning
beneficiaries to ACOs in all three tracks
for the 2018 performance year. For
example, if the automated mechanism is
available for beneficiaries in early 2017,
we would be able to use the information
in the fall of 2017 to develop ACO
assignment lists for 2018 for ACOs that
are currently participating in the Shared
Saving Program, as well as those
applying for participation. Voluntary
alignment data would be accessed and
incorporated in the beneficiary
assignment process each time we run
the assignment algorithm. Under the
automated approach, beneficiaries
would be able to change their attestation
about their ‘‘main doctor’’ at any time,
however, we note there may be a lag in
using the information to update an
ACO’s assignment list depending on the
timing of the beneficiary’s updated
designation and the track under which
the ACO is participating. For example,
we propose that beneficiaries who
designate an ACO professional in a
Track 3 ACO as their ‘‘main doctor’’
would be prospectively assigned to that
Track 3 ACO based on their designation
prior to the start of the performance year
as currently provided under
§ 425.400(a)(3). These beneficiaries
would remain assigned to the Track 3
ACO until the end of the benchmark or
performance year, even if they
subsequently designate a practitioner
outside the ACO as their ‘‘main doctor’’,
unless they meet any of the exclusion
criteria under § 425.401(b). We
considered incorporating voluntary
alignment as part of the exclusion
criteria under 425.401(b), however, we
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believe it would be appropriate, when
incorporating voluntary alignment for
Track 3 ACOs, to continue the current
prospective assignment policy provided
under § 425.400(a)(3) because the intent
of prospective assignment is to provide
stability in ACOs’ beneficiary
assignment lists to allow ACOs to
coordinate care appropriately for the
patients assigned to them. This policy
would also align with our policy
regarding the SNF 3-day rule waiver
under § 425.612, which is limited to
eligible beneficiaries who have been
prospectively aligned to a Track 3 ACO,
because it is important for the ACO to
have clear information about which
beneficiaries are eligible to receive SNF
services pursuant to the waiver. The
updated designation would, however,
be considered when conducting
beneficiary assignment for the
subsequent benchmark or performance
year.
Further, we propose to incorporate
voluntary alignment for ACOs in Tracks
1 and 2 on a quarterly basis; that is,
beneficiaries who are not currently
assigned to a Track 3 ACO and who
voluntarily align with a healthcare
provider that is an ACO professional
participating in an ACO under Track 1
or 2 would be reflected in the ACO’s
next preliminary prospective or final
assignment list as provided under
§ 425.400(a)(2). We believe this policy
would be appropriate because it aligns
with the current timing for updates to
Track 1 and 2 ACO assignment lists.
Finally, we propose that if a
beneficiary voluntarily aligns with a
provider or supplier whose services
would be considered in assignment but
who is not participating in an ACO as
an ACO professional, the beneficiary
would not be eligible for alignment to
an ACO, even if the beneficiary would
have otherwise been assigned to an ACO
under our claims-based approach.
We further propose that, if this
automated voluntary alignment process
is not operationally ready for
implementation under the proposed
timeframe, we would implement a
manual voluntary alignment process for
Track 3 ACOs only that builds upon
experience previously gained under the
Pioneer ACO Model. Because a manual
voluntary alignment process is resource
intensive for both ACOs and CMS, we
believe that if it were necessary to adopt
a manual voluntary alignment process
under the Shared Savings Program, it
would be appropriate to initially limit it
to ACOs participating in the Shared
Savings Program under Track 3 because
beneficiaries are prospectively aligned
to Track 3 ACOs (as they are to ACOs
under the Pioneer ACO Model and the
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Next Generation Model). The process
and timing for sending letters to
beneficiaries regarding voluntary
alignment under the manual process
was developed specifically for
prospective alignment and for a limited
number ACOs. It is likely that
attempting to implement such a manual
process for the hundreds of ACOs in
Track 1 and Track 2, whose
beneficiaries are only preliminarily
prospectively aligned with retrospective
reconciliation, would result in
operational challenges for ACOs and
CMS and could have unintended
consequences that could be confusing or
harmful to beneficiaries. Because it is
impossible to anticipate what issues
might arise if we were to try to
implement a manual process across a
large number of ACOs operating under
a preliminary prospective assignment
methodology with retrospective
reconciliation, we are not confident at
this time that we can propose
appropriate procedures and any
additional safeguards that might be
necessary to allow implementation in
all tracks. Therefore, we propose that if
an automated process is not available to
allow beneficiaries to designate their
primary healthcare provider in time to
allow the information to be considered
for beneficiary assignment for
performance year 2018, we would
implement voluntary alignment in a
step-wise fashion over time, beginning
with ACOs in Track 3, whose
beneficiaries are prospectively assigned.
Limiting voluntary alignment to ACOs
to which beneficiaries are prospectively
aligned would permit ACOs and CMS to
initially focus limited resources on
voluntary alignment efforts on a
population of beneficiaries that can be
identified for targeting and outreach
regarding the voluntary alignment
process and the benefits of designating
an ACO professional as responsible for
coordinating their overall care.
More specifically, we propose that if
we determine, by no later than spring
2017, that an automated voluntary
alignment process is not ready for
implementation to allow beneficiaries to
voluntarily align with ACO across all
three Tracks for the 2018 performance
year, then we would implement an
alternative manual voluntary alignment
process to allow beneficiaries to align
with Track 3 ACOs for the 2018
performance year and until such time as
an automated process is available. This
proposed alternative manual voluntary
alignment process for Track 3 ACOs
would be similar to the updated process
that was used under the Pioneer ACO
Model to allow beneficiaries to
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voluntarily align with participating
ACOs for the 2016 performance year
and that we will follow under the Next
Generation ACO Model for the 2017
performance year. Early each year,
starting in 2017, Track 3 ACOs would
notify us as to whether they want to
participate in voluntary alignment for
the upcoming performance year.
Specifically, similar to the process used
under the Pioneer ACO Model and the
Next Generation ACO Model, each
spring starting in 2017, those Track 3
ACOs that have notified CMS that they
would like to participate in voluntary
alignment would be required to provide
us with a list of the beneficiaries they
plan to contact to request that the
beneficiary designate an ACO
professional whose services are
considered in assignment as their ‘‘main
doctor.’’ The ACOs must also submit to
CMS for approval the criteria used to
identify the listed beneficiaries. We
would review these beneficiary lists to
determine if the beneficiary is eligible to
be contacted regarding voluntary
alignment depending on whether the
beneficiary was prospectively assigned
yo the ACO in prior performance years,
similar to the approach used under the
Pioneer ACO Model and the Next
Generation ACO Model approach as
described above. ACOs could then
contact the eligible beneficiaries by
sending them a form letter approved by
CMS, similar to the letter ACOs sent
under the Pioneer ACO Model for 2016,
that would include a copy of a CMSapproved form that the beneficiary
could complete to confirm their care
relationship with an ACO professional,
whose services are considered in the
assignment process, who the ACO
believes may be their ‘‘main doctor.’’
Alternatively, the ACO could provide an
opportunity for beneficiaries to obtain a
copy of the CMS-approved form in the
offices of ACO professionals that furnish
primary care services on which
assignment is based.
Under the manual voluntary
alignment process, by September of
each year, Track 3 ACOs participating in
voluntary alignment for the upcoming
performance year would notify CMS as
to which beneficiaries had agreed to
voluntarily align with their ACO for the
upcoming performance year by
submitting a form designating an ACO
professional whose services are
considered in alignment as responsible
for coordinating their overall care. We
would verify that the beneficiaries are
still eligible for assignment to the ACO,
and prospectively assign all eligible
beneficiaries to the Track 3 ACO for the
upcoming performance year. We would
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repeat this process annually; that is,
under this process, beneficiaries would
be required to voluntarily align each
year by submitting a new form
confirming a care relationship with an
ACO professional whose services are
used in assignment. This approach
would enable us to begin the process of
incorporating beneficiary attestations
into the assignment of beneficiaries to
Track 3 ACOs until a more automated,
direct method of voluntary alignment is
operationally feasible. We believe even
this more limited approach to voluntary
alignment may increase patient
centeredness over the current approach
of assigning beneficiaries to ACOs based
only on the claims-based algorithm
driven methodology for the reasons
discussed above and because some level
of additional beneficiary engagement in
the alignment process may be preferable
to no beneficiary engagement.
Therefore, regardless of process
(manual or automatic), we are proposing
to begin to incorporate beneficiary
attestation into the assignment
methodology for the Shared Savings
Program, effective for assignment for the
2018 performance year. In brief, under
the proposal, an eligible beneficiary
would be assigned to an ACO based on
the existing claims-based assignment
process unless the beneficiary has
designated a healthcare provider as
being responsible for their overall care.
If an eligible beneficiary has made such
a designation then the voluntary
alignment would override the claims
based assignment process. Under an
automated process, beneficiaries would
be able to modify their designation at
any time (not just annually, as under a
manual process), however, as noted
above, there may necessarily be a lag
before that information can be
incorporated into the assignment
methodology for purposes of
determining an ACO’s assignment list,
depending on the timing of the
designation and the track in which the
ACO is participating. The latest that the
information would be updated would be
prior to the start of the next performance
year at a timepoint designated by CMS
in cases where beneficiaries are
prospectively aligned to a Track 3 ACO.
There may also be a lag when a
beneficiary voluntarily aligns with a
practitioner identified by an NPI who is
an ACO professional in an ACO, but
chooses to leave the ACO during a
performance year. For example, there
may be situations in which an eligible
beneficiary voluntarily aligns to a
practitioner billing under ACO
participant TIN A in ACO A
participating in Track 3 and becomes
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prospectively assigned for performance
year 2018 on that basis. In the first
quarter of 2018, the practitioner
reassigns billing rights to ACO
participant TIN B in ACO B, thus
switching ACOs. Under our proposal,
the beneficiary would remain
prospectively aligned to ACO A for the
duration of performance year 2018.
Similarly, there may be situations in
which an eligible beneficiary
voluntarily aligns to a practitioner
billing under ACO participant TIN in
ACO C participating in Track 1 using an
automated process and becomes
preliminarily prospectively aligned
during the first quarter of a performance
year. In the second quarter of the
performance year, the practitioner
reassigns billing rights to a non-ACO
participant TIN. Under our proposals,
the next time a preliminary prospective
assignment list is issued, the beneficiary
would no longer appear on ACO C’s list.
Moreover, voluntary alignment in no
way limits or changes benefits under
FFS Medicare. Because of this, a
beneficiary that meets the eligibility
criteria may voluntarily align with a
practitioner participating in an ACO,
become aligned to the ACO, but
subsequently choose to receive all his or
her primary care from a practitioner that
is unaffiliated with the ACO. In this
case, the beneficiary would continue to
be assigned to the ACO based upon the
beneficiary’s designation of an ACO
professional as their ‘‘main doctor’’ for
the remainder of the performance year
under the manual process, and
indefinitely until the beneficiary
changes his or her designation under the
automated process. Finally, we can
imagine a scenario where a beneficiary
designates as their ‘‘main doctor’’ a
practitioner that is unaffiliated with any
ACO and therefore the beneficiary is not
assigned to an ACO even though the
ACO’s practitioners provided a plurality
of the beneficiary’s primary care
services and would have otherwise been
held accountable for the beneficiary’s
care. Given the high interest in taking
beneficiary preferences for alignment
into account and the potential for
improving beneficiary engagement, we
believe these scenarios, which may
involve undesirable effects on the
accuracy of beneficiary alignment, can
be limited when beneficiaries are
provided sufficient information about
the importance of keeping the
designation of their ‘‘main doctor’’ up to
date.
We emphasize that we do not intend
for the voluntary alignment process
(whether automated or manual) to be
used as a mechanism for ACOs (or their
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ACO participants, ACO providers/
suppliers, ACO professionals or other
individuals or entities performing
functions or services on behalf of the
ACO) to target beneficiaries for whose
treatment the ACO might expect to earn
shared savings, or to avoid those for
whose treatment the ACO might be less
likely to generate shared savings.
Further, as discussed in more detail
later in this section, we do not believe
ACOs or others should be permitted to
offer gifts or other inducements to
beneficiaries, nor should they be
allowed to withhold or threaten to
withhold services, for the purposes of
coercing or influencing beneficiaries’
voluntary alignment decisions.
However, we believe it is important to
promote engagement and discussion
between beneficiaries and their
healthcare providers and therefore do
not propose to prohibit an ACO or its
ACO participants, ACO providers/
suppliers, or ACO professionals from
providing a beneficiary with accurate
descriptive information about the
potential patient care benefits of
designating an ACO professional as
responsible for the beneficiary’s overall
care.
Accordingly, we propose to revise the
regulations governing the assignment
methodology to add a new paragraph (e)
to § 425.402. Under this paragraph, if an
automated system is available by spring
of 2017 to allow a beneficiary to
designate an ACO professional whose
services are used in alignment as
responsible for coordinating their
overall care and for CMS to process the
designation electronically, then the
voluntary alignment process would be
available for ACOs participating in
Track 1, Track 2, or Track 3, as specified
in § 425.600(a) of this part. However, if
such an electronic system is not
available by spring of 2017, then CMS
will specify the form and manner in
which a beneficiary may designate an
ACO professional whose services are
used in assignment as responsible for
coordinating their overall care using a
manual process, but the voluntary
alignment process will be limited to
ACOs participating in Track 3 until an
automated system is available. In either
case, under the proposal, beginning in
performance year 2018 beneficiaries that
have voluntarily aligned with an ACO
by designating an ACO professional
whose services are used in assignment
as responsible for coordinating their
overall care will be added to the ACO’s
list of assigned beneficiaries, for a
performance year under the following
conditions:
• The beneficiary must have had at
least one primary care service with a
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physician who is an ACO professional
in the ACO and who is a primary care
physician as defined under § 425.20 of
this subpart or who has one of the
primary specialty designations included
in § 425.402(c).
• The beneficiary must meet the
assignment eligibility criteria
established in § 425.401, and must not
be excluded by the criteria at
§ 425.401(b).
• The beneficiary must have
designated an ACO professional who is
a primary care physician as defined at
§ 425.20 of this part, a physician with a
specialty designation included at
§ 425.402(c) of this subpart, or a nurse
practitioner, physician assistant, or
clinical nurse specialist as responsible
for their overall care.
• The designation must be made in
the form and manner and by a deadline
determined by CMS. In contrast, if a
beneficiary designates a provider or
supplier outside the ACO, who is a
primary care physician as defined at
§ 425.20 of this part, a physician with a
specialty designation included at
§ 425.402(c), or a nurse practitioner,
physician assistant, or clinical nurse
specialist, as responsible for
coordinating their overall care, the
beneficiary will not be added to the
ACO’s list of assigned beneficiaries for
a performance year, even if the
beneficiary would otherwise be
included in the ACO’s assigned
beneficiary population under the
assignment methodology in
§ 425.402(b).
Further, we propose that the ACO,
ACO participants, ACO providers/
suppliers, ACO professionals, and other
individuals or entities performing
functions or services related to ACO
activities are prohibited from directly or
indirectly, committing any act or
omission, or adopting any policy that
coerces or otherwise influences a
Medicare beneficiary’s decision to
designate or not designate an ACO
professional as responsible for
coordinating their overall care,
including but not limited to the
following:
• Offering anything of value to the
Medicare beneficiary as an inducement
for influencing the Medicare
beneficiary’s decision to designate or
not to designate an ACO professional as
responsible for coordinating their
overall care. Any items or services
provided in violation of this prohibition
will not be considered to have a
reasonable connection to the medical
care of the beneficiary, as required
under § 425.304(a)(2);
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• Withholding or threatening to
withhold medical services or limiting or
threatening to limit access to care; and
• Including any voluntary alignment
or change of preference forms requiring
a beneficiary signature with any other
materials or forms, including but not
limited to any other materials requiring
the signature of the Medicare
beneficiary. (We note this requirement
would only be applicable if we
implement a manual process);
To maintain flexibility for ACOs, ACO
participants, ACO providers/suppliers,
ACO professionals, beneficiaries, and
CMS, we would intend to provide
further operational details regarding the
voluntary alignment process and the
applicable implementation timelines
through subregulatory guidance and
other outreach activities.
We seek comments on this proposal,
on the effective date, and on any other
related issues that we should consider
for the final rule to address issues
related to voluntary alignment under the
Shared Savings Program. In particular,
we seek comment on whether voluntary
alignment is an appropriate mechanism
for assigning beneficiaries
retrospectively to an ACO. Specifically,
is it appropriate to retrospectively align
a beneficiary to an ACO, if the
beneficiary designated an ACO
professional whose services are used in
assignment as responsible for the
beneficiary’s overall care, but did not
receive a plurality of primary care
services from ACO professionals in the
ACO during the performance year? We
seek comment on whether including
voluntary alignment information in our
assignment algorithm should be
discretionary, that is, whether ACOs
should be permitted to opt into or out
of voluntary alignment. We seek
comment on whether we should
exclude a beneficiary from an ACO’s
prospective assignment list for a
performance year if later during the
performance year the beneficiary
voluntarily aligns with a healthcare
provider that is not an ACO professional
in the ACO. We also seek input on how
concerns about ACO avoidance of at risk
beneficiaries might be addressed.
We also note that under the proposed
automated voluntary alignment process,
a beneficiary’s designation of a
healthcare provider as responsible for
coordinating their overall care would
stay in effect until the beneficiary chose
to make a subsequent change. We have
concerns that in some cases a
beneficiary may develop a closer
healthcare relationship with a primary
care provider who is different than the
one they initially designated but the
beneficiary might not necessarily
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change their designation to reflect this
new choice. However, requiring a
beneficiary to update his or her
designation annually seems
burdensome. Therefore, under the
proposal we would continue to use their
designation and rely on appropriate
information shared with beneficiaries at
the point of care to ensure the
beneficiary’s designation is kept up to
date. We seek comment on this issue
and our proposal under the automated
system to continue to use a beneficiary’s
designation of the healthcare provider
responsible for coordinating their
overall care until it is changed.
In addition, although we are not
proposing to specify operational
processes in regulations, nevertheless
we also welcome suggestions regarding
the operational process, implementation
timelines, and related issues regarding
the process for beneficiaries to
voluntarily align with an ACO,
including how to strengthen ACOs’
beneficiary engagement activities. We
note that although we are proposing to
establish a process under which
beneficiaries may designate their ‘‘main
doctor’’ who they consider responsible
for coordinating their overall care, in
establishing the operational processes
for allowing beneficiaries to designate
their ‘‘main doctor’’ we may not
explicitly use the phrase ‘‘responsible
for coordinating overall care’’ which we
have included in the proposed
provision at § 425.402(e). Instead, we
may consider using other terminology
based on focus group testing and/or
other feedback from beneficiary
representatives. We welcome comments
on what terminology would be
preferable to ensure beneficiaries
understand the significance of
designating a provider or supplier as
responsible for coordinating their
overall care. We will consider such
suggestions further as we develop
program guidance and outreach
activities for beneficiaries and ACOs.
3. SNF 3-Day Rule Waiver Beneficiary
Protections
a. Background
The Medicare SNF benefit is for
beneficiaries who require a short-term
intensive stay in a SNF, requiring
skilled nursing, or skilled rehabilitation
care, or both. Under section 1861(i) of
the Act, beneficiaries must have a prior
inpatient hospital stay of no fewer than
three consecutive days in order to be
eligible for Medicare coverage of
inpatient SNF care. In the June 2015
final rule (80 FR 32804 through 32806),
we provided ACOs participating in
Track 3 with additional flexibility to
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46437
attempt to increase quality and decrease
costs by allowing these ACOs to apply
for a waiver of the SNF 3-day rule for
their prospectively assigned
beneficiaries when they are admitted to
certain ‘‘SNF affiliates,’’ that is, SNFs
with whom the ACO has executed SNF
affiliate agreements. (See
§ 425.612(a)(1)). Waivers are effective
upon CMS notification of approval for
the waiver or the start date of the ACO’s
participation agreement, whichever is
later. (See § 425.612(c)). We stated in the
June 2015 final rule that the SNF 3-day
rule waiver would be effective for
services furnished on or after January 1,
2017. Program requirements for this
waiver are codified at § 425.612. These
requirements are primarily based on
criteria previously developed under the
Pioneer ACO Model. Specifically, under
§ 425.612(a)(1), we waive the
requirement in section 1861(i) of the Act
for a 3-day inpatient hospital stay prior
to a Medicare covered post-hospital
extended care service for eligible
beneficiaries prospectively assigned to
ACOs participating in Track 3 that have
been approved to implement the waiver
that receive otherwise covered posthospital extended care services
furnished by an eligible SNF that has
entered into a written agreement to
partner with the ACO for purposes of
this waiver. All other provisions of the
statute and regulations regarding
Medicare Part A post-hospital extended
care services continue to apply.
We believe that clarity regarding
whether a waiver applies to SNF
services furnished to a particular
beneficiary is important to help ensure
compliance with the conditions of the
waiver and also improve our ability to
monitor waivers for misuse. Therefore,
in the June 2015 final rule, we limited
the waiver to ACOs in Track 3 because
under the prospective assignment
methodology used in Track 3,
beneficiaries are assigned in advance to
the ACO for the entire performance year
(unless they meet any of the exclusion
criteria under § 425.401(b) during the
performance year), so it will be clearer
to a Track 3 ACO whether the waiver
applies to SNF services furnished to a
particular beneficiary than it would be
to an ACO in Track 1 or 2, where
beneficiaries are assigned using a
preliminary prospective assignment
methodology with retrospective
reconciliation (80 FR 32804). An ACO’s
use of the SNF 3-day rule waiver will be
associated with a distinct and easily
identifiable event, specifically,
admission of a prospectively assigned
beneficiary to a previously identified
SNF affiliate without prior inpatient
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hospitalization or after an inpatient
hospitalization of fewer than 3 days.
Based on our experiences under the
Pioneer ACO Model, and in response to
comments, we established certain
requirements under § 425.612 for ACOs,
ACO providers/suppliers, SNF affiliates,
and beneficiaries with respect to the
SNF 3-day rule waiver under the Shared
Savings Program. All ACOs electing to
participate in Track 3 will be offered the
opportunity to apply for a waiver of the
SNF 3-day rule for their prospectively
assigned beneficiaries at the time of
their initial application to participate in
Track 3 of the program and annually
thereafter while participating in Track 3.
We anticipate accepting the first SNF 3day rule waiver applications from Track
3 ACOs later this summer. As set forth
at § 425.612(a)(1)(i), in their waiver
applications, ACOs must demonstrate
that they have the capacity to identify
and manage beneficiaries who would be
either directly admitted to a SNF or
admitted to a SNF after an inpatient
hospitalization of fewer than 3 days. As
part of the application process, the ACO
will be required to submit a list of the
SNFs with which the ACO will partner
(called ‘‘SNF affiliates’’) along with
executed SNF affiliate agreements for
each listed SNF. These SNF affiliates
will be subject to program integrity
screening under § 425.612(b).
Additionally, the ACO must submit
narratives describing how the ACO
plans to implement the waiver,
including the communication plan
between the ACO and its SNF affiliates;
a care management plan for
beneficiaries admitted to a SNF affiliate;
a beneficiary evaluation and admission
plan approved by the ACO medical
director and the healthcare professional
responsible for the ACO’s quality
improvement and assurance processes;
and a description of any financial
relationships between the ACO, SNF,
and acute care hospitals.
To be eligible to receive covered SNF
services under the waiver, a beneficiary
must be prospectively assigned to the
ACO for the performance year in which
he or she is admitted to the SNF
affiliate, may not reside in a SNF or
other long-term care setting, must be
medically stable and have an identified
skilled nursing or rehabilitation need
that cannot be provided as an
outpatient, and must meet the other
requirements set forth at
§ 425.612(a)(1)(ii).
For a SNF to be eligible to partner
with ACOs for purposes of the waiver,
a SNF must have an overall quality
rating of 3 or more stars under the CMS
5 Star Quality Rating System, must sign
a written agreement with the ACO,
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which we refer to as the ‘‘SNF affiliate
agreement,’’ that includes elements
determined by CMS, including: A clear
indication of the effective dates of the
SNF affiliate agreement; agreement to
comply with Shared Savings Program
rules, including but not limited to those
specified in the participation agreement
between the ACO and CMS; agreement
to validate beneficiary eligibility to
receive covered SNF services under the
waiver prior to admission; remedial
processes and penalties for
noncompliance with the terms of the
waiver, and other requirements set forth
at § 425.612(a)(1)(iii). The SNF affiliate
agreement must include these elements
to ensure that the SNF affiliate
understands its responsibilities related
to implementation of the SNF 3-day rule
waiver.
We indicated in the June 2015 final
rule that the SNF 3-day rule waiver
would be effective no earlier than
January 1, 2017; thereafter, the waiver
will be effective upon CMS notification
to the ACO of approval for the waiver
or the start date of the ACO’s
participation agreement, whichever is
later, and will not extend beyond the
term of the ACO’s participation
agreement. If CMS terminates the
participation agreement under
§ 425.218, then the waiver will end on
the date specified by CMS in the notice
of termination. If the ACO terminates its
participation agreement, then the waiver
will end on the effective date of
termination as specified in the written
notification required under § 425.220.
We also indicated in the June 2015
final rule that we established the
timeline for implementation of the SNF
3-day rule waiver to allow for
development of additional
subregulatory guidance, including
necessary education and outreach for
ACOs, ACO participants, ACO
providers/suppliers, and SNF affiliates.
We noted that we would continue to
evaluate the waiver of the SNF 3-day
rule, including further lessons learned
from Innovation Center models in
which a waiver of the SNF 3-day rule
is being tested. We indicated that in the
event we determined that additional
safeguards or protections for
beneficiaries or other changes were
necessary, such as to incorporate
additional protections for beneficiaries
into the ACO’s participation agreement
or SNF affiliate agreements, we would
propose the necessary changes through
future rulemaking.
In considering additional beneficiary
protections that may be necessary to
ensure proper use of the SNF 3-day rule
waiver under the Shared Savings
Program, we note that there are existing,
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well established payment and coverage
policies for SNF services based on
sections 1861(i), 1862(a)(1), and 1879 of
the Act that include protections for
beneficiaries from liability for certain
non-covered SNF charges. These
existing payment and coverage policies
for SNF services continue to apply to
SNF services furnished to beneficiaries
assigned to ACOs participating in the
Shared Savings Program, including
services furnished pursuant to the SNF
3-day rule waiver. (For example, see the
Medicare Claims Processing Manual,
Chapter 30—Financial Liability
Protections, section 70, available at
https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/
Downloads/clm104c30.pdf; Medicare
Coverage of Skilled Nursing Facility
Care beneficiary booklet, Section 6:
Your Rights & Protections, available at
https://www.medicare.gov/Pubs/pdf/
10153.pdf; and Medicare Benefit Policy
Manual, Chapter 8—Coverage of
Extended Care (SNF) Services Under
Hospital Insurance available at https://
www.cms.gov/Regulations-andGuidance/Guidance/Manuals/
downloads/bp102c08.pdf). In general,
CMS requires that the SNF inform a
beneficiary in writing about services
and fees before the beneficiary is
admitted to the SNF (§ 483.10(b)(6)); the
beneficiary cannot be charged by the
SNF for items or services that were not
requested (§ 483.10(c)(8)(iii)(A)); a
beneficiary cannot be required to
request extra services as a condition of
continued stay (§ 483.10(c)(8)(iii)(B));
and the SNF must inform a beneficiary
that requests an item or service for
which a charge will be made that there
will be a charge for the item or service
and what the charge will be
(§ 483.10(c)(8)(iii)(C)). (See also section
6 of Medicare Coverage of Skilled
Nursing Facility Care at https://
www.medicare.gov/Pubs/pdf/
10153.pdf.)
b. Proposals
Since publication of the June 2015
final rule, we have continued to learn
from implementation and refinement of
the SNF 3-day rule waiver in the
Pioneer ACO Model (see https://
innovation.cms.gov/initiatives/Pioneeraco-model/) and the Next Generation
ACO Model (see https://
innovation.cms.gov/initiatives/NextGeneration-ACO-Model). Based on these
experiences, we believe there are
situations where it would be
appropriate to require additional
beneficiary financial protections under
the SNF 3-day rule waiver for the
Shared Savings Program. Specifically,
we are concerned about potential
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beneficiary financial liability for noncovered Part A SNF services that might
be directly related to use of the SNF 3day rule waiver under the Shared
Savings Program.
First, one example of a scenario under
which a beneficiary may be at financial
risk relates to the quarterly exclusions
from a Track 3 ACO’s prospective
assignment list. For example, assume a
beneficiary was prospectively assigned
to a Track 3 ACO that has been
approved for the SNF 3-day rule waiver
(a waiver-approved ACO), but during
the first quarter of the year, the
beneficiary’s Part B coverage terminated
and the beneficiary is therefore no
longer eligible to be assigned to the
ACO. As a result, the beneficiary would
be excluded from the ACO’s prospective
assignment list because the beneficiary
meets one or more of the exclusion
criteria specified at § 425.401(b). That is,
although SNF services are covered
under Part A, not Part B, the beneficiary
would be dropped from the ACO’s
prospective assignment list if during the
performance year the beneficiary is no
longer enrolled in Part B and thus no
longer eligible to be assigned to the
ACO. We are concerned about some
very limited situations, such as when a
beneficiary’s Part B coverage terminates
during a quarter when the beneficiary is
also receiving SNF services. The
beneficiary may be admitted to a SNF
without a prior 3-day inpatient hospital
stay after his or her Part B coverage
ended, but before the beneficiary
appears on a quarterly exclusion list. It
is not operationally feasible for CMS to
notify the ACO and for the ACO, in
turn, to notify its SNF affiliates, ACO
participants, and ACO providers/
suppliers immediately of the
beneficiary’s exclusion. The lag in
communication may then cause the SNF
affiliate to unknowingly admit a
beneficiary who no longer qualifies for
the waiver without a prior 3-day
inpatient hospital stay. Absent specific
beneficiary protections, we are
concerned that the beneficiary could be
charged for such non-covered SNF
services. We do not believe it would be
appropriate for CMS to hold the
beneficiary or the SNF affiliate
financially liable for such services. We
believe we should allow for a reasonable
amount of time for CMS to
communicate beneficiary exclusions to
an ACO and for the ACO to
communicate the exclusions to its SNF
affiliates, ACO participants, and ACO
providers/suppliers. Typically there
would be no way for the SNF affiliate
to verify in real-time that a beneficiary
continues to be prospectively assigned
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to the ACO; the SNF affiliate must rely
upon the assignment list and quarterly
exclusion lists provided by CMS to the
ACO and communicated by the ACO to
its SNF affiliates, ACO participants, and
ACO providers/suppliers. Further, the
beneficiary does not receive a
notification regarding his or her
eligibility for the SNF 3-day rule waiver
prior to receiving SNF services under
the waiver, so beneficiaries are not able
to check their own eligibility.
To address delays in communicating
beneficiary exclusions from the
prospective assignment list, the Pioneer
ACO Model and Next Generation ACO
Model provide for a 90-day grace period
that functionally acts as an extension of
beneficiary eligibility for the SNF 3-day
rule waiver and permits some additional
time for the ACO to receive quarterly
exclusions lists from CMS and
communicate beneficiary exclusions to
its SNF affiliates. We believe that it
would be appropriate, in order to
protect beneficiaries from potential
financial liability related to the SNF 3day rule waiver under the Shared
Savings Program, to establish a similar
90-day grace period in the case of a
beneficiary who was prospectively
assigned to a waiver-approved ACO at
the beginning of the performance year
but is later excluded from assignment to
the ACO.
Therefore, we believe it is necessary
for purposes of carrying out the Shared
Savings Program to allow these formerly
assigned beneficiaries to receive covered
SNF services under the SNF 3-day rule
waiver when the beneficiary is admitted
to a SNF affiliate within a 90-day grace
period following the date that CMS
delivers the quarterly beneficiary
exclusion list to an ACO. The equitable
and efficient implementation of the SNF
3-day rule waiver is necessary to further
support ACOs’ efforts to increase quality
and decrease costs under two-sided
performance-based risk arrangements.
(See 80 FR 32804 for a detailed
discussion of the rationale for
establishing the SNF 3-day rule waiver).
Based upon the experience in the
Pioneer ACO Model, we believe it is not
possible to adopt such a waiver without
providing some protection for certain
beneficiaries who were prospectively
assigned to the ACO at the start of the
year, but are subsequently excluded
from assignment. Accordingly, we are
proposing to modify the waiver to
include a 90-day grace period to allow
sufficient time for CMS to notify the
ACO of any beneficiary exclusions, and
for the ACO then to inform its SNF
affiliates, ACO participants, and ACO
providers/suppliers of those exclusions.
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More specifically, we propose to
modify the waiver under § 425.612(a)(1)
to include a 90-day grace period that
would permit payment for SNF services
provided to beneficiaries who were
initially on the ACO’s prospective
assignment list for a performance year
but were subsequently excluded during
the performance year. CMS would make
payments for SNF services furnished to
such a beneficiary under the terms of
the SNF 3-day rule waiver if the
following conditions are met:
• The beneficiary was prospectively
assigned to a waiver-approved ACO at
the beginning of the performance year
but was excluded in the most recent
quarterly exclusion list.
• The SNF affiliate services are
furnished to a beneficiary admitted to
the SNF affiliate within 90 days
following the date that we deliver the
quarterly exclusion list to the ACO.
• We would have otherwise made
payment to the SNF affiliate for the
services under the SNF 3-day rule
waiver, but for the beneficiary’s
exclusion from the waiver-approved
ACO’s prospective assignment list.
We further note that we anticipate
that there would be very few instances
where it would be appropriate for SNF
services to qualify for payment under
this 90-day grace period. This is because
this waiver only allows for payment for
claims that meet all applicable
requirements except the requirement for
a prior 3-day inpatient hospital stay. For
example, assume that a beneficiary who
had been assigned to a waiver-approved
ACO was admitted to a SNF without a
prior 3-day inpatient hospital stay after
his or her enrollment in an MA Plan,
but before the beneficiary appears on a
quarterly exclusion list. In this case,
these SNF services would not be
covered under FFS because the waiver
does not expand coverage to include
services furnished to Medicare
beneficiaries enrolled in MA Plans. Both
beneficiaries and healthcare providers
are expected to know that the
beneficiary is covered under an MA
plan and not FFS Medicare.
Second, we are concerned that there
could be other more likely scenarios
where a beneficiary could be charged for
non-covered SNF services that were a
result of an ACO’s or SNF’s
inappropriate use of the SNF 3-day rule
waiver. Specifically, we are concerned
that a beneficiary could be charged for
non-covered SNF services if a SNF
affiliate were to admit a FFS beneficiary
who is not prospectively assigned to the
waiver-approved ACO, and payment for
SNF services is denied for lack of a
qualifying inpatient hospital stay.
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We believe this situation could occur
as a result of a breakdown in one or
more of processes the ACO and SNF
affiliate are required to have in place to
implement the waiver. For example, the
SNF affiliate and the admitting ACO
provider/supplier may not verify that
the beneficiary appears on the ACO’s
prospective assignment list prior to
admission, as required under the SNF 3day rule waiver
(§ 425.612(a)(1)(iii)(B)(4)) and the terms
of the SNF’s affiliate agreement with the
ACO. In this scenario, Medicare would
deny payment of the SNF claim under
existing FFS rules because the
beneficiary did not have a qualifying
inpatient hospital stay. We are
concerned that, once the claim is
rejected, the beneficiary may not be
protected from financial liability, and
thus could be charged by the SNF
affiliate for these non-covered SNF
services that were a result of an
inappropriate attempt to use the waiver,
potentially subjecting the beneficiary to
significant financial liability. However,
in this scenario, a SNF with a
relationship to the ACO submitted the
claim that was rejected for lack of a
qualifying inpatient hospital stay, but
that otherwise would have been paid by
Medicare. In this circumstance, we
propose to assume the SNF’s intent was
to rely upon the SNF 3-day waiver, but
the waiver requirements were not met.
We believe it is reasonable to assume
the SNF’s intent was to use the SNF 3day rule waiver because, as a SNF
affiliate, the SNF should be well aware
of the ability to use the SNF 3-day rule
waiver and, by submitting the claim,
demonstrated an expectation that CMS
would pay for SNF services that would
otherwise have been rejected for lack of
a 3-day inpatient hospital stay. We
believe that in this scenario, the
rejection of the claim under the SNF 3day rule waiver could easily have been
avoided if the ACO, the admitting ACO
provider/supplier, and the SNF affiliate
had confirmed that the requirements for
use of the SNF 3-day rule waiver were
satisfied. Because each of these entities
is in a better position to know the
requirements of the waiver and ensure
that they are met than the beneficiary is,
we believe that the ACO and/or the SNF
affiliate should be accountable for such
rejections and the SNF affiliate should
be prevented from attempting to charge
the beneficiary for the non-covered SNF
stay.
To address situations similar to this
scenario where the beneficiary may be
subject to financial liability due to an
eligible SNF submitting a claim that is
not paid only as a result of the lack of
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a qualifying inpatient hospital stay, the
Next Generation ACO Model generally
places the financial responsibility on
the SNF, where the SNF knew or
reasonably could be expected to have
known that payment would not be made
for the non-covered SNF services. In
such cases, CMS makes no payment for
the services and the SNF may not charge
the beneficiary for the services and must
return any monies collected from the
beneficiary. Additionally, under the
Next Generation ACO Model, the ACO
must indemnify and hold the
beneficiary harmless for payment for the
services. We believe it is appropriate to
propose to adopt a similar policy under
the Shared Savings Program because,
under § 425.612(a)(1)(iii)(B), to be a SNF
affiliate, a SNF must agree to validate
the eligibility of a beneficiary to receive
covered SNF services in accordance
with the waiver prior to admission to
the SNF, and otherwise comply with the
requirements and conditions of the
Shared Savings Program. SNF affiliates
are required to be familiar with the SNF
3-day rule and the terms and conditions
of the SNF 3-day rule waiver for the
Shared Savings Program, and should
know to verify that a FFS Medicare
beneficiary who is a candidate for
admission has completed a qualifying
hospital stay or that the admission
meets the criteria under a waiver of the
SNF 3-day rule that is properly in place.
Additionally, ACOs and their SNF
affiliates are required to develop plans
that will govern communication and
beneficiary evaluation and admission
prior to use of the SNF 3-day rule
waiver. In these circumstances, we
believe it is reasonable that the ultimate
responsibility and liability for a noncovered SNF admission should rest with
the admitting SNF affiliate.
Therefore, to protect FFS beneficiaries
from being charged in certain
circumstances for non-covered SNF
charges related to the waiver of the SNF
3-day rule under the Shared Savings
Program, potentially subjecting such
beneficiaries to significant financial
liability, we are proposing to add certain
beneficiary protection requirements in
§ 425.612(a)(1). These requirements
would apply to SNF services furnished
by a SNF affiliate that would otherwise
have been covered except for the lack of
a qualifying hospital stay preceding the
admission to the SNF affiliate.
Specifically, we propose that we would
make no payment to the SNF, and the
SNF may not charge the beneficiary for
the non-covered SNF services, in the
event that a SNF that is a SNF affiliate
of a Track 3 ACO that has been
approved for the SNF 3-day rule waiver
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admits a FFS beneficiary who was never
prospectively assigned to the waiverapproved ACO (or was assigned but
later excluded and the 90 day grace
period has lapsed), and the claim is
rejected only for lack of a qualifying
inpatient hospital stay.
In this situation, we propose that we
would apply the following rules:
• We would make no payment to the
SNF affiliate for such services.
• The SNF affiliate must not charge
the beneficiary for the expenses
incurred for such services; and the SNF
affiliate must return to the beneficiary
any monies collected for such services.
• The ACO may be required to submit
a corrective action plan to CMS for
approval as specified at § 425.216(b)
addressing what actions the ACO will
take to ensure that the SNF 3-day rule
waiver is not misused in the future. If
after being given an opportunity to act
upon the corrective action plan the ACO
fails to come into compliance, approval
to use the waiver will be terminated in
accordance with § 425.612(d). We note
that in accordance with our existing
program rules at §§ 425.216 and
425.218, CMS retains the authority to
take corrective action, including
terminating an ACO for non-compliance
with program rules. A misuse of a
waiver under § 425.612 would
constitute non-compliance with
program rules. Accordingly, we propose
to codify at new provision
§ 425.612(d)(4) that misuse of a waiver
under § 425.612 may result in CMS
taking remedial action against the ACO
under §§ 425.216 and 425.218, up to
and including termination of the ACO
from the Shared Savings Program.
We propose that if the SNF submitting
the claim is a SNF affiliate for a waiverapproved ACO, and the only reason for
the rejection of the claim is lack of a
qualifying inpatient hospital stay, then
CMS would assume the SNF intended to
rely upon the SNF 3-day rule waiver.
We would not assume the SNF intended
to rely upon the SNF 3-day rule waiver
if the SNF is not a SNF affiliate of a
waiver-approved ACO because the
waiver is not available to SNFs more
broadly. We believe intended reliance
on the waiver is an important factor in
determining whether the additional
beneficiary protections proposed here
should apply as explained above.
Outside the context of an intent to rely
on the SNF 3-day rule waiver, we do not
believe it would be necessary to include
additional beneficiary protections under
the Shared Savings Program because
there is no reason for either the
beneficiary or the SNF to expect that
different coverage rules would apply to
SNF services. In these other situations,
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the beneficiary protections generally
applicable under traditional FFS
Medicare, noted earlier in this section,
continue to apply.
As previously noted in this section,
we anticipate accepting the first SNF 3day rule waiver applications from Track
3 ACOs later this summer. We strongly
believe it is important to ensure that
beneficiaries have appropriate financial
protections against misuse of the waiver
prior to approving any SNF 3-day rule
waiver applications. We also recognize
that ACOs and their SNF affiliates could
be reluctant to enter into a SNF affiliate
agreement without there being clarity as
to their potential responsibility for noncovered SNF services related to the
waiver. For these reasons, although we
will still accept applications from Track
3 ACOs for the SNF 3-day rule waiver
later this summer, in the event we
finalize any of the proposed beneficiary
protections in the CY 2017 PFS final
rule with comment period, we plan to
develop a process for ACOs to confirm
that they and their SNF affiliates agree
to comply with all requirements related
to the SNF 3-day rule waiver, including
any new requirements adopted in this
rulemaking. ACOs and SNF affiliates
that do not agree to comply with all
requirements would be ineligible for the
SNF 3-day rule waiver. We note that
this confirmation process may delay
approval of ACOs’ applications for the
SNF 3-day rule waiver; however, we do
not anticipate approval would be
delayed beyond the first quarter of 2017.
We seek comments on these
proposals. We note that under our
proposed beneficiary protection
provision, a SNF affiliate would be
prohibited from charging a beneficiary
for non-covered SNF services even in
cases where the beneficiary explicitly
requested or agreed to being admitted to
the SNF in the absence of a qualifying
3-day hospital stay if all other
requirements for coverage are met. We
therefore specifically seek comment on
whether it is reasonable to hold SNFs
that are SNF affiliates responsible for all
claims that are rejected solely as a result
of lack of a qualifying inpatient hospital
stay. We also seek comment on whether
the ACO rather than or in addition to
the SNF affiliate, should be held liable
for such claims and under what
circumstances. We also seek comment
on our proposal to modify the waiver
under § 425.612(a)(1) to include a 90day grace period for beneficiaries
prospectively assigned to a waiverapproved ACO at the start of the
performance year but later excluded. We
seek comment on the proposed length of
the grace period, and in particular
whether the grace period should be less
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than 90 days, given our expectation that
ACOs will share the quarterly
beneficiary exclusion lists with their
SNF affiliates, ACO participants, and
ACO providers/suppliers in a timely
manner. Finally, we seek comment on
any other related issues that we should
consider in connection with these
proposals to protect beneficiaries from
significant financial liability for noncovered SNF services related to the
waiver of the SNF 3-day rule under the
Shared Savings Program.
4. Technical Changes
a. Financial Reconciliation for ACOs
That Fall Below 5,000 Assigned
Beneficiaries
Section 1899(b)(2)(D) of the Act
includes a requirement that a
participating ACO must have a
minimum of 5,000 Medicare FFS
beneficiaries assigned to it. Currently,
the regulations at § 425.110(b) indicate
that if at any time during the
performance year, an ACO’s assigned
population falls below 5,000, the ACO
may be subject to the actions described
in §§ 425.216 and 425.218; the
regulations further indicate at
§ 425.110(b)(1) that while under a CAP,
the ACO remains eligible for shared
savings and losses and the MSR and
MLR (if applicable) is set ‘‘at a level
consistent with the number of assigned
beneficiaries.’’ We have applied this
rule in the past to perform financial
reconciliation for ACOs that fell below
5,000 assigned beneficiaries. In these
cases, the ACO was subject to a CAP
and financial reconciliation was based
on a variable MSR/MLR that was
determined by the number of assigned
beneficiaries. For example, we have
calculated the ACO’s MSR based on an
expanded sliding scale that include a
range of 3,000 to 4,999 assigned
beneficiaries with a corresponding MSR
range of 5.0 to 3.9 percent.
However, ACOs under risk-based
tracks are not limited to financial
reconciliation under a variable MSR/
MLR that is based on the number of
assigned beneficiaries. In the June 2015
final rule (see 80 FR 32769– 32771, and
32779–32780), we finalized a policy that
provides ACOs under two-sided
performance-based risk tracks with an
opportunity to choose among several
options for establishing their MSR/MLR.
In addition to being able to choose a
symmetrical MSR/MLR that varies
based on the ACO’s number of assigned
beneficiaries, ACOs under two-sided
performance-based risk tracks can also
choose from a menu of non-variable
MSR/MLR options (either a 0 percent
MSR/MLR or a symmetrical MSR/MLR
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46441
in a 0.5 percent increment between 0.5
through 2.0 percent).
We believe it is important to clarify
the policy regarding situations where an
ACO under a two-sided performancebased risk track has chosen a nonvariable MSR/MLR at the start of the
agreement period but has fallen below
5,000 assigned beneficiaries at the time
of financial reconciliation. As discussed
in detail in the June 2015 final rule, we
continue to believe that ACOs under
two-sided performance-based risk tracks
are best positioned to determine the
level of risk that they are prepared to
accept. Therefore, we are proposing to
update the regulations at § 425.110(b)(1)
to be consistent with the regulatory
changes in the June 2015 final rule that
permit ACOs under a two-sided
performance-based risk track (Track 2
and Track 3) to choose their own MSR/
MLR from a menu of options.
Specifically, we are proposing to update
the regulations at § 425.110(b)(1) to
indicate that in the event an ACO falls
below 5,000 assigned beneficiaries at
the time of financial reconciliation, the
ACO participating under a two-sided
risk track will be eligible to share in
savings (or losses) and the MSR/MLR
will be set at a level consistent with the
choice of MSR/MLR that the ACO made
at the start of the agreement period. If
the Track 2 or Track 3 ACO selected a
symmetrical MSR/MLR option based on
a fixed percentage (for example, zero
percent or a percentage between 0.5 and
2 percent) regardless of ACO size, then
the current methodology for use of a
variable MSR/MLR based on the ACO’s
number of assigned beneficiaries would
not apply. For example, if at the
beginning of the agreement period the
ACO chose a 1.0 percent MSR/MLR and
the ACO’s assigned population falls
below 5,000, the MSR/MLR will remain
1.0 percent for purposes of financial
reconciliation while the ACO is under a
CAP. Further, as we noted in earlier
rulemaking, if the ACO has elected a
variable MSR/MLR, the methodology for
calculating the variable MSR/MLR
under a two-sided model is consistent
with the methodology for calculating
the variable MSR that is required under
the under the one-sided model (Track 1)
(see 80 FR 32769 through 32771; 32779
through 32780). Under the one-sided
shared savings model (Track 1), we have
accounted for circumstances where an
ACO’s number of assigned beneficiaries
falls below 5,000, by expanding the
variable MSR range based on input from
the CMS Office of the Actuary (OACT).
Thus, in the case where a Track 2 or
Track 3 ACO selects a variable MSR/
MLR based on its number of assigned
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beneficiaries, and the ACO’s number of
assigned beneficiaries falls below 5,000,
we would continue to use an approach
for determining the MSR/MLR range
consistent with the approach for
calculating the MSR range under the
one-sided model.
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b. Requirements for Merged or Acquired
TINs
ACOs frequently request that we take
into account the claims billed by the
TINs of practices that have been
acquired by sale or merger for the
purpose of meeting the minimum
assigned beneficiary threshold,
establishing a more accurate financial
benchmark, and determining the
prospective or preliminary prospective
assignment list for the upcoming
performance year. In response to these
inquiries, we initially developed
subregulatory guidance that allowed
claims billed under the TIN of a merged
or acquired entity to be considered in
certain circumstances. In that guidance
we indicated that the merged or
acquired entity’s TIN may no longer be
used to bill Medicare. In the June 2015
final rule, we codified the policies
outlined in this guidance allowing for
consideration of claims billed under
merged or acquired entities’ TINs for
purposes of beneficiary assignment and
establishing the ACO’s benchmark,
provided certain requirements were met
(§§ 425.204(g), 425.118(a)(2)). However,
the regulation at § 425.204(g) indicates
that an ACO may request that CMS
consider, for purposes of beneficiary
assignment and establishing the ACO’s
benchmark under § 425.602, claims
billed by ‘‘Medicare-enrolled’’ entities’
TINs that have been acquired through
sale or merger by an ACO participant.
Because the regulation at § 425.204(g)
refers to such merged or acquired TINs
as ‘‘Medicare-enrolled,’’ we have
received inquiries from ACOs regarding
whether such merged or acquired TINs
must continue to be Medicare-enrolled
after the merger or acquisition has been
completed and the TINs are no longer
used to bill Medicare.
It was not our intent to establish such
a requirement. We do not believe there
would be a program purpose to require
the TIN of a merged or acquired entity
to maintain Medicare enrollment if it is
no longer used to bill Medicare.
Therefore, to address this issue, we are
proposing a technical change to
§ 425.204(g) to clarify that the merged/
acquired TIN is not required to remain
Medicare enrolled after it has been
merged or acquired and no longer used
to bill Medicare.
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L. 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
(EPs) 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 and Physician
Feedback program continue CMS’
initiative to recognize and reward
clinicians based on the quality and cost
of care provided to their patients,
increase the transparency of health care
quality information and to assist
clinicians and beneficiaries in
improving medical decision-making and
health care delivery. As stated in the CY
2016 PFS final rule with comment
period (80 FR 71277), the MACRA was
enacted on April 16, 2015. Under
section 1848(p)(4)(B)(iii) of the Act, as
amended by section 101(b)(3) of
MACRA, the VM shall not be applied to
payments for items and services
furnished on or after January 1, 2019.
Section 1848(q) of the Act, as added by
section 101(c) of MACRA, establishes
the Merit-based Incentive Payment
System (MIPS) that shall apply to
payments for items and services
furnished on or after January 1, 2019.
2. Overview of Existing Policies for the
VM
In the CY 2013 PFS final rule with
comment period, we discussed the goals
of the VM and also established that
specific principles should govern the
implementation of the VM (77 FR
69307). We refer readers to that rule for
a detailed discussion. 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 EPs. A summary of the
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 EPs. Then, in the CY 2015
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PFS final rule with comment period (79
FR 67931 through 67966), we finalized
policies to complete the phase-in of the
VM by applying it starting January 1,
2017, to payments under the Medicare
PFS for physicians in groups of 2 or
more EPs and to physician solo
practitioners. In the CY 2016 PFS final
rule with comment period (80 FR 71277
through 71279), we finalized that in the
CY 2018 payment adjustment period,
the VM will apply to nonphysician EPs
who are physician assistants (PAs),
nurse practitioners (NPs), clinical nurse
specialists (CNSs), and certified
registered nurse anesthetists (CRNAs) in
groups with 2 or more EPs and to PAs,
NPs, CNSs, and CRNAs who are solo
practitioners.
3. Provisions of This Proposed Rule
As a general summary, we are
proposing to update the VM informal
review policies and establish how the
quality and cost composites under the
VM would be affected for the CY 2017
and CY 2018 payment adjustment
periods in the event that unanticipated
program issues arise.
a. Expansion of the Informal Inquiry
Process To Allow Corrections for the
VM
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.
• 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.
• The determination of costs.
These statutory requirements
regarding limitations of review are
reflected in § 414.1280. 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.
In the CY 2015 PFS final rule with
comment period (79 FR 67960), for the
CY 2015 payment adjustment period,
we finalized: (1) A February 28, 2015
deadline for a group to request
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correction of a perceived error made by
CMS in the determination of its VM;
and (2) 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
finalized a deadline of 60 days that
would start after the release of the
Quality and Resource Use Reports
(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 stated we would take steps to
establish a process for accepting
requests from physicians to correct
certain errors made by CMS or a thirdparty vendor (for example, PQRSqualified registry). Our intent was to
design this process as a means to
recompute a TIN’s quality composite
and/or cost composite in the event we
determine that we initially made an
erroneous calculation. We noted that if
the operational infrastructure was not
available to allow this recomputation,
we would 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. We finalized that we
would recalculate the cost composite in
the event that an error was made in the
cost composite calculation. We noted
that we would provide additional
operational details as necessary in
subregulatory guidance.
Moreover, for both the CY 2015
payment adjustment period and future
adjustment periods, we finalized a
policy to adjust a TIN’s quality-tier if we
make a correction to a TIN’s quality
and/or cost composites because of this
correction process. We further noted
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. In the CY 2015
PFS final rule for the CY 2016 payment
adjustment period, we noted that if the
operational infrastructure is not
available to allow the recomputation of
quality measure data we would
continue the approach of the initial
corrections process to classify a TIN as
‘‘average quality’’ in the event we
determine a third-party vendor error or
CMS made an error in the calculation of
the quality composite.
In the CY 2016 PFS final rule with
comment period (80 FR 71294 through
71295), for the CY 2017 and CY 2018
payment adjustment periods, we
finalized a deadline of 60 days that
would start after the release of the
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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. We also
finalized the continuation of the process
for accepting requests from groups and
solo practitioners to correct certain
errors made by CMS or a third-party
vendor (for example, PQRS-qualified
registry). We stated we would continue
the approach of the initial corrections
process to classify a TIN as ‘‘average
quality’’ in the event we determine a
third-party vendor error or CMS made
an error in the calculation of the quality
composite and the infrastructure was
not available to allow for recomputation
of the quality measure data.
Additionally, we finalized that we
would reclassify a TIN as Category 1
when PQRS determines on informal
review that at least 50 percent of the
TIN’s EPs meet the criteria to avoid the
PQRS downward payment adjustment
for the relevant payment adjustment
year. If the group was initially classified
as Category 2, then we would not expect
to have data for calculating their quality
composite, in which case they would be
classified as ‘‘average quality’’; however,
if the data is available in a timely
manner, then we would recalculate the
quality composite.
As a result of issues that we became
aware of prior to and during the CY
2016 VM informal review process that
are discussed below, we have learned
that re-running QRURs and
recalculating the quality composite is
not always practical or possible, given
the diversity and magnitude of the
errors, timing of when we become aware
of an error, and practical considerations
in needing to compute a final VM
upward payment adjustment factor after
the performance period has ended based
on the aggregate amount of downward
payment adjustments. Furthermore, this
approach can create uncertainty for
groups and solo practitioners about their
final VM payment adjustment making it
difficult for them to plan and make
forecasts.
• Electronic Health Record (EHR) and
Qualified Clinical Data Registry (QCDR)
Issues: CMS was unable to determine
the accuracy of PQRS data submitted via
EHR and QCDR for the CY 2014
performance period due to data integrity
issues. Consequently, if a group (as
identified by its Medicare Taxpayer
Identification Number (TIN)) or the EPs
in a group reported PQRS measures only
through the EHR or QCDR reporting
mechanism, then the TIN’s quality
composite score for the CY 2016 VM
was based on the TIN’s performance on
the CMS-calculated quality outcome
measures and the Consumer Assessment
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of Healthcare Providers and Systems
(CAHPS) for PQRS survey measures (if
applicable). If a TIN was classified as
‘‘low quality’’ based on its performance
on these measures, then we reclassified
the TIN as ‘‘average quality.’’ If the
TIN’s initial quality tier designation was
‘‘average quality’’ or ‘‘high quality’’,
then that quality tier designation was
retained. Without the additional PQRS
data submitted via EHR and QCDR, we
were concerned that a low quality
designation based on the three CMScalculated quality outcome measures
and CAHPS for PQRS survey measures
(if applicable) may not necessarily
represent a TIN’s quality performance If
the TIN also reported PQRS measures
for the CY 2014 performance period
through reporting mechanisms other
than EHR or QCDR, then those PQRS
quality measures, along with CMScalculated quality outcome measures,
and CAHPS for PQRS survey measures
(if applicable), were used to calculate
the TIN’s quality composite score for the
CY 2016 VM.
• Incomplete Claims Identification
Issue: After the release of the 2014
Annual QRURs in September 2015, we
discovered a defect in the program used
to identify the claims from CY 2014,
which is the performance period for the
VM CY 2016 payment adjustment
period: Only claims from January 12
through December 31 were identified;
claims from January 1 through January
11 were incorrectly omitted from 2016
VM calculations. These missing claims
accounted for 2.73 percent of the CY
2014 claims. We re-ran all of the 2014
annual QRURs to correct this issue,
including recalculating benchmarks and
standard deviations for the cost
measures to avoid disadvantaging
groups as a result of using artificially
low cost benchmarks. Of the
approximately 13,800 TINs subject to
the CY 2016 VM, 28 TINs received a
lower VM and 8 TINs received a higher
VM. There were also 27 TINs newly
subject to the CY 2016 VM. Out of these
27 TINs, 12 were classified as Category
1 TINs and 15 were classified as
Category 2 TINs. TINs were not held
harmless from a lower VM resulting
from these corrections. We notified the
TINs that were affected by this issue.
• Specialty Adjustment Issue: In the
course of performing quality assurance
for the 2015 Mid-Year QRURs, we
discovered a defect in the program used
to specialty-adjust the cost measures. As
a result of this defect, we determined
that the CY 2016 VM for 28 TINs (out
of approximately 13,800 TINs subject to
the CY 2016 VM) were incorrectly
calculated. Holding the benchmarks for
the cost measures and the mean cost
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composite score constant, 8 TINs would
have had a lower VM and 20 TINs
would have had a higher VM in CY
2016. We corrected the cost composite
designation for the 20 TINs whose CY
2016 VM was higher after the
recalculation and left the original cost
composite designation for the 8 TINs
whose VM was adversely affected by the
recalculation.
Due to the volume and complexities
of the informal review issues, the
inconsistency of available PQRS data to
calculate a TIN’s quality composite, the
case-by-case nature of the informal
review process, and the condensed
timeline to calculate an accurate VM
upward payment adjustment factor, we
believe that we need to update the VM
informal review policies and establish
in rulemaking how the quality and cost
composites under the VM would be
affected if unanticipated issues arise (for
example, the program issues described
above, errors made by a third-party such
as a vendor, or errors in our calculation
of the quality and/or cost composites).
The intent of these proposals are not to
provide relief for EPs and groups who
fail to report under PQRS, but rather to
provide a mechanism for addressing
unexpected issues such as the data
integrity issues discussed above.
Recalculating the quality composite is
operationally complex, and does not
align with the current timeline given the
volume of informal reviews and the
need to calculate the VM upward
payment adjustment factor as close to
the beginning of the payment
adjustment period as possible. We want
to close out as many informal reviews
as possible before the VM upward
payment adjustment factor is calculated,
to lend confidence to the adjustment
factor and to provide finality for the
clinicians, and to minimize claims
reprocessing. Limiting the potential
movement of TINs between VM quality
tiers based on informal review may
result in a more accurate adjustment
factor calculation and provide greater
predictability for the CMS’ Office of the
Actuary (OACT) in making assumptions
around the adjustment factor including
assumptions around the impact of
outstanding informal reviews at the time
of the calculations. We believe that our
proposals would help groups and solo
practitioners to better predict the
outcome of their final VM adjustment
and reduce uncertainty as we continue
to improve our systems.
Table 38 summarizes our proposals.
TABLE 38—PROPOSED QUALITY AND COST COMPOSITE STATUS FOR TINS DUE TO INFORMAL REVIEW DECISIONS AND
WIDESPREAD QUALITY AND COST DATA ISSUES
Scenario 1: TINS moving from
Category 2 to Category 1 as a
result of PQRS or VM informal
review process
Scenario 2: Non-GPRO Category
1 TINs with additional EPs avoiding PQRS payment adjustment as
a result of PQRS informal review
process
Initial
composite
Quality ................
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Cost ....................
Revised
composite
Initial
composite
Revised
composite
N/A ..................
N/A ..................
N/A ..................
Low ..................
Average ...........
High .................
Average ...........
Average ...........
Average ...........
Low ..................
Average ...........
Average ...........
Low ..................
Average ...........
High .................
Low ..................
Average ...........
High .................
Average ...........
Average ...........
High .................
Low ..................
Average ...........
High .................
Scenario 1: TINs Moving From Category
2 to Category 1 as a Result of PQRS or
VM Informal Review Process
For the CY 2017 VM, Category 1 will
include those groups that meet the
criteria to avoid the CY 2017 PQRS
payment adjustment as a group practice
participating in the PQRS Group
Practice Reporting Option (GPRO) in CY
2015 and groups that have at least 50
percent of the group’s EPs meet the
criteria to avoid the CY 2017 PQRS
payment adjustment as individuals (80
FR 71280). Category 1 also includes
those solo practitioners that meet the
criteria to avoid the CY 2017 PQRS
payment adjustment as individuals.
Category 2 will include groups and solo
practitioners that are subject to the CY
2017 VM and do not fall within
Category 1 (79 FR 67939). We finalized
a similar two-category approach for the
CY 2018 VM based on participation in
the PQRS by groups and solo
practitioners in 2016 (80 FR 71280
through 71281).
If a TIN is initially classified as
Category 2, and subsequently, through
the PQRS or VM informal review
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Scenario 3: Category 1 TINs with
widespread quality data issues
Initial
composite
Revised
composite
Recalculated
composite
N/A ..................
N/A ..................
N/A ..................
Low ..................
Average ...........
High .................
Average ...........
Average ...........
Average ...........
Low ..................
Average ...........
Average ...........
Low ..................
Average ...........
High .................
Low ..................
Average ...........
High .................
process, the TIN is classified as Category
1 then we propose to classify the TIN’s
quality composite as ‘‘average quality’’
instead of attempting to calculate the
quality composite. We also propose to
calculate the TIN’s cost composite using
the quality-tiering methodology. If the
TIN is classified as ‘‘high cost’’ based on
its performance on the cost measures,
then we propose to reclassify the TIN’s
cost composite as ‘‘average cost.’’ If the
TIN is classified as ‘‘average cost’’ or
‘‘low cost’’, then we propose that the
TIN would retain the calculated cost tier
designation. We note that in the CY
2016 PFS final rule with comment
period (80 FR 71280), we finalized a
policy for the CY 2017 and 2018
payment adjustment periods that when
determining whether a group will be
included in Category 1, we will consider
whether the 50 percent threshold has
been met regardless of whether the
group registered to participate in the
PQRS GPRO for the relevant
performance period. We believe this
policy will allow groups that register for
a PQRS GPRO, but fail as a group to
meet the criteria to avoid the PQRS
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Scenario 4: Category 1 TINs with
widespread claims data issues
Revised
composite
Average.
Average.
High.
Low.
Average.
Average.
payment adjustment an additional
opportunity for the quality data reported
by individual EPs in the group to be
taken into account for the purposes of
applying the VM. Consequently,
because of this policy we anticipate that
the number of TINs who could fall into
Scenario 1 would be minimal; however,
we believe it is necessary to have a
policy in the event that CMS determines
on informal review that Category 2 TINs
were negatively impacted by a thirdparty vendor error or CMS made an
error in the calculation of the quality
composite. We propose to apply these
policies for the CY 2017 VM and CY
2018 VM.
Calculating the quality composite for
a TIN that was initially classified as
Category 2 would be operationally
complex given the timeline for
determining and applying the VM
adjustments for all TINs subject to the
VM, the volume of informal reviews, the
need to calculate the VM upward
payment adjustment factor as close to
the beginning of the payment
adjustment period as possible, and
uncertainty about the availability of the
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PQRS quality data. Therefore,
classifying the quality composite as
‘‘average quality’’ would offer a
predictable decision for all informal
reviews where a TIN changes
classification from Category 2 to
Category 1.
Our proposal to calculate the cost
composite and assign ‘‘average cost’’ if
the cost composite is initially classified
as ‘‘high cost’’ would alleviate concerns
from stakeholders that a TIN may
receive a downward VM payment
adjustment under the quality-tiering
methodology as a result of being
classified as average quality and high
cost. Under our proposal discussed
above, for TINs in Scenario 1, we would
not consider a TIN’s actual performance
on the quality measures or calculate a
quality composite score; rather, we
would classify the TIN’s quality
composite as average quality for the
reasons stated above. In this scenario,
we do not believe that we should retain
a TIN’s ‘‘high cost’’ designation when
the TIN’s actual cost performance is not
being compared to the TIN’s actual
quality performance, as it is possible the
TIN might have scored high quality if
actual performance had been
considered. We believe that these
proposals would help groups and solo
practitioners to better predict the
outcome of their final VM adjustment
and reduce uncertainty about the impact
of the informal review. Additionally, it
is important to note that groups or solo
practitioners who submit an informal
review request would not automatically
be covered by the policy proposed for
Scenario 1. We would verify on
informal review that the group or solo
practitioner did submit complete and
accurate data and did meet the criteria
to avoid the PQRS payment adjustment
to be included in Category 1.
We request comments on these
proposals.
Scenario 2: Non-GPRO Category 1 TINs
With Additional EPs Avoiding PQRS
Payment Adjustment as a Result of
PQRS Informal Review Process
For the CY 2017 VM, Category 1 will
include groups that have at least 50
percent of the group’s EPs meet the
criteria to avoid the CY 2017 PQRS
payment adjustment as individuals (80
FR 71280). A similar policy was
finalized for the CY 2018 VM (80 FR
71280). If a TIN is classified as Category
1 for the CY 2017 VM by having at least
50 percent of the group’s EPs meet the
criteria to avoid the CY 2017 PQRS
payment adjustment as individuals, and
subsequently, through the PQRS
informal review process, it is
determined that additional EPs that are
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in the TIN also meet the criteria to avoid
the CY 2017 PQRS payment adjustment
as individuals, then we propose the
following policies to determine the
TIN’s quality and cost composites:
• If the TIN’s quality composite is
initially classified as ‘‘low quality’’,
then we propose to reclassify the TIN’s
quality composite as ‘‘average quality.’’
If the TIN’s quality composite is initially
classified as ‘‘average quality’’ or ‘‘high
quality’’, then we propose that the TIN
would retain that quality tier
designation.
• We would maintain the cost
composite that was initially calculated.
We propose to apply these policies for
the CY 2017 VM and CY 2018 VM.
Under these policies, we would not
recalculate the TIN’s quality composite
to include the additional EPs that were
determined to have met the criteria to
avoid the PQRS payment adjustment as
individuals through the PQRS informal
review process. As discussed under
Scenario 1, recalculating the quality
composite is operationally complex, and
we may not have PQRS data for the
additional EPs because they did not
meet the criteria to avoid the PQRS
payment adjustment during the initial
determination. In addition, we seek to
avoid a situation where by recalculating
the quality composite, a TIN may be
subject to a lower quality tier
designation because a few EPs in the
TIN independently pursued PQRS
informal reviews. As stated above, we
are proposing to reclassify a TIN’s
quality composite as average quality if
it is initially classified as ‘‘low quality’’
in order to avoid a situation where we
do not have the PQRS quality data for
those few EPs whose quality
performance could have bumped the
TIN up from a low quality designation
as the EPs did not meet the criteria to
avoid the PQRS payment adjustment
during the initial determination.
Additionally, it is important to note that
TINs whose EPs submit an informal
review request would not automatically
be covered by the policy proposed for
Scenario 2. We would verify on
informal review that an EP did submit
complete and accurate data and did
meet the criteria to avoid the PQRS
payment adjustment as an individual in
order for the TIN to be included in
Category 1.
We request comments on these
proposals.
Scenario 3: Category 1 TINs With
Widespread Quality Data Issues
In cases where there is a systematic
issue with any of a Category 1 TIN’s
quality data that renders it unusable for
calculating a TIN’s quality composite,
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we propose to classify the TIN’s quality
composite as average quality. For this
proposal, we consider widespread
quality data issues, as issues that impact
multiple TINs and we are unable to
determine the accuracy of the data
submitted via these TINs (for example,
the EHR and QCDR issues for the CY
2014 performance period as described
above). This proposal would offer a
predictable designation for all TINs
under this scenario.
We also propose to calculate the TIN’s
cost composite using the quality-tiering
methodology. If the TIN is classified as
‘‘high cost’’ based on its performance on
the cost measures, then we propose to
reclassify the TIN’s cost composite as
‘‘average cost.’’ If the TIN is classified as
‘‘average cost’’ or ‘‘low cost’’, then we
propose that the TIN would retain the
calculated cost tier designation. We
propose to apply these policies for the
CY 2017 VM and CY 2018 VM.
As discussed under Scenario 1, our
proposal to calculate the cost composite
and assign ‘‘average cost’’ if the cost
composite is initially classified as ‘‘high
cost’’ would alleviate concerns from
stakeholders that a TIN may receive a
downward VM payment adjustment
under the quality-tiering methodology
as a result of being classified as average
quality and high cost. Similarly, for
TINs in Scenario 3, we would not
consider a TIN’s actual performance on
the quality measures or calculate a
quality composite score; rather, we
would classify the TIN’s quality
composite as average quality for the
reasons stated above. In this scenario,
we do not believe that we should retain
a TIN’s high cost designation when the
TIN’s actual cost performance is not
being compared to the TIN’s actual
quality performance, as it is possible the
TIN might have scored high quality if
actual performance had been
considered. We would continue to show
and designate these groups as high cost
in their annual QRURs so they have the
opportunity to understand and improve
their performance, but under our
proposal, we would classify their cost
composite as average cost for purposes
of determining their VM adjustment.
Additionally, it is important to note that
groups or solo practitioners would only
be covered by the policy proposed for
Scenario 3 once we verify that the group
or solo practitioner did submit complete
and accurate data and did meet the
criteria to avoid the PQRS payment
adjustment in order to be included in
Category 1.
We request comments on these
proposals.
Further, we note that we expect
quality data issues such as these to be
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significantly limited moving forward.
We have included new front-end edits
to the data submission process to catch
errors that result in such quality data
issues early enough to be corrected.
Additionally, we note that TINs are
ultimately responsible for the data that
are submitted by their third-party
vendors and expect that TINs are
holding their vendors accountable for
accurate reporting. While we
understand that data submission
requirements are evolving and that both
vendors and CMS are developing
capabilities for reporting and assessing
performance, we are considering further
policies to promote complete and
accurate reporting by registries and
other third-party entities that submit
data on behalf of groups and EPs.
Scenario 4: Category 1 TINs With
Widespread Claims Data Issues
If we determine after the release of the
Quality and Resource Use Reports
(QRURs) that there is a widespread
claims data issue that impacts the
calculation of the quality and/or cost
composites for Category 1 TINs, we
propose to recalculate the quality and
cost composites for affected TINs. For
this proposal, we consider widespread
claims data issues, as issues that impact
multiple TINs and require the
recalculation of the quality and/or cost
composites (for example, the incomplete
claims identification and specialty
adjustment issues described above).
After recalculating the composites, if
the TIN’s quality composite is classified
as low quality, then we propose to
reclassify the quality composite as
average quality, and conversely, if the
TIN’s cost composite is classified as
high cost, we propose to reclassify the
cost composite as average cost. If the
TIN is classified as average quality, high
quality, average cost or low cost, then
we propose that the TIN would retain
the calculated quality or cost tier
designation. We are proposing to assign
average quality if the quality composite
is classified as low quality and assign
average cost if the cost composite is
classified as high cost after recalculating
the quality and cost composites because,
after a claims data issue is identified, it
would take approximately 6 weeks to
recalculate the composites and notify
groups and solo practitioners about their
recalculated VM. Given that the VM
informal review period lasts for 60 days
after the release of the QRURs and the
timing of when we become aware of an
error, we would likely not be able to
notify groups and solo practitioners
about their recalculated VM before the
end of the informal review period. We
believe these proposed policies are
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necessary to provide certainty for
groups and solo practitioners about their
final VM payment adjustment and due
to the condensed timeline to calculate
an accurate VM upward payment
adjustment factor.
We propose to apply these policies for
the CY 2017 VM and CY 2018 VM.
We request comments on these
proposals.
The proposals described in this
section would allow us to make
predictable decisions as a result of
informal reviews and unanticipated
issues that may arise, providing greater
certainty for groups and solo
practitioners about impact of their
results, as we foresee that several of the
issues that impacted the CY 2016 VM,
as described above, may continue to
impact the CY 2017 and CY 2018 VM
and/or new unanticipated issues may be
identified. The proposals would also
minimize the need to use PQRS data to
recalculate the quality composite and
prevent situations where we are making
decisions on a case-by-case basis based
on the TIN’s PQRS reporting
mechanism.
b. Application of the VM to Participant
TINs in Shared Savings Program ACOs
That Do Not Complete Quality
Reporting
In the CY 2015 PFS final rule with
comment period (79 FR 67946), for
groups and solo practitioners, as
identified by their TIN, that participate
in a Shared Savings Program ACO, we
finalized 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. We stated
that, consistent with the application of
the VM to other groups and solo
practitioners that report under PQRS, 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. We finalized this policy for
the 2017 payment adjustment period for
the VM. In the CY 2016 PFS proposed
rule with comment period (80 FR
41899), we proposed to continue this
policy in the CY 2018 payment
adjustment period for all groups and
solo practitioners subject to the VM that
participate in a Shared Savings Program
ACO and finalized our proposal in the
CY 2016 PFS final rule (80 FR 71285).
As discussed in sections III.I. and
III.L.1.e. of this proposed rule, we are
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proposing to remove the prohibition on
EPs who are part of a group or solo
practitioner that participates in a Shared
Savings Program ACO, for purposes of
PQRS reporting for the CY 2017 and CY
2018 payment adjustments, to report
outside the ACO. As a result of this
proposed policy, the EPs in groups and
those who are solo practitioners would
be allowed to report to the PQRS as a
group (using one of the group registry,
QCDR, or EHR reporting options) or
individually (using the registry, QCDR,
or EHR reporting option) outside of the
ACO. This section addresses how we
propose to use the PQRS data reported
by EPs outside of the ACO for the CY
2018 VM when the ACO does not
successfully report quality data on
behalf of their EPs for purposes of PQRS
as required by the Shared Savings
Program under § 425.504.
For the CY 2018 payment adjustment
period, if a Shared Savings Program
ACO does not successfully report
quality data on behalf of their EPs for
purposes of PQRS as required by the
Shared Savings Program under
§ 425.504, then we propose to use the
data reported to the PQRS by the EPs (as
a group (using one of the group registry,
QCDR, or EHR reporting options) or as
individuals (using the registry, QCDR,
or EHR reporting option) under the
participant TIN) outside of the ACO to
determine whether the TIN would fall
in Category 1 or Category 2 under the
VM. We propose to apply the twocategory approach finalized for the CY
2018 VM (80 FR 71280) based on
participation in the PQRS by groups and
solo practitioners to determine whether
groups and solo practitioners that
participate in a Shared Savings Program
ACO, but report to the PQRS outside of
the ACO, would fall in Category 1 or
Category 2 under the VM. This proposed
policy is consistent with our policy for
groups and solo practitioners who are
subject to the VM and do not participate
in the Shared Savings Program, and we
believe it would further encourage
quality reporting by EPs in the event the
ACO does not successfully report
quality data as required by the Shared
Savings Program under § 425.504. For
example, if groups that participate in a
Shared Savings Program ACO in 2016
report quality data to the PQRS outside
of the ACO and meet the criteria to
avoid PQRS payment adjustment for CY
2018 as a group using one of the group
registry, QCDR, or EHR reporting
options or have at least 50 percent of the
group’s EPs meet the criteria to avoid
the PQRS payment adjustment for CY
2018 as individuals using the registry,
QCDR, or EHR reporting option by
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reporting quality data to PQRS outside
of the ACO, then they would be
included in Category 1 for the CY 2018
VM. If solo practitioners that participate
in a Shared Savings Program ACO in
2016 report quality data to the PQRS
outside of the ACO and meet the criteria
to avoid the PQRS payment adjustment
for CY 2018 as individuals using the
registry, QCDR, or EHR reporting
option, then they would also be
included in Category 1. Category 2
would include those groups and solo
practitioners subject to the CY 2018 VM
that participate in a Shared Savings
Program ACO and do not fall within
Category 1.
As finalized for the CY 2018 payment
adjustment period (80 FR 71285), all
groups and solo practitioners that
participate in a Shared Savings Program
ACO and fall in Category 2 will be
subject to an automatic downward
payment adjustment under the VM. For
groups and solo practitioners that
participate in a Shared Savings Program
ACO that did not successfully report
quality data as required by the Shared
Savings Program under § 425.504 and
are in Category 1 as a result of reporting
quality data to the PQRS outside of the
ACO, we propose to classify their
quality composite for the VM for the CY
2018 payment adjustment period as
‘‘average quality.’’ As finalized in the
CY 2015 PFS final rule with comment
period (79 FR 67943), the cost
composite for groups and solo
practitioners that participate in a Shared
Savings Program ACO will be classified
as ‘‘average cost.’’ Because we would
not have the ACO’s quality data for
these groups and solo practitioners, we
believe it would be appropriate to use
the quality data they reported to the
PQRS outside the ACO to determine
whether they avoided the PQRS
payment adjustment and whether they
would be in Category 1 or 2 for purposes
of the VM, but not to calculate a quality
composite using the quality-tiering
methodology. As we stated previously,
we continue to believe 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 (79 FR 67944). This
proposal is not intended to encourage
groups and solo practitioners that
participate in a Shared Savings Program
ACO to report to the PQRS outside the
ACO, but in the event the ACO does not
successfully report quality data on
behalf of their EPs for purposes of
PQRS, to provide them with a safeguard
that would allow them to avoid the
PQRS payment adjustment and the
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automatic downward adjustment under
the VM. We encourage groups and solo
practitioners to continue to report
through the ACO in order to promote
clinical and financial integration within
the ACO and for the Medicare
beneficiaries they treat. For groups and
solo practitioners that participate in a
Shared Savings Program ACO that
successfully reports quality data on
behalf of their EPs for purposes of PQRS
as required by the Shared Savings
Program under § 425.504, we will
calculate their VM for the CY 2018
payment adjustment period according to
the policies established in the CY 2015
PFS final rule with comment period (79
FR 67941 to 67947 and 79 FR 67956 to
67957) and CY 2016 PFS final rule with
comment period (80 FR 71283 to 71286
and 80 FR 71294). We solicit comment
on these proposals. We are also
proposing corresponding revisions to
§ 414.1210(b)(2).
As discussed in section III.H. of this
proposed rule, to allow affected EPs that
participate in an ACO to report
separately for the CY 2017 PQRS
payment adjustment, we are proposing
a secondary PQRS reporting period for
EPs that were in an ACO that did not
successfully report quality data on
behalf of the EPs in the group and those
who are solo practitioners. Specifically,
we are proposing that affected
individual EPs or groups, who report
under an ACO, may separately report
outside the ACO either as individual
EPs (using the registry, QCDR, or EHR
reporting option) or using one of the
group registry, QCDR, or EHR reporting
options (note these EPs and groups
would not need to register for one of
these group reporting options, but rather
mark the data as group data in their
submission) during a secondary PQRS
reporting period for the CY 2017 PQRS
payment adjustment if they were a
participant in an ACO that did not
successfully report quality data on their
behalf during the established reporting
period for the CY 2017 PQRS payment
adjustment. We are proposing the
secondary PQRS reporting period for the
CY 2017 PQRS payment adjustment
would coincide with the reporting
period for the CY 2018 PQRS payment
adjustment (that is, January 1, 2016
through December 31, 2016).
This section addresses how we
propose to use, for purposes of the CY
2017 VM, the PQRS data reported by the
EPs in the group and those who are solo
practitioners outside of the ACO using
the secondary PQRS reporting period
when the ACO did not successfully
report quality data on behalf of their EPs
for purposes of PQRS as required by the
Shared Savings Program under
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46447
§ 425.504 for the CY 2017 PQRS
payment adjustment. For the CY 2017
payment adjustment period, if a Shared
Savings Program ACO did not
successfully report quality data on
behalf of their EPs for purposes of PQRS
as required by the Shared Savings
Program under § 425.504 for the CY
2017 PQRS payment adjustment, then
we propose to use the data reported to
the PQRS by the EPs (as a group using
one of the group registry, QCDR, or EHR
reporting options or as individuals
using the registry, QCDR, or EHR
reporting option) under the participant
TIN) outside of the ACO during the
secondary PQRS reporting period to
determine whether the TIN would fall
in Category 1 or Category 2 under the
VM. We propose to apply the twocategory approach finalized for the CY
2017 VM (79 FR 67938 to 67939 and as
revised in 80 FR 71280 to 71281) based
on participation in the PQRS by groups
and solo practitioners to determine
whether groups and solo practitioners
that participate in a Shared Savings
Program ACO, but report to the PQRS
outside of the ACO, would fall in
Category 1 or Category 2 under the VM.
In section III.H. of this proposed rule,
we are proposing to assess the
individual EP or group’s 2016 data
submitted outside the ACO and during
the secondary PQRS reporting period
against the reporting requirements for
the CY 2018 PQRS payment adjustment.
Therefore, we propose that groups that
meet the criteria to avoid PQRS
payment adjustment for CY 2018 as a
group practice participating in the PQRS
GPRO (using one of the group registry,
QCDR, or EHR reporting options) or
have at least 50 percent of the group’s
EPs meet the criteria to avoid the PQRS
payment adjustment for CY 2018 as
individuals (using the registry, QCDR,
or EHR reporting option), based on data
submitted outside the ACO and during
the secondary PQRS reporting period,
would be included in Category 1 for the
CY 2017 VM. We also propose that solo
practitioners that meet the criteria to
avoid the PQRS payment adjustment for
CY 2018 as individuals using the
registry, QCDR, or EHR reporting
option, based on data submitted outside
the ACO and during the secondary
PQRS reporting period, would be
included in Category 1 for the CY 2017
VM. Category 2 would include those
groups and solo practitioners subject to
the CY 2017 VM that participate in a
Shared Savings Program ACO and do
not fall within Category 1.
As finalized for the CY 2017 payment
adjustment period (79 FR 67946), all
groups and solo practitioners that
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participate in a Shared Savings Program
ACO and fall in Category 2 will be
subject to an automatic downward
payment adjustment under the VM. For
groups and solo practitioners that
participate in a Shared Savings Program
ACO that did not successfully report
quality data as required by the Shared
Savings Program under § 425.504 and
are in Category 1 as a result of reporting
quality data to the PQRS outside of the
ACO using the secondary PQRS
reporting period, we propose to classify
their quality composite for the VM for
the CY 2017 payment adjustment period
as ‘‘average quality’’ for the same
reasons described above for the CY 2018
payment adjustment period. As
finalized in the CY 2015 PFS final rule
with comment period (79 FR 67943), the
cost composite for groups and solo
practitioners that participate in a Shared
Savings Program ACO will be classified
as ‘‘average cost.’’
If EPs who are part of a group or a
solo practitioner that participated in a
Shared Savings Program ACO in 2015
that did not successfully report quality
data on their behalf decide to use the
secondary PQRS reporting period, it is
important to note that such groups and
solo practitioners should expect to be
initially classified as Category 2 and
receive an automatic downward
adjustment under the VM for items and
services furnished in CY 2017 until
CMS is able to determine whether the
group or solo practitioner met the
criteria to avoid the PQRS payment
adjustment as described above. First, we
would need to process the data
submitted for 2016. Second, we would
need to determine whether or not the
group or solo practitioner would be
classified as Category 1 or Category 2 for
the CY 2017 VM and notify the group
or solo practitioner if there is a change
in the VM status. Third, we would need
to update the group or solo
practitioner’s status so that they will
stop receiving an automatic downward
adjustment under the VM for items and
services furnished in CY 2017 and
reprocess all claims that were
previously paid. Since groups and solo
practitioners taking advantage of this
secondary reporting period for the 2017
VM will have missed the deadline for
submitting an informal review request
for the 2017 VM, we propose the
informal review submission periods for
these groups and solo practitioners
would occur during the 60 days
following the release of the QRURs for
the 2018 VM.
We request comment on these
proposals. We are also proposing
corresponding revisions to
§ 414.1210(b)(2).
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M. Physician Self-Referral Updates
1. Unit-Based Compensation in
Arrangements for the Rental of Office
Space or Equipment
laboratory services were effective
retroactively to January 1, 1992, while
other provisions became effective on
January 1, 1995.
a. The Physician Self-Referral Statute
and Regulations
(2) Regulatory History
(1) Section 1877 of the Act
Section 6204 of the Omnibus Budget
Reconciliation Act of 1989 (Pub. L. 101–
239) (OBRA 1989), enacted on
December 19, 1989, added section 1877
to the Act. Section 1877 of the Act, also
known as the physician self-referral law:
(1) Prohibits a physician from making
referrals for certain designated health
services (DHS) payable by Medicare to
an entity with which he or she (or an
immediate family member) has a
financial relationship (ownership or
compensation), unless an exception
applies; and (2) prohibits the entity from
filing claims with Medicare (or billing
another individual, entity, or third party
payer) for those referred services. The
statute establishes a number of specific
exceptions, and grants the Secretary the
authority to create regulatory exceptions
for financial relationships that pose no
risk of program or patient abuse.
Additionally, the statute mandates
refunding any amount collected under a
bill for an item or service furnished
under a prohibited referral. Finally, the
statute imposes reporting requirements
and provides for sanctions, including
civil monetary penalty provisions.
Section 1877 of the Act became effective
on January 1, 1992.
Section 4207(e) of the Omnibus
Budget Reconciliation Act of 1990 (Pub.
L. 101–508) (OBRA 1990), enacted on
November 5, 1990, amended certain
provisions of section 1877 of the Act to
clarify definitions and reporting
requirements relating to physician
ownership and referrals and to provide
an additional exception to the
prohibition. Several subsequent laws
further changed section 1877 of the Act.
Section 13562 of the Omnibus Budget
Reconciliation Act of 1993 (Pub. L. 103–
66) (OBRA 1993), enacted on August 10,
1993, expanded the referral prohibition
to cover certain other ‘‘designated
health services’’ in addition to clinical
laboratory services, modified some of
the existing statutory exceptions, and
added new exceptions. Section 152 of
the Social Security Act Amendments of
1994 (SSA 1994) (Pub. L. 103–432),
enacted on October 31, 1994, amended
the list of designated health services,
changed the reporting requirements at
section 1877(f) of the Act, and modified
some of the effective dates established
by OBRA 1993. Some provisions
relating to referrals for clinical
The following discussion provides a
chronology of our more significant and
comprehensive rulemakings; it is not an
exhaustive list of all rulemakings related
to the physician self-referral law.
Following the passage of section 1877
of the Act, we proposed rulemakings in
1992 (related only to referrals for
clinical laboratory services) (57 FR
8588) (the 1992 proposed rule) and 1998
(addressing referrals for all DHS) (63 FR
1659) (the 1998 proposed rule). We
finalized the proposals from the 1992
proposed rule in 1995 (60 FR 41914)
(the 1995 final rule), and issued final
rules following the 1998 proposed rule
in three stages. The first final
rulemaking (Phase I) was published in
the January 4, 2001 Federal Register (66
FR 856) as a final rule with comment
period. The second final rulemaking
(Phase II) was published in the March
26, 2004 Federal Register (69 FR 16054)
as an interim final rule with comment
period. Due to a printing error, a portion
of the Phase II preamble was omitted
from the March 26, 2004 Federal
Register publication. That portion of the
preamble, which addressed reporting
requirements and sanctions, was
published on April 6, 2004 (69 FR
17933). The third final rulemaking
(Phase III) was published in the
September 5, 2007 Federal Register (72
FR 51012) as a final rule. In addition to
Phase I, Phase II, and Phase III, we
issued final regulations on August 19,
2008 in the ‘‘Changes to the Hospital
Inpatient Prospective Payment Systems
and Fiscal Year 2009 Rates’’ final rule
with comment period (73 FR 48434) (the
FY 2009 IPPS final rule). That
rulemaking made various revisions to
the physician self-referral regulations,
including provisions that prohibited
certain per unit-of-service (often
referred to as ‘‘per-click’’) and
percentage-based compensation
formulas for determining the rental
charges for office space and equipment
lease arrangements.
We issued additional final regulations
after passage of the Affordable Care Act.
In the CY 2011 PFS final rule with
comment period (75 FR 73170), we
codified a disclosure requirement
established by the Affordable Care Act
for the in-office ancillary services
exception. We also issued regulations in
the CY 2011 OPPS final rule with
comment period (75 FR 71800), the CY
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(a) General Background
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2012 OPPS final rule with comment
period (76 FR 74122), and the CY 2015
OPPS final rule with comment period
(79 FR 66770) that established or
revised certain regulatory provisions
concerning physician-owned hospitals
to codify and interpret the Affordable
Care Act’s revisions to section 1877 of
the Act. Finally, in the CY 2016 PFS
final rule (80 FR 70886), we issued
regulations to accommodate delivery
and payment system reform, reduce
burden, and to facilitate compliance. In
that rulemaking, we established two
new exceptions, clarified certain
provisions of the physician self-referral
law, updated regulations to reflect
changes in terminology, and revised
definitions related to physician-owned
hospitals. One of the new exceptions,
the exception for timeshare
arrangements at § 411.357(y), includes a
prohibition on certain per unit-ofservice compensation formulas.
(b) Unit-Based Compensation
We have addressed the issue of unitbased compensation in several
rulemakings. Sections 1877(e)(1)(A)(iv)
and (B)(iv) of the Act provide that, for
an arrangement for the rental of office
space or equipment to satisfy the
relevant exceptions to the physician
self-referral law, the rental charges over
the term of the lease must be set in
advance, be consistent with fair market
value, and not be determined in a
manner that takes into account the
volume or value of any referrals or other
business generated between the parties.
Interpreting this ‘‘volume or value’’
standard in the 1998 proposed rule, we
proposed that compensation could be
based on units of service (for example,
‘‘per-use’’ equipment rentals) provided
that the units of service did not include
services provided to patients who were
referred by the physician receiving the
payment. For example, a physician who
owned a lithotripter could rent it to a
hospital on a per-procedure basis,
except for lithotripsies for patients
referred by the physician owner.
Instead, payments for the use of the
lithotripter for those patients would
have to use a methodology that did not
vary with referrals. (63 FR 1714; see also
66 FR 876). We further proposed that
arrangements in which a physician rents
equipment to an entity that furnishes a
designated health service, such as a
hospital that rents an MRI machine,
with the physician receiving rental
payments on a ‘‘per-use’’ or ‘‘per-click’’
basis (that is, a rental payment is
generated each time the machine is
used) do not prohibit the physician from
otherwise referring to the entity,
provided that these kinds of
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arrangements are typical and comply
with the fair market value and other
standards that are included under the
rental exception. However, because a
physician’s compensation under this
exception cannot reflect the volume or
value of the physician’s own referrals,
we proposed that the rental payments
may not reflect ‘‘per-use’’ or ‘‘per-click’’
payments for patients who are referred
for the service by the physician lessor.
(63 FR 1714)
After reviewing the public comments
in response to the 1998 proposed rule,
we finalized in Phase I significant
revisions with respect to the scope of
the volume or value standard. We
revised our interpretation of the
‘‘volume or value’’ standard for
purposes of section 1877 of the Act to
permit, among other things, payments
based on a unit of service, provided that
the unit-based payment is fair market
value and does not vary over time. (66
FR 876 through 879) Importantly, we
permitted unit-based compensation
formulas, even when the physician
receiving the payment has generated the
payment through a DHS referral. To
reach this position, we reviewed the
legislative history with respect to the
statutory exceptions for the rental of
office space and equipment and
concluded that Congress intended that
unit-of-service-based payments be
protected under certain circumstances.
(66 FR 878) Specifically, with respect to
the exceptions for the rental of office
space and equipment, the Conference
Committee report, H. Rep. No. 213,
103rd Cong., 1st Sess. (1993) (the House
Conference Report) states at page 814
that the conferees ‘‘intend[ed] that
rental charges for [office] space and
equipment leases may be based on
daily, monthly, or other time-based
rates, or rates based on units of service
furnished, so long as the amount of the
time-based or units of service rates does
not fluctuate during the contract period
based on the volume or value of
referrals between the parties to the lease
or arrangement.’’ However, we stated
our unequivocal belief that
arrangements in which the lessor is
compensated each time that the lessor
refers a patient to the lessee for a service
performed in the leased office space or
using the leased equipment have an
obvious potential for abuse and could
incent overutilization (66 FR 878). We
indicated that we would continue to
monitor financial arrangements in the
health care industry and would revisit
particular regulatory decisions if we
determine that there has been abuse or
overutilization (66 FR 860).
In the CY 2008 PFS proposed rule (72
FR 38122), we stated that arrangements
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46449
between a physician lessor and an entity
lessee under which the physician lessor
receives unit-of-service payments are
inherently susceptible to abuse because
the physician lessor has an incentive to
profit from referring a higher volume of
patients to the lessee. We proposed that
space and equipment leases may not
include per-click payments to a
physician lessor for services rendered
by an entity lessee to patients who are
referred by a physician lessor to the
entity (72 FR 38183). We also solicited
comments on the question of whether
we should prevent per-click payments
in situations in which the physician is
the lessee and a DHS entity is the lessor.
The CY 2008 PFS proposed rule also
included eight other significant
proposed revisions to the physician selfreferral regulations. Due to the large
number of physician self-referral
proposals, the significance of the
provisions both individually and in
concert with each other, and the volume
of public comments received in
response to the CY 2008 PFS proposed
rule, we declined to finalize our
proposals, including our proposal to
prohibit certain per unit-of-service
compensation formulas in arrangements
for the rental of office space and
equipment, in the CY 2008 PFS final
rule (72 FR 66222).
After consideration of the public
comments and our independent
research, we finalized regulations
prohibiting certain per-unit of service
compensation formulas for determining
office space and equipment rental
charges in the FY 2009 IPPS final rule
(73 FR 48434). Specifically, we revised
§ 411.357(a)(4) and (b)(4) to prohibit
rental charges for the rental of office
space or equipment that are determined
using a formula based on per-unit of
service rental charges, to the extent that
such charges reflect services provided to
patients referred by the lessor to the
lessee. In doing so, we relied on our
authority in section 1877(e)(1)(A)(vi)
and (B)(vi) of the Act, which permits the
secretary to impose by regulation other
requirements needed to protect against
program or patient abuse. We also
revised the exceptions at §§ 411.357(l)
and (p) for fair market value
compensation and indirect
compensation arrangements,
respectively, to include similar
limitations on the formula for
determining office space and equipment
rental charges, as applicable. We did so
using our authority at section 1877(b)(4)
of the Act, as those exceptions were
established using that authority. (See 73
FR 48713 through 48721) We
determined it necessary to limit the type
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of per-click compensation formulas
available for arrangements for the rental
of office space and equipment because
we believe that arrangements under
which a lessor receives unit-of-service
payments are inherently susceptible to
abuse. Specifically, we believe that the
lessor has an incentive to profit from
referring a higher volume of patients to
the lessee and from referring patients to
the lessee that might otherwise go
elsewhere for services.
b. Development of This Rulemaking
(1) Council for Urological Interests v.
Burwell
On June 12, 2015, the D.C. Circuit (the
Court) issued an opinion in Council for
Urological Interests v. Burwell, 790 F.3d
212 (D.C. Cir. 2015), that addressed the
prohibition on per-click rental charges
for the lease of equipment found at
§ 411.357(b)(4)(ii)(B). In its ruling, the
Court agreed with CMS that section
1877(e)(1)(B)(vi) of the Act provides the
Secretary the authority to prohibit perclick leasing arrangements. The Court
concluded that—
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The text of the statute does not
unambiguously preclude the Secretary from
using her authority to add a requirement that
bans per-click leases. To the contrary, the
statutory text of the exception clearly
provides the Secretary with the discretion to
impose any additional requirements that she
deems necessary ‘‘to protect against program
or patient abuse.’’ (Council for Urological
Interests, 790 F.3d at 219.)
The Court further concluded that the
relevant language in the House
Conference Report merely interpreted
section 1877(e)(1)(B)(iv) of the Act, and
thus did not preclude CMS from
imposing additional requirements under
section 1877(e)(1)(B)(vi) of the Act. It
stated that the legislative history
‘‘simply indicates that, as written, the
rental-charge clause [in section
1877(e)(1)(B)(iv) of the Act] does not
preclude per-click leases’’ and stated
further that ‘‘[n]othing in the legislative
history suggests a limit on [the
Secretary’s] authority to prohibit perclick leases under section
1877(e)(1)(B)(vi) of the Act).’’ Id. at 222.
The Court also concluded, however,
that CMS’s discussion of the House
Conference Report in the FY 2009 IPPS
final rule contained an unreasonable
interpretation of the conferees’
statements concerning sections
1877(e)(1)(A)(iv) and (B)(iv) of the Act,
and it remanded the case to the agency
to permit a fuller consideration of the
legislative history. This rulemaking
addresses that decision.
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(2) The FY 2009 IPPS Final Rule
As discussed above, in the FY 2009
IPPS final rule, we revised the
exceptions for the rental of office space
and equipment to include in each a
requirement that the rental charges for
the office space or equipment are not
determined using a formula based on
per-unit of service rental charges, to the
extent that such charges reflect services
provided to patients referred by the
lessor to the lessee. We explained that
our decision to add this requirement
was ultimately based on our authority
under section 1877(e)(1)(B)(vi) of the
Act to promulgate ‘‘other requirements’’
needed to protect against program or
patient abuse. However, we also
discussed certain legislative history
contained in the House Conference
Report addressing sections
1877(e)(1)(A)(iv) and 1877(e)(1)(B)(iv) of
the Act, which establish requirements
that rental charges over the term of a
lease for office space or rental
equipment be set in advance, be
consistent with fair market value, and
not be determined in a manner that
takes into account the volume or value
of any referrals or other business
generated between the parties. With
respect to those statutory conditions, the
language in the House Conference
Report states that—
The conferees intend that charges for space
and equipment leases may be based on daily,
monthly, or other time-based rates, or rates
based on units of service furnished, so long
as the amount of time-based or units of
service rates does not fluctuate during the
contract period based on the volume or value
of referrals between the parties to the lease
or arrangement. (H.R. Rep. No. 103–213, at
814 (1993).)
In the FY 2009 IPPS final rule, we
noted that CMS had previously
concluded that this language indicated
that Congress intended to permit leases
that included per-click payments, even
for patients referred by the physician
lessor (66 FR 940), but asserted that the
language could also be interpreted as
excluding from the office space and
equipment lease exceptions those lease
arrangements that include per-click
payments for services provided to
patients referred from one party to the
other (73 FR 48716). Specifically, we
stated that, where the total amount of
rent (that is, the rental charges) over the
term of the lease is directly affected by
the number of patients referred by one
party to the other, those rental charges
can arguably be said to ‘‘take into
account’’ or ‘‘fluctuate during the
contract period based on’’ the volume or
value of referrals between the parties.
The Court found this revised
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interpretation to be an unreasonable
reading of the language of the House
Conference Report. The Court remanded
§ 411.357(b)(4)(ii)(B) to the Secretary for
further proceedings consistent with its
opinion, and directed that the Secretary
should consider whether a ban on perclick equipment leases is consistent
with the House Conference Report.
c. Re-proposal of Limitation on the
Types of Per-Unit of Service
Compensation Formulas for
Determining Office Space and
Equipment Rental Charges
In this proposed rule, we are reproposing certain requirements for
arrangements involving the rental of
office space or equipment. Specifically,
using the same language in existing
§§ 411.357(a)(5)(ii)(B), (b)(4)(ii)(B),
(l)(3)(ii), and (p)(1)(ii)(B), we are
proposing to include at
§§ 411.357(a)(5)(ii)(B), (b)(4)(ii)(B),
(l)(3)(ii), and (p)(1)(ii)(B) a requirement
that rental charges for the office space
or equipment are not determined using
a formula based on per-unit of service
rental charges, to the extent that such
charges reflect services provided to
patients referred by the lessor to the
lessee. We are using the authority
granted to the Secretary in sections
1877(e)(1)(A)(vi) and (B)(vi) of the Act
to re-propose this requirement in the
exceptions at § 411.357(a) and (b) for the
rental of office space and equipment,
respectively. We are using the authority
granted to the Secretary in section
1877(b)(4) of the Act to re-propose this
requirement in the exceptions at
§ 411.357(l) and (p) for fair market value
compensation and indirect
compensation arrangements,
respectively.
We emphasize that we are not
proposing an absolute prohibition on
rental charges based on units of service
furnished. In general, per-unit of service
rental charges for the rental of office
space or equipment are permissible. We
are proposing to limit the general rule
by prohibiting per-unit of service rental
charges where the lessor generates the
payment from the lessee through a
referral to the lessee for a service to be
provided in the rented office space or
using the rented equipment. Thus, perunit of service rental charges for the
rental of office space or equipment
would be permissible, but only in those
instances where the referral for the
service to be provided in the rented
office space or using the rented
equipment did not come from the lessor.
(1) Authority
In accordance with the Court’s
opinion in Council for Urological
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Interests, we set forth below the
Secretary’s authority to include in the
exceptions applicable to office space
and equipment leases a requirement that
rental charges are not determined using
a formula based on per-unit of service
rental charges that reflect services
provided to patients referred by the
lessor to the lessee. Our determination
follows the Court’s reasoning, which we
excerpt below, in rejecting the Council
for Urological Interests’ assertion that
the Secretary lacks the authority to
impose a ban on ‘‘per-click’’
equipment—and by correlation—office
space leases. We also describe why
limiting the types of per-click rental
charges that would not violate the
physician self-referral law’s referral and
claims submission prohibitions is
consistent with the language of the
House Conference Report.
As the Court stated, the physician
self-referral law gives the Secretary
power to add requirements as needed to
protect against program or patient
abuse, even if Congress did not
anticipate such abuses at the time of
enactment of the statute. Specifically,
although Congress may not have
originally included a ban on per-click
rental charges in office space and
equipment lease arrangements, it
‘‘empowered the Secretary to make her
own assessment of the needs of the
Medicare program and regulate
accordingly.’’ (Council for Urological
Interests, 790 F.3d at 220.) The statute
explicitly permits the Secretary to
impose additional conditions on
arrangements for the rental of office
space or equipment, and nowhere
expressly states that per-click rates must
always be permitted. Thus, as the Court
confirmed, the Secretary’s regulation
‘‘can properly be classified as an ‘other’
requirement expressly permitted by
sections 1877(e)(1)(A)(vi) and (B)(vi) of
the Act.’’ (Id.)
The Secretary’s authority to impose
requirements regarding the type of
compensation formulas upon which
office space and equipment rental
charges may be based is not constrained
by the House Conference Report. As
discussed elsewhere in this proposed
rule, we acknowledge that the language
in the House Conference Report states
Congress’ intent at the time of
enactment of the physician self-referral
law that sections 1877(e)(1)(A)(iv) and
(B)(iv) of the Act not be interpreted as
prohibiting charges for the rental of
office space or equipment that are based
on units of service furnished. We do not
purport here to interpret this language
as implying anything other than the
conferees’ understanding—at the time of
enactment of the statute—that the
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statute as written did not prohibit rental
charges based on units of service rates.
But Congress also gave the Secretary the
authority in sections 1877(e)(1)(A)(vi)
and (B)(vi) of the Act to impose by
regulation other requirements as needed
to protect against program or patient
abuse, which could only happen after
the enactment of the statute. Nowhere in
the House Conference Report did
Congress express an intent to limit the
authority granted to the Secretary in
sections 1877(e)(1)(A)(vi) and (B)(vi) of
the Act (as enacted). In fact, the House
Conference Report was completely
silent regarding sections
1877(e)(1)(A)(vi) and (B)(vi) of the Act,
leaving the express words of the statute
to speak for themselves. As the Court
noted—
The conference report . . . states only that
rental charges ‘‘may’’ be based on units of
service. The language is not obligatory.
Instead, it simply indicates that, as written,
the rental-charge clause [(section
1877(e)(1)(B)(iv) of the Act)] does not
preclude per-click leases. But, as we have
already explained, there is more to the statute
than this clause, and to qualify for the
exception, a rental agreement must comply
with all six clauses, not merely the rentalcharge clause alone. The final clause
[(section 1877(e)(1)(B)(vi) of the Act)] gives
the Secretary the authority to add further
requirements. Nothing in the legislative
history suggests a limit on this authority. We
conclude that the statute does not
unambiguously forbid the Secretary from
banning per-click leases as she evaluates the
needs of the Medicare system and its
patients. (790 F.3d at 221–22 (footnote
omitted))
Moreover, as the Court further noted,
a statement that unit of service-based
rental charges are not precluded by
sections 1877(e)(1)(A)(iv) and (B)(iv) of
the Act as they are written is not
equivalent to a statement that the
Secretary must continue to permit such
charges as she reevaluates, in light of
experience, the operation of the statute
and the need to protect the Medicare
program and its beneficiaries against
abuse. (Id. at 222 n.7; see also id. at 222
n.6 (‘‘Congress has expressly delegated
to the Secretary the authority to
promulgate additional requirements, as
she has done here, and the legislative
history does not clearly impose a
constraint on that power.’’)).
The Secretary has broad authority
under sections 1877(e)(1)(A)(vi) and
(B)(vi) of the Act to impose conditions
on arrangements for the rental of office
space or equipment in order to protect
against program or patient abuse. That
authority is not limited by the express
words of the statute as it is in other
provisions of section 1877 of the Act. In
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46451
agreement, the Court in Council for
Urological Interests explained—
. . . Congress knew how to limit the
Secretary’s authority to impose additional
requirements to the various exceptions [to
the physician self-referral law]. In [section
1877(e)(2) of the Act], Congress excludes
bona fide employment relationships from the
definition of compensation arrangements.
This provision states that the employment
relationship must comply with various
requirements, including that the pay not be
determined ‘‘in a manner that takes into
account (directly or indirectly) the volume or
value of any referrals by the referring
physician.’’ This employment exception also
allows the Secretary to impose ‘‘other
requirements,’’ just as the equipment rental
exception. But the statute then goes on to say
that the listed requirements ‘‘shall not
prohibit the payment of remuneration in the
form of a productivity bonus based on
services performed personally by the
physician.’’ This language shows that
Congress knew how to cabin the Secretary’s
authority to impose ‘‘other’’ requirements
and that it knew how to further clarify what
it meant by compensation that does not take
into account the volume of business
generated between parties. That Congress
employed neither of these tools with
reference to the [exception for the rental of
office space or equipment] again supports
reading the statute as giving the Secretary
broad discretion as she regulates in this area.
(790 F.3d at 221 (citations omitted))
The Secretary’s authority to limit the
use of per-unit of service rental charges
in arrangements for the rental of office
space or equipment is particularly clear
when the exceptions for the rental of
office space and equipment are
compared to other provisions in section
1877 of the Act. According to the Court
in Council for Urological Interests—
[T]he statute elsewhere expressly permits
charging per-click fees in other contexts,
showing that Congress knew how to
authorize such payment terms when it
wanted to. In [section 1877(e)(7)(A) of the
Act], Congress created an exception to the
[physician self-referral law] that allows the
continuation of certain group practice
arrangements with a hospital. . . . The
provision states that ‘‘[a]n arrangement
between a hospital and a group under which
designated health services are provided by
the group but are billed by the hospital’’ is
excepted from the ban on referrals if, among
other things, ‘‘the compensation paid over
the term of the agreement is consistent with
fair market value and the compensation per
unit of services is fixed in advance and is not
determined in a manner that takes into
account the volume or value of any referrals
or other business generated between the
parties.’’ Comparing this provision to the
[exceptions for the rental of office space and
equipment] shows that Congress knew how
to permit per-click payments explicitly,
suggesting that the omission in this particular
context was deliberate. . . . In other words,
Congress’s decision not to include similar
language in the [exceptions for the rental of
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office space and equipment] supports our
conclusion that the statute is silent regarding
the permissibility of per-click leases for
equipment rentals. (790 F.3d at 220–21
(citations omitted))
In summary, as we stated in the FY
2009 IPPS final rule (73 FR 48716), the
physician self-referral statute responds
to the context of the times in which it
was enacted (by addressing known risks
of overutilization and, in particular, by
creating exceptions for common
business arrangements), and also
incorporates sufficient flexibility to
adapt to changing circumstances and
developments in the health care
industry. For example, in section
1877(b)(4) of the Act, Congress
authorized the Secretary to protect
additional beneficial arrangements by
promulgating new regulatory
exceptions. In addition, Congress
included the means to address evolving
fraud risks by inserting into many of the
exceptions—and notably, for our
purposes, in the lease exceptions—
specific authority for the Secretary to
add conditions as needed to protect
against abuse. This design reflects a
recognition that a fraud and abuse law
with sweeping coverage over most of the
health care industry could not achieve
its purpose over the long term if it were
frozen in time. In short, the statute
evidences Congress’ foresight in
anticipating that the nature of fraud and
abuse—and of beneficial industry
arrangements—might change over time.
(73 FR 48716 (citations omitted))
As we did in 2007 when we first
proposed to impose additional
requirements for rental charges in
arrangements for the rental of office
space and equipment, and in 2008 when
we finalized regulations incorporating
such additional requirements, we are
relying in this proposal on the
Secretary’s clear authority in sections
1877(e)(1)(A)(vi) and (B)(vi) of the Act
to impose such other requirements
needed to protect against program or
patient abuse. With respect to our
proposal to include the same
requirements at § 411.357(l) and (p), we
have determined that the proposed
revisions to § 411.357(l) and (p) are
necessary to meet the standard set forth
in section 1877(b)(4) of the Act, which
authorizes the Secretary to establish
exceptions to the statute’s referral and
billing prohibitions only where the
excepted financial relationships do not
pose a risk of program or patient abuse.
(2) Rationale for Proposal
As we discussed in prior rulemakings,
including the 1998 proposed rule, a
number of studies prior to the
enactment of the physician self-referral
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law found that physicians who had
financial relationships with entities to
which they referred patients ordered
more services than physicians without
such financial relationships (63 FR
1661). Studies conducted since that
time, including recent studies by GAO,
indicate that financial self-interest
continues to affect physicians’ medical
decision making.
In the FY 2009 IPPS final rule, we
discussed in detail our rationale for
finalizing the limitation on per-unit of
service rental charges in arrangements
for the rental of office space or
equipment. We noted primary concerns
regarding the potential for
overutilization, patient steering and
other anti-competitive effects, and
reduction in quality of care and patient
outcomes, as well as concerns regarding
the potential for increased costs to the
Medicare program. For the reasons set
forth in the FY 2009 IPPS final rule,
some of which are restated below, we
believe that, in order to protect against
program or patient abuse, it is necessary
to impose additional requirements on
arrangements for the rental of office
space or equipment. Specifically, we
believe that it is necessary to prohibit
rental charges that are determined using
a formula based on per-unit of service
rental charges to the extent that such
charges reflect services provided to
patients referred by the lessor to the
lessee of the office space or equipment.
Commenters responding to our
proposal in the CY 2008 PFS proposed
rule to impose additional requirements
for office space and equipment lease
arrangements provided compelling
information regarding potential program
or patient abuse. We were persuaded in
2008 to finalize requirements limiting
per-unit of service rental charges in the
exceptions applicable to the rental of
office space or equipment, and believe
today that these requirements continue
to be necessary, due to our concerns that
‘‘per-click’’ lease arrangements in which
the lessor makes referrals to the lessee
that generate payments to the lessor—
• Creates an incentive for
overutilization of imaging services (as
described by MedPAC in its comments
to our proposal in the CY 2008 PFS
proposed rule), as well as other services,
including therapeutic services;
• Creates an incentive for physicians
to narrow their choice of treatment
options to those for which they will
realize a profit, even where the best
course of action may be no treatment;
• Influence physicians to refer to the
lessee instead of referring to another
entity that utilizes the same or different
(and perhaps more efficacious)
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technology to treat the patient’s
condition;
• Result in physicians steering
patients to equipment they own, even if
it means having the patient travel to a
non-convenient site for services using
the leased equipment; and
• Increase costs to the Medicare
program when referring physicians
pressure hospitals to use their leasing
company despite not being the low cost
provider.
Most recently, in the CY 2016 PFS
final rule, we expressed our continued
concern that, when physicians have a
financial incentive to refer a patient to
a particular entity, this incentive can
affect utilization, patient choice, and
competition. Physicians can overutilize
by ordering items and services for
patients that, absent a profit motive,
they would not have ordered. A
patient’s choice is diminished when
physicians steer patients to less
convenient, lower quality, or more
expensive providers of health care, just
because the physicians are sharing
profits with, or receiving remuneration
from, the providers. And lastly, where
referrals are controlled by those sharing
profits or receiving remuneration, the
medical marketplace suffers if new
competitors cannot win business with
superior quality, service, or price (80 FR
41926). In that rule, in establishing the
exception at § 411.357(y) for timeshare
arrangements, we determined it
necessary to exclude from the exception
any timeshare arrangements that
incorporate compensation formulas
based on: (1) A percentage of the
revenue raised, earned, billed, collected,
or otherwise attributable to the services
provided while using the timeshare; or
(2) per-unit of service fees, to the extent
that such fees reflect services provided
to patients referred by the party granting
permission to use the timeshare to the
party to which the permission is
granted. We explained our belief that
timeshare arrangements based on
percentage compensation or per-unit of
service compensation formulas present
a risk of program or patient abuse
because they may incentivize
overutilization and patient steering. We
noted, by way of example, that a perpatient compensation formula could
incent the timeshare grantor to refer
patients (potentially for unnecessary
consultations or services) to the party
using the timeshare because the grantor
will receive a payment each time the
premises, equipment, personnel, items,
supplies, or services are used. (80 FR
71331 through 71332) Similarly, we
believe that arrangements utilizing
rental charges for the rental of office
space or equipment that are determined
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using a formula that rewards the lessor
for each service the lessor refers to the
lessee are susceptible to this and other
abuse.
Finally, we note that we are not alone
in our concern regarding overutilization
and steering of beneficiaries resulting
from arrangements in which a
physician’s referral may provide future
remuneration back to the physician. In
two notable advisory opinions, OIG
expressed its concern with per-unit of
service compensation arrangements.
Specifically, in Advisory Opinion 03–
08, OIG stated that ‘‘ ‘[p]er patient,’ ‘per
click,’ ‘per order,’ and similar payment
arrangements with parties in a position,
directly or indirectly, to refer or
recommend an item or service payable
by a federal health care program are
disfavored under the anti-kickback
statute. The principal concern is that
such arrangements promote
overutilization . . . .’’ In Advisory
Opinion 10–23, OIG noted that the
arrangement that was the subject of the
opinion ‘‘involves a ‘per-click’ fee
structure, which is inherently reflective
of the volume or value of services
ordered and provided . . . .’’
2. Technical Correction: Advisory
Opinions Relating to Physician
Referrals, Procedure for Submitting a
Request
We are proposing to revise
§ 411.372(a) by making a minor
technical correction to change the
instructions for submitting a request for
an advisory opinion relating to
physician referrals. The current
language in this subsection directs a
requesting party to submit its request to
a physical address that is out of date. In
an effort to expedite the receipt and
processing of these requests, and to
account for any future changes, we are
proposing to revise paragraph (a) to state
a party or parties must submit a request
for an advisory opinion to CMS
according to the instructions specified
on the CMS Web site.
We note that, at the time of this
rulemaking, the correct address for such
advisory opinion requests is: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Office of Financial
Management, Division of Premium
Billing and Collections, Mail Stop C3–
09–27, Attention: Advisory Opinions,
7500 Security Boulevard, Baltimore, MD
21244–1850. However, we note that this
address is subject to change, per this
technical correction, and that parties
seeking to submit a request for an
advisory opinion relating to physician
referrals will need to refer to the
instructions on the CMS Web site.
IV. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995 (PRA), we are required to
publish a 60-day 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 PRA 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 burden
estimates.
• The quality, utility, and clarity of
the information to be collected.
• Our effort to minimize the
information collection burden on the
affected public, including the use of
automated collection techniques.
We are soliciting public comment on
each of the required issues under
section 3506(c)(2)(A) of the PRA for the
following information collection
requirements (ICRs).
A. Wage Estimates
To derive average costs, we used data
from the U.S. Bureau of Labor Statistics’
May 2015 National Occupational
Employment and Wage Estimates for all
salary estimates (https://www.bls.gov/
oes/current/oes_nat.htm). In this regard,
Table 39 presents the mean hourly
wage, the cost of fringe benefits
(calculated at 100 percent of salary), and
the adjusted hourly wage.
TABLE 39—NATIONAL OCCUPATIONAL EMPLOYMENT AND WAGE ESTIMATES
Occupation
code
Occupation title
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Compliance Officer ..........................................................................................
Epidemiologist ..................................................................................................
Medical Scientist ..............................................................................................
Medical Secretary ............................................................................................
Non-Physician Practitioner (Health Diagnosing and Treating Practitioners) ...
Office and Administrative Support Operations ................................................
Physicians and Surgeons ................................................................................
Physicians and Surgeons, All Other ................................................................
Statistician ........................................................................................................
As indicated, we are adjusting our
employee hourly wage estimates by a
factor of 100 percent. This is necessarily
a rough adjustment, both because fringe
benefits and overhead costs vary
significantly from employer to
employer, and because methods of
estimating these costs vary widely from
study to study. Nonetheless, there is no
practical alternative and we believe that
doubling the hourly wage to estimate
total cost is a reasonably accurate
estimation method.
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13–1041
19–1040
19–1042
43–6013
29–1000
43–0000
29–1060
29–1069
15–2041
B. Proposed Information Collection
Requirements (ICRs) and Burden
Estimates
1. ICRs Regarding the Physician Quality
Reporting System (PQRS) (§ 414.90)
For individual EPs or group practices,
who choose to separately report quality
measures during the proposed
secondary PQRS reporting period for the
2017 PQRS payment adjustment, who
bill under the TIN of an ACO
participant if the ACO failed to report
on behalf of such EPs or group practices
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Mean hourly
wage
($/hr)
33.26
36.97
45.06
16.50
46.65
17.47
97.33
95.05
40.60
Fringe benefit
($/hr)
33.26
36.97
45.06
16.50
46.65
17.47
97.33
95.05
40.60
Adjusted
hourly wage
($/hr)
66.52
73.94
90.12
33.00
93.90
34.94
194.66
190.10
81.20
during the previously established
reporting period for the 2017 PQRS
payment adjustment, we do not believe
the individual EP or group practice
incurs any additional burden. The
associated reporting burden which is
currently approved by OMB under
control number 0938–1059 (CMS–
10276) explains that the PQRS annual
burden estimate was calculated
separately for (1) individual eligible
professionals and group practices using
the claims (for eligible professionals
only), (2) qualified registry and QCDR,
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(3) EHR-based reporting mechanisms,
and (4) group practices using the GPRO.
We estimated that ALL 1.25 million
eligible professionals will participate in
the PQRS in 2016 for purposes of
meeting the criteria for satisfactory
reporting (or, in lieu of satisfactory
reporting, satisfactory participation in a
QCDR) for the 2018 PQRS payment
adjustment. This is a high estimate
according to the 2014 PQRS Reporting
Experience and Trends Report which
found approximately 822,000 EPs
participated in PQRS in 2014.
Therefore, the additional EPs who
choose to report separately from the
ACOs have already been accounted for
in the PQRS burden. We estimate there
were approximately 1,947 EPs that are
part of the 218 participant TINs that are
under the 8 ACOs that failed to
successfully report their 2015 quality
data. There is no change in the reporting
mechanisms or reporting criteria for
PQRS. It is important to note that if the
ACO fails to report on behalf of an EP
or group practice and the EP or group
practice does not utilize this secondary
reporting period they may be subject to
a downward adjustment.
2. ICRs Regarding Appropriate Use
Criteria for Advanced Diagnostic
Imaging Services (§ 414.94)
Consistent with section 1834(q) of the
Act (as amended by section 218(b) of the
PAMA), we have proposed specific
requirements for clinical decision
support mechanisms (CDSMs) that can
be qualified CDSMs under § 414.94 of
our regulations as part of the Medicare
appropriate use criteria (AUC) program.
CDSMs that believe they meet the
requirements to be qualified CDSMs (for
the purpose of this section) may apply
to CMS to be specified as a qualified
CDSM.
Applications must be submitted
electronically and demonstrate how the
CDSM meets the requirements under
§ 414.94(g)(1). Specifically, applications
must demonstrate how the CDSM: (1)
Makes available specified applicable
AUC and related documentation
supporting the appropriateness of the
applicable imaging service ordered; (2)
identifies the appropriate use criterion
consulted in the event the CDSM makes
available more than one criterion
relevant to a consultation for a patient’s
specific clinical scenario; (3) makes
available, at a minimum, specified
applicable AUC that reasonably
encompass the entire clinical scope of
all priority clinical areas identified in
§ 414.94(e)(5); (4) has the technical
capability to incorporate specified
applicable AUC from more than one
qualified PLE; (5) determines the extent
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to which an applicable imaging service
is consistent with a specified applicable
appropriate use criterion consulted for a
patient’s specific clinical scenario, or a
determination of ‘‘not applicable’’ when
the mechanism does not contain a
criterion applicable to that patient’s
specific clinical scenario; (6) generates
and provides a certification or
documentation each time an ordering
professional consults a qualified CDSM
that includes a unique consultation
identifier to the ordering professional
that documents which qualified CDSM
was consulted, the name and national
provider identifier (NPI) of the ordering
professional that consulted the CDSM,
and whether the service ordered would
adhere to specified applicable AUC or
whether specified applicable AUC was
not applicable to the service ordered; (7)
updates AUC content at least every 12
months to reflect revisions or updates
made by qualified PLEs to their AUC
sets or an individual appropriate use
criterion; (8) has a protocol to
expeditiously remove AUC determined
by the qualified PLE to be potentially
dangerous to patients and/or harmful if
followed; (9) makes available for
consultation specified applicable AUC
that reasonably encompass the entire
clinical scope of any new priority
clinical area within 12 months of the
priority clinical area being finalized by
CMS; (10) meets privacy and security
standards under applicable provisions
of law; (11) provides the ordering
professional aggregate feedback
regarding their consultation with
specified applicable AUC in the form of
an electronic report on an annual basis;
(12) maintains electronic storage of
clinical, administrative, and
demographic information of each
unique consultation for a minimum of 6
years; and (13) complies with
modification(s) to any requirements
under § 414.94(g)(1) made through
rulemaking within 12 months of the
effective date of the modification.
To be specified as a qualified CDSM
by CMS, mechanism developers must
document adherence to the
requirements in their application for
CMS review and use the application
process identified in § 414.94(g)(2)
which includes: (1) Applications
submitted by CDSMs documenting
adherence to each requirement outlined
in § 414.94(g)(1) must be received
annually by January 1; (2) all approved
qualified CDSMs in each year will be
included on the list of qualified CDSMs
posted to the CMS Web site by June 30
of that year; (3) approved CDSMs are
qualified for a period of 5 years; and (4)
all qualified CDSMs must re-apply every
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5 years and applications must be
received by CMS by January 1 of the 5th
year after the developer’s most recent
approval date. If a qualified CDSM is
found to be non-adherent to the
requirements identified above, CMS
may terminate its qualified status or
may consider this information during
re-qualification.
The one-time burden associated with
the requirements under § 414.94(g)(2) is
the time and effort it would take each
of the approximately 30 CDSM
developers (as estimated by CMS, the
Office of the National Coordinator
(ONC), and the Agency for Healthcare
Research and Quality (AHRQ)) that have
interests in incorporating AUC
consultation into their mechanisms’
functionality to compile, review and
submit documentation demonstrating
adherence to the proposed CDSM
requirements. We anticipate 30
respondents based on the number of
existing CDSMs that have expressed an
interest in incorporating AUC for
advanced diagnostic imaging, as well as
our estimation of the number of CDSM
developers that may be interested in
incorporating AUC for advanced
diagnostic imaging in the future as their
mechanisms develop and evolve. Each
respondent will voluntarily compile,
review and submit documentation that
demonstrates their adherence to the
proposed CDSM requirements listed
above.
We estimate it would take 10 hours at
$68.18/hr for a business operations
specialist to compile, prepare and
submit the required information, 2.5
hours at $86.72/hr for a computer
system analyst to review and approve
the submission, 2.5 hours at $135.58/hr
for a computer and information systems
manager to review and approve the
submission, and 5 hours at $131.02/hr
for a lawyer to review and approve the
submission. In this regard, we estimate
20 hours per submission at a cost of
$1,892.65. In aggregate, we estimate 600
hours (20 hr × 30 submissions) at
$56,779.50 ($1,892.65 × 30
submissions).
After the anticipated initial 30
respondents, we expect less than 10
applicants to apply to become qualified
CDSMs annually. Since we estimate
fewer than 10 respondents, the
information collection requirements and
burden are exempt (5 CFR 1320.2(c))
from the requirements of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq).
Given that qualified CDSMs must reapply every 5 years, in years 6–10, we
expect the initial 30 entities will reapply. The ongoing burden for reapplying is expected to be half the
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burden of the initial application
process. The CDSM developers will be
able to make modifications to their
original application which should result
in a burden of 5 hr at $68.18/hr for a
business operations specialist to
compile, prepare and submit the
required information, 1.25 hr at $86.72/
hr for a computer system analyst to
review and approve the submission,
1.25 hr at $135.58/hr for a computer and
information systems manager to review
and approve the submission, and 2.5 hr
at $131.02/hr for a lawyer to review and
approve the submission. Annually, we
estimate 10 hr per submission at a cost
of $946.33 per CDSM developer. In
aggregate, we estimate 300 hr (10 hr ×
30 submissions) at $28,389.90 ($946.33
× 30 submissions).
As regulatory requirements become
more complex, we will look to
innovative technologies that minimize
the burden on an organizations’ budget
and manpower. To this end, the
proposed CDSM functionality
requirements identified in § 414.94(g)(1)
will help practitioners meet the
requirements of the AUC program.
While the CDSM application process
proposed in § 414.94(g)(2) is a new
burden under this program, the CDSM
functionality requirements proposed in
§ 414.94(g)(1) do not add burden as they
are functions of the CDSM. These
mechanisms function consistently with
their voluntary and individualized
design so the proposed requirements in
§ 414.94(g)(1) are either part of a
mechanism’s functionality or not. If
CDSM developers wish to become
qualified under this program, they may
choose to develop the functionality of
their mechanisms consistent with these
requirements to be qualified, but all
CDSMs are not required to participate in
this program. For example, a CDSM that
does not incorporate AUC for any
advanced diagnostic imaging services
would likely choose not to seek to
become qualified under this Medicare
AUC program. As such, only CDSMs
that wish to participate in the Medicare
AUC for advanced diagnostic imaging
services program are required to apply
for qualification and, in choosing to
seek qualification, CDSM developers
would also choose to incorporate the
proposed requirements into their
mechanism’s functionality.
The proposed requirements and
burden will be submitted to OMB under
control number 0938—New (CMS–
10624).
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3. ICRs Regarding the Enrollment of MA
Providers, Suppliers, and First-Tier,
Downstream, and Related Entities
(FDRs) (§ 422.222)
There are approximately 1.9 million
providers and suppliers nationwide that
are enrolled in Medicare. Through our
analysis of currently available encounter
data provided by MA organizations, we
have found that some providers and
suppliers that furnish items or services
to MA organization enrollees are not
enrolled in Medicare in an approved
status. Based on preliminary data, we
estimate that 64,000 MA providers and
suppliers would have to enroll in
Medicare pursuant to proposed
§ 422.222 in order to treat enrollees.
About half of the approximately
64,000 unenrolled providers and
suppliers, or 32,000, are individuals and
the other half are organizations. We do
not have data at this point to confirm
the number of unenrolled individuals
who are physicians as opposed to nonphysician practitioners. For purposes of
fulfilling the requirements of the PRA,
we will project that one-half (16,000) are
physicians and the other half (16,000)
are practitioners.
Consistent with our prior time (per
respondent) estimates, we project that it
would take 3 hours at $194.66/hr for a
physician and $93.30/hr for a nonphysician practitioner to complete their
individual enrollments. For
organizations (office and administrative
support personnel), we estimate it
would take 6 hours at $34.94/hr, since
organizations typically submit more
data than individuals. For physicians,
we estimate 48,000 hours (16,000
applicants × 3 hours) at a cost of
$9,343,680 (48,000 hr × $194.66/hr). For
non-physician practitioners, we
estimate 48,000 hours (16,000
applicants × 3 hours) at a cost of
$4,478,400 (48,000 hr × $93.30/hr). For
organizations, we estimate 192,000
hours (32,000 applicants × 6 hours) at a
cost of $6,708,480 (192,000 hr × $34.94).
In aggregate, we estimate 288,000 hours
at $20,530,560.
When projected annually over OMB’s
maximum 3-year approval period, we
estimate 96,000 hours at a cost of
$6,843,520.
For physicians and non-physician
practitioners, the proposed
requirements and annualized burden
(32,000 hours) will be submitted to
OMB under control number 0938–0685
(Form CMS–855I) because physicians
and non-physician practitioners enroll
via the Form CMS–855I. For
organizations, the proposed
requirements and annualized burden
(64,000 hours) will be submitted to
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OMB under control number 0938–0685
(21,333.3 hours for Form CMS–855A
and 21,333.3 hours for Form CMS–
855B) and control number 0938–1056
(21,333.3 hours for Form CMS–855S).
The specific form to be completed
would depend upon the provider or
supplier type at issue. For instance, and
consistent with current enrollment
policy, certified providers and certain
certified suppliers would complete the
Form CMS–855A; group practices,
ambulance suppliers, and certain other
supplier types would complete the
Form CMS–855B; suppliers of durable
medical equipment, prosthetics,
orthotics and supplies (DMEPOS) would
complete the Form CMS–855S.
Please note that breakout of the
organization burden (dividing 64,000
hours by 3 forms) is an estimate.
Logistically this is necessary for the
purposes of submitting burden for
approval. We have no way of estimating
the number of providers/suppliers that
will complete the individual forms. We
welcome comment to help us derive a
more reliable breakout.
4. ICRs Regarding Application
Requirements (§ 422.501) and
Termination of Contract by CMS
(§ 422.510)
Changes proposed for §§ 422.501 and
422.510 involve only CMS contract
changes and will not result in any
external charges or operational costs to
MA organizations. Many MA
organizations already require Medicare
enrollment for all their network
providers and suppliers. So there will
be no additional costs to most MA and
MA- PD plans. The only tangible costs
would be to those providers or suppliers
that are not enrolled and those costs are
estimated above.
5. ICRs Regarding the Release of
Medicare Advantage Bid Pricing Data
(§ 422.272) and the Release of Part C and
Part D Medical Loss Ratio (MLR) Data
(§§ 422.2490 and 423.2490)
Section 422.272 proposes an annual
public release of MA bid pricing data
(with specified exceptions from release),
which would occur after the first
Monday in October and would contain
MA bid pricing data that was approved
by CMS for a contract year at least five
years prior to the upcoming calendar
year. Under Part C, MA organizations
(MAOs) are required to submit bid data
to CMS each year for MA plans they
wish to offer in the upcoming contract
year (calendar year), under current
authority at § 422.254.
Proposed §§ 422.2490 (for Part C) and
423.2490 (for Part D) would also provide
for the public release of Part C and Part
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D MLR data for each contract year,
which would occur no sooner than 18
months after the end of the contract year
for which the MLR Report was
submitted. Starting with contract year
2014, if an MAO or Part D sponsor fails
to spend at least 85 percent of the
revenue received under an MA or Part
D contract on incurred claims and
quality improving activities, the MAO
or Part D sponsor must remit to the
Secretary the product of: (1) The
contract’s total revenue; and (2) the
difference between 85 percent and the
contract’s MLR. For each contract year,
each MAO and Part D sponsor must
submit an MLR Report to CMS which
includes the data needed by the MAO
no impact on respondent requirements
or burden, the changes will be
submitted to OMB for approval under
control number 0938–0944 (CMS–
10142) for MA bid pricing data and
0938–1232 (CMS–10476) for Part C and
Part D MLR data.
or Part D sponsor to calculate and verify
the MLR and remittance amount, if any,
for each contract. The proposed rule
would allow us to release the Part C and
Part D MLR data contained in the MLR
Reports that we receive from MAOs and
Part D sponsors, with specified
exceptions to release.
The proposed provisions on release of
MA bid pricing data and release of Part
C and Part D MLR data do not change
any of the existing requirements
regarding submission of bid data and
MLR data by MAOs or Part D sponsors.
Nor does this rule propose any new or
revised reporting, recordkeeping, or
third-party disclosure requirements.
Although the proposed provisions have
6. ICRs Regarding the Medicare Shared
Savings Program (Part 425)
Section 1899(e) of the Act provides
that chapter 35 of title 44 of the U.S.
Code, which includes such provisions
as the PRA, shall not apply to the
Shared Savings Program.
C. Summary of Annual Burden
Estimates for Proposed Requirements
TABLE 40—PROPOSED ANNUAL RECORDKEEPING AND REPORTING REQUIREMENTS
Burden per
response
(hours)
Total annual
burden
(hours)
Labor cost of
reporting
($)
Regulation section(s) under
title 42 of the CFR
OMB Control
No.
Respondents
Total responses
Total cost
($) *
§ 414.94(g)(2) ........................
§ 414.94(g)(2) (reapply) ........
§ 422.222 (physicians and
non-physician practitioners).
§ 422.222 (organizations) ......
0938—New ....
0938—New ....
0938–0685 .....
30
........................
32,000
20
10
3
600
300
32,000
varies
varies
varies
56,780
28,390
4,607,360
0938–0685 .....
32,000
6
42,666.6
34.94
1,490,771
§ 422.222 (organizations) ......
0938–1056 .....
........................
30 ..........................................
30 ..........................................
10,666.6 (32,000 responses
annualized over 3 years).
7,111.1 for two CMS–855
forms (21,333.3 responses
annualized over 3 years).
3,555.6 for one CMS–855
form.
6
21,333.3
34.94
745,386
Total ...............................
........................
64,030
64,060 ...................................
........................
96,900
varies
6,928,687
* This rule does not propose any non-labor costs.
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D. Associated Information Collections
Not Specified in Regulatory Text
In this proposed rule, we make
reference to proposed associated
information collection requirements that
were not discussed in the regulation text
contained in this proposed rule. The
following is a discussion of those
requirements.
Physician Fee Schedule which includes
but is not limited to surveys of
physicians, other suppliers, providers of
services, manufacturers, and vendors;
surgical logs, billing systems, or other
practice or facility records; electronic
health records; and, any other
mechanism deemed appropriate by the
Secretary.
1. Global Surgical Services
Section II.D.2. of this proposed rule
details our plans for a proposed claims
based reporting program for global
surgical services. Specifically, that
section describes our proposal for
claims-based data collection that would
be applicable to 10- and 90-day global
services furnished on or after January 1,
2017, including who would be required
to report, what they would be required
to report, and how reports would be
submitted. As currently proposed, this
data collection would be subject to the
PRA. As stated in section 220 of the
Protecting Access to Medicare Act
(PAMA) of 2014 (Pub. L. 113–93),
Chapter 35 of title 44, United States
Code, shall not apply to information
collected or obtained under this
paragraph. Specifically, information
collected to ensure the accurate
valuation of services under the
2. Survey of Practitioners
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As discussed earlier in section II.D.6.
e.(1)–(2) of this document, we are
proposing to conduct a survey of
providers to help us explore options and
collect data with respect to assessing
and revaluing the global surgery
services. If we finalize this proposal, the
associated information collection
request will be exempt from the PRA.
As stated in stated in section 220 of
PAMA of 2014, Chapter 35 of title 44,
United States Code, shall not apply to
information collected to ensure the
accurate valuation of services under the
Physician Fee Schedule. Consequently,
the information collection requirements
associated with this proposed survey
need not be reviewed by the Office of
Management and Budget.
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3. Data Collection for Accountable Care
Organizations
In section II.D6.e.(3) of this document,
we propose to conduct a survey of ACOs
on a number of issues surrounding preand post-operative surgical services.
Once developed and implemented, the
survey would be exempt from the PRA.
As stated in section 3022 of the
Affordable Care Act, Chapter 35 of title
44, United States Code, shall not apply
to the Medicare Shared Savings
Program. Similarly, as stated in stated in
section 220 of PAMA of 2014, Chapter
35 of title 44, United States Code, shall
not apply to information collected to
ensure the accurate valuation of services
under the Physician Fee Schedule.
Consequently, the information
collection requirements associated with
this proposed survey need not be
reviewed by the Office of Management
and Budget.
E. Submission of PRA-Related
Comments
We have submitted a copy of this
proposed rule to OMB for its review of
the rule’s information collection and
recordkeeping requirements. These
requirements are not effective until they
have been approved by the OMB.
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To obtain copies of the supporting
statement and any related forms for the
proposed collections discussed above,
please visit CMS’ Web site at
www.cms.hhs.gov/
PaperworkReductionActof1995, or call
the Reports Clearance Office at 410–
786–1326.
We invite public comments on these
potential information collection
requirements. If you wish to comment,
please submit your comments
electronically as specified in the
ADDRESSES section of this proposed rule
and identify the rule (CMS–1654–P) the
ICR’s CFR citation, CMS ID number, and
OMB control number.
ICR-related comments are due
September 13, 2016.
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. Regulatory Impact Analysis
A. Statement of Need
This proposed rule is necessary to
make payment and policy changes
under the Medicare PFS and to make
required statutory changes under the
Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA)
and the Achieving a Better Life
Experience Act of 2014 (ABLE). This
proposed rule is also necessary to make
changes to payment policy and other
related policies for Medicare Part B, Part
D, and Medicare Advantage.
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B. Overall Impact
We 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
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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
($100 million or more in any 1 year). We
estimate, as discussed in this section,
that the PFS provisions included in this
proposed rule would 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 prepared an 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
proposed rule 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
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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 603
of the RFA. For purposes of section
1102(b) of the Act, we define a small
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 did not prepare an analysis for
section 1102(b) of the Act because we
determined, and the Secretary certified,
that this proposed rule 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 2016, that
threshold is approximately $146
million. This proposed rule 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 issues 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 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 proposed rule; 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 proposed rule, we are
proposing to implement 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 proposed rule.
We are unaware of any relevant federal
rules that duplicate, overlap, or conflict
with this proposed rule. The relevant
sections of this proposed rule contain a
description of significant alternatives if
applicable.
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C. Changes in Relative Value Unit
(RVU) Impacts
1. Resource-Based Work, PE, and MP
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
expenditures for PFS services compare
payment rates for CY 2016 with
proposed payment rates for CY 2017
using CY 2015 Medicare utilization. The
payment impacts in this proposed rule
reflect averages by 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
practitioner furnishes. The average
percentage change in total revenues
would be less than the impact displayed
here because practitioners and other
entities generally furnish services to
both Medicare and non-Medicare
patients. In addition, practitioners and
other entities may receive substantial
Medicare revenues for services under
other Medicare payment systems. For
instance, independent laboratories
receive approximately 83 percent of
their Medicare revenues from clinical
laboratory services that are paid under
the Clinical Lab Fee Schedule.
The annual update to the PFS
conversion factor (CF) was previously
calculated based on a statutory formula;
for details about this formula, we refer
readers to the CY 2015 PFS final rule
with comment period (79 FR 67741
through 67742). Section 101(a) of the
MACRA repealed the previous statutory
update formula amended section
1848(d) of the Act to specify the update
adjustment factors for calendar years
2015 and beyond. For 2017, the
specified update is 0.5 percent.
We note that section 220(d) of the
PAMA added a new paragraph at
section 1848(c)(2)(O) of the Act to
establish an annual target for reductions
in PFS expenditures resulting from
adjustments to relative values of
misvalued codes. Under section
1848(c)(2)(O)(ii) of the Act, if the net
reduction in expenditures for the year is
equal to or greater than the target for the
year, reduced expenditures attributable
to such adjustments shall be
redistributed in a budget-neutral
manner within the PFS in accordance
with the existing budget neutrality
requirement under section
1848(c)(2)(B)(ii)(II) of the Act. Section
1848(c)(2)(O)(iii) of the Act specifies
that, if the estimated net reduction in
PFS expenditures for the year is less
than the target for the year, an amount
equal to the target recapture amount
shall not be taken into account when
applying the budget neutrality
requirements specified in section
1848(c)(2)(B)(ii)(II) of the Act. We
estimate the CY 2017 net reduction in
expenditures resulting from proposed
adjustments to relative values of
misvalued codes to be 0.51 percent.
Since, if finalized, this amount would
exceed the 0.5 percent target established
by the Achieving a Better Life
Experience Act of 2014 (ABLE)
(Division B of Pub. L. 113–295, enacted
December 19, 2014), there is no residual
difference between the target for the
year and the estimated net reduction in
expenditures (the ‘‘Target Recapture
Amount’’) by which to reduce payments
made under the PFS. As a result, we
estimate that the proposed PFS rates
would not produce a CY 2017 Target
Recapture Amount applicable to the CY
2017 CF. However, we note that the
final Target Recapture Amount will be
calculated based on the adjustments to
misvalued codes as finalized in the CY
2017 PFS Final Rule.
Effective January 1, 2012, we
implemented an MPPR of 25 percent on
the professional component (PC) of
advanced imaging services. Section
502(a)(2)(A) of the Consolidated
Appropriations Act of 2016 (Pub. L 114–
113, enacted on December 18, 2015)
added a new section 1848(b)(10) of the
Act which revises the multiple
procedure payment reduction on the
professional component of imaging
services from 25 percent to 5 percent,
effective January 1, 2017. Section
502(a)(2)(B) added a new subclause at
section 1848(c)(2)(B)(v)(XI) which
exempts the MPPR reductions
attributable to the new 5 percent MPPR
on the PC of imaging from the PFS
budget neutrality provision. However,
the provision does not exempt the
change from the 25 percent MPPR from
PFS budget neutrality. Therefore, for CY
2017 we must calculate PFS rates in a
manner that exempts the 5 percent
MPPR from budget neutrality but
ensures that the elimination of the 25
percent MPPR is included in PFS
budget neutrality. We note that the
application of the 25 percent MPPR has
been applied in a budget neutral fashion
to date.
The CY 2017 proposed PFS rates
exclude the 5 percent MPPR for the
professional component of imaging
services by calculating the rates as if the
discount does not occur, consistent with
our approach to other discounts that
occur outside of PFS budget neutrality.
In order to implement the change from
the 25 percent discount in 2016 to the
5 percent discount in 2017 within PFS
budget neutrality, we measured the
difference in total RVUs for the relevant
services assuming an MPPR of 25
percent and the total RVUs for the same
services without an MPPR and then
applied that difference as an adjustment
to the conversion factor to account for
the increased expenditures attributable
to the change, within PFS budget
neutrality. This approach is consistent
with the statutory provision that
requires the 5 percent MPPR to be
implemented outside of PFS budget
neutrality.
To calculate the proposed conversion
factor for this year, we multiply the
product of the current year conversion
factor and the update adjustment factor
by the budget neutrality adjustment and
the imaging MPPR adjustment described
in the preceding paragraphs. We
estimate the CY 2017 PFS conversion
factor to be 35.7751, which reflects the
budget neutrality adjustment, the 0.5
percent update adjustment factor
specified under section 1848(d)(18) of
the Act, and a the adjustment due to the
non-budget neutral 5 percent MPPR for
the professional component of imaging
services. We did not need to apply an
adjustment for atarget recapture for the
reasons described above. We estimate
the CY 2017 anesthesia conversion
factor to be 21.9756, which reflect the
same overall PFS adjustments.
TABLE 41—CALCULATION OF THE PROPOSED CY 2017 PFS CONVERSION FACTOR
Conversion factor in effect in CY 2016
35.8043
Update Factor .............................................................................
CY 2017 RVU Budget Neutrality Adjustment .............................
CY 2017 Target Recapture Amount ...........................................
CY 2017 Imaging MPPR Adjustment .........................................
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0.50 percent (1.0050) .................................................................
¥0.51 percent (0.9949) .............................................................
0 percent (1.0000) ......................................................................
¥0.07 percent (0.9993) .............................................................
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Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
TABLE 41—CALCULATION OF THE PROPOSED CY 2017 PFS CONVERSION FACTOR—Continued
Conversion factor in effect in CY 2016
35.8043
CY 2017 Conversion Factor .......................................................
.....................................................................................................
35.7751
TABLE 42—CALCULATION OF THE PROPOSED CY 2017 ANESTHESIA CONVERSION FACTOR
CY 2016 national average anesthesia conversion factor
21.9935
Update Factor .............................................................................
CY 2017 RVU Budget Neutrality Adjustment .............................
CY 2017 Target Recapture Amount ...........................................
CY 2017 Imaging MPPR Adjustment .........................................
CY 2017 Conversion Factor .......................................................
Table 43 shows the payment impact
on PFS services of the proposals
contained in this proposed rule. To the
extent that there are year-to-year
changes in the volume and mix of
services provided by practitioners, the
actual impact on total Medicare
revenues would be different from those
shown in Table 43 (CY 2017 PFS
Estimated Impact on Total Allowed
Charges by Specialty). The following is
an explanation of the information
represented in Table 43.
• Column A (Specialty): Identifies the
specialty for which data is shown.
• Column B (Allowed Charges): The
aggregate estimated PFS allowed
charges for the specialty based on CY
2015 utilization and CY 2016 rates. That
0.50 percent (1.0050) .................................................................
¥0.51 percent (0.9949) .............................................................
0 percent (1.0000) ......................................................................
¥0.07 percent (0.9993) .............................................................
.....................................................................................................
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 2017 impact on total
allowed charges of the changes in the
work RVUs, including the impact of
changes due to potentially misvalued
codes.
• Column D (Impact of PE RVU
Changes): This column shows the
estimated CY 2017 impact on total
........................
........................
........................
........................
21.9756
allowed charges of the changes in the PE
RVUs.
• Column E (Impact of RVU
Changes): This column shows the
estimated CY 2017 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 (Combined Impact): This
column shows the estimated CY 2017
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.
TABLE 43—CY 2017 PFS ESTIMATED IMPACT ON TOTAL ALLOWED CHARGES BY SPECIALTY *
Allowed
Charges (mil)
Impact of
Work RVU
Changes
Impact of PE
RVU Changes
Impact of MP
RVU Changes
Combined
Impact **
(A)
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
Specialty
(B)
(C)
(D)
(E)
(F)
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 PHYS .........................
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$89,467
230
1,977
61
322
6,461
779
727
601
160
308
3,305
750
3,133
458
6,087
1,744
451
2,157
211
182
1,746
701
652
10,849
767
315
128
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0%
0
0
0
0
0
0
0
0
0
0
0
0
0
1
1
0
1
0
1
0
1
0
0
1
1
¥1
1
E:\FR\FM\15JYP2.SGM
0%
1
¥1
0
0
0
0
0
0
0
0
0
¥2
0
1
1
0
1
0
1
0
1
¥5
0
1
0
¥5
1
15JYP2
0%
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0%
2
0
1
0
1
0
0
0
0
0
1
¥2
0
2
3
¥1
2
0
2
0
2
¥5
1
2
0
¥7
1
46460
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
TABLE 43—CY 2017 PFS ESTIMATED IMPACT ON TOTAL ALLOWED CHARGES BY SPECIALTY *—Continued
Specialty
Allowed
Charges (mil)
Impact of
Work RVU
Changes
Impact of PE
RVU Changes
Impact of MP
RVU Changes
Combined
Impact **
(A)
(B)
(C)
(D)
(E)
(F)
NEPHROLOGY ....................................................................
NEUROLOGY ......................................................................
NEUROSURGERY ..............................................................
NUCLEAR MEDICINE .........................................................
NURSE ANES/ANES ASST ................................................
NURSE PRACTITIONER .....................................................
OBSTETRICS/GYNECOLOGY ............................................
OPHTHALMOLOGY ............................................................
OPTOMETRY ......................................................................
ORAL/MAXILLOFACIAL SURGERY ...................................
ORTHOPEDIC SURGERY ..................................................
OTHER .................................................................................
OTOLARNGOLOGY ............................................................
PATHOLOGY .......................................................................
PEDIATRICS ........................................................................
PHYSICAL MEDICINE .........................................................
PHYSICAL/OCCUPATIONAL THERAPY ............................
PHYSICIAN ASSISTANT .....................................................
PLASTIC SURGERY ...........................................................
PODIATRY ...........................................................................
PORTABLE X–RAY SUPPLIER ..........................................
PSYCHIATRY ......................................................................
PULMONARY DISEASE ......................................................
RADIATION ONCOLOGY ....................................................
RADIATION THERAPY CENTERS .....................................
RADIOLOGY ........................................................................
RHEUMATOLOGY ...............................................................
THORACIC SURGERY .......................................................
UROLOGY ...........................................................................
VASCULAR SURGERY .......................................................
2,205
1,514
784
47
1,211
2,974
647
5,493
1,213
48
3,685
26
1,208
1,127
61
1,062
3,395
1,959
374
1,954
104
1,250
1,759
1,720
43
4,670
536
356
1,764
1,045
¥1
1
0
0
0
1
1
¥2
¥1
0
0
0
0
¥2
1
0
0
1
0
0
¥1
1
0
0
¥1
¥1
1
0
0
¥2
0
1
¥1
0
0
1
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
1
0
0
0
0
1
0
¥1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
¥1
1
¥1
0
0
2
1
¥2
¥1
0
0
0
0
¥2
2
1
1
1
0
1
¥1
1
1
0
¥1
¥1
2
0
¥1
¥2
** Column F may not equal the sum of columns C, D, and E due to rounding.
2. CY 2017 PFS Impact Discussion
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
a. Changes in RVUs
The most widespread specialty
impacts of the proposed RVU changes
are generally related to the proposed
changes to RVUs for specific services
resulting from the Misvalued Code
Initiative, including proposed RVUs for
new and revised codes. Several
specialties, including interventional
radiology and independent labs, would
experience significant decreases to
overall payments for services that they
frequently furnish as a result of
revisions to the coding structure or the
proposed inputs used to develop RVUs
for the codes that describe particular
services. Other specialties, including
endocrinology and family practice,
would experience significant increases
to payments for similar reasons.
b. Impact
Column F of Table 43 displays the
estimated CY 2017 impact on total
allowed charges by specialty of all the
RVU changes. A table shows the
estimated impact on total payments for
selected high volume procedures of all
of the changes is available under
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‘‘downloads’’ on CY 2017 PFS proposed
rule Web site at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/. We
selected these procedures for 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 on the CMS
Web site at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/.
D. Effect of Proposed Changes in
Telehealth List
As discussed in section II.I. of this
proposed rule, we proposed to add
several new codes to the list of Medicare
telehealth services. Although we expect
these changes to increase access to care
in rural areas, based on recent
utilization of similar services already on
the telehealth list, we estimate no
significant impact on PFS expenditures
from the additions relative to overall
PFS expenditures.
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E. Geographic Practice Cost Indices
(GPCIs)
Based upon statutory requirements,
we are proposing new GPCIs for each
Medicare payment locality. The
proposed GPCIs incorporate updated
data and cost share weights as discussed
in II.E. The Act requires that updated
GPCIs be phased in over two years.
Addendum D shows the estimated
effects of the revised GPCIs on area
GAFs for the transition year (CY 2017)
and the fully implemented year (CY
2018). The GAFs reflect the use of the
updated underlying GPCI data, and the
cost share weights remain unchanged
from the previous (seventh) GPCI
update. The GAFs are a weighted
composite of each area’s work, PE and
malpractice expense GPCIs using the
national GPCI cost share weights. While
we do not actually use the GAFs in
computing the fee schedule payment for
a specific service, 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 malpractice
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Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
F. Other Provisions of the Proposed
Regulation
1. Proposal To Change Direct
Supervision Requirement to General
Supervision for CCM Services
Furnished Incident to RHCs and FQHCs
In section III.A., we proposed to
revise § 405.2413(a)(5) and
§ 405.2415(a)(5) to state that services
and supplies furnished incident to TCM
and CCM services can be furnished
under general supervision of a RHC or
FQHC practitioner. In section III.A., we
proposed revising the CCM
requirements for RHCs and FQHCs to be
consistent with the proposed revisions
to the CCM requirements for
practitioners billing under the PFS.
3. Appropriate Use Criteria for
Advanced Diagnostic Imaging Services
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
We are proposing and requesting
public comment on clinical decision
support mechanism (CDSM)
requirements as well as an application
process that CDSM developers must
comply with for their mechanisms to be
specified as qualified under this
program. These proposals would not
impact CY 2017 physician payments
under the PFS.
4. Reports of Payments or Other
Transfers of Value to Covered
Recipients
We are soliciting comments to inform
future rulemaking. We do not intend to
finalize any requirements directly as a
result of this proposed rule; so there is
no impact to CY 2017 physician
payments under the PFS.
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As discussed in section III.B of this
proposed rule, we are proposing to
create a 2013-based FQHC market basket
to update the FQHC PPS base payment
rate. Table 44 shows the 5-year and 10year fiscal cost estimates from switching
from a MEI-adjusted base payment rate
to a FQHC PPS market basket-adjusted
base payment rate. This was determined
by compiling data on historical FQHC
spending, projecting it forward, and
creating two separate baselines. The first
baseline assumed an MEI price update
and the second baseline assumed an
FQHC specific market basket price
update which was created by the Office
of the Actuary within CMS. The
utilization of services was held constant
between the two baselines, and
therefore, the impact table specifically
captures the change in price from now
growing at an FQHC MB update relative
to how it was growing at the MEI
updates. We estimate that this would
cost approximately 170 million dollars
over 10 years from FY 2017–2026, 35
million of which would be paid for
through beneficiary premiums and the
remaining 135 million would be paid
for through Part B.
5. Release of Part C Medicare Advantage
Bid Pricing Data and Part C and Part D
Medical Loss Ratio (MLR) Data
Under section III.E. of the preamble of
this proposed rule, we are proposing to
revise the existing regulations by adding
§ 422.272 to provide for an annual
public release of MA bid pricing data
(with specified exceptions from release).
The annual release would occur after
the first Monday in October and would
contain MA bid pricing data that was
accepted or approved by CMS for a
contract year at least 5 years prior to the
upcoming calendar year. Under current
authority at § 422.254, MA organizations
(MAOs) are required to submit bid
pricing data to CMS each year for MA
plans they wish to offer in the upcoming
contract year (calendar year).
In addition, the proposed rule adds
§ 422.2490 for Part C and § 423.2490 for
Part D to provide for an annual public
release of Part C and Part D medical loss
ratio (MLR) data (with specified
exceptions from release). This annual
release would occur no sooner than 18
months after the end of the contract year
for which MLR data was reported to
CMS. Starting with contract year 2014,
each MAO or Part D sponsor that fails
to spend at least 85 percent of revenue
received under an MA or Part D contract
on incurred claims and quality
improving activities must remit the
difference to the government. Under
current authority at § 422.2460 and
§ 423.2460, each year MAOs and Part D
sponsors must submit an MLR Report to
CMS, which includes the data needed
by the MAO or Part D sponsor to
calculate and verify the MLR and
remittance amount, if any, for each
contract.
We are proposing to add regulatory
language to authorize CMS’ release of
such data to the public. We have
determined that the proposed regulatory
amendments do not impose any
mandatory costs on the public or
entities that seek to download and use
the released data. We expect that this
These proposed revisions will allow
RHCs and FQHCs to provide TCM and
CCM services at the level that was
projected when the programs were
authorized and therefore no impact on
spending is expected.
As outlined in section III.A., we
proposed to change the direct
supervision requirement to a general
supervision for CCM services furnished
incident to RHCs and FQHCs. This
regulatory change was already made for
CCM services furnished by practitioners
billing the PFS, and changes to RHC and
FQHC regulations have no impact on
regulations for practitioners billing
under the PFS. The impact on RHCs and
FQHCs in 2017 is negligible, as
estimates are rounded to the nearest 5
million and 2017 was too small of an
impact to have a notable effect on the
estimate.
2. FQHC-Specific Market Basket
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EP15JY16.096</GPH>
expense RVUs for the service differ from
those of the GAF.
The most significant changes occur in
19 non-California payment localities,
where the fully implemented (CY 2018)
GAF moves up by more than 1 percent
(14 payment localities) or down by more
than 2 percent (5 payment localities).
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Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
data will be available to the public from
the CMS Web site (https://
www.cms.gov/). The public may elect to
download the data files, which will not
impose mandatory costs on any user.
Therefore, we have determined that
there are not any economically
significant effects of the proposed
provisions. We also have determined
that the proposed regulatory
amendments would not impose a
burden on the entity requesting or
downloading data files.
6. Prohibition on Billing Qualified
Medicare Beneficiary Individuals for
Medicare Cost-Sharing
We are restating information to inform
providers to take steps to educate
themselves and their staff about QMB
billing prohibitions and to exempt QMB
individuals from Medicare cost-sharing
billing and related collection efforts.
Therefore, there is no impact to CY 2017
physician payments under the PFS.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
7. Recoupment or Offset of Payments to
Providers Sharing the Same Taxpayer
Identification Number
This proposed rule implements
section 1866(j) of the Act which grants
the Secretary the authority to authority
to make any necessary adjustments to
the payments of an applicable provider
of services or supplier who shares a TIN
with an obligated provider of services or
supplier that has an outstanding
Medicare overpayment. The Secretary is
authorized to adjust the payments of
such applicable provider, regardless of
whether that applicable provider is
assigned a different Medicare billing
number or National Provider Identifier
(NPI) number from the obligated
provider with the outstanding Medicare
overpayment. The concept of offsetting
or recouping payments of providers
sharing a TIN to satisfy a Medicare
overpayment is analogous to Treasury’s
current practice of offsetting against
entities that share a TIN to collect
Medicare overpayments. This proposed
rule would help support our efforts to
safeguard the Medicare Trust Funds by
collecting its own overpayments more
quickly and reducing the accounts
receivable delinquency rates reported in
the Treasury Report on Receivables.
This proposed rule also helps the
obligated provider because we would
collect the overpayments more quickly;
thus reducing the additional interest
assessments that would continue on the
provider’s outstanding delinquent
balance until paid in full. Therefore,
there is no impact to CY 2017 physician
payments under the PFS.
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8. Provider Enrollment Part C Program
This proposed rule would require that
providers and suppliers must be
enrolled in Medicare in approved status
in order to render services to
beneficiaries in the Medicare Advantage
program. This proposed rule will not
have a significant economic impact on
a substantial number of small
businesses because the number not
enrolled in Medicare appears to be
small in comparison to the general
population of providers. The
completion of the Form CMS–855 (as
explained in section III) would be
required very infrequently, in many
cases either only one time or once every
several years. Also, the hour and cost
burden per provider or supplier will not
pose a significant burden on a provider
and supplier, especially when
considering the overall revenue that
providers and suppliers receive per
year. We thus do not believe our
proposal would impact a substantial
number of small businesses.
Virtually all of the quantifiable costs
associated with this proposed rule
involve the paperwork burden to
providers and suppliers (see section IV.
of this proposed rule). The estimates
presented in this section do not address
the potential financial benefits of this
proposed rule from the standpoint of the
rule’s effectiveness in preventing or
deterring certain providers from
enrolling in or maintaining their
enrollment in Medicare. We simply
have no means of quantifying these
benefits in monetary terms.
There are three main uncertainties
associated with this proposed rule.
First, we are uncertain as to the number
of providers and suppliers that would
be required to enroll in Medicare under
§ 422.222. Second, we cannot estimate
the savings in fraud and abuse
prevention that would accrue from this
rule. Third, since we have no systematic
method to know how many FDRs may
be used by MA or MA–PD organizations
to deliver services to Medicare
beneficiaries, therefore, we cannot
estimate the possible impact to FDRs.
9. Proposed Expansion of the Diabetes
Prevention Program (DPP) Model
In this rule, we propose to expand the
Diabetes Prevention Program (DPP)
Model in accordance with section
1115A(c) of the Act, and we propose to
refer to this expanded model as the
Medicare Diabetes Prevention Program
(MDPP). We propose that MDPP will
become effective January 1, 2018, and
CMS will continue to test and evaluate
MDPP as finalized. In the future, CMS
will assess whether the nationwide
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implementation of the MDPP is
continuing to either reduce Medicare
spending without reducing quality of
care or improve the quality of patient
care without increasing spending, and
could modify the nationwide MDPP as
appropriate. In this proposed rule, we
propose a basic framework for the
MDPP. If finalized, we will engage in
additional rulemaking, likely within the
next year, to establish specific
requirements of the MDPP. The
comments received from this proposed
rule will inform key design parameters
of the MDPP. Modifications to the
proposed MDPP could result in changes
to our current financial projections and
therefore affect economic impact
estimates of MDPP. For these reasons, it
is premature to provide an impact
statement at this time. We intend to
provide an impact statement in future
rulemaking.
10. Medicare Shared Savings Program
We are proposing certain rules having
to do with ACO quality reporting: (1)
We are proposing conforming changes
to align with the policies included in
the QPP proposed rule, including
changes to the quality measure set; (2)
we are proposing to streamline the
quality validation audit process and use
the results to modify an ACO’s overall
quality score; (3) we are proposing
revisions to references to the Quality
Performance Standard and Minimum
Attainment; (4) we are clarifying that
measures calculated as ratios are
excluded from use of flat percentages
when such benchmarks appear
‘‘clustered’’ or ‘‘topped out’’; and (5) we
are proposing to modify our PQRS
alignment rules to permit flexibility for
EPs to report quality data to PQRS to
avoid the PQRS and VM downward
adjustments for 2017 and 2018 in cases
where an ACO fails to report on their
behalf. In addition, we are proposing
updates to the assignment methodology
to include beneficiaries who identify
ACO professionals as being responsible
for coordinating their overall care.
We are also proposing additional
beneficiary protections when ACOs in
Track 3 make use of the SNF 3-day rule
waiver. Finally, we are proposing
certain technical changes and
clarifications related to reconciliation
for ACOs that fall below 5,000 assigned
beneficiaries and related to our policies
for consideration of claims billed by
merged and acquired TINs.
Because the proposed policies are not
expected to substantially change the
quality reporting burden for ACOs
participating in the Shared Savings
Program and their ACO participants or
change the financial calculations, we do
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Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
not anticipate any impact for these
proposals.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
11. Value-Based Payment Modifier and
the Physician Feedback Program
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. 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 and groups
of physicians equal the reduced
payments to low performing physicians
and groups of physicians.
In the CY 2015 PFS final rule with
comment period (79 FR 67936 and
67941 through 67942), we established
that, beginning with the CY 2017
payment adjustment period, the VM
will apply to physicians in groups with
two or more EPs and to physicians who
are solo practitioners based on the
applicable performance period,
including physicians that participate in
an ACO under the Shared Savings
Program. In the CY 2014 PFS final rule
with comment period (78 FR 74771
through 74772), we established CY 2015
as the performance period for the VM
that will be applied to payments during
CY 2017. In CY 2017, the VM will be
waived for groups and solo
practitioners, as identified by their TIN,
if at least one EP who billed for
Medicare PFS items and services under
the TIN during 2015 participated in the
Pioneer ACO Model or the
Comprehensive Primary Care initiative
in 2015 (80 FR 71288).
In the CY 2015 PFS final rule with
comment period (79 FR 67938 through
67939), we adopted a two-category
approach for the CY 2017 VM based on
participation in the PQRS by groups and
solo practitioners. Category 1 will
include those groups that meet the
criteria to avoid the PQRS payment
adjustment for CY 2017 as a group
practice participating in the PQRS
GPRO in CY 2015. We finalized in the
CY 2016 PFS final rule with comment
period (80 FR 71280 through 71281)
that, for the CY 2017 VM, Category 1
will also include groups that have at
least 50 percent of the group’s EPs meet
the criteria to avoid the PQRS payment
adjustment for CY 2017 as individuals.
In determining whether a group will be
included in Category 1, we will consider
whether the 50 percent threshold has
been met regardless of whether the
group registered to participate in the
PQRS GPRO in CY 2015. Lastly,
Category 1 will include those solo
practitioners that meet the criteria to
avoid the PQRS payment adjustment for
CY 2017 as individuals.
For groups and solo practitioners that
participated in an ACO under the
Shared Savings Program in CY 2015,
they are considered to be Category 1 for
the CY 2017 VM if the ACO in which
they participated successfully reported
on quality measure via the GPRO Web
Interface in CY 2015 (79 FR 67946). As
discussed in sections III.I. and III.L.1.e.
of this proposed rule, we are proposing
to remove the prohibition on EPs who
are part of a group or solo practitioner
that participates in a Shared Savings
Program ACO, for purposes of PQRS
reporting for the CY 2017 and CY 2018
payment adjustments, to report outside
the ACO. In section III.L.3.b. of this
proposed rule, we are proposing for the
CY 2017 payment adjustment period, if
a Shared Savings Program ACO did not
successfully report quality data as
required by the Shared Savings Program
under § 425.504 for the CY 2017 PQRS
payment adjustment, then we propose
to use the data reported to the PQRS by
the EPs (as a group using one of the
group registry, QCDR, or EHR reporting
options or as individuals using the
registry, QCDR, or EHR reporting
option) under the participant TIN)
outside of the ACO during the
secondary PQRS reporting period to
determine whether the TIN would fall
in Category 1 or Category 2 under the
VM. We are proposing that groups that
meet the criteria to avoid PQRS
payment adjustment for CY 2018 as a
group practice participating in the PQRS
GPRO (using one of the group registry,
QCDR, or EHR reporting options) or
have at least 50 percent of the group’s
EPs meet the criteria to avoid the PQRS
payment adjustment for CY 2018 as
individuals (using the registry, QCDR,
or EHR reporting option), based on data
submitted outside the ACO and during
the secondary PQRS reporting period,
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would be included in Category 1 for the
CY 2017 VM. We are also proposing that
solo practitioners that meet the criteria
to avoid the PQRS payment adjustment
for CY 2018 as individuals using the
registry, QCDR, or EHR reporting
option, based on data submitted outside
the ACO and during the secondary
PQRS reporting period, would be
included in Category 1 for the CY 2017
VM. Category 2 would include those
groups and solo practitioners subject to
the CY 2017 VM that participate in a
Shared Savings Program ACO and do
not fall within Category 1.
The CY 2017 VM payment adjustment
amount for groups and solo
practitioners in Category 2 is ¥4.0
percent for groups of physicians with 10
or more EPs and ¥2.0 percent for
groups of physicians with between 2 to
9 EPs and physician solo practitioners.
In the CY 2015 PFS final rule with
comment period (79 FR 67939 through
67941), we finalized that quality-tiering,
which is the methodology for evaluating
performance on quality and cost
measures for the VM, will apply to all
groups of physicians and physician solo
practitioners in Category 1 for the VM
for CY 2017. However, groups of
physicians with between 2 to 9 EPs and
physician solo practitioners will be
subject only to upward or neutral
adjustments derived under qualitytiering, while groups of physicians with
10 or more EPs will be subject to
upward, neutral, or downward
adjustments derived under qualitytiering. That is, groups of physicians
with between 2 to 9 EPs and physician
solo practitioners in Category 1 would
be held harmless from any downward
adjustments derived under qualitytiering for the CY 2017 VM.
Under the quality-tiering
methodology, each group and solo
practitioner’s quality and cost
composites will be classified into high,
average, and low categories depending
upon whether the composites are at
least one standard deviation above or
below the mean and statistically
different from the mean. We will
compare their quality of care composite
classification with the cost composite
classification to determine their VM
adjustment for the CY 2017 payment
adjustment period according to the
amounts in Tables 45 and 46.
TABLE 45—CY 2017 VM PAYMENT ADJUSTMENT AMOUNTS UNDER QUALITY-TIERING FOR GROUPS OF PHYSICIANS WITH
TWO TO NINE EPS AND PHYSICIAN SOLO PRACTITIONERS
Cost/quality
Low quality
Low cost .....................................................................................................................
Average cost ..............................................................................................................
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Average quality
+0.0%
+0.0%
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* +1.0x
+0.0%
15JYP2
High quality
* +2.0x
* +1.0x
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TABLE 45—CY 2017 VM PAYMENT ADJUSTMENT AMOUNTS UNDER QUALITY-TIERING FOR GROUPS OF PHYSICIANS WITH
TWO TO NINE EPS AND PHYSICIAN SOLO PRACTITIONERS—Continued
Cost/quality
Low quality
High cost ....................................................................................................................
Average quality
+0.0%
+0.0%
High quality
+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 46—CY 2017 VM PAYMENT ADJUSTMENT AMOUNTS UNDER QUALITY-TIERING FOR GROUPS OF PHYSICIANS WITH
TEN OR MORE EPS
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%
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* 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.
Under the quality-tiering
methodology, for groups and solo
practitioners that participated in a
Shared Savings ACO that successfully
reports quality data for CY 2015, the
cost composite will be classified as
‘‘Average’’ and the quality of care
composite will be based on ACO-level
quality measures. We will compare their
quality of care composite classification
with the ‘‘Average’’ cost composite
classification to determine their VM
adjustment for the CY 2017 payment
adjustment period according to the
amounts in Tables 45 and 46.
We are proposing in section III.M.3.b.
of this proposed rule, for groups and
solo practitioners that participate in a
Shared Savings Program ACO that did
not successfully report quality data for
CY 2015 and are in Category 1 as a
result of reporting quality data to the
PQRS outside of the ACO using the
secondary PQRS reporting period, we
are proposing to classify their quality
composite for the VM for the CY 2017
payment adjustment period as ‘‘average
quality.’’ Their cost composite will be
classified as ‘‘average cost’’ (79 FR
67943).
To ensure budget neutrality, we first
aggregate the downward payment
adjustments in Tables 45 and 46 for
those groups and solo practitioners in
Category 1 with the automatic
downward payment adjustments of
¥2.0 percent or ¥4.0 percent for groups
and solo practitioners 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). We plan to incorporate assumptions
about the number of physicians in
groups and physician solo practitioners
in the ACOs that did not successfully
report their CY 2015 quality data whose
status could potentially change from
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Category 2 to Category 1 if the group or
solo practitioner satisfactorily report
their 2016 data during the secondary
PQRS reporting period. Additionally, as
we had done when calculating the
upward payment adjustment factor for
the 2016 VM, we will also incorporate
adjustments made for estimated changes
in physician behavior (i.e., changes in
the volume and/or intensity of services
delivered and shifting of services to
TINs that receive higher VM
adjustments) and estimated impact of
pending PQRS and VM informal
reviews. These calculations will be done
after the performance period has ended.
At the time of this proposed rule, we
have not completed the analysis of the
impact of the VM in CY 2017 on
physicians in groups with 2 or more EPs
and physician solo practitioners based
on their performance in CY 2015. In the
CY 2017 PFS final rule with comment
period, we will present the number of
groups of physicians and physician solo
practitioners that will be subject to the
VM in CY 2017.
12. Physician Self-Referral Updates
The physician self-referral update
provisions are discussed in section III.M
of this proposed rule. We are reproposing regulatory provisions
prohibiting certain per-unit of service
compensation formulas for determining
rental charges in the exceptions for the
rental of office space, rental of
equipment, fair market value
compensation, and indirect
compensation arrangements. These
provisions are necessary to protect
against potential abuses such as
overutilization and anti-competitive
behavior. We believe that most parties
comply with these regulatory provisions
since they originally became effective
on October 1, 2009, and the re-proposed
regulations text is identical to the
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Sfmt 4702
existing regulations text. Therefore, we
do not believe that the proposals will
have a significant burden.
G. Alternatives Considered
This proposed rule 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. For
purposes of the payment impact on PFS
services of the proposals contained in
this proposed rule, we presented the
estimated impact on total allowed
charges by specialty. The alternatives
we considered, as discussed in the
preceding preamble sections, would
result in different proposed payment
rates, and therefore result in different
estimates than those shown in Table 43
(CY 2017 PFS Estimated Impact on
Total Allowed Charges by Specialty).
For example, the estimated increases to
primary care specialties would be
lessened without the proposals to revise
payment policies for certain care
management and patient-specific
services as described in section II.E.
However, because PFS rates are based
on relative value units, the proposed
rates reflect all of the proposed changes
and eliminating some of the proposed
changes might have multi-faceted
impacts on the payment rates for other
services.
H. Impact on Beneficiaries
There are a number of changes in this
proposed rule that would have an effect
on beneficiaries. In general, we believe
that many of these changes, including
those intended to improve accuracy in
payment through revisions to the inputs
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used to calculate payments under the
PFS, would have a positive impact and
improve the quality and value of care
provided to Medicare beneficiaries. In
particular, we believe that improving
payment for primary care and care
management services based more
accurate assessment of patient needs
and the resources involved in caring for
them will benefit beneficiaries by
improving care coordination and
providing more effective treatment,
particularly to those beneficiaries with
behavioral health conditions and
mobility-related disabilities.
Most of the aforementioned proposed
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 our
Public User File Impact on Payment for
Selected Procedures table available on
the CMS Web site at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/, the CY 2016
national payment amount in the
nonfacility setting for CPT code 99203
(Office/outpatient visit, new) was
$108.85, which means that in CY 2016,
a beneficiary would be responsible for
20 percent of this amount, or $21.77.
Based on this proposed rule, using the
CY 2017 CF, the CY 2017 national
payment amount in the nonfacility
setting for CPT code 99203, as shown in
the Impact on Payment for Selected
Procedures table, is $108.76, which
means that, in CY 2017, the proposed
beneficiary coinsurance for this service
would be $21.75.
As discussed in section III.B of this
proposed rule, we are proposing that
beginning on January 1, 2017, the FQHC
base rate would be updated using a
FQHC-specific market basket instead of
using the MEI to more accurately reflect
changes in the cost of furnishing FQHC
services. This would result in a higher
payment to FQHCs, and since
coinsurance is 20 percent of the lesser
of the FQHC’s charge for the specific
payment code or the PPS rate,
beneficiary coinsurance would also
increase. The FQHC market basket cost
estimates in Table 44 includes a
premium offset line which is the
amount of cost that would be offset by
the beneficiaries. The beneficiaries
would pay approximately $5 million
and $35 million over the 5 and 10 year
projection windows.
I. Accounting Statement
As required by OMB Circular A–4
(available at https://
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www.whitehouse.gov/omb/circulars/
a004/a-4.pdf), in Table 47 (Accounting
Statement), we have prepared an
accounting statement. This estimate
includes growth in incurred benefits
from CY 2016 to CY 2017 based on the
FY 2017 President’s Budget baseline.
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42 CFR Part 411
Kidney diseases, Medicare, Physician
referral, Reporting and recordkeeping
requirements.
42 CFR Part 414
Administrative practice and
procedure, Biologics, Drugs, Health
TABLE 47—ACCOUNTING STATEMENT: facilities, Health professions, Kidney
CLASSIFICATION OF ESTIMATED EX- diseases, Medicare, Reporting and
recordkeeping requirements.
PENDITURES
Category
CY 2017 Annualized
Monetized Transfers.
From Whom To
Whom?
Transfers
Estimated increase in
expenditures of
$0.5 billion for PFS
CF update.
Federal Government
to physicians, other
practitioners and
providers and suppliers who receive
payment under
Medicare.
42 CFR Part 417
Administrative practice and
procedure, Grant programs—health,
Health care, Health insurance, Health
maintenance organizations (HMO), Loan
programs—health, Medicare, Reporting
and recordkeeping requirements.
42 CFR Part 422
Administrative practice and
procedure, Health facilities, Health
maintenance organizations (HMO),
Medicare, Penalties, Privacy, Reporting
and recordkeeping requirements.
TABLE 48—ACCOUNTING STATEMENT:
CLASSIFICATION
OF
ESTIMATED 42 CFR Part 423
Administrative practice and
COSTS, TRANSFER, AND SAVINGS
Category
CY 2017 Annualized
Monetized Transfers of beneficiary
cost coinsurance.
From Whom to
Whom?
Transfers
$0.1 billion.
42 CFR Part 424
Federal Government
to Beneficiaries.
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.
List of Subjects
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.
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Fmt 4701
procedure, Emergency medical services,
Health facilities, Health maintenance
organizations (HMO), Medicare,
Penalties, Privacy, Reporting and
recordkeeping requirements.
Sfmt 4702
Emergency medical services, Health
facilities, Health professions, Medicare,
Reporting and recordkeeping
requirements.
42 CFR Part 425
Administrative practice and
procedure, Health facilities, Health
professions, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 460
Aged, Health care, Health records,
Medicaid, Medicare, Reporting and
recordkeeping requirements.
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services proposes to amend
42 CFR chapter IV as set forth below:
PART 405—FEDERAL HEALTH
INSURANCE FOR THE AGED AND
DISABLED
1. 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).
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2. Section 405.373 is amended by—
a. Revising paragraphs (a)
introductory text and (b).
■ b. Adding paragraph (f).
The revisions and addition read as
follows:
■
■
§ 405.373 Proceeding for offset or
recoupment.
(a) General rule. Except as specified in
paragraphs (b) and (f) of this section, if
the Medicare Administrative Contractor
or CMS has determined that an offset or
recoupment of payments under
§ 405.371(a)(2) should be put into effect,
the Medicare Administrative Contractor
must—
*
*
*
*
*
(b) Paragraph (a) of this section does
not apply if the Medicare
Administrative Contractor, after
furnishing a provider a written notice of
the amount of program reimbursement
in accordance with § 405.1803, recoups
payment under paragraph (c) of
§ 405.1803. (For provider rights in this
circumstance, see §§ 405.1809,
405.1811, 405.1815, 405.1835, and
405.1843.)
*
*
*
*
*
(f) Paragraph (a) of this section does
not apply in instances where the
Medicare Administrative Contractor
intends to offset or recoup payments to
the applicable provider of services or
supplier to satisfy an amount due from
an obligated provider of services or
supplier when the applicable and
obligated provider of services or
supplier share the same Taxpayer
Identification Number.
■ 3. Section 405.2413 is amended by
revising paragraph (a)(5) to read as
follows:
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§ 405.2413 Services and supplies incident
to a physician’s services.
(a) * * *
(5) Furnished under the direct
supervision of a physician, except that
services and supplies furnished incident
to transitional care management and
chronic care management services can
be furnished under general supervision
of a physician when these services or
supplies are furnished by auxiliary
personnel, as defined in § 410.26(a)(1) of
this chapter.
*
*
*
*
*
■ 4. Section 405.2415 is amended by
revising paragraph (a)(5) to read as
follows:
§ 405.2415 Incident to services and direct
supervision.
(a) * * *
(5) Furnished under the direct
supervision of a nurse practitioner,
physician assistant, or certified nurse-
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midwife, except that services and
supplies furnished incident to
transitional care management and
chronic care management services can
be furnished under general supervision
of a nurse practitioner, physician
assistant, or certified nurse-midwife,
when these services or supplies are
furnished by auxiliary personnel, as
defined in § 410.26(a)(1) of this chapter.
*
*
*
*
*
PART 410—SUPPLEMENTARY
MEDICAL INSURANCE (SMI)
BENEFITS
5. 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).
6. Section 410.26 is amended by—
a. Redesignating paragraphs (a)(3)
through (7) as paragraphs (a)(4) through
(8), respectively.
■ b. Adding new paragraph (a)(3).
■ c. Revising paragraph (b)(5).
The addition and revision reads as
follows:
■
■
§ 410.26 Services and supplies incident to
a physician’s professional services:
Conditions.
(a) * * *
(3) General supervision means the
level of supervision by the physician (or
other practitioner) of auxiliary
personnel as defined in § 410.32(b)(3)(i).
*
*
*
*
*
(b) * * *
(5) In general, services and supplies
must be furnished under the direct
supervision of the physician (or other
practitioner). Designated non-face-toface care management services can be
furnished under general supervision of
the physician (or other practitioner)
when these services or supplies are
provided incident to the services of a
physician (or other practitioner). The
physician (or other practitioner)
supervising the auxiliary personnel
need not be the same physician (or other
practitioner) who is treating the patient
more broadly. However, only the
supervising physician (or other
practitioner) may bill Medicare for
incident to services.
*
*
*
*
*
■ 7. Section 410.79 is added to subpart
B to read as follows:
§ 410.79 Medicare diabetes prevention
program expanded model: Conditions of
coverage.
(a) Medicare Diabetes Prevention
Program (MDPP) services will be
available beginning on January 1, 2018.
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(b) Definitions. For the purposes of
this section the following definitions
apply:
Baseline weight refers to the eligible
beneficiary’s body weight recorded
during that beneficiary’s first core
session.
CDC-approved DPP core curriculum
(core curriculum) refers to the content of
the core sessions delivered during the
first 6 months of the MDPP core benefit.
All of the following 16 covered topics
must be addressed:
(i) Welcome to the National Diabetes
Prevention Program.
(ii) Self-Monitoring weight and food
intake.
(iii) Eating less.
(iv) Healthy eating.
(v) Introduction to physical activity
(Move those muscles).
(vi) Overcoming barriers to physical
activity (Being active—A way of life).
(vii) Balancing calorie intake and
output.
(viii) Environmental cues to eating
and physical activity.
(ix) Problem solving.
(x) Strategies for healthy eating out.
(xi) Reversing negative thoughts.
(xii) Dealing with slips in lifestyle
change.
(xiii) Mixing up your physical
activity: Aerobic fitness.
(xiv) Social cues.
(xv) Managing stress.
(xvi) Staying motivated, Program
wrap up.
CDC-approved DPP maintenance
curriculum (maintenance curriculum)
refers to the content of the core
maintenance Sessions and ongoing
maintenance sessions that are delivered
as part of the MDPP core benefit and
MDPP maintenance benefit,
respectively. Core maintenance sessions
and ongoing maintenance sessions must
address one or more of the following
topics:
(i) Welcome to the second phase of
the program.
(ii) Healthy eating: Taking it one meal
at a time.
(iii) Making active choices.
(iv) Balance your thoughts for longterm maintenance.
(v) Healthy eating with variety and
balance.
(vi) Handling holidays, vacations, and
special events.
(vii) More volume, fewer calories
(adding water, vegetables, and fiber).
(viii) Dietary fats.
(ix) Stress and time management.
(x) Healthy cooking: Tips for food
preparation and recipe modification.
(xi) Physical activity barriers.
(xii) Preventing relapse.
(xiii) Heart health.
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(xiv) Life with Type 2 Diabetes.
(xv) Looking back and looking
forward.
Coach means an individual person
who furnishes MDPP services on behalf
of an MDPP supplier as an employee or
contractor.
Core maintenance sessions refers to
the 6 months of monthly sessions
delivered after the core sessions and are
included in the core benefit. All core
maintenance sessions must address
different maintenance curriculum
topics.
Core sessions refers to the 16 sessions
that are furnished over a period of
between 16 and 26 weeks that teach the
core curriculum. Each of the core
sessions must address one of the core
curriculum topics, and all topics must
be addressed by the end of the 16
sessions.
Diabetes Prevention Recognition
Program (DPRP) means a program
administered by the Centers for Disease
Control and Prevention (CDC) that
recognizes organizations that are able to
deliver diabetes prevention program
(DPP) services, follow the CDCapproved DPP curriculum, and meet
CDC’s performance standards and
reporting requirements.
Evaluation weight refers to the
beneficiary’s body weight updated from
the first core session and recorded
before or during that beneficiary’s final
core session.
Full DPRP recognition refers to the
designation from the CDC that an
organization has consistently delivered
CDC-approved DPP sessions, met CDCperformance standards and met CDC
reporting requirements for at least 24–36
months following the organization’s
application to participate in the DPRP.
MDPP core benefit (core benefit)
means a 12-month intensive behavioral
change program that applies the core
curriculum. The core benefit consists of
16 core sessions and 6 core maintenance
sessions.
MDPP eligible beneficiary means an
individual who satisfies the criteria
defined in § 410.79(c)(1).
MDPP maintenance benefit
(maintenance benefit) is furnished after
core benefit has been completed and
that covers beneficiaries who achieve
and maintain the required minimum
weight loss percentage.
MDPP services means the core
sessions, core maintenance sessions,
and ongoing maintenance sessions.
MDPP supplier means an entity that
has either preliminary or full DPRP
recognition and is enrolled in Medicare
to bill for MDPP services.
Medicare Diabetes Prevention
Program (MDPP) refers to an expanded
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model under section 1115A(c) of the Act
that makes MDPP services available to
beneficiaries who meet the eligibility
requirements specified in paragraph
(c)(1) of this section.
National Diabetes Prevention Program
(DPP) means an evidence-based
intervention targeted to individuals
with pre-diabetes that is delivered in
community and health care settings and
administered by the Centers for Disease
Control and Prevention (CDC).
Ongoing maintenance sessions refers
to the monthly sessions furnished after
the core benefit has been completed and
that teach the maintenance curriculum.
Preliminary DPRP recognition refers
to the designation from the CDC that an
organization has delivered CDCapproved DPP sessions and has met
CDC DPRP performance standards and
reporting requirements for 12
consecutive months immediately
following the organization’s application
to participate in the DPRP.
Required minimum weight loss means
the percentage by which the evaluation
weight is less than the baseline weight.
The required minimum weight loss
percentage is 5 percent.
(c) General rule—(1) Beneficiary
inclusion criteria. Medicare Part B pays
for MDPP services for beneficiaries who
meet all of the following criteria:
(i) Are enrolled in Medicare Part B.
(ii) Have as of the date of attendance
at the first core session a body mass
index (BMI) of at least 25 if not selfidentified as Asian and a BMI of at least
23 if self-identified as Asian.
(iii) Have within the 12 months prior
to attending the first core session a
hemoglobin A1c test with a value
between 5.7 and 6.4 percent, a fasting
plasma glucose of 110–125 mg/dL, or a
2-hour plasma glucose of 140–199 mg/
dL (oral glucose tolerance test).
(iv) Have no previous diagnosis of
Type 1 or Type 2 diabetes.
(v) Does not have end-stage renal
disease (ESRD).
(2) Medicare diabetes prevention
program services—(i) Core sessions and
core maintenance sessions. MDPP
suppliers must furnish to eligible
beneficiaries the core benefit, which
includes at least 16 core sessions that
apply the core curriculum and 6 core
maintenance sessions. All core sessions
and core maintenance sessions shall
have a duration of at least one hour.
Sessions may be provided in-person or
via remote technologies. MDPP
suppliers shall address all 16 topics in
the core curriculum in the core sessions
and at least 6 topics in the maintenance
curriculum in the core maintenance
sessions.
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(ii) Ongoing maintenance sessions.
MDPP Suppliers shall furnish ongoing
maintenance sessions to MDPP eligible
beneficiaries who have achieved and
maintained the required minimum
weight loss percentage after they have
completed the core maintenance
sessions. All ongoing maintenance
sessions shall have a duration of at least
one hour. Sessions may be provided inperson or via remote technologies.
(d) Limitations on coverage of
Medicare diabetes prevention program
services. (1) The MDPP core benefit is
available only once per lifetime per
MDPP eligible beneficiary.
(2) The MDPP maintenance benefit is
available only if the MDPP eligible
beneficiary has achieved and maintains
the required minimum weight loss
percentage.
PART 411—EXCLUSIONS FROM
MEDICARE AND LIMITATIONS ON
MEDICARE PAYMENT
8. 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).
9. Section 411.357 is amended by
revising paragraphs (a)(5)(ii)(B),
(b)(4)(ii)(B), (l)(3)(ii), and (p)(1)(ii)(B) to
read as follows:
■
§ 411.357 Exceptions to the referral
prohibition related to compensation
arrangements.
*
*
*
*
*
(a) * * *
(5) * * *
(ii) * * *
(B) Per-unit of service rental charges,
to the extent that such charges reflect
services provided to patients referred by
the lessor to the lessee.
*
*
*
*
*
(b) * * *
(4) * * *
(ii) * * *
(B) Per-unit of service rental charges,
to the extent that such charges reflect
services provided to patients referred by
the lessor to the lessee.
*
*
*
*
*
(l) * * *
(3) * * *
(ii) Per-unit of service rental charges,
to the extent that such charges reflect
services provided to patients referred by
the lessor to the lessee.
*
*
*
*
*
(p) * * *
(1) * * *
(ii) * * *
(B) Per-unit of service rental charges,
to the extent that such charges reflect
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services provided to patients referred by
the lessor to the lessee.
*
*
*
*
*
■ 10. Section 411.372 is amended by
revising paragraph (a) to read as follows:
§ 411.372
request.
Procedure for submitting a
(a) Format for a request. A party or
parties must submit a request for an
advisory opinion to CMS according to
the instructions specified on the CMS
Web site.
*
*
*
*
*
PART 414—PAYMENT FOR PART B
MEDICAL AND OTHER HEALTH
SERVICES
11. 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)).
12. Section 414.22 is amended by
revising paragraphs (b)(5) introductory
text, (b)(5)(i)(A), (b)(5)(i)(B), and
(b)(5)(ii) to read as follows:
■
§ 414.22
Relative value units (RVUs).
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*
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(b) * * *
(5) For services furnished in 2002 and
subsequent years, the practice expense
RVUs are based entirely on relative
practice expense resources.
(i) * * *
(A) Facility practice expense RVUs.
The facility practice expense RVUs
apply to services furnished to patients
in a hospital (except for some services
furnished in a provider-based
department), a skilled nursing facility, a
community mental health center, a
hospice, or an ambulatory surgical
center, or in a wholly owned or wholly
operated entity providing preadmission
services under § 412.2(c)(5) of this
chapter, or via telehealth under § 410.78
of the chapter.
(B) Nonfacility practice expense
RVUs. The nonfacility practice expense
RVUs apply to services furnished to
patients in all locations other than those
listed in paragraph (A) including, but
not limited to, a physician’s office, the
patient’s home, a nursing facility, or a
comprehensive outpatient rehabilitation
facility (CORF).
*
*
*
*
*
(ii) Only one practice expense RVU
per code can be applied for each of the
following services: Services that have
only technical component practice
expense RVUs or only professional
component practice expense RVUs;
evaluation and management services,
such as hospital or nursing facility visits
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that are furnished exclusively in one
setting; and major surgical services.
*
*
*
*
*
§ 414.94 Appropriate use criteria for
advanced diagnostic imaging services.
§ 414.32
*
[Removed]
13. Section 414.32 is removed.
14. Section 414.90 is amended by
adding paragraphs (j)(1)(ii), (j)(4)(v),
(j)(7)(viii) and (k)(4)(ii) to read as
follows:
■
■
§ 414.90 Physician Quality Reporting
System (PQRS).
*
*
*
*
*
(j) * * *
(1) * * *
(ii) Secondary Reporting Period for
the 2017 PQRS payment adjustment for
certain eligible professionals or group
practices—Individual eligible
professionals or group practices, who
bill under the TIN of an ACO
participant if the ACO failed to report
data on behalf of such EPs or group
practices during the previously
established reporting period for the
2017 PQRS payment adjustment, may
separately report during a secondary
reporting period for the 2017 PQRS
payment adjustment. The secondary
reporting period for the 2017 PQRS
payment adjustment for the affected
individual eligible professionals or
group practices is January 1, 2016
through December 31, 2016.
*
*
*
*
*
(4) * * *
(v) Paragraphs (j)(8)(ii), (iii), and (iv)
of this section apply to individuals
reporting using the secondary reporting
period established under paragraph
(j)(1)(ii) of this section for the 2017
PQRS payment adjustment.
*
*
*
*
*
(7) * * *
(viii) Paragraphs 414.90(j)(9)(ii), (iii),
and (iv) of this section apply to group
practices reporting using the secondary
reporting period established under
paragraph (j)(1)(ii) of this section for the
2017 PQRS payment adjustment.
*
*
*
*
*
(k) * * *
(4) * * *
(ii) Section 414.90(k)(5) applies to
individuals and group practices
reporting using the secondary reporting
period established under paragraph
(j)(1)(ii) of this section for the 2017
PQRS payment adjustment.
*
*
*
*
*
■ 15. Section 414.94 is amended by—
■ a. Amending paragraph (b) to add the
definitions of ‘‘Applicable payment
system’’ and ‘‘Clinical decision support
mechanism’’ in alphabetical order.
■ b. Adding paragraphs (e)(5), (g), (h),
and (i).
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The additions read as follows:
*
*
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*
(b) * * *
Applicable payment system means the
following:
(i) The physician fee schedule
established under section 1848(b) of the
Act;
(ii) The prospective payment system
for hospital outpatient department
services under section 1833(t) of the
Act; and
(iii) The ambulatory surgical center
payment systems under section 1833(i)
of the Act.
*
*
*
*
*
Clinical decision support mechanism
(CDSM) means the following: An
interactive, electronic tool for use by
clinicians that communicates AUC
information to the user and assists them
in making the most appropriate
treatment decision for a patient’s
specific clinical condition. Tools may be
modules within or available through
certified EHR technology (as defined in
section 1848(o)(4)) of the Act or private
sector mechanisms independent from
certified EHR technology or established
by the Secretary.
*
*
*
*
*
(e) * * *
(5) Priority clinical areas include the
following:
(i) Chest pain (including angina,
suspected myocardial infarction and
suspected pulmonary embolism).
(ii) Abdominal pain (any location
including flank pain).
(iii) Headache (non-traumatic and
traumatic).
(iv) Altered mental status.
(v) Low back pain.
(vi) Suspected stroke.
(vii) Cancer of the lung (primary or
metastatic, suspected or diagnosed).
(viii) Cervical or neck pain.
*
*
*
*
*
(g) Qualified clinical decision support
mechanisms (CDSMs). Qualified CDSMs
are those specified as such by CMS.
Qualified CDSMs must adhere to the
requirements described in paragraph
(g)(1) of this section.
(1) Requirements for qualification of
CDSMs. A CDSM must meet all of the
following requirements:
(i) Make available specified applicable
AUC and the related documentation
supporting the appropriateness of the
applicable imaging service ordered.
(ii) Identify the appropriate use
criterion consulted if the CDSM makes
available more than one criterion
relevant to a consultation for a patient’s
specific clinical scenario.
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(iii) Make available, at a minimum,
specified applicable AUC that
reasonably encompass the entire clinical
scope of all priority clinical areas
identified in paragraph (e)(5) of this
section.
(iv) Be able to incorporate specified
applicable AUC from more than one
qualified PLE.
(v) Determines, for each consultation,
the extent to which the applicable
imaging service is consistent with
specified applicable AUC or a
determination of ‘‘not applicable’’ when
the mechanism does not contain a
criterion that would apply to the
consultation.
(vi) Generate and provide a
certification or documentation to the
ordering professional that documents
which qualified CDSM was consulted;
the name and national provider
identifier (NPI) of the ordering
professional that consulted the CDSM;
and whether the service ordered would
adhere to specified applicable AUC,
whether the service ordered would not
adhere to specified applicable AUC or
whether specified applicable AUC was
not applicable to the service ordered.
(A) Certification or documentation
must be issued each time an ordering
professional consults a qualified CDSM.
(B) Certification or documentation
must include a unique consultation
identifier generated by the CDSM.
(vii) Update AUC content at least
every 12 months to reflect revisions or
updates made by qualified PLEs to their
AUC sets or an individual appropriate
use criterion.
(A) A protocol must be in place to
expeditiously remove AUC determined
by the qualified PLE to be potentially
dangerous to patients and/or harmful if
followed.
(B) Specified applicable AUC that
reasonably encompass the entire clinical
scope of any new priority clinical area
must be made available for consultation
through the qualified CDSM within 12
months of the priority clinical area
being finalized by CMS.
(viii) Meet privacy and security
standards under applicable provisions
of law.
(ix) Provide to the ordering
professional aggregate feedback
regarding their consultations with
specified applicable AUC in the form of
an electronic report on at least an
annual basis.
(x) Maintain electronic storage of
clinical, administrative, and
demographic information of each
unique consultation for a minimum of 6
years.
(xi) Comply with modification(s) to
any requirements under paragraph (g)(1)
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of this section made through rulemaking
within 12 months of the effective date
of the modification.
(2) Process to specify qualified
CDSMs. (i) The CDSM developer must
submit an application to CMS for review
that documents adherence to each of the
CDSM requirements outlined in
paragraph (g)(1) of this section;
(ii) Applications must be received by
CMS annually by January 1;
(iii) All qualified CDSMs specified by
CMS in each year will be included on
the list of specified qualified CDSMs
posted to the CMS Web site by June 30
of that year; and
(iv) Qualified CDSMs are specified by
CMS as such for a period of 5 years.
(v) Qualified CDSMs are required to
re-apply during the fifth year after they
are specified by CMS in order to
maintain their status as qualified
CDSMs. This application must be
received by CMS by January 1 of the 5th
year after the developers’ most recent
approval date.
(h) Identification of non-adherence to
requirements for qualified CDSMs. (1) If
a qualified CDSM is found non-adherent
to the requirements in paragraph (g)(1)
of this section, CMS may terminate its
qualified status or may consider this
information during requalification.
(i) Exceptions. Consulting and
reporting requirements are not required
for orders for applicable imaging
services made by ordering professionals
under the following circumstances:
(1) Emergency services when
provided to individuals with emergency
medical conditions as defined in section
1867(e)(1) of the Act.
(2) For an inpatient and for which
payment is made under Medicare Part
A.
(3) Ordering professionals who are
granted a significant hardship exception
to the Medicare EHR Incentive Program
payment adjustment for that year under
§ 495.102(d)(4) of this chapter, except
for those granted such an exception
under § 495.102(d)(4)(iv)(C) of this
chapter.
■ 16. Section 414.1210 is amended by
revising paragraphs (b)(2)(i)(B), (C), (D),
and (F) to read as follows:
§ 414.1210 Application of the value-based
payment modifier.
*
*
*
*
*
(b) * * *
(2) * * *
(i) * * *
(B) For groups and solo practitioners
that participate in a Shared Savings
Program ACO that successfully reports
quality data as required by the Shared
Savings Program under § 425.504, the
quality composite score is calculated
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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) of this chapter or another
mechanism specified by CMS and the
ACO all-cause readmission measure.
Groups and solo practitioners that
participate in two or more ACOs during
the applicable performance period
receive the quality composite score of
the ACO that has the highest numerical
quality composite score. For the CY
2018 payment adjustment period, the
CAHPS for ACOs survey also will be
included in the quality composite score.
For the CY 2017 and 2018 payment
adjustment periods, for groups and solo
practitioners who participate in a
Shared Savings Program ACO that does
not successfully report quality data as
required by the Shared Savings Program
under § 425.504 and who meet the
requirements to avoid the PQRS
payment adjustment for CY 2018 by
reporting to the PQRS outside the ACO,
the quality composite is classified as
‘‘average’’ under § 414.1275(b).
(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 (or
groups and solo practitioners that
participate in 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 of physicians with 10 or more
eligible professionals and equal to ¥2%
for groups of physicians with two to
nine eligible professionals and for
physician solo practitioners. If the ACO
has an assigned beneficiary population
during the performance period with an
average risk score in the top 25 percent
of the risk scores of beneficiaries
nationwide, and a group of physician or
physician solo practitioner that
participates in the ACO during the
performance period is classified as high
quality/average cost under qualitytiering for the CY 2017 payment
adjustment period, the group or solo
practitioner receives an upward
adjustment of +3 × (rather than +2 ×) if
the group has 10 or more eligible
professionals or +2 × (rather than +1 ×)
for a solo practitioner or the group has
two to nine eligible professionals.
(D) For the CY 2018 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 (or
groups and solo practitioners that
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participate in 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 the
downward payment adjustment
amounts described at § 414.1270(d)(1). If
the ACO has an assigned beneficiary
population during the performance
period with an average risk score in the
top 25 percent of the risk scores of
beneficiaries nationwide, and a group or
solo practitioner that participates in the
ACO during the performance period is
classified as high quality/average cost
under quality-tiering for the CY 2018
payment adjustment period, the group
or solo practitioner receives an upward
adjustment of +3 × (rather than +2 ×) if
the group of physicians has 10 or more
eligible professionals, +2 × (rather than
+1 ×) for a physician solo practitioner or
if the group of physicians has two to
nine eligible professionals, or +2 ×
(rather than +1 ×) for a solo practitioner
who is a nonphysician eligible
professional or if the group consists of
nonphysician eligible professionals.
*
*
*
*
*
(F) For groups and solo practitioners
that participate in a Shared Savings
Program ACO that successfully reports
quality data as required by the Shared
Savings Program under § 425.504 of this
chapter, 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.
*
*
*
*
*
PART 417—HEALTH MAINTENANCE
ORGANIZATIONS, COMPETITIVE
MEDICAL PLANS, AND HEALTH CARE
PREPAYMENT PLANS
17. The authority citation for part 417
continues to read as follows:
■
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh), secs. 1301, 1306, and 1310 of the
Public Health Service Act (42 U.S.C. 300e,
300e–5, and 300e–9), and 31 U.S.C. 9701.
18. Section 417.478 is amended by
adding paragraph (e) to read as follows:
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§ 417.478 Requirements of other laws and
regulations.
*
*
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*
*
(e) Sections 422.222 and 422.224 of
this chapter which requires all
providers or suppliers, as defined in
section 1861 of the Act, to be enrolled
in Medicare in an approved status and
prohibits payment to providers and
suppliers that are excluded or revoked.
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19. Section 417.484 is amended by
adding paragraph (b)(3) to read as
follows:
■
§ 417.484 Requirement applicable to
related entities.
(b) * * *
(3) All providers and suppliers, as
defined in section 1861 of the Act, are
enrolled in Medicare in an approved
status.
PART 422—MEDICARE ADVANTAGE
PROGRAM
20. The authority citation for part 422
continues to read as follows:
■
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh).
21. Section 422.1 is amended by
redesignating paragraphs (a)(1)(i)
through (x) as paragraphs (a)(1)(ii)
through (xi) and adding new paragraph
(a)(1)(i) to read as follows:
■
§ 422.1
Basis and scope.
(a) * * *
(1) * * *
(i) 1106—Disclosure of information in
possession of agency.
*
*
*
*
*
■ 22. Section 422.204 is amended by
adding paragraph (b)(5) to read as
follows:
§ 422.204 Provider selection and
credentialing.
*
*
*
*
*
(b) * * *
(5) Ensures compliance with the
provider and supplier enrollment
requirements at § 422.222.
■ 23. Section 422.222 is added to
subpart E to read as follows:
§ 422.222 Enrollment of MA organization
network providers and suppliers; first-tier,
downstream, and related entities (FDRs);
and providers and suppliers in Program of
All-inclusive Care for the Elderly (PACE)
plans, cost HMO or CMP, and
demonstration and pilot programs.
(a) Providers or suppliers that are
types of individuals or entities that can
enroll in Medicare in accordance with
section 1861 of the Act, must be
enrolled in Medicare and be in an
approved status in Medicare in order to
provide health care items or services to
a Medicare enrollee who receives his or
her Medicare benefit through an MA
organization. This requirement applies
to all of the following providers and
suppliers:
(1) Network providers and suppliers.
(2) First-tier, downstream, and related
entities (FDR).
(3) Providers and suppliers in
Program of All-inclusive Care for the
Elderly (PACE) plans.
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(4) Providers and suppliers in Cost
HMOs or CMPs, as defined in 42 CFR
part 417.
(5) Providers and suppliers
participating in demonstration
programs.
(6) Providers and suppliers in pilot
programs.
(7) Locum tenens suppliers.
(8) Incident-to suppliers.
(b) MA organizations that do not
ensure that providers and suppliers
comply with paragraph (a) of this
section, may be subject to sanctions
under § 422.750 and termination under
§ 422.510.
■ 24. Section 422.224 is added to
subpart E to read as follows:
§ 422.224 Payment to providers or
suppliers excluded or revoked.
(a) An MA organization may not pay,
directly or indirectly, on any basis, for
items or services (other than emergency
or urgently needed services as defined
in § 422.2) furnished to a Medicare
enrollee by any individual or entity that
is excluded by the Office of the
Inspector General (OIG) or is revoked
from the Medicare program except as
provided in paragraph (b) of this
section.
(b) If an MA organization receives a
request for payment by, or on behalf of,
an individual or entity that is excluded
by the OIG or is revoked in the Medicare
program, the MA organization must
notify the enrollee and the excluded or
revoked individual or entity in writing,
as directed by contract or other
direction provided by CMS, that future
payments must not be made. Payment
may not be made to, or on behalf of, an
individual or entity after the first
payment is made or as permitted inwriting by CMS.
■ 25. Section 422.250 is revised to read
as follows:
§ 422.250
Basis and scope.
This subpart is based largely on
section 1854 of the Act, but also
includes provisions from sections 1853
and 1858 of the Act, and is also based
on section 1106 of the Act. It sets forth
the requirements for the Medicare
Advantage bidding payment
methodology, including CMS’
calculation of benchmarks, submission
of plan bids by Medicare Advantage
(MA) organizations, establishment of
beneficiary premiums and rebates
through comparison of plan bids and
benchmarks, negotiation and approval
of bids by CMS, and the release of MA
bid submission data.
■ 26. Section 422.272 is added to
subpart F to read as follows:
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§ 422.272
Release of MA bid pricing data.
(a) Terminology. For purposes of this
section, the term ‘‘MA bid pricing data’’
means the following information that
MA organizations must submit for each
MA plan bid for the annual bid
submission:
(1) The pricing-related information
described at § 422.254(a)(1); and
(2) The information required for MSA
plans, described at § 422.254(e).
(b) Release of MA bid pricing data.
Subject to paragraph (c) of this section
and to the annual timing identified in
paragraph (d) of this section, CMS will
release to the public MA bid pricing
data for MA plan bids accepted or
approved by CMS for a contract year
under § 422.256. The annual release will
contain MA bid pricing data from the
final list of MA plan bids accepted or
approved by CMS for a contract year
that is at least 5 years prior to the
upcoming calendar year.
(c) Exclusions from release of MA bid
pricing data. For the purpose of this
section, the following information is
excluded from the data released under
paragraph (b) of this section:
(1) For an MA plan bid that includes
Part D benefits, the information
described at § 422.254(b)(1)(ii), (c)(3)(ii),
and (c)(7);
(2) Additional information that CMS
requires to verify the actuarial bases of
the bids for MA plans for the annual bid
submission as follows:
(i) Narrative information on base
period factors, manual rates, costsharing methodology, optional
supplement benefits, and other required
narratives; and
(ii) Supporting documentation.
(3) Any information that could be
used to identify Medicare beneficiaries
and other individuals.
(4) Bid review correspondence and
reports.
(d) Timing of data release. CMS will
release MA bid pricing data as provided
in paragraph (b) of this section on an
annual basis after the first Monday in
October.
■ 27. Section 422.501 is amended by
adding paragraph (c)(1)(iv) and revising
paragraph (c)(2) to read as follows:
§ 422.501
Application requirements.
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(c) * * *
(1) * * *
(iv) Documentation that all providers
and suppliers in the MA or MA–PD plan
who can enroll in Medicare, are
enrolled in an approved status.
(2) The authorized individual must
thoroughly describe how the entity and
MA plan meet, or will meet, all the
requirements described in this part,
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including providing documentation that
all providers and suppliers referenced
in § 422.222 are enrolled in Medicare in
an approved status.
*
*
*
*
*
■ 28. Section 422.504 is amended by—
■ A. Revising paragraph (a)(6).
■ B. Adding paragraph (i)(2)(v).
■ C. Revising paragraph (n).
The revisions and addition read as
follows:
§ 422.504
Contract provisions.
*
*
*
*
*
(a) * * *
(6) To comply with all applicable
provider and supplier requirements in
subpart E of this part, including
provider certification requirements,
anti-discrimination requirements,
provider participation and consultation
requirements, the prohibition on
interference with provider advice, limits
on provider indemnification, rules
governing payments to providers, limits
on physician incentive plans, and
Medicare provider and supplier
enrollment requirements.
*
*
*
*
*
(i) * * *
(2) * * *
(v) They will require all of their
providers and suppliers to be enrolled
in Medicare in an approved status
consistent with § 422.222.
*
*
*
*
*
(n) Acknowledgements of CMS release
of data—(1) Summary CMS payment
data. The contract must provide that the
MA organization acknowledges that
CMS releases to the public summary
reconciled CMS payment data after the
reconciliation of Part C and Part D
payments for the contract year as
follows:
(i) For Part C, the following data—
(A) Average per member per month
CMS payment amount for A/B (original
Medicare) benefits for each MA plan
offered, standardized to the 1.0 (average
risk score) beneficiary.
(B) Average per member per month
CMS rebate payment amount for each
MA plan offered (or, in the case of MSA
plans, the monthly MSA deposit
amount).
(C) Average Part C risk score for each
MA plan offered.
(D) County level average per member
per month CMS payment amount for
each plan type in that county, weighted
by enrollment and standardized to the
1.0 (average risk score) beneficiary in
that county.
(ii) For Part D plan sponsors, plan
payment data in accordance with
§ 423.505(o) of this subchapter.
(2) MA bid pricing data and Part C
MLR data. The contract must provide
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that the MA organization acknowledges
that CMS releases to the public data as
described at §§ 422.272 and 422.2490.
*
*
*
*
*
■ 29. Section 422.510 is amended by
adding paragraph (a)(4)(xiii) to read as
follows:
§ 422.510
Termination of contract by CMS.
(a) * * *
(4) * * *
(xiii) Fails to meet provider and
supplier enrollment requirements in
accordance with §§ 422.222 and
422.224.
*
*
*
*
*
■ 30. Section 422.752 is amended by
adding paragraph (a)(13) to read as
follows:
§ 422.752 Basis for imposing intermediate
sanctions and civil money penalties.
(a) * * *
(13) Fails to comply with §§ 422.222
and 422.224, that requires the MA
organization to ensure providers and
suppliers are enrolled in Medicare and
not make payment to excluded or
revoked individuals or entities.
*
*
*
*
*
■ 31. Section 422.2400 is revised to read
as follows:
§ 422.2400
Basis and scope.
This subpart is based on sections
1857(e)(4), 1860D–12(b)(3)(D), and 1106
of the Act, and sets forth medical loss
ratio requirements for Medicare
Advantage organizations, financial
penalties and sanctions against MA
organizations when minimum medical
loss ratios are not achieved by MA
organizations, and release of medical
loss ratio data to entities outside of
CMS.
■ 32. Section 422.2490 is added to
subpart X to read as follows:
§ 422.2490
Release of Part C MLR data.
(a) Terminology. Subject to the
exclusions in paragraph (b) of this
section, Part C MLR data consists of the
information contained in reports
submitted under § 422.2460.
(b) Exclusions from Part C MLR data.
For the purpose of this section, the
following items are excluded from Part
C MLR data:
(1) Narrative descriptions that MA
organizations submit to support the
information reported to CMS pursuant
to the reporting requirements at
§ 422.2460, such as descriptions of
expense allocation methods;
(2) Information that is reported at the
plan level, such as the number of
member months associated with each
plan under a contract;
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(3) Any information that could be
used to identify Medicare beneficiaries
and other individuals; and
(4) MLR review correspondence.
(c) Data release. CMS releases to the
public Part C MLR data, for each
contract for each contract year, no
earlier than 18 months after the end of
the applicable contract year.
PART 423—VOLUNTARY MEDICARE
PRESCRIPTION DRUG BENEFIT
33. The authority citation for part 423
continues to read as follows:
■
Authority: Sections 1102, 1106, 1860D–1
through 1860D–42, and 1871 of the Social
Security Act (42 U.S.C. 1302, 1306, 1395w–
101 through 1395w–152, and 1395hh).
34. Section 423.505 is amended by
revising paragraph (o) to read as follows:
■
§ 423.505
Contract provisions.
*
*
*
*
*
(o) Acknowledgements of CMS release
of data—(1) Summary CMS payment
data. The contract must provide that the
Part D sponsor acknowledges that CMS
releases to the public summary
reconciled Part D payment data after the
reconciliation of Part D payments for the
contract year as follows:
(i) The average per member per month
Part D direct subsidy standardized to
the 1.0 (average risk score) beneficiary
for each Part D plan offered.
(ii) The average Part D risk score for
each Part D plan offered.
(iii) The average per member per
month Part D plan low-income cost
sharing subsidy for each Part D plan
offered.
(iv) The average per member per
month Part D Federal reinsurance
subsidy for each Part D plan offered.
(v) The actual Part D reconciliation
payment data summarized at the Parent
Organization level including breakouts
of risk sharing, reinsurance, and low
income cost sharing reconciliation
amounts.
(2) Part D MLR data. The contract
must provide that the Part D sponsor
acknowledges that CMS releases to the
public data as described at § 423.2490.
*
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*
*
*
■ 35. Section 423.2400 is revised to read
as follows:
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§ 423.2400
Basis and scope.
This subpart is based on sections
1857(e)(4), 1860D–12(b)(3)(D), and 1106
of the Act, and sets forth medical loss
ratio requirements for Part D sponsors,
financial penalties and sanctions against
Part D sponsors when minimum
medical loss ratios are not achieved by
Part D sponsors and release of medical
loss ratio data to entities outside of
CMS.
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36. Section 423.2490 is added to
subpart X to read as follows:
■
§ 423.2490
Release of Part D MLR data.
(a) Terminology. Subject to the
exclusions in paragraph (b) of this
section, Part D MLR data consists of the
information contained in reports
submitted under § 423.2460.
(b) Exclusions from Part D MLR data.
For the purpose of this section, the
following items are excluded from Part
D MLR data:
(1) Narrative descriptions that Part D
sponsors submit to support the
information reported to CMS pursuant
to the reporting requirements at
§ 423.2460, such as descriptions of
expense allocation methods;
(2) Information that is reported at the
plan level, such as the number of
member months associated with each
plan under a contract;
(3) Any information that could be
used to identify Medicare beneficiaries
and other individuals; and
(4) MLR review correspondence.
(c) Data release. CMS releases to the
public Part D MLR data, for each
contract for each contract year, no
earlier than 18 months after the end of
the applicable contract year.
PART 424—CONDITIONS FOR
MEDICARE PAYMENT
37. The authority citation for part 424
continues to read as follows:
■
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh).
38. Section 424.59 is added to subpart
D to read as follows:
■
§ 424.59 Payment to organizations that
provide Medicare Diabetes Prevention
Program Services.
(a) Conditions for enrollment. An
entity that is not already enrolled in
Medicare on the basis of being an
existing Medicare provider or supplier
may enroll as an MDPP supplier if it
satisfies the following criteria:
(1) Has Full DPRP recognition, or has
preliminary DPRP recognition and
progresses to full DPRP recognition
within 36 months of the date upon
which it applied for DPRP recognition.
(2) Has obtained and maintains an
active and valid TIN and NPI at the
organizational level.
(3) Has passed application screening
at a high categorical risk level per
§ 424.518(c).
(4) All coaches who will be furnishing
MDPP services on the entity’s behalf
have obtained and maintain active and
valid NPIs.
(b) Conditions for existing Medicare
providers or suppliers. An existing
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Medicare provider or supplier that
wishes to bill for MDPP would not have
to submit a separate enrollment
application but must satisfy the
following criteria:
(1) Has Full DPRP recognition, or has
preliminary DPRP recognition and
progresses to full DPRP recognition
within 36 months of the date upon
which it applied for DPRP recognition.
(2) All coaches who will be furnishing
MDPP services on the entity’s behalf
have obtained and maintain active and
valid NPIs.
(c) Conditions for payment of claims
for MDPP services provided. An MDPP
supplier must meet all of the following
requirements in order to receive
payment for claims made for MDPP
Services provided:
(1) Establishes and maintains a
recordkeeping system that is adequate to
document and monitor beneficiaries’
session attendance and weight at every
MDPP session. MDPP suppliers are
required to maintain and handle any
beneficiary PII and PHI in compliance
with HIPAA, other applicable privacy
laws and CMS standards.
(2) Maintains a crosswalk between the
beneficiary identifiers submitted to CMS
for billing and the beneficiary identifiers
submitted to CDC for beneficiary levelclinical data.
(3) Attests that the MDPP eligible
beneficiary for which it is submitting a
claim has attended 1, 4 or 9 core
sessions, and, if applicable, achieved
the required minimum weight loss
percentage specified in § 410.79 of this
chapter.
(4) If applicable, attests that the MDPP
eligible beneficiary for which it is
submitting a claim has maintained the
required minimum weight loss
percentage and attended core
maintenance sessions.
(5) If applicable, attests that the MDPP
eligible beneficiary for which it is
submitting a claim has maintained the
required minimum weight loss
percentage and attended ongoing
maintenance sessions.
(6) Submits any documentation
requested by CMS or a Medicare
contractor to substantiate the
attestations described in this section or
claims submitted for payment under the
Medicare program.
(7) Submits any documentation
requested by CMS or a Medicare
contractor to support supplier or coach
enrollment in Medicare.
(8) Complies with the requirements of
subpart P of this part.
(9) Retains beneficiary records for 7
years from the date of service, and upon
request of CMS or a Medicare contractor
provides access to such records.
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(i) The records must contain detailed
documentation of the services provided
including the beneficiary’s eligibility
status, sessions attended, the coach
furnishing the session attended, the date
and place of service of sessions
attended, and weight.
(ii) The records shall be maintained
within a larger medical record, or
within a medical record that an MDPP
supplier establishes for the purposes
administering MDPP.
(d) Loss of MDPP billing privileges. An
MDPP supplier is subject to revocation
of Medicare billing privileges for MDPP
services if any of the following occur:
(1) Fails to move from Preliminary to
Full Recognition within 36 months of
applying for DPRP recognition.
(2) Loses its DPRP recognition or
withdraws from seeking DPRP
recognition.
(3) Medicare suppliers that lose DPRP
recognition will lose Medicare billing
privileges for MDPP services, but may
continue to bill for non-MDPP services
for which they remain eligible to bill.
(e) Restoration of MDPP billing
privileges; appeal rights. An MDPP
supplier that has lost its MDPP billing
privileges may:
(1) Become eligible to bill for MDPP
services again if it reapplies for DPRP
recognition, successfully achieves
preliminary DPRP recognition, and, as
applicable, reenrolls in Medicare as an
MDPP supplier subject to § 424.59(a).
(2) Appeal in accordance with the
procedures specified in 42 CFR part
405, subpart H, 42 CFR part 424, and 42
CFR part 498.
PART 425—MEDICARE SHARED
SAVINGS PROGRAM
39. Authority: Secs. 1102, 1106, 1871,
and 1899 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
■ 40. Section 425.110 is amended by
revising paragraph (b)(1) to read as
follows:
■
§ 425.110 Number of ACO professionals
and beneficiaries.
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*
*
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*
(b) * * *
(1) While under the CAP, the ACO
remains eligible for shared savings and
losses.
(i) For ACOs with a variable MSR and
MLR (if applicable), the MSR and MLR
(if applicable) will be set at a level
consistent with the number of assigned
beneficiaries.
(ii) For ACOs with a fixed MSR/MLR,
the MSR/MLR will remain fixed at the
level consistent with the ACO’s choice
of MSR and MLR that the ACO made at
the start of the agreement period.
*
*
*
*
*
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§ 425.204
[Amended]
41. § 425.204 is amended by—
a. Amending paragraph (g) heading to
remove the phrase ‘‘and acquired
Medicare-enrolled TINs’’ and adding in
its place the phrase ‘‘and acquired
entities’ TINs’’.
■ b. Amending paragraph (g)
introductory text to remove the phrase
‘‘claims billed by Medicare-enrolled
entities’ TINs that’’ and adding in its
place the phrase ‘‘claims billed under
the TINs of entities that’’.
■ c. Amending paragraph (g)(1)
introductory text to remove the phrase
‘‘an acquired Medicare-enrolled entity’s
TIN’’ and adding in its place the phrase
‘‘an acquired entity’s TIN’’.
■ d. Amending paragraph (g)(1)(i) to
remove the phrase ‘‘the acquired entity’s
Medicare-enrolled TIN’’ and adding in
its place the phrase ‘‘the acquired
entity’s TIN’’
■ e. Amending paragraph (g)(2)(i)(A) to
remove the phrase ‘‘Identifies by
Medicare-enrolled TIN’’ and adding in
its place the phrase ‘‘Identifies by TIN’’.
■
■
§ 425.316
[Amended]
42. Amend 425.316—
a. In paragraph (c)(1), by removing the
phrase ‘‘minimum attainment level in
one or more domains as determined
under § 425.502 and may be subject to
a CAP. CMS, may forgo the issuance’’
and adding in its place the phrase
‘‘minimum attainment level on at least
70 percent of the measures, as
determined under § 425.502, in one or
more domains and may be subject to a
CAP. CMS may forgo the issuance’’.
■ b. In paragraph (c)(2) by removing the
phrase ‘‘quality performance standards’’
and adding in its place the phrase
‘‘quality performance standard’’.
■ 43. Section 425.402 is amended by
adding paragraph (e) to read as follows:
■
■
§ 425.402
Basic assignment methodology.
*
*
*
*
*
(e) Beginning in performance year
2018, CMS will supplement the claimsbased assignment methodology
described in this section with
information provided by beneficiaries
regarding the provider or supplier they
consider responsible for coordinating
their overall care. If a system is available
by spring 2017 to allow a beneficiary to
designate a provider or supplier as
responsible for coordinating their
overall care and CMS to process the
designation electronically, then the
voluntary alignment process under
paragraph (e) will be available for ACOs
participating in Track 1, Track 2, or
Track 3, as specified in § 425.600(a). If
such an electronic system is not
available by spring 2017, CMS will
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specify the form and manner in which
a beneficiary may designate a provider
or supplier as responsible for
coordinating their overall care using a
manual process, but the voluntary
alignment process will be limited to
ACOs participating in Track 3 until an
electronic system is available.
(1) Notwithstanding the assignment
methodology under paragraph (b) of this
section, beneficiaries who designate an
ACO professional participating in an
ACO as responsible for coordinating
their overall care will be added to the
ACO’s list of assigned beneficiaries for
a performance year under all of the
following conditions:
(i) The beneficiary must have had at
least one primary care service with a
physician who is an ACO professional
in the ACO and who is a primary care
physician as defined under § 425.20 or
who has one of the primary specialty
designations included in paragraph (c)
of this section.
(ii) The beneficiary meets the
eligibility criteria established at
§ 425.401(a) and must not be excluded
by the criteria at § 425.401(b).
(iii) The beneficiary must have
designated an ACO professional who is
a primary care physician as defined at
§ 425.20, a physician with a specialty
designation included at paragraph (c) of
this section, or a nurse practitioner,
physician assistant, or clinical nurse
specialist as responsible for their overall
care.
(iv) If a beneficiary has designated a
provider or supplier outside the ACO
who is a primary care physician as
defined at § 425.20, a physician with a
specialty designation included at
paragraph (c) of this section, or a nurse
practitioner, physician assistant, or
clinical nurse specialist, as responsible
for coordinating their overall care, the
beneficiary will not be added to the
ACO’s list of assigned beneficiaries for
a performance year under the
assignment methodology in paragraph
(b).
(2) The ACO, ACO participants, ACO
providers/suppliers, ACO professionals,
and other individuals or entities
performing functions and services
related to ACO activities are prohibited
from providing or offering gifts or other
remuneration to Medicare beneficiaries
as inducements for influencing a
Medicare beneficiary’s decision to
designate or not to designate an ACO
professional under paragraph (e) of this
section. The ACO, ACO participants,
ACO providers/suppliers, ACO
professionals, and other individuals or
entities performing functions and
services related to ACO activities must
not, directly or indirectly, commit any
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act or omission, nor adopt any policy
that coerces or otherwise influences a
Medicare beneficiary’s decision to
designate or not to designate an ACO
professional as responsible for
coordinating their overall care under
paragraph (e) of this section, including
but not limited to the following:
(i) Offering anything of value to the
Medicare beneficiary as an inducement
for influencing the Medicare
beneficiary’s decision to designate or
not to designate an ACO professional as
responsible for coordinating their
overall care under paragraph (e) of this
section. Any items or services provided
in violation of paragraph (e)(3) will not
be considered to have a reasonable
connection to the medical care of the
beneficiary, as required under
§ 425.304(a)(2);
(ii) Withholding or threatening to
withhold medical services or limiting or
threatening to limit access to care.
(iii) If a manual process is
implemented by CMS, including any
voluntary alignment form that requires
a beneficiary signature with any other
materials or forms, including but not
limited to, any other materials requiring
the signature of the Medicare
beneficiary.
■ 44. Section 425.500 is amended by
revising paragraphs (e)(2) and (3) to read
as follows:
§ 425.500 Measures to assess the quality
of care furnished by an ACO.
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*
(e) * * *
(2) If, at the conclusion of the audit
process the overall audit match rate
between the quality data reported and
the medical records provided under
paragraph (e)(1) of this section is less
than 90 percent, CMS will adjust the
ACO’s overall quality score proportional
to the ACO’s audit performance.
(3) If, at the conclusion of the audit
process CMS determines there is an
audit match rate of less than 90 percent,
the ACO may be required to submit a
CAP under § 425.216 for CMS approval.
*
*
*
*
*
■ 45. Section 425.502 is amended by—
■ a. Revising paragraph (a) introductory
text.
■ b. In paragraph (a)(1), removing the
phrase ‘‘period, CMS, CMS defines’’ and
adding in its place the phrase ‘‘period,
CMS defines’’
■ c. In paragraphs (a)(2) and (a)(3),
removing the phrase ‘‘level of certain
measures’’ and adding in its place ‘‘level
of all measures’’
■ d. In paragraph (a)(4), removing the
phrases ‘‘The quality performance
standard for a newly’’ and ‘‘periods, the
quality performance standard for the
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measure’’ and adding in its place the
phrases ‘‘A newly’’ and ‘‘periods, the
measure’’, respectively.
■ e. In paragraph (b)(2)(ii), removing the
phrase ‘‘95 percentt’’ and adding in its
place the phrase ‘‘95 percent’’.
■ f. Revising paragraph (b)(3).
■ g. In paragraph (c)(2), removing the
phrase ‘‘level for a measure’’ and adding
in its place the phrase ‘‘level for a payfor-performance measures’’.
■ h. Adding paragraph (c)(5).
■ i. In paragraph (d), removing the
phrase ‘‘quality performance
requirements’’ each time it appears and
adding in its place the phrase ‘‘quality
requirements’’.
■ j. In paragraph (d)(1) introductory
text, removing the phrase ‘‘individual
quality performance standard measures’’
and adding in its place the phrase
‘‘individual measures’’.
■ k. Revising paragraph (d)(2)(ii).
The revisions and addition read as
follows:
§ 425.502 Calculating the ACO quality
performance score.
(a) Establishing a quality performance
standard. CMS designates the quality
performance standard in each
performance year. The quality
performance standard is the overall
standard the ACO must meet in order to
be eligible for shared savings.
*
*
*
*
*
(b) * * *
(3) The minimum attainment level for
pay for performance measures is set at
30 percent or the 30th percentile of the
performance benchmark. The minimum
attainment level for pay for reporting
measures is set at the level of complete
and accurate reporting.
*
*
*
*
*
(c) * * *
(5) Performance equal to or greater
than the minimum attainment level for
pay-for-reporting measures will receive
the maximum available points.
*
*
*
*
*
(d) * * *
(2) * * *
(ii) CMS may take the compliance
actions described in § 425.216 for ACOs
exhibiting poor performance on a
domain, as determined by CMS under
§ 425.316.
■ 46. Section 425.504 is amended by—
■ a. Amending paragraph (c) to remove
the phrase ‘‘for 2016 and subsequent
years’’ everywhere it appears and
adding in its place the phrase ‘‘for
2016’’.
■ b. Redesignating paragraph (d) as
paragraph (c)(5).
■ c. Adding new paragraph (d).
The addition reads as follows:
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§ 425.504 Incorporating reporting
requirements related to the Physician
Quality Reporting System Incentive and
Payment Adjustment.
*
*
*
*
*
(d) Physician Quality Reporting
System payment adjustment for 2017
and 2018. (1) ACOs, on behalf of eligible
professionals who bill under the TIN of
an ACO participant, must submit all of
the ACO GPRO measures determined
under § 425.500 using a CMS web
interface, to satisfactorily report on
behalf of their eligible professionals for
purposes of the Physician Quality
Reporting System payment adjustment
under the Shared Savings Program for
2017 and 2018.
(2) Eligible professionals who bill
under the TIN of an ACO participant
within an ACO participate under their
ACO participant TIN as a group practice
under the Physician Quality Reporting
System Group Practice Reporting
Option of the Shared Savings Program
for purposes of the Physician Quality
Reporting System payment adjustment
under the Shared Savings Program for
2017 and 2018.
(3) If an ACO, on behalf of eligible
professionals who bill under the TIN of
an ACO participant, does not
satisfactorily report for purposes of the
Physician Quality Reporting System
payment adjustment for 2017 or 2018,
each eligible professional who bills
under the TIN of an ACO participant
will receive a payment adjustment, as
described in § 414.90(e) of this chapter,
unless such eligible professionals have
reported quality measures apart from
the ACO in the form and manner
required by the Physician Quality
Reporting System.
(4) For eligible professionals subject
to the Physician Quality Reporting
System payment adjustment under the
Medicare Shared Savings Program for
2017 or 2018, the Medicare Part B
Physician Fee Schedule amount for
covered professional services furnished
during the program year is equal to the
applicable percent of the Medicare Part
B Physician Fee Schedule amount that
would otherwise apply to such services
under section 1848 of the Act, as
described in § 414.90(e) of this chapter.
(5) The reporting period for a year is
the calendar year from January 1
through December 31 that occurs 2 years
prior to the program year in which the
payment adjustment is applied, unless
otherwise specified by CMS under the
Physician Quality Reporting System.
■ 47. Section 425.506 is amended by—
■ a. Revising the section heading.
■ b. Amending paragraph (d) to remove
the phrase ‘‘Eligible professionals
participating in an ACO’’ and adding in
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its place the phrase ‘‘Through reporting
period 2016, eligible professionals
participating in an ACO’’
■ c. Adding paragraph (e).
The revision and addition read as
follows:
§ 425.506 Incorporating reporting
requirements related to adoption of certified
electronic health record technology.
*
*
*
*
*
(e) For 2017 and subsequent years,
CMS will annually assess the degree of
use of certified EHR technology by
eligible clinicians billing through the
TINs of ACO participants for purposes
of meeting the CEHRT criterion
necessary for Advanced Alternative
Payment Models under the Quality
Payment Program.
(1) During years in which the measure
is designated as pay for reporting, in
order to demonstrate complete and
accurate reporting, at least one eligible
clinician billing through the TIN of an
ACO participant must meet the
reporting requirements under the
Advancing Clinical Information
category under the Quality Payment
Program.
(2) During years in which the measure
is designated as pay for performance,
the quality measure regarding EHR
adoption will be measured based on a
sliding scale.
■ 48. Section 425.508 is added to
subpart F to read as follows:
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§ 425.508 Incorporating quality reporting
requirements related to the Quality Payment
Program.
(a) For 2017 and subsequent reporting
years. ACOs, on behalf of eligible
clinicians who bill under the TIN of an
ACO participant, must submit all of the
CMS web interface measures
determined under § 425.500 to
satisfactorily report on behalf of their
eligible clinicians for purposes of the
quality performance category of the
Quality Payment Program.
(b) [Reserved]
■ 49. Section 425.612 is amended by—
■ a. Amending paragraph (a)(1)
introductory text to remove the phrase
‘‘ACOs participating in Track 3 that
receive otherwise’’ and adding in its
place the phrase ‘‘ACOs participating in
Track 3, and as provided in paragraph
(a)(1)(iv) of this section during a grace
period for beneficiaries excluded from
prospective assignment to a Track 3
ACO, who receive otherwise’’.
■ b. Adding paragraphs (a)(1)(iv),
(a)(1)(v), and (d)(4).
The additions read as follows:
§ 425.612 Waivers of payment rules or
other Medicare requirements.
(a) * * *
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(1) * * *
(iv) For a beneficiary who was
included on the prospective assignment
list under § 425.400(a)(3) for a
performance year for a Track 3 ACO for
which a waiver of the SNF 3-day rule
has been approved under paragraph
(a)(1) of this section, but who was
subsequently excluded from the ACO’s
prospective assignment list, CMS makes
payment for SNF services furnished to
the beneficiary by a SNF affiliate if the
following conditions are met:
(A) The beneficiary was prospectively
assigned to the ACO at the beginning of
the applicable performance year but was
excluded in the most recent quarterly
update to the prospective assignment
list under § 425.401(b).
(B) The SNF services are furnished to
a beneficiary who was admitted to a
SNF affiliate within 90 days following
the date that CMS delivers the quarterly
exclusion list to the ACO.
(C) But for the beneficiary’s exclusion
from the ACO’s prospective assignment
list, CMS would have made payment to
the SNF affiliate for such services under
the waiver under paragraph (a)(1) of this
section.
(v) The following beneficiary
protections apply when a beneficiary
receives SNF services without a prior 3day inpatient hospital stay from a SNF
affiliate that intended to provide
services pursuant to a SNF 3-day rule
waiver under paragraph (a)(1) of this
section, but the beneficiary was not
prospectively assigned to the ACO and
was not in the 90 day grace period
under paragraph (a)(1)(iv) of this
section. The SNF affiliate services must
be non-covered only because the SNF
affiliate stay was not preceded by a
qualifying hospital stay under section
1861(i) of the Act.
(A) A SNF is presumed to intend to
provide services pursuant to the SNF 3day rule waiver under paragraph (a)(1)
of this section if the SNF submitting the
claim is a SNF affiliate of an ACO for
which such a waiver has been approved.
(B) CMS makes no payments for SNF
services to a SNF affiliate of an ACO for
which a waiver of the SNF 3-day rule
has been approved when the SNF
affiliate admits a FFS beneficiary who
was never prospectively assigned to the
ACO or was prospectively assigned but
was later excluded and the 90 day grace
period under paragraph (a)(1)(iv) of this
section has lapsed.
(C) In the event that CMS makes no
payment for SNF services furnished by
a SNF affiliate as a result of paragraph
(a)(1)(v)(B) of this section and the only
reason the claim was non-covered is due
to the lack of a qualifying inpatient stay,
PO 00000
Frm 00315
Fmt 4701
Sfmt 4702
46475
the following beneficiary protections
will apply:
(1) The SNF must not charge the
beneficiary for the expenses incurred for
such services; and
(2) The SNF must return to the
beneficiary any monies collected for
such services; and
(3) The ACO may be required to
submit a corrective action plan under
§ 425.216(b) for CMS approval. If after
being given an opportunity to act upon
the corrective action plan the ACO fails
to come into compliance with the
requirements of paragraph (a)(1),
approval for the SNF 3-day rule waiver
under this section will be terminated as
provided under paragraph (d) of this
section.
*
*
*
*
*
(d) * * *
(4) CMS reserves the right to take
compliance action, including
termination, against an ACO for
noncompliance with program rules,
including misuse of a waiver under this
section, as specified at §§ 425.216 and
425.218.
*
*
*
*
*
PART 460—PROGRAMS OF ALLINCLUSIVE CARE FOR THE ELDERLY
(PACE)
50. The authority citation for part 460
continues to read as follows:
■
Authority: Secs. 1102, 1871, 1894(f), and
1934(f) of the Social Security Act (42 U.S.C.
1302, 1395, 1395eee(f), and 1396u–4(f)).
51. Section 460.32 is amended by
adding paragraph (a)(14) to read as
follows:
■
§ 460.32 Content and terms of PACE
program agreement.
(a) * * *
(14) Name and National Provider
Identifier (NPI) of all providers and
suppliers, as defined in 1861 of the Act,
reflecting enrollment in Medicare in an
approved status.
*
*
*
*
*
■ 52. Section 460.40 is amended by
adding paragraph (j) to read as follows:
§ 460.40 Violations for which CMS may
impose sanctions.
*
*
*
*
*
(j) Employs or contracts with any
provider or supplier, as defined in
section 1861 of the Act, that is not
enrolled in Medicare in an approved
status.
■ 53. Section 460.50 is amended by
revising paragraph (b)(1)(ii) to read as
follows:
§ 460.50 Termination of PACE program
agreement.
(b) * * *
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Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Proposed Rules
(1) * * *
(ii) The PACE organization failed to
comply substantially with conditions
for a PACE program or PACE
organization under this part, or with
terms of its PACE program agreement,
including employing or contracting with
any provider or supplier, as defined in
section 1861 of the Act, that is not
enrolled in Medicare in an approved
status.
*
*
*
*
*
■ 54. Section 460.68 is amended by
adding paragraph (a)(4) to read as
follows:
§ 460.68
Program integrity.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
(a) * * *
VerDate Sep<11>2014
19:43 Jul 14, 2016
Jkt 238001
(4) That are not enrolled in Medicare
in an approved status, if they are a
provider or supplier that is eligible to
enroll in Medicare, as defined in section
1861 of the Act.
*
*
*
*
*
■ 55. Section 460.70 is amended by
revising paragraph (b)(1)(ii) to read as
follows:
§ 460.70
Contracted services.
*
*
*
*
*
(b) * * *
(1) * * *
(ii) A practitioner or supplier must
meet Medicare or Medicaid
requirements applicable to the services
it furnishes, including enrollment in
PO 00000
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Fmt 4701
Sfmt 9990
Medicare in an approved status, if they
are a provider or supplier that is eligible
to enroll in Medicare, as defined in
section 1861 of the Act.
*
*
*
*
*
Dated: June 2, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
Dated: June 23, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human
Services.
[FR Doc. 2016–16097 Filed 7–7–16; 4:15 pm]
BILLING CODE 4120–01–P
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]]>Agencies
[Federal Register Volume 81, Number 136 (Friday, July 15, 2016)]
[Proposed Rules]
[Pages 46161-46476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16097]
[[Page 46161]]
Vol. 81
Friday,
No. 136
July 15, 2016
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 405, 410, 411, et al.
Medicare Program; Revisions to Payment Policies Under the Physician
Fee Schedule and Other Revisions to Part B for CY 2017; Medicare
Advantage Pricing Data Release; Medicare Advantage and Part D Medical
Low Ratio Data Release; Medicare Advantage Provider Network
Requirements; Expansion of Medicare Diabetes Prevention Program Model;
Proposed Rules
Federal Register / Vol. 81 , No. 136 / Friday, July 15, 2016 /
Proposed Rules
[[Page 46162]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 411, 414, 417, 422, 423, 424, 425, and 460
[CMS-1654-P]
RIN 0938-AS81
Medicare Program; Revisions to Payment Policies Under the
Physician Fee Schedule and Other Revisions to Part B for CY 2017;
Medicare Advantage Pricing Data Release; Medicare Advantage and Part D
Medical Low Ratio Data Release; Medicare Advantage Provider Network
Requirements; Expansion of Medicare Diabetes Prevention Program Model
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This major proposed rule addresses changes to the physician
fee schedule and other Medicare Part B payment policies, such as
changes to the Value Modifier, 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. This proposed rule also
includes proposals related to the Medicare Shared Saving Program, and
the release of certain pricing data from Medicare Advantage bids and
medical loss ratio reports from Medicare health and drug plans. In
addition, this rule proposes to expand the Medicare Diabetes Prevention
Program model.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on September 6,
2016.
ADDRESSES: In commenting, please refer to file code CMS-1654-P. 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-1654-P, 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-1654-P, 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:
Jessica Bruton, (410) 786-5991 for issues related to any physician
payment issues not identified below.
Gail Addis, (410) 786-4522, for issues related to diabetes self-
management training.
Jaime Hermansen, (410) 786-2064, for issues related to moderate
sedation coding and anesthesia services.
Jessica Bruton, (410) 786-5991, for issues related to
identification of potentially misvalued services.
Roberta Epps, (410) 786-4503, for issues related to PAMA section
218(a) policy and the transition from traditional x-ray imaging to
digital radiography.
Ken Marsalek, (410) 786-4502, for issues related to telehealth
services.
Ann Marshall, (410) 786-3059, for primary care issues related to
chronic care management (CCM), burden reduction and evaluation and
management services.
Emily Yoder, (410) 786-1804, for primary care issues related to
resource intensive services and other primary care issues.
Lindsey Baldwin, (410) 786-1694, for primary care issues related to
behavioral health integration services.
Geri Mondowney, (410) 786-4584, and Donta Henson, (410) 786-1947,
for issues related to geographic practice cost indices.
Michael Soracoe, (410) 786-6312, for issues related to the target
and phase-in provisions, the practice expense methodology, impacts,
conversion factor, and the valuation of surgical procedures.
Pamela West, (410) 786-2302, for issues related to therapy.
Patrick Sartini, (410) 786-9252, for issues related to malpractice
RVUs, radiation treatment, mammography and other imaging services.
Kathy Bryant, (410) 786-3448, for issues related to collecting data
on resources used in furnishing global services.
Donta Henson, (410) 786-1947, for issues related to pathology and
ophthalmology services.
Corinne Axelrod, (410) 786-5620, for issues related to rural health
clinics or federally qualified health centers for comprehensive care
management services furnished incident to.
Simone Dennis (410) 786-8409, for issues related to FQHC-specific
market basket.
JoAnna Baldwin (410) 786-7205, or Sarah Fulton (410) 786-2749, for
issues related to appropriate use criteria for advanced diagnostic
imaging services.
Erin Skinner (410) 786-0157, for issues related to open payments.
Sean O'Grady (410) 786-2259, or Julie Uebersax (410) 786-9284, for
issues related to release of pricing data from Medicare Advantage bids
and release of medical loss ratio data submitted by Medicare Advantage
organizations and Part D sponsors.
Sara Vitolo (410) 786-5714, for issues related to prohibition on
billing qualified Medicare beneficiary individuals for Medicare cost-
sharing.
Michelle Peterman (410) 786-2591, for issues on the technical
correction for PQRS.
Katie Mucklow (410) 786-0537 or John Spiegel (410) 786-1909, for
issues related to Provider Enrollment Medicare Advantage Program.
Jen Zhu (410) 786-3725, Carlye Burd (410) 786-1972, or Nina Brown
(410)
[[Page 46163]]
786-6103, for issues related to Medicare Diabetes Prevention Program
model expansion.
Rabia Khan or Terri Postma, (410) 786-8084 or ACO@cms.hhs.gov, for
issues related to Medicare Shared Savings Program.
Sabrina Ahmed (410) 786-7499, or Fiona Larbi (410) 786-7224, for
issues related to Value-based Payment Modifier and Physician Feedback
Program.
Lisa Ohrin Wilson (410) 786-8852, or Gabriel Scott (410) 786-3928,
for issues related to physician self-referral updates.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of 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
II. Provisions of the Proposed Rule for PFS
A. Determination of Practice Expense Relative Value Units (PE
RVUs)
B. Determination of Malpractice Relative Value Units (MRVUs)
C. Medicare Telehealth Services
D. Potentially Misvalued Services Under the Physician Fee
Schedule
1. Background
2. Progress in Identifying and Reviewing Potentially Misvalued
Codes
3. Validating RVUs of Potentially Misvalued Codes
4. CY 2017 Identification and Review of Potentially Misvalued
Services
5. Valuing Services That Include Moderate Sedation as an
Inherent Part of Furnishing the Procedure
6. Collecting Data on Resources Used in Furnishing Global
Services
E. Improving Payment Accuracy for Primary Care, Care Management
Services, and Patient-Centered Services
F. Improving Payment Accuracy for Preventive Services: Diabetes
Self-Management Training (DSMT)
G. Target for Relative Value Adjustments for Misvalued Services
H. Phase-In of Significant RVU Reductions
I. Geographic Practice Cost Indices (GPCIs)
J. Payment Incentive for the Transition From Traditional X-Ray
Imaging to Digital Radiography and Other Imaging Services
K. Procedures Subject to the Multiple Procedure Payment
Reduction (MPPR) and the OPPS Cap
L. Valuation of Specific Codes
III. Other Provisions of the Proposed Rule for PFS
A. Chronic Care Management (CCM) and Transitional Care
Management (TCM) Supervision Requirements in Rural Health Clinics
(RHCs) and Federally Qualified Health Centers (FQHCs)
B. FQHC-Specific Market Basket
C. Appropriate Use Criteria for Advanced Diagnostic Imaging
Services
D. Reports of Payments or Other Transfers of Value to Covered
Recipients: Solicitation of Public Comments
E. Release of Part C Medicare Advantage Bid Pricing Data and
Part C and Part D Medical Loss Ratio (MLR) Data
F. Prohibition on Billing Qualified Medicare Beneficiary
Individuals for Medicare Cost-Sharing
G. Recoupment or Offset of Payments to Providers Sharing the
Same Taxpayer Identification Number
H. Accountable Care Organization (ACO) Participants Who Report
Physician Quality Reporting System (PQRS) Quality Measures
Separately
I. Medicare Advantage Provider Enrollment
J. Proposed Expansion of the Diabetes Prevention Program (DPP)
Model
K. Medicare Shared Savings Program
L. Value-Based Payment Modifier and Physician Feedback Program
M. Physician Self-referral Updates
IV. Collection of Information Requirements
V. Response to Comments
VI. Regulatory Impact Analysis
Regulations Text
Acronyms
In addition, because of the many organizations and terms to which
we refer by acronym in this proposed rule, we are listing these
acronyms and their corresponding terms in alphabetical order below:
A1c--Hemoglobin A1c
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)
AWV--Annual wellness visit
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
CoA--Certificate of Accreditation
CoC--Certificate of Compliance
CoR--Certificate of Registration
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 2015 American Medical
Association. All rights reserved.)
CQM--Clinical quality measure
CSW--Clinical social worker
CT--Computed tomography
CW--Certificate of Waiver
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
ED--Emergency Department
EHR--Electronic health record
E/M--Evaluation and management
EMT--Emergency Medical Technician
EP--Eligible professional
eRx--Electronic prescribing
ESRD--End-stage renal disease
FAR--Federal Acquisition Regulations
FDA--Food and Drug Administration
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
IPPE--Initial preventive physical exam
IPPS--Inpatient Prospective Payment System
IQR--Inpatient Quality Reporting
ISO--Insurance service office
IT--Information technology
IWPUT--Intensity of work per unit of time
LCD--Local coverage determination
MA--Medicare Advantage
MAC--Medicare Administrative Contractor
MACRA--Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L.
114-10)
MAP--Measure Applications Partnership
MAPCP--Multi-payer Advanced Primary Care Practice
MAV--Measure application validity [process]
MCP--Monthly capitation payment
[[Page 46164]]
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
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
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
PPM--Provider-Performed Microscopy
PQRS--Physician Quality Reporting System
PPIS--Physician Practice Expense Information Survey
PT--Physical therapy
PT--Proficiency Testing
PT/INR--Prothrombin Time/International Normalized Ratio
PY--Performance year
QA--Quality Assessment
QC--Quality Control
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 proposed rule 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 2017 PFS Proposed Rule, refer
to item CMS-1654-P. 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 Jessica Bruton at
(410) 786-5991.
CPT (Current Procedural Terminology) Copyright Notice
Throughout this proposed rule, we use CPT codes and descriptions to
refer to a variety of services. We note that CPT codes and descriptions
are copyright 2015 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 proposed rule proposes to revise payment polices under
the Medicare Physician Fee Schedule (PFS) and make other policy changes
related to Medicare Part B payment. These changes would be applicable
to services furnished in CY 2017. In addition, this proposed rule
includes proposals related to: the Medicare Shared Savings Program and
release of pricing data submitted to CMS by Medicare Advantage (MA)
organizations; and medical loss ratio reports submitted by MA plans and
Part D plans. These additional proposals are addressed in section III.
of this proposed rule.
2. Summary of the Major Provisions
The statute 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 statute 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 paid under the PFS, incorporating geographic adjustments to
reflect the variations in the costs of furnishing services in different
geographic areas. In this major proposed rule, we are proposing to
establish RVUs for CY 2017 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 proposed rule
includes discussions and proposals regarding:
Potentially Misvalued PFS Codes.
Telehealth Services.
Establishing Values for New, Revised, and Misvalued
Codes.
Target for Relative Value Adjustments for Misvalued
Services.
Phase-in of Significant RVU Reductions.
Chronic Care Management (CCM) and Transitional Care
Management (TCM) Supervision Requirements in Rural Health Clinics
(RHCs) and Federally Qualified Health Centers (FQHCs).
FQHC-Specific Market Basket.
Appropriate Use Criteria for Advanced Diagnostic
Imaging Services.
Reports of Payments or Other Transfers of Value to
Covered Recipients: Solicitation of Public Comments.
Release of Part C Medicare Advantage Bid Pricing Data
and Part C and Part D Medical Loss Ratio (MLR) Data.
Prohibition on Billing Qualified Medicare Beneficiary
Individuals for Medicare Cost-Sharing.
Recoupment or Offset of Payments to Providers Sharing
the Same Taxpayer Identification Number.
Accountable Care Organization (ACO) Participants Who
Report Physician Quality Reporting System (PQRS) Quality Measures
Separately.
Medicare Advantage Provider Enrollment.
Proposed Expansion of the Diabetes Prevention Program
(DPP) Model.
Medicare Shared Savings Program.
Value-Based Payment Modifier and the Physician Feedback
Program.
Physician Self-referral Updates.
3. Summary of Costs and Benefits
The statute requires that annual adjustments to PFS RVUs may not
cause annual estimated expenditures to differ by more than $20 million
from what
[[Page 46165]]
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 changes proposed in this proposed
rule would affect the specialty distribution of Medicare expenditures.
When considering the combined impact of proposed work, PE, and MP RVU
changes, the projected payment impacts would be small for most
specialties; however, the impact would be larger for a few specialties.
We have determined that this major proposed rule is economically
significant. For a detailed discussion of the economic impacts, see
section VI. of this proposed rule.
B. Background
Since January 1, 1992, Medicare has paid for physicians' services
under section 1848 of the Social Security Act (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 major proposed rule, 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
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. 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.
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
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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.B.2. of this proposed rule.
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.
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 proposed rule, in accordance
with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs
cause 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 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 work,
PE, and MP in an area compared to the national average costs for each
component.
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 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 ensure 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
Section 220(d) of the Protecting Access to Medicare Act of 2014
(Pub. L. 113-93, enacted on April 1, 2014) (PAMA) added a new
subparagraph (O) to section 1848(c)(2) of the Act to establish an
annual target for reductions in PFS expenditures resulting from
adjustments to relative values of misvalued codes. If the estimated net
reduction in expenditures for a year is equal to or greater than the
target for that year, the provision specifies that reduced expenditures
attributable to such adjustments shall be redistributed in a budget-
neutral manner within the PFS. The provision specifies that the amount
by which such reduced expenditures exceed the target for a given year
shall be treated as a reduction in expenditures for the subsequent year
for purposes of determining whether the target for the subsequent year
has been met. The provision also specifies that an amount equal to the
difference between the target and the estimated net reduction in
expenditures, called the target recapture amount, shall not be taken
into account when applying the budget neutrality requirements specified
in section 1848(c)(2)(B)(ii)(II) of the Act. The PAMA amendments
originally made the target provisions applicable for CYs 2017 through
2020 and set the target for reduced expenditures at 0.5 percent of
estimated expenditures under the PFS for each of those 4 years.
Subsequently, section 202 of the Achieving a Better Life Experience
Act of 2014 (Division B of Pub. L. 113-295, enacted December 19, 2014)
(ABLE) accelerated the application of the target, amending section
1848(c)(2)(O) of the Act to specify that target provisions apply for
CYs 2016, 2017, and 2018; and setting a 1 percent target for reduced
expenditures for CY 2016 and a 0.5 percent target for CYs 2017 and
2018. The implementation of the target legislation was finalized in the
CY 2016 PFS final rule with comment period, and proposed revisions are
discussed in section II.G. of this proposed rule.
Section 1848(c)(7) of the Act, as added by section 220(e) of the
PAMA, specified that for services that are not new or revised codes, if
the total RVUs for a service for a year would otherwise be decreased by
an estimated 20 percent or more as compared to the total RVUs for the
previous year, the applicable
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adjustments in work, PE, and MP RVUs shall be phased in over a 2-year
period. Section 220(e) of the PAMA required the phase-in of RVU
reductions of 20 percent or more to begin for 2017. Section 1848(c)(7)
of the Act was later amended by section 202 of the ABLE Act to require
instead that the phase-in must begin in CY 2016. The implementation of
the phase-in legislation was finalized in the CY 2016 PFS final rule
with comment period and proposed revisions in this year's rulemaking
are discussed in section II.H. of this proposed rule.
II. Provisions of the Proposed Rule for PFS
A. Determination of 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 physicians'
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.
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 Medicare Economic Index (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). We have incorporated the available utilization data for
interventional cardiology, which became a recognized Medicare specialty
during 2014. We finalized the use of a proxy PE/HR value for
interventional cardiology in the CY 2016 final rule with comment period
(80 FR 70892), as there are no PPIS data for this specialty, by
crosswalking the PE/HR for from
[[Page 46168]]
Cardiology, since the specialties furnish similar services in the
Medicare claims data.
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 proposed rule 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 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 used 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. That is, 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 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 added 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 incorporated 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.
(3) 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. 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. For this reason, 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.
(4) Services With Technical Components (TCs) and Professional
Components (PCs)
Diagnostic services are generally composed 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.)
(5) 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). We also direct interested readers to the file called
``Calculation of PE RVUs under Methodology for Selected Codes'' which
is available on our Web site under downloads for the CY 2017 PFS
proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This
file contains a table that illustrates the calculation of PE RVUs as
described below for individual PFS codes.
(a) 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.
(b) 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.
Step 2: Calculate the aggregate pool of direct PE costs for the
current year. We set the aggregate pool of PE costs equal to the
product of the ratio of the current aggregate PE RVUs to current
aggregate work RVUs and the proposed aggregate work RVUs.
Step 3: Calculate the aggregate pool of direct PE costs for use in
ratesetting. This is the product of the aggregate 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 factor 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
[[Page 46169]]
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.
(c) 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.
We use an average of the 3 most recent years of available Medicare
claims data to determine the specialty mix assigned to each code. As we
stated in the CY 2016 final rule with comment period (80 FR 70894), we
believe that the 3-year average will mitigate the need to use dominant
or expected specialty instead of the claims data. Because we are
incorporating CY 2015 claims data for use in the CY 2017 proposed
rates, we believe that the proposed PE RVUs associated with the CY 2017
PFS proposed rule provide a first opportunity to determine whether
service-level overrides of claims data are necessary. Currently, in the
development of PE RVUs we apply only the overrides that also apply to
the MP RVU calculation. Since the proposed PE RVUs include a new year
of claims into the 3 year average for the first time, we are seeking
comment on the proposed CY 2017 PFS rates and whether or not the
incorporation of a new year of utilization data into a three year
average mitigates the need for alternative service-level overrides such
as a claims-based approach (dominant specialty) or stakeholder-
recommended approach (expected specialty) in the development of PE (and
MP) RVUs for low-volume codes. Prior year RVUs are available at several
locations on the PFS Web site located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
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 labor 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 the download file
called ``Calculation of PE RVUs under Methodology for Selected Codes'',
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 the result of step 8 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.
(d) Calculate the Final PE RVUs
Step 18: Add the direct PE RVUs from Step 5 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 sum of steps
5 and 17 of to the proposed aggregate work RVUs scaled by the ratio of
current aggregate PE and work RVUs. This adjustment ensures that all PE
RVUs in the PFS account for the fact that certain specialties are
excluded from the calculation of PE RVUs but included in maintaining
overall PFS budget neutrality. (See ``Specialties excluded from
ratesetting calculation'' later in this section.)
(e) 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.
[[Page 46170]]
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-orthotist.
54................................ Medical supply company not included
in 51, 52, or 53.
55................................ Individual certified orthotist.
56................................ Individual certified prosthetist.
57................................ Individual certified prosthetist-
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 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 Preoperative + Preoperative +
only. Intraoperative Intraoperative
Percentages on the portion.
payment files used by
Medicare contractors
to process Medicare
claims.
55................................... Postoperative Care only Postoperative Postoperative portion.
Percentage on the
payment files used by
Medicare contractors
to process Medicare
claims.
[[Page 46171]]
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 (MPPRs). 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 we use the average allowed charge when simulating RVUs;
therefore, the RVUs as calculated already reflect the payments as
adjusted by modifiers, and no volume adjustments are necessary.
However, a time adjustment of 33 percent is made only for medical
direction of two to four cases since that is the only situation where a
single practitioner is involved with multiple beneficiaries
concurrently, so that counting each service without regard to the
overlap with other services would overstate the amount of time spent by
the practitioner furnishing these services.
Work RVUs: The setup file contains the work RVUs from this
proposed rule.
(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) [supcaret] 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.
Stakeholders have often suggested that particular equipment items
are used less frequently than 50 percent of the time in the typical
setting and that CMS should reduce the equipment utilization rate based
on these recommendations. We appreciate and share stakeholders'
interest in using the most accurate assumption regarding the equipment
utilization rate for particular equipment items. However, we believe
that absent robust, objective, auditable data regarding the use of
particular items, the 50 percent assumption is the most appropriate
within the relative value system. We welcome the submission of data
that illustrates an alternative rate.
Maintenance: This factor for maintenance was proposed and finalized
during rulemaking for CY 1998 PFS (62 FR 33164).
We continue to investigate potential avenues for determining
equipment maintenance costs across a broad range of equipment items.
Interest Rate: In the CY 2013 PFS final rule with comment period
(77 FR 68902), we updated the interest rates used in 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.) We are not proposing any changes to
these interest rates for CY 2017.
Table 3--SBA Maximum Interest Rates
------------------------------------------------------------------------
Useful
Price life Interest
(years) rate (%)
------------------------------------------------------------------------
<$25K........................................... <7 7.50
$25K to $50K.................................... <7 6.50
>$50K........................................... <7 5.50
<$25K........................................... 7+ 8.00
$25K to $50K.................................... 7+ 7.00
>$50K........................................... 7+ 6.00
------------------------------------------------------------------------
d. Proposed Changes to Direct PE Inputs for Specific Services
This section focuses on specific PE inputs. The direct PE inputs
are included in the CY 2017 direct PE input database, which is
available on our Web site under downloads for the CY 2017 PFS proposed
rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
(1) PE Inputs for Digital Imaging Services
Prior to the CY 2015 PFS rulemaking cycle, the RUC provided a
recommendation regarding the PE inputs for digital imaging services.
Specifically, the RUC recommended that we remove supply and equipment
items associated with film technology from a previously specified list
of codes since these items were no longer typical resource inputs. The
RUC also recommended that the Picture Archiving and Communication
System (PACS) equipment be included for these imaging services since
these items had been become typically used in furnishing imaging
services. However, since we did not receive any invoices for the PACS
system prior to that year's proposed rule, we were unable to determine
the appropriate pricing to use for the inputs. For CY 2015, we
finalized our proposal to remove the film supply and equipment items,
and to create a new equipment item as a proxy for the PACS workstation
as a direct expense (79 FR 67561-67563). We used the price associated
with ED021 (computer, desktop, w-monitor) to price the new item, ED050
(PACS Workstation Proxy), pending receipt of invoices to facilitate
pricing specific to the PACS workstation. Subsequent to establishing
payment rates for CY 2015, we received information from several
stakeholders regarding pricing for items related to the digital
acquisition and storage of images. We received invoices from one
stakeholder that facilitated a proposed price update for the PACS
workstation in the CY 2016 PFS proposed rule, and we updated the price
for the PACS workstation to $5,557 in the CY 2016 PFS final rule with
comment period (80 FR 70899).
In addition to the workstation used by the clinical staff acquiring
the images and furnishing the TC of the services, a stakeholder also
submitted more detailed information regarding a workstation used by the
practitioner interpreting the image in furnishing the PC of many of
these services.
As we stated in the CY 2015 PFS final rule with comment period (79
FR 67563), we generally believe that workstations used by these
practitioners
[[Page 46172]]
are more accurately considered indirect costs associated with the PC of
the service. However, we understand that the professional workstations
for interpretation of digital images are similar in principle to some
of the previous film inputs incorporated into the global and technical
components of the codes, such as the view box equipment. Given that the
majority of these services are reported globally in the nonfacility
setting, we believe it is appropriate to include these costs as direct
inputs for the associated HCPCS codes. Based on our established
methodology in which single codes with professional and technical
components are constructed by assigning work RVUs exclusively to the
professional component and direct PE inputs exclusively to the
technical components, these costs would be incorporated into the PE
RVUs of the global and technical component of the HCPCS code.
We stated in the CY 2016 PFS final rule with comment period that
the costs of the professional workstation may be analogous to costs
related to the use of film previously incorporated as direct PE inputs
for these services. We also solicited comments on whether including the
professional workstation as a direct PE input for these codes would be
appropriate, given that the resulting PE RVUs would be assigned to the
global and technical components of the codes. Commenters responded by
indicating their approval of the concept of a professional PACS
workstation used for interpretation of digital images. We received
invoices for the pricing of a professional PACS workstation, as well as
additional invoices for the pricing of a mammography-specific version
of the professional PACS workstation. The RUC also included these new
equipment items in its recommendations for the CY 2017 PFS rulemaking
cycle.
Based on our analysis of submitted invoices, we are proposing to
price the professional PACS workstation (ED053) at $14,616.93. We are
not proposing a change in price for the current technical PACS
workstation (ED050), which will remain at a price of $5,557.00.
The price of the professional PACS workstation is based upon
individual invoices submitted for the cost of a PC Tower ($1531.52), a
pair of 3 MP monitors ($10,500.00 in total), a keyboard and mouse
($84.95), a UPS power backup devices for TNP ($1098.00), and a switch
for PACS monitors/workstations ($1402.46).
We are proposing to add the professional PACS workstation to many
CPT codes in the 70000 series that use the current technical PACS
workstation (ED050) and include professional work for which such a
workstation would be used. We are not proposing to add the equipment
item to add-on codes since the base codes would include minutes for the
item. We are also not proposing to add the item to codes that are
therapeutic in nature, as the professional PACS workstation is intended
for use in diagnostic services. We are therefore not proposing to add
the item to codes in the Radiation Therapy section (77261 through
77799) or the Nuclear Medicine Cardiology section (78414-78499). We
also are not proposing to add the item to image guidance codes where
the dominant provider is not a radiologist (77002, 77011, 77071, 77077,
and 77081) according to the most recent year of claims data, since we
believe a single workstation would be more typical in those cases. We
have identified approximately 426 codes to which we are proposing to
add a professional PACS workstation. Please see Table 4 for the full
list of affected codes.
For the professional PACS workstation, we are proposing to assign
equipment time equal to the intraservice work time plus half of the
preservice work time associated with the codes, since the work time
generally reflects the time associated with the professional
interpretation. We are proposing half of the preservice work time for
the professional PACS workstation, as we do not believe that the
practitioner would typically spend all of the preservice work period
using the equipment. For older codes that do not have a breakdown of
physician work time by service period, and only have an overall
physician work time, we are proposing to use half the total work time
as an approximation of the intraservice work time plus one half of the
preservice work time. In our review of services that contained an
existing PACS workstation and had a breakdown of physician work time,
we found that half of the total time was a reasonable approximation for
the value of intraservice work time plus one half of preservice work
time where no such breakdown existed. We also considered using an
equipment time formula of the physician intraservice time plus 1 minute
(as a stand-in for the physician preservice work time). We are seeking
public comment on the most accurate equipment time formula for the
professional PACS workstation.
We are seeking public comment on the proposed list of codes that
would incorporate either the professional PACS workstation. We are
interested in public comment on the codes for which a professional PACS
workstation should be included, and whether one of these professional
workstations should be included for codes outside the 70000 series. In
cases within the 70000 series where radiologists are not the typical
specialty reporting the code, such as CPT codes 77002 and 77011, we are
asking whether it would be appropriate to add one of the professional
PACS workstations to these services.
Table 4--Codes With Professional PACS Workstation in the Proposed Direct
PE Input Database
------------------------------------------------------------------------
HCPCS ED053 minutes
------------------------------------------------------------------------
70015................................................... 12
70030................................................... 3
70100................................................... 3
70110................................................... 4
70120................................................... 3
70130................................................... 4
70134................................................... 4
70140................................................... 3
70150................................................... 4
70160................................................... 3
70190................................................... 3
70200................................................... 4
70210................................................... 3
70220................................................... 4
70240................................................... 3
70250................................................... 4
70260................................................... 7
70300................................................... 2
70310................................................... 3
70320................................................... 3
70328................................................... 3
70330................................................... 22
70332................................................... 6
70336................................................... 20
70350................................................... 3
70355................................................... 5
70360................................................... 3
70370................................................... 4
70371................................................... 9
70380................................................... 3
70390................................................... 5
70450................................................... 12
70460................................................... 15
70470................................................... 18
70480................................................... 13
70481................................................... 13
70482................................................... 14
70490................................................... 13
70491................................................... 13
70492................................................... 14
70540................................................... 14
70542................................................... 19
70543................................................... 19
70544................................................... 13
70545................................................... 18
70546................................................... 18
70547................................................... 13
70548................................................... 20
70549................................................... 25
70551................................................... 21
70552................................................... 23
70553................................................... 28
70554................................................... 43
71010................................................... 4
71015................................................... 3
[[Page 46173]]
71020................................................... 4
71021................................................... 4
71022................................................... 4
71023................................................... 5
71030................................................... 4
71034................................................... 5
71035................................................... 3
71100................................................... 5
71101................................................... 4
71110................................................... 4
71111................................................... 5
71120................................................... 3
71130................................................... 3
71250................................................... 18
71260................................................... 17
71270................................................... 13
71275................................................... 28
71550................................................... 15
71551................................................... 30
71552................................................... 28
71555................................................... 33
72020................................................... 3
72040................................................... 4
72050................................................... 6
72052................................................... 6
72070................................................... 4
72072................................................... 3
72074................................................... 3
72080................................................... 3
72081................................................... 6
72082................................................... 7
72083................................................... 8
72084................................................... 9
72100................................................... 4
72110................................................... 6
72114................................................... 6
72120................................................... 4
72125................................................... 18
72126................................................... 12
72127................................................... 12
72128................................................... 18
72129................................................... 12
72130................................................... 12
72131................................................... 18
72132................................................... 12
72133................................................... 12
72141................................................... 23
72142................................................... 26
72146................................................... 23
72147................................................... 26
72148................................................... 23
72149................................................... 26
72156................................................... 28
72157................................................... 28
72158................................................... 28
72159................................................... 31
72170................................................... 5
72190................................................... 3
72191................................................... 28
72192................................................... 12
72193................................................... 12
72194................................................... 12
72195................................................... 30
72196................................................... 26
72197................................................... 30
72198................................................... 28
72200................................................... 3
72202................................................... 3
72220................................................... 3
72240................................................... 19
72255................................................... 18
72265................................................... 18
72270................................................... 23
72275................................................... 36
72285................................................... 9
72295................................................... 9
73000................................................... 3
73010................................................... 3
73020................................................... 3
73030................................................... 5
73040................................................... 6
73050................................................... 3
73060................................................... 4
73070................................................... 3
73080................................................... 4
73085................................................... 6
73090................................................... 3
73092................................................... 3
73100................................................... 4
73110................................................... 4
73115................................................... 6
73120................................................... 4
73130................................................... 4
73140................................................... 3
73200................................................... 18
73201................................................... 11
73202................................................... 12
73206................................................... 35
73218................................................... 25
73219................................................... 25
73220................................................... 30
73221................................................... 23
73222................................................... 23
73223................................................... 35
73225................................................... 31
73501................................................... 4
73502................................................... 5
73503................................................... 6
73521................................................... 5
73522................................................... 6
73523................................................... 7
73525................................................... 6
73551................................................... 4
73552................................................... 5
73560................................................... 4
73564................................................... 6
73565................................................... 4
73580................................................... 6
73590................................................... 4
73592................................................... 3
73600................................................... 4
73610................................................... 4
73615................................................... 6
73620................................................... 4
73630................................................... 4
73650................................................... 3
73660................................................... 3
73700................................................... 18
73701................................................... 11
73702................................................... 12
73706................................................... 35
73718................................................... 20
73719................................................... 25
73720................................................... 30
73721................................................... 23
73722................................................... 24
73723................................................... 32
73725................................................... 33
74000................................................... 4
74010................................................... 3
74020................................................... 4
74022................................................... 4
74150................................................... 14
74160................................................... 17
74170................................................... 21
74174................................................... 33
74175................................................... 28
74176................................................... 25
74177................................................... 28
74178................................................... 33
74181................................................... 15
74182................................................... 28
74183................................................... 35
74185................................................... 33
74210................................................... 5
74220................................................... 5
74230................................................... 12
74240................................................... 7
74241................................................... 7
74245................................................... 9
74246................................................... 7
74247................................................... 18
74249................................................... 9
74250................................................... 5
74251................................................... 33
74260................................................... 6
74261................................................... 43
74262................................................... 48
74263................................................... 42
74270................................................... 7
74280................................................... 23
74283................................................... 19
74290................................................... 4
74400................................................... 18
74410................................................... 6
74415................................................... 6
74430................................................... 4
74440................................................... 5
74455................................................... 4
74485................................................... 6
74710................................................... 4
74712................................................... 68
74740................................................... 5
75557................................................... 45
75559................................................... 58
75561................................................... 50
75563................................................... 66
75571................................................... 13
75572................................................... 25
75573................................................... 38
75574................................................... 35
75600................................................... 6
75605................................................... 11
75625................................................... 11
75630................................................... 13
75635................................................... 50
75658................................................... 13
75705................................................... 20
75710................................................... 11
75716................................................... 13
75726................................................... 11
[[Page 46174]]
75731................................................... 11
75733................................................... 13
75736................................................... 11
75741................................................... 13
75743................................................... 16
75746................................................... 11
75756................................................... 11
75791................................................... 33
75809................................................... 5
75820................................................... 7
75822................................................... 11
75825................................................... 11
75827................................................... 11
75831................................................... 11
75833................................................... 14
75840................................................... 11
75842................................................... 14
75860................................................... 11
75870................................................... 11
75872................................................... 11
75880................................................... 7
75885................................................... 14
75887................................................... 14
75889................................................... 11
75891................................................... 11
75893................................................... 6
75901................................................... 11
75902................................................... 13
75962................................................... 6
75966................................................... 13
75978................................................... 6
75984................................................... 8
75989................................................... 12
76000................................................... 3
76010................................................... 3
76080................................................... 6
76098................................................... 3
76100................................................... 6
76101................................................... 6
76102................................................... 6
76120................................................... 5
76376................................................... 8
76380................................................... 10
76390................................................... 28
76506................................................... 10
76536................................................... 12
76604................................................... 9
76700................................................... 14
76705................................................... 11
76770................................................... 13
76775................................................... 11
76776................................................... 13
76800................................................... 14
76801................................................... 18
76805................................................... 18
76811................................................... 35
76813................................................... 23
76815................................................... 8
76816................................................... 18
76817................................................... 13
76818................................................... 35
76819................................................... 28
76820................................................... 13
76821................................................... 13
76825................................................... 45
76826................................................... 11
76830................................................... 13
76831................................................... 30
76856................................................... 13
76857................................................... 10
76870................................................... 10
76872................................................... 20
76873................................................... 40
76881................................................... 18
76885................................................... 20
76886................................................... 15
76936................................................... 71
76942................................................... 19
76970................................................... 8
77012................................................... 11
77014................................................... 9
77021................................................... 53
77053................................................... 5
77054................................................... 5
77058................................................... 50
77059................................................... 55
77072................................................... 3
77074................................................... 5
77075................................................... 6
77076................................................... 12
77084................................................... 15
78012................................................... 8
78013................................................... 13
78014................................................... 13
78015................................................... 31
78016................................................... 49
78018................................................... 29
78070................................................... 13
78071................................................... 18
78072................................................... 23
78075................................................... 38
78102................................................... 18
78103................................................... 22
78104................................................... 20
78135................................................... 48
78140................................................... 40
78185................................................... 16
78190................................................... 40
78195................................................... 30
78201................................................... 16
78202................................................... 20
78205................................................... 20
78206................................................... 25
78215................................................... 13
78216................................................... 22
78226................................................... 13
78227................................................... 18
78230................................................... 19
78231................................................... 23
78232................................................... 28
78258................................................... 27
78261................................................... 21
78262................................................... 25
78264................................................... 13
78265................................................... 18
78266................................................... 23
78278................................................... 18
78290................................................... 18
78291................................................... 31
78300................................................... 15
78305................................................... 22
78306................................................... 11
78315................................................... 11
78320................................................... 24
78579................................................... 8
78580................................................... 13
78582................................................... 15
78597................................................... 13
78598................................................... 13
78600................................................... 16
78601................................................... 18
78605................................................... 21
78606................................................... 22
78607................................................... 29
78610................................................... 10
78630................................................... 24
78635................................................... 36
78645................................................... 32
78647................................................... 15
78650................................................... 40
78660................................................... 16
78700................................................... 17
78701................................................... 18
78707................................................... 22
78708................................................... 32
78709................................................... 40
78710................................................... 21
78740................................................... 30
78761................................................... 20
78800................................................... 28
78801................................................... 32
78802................................................... 24
78803................................................... 43
78804................................................... 35
78805................................................... 25
78806................................................... 23
78807................................................... 37
79440................................................... 24
G0389................................................... 9
767X1................................................... 13
------------------------------------------------------------------------
(2) Standardization of Clinical Labor Tasks
As we noted in the CY 2015 PFS rule (79 FR 67640-67641), we
continue to work on revisions to the direct PE input database to
provide the number of clinical labor minutes assigned for each task for
every code in the database instead of only including the number of
clinical labor minutes for the preservice, service, and postservice
periods for each code. In addition to increasing the transparency of
the information used to set PE RVUs, this improvement would allow us to
compare clinical labor times for activities associated with services
across the PFS, which we believe is important to maintaining the
relativity of the direct PE inputs. This information would facilitate
the identification of the usual numbers of minutes for clinical labor
tasks and the identification of exceptions to the usual values. It
would also allow for greater transparency and consistency in the
assignment of equipment minutes based on clinical labor times. Finally,
we believe that the
[[Page 46175]]
information can be useful in maintaining standard times for particular
clinical labor tasks that can be applied consistently to many codes as
they are valued over several years, similar in principle to the use of
physician preservice time packages. We believe such standards would
provide greater consistency among codes that share the same clinical
labor tasks and could improve relativity of values among codes. For
example, as medical practice and technologies change over time, changes
in the standards could be updated at once for all codes with the
applicable clinical labor tasks, instead of waiting for individual
codes to be reviewed.
In the following paragraphs, we address a series of issues related
to clinical labor tasks, particularly relevant to services currently
being reviewed under the misvalued code initiative.
(a) Clinical Labor Tasks Associated With Digital Imaging
In the CY 2015 PFS rule, we noted that the RUC recommendation
regarding inputs for digital imaging services indicated that, as each
code is reviewed under the misvalued code initiative, the clinical
labor tasks associated with digital technology (instead of film) would
need to be addressed. When we reviewed that recommendation, we did not
have the capability of assigning standard clinical labor times for the
hundreds of individual codes since the direct PE input database did not
previously allow for comprehensive adjustments for clinical labor times
based on particular clinical labor tasks. Therefore, consistent with
the recommendation, we proposed to remove film-based supply and
equipment items but maintain clinical labor minutes that were assigned
based on film technology.
As noted in the paragraphs above, we continue to improve the direct
PE input database by specifying for each code the minutes associated
with each clinical labor task. Once completed, this work would allow
adjustments to be made to minutes assigned to particular clinical labor
tasks related to digital technology that occur in multiple codes,
consistent with the changes that were made to individual supply and
equipment items. In the meantime, we believe it would be appropriate to
establish standard times for clinical labor tasks associated with all
digital imaging services for purposes of reviewing individual services
at present, and for possible broad-based standardization once the
changes to the direct PE input database facilitate our ability to
adjust time across services. During the CY 2016 PFS rulemaking cycle,
we proposed appropriate standard minutes for five different clinical
labor tasks associated with services that use digital imaging
technology. In the CY 2016 PFS final rule with comment period (80 FR
70901), we finalized appropriate standard minutes for four of those
five activities, which are listed in Table 5.
Table 5--Clinical Labor Tasks Associated With Digital Imaging Technology
------------------------------------------------------------------------
Typical
Clinical labor task minutes
------------------------------------------------------------------------
Availability of prior images confirmed..................... 2
Patient clinical information and questionnaire reviewed by 2
technologist, order from physician confirmed and exam
protocoled by radiologist.................................
Review examination with interpreting MD.................... 2
Exam documents scanned into PACS. Exam completed in RIS 1
system to generate billing process and to populate images
into Radiologist work queue...............................
------------------------------------------------------------------------
We did not finalize standard minutes for the activity
``Technologist QC's images in PACS, checking for all images, reformats,
and dose page.'' We agreed with commenters that this task may require a
variable length of time depending on the number of images to be
reviewed. We stated that it may be appropriate to establish several
different standard times for this clinical labor task for a low/medium/
high quantity of images to be reviewed, in the same fashion that the
clinical labor assigned to clean a surgical instrument package has two
different standard times depending on the use of a basic pack (10
minutes) or a medium pack (30 minutes). We solicited public comment and
feedback on this subject, with the anticipation of including a proposal
in the CY 2017 proposed rule.
We received many comments suggesting that this clinical labor
activity should not have a standard time value. Commenters stated that
the number of minutes varies significantly for different imaging
modalities; and the time is not simply based on the quantity of images
to be reviewed, but also the complexity of the images. The commenters
recommended that time for this clinical labor activity should be
assigned on a code by code basis. We agree with the commenters that the
amount of clinical labor needed to check images in a PACS workstation
may vary depending on the service. However, we do not believe that this
precludes the possibility of establishing standards for clinical labor
tasks as we have done in the past by creating multiple standard times,
for example, those assigned to cleaning different kinds of scopes. We
continue to believe that the use of clinical labor standards provides
greater consistency among codes that share the same clinical labor
tasks and can improve relativity of values among codes. We are
proposing to establish a range of appropriate standard minutes for the
clinical labor activity Technologist QCs images in PACS, checking for
all images, reformats, and dose page. These standard minutes will be
applied to new and revised codes that make use of this clinical labor
activity when they are reviewed by us for valuation. We are proposing 2
minutes as the standard for the simple case, 3 minutes as the standard
for the intermediate case, and 4 minutes as the standard for the
complex case. We are proposing the simple case of 2 minutes as the
standard for the typical procedure code involving routine use of
imaging. These values are based upon a review of the existing minutes
assigned for this clinical labor activity; we have determined that 2
minutes is the duration for most services and a small number of codes
with more complex forms of digital imaging have higher values. We are
proposing to use 2 minutes for services involving routine x-rays
(simple), 3 minutes for services involving CTs and MRIs (intermediate),
and 4 minutes for the most highly complex services which would exceed
these more typical cases. We are soliciting comments regarding the most
accurate category--simple, intermediate, or complex for existing codes,
and in particular what criteria
[[Page 46176]]
might be used to identify complex cases systematically.
(b) Pathology Clinical Labor Tasks
As with the clinical labor tasks associated with digital imaging,
many of the currently assigned times for the specialized clinical labor
tasks associated with pathology services are not consistent across
codes. In reviewing past RUC recommendations for pathology services, we
have not identified information that supports the judgment that the
same tasks take significantly more or less time depending on the
individual service for which they are performed, especially given the
high degree of specificity with which the tasks are described. We
continue to believe that, in general, a clinical labor task will tend
to take the same amount of time to perform as the same clinical labor
task when it is performed in a clinically similar service.
Therefore, we developed standard times for clinical labor tasks
that we have used in finalizing direct PE inputs in recent years,
starting in the CY 2012 PFS final rule with comment period (76 FR
73213). These times were based on our review and assessment of the
current times included for these clinical labor tasks in the direct PE
input database. We proposed in the CY 2016 PFS proposed rule to
establish standard times for a list of 17 clinical labor tasks related
to pathology services, and solicited public feedback regarding our
proposed standards. Many commenters stated in response to our proposal
that they did not support the standardization of clinical labor
activities across pathology services. Commenters stated that
establishing a single standard time for each clinical labor task was
infeasible due to the differences in batch size or number of blocks
across different pathology procedures. Several commenters indicated
that it might be possible to standardize across codes with the same
batch sizes, and urged us to consider pathology-specific details, such
as batch size and block number, in the creation of any future standard
times for clinical labor tasks related to pathology services.
As we stated in the CY 2016 PFS proposed rule, we developed the
proposed standard times based on our review and assessment of the
current times included for these clinical labor tasks in the direct PE
input database. We believe that, generally speaking, clinical labor
tasks with the same description are comparable across different
pathology procedures. We believe this to be true based on the
comparability of clinical labor tasks in non-pathology services, as
well as the high degree of specificity with which most pathology tasks
are described relative to clinical labor tasks associated with other
PFS services. We concurred with commenters that accurate clinical labor
times for pathology codes may be dependent on the number of blocks or
batch size typically used for each individual service. However, we also
believe that it is appropriate and feasible to establish ``per block''
standards or standards varied by batch size assumptions for many
clinical labor activities that would be comparable across a wide range
of individual services. We have received detailed information regarding
batch size and number of blocks during review of individual pathology
services on an intermittent basis in the past. We requested regular
submission of these details on the PE worksheets supplied by the RUC as
part of the review process for pathology services, as a means to assist
in the determination of the most accurate direct PE inputs.
We also stated our belief that many of the clinical labor
activities for which we proposed to establish standard times were tasks
that do not depend on number of blocks or batch size. Clinical labor
activities such as ``Clean room/equipment following procedure'' and
``Dispose of remaining specimens'' would typically remain standard
across different services without varying by block number or batch
size, with the understanding that additional time may be required above
the standard value for a clinical labor task that is part of an
unusually complex or difficult service. As a result, we ultimately
finalized standard times for 6 of the 17 proposed clinical labor
activities in the CY 2016 final rule with comment period (80 FR 70902).
We have listed the finalized standard times in Table 6. We are
currently proposing no further action on the remaining 11 clinical
labor activities pending further action by the RUC (see below).
Table 6--Standard Times for Clinical Labor Tasks Associated With
Pathology Services
------------------------------------------------------------------------
Standard clinical
Clinical labor task labor time
(minutes)
------------------------------------------------------------------------
Accession specimen/prepare for examination........... 4
Assemble and deliver slides with paperwork to 0.5
pathologists........................................
Assemble other light microscopy slides, open nerve 0.5
biopsy slides, and clinical history, and present to
pathologist to prepare clinical pathologic
interpretation......................................
Clean room/equipment following procedure (including 1
any equipment maintenance that must be done after
the procedure)......................................
Dispose of remaining specimens, spent chemicals/other 1
consumables, and hazardous waste....................
Prepare, pack and transport specimens and records for 1
in-house storage and external storage (where
applicable).........................................
------------------------------------------------------------------------
We remain committed to the process of establishing standard
clinical labor times for tasks associated with pathology services. This
may include establishing standards on a per-block or per-batch basis,
as we indicated during the previous rulemaking cycle. However, we are
aware that the PE Subcommittee of the RUC is currently working to
standardize the pathology clinical labor activities they use in making
their recommendations. We believe the RUC's efforts to narrow the
current list of several hundred pathology clinical labor tasks to a
more manageable number through the consolidation of duplicative or
highly similar activities into a single description may serve PFS
relativity and facilitate greater transparency in PFS ratesetting. We
also believe that the RUC's standardization of pathology clinical labor
tasks would facilitate our capacity to establish standard times for
pathology clinical labor tasks in future rulemaking. Therefore, we are
not proposing any additional change to clinical labor tasks associated
with pathology services at this time.
(3) Equipment Recommendations for Scope Systems
During our routine reviews of direct PE input recommendations, we
have regularly found unexplained inconsistencies involving the use of
scopes and the video systems associated with them. Some of the scopes
include video systems bundled into the
[[Page 46177]]
equipment item, some of them include scope accessories as part of their
price, and some of them are standalone scopes with no other equipment
included. It is not always clear which equipment items related to
scopes fall into which of these categories. We have also frequently
found anomalies in the equipment recommendations, with equipment items
that consist of a scope and video system bundle recommended along with
a separate scope video system. Based on our review, the variations do
not appear to be consistent with the different code descriptions.
To promote appropriate relativity among the services and facilitate
the transparency of our review process, during review of recommended
direct PE inputs for the CY 2017 PFS proposed rule, we developed a
structure that separates the scope and the associated video system as
distinct equipment items for each code. Under this approach, we are
proposing standalone prices for each scope, and separate prices for the
video systems that are used with scopes. We would define the scope
video system as including: (1) A monitor; (2) a processor; (3) a form
of digital capture; (4) a cart; and (5) a printer. We believe that
these equipment components represent the typical case for a scope video
system. Our model for this system is the ``video system, endoscopy
(processor, digital capture, monitor, printer, cart)'' equipment item
(ES031), which we are proposing to re-price as part of this separate
pricing approach. We obtained current pricing invoices for the
endoscopy video system as part of our investigation of these issues
involving scopes, which we are proposing to use for this re-pricing. We
understand that there may be other accessories associated with the use
of scopes; we are proposing to separately price any scope accessories,
and individually evaluate their inclusion or exclusion as direct PE
inputs for particular codes as usual under our current policy based on
whether they are typically used in furnishing the services described by
the particular codes.
We are also proposing standardizing refinements to the way scopes
have been defined in the direct PE input database. We believe that
there are four general types of scopes: Non-video scopes; flexible
scopes; semi-rigid scopes, and rigid scopes. Flexible scopes, semi-
rigid scopes, and rigid scopes would typically be paired with one of
the video scope systems, while the non-video scopes would not. The
flexible scopes can be further divided into diagnostic (or non-
channeled) and therapeutic (or channeled) scopes. We are proposing to
identify for each anatomical application: (1) A rigid scope; (2) a
semi-rigid scope; (3) a non-video flexible scope; (4) a non-channeled
flexible video scope; and (5) a channeled flexible video scope. We are
proposing to classify the existing scopes in our direct PE database
under this classification system, to improve the transparency of our
review process and improve appropriate relativity among the services.
We plan to propose input prices for these equipment items through
future rulemaking.
We have proposed these changes only for the reviewed codes that
make use of scopes; this applies to the codes in the Flexible
Laryngoscopy family (CPT codes 31575, 31576, 31577, 31578, 315X1,
315X2, 315X3, 31579) (see section II.L) and the Laryngoplasty family
(CPT codes 31580, 31584, 31587, 315Y1, 315Y2, 315Y3, 315Y4, 315Y5,
315Y6) (see section II.L) along with updated prices for the equipment
items related to scopes utilized by these services. We are also
soliciting comment on this separate pricing structure for scopes, scope
video systems, and scope accessories, which we could consider proposing
to apply to other PFS codes in future rulemaking.
(4) Technical Corrections to Direct PE Input Database
Subsequent to the publication of the CY 2016 PFS final rule with
comment period, stakeholders alerted us to several clerical
inconsistencies in the direct PE database. We propose to correct these
inconsistencies as described below and reflected in the CY 2017 direct
PE input database displayed on our Web site under downloads for the CY
2017 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
For CY 2017, we are proposing the following technical corrections:
For CPT codes 72081-72084, a stakeholder informed us that
the equipment time for the PACS workstation (ED050) should be equal to
the clinical labor during the service period; the equipment time
formula we used for these codes for CY 2016 erroneously included 4
minutes of preservice clinical labor. We agree with the stakeholder
that the PACS workstation should use the standard equipment time
formula for a PACS workstation for these codes. As a result, we are
proposing to refine the ED050 equipment time to 21 minutes for CPT code
72081, 36 minutes for CPT code 72082, 44 minutes for CPT code 72083,
and 53 minutes for CPT code 72084 to reflect the clinical labor time
associated with these codes. This same commenter also indicated that a
number of clinical labor activities had been entered in the database in
the incorrect service period for CPT codes 37215, 50432, 50694, and
72081. These clinical labor activities were incorrectly listed in the
``postservice'' period instead of the ``service post'' period. We are
proposing to make these technical corrections as well so that the
minutes are assigned to the appropriate service period within the
direct PE input database.
Another stakeholder alerted us that Ileoscopy codes 44380,
44381 and 44382 did not include the direct PE input equipment item
called the Gomco suction machine (EQ235) and indicated that this
omission appeared to be inadvertent. We agree that it was. We have
included the item EQ235 in the proposed direct PE input database for
CPT code 44380 at a time of 29 minutes, for CPT code 44381 at a time of
39 minutes, and to CPT code 44382 at a time of 34 minutes.
The PE RVUs displayed in Addendum B on our Web site were calculated
with the inputs displayed in the CY 2017 direct PE input database.
(5) Restoration of Inputs
Several of the PE worksheets included in the RUC recommendations
for CY 2016 contained time for the equipment item ``xenon light
source'' (EQ167). Because there appeared to be two special light
sources already present (the fiberoptic headlight and the endoscope
itself) in the services for which this equipment item was recommended
by the RUC, we believed that the use of only one of these light sources
would be typical and removed the xenon light equipment time. In the CY
2016 PFS final rule with comment period, we restored the xenon light
(EQ167) and removed the fiberoptic headlight (EQ170) with the same
number of equipment minutes for CPT codes 30300, 31295, 31296, 31297,
and 92511.
We received comments expressing approval for the restoration of the
xenon light. However, the commenters also stated that the two light
sources were not duplicative, but rather, both a headlight and a xenon
light source are required concurrently for otolaryngology procedures
when scopes are utilized. The commenters requested that the fiberoptic
headlight be restored to these codes.
We agree with the commenters that the use of both light sources
would be typical for these procedures. We are therefore proposing to
add the fiberoptic headlight (EQ170) to CPT codes 30300,
[[Page 46178]]
31295, 31296, 31297, and 92511 at the same number of equipment minutes
as the xenon light (EQ167).
(6) Updates to Prices for Existing Direct PE 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. For CY 2017, we are
proposing the following price updates for existing direct PE inputs:
Several commenters wrote to discuss the price of the Antibody
Estrogen Receptor monoclonal (SL493). We received information including
three invoices with new pricing information regarding the SL493 supply.
We are proposing to use this information to propose for the supply item
SL493 a price of $14.00 per test, which is the average price based on
the invoices that we received in total for the item.
We are also proposing to update the price for two supplies in
response to the submission of new invoices. The proposed price for
``antigen, venom'' supply (SH009) reflects an increase from $16.67 to
$20.14 per milliliter, and the proposed price for ``antigen, venom,
tri-vespid'' supply (SH010) reflects an increase from $30.22 to $44.05
per milliliter.
We routinely accept public submission of invoices as part of our
process for developing payment rates for new, revised, and potentially
misvalued codes. Often these invoices are submitted in conjunction with
the RUC recommended values for the codes. For CY 2017, we note that
some stakeholders have submitted invoices for new, revised, or
potentially misvalued codes since the February deadline established for
code valuation recommendations. To be included a given year's proposed
rule, we generally need to receive invoices by the same February
deadline. Of course, we will consider invoices submitted as public
comments during the comment period following the publication of the
proposed rule, and will consider any invoices received after February
and/or outside of the public comment process as part of our established
annual process for requests to update supply and equipment prices.
B. Determination of Malpractice Relative Value Units (RVUs)
1. Overview
Section 1848(c) of the Act requires that each service paid under
the PFS be composed of three components: Work, PE, and malpractice
expense (MP). As required by section 1848(c)(2)(C)(iii) 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. In the CY 2015 PFS final rule with
comment period, we implemented the third review and update of MP RVUs.
For a comprehensive discussion of the third review and update of MP
RVUs see the CY 2015 proposed rule (79 FR 40349 through 40355) and
final rule with comment period (79 FR 67591 through 67596).
To determine MP RVUs for individual PFS services, our MP
methodology uses three primary kinds of data: Specialty-level risk
factors based on the collection of specialty-specific MP premium data
that represent the actual expense incurred by practitioners to obtain
MP insurance; Medicare claims data to determine service level risk
factors based on a weighted average risk factors of the specialties
that furnish each service, and the higher of the work RVU or clinical
labor RVU to adjust the service level risk factor for the intensity and
complexity of the service. Prior to CY 2016, MP RVUs were only updated
once every 5 years, except in the case of new and revised codes.
As explained in the CY 2011 PFS final rule with comment period (75
FR 73208), MP RVUs for new and revised codes effective before the next
5-year review of MP RVUs were determined either by a direct crosswalk
from a similar source code or by a modified crosswalk to account for
differences in work RVUs between the new/revised code and the source
code. For the modified crosswalk approach, we adjust (or scale) the MP
RVU for the new/revised code to reflect the difference in work RVU
between the source code and the new/revised work RVU (or, if greater,
the difference in the clinical labor portion of the fully implemented
PE RVU) for the new code. For example, if the proposed work RVU for a
revised code were 10 percent higher than the work RVU for its source
code, the MP RVU for the revised code would be increased by 10 percent
over the source code MP RVU. Under this approach the same risk factor
is applied for the new/revised code and source code, but the work RVU
for the new/revised code is used to adjust the MP RVUs for risk.
In the CY 2016 PFS final rule with comment period (80 FR 70906
through 70910), we finalized a policy to begin conducting annual MP RVU
updates to reflect changes in the mix of practitioners providing
services (using Medicare claims data), and to adjust MP RVUs for risk
for intensity and complexity (using the work RVU or clinical labor
RVU). We also finalized a policy to modify the specialty mix assignment
methodology (for both MP and PE RVU calculations) to use an average of
the 3 most recent years of data instead of a single year of data. We
stated that under this approach, the specialty-specific risk factors
would continue to be updated through notice and comment rulemaking
every 5 years using updated premium data, but would remain unchanged
between the 5-year reviews.
For CY 2016, we did not propose to discontinue our current approach
for determining MP RVUs for new/revised codes. For the new and revised
codes for which we proposed work RVUs and PE inputs, we also published
the proposed MP crosswalks used to determine their MP RVUs. We address
comments regarding valuation of new and revised codes in section II.L
of this proposed rule, which makes clear the codes with interim final
values for CY 2016 have newly proposed values for CY 2017, all of which
are again open for comment. The MP crosswalks for new and revised codes
with interim final values were established in the CY 2016 PFS final
rule with comment period; we will respond to comments regarding these
interim final values in the CY 2017 PFS final rule.
2. Updating Specialty Specific Risk Factors
The proposed CY 2017 GPCI update (eighth update), discussed in
section II.E of this proposed rule, reflects updated MP premium data,
collected for the purpose of proposing updates to the MP GPCIs. While
we could use the updated MP premium data obtained for the purposes of
the proposed eighth GPCI update to propose updates to the specialty
risk factors used in the calculation of MP RVUs, this would not be
consistent with the policy we previously finalized in the CY 2016 PFS
final rule with comment period. In that rule, we indicated that the
specialty-specific risk factors would continue to be updated through
notice and comment rulemaking every 5 years using updated premium data,
but would remain unchanged between the 5-year reviews. Additionally,
consistent with the statutory requirement at section 1848(e)(1)(C) of
the Act, only \1/2\ of the adjustment to MP GPCIs would be applied for
CY 2017 based on the new
[[Page 46179]]
MP premium data. As such, we do not think it would be appropriate to
propose to update the specialty risk factors for CY 2017 based on the
updated MP premium data that is reflected in the proposed CY 2017 GPCI
update. Therefore, we are not currently proposing to update the
specialty-risk factors based on the new premium data collected for the
purposes of the 3-year GPCI update for CY 2017 at this time. However,
we seek comment on whether we should consider doing so, perhaps as
early as for 2018, prior to the fourth review and update of MP RVUs
that must occur no later than CY 2020.
C. Medicare Telehealth Services
1. Billing and Payment for Telehealth Services
Several conditions must be met for Medicare to make payments for
telehealth services under the PFS. The service must be on the list of
Medicare telehealth services and meet all of the following additional
requirements:
The service must be furnished via an interactive
telecommunications system.
The service must be furnished by a physician or other
authorized practitioner.
The service must be furnished to an eligible telehealth
individual.
The individual receiving the service must be located in a
telehealth originating site.
When all of these conditions are met, Medicare pays a facility fee
to the originating site and makes a 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 stand-alone 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 Sec. 410.78(a)(1),
asynchronous store-and-forward is the transmission of medical
information from an originating site for review by the distant site
physician or practitioner at a later time.
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 is an individual
enrolled under Part B who receives a telehealth service furnished at a
telehealth 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 MACs 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 facility 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 area (MSA).
Historically, we have defined rural HPSAs to be those located
outside of MSAs. Effective January 1, 2014, we modified the regulations
regarding originating sites to define rural HPSAs as those located in
rural census tracts as determined by the Office of Federal Rural Health
Policy (FORHP) 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 https://www.cms.gov/Medicare/Medicare-General-Information/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 status for an originating site would be established and
maintained on an annual basis, consistent with other telehealth payment
policies (78 FR 74400). Geographic status 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
[[Page 46180]]
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 who is present
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. 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 telehealth services, see the CMS Web site at
https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/.
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 2016 will
be considered for the CY 2018 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, requesters 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 https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/.
3. Submitted Requests To Add Services to the List of Telehealth
Services for CY 2017
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 for 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, but also
expedite our ability to identify codes for the telehealth list that
resemble those services already on this list.
We received several requests in CY 2015 to add various services as
Medicare telehealth services effective for CY 2017. The following
presents a discussion of these requests, and our proposals for
additions to the CY 2017 telehealth list. Of the requests received, we
found that four services were sufficiently similar to ESRD-related
services currently on the telehealth list to qualify on a category 1
basis. Therefore, we propose to add the following services to the
telehealth list on a category 1 basis for CY 2017:
CPT codes 90967 (End-stage renal disease (ESRD) related
services for dialysis less than a full month of service, per day; for
patients younger than 2 years of age; 90968 (End-stage renal disease
(ESRD) related services for dialysis less than a full month of service,
per day; for patients 2-11 years of age; 90969 (End-stage renal disease
(ESRD) related services for dialysis less than a full month of service,
per day; for patients 12-19 years of age); and 90970 (End-stage renal
disease (ESRD) related services for dialysis less than a full month of
service, per day; for patients 20 years of age and older).
As we indicated in the CY 2015 final rule (80 FR 41783) for the
ESRD-related services (CPT codes 90963-90966) added to the telehealth
list for CY 2016, the required clinical examination of the catheter
access site must be furnished face-to-face ``hands on'' (without the
use of an interactive telecommunications system) by a physician, CNS,
NP, or PA. This requirement also applies to CPT codes 90967-90970.
While we did not receive a specific request, we also propose to add
two advance care planning services to the telehealth list. We have
determined that these services are similar to the annual wellness
visits (HCPCS codes G0438 & G0439) currently on the telehealth list:
CPT codes 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 care professional; first 30 minutes, face-to-
face with the patient, family member(s), or surrogate); and 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 care
professional; each additional 30 minutes (list separately in addition
to code for primary procedure)).
We also received requests to add services to the telehealth list
that do not meet our criteria for Medicare telehealth services. We are
not proposing to add the following procedures for the reasons noted:
a. Observation Care: CPT codes--
99217 (observation care discharge day management (this
code is to be utilized to report all services provided to a patient on
discharge from ``observation status'' if the discharge is on other than
the initial date of ``observation status.'' To report services to a
patient designated as ``observation status'' or ``inpatient status''
and discharged on the same date, use the codes for observation or
inpatient care services [including admission and discharge services,
99234-99236 as appropriate.]));
99218 (initial observation care, per day, for the
evaluation and management
[[Page 46181]]
of a patient which requires these three key components: A detailed or
comprehensive history; a detailed or comprehensive examination; and
medical decision making that is straightforward or of low complexity.
Counseling and coordination of care with other physicians, other
qualified health care professionals, or agencies are provided
consistent with the nature of the problem(s) and the patient's and
family's needs. Usually, the problem(s) requiring admission to
``observation status'' are of low severity. Typically, 30 minutes are
spent at the bedside and on the patient's hospital floor or unit);
99219 (initial observation care, per day, for the
evaluation and management of a patient, which requires these three key
components: A comprehensive history; a comprehensive examination; and
medical decision making of moderate complexity. Counseling and
coordination of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and family's needs. Usually, the
problem(s) requiring admission to ``observation status'' are of
moderate severity. Typically, 50 minutes are spent at the bedside and
on the patient's hospital floor or unit);
99220 (initial observation care, per day, for the
evaluation and management of a patient, which requires these three key
components: A comprehensive history; a comprehensive examination; and
medical decision making of high complexity. Counseling and coordination
of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and family's needs. Usually, the
problem(s) requiring admission to ``observation status'' are of high
severity. Typically, 70 minutes are spent at the bedside and on the
patient's hospital floor or unit);
99224 (subsequent observation care, per day, for the
evaluation and management of a patient, which requires at least two of
these three key components: Problem focused interval history; problem
focused examination; medical decision making that is straightforward or
of low complexity. Counseling and coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and family's needs. Usually, the patient is stable, recovering, or
improving. Typically, 15 minutes are spent at the bedside and on the
patient's hospital floor or unit);
99225 (subsequent observation care, per day, for the
evaluation and management of a patient, which requires at least two of
these three key components: An expanded problem focused interval
history; an expanded problem focused examination; medical decision
making of moderate complexity. Counseling and coordination of care with
other physicians, other qualified health care professionals, or
agencies are provided consistent with the nature of the problem(s) and
the patient's and family's needs. Usually, the patient is responding
inadequately to therapy or has developed a minor complication.
Typically, 25 minutes are spent at the bedside and on the patient's
hospital floor or unit);
99226 (subsequent observation care, per day, for the
evaluation and management of a patient, which requires at least two of
these three key components: A detailed interval history; a detailed
examination; medical decision making of high complexity. Counseling and
coordination of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and family's needs. Usually, the
patient is unstable or has developed a significant complication or a
significant new problem. Typically, 35 minutes are spent at the bedside
and on the patient's hospital floor or unit);
99234 (observation or inpatient hospital care, for the
evaluation and management of a patient including admission and
discharge on the same date, which requires these three key components:
A detailed or comprehensive history; a detailed or comprehensive
examination; and medical decision making that is straightforward or of
low complexity. Counseling and coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and family's needs. Usually the presenting problem(s) requiring
admission are of low severity. Typically, 40 minutes are spent at the
bedside and on the patient's hospital floor or unit);
99235 (observation or inpatient hospital care, for the
evaluation and management of a patient including admission and
discharge on the same date, which requires these three key components:
A comprehensive history; a comprehensive examination; and medical
decision making of moderate complexity. Counseling and coordination of
care with other physicians, other qualified health care professionals,
or agencies are provided consistent with the nature of the problem(s)
and the patient's and family's needs. Usually the presenting problem(s)
requiring admission are of moderate severity. Typically, 50 minutes are
spent at the bedside and on the patient's hospital floor or unit);
99236 (observation or inpatient hospital care, for the
evaluation and management of a patient including admission and
discharge on the same date, which requires these three key components:
A comprehensive history; a comprehensive examination; and medical
decision making of high complexity. Counseling and coordination of care
with other physicians, other qualified health care professionals, or
agencies are provided consistent with the nature of the problem(s) and
the patient's and family's needs. Usually the presenting problem(s)
requiring admission are of high severity. Typically, 55 minutes are
spent at the bedside and on the patient's hospital floor or unit);
The request to add these observation services referenced various
studies supporting the use of observation units. The studies indicated
that observation units provide safe, cost effective care to patients
that need ongoing evaluation and treatment beyond the emergency
department visit by having reduced hospital admissions, shorter lengths
of stay, increased safety and reduced cost. Additional studies cited
indicated that observation units reduce the work load on emergency
department physicians, and reduce emergency department overcrowding.
In the CY 2005 PFS proposed rule (69 FR 47510), we considered a
request but did not propose to add the observation CPT codes 99217-
99220 to the list of Medicare telehealth services on a category two
basis for the reasons described in that rule. The most recent request
did not include any information that would cause us to question the
previous evaluation under the category one criterion, which has not
changed, regarding the significant differences in patient acuity
between these services and services on the telehealth list. (69 FR
66277) While the request included evidence of the general benefits of
observation units, it did not include specific information
demonstrating that the services described by these codes provided
clinical benefit when furnished via telehealth, which is necessary for
us to consider these codes on a category two basis. Therefore, we are
not proposing to add these services to the list of approved telehealth
services.
[[Page 46182]]
b. Emergency Department Visits: CPT Codes--
99281 (emergency department visit for the evaluation and
management of a patient, which requires these three key components: A
problem focused history; a problem focused examination; and
straightforward medical decision making. Counseling and coordination of
care with other physicians, other qualified health care professionals,
or agencies are provided consistent with the nature of the problem(s)
and the patient's and family's needs. Usually, the presenting
problem(s) are self-limited or minor);
99282 (emergency department visit for the evaluation and
management of a patient, which requires these three key components: An
expanded problem focused history; an expanded problem focused
examination; and medical decision making of low complexity. Counseling
and coordination of care with other physicians, other qualified health
care professionals, or agencies are provided consistent with the nature
of the problem(s) and the patient's and family's needs. Usually, the
presenting problem(s) are of low to moderate severity);
99283 (emergency department visit for the evaluation and
management of a patient, which requires these three key components: An
expanded problem focused history; an expanded problem focused
examination; and medical decision making of moderate complexity.
Counseling and coordination of care with other physicians, other
qualified health care professionals, or agencies are provided
consistent with the nature of the problem(s) and the patient's and
family's needs. Usually, the presenting problem(s) are of moderate
severity);
99284 (emergency department visit for the evaluation and
management of a patient, which requires these three key components: A
detailed history; a detailed examination; and medical decision making
of moderate complexity. Counseling and coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and family's needs. Usually, the presenting problem(s) are of high
severity, and require urgent evaluation by the physician, or other
qualified health care professionals but do not pose an immediate
significant threat to life or physiologic function); and
99285 (emergency department visit for the evaluation and
management of a patient, which requires these three key components
within the constraints imposed by the urgency of the patient's clinical
condition and mental status: A comprehensive history; a comprehensive
examination; and medical decision making of high complexity. Counseling
and coordination of care with other physicians, other qualified health
care professionals, or agencies are provided consistent with the nature
of the problem(s) and the patient's and family's needs. Usually, the
presenting problem(s) are of high severity and pose an immediate
significant threat to life or physiologic function).
In the CY 2005 PFS proposed rule (69 FR 47510), we considered a
request but did not propose to add the emergency department visit CPT
codes 99281-99285 to the list of Medicare telehealth services for the
reasons described in that rule.
The current request to add the emergency department E/M services
stated that the codes are similar to outpatient visit codes (CPT codes
99201-99215) that have been on the telehealth list since CY 2002. As we
noted in the CY 2005 PFS final rule, while the acuity of some patients
in the emergency department might be the same as in a physician's
office; we believe that, in general, more acutely ill patients are more
likely to be seen in the emergency department, and that difference is
part of the reason there are separate codes describing evaluation and
management visits in the Emergency Department setting. The practice of
emergency medicine often requires frequent and fast-paced patient
reassessments, rapid physician interventions, and sometimes the
continuous physician interaction with ancillary staff and consultants.
This work is distinctly different from the pace, intensity, and acuity
associated with visits that occur in the office or outpatient setting.
Therefore, we are not proposing to add these services to the list of
approved telehealth services on a category one basis.
The requester did not provide any studies supporting the clinical
benefit of managing emergency department patients with telehealth which
is necessary for us to consider these codes on a category two basis.
Therefore, we are not proposing to add these services to the list of
approved telehealth services on a category two basis.
Many requesters of additions to the telehealth list urged us to
consider the potential value of telehealth for providing beneficiaries
access to needed expertise. We note that if clinical guidance or advice
is needed in the emergency department setting, a consultation may be
requested from an appropriate source, including consultations that are
currently included on the list of telehealth services.
c. Critical Care Evaluation and Management: CPT Codes--
99291 (critical care, evaluation and management of the
critically ill or critically injured patient; first 30-74 minutes); and
99292 (critical care, evaluation and management of the critically ill
or critically injured patient; each additional 30 minutes (list
separately in addition to code for primary service).
We previously considered and rejected adding these codes to the
list of Medicare telehealth services in the CY 2009 PFS final rule (74
FR 69744) on a category 1 basis because, due to the acuity of
critically ill patients, we did not believe critical care services are
similar to any services on the current list of Medicare telehealth
services. In that rule, we said that critical care services must be
evaluated as category 2 services. Because we considered critical care
services under category 2, we needed to evaluate whether these are
services for which telehealth can be an adequate substitute for a face-
to-face encounter, based on the category 2 criteria at the time of that
request. We had no evidence suggesting that the use of telehealth could
be a reasonable surrogate for the face-to-face delivery of this type of
care.
The American Telemedicine Association (ATA) submitted a new request
for CY 2016 that cited several studies to support adding these services
on a category 2 basis. To qualify under category 2, we would need
evidence that the service furnished via telehealth is still described
accurately by the requested code and produces a clinical benefit for
the patient via telehealth. However, in reviewing the information
provided by the ATA and a study titled, ``Impact of an Intensive Care
Unit Telemedicine Program on Patient Outcomes in an Integrated Health
Care System,'' published July 2014 in JAMA Internal Medicine, which
found no evidence that the implementation of ICU telemedicine
significantly reduced mortality rates or hospital length of stay, which
could be indicators of clinical benefit. Therefore, we stated that we
do not believe that the submitted evidence demonstrates a clinical
benefit to patients. Therefore, we did not propose to add these
services on a category 2 basis to the list of Medicare telehealth
services for CY 2016 (80 FR 71061).
This year, requesters cited additional studies to support adding
critical care
[[Page 46183]]
services on a category 2 basis. Eight of the studies dealt with
telestroke and one with teleneurology. Telestroke is an approach that
allows a neurologist to provide remote treatment to vascular stroke
victims. Teleneurology offers consultations for neurological problems
from a remote location. It may be initiated by a physician or a
patient, for conditions such as headaches, dementia, strokes, multiple
sclerosis and epilepsy.
However, according to the literature, the management of stroke via
telehealth requires more than a single practitioner and is distinct
from the work described by the E/M codes. One additional study cited
involved pediatric patients, while another noted that the Department of
Defense has used telehealth to provide critical care services to
hospitals in Guam for many years. Another reference study indicated
that consulting intensivists thought that telemedicine consultations
were superior to telephone consultations. In all of these cases, we
believe the evidence demonstrates that interaction between these
patients and distant site practitioners can have clinical benefit.
However, we do not agree that the kinds of services described in the
study are those that are included in the critical care E/M codes. We
note that CPT guidance makes clear that a variety of other services are
bundled into the payment rates for critical care, including gastric
intubations and vascular access procedures among others We do not
believe these kinds of services are furnished via telehealth. Public
comments, included cited studies, can be viewed at https://www.regulations.gov/#!documentDetail;D=CMS-2015-0081-0002. Therefore,
we are not proposing to add these services to the list of Medicare
telehealth services for CY 2017.
However, we are persuaded by the requests that we recognize the
potential benefit of critical care consultation services that are
furnished remotely. We note that there are currently codes on the
telehealth list that could be reported when consultation services are
furnished to critically ill patients. But in consideration of these
public requests, we recognize that there may be greater resource costs
involved in furnishing these services relative to the existing
telehealth consultation codes. We also agree with the requesters that
there may be potential benefits of remote care by specialists for these
patients. For these reasons, we think it would be advisable to create a
coding distinction between telehealth consultations for critically ill
patients relative to telehealth consultations for other hospital
patients. Such a coding distinction would allow us to recognize the
additional resource costs in terms of time and intensity involved in
furnishing such services under the conditions where remote, intensive
consultation is required to provide access to appropriate care for the
critically ill patient. We recognize that the current set of codes may
not adequately describe such services because current E/M coding
presumes that the services are occurring in-person, in which case the
expert care would be furnished in a manner described by the current
codes for critical care.
Therefore, we are proposing to make payment through new codes,
initial and subsequent, used to describe critical care consultations
furnished via telehealth. This coding would provide a mechanism to
report an intensive telehealth consultation service, initial or
subsequent, for the critically ill patient under the circumstance when
a qualified health care professional has in-person responsibility for
the patient but the patient benefits from additional services from a
distant-site consultant specially trained in providing critical care
services. We propose limiting these services to once per day per
patient. Like the other telehealth consultations, these services would
be valued relative to existing E/M services (see Section II.L.2.b for
proposed code valuations).
More details on the new coding (GTTT1 and GTTT2) and proposed
valuation for these services are discussed in section II.L. of this
proposed rule and the proposed RVUs for this service are included in
Addendum B of this proposed rule. Like the other telehealth
consultation codes, we are proposing that these services would be added
to the telehealth list and would be subject to the geographic and other
statutory restrictions that apply to telehealth services.
We request comment on this proposal, specifically as to whether the
use of new coding would create a helpful distinction between telehealth
consultations for critically ill patients relative to telehealth
consultations for other hospital patients. We are also specifically
interested in comments on how these services would be distinguished
from existing critical care services and examples of different
scenarios when each code would be appropriate. Such comments will help
us to refine provider communication materials.
d. Psychological Testing: CPT Codes--
96101 (psychological testing (includes psychodiagnostic
assessment of emotionality, intellectual abilities, personality and
psychopathology, e.g., 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, e.g., 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 (e.g., 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 (e.g., 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).
Requesters indicated that there is nothing in the Minnesota
Multiphasic Personality Inventory (MMPI), the Rorschach inkblot test,
the Wechsler Adult Intelligence Scale (WAIS), the Halstead-Reitan
Neuropsychological Battery and Allied Procedures, or the Wisconsin Card
Sorting Test (WCST), that cannot be done via telehealth nor is
different than neurological tests done for Parkinson's disease, seizure
medication side effects, gait assessment, nor any of the many
neurological examinations done via telehealth with the approved
outpatient office visit and inpatient visit CPT codes currently on the
telehealth list. As an example, requesters indicated that the MPPI is
administered by a computer, which generates a report that is
interpreted by the clinical psychologist, and that the test requires no
interaction between the clinician and the patient.
We previously considered the request to add these codes to the
Medicare telehealth list in the CY 2015 final rule (79 FR 67600). We
decided not to add these codes, indicating that these services are not
similar to other services on the telehealth list because they require
close observation of how a patient responds. We noted that the
requesters did not submit evidence supporting the clinical benefit of
furnishing these services via telehealth so that we could evaluate them
on a
[[Page 46184]]
category 2 basis. While we acknowledge that requesters believe that
some of these tests require minimal, if any, interaction between the
clinician and patient, we disagree. We continue to believe that
successful completion of the tests listed as examples in these codes
require the clinical psychologist to closely observe the patient's
response, which cannot be performed via telehealth. Some patient
responses, for example, sweating and fine tremors, may be missed when
the patient and examiner are not in the same room. Therefore, we are
not proposing to add these services to the list of Medicare telehealth
services for CY 2017.
e. Physical and Occupational Therapy and Speech-Language Pathology
Services: CPT Codes--
92507 (treatment of speech, language, voice,
communication, and auditory processing disorder; individual); and,
92508 (treatment of speech, language, voice, communication, and
auditory processing disorder; group, 2 or more individuals); 92521
(evaluation of speech fluency (e.g., stuttering, cluttering)); 92522
(evaluation of speech sound production (e.g., articulation,
phonological process, apraxia, dysarthria)); 92523 (evaluation of
speech sound production (e.g., articulation, phonological process,
apraxia, dysarthria); with evaluation of language comprehension and
expression (e.g., receptive and expressive language)); 92524
(behavioral and qualitative analysis of voice and resonance);
(evaluation of oral and pharyngeal swallowing function); 92526
(treatment of swallowing dysfunction or oral function for feeding);
92610 (evaluation of oral and pharyngeal swallowing function); CPT
codes 97001 (physical therapy evaluation); 97002 (physical therapy re-
evaluation); 97003 (occupational therapy evaluation); 97004
(occupational therapy re-evaluation); 97110 (therapeutic procedure, 1
or more areas, each 15 minutes; therapeutic exercises to develop
strength and endurance, range of motion and flexibility); 97112
(therapeutic procedure, 1 or more areas, each 15 minutes; neuromuscular
reeducation of movement, balance, coordination, kinesthetic sense,
posture, or proprioception for sitting or standing activities); 97116
(therapeutic procedure, 1 or more areas, each 15 minutes; gait training
(includes stair climbing)); 97532 (development of cognitive skills to
improve attention, memory, problem solving (includes compensatory
training), direct (one-on-one) patient contact, each 15 minutes); 97533
(sensory integrative techniques to enhance sensory processing and
promote adaptive responses to environmental demands, direct (one-on-
one) patient contact, each 15 minutes); 97535 (self-care/home
management training (e.g., activities of daily living (adl) and
compensatory training, meal preparation, safety procedures, and
instructions in use of assistive technology devices/adaptive equipment)
direct one-on-one contact, each 15 minutes); 97537 (community/work
reintegration training (e.g., shopping, transportation, money
management, avocational activities or work environment/modification
analysis, work task analysis, use of assistive technology device/
adaptive equipment), direct one-on-one contact, each 15 minutes); 97542
(wheelchair management (e.g., assessment, fitting, training), each 15
minutes); 97750 (physical performance test or measurement (e.g.,
musculoskeletal, functional capacity), with written report, each 15
minutes); 97755 (assistive technology assessment (e.g., to restore,
augment or compensate for existing function, optimize functional tasks
and maximize environmental accessibility), direct one-on-one contact,
with written report, each 15 minutes); 97760 Orthotic(s) management and
training (including assessment and fitting when not otherwise
reported), upper extremity(s), lower extremity(s) and/or trunk, each 15
minutes); 97761 (prosthetic training, upper and lower extremity(s),
each 15 minutes); and 97762 (checkout for orthotic/prosthetic use,
established patient, each 15 minutes).
The statute defines who is an authorized practitioner of telehealth
services. Physical therapists, occupational therapists and speech-
language pathologists are not authorized practitioners of telehealth
under section 1834(m)(4)(E) of the Act, as defined in section
1842(b)(18)(C) of the Act. Because the above services are predominantly
furnished by physical therapists, occupational therapists and speech-
language pathologists, we do not believe it would be appropriate to add
them to the list of telehealth services at this time. One requester
suggested that we can add telehealth practitioners without legislation,
as evidenced by the addition of nutritional professionals. However, we
do not believe we have such authority and note that nutritional
professionals are included as practitioners in the definition at
section 1834(b)(18)(C)(vi) of the Act, and thus, are within the
statutory definition of telehealth practitioners. Therefore, we are not
proposing to add these services to the list of Medicare telehealth
services for CY 2017.
In summary, we propose to add the following codes to the list of
Medicare telehealth services beginning in CY 2017 on a category 1
basis:
ESRD-related services 90967 through 90970. The required
clinical examination of the catheter access site must be furnished
face-to-face ``hands on'' (without the use of an interactive
telecommunications system) by a physician, CNS, NP, or PA.
Advance care planning (CPT codes 99497 and 99498).
Telehealth Consultations for a Patient Requiring Critical
Care Services (GTTT1 and GTTT2)
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
2018, these requests must be submitted and received by December 31,
2016. 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 https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/.
4. Place of Service (POS) Code for Telehealth Services
CMS has received multiple requests from various stakeholders to
establish a POS code to identify services furnished via telehealth.
These requests have come from other payers, but may also be related to
confusion concerning whether to use the POS where the distant site
physician is located or the POS where the patient is located. The
process for establishing POS codes, is managed by the POS Workgroup
within CMS, is available for use by all payers, and is not contingent
upon Medicare PFS rulemaking. However, if such a POS code were to be
created, in order to make it valid for use in Medicare, we would have
to determine the appropriate payment rules associated with the code.
Therefore, we are proposing how a POS code for telehealth would be used
under the PFS with the expectation that, if such a code is available,
it would be used as early as January 1, 2017. We propose that the
physicians or practitioners furnishing telehealth services would be
required to report the telehealth POS code to
[[Page 46185]]
indicate that the billed service is furnished as a telehealth service
from a distant site.
Our proposed requirement for physicians and practitioners to use
the telehealth POS code to report that telehealth services were
furnished from a distant site would improve payment accuracy and
consistency in telehealth claims submission. Currently, for services
furnished via telehealth, we have instructed practitioners to report
the POS code that would have been reported had the service been
furnished in person. However, some practitioners use the POS where they
are located when the service is furnished, while others use the POS
corresponding to the patient's location.
Under the PFS, the POS code determines whether a service is paid
using the facility or non-facility practice expense relative value
units (PE RVUs). The facility rate is paid when a service is furnished
in a location where Medicare is making a separate facility payment to
an entity other than the physician or practitioner that is intended to
reflect the facility costs associated with the service (clinical staff,
supplies and equipment). We note that in accordance with section
1834(m)(2)(B) of the Act, the payment amount for the telehealth
facility fee paid to the originating site is a national fee, paid
without geographic or site of service adjustments that generally are
made for payments to different kinds of Medicare providers and
suppliers. In the case of telehealth services, we believe that facility
costs (clinical staff, supplies, and equipment) associated with the
provision of the service would generally be incurred by the originating
site, where the patient is located, and not by the practitioner at the
distant site. And, by statute, the Medicare pays a fee to the site that
hosts the patient. This is analogous to the circumstances under which
the facility PE RVUs are used to pay for services under the PFS.
Therefore, we are proposing to use the facility PE RVUs to pay for
telehealth services reported by physicians or practitioners with the
telehealth POS code. We note that there are only three codes on the
telehealth list with a difference greater than 1.0 PE RVUs between the
facility PE RVUs and the non-facility PE RVUs. The remainder of the
physician payments for telehealth services would be unchanged by this
proposal. We do not anticipate that this proposal would result in a
significant change in the total payment for the majority of services on
the telehealth list. Moreover, many practitioners already use a
facility POS when billing for telehealth services (those that report
the POS of the originating site where the beneficiary is located). The
proposed policy to use the telehealth POS code for telehealth services
would not affect payment for telehealth services for these
practitioners.
The POS code for telehealth would not apply to originating sites
billing the facility fee. Originating sites are not furnishing a
service via telehealth since the patient is physically present in the
facility. Accordingly, the originating site would continue to use the
POS code that applies to the type of facility where the patient is
located.
We are also proposing a change to our regulation at Sec.
414.22(b)(5)(i)(A) that addresses the PE RVUs used in different
settings. These proposed revisions would improve clarity regarding our
current and proposed policies. Specifically, we are proposing to amend
this section to specify that the facility PE RVUs are paid for
practitioner services furnished via telehealth under Sec. 410.78. In
addition, we are proposing a change to resolve any potential ambiguity
and clarify that payment under the PFS is made at the facility rate
(facility PE RVUs) when services are furnished in a hospital but for
which the hospital is not being paid. Finally, to streamline the
existing regulation, we are also proposing to delete Sec. 414.32 of
our regulation that refers to the calculating of payments for certain
services prior to 2002.
This proposed change is aligned with regulatory changes being
proposed in the ``Medicare Program: Hospital Outpatient Prospective
Payment and Ambulatory Surgical Center Payment Systems and Quality
Reporting Programs; Organ Procurement Organization Reporting and
Communication; Transplant Outcome Measures and Documentation
Requirements; Electronic Health Record (EHR) Incentive Programs;
Payment to Certain Off-Campus Provider-Based Departments'' proposed
rule to implement section 603 of the Bipartisan Budget Act of 2015. In
that proposed rule, we discuss payment rates for services furnished to
patients in off-campus provider-based departments.
D. Potentially Misvalued Services Under the Physician Fee Schedule
1. 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) to 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 II.B. of this proposed rule, 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 System (PQRS) 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 for
our review. 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 and requires us to take into
account the results of consultations with organizations representing
physicians who provide the services. 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 (https://www.medpac.gov/documents/reports/Mar06_EntireReport.pdf?sfvrsn=0), MedPAC discussed
the importance of appropriately valuing physicians' services, noting
that misvalued services can distort the market for physicians'
[[Page 46186]]
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 (https://www.medpac.gov/documents/reports/march-2009-report-to-congress-medicare-payment-policy.pdf?sfvrsn=0), in the intervening years since
MedPAC made the initial recommendations, CMS and the RUC have taken
several steps to improve the review process. Also, section
1848(c)(2)(K)(ii) of the Act augments our efforts by directing the
Secretary to specifically examine, as determined appropriate,
potentially misvalued services in the following categories:
Codes that have experienced the fastest growth.
Codes that have experienced substantial changes in
practice expenses.
Codes that describe new technologies or services within an
appropriate time period (such as 3 years) after the relative values are
initially established for such codes.
Codes which are 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 that have not been subject to review since
implementation of the fee schedule.
Codes that account for the majority of spending under the
physician fee schedule.
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 practice expense relative value units.
Codes with high cost supplies.
Codes as determined appropriate by the Secretary.
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 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.
2. 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 in these areas over the upcoming
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 1,671
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 PFS 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 PFS 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 (76 FR 32410), we
requested recommendations from the RUC to aid in our review of Harvard-
valued codes with annual utilization of greater than 30,000. In the CY
2013 PFS final rule with comment period, we identified specific
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 PFS 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 2016 PFS final rule with comment period, we finalized for
review a list of potentially misvalued services, which included eight
codes in the neurostimulators analysis-programming family (CPT 95970-
95982). We also finalized as potentially misvalued 103 codes identified
through
[[Page 46187]]
our screen of high expenditure services across specialties.
3. 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 to be 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. A summary of the comments along with our
responses are included in the CY 2011 PFS final rule with comment
period (75 FR 73217) and the CY 2012 PFS final rule with comment period
(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 develop
empirical time estimates based on data collected from several health
systems with multispecialty group practices. The Urban Institute
collected data by directly observing the delivery of services and
through the use of electronic health records for services selected by
the contractor in consultation with CMS and is using this data to
produce objective time estimates. We expect the final Urban Institute
report will be made available on the CMS Web site later this summer.
The second contract is with the RAND Corporation, which used
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 consulted with a
technical expert panel on model design issues and the test results. The
RAND report is available under downloads on the Web site 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-Items/CMS-1612-FC.html.
After posting RAND's report on the models and results on our Web
site, we received comments indicating that the models did not
adequately address global surgery services due to the lack of available
data on included visits. Therefore, we modified the RAND contract to
include the development of G-codes that could be used to collect data
about post-surgical follow-up visits on Medicare claims to meet the
requirements in section 1848(c)(8)(B) of the Act regarding collection
of data on global services. Our proposals related to this data
collection requirement are discussed in section II.D.6. Also, the data
from this project would provide information that would allow the time
for these services to be included in the model for validating RVUs.
4. CY 2017 Identification and Review of Potentially Misvalued Services
a. 0-day Global Services That Are Typically Billed With an Evaluation
and Management (E/M) Service With Modifier 25
Because routine E/M is included in the valuation of codes with 0-,
10-, and 90-day global periods, Medicare only makes separate payment
for E/M services that are provided in excess of those considered
included in the global procedure. In such cases, the physician would
report the additional E/M service with Modifier 25, which is defined as
a significant, separately identifiable E/M service performed by the
same physician on the day of a procedure above and beyond other
services provided or beyond the usual preservice and postservice care
associated with the procedure that was performed. Modifier 25 allows
physicians to be paid for E/M services that would otherwise be denied
as bundled.
In reviewing misvalued codes, both CMS and the RUC have often
considered how frequently particular codes are reported with E/M codes
to account for potential overlap in resources. Some stakeholders have
expressed concern with this policy especially with regard to the
valuation of 0-day global services that are typically billed with a
separate E/M service with the use of Modifier 25. For example, when we
established our valuation of the osteopathic manipulation services,
described by CPT codes 98925-98929, we did so with the understanding
that these codes are usually reported with E/M codes.
Medicare claims data for CY 2015 show that 19 percent of the codes
that describe 0-day global services were billed over 50 percent of the
time with an E/M with Modifier 25. Since routine E/M is included in the
valuation of 0-day global services, we believe that the routine billing
of separate E/M services may indicate a possible problem with the
valuation of the bundle, which is intended to include all the routine
care associated with the service.
We believe that reviewing the procedure codes typically billed with
an E/M with Modifier 25 as potentially misvalued may be one avenue to
improve valuation of these services. To develop the CY 2017 proposed
list of potentially misvalued services in this category, we identified
0-day global codes billed with an E/M 50 percent of the time or more,
on the same day of service, with the same physician and same
beneficiary. To prioritize review of these potentially misvalued
services, we are identifying the codes that have not been reviewed in
the last 5 years, and with greater than 20,000 allowed services. Table
7 lists the 83 codes that meet these review criteria and we are
proposing these as potentially misvalued for CY 2017. We request public
input on additional ways to address appropriate valuations for all
services that are typically billed with an E/M with Modifier 25.
[[Page 46188]]
Table 7--0-Day Global Services That Are Typically Billed With an
Evaluation and Management (E/M) Service With Modifier 25
------------------------------------------------------------------------
HCPCS Long descriptor
------------------------------------------------------------------------
11000............................ Removal of inflamed or infected skin,
up to 10% of body surface.
11100............................ Biopsy of single growth of skin or
tissue.
11300............................ Shaving of 0.5 centimeters or less
skin growth of the trunk, arms, or
legs.
11301............................ Shaving of 0.6 centimeters to 1.0
centimeters skin growth of the
trunk, arms, or legs.
11302............................ Shaving of 1.1 to 2.0 centimeters
skin growth of the trunk, arms, or
legs.
11305............................ Shaving of 0.5 centimeters or less
skin growth of scalp, neck, hands,
feet, or genitals.
11306............................ Shaving of 0.6 centimeters to 1.0
centimeters skin growth of scalp,
neck, hands, feet, or genitals.
11307............................ Shaving of 1.1 to 2.0 centimeters
skin growth of scalp, neck, hands,
feet, or genitals.
11310............................ Shaving of 0.5 centimeters or less
skin growth of face, ears, eyelids,
nose, lips, or mouth.
11311............................ Shaving of 0.6 centimeters to 1.0
centimeters skin growth of face,
ears, eyelids, nose, lips, or mouth.
11312............................ Shaving of 1.1 to 2.0 centimeters
skin growth of face, ears, eyelids,
nose, lips, or mouth.
11740............................ Removal of blood accumulation between
nail and nail bed.
11755............................ Biopsy of finger or toe nail.
11900............................ Injection of up to 7 skin growths.
11901............................ Injection of more than 7 skin
growths.
12001............................ Repair of wound (2.5 centimeters or
less) of the scalp, neck, underarms,
trunk, arms or legs.
12002............................ Repair of wound (2.6 to 7.5
centimeters) of the scalp, neck,
underarms, genitals, trunk, arms or
legs.
12004............................ Repair of wound (7.6 to 12.5
centimeters) of the scalp, neck,
underarms, genitals, trunk, arms or
legs.
12011............................ Repair of wound (2.5 centimeters or
less) of the face, ears, eyelids,
nose, lips, or mucous membranes.
12013............................ Repair of wound (2.6 to 5.0
centimeters) of the face, ears,
eyelids, nose, lips, or mucous
membranes.
17250............................ Application of chemical agent to
excessive wound tissue.
20526............................ Injection of carpal tunnel.
20550............................ Injections of tendon sheath,
ligament, or muscle membrane.
20551............................ Injections of tendon attachment to
bone.
20552............................ Injections of trigger points in 1 or
2 muscles.
20553............................ Injections of trigger points in 3 or
more muscles.
20600............................ Aspiration or injection of small
joint or joint capsule.
20604............................ Arthrocentesis, aspiration or
injection, small joint or bursa
(e.g., fingers, toes); with
ultrasound guidance, with permanent
recording and reporting.
20605............................ Aspiration or injection of medium
joint or joint capsule.
20606............................ Arthrocentesis, aspiration or
injection, intermediate joint or
bursa (e.g., temporomandibular,
acromioclavicular, wrist, elbow or
ankle, olecranon bursa); with
ultrasound guidance, with permanent
recording and reporting.
20610............................ Aspiration or injection of large
joint or joint capsule.
20611............................ Arthrocentesis, aspiration or
injection, major joint or bursa
(e.g., shoulder, hip, knee,
subacromial bursa); with ultrasound
guidance, with permanent recording
and reporting.
20612............................ Aspiration or injection of cysts.
29105............................ Application of long arm splint
(shoulder to hand).
29125............................ Application of non-moveable, short
arm splint (forearm to hand).
29515............................ Application of short leg splint (calf
to foot).
29540............................ Strapping of ankle or foot.
29550............................ Strapping of toes.
30901............................ Simple control of nose bleed.
30903............................ Complex control of nose bleed.
31231............................ Diagnostic examination of nasal
passages using an endoscope.
31238............................ Control of nasal bleeding using an
endoscope.
31500............................ Emergent insertion of breathing tube
into windpipe cartilage using an
endoscope.
31575............................ Diagnostic examination of voice box
using flexible endoscope.
31579............................ Examination to assess movement of
vocal cord flaps using an endoscope.
31645............................ Aspiration of lung secretions from
lung airways using an endoscope.
32551............................ Removal of fluid from between lung
and chest cavity, open procedure.
32554............................ Removal of fluid from chest cavity.
40490............................ Biopsy of lip.
43760............................ Change of stomach feeding, accessed
through the skin.
45300............................ Diagnostic examination of rectum and
large bowel using an endoscope.
46600............................ Diagnostic examination of the anus
using an endoscope.
51701............................ Insertion of temporary bladder
catheter.
51702............................ Insertion of indwelling bladder
catheter.
51703............................ Insertion of indwelling bladder
catheter.
56605............................ Biopsy of external female genitals.
57150............................ Irrigation of vagina or application
of drug to treat infection.
57160............................ Fitting and insertion of vaginal
support device.
58100............................ Biopsy of uterine lining.
64405............................ Injection of anesthetic agent,
greater occipital nerve.
64418............................ Injection of anesthetic agent, collar
bone nerve.
64455............................ Injections of anesthetic or steroid
drug into nerve of foot.
65205............................ Removal of foreign body in external
eye, conjunctiva.
65210............................ Removal of foreign body in external
eye, conjunctiva or sclera.
65222............................ Removal of foreign body, external
eye, cornea with slit lamp
examination.
67515............................ Injection of medication or substance
into membrane covering eyeball.
67810............................ Biopsy of eyelid.
67820............................ Removal of eyelashes by forceps.
[[Page 46189]]
68200............................ Injection into conjunctiva.
69100............................ Biopsy of ear.
69200............................ Removal of foreign body from ear
canal.
69210............................ Removal of impact ear wax, one ear.
69220............................ Removal of skin debris and drainage
of mastoid cavity.
92511............................ Examination of the nose and throat
using an endoscope.
92941............................ Insertion of stent, removal of plaque
or balloon dilation of coronary
vessel during heart attack, accessed
through the skin.
92950............................ Attempt to restart heart and lungs.
98925............................ Osteopathic manipulative treatment to
1-2 body regions.
98926............................ Osteopathic manipulative treatment to
3-4 body regions.
98927............................ Osteopathic manipulative treatment to
5-6 body regions.
98928............................ Osteopathic manipulative treatment to
7-8 body regions.
98929............................ Osteopathic manipulative treatment to
9-10 body regions.
G0168............................ Wound closure utilizing tissue
adhesive(s) only.
G0268............................ Removal of impacted cerumen (one or
both ears) by physician on same date
of service as audiologic function
testing.
------------------------------------------------------------------------
b. End-Stage Renal Disease Home Dialysis Services (CPT Codes 90963
Through 90970)
In the CY 2004 PFS final rule with comment period (68 FR 63216), we
established new Level II HCPCS G-codes for end-stage renal disease
(ESRD) services and established payment for those codes through monthly
capitation payment (MCP) rates. For ESRD center-based patients, payment
for the G-codes varied based on the age of the beneficiary and the
number of face-to-face visits furnished each month (for example, 1
visit, 2-3 visits and 4 or more visits). We believed that many
physicians would provide 4 or more visits to center-based ESRD patients
and a small proportion will provide 2-3 visits or only one visit per
month. Under the MCP methodology, to receive the highest payment, a
physician would have to provide at least four ESRD-related visits per
month. However, payment for home dialysis MCP services only varied by
the age of beneficiary. Although we did not initially specify a
frequency of required visits for home dialysis MCP services, we stated
that we expect physicians to provide clinically appropriate care to
manage the home dialysis patient.
The CPT Editorial Panel created new CPT codes to replace the G-
codes for monthly ESRD-related services, and we accepted the new codes
for use under the PFS in CY 2009. The CPT codes created were 90963-
90966 for monthly ESRD-related services for home dialysis patient and
CPT codes 90967-90970 for dialysis with less than a full month of
services.
In a GAO report titled ``END-STAGE RENAL DISEASE Medicare Payment
Refinements Could Promote Increased Use of Home Dialysis'' dated
October 2015, https://www.gao.gov/products/GAO-16-125, the GAO stated
that experts and stakeholders they interviewed indicated that home
dialysis could be clinically appropriate for at least half of patients.
Also, at a meeting in 2013, the chief medical officers of 14 dialysis
facility chains jointly estimated that a realistic target for home
dialysis would be 25 percent of dialysis patients. The GAO noted that
CMS data showed that about 10 percent of adult Medicare dialysis
patients use home dialysis as of March 2015.
In the report, the GAO noted that CMS intended for the existing
payment structure to create an incentive for physicians to prescribe
home dialysis, because the monthly payment rate for managing the
dialysis care of home patients, which requires a single in-person
visit, was approximately equal to the rate for managing and providing
two to three visits to ESRD center-based patients. However, GAO found
that, in 2013, the rate of $237 for managing home patients was lower
than the average payment of $266 and maximum payment of $282 for
managing ESRD center-based patients. The GAO stated that this
difference in payment rates may discourage physicians from prescribing
home dialysis.
Physician associations and other physicians GAO interviewed stated
that the visits with home patients are often longer and more
comprehensive than in-center visits; this is in part because physicians
may conduct visits with individual home patients in a private setting,
but they may be able to more easily visit multiple in-center patients
on a single day as they receive dialysis. The physician associations
GAO interviewed also said that they may spend a similar amount of time
outside of visits to manage the care of home patients and that they are
required to provide at least one visit per month to perform a complete
assessment of the patient.
It is important to note that, as stated in the CY 2011 PFS final
rule with comment period (75 FR 73296), we believe that furnishing
monthly face-to-face visits is an important component of high quality
medical care for ESRD patients being dialyzed at home and generally
would be consistent with the current standards of medical practice.
However, we also acknowledged that extenuating circumstances may arise
that make it difficult for the MCP physician (or NPP) to furnish a
visit to a home dialysis patient every month. Therefore, we allow
Medicare contractors the discretion to waive the requirement for a
monthly face-to-face visit for the home dialysis MCP service on a case-
by-case basis, for example, when the MCP physician's (or NPP's) notes
indicate that the MCP physician (or NPP) actively and adequately
managed the care of the home dialysis patient throughout the month.
The GAO recommended, and we agreed, that CMS examine Medicare
policies for monthly payments to physicians to manage the care of
dialysis patients and revise them if necessary to ensure that these
policies are consistent with our goal of encouraging the use of home
dialysis among patients for whom it is appropriate. Therefore, we are
proposing to identify CPT codes 90963 through 90970 as potentially
misvalued codes based on the volume of claims submitted for these
services relative to those submitted for facility ESRD services.
[[Page 46190]]
c. Direct PE Input Discrepancies
i. Appropriate Direct PE Inputs Involved in Procedures Involving
Endoscopes
Stakeholders have raised concerns about potential inconsistencies
with the inputs and the prices related to endoscopic procedures in the
direct PE database. Upon review, we noted that there are 45 different
pieces of endoscope related-equipment and 25 different pieces of
endoscope related-supplies that are currently associated with these
services. Relative to other kinds of equipment items in the direct PE
input, these items are much more varied and used for many fewer
services. Given the frequency with which individual codes can be
reviewed and the importance of standardizing inputs for purposes of
maintaining relativity across PFS services, we believe that this
unusual degree of variation is likely to result in code misvaluation.
To facilitate efficient review of this particular kind of misvaluation,
and because we believe that stakeholders will prefer the opportunity to
contribute to such standardization, we request that stakeholders like
the RUC review and make recommendations on the appropriate endoscopic
equipment and supplies typically provided in all endoscopic procedures
for each anatomical body region, along with their appropriate prices.
ii. Appropriate Direct PE Inputs in the Facility Post-Service Period
When Post-Operative Visits Are Excluded
We identified a potential inconsistency in instances where there
are direct PE inputs included in the facility postservice period even
though post-operative visit is not included in a service. We identified
13 codes that are affected by this issue and we are unclear if the
discrepancy is caused by inaccurate direct PE inputs or inaccurate
post-operative data in the work time file. We request that stakeholders
including the RUC review these discrepancies and provide their
recommendations on the appropriate direct PE inputs for the codes
listed in Table 8.
Table 8--Codes That Have Direct PE Inputs in the Facility Postservice
Period When Post-Operative Visits Are Excluded
------------------------------------------------------------------------
CPT Code Long descriptor
------------------------------------------------------------------------
21077............................. Impression and preparation of eye
socket prosthesis.
21079............................. Impression and custom preparation of
temporary oral prosthesis.
21080............................. Impression and custom preparation of
permanent oral prosthesis.
21081............................. Impression and custom preparation of
lower jaw bone prosthesis.
21082............................. Impression and custom preparation of
prosthesis for roof of mouth
enlargement.
21083............................. Impression and custom preparation of
roof of mouth prosthesis.
21084............................. Impression and custom preparation of
speech aid prosthesis.
28636............................. Insertion of hardware to foot bone
dislocation with manipulation,
accessed through the skin.
28666............................. Insertion of hardware to toe joint
dislocation with manipulation,
accessed through the skin.
43652............................. Incision of vagus nerves of stomach
using an endoscope.
46900............................. Chemical destruction of anal
growths.
47570............................. Connection of gall bladder to bowel
using an endoscope.
66986............................. Exchange of lens prosthesis.
------------------------------------------------------------------------
d. Insertion and Removal of Drug Delivery Implants--CPT Codes 11981 and
11983
Stakeholders have urged CMS to create new coding describing the
insertion and removal of drug delivery implants for buprenorphine
hydrochloride, formulated as a 4 rod, 80 mg, long acting subdermal drug
implant for the treatment of opioid addiction. These stakeholders have
suggested that current coding that describes insertion and removal of
drug delivery implants is too broad and that new coding is needed to
account for specific additional resource costs associated with
particular treatment. We are identifying existing CPT codes 11981
(Insertion, non-biodegradable drug delivery implant), 11982 (Removal,
non-biodegradable drug delivery implant), and 11983 (Removal with
reinsertion, non-biodegradable drug delivery implant) as potentially
misvalued codes and are seeking comment and information regarding
whether the current resource inputs in work and practice expense for
these codes appropriately account for variations in the service
relative to which devices and related drugs are inserted and removed.
5. Valuing Services That Include Moderate Sedation as an Inherent Part
of Furnishing the Procedure
The CPT manual identifies more than 400 diagnostic and therapeutic
procedures (listed in Appendix G) for which the CPT Editorial Committee
has determined that moderate sedation is an inherent part of furnishing
the procedure. In developing RVUs for these services, we include the
resource costs associated with moderate sedation in the valuation since
the CPT codes include moderate sedation as an inherent part of the
procedure. Therefore, only the procedure code is currently reported
when furnishing the service. Endoscopic procedures constitute a
significant portion of the services identified in Appendix G. In the CY
2015 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,
meaning that the resource costs associated with sedation were no longer
incurred by the practitioner reporting the Appendix G procedure. We
indicated that, in order to reflect apparent changes in medical
practice, we were considering establishing a uniform approach to the
appropriate valuation of all Appendix G services for which moderate
sedation is no longer inherent, rather than addressing the issue at the
procedure level as individual codes are revalued. We solicited public
comment on approaches to the appropriate valuation of these services.
In the CY 2016 PFS proposed rule (80 FR 41707), we again solicited
public comment and recommendations on approaches to address the
appropriate valuation of moderate sedation related to Appendix G
services. In response to our comment solicitation, the CPT Editorial
Panel created CPT codes for separately reporting moderate sedation
services in association with the elimination of Appendix G from the CPT
Manual for CY 2017. This coding change would provide for payment for
[[Page 46191]]
moderate sedation services only in cases where it is furnished. In
addition to providing recommended values for the new codes used to
separately report moderate sedation, the RUC has also provided a
methodology for revaluing all services previously identified in
Appendix G, without moderate sedation, in order to make appropriate
corresponding adjustments for the procedural services. The RUC
recommended this methodology to address moderate sedation valuation
generally instead of recommending that it be addressed as individual
codes are reviewed. The RUC's recommended methodology would remove work
RVUs for moderate sedation from Appendix G codes based on a code-level
assessment of whether the procedures are typically performed on
straightforward patients or more difficult patients. Based on its
recommended methodology, the RUC is recommending removal of fewer RVUs
from each of the procedural services than it recommends for valuing the
moderate sedation services. If we were to use the RUC-recommended
values for both the moderate sedation codes and the Appendix G
procedural codes without refinement, overall payments for these
procedures, when moderate sedation is furnished, would increase
relative to the current payment.
We direct readers to section II.L. of this proposed rule, which
includes more details regarding our proposed valuation of the new
moderate sedation codes and our proposed uniform methodology for
revaluation of the procedural codes previously identified in Appendix
G. We believe that the RVUs assigned under the PFS should reflect the
overall resource costs of PFS services, regardless of how many codes
are used to report the services. Therefore, our proposed methodology
for valuation of Appendix G procedural services would maintain current
resource assumptions for the procedures when furnished with moderate
sedation and redistribute the RVUs associated with moderate sedation
(previously included in Appendix G procedural codes) to other PFS
services. We believe that our proposed uniform methodology for
revaluation of Appendix G services without moderate sedation is
consistent with our general principle that the overall resource costs
for the procedures do not change based solely on changes in coding.
We also note that stakeholders presented information to CMS
regarding specialty group survey data for physician work. The
stakeholders shared survey results for physician work involved in
furnishing moderate sedation that demonstrated a significant bimodal
distribution between procedural services furnished by
gastroenterologists (GI) and procedural services furnished by other
specialties. Since we believe that gastroenterologists furnish the
highest volume of services previously identified in Appendix G, and
services primarily furnished by gastroenterologists prompted the
concerns that led to our identification of changes in medical practice
and potentially duplicative payment for these codes, we have addressed
the variations between the GI and other specialties in our review of
the new moderate sedation CPT codes and their recommended values. We
again direct readers to section II.L. of this proposed rule where we
discuss our proposal to augment the new CPT codes for moderate sedation
with an endoscopy-specific moderate sedation code, as well as proposed
valuations reflecting the differences in the physician survey data
between GI and other specialties.
6. Collecting Data on Resources Used in Furnishing Global Services
a. Background
(1) Current Payment Policy for Global Packages
Under the PFS, certain services, such as surgery, are valued and
paid for as part of global packages that include the procedure and the
services typically furnished in the periods immediately before and
after the procedure. For each of these global packages, 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 packages
include the surgical procedure and the pre-operative and post-operative
services furnished by the physician on the day of the service. The 10-
day global packages include these services and, in addition, visits
related to the procedure during the 10 days following the day of the
procedure. The 90-day global packages 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 Chapter
12 of the Claims Processing Manual (Pub. 100-04) defines the global
surgical package to include the following services related to the
surgery when furnished during the global period by the same physician
or another practitioner in the same group practice:
Pre-operative Visits: Pre-operative 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 post-operative
period of the surgery because of complications that do not require
additional trips to the operating room;
Post-operative Visits: Follow-up visits during the post-
operative period of the surgery that are related to recovery from the
surgery;
Post-surgical 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.
In the CY 2015 PFS proposed and final rules we extensively
discussed the problems with accurate valuation of 10-and 90-day global
packages. Our concerns included the fact that we do not use actual data
on services furnished in order to update the rates, questions regarding
the accuracy of our current assumptions about typical services, whether
we will be able to adjust values on a regular basis to reflect changes
in the practice of medicine and health care delivery, and how our
global payment policies affect what services are actually furnished (79
FR 67582 through 67585). In finalizing a policy to transform all 10-day
and 90-day global codes to 0-day global codes in CY 2017 and CY 2018,
respectively, to improve the accuracy of valuation and payment for the
various components of global packages, including pre- and post-
operative visits and the procedure itself, we stated that we were
adopting this policy because we believe it is critical that PFS payment
rates be based upon RVUs that reflect the resource costs of furnishing
the services. We also stated our belief that transforming all 10- and
90-day global codes to 0-day global packages would:
[[Page 46192]]
Increase the accuracy of PFS payment by setting payment
rates for individual services that more closely reflect the typical
resources used in furnishing the procedures;
Avoid potentially duplicative or unwarranted payments when
a beneficiary receives post-operative care 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 packages; and
Facilitate the availability of more accurate data for new
payment models and quality research.
(2) Data Collection and Revaluation of Global Packages Required by
MACRA
Section 523(a) of the Medicare Access and CHIP Reauthorization Act
of 2015 (MACRA) (Pub. L. 114-10, enacted April 16, 2015) prohibits the
Secretary from implementing the policy, described above, that would
have transformed all 10-day and 90-day global surgery packages to 0-day
global packages.
Section 1848(c)(8)(B) of the Act, which was also added by section
523(a) of the MACRA, requires us to collect data to value surgical
services. Section 1848(c)(8)(B)(i) of the Act requires us to develop,
through rulemaking, a process to gather information needed to value
surgical services from a representative sample of physicians, and
requires that the data collection begin no later than January 1, 2017.
The collected information must include the number and level of medical
visits furnished during the global period and other items and services
related to the surgery and furnished during the global period, as
appropriate. This information must be reported on claims at the end of
the global period or in another manner specified by the Secretary.
Section 1848(c)(8)(B)(ii) of the Act requires that, every 4 years, we
reassess the value of this collected information; and allows us to
discontinue the collection of this information if the Secretary
determines that we have adequate information from other sources to
accurately value global surgical services. Section 1848(c)(8)(B)(iii)
of the Act specifies that the Inspector General shall audit a sample of
the collected information to verify its accuracy. Section 1848(c)(9) of
the Act (added by section 523(b) of the MACRA) authorizes the
Secretary, through rulemaking, to delay up to 5 percent of the PFS
payment for services for which a physician is required to report
information under section 1848(c)(8)(B)(i) of the Act until the
required information is reported.
Section 1848(c)(8)(C) of the Act, which was also added by section
523(a) of the MACRA, requires that, beginning in CY 2019, we must use
the information collected as appropriate, along with other available
data, to improve the accuracy of valuation of surgical services under
the PFS.
(3) Public Input
As noted above, section 1848(c)(8)(C) of the Act mandates that we
use the collected data to improve the accuracy of valuation of surgery
services beginning in 2019. We described in the CY 2015 PFS final rule
(79 FR 67582 through 67591) the limitations and difficulties involved
in the appropriate valuation of the global packages, especially when
the resources and the related values assigned to the component services
are not defined. To gain input from stakeholders on implementation of
this data collection, we sought comment on various aspects of this task
in the CY 2016 proposed rule (80 FR 41707 through 41708). We solicited
comments from the public regarding the kinds of auditable, objective
data (including the number and type of visits and other services
furnished during the post-operative period by the practitioner
furnishing the procedure) needed to increase the accuracy of the values
for surgical services. We also solicited comment on the most efficient
means of acquiring these data as accurately and efficiently as
possible. For example, we sought information on the extent to which
individual practitioners or practices may currently maintain their own
data on services, including those furnished during the post-operative
period, and how we might collect and objectively evaluate those data
for use in increasing the accuracy of the values beginning in CY 2019.
We received many comments regarding potential methods of valuing
the individual components of the global surgical package. A large
number of comments expressed strong support for our proposal to hold an
open door forum or town hall meetings with the public. Toward this end,
we held a national listening session on January 20, 2016. Prior to the
listening session, the topics for which guidance was being sought were
sent electronically to those who registered for the session and made
available on our Web site. The topics were:
Mechanisms for capturing the types of services typically
furnished during the global period.
Determining the representative sample for the claims-based
data collection.
Determining whether we should collect data on all surgical
services or, if not, which services should be sampled.
Potential for designing data collection elements to
interface with existing infrastructure used to track follow-up visits
within the global period.
Consideration of use of 5 percent withhold until required
information is furnished.
The 658 participants in the national listening session provided
valuable information on this task. A written transcript and an audio
recording of this session are available at https://www.cms.gov/Outreach-and-Education/Outreach/NPC/National-Provider-Calls-and-Events-Items/2016-01-20-MACRA.html.
We considered both the comments submitted on the CY 2016 PFS
proposed rule and the input provided at the listening session as we
developed this proposal for data collection. When relevant, we discuss
this stakeholder input below without distinguishing between comments on
the proposed rule and input provided at the national listening session.
b. Data Collection Required To Accurately Value Global Packages
Resource-based valuation of individual physicians' services is a
critical foundation for Medicare payment to physicians. It is essential
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 make appropriate payment and
preserve relativity among services. For global surgical packages, this
requires using objective data on all of the resources used to furnish
the services that are included in the package. Not having such data for
some components may significantly skew relativity and create
unwarranted payment disparities within the PFS.
The current valuations for many services valued as global packages
are based upon the total package as a unit rather than by determining
the resources used in furnishing the procedure and each additional
service/visit and summing the results. As a result, we do not have the
same level of information about the components of global packages as we
do for other services. To value global packages accurately and
[[Page 46193]]
relative to other procedures, we need accurate information about the
resources--work, PEs and malpractice--used in furnishing the procedure,
similar to what is used to determine RVUs for all services. In addition
we need the same information on the post-operative services furnished
in the global period (and pre-operative services the day before for 90-
day global packages). Public comments about our proposal to value all
global services as 0-day global services and pay separately for
additional post-operative services when furnished indicated that there
were no reliable data available on the value of the underlying
procedure that did not also incorporate the value of the post-operative
services, reinforcing our view that more data are needed across the
board.
While we believe that most of the services furnished in the global
period are visits for follow-up care, we do not have accurate
information on the number and level of visits typically furnished
because those billing for global services are not required to submit
claims for post-operative visits. A May 2012 Office of Inspector
General (OIG) report, entitled Cardiovascular Global Surgery Fees Often
Did Not Reflect the Number of Evaluation and Management Services
Provided (https://oig.hhs.gov/oas/reports/region5/50900054.pdf) found
that for 202 of the 300 sampled cardiovascular global surgeries, the
Medicare payment rates were based on a number of visits that did not
reflect the actual number of services provided. Specifically,
physicians provided fewer services than the visits included in the
payment calculation for 132 global surgery services and provided more
services than were included in the payment calculations for 70
services. Similar results were found in OIG reports entitled
``Musculoskeletal Global Surgery Fees Often Did Not Reflect The Number
Of Evaluation And Management Services Provided'' (https://oig.hhs.gov/oas/reports/region5/50900053.asp) and ``Review of Cataract Global
Surgeries and Related Evaluation and Management Services, Wisconsin
Physicians Service Insurance Corporation Calendar Year 2003, March
2007'' (https://oig.hhs.gov/oas/reports/region5/50600040.pdf).
Claims data plays a major role in PFS rate-setting. Specifically,
Medicare claims data is a primary driver in the allocation of indirect
PE RVUs and MP RVUs across the codes used by particular specialties,
and in making overall budget neutrality and relativity adjustments. In
most cases, a claim must be filed for all visits. Such claims provide
information such as the place of service, the type and, if relevant,
the level of the service, the date of the service, and the specialty of
the practitioner furnishing the services. Because we have not required
claims reporting of visits included in global surgical packages, we do
not have any of this information for the services bundled in the
package.
In addition to the lack of information about the number and level
of visits actually furnished, the current global valuations rely on
crosswalks to E/M visits, based upon the assumption that the resources,
including work, used in furnishing pre- and post-operative visits are
similar to those used in furnishing E/M visits. We are unaware of any
studies or surveys that verify this assertion. Although we generally
value global packages using the same direct PE inputs as are used for
the E/M services, for services for which the RUC recommendations
include specific PE inputs in addition to those typically included for
E/M services, we generally use the additional inputs in the global
package valuation. Of note, when a visit included in a global package
would use fewer resources than a comparable E/M service, the RUC
generally does not include recommendations to decrease the PE inputs of
the visit included in the global package, and we have not generally
made comparable reductions. Another inconsistency with our current
global package valuation approach is that even though we effectively
assume that the E/M codes are appropriate for valuing pre- and post-
operative services, the indirect PE inputs used for calculating
payments for global services are based upon the specialty mix
furnishing the global service, not the specialty mix of the physicians
furnishing the E/M services, resulting in a different valuation for the
E/M services contained in global packages than for separately billable
E/M services. There is a critical need to obtain complete information
if we are to value global packages accurately and in a way that
preserves relativity across the fee schedule.
To meet the requirement under section 1848(c)(8)(B)(i) of the Act,
we develop, through rulemaking, a process to gather information needed
to value surgical services. Therefore, we are proposing a rigorous data
collection effort that we believe would provide us the data needed to
accurately value the 4,200 codes with a 10- or 90-day global period.
Using our authority under sections 1848(c)(2)(M) and (c)(8)(B)(i) of
the Act, we propose to gather the data needed to determine how to best
structure global packages with post-operative care that is typically
delivered days, weeks or months after the procedure and whether there
are some procedures for which accurate valuation for packaged post-
operative care is not possible. Finally, we believe these data would
provide useful information to assess the resources used in furnishing
pre- and post-operative care. To accurately do so, we need to know the
volume and costs of the resources typically used. Although it may not
be possible to gather all the necessary data and to complete the
analysis required to re-value all of the codes currently valued as 10-
or 90-day global packages by January 1, 2019, we believe the proposed
data collection would provide the foundation for such valuations and
would allow us to re-value, as appropriate, the surgical services on a
flow basis, starting in rulemaking for CY 2019.
We are proposing a three-pronged approach to collect timely and
accurate data on the frequency of, and inputs involved in furnishing,
global services including the procedure and the pre-operative visits,
post-operative visits, and other services for which payment is included
in the global surgical payment. By analyzing these data, we would not
only have the most comprehensive information available on the resources
used in furnishing these services, but also would be able to determine
the appropriate packages for such services. Specifically, the effort
would include:
Comprehensive claims-based reporting about the number and
level of pre- and post-operative visits furnished for 10- and 90-day
global services.
A survey of a representative sample of practitioners about
the activities involved in and the resources used in providing a number
of pre- and post-operative visits during a specified, recent period of
time, such as two weeks.
A more in-depth study, including direct observation of the
pre- and post-operative care delivered in a small number of sites,
including some ACOs.
This work is critical to understanding and characterizing the work
and other resources involved in furnishing services throughout the
current global periods assigned to specific surgical procedures. The
information collected and analyzed through the activities would be the
first comprehensive look at the volume and level of services in a
global period, and the activities and inputs involved in furnishing
global services. The data from these activities would ultimately inform
our revaluation of global surgical packages.
[[Page 46194]]
(1) Statutory Authority for Data Collection
As described above, section 1848(c)(8)(B)(i) of the Act requires us
to develop, through rulemaking, a process to gather information needed
to value surgical services from a representative sample of physicians.
The statute requires that the collected information include the number
and level of medical visits furnished during the global period and
other items and services related to the surgery and furnished during
the global period, as appropriate.
In addition, section 1848(c)(2)(M) of the Act, which was added to
the Act by section 220 of the PAMA, authorizes the Secretary to collect
or obtain information on resources directly or indirectly related to
furnishing services for which payment is made under the PFS. Such
information may be collected or obtained from any eligible professional
or any other source. Information may be collected or obtained from
surveys of physicians, other suppliers, providers of services,
manufacturers, and vendors. That section also authorizes the Secretary
to collect information through any other mechanism determined
appropriate. When using information gathered under this authority, the
statute requires the Secretary to disclose the information source and
discuss the use of such information in the determination of relative
values through notice and comment rulemaking.
As described above, to gain all the information that is needed to
determine the appropriate packages for global services and to revalue
those services, we need to conduct a comprehensive study on the
resources used in furnishing such services. Through such a study, we
would have much more robust data to use in valuation than has been
typically available. We anticipate that such efforts would inform how
to more regularly collect data on the resources used in furnishing
physicians' services. To the extent that such mechanisms prove
valuable, they may be used to collect data for valuing other services.
To achieve this significant data collection, we are proposing to
collect data under the authority of both section 1848(c)(8)(B) and
(c)(2)(M) of the Act.
(2) Claims-Based Data Collection
This section describes our proposal for claims-based data
collection that would be applicable to 10- and 90-day global services
furnished on or after January 1, 2017, including who would be required
to report, what they would be required to report, and how reports would
be submitted.
(a) Information To Be Reported
A key element of claims-based reporting is using codes that
appropriately reflect the services furnished. In response to the
comment solicitation in the CY 2016 PFS proposed rule and in the
January 2016 listening session, we received numerous recommendations
for the information to be reported on claims. The most frequently
recommended approach was for practitioners to report the existing CPT
code for follow-up visits included in the surgical package (CPT 99024--
Postoperative follow-up visit, normally included in the surgical
package, to indicate that an E/M service was performed during a
postoperative period for a reason(s) related to the original
procedure). Others suggested using this code for outpatient visits and
using length of stay data for estimating the number of inpatient visits
during the global period. In response to our concerns that CPT code
99024 would provide only the number of visits and not the level of
visits as required by the statute, one commenter suggested using
modifiers in conjunction with CPT code 99024 to indicate the level of
the visit furnished. Others recommended using existing CPT codes for E/
M visits to report post-operative care. One commenter suggested that
CMS analyze data from a sample of large systems and practices that are
using electronic health records that require entry of some CPT code for
every visit to capture the number of post-operative visits. After
noting that the documentation requirements and PEs required for post-
operative visits differ from those of E/M visits outside the global
period, one commenter encouraged us to develop a separate series of
codes to capture the work of the post-operative services and to
measure, not just estimate, the number and complexity of visits during
the global period.
Other commenters opposed the use of a new set of codes or the use
of modifiers to report post-operative visits. Commenters also noted
several issues for us to consider in developing data collection
mechanisms, including that many post-operative services do not have CPT
codes to bill separately, that surgeons perform a wide range of
collaborative care services, and that patient factors, including
disease severity and comorbidities, influence what post-operative care
is furnished.
To assist us in determining appropriate coding for claims-based
reporting, we added a task to the RAND contract for developing a model
to validate the RVUs in the PFS, which was awarded in response to a
requirement in the Affordable Care Act. Comments that we received on
RAND's report suggested the models did not adequately address global
surgery services due to the lack of available data on included visits.
Therefore, we modified the RAND contract to include the development of
G-codes that could be used to collect data about post-surgical follow-
up visits on Medicare claims for valuing global services under MACRA
and so that this time could be included in the model for validating
RVUs.
To inform its work, RAND conducted interviews with surgeons and
other physicians/non-physician practitioners (NPP) who provide post-
operative care. A technical expert panel (TEP), convened by RAND,
reviewed the findings of the interviews and provided input on how to
best capture care provided in the post-operative period on claims.
In summarizing the input from the interviews and the TEP, RAND
indicated that several considerations were important in developing a
claims-based method for capturing post-operative services. First, a
simple system to facilitate reporting was needed. Since it was reported
that a majority of post-operative visits are straightforward, RAND
found that a key for any proposed system is identifying the smaller
number of complex post-operative visits. Another consideration for RAND
was not using the existing CPT E/M structure to capture postoperative
care because of concerns that E/M codes are inadequately designed to
capture the full scope of post-operative care and that using such codes
might create confusion. Another consideration was that the TEP was most
enthusiastic about a set of codes that used site of care, time, and
complexity to report visits. RAND also believed it was important to
distinguish--particularly in the inpatient setting--between
circumstances where a surgeon is providing primary versus secondary
management of a patient. Finally, a mechanism for reporting the
postoperative care occurs outside of in-person visits and by clinical
staff was needed. RAND noted that in the inpatient setting in
particular, surgeons spend considerable time reviewing test results and
coordinating care with other practitioners.
After reviewing various approaches, RAND recommended a set of time-
based, post-operative visit codes that could be used for reporting care
provided during the post-operative period.
[[Page 46195]]
The recommended codes are distinguished by the setting of care and
whether they are furnished by a physician/NPP or by clinical staff. All
codes are intended to be reported in 10-minute increments. A copy of
the report is available available on the CMS Web site under downloads
for the CY 2017 PFS proposed rule with comment period at https://www.cms.gov/physicianfeesched/downloads/.
Based upon the work done by RAND, we are proposing the following
codes be used for reporting on claims the services actually furnished
but not paid separately because they are part of global packages. No
separate payment would be made for these codes.
TABLE 9--Proposed Global Service Codes
------------------------------------------------------------------------
------------------------------------------------------------------------
Inpatient...................... GXXX1 Inpatient visit,
typical, per 10
minutes, included in
surgical package.
GXXX2 Inpatient visit,
complex, per 10
minutes, included in
surgical package.
GXXX3 Inpatient visit,
critical illness, per
10 minutes, included
in surgical package.
Office or Other Outpatient..... GXXX4 Office or other
outpatient visit,
clinical staff, per
10 minutes, included
in surgical package.
GXXX5 Office or other
outpatient visit,
typical, per 10
minutes, included in
surgical package.
GXXX6 Office or other
outpatient visit,
complex, per 10
minutes, included in
surgical package.
Via Phone or Internet.......... GXXX7 Patient interactions
via electronic means
by physician/NPP, per
10 minutes, included
in surgical package.
GXXX8 Patient interactions
via electronic means
by clinical staff,
per 10 minutes,
included in surgical
package.
------------------------------------------------------------------------
(i) Coding for Inpatient Global Service Visits
Our coding proposal includes three codes for reporting inpatient
pre- and post-operative visits that distinguish the intensity involved
in furnishing the services. The typical inpatient visit would be
reported using HCPCS code GXXX1, Inpatient visit, typical, per 10
minutes, included in surgical package. The activities listed in Table
10 are those that RAND recommended to be reported as a typical visit.
Under our proposal, visits that involve any combination or number of
the services listed in Table 10 would be reported using GXXX1. Based on
the findings from the interviews and the TEP, RAND reports that the
vast majority of inpatient post-operative visits would be expected to
be reported using GXXX1.
Table 10--Activities Included in Typical Visit (GXXX1 & GXXX5)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Review vitals, laboratory or pathology results, imaging, progress notes
Take interim patient history and evaluate post-operative progress
Assess bowel function
Conduct patient examination with a specific focus on incisions and
wounds, post-surgical pain, complications, fluid and diet intake
Manage medications (for example, wean pain medications)
Remove stitches, sutures, and staples
Change dressings
Counsel patient and family in person or via phone
Write progress notes, post-operative orders, prescriptions, and
discharge summary
Contact/coordinate care with referring physician or other clinical staff
Complete forms or other paperwork
------------------------------------------------------------------------
Inpatient pre- and post-operative visits that are more complex than
typical visits but do not qualify as critical illness visits would be
coded using GXXX2 (Inpatient visit, complex, per 10 minutes, included
in surgical package). To report this code, the practitioner would be
required to furnish services beyond those included in a typical visit
and have documentation that indicates what services were provided that
exceeded those included in a typical visit. Some circumstances that
might merit the use of the complex visit code are secondary management
of a critically ill patient where another provider such as an
intensivist is providing the primary management, primary management of
a particularly complex patient such as a patient with numerous
comorbidities or high likelihood of significant decline or death,
management of a significant complication, or complex procedures outside
of the operating room (For example, significant debridement at the
bedside).
The highest level of inpatient pre- and post-operative visits,
critical illness visits (GXXX3--Inpatient visit, critical illness, per
10 minutes, included in surgical package) would be reported when the
physician is providing primary management of the patient at a level of
care that would be reported using critical care codes if it occurred
outside of the global period. This involves acute impairment of one or
more vital organ systems such that there is a high probability of
imminent or life threatening deterioration in the patient's condition.
Similar to how time is now counted for the existing CPT critical
care codes, all time spent engaged in work directly related to the
individual patient's care would count toward the time reported with the
inpatient visit codes; this includes time spent at the immediate
bedside or elsewhere on the floor or unit, such as time spent with the
patient and family members, reviewing test results or imaging studies,
discussing care with other staff, and documenting care.
(ii) Coding for Office and Other Outpatient Global Services Visits
Our proposal includes three codes that would be used for reporting
post-operative visits in the office or other outpatient settings. For
these three codes, time would be defined as the face-to-face time with
patient, which reflects the current rules for time-based outpatient
codes.
Under our proposal, GXXX4 (Office or other outpatient visit,
clinical staff, per 10 minutes, included in surgical package) would be
used for visits in which the clinical care is provided by clinical
staff.
GXXX5 (Office or other outpatient visit, typical, per 10 minutes,
included in surgical package) would be used for reporting any
combination of activities in Table 10. Based on the findings from the
interviews and the TEP, RAND reports that the vast majority of office
or other outpatient visits would be expected to be reported using the
GXXX5 code.
Accordingly, we would expect the office or other outpatient visit
code, complex, GXXX6 (Office or other outpatient visit, complex, per 10
minutes, included in surgical package), to be used infrequently.
Examples of when it might be used include management of a particularly
complex patient such as a patient with numerous comorbidities or high
likelihood of dying, management of a significant complication, or
management or discussion of a complex diagnosis (For
[[Page 46196]]
example, new cancer diagnosis, high risk of mortality). Practitioners
would include documentation in the medical record as to what services
were provided that exceeded those included in a typical visit.
Only face-to-face time spent by the practitioner with the patient
and their family members would count toward the time reported with the
office visit codes. Therefore, even though the codes for both inpatient
and outpatient settings use the same time increment, the services that
are included differ by setting, consistent with the variation in
existing coding conventions.
(iii) Coding for Services Furnished Via Electronic Means
Services that are provided via phone, the internet, or other
electronic means outside the context of a face-to-face visit would be
reported using GXXX7 when furnished by a practitioner and GXXX8 when
furnished by clinical staff. We are proposing that practitioners would
not report these services if they are furnished the day before, the day
of, or the day after a visit as we believe these would be included in
the pre- and post-service activities in the typical visit. However, we
are proposing that these codes be used to report non-face-to-face
services provided by clinical staff prior to the primary procedure
since global surgery codes are typically valued with assumptions
regarding pre-service clinical labor time. Given that some
practitioners have indicated that services they furnish commonly
include activities outside the face-to-face service, we believe it is
important to capture information about those activities in both the
pre- and post-service periods. We believe these requirements to report
on clinical labor time are consistent with and no more burdensome than
those used to report clinical labor time associated with chronic care
management services, which similarly describe care that takes place
over more than one patient encounter.
In addition, for services furnished via interactive
telecommunications that meet the requirements of a Medicare telehealth
service visit, the appropriate global service G-code for the services
should be reported with the GT modifier to indicate that the service
was furnished ``via interactive audio and video telecommunications
systems.''
(iv) Benefits of G-Codes
One commenter indicated that the documentation requirements and PEs
for post-operative visits differ from those of other E/M visits, and
encouraged us to develop a separate series of codes to capture the work
of the post-operative services and to measure, not just estimate, the
number and complexity of visits during the global period. Others
opposed the use of a new set of codes or the use of modifiers to
collect information on post-operative visits. After considering the
RAND report, the comments and other stakeholder input that we have
received, and our needs for data to fulfill our statutory mandate and
to value surgical services appropriately, we are proposing this new set
of codes because we believe it provides us the most robust data upon
which to determine the most appropriate way and amounts to pay for PFS
surgical services. We believe that the codes being proposed would
provide data of the kind that can reasonably collected through claims
data and that reflect what we believe are key issues in the post-
operative care where the service is provided, who furnishes the
service, its relative complexity, and the time involved in the service.
We seek public comments about all aspects of these codes, including
the nature of the services described, the time increment, and any other
areas of interest to stakeholders. We are particularly interested in
any pre- or post-operative services furnished that could not be
appropriately captured by these codes. Although RAND developed this set
of codes to collect data on post-operative services, we are proposing
to also use such codes to collect data on pre-operative services. We
are seeking comments on whether the codes discussed above are
appropriate for collecting data on pre-operative services or whether
additional codes should be added to distinguish in the data collected
the resources used for pre-operative services from those used for post-
operative services. We also seek comment on any activities that should
be added to the list of activities in Table 10 to reflect typical pre-
operative visit activities.
(v) Alternative Approach to Coding
As noted above, many stakeholders expressed strong support for the
use of CPT code 99024 (Postoperative follow-up visit, normally included
in the surgical package, to indicate that an evaluation and management
service was performed during a postoperative period for a reason(s)
related to the original procedure) to collect data on post-operative
care. Stakeholders suggest that practitioners are familiar with this
existing CPT code and the burden on practitioners would be minimized by
only having to report that a visit occurred, not the level of the
visit. We do not believe that this code alone would provide the
information that we need for valuing surgical services nor do we
believe it alone can meet the statutory requirement that we collect
data on the number and level of visits because it does not provide any
information beyond the number of visits. Although we are proposing to
use the G-codes detailed above to measure pre- and post-operative
visits, given the strong support that many stakeholders have for the
use of CPT code 99024, we are soliciting comments specifically on how
we could use this code to capture the statutorily required data on the
number and level of visits and the data that we would need to value
global services in the future.
Some have suggested using CPT code 99024 with modifiers to indicate
to which of the existing levels of E/M codes the visit corresponds. As
outlined in the RAND report, E/M visits may not accurately capture what
drives greater complexity in post-operative visits. E/M billing
requirements are built upon complexity in elements such as medical
history, review of systems, family history, social history, and how
many organ systems are examined. In the context of a post-operative
visit, many of these elements may be irrelevant. RAND also noted that
there was significant concern from interviewees and the expert panel
about documentation that is required for reporting E/M codes.
Specifically, they argued that documentation requirements for surgeons
to support the relevant E/M visit code would place undue administrative
burden on surgeons. RAND reported that many surgeons currently use
minimal documentation when they provide a postoperative visit.
Moreover, to value surgical packages accurately we need to understand
the activities involved in furnishing post-operative care and as
discussed above, we lack information that would demonstrate that
activities involved in post-operative care are similar to those in E/M
services. In addition, the use of modifiers to report levels of
services is more difficult to operationalize than using unique HCPCS
codes. However, we would be interested in whether, and if so, why,
practitioners would find it easier to report CPT code 99024 with
modifiers corresponding to the proposed G-code levels rather than the
new G-codes, as proposed. We are also seeking comment on whether
practitioners would find it difficult to use this for pre-operative
visits since the CPT code descriptor specifically defines it as a
``post-operative follow-up'' service.
[[Page 46197]]
We are also seeking comment on whether time of visits could alone
be a proxy for the level of visit. If pre- and post-operative care
varies only by the time the practitioner spends care so that time could
be a proxy for complexity of the service, then we could use the
reporting of CPT code 99024 in 10-minute increments to meet the
statutory requirement of collecting claims-based data on the number and
level of visits. In addition to comments on whether time is an accurate
proxy for level of visit, we are seeking comment on the feasibility and
desirability of reporting CPT 99024 in 10-minute increments.
c. Reporting of Claims
We propose that the G-codes detailed above would be reported for
services related to and within 10- and 90-day global periods for
procedures furnished on or after January 1, 2017. Services related to
the procedure furnished following recovery and otherwise within the
relevant global period would be required to be reported. These codes
would be included on claims filed through the usual process. Through
this mechanism, we would collect all of the information reported on a
claim for services, including information about the practitioner,
service furnished, date of service, and the units of service. By not
imposing special reporting requirements on the reporting of these
codes, we intend to allow practitioners the flexibility to report the
services on a rolling basis as they are furnished or to report all of
the services on one claim once all have been furnished, as long as the
filed claims meet the requirements for filing claims. As with all other
claims, we would expect the patient's medical record to include
documentation of the services furnished. Documentation that would be
expected is an indication that a visit occurred or a service was
furnished and sufficient information to determine that the appropriate
G-code was reported.
We are not proposing any special requirements for inclusion of
additional data on claims that could be used for linking the post-
operative care furnished to a particular service. To use the data
reported on post-operative visits for analysis and valuation, we will
link the data reported on post-operative care to the related procedure
using date of service, practitioner, beneficiary, and diagnosis. We
believe this approach to matching will allow us to accurately link the
preponderance of G-codes to the related procedure. However, we solicit
comment on the extent to which post-operative care may not be
appropriately linked to related procedures whether we should consider
using additional variables to link these aspects of the care, and
whether additional data should be required to be reported to enable a
higher percentage of matching.
d. Special Provisions for Teaching Physicians
We are seeking comment on whether special provisions are needed to
capture the pre- and post-operative services provided by residents in
teaching settings. If the surgeon is present for the key portion of the
visit, should the surgeon report the joint time spent by the resident
and surgeon with the patient? If the surgeon is not present for the key
portion of the visit, should the resident report the service? If we
value services without accounting for services provided by residents
that would otherwise be furnished by the surgeon in non-teaching
settings, subsequent valuations based upon the data we collect may
underestimate the resources used, particularly for the types of
surgeries typically furnished in teaching facilities. However, there is
also a risk of overvaluing services if the reporting includes services
that are provided by residents when those services would otherwise be
furnished by a physician other than the surgeon, such as a hospitalist
or intensivist, and as such, should not be valued in the global
package.
e. Who Reports
In both the comments on the CY 2016 proposed rule and in the
national listening session, there was a great deal of discussion
regarding the challenges that we are likely to encounter in obtaining
adequate data to support appropriate valuation. Some indicated that a
broad sample and significant cooperation from physicians would be
necessary to understand what is happening as part of the global
surgical package. One commenter suggested that determining a
representative sample would be difficult and, due to the variability
related to the patient characteristics, it would be easier to have all
practitioners report. Many suggested that we conduct an extensive
analysis across surgical specialties with a sample that is
representative of the entire physician community and covers the broad
spectrum of the various types of physician practice to avoid problems
that biased or inadequate data collection would cause. Suggestions of
factors to account for in selecting a sample include specialty,
practice size (including solo practices), practice setting, volume of
claims, urban, rural, type of surgery, and type of health care delivery
systems. Another commenter pointed out that small sample sizes may lead
to unreliable data. On the other hand, some commenters stated that
requiring all practitioners to report this information is unreasonable
and would be an insurmountable burden. A participant acknowledged that
it would be difficult for practitioners to report on only certain
procedures, while another stated that this would not be an
administrative burden.
After considering the input of stakeholders, we are proposing that
any practitioner who furnishes a procedure that is a 10- or 90-day
global report the pre- and post-operative services furnished on a claim
using the codes proposed above. We agree with stakeholders that it is
necessary to obtain data from a broad, representative sample across
specialties, geographic location, and practice size, practice model,
patient acuity, and differing practice patterns. However, as we
struggled to develop a sampling approach that would result in
statistically reliable and valid data, it became apparent that we do
not have adequate information about how post-operative care is
delivered, how it varies and, more specifically, what drives variation
in post-operative care. In its work to develop the coding used for its
study, RAND found a range of opinions on what drives variation in post-
operative care. (The report is available on the CMS Web site under
downloads for the CY 2017 PFS proposed rule with comment period at
https://www.cms.gov/physicianfeesched/downloads/.) Without information
on what drives variation in pre- and post-operative care, we would have
to speculate about the factors upon which to base a sample or assume
that the variation in such care results from the same variables as are
frequently identified for explaining variation in health care and
clinical practice. In addition, we have concerns about whether a sample
could provide sufficient volume to value accurately the global package,
except in the case of a few high-volume procedures.
In addition to concerns about achieving an appropriate, sufficient,
and unbiased representative sample of practitioners, we have
significant operational concerns with collecting data from a limited
sample of practitioners or on a limited sample of services. These
include how to gain sufficient information on practitioners to
sufficiently stratify the sample, how to identify the practitioners who
must report, determining which services, and for those who practice in
multiple settings and/or with multiple groups in which settings the
practitioner would report. Establishing the rules to govern
[[Page 46198]]
which post-operative care should be reported for which procedures would
be challenging for us to develop for a random sample and difficult for
physicians to apply.
With the limited time between the issuance of the CY 2017 PFS final
rule with comment period and the beginning of reporting on January 1st,
it would be challenging to make sure that affected practitioners are
aware of the requirement to report and have an ability to determine
which post-operative care to report. If, instead, we require all
practitioners to report, we can take a uniform approach to notifying
practitioners. The national medical and coding organizations are
routinely relied upon by practitioners for information on new coding
and billing requirements and play a major role in the expeditious
adoption of new coding or billing requirements. Similarly, adjustments
to software used for medical records and coding are made by national
organizations. We have concerns that if this requirement is only
applied to a small segment of practitioners that these organizations
will not be able to ensure that the affected practitioners are aware
and easily able to comply with the requirements.
The more robust the reported data, the more accurate our ultimate
valuations can be. Given the importance of data on visits in accurate
valuations for global packages, we believe that collecting data on all
pre- and post-operative visits in the global period is the best way to
accurately value surgical procedures with global packages.
We recognize that reporting of all pre- and post-operative visits
would require submission of additional claims by those practitioners
furnishing global services, but we believe the benefits of accurate
data for valuation of services merits the imposition of this
requirement. By using the claims system to report the data, we believe
the additional burden is minimized. Stakeholders have reported that
many practitioners are already required by their practice or health
care system to report a code for each visit for internal control
purposes and some of these systems already submit claims for these
services, which are denied. For these practices, the additional burden
would be minimal. We believe that requiring only some physicians to
report this information, or requiring reporting for only some services,
could actually be more burdensome to physicians than requiring this
information from all physicians on all services because of the
additional steps necessary to determine whether a report is required
for a particular service and adopting a mechanism to assure that data
is collected and reported when required. Moreover, we believe the
challenges with implementing a limited approach at the practice level
as compared to a requirement for all global services would result in
less reliable data being reported.
As we analyze the data collected and make decisions about
valuations, we would reassess the data needed and what should be
required from whom. Under section 1848(c)(8)(B)(ii) of the Act, we are
required to reassess every 4 years whether continued collection of
these data is needed. However, we can modify through rulemaking what
data is collected at any time, as appropriate. By collecting data on
all procedures with a 10- or 90-day global package, we would have the
information to assess whether the post-operative care furnished varies
by factors such as specialty, geography, practice setting, and practice
size, and thus, the information needed for a selection of a
representative sample. By initially collecting information from all
practitioners that furnish surgical services, we believe we would be
able to reduce required reporting in the future if we find that
adequate information can be obtained by selective reporting. Without
the broader set of data we would not be able to evaluate the
variability of pre- and post-operative care in order to identify a
useful targeted data collection.
While section 1848(c)(8)(B) of the Act requires us to collect data
from a representative sample of physicians on the number and level of
visits provided during the global period, it does not prohibit us from
collecting data from a broad set of physicians. In addition, section
1848(c)(2)(M) of the Act authorizes the collection of data from a wide
range of physicians. Given the benefits of more robust data, including
avoiding sample bias, obtaining more accurate data, and facilitating
operational simplicity, we believe collecting data on all post-
operative care initially is the best way to undertake an accurate
valuation of surgical services in the future.
(1) Survey of Practitioners
We agree with commenters that we need more information than is
currently provided on claims and that we should utilize a number of
different data sources and collection approaches to collect the data
needed to assess and revalue global surgery services. In addition to
the claims-based reporting, we are proposing to survey a large,
representative sample of practitioners and their clinical staff in
which respondents would report information about approximately 20
discrete pre-operative and post-operative visits and other global
services like care coordination and patient training. The proposed
survey would produce data on a large sample of pre-operative and post-
operative visits and is being designed so that we could analyze the
data collected in conjunction with the claims-based data that we would
be collecting. We expect to obtain data from approximately 5,000
practitioners.
We have contracted with RAND to develop and, if our proposal is
finalized, conduct this survey. RAND would also assist us in analyzing
data collected under this survey and the claims-based data. While the
primary data collection would be via a survey instrument, RAND would
conduct semi-structured interviews and direct observations of data in a
small number of pilot sites to inform survey design, validate survey
results, and collect information that is not conducive to survey-based
reporting.
Our proposed sampling approach would sample practitioners rather
than for procedures or visits to streamline survey data collection and
minimize respondent burden. Specifically, we propose to representative
and random sample from a frame of providers who billed Medicare for
more than a minimum threshold of surgical procedures with a 10- or 90-
day global period (for example, 200 procedures) in the most recent
available prior year of claims data. We expect to survey approximately
5,000 practitioners, stratified by specialty, geography, and practice
type. Based upon preliminary analysis we believe this number of
participants will allow us to collect information on post-operative
care following the full range of CPT level-2 surgical procedure code
groups. A smaller sample size would reduce the precision of estimates
from the survey and more importantly risk missing important differences
in post-operative care for specific specialties or following different
types of surgical procedures. We expect a response rate in excess of 50
percent.
We are not proposing that respondents report on the entire period
of post-operative care for individual patients, as a 90-day follow-up
window (for surgeries currently with a 90-day global period) is too
long to implement practically in this study setting and would be more
burdensome to practitioners. Instead, we propose to collect information
on a range of different post-operative services resulting from
surgeries furnished by
[[Page 46199]]
the in-sample practitioner prior to or during a fixed reporting period.
Each sampled practitioner will be assigned to a specified and brief
(for example, 2-week) reporting period. Given the proposed overall data
collection period, the selected sample of providers will be randomly
divided into 6 subsets within each specialty, each of which will be
assigned to a specified reporting period. Practitioners will be asked
to describe 20 post-operative visits furnished to Medicare
beneficiaries or other patients during the reporting period. The
information collected through the survey instrument, which will be
developed based upon direct observation and discussions in a small
number of pilot sites, will include contextual information to describe
the background for the post-operative care, including, for example:
Procedure codes(s) and date of service for procedure upon
which the global period is based.
Procedure place of service (type).
Whether or not there were complications during or after
the procedure.
The number in sequence of the follow-up visit (for
example, the first visit after the procedure).
The survey instrument will also collect information on the visit in
question including, for example:
Which level of visit using the finalized no-pay codes.
Specific pre-service, face-to-face, and post-service
activities furnished during the visit.
Times for each activity.
Identify who performed each activity (physician or other
practitioner).
PE components used during the visit, for example supplies
like surgical dressings and clinical staff time.
Finally, the instrument will ask respondents to report other prior
or anticipated care furnished to the patient by the practice outside of
the context of a post-operative visit, for example non-face-to-face
services.
The survey approach will complement the claims data collection by
collecting detailed information on the activities, time, intensity, and
resources involved in delivering global services. The resulting visit-
level survey data would allow us to explore in detail the variation in
activities, time, intensity, and resources associated with global
services within and between physicians and procedures, and would help
to validate the information gathered through claims. A summary of the
work that RAND would be doing is available on the CMS Web site under
downloads for the CY 2017 PFS proposed rule with comment period at
https://www.cms.gov/physicianfeesched/downloads/.
(2) Required Participation in Data Collection
Using the authority we are provided under sections 1848(c)(8) and
1848(c)(2)(M) of the Act, we are proposing to require all practitioners
who furnish a 10- or 90-day global service to submit a claim(s)
providing information on all services furnished within the relevant
global service period in the form and manner described below, beginning
with surgical or procedural services furnished on or after January 1,
2017. We are also proposing to require participation by practitioners
selected for the broad-based survey through which we are proposing to
gather additional data needed to value surgical services, such as the
clinical labor and equipment involved that cannot be efficiently
collected on claim (see below).
Given the importance of the proposed survey effort, making sure
that we get valid data is critical. By eliminating the bias that would
be associated with using only data reported voluntarily, we believe we
will get more accurate and representative data. In addition to the
potential bias inherent in voluntary surveys, we are concerned that
relying on voluntary data reporting would limit the adequacy of the
volume of data we obtain, will require more effort to recruit
participation, and may make it impossible to obtain data for valuation
for CY 2019 as required by the statute.
Based on our previous experience with requesting voluntary
cooperation in data collection activity, voluntary participation poses
a significant challenge in data collection. Specifically, the Urban
Institute's work (under contract with us) to validate work RVUs by
conducting direct observation of the time it took to furnish certain
elements of services paid under the physician fee schedule provides
evidence of this challenge. (See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/RVUs-Validation-Urban-Interim-Report.pdf for an interim report that describes
challenges in securing participation in voluntary data collection.)
Similarly, we routinely request invoices on equipment and supplies that
are used in furnishing services and often receive no more than one
invoice. These experiences support the idea that mandatory
participation in data collection activities is essential if we are to
collect valid and unbiased data.
Section 1848(a)(9) of the Act authorizes us, through rulemaking, to
withhold payment of up to 5 percent of the payment for services on
which the practitioner is required to report under section
1848(c)(8)(B)(i) of the Act until the practitioner has completed the
required reporting. Some commenters opposed the imposition of this
payment withhold, and others said it was too large of a penalty. While
we believe this is a way to encourage practitioners to report on claims
the information we propose to require on care that is furnished in the
global period, we are not proposing to implement this option at this
time. We believe that requiring physicians to report the information on
claims, combined with the incentive to report complete information so
that we can make appropriate revisions when we revalue payments for
global surgical services, would result in compliance with the reporting
requirements. However, we note that if we find that compliance with
required claims-based reporting is not acceptable, we would consider in
future rulemaking imposing up to a 5 percent payment withhold as
authorized by the statute.
Consistent with the requirements of section 1848(c)(2)(M) of the
Act, should the data collected under this requirement be used to
determine RVUs, we will disclose the information source and discuss the
use of such information in such determination of relative values
through future notice and comment rulemaking.
(3) Data Collection From Accountable Care Organizations (ACOs)
We are particularly interested in knowing whether physicians and
practices affiliated with ACOs expend greater time and effort in
providing post-operative global services in keeping with their goal of
improving care coordination for their assigned beneficiaries. ACOs are
organizations in which practitioners and hospitals voluntarily come
together to provide high-quality and coordinated care for their
patients. Because such organizations share in the savings realized by
Medicare, their incentive is to minimize post-operative visits while
maintaining high quality post-operative care for patients. In addition,
we believe that such organizations offer us the opportunity to gain
more in-depth information about delivery of surgical services.
We propose to collect primary data on the activities and resources
involved in delivering services in and around surgical events in the
ACO context by surveying a small number of ACOs (Pioneer and Next
Generation ACOs).
[[Page 46200]]
Similar to the approach of the more general practitioner survey, this
effort would begin with an initial phase of primary data collection
using a range of methodologies in a small number of ACOs; development,
piloting, and validation of an additional survey module specific to
ACOs. A survey of practitioners participating in approximately 4 to 6
ACOs using the survey instrument along with the additional ACO-specific
module will be used to collect data from on pre- and post-operative
visits.
(4) Conclusion
We recognize that the some of the data collection activity proposed
here varies greatly from how the data is currently gathered to support
PFS valuations for global surgery services. However, we believe the
proposed claims-based data collection is generally consistent with how
claims data is reported for other kinds of services paid under the PFS.
We believe that the authority and requirements included in the statute
through the MACRA and PAMA were intended to expand and enhance data
that might be available to enhance the accuracy of PFS payments.
Because these are new approaches to collecting data and in an area--
global surgery--where very little data has previously been collected,
we cannot describe exactly how this information would be used in
valuing services. What is clear is that the claims-based data would
provide information parallel to the kinds of claims-data used in
developing RVUs for other PFS services and that by collecting these
data, we would know far more than we do now about how post-operative
care is delivered and gain insight to support appropriate packaging and
valuation. We would include any revaluation proposals based on these
data in subsequent notice and comment rulemaking.
E. Improving Payment Accuracy for Primary Care, Care Management, and
Patient-Centered Services
1. Overview
In recent years, we have undertaken ongoing efforts to support
primary care and patient-centered care management within the PFS as
part of HHS' broader efforts to achieve better care, smarter spending
and healthier people through delivery system reform. We have recognized
the need to improve payment accuracy for primary care and patient-
centered care management over several years, especially beginning in
the CY 2012 PFS proposed rule (76 FR 42793) and continuing in each
subsequent year of rulemaking. In the CY 2012 proposed rule, we
acknowledged the limitations of the current code set that describes
evaluation & management (E/M) services within the PFS. For example, E/M
services represent a high proportion of PFS expenditures but have not
been recently revalued to account for significant changes in the
disease burden of the Medicare patient population and changes in health
care practice that are underway, to meet the current population's
health care needs. These trends in the Medicare population and health
care practice have been widely recognized in the provider community and
by health services researchers and policymakers alike.\1\ We believe
the focus of the health care system has shifted to delivery system
reforms, such as patient-centered medical homes, clinical practice
improvement, and increased investment in primary and comprehensive care
management/coordination services for chronic and other conditions. This
shift requires centralized management of patient needs and extensive
care coordination among practitioners and providers (often on a non-
face-to-face basis across an extended period of time). In contrast, the
current CPT code set is designed with an overall orientation to pay for
discrete services and procedural care as opposed to ongoing primary
care, care management and coordination, and cognitive services. It
includes thousands of separately paid, individual codes, most of which
describe highly specialized procedures and diagnostic tests, while
there are relatively few codes that describe care management and
cognitive services. Further, in the past, we have not recognized as
separately payable many existing CPT codes that describe care
management and cognitive services, viewing them as bundled and paid as
part of other services including the broadly drawn E/M codes that
describe face-to-face visits billed by physicians and practitioners in
all specialties.
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\1\ See, for example, https://content.healthaffairs.org/content/25/5/w378.full; https://www.commonwealthfund.org/publications/issue-
briefs/2008/feb/how-disease-burden-influences-medication-patterns-
for-medicare-beneficiaries--implications-for-polic; https://www.hhs.gov/ash/about-ash/multiple-chronic-conditions/;
https://www.nejm.org/doi/full/10.1056/NEJMp1600999#t=article; https://www.pcpcc.org/about; https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html.
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This has resulted in minimal service variation for ongoing primary
care, care management and coordination, and cognitive services relative
to other PFS services, and in potential misvaluation of E/M services
under the PFS (76 FR 42793). Some stakeholders believe that there is
substantial misvaluation of physician work within the PFS, and that the
current service codes fail to capture the range and intensity of
nonprocedural physician activities (E/M services) and the ``cognitive''
work of certain specialties (https://www.nejm.org/doi/full/10.1056/NEJMp1600999#t=article).
Recognizing the inverse for specialties that furnish other kinds of
services, MedPAC has noted that the PFS allows some specialties to more
easily increase the volume of services they provide (and therefore
their revenue from Medicare) relative to other specialties,
particularly those that spend most of their time providing E/M
services. (MedPAC March 2015 Report to the Congress, available at
https://www.medpac.gov/-documents-/reports). We agree with this
analysis, and we recognize that the current set of E/M codes limits
Medicare's ability under the PFS to appropriately recognize the
relative resource costs of primary care, care management/coordination
and cognitive services relative to specialized procedures and
diagnostic tests.
In recent years, we have been engaged in an ongoing incremental
effort to update and improve the relative value of primary care, care
management/coordination, and cognitive services within the PFS by
identifying gaps in appropriate payment and coding. These efforts
include changes in payment and coding for a broad range of PFS
services. This effort is particularly vital in the context of the
forthcoming transition to the Merit-Based Incentive Payment System
(MIPS) and Alternative Payment Models (APMs) incentives under The
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L.
114-10, enacted April 16, 2015), since MIPS and many APMs will adopt
and build on PFS coding, RVUs and PFS payment as their foundation.
In CY 2013, we began by focusing on post-discharge care management
and transition of beneficiaries back into the community, establishing
new codes to pay separately for transitional care management (TCM)
services. Next we finalized new coding and separate payment beginning
in CY 2015 for chronic care management (CCM) services provided by
clinical staff. Most recently, in the CY 2016 PFS proposed rule (80 FR
41708 through 41711), we solicited public comments on three additional
policy areas of consideration: (1) Improving payment for the
professional work of care management
[[Page 46201]]
services through coding that would more accurately describe and value
the work of primary care and other cognitive specialties for complex
patients (for example, monthly timed services including care
coordination, patient/caregiver education, medication management,
assessment and integration of data, care planning); (2) establishing
separate payment for collaborative care, particularly, how we might
better value and pay for robust inter-professional consultation,
between primary care physicians and psychiatrists (developing codes to
describe and provide payment for the evidence-based psychiatric
collaborative care model (CoCM), and between primary care physicians
and other (non-mental health) specialists; and (3) assessing whether
current PFS payment for CCM services is adequate and whether we should
reduce the administrative burden associated with furnishing and billing
these services.
In the CY 2016 PFS final rule with comment period (80 FR 70919
through 70921), we summarized the many public comments we received in
response to last year's comment solicitation. Instead of the specific
policies we sought comment on, several commenters recommended an
overhaul and complete revaluation of the E/M codes through a major
research initiative akin to that undertaken when the PFS was first
established. Many other commenters recommended that, until a major
research initiative could be conducted to fully address the
deficiencies in the current E/M code set, CMS should make separate
payment under Medicare for a number of existing CPT codes to improve
payment in the areas in which we solicited comments, including the
codes used to describe complex CCM services (CPT codes 99487 and
99489). Other commenters also suggested that care management services
may be beneficial to a number of other patient populations in addition
to those transitioning into the community from an inpatient setting and
those with multiple chronic conditions.
Also in response to our CY 2016 comment solicitation, the AMA
restructured its existing CPT/RUC workgroup on these issues and
convened the relevant individual specialty societies to develop new CPT
coding that would address these issues. We understand that these
efforts are ongoing, and that at this time, two sets of new codes are
scheduled to be included in the CY 2018 CPT code set in response to our
2016 comment solicitation. One is a set of new codes describing
services furnished under the psychiatric CoCM and the other is a code
for assessment and care planning services for patients with cognitive
impairment. Several stakeholders have urged us to facilitate Medicare
payment for these and other new primary care, care management, and
cognitive services sooner than CY 2018 by proposing payment using G-
codes for CY 2017.
In response to our comment solicitation in the CY 2016 proposed
rule, MedPAC commented that the PFS is an ill-suited payment mechanism
for primary care and cognitive care generally. MedPAC recommended that
Congress replace the expired Primary Care Incentive Payment (PCIP) with
a capitated payment mechanism and expressed preference for codes like
CCM that are beneficiary-centered and do not pay for each distinct care
coordination activity.
Finally, many public commenters recommended a number of
modifications to the current CCM payment rules. According to many
commenters, current payment does not cover the cost of furnishing these
services, and therefore, the codes are underutilized. As referenced in
section II.E.3 on improving access and payment for CCM services, our
assessment of claims data for CY 2015 for CPT code 99490 suggests that
CCM services may be underutilized relative to the intended eligible
patient population.
After considering the commenters' perspective and recommendations,
as well as monitoring the ongoing efforts at the AMA/RUC and CPT to
respond with new/revised coding, for CY 2017 we are proposing a number
of changes to coding and payment policies under the PFS. These
proposals are intended to accomplish the following:
Improve payment for care management services provided in
the care of beneficiaries with behavioral health conditions (including
services for substance use disorder treatment) through new coding,
including three codes used to describe services furnished as part of
the psychiatric CoCM and one to address behavioral health integration
more broadly.
Improve payment for cognition and functional assessment,
and care planning for beneficiaries with cognitive impairment.
Adjust payment for routine visits furnished to
beneficiaries whose care requires additional resources due to their
mobility-related disabilities.
Recognize for Medicare payment the additional CPT codes
within the Chronic Care Management family (for Complex CCM services)
and adjust payment for the visit during which CCM services are
initiated (the initiating CCM visit) to reflect resources associated
with the assessment for, and development of, a new care plan.
Recognize for Medicare payment CPT codes for non-face-to-
face Prolonged E/M services by the physician (or other billing
practitioner) that are currently bundled, and increase payment rates
for face-to-face prolonged E/M services by the physician (or other
billing practitioner) based on existing RUC recommended values.
We are aware that CPT has approved a code to describe assessment
and care planning for patients with cognitive impairment; however, it
will not be ready in time for valuation in CY 2017. Therefore, we are
proposing to make payment using a G-code (GPPP6--see below) for this
service in 2017. We are also aware that CPT has approved three codes
that describe services furnished consistent with the psychiatric CoCM,
but that they will also not be ready in time for valuation in CY 2017.
We discuss these services in more detail in the next section of this
proposed rule. To facilitate separate payment for these services
furnished to Medicare beneficiaries during CY 2017, we are proposing to
make payment through the use of three G-codes (GPPP1, GPPP2, and
GPPP3--see below) that parallel the new CPT codes, as well as a fourth
G-code (GPPPX--see below) to describe services furnished using a
broader application of behavioral health integration in the primary
care setting. We intend for these to be temporary codes (for perhaps
only one year) and will consider whether to adopt and establish values
for the new CPT codes under our standard process, presumably for CY
2018. While we recognize that there may be overlap in the patient
populations for the proposed new G-codes, we note that time spent by a
practitioner or clinical staff cannot be counted more than once for any
code (or assigned to more than one patient), consistent with PFS coding
conventions.
Proposed payment for services described by new coding are as
follows (please note that the descriptions included for GPPP1, GPPP2,
and GPPP3 are from Current Procedural Terminology (CPT[supreg])
Copyright 2016 American Medical Association (and will be effective as
part of CPT codes January 1, 2018). All rights reserved):
GPPP1: Initial psychiatric collaborative care management,
first 70 minutes in the first calendar month of behavioral health care
manager activities, in consultation with a psychiatric consultant, and
directed by the treating physician or other qualified
[[Page 46202]]
health care professional, with the following required elements:
++ Outreach to and engagement in treatment of a patient directed by
the treating physician or other qualified health care professional;
++ Initial assessment of the patient, including administration of
validated rating scales, with the development of an individualized
treatment plan;
++ Review by the psychiatric consultant with modifications of the
plan if recommended;
++ Entering patient in a registry and tracking patient follow-up
and progress using the registry, with appropriate documentation, and
participation in weekly caseload consultation with the psychiatric
consultant; and
++ Provision of brief interventions using evidence-based techniques
such as behavioral activation, motivational interviewing, and other
focused treatment strategies.
GPPP2: Subsequent psychiatric collaborative care
management, first 60 minutes in a subsequent month of behavioral health
care manager activities, in consultation with a psychiatric consultant,
and directed by the treating physician or other qualified health care
professional, with the following required elements:
++ Tracking patient follow-up and progress using the registry, with
appropriate documentation;
++ Participation in weekly caseload consultation with the
psychiatric consultant;
++ Ongoing collaboration with and coordination of the patient's
mental health care with the treating physician or other qualified
health care professional and any other treating mental health
providers;
++ Additional review of progress and recommendations for changes in
treatment, as indicated, including medications, based on
recommendations provided by the psychiatric consultant;
++ Provision of brief interventions using evidence-based techniques
such as behavioral activation, motivational interviewing, and other
focused treatment strategies;
++ Monitoring of patient outcomes using validated rating scales;
and relapse prevention planning with patients as they achieve remission
of symptoms and/or other treatment goals and are prepared for discharge
from active treatment.
GPPP3: Initial or subsequent psychiatric collaborative
care management, each additional 30 minutes in a calendar month of
behavioral health care manager activities, in consultation with a
psychiatric consultant, and directed by the treating physician or other
qualified health care professional (List separately in addition to code
for primary procedure) (Use GPPP3 in conjunction with GPPP1, GPPP2).
GPPPX: Care management services for behavioral health
conditions, at least 20 minutes of clinical staff time, directed by a
physician or other qualified health care professional time, per
calendar month.
GPPP6: Cognition and functional assessment using
standardized instruments with development of recorded care plan for the
patient with cognitive impairment, history obtained from patient and/or
caregiver, by the physician or other qualified health care professional
in office or other outpatient setting or home or domiciliary or rest
home.
GPPP7: Comprehensive assessment of and care planning by
the physician or other qualified health care professional for patients
requiring chronic care management services, including assessment during
the provision of a face-to-face service (billed separately from monthly
care management services) (Add-on code, list separately in addition to
primary service).
GDDD1: Resource-intensive services for patients for whom
the use of specialized mobility-assistive technology (such as
adjustable height chairs or tables, patient lifts, and adjustable
padded leg supports) is medically necessary and used during the
provision of an office/outpatient evaluation and management visit (Add-
on code, list separately in addition to primary procedure).
Additionally, we are aware that other codes are being developed
through the CPT process. We have noted with interest that the CPT
Editorial Panel and AMA/RUC restructured the former Chronic Care
Coordination Workgroup to establish a new Emerging CPT and RUC Issues
Workgroup that we hope will continue to consider the issues raised in
this section of our CY 2017 proposed rule. We are continuing to
consider possible additional codes for CCM services that would describe
the time of the physician or other billing practitioner. We also remain
interested in whether there should be changes under the PFS to reflect
additional models of inter-professional collaboration for health
conditions, in addition to those we are proposing for behavioral health
integration.
For additional details on the coding and proposed valuation related
to these proposals, see section II.L of this proposed rule for
Valuation of Specific Codes. We note that the development of coding for
these and other kinds of services across the PFS is typically an
iterative process that responds to changes in medical practice and may
be best refined over several years, with PFS rulemaking and the
development of CPT codes as important parts of that process. Thus, we
anticipate continuing the multi-year process of implementing
initiatives designed to improve payment for, and recognize long-term
investment in, primary care, care management and cognitive services,
and patient-centered services.
2. Non-Face-To-Face Prolonged Evaluation & Management (E/M) Services
In public comments to the CY 2016 PFS proposed rule, many
commenters recommended that CMS should establish separate payment for
non-face-to-face prolonged E/M service codes that we currently consider
to be ``bundled'' under the PFS (CPT codes 99358, 99359). The CPT
descriptors are:
CPT code 99358 (Prolonged evaluation and management
service before and/or after direct patient care, first hour); and
CPT code 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).
Commenters believed that separate payment for these existing CPT
codes would provide a means for physicians and other billing
practitioners to receive payment that more appropriately accounts for
time that they spend providing non-face-to-face care. We agree that
these codes would provide a means to recognize the additional resource
costs of physicians and other practitioners when they spend an
extraordinary amount of time outside the in-person office visit caring
for the individual needs of their patients. And we believe that doing
so in the context of the ongoing changes in health care practice to
meet the current population's health care needs would be beneficial for
Medicare beneficiaries and consistent with our overarching goals
related to patient-centered care.
These non-face-to-face prolonged service codes are broadly
described (although they include only time spent personally by the
physician or other billing practitioner) and have a relatively high
time threshold (the time counted must be beyond the usual service time
for the primary or companion E/M code that is also billed). We believe
this makes them sufficiently distinct from the other codes we propose
to pay in CY 2017 as part of our
[[Page 46203]]
primary care/care management/cognitive care initiative described in
this section of our proposed rule. Accordingly, beginning in CY 2017 we
propose to recognize CPT codes 99358 and 99359 for separate payment
under the PFS. We note that time could not be counted more than once
towards the provision of CPT codes 99358 or 99359 and any other PFS
service. See section II.L for a discussion of our proposed valuation of
CPT codes 99358 and 99359.
We propose to require the services to be furnished on the same day
by the same physician or other billing practitioner as the companion E/
M code. However, in reviewing the CPT guidance for CPT codes 99358 and
99359, we noted that CPT codes 99358 and 99359 should not be reported
during the same service period as complex CCM services (CPT codes
99487, 99489) or TCM services (CPT codes 99495, 99496). One reason for
excluding TCM and complex CCM services from concurrent billing would be
that, like prolonged services, TCM and complex CCM services include
substantial non-face-to-face work by the billing physician or other
practitioner (an E/M visit and/or medical decision-making of moderate
or high complexity). However, the CPT prolonged service with patient
contact codes are billable on the same day an E/M service is furnished,
and the CPT prolonged service codes without direct patient contact are
services furnished during a single day that are directly related to a
discrete face-to-face service. In contrast, TCM and CCM codes are
billed monthly and focused on a broader episode of patient care. We are
seeking public input on the intersection of the prolonged service codes
with CCM and TCM services. We are also seeking public comment on the
potential intersection of the prolonged service CPT codes 99358 and
99359 with proposed code GPPP7 (Comprehensive assessment of and care
planning for patients requiring CCM services). Specifically, we are
seeking comment regarding how distinctions among these services can be
clearly delineated, including how the prolonged time can be clearly
distinguished from typical pre- and post-service time, which is
continued to be bundled with other codes. For all of these services, we
have concerns that there may potentially be program integrity risks as
the same non-face-to-face activities could be undertaken to meet the
billing requirements for any of the above. We are seeking public
comment to help us identify the full extent of program integrity
considerations, as well as options for mitigating program integrity
risks associated with these and other potentially overlapping codes.
3. Establishing Separate Payment for Behavioral Health Integration
(BHI)
a. Psychiatric Collaborative Care Model (CoCM)
In the CY 2016 PFS final rule with comment period (80 FR 70920), we
stated that we believed the care and management for Medicare
beneficiaries with behavioral health conditions may include extensive
discussion, information sharing and planning between a primary care
physician and a specialist. We refer to this practice broadly as
``Behavioral Health Integration'' (BHI). In CY 2016 rulemaking, we
described that in recent years, many randomized controlled trials have
established an evidence base for an approach to caring for patients
with behavioral health conditions called the psychiatric Collaborative
Care Model (CoCM). A specific model for BHI, CoCM typically is provided
by a primary care team, consisting of a primary care provider and a
care manager who works in collaboration with a psychiatric consultant,
such as a psychiatrist. Care is directed by the primary care team and
includes structured care management with regular assessments of
clinical status using validated tools and modification of treatment as
appropriate. The psychiatric consultant provides regular consultations
to the primary care team to review the clinical status and care of
patients and to make recommendations. As we previously noted, several
resources have been published that describe the psychiatric CoCM in
greater detail and assess the impact of the model, including pieces
from the University of Washington (https://aims.uw.edu/), the Institute
for Clinical and Economic Review (https://icer-review.org/announcements/icer-report-presents-evidence-based-guidance-to-support-integration-of-behavioral-health-into-primary-care/), and the Cochrane Collaboration
(https://www.cochrane.org/CD006525/DEPRESSN_collaborative-care-forpeople-with-depression-and-anxiety). Because this particular kind of
collaborative care model has been tested and documented in medical
literature, we expressed that we were particularly interested in
comments on how coding under the PFS might facilitate appropriate
valuation of the services furnished under the model. We also solicited
comments to assist us in considering refinements to coding and payment
to address this model in particular relative to current coding and
payment policies, as well as information related to various
requirements and aspects of these services.
After consideration of the comments, we are proposing to begin
making separate payment for services furnished using the psychiatric
CoCM beginning January 1, 2017. We are aware that CPT, recognizing the
need for new coding for services under this model of care, has approved
three codes to describe psychiatric collaborative care that is
consistent with this model, but the codes will not be ready in time for
valuation in CY 2017. Current CPT coding does not accurately describe
or facilitate appropriate payment for the treatment of Medicare
beneficiaries under this model of care. For example, under current
Medicare payment policy, there is no payment made specifically for
regular monitoring of patients using validated clinical rating scales
or for regular psychiatric caseload review and consultation that does
not involve face-to-face contact with the patient. We believe that
these resources are directly involved in furnishing ongoing care
management services to specific patients with specific needs, but they
are not appropriately recognized under current coding and payment
mechanisms. Because PFS valuation is based on the relative resource
costs of the PFS services furnished to Medicare beneficiaries, we
believe that appropriate coding for these services for CY 2017 will
facilitate accurate payment for these and other PFS services.
Therefore, we are proposing separate payment for services under the
psychiatric CoCM using three new G-codes, as detailed above: GPPP1,
GPPP2, and GPPP3, which would parallel the CPT codes that are being
created to report these services. We intend for these to be temporary
codes (for perhaps only one year) and will consider whether to adopt
and establish values for the new CPT codes under our standard process,
presumably for CY 2018.
Services in the psychiatric CoCM are provided under the direction
of a treating physician or other qualified health care professional
during a calendar month. These services are provided when a patient has
a diagnosed psychiatric disorder that requires a behavioral health care
assessment; establishing, implementing, revising, or monitoring a care
plan; and provision of brief interventions. The diagnosis may be either
pre-existing or made by the billing practitioner. These services are
reported by the treating physician or other qualified health care
[[Page 46204]]
professional and include the services of the treating physician or
other qualified health care professional, the behavioral health care
manager (see description below) who furnishes services incident to
services of the treating physician or other qualified health care
professional, and the psychiatric consultant (see description below)
whose consultative services are furnished incident to services of the
treating physician or other qualified health care professional.
Patients who are appropriate candidates to participate in the
psychiatric CoCM may have newly diagnosed conditions, need help in
engaging in treatment, have not responded to standard care delivered in
a non-psychiatric setting, or require further assessment and engagement
prior to consideration of referral to a psychiatric care setting.
Patients are treated under this model for an episode of care, defined
as beginning when the behavioral health care manager engages in care of
the patient under the appropriate supervision of the treating physician
and ending with:
The attainment of targeted treatment goals, which
typically results in the discontinuation of care management services
and continuation of usual follow-up with the treating physician or
other qualified healthcare professional; or
Failure to attain targeted treatment goals culminating in
referral to a psychiatric care provider for ongoing treatment; or
Lack of continued engagement with no psychiatric
collaborative care management services provided over a consecutive six
month calendar period (break in episode).
A new episode of care starts after a break in episode of six
calendar months or more.
The treating physician or other qualified health care professional
directs the behavioral health care manager and continues to oversee the
patient's care, including prescribing medications, providing treatments
for medical conditions, and making referrals to specialty care when
needed. Medically necessary E/M and other services may be reported
separately by the treating physician or other qualified health care
professional, or other physicians or practitioners, during the same
calendar month. Time spent by the treating physician or other qualified
health care professional on activities for services reported separately
may not be included in the services reported using GPPP1, GPPP2, and
GPPP3. The behavioral health care manager under this model of care is a
member of the treating physician or other qualified health care
professional's clinical staff with formal education or specialized
training in behavioral health (which could include a range of
disciplines, for example, social work, nursing, and psychology) who
provides care management services, as well as an assessment of needs,
including the administration of validated rating scales,\2\ the
development of a care plan, provision of brief interventions, ongoing
collaboration with the treating physician or other qualified health
care professional, maintenance of a registry,\3\ all in consultation
with a psychiatric consultant. The behavioral health care manager
furnishes these services both face-to-face and non-face-to-face, and
consults with the psychiatric consultant minimally on a weekly basis.
We would expect that the behavioral health care manager would be on-
site at the location where the treating physician or other qualified
health care professional furnishes services to the beneficiary.
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\2\ For example, see https://aims.uw.edu/resource-library/measurement-based-treatment-target.
\3\ For example, see https://aims.uw.edu/collaborative-care/implementation-guide/plan-clinical-practice-change/identify-population-based.
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The behavioral health care manager may or may not be a professional
who meets all the requirements to independently furnish and report
services to Medicare. If otherwise eligible, then that individual may
report separate services furnished a beneficiary receiving the services
described by GPPP1, GPPP2, GPPP3, and GPPPX in the same calendar month.
These could include: psychiatric evaluation (90791, 90792),
psychotherapy (90832, 90833, 90834, 90836, 90837, 90838), psychotherapy
for crisis (90839, 90840), family psychotherapy (90846, 90847),
multiple family group psychotherapy (90849), group psychotherapy
(90853), smoking and tobacco use cessation counseling (99406, 90407),
and alcohol or substance abuse structured screening and brief
intervention services (99408, 99409). Time spent by the behavioral
health care manager on activities for services reported separately may
not be included in the services reported using time applied to GPPP1,
GPPP2, and GPPP3.
The psychiatric consultant involved in the ``incident to'' care
furnished under this model is a medical professional trained in
psychiatry and qualified to prescribe the full range of medications.
The psychiatric consultant advises and makes recommendations, as
needed, for psychiatric and other medical care, including psychiatric
and other medical diagnoses, treatment strategies including appropriate
therapies, medication management, medical management of complications
associated with treatment of psychiatric disorders, and referral for
specialty services, that are communicated to the treating physician or
other qualified health care professional, typically through the
behavioral health care manager. The psychiatric consultant does not
typically see the patient or prescribe medications, except in rare
circumstances, but can and should facilitate a referral to a
psychiatric care provider when clinically indicated.
In the event that the psychiatric consultant furnishes services to
the beneficiary directly in the calendar month described by other
codes, such as E/M services or psychiatric evaluation (90791, 90792),
the services may be reported separately by the psychiatric consultant.
Time spent by the psychiatric consultant on activities for services
reported separately may not be included in the services reported using
GPPP1, GPPP2, and GPPP3.
We also note that, although the psychiatric CoCM has been studied
extensively in the setting of specific behavioral health conditions
(for example, depression), we received persuasive comments last year
recommending that we not specify particular diagnoses required for use
of the codes for several reasons, including that: there may be overlap
in behavioral health conditions; there are concerns that there could be
modification of diagnoses to fit within payment rules which could skew
the accuracy of submitted diagnosis code data; and for many patients
for whom specialty care is not available, or who choose for other
reasons to remain in primary care, primary care treatment will be more
effective if it is provided within a model of integrated care that
includes care management and psychiatric consultation.
(1) General Behavioral Health Integration (BHI)
We recognize that the psychiatric CoCM is prescriptive and that
much of its demonstrated success may be attributable to adherence to a
set of elements and guidelines of care as described in the preceding
paragraphs. Therefore, we are proposing the use of these codes to pay
accurately for this specific model of care for the benefit of Medicare
beneficiaries, given its wide-spread adoption and recognized
effectiveness. However, we note that PFS coding, in general, does not
dictate how physicians practice medicine and believe that it should,
instead, reflect the practice of medicine. We also recognize that there
are primary care practices that are incurring, or may
[[Page 46205]]
incur, resource costs inherent to treatment of patients with similar
conditions based on other models of BHI that may benefit beneficiaries
with behavioral health conditions (see, for example, the approach
described at https://www.integration.samhsa.gov/integrated-care-models.)
These models of care include resource costs associated with care
managers and consultants that are not accurately characterized by the
descriptions in the preceding paragraphs. However, these costs are also
not included as direct PE inputs in other PFS services, such as E/M
codes. In its comment regarding the psychiatric CoCM, MedPAC noted its
preference for beneficiary-centered treatment that would allow for
flexibility in addressing patient needs, rather than approaches that
are tied to a particular model of care. MedPAC also urged CMS not to
make separate payment for each care management activity.
Therefore, to recognize the resource costs associated with
furnishing behavioral health care management services to Medicare
beneficiaries under related but different models of care without paying
for each activity separately, we are also proposing to make payment
using a new G-code that describes care management for beneficiaries
with diagnosed behavioral health conditions under a broader application
of integration in the primary care setting. We believe that for this
subset of Medicare beneficiaries, the resources associated with
medically necessary care management services are not otherwise
adequately reflected under the PFS. The proposed code is GPPPX (Care
management services for behavioral health conditions, at least 20
minutes of clinical staff time, directed by a physician or other
qualified health care professional time, per calendar month). We note
that we expect this coding to be refined over time as we receive more
information about other behavioral health care models being used and
how they are implemented.
We are seeking stakeholder input on whether we should consider
requiring a longer duration of time for this code or an add-on to the
code that would allow, for example, additional 20 minute increments. In
addition, while we recognize that services inherent to models of BHI
provided under this code may range in resource costs, we hope that
appropriate payment for these services will lead to appropriate use of
BHI models of care, which, in turn, will inform further refinement of
the valuation in the future. For additional information on proposed
valuation of these codes, see section II.L of this proposed rule.
(2) Initiating Visit for Proposed BHI Codes (GPPP1, GPPP2, GPPP3, and
GPPPX)
Similar to CCM services (see section II.E.4), we propose to require
an initiating visit for the BHI codes (both the psychiatric CoCM model
and the general BHI code), that would be billable separately from the
services themselves. We propose that the same services that can serve
as the initiating visit for CCM services (see section II.E.3 of this
proposed rule) can serve as the initiating visit for the proposed BHI
codes. The initiating visit would establish the beneficiary's
relationship with the billing practitioner (most aspects of the BHI
services would be furnished incident to the billing practitioner's
professional services), ensure the billing treating physician or other
qualified health care professional assesses the patient prior to
initiating other care management processes, and provides an opportunity
to obtain beneficiary consent (discussed below). We welcome public
comment on the types of services that are appropriate for an initiating
visit for the BHI codes, and within what timeframe the initiating visit
should be conducted prior to furnishing BHI services.
(3) Beneficiary Consent
Commenters to the CY 2016 PFS proposed rule indicated that they did
not believe a specific patient consent for BHI services is necessary
and, in fact, that requiring special informed consent for these
services may reduce access due to stigma associated with behavioral
health conditions. Instead, the commenters recommended requiring a more
general consent prior to initiating these services whereby the
beneficiary gives the initiating physician or practitioner permission
to consult with relevant specialists, which would include conferring
with a psychiatric consultant. Accordingly, we propose to require a
general beneficiary consent to consult with relevant specialists prior
to initiating these services, recognizing that applicable rules
continue to apply regarding privacy. The proposed general consent would
encompass conferring with a psychiatric consultant when furnishing the
psychiatric CoCM codes (GPPP1, GPPP2, and GPPP3) or the broader BHI
code (GPPPX). Similar to the proposed beneficiary consent process for
CCM services (see section II.E.4 of this proposed rule), we propose
that the billing practitioner must document in the beneficiary's
medical record that the beneficiary's consent was obtained to consult
with relevant specialists including a psychiatric consultant, and that,
as part of the consent, the beneficiary is informed that there is
beneficiary cost-sharing, including potential deductible and
coinsurance amounts, for both in-person and non-face-to-face services
that are provided. We welcome stakeholder comments on this proposal.
We recognize that special informed consent can also be helpful in
cases when a particular service is limited to being billed by a single
practitioner for a particular beneficiary. We do not believe that there
are circumstances where it would reasonable for multiple practitioners
to be reporting these codes during the same month. However, we are not
proposing a formal limit at this time. We are seeking comment on
whether such a limitation would be beneficial or whether there are
circumstances under which a beneficiary might reasonably receive BHI
services from more than one practitioner during a given month.
In recent months, many stakeholders have advised that we should
waive the applicable Part B coinsurance for services such as those
included in our proposed BHI codes. However, we currently lack
statutory authority to waive the coinsurance for services such as
these.
4. Reducing Administrative Burden and Improving Payment Accuracy for
Chronic Care Management (CCM) Services
Beginning in CY 2015, we implemented separate payment for chronic
care management (CCM) services under CPT code 99490 (Chronic care
management services, at least 20 minutes of clinical staff time
directed by a physician or other qualified health 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.
We finalized a proposal to make separate payment for CCM services
as one initiative in a series of initiatives designed to improve
payment for, and encourage long-term investment in, care management
services (79 FR 67715). In particular, we sought to address an issue
raised to us by the physician community, which asserted that the care
management included in many of the existing E/M services, such as
office visits, does not adequately describe the
[[Page 46206]]
typical non-face-to-face care management work required by certain
categories of beneficiaries (78 FR 43337). We began to re-examine how
Medicare should pay under the PFS for non-face-to-face care management
services that were bundled into the PFS payment for face-to-face E/M
visits, being included in the pre- and post-encounter work (78 FR
43337). In proposing separate payment for CCM, we acknowledged that,
even though we had previously considered non-face-to-face care
management services as bundled into the payment for face-to-face E/M
visits, the E/M office/outpatient visit CPT codes may not reflect all
the services and resources required to furnish comprehensive,
coordinated care management for certain categories of beneficiaries. We
stated that we believed that the resources required to furnish complex
chronic care management services to beneficiaries with multiple (that
is, two or more) chronic conditions were not adequately reflected in
the existing E/M codes. Medical practice and patient complexity
required physicians, other practitioners and their clinical staff to
spend increasing amounts of time and effort managing the care of
comorbid beneficiaries outside of face-to-face E/M visits, for example
complex and multidisciplinary care modalities that involve regular
physician development and/or revision of care plans; subsequent report
of patient status; review of laboratory and other studies;
communication with other health care professionals not employed in the
same practice who are involved in the patient's care; integration of
new information into the care plan; and/or adjustments of medical
therapy.
Therefore, in the CY 2014 PFS final rule with comment period, we
established a separate payment under the PFS for CPT code 99490 (78 FR
43341 through 43342). We sought to include a relatively broad eligible
patient population within the code descriptor, established a moderate
payment amount, and established bundled payment for concurrently new
CPT codes that were reserved for beneficiaries requiring ``complex''
CCM services (base CPT code 99487 and its add-on code 99489) (79 FR
67716 through 67719). We stated that we would evaluate the services
reported under CPT code 99490 to assess whether the service is targeted
to the right population and whether the payment amount is appropriate
(79 FR 67719). We remind stakeholders that CMS did not limit the
eligible population to any particular list of chronic conditions other
than the language in the CPT code descriptor. Accordingly, one or more
of the chronic conditions being managed through CCM services could be
chronic mental health or behavioral health conditions or chronic
cognitive disorders, as long as the chronic conditions meet the
eligibility language in the CPT code descriptor for CCM services and
the billing practitioner meets all of Medicare's requirements to bill
the code including comprehensive, patient-centered care planning for
all health conditions (see Table 11).
In finalizing separate payment for CPT code 99490, we considered
whether we should develop standards to ensure that physicians and other
practitioners billing the service would have the capability to fully
furnish the service (79 FR 67721). We sought to make certain that the
new PFS code(s) would provide beneficiary access to appropriate care
management services that are characteristic of advanced primary care,
such as patient support for chronic diseases to achieve health goals;
24/7 patient access to care and health information; receipt of
preventive care; patient, family and caregiver engagement; and timely
coordination of care through electronic health information exchange.
Accordingly, we established a set of scope of service elements and
payment rules in addition to or in lieu of those established in CPT
guidance (in the CPT code descriptor and CPT prefatory language), that
the physician or nonphysician practitioner must satisfy to fully
furnish CCM services and report CPT code 99490 (78 FR 74414 through
74427, 79 FR 67715 through 67730, and 80 FR 14854). We established
requirements to furnish a preceding qualifying visit, obtain advance
written beneficiary consent, use certified electronic health record
(EHR) technology to furnish certain elements of the service, share the
care plan and clinical summaries electronically, document specified
activities, and other items summarized in Table 11. For the CCM service
elements for which we required use of a certified EHR, the billing
practitioner must use, at a minimum, technology meeting 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. (For the CY 2017 PFS payment year, this would
mean technology meeting the 2014 edition of certification criteria).
These elements and requirements for separately payable CCM services are
extensive and generally exceed those required for payment of codes
describing procedures, diagnostic tests, or other E/M services under
the PFS. In addition, both CPT guidance and our rules specify that only
a single practitioner who assumes the care management role for a given
beneficiary can bill CPT code 99490 per service period (calendar
month). Because the new CCM service closely overlapped with several
Medicare demonstration models of advanced primary care (the Multi-Payer
Advanced Primary Care Practice (MAPCP) demonstration and the
Comprehensive Primary Care Initiative (CPCI)), we provided that
practitioners participating in one of these two initiatives could not
be paid for CCM services furnished to a beneficiary attributed by the
initiative to their practice (79 FR 67729).
Given the non-face-to-face nature of CCM services, we also sought
to ensure that beneficiaries would receive advance notice that Part B
cost sharing applies since we currently have no legislative authority
to ``waive'' cost sharing for this service. Also since only one
practitioner can bill for CCM each service period, we believed the
beneficiary notice requirement would help prevent duplicate payment to
multiple practitioners.
Since the establishment of CPT code 99490 for separate payment of
CCM services, in a number of forums and in public comments to the CY
2016 PFS final rule (80 FR 70921), many practitioners have stated that
the service elements and billing requirements are burdensome, redundant
and prevent them from being able to provide the services to
beneficiaries who could benefit from them. Stakeholders have stated
that CPT 99490 is underutilized because it is underpaid relative to the
resources involved in furnishing the services, especially given the
extensive Medicare rules for payment, and they have suggested a number
of potential changes to our current payment rules. Stakeholders
continue to believe that many of the CCM payment rules are duplicative
of other statutory and regulatory provisions, and to recommend that we
reduce the rules and expand CCM coding and payment to distinguish among
different levels of patient complexity. We also note that section 103
of the MACRA requires CMS to assess and report to Congress (no later
than December 31, 2017) on access to CCM services by underserved rural
and racial and ethnic minority populations and to conduct an outreach/
education campaign that is underway.
Our assessment of claims data for CY 2015 for CPT code 99490
suggests that
[[Page 46207]]
CCM services may indeed be underutilized considering the number of
eligible Medicare beneficiaries. Our analysis of Medicare claims data
indicates that for CY 2015, approximately 275,000 unique Medicare
beneficiaries received the service an average of 3 times each, totaling
$37 million in allowed charges. Since CPT code 99490 describes a
minimum of 20 minutes of clinical staff time spent furnishing CCM
services during a month and does not have a time limit, and since we
currently do not separately pay the other codes in the CCM family of
CPT codes (which would provide us with utilization data on the number
of patients requiring longer service times during a billing period), we
do not know how often patients required more than 20 minutes of CCM
services per month. We also do not know their relative complexity,
other than meeting the acuity criteria in the CPT code descriptor. We
also have no way to know the relative complexity of the CCM services
furnished to beneficiaries.
In light of this stakeholder feedback and our mandate under MACRA
section 103 to encourage and report on access to CCM services, we are
proposing several changes in the payment rules for CCM services. Our
primary goal and statutory mandate is to pay as accurately as possible
for services furnished to Medicare beneficiaries based on the relative
resources required to furnish PFS services, including CCM services. In
so doing, we also expect to facilitate beneficiaries' access to
reasonable and necessary CCM services that improve health outcomes.
First, for CY 2017 we are proposing to more appropriately recognize and
pay for the other codes in the CPT family of CCM services (CPT codes
99487 and 99489 describing complex CCM), consistent with our general
practice to price services according to their relative ranking within a
given family of services. We direct the reader to section II.L of this
proposed rule for a discussion of proposed valuation for base CPT code
99487 and its add-on CPT code 99489. The CPT code descriptors are:
CPT code 99487--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.
CPT code 99489--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).
As CPT provides, less than 60 minutes of clinical staff time in the
service period could not be reported separately, and similarly, less
than 30 minutes in addition to the first 60 minutes of complex CCM in a
service period could not be reported. We would require 60 minutes of
services for reporting CPT code 99487 and 30 additional minutes for
each unit of CPT code 99489.
We propose to adopt the CPT provision that CPT codes 99487, 99489,
99490 may only be reported once per service period (calendar month) and
only by the single practitioner who assumes the care management role
with a particular beneficiary for the service period. That is, a given
beneficiary would be classified as eligible to receive either complex
or non-complex CCM during a given service period (calendar month), not
both, and only one professional claim could be submitted to the PFS for
CCM for that service period by one practitioner.
Except for differences in the CPT code descriptors, we propose to
require the same CCM service elements for CPT codes 99487, 99489 and
99490. In other words, all the requirements in Table 11 would apply
whether the code being billed for the service period is CPT code 99487
(plus 99489 if applicable) or CPT code 99490. These three codes would
differ in the amount of clinical staff service time provided; the
complexity of medical decision-making as defined in the E/M guidelines
(determined by the problems addressed by the reporting practitioner
during the month); and the nature of care planning that was performed
(establishment or substantial revision of the care plan for complex CCM
versus establishment, implementation, revision or monitoring of the
care plan for non-complex CCM). Billing practitioners could consider
identifying beneficiaries who require complex CCM services using
criteria suggested in CPT guidance (such as number of illnesses, number
of medications or repeat admissions or emergency department visits) or
the profile of typical patients in the CPT prefatory language, but
these would not comprise Medicare conditions of eligibility for complex
CCM.
We are proposing several changes to our current scope of service
elements for CCM, and are proposing that the same scope of service
elements, as amended, would apply to all codes used to report CCM
services beginning in 2017 (i.e., CPT codes 99487, 99489 and 99490). In
particular, we are proposing changes in the requirements for the
initiating visit, 24/7 access to care and continuity of care, format
and sharing of the care plan and clinical summaries, beneficiary
receipt of the care plan, beneficiary consent, and documentation. In
Table 11, we summarize the current scope of service elements and
payment rules for CCM and indicate whether we are proposing to retain,
remove or revise each element.
a. Initiating Visit
As provided in the CY 2014 PFS final rule with comment period (78
FR 74425) and subregulatory guidance (available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/Payment_for_CCM_Services_FAQ.pdf), CCM must be initiated by the billing
practitioner during a ``comprehensive'' E/M visit, annual wellness
visit (AWV) or initial preventive physical exam (IPPE). This face-to-
face, initiating visit is not part of the CCM service and can be
separately billed to the PFS, but is required before CCM services can
be provided directly or under other arrangements. The billing
practitioner must discuss CCM with the patient at this visit. While
informed patient consent does not have to be obtained during this
visit, the visit is an opportunity to obtain the required consent. The
face-to-face visit included in transitional care management (TCM)
services (CPT 99495 and 99496) qualifies as a ``comprehensive'' visit
for CCM initiation. Levels 2 through 5 E/M visits (CPT 99212 through
99215) also qualify; CMS does not require the practice to initiate CCM
during a level 4 or 5 E/M visit. However CPT codes that do not involve
a face-to-face visit by the billing practitioner or are not separately
payable by Medicare (such as CPT 99211, anticoagulant management,
online services, telephone and other E/M services) do not qualify as
initiating visits. If the practitioner furnishes a ``comprehensive'' E/
M, AWV, or IPPE and does not discuss CCM with the patient at that
visit, that visit cannot count as the initiating visit for CCM.
We continue to believe that we should require an initiating visit
in advance of furnishing CCM services, separate from the services
themselves, because a face-to-face visit establishes the beneficiary's
relationship with the billing practitioner
[[Page 46208]]
(most aspects of the CCM services are furnished incident to the billing
practitioner's professional services). The initiating visit also
ensures collection of comprehensive health information to inform the
care plan. We continue to believe that the types of face-to-face
services that qualify as an initiating visit for CCM are appropriate.
We are not proposing to change the kinds of visits that can qualify as
initiating CCM visits. However we are proposing to require the
initiating visit only for new patients or patients not seen within one
year instead of for all beneficiaries receiving CCM services. We
believe this will allow practitioners with existing relationships with
patients who have been seen relatively recently to initiate CCM
services without furnishing a potentially unnecessary E/M visit. We are
seeking public comment on whether a period of time shorter than one
year would be more appropriate.
We are also proposing for CY 2017 to create a new add-on G-code
that would improve payment for visits that qualify as initiating visits
for CCM services. The code would be billable for beneficiaries who
require extensive face-to-face assessment and care planning by the
billing practitioner (as opposed to clinical staff), through an add-on
code to the initiating visit, GPPP7 (Comprehensive assessment of and
care planning by the physician or other qualified health care
professional for patients requiring chronic care management services
(billed separately from monthly care management services) (Add-on code,
list separately in addition to primary service). We propose that when
the billing practitioner initiating CCM personally performs extensive
assessment and care planning outside of the usual effort described by
the billed E/M code (or AWV or IPPE code), the practitioner could bill
GPPP7 in addition to the E/M code for the initiating visit (or in
addition to the AWV or IPPE), and in addition to the CCM CPT code 99490
(or proposed 99487 and 99489) if all requirements to bill for CCM
services are also met. See section II.L for proposed valuation of
GPPP7.
The code GPPP7 would account specifically for additional work of
the billing practitioner in personally performing a face-to-face
assessment of a beneficiary requiring CCM services, and personally
performing CCM care planning (the care planning could be face-to-face
and/or non-face-to-face) that is not already reflected in the
initiating visit itself (nor in the monthly CCM service code). We
believe GPPP7 might be particularly appropriate to bill when the
initiating visit is a less complex visit (such as a level 2 or 3 E/M
visit), although GPPP7 could be billed along with higher level visits
if the billing practitioner's effort and time exceeded the usual effort
described by the initiating visit code. It could also be appropriate to
bill GPPP7 when the initiating visit addresses problems unrelated to
CCM, and the billing practitioner does not consider the CCM-related
work he or she performs in determining what level of initiating visit
to bill. We believe that this proposal will more appropriately
recognize the relative resource costs for the work of the billing
practitioner in initiating CCM services, specifically for extensive
work assessing the beneficiary and establishing the CCM care plan that
is reasonable and necessary, and that is not accounted for in the
billed initiating visit or in the unit of the CCM service itself that
is billed for a given service period. In addition, we believe this
proposal will help ensure that the billing practitioner personally
performs and meaningfully contributes to the establishment of the CCM
care plan when the patient's complexity warrants it.
Consistent with general coding guidance, the work that is reported
under GPPP7 (including time) could not also be reported under or
counted towards the reporting of any other billed code, including any
of the monthly CCM services codes. The care plan that the practitioner
must create in order to bill GPPP7 would be subject to the same
requirements as the care plan included in the monthly CCM services,
namely it must be an electronic 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. This would distinguish
it from the more limited care plan included in the BHI codes GPPP1,
GPPP2, GPPP3 or GPPPX which focus on behavioral health issues, or the
care plan included in GPPP6 which focuses on cognitive status. We are
seeking public input on potential overlap among these codes and further
clinical input as to how the assessments and care planning that is
included in them would differ.
Finally, although not part of our proposals for 2017, we have noted
with interest a recent CPT coding proposal for a code that would
potentially identify and separately pay for monthly CCM work that is
personally performed by the billing physician or other practitioner. We
will continue to follow any CPT developments in this area.
b. 24/7 Access to Care and Continuity of Care
We propose several revisions to the scope of service elements of
24/7 Access to care and Continuity of Care. We continue to believe
these elements are important aspects of CCM services, but that it would
be appropriate to improve alignment with CPT provisions and remove the
requirement for the care plan to be available remotely to individuals
providing CCM services after hours. Studies have shown that after-hours
care is best implemented as part of a larger practice approach to
access and continuity (see for example, the peer-review article
available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3475839/).
There is substantial local variation in how 24/7 access and continuity
of care are achieved, depending on the contractual relationships among
practitioners and providers in a particular geographic area and other
factors. Care models include various contractual relationships between
physician practices and after-hours clinics, urgent care centers and
emergency departments; extended primary care office hours; physician
call-sharing; telephone triage systems; and health information
technology such as shared EHRs and systematic notification procedures
(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3475839/). Some or all of
these may be used to provide access to urgent care on a 24/7 basis
while maintaining information continuity between providers.
We recognize that some models of care require more significant
investment in practice infrastructure than others, for example
resources in staffing or health information technology. In addition, we
believe there is room to reduce the administrative complexity of our
current payment rules for CCM services to accommodate a range of
potential care models. In re-examining what should be included in the
CCM scope of service elements for 24/7 Access to Care and Continuity of
Care, we believe the CPT language adequately and more appropriately
describes the services that should, at a minimum, be included in these
service elements. Therefore, we propose to adopt the CPT language for
these two elements. For 24/7 Access to Care, the scope of service
element would be to provide 24/7 access to physicians or other
qualified health care professionals or clinical staff including
providing patients/caregivers with a means to make contact with health
care professionals in the practice to address urgent needs regardless
of the time of day or day of week. We believe
[[Page 46209]]
the CPT language more accurately reflects the potential role of
clinical staff or call-sharing services in addressing after-hours care
needs than our current language does. In addition, the 24/7 access
would be for ``urgent'' needs rather than ``urgent chronic care
needs,'' because we believe after-hours services typically would and
should address any urgent needs and not only those explicitly related
to the beneficiary's chronic conditions.
We recognize that health information systems that include remote
access to the care plan or the full EHR after hours, or a feedback loop
that communicates back to the primary care physician and others
involved in the beneficiary's care regarding after-hours care or advice
provided, are extremely helpful (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3475839/#CR25). They help ensure that the beneficiary
receives necessary follow up, particularly if he or she is referred to
the emergency department, and follow up after an emergency department
visit is required under the CCM element of Management of Care
Transitions. Accordingly, we continue to support and encourage the use
of interoperable EHRs or remote access to the care plan in providing
the CCM service elements of 24/7 Access to Care, Continuity of Care,
and Management of Care Transitions. However, adoption of such
technology would be optimal not only for CCM services, but also for a
number of other PFS services and procedures (including various other
care management services), and we have not required adoption of any
certified or non-certified health information technology as a condition
of payment for any other PFS service. We note that there are incentives
under other Medicare programs to adopt such information technology, and
are concerned that imposing EHR-related requirements at the service
level as a condition of PFS payment could create disparities between
these services and others under the fee schedule. Lastly, we recognize
that not all after-hours care warrants follow-up or a feedback loop
with the practitioner managing the beneficiary's care overall, and that
under particular circumstances feedback loops can be achieved through
oral, telephone or other less sophisticated communication methods.
Therefore at this time, we propose to remove the requirement that the
individuals providing CCM after hours must have access to the
electronic care plan. This proposal reflects our understanding that
flexibility in how practices can provide the requisite 24/7 access to
care, as well as continuity of care and management of care transitions,
for their CCM patients can facilitate appropriate access to these
services for Medicare beneficiaries. This proposal is not intended to
undermine the significance of standardized communication methods as
part of effective care. Instead, we recognize that other CMS
initiatives may be better mechanisms to incentivize increased
interoperability of health information systems than conditions of
payment assigned to particular services under the PFS. We also
anticipate that improved accuracy of payment for care management
services and reduced administrative burden associated with billing for
them will contribute to practitioners' capacity to invest in the best
tools for managing the care of Medicare beneficiaries.
For Continuity of Care, we currently require the ability to obtain
successive routine appointments ``with the practitioner or a designated
member of the care team,'' while CPT only references successive routine
appointments ``with a designated member of the care team.'' We do not
believe there is any practical difference between these two phrases and
therefore are proposing to omit the words ``practitioner or'' from our
requirement. The billing practitioner is a member of the CCM care team,
so the CPT language already allows for successive routine appointments
either with the billing practitioner or another appropriate member of
the CCM care team.
c. Electronic Care Plan
Based on review of extensive public comment and stakeholder
feedback, we have come to believe that we should not require
individuals providing the beneficiary with the required 24/7 access to
care for urgent needs to have access to the care plan as a condition of
CCM payment. As discussed above, we believe that in general, provision
of effective after-hours care of the beneficiary would require access
to the care plan, if not the full EHR. However, we have heard from
rural and other practices that remote access to the care plan is not
always necessary or possible because urgent care needs after-hours are
often referred to a practitioner or care team member who established
the care plan or is familiar with the beneficiary. In some instances,
the care plan does not need to be available in order to address urgent
patient needs after business hours. In addition, we have not required
the use of any certified or non-certified health information technology
in the provision of any other PFS services (including various other
care management services). We are concerned that imposing EHR-related
requirements at the service level as a condition of PFS payment could
distort the relative valuation of services priced under the fee
schedule. Therefore, we propose to change the CCM service element to
require timely electronic sharing of care plan information within and
outside the billing practice, but not necessarily on a 24/7 basis, and
to allow transmission of the care plan by fax.
We acknowledge that it is best for practitioners and providers to
have access to care plan information any time they are providing
services to beneficiaries who require CCM services. This proposal is
not intended to undermine the significance of electronic communication
methods other than fax transmission in providing effective, continuous
care. On the contrary, we believe that fax transmission, while commonly
used, is much less efficient and secure than other methods of
communicating patient health information, and we encourage
practitioners to adopt and use electronic technologies other than fax
for transmission and exchange of the CCM care plan. We continue to
believe the best means of exchange of all relevant patient health
information is through standardized electronic means. However, we
recognize that other CMS initiatives may be better mechanisms to
incentivize increased interoperability of health information systems
than conditions of payment assigned to particular services under the
PFS. We believe our proposal would still allow timely availability of
health information within and outside the practice for purposes of
providing CCM, and would simplify the rules governing provision of the
service and improve access to the service. These proposed revisions
would better align the service with appropriate CPT prefatory language,
which may reduce unnecessary administrative complexity for
practitioners in navigating the differences between CPT guidance and
Medicare rules.
d. Clinical Summaries
The CCM scope of service element Management of Care Transitions
includes a requirement for the creation and electronic transmission and
exchange of continuity of care documents referred to as ``clinical
summaries'' (see Table 11). We patterned our requirements regarding
clinical summaries after the EHR Incentive Program requirement that an
eligible professional who transitions their patient to another setting
of care or provider of care, or refers their patient to another
provider of care, should
[[Page 46210]]
provide a summary care record for each transition of care or referral.
This clinical summary includes demographics, the medication list,
medication allergy list, problem list, and a number of other data
elements if the practitioner knows them. As a condition of CCM payment,
we required standardized content for clinical summaries (that they must
be created/formatted according to certified EHR technology). For the
exchange/transport function, we did not require the use of a specific
tool or service to exchange/transmit clinical summaries, as long as
they are transmitted electronically (this can include fax only when the
receiving practitioner or provider can only receive by fax).
Based on review of extensive public comment and stakeholder
feedback, we have come to believe that we should not require the use of
any specific electronic technology in managing a beneficiary's care
transitions as a condition of payment for CCM services. Instead we are
proposing more simply to require the billing practitioner to create and
exchange/transmit continuity of care document(s) timely with other
practitioners and providers. To avoid confusion with the requirements
of the EHR Incentive Programs, and since we would no longer require
standardized content for the CCM continuity of care document(s), we
would refer to them as continuity of care documents instead of clinical
summaries. We would no longer specify how the billing practitioner must
transport or exchange these document(s), as long as it is done timely
and consistent with the Care Transitions Management scope of service
element. We welcome public input on how we should refer to these
document(s), noting that CPT does not provide model language specific
to CCM services. The proposed term ``continuity of care document(s)''
draws on CPT prefatory language for TCM services, which CPT provides
may include ``obtaining and reviewing the discharge information (for
example, discharge summary, as available, or continuity of care
document).''
Again, this proposal is not intended to undermine the significance
of a standardized, electronic format and means of exchange (other than
fax) of all relevant patient health information, for achieving timely,
seamless care across settings especially after discharge from a
facility. On the contrary, we believe that fax transmission, while
commonly used, is much less efficient and secure than other methods of
communicating patient health information, and we encourage
practitioners to adopt and use electronic technologies other than fax
for transmission and exchange of continuity of care documents in
providing CCM services. We continue to believe the best means of
exchange of all relevant patient health information is through
standardized electronic means. However, as we discussed above regarding
the CCM care plan, we have not applied similar requirements to other
PFS services specifically (including various other care management
services) and have concerns about how doing so may create disparities
between these services and others under the PFS. We also recognize that
other CMS initiatives may be better mechanisms to incentivize increased
interoperability of health information systems than conditions of
payment assigned to particular services under the PFS. However, we also
anticipate that our proposals will contribute to practitioners'
capacity to invest in the best tools for managing the care of Medicare
beneficiaries.
e. Beneficiary Receipt of Care Plan
We propose to simplify the current requirement to provide the
beneficiary with a written or electronic copy of the care plan, by
instead adopting the CPT language specifying more simply that a copy of
the care plan must be given to the patient or caregiver. While we
believe beneficiaries should and must be provided a copy of the care
plan, and that practitioners may choose to provide the care plan in
hard copy or electronic form in accordance with patient preferences, we
do not believe it is necessary to specify the format of the care plan
that must be provided as a condition of CCM payment. Additionally, we
recognize that there may be times that sharing the care plan with the
caregiver (in a manner consistent with applicable privacy and security
rules and regulations) may be appropriate.
f. Beneficiary Consent
We continue to believe that obtaining advance beneficiary consent
to receive CCM services is important to ensure the beneficiary is
informed, educated about CCM services, and is aware of applicable cost
sharing. We also believe that querying the beneficiary about whether
another practitioner is already providing CCM services helps to reduce
the potential for duplicate provision or billing of the services.
However, we believe the consent process could be simplified, and that
it should be left to the practitioner and the beneficiary to decide the
best way to establish consent. Therefore, we propose to continue to
require billing practitioners to inform the beneficiary of the
currently required information (that is, inform the beneficiary of the
availability of CCM services; inform the beneficiary that only one
practitioner can furnish and be paid for these services during a
calendar month; and inform the beneficiary of the right to stop the CCM
services at any time (effective at the end of the calendar month)).
However, we propose to specify that the practitioner could document in
the beneficiary's medical record that this information was explained
and note whether the beneficiary accepted or declined CCM services
instead of obtaining a written agreement.
We also propose to remove the language requiring beneficiary
authorization for the electronic communication of his or her medical
information with other treating providers as a condition of payment for
CCM services, because under the Health Insurance Portability and
Accountability Act (HIPAA) Privacy Rule (45 CFR 164.506), a covered
entity is permitted to use or disclose protected health information for
purposes of treatment without patient authorization. Moreover, if such
disclosure is electronic, the HIPAA Security Rule requires secure
transmission (45 CFR 164.312(e)). In previous regulations we have
reminded practitioners that for all electronic sharing of beneficiary
information in the provision of CCM services, HIPAA Privacy and
Security Rule standards apply in the usual manner (79 FR 67728).
g. Documentation
We have heard from practitioners that the requirements to document
certain information in a certified EHR format are redundant because the
CCM billing rules already require documentation of core clinical
information in a certified EHR format. Specifically, we already require
structured recording of demographics, problems, medications and
medication allergies, and the creation of a clinical summary record,
using a qualifying certified EHR; and that a full list of problems,
medications and medication allergies in the EHR must inform the care
plan, care coordination and ongoing clinical care. Therefore, we
propose to no longer require the use of a qualifying certified EHR to
document communication to and from home- and community-based providers
regarding the patient's psychosocial needs and functional deficits and
to document beneficiary consent. We would continue to require
documentation in the medical record of beneficiary consent (discussed
above) and of communication to and from home- and community-based
providers
[[Page 46211]]
regarding the patient's psychosocial needs and functional deficits.
In summary, we believe our proposed changes would retain elements
of the CCM service that are most characteristic of the changes in
medical practice toward advanced primary care, while eliminating
redundancy, simplifying provision of the services, and improving access
without compromising quality of care and beneficiary privacy or advance
notice and consent. We also anticipate that improved accuracy of
payment for care management services and reduced administrative burden
associated with billing for these services will contribute to
practitioners' capacity to invest in the best tools for managing the
care of Medicare beneficiaries.
g. CCM Requirements for Rural Health Clinics (RHCs) and Federally
Qualified Health Centers (FQHCs)
RHCs and FQHCs have been authorized to bill for CCM services since
January 1, 2016, and are paid based on the Medicare PFS national
average non-facility payment rate when CPT code 99490 is billed alone
or with other payable services on a RHC or FQHC claim. The RHC and FQHC
requirements for billing CCM services have generally followed the
requirements for practitioners billing under the PFS, with some
adaptations based on the RHC and FQHC payment methodologies.
To assure that CCM requirements for RHCs and FQHCs are not more
burdensome than those for practitioners billing under the PFS, we are
proposing revisions for CCM services furnished by RHCs and FQHCs
similar to the revisions proposed under the section above entitled,
``Reducing Administrative Burden and Improving Payment Accuracy for
Chronic Care Management (CCM) Services'' for RHCs and FQHCs.
Specifically, we propose to:
Require that CCM be initiated during an AWV, IPPE, or
comprehensive E/M visit only for new patients or patients not seen
within one year. This would replace the requirement that CCM could only
be initiated during an AWV, IPPE, or comprehensive E/M visit where CCM
services were discussed.
Require 24/7 access to a RHC or FQHC practitioner or
auxiliary staff with a means to make contact with a RHC or FQHC
practitioner to address urgent health care needs regardless of the time
of day or day of week. This would replace the requirement that CCM
services be available 24/7 with health care practitioners in the RHC or
FQHC who have access to the patient's electronic care plan to address
his or her urgent chronic care needs, regardless of the time of day or
day of the week.
Require timely electronic sharing of care plan information
within and outside the RHC or FQHC, but not necessarily on a 24/7
basis, and allow transmission of the care plan by fax. This would
replace the requirement that the electronic care plan be available on a
24/7 basis to all practitioners within the RHC or FQHC whose time
counts towards the time requirement for the practice to bill the CCM
code, and removes the restriction on allowing the care plan to be
faxed.
Require that in managing care transitions, the RHC or FQHC
creates, exchanges, and transmits continuity of care document(s) in a
timely manner with other practitioners and providers. This would
replace the requirements that clinical summaries must be created and
formatted according to certified EHR technology, and the requirement
for electronic exchange of clinical summaries by a means other than
fax.
Require that a copy of the care plan be given to the
patient or caregiver. This would remove the description of the format
(written or electronic) and allows the care plan to be provided to the
caregiver when appropriate (and in a manner consistent with applicable
privacy and security rules and regulations).
Require that the RHC or FQHC practitioner documents in the
beneficiary's medical record that all the elements of beneficiary
consent (for example, that the beneficiary was informed of the
availability of CCM services; only one practitioner can furnish and be
paid for these services during a calendar month; the beneficiary may
stop the CCM services at any time, effective at the end of the calendar
month, etc.) were provided, and whether the beneficiary accepted or
declined CCM services. This would replace the requirement that RHCs and
FQHCs obtain a written agreement that these elements were discussed,
and removes the requirement that the beneficiary provide authorization
for the electronic communication of his or her medical information with
other treating providers as a condition of payment for CCM services.
Require that communication to and from home- and
community-based providers regarding the patient's psychosocial needs
and functional deficits be documented in the patient's medical record.
This would replace the requirement to document this patient health
information in a certified EHR format.
We note that we are not proposing an additional payment adjustment
for patients who require extensive assessment and care planning as part
of the initiating visit, as payments for RHC and FQHC services are not
adjusted for length or complexity of the visit.
We believe these proposed changes would keep the CCM requirements
for RHCs and FQHCs consistent with the CCM requirements for
practitioners billing under the PFS, simplify the provision of CCM
services by RHCs and FQHCs, and improve access to these services
without compromising quality of care, beneficiary privacy, or advance
notice and consent.
Table 11--Chronic Care Management (CCM) Scope of Service Elements and Billing Requirements
----------------------------------------------------------------------------------------------------------------
CCM Scope of service element/billing Propose to Propose to
requirement retain remove Proposed revision
----------------------------------------------------------------------------------------------------------------
Initiating Visit--Initiation during an AWV, ............... ............... Initiation during an AWV, IPPE,
IPPE, or face-to-face E/M visit for all or face-to-face E/M visit
patients (Level 4 or 5 visit not required). (Level 4 or 5 visit not
required) for new patients or
patients not seen within 1
year.
Structured Recording of Patient Information ............... ............... Structured Recording of Patient
Using Certified EHR Technology--Structured Information Using Certified
recording of demographics, problems, EHR Technology--Structured
medications, medication allergies, and the recording of demographics,
creation of a structured clinical summary problems, medications and
record, using certified EHR technology. A medication allergies using
full list of problems, medications and certified EHR technology. A
medication allergies in the EHR must inform full list of problems,
the care plan, care coordination and ongoing medications and medication
clinical care. allergies in the EHR must
inform the care plan, care
coordination and ongoing
clinical care.
[[Page 46212]]
24/7 Access to Care--Access to care ............... ............... Provide 24/7 access to
management services 24/7 (providing the physicians or other qualified
beneficiary with a means to make timely health professionals or
contact with health care practitioners in clinical staff including
the practice who have access to the providing patients/caregivers
patient's electronic care plan to address with a means to make contact
his or her urgent chronic care needs with health care professionals
regardless of the time of day or day of the in the practice to address
week). urgent needs regardless of the
time of day or day of week.
Continuity of Care--Continuity of care with a ............... ............... Continuity of care with a
designated practitioner or member of the designated member of the care
care team with whom the beneficiary is able team with whom the beneficiary
to get successive routine appointments. is able to schedule successive
routine appointments.
Comprehensive Care Management--Care X ............... ...............................
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.
Electronic Comprehensive Care Plan--Creation X ............... ...............................
of an electronic 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.
Electronic Sharing of Care Plan--Must at ............... ............... Must at least electronically
least electronically capture care plan capture care plan information,
information; make this information available and make this information
on a 24/7 basis to all practitioners within available timely within and
the practice whose time counts towards the outside the billing practice
time requirement for the practice to bill as appropriate. Share care
the CCM code; and share care plan plan information
information electronically (by fax in electronically (can include
extenuating circumstance) as appropriate fax) and timely within and
with other practitioners and providers. outside the billing practice
to individuals involved in the
beneficiary's care.
Beneficiary Receipt of Care Plan--Provide the ............... ............... A copy of the plan of care must
beneficiary with a written or electronic be given to the patient or
copy of the care plan. caregiver.
Documentation of care plan provision to ............... X ...............................
beneficiary-- Document provision of the care
plan as required to the beneficiary using
certified EHR technology.
Management of Care Transitions............... ............... ............... Management of Care Transitions
Management of care transitions Management of care
between and among health care providers and transitions between and among
settings, including referrals to other health care providers and
clinicians; follow-up after an emergency settings, including referrals
department visit; and follow-up after to other clinicians; follow-up
discharges from hospitals, skilled nursing after an emergency department
facilities or other health care facilities. visit; and follow-up after
Format clinical summaries according discharges from hospitals,
to certified EHR technology (content skilled nursing facilities or
standard). other health care facilities.
Not required to use a specific tool Create and exchange/
or service to exchange/transmit clinical transmit continuity of care
summaries, as long as they are transmitted document(s) timely with other
electronically (by fax in extenuating practitioners and providers.
circumstance).
Home- and Community-Based Care Coordination-- X ............... ...............................
Coordination with home and community based
clinical service providers.
Documentation of Home- and Community-Based ............... ............... Communication to and from home-
Care Coordination--Communication to and from and community-based providers
home- and community-based providers regarding the patient's
regarding the patient's psychosocial needs psychosocial needs and
and functional deficits must be documented functional deficits must be
in the patient's medical record using documented in the patient's
certified EHR technology. medical record.
[[Page 46213]]
Enhanced Communication Opportunities-- X ............... ...............................
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
Inform the beneficiary of the of the availability of CCM
availability of CCM services and obtain his services.
or her written agreement to have the Inform the beneficiary
services provided, including authorization that only one practitioner can
for the electronic communication of his or furnish and be paid for these
her medical information with other treating services during a calendar
providers. month.
Inform the beneficiary of the right Inform the beneficiary
to stop the CCM services at any time of the right to stop the CCM
(effective at the end of the calendar month) services at any time
and the effect of a revocation of the (effective at the end of the
agreement on CCM services. calendar month).
Inform the beneficiary that only one Document in the
practitioner can furnish and be paid for beneficiary's medical record
these services during a calendar month. that the required information
Document the beneficiary's written was explained and whether the
consent and authorization using certified beneficiary accepted or
EHR technology. declined the services.
----------------------------------------------------------------------------------------------------------------
5. Assessment and Care Planning for Patients With Cognitive Impairment
For CY 2017 we are proposing a G-code that would provide separate
payment to recognize the work of a physician (or other appropriate
billing practitioner) in assessing and creating a care plan for
beneficiaries with cognitive impairment, GPPP6 (Cognition and
functional assessment using standardized instruments with development
of recorded care plan for the patient with cognitive impairment,
history obtained from patient and/or caregiver, in office or other
outpatient setting or home or domiciliary or rest home). We understand
that a similar code was recently approved by the CPT Editorial Panel
and is scheduled to be included in the CY 2018 CPT code set. We intend
for GPPP6 to be a temporary code (perhaps for only one-year) and will
consider whether to adopt and establish relative value units for the
new CPT code under our standard process, presumably for CY 2018.
We reviewed the list of service elements that were proposed at CPT,
and are proposing the following as required service elements of GPPP6:
Cognition-focused evaluation including a pertinent history
and examination.
Medical decision making of moderate or high complexity
(defined by the E/M guidelines).
Functional assessment (for example, Basic and Instrumental
Activities of Daily Living), including decision-making capacity.
Use of standardized instruments to stage dementia.
Medication reconciliation and review for high-risk
medications, if applicable.
Evaluation for neuropsychiatric and behavioral symptoms,
including depression, including use of standardized instrument(s).
Evaluation of safety (for example, home), including motor
vehicle operation, if applicable.
Identification of caregiver(s), caregiver knowledge,
caregiver needs, social supports, and the willingness of caregiver to
take on caregiving tasks.
Advance care planning and addressing palliative care
needs, if applicable and consistent with beneficiary preference.
Creation of a care plan, including initial plans to
address any neuropsychiatric symptoms and referral to community
resources as needed (for example, adult day programs, support groups);
care plan shared with the patient and/or caregiver with initial
education and support.
The proposed valuation of GPPP6 (discussed in section II.E.1)
assumes that this code would include services that are personally
performed by the physician (or other appropriate billing practitioner)
and would significantly overlap with services described by certain E/M
visit codes, advance care planning services, and certain psychological
or psychiatric service codes that are currently separately payable
under the PFS. Accordingly, we propose that GPPP6 must be furnished by
the physician (or other appropriate billing practitioner) and could not
be billed on the same date of service as CPT codes 90785 (Psytx complex
interactive), 90791 (Psych diagnostic evaluation), 90792 (Psych diag
eval w/med srvcs), 96103 (Psycho testing admin by comp), 96120
(Neuropsych tst admin w/comp), 96127 (Brief emotional/behav assmt),
99201-99215 (Office/outpatient visits new), 99324-99337 (Domicil/r-home
visits new pat), 99341-99350 (Home visits new patient), 99366-99368
(Team conf w/pat by hc prof), 99497 (Advncd care plan 30 min), 99498
(Advncd care plan addl 30 min)), since these codes all reflect face-to-
face services provided by the physician or other billing practitioner
for related services that are separately payable. In addition, we are
proposing to prohibit billing of GPPP6 with other care planning
services, such as care plan oversight services (CPT code 99374), home
health care and hospice supervision (G0181, G0182), or our proposed
add-on code for comprehensive assessment and care planning by the
billing practitioner for patients requiring CCM services (GPPP7). We
are seeking comment on whether there are circumstances where multiple
care planning codes could be furnished without significant overlap. We
propose to specify that GPPP6 may serve as a companion or primary E/M
code to the prolonged service codes (those that are currently
separately paid, and those we propose to separately pay beginning in
2017), but are interested in
[[Page 46214]]
public input on whether there is any overlap among these services. We
are seeking comment on how to best delineate the post-service work for
GPPP6 from the work necessary to provide the prolonged services code.
We do not believe the services described by GPPP6 would
significantly overlap with proposed or current medically necessary CCM
services (CPT codes 99487, 99489, 99490); TCM services (99495, 99496);
or the proposed behavioral health integration service codes (GPPP1,
GPPP2, GPPP3, GPPPX). Therefore we propose that GPPP6 could be billed
on the same date-of-service or within the same service period as these
codes (CPT codes 99487, 99489, 99490, 99495, 99496, GPPP1, GPPP2,
GPPP3, GPPPX). There may be overlap in the patient population eligible
to receive these services and the population eligible to receive the
services described by GPPP6, but we believe there would be sufficient
differences in the nature and extent of the assessments, interventions
and care planning, as well as the qualifications of individuals
providing the services, to allow concurrent billing for services that
are medically reasonable and necessary. We welcome public comment on
potential overlap between GPPP6 and existing PFS billing codes, as well
as the other primary care/cognitive services addressed in this section
of the proposed rule.
6. Improving Payment Accuracy for Care of People With Disabilities
a. Background
People with disabilities face significant challenges accessing the
health care system. Medicare beneficiaries who are under age 65 with
disabilities are three times more likely to report having difficulties
finding a doctor who accepts Medicare than beneficiaries age 65 and
older.\4\ When able to find a Medicare participating physician, people
with disabilities report worse experiences than people without
disabilities on many quality measures, including those related to
patient-centered care and patient safety based on data from the
National Healthcare Disparities Report, produced by the Agency for
Healthcare Research and Quality (AHRQ).\5\ The reasons for these access
and quality disparities are multifaceted and may include a range of
payment challenges, accessibility issues with equipment and facilities,
communication obstacles, and sometimes lack of practitioner
understanding of how to assess and fully address the needs and
preferences of people with disabilities. The Equity Plan for Improving
Quality in Medicare, released last fall by CMS, highlights many
challenges in achieving better outcomes for people with disabilities.
---------------------------------------------------------------------------
\4\ The Henry J Kaiser Family Foundation. 2010. ``Medicare and
Nonelderly People with Disabilities.''
\5\ National Healthcare Disparities Report, 2013. May 2014.
Agency for Healthcare Research and Quality, Rockville, MD. The
National Healthcare Disparities Report summarizes health care
quality and access among various racial, ethnic, and income groups
and other priority populations, such as residents of rural areas and
people with disabilities.
---------------------------------------------------------------------------
One way to help improve access to high-quality physicians' services
for people with disabilities is to ensure Medicare Physician Fee
Schedule payments are based on the accurate relative resource costs of
services furnished to people with disabilities.
As described in section I.B. of this proposed rule, PFS payments
are required to be based on the relative resources involved in
furnishing a service. To determine the relative resources required to
furnish a service described by a specific HCPCS code, CMS considers the
``typical'' Medicare service described by that code, and identifies the
resources involved in that scenario. This approach assumes that while
practitioners might incur greater or fewer costs in furnishing any
specific service to any particular beneficiary, RVUs are allocated
appropriately based on a ``typical'' Medicare case-mix.
For HCPCS codes that describe narrowly-defined procedures and
tests, PFS payment rates based on the typical resources may be accurate
for most kinds of practitioners and many beneficiaries, because the
granularity of coding corresponds with practitioners' use of resources
based on the specific medical needs of their patients. However, the
HCPCS codes that describe the office/outpatient E/M services are
broadly defined, so the typical service billed using one of those HCPCS
codes matches a much smaller percentage of all the services billed
using that HCPCS code. Medicare payment rates for these kinds of
services under the PFS do not vary by the population being served, or
by the particular practitioner furnishing the services. Payment for
these kinds of service vary only based on the delineations among the
level of visits, despite the reality that adequately serving certain
patients requires much greater resources in ways that are generally not
reflected in the described differentiation between visit levels.
For example, the same codes and rates are used to pay for routine
care of all patients, including furnishing care to patients with
disabilities that often require greater resources relating to
equipment, clinical staff, and physician time relative to the resource
costs associated with providing the same kind of care to other Medicare
beneficiaries. Thus, the payment rate for the code may not accurately
reflect the resources involved in providing the service to certain
categories of beneficiaries. For these reasons, the resources involved
in furnishing care, including and especially routine care of both acute
and chronic illness, to beneficiaries with disabilities may be
routinely and systematically underestimated under PFS payment made on
the basis of the broadly described visit codes. This effectively
reduces overall payment relative to resource needs for practitioners
who more frequently serve such patients, which could negatively impact
access or quality of care for beneficiaries with disabilities.
b. Establishing a HCPCS G-Code To Improve Payment Accuracy for Care of
People With Mobility-Related Disabilities
We estimate that about 7 percent of all Medicare beneficiaries have
a potentially disabling mobility-related diagnosis (the Medicare-only
prevalence is 5.5 percent and the prevalence for Medicare-Medicaid dual
eligible beneficiaries is 11 percent), using 2010 Medicare (and for
dual eligible beneficiaries, Medicaid) claims data.
When a beneficiary with a mobility-related disability goes to a
physician or other practitioner's office for an E/M visit, the
resources associated with providing the visit can exceed the resources
required for the typical E/M visit. An E/M visit for a patient with a
mobility-related disability can require more physician and clinical
staff time to provide appropriate care because the patient may require
skilled assistance throughout the visit to carefully move and adjust
his/her body. Furthermore, an E/M visit for a patient with a mobility-
related disability commonly requires specialized equipment such as a
wheel chair accessible scale, floor and overhead lifts, a movable exam
table, padded leg supports, a stretcher and transfer board. The current
E/M visit payment rates, based on an assumption of ``typical''
resources involved in furnishing an E/M visit to a ``typical'' patient,
do not accurately reflect these additional resources associated with
furnishing appropriate care to many beneficiaries with mobility-related
disabilities.
When furnishing E/M services to beneficiaries with mobility-related
[[Page 46215]]
disabilities, practitioners face difficult choices in deciding whether
to take the extra time necessary and invest in the required specialized
equipment for these visits even though the payment rate for the service
does not account for either expense; potentially providing less than
optimal care for a beneficiary whose needs exceed the standard
appointment block of time in the standard equipped exam room reflected
in the current E/M visit payment rate; or declining to accept
appointments altogether for beneficiaries who require additional time
and specialized equipment.
Each of these scenarios is potentially problematic. The first two
scenarios suggest that the quality of care for this beneficiary
population might be compromised by assumptions under the PFS regarding
relative resource costs in furnishing services to this population. The
third scenario reflects an obvious access problem for these
beneficiaries. To improve payment accuracy and help ameliorate
potential disparity in access and quality for beneficiaries with
mobility-related disabilities, we propose to create a new add-on G-
code, effective for CY 2017, to describe the additional services
furnished in conjunction with E/M services to beneficiaries with
disabilities that impair their mobility:
GDDD1: Resource-intensive services for patients for whom
the use of specialized mobility-assistive technology (such as
adjustable height chairs or tables, patient lifts, and adjustable
padded leg supports) is medically necessary and used during the
provision of an office/outpatient evaluation and management service
visit (Add-on code, list separately in addition to primary procedure).
Effective January 1, 2017, we propose that this add-on code could
be billed with new and established patient office/outpatient E/M codes
(CPT codes 99201 through 99205, and 99212 through 99215), as well as
transitional care management codes (CPT codes 99495 and 99496), when
the additional resources described by the code are medically necessary
and used in the provision of care. In addition to seeking comment on
this proposal, we are also seeking comment on other HCPCS codes that
may be appropriate base codes for this proposed add-on code, including
those describing preventive visits and services. We remind potential
commenters that the rationale for this proposal is based in large part
on the broad use and lack of granularity in coding for E/M services
relative to other PFS services in conjunction with the additional
resources used.
The proposed inputs and valuation for this code are detailed in
section II.L of this proposed rule.
c. Soliciting Comment on Other Coding Changes To Improve Payment
Accuracy for Care of People With Disabilities
When furnishing care to a beneficiary with a mobility-related
disability, the current E/M visit payment rates may not fully reflect
the associated resource costs that are being incurred by practitioners.
We recognize that there are other populations for which payment
adjustment may be appropriate. Our proposal regarding beneficiaries
with mobility-related disabilities reflects the discrete nature of the
additional resource costs for this population, the clear lack of
differentiation in resource costs regarding particular kinds of
frequently-furnished services, and the broad recognition of access
problems. We recognize that some physician practices may frequently
furnish services to particular populations for which the relative
resource costs are similarly systemically undervalued and we seek
comment regarding other circumstances where these dynamics can be
discretely observed.
7. Supervision for Requirements for Non-Face-to-Face Care Management
Services
Our current regulations in Sec. 410.26(b) provide for an exception
to allow general supervision of CCM services (and similarly, for the
non-face-to-face portion of TCM services), because these are non-face-
to-face care management/care coordination services that would commonly
be provided by clinical staff when the billing practitioner, and hence,
the supervising physician, is not physically present; and the CPT codes
are comprised solely (or largely) of non-face-to-face services provided
by clinical staff. A number of codes that we are proposing to establish
for separate payment in CY 2017 under our initiative to improve payment
accuracy for primary care and care management are similar to CCM
services in that a critical element of the services is non-face-to-face
care management/care coordination services provided by clinical staff
when the billing practitioner may not be physically present.
Accordingly, we are proposing to amend Sec. 410.26(a)(3) and Sec.
410.26 (b) to better define general supervision and to allow general
supervision not only for CCM services and the non-face-to-face portion
of TCM services, but also for proposed codes GPPP1, GPPP2, GPPP3,
GPPPX, CPT code 99487, and CPT code 99489. Instead of adding each of
these proposed codes requiring general supervision to the regulation
text on an individual basis, we propose to revise our regulation under
paragraph (b)(1) of Sec. 410.26 to allow general supervision of the
non-face-to-face portion of designated care management services, and we
would designate the applicable services through notice and comment
rulemaking.
F. Improving Payment Accuracy for Services: Diabetes Self-Management
Training (DSMT)
Section 1861(s)(2)(S) of the Act specifies that medical and other
health services include DSMT services as defined in section 1861(qq) of
the Act. DSMT services are intended to educate beneficiaries in the
successful self-management of diabetes. DSMT includes, as applicable,
instructions in self-monitoring of blood glucose; education about diet
and exercise; an insulin treatment plan developed specifically for the
patient who is insulin-dependent; and motivation for patients to use
the new skills for self-management (see Sec. 410.144(a)(5)). DSMT
services are reported under HCPCS codes G0108 (Diabetes outpatient
self-management training services, individual, per 30 minutes) and
G0109 (Diabetes outpatient self- management training services, group
session (2 or more), per 30 minutes). The benefit, as specified at
Sec. 410.141, consists of 1 hour of individual and 9 hours of group
training unless special circumstances warrant more individual training
or no group session is available within 2 months of the date the
training is ordered.
Section 1861(qq) of the Act specifies that DMST services are
furnished by a certified provider, defined as a physician or other
individual or entity that also provides, in addition to DSMT, other
items or services for which payment may be made under Medicare. The
physician, individual or entity that furnishes the training also must
meet certain quality standards. The physician, individual or entity can
meet standards established by us or standards originally established by
the National Diabetes Advisory Board and subsequently revised by
organizations who participated in their establishment, or can be
recognized by an organization that represents individuals with diabetes
as meeting standards for furnishing the services.
We require that all those who furnish DSMT services be accredited
as meeting quality standards by a CMS-approved national accreditation
organization (NAO). In accordance with Sec. 410.144, a CMS-approved
NAO may accredit an
[[Page 46216]]
individual, physician or entity to meet one of three sets of DSMT
quality standards: CMS quality standards; the National Standards for
Diabetes Self-Management Education Programs (National Standards); or
the standards of an NAO that represents individuals with diabetes that
meet or exceed our quality standards. Currently, we recognize the
American Diabetes Association and the American Association of Diabetes
Educators as approved NAOs, both of whom follow National Standards.
Medicare payment for outpatient DSMT services is made in accordance
with Sec. 414.63.
An article titled ``Use of Medicare's Diabetes Self-Management
Training Benefit'' was published in the Health Education Behavior on
January 23, 2015. The article noted that only 5 percent of Medicare
beneficiaries with newly diagnosed diabetes used DSMT services. The
article recommended that future research identify barriers to DSMT
access.
We understand there are a number of issues that may contribute to
the low utilization of these services. Some of the issues that have
been brought to our attention by the DSMT community and NAOs are:
Concerns that claims have been rejected or denied because
of confusion about the credentials of the individuals who furnish DSMT
services. In entities following the National Standards, the credentials
of the educators actually providing the training are determined by the
NAO and are not to be determined by the Medicare Administrative
Contractor. Many individuals who actually furnish DSMT services, such
as registered nurses and pharmacists, do not qualify to enroll in
Medicare as certified providers, as that term is defined at section
1861(qq)(2)(A) of the Act, and codified in our regulations at Sec.
410.140 as approved entit(ies).
Questions about when individual (rather than group) DSMT
services are available. As noted above, the benefit consists of 1 hour
of individual and 9 hours of group training unless special
circumstances warrant more individual training or no group session is
available within 2 months of the date the training is ordered. The
special circumstances are when the beneficiary's physician or qualified
NPP documents in the beneficiary's medical record that the beneficiary
has special needs resulting from conditions such as severe vision,
hearing, or language limitations that would hinder effective
participation in a group training session. In all cases, however, the
physician or NPP must order individual training.
Concerns that the Medicare Benefit Policy Manual, Chapter
15, section 300 does not clarify the settings and locations in which
DSMT services may be provided. As a result, some providers (and perhaps
some Medicare contractors) are confused. In regard to this issue, we
note that a forthcoming manual update will reiterate the guidance we
provided to the DSMT community, including the NAOs, in a response to
their letter requesting clarification regarding the settings and
locations in which DSMT services can be provided. The manual update
will clarify that: (a) In the case of DSMT services furnished by an
entity that submits professional claims to the A/B Medicare
Administrative Contractor (MAC), such as a physician's office or an
RD's practice, DSMT services may be furnished at alternate locations
used by the entity as a practice location; and (b) when the DSMT
services are furnished by an entity that is a hospital outpatient
department (HOPD), these DSMT services must be furnished in the
hospital (including a provider-based department) and cannot be
furnished at alternate non-hospital locations. We plan to address and
clarify the above issues through Medicare program instructions as
appropriate. We also recognize the possibility that Medicare payment
for these services may not fully reflect the resources required to
provide them and this may be contributing to relatively low
utilization. There may also be other barriers to access of which we are
not aware. We are seeking public comment on such barriers to help us
identify and address them. We also seek comment and information on
whether Medicare payment for these services is accurate. In particular,
we would appreciate information on the time and intensity of services
provided, and on the services and supplies that should be included in
the calculation of practice expenses. We will consider this information
to determine whether to propose an update to resource inputs used to
develop payment rates for these services in future rulemaking.
G. Target for Relative Value Adjustments for Misvalued Services
Section 1848(c)(2)(O) of the Act establishes an annual target for
reductions in PFS expenditures resulting from adjustments to relative
values of misvalued codes. Under section 1848(c)(2)(O)(ii) of the Act,
if the estimated net reduction in expenditures for a year as a result
of adjustments to the relative values for misvalued codes is equal to
or greater than the target for that year, reduced expenditures
attributable to such adjustments shall be redistributed in a budget-
neutral manner within the PFS in accordance with the existing budget
neutrality requirement under section 1848(c)(2)(B)(ii)(II) of the Act.
The provision also specifies that the amount by which such reduced
expenditures exceeds the target for a given year shall be treated as a
net reduction in expenditures for the succeeding year, for purposes of
determining whether the target has been met for that subsequent year.
Section 1848(c)(2)(O)(iv) of the Act defines a target recapture amount
as the difference between the target for the year and the estimated net
reduction in expenditures under the PFS resulting from adjustments to
RVUs for misvalued codes. Section 1848(c)(2)(O)(iii) of the Act
specifies that, if the estimated net reduction in PFS expenditures for
the year is less than the target for the year, an amount equal to the
target recapture amount shall not be taken into account when applying
the budget neutrality requirements specified in section
1848(c)(2)(B)(ii)(II) of the Act. Under section 1848(c)(2)(O)(v) of the
Act, the target that applies to calendar years (CYs) 2017 and 2018 is
calculated as 0.5 percent of the estimated amount of expenditures under
the PFS for the year.
In CY 2016 PFS rulemaking, we proposed and finalized a methodology
to implement this statutory provision.
Because the annual target is calculated by measuring changes from
one year to the next, for CY 2016, we considered how to account for
changes in values that are best measured over 3 years, instead of 2
years. As we described in the CY 2016 final rule with comment period
(80 FR 70932), our general valuation process for potentially misvalued,
new, and revised codes was to establish values on an interim final
basis for a year in the PFS final rule with comment period. Then,
during the 60-day period following the publication of the final rule
with comment period, we would accept public comment about those
valuations. In the final rule with comment period for the subsequent
year, we would consider and respond to public comments received on the
interim final values, and make any appropriate adjustments to values
based on those comments. Under that process for revaluing new, revised,
and misvalued codes, we believe the overall change in valuation for
many codes would best measured across values for 3 years: Between the
original value in the first year; the interim final value in the second
year; and the finalized value in the third year. However, the target
calculation for a year would only be comparing changes in RVUs between
2 years and not among 3 years, so the
[[Page 46217]]
contribution of a particular change towards the target for any single
year would be measured against only the preceding year without regard
to the overall change that takes place over 3 years.
For recent years, interim final values for misvalued codes (year 2)
have generally reflected reductions relative to original values (year
1), and for most codes, the interim final values (year 2) are
maintained and finalized (year 3). However, when values for particular
codes have changed between the interim final (year 2) and final values
(year 3) based on public comment, the general tendency has been that
codes increase in the final value (year 3) relative to the interim
final value (year 2), even in cases where the final value (year 3)
represents a decrease from the original value (year 1). Therefore, for
these codes, the year 2 changes compared to year 1 would risk over-
representing the overall reduction, while the year 3 to year 2 changes
would represent an increase in value. We noted that if there were
similar targets in every PFS year, and a similar number of misvalued
code changes made on an interim final basis, the incongruence in
measuring what is really a 3-year change in 2-year increments might not
be particularly problematic since each year's calculation would
presumably include a similar number of codes measured between years 1
and 2 and years 2 and 3.
However, including changes that take place over 3 years generated
challenges in calculating the target for CY 2016. Because there was no
target for CY 2015, any reductions that occurred on an interim final
basis for CY 2015 were not counted toward achievement of a target. If
we had then included any upward adjustments made to these codes based
on public comment as ``misvalued code'' changes for CY 2016, we would
effectively be counting the service-level increases for 2016 (year 3)
relative to 2015 (year 2) against achievement of the target without any
consideration to the service-level changes relative to 2014 (year 1),
even in cases where the overall change in valuation was negative.
Therefore, we proposed and finalized the decision to exclude code-
level input changes for CY 2015 interim final values from the
calculation of the CY 2016 misvalued code target since the misvalued
change occurred over multiple years, including years not applicable to
the misvalued code target provision.
For the CY 2017 final rule with comment period, we will be
finalizing values (year 3) for codes that were interim final in CY 2016
(year 2). Unlike codes that were interim final for CY 2015, the codes
that are interim final for CY 2016 were included as misvalued codes and
will fall within the range of years for which the misvalued code target
provision applies. Thus, overall changes in values for these codes
would be measured in the target across 3 full years: The original value
in the first year (CY 2015); the interim final value in the second year
(CY 2016); and the finalized value in the third year (CY 2017). The
changes in valuation for these CY 2016 interim final codes were
previously measured and counted towards the target during their initial
change in valuation between years 1 and 2.
As such, we are proposing to include changes in values of the CY
2016 interim final codes toward the CY 2017 misvalued code target. We
believe that this is consistent with the approach that we finalized in
last year's final rule with comment period. The changes in values of CY
2015 interim final codes were not counted towards the misvalued code
target in CY 2016 since the valuation change occurred over multiple
years, including years not applicable to the misvalued code target
provision. However, both of the changes in valuation for the CY 2016
interim final codes, from year 1 to year 2 (CY 2015 to CY 2016) and
from year 2 to year 3 (CY 2016 to CY 2017), have taken place during
years that occur within the misvalued code target provision. We
therefore believe that any adjustments made to these codes based on
public comment should be considered towards the achievement of the
target for CY 2017, just as any changes in valuation for these same CY
2016 interim final codes previously counted towards the achievement of
the target for CY 2016.
We seek public comments regarding this proposal. We also remind
commenters that we have revised our process for revaluing new, revised
and misvalued codes so that we will be proposing and finalizing values
for most of the misvalued codes during a single calendar year. After
this year, there will be far fewer instances of interim final codes and
changes that are best measured over 3 years far.
We refer readers to the regulatory impact analysis section of this
proposed rule for our estimate of the proposed net reduction in
expenditures relative to the 0.5 percent target for CY 2017, and the
resulting adjustment required to be made to the conversion factor.
Additionally, we refer readers to the public use file that provides a
comprehensive description of how the target is calculated as well as
the estimated impact by code family on the CMS Web site under the
supporting data files for the CY 2017 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
H. Phase-In of Significant RVU Reductions
Section 1848(c)(7) of the Act specifies that for services that are
not new or revised codes, if the total RVUs for a service for a year
would otherwise be decreased by an estimated 20 percent or more as
compared to the total RVUs for the previous year, the applicable
adjustments in work, PE, and MP RVUs shall be phased in over a 2-year
period.
In the CY 2016 PFS rulemaking, we proposed and finalized a
methodology to implement this statutory provision. To determine which
services are described by new or revised codes for purposes of the
phase-in provision, we apply the phase-in to all services that are
described by the same, unrevised code in both the current and update
year, and exclude codes that describe different services in the current
and update year.
Because the phase-in of significant reductions in RVUs falls within
the budget neutrality requirements specified in section
1848(c)(2)(B)(ii)(II) of the Act, we estimate the total RVUs for a
service prior to the budget-neutrality redistributions that result from
implementing phase-in values. In implementing the phase-in, we consider
a 19 percent reduction as the maximum 1-year reduction for any service
not described by a new or revised code. This approach limits the year
one reduction for the service to the maximum allowed amount (that is,
19 percent), and then phases in the remainder of the reduction.
The statute provides that the applicable adjustments in work, PE,
and MP RVUs shall be phased in over a 2-year period when the RVU
reduction for a code for a year is estimated to be equal to or greater
than 20 percent. Since CY 2016 was the first year in which we applied
the phase-in transition, CY 2017 will be the first year in which a
single code could be subject to RVU reductions greater than 20 percent
for 2 consecutive years.
Under our finalized policy, the only codes that are not subject to
the phase-in are those that are new or revised, which we defined as
those services that are not described by the same, unrevised code in
both the current and update year, or by the same codes that describe
different services in the current and update year. Since CY 2016 was
the first year for which the phase-in provision applied, we did not
address how we would handle codes with
[[Page 46218]]
values that had been partially phased in during the first year, but
that have a remaining phase-in reduction of 20 percent or greater.
The significant majority of codes with reductions in RVUs that are
greater than 20 percent in year one would not be likely to meet the 20
percent threshold in a consecutive year. However, in a few cases,
significant changes (for example, in the input costs included in the
valuation of a service) could produce reductions of 20 percent or
greater in consecutive years.
We believe that a consistent methodology regarding the phase-in
transition should be applied to these cases. We propose to reconsider
in each year, for all codes that are not new or revised codes and
including codes that were assigned a phase-in value in the previous
year, whether the total RVUs for the service would otherwise be
decreased by an estimated 20 percent or more as compared to the total
RVUs for the previous year. Under this proposed policy, the 19 percent
reduction in total RVUs would continue to be the maximum one-year
reduction for all codes (except those considered new and revised),
including those codes with phase-in values in the previous year. In
other words, for purposes of the 20 percent threshold, every service is
evaluated anew each year, and any applicable phase-in is limited to a
decrease of 19 percent. For example, if we were to adopt a 50 percent
reduction in total RVUs for an individual service, the reduction in any
particular year would be limited to a decrease of 19 percent in total
RVUs. Because we do not set rates 2 years in advance, the phase-in
transition continues to apply until the year-to-year reduction for a
given code does not meet the 20 percent threshold.
We are soliciting comments regarding this proposal.
The list of codes proposed to be subject to the phase-in and the
associated proposed RVUs that result from this methodology are
available on the CMS Web site under downloads for the CY 2017 PFS
proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
I. 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
malpractice (MP)). The PFS localities are discussed in section II.E.3.
of this proposed rule. 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, 2015. Section
201 of the MACRA amended the statute to extend the 1.0 floor for the
work GPCIs through CY 2017 (that is, for services furnished no later
than December 31, 2017).
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 GPCI adjustment, the adjustment to
be applied in the first year of the next adjustment shall be half of
the adjustment that otherwise would be made. Therefore, since the
previous GPCI update was implemented in CY 2014 and CY 2015, we are
proposing to phase in 1/2 of the latest GPCI adjustment in CY 2017.
We have completed a review of the GPCIs and are proposing new GPCIs
in this proposed rule. We also calculate a geographic adjustment factor
(GAF) for each PFS locality. The GAFs are a weighted composite of each
area's work, PE and malpractice expense GPCIs using the national GPCI
cost share weights. While we do not actually use GAFs in computing the
fee schedule payment for a specific service, they are useful in
comparing overall areas costs and payments. The actual effect on
payment for any actual service would 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 noted above, section 201 of the MACRA extended the 1.0 work GPCI
floor for services furnished through December 31, 2017. Therefore, the
proposed CY 2017 work GPCIs and summarized GAFs 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 2017. See Addenda D and E to this proposed rule for
the proposed CY 2017 GPCIs and summarized GAFs available on the CMS Web
site under the supporting documents section of the CY 2017 PFS proposed
rule located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
2. GPCI Update
The proposed updated GPCI values were calculated by a contractor.
There are three GPCIs (work, PE, and MP), and all GPCIs are calculated
through comparison to a national average for each. Additionally, each
of the three GPCIs relies on its own data source(s) and methodology for
calculating its value as described below. Additional information on the
CY 2017 GPCI update may be found in our contractor's draft report,
``Draft Report on the CY 2017 Update of the Geographic Practice Cost
Index for the Medicare Physician Fee Schedule,'' which is available on
our Web site. It is located under the supporting documents section for
the CY 2017 PFS proposed rule located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
a. Work GPCIs
The work GPCIs are designed to reflect the relative costs of
physician labor by Medicare PFS locality. As required by statute, the
work GPCI reflects one quarter of the relative wage differences for
each locality compared to the national average.
To calculate the work GPCIs, we use wage data for seven
professional specialty occupation categories, adjusted to reflect one-
quarter of the relative cost differences for each locality compared to
the national average, as a proxy for physicians' wages. Physicians'
wages are not included in the occupation categories used in calculating
the work GPCI because Medicare payments are a key determinant of
physicians' earnings. Including physician wage data in calculating the
work GPCIs would potentially introduce some circularity to the
adjustment since Medicare payments typically contribute to or influence
physician wages. That is, including physicians' wages in the physician
work GPCIs would, in effect, make the indices, to some extent,
dependent upon Medicare payments.
[[Page 46219]]
The work GPCI updates in CYs 2001, 2003, 2005, and 2008 were based
on professional earnings data from the 2000 Census. However, for the CY
2011 GPCI update (75 FR 73252), the 2000 data were outdated and wage
and earnings data were not available from the more recent Census
because the ``long form'' was discontinued. Therefore, we used the
median hourly earnings from the 2006 through 2008 Bureau of Labor
Statistics (BLS) Occupational Employment Statistics (OES) wage data as
a replacement for the 2000 Census data. The BLS OES data meet several
criteria that we consider to be important for selecting a data source
for purposes of calculating the GPCIs. For example, the BLS OES wage
and employment data are derived from a large sample size of
approximately 200,000 establishments of varying sizes nationwide from
every metropolitan area and can be easily accessible to the public at
no cost. Additionally, the BLS OES is updated regularly, and includes a
comprehensive set of occupations and industries (for example, 800
occupations in 450 industries). For the CY 2014 GPCI update, we used
updated BLS OES data (2009 through 2011) as a replacement for the 2006
through 2008 data to compute the work GPCIs.
Because of its reliability, public availability, level of detail,
and national scope, we believe the BLS OES continues to be the most
appropriate source of wage and employment data for use in calculating
the work GPCIs (and as discussed in section II.E.2.b the employee wage
component and purchased services component of the PE GPCI). Therefore,
for the proposed CY 2017 GPCI update, we used updated BLS OES data
(2011 through 2014) as a replacement for the 2009 through 2011 data to
compute the work GPCIs.
b. Practice Expense GPCIs
The PE GPCIs are designed to measure the relative cost difference
in the mix of goods and services comprising practice expenses (not
including malpractice expenses) among the PFS localities as compared to
the national average of these costs. Whereas the physician work GPCIs
(and as discussed later in this section, the MP GPCIs) are comprised of
a single index, the PE GPCIs are comprised of four component indices
(employee wages; purchased services; office rent; and equipment,
supplies and other miscellaneous expenses). The employee wage index
component measures geographic variation in the cost of the kinds of
skilled and unskilled labor that would be directly employed by a
physician practice. Although the employee wage index adjusts for
geographic variation in the cost of labor employed directly by
physician practices, it does not account for geographic variation in
the cost of services that typically would be purchased from other
entities, such as law firms, accounting firms, information technology
consultants, building service managers, or any other third-party
vendor. The purchased services index component of the PE GPCI (which is
a separate index from employee wages) measures geographic variation in
the cost of contracted services that physician practices would
typically buy. (For more information on the development of the
purchased service index, we refer readers to the CY 2012 PFS final rule
with comment period (76 FR 73084 through 73085)). The office rent index
component of the PE GPCI measures relative geographic variation in the
cost of typical physician office rents. For the medical equipment,
supplies, and miscellaneous expenses component, we believe there is a
national market for these items such that there is not significant
geographic variation in costs. Therefore, the equipment, supplies and
other miscellaneous expense cost index component of the PE GPCI is
given a value of 1.000 for each PFS locality.
For the previous update to the GPCIs (implemented in CY 2014) we
used 2009 through 2011 BLS OES data to calculate the employee wage and
purchased services indices for the PE GPCI. As discussed in section
II.E.2.a., because of its reliability, public availability, level of
detail, and national scope, we continue to believe the BLS OES is the
most appropriate data source for collecting wage and employment data.
Therefore, in calculating the proposed CY 2017 GPCI update, we used
updated BLS OES data (2011 through 2014) as a replacement for the 2009
through 2011 data for purposes of calculating the employee wage
component and purchased service index of the PE GPCI.
c. Malpractice Expense (MP) GPCIs
The MP GPCIs measure the relative cost differences among PFS
localities for the purchase of professional liability insurance (PLI).
The MP GPCIs are calculated based on insurer rate filings of premium
data for $1 million to $3 million mature claims-made policies (policies
for claims made rather than services furnished during the policy term).
For the CY 2014 GPCI update (seventh update) we used 2011 and 2012
malpractice premium data (78 FR 74382). The proposed CY 2017 MP GPCI
update reflects 2014 and 2015 premium data. Additionally, the proposed
CY 2017 MP GPCI update reflects several proposed technical refinements
to the MP GPCI methodology as discussed later in section 5.
d. GPCI Cost Share Weights
For the proposed CY 2017 GPCIs, we are continuing to use the
current cost share weights for determining the PE GPCI values and
locality GAFs. We refer readers to the CY 2014 PFS final rule with
comment period (78 FR 74382 through 74383), for further discussion
regarding the 2006-based MEI cost share weights revised in CY 2014 that
were also finalized for use in the CY 2014 (seventh) GPCI update.
The proposed GPCI cost share weights for CY 2017 are displayed in
Table 12.
Table 12--Proposed Cost Share Weights for CY 2017 GPCI Update
------------------------------------------------------------------------
Proposed CY
Current cost 2017 cost
Expense category share weight share weight
(%) (%)
------------------------------------------------------------------------
Work.................................... 50.866 50.866
Practice Expense........................ 44.839 44.839
--Employee Compensation............. 16.553 16.553
--Office Rent....................... 10.223 10.223
--Purchased Services................ 8.095 8.095
--Equipment, Supplies, Other........ 9.968 9.968
Malpractice Insurance................... 4.295 4.295
Total............................... 100.000 100.000
------------------------------------------------------------------------
[[Page 46220]]
e. PE GPCI Floor for Frontier States
Section 10324(c) of the Affordable Care Act added a new
subparagraph (I) under section 1848(e)(1) of the Act to establish a 1.0
PE GPCI floor for physicians' services furnished in frontier states
effective January 1, 2011. In accordance with section 1848(e)(1)(I) of
the Act, beginning in CY 2011, we applied a 1.0 PE GPCI floor for
physicians' services furnished in states determined to be frontier
states. In general, a frontier state is one in which at least 50
percent of the counties are ``frontier counties,'' which are those that
have a population per square mile of less than 6. For more information
on the criteria used to define a frontier state, we refer readers to
the FY 2011 Inpatient Prospective Payment System (IPPS) final rule (75
FR 50160 through 50161). There are no changes in the states identified
as Frontier States for the CY 2017 proposed rule. The qualifying states
are: Montana, Wyoming, North Dakota, South Dakota, and Nevada. In
accordance with statute, we would apply a 1.0 PE GPCI floor for these
states in CY 2017.
f. Proposed GPCI Update
As explained above in the background section, the periodic review
and adjustment of GPCIs is mandated by section 1848(e)(1)(C) of the
Act. At each update, the proposed GPCIs are published in the PFS
proposed rule to provide an opportunity for public comment and further
revisions in response to comments prior to implementation. The proposed
CY 2017 updated GPCIs for the first and second year of the 2-year
transition, along with the GAFs, are displayed in Addenda D and E to
this proposed rule available on our Web site under the supporting
documents section of the CY 2017 PFS proposed rule Web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
3. Payment Locality Discussion
a. Background
The current PFS locality structure was developed and implemented in
1997. There are currently 89 total PFS localities; 34 localities are
statewide areas (that is, only one locality for the entire state).
There are 52 localities in the other 16 states, with 10 states having 2
localities, 2 states having 3 localities, 1 state having 4 localities,
and 3 states having 5 or more localities. The combined District of
Columbia, Maryland, and Virginia suburbs; Puerto Rico; and the Virgin
Islands are the remaining three localities of the total of 89
localities. The development of the current locality structure is
described in detail in the CY 1997 PFS proposed rule (61 FR 34615) and
the subsequent final rule with comment period (61 FR 59494). We note
that the localities generally represent a grouping of one or more
constituent counties.
Prior to 1992, Medicare payments for physicians' services were made
under the reasonable charge system. Payments were based on the charging
patterns of physicians. This resulted in large differences in payment
for physicians' services among types of services, geographic payment
areas, and physician specialties. Recognizing this, the Congress
replaced the reasonable charge system with the Medicare PFS in the
Omnibus Budget Reconciliation Act (OBRA) of 1989, and the PFS went into
effect January 1, 1992. Payments under the PFS are based on the
relative resources involved with furnishing services, and are adjusted
to account for geographic variations in resource costs as measured by
the GPCIs.
Payment localities originally were established under the reasonable
charge system by local Medicare carriers based on their knowledge of
local physician charging patterns and economic conditions. These
localities changed little between the inception of Medicare in 1967 and
the beginning of the PFS in 1992. Shortly after the PFS took effect, we
undertook a study in 1994 that culminated in a comprehensive locality
revision that was implemented in 1997 (61 FR 59494).
The revised locality structure reduced the number of localities
from 210 to the current 89, and the number of statewide localities
increased from 22 to 34. The revised localities were based on locality
resource cost differences as reflected by the GPCIs. For a full
discussion of the methodology, see the CY 1997 PFS final rule with
comment period (61 FR 59494). The current 89 fee schedule areas are
defined alternatively by state boundaries (for example, Wisconsin),
metropolitan areas (for example, Metropolitan St. Louis, MO), portions
of a metropolitan area (for example, Manhattan), or rest-of-state areas
that exclude metropolitan areas (for example, Rest of Missouri). This
locality configuration is used to calculate the GPCIs that are in turn
used to calculate payments for physicians' services under the PFS.
As stated in the CY 2011 PFS final rule with comment period (75 FR
73261), changes to the PFS locality structure would generally result in
changes that are budget neutral within a state. For many years, before
making any locality changes, we have sought consensus from among the
professionals whose payments would be affected. In recent years, we
have also considered more comprehensive changes to locality
configuration. In 2008, we issued a draft comprehensive report
detailing four different locality configuration options (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/downloads/ReviewOfAltGPCIs.pdf). We refer readers to
the CY 2014 PFS final rule with comment period for further discussion
regarding that report, as well as a discussion about the Institute of
Medicine's empirical study of the Medicare GAFs established under
sections 1848(e) (PFS GPCI) and 1886(d)(3)(E) (IPPS wage index) of the
Act.
b. California Locality Update to the Fee Schedule Areas Used for
Payment Under Section 220(h) of the Protecting Access to Medicare Act
(1) General Discussion and Legislative Change
Section 220(h) of the PAMA added a new section 1848(e)(6) to the
Act, that modifies the fee schedule areas used for payment purposes in
California beginning in CY 2017.
Currently, the fee schedule areas used for payment in California
are based on the revised locality structure that was implemented in
1997 as previously discussed. Beginning in CY 2017, section
1848(e)(6)(A)(i) of the Act requires that the fee schedule areas used
for payment in California must be Metropolitan Statistical Areas (MSAs)
as defined by the Office of Management and Budget (OMB) as of December
31 of the previous year; and section 1848(e)(6)(A)(ii) of the Act
requires that all areas not located in an MSA must be treated as a
single rest-of-state fee schedule area. The resulting modifications to
California's locality structure would increase its number of localities
from 9 under the current locality structure to 27 under the MSA-based
locality structure.
However, section 1848(e)(6)(D) of the Act defines transition areas
as the fee schedule areas for 2013 that were the rest-of-state
locality, and locality 3, which was comprised of Marin county, Napa
county, and Solano county. Section 1848(e)(6)(B) specifies that the
GPCI values used for payment in a transition area are to be phased in
over 6 years, from 2017 through 2021, using a weighted sum of the GPCIs
calculated under the new MSA-based locality structure and the GPCIs
calculated under the current PFS locality structure. That is, the GPCI
values applicable for
[[Page 46221]]
these areas during this transition period are a blend of what the GPCI
values would have been under the current locality structure, and what
the GPCI values would be under the MSA-based locality structure. For
example, in the first year, CY 2017, the applicable GPCI values for
counties that were previously in rest-of-state or locality 3 and are
now in MSAs are a blend of 1/6 of the GPCI value calculated for the
year under the MSA-based locality structure, and 5/6 of the GPCI value
calculated for the year under the current locality structure. The
proportions shift by 1/6 in each subsequent year so that, by CY 2021,
the applicable GPCI values for counties within transition areas are a
blend of 5/6 of the GPCI value for the year under the MSA-based
locality structure, and 1/6 of the GPCI value for the year under the
current locality structure. Beginning in CY 2022, the applicable GPCI
values for counties in transition areas are the values calculated under
the new MSA-based locality structure. For the sake of clarity, we
reiterate that this incremental phase-in is only applicable to those
counties that are in transition areas that are now in MSAs, which are
only some of the counties in the 2013 California rest-of state locality
and locality 3.
Additionally, section 1848(e)(6)(C) of the Act establishes a hold
harmless for transition areas beginning with CY 2017 whereby the
applicable GPCI values for a year under the new MSA-based locality
structure may not be less than what they would have been for the year
under the current locality structure. There are a total of 58 counties
in California, 50 of which are in transition areas as defined in
section 1848(e)(6)(D) of the Act. Therefore, 50 counties in California
are subject to the hold harmless provision. The other 8 counties, which
are metropolitan counties that are not defined as transition areas, are
not held harmless for the impact of the new MSA-based locality
structure, and may therefore potentially experience slight decreases in
their GPCI values as a result of the provisions in section 1848(e)(6)
of the Act, insofar as the locality in which they are located now newly
includes data from adjacent counties that decreases their GPCI values
relative to those that would have applied had the new data not been
incorporated. Therefore, the GPCIs for these eight counties under the
MSA-based locality structure may be less than they would have been
under the current GPCI structure. The eight counties that are not
within transition areas are: Orange; Los Angeles; Alameda; Contra
Costa; San Francisco; San Mateo; Santa Clara; and Ventura counties.
We emphasize that while transition areas are held harmless from the
impact of the GPCI changes using the new MSA-based locality structure,
because we are proposing other updates for CY 2017 as part of the
eighth GPCI update, including the use of updated data, transition areas
would still be subject to impacts resulting from those other updates.
Table 13 illustrates using GAFs, for CY 2017, the isolated impact of
the MSA-based locality changes and hold-harmless for transition areas
required by section 1848(e)(6) of the Act, the impact of the proposed
use of updated data for GPCIs, and the combined impact of both of these
proposed changes.
Table 13--Impact on California GAFs as a Result of Section 1848(e)(6) of the Act and Proposed Updated Data by Fee Schedule Area
[Sorted alphabetically by locality name]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combined
Transition 2016 2017 GAF w/o % Change due 2017 GAF w/ % Change due impact of PAMA
Medicare fee schedule area area GAF 1848(e)(6) to new GPCI 1848(e)(6) to 1848(e)(6) and new GPCI
data data (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bakersfield........................................ 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Chico.............................................. 1 1.04 1.031 -0.50 1.031 0.00 -0.50
El Centro.......................................... 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Fresno............................................. 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Hanford-Corcoran................................... 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Los Angeles-Long Beach-Anaheim (Los Angeles County) 0 1.09 1.09 -0.20 1.091 0.10 -0.10
Los Angeles-Long Beach-Anaheim (Orange County)..... 0 1.09 1.104 1.10 1.101 -0.30 0.80
Madera............................................. 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Merced............................................. 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Modesto............................................ 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Napa............................................... 1 1.14 1.128 -0.80 1.128 0.00 -0.80
Oxnard-Thousand Oaks-Ventura....................... 0 1.09 1.083 -0.60 1.083 0.00 -0.60
Redding............................................ 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Rest Of California................................. 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Riverside-San Bernardino-Ontario................... 1 1.04 1.031 -0.50 1.032 0.10 -0.40
Sacramento-Roseville-Arden-Arcade.................. 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Salinas............................................ 1 1.04 1.031 -0.50 1.033 0.20 -0.30
San Diego-Carlsbad................................. 1 1.04 1.031 -0.50 1.035 0.40 -0.10
San Francisco-Oakland-Hayward (Alameda/Contra Costa 0 1.18 1.125 -4.80 1.142 1.50 -3.40
County)...........................................
San Francisco-Oakland-Hayward (Marin County)....... 1 1.14 1.128 -0.80 1.129 0.10 -0.70
San Francisco-Oakland-Hayward (San Francisco 0 1.18 1.194 1.00 1.175 -1.60 -0.60
County)...........................................
San Francisco-Oakland-Hayward (San Mateo County)... 0 1.18 1.187 0.40 1.171 -1.30 -0.90
San Jose-Sunnyvale-Santa Clara (San Benito County). 1 1.04 1.031 -0.50 1.053 2.10 1.60
San Jose-Sunnyvale-Santa Clara (Santa Clara County) 0 1.18 1.176 0.10 1.175 -0.10 0.00
[[Page 46222]]
San Luis Obispo-Paso Robles-Arroyo Grande.......... 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Santa Cruz-Watsonville............................. 1 1.04 1.031 -0.50 1.042 1.10 0.60
Santa Maria-Santa Barbara.......................... 1 1.04 1.031 -0.50 1.036 0.50 0.00
Santa Rosa......................................... 1 1.04 1.031 -0.50 1.037 0.60 0.10
Stockton-Lodi...................................... 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Vallejo-Fairfield.................................. 1 1.14 1.128 -0.80 1.128 0.00 -0.80
Visalia-Porterville................................ 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Yuba City.......................................... 1 1.04 1.031 -0.50 1.031 0.00 -0.50
--------------------------------------------------------------------------------------------------------------------------------------------------------
Additionally, for the purposes of calculating budget neutrality and
consistent with the PFS budget neutrality requirements as specified
under section 1848(c)(2)(B)(ii)(II) of the Act, we are proposing to
start by calculating the national GPCIs as if the current localities
are still applicable nationwide; then for the purposes of payment in
California, we will override the GPCI values with the values that are
applicable for California consistent with the requirements of section
1848(e)(6) of the Act. This approach is consistent with the
implementation of the GPCI floor provisions that have previously been
implemented--that is, as an after-the-fact adjustment that is
implemented for purposes of payment after both the GPCIs and PFS budget
neutrality have already been calculated.
(2) Proposed Operational Considerations
As discussed above, under section 1848(e)(6) of the Act, counties
that were previously in the rest-of-state locality or locality 3 and
are now in MSAs would have their GPCI values under the new MSA-based
locality structure phased in gradually, in increments of one-sixth over
6 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 GPCI 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. While
section 1848(e)(6)(B) of the Act establishes a blended phase-in for the
MSA-based GPCI values, it does not explicitly state whether or how that
provision is to be reconciled with the requirement at section
1848(e)(1)(C) of the Act. We believe that since section 1848(e)(6)(A)
of the Act requires that we must make the change to MSA-based fee
schedule areas for California GPCIs notwithstanding the preceding
provisions of section 1848(e) of the Act, and subject to the succeeding
provisions of section 1848(e)(6) of the Act, that applying the two-year
phase-in specified by the preceding provisions simultaneously with the
six-year phase-in would undermine the incremental 6-year phase-in
specified in section 1848(e)(6)(B) of the Act. Therefore, we are
proposing that the requirement at section 1848(e)(1)(C) of the Act to
phase in \1/2\ of the adjustment in year 1 of the GPCI update would not
apply to counties that were previously in the rest-of-state or locality
3 and are now in MSAs, and therefore, are subject to the blended phase-
in as described above. Since section 1848(e)(6)(B) of the Act provides
for a gradual phase in of the GPCI values under the new MSA-based
locality structure, specifically in one-sixth increments over 6 years,
if we were to also apply the requirement to phase in 1/2 of the
adjustment in year 1 of the GPCI update then the first year increment
would effectively be one-twelfth. We note that this issue is only of
concern if more than 1 year has elapsed since the previous GPCI update,
and would only be applicable through CY 2021 since, beginning in CY
2022, the GPCI values for such areas in an MSA would be fully based on
the values calculated under the new MSA-based locality structure for
California.
As previously stated, the resulting modifications to California's
locality structure increase its number of localities from 9 under the
current locality structure to 27 under the MSA-based locality
structure. However, both the current localities and the MSA-based
localities are comprised of various component counties, and in some
localities only some of the component counties are subject to the
blended phase-in and hold harmless provisions required by section
1848(e)(6)(B) and (C) of the Act. Therefore, the application of these
provisions may produce differing GPCI values among counties within the
same fee schedule area under the MSA-based locality structure. For
example, the MSA-based San Jose-Sunnyvale-Santa Clara locality, is
comprised of 2 constituent counties--San Benito county, and Santa Clara
county. San Benito County is in a transition area (2013 rest-of-state),
while Santa Clara county is not. Hence, although the counties are in
the same MSA, the requirements of section 1848(e)(6)(B) and (C) of the
Act may produce differing GPCI values for each county. To address this
issue, we propose to assign a unique locality number to the counties
that would be impacted in the aforementioned manner. As a result,
although the modifications to California's locality structure increase
the number of localities from 9 under the current locality structure to
27 under the MSA-based locality structure, for purposes of payment, the
actual number of localities under the MSA-based locality structure
would be 32 to account for instances where unique locality numbers are
needed as described above. Additionally, while the fee schedule area
names are consistent with the MSAs designated by OMB, we are proposing
to maintain 2-digit locality numbers to correspond to the existing fee
schedule areas. Pursuant to the implementation of the new MSA-based
locality structure for California, the total number of PFS localities
would increase from 89 to 112. Table 14 displays the current fee
schedule areas in California, and Table 15 displays the MSA-based fee
schedule areas in California required by section 1848(e)(6) of the Act.
Additional information on the California locality update may be found
in our contractor's draft report, ``Draft Report on the CY 2017 Update
of the Geographic Practice Cost Index for the Medicare Physician Fee
Schedule,'' which is available on the CMS Web site.
[[Page 46223]]
It is located under the supporting documents section of the CY 2017 PFS
proposed rule located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
Table 14--Current Fee Schedule Areas in California
[Sorted alphabetically by locality name]
------------------------------------------------------------------------
Locality number Fee schedule area Counties
------------------------------------------------------------------------
26.............................. Anaheim/Santa Ana. Orange
18.............................. Los Angeles....... Los Angeles
03.............................. Marin/Napa/Solano. Marin, Napa, And
Solano
07.............................. Oakland/Berkley... Alameda And Contra
Costa
05.............................. San Francisco..... San Francisco
06.............................. San Mateo......... San Mateo
09.............................. Santa Clara....... Santa Clara
17.............................. Ventura........... Ventura
99.............................. Rest Of State..... All Other Counties
------------------------------------------------------------------------
Table 15--MSA-Based Fee Schedule Areas in California
[Sorted alphabetically by locality name]
----------------------------------------------------------------------------------------------------------------
Proposed new
Current locality number locality Fee schedule area Counties Transition area
number (MSA name)
----------------------------------------------------------------------------------------------------------------
99............................... 54 Bakersfield, CA..... Kern................ YES.
99............................... 55 Chico, CA........... Butte............... YES.
99............................... 71 El Centro, CA....... Imperial............ YES.
99............................... 56 Fresno, CA.......... Fresno.............. YES.
99............................... 57 Hanford-Corcoran, CA Kings............... YES.
18............................... 18 Los Angeles-Long Los Angeles......... NO.
Beach-Anaheim, CA
(Los Angeles
County).
26............................... 26 Los Angeles-Long Orange.............. NO.
Beach-Anaheim, CA
(Orange County).
99............................... 58 Madera, CA.......... Madera.............. YES.
99............................... 59 Merced, CA.......... Merced.............. YES.
99............................... 60 Modesto, CA......... Stanislaus.......... YES.
3................................ 51 Napa, CA............ Napa................ YES.
17............................... 17 Oxnard-Thousand Oaks- Ventura............. NO.
Ventura, CA.
99............................... 61 Redding, CA......... Shasta.............. YES.
99............................... 75 REST OF STATE....... All Other Counties.. YES.
99............................... 62 Riverside-San Riverside, and San YES.
Bernardino-Ontario, Bernardino.
CA.
99............................... 63 Sacramento--Rosevill El Dorado, Placer, YES.
e--Arden-Arcade, CA. Sacramento, and
Yolo.
99............................... 64 Salinas, CA......... Monterey............ YES.
99............................... 72 San Diego-Carlsbad, San Diego........... YES.
CA.
7................................ 7 San Francisco- Alameda, Contra NO.
Oakland-Hayward, CA Costa.
(Alameda County/
Contra Costa
County).
3................................ 52 San Francisco- Marin............... YES.
Oakland-Hayward, CA
(Marin County).
5................................ 5 San Francisco- San Francisco....... NO.
Oakland-Hayward, CA
(San Francisco
County).
6................................ 6 San Francisco- San Mateo........... NO.
Oakland-Hayward, CA
(San Mateo County).
99............................... 65 San Jose-Sunnyvale- San Benito.......... YES.
Santa Clara, CA
(San Benito County).
9................................ 9 San Jose-Sunnyvale- Santa Clara......... NO.
Santa Clara, CA
(Santa Clara
County).
99............................... 73 San Luis Obispo-Paso San Luis Obispo..... YES.
Robles-Arroyo
Grande, CA.
99............................... 66 Santa Cruz- Santa Cruz.......... YES.
Watsonville, CA.
99............................... 74 Santa Maria-Santa Santa Barbara....... YES.
Barbara, CA.
99............................... 67 Santa Rosa, CA...... Sonoma.............. YES.
99............................... 73 Stockton-Lodi, CA... San Joaquin......... YES.
3................................ 53 Vallejo-Fairfield, Solano.............. YES.
CA.
99............................... 69 Visalia-Porterville, Tulare.............. YES.
CA.
99............................... 70 Yuba City, CA....... Sutter, and Yuba.... YES.
----------------------------------------------------------------------------------------------------------------
4. Proposed Update to the Methodology for Calculating GPCIs in the U.S.
Territories
In calculating GPCIs within U.S. states, we use county-level wage
data from the Bureau of Labor Statistics (BLS) Occupational Employment
Statistics Survey (OES), county-level residential rent data from the
American Community Survey (ACS), and malpractice insurance premium data
from state departments of insurance. In calculating GPCIs for the U.S.
territories, we currently use three distinct methodologies--one for
Puerto Rico, another for the Virgin Islands, and a third for the
Pacific Islands (Guam, American Samoa, and Northern Marianas Islands).
These three methodologies were adopted at different times based
primarily on the data that were available at the time they were
adopted. At present, because Puerto Rico is the only territory where
county-level BLS OES, county-level ACS, and malpractice premium data
are available, it is the only territory for which we use territory-
specific data to calculate GPCIs. For the Virgin Islands, because
county-level wage and rent data are not available, and insufficient
malpractice premium data are available, CMS has set the work, PE, and
MP GPCI values for the Virgin Islands payment locality at the national
average of 1.0 even though,
[[Page 46224]]
like Puerto Rico, the Virgin Islands is its own locality and county-
level BLS OES data are available for the Virgin Islands. For the U.S.
territories in the Pacific Ocean, we currently crosswalk GPCIs from the
Hawaii locality for each of the three GPCIs, and incorporate no local
data from these territories into the GPCI calculations even though
county-level BLS OES data does exist for Guam, but not for American
Samoa or the Northern Mariana Islands.
As noted above, currently Puerto Rico is the only territory for
which we calculate GPCIs using the territory-specific information
relative to data from the U.S. States. For several years stakeholders
in Puerto Rico have raised concerns regarding the applicability of the
proxy data in Puerto Rico relative to their applicability in the U.S.
states. We believe that these concerns may be consistent across island
territories, but lack of available, appropriate data has made it
difficult to quantify such variation in costs. For example, some
stakeholders previously indicated that shipping and transportation
expenses increase the cost of acquiring medical equipment and supplies
in islands and territories relative to the mainland. While we have
previously attempted to locate data sources specific to geographic
variation in such shipping costs, we found no comprehensive national
data source for this information (we refer readers to 78 FR 74387
through 74388 for the detailed discussion of this issue). Therefore, we
have not been able to quantify variation in costs specific to island
territories in the calculation of the GPCIs.
For all the island territories other than Puerto Rico, the lack of
comprehensive data about unique costs for island territories has had
minimal impact on GPCIs because we have used either the Hawaii GPCIs
(for the Pacific territories) or used the unadjusted national averages
(for the Virgin Islands). In an effort to provide greater consistency
in the calculation of GPCIs given the lack of comprehensive data
regarding the validity of applying the proxy data used in the States in
accurately accounting for variability of costs for these island
territories, we are proposing to treat the Caribbean Island territories
(the Virgin Islands and Puerto Rico) in a consistent manner. We propose
to do so by assigning the national average of 1.0 to each GPCI index
for both Puerto Rico and the Virgin Islands. We are not proposing any
changes to the GPCI methodology for the Pacific Island territories
(Guam, American Samoa, and Northern Marianas Islands) where we already
consistently assign the Hawaii GPCI values for each of the three GPCIs.
Additional information on the Proposed Update to the Methodology for
Calculating GPCIs in the U.S. Territories may be found in our
contractor's draft report, ``Draft Report on the CY 2017 Update of the
Geographic Practice Cost Index for the Medicare Physician Fee
Schedule,'' which is available on our Web site. It is located under the
supporting documents section of the CY 2017 PFS proposed rule located
at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
5. Proposed Refinement to the MP GPCI Methodology
In the process of calculating MP GPCIs for the purposes of this
proposed rule, we identified several technical refinements to the
methodology that yield improvements over the current method. We are
also proposing refinements that conform to our proposed methodology for
calculating the GPCIs for the U.S. Territories described above.
Specifically, we are proposing modifications to the methodology to
account for missing data used in the calculation of the MP GPCI. Under
the methodology used in the CY 2014 GPCI update (78 FR 74380 through
74391), we first calculated the average premiums by insurer and
specialty, then imputed premium values for specialties for which we did
not have specific data, before adjusting the specialty-specific premium
data by market share weights. We are proposing to revise our
methodology to instead calculate the average premiums for each
specialty using issuer market share for only available companies. This
proposed methodological improvement would reduce potential bias
resulting from large amounts of imputation, an issue that is prevalent
for insurers that only write policies for ancillary specialties for
which premiums tend to be low. The current method would impute the low
premiums for ancillary specialties across the remaining specialties,
and generally greater imputation leads to less accuracy. Additional
information on the MP GPCI methodology, and the proposed refinement to
the MP GPCI methodology may be found in our contractor's draft report,
``Draft Report on the CY 2017 Update of the Geographic Practice Cost
Index for the Medicare Physician Fee Schedule,'' which is available on
our Web site. It is located under the supporting documents section of
the CY 2017 PFS proposed rule located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
J. Payment Incentive for the Transition From Traditional X-Ray Imaging
to Digital Radiography and Other Imaging Services
Section 502(a)(1) of the Consolidated Appropriations Act of 2016
(H.R. 2029) amended section 1848(b) of the Act by establishing new
paragraph (b)(9). Effective for services furnished beginning January 1,
2017, section 1848(b)(9)(A) of the Act reduces by 20 percent the
payment amounts under the PFS for the technical component (TC)
(including the TC portion of a global service) of imaging services that
are X-rays taken using film. The reduction is made prior to any other
adjustment under this section and without application of this new
paragraph.
Section 1848(b)(9)(B) of the Act provides for a 7 percent reduction
in payments for imaging services made under the PFS that are X-rays
(including the X-ray component of a packaged service) taken using
computed radiology furnished during CY 2018, 2019, 2020, 2021, or 2022,
and for a 10 percent reduction for such imaging services taken using
computed radiology furnished during CY 2023 or a subsequent year.
Computed radiology technology is defined for purposes of this paragraph
as cassette-based imaging, which utilizes an imaging plate to create
the image involved. Section 1848(b)(9) of the Act also requires
implementation of the reductions in payment for X-rays through
appropriate mechanisms, which can include the use of modifiers. In
accordance with section 1848(c)(2)(B)(v)(X), the adjustments under
section 1848(b)(9)(A) of the Act are exempt from budget neutrality.
In this section of the rule, we discuss the proposed implementation
of the reduction in payment for X-rays taken using film provided for in
section 1848(b)(9)(A) of the Act. Because the required reductions in
PFS payment for imaging services (including the imaging portion of a
service) that are X-rays taken using computed radiography technology
does not apply for CY 2017, we will address implementation of section
1848(b)(9)(B) of the Act in future rulemaking.
To implement the provisions of sections 1848(b)(9)(A) of the Act
relating to the PFS payment reduction for X-rays taken using film that
are furnished during CY 2017 or subsequent years, in this proposed
rule, we are proposing to establish a new modifier (modifier ``XX'') to
be used on claims, as allowed under the section 1848(b)(9)(D) of the
Act. The list of CY 2017 applicable HCPCS codes describing imaging
services that are X-ray services are on
[[Page 46225]]
the CMS Web site under downloads for the CY 2017 PFS proposed rule with
comment period at https://www.cms.gov/physicianfeesched/downloads/. We
are proposing that, beginning January 1, 2017, this modifier would be
required on claims for X-rays that are taken using film. The modifier
would be required on claims for the technical component of the X-ray
service, including when the service is billed globally, since the PFS
payment adjustment is made to the technical component regardless of
whether it is billed globally or separately using the -TC modifier. The
use of this proposed modifier to indicate an X-ray taken using film
would result in a 20-percent reduction for the technical component of
the X-ray service, as specified under section 1848(b)(9)(A) of the Act
that would be exempt from budget neutrality as specified under section
1848(c)(2)(B)(v)(X) of the Act.
K. Procedures Subject to the Multiple Procedure Payment Reduction
(MPPR) and the OPPS Cap
Effective January 1, 2012, we implemented an MPPR of 25 percent on
the professional component (PC) of advanced imaging services. The
reduction applies when multiple imaging procedures are furnished by the
same physician (or physician in the same group practice) to the same
patient, in the same session, on the same day. Full payment is made for
the PC of the highest priced procedure. Payment for the PC of
subsequent services is reduced by 25 percent.
Section 502(a)(2)(A) of the Consolidated Appropriations Act, 2016
(Pub. L. 114-113, enacted on December 18, 2015) added a new section
1848(b)(10) of the Act which revises the payment reduction from 25
percent to 5 percent, effective January 1, 2017. Section 502(a)(2)(B)
added a new subclause at section 1848(c)(2)(B)(v)(XI) which exempts the
reduced expenditures attributable to the revised 5 percent MMPR on the
PC of imaging from the PFS budget neutrality provision. We propose to
implement these provisions for services furnished on or after January
1, 2017. We refer readers to section VI.C of this proposed rule
regarding the necessary adjustment to the proposed PFS conversion
factor to account for the mandated exemption from PFS budget
neutrality.
We note that the lists of services for the upcoming calendar year
that are subject to the MPPR on diagnostic cardiovascular services,
diagnostic imaging services, diagnostic ophthalmology services, and
therapy services; and the list of procedures that meet the definition
of imaging under section 5102(b) of the DRA, and therefore, are subject
to the OPPS cap, are displayed in the public use files for the PFS
proposed and final rules for each year. The public use files for CY
2017 are available on our Web site under downloads for the CY 2017 PFS
proposed rule with comment period at https://www.cms.gov/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html.
L. Valuation of Specific Codes
1. Background: Process for 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 make sure
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 5-year review
process, which resulted in revised work RVUs for CY 1997, CY 2002, CY
2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY
2011. Under the 5-year review process, revisions in RVUs were proposed
and finalized via rulemaking. In addition to the 5-year reviews,
beginning with CY 2009, CMS and the RUC have identified a number of
potentially misvalued codes each year using various identification
screens, as discussed in section II.B.5. of this proposed rule.
Historically, when we received RUC recommendations, our process had
been to establish interim final RVUs for the potentially misvalued
codes, new codes, and any other codes for which there were coding
changes in the final rule with comment period for a year. Then, during
the 60-day period following the publication of the final rule with
comment period, we accepted public comment about those valuations. For
services furnished during the calendar year following the publication
of interim final rates, we paid for services based upon the interim
final values established in the final rule with comment period. In the
final rule with comment period for the subsequent year, we considered
and responded to public comments received on the interim final values,
and typically made any appropriate adjustments and finalized those
values.
In the CY 2015 PFS final rule with comment period, we finalized a
new process for establishing values for new, revised and potentially
misvalued codes. Under the new process, we include proposed values for
these services in the proposed rule, rather than establishing them as
interim final in the final rule with comment period. Beginning with
this CY 2017 proposed rule, the new process will be applicable to all
codes, except for new codes that describe truly new services. For CY
2017, we are proposing new values in this proposed rule for the vast
majority of new, revised, and potentially misvalued codes for which we
received complete RUC recommendations by February 10, 2016. To complete
the transition to this new process, for codes where we established
interim final values in the CY 2016 PFS final rule with comment period,
we reviewed the comments received during the 60-day public comment
period following release of the CY 2016 PFS final rule with comment
period, and are re-proposing values for those codes in this CY 2017
proposed rule.
We will consider public comments received during the 60-day public
comment period for this proposed rule before establishing final values
in the final rule with comment period, and adopt interim final values
only in the case of wholly new services for which there are no
predecessor codes or values and for which we do not receive
recommendations in time to propose values. Recommendations regarding
any new or revised codes received after February 10th will be
considered in the next year's proposed rule (that is, CY 2018 PFS
rulemaking).
2. Methodology for Proposing Work RVUs
We conduct a review of each code identified in this section and
review the current work RVU (if any), RUC-recommended work RVU,
intensity, time to furnish the preservice, intraservice, and
postservice activities, as well as other components of the service that
contribute to the value. Our review of recommended work RVUs and time
inputs generally includes, but is not limited to, a review of
information provided by the RUC, HCPAC (Health Care Professionals
Advisory Committee), and other public commenters, medical literature,
and comparative databases, as well as a comparison with other codes
within the PFS, consultation with other physicians and health care
professionals within CMS and the federal government, as well as
Medicare claims data. 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 the recommendations. In the CY 2011
PFS final rule with comment period (75
[[Page 46226]]
FR 73328 through 73329), we discussed a variety of methodologies and
approaches used to develop work RVUs, including survey data, building
blocks, crosswalks to key reference or similar codes, and magnitude
estimation (see the CY 2011 PFS final rule with comment period for more
information). 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 building block
components could be the CPT codes that make up the bundled code and the
inputs associated with those codes. Magnitude estimation refers to a
methodology for valuing work that determines the appropriate work RVU
for a service by gauging the total amount of work for that service
relative to the work for a similar service across the PFS without
explicitly valuing the components of that work. In addition to these
methodologies, we have frequently utilized an incremental methodology
in which we value a code based upon its incremental difference between
another code or another family of codes. The statute specifically
defines the work component as the resources in time and intensity
required in furnishing the service. Also, the published literature on
valuing work has recognized the key role of time in overall work. For
particular codes, we refine the work RVUs in direct proportion to the
changes in the best information regarding the time resources involved
in furnishing particular services, either considering the total time or
the intraservice time.
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
value services appropriately when they have common billing patterns. In
cases where a service is typically furnished to a beneficiary on the
same day as an 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. Our longstanding
adjustments have reflected a broad assumption that at least one-third
of the work 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 multiplied by 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, now addresses the
overlap in time and work when a service is typically furnished on the
same day as an E/M service.
We note that many commenters and stakeholders have expressed
concerns with our ongoing adjustment of work RVUs based on changes in
the best information we have regarding the time resources involved in
furnishing individual services. We are particularly concerned with the
RUC's and various specialty societies' objections to our approach given
the significance of their recommendations to our process for valuing
services and since much of the information we have used to make the
adjustments is derived from their survey process. As explained in the
CY 2016 PFS final rule with comment period (80 FR 70933), we recognize
that adjusting work RVUs for changes is not always a straightforward
process, so we apply various methodologies to identify several
potential work values for individual codes. However, we want to
reiterate that we are statutorily obligated to consider both time and
intensity in establishing work RVUs for PFS services.
We have observed that for many codes reviewed by the RUC, final
recommended work RVUs appear to be incongruous with recommended
assumptions regarding the resource costs in time. This is the case for
a significant portion of codes for which we have recently established
or proposed work RVUs that are based on refinements to the RUC-
recommended values. When we have adjusted work RVUs to account for
significant changes in time, we begin by looking at the change in the
time in the context of the RUC-recommended work RVU. When the
recommended work RVUs do not appear to account for significant changes
in time, we employ the different approaches to identify potential
values that reconcile the recommended work RVUs with the recommended
time values. Many of these methodologies, such as survey data, building
blocks, crosswalks to key reference or similar codes, and magnitude
estimation have long been used in developing work RVUs under the PFS.
In addition to these we sometimes use the relationship between the old
time values and the new time values for particular services to identify
alternative work RVUs based on changes in time components.
In so doing, rather than ignoring the RUC-recommended value, we are
using the recommended values as a starting reference and then applying
one of these several methodologies to account for the reductions in
time that we believe have not otherwise been reflected in the RUC
recommended value. When we believe that such changes in time have
already been accounted for in the RUC recommendation, then we do not
make such adjustments. Likewise, we do not arbitrarily apply time
ratios to current work RVUs to calculate proposed work RVUs. We use the
ratios to identify potential work RVUs and consider these work RVUs as
potential options relative to the values developed through other
options.
We want to make it clear that we are not implying that the decrease
in time as reflected in survey values must equate to a one-to-one or
linear decrease in newly valued work RVUs. Instead, we believe that
since the two components of work are time and intensity that absent an
obvious or explicitly stated rationale for why the relative intensity
of a given procedure has increased, that significant decreases in time
should be reflected in decreases
[[Page 46227]]
to work RVUs. If the RUC recommendation has appeared to disregard or
dismiss the changes in time, without a persuasive explanation of why
such a change should not be accounted for in the overall work of the
service, then we generally use one of the aforementioned referenced
methodologies to identify potential work RVUs, including the
methodologies intended to account for the changes in the resources
involved in furnishing the procedure.
Several commenters, including the RUC, in general have objected to
our use of these methodologies and deemed our actions in adjusting the
recommended work RVUs as inappropriate. We received several specific
comments regarding this issue in response to the CY 2016 PFS final rule
with comment period, those comments are summarized below.
Comment: Several commenters, including the RUC, stated that our
methodology for adjusting work RVUs appears to be contrary to the
statute.
Response: We disagree with these comments. Since section
1848(c)(1)(A) of the Act explicitly identifies time as one of the two
types of resources that encompass the work component of the PFS
payment, we do not believe that our use of the aforementioned
methodologies to adjust the work RVU to account for the changes in
time, which is one of the resources involved, is inconsistent with the
statutory requirements related to the maintenance of work RVUs, and we
have regularly used these and other methodologies in developing values
for PFS services. 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. In our review of RUC
recommended values, we have observed that the RUC also uses a variety
of methodologies to develop work RVUs for individual codes, and
subsequently validates the results of these approaches through
magnitude estimation or crosswalk to established values for other
codes.
Comment: Several commenters, including the RUC, stated that we
could not take one element of the services that has changed such as
intra-service time, and apply an overall ratio for reduction to the
work RVU based on changes to time, as that renders the value no longer
resource-based in comparison to the RUC-recommended values.
Response: We disagree with the commenters. We continue to believe
that the use of time ratios is one of several reasonable methods for
identifying potential work RVUs for particular PFS services,
particularly when the alternative values do not account for information
that suggests the amount of time involved in furnishing the service has
changed significantly. We reiterate that, consistent with the statute,
we are required to value the work RVU based on the relative resources
involved in furnishing the service, which include time and intensity.
When our review of recommended values determines that changes in the
resource of time have been unaccounted for in a recommended RVU, then
we believe we have the obligation to account for that change in
establishing work RVUs since the statute explicitly identifies time as
one of the two elements of the work RVUs. We recognize that it would
not be appropriate to develop work RVUs solely based on time given that
intensity is also an element of work, but in applying the time ratios
we are using derived intensity measures based on current work RVUs for
individual procedures. Were we to disregard intensity altogether, the
work RVUs for all services would be developed based solely on time
values and that is definitively not the case. Furthermore, we reiterate
that we use time ratios to identify potential work RVUs, and then use
other methods (including estimates of work from CMS medical personnel
and crosswalks to key reference or similar codes) to validate these
RVUs. We also disagree with several commenters' implications that a
work RVU developed through such estimation methods is only resource-
based through the RUC process.
Comment: Several commenters, including the RUC, stated that our
inconsistent use of the time ratio methodology has rendered it
ineffective for valuation purposes and that by choosing the starting
base work value and/or physician time at random, we are essentially
reverse engineering the work value we want under the guise of a
standard algorithm.
Response: We do not choose a starting base work value and/or
physician time at random as suggested by the commenters. We use the RUC
recommended values or the existing values as the base values;
essentially, we are taking one of those values and applying adjustments
to account for the change in time that based on our analysis of the RUC
recommendation, we determine has not been properly accounted for to
determine an appropriate work RVU. In circumstances where adjustments
to time and the corresponding work RVU are relatively congruent or
persuasively explained, our tendency has been to use those values as
recommended. Where the RUC recommendations do not account for changes
in time, we have made changes to RUC-recommended values to account for
the changes in time.
Comment: Commenters, including the RUC, also stated that the use of
time ratio methodologies distills the valuation of the service into a
basic formula with the only variable being either the new total
physician time or the new intra-service physician time, and that these
methodologies are based on the incorrect assumption that the per minute
physician work intensity established is permanent regardless of when
the service was last valued. Other commenters have suggested that
previous assumed times are inaccurate.
Response: We agree with commenters that per minute intensity for a
given service may change over time. If we believed that the per-minute
intensity for a given service were immutable, then a reverse-building
block approach to revaluation based on new time data could be
appropriate. However, we have not applied such an approach specifically
because we agree that the per-minute intensity of work is not
necessarily static over time or even necessarily during the course of a
procedure. Instead, we utilize time ratios to identify potential values
that account for changes in time and compare these values to other PFS
services for estimates of overall work. When the values we develop
reflect a similar derived intensity, we agree that our values are the
result of our assessment that the relative intensity of a given service
has remained similar.
Regarding the validity of comparing new times to the old times, we,
too, hope that time estimates have improved over many years especially
when many years have elapsed since the last time the service in
question was valued. However, we also believe that our operating
assumption regarding the validity of the pre-existing values as a point
of comparison is critical to the integrity of the relative value system
as currently constructed. Pre-existing times are a very important
element in the allocation of indirect PE RVUs by specialty, and had the
previously recommended times been overestimated, the specialties that
furnish such services would be benefitting from these times in the
allocation of indirect PE RVUs. As long time observers of the RUC
process, we also recognize that the material the RUC uses to develop
overall work recommendations includes the data
[[Page 46228]]
from the surveys about time. We have previously stated concerns
regarding the validity of much of the RUC survey data. However, we
believe additional kinds of concern would be warranted if the RUC
itself were operating under the assumption that its pre-existing data
were typically inaccurate.
We understand stakeholders' concerns regarding how best to consider
changes in time in improving the accuracy of work RVUs and have
considered all of the issues raised by commenters. In conjunction with
our review of recommended code values for CY 2017, we conducted a
preliminary analysis to identify general tendencies in the relationship
between changes in time and changes in work RVUs for CY 2014 and CY
2015. We looked at services for which there were no coding changes to
simplify the analysis. The intent of this preliminary analysis was to
examine commenters' beliefs that CMS is only considering time when
making refinements to RUC recommended work values. For CY 2014, we
found that in the aggregate, the average difference between the RUC
recommended intraservice time and existing intraservice time was -17
percent, but the average difference between the RUC recommended work
RVU and existing work RVU was only -4 percent. However, the average
difference between the CMS refined work RVU and existing work RVU was -
7 percent. For CY 2015, the average difference between the RUC
recommended intraservice time and existing intraservice time was -17
percent, but the average difference between the RUC recommended work
RVU and existing work RVU was 1 percent, and the average difference
between the CMS refined work RVU and existing work RVU was -6 percent.
This preliminary analysis demonstrates that we are not making
refinements solely in consideration of time, if that were the case, the
changes in the work RVU values that we adopted would be comparable to
the changes in the time that we adopted, but that is not the case.
We believe that we should account for efficiencies in time when the
recommended work RVU does not account for those efficiencies, otherwise
relativity across the PFS can be significantly skewed over periods of
time. For example, if when a code is first valued, a physician was
previously able to do only 5 procedures per day, but due to new
technologies, the same physician can now do 10 procedures per day,
resource costs in time have empirically been lessened, and we believe
that relative reduction in resources involved in furnishing that
service should be accounted for in the assignment of work RVUs for that
service, since the statute explicitly identifies time as one of the two
components of work. Of course, if more resource intensive technology
has allowed for the increased efficiency in furnishing the procedure,
then the nonfacility PE RVUs for the service should also be adjusted to
account for this change. Additionally, we believe it may be that the
intensity per minute of the procedure may have changed with the greater
efficiency in time. Again, that is why we do not generally reduce work
RVUs in strict proportion to changes in time. We understand that
intensity is not entirely linear, and that data related to time as
obtained in the RUC survey instrument may improve over time, and that
the number of survey respondents may improve over time. However, we
also understand time as a tangible resource cost in furnishing PFS
services, and a cost that by statute, is one of the two kinds of
resources to be considered as part of the work RVU.
Therefore, we are interested in receiving comments on whether,
within the statutory confines, there are alternative suggestions as to
how changes in time should be accounted for when it is evident that the
survey data and/or the RUC recommendation regarding the overall work
RVU does not reflect significant changes in the resource costs of time
for codes describing PFS services. We are also seeking comment on
potential alternatives, including the application of the reverse
building block methodology, to making the adjustments that would
recognize overall estimates of work in the context of changes in the
resource of time for particular services.
Table 16 contains a list of codes for which we are proposing work
RVUs; this includes all RUC recommendations received by February 10,
2016, and codes for which we established interim final values in the CY
2016 PFS final rule with comment period. When the proposed work RVUs
vary from those recommended by the RUC or for which we do not have RUC
recommendations, we address those codes in the portions of this section
that are dedicated to particular codes. The proposed work RVUs and
other payment information for all proposed CY 2017 payable codes are
available in Addendum B. Addendum B is available on the CMS Web site
under downloads for the CY 2017 PFS proposed rule with comment period
at https://www.cms.gov/physicianfeesched/downloads/. The proposed time
values for all CY 2017 codes are listed in a file called ``CY 2017 PFS
Proposed Work Time,'' available on the CMS Web site under downloads for
the CY 2017 PFS proposed rule with comment period at https://www.cms.gov/physicianfeesched/downloads/.
3. Methodology for Proposing the Direct PE Inputs To Develop PE RVUs
a. Background
On an annual basis, the RUC provides us 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.
Like our review of recommended work RVUs, our review of recommended
direct PE inputs generally includes, but is not limited to, a review of
information provided by the RUC, HCPAC, and other public commenters,
medical literature, and comparative databases, as well as a comparison
with other codes within the PFS, consultation with physicians and
health care professionals within CMS and the federal government, as
well as Medicare claims data. 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 the recommendations. 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, consistent with the
principles of relativity, and reflect our payment policies, we use
those direct PE inputs to value a service. If not, we refine the
recommended 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.
Our review and refinement of RUC-recommended direct PE inputs
includes many refinements that are common across codes as well as
refinements that are specific to particular services. Table 16 details
our proposed refinements of the RUC's direct PE recommendations at the
code-specific level. In this proposed rule, we address several
refinements that are common across codes, and refinements to particular
codes are addressed in the portions of this section that are dedicated
to particular codes. We note that for each refinement, we indicate the
proposed impact on direct costs for that service. We note that, on
average, in any case where the impact on the direct cost for a
particular refinement is $0.32 or less, the refinement has no impact on
the proposed PE RVUs. This calculation
[[Page 46229]]
considers both the impact on the direct portion of the PE RVU, as well
as the impact on the indirect allocator for the average service. We
also note that nearly half of the proposed refinements listed in Table
16 result in changes under the $0.32 threshold and are unlikely to
result in a change to the proposed RVUs.
We also note that the proposed direct PE inputs for CY 2017 are
displayed in the proposed CY 2017 direct PE input database, available
on the CMS Web site under the downloads for the CY 2017 proposed rule
at www.cms.gov/PhysicianFeeSched/. The inputs displayed there have also
been used in developing the proposed CY 2017 PE RVUs as displayed in
Addendum B.
b. Common Refinements
(1) Changes in Work Time
Some direct PE inputs are directly affected by revisions in work
time. Specifically, changes in the intraservice portions of the work
time and changes in the number or level of postoperative visits
associated with the global periods result in corresponding changes to
direct PE inputs. The direct PE input recommendations generally
correspond to the work time values associated with services. We believe
that inadvertent discrepancies between work time values and direct PE
inputs should be refined or adjusted in the establishment of proposed
direct PE inputs to resolve the discrepancies.
(2) 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 over several years of rulemaking, indicating that we consider
equipment time as the time within the intraservice 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 those services for
which we allocate cleaning time to portable equipment items, because
the portable equipment does not need to be cleaned in the room where
the service is furnished, we do not include that cleaning time for the
remaining equipment items, as those items and the room are both
available for use for other patients during that time. In addition,
when a piece of equipment is typically used during follow-up post-
operative 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 preservice
or postservice tasks performed by clinical labor staff on the day of
the procedure (the clinical labor service period) and are typically
available for other patients even when one member of the clinical staff
may be occupied with a preservice or postservice task related to the
procedure. We also note that we believe these same assumptions would
apply to inexpensive equipment items that are used in conjunction with
and located in a room with non-portable highly technical equipment
items since any items in the room in question would be available if the
room is not being occupied by a particular patient. For additional
information, we refer readers to our discussion of these issues in the
CY 2012 PFS final rule with comment period (76 FR 73182) and the CY
2015 PFS final rule with comment period (79 FR 67639).
(3) Standard Tasks and Minutes for Clinical Labor Tasks
In general, the preservice, intraservice, 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 RUC-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, we review
the deviations from the standards and any rationale provided for the
deviations. When we do not accept the RUC-recommended exceptions, we
refine the proposed direct PE inputs to conform to the standard times
for those tasks. In addition, in cases when a service is typically
billed with an E/M service, we remove the preservice 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.''
We believe that continual addition of new and distinct clinical labor
tasks each time a code is reviewed under the misvalued code initiative
is likely to degrade relativity between newly reviewed services and
those with already existing inputs. This is because codes more recently
reviewed would be more likely to have a greater number of clinical
labor tasks as a result of the general tendency to increase the number
of clinical labor tasks. To mitigate the potential negative impact of
these additions, we review these tasks to determine whether they are
fully distinct from existing clinical labor tasks, typically included
for other clinically similar services under the PFS, and thoroughly
explained in the recommendation. For those tasks that do not meet these
criteria, we do not accept these newly recommended clinical labor
tasks.
(4) Recommended Items That Are Not Direct PE Inputs
In some cases, the PE worksheets included with the RUC
recommendations include items that are not clinical labor, disposable
supplies, or medical equipment or that cannot be allocated to
individual services or patients. We have addressed these kinds of
recommendations in previous rulemaking (78 FR 74242), and we do not use
items included in these recommendations as direct PE inputs in the
calculation of PE RVUs.
(5) 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, however, include
supply or equipment items that are not currently in the direct PE input
database. In these cases, the RUC has historically recommended that a
new item be created and has facilitated our pricing of that item by
working with the specialty societies to provide us copies of sales
invoices. For CY 2017, we received invoices for several new supply and
equipment items. Tables 16 and 17 detail the invoices received for new
and existing items in the direct PE database. As discussed in section
II.A. of this proposed rule with comment
[[Page 46230]]
period, we encourage stakeholders to review the prices associated with
these new and existing items to determine whether these prices appear
to be accurate. Where prices appear inaccurate, we encourage
stakeholders to provide invoices or other information to improve the
accuracy of pricing for these items in the direct PE database during
the 60-day public comment period for this proposed rule. We expect that
invoices received outside of the public comment period would be
submitted by February 10th of the following year for consideration in
future rulemaking, similar to our new process for consideration of RUC
recommendations.
We remind stakeholders that due to the relativity inherent in the
development of RVUs, reductions in existing prices for any items in the
direct PE database increase the pool of direct PE RVUs available to all
other PFS services. Tables 16 and 17 also include the number of
invoices received, as well as the number of nonfacility allowed
services for procedures that use these equipment items. We provide the
nonfacility allowed services so that stakeholders will note the impact
the particular price might have on PE relativity, as well as to
identify items that are used frequently, since we believe that
stakeholders are more likely to have better pricing information for
items used more frequently. A single invoice may not be reflective of
typical costs and we encourage stakeholders to provide additional
invoices so that we might identify and use accurate prices in the
development of PE RVUs.
In some cases, we do not use the price listed on the invoice that
accompanies the recommendation because we identify publicly available
alternative prices or information that suggests a different price is
more accurate. In these cases, we include this in the discussion of
these codes. In other cases, we cannot adequately price a newly
recommended item due to inadequate information. Sometimes, no
supporting information regarding the price of the item has been
included in the recommendation. In other cases, the supporting
information does not demonstrate that the item has been purchased at
the listed price (for example, vendor price quotes instead of paid
invoices). In cases where the information provided on the item allows
us to identify clinically appropriate proxy items, we might use
existing items as proxies for the newly recommended items. In other
cases, we have included the item in the direct PE input database
without any associated price. Although including the item without an
associated price means that the item does not contribute to the
calculation of the proposed PE RVU for particular services, it
facilitates our ability to incorporate a price once we obtain
information and are able to do so.
(6) Service Period Clinical Labor Time in the Facility Setting
Generally speaking, our proposed inputs do not include clinical
labor minutes assigned to the service because the cost of clinical
labor during the service period for a procedure in the facility setting
is not considered a resource cost to the practitioner since Medicare
makes separate payment to the facility for these costs. We address
proposed code-specific refinements to clinical labor in the individual
code sections.
(7) Procedures Subject to the Multiple Procedure Payment Reduction
(MPPR) and the OPPS Cap
We note that the public use files for the PFS proposed and final
rules for each year display both the services subject to the MPPR lists
on diagnostic cardiovascular services, diagnostic imaging services,
diagnostic ophthalmology services and therapy services and the list of
procedures that meet the definition of imaging under section
1848(b)(4)(B) of the Act, and therefore, are subject to the OPPS cap
for the upcoming calendar year. The public use files for CY 2017 are
available on the CMS Web site under downloads for the CY 2017 PFS
proposed rule with comment period at https://www.cms.gov/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html.
4. Specialty-Mix Assumptions for Proposed Malpractice RVUs
The proposed CY 2017 malpractice crosswalk table is displayed in
the public use files for the PFS proposed and final rules. The public
use files for CY 2017 are available on the CMS Web site under downloads
for the CY 2017 PFS proposed rule with comment period at https://www.cms.gov/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html. The table lists the CY 2017 HCPCS
codes and their respective source codes used to set the proposed CY
2017 MP RVUs where the source code for this calculation deviates from
the source code for the utilization otherwise used for purposes of PFS
ratesetting. The proposed MP RVUs for all PFS services and the
utilization crosswalk used to identify the source codes for all other
PFS codes are reflected in Addendum B on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
5. Valuation of Specific Codes
a. CY 2017 Proposed Codes That Were Also CY 2016 Proposed Codes
(1) Soft Tissue Localization (CPT Codes 10035 and 10036)
In the CY 2016 PFS final rule with comment period, we established
the RUC-recommended work value as interim final for CPT codes 10035 and
10036. We also made standard refinements to remove duplicative clinical
labor and utilize standard equipment time formulas for the PACS
workstation proxy (ED050).
Comment: A commenter stated that the clinical labor task ``Review/
read X-ray, lab, and pathology reports'' occurs during the preservice
period, and it is a separate activity than ``Review examination with
interpreting MD'', which occurs during the service period.
Response: We continue to believe that this clinical labor is
duplicative with the clinical labor for Review examination with
interpreting MD because we believe that these two descriptors detail
the same clinical labor activity taking place, rather than two separate
and distinct tasks. We are proposing to maintain our previous
refinement to 0 minutes for this clinical labor task for CPT codes
10035 and 10036.
We are also proposing to maintain the interim final work RVUs for
CPT codes 10035 and 10036.
(2) Repair Flexor Tendon (CPT Codes 26356, 26357, and 26358)
In the CY 2016 PFS final rule with comment period, we established
an interim final work RVU of 9.56 for CPT code 26356 after considering
both its similarity in time to CPT code 25607 (Open treatment of distal
radial extra-articular fracture) and the recommended reduction in time
relative to the current times assumed for this procedure. We
established an interim final work RVU of 10.53 for CPT code 26357 based
on a direct crosswalk from CPT code 27654 (Repair, secondary, Achilles
tendon, with or without graft), as we believed that this work RVU
better reflected the changes in time for this procedure. For the last
code in the family, we established an interim final work RVU of 12.13
for CPT code 26358, based on the RUC recommended increment of 1.60 work
RVUs relative to CPT code 26357.
Comment: We received several comments regarding the interim final
work values for this family of codes.
[[Page 46231]]
One commenter stated that it was inappropriate to use time ratios to
evaluate CPT code 26356 as it was last valued in 1995, noting that
there was an anomalous relationship between the current work RVU and
the imputed time components in the RUC database. This commenter also
pointed out that when the previous time was developed, fabrication of a
splint was considered to be part of the intraservice work, while in the
current survey instrument, the fabrication of the splint is considered
to be part of the postservice work since it is a dressing. This
commenter urged CMS to adopt the RUC recommendations. A different
commenter agreed that the CMS crosswalk to CPT code 25607 was an
appropriate crosswalk for CPT code 26356 and supported the CMS work RVU
of 9.56.
Response: We appreciate the support from the commenter. We continue
to believe that our crosswalk for this code is an appropriate choice,
due to our estimate of overall work between CPT code 26356 and CPT code
25607. We appreciate the commenters' concerns regarding the time ratio
methodologies and have responded to these concerns about our
methodology in section II.L.2 of this proposed rule. Although we note
the commenter's statement about how the service period in which
fabrication of a splint takes place may have evolved over time, we do
not agree that this task would be responsible for a decrease in
intraservice survey time, as the postservice survey time for CPT code
26356 remained unchanged at 30 minutes. If the decrease in intraservice
time had been due to the shift of splinting from the intraservice
period to the postservice period, then we would have expected to see an
increase in the postservice period minutes. However, they remained
exactly the same in the physician survey for CPT 26356. As we wrote
earlier in this section, we believe in the validity of using pre-
existing time values as a point of comparison, and we believe that we
should account for efficiencies in time when the recommended work RVU
does not account for those efficiencies. After consideration of
comments received, we are proposing to maintain CPT code 26356 at its
current work RVU of 9.56 for CY 2017.
Comment: Several commenters disagreed with the work RVU for CPT
code 26357. One commenter stated that the CMS crosswalk to CPT code
27654 had less total time and resulted in an inappropriately lower
intensity. This commenter urged CMS to adopt the RUC-recommended work
value. Another commenter stated that a better crosswalk for CPT code
26357 would be CPT code 25608 (Open treatment of distal radial intra-
articular fracture or epiphyseal separation), the next code in the same
upper extremity family that CMS used for the initial crosswalk. This
commenter stated that the CMS crosswalk for CPT code 26357 created a
rank order anomaly in terms of intensity within this family, and that
the commenter's suggested crosswalk would create two pairs of matched
codes, survey CPT codes 26356/26357 with crosswalk CPT codes 25607/
25608.
Response: We appreciate the suggested crosswalk from the
commenters, and we agree that the choice of the initial CMS crosswalk
creates a rank order anomaly within the family in terms of intensity.
As a result, after consideration of comments received, we are proposing
to instead value CPT code 26357 at the 25th percentile survey work RVU
of 11.00 for CY 2017. This valuation corrects the anomalous intensity
within the Repair Flexor Tendon family of codes, and preserves the RUC-
recommended increment between CPT codes 26356 and 26357.
Comment: The commenters agreed that the RUC-recommended increment
of 1.60 was appropriate for the work RVU of CPT code 26358 when added
to the work RVU of CPT code 26357. However, commenters stated that this
increment of 1.60 should be added to the RUC-recommended work value for
CPT code 26357, and not the CMS refined value from the CY 2016 PFS
final rule with comment period.
Response: We also continue to believe that the increment of 1.60 is
appropriate for the work RVU of CPT code 26358. After consideration of
comments received, we are therefore proposing to set the work RVU for
this code at 12.60 for CY 2017, based on the increment of 1.60 from CPT
code 26357's proposed work RVU of 11.00.
We are proposing to maintain the current direct PE inputs for all
three codes.
(3) Esophagogastric Fundoplasty Trans-Oral Approach (CPT Code 43210)
For CY 2016, the CPT Editorial Panel established CPT code 43210 to
describe trans-oral esophagogastric fundoplasty. The RUC recommended a
work RVU of 9.00 for CPT code 43210. We noted our determination that a
work RVU of 7.75, which corresponds to the 25th percentile survey
result, more accurately reflects the resources used in furnishing the
service associated with CPT code 43210. Therefore, for CY 2016 we
established an interim final work RVU of 7.75 for CPT code 43210.
Comment: A few commenters urged CMS to accept the RUC-recommended
work RVU of 9.00 for CPT code 43210. The commenters believed that the
RUC-recommended value compared well with the key reference service, CPT
code 43276 (Endoscopic retrograde cholangiopancreatography (ERCP); with
removal and exchange of stent(s), biliary or pancreatic duct, including
pre- and post-dilation and guide wire passage, when performed,
including sphincterotomy, when performed, each stent exchanged), which
has a work RVU of 8.94 and an intraservice time of 60 minutes.
Commenters believed that due to similar intra-service times and
intensities, that CPT code 43210 should be valued nearly identically to
CPT code 43276. Some commenters also stated that to maintain relativity
within the upper GI code families, CPT code 43210 should not have a
lower work RVU than CPT code 43276, especially since the majority of
survey participants indicated that CPT code 43210 is ``somewhat more''
complex than CPT code 43276. Additionally, one commenter noted that an
EGD (Esophagogastroduodenoscopy) is used twice during this service,
before and after fundoplication. They stated that because this is a
multi-stage procedure, other EGD codes are not comparable. The
commenter also pointed out that this technology has a small number of
users and urged us to accept the RUC-recommended work RVU of 9.00 until
there is increased volume and then reassess in 2 years. Commenters also
requested refinement panel consideration for this service.
Response: Per the commenters' request, we referred this code to the
CY 2016 multi-specialty refinement panel for further review. The result
of the panel was a recommendation that we accept the RUC-recommended
value of 9.00 work RVUs. However, since there are four ERCP codes with
60 minutes of intraservice time, three of which have work RVUs of less
than 7.00 and only one of the four codes has a work RVU higher than
7.75 RVUs (8.94), based on our estimate of overall work for this
service, we continue to believe that the 25th percentile of the survey
most accurately reflects the relative resource costs associated with
CPT code 43210. Therefore, for CY 2017 we are proposing a work RVU of
7.75 for CPT code 43210.
(4) Percutaneous Biliary Procedures Bundling (CPT Codes 47531, 47532,
47533, 47534, 47535, 47536, 47537, 47538, 47539, 47540, 47541, 47542,
47543, and 47544)
These codes were revalued with new recommendations at the October
2015
[[Page 46232]]
RUC meeting; we will discuss the CY 2016 interim final comments
alongside the new recommendations. Please see section II.L for a
discussion of the CY 2017 proposed code values.
(5) Percutaneous Image Guided Sclerotherapy (CPT Code 49185)
For CY 2016, we established an interim final work RVU of 2.35 for
CPT code 49185 based on a crosswalk from CPT code 62305 (Myelography
via lumbar injection, including radiological supervision and
interpretation; 2 or more regions (e.g., lumbar/thoracic, cervical/
thoracic, lumbar/cervical, lumbar/thoracic/cervical)); which we
believed accurately reflected the time and intensity involved in
furnishing CPT code 49185. We also requested stakeholder input on the
price of supply item SH062 (sclerosing solution) as the volume of the
solution in this procedure (300 mL) is much higher than other CPT codes
utilizing SH062 (between 1 and 10 mL).
Comment: Commenters disagreed with our proposed crosswalk of CPT
code 49185 from CPT code 62305. Commenters believed that the RUC-
recommended crosswalk from CPT code 31622 (Bronchoscopy, rigid or
flexible, including fluoroscopic guidance, when performed; diagnostic,
with cell washing, when performed (separate procedure)) was a more
appropriate comparison due to similarity in service. Commenters
requested that CPT code 49185 be referred to the refinement panel.
Response: The requests did not meet the requirements related to new
clinical information for referral to the refinement panel. After review
of the comments, we continue to believe that a crosswalk of CPT code
49185 from the value for CPT code 62305 is most appropriate due to
similarities in overall work. Therefore, we are proposing a work RVU of
2.35 for CPT code 49185 for CY 2017 and seek additional rationale for
why a different work RVU or crosswalk would more accurately reflect the
resources involved in furnishing this service.
Comment: A commenter stated that the procedure described by CPT
code 49185 involved a separate clinical labor staff type. Due to the
inclusion of this additional individual, the L037D clinical labor and
additional gloves were appropriate to include in the procedure.
Response: The commenter did not provide any evidence for this
claim. We continue to believe that this additional use of clinical
staff would not be typical for CPT code 49185. This procedure does not
involve moderate sedation, and therefore, we do not believe that there
would be a typical need for a third staff member. As a result, we are
proposing to maintain our direct PE refinements from the CY 2016 PFS
final rule with comment period.
Additionally, we did not receive any information regarding SH062
that supports maintaining an input of 300 mL, and as noted above, this
level far exceeds the volume associated with other CPT codes;
therefore, we are proposing to refine the direct practice expense
inputs for SH062 from 300 mL to 10 mL, which is the highest level
associated with other CPT codes utilizing SH062.
(6) Genitourinary Procedures (CPT Codes 50606, 50705, and 50706)
In the CY 2016 PFS final rule with comment period, we established
as interim final the RUC-recommended work RVUs for all three codes. We
did not receive any comments on the work values for these codes, and we
are proposing to maintain all three at their current work RVUs.
The RUC recommended the inclusion of ``room, angiography'' (EL011)
for this family of codes. As we discussed in the CY 2016 PFS final rule
with comment period, we did not believe that an angiography room would
be used in the typical case for these procedures, and we therefore
replaced the recommended equipment item ``room, angiography'' with
equipment item ``room, radiographic-fluoroscopic'' (EL014) for all
three codes on an interim final basis. We also stated our belief that
since the predecessor procedure codes generally did not include an
angiography room and we did not have a reason to believe that the
procedure would have shifted to an angiography room in the course of
this coding change, we did not believe that the use of an angiography
room would be typical for these procedures.
Comment: Several commenters disagreed with the CMS substitution of
the fluoroscopic room in place of the angiography room. The commenters
stated that all three of these procedures were previously reported
using CPT code 53899 (Unlisted procedure, urinary system) which does
not have any PE inputs, and the RUC recommendations included as a
reference CPT code 50387 (Removal and replacement of externally
accessible transnephric ureteral stent), which includes an angiography
room. The commenters suggested that CPT code 50387 was an example of a
predecessor code that included the use of an angiography room, along
with other codes that are being bundled together to create the new
Genitourinary codes.
Response: We do not agree with the commenter's implication that
because CPT code 50387 was an appropriate reference code for use in
valuation, that it necessarily would have previously been used to
describe services that are now reported under CPT codes 50606, 50705,
or 50706. Our perspective is consistent with the RUC-recommended
utilization crosswalk for the three new codes, which did not suggest
that the services were previously reported using 50706. We do not
believe that use of one particular code for reference in developing
values for another necessarily means that the all of the same equipment
would be used for both services.
We do not believe that these codes describe the same clinical work
either. CPT code 50387 is for the ``Removal and replacement of
externally accessible transnephric ureteral stent'' while CPT code
50606 describes an ``Endoluminal biopsy of ureter and/or renal
pelvis'', CPT code 50705 refers to ``Ureteral embolization or
occlusion'', and CPT code 50706 details ``Balloon dilation, ureteral
stricture.'' Additionally, the codes do not have the same global
periods, which makes comparisons between CPT code 50387 and CPT codes
506060, 50705, and 50706 even more difficult. We note that despite the
commenter's claim that CPT code 50387 was provided as a reference for
these procedures, 50387 is not in fact listed as a reference for any of
these three codes, or mentioned at all in the codes' respective summary
of recommendations. However, we acknowledge that among the procedures
that are provided as references, many of them include the use of an
angiography room, such as CPT code 36227 (Selective catheter placement,
external carotid artery) and CPT code 37233 (Revascularization,
endovascular, open or percutaneous, tibial/peroneal artery, unilateral,
each additional vessel). Therefore, we agree that the use of the
angiography room in these procedures, or at least some of its component
parts, may be warranted.
Comment: A commenter stated that the substitution of the
fluoroscopic room for the angiography room was clinically unjustified.
The commenter stated that the angiography room was needed for these
procedures to carry out 3-axis rotational imaging (so as to avoid
rolling the patient), ensure sterility, and avoid unacceptable
radiation exposure to physicians, their staff, and their patients. The
commenter indicated that the only piece of equipment listed in the
angiography room that would not be typically utilized for these
procedures is the Provis Injector. All of the other
[[Page 46233]]
items are used for these Genitourinary procedures. The commenter urged
CMS to restore the angiography room to these procedures.
Response: We agree that it is important to provide equipment that
is medically reasonable and necessary. Our concern with the use of the
angiography room for these codes is that we do not believe all of the
equipment would be typically necessary to furnish the procedure. For
example, the commenter agreed that the Provis Injector would not be
required for these Genitourinary codes. Therefore, we are proposing to
remove the angiography room from these three procedures and add in its
place the component parts that make up the room. Table 16 details these
components:
Table 16--Angiography Room (EL011) Components
------------------------------------------------------------------------
-------------------------------------------------------------------------
100 KW at 100 kV (DIN6822) generator
C-arm single plane system, ceiling mounted, integrated multispace
T motorized rotation, multiple operating modes
real-time digital imaging
40 cm image intensifier at 40/28/20/14cm
30 x 38 image intensifier dynamic flat panel detector
floor-mounted patient table with floating tabletop designed for
angiographic exams and interventions (with peistepping for image
intensifiers 13in+)
18 in TFT monitor
network interface (DICOM)
Careposition: Radiation free positioning of collimators
Carewatch: Acquisition and monitoring of configurable dose area product
Carefilter: Cu-prefiltration
DICOM HIS/RIS
Control room interface
Injector, Provis
Shields, lower body and mavig
Leonardo software
Fujitsu-Siemens high performance computers
Color monitors
Singo modules for dynamic replay and full format images
Prepared for internal networking and Siemens remote servicing, both
hardware and software
------------------------------------------------------------------------
We will include all of the above components except the Provis
Injector, as commenters have indicated that its use would not be
typical for these procedures. We welcome additional comment regarding
if these or other components are typically used in these Genitourinary
procedures. We currently lack pricing information for these components;
we are therefore proposing to include each of these components in the
direct PE input database at a price of $0.00 and we are soliciting
invoices from the public for their costs so that we may be able to
price these items for use in developing final PE RVUs for CY 2017
We also note that we believe that this issue illustrates a
potentially broad problem with our use of equipment ``rooms'' in the
direct PE input database. For most services, we only include equipment
items that are used and unavailable for other uses due to their use
during the services described by a particular code. However, for items
included in equipment ``rooms,'' we allocate costs regardless of
whether the individual items that comprise the room are actually used
in the particular service.
To maintain relativity among different kinds of procedures, we are
interested in obtaining more information specifying the exact resources
used in furnishing services described by different codes. We hope to
address this subject in greater detail in future rulemaking.
(7) Laparoscopic Radical Prostatectomy (CPT code 55866)
In the CY 2016 PFS final rule with comment period, we established
an interim final work RVU of 21.36 for CPT code 55866 based on a direct
crosswalk to CPT code 55840 (Prostatectomy, retropubic radical, with or
without nerve sparing). We stated that we believed these codes were
medically similar procedures with nearly identical time values, and we
did not believe that the difference in intensity between CPT code 55840
and CPT code 55866 was significant enough to warrant the RUC-
recommended difference of 5.50 work RVUs. We also compared CPT code
55866 to the work RVU of 25.18 for CPT code 55845, and stated our
belief that, in general, a laparoscopic procedure would not require
greater resources than an open procedure.
Comment: Several commenters disagreed with the statement that a
laparoscopic procedure, such as CPT code 55866, would generally require
fewer resources than an open procedure, such as CPT code 55840.
Commenters stated that developing the skill necessary to perform a
minimally invasive laparoscopic surgery requires a greater degree of
experience and specialized training than that required to perform an
open prostatectomy. Commenters indicated that this level of
practitioner skill should be reflected in the work RVU for the
procedure, as intensity is based in part upon skill, mental effort, and
psychological stress.
Response: We agree with the commenters that skill and technique as
well as mental effort and psychological stress on the part of the
practitioner contribute to the overall intensity of the furnishing a
given service, and therefore, are one of the two components in
determining code-level work RVUs. However, we do not believe that
relative increases in requisite skill or technique can be considered
alone. Although the development of new technology (such as robotic
assistance) may create a greater burden of knowledge on the part of the
practitioner, it can also make procedures faster, safer, and easier to
perform. This means that there may be reductions in time for such a
procedure (which is the other component of the work RVU), but also that
the mental effort and psychological stress for a given procedure may be
mitigated by the improvements in safety. Therefore, we do not agree
that a newer procedure that includes additional technology and requires
greater training would inherently be valued at a higher rate than an
older and potentially more invasive procedure.
Comment: A commenter stated that CPT code 55866 describes two very
different procedures in one code. The descriptor for the code states
``includes robotic assistance when performed'', and the procedure is
performed differently depending on whether or not the robotic
assistance is included. The commenter indicated that the vast majority
of radical prostatectomies are performed with the robot, and although
the outcomes are the same in both cases, the procedures are completely
different.
Response: We agree with the commenter that the descriptor includes
the possibility for confusion, especially on the part of the survey
respondents. Valuing this code based on the typical case is difficult
when the procedure differs depending on the inclusion or exclusion of
robotic assistance. We would recommend that valuation might be improved
if the CPT Editorial Panel were to consider further revisions to this
code to describe the two cases of laparoscopic radical prostatectomy:
With and without robotic assistance.
Comment: One commenter stated that the application of the phase-in
transition for facility-only codes like CPT code 55866 would have a
particularly egregious impact in the second year of the transition. The
commenter urged CMS to ensure that its implementation of the phase-in
transition does not undermine the protections created by the statute.
Response: Please see Sections II.G and II.H or a discussion of the
phase-in transition and its implementation in its second year.
Comment: Several commenters requested that CMS refer CPT code 55866
to the refinement panel for
[[Page 46234]]
review. At the refinement panel, the presenters brought up new evidence
in the form of a study published in 2016 describing discharge data for
radical laparoscopic prostatectomies. The presenters stated that there
were many more people included in this study as opposed to the 30
respondents in the survey data, and that on average the robotic
procedure took 90 minutes longer than the open procedure. The
additional time needed to perform the procedure, as indicated by this
new study's results, was presented as a new rationale as to why CMS
should accept the RUC-recommended work RVU.
Response: CPT code 55866 was referred to the CY 2016 Multi-
Specialty Refinement Panel per the request of commenters. The outcome
of the refinement panel was a median work RVU of 26.80, the same value
as the RUC recommended in the previous rulemaking cycle. After
consideration of the comments and the results of the refinement panel,
we are proposing for CY 2017 to maintain the interim final work RVU of
21.36 for CPT code 55866. We are interested in the results of the study
mentioned at the refinement panel, and we will consider incorporating
this data into the valuation of this code, including, if appropriate,
adjustments to the work times used in PFS ratesetting. We are also
seeking that the study be submitted through the public comment process
so that we can allow it proper consideration along with other
information submitted by the public, rather than using the results of a
single study to propose valuations. We are also curious about the time
values regarding the duration of CPT code 55866. One of the members of
the refinement panel stated that on average the robotic procedure took
90 minutes longer than the open procedure. This is not what was
indicated by the survey data from the RUC recommendations, which had
the two procedures valued at virtually identical times (same
intraservice time, 6 minutes difference total time). We are therefore
seeking comment on whether the times included in this study are more
accurate than the time reflected in the RUC surveys.
(8) Intracranial Endovascular Intervention (CPT codes 61645, 61650, and
61651)
For CY 2016, we established interim final work RVUs of 15.00 for
CPT code 61645, 10.00 for CPT code 61650 and 4.25 for CPT code 61651.
The RUC-recommended values for CPT codes 61645, 61650 and 61651 were
17.00, 12.00 and 5.50, respectively. We valued CPT code 61645 by
applying the ratio between the RUC-recommended reference code's, CPT
37231 (revascularization, endovascular, open or percutaneous, tibial,
peroneal artery, unilateral, initial vessel; with transluminal stent
placement(s) and atherectomy, includes angioplasty within the same
vessel, when performed), work and time to CPT code 61645. We valued CPT
code 61650 based on a crosswalk to CPT code 37221 (revascularization,
endovascular, open or percutaneous, iliac artery, unilateral, initial
vessel; with transluminal stent placement(s), includes angioplasty
within the same vessel, when performed), due to similar intensity and
intraservice time. We valued CPT code 61651 based on a crosswalk to CPT
code 37223 (revascularization, endovascular, open or percutaneous,
iliac artery, each additional ipsilateral iliac vessel; with
transluminal stent placement(s), includes angioplasty within the same
vessel, when performed (list separately in addition to the code for
primary procedure, due to similar intraservice time and intensity.
Both CPT codes 61645 and 61650 included postservice work time
associated with CPT code 99233 (Subsequent hospital care, per day, for
the evaluation and management of a patient, which requires at least 2
of these 3 key components: A detailed interval history; A detailed
examination; Medical decision making of high complexity. Counseling
and/or coordination of care with other physicians, other qualified
health care professionals, or agencies are provided consistent with the
nature of the problem(s) and the patient's and/or family's needs.
Usually, the patient is unstable or has developed a significant
complication or a significant new problem. Typically, 35 minutes are
spent at the bedside and on the patient's hospital floor or unit). In
the CY 2016 PFS final rule with comment period, we stated that we
believe that for the typical patient, these services would be
considered hospital outpatient services, not inpatient services. As a
result the intraservice time of the hospital observation care service
was valued in the immediate postservice time. We refined the work time
for CPT code 61645 by removing 55 minutes of work time associated with
CPT code 99233, and added 30 minutes of time from CPT code 99233 to the
immediate postservice. Therefore the total time for CPT code 61645 was
reduced to 241 minutes and the immediate postservice time increased to
83 minutes. We also removed the inpatient visit from CPT code 61650,
which reduced the total time to 206 minutes and increased the
postservice time to 75 minutes.
Comment: Commenters disagreed with our categorization of these
codes as outpatient only, and therefore, subject to the 23-hour
outpatient policy. Commenters stated that according to Medicare claims
data, the predecessor codes were performed primarily on an inpatient
basis. Additionally, commenters pointed out that the new codes would
typically be performed on acute stroke patients. Commenters also said
as the new codes are inpatient-only, the CMS reductions in work and
time based on the assumption of outpatient status are flawed; as a
result, commenters suggested we accept the RUC-recommended values.
Commenters also requested that these codes be referred to the
refinement panel.
Response: We valued CPT codes 61645, 61650, and 61651 based on
comparisons to reference CPT codes 37231, 37221, and 37223,
respectively. We continue to believe that these codes are appropriate
comparisons based on intensity and intra-service time because no
persuasive information was presented at the refinement panel that
indicated that these comparisons are not appropriate. Therefore we are
proposing an RVU of 15.00 for CPT code 61645, 10.00 for CPT code 61650,
and 4.25 for CPT code 61651. We are also proposing time inputs based on
our refinements of the RUC recommendations, including removing the time
associated with hospital inpatient visit CPT code 99233 from the
intraservice work time, and adding 30 minutes to the immediate
postservice time for both CPT codes 61645 and 61650.
We are also seeking comment on the inclusion of post-operative
visits in a 0-day global. Both CPT codes 61645 are 0-day global codes,
and the refinements described above reflect changes to more appropriate
value these codes as 0-day codes. We do not believe that 0-day globals
codes should include post-operative visits; rather, if global codes
require post-operative visits, they are more appropriately assigned 10-
or 90-day global periods based on our current criteria. Our policy has
been to remove the visit from the post-operative period and the
associated minutes from the total time while adding 30 minutes to the
immediate postservice period without necessarily making an adjustment
to the work RVU (see the CY 2010 PFS proposed rule, 74 FR 33557; also
see the CY 2011 PFS proposed rule, 75 FR 40072).
[[Page 46235]]
(9) Paravertebral Block Injection (CPT codes 64461, 64462, and 64463)
In CY 2015, the CPT Editorial Panel created three new codes to
describe paravertebral block injections at single or multiple levels,
as well as for continuous infusion for the administration of local
anesthetic for post-operative pain control and thoracic and abdominal
wall analgesia. For the CY 2016 PFS final rule with comment period, we
established the RUC-recommended work RVUs, 1.75 and 1.10, as interim
final for CPT codes 64461 and 64462, respectively.
For CPT code 64463, we utilized a direct crosswalk from three other
injection codes (CPT codes 64416 (Injection, anesthetic agent; brachial
plexus, continuous infusion by catheter (including catheter placement),
64446 (Injection, anesthetic agent; sciatic nerve, continuous infusion
by catheter (including catheter placement), and 64449 (Injection,
anesthetic agent; lumbar plexus, posterior approach, continuous
infusion by catheter (including catheter placement)) which all had a
work RVU of 1.81 as we believed this crosswalk more accurately
reflected the work involved in furnishing this service.
Comment: The RUC stated that CPT code 64463 is more comparable to
CPT code 64483 (Injection(s), anesthetic agent and/or steroid,
transforaminal epidural, with imaging guidance (fluoroscopy or CT);
lumbar or sacral, single), which has a work RVU of 1.90 and requires
the same physician work and time to perform. The RUC recommended we
accept the 25th percentile survey work RVU of 1.90. Another commenter
stated that our value for CPT code 64463 was inappropriate since
imaging guidance is not part of our comparison codes. The commenter
advocated for us to accept the survey respondent's selection of CPT
code 64483 as the most appropriate comparison code and assign a work
RVU of 1.90.
Response: After reviewing and considering the comments, we continue
to believe that CPT codes 64416, 64446, and 64449, all of which have 20
minutes of intraservice time, are better crosswalks to CPT code 64463,
which also has 20 minutes of intraservice time and a similar total
time. In contrast, the crosswalk code recommended by commenters, CPT
64483, only has 15 minutes of intraservice time. Therefore, we are
proposing a work RVU of 1.81 for CPT code 64463 for CY 2017.
(10) Implantation of Neuroelectrodes (CPT codes 64553 and 64555)
The RUC identified CPT codes 64553 and 64555 as a site of service
anomaly during the CY 2016 PFS rulemaking cycle. In the Medicare claims
data, these services were typically reported in the nonfacility
setting, yet the survey data was predicated on a facility-based
procedure. We agreed with the RUC that these two codes should be
referred to the CPT Editorial Panel to better define the services, in
particular to investigate the possibility of establishing one code to
describe temporary or testing implantation and another code to describe
permanent implantation. We maintained the CY 2015 work RVUs and direct
PE inputs for these two codes on an interim basis until receiving
updated recommendations from CPT and the RUC.
Comment: A commenter requested that CMS allow practitioners to bill
the MACs separately for a percutaneous electrode kit (SA022) for CPT
code 64555. The commenter stated that without allowing for a separate
payment for the percutaneous electrode kit, the payment for the
procedure would be insufficient to cover the physician's costs.
Response: We agree that CPT codes 64553 and 64555 as currently
constructed are potentially misvalued codes, which is why we are
maintaining the CY 2015 work RVUs and direct PE inputs on an interim
basis. We believe that the disposable supplies furnished incident to
the procedure are paid through the nonfacility PE RVUs. The
percutaneous electrode kit (SA022) was not previously included in the
direct PE inputs for either of these two services, and since we are
proposing to maintain current direct PE inputs pending additional
recommendations, we do not agree that disposable supplies should be
separately payable. We are proposing to maintain the interim final work
RVUs and direct PE inputs for these two codes, and we look forward to
reviewing recommendations regarding these procedures again for future
rulemaking.
Additionally, we were alerted to a discrepancy regarding the times
for these codes in the CY 2016 work time file. Our proposed CY 2017
work time file addresses this discrepancy by reflecting the RUC
recommended times of 155 minutes for CPT code 64553 and 140 minutes for
CPT code 64555.
(11) Ocular Reconstruction Transplant (CPT code 65780)
In CY 2015, the RUC identified CPT code 65780 as potentially
misvalued through a misvalued code screen for 90-day global services
that included more than 6 office visits. The RUC recommended a direct
work RVU crosswalk from CPT code 27829 (Open treatment of distal
tibiofibular joint (syndesmosis) disruption, includes internal
fixation, when performed). After examining comparable codes, we
determined the RUC-recommended work RVU of 8.80 for CPT code 65780
would likely overstate the work involved in the procedure given the
change in intraservice and total times compared to the previous values.
We believed that the ratio of the total times (230/316) applied to the
work RVU (10.73) more accurately reflected the work involved in this
procedure. Therefore, we established an interim final work RVU of 7.81
for CPT code 65780.
Comment: The RUC and other commenters disagreed with our interim
final values based on objections to our use of time ratios in
developing work RVUs for PFS services.
Response: We appreciate the commenters' concerns and have responded
to these concerns about our methodology in section II.L of this
proposed rule. After review of the comments, we continue to consider
the work RVU of 7.81 to accurately represent the work involved in CPT
code 65780. We believe this service is similar in overall intensity to
CPT code 27766 (Open treatment of medial malleolus fracture, includes
internal fixation, when performed) that has a work RVU of 7.89 and a
total time that more closely approximates that of CPT code 65780.
Therefore, we are proposing a work RVU of 7.81 for CPT code 65780 for
CY 2017.
(12) Trabeculoplasty by Laser Surgery (CPT code 65855)
In CY 2015, the RUC identified CPT code 65855 as potentially
misvalued through the review of 10-day global services with more than
1.5 postoperative visits. The RUC noted that the code was changed from
a 90-day to a 10-day global period when it was last valued in 2000.
However, the descriptor was not updated to reflect that change. CPT
code 65855 describes multiple laser applications to the trabecular
meshwork through a contact lens to reduce intraocular pressure. The
current practice is to perform only one treatment session during a 10-
day period and then wait for the effect on the intraocular pressure.
The descriptor for CPT code 65855 has been revised and removes the
language ``1 or more sessions'' to clarify this change in practice.
[[Page 46236]]
The RUC recommended a work RVU of 3.00 for CPT code 65855. While
the RUC-recommended value represents a reduction from the CY 2015 work
RVU of 3.99, we stated that significant reductions in the intraservice
time, the total time, and the change in the office visits represent a
more significant change in the work resources involved in furnishing
the typical service. The intraservice and total times were decreased by
approximately 33 percent while the elimination of two post-operative
visits (CPT code 99212) alone would reduce the overall work RVU by at
least 24 percent under the reverse building block method. However, the
RUC-recommended work RVU only represents a 25 percent reduction
relative to the previous value. To identify potential work RVUs for
this service, we calculated an intraservice time ratio between the CY
2015 intraservice time, 15 minutes, and the RUC-recommended
intraservice time, 10 minutes, and applied this ratio to the current
work RVU of 3.99 to arrive at a work RVU of 2.66 for CPT code 65855,
which we established as interim final for CY 2016.
Comment: A few commenters, including the RUC, provided explanations
as to how the RUC recommendation had already accounted for the
reduction in physician intra-service time and post-operative visits.
Some commenters disagreed with CMS' interim final values based on
objections to CMS' use of time ratios in developing work RVUs for PFS
services.
Response: We appreciate the commenters' concerns regarding the time
ratio methodologies and have responded to these concerns about our
methodology in section II.H.2 of this proposed rule. After considering
the explanations provided by commenters through public comments
describing the RUC's methodologies in more detail, we agree that the
proposed value did not accurately reflect the physician work involved
in furnishing the service. Therefore, for CY 2017 we are proposing the
RUC-recommended work RVU value of 3.00 for CPT code 65855.
(13) Glaucoma Surgery (CPT codes 66170 and 66172)
The RUC identified CPT codes 66170 and 66172 as potentially
misvalued through a screen for 90-day global codes that included more
than 6 office visits). We believed the RUC-recommended work RVU of
13.94 for CPT code 66170 did not accurately account for the reductions
in time. Specifically, the survey results indicated reductions of 25
percent in intraservice time and 28 percent in total time. These
reductions suggested that the RUC-recommended work RVU for CPT code
66170 overstated the work involved in furnishing the service, since the
recommended value only represented a reduction of approximately seven
percent. We believed that applying the intraservice time ratio, the
ratio between the CY 2015 intraservice time, 60 minutes, and the RUC-
recommended intraservice time, 45 minutes, applied to the current work
RVU, 15.02, resulted in a more appropriate work RVU. Therefore, for CY
2016, we established an interim final work RVU of 11.27 for CPT code
66170.
For CPT code 66172, the RUC recommended a work RVU of 14.81. After
comparing the RUC-recommended work RVU for this code to the work RVU
for similar codes (for example, CPT code 44900 (Incision and drainage
of appendiceal abscess, open) and CPT code 52647 (Laser coagulation of
prostate, including control of postoperative bleeding, complete
(vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or
dilation, and internal urethrotomy are included if performed))), we
believed the RUC-recommended work RVU of 14.81 overstated the work
involved in this procedure. For the same reasons and following the same
valuation methodology utilized above, we applied the intraservice time
ratio between the CY 2015 intraservice time and the survey intraservice
time, 60/90, to the CY 2015 work RVU of 18.86. This resulted in a work
RVU of 12.57 for CPT code 66172. Therefore, for CY 2016, we established
an interim final work RVU of 12.57 for CPT code 66172.
Comment: Several commenters, including the RUC, disagreed with our
interim final values based on objections to our use of time ratios in
developing work RVUs for PFS services. Commenters also requested CMS
refer CPT codes 66170 and 66172 to the refinement panel.
Response: We appreciate the commenters' concerns regarding the time
ratio methodologies and have responded to these concerns in section
II.H.2 of this proposed rule. CPT codes 66170 and 66172 were referred
to the CY 2016 multi-specialty refinement panel per commenters'
request. The outcome of the refinement panel was a median of 13.94 RVUs
for CPT code 66170 and 14.84 RVUs for CPT code 66172. Due to the new
information presented to the refinement panel regarding the level of
intensity required to perform millimeter incisions in the eye, we agree
with the assessment of the refinement panel and therefore, for CY 2017
we are proposing a work RVU of 13.94 for CPT code 66170 and 14.84 for
CPT code 66172.
(14) Retinal Detachment Repair (CPT codes 67107, 67108, 67110, and
67113)
CPT codes 67107, 67108, 67110 and 67113 were identified as
potentially misvalued through a screen for 90-day global post-operative
visits. The RUC recommended a work RVU of 16.00 for CPT code 67107,
which corresponded to the 25th percentile of the survey. While the RUC
recommendation represented a five percent reduction from the current
work RVU of 16.71, we believed the RUC recommendation still overvalued
the service given the 15 percent reduction in intraservice time and 25
percent reduction in total time. We used the intraservice time ratio
between the existing and new time values to identify an interim final
work RVU of 14.06. We believed this value accurately reflected the work
involved in this service and was comparable to other codes that have
the same global period and similar intraservice time and total time.
For CY 2016, we established an interim final work RVU of 14.06 for CPT
code 67107.
For CPT code 67108, the RUC recommended a work RVU of 17.13 based
on the 25th percentile of the survey, which reflected a 25 percent
reduction from the current work RVU. The survey results reflected a 53
percent reduction in intraservice time and a 42 percent reduction in
total time. We believe the RUC-recommended work RVU overestimated the
work, given the significant reductions in intraservice time and total
time and does not maintain relativity among the codes in this family.
To determine the appropriate value for this code and maintain
relativity within the family, we preserved the 1.13 work RVU increment
recommended by the RUC between this code and CPT code 67107 and applied
that increment to the interim final work RVU of 14.06 for CPT code
67107. Therefore, we established an interim final work RVU of 15.19 for
CPT code 67108.
For CPT code 67110, the RUC recommended maintaining the current
work RVU of 10.25. To maintain appropriate relativity with the work
RVUs established for the other services within this family, we used the
RUC-recommended -5.75 RVU differential between CPT code 67107 and CPT
code 67110 to establish the CY 2016 interim final work RVU of 8.31 for
CPT code 67110. For CPT code 67113, the RUC recommended and we
established an interim final work RVU of 19.00 based on the 25th
percentile of the survey.
[[Page 46237]]
Comment: Several commenters, including the RUC, disagreed with our
interim final values based on objections to our use of time ratios in
developing work RVUs for PFS services. Some commenters also stated that
by using some RUC-recommended increments and rejecting others, we have
not only established inconsistencies within the family of codes, but
potentially opened up anomalies across a wide range of services. The
RUC also expressed disagreement with using the recommended work RVU
increments without using the recommended work RVU. Some commenters also
stated the new IWPUT values for these three services are
inappropriately low and pointed to the derived per minute intensity of
0.064 for CPT code 67110 as particularly problematic.
Response: We appreciate the commenters' concerns regarding the time
ratio methodologies and have responded to these concerns in section
II.H.2 of this proposed rule. We disagree with the statement about
inconsistencies as the codes in this family are valued relative to one
another based on the times and level of physician work required for
each code. Also, we generally do not agree that a low IWPUT itself
indicates overall misvaluation as the validity of the IWPUT as a
measure of intensity depends on the accuracy of the assumptions
regarding the number, level, and work RVUs attributable to visits for
services in the post-operative global period for individual services.
For example, a service with an unrealistic number or level of post-
operative visits may have a very low derived intensity for the intra-
service time.
CPT codes 67107, 67108, and 67110 were referred to the CY 2016
multi-specialty refinement panel per commenters' request. The outcome
of the refinement panel was a median of 16.00, 17.13, and 10.25 work
RVUs; respectively. After consideration of the comments and the results
of the refinement panel, we are proposing a work RVU of 16.00, 17.13,
and 10.25 for CPT codes 67107, 67108, and 66110, respectively, for CY
2017.
(15) Fetal MRI (CPT Codes 74712 and 74713)
For CY 2016, we established the RUC-recommended work RVU of 3.00 as
interim final for CPT code 74712. We established an interim final work
RVU of 1.78 for CPT code 74713 based on a refinement of the RUC-
recommended work RVU of 1.85 using the ratio of work to time for both
codes. This proposed value also corresponds to the 25th percentile
survey result.
Comment: Commenters stated that the work RVU of 1.78 for CPT code
74713 did not reflect the higher intensity inherent in the procedure's
typical patient. The commenter explained that the typical patient is
pregnant with twins and has a higher likelihood of complications
related to congenital anomalies, as well as of ischemic brain injury
with twin gestations. The commenter further stated that twin gestations
are more difficult to image. Commenters requested that CPT code 74713
be referred to the multispecialty refinement panel.
Response: CPT code 74713 was referred to the CY 2016 multispecialty
refinement panel. After considering the comments and the results of the
refinement panel, we agree with commenters that an RVU of 1.78
underestimates the work for CPT code 74713. Therefore, we propose a
work RVU of 1.85 for the service for CY 2017.
(16) Interstitial Radiation Source Codes (CPT Codes 77778 and 77790)
In CY 2016 PFS final rule with comment period, we established an
interim final value for CPT code 77790 without a work RVU, consistent
with the RUC's recommendation. We did not use the RUC-recommended work
RVU to establish the interim final values for CPT code 77778. We stated
that the specialty society survey included a work time that was
significantly higher than the RUC-recommended work time without a
commensurate change in RVU. For CY 2016, we established the 25th
percentile work RVU survey result of 8.00 as interim final for CPT code
77778.
Comment: Commenters agreed that the preservice survey times and the
RUC-recommended survey times were inconsistent and explained that this
inconsistency resulted from the RUC's use of preservice packages in
developing recommendations. In addition, commenters stated that because
the work associated with CPT code 77790 (including pre-time
supervision, handling, and loading of radiation seeds into needles) was
bundled into CPT code 77778, that the additional work should be
reflected in the RVU for CPT code 77778. Commenters encouraged us to
accept the RUC-recommended work RVU of 8.78 and requested that CPT code
77778 be referred to the refinement panel.
Response: We did not refer CPT code 77778 to the CY 2016
multispecialty refinement panel because commenters did not provide new
clinical information. We continue to believe that, based on the
reduction in total work time, an RVU of 8.00 accurately reflects the
work involved in furnishing CPT code 77778. Therefore for CY 2017, we
are proposing a work RVU of 8.00 for CPT code 77778 and 0 work RVUs for
CPT code 77790. We are also seeking comment on whether we should use
time values based on preservice packages if the recommended work value
is based on time values that are significantly different than those
ultimately recommended.
(17) Colon Transit Imaging (CPT Codes 78264, 78265, and 78266)
In establishing CY 2016 interim final values, we accepted the RUC-
recommended work RVUs for CPT codes 78265 and 78266. We believed that
the RUC-recommended RVU of 0.80 overestimated the work involved in
furnishing CPT code 78264 and as a result, we established an interim
final work RVU of 0.74 based on a crosswalk to CPT code 78226
(hepatobiliary system imaging, including gallbladder when present), due
to similar intraservice times and intensities.
Comment: Commenters did not support our interim final work RVU for
CPT code 78264. Commenters disagreed with our assessment of CPT code
78264 as having a higher work RVU and shorter intraservice time
relative to the other codes in the family. One commenter stated that a
difference of two minutes in intraservice time was insignificant and
should not be used as a rationale for revaluing. Another commenter
stated that we should have maintained the RUC-recommended crosswalk of
CPT code 78264 to CPT code 78227 (Hepatobiliary system imaging,
including gallbladder when present; with pharmacologic intervention,
including quantitative measurement(s) when performed) due to
similarities in service, work and intensity. Based on these concerns,
commenters requested that CPT code 78264 be referred to the refinement
panel.
Response: CPT code 78264 was referred to the CY 2016 multi-
specialty refinement panel for further review. We calculate the
refinement panel results as the median of each vote. That result for
CPT code 78264 was 0.79 RVUs. After consideration of the comments and
the refinement panel results, we agree that 0.79 accurately captures
the overall work involved in furnishing this service and are proposing
a value of 0.79 for CPT code 78264.
[[Page 46238]]
(18) Cytopathology Fluids, Washings or Brushings and Cytopathology
Smears, Screening, and Interpretation (CPT Codes 88104, 88106, 88108,
88112, 88160, 88161, and 88162)
In the CY 2016 PFS final rule with comment period, we made a series
of refinements to the recommended direct PE inputs for this family of
codes. We removed the equipment time for the solvent recycling system
(EP038) and the associated clinical labor described by the tasks
``Recycle xylene from stainer'' and ``Order, restock, and distribute
specimen containers and or slides with requisition forms'' due to our
belief that these were forms of indirect PE. This refinement applied to
all seven codes in the family. We also noticed what appeared to be an
error in the quantity of non-sterile gloves (SB022), impermeable staff
gowns (SB027), and eye shields (SM016) assigned to CPT codes 88108 and
88112. The recommended value of these supplies was a quantity of 0.2,
which we believed was intended to be a quantity of 2. We therefore
refined the value of these supplies to 2 for CPT codes 88108 and 88112.
Comment: Several commenters disagreed with our characterization of
the solvent recycling system and its associated clinical labor tasks as
indirect PE. Commenters stated that the solvent recycling system costs
are direct expenses since they are based on the amount of recycled
solvent allocated to each specimen, with solvents allocated to specific
specimens based on batch size. They indicated that the related clinical
labor tasks are also forms of direct PE as they are also based on the
amount of recycled solvent allocated to each specimen. The time for
these tasks varies based on the batch size, which varies by procedure.
Response: We maintain our previously stated belief that these are
forms of indirect PE, as they are not allocated to any individual
service. We have defined direct PE inputs as clinical labor, medical
supplies, or medical equipment that are individually allocable to a
particular patient for a particular service. We continue to believe
that a solvent recycling system would be in general use for a lab
practice, and that the associated clinical labor tasks for ordering and
restocking specimen containers can be more accurately described as
administrative activities. We are proposing to maintain these
refinements from the previous rulemaking cycle for CPT codes 88104-
88162.
Comment: A commenter indicated that we did not account for the
batch size when considering the supply quantities for CPT codes 88108
and 88112. The commenter indicated that the practice expense inputs
should be assumed to have a batch size of five for these two codes, and
therefore, no edits should be made. The commenter requested that we
restore the quantity of 0.2 for the gloves, gowns, and eye shields
associated with these procedures. This did not apply to the other codes
on the submitted spreadsheet, which had a batch size of one.
Response: We appreciate the assistance of the commenter in
clarifying the batch size for these procedures. As a result, we are
proposing to refine the supply quantity of the non-sterile gloves
(SB022), impermeable staff gowns (SB027), and eye shields (SM016) back
to the RUC-recommended value of 0.2 for CPT codes 88108 and 88112.
(19) Immunohistochemistry (CPT Codes 88341, 88342, 88344, and 88350)
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 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. In the past for similar procedures in this family, the RUC
recommended a work RVU for the add-on code (CPT code 88364) that was 60
percent of the base code (CPT code 88365). In the CY 2015 PFS final
rule with comment period, we stated that the relative resources
involved in furnishing an add-on service in this family would be
reflected appropriately using the same 60 percent metric and
subsequently established an interim final work RVU of 0.42 for CPT code
88341, which was 60 percent of the work RVU of the base CPT code 88342
(0.70). In the CY 2016 PFS proposed rule, we revised the add-on codes
from 60 percent to 76 percent of the base code and subsequently
revalued CPT code 88341 at 0.53 work RVUs. However, we inadvertently
published work RVUs for CPT code 88341 in Addendum B without explicitly
discussing it in the preamble text. In the CY 2016 PFS final rule with
comment period, we maintained CPT code 88341's CY 2015 work RVU of 0.53
as interim final for CY 2016 and requested public comment. Also, in the
CY 2016 PFS final rule with comment period, we established an interim
final value of 0.70 work RVUs for CPT codes 88342 and 88344.
Comment: Several commenters expressed their opposition to a
standard discount for the physician work involved in pathology add-on
services and urged us to accept the RUC-recommend value of 0.65 RVUs
for CPT code 88341.
Response: We appreciate commenters' concerns regarding a standard
discount; however, we believe that it is reasonable to estimate work
RVUs for a base and an add-on code, and to recognize efficiencies
between them, by looking at how similar efficiencies are reflected in
work RVUs for other PFS services. Also we note that the intravascular
codes for which we initially established our base/add-on code
relationship for CPT codes 88346 and 88350 were deleted in CY 2016 and
replaced with two new codes; CPT codes 37252 and 37253. The
relationship between 37252 and 37253 represents a 20 percent discount
for the add-on code as the base CPT code 37252 has a work RVU of 1.80
and 37523 and work RVU of 1.44. As CPT codes 37252 and 37253 replaced
the codes on which our discounts for base and add-on codes were based
(please see the CY 2016 PFS final rule with comment period (80 FR
70972) for a detailed discussion) we believed it would be appropriate
to maintain the same 20 percent relationship for 88346 and 88350.
Therefore, for CY 2017, we are proposing a work RVU of 0.56 for CPT
code 88341, which represents 80 percent of 0.70, the work RVU of the
base code.
For CY 2016, we finalized a work RVU of 0.56 for CPT code 88350
which represented 76 percent of 0.74, the RVU for the base code. To
maintain consistency within this code family, we are proposing to
revalue CPT code 88350 using the 20 percent discount discussed above.
To value CPT code 88350, we multiplied the work RVU of CPT code 88346,
0.74, by 80 percent, and then subtracted the product from 0.74,
resulting in a work RVU of 0.59 for CPT code 88350. Therefore, for CY
2017, we are proposing a work RVU of 0.59 for CPT code 88350.
A stakeholder has suggested to us that an error was made in the
implementation of direct PE inputs for code 88341 and several other
related codes. This stakeholder stated that when CMS reclassified
equipment code EP112 (Benchmark ULTRA automated slide preparation
system) and EP113 (E-Bar II Barcode Slide Label System) into a single
equipment item, with a price of $150,000 using equipment code EP112,
[[Page 46239]]
the equipment minutes assigned to the E-Bar II Barcode Slide Label
System should have been added into the new EP112 equipment time. The
stakeholder requested that these minutes should be added into the EP112
equipment time; for example, 1 additional minute should be added to CPT
code 88341 for a total of 16 minutes.
We appreciate the additional information, and are soliciting
additional information on this topic through public comment on this
proposed rule to assess whether it would be appropriate to add the
former EP113 minutes into EP112. We are specifically seeking comment
from other stakeholders, including the RUC, since the assigned number
of minutes was originally based on a RUC recommendation. This
information would be potentially relevant for CPT codes 88341
(Immunohistochemistry or immunocytochemistry, per specimen; each
additional single antibody stain procedure), 88342
(Immunohistochemistry or immunocytochemistry, per specimen; initial
single antibody stain procedure), 88344 (Immunohistochemistry or
immunocytochemistry, per specimen; each multiplex antibody stain
procedure), 88360 (Morphometric analysis, tumor immunohistochemistry,
quantitative or semiquantitative, per specimen, each single antibody
stain procedure; manual), and 88361 (Morphometric analysis, tumor
immunohistochemistry, quantitative or semiquantitative, per specimen,
each single antibody stain procedure; using computer-assisted
technology).
(20) Morphometric Analysis (CPT Codes 88364, 88365, 88367, 88368, 88369
and 88373)
For CY 2015, the CPT editorial panel revised the code descriptors
for the in situ hybridization procedures, CPT codes 88365, 88367 and
88368, to specify ``each separately identifiable probe per block.''
Additionally, three new add-on codes (CPT codes 88364, 88369, 88373,)
were created to specify ``each additional separately identifiable probe
per slide.'' 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. We believed this accurately reflected the resources used in
furnishing these add-on codes and subsequently established 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).
For CY 2016, the RUC re-reviewed these services due to the
specialty society's initially low survey response rate. In our review
of these codes, we noticed that the latest RUC recommendation was
identical to the RUC recommendation provided for CY 2015. Therefore, we
proposed to retain the CY 2015 work RVUs and work time for CPT codes
88367 and 88368 for CY 2016. For CPT code 88365 we finalized a work RVU
of 0.88.
For CPT codes 88364 and 88369, we increased the work RVUs of these
add-on codes from 0.53 to 0.67, which reflected 76 percent of the work
RVUs of the base procedures for these services. However, we
inadvertently omitted the rationale for this revision to the work RVUs
in the proposed rule. Consequently, we maintained the CY 2015 interim
final values of the work RVU of 0.67 for CPT codes 88464 and 88369 and
sought comment on these values for CY 2016. For CPT code 88373 we
finalized a work RVU of 0.43.
Comment: A few commenters stated their objection to our use of a
standard discount for pathology add-on services and for suggesting that
each service is separate and unique. Commenters also stated there
should be no comparison of intravascular ultrasound services to
morphometric analysis, immunohistochemistry, immunofluorescence, or any
pathology service.
Response: In reviewing the RUC-recommended base/add-on
relationships between several pathology codes, we continue to believe
the base/add-on code time relationships for pathology services are
appropriate and have not been presented with any compelling evidence
that conflicts with the RUC-recommended relationships. However, as we
stated above, the intravascular codes we initially examined in
revaluing CPT codes 88364 and 88369 were deleted in CY 2016 and
replaced with CPT codes 37252 and 37253. For the reasons stated above
we continue to believe this 20 percent discount relationship between
the base and add-on code accurately reflects the work involved in
furnishing these services.
Therefore, for CY 2017, we are proposing a work RVU of 0.70 for CPT
codes 88364 and 88369 which represents a 20 percent discount from the
base code. As the relationship between the base code and add-on code
now represents a 20 percent difference we are proposing to revalue CPT
code 88373 at 0.58 work RVUs. Therefore, for CY 2017 we are proposing a
work RVU of 0.58 for CPT code 88373.
(21) Liver Elastography (CPT Code 91200)
For CY 2016, we received a RUC recommendation of 0.27 RVU for CPT
code 91200. After careful review of the recommendation, we established
the RUC-recommended work RVU and direct PE inputs as interim final for
CY 2016.
Comment: A few commenters requested that we reconsider the level of
payment assigned to this service when furnished in a non-facility
setting, stating that the code met the definition for the potentially
misvalued code list as there is a significant difference in payment
between sites of service. The commenters also asked us to reconsider
the assigned 50 percent utilization rate for the FibroScan equipment in
this procedure as the current utilization rate would translate to over
50 procedures per week. Instead, the commenters suggested the typical
number of procedures done per week ranges between 15 and 25 and
requested we adopt a 25 percent utilization rate which corresponds to
that number of procedures.
Response: We refer commenters to the CY 2016 final rule with
comment period (80 FR 71057-71058) where we discussed and addressed the
comparison of the PFS payment amount to the OPPS payment amount for CPT
91200. For the commenter's statement about the utilization rate, we
have previously addressed the accuracy of these default assumptions as
they apply to particular equipment resources and particular services.
In the CY 2008 PFS proposed rule (72 FR 38132), we discussed the 50
percent utilization assumption and acknowledged that the default 50
percent usage assumption is unlikely to capture the actual usage rates
for all equipment. However, we stated that we did not believe that we
had strong empirical evidence to support any alternative approaches. We
indicated that we would continue to monitor the appropriateness of the
equipment utilization assumption, and evaluate whether changes should
be proposed in light of the data available. The commenters did not
provide any verifiable data suggesting a lower utilization rate.
Therefore, for CY 2017 we are proposing a work RVU of 0.27 for CPT code
91200, consistent with the CY 2016 interim final value, and we continue
to explore and seek comments regarding publicly available data sources
to identify the most accurate equipment utilization rate assumptions
possible. We also note that following the
[[Page 46240]]
publication of the CY 2016 PFS final rule with comment period (80 FR
70886) there was an inconsistency in the Work Time file published on
the CMS Web site. For CPT code 91200 the RUC recommended 16 minutes
total service time whereas our file reflected 18 minutes total time for
the service. For CY 2017, we are proposing to update the Work Time file
to reflect the RUC's recommendation, which is 16 minutes for CPT code
91200.
b. CY 2017 Proposed Codes
(1) Anesthesia Services Furnished in Conjunction with Lower
Gastrointestinal (GI) Procedures (CPT Codes 00740 and 00810)
The anesthesia procedure CPT codes 00740 and 00810 are used for
anesthesia furnished in conjunction with lower gastrointestinal (GI)
procedures. In the CY 2016 PFS proposed rule (80 FR 41686), we
discussed that in reviewing Medicare claims data, a separate anesthesia
service is now reported more than 50 percent of the time that several
types of colonoscopy procedures are reported. We discussed that given
the significant change in the relative frequency with which anesthesia
codes are reported with colonoscopy services, we believe the relative
values of the anesthesia services should be reexamined. We proposed to
identify CPT codes 00740 and 00810 as potentially misvalued and sought
public comment regarding valuation for these services.
The RUC recommended maintaining the base unit value of 5 as an
interim base value for both CPT code 00740 and 00810 on an interim
basis, due to their concerns about the specialty society surveys. The
RUC suggested that the typical patient vignettes used in the surveys
for both CPT codes 00740 and 00810 were not representative of current
typical practice and recommended that the codes be resurveyed with
updated vignettes. We agree that it is premature to propose any changes
to the valuation of CPT codes 00740 and 00810, but continue to believe
that these services are potentially misvalued and look forward to
receiving input from interested parties and specialty societies for
consideration during future notice and comment rulemaking.
(2) Removal of Nail Plate (CPT Code 11730)
We identified CPT code 11730 (Avulsion of nail plate, partial or
complete, simple; single) through a screen of high expenditures by
specialty. The HCPAC recommended a work RVU of 1.10. We believe the
recommendation for this service overestimates the work involved in
performing this procedure, specifically given the decrease in physician
intraservice and total time concurrently recommended by the HCPAC. We
believe that a work RVU of 1.05, which corresponds to the 25th
percentile of the survey results, more accurately represents the time
and intensity of furnishing the service. To further support the
validity of the use of the 25th percentile of the survey, a work RVU of
1.05, we identified two crosswalk CPT codes, 20606 (Arthrocentesis,
aspiration and/or injection, intermediate joint or bursa), with a work
RVU of 1.00, and 50389 (Removal of nephrostomy tube, requiring
fluoroscopic guidance) with a work RVU of 1.10, both of which have
identical intraservice times, similar total times and similar
intensity. We note that our proposed work RVU of 1.05 for CPT code
11730 falls halfway between the work RVUs for these two crosswalk-
codes. CPT Code 11730 may be reported with add-on CPT code 11732 to
report performance of the same procedure for each additional nail plate
procedure.
Since CPT code 11732 was not reviewed by the HCPAC for CY 2017, we
are proposing a new work value to maintain the consistency of this add-
on code with the base code, CPT code 11730. We are proposing to remove
2 minutes from the physician intraservice time to maintain consistency
with the HCPAC-recommended reduction of 2 minutes from the physician
intraservice time period for the base code. We are using a crosswalk
from the value for CPT code 77001 (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)), which has similar physician intraservice and total time
values; therefore, we are proposing a work RVU of 0.38 for CPT code
11732. As further support for this proposal, we note that this proposed
RVU reduction is similar to the value obtained by subtracting the
incremental difference in the current and recommended work RVUs for the
base code from the current value of CPT code 11732.
We are proposing to use the HCPAC-recommended direct PE inputs for
CPT code 11730. We are proposing to apply some of HCPAC-recommended
refinements for CPT code 11730 to11732, including the removal of the
penrose drain (0.25in x 4in), lidocaine 1%-2% inj (Xylocaine),
applicator (cotton-tipped, sterile) and silver sulfadiazene cream
(Silvadene), as well as the reduction of the swab-pad, alcohol from 2
to 1. In addition, we are proposing not to include the recommended the
supply items ``needle, 30g, and syringe, 10-12ml'' since other similar
items are present, and we think inclusion of these additional supply
items would be duplicative. For clinical labor, we are proposing to
assign 8 minutes to ``Assist physician in performing procedure'' for to
maintain a reduction that is proportionate to that recommended for
11730. For the supply item ``ethyl chloride spray,'' we believe that
the listed input price of $4.40 per ounce overestimates the cost of
this supply item, and we are seeking comment on the accuracy of this
supply item price. Finally, we are adding two equipment items as was
done in the base code, basic instrument pack and mayo stand, and are
proposing to adjust the times for all pieces of equipment to 8 minutes
to reflect the clinical service period time.
(3) Bone Biopsy Excisional (CPT Code 20245)
In CY 2014, CPT code 20245 was identified by the RUC's 10-Day
Global Post-Operative Visits Screen.
For CY 2017, the RUC recommended a value of 6.50 work RVUs for CPT
code 20245, including a change in global period from 10- to 0- days. We
disagree with this value given the significant reductions in the
intraservice time, total time, and the change in the office visits
assuming the change in global period. The intraservice and total times
were decreased by approximately 33 and 53 percent respectively; while
the elimination of three post-operative visits (one CPT code 99214 and
two CPT code 99213 visits) alone would reduce the overall work RVU by
at least 38 percent under the reverse building block methodology. We
also note that the RUC-recommended work RVU of 6.50 only represents a
27 percent reduction relative to the previous work RVU of 8.95. To
develop a work RVU for this service, we used a crosswalk from CPT code
19298 (Placement of radiotherapy after loading brachytherapy catheters
(multiple tube and button type) into the breast for interstitial
radioelement application following (at the time of or subsequent to)
partial mastectomy, includes imaging guidance), since we believe the
codes share similar intensity and total time and the same intraservice
time of 60 minutes. Therefore, for CY
[[Page 46241]]
2017, we are proposing a work RVU of 6.00 for CPT code 20245.
(4) Insertion of Spinal Stability Distractive Device (CPT Codes 228X1,
228X2, 228X4, and 228X5)
For CY 2016, the CPT Editorial Panel converted two Category III
codes to Category I codes describing the insertion of an interlaminar/
interspinous process stability device (CPT codes 228X1 and 228X4) and
developed two corresponding add-on codes (CPT codes 228X2 and 228X5).
The RUC recommended a work RVU of 15.00 for CPT code 228X1, 4.00 for
CPT code 228X2, 7.39 for CPT code 228X4, and 2.34 for CPT code 228X5.
We believe that the RUC recommendations for CPT codes 228X1 and
228X4 overestimate the work involved in furnishing these services. We
believe that a crosswalk to CPT code 36832 (Revision, open,
arteriovenous fistula; without thrombectomy, autogenous or
nonautogenous dialysis graft (separate procedure)) which has a work RVU
of 13.50 is an accurate comparison. CPT code 36832 is similar in total
time, work intensity, and number of visits to 228X1. This is supported
by the ratio between total time and work in the key reference service,
CPT code 63047 (Laminectomy, facetectomy and foraminotomy (unilateral
or bilateral with decompression of spinal cord, cauda equina and/or
nerve root[s], [e.g., spinal or lateral recess stenosis]), single
vertebral segment; lumbar). Therefore, we are proposing a work RVU of
13.50 for CPT code 228X1. For CPT code 228X4, we believe that CPT code
29881 (Arthroscopy, knee, surgical; with meniscectomy (medial OR
lateral, including any meniscal shaving) including debridement/shaving
of articular cartilage (chondroplasty), same or separate
compartment(s), when performed) is an appropriate crosswalk based on
clinical similarity as well as intensity and total time. CPT code 29881
has an RVU of 7.03; therefore, we are proposing a work RVU of 7.03 for
CPT code 228X4. We are proposing to accept the RUC-recommended work RVU
for CPT codes 228X2 and 228X5 without refinement.
(5) Biomechanical Device Insertion (CPT Codes 22X81, 22X82, and 22X83)
For CY 2016, the CPT Editorial Panel established three new category
I add-on codes and deleted one code to provide a more detailed
description of the placement and attachment of biomechanical spinal
devices. For CPT code 22X81, the RUC recommended a work RVU of 4.88.
For CPT code 22X82, and CPT code 22X83, the recommended work RVUs are
5.50 and 6.00, respectively.
In reviewing the code descriptors, descriptions of work and
vignettes associated with CPT codes 22X82 and 22X83, we determined that
the two procedures, in addition to having identical work time, contain
many clinical similarities and do not have quantifiable differences in
overall intensity. Therefore, we are proposing the RUC-recommended work
RVU of 5.50 for both CPT code 22X82 and CPT code 228X3. We believe that
the RUC-recommended work RVU for CPT code 22X81 overestimates the work
in the procedure relative to the other codes in the family. We are
proposing a work RVU of 4.25 for CPT code 228X1 based a crosswalk from
CPT code 37237 (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)), which is similar in time and
intensity to the work described by CPT code 22X81.
(6) Closed Treatment of Pelvic Ring Fracture (CPT Codes 271X1 and
271X2)
For CY 2017, the CPT Editorial Panel deleted CPT codes 27193 and
27194 and replaced them with two new codes, 271X1 and 271X2, and the
RUC recommended a work RVU of 5.50 for CPT code 27193, and a work RVU
of 9.00 for CPT code 271X2 to describe closed treatment of pelvic ring
fracture. We are proposing to change the global period for these
services from 90 days to 0 days because these codes typically represent
emergent procedures with which injuries beyond pelvic ring fractures
are likely to occur; we believe it is typical that multiple
practitioners would be involved in providing post-operative care and it
is likely that a practitioner furnishing a different procedure is more
likely to be providing the primary post-operative care. If other
practitioners are typically furnishing care in the post-surgery period,
we believe that the six postservice visits included in CPT code 271X1,
and the seven included in 271X2, would likely not occur. This is
similar to our CY 2016 review and valuation of CPT codes 21811 (Open
treatment of rib fracture(s) with internal fixation, includes
thoracoscopic visualization when performed, unilateral; 1-3 ribs),
21812 (Open treatment of rib fracture(s) with internal fixation,
includes thoracoscopic visualization when performed, unilateral; 4-6
ribs), and 21813 (Open treatment of rib fracture(s) with internal
fixation, includes thoracoscopic visualization when performed,
unilateral; 7 or more ribs). In our valuation of those codes, we
determined that a 0-day, rather than a 90-day global period was
preferable, in part because those codes describe rib fractures that
would typically occur along with other injuries, and the patient would
likely already be receiving post-operative care because of the other
injuries. We believe that the same rationale applies here. To establish
a work RVU for 271X1, we are crosswalking this code to CPT code 65800
(Paracentesis of anterior chamber of eye (separate procedure); with
removal of aqueous), due to its identical intraservice time and similar
total time, after removing the work associated with postoperative
visits, and its similar level of intensity. Therefore, we are proposing
a work RVU of 1.53 for CPT code 271X1. For 271X2, we are crosswalking
to CPT code 93452 (Left heart catheterization including intraprocedural
injection(s) for left ventriculography, imaging supervision and
interpretation, when performed) which has an identical intraservice
time and similar total time after removing the work associated with
postoperative visits from 271X2. We are proposing a work RVU of 4.75
for code 271X2.
(7) Bunionectomy (CPT Codes 28289, 282X1, 28292, 28296, 282X2, 28297,
28298, and 28299)
The RUC identified CPT Code 28293 as a 90-day global service with
more than 6 office visits and CPT codes 28290-28299 as part of the
family of services. In October 2015, the CPT Editorial Panel created
two new CPT codes (282X1, 282X2), deleted CPT codes 28290, 28293, 28294
and revised CPT codes 28289, 28292, 28296, 28297, 28298 and 28299 based
on the rationale that more accurate descriptions of the services needed
to be developed.
For CPT codes 28289, 28292, 28296, 28297, 28298, and 28299 the RUC
recommended and we are proposing work RVUs of 6.90, 7.44, 8.25, 9.29,
7.75, and 9.29 respectively. For CPT code 282X1, the RUC recommended a
work RVU of 8.01 based on the 25th percentile of the survey. We believe
the recommendation for this service overestimates the overall work
involved in performing this procedure given the decrease in
intraservice time, total time, and post-operative visits when compared
to deleted predecessor CPT code 28293. Due to similarity in
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intraservice and total times, we believe a direct crosswalk of the work
RVUs for CPT code 65780 (Ocular surface reconstruction; amniotic
membrane transplantation, multiple layers), to CPT code 282X1 more
accurately reflects the time and intensity of furnishing the service.
Therefore, for CY 2017, we are proposing a work RVU of 7.81 for CPT
code 282X1.
For CPT code 282X2, the RUC recommended a work RVU of 8.57 based on
the 25th percentile of the survey. We believe the recommendation for
this service overestimates the work involved in performing this
procedure given the similarity in the intensity of the services and
identical intraservice and total times as CPT code 28296. Therefore, we
propose a direct RVU crosswalk from CPT code 28296 to CPT code 282X2.
For CY 2017, we are proposing a work RVU of 8.25 for CPT code 282X2.
(8) Endotracheal Intubation (CPT Code 31500)
In the CY 2016 PFS final rule with comment period (80 FR 70914), we
identified CPT code 31500 as potentially misvalued. The specialty
societies surveyed this code, and after reviewing the survey responses,
including increases in time, the RUC recommended an increase in work
RVUs to 3.00 for CPT code 31500. After reviewing the RUC's
recommendation, we are proposing a work RVU of 2.66, based on a direct
crosswalk to CPT code 65855, which has similar intensity and service
times as reflected in the survey data reported by the specialty groups.
(9) Closure of Left Atrial Appendage With Endocardial Implant (CPT Code
333X3)
The CPT Editorial Panel deleted category III code 0281T
(Percutaneous transcatheter closure of the left atrial appendage with
implant, including fluoroscopy, transseptal puncture, catheter
placement(s), left atrial angiography, left atrial appendage
angiography, radiological supervision and interpretation) and created
new CPT code 333X3 to describe percutaneous transcatheter closure of
the left atrial appendage with implant. The RUC recommended a work RVU
of 14.00, which is the 25th percentile survey result. After reviewing
that recommendation, we are proposing a work RVU of 13.00 for CPT code
333X3, which is the minimum survey result. Based on our clinical
judgment and that the key reference codes discussed in the RUC
recommendations have higher intraservice and total service times than
the median survey results for CPT code 333X3, we believe a work RVU of
13.00 more accurately represents the work value for this service.
(10) Valvuloplasty (CPT Codes 334X1 and 334X2)
The CPT Editorial Committee created new codes to describe
valvuloplasty procedures and deleted existing CPT code 33400
(Valvuloplasty, aortic valve; open, with cardiopulmonary bypass). New
CPT code 334X1 represents a simple valvuloplasty procedure and new CPT
code 334X2 describes a more complex valvuloplasty procedure. We are
proposing to use the RUC-recommended values for CPT code 334X1. For CPT
code 334X2, the RUC recommended a work RVU of 44.00, the 25th
percentile survey result. The RUC estimated that approximately 70
percent of the services previously reported using CPT code 33400 would
have been reported using CPT code 334X2 with 30 percent reported using
new CPT code 334X1. Therefore, the typical service previously reported
with 33400 ought to now be reported with 334X2. Compared to deleted CPT
code 33400, the survey results for CPT 334X2 showed the median
intraservice time to be similar but total service time to be decreased.
Therefore, we do not believe the increase recommended by the RUC is
warranted, and we are proposing a work RVU of 41.50 for CPT code 334X2.
This is the current value of CPT code 33400, and given that the typical
service should remain consistent between the two codes, we believe the
work RVU should remain consistent as well.
(11) Dialysis Circuit (CPT Codes 369X1, 369X2, 369X3, 369X4, 369X5,
369X6, 369X7, 369X8, 369X9)
In January 2015, a CPT/RUC workgroup identified the following CPT
codes as being frequently reported together in various combinations:
35475 (Transluminal balloon angioplasty, percutaneous; brachiocephalic
trunk or branches, each vessel), 35476 (Transluminal balloon
angioplasty, percutaneous; venous), 36147 (Introduction of needle and/
or catheter, arteriovenous shunt created for dialysis (graft/fistula);
initial access with complete radiological evaluation of dialysis
access, including fluoroscopy, image documentation and report), 36148
(Introduction of needle and/or catheter, arteriovenous shunt created
for dialysis (graft/fistula); additional access for therapeutic
intervention), 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),
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), 75791 (Angiography, arteriovenous shunt (e.g., dialysis patient
fistula/graft), complete evaluation of dialysis access, including
fluoroscopy, image documentation and report (includes injections of
contrast and all necessary imaging from the arterial anastomosis and
adjacent artery through entire venous outflow including the inferior or
superior vena cava), radiological supervision and interpretation),
75962 (Transluminal balloon angioplasty, peripheral artery other than
renal, or other visceral artery, iliac or lower extremity, radiological
supervision and interpretation), and 75968 (Transluminal balloon
angioplasty, each additional visceral artery, radiological supervision
and interpretation). These codes are frequently reported together for
both dialysis circuit services and transluminal angioplasty services.
At the October 2015 CPT Editorial Panel meeting, the panel approved the
creation of nine new codes and deletion of four existing codes used to
describe bundled dialysis circuit intervention services, and the
creation of four new codes and deletion of 13 existing codes used to
describe bundled percutaneous transluminal angioplasty services (see
discussion of the latter code family in the next section). The Dialysis
Circuit family of codes overlaps with the Open and Percutaneous
Transluminal Angioplasty family of codes (CPT codes 372X1-372X4), as
they are both being constructed from the same set of frequently
reported together codes. We reviewed these two families of codes
concurrently to maintain relativity between these clinically similar
procedures based upon the same collection of deleted codes.
For CPT code 369X1, we are proposing a work RVU of 2.82 instead of
the RUC-recommended work RVU of 3.36. When we compared CPT code 369X1
against other codes in the RUC database, we found that the RUC-
recommended work RVU of 3.36 would be the highest value in the database
among the 32 0-day global codes with 25 minutes of intraservice time.
Generally speaking, we are particularly skeptical of RUC-recommended
values for newly ``bundled'' codes that appear not to recognize the
full resource
[[Page 46243]]
overlap between predecessor codes. Since the recommended values would
establish a new highest value when compared to other services with
similar time, we believe it likely that the recommended value for the
new code does not reflect the efficiencies in time. Of course, were the
compelling evidence for this valuation accompanying the recommendation,
we would consider such information. We also note that the reference
code selected by the survey participants, CPT code 36200 (Introduction
of catheter, aorta), has a higher intraservice time and total time, but
a lower work RVU of 3.02. We believe that there are more accurate CPT
codes that can serve as a reference for CPT code 369X1. As a result, we
are proposing to crosswalk CPT code 369X1 to CPT code 44388
(Colonoscopy through stoma; diagnostic). CPT code 44388 has a work RVU
of 2.82, and we believe it is a more accurate crosswalk for valuation
due to its similar overall intensity and shared intraservice time of 25
minutes with 369X1 and similar total time of 65 minutes.
We are proposing a work RVU of 4.24 for CPT code 369X2 instead of
the RUC-recommended work RVU of 4.83. The RUC-recommended work RVU is
based upon a direct crosswalk to CPT code 43253
(Esophagogastroduodenoscopy, flexible, transoral) which shares the same
40 minutes of intraservice time with CPT code 369X2. However, CPT code
43253 has significantly longer total time than CPT code 369X2, 104
minutes against 86 minutes, which we believe reduces its utility for
comparison. We are instead proposing to crosswalk the work RVU for CPT
code 369X2 from CPT code 44408 (Colonoscopy through stoma), which has a
work RVU of 4.24. In addition to our assessment that the two codes
share similar intensities, CPT code 44408 also shares 40 minutes of
intraservice time with CPT code 369X2 but has only 95 minutes of total
time and matches the duration of the procedure under review more
closely than the RUC-recommended crosswalk to CPT code 43253. We also
note that the RUC-recommended work increment between CPT codes 369X1
and 369X2 was 1.47, and by proposing a work RVU of 4.24 for CPT code
369X2, we maintain a very similar increment of 1.42. As a result, we
are proposing a work RVU of 4.24 for CPT code 369X2, based on this
direct crosswalk to CPT code 44408.
For CPT code 369X3, we are proposing a work RVU of 5.85 instead of
the RUC-recommended work RVU of 6.39. The RUC-recommended value is
based on a direct crosswalk to CPT code 52282 (Cystourethroscopy, with
insertion of permanent urethral stent). Like the previous pair of RUC-
recommended crosswalk codes, CPT code 52282 shares the same
intraservice time of 50 minutes with CPT code 369X3, but has
substantially longer total time (120 minutes against 96 minutes) which
we believe limits its utility as a crosswalk. We are proposing a work
RVU of 5.85 based on maintaining the RUC-recommended work RVU increment
of 3.03 as compared to CPT code 369X1 (proposed at a work RVU of 2.82),
the base code for this family of related procedures. We also point to
CPT code 44403 (Colonoscopy through stoma; with endoscopic mucosal
resection) as a reference point for this value. CPT code 44403 has a
work RVU of 5.60, but also lower intraservice time (45 minutes as
compared to 50 minutes) and total time (92 minutes as compared to 96
minutes) in relation to CPT code 369X3, suggesting that a work RVU a
bit higher than 5.60 would be an accurate valuation. Therefore, we are
proposing a work RVU of 5.85 for CPT code 369X3, based on an increment
of 3.03 from the work RVU of CPT code 369X1.
We are proposing a work RVU of 6.73 instead of the RUC-recommended
work RVU of 7.50 for CPT code 369X4. Our proposed value comes from a
direct crosswalk from CPT code 43264 (Endoscopic retrograde
cholangiopancreatography), which shares the same intraservice time of
60 minutes with CPT code 369X4 and has a higher total time. We also
looked to the intraservice time ratio between CPT codes 369X1 and
369X4; this works out to 60 minutes divided by 25 minutes, for a ratio
of 2.4, and a suggested work RVU of 6.77 (derived from 2.4 times CPT
code 369X1's work RVU of 2.82). This indicates that our proposed work
RVU of 6.73 maintains relativity within the Dialysis Circuit family. As
a result, we are proposing a work RVU of 6.73 for CPT code 369X4, based
on a direct crosswalk to CPT code 43264.
We are proposing a work RVU of 8.46 instead of the RUC-recommended
work RVU of 9.00 for CPT code 369X5. We looked at the intraservice time
ratio between CPT codes 369X1 and 369X5 as one potential method for
valuation, which is a 1:3 ratio (25 minutes against 75 minutes) for
this case. This means that one potential value for CPT code 369X5 would
be triple the work RVU of CPT code 369X1, or 2.82 times 3, which
results in a work RVU of 8.46. We also investigated preserving the RUC-
recommended work RVU increment between CPT code 369X1 and 369X5, which
was an increase of 5.64. When this increment is added to the work RVU
of 2.82 for CPT code 369X1, it also resulted in a work RVU of 8.46 for
CPT code 369X5. Therefore, we are proposing a work RVU of 8.46 for CPT
code 369X5, based on both the intraservice time ratio with CPT code
369X1 and the RUC-recommended work increment with the same code.
For CPT code 369X6, we are proposing a work RVU of 9.88 instead of
the RUC-recommended work RVU of 10.42. We based the proposed value upon
the RUC-recommended work RVU increment between CPT codes 369X1 and
369X6, which is 7.06. When added to the work RVU of 2.82 for CPT code
369X1, the work RVU for CPT code 369X6 would be 9.88. We are supporting
this value through the use of two crosswalks that both share the same
90 minutes of intraservice time with 369X6. These are CPT code 31546
(Laryngoscopy, direct, with submucosal removal of non-neoplastic
lesion(s) of vocal cord) at a work RVU of 9.73 and CPT code 61623
(Endovascular temporary balloon arterial occlusion, head or neck) at a
work RVU of 9.95.
The final three codes in the Dialysis Circuit family are all add-on
codes, which make comparisons difficult to the global 0-day codes that
make up the rest of the family. We are proposing a work RVU of 2.48
instead of the RUC-recommended work RVU of 3.00 for CPT code 369X7. Due
to the difficulty of comparing CPT code 369X7 with the non-add-on codes
in the rest of the Dialysis Circuit family, we looked instead to
compare the value to the add-on codes in the Open and Percutaneous
Transluminal Angioplasty family of codes (CPT codes 372X1-372X4). As we
stated previously, both of these groups of new codes are being
constructed from the same set of frequently reported together codes. We
reviewed these two families of codes together to maintain relativity
across the two families, and so that we could compare codes that shared
the same global period.
We are proposing the RUC-recommended work RVUs for all four codes
in the Open and Percutaneous Transluminal Angioplasty family of codes.
As a result, we compared CPT code 369X7 with the RUC-recommended work
RVU of 2.97 for CPT code 372X4, which is also an add-on code. These
procedures should be clinically very similar, since both of them are
performing percutaneous transluminal angioplasty on a central vein, and
both of them are add-on procedures. We looked at the intraservice time
ratio between these two codes, which was a comparison between 25
minutes for CPT code 369X7 against 30 minutes for CPT code 372X4.
[[Page 46244]]
This produces a ratio of 0.83, and a proposed work RVU of 2.48 for CPT
code 369X7 when multiplied with the RUC-recommended work RVU of 2.97
for CPT code 372X4. We note as well that the intensity was markedly
higher for CPT code 369X7 as compared to CPT code 372X4 when using the
RUC-recommended work values, which did not make sense since CPT code
369X7 would typically be a clinically less intense procedure. Using the
intraservice time ratio results in the two codes having exactly the
same intensity. As a result, we are therefore proposing a work RVU of
2.48 for CPT code 369X7, based on this intraservice time ratio with the
RUC-recommended work RVU of CPT code 372X4.
For CPT code 369X8, we disagree with the RUC-recommended work RVU
of 4.25, and we are instead proposing a work RVU of 3.73. We do not
consider the RUC work value of 4.25 to be accurate for CPT code 369X8,
as this was higher than our proposed work value for CPT code 369X2
(4.24), and we do not believe that an add-on code should typically have
a higher work value than a similar non-add-on code with the same
intraservice time. We identified two appropriate crosswalks for valuing
CPT code 369X8: CPT code 93462 (Left heart catheterization by
transseptal puncture through intact septum or by transapical puncture)
and CPT code 37222 (Revascularization, endovascular, open or
percutaneous, iliac artery). Both of these codes share the same
intraservice time as CPT code 369X8, and both of them also have the
same work RVU of 3.73, which results in these codes also sharing the
same intensity since they are all add-on codes. We are therefore
proposing a work value of 3.73 for CPT code 369X8, based on a direct
crosswalk to CPT codes 93462 and 37222.
Finally, we are proposing a work RVU of 3.48 for CPT code 369X9
instead of the RUC-recommended work RVU of 4.12. The RUC recommended
value comes from a direct crosswalk from CPT code 38746 (Thoracic
lymphadenectomy by thoracotomy). We compared the RUC-recommended work
RVU for this procedure to other add-on codes with 30 minutes of
intraservice time and found that the recommended work RVU of 4.12 would
overestimate the overall intensity of this service relative to those
with similar times. In reviewing the range of these codes, we believe
that a more appropriate crosswalk is to CPT code 61797 (Stereotactic
radiosurgery (particle beam, gamma ray, or linear accelerator)) at a
work RVU of 3.48. We believe that this value is more accurate when
compared to other add-on procedures with 30 minutes of intraservice
time across the PFS. As a result, we are proposing a work RVU of 3.48
for CPT code 369X9 based on a direct crosswalk from CPT code 61797.
We are proposing to use the RUC-recommended direct PE inputs for
these nine codes with several refinements. We are not proposing to
include the recommended additional preservice clinical labor for CPT
codes 369X4, 369X5, and 369X6. The preservice work description is
identical for all six of the global 0-day codes in this family; there
is no justification given in the RUC recommendations as to why the
second three codes need additional clinical labor time beyond the
minimal preservice clinical labor assigned to the first three codes. We
do not believe that the additional staff time would be typical. Patient
care already would have been coordinated ahead of time in the typical
case, and the need for unscheduled dialysis or other unusual
circumstances would be discussed prior to the day of the procedure. We
are therefore proposing to refine the preservice clinical labor for CPT
codes 369X4, 369X5, and 369X6 to match the preservice clinical labor of
CPT codes 369X1, 369X2, and 369X3.
We are proposing to refine the L037D clinical labor for ``Prepare
and position patient/monitor patient/set up IV'' from 5 minutes to 3
minutes for CPT codes 369X1-369X6. The RUC recommendation included a
written justification for additional clinical labor time beyond the
standard 2 minutes for this activity, stating that the extra time is
needed to prepare the patient's arm for the procedure. We agree that
extra time may be needed for this activity as compared to the default
standard of 2 minutes; however, we are assigning 1 extra minute for
preparing the patient's arm, resulting in a total of 3 minutes for this
task. We do not believe that 3 extra minutes would be typically needed
for arm positioning.
We are proposing to remove the ``kit, for percutaneous thrombolytic
device (Trerotola)'' supply (SA015) from CPT codes 369X4, 369X5, and
369X6. We believe that this thrombolytic device kit and the ``catheter,
thrombectomy-Fogarty'' (SD032) provide essentially the same supply, and
the use of only one of them would be typical in these procedures. We
believe that each of these supplies can be used individually for
thrombectomy procedures. We are proposing to remove the SA015 supply
and retain the SD032 supply, and we seek additional comment and
information regarding the use of these two supplies.
We are also proposing to remove the recommended supply item
``covered stent (VIABAHN, Gore)'' (SD254) and replace it with the
``stent, vascular, deployment system, Cordis SMART'' (SA103) for CPT
codes 369X3 and 369X6. The Cordis SMART vascular stent was previously
used in the past for CPT code 37238, which is the deleted code for
transcatheter placement of an intravascular stent that CPT codes 369X3
and 369X6 are replacing. We do not have a stated rationale as to the
need for this supply substitution, and therefore, we do not believe it
would be appropriate to replace the current items with a significantly
higher-priced item without additional information.
We are also proposing to refine the quantity of the ``Hemostatic
patch'' (SG095) from 2 to 1 for CPT codes 369X4, 369X5, and 369X6. This
supply was not included in any of the deleted base codes out of which
the new codes are being constructed, and while we agree that the use of
a single hemostatic patch has become common clinical practice, we do
not agree that CPT codes 369X4-369X6 would typically require a second
patch. As a result, we are proposing to refine the SG095 supply
quantity from 2 to 1 for CPT codes 369X4-369X6, which also matches the
supply quantity for CPT codes 369X1-369X3.
Included in the RUC recommendation for the Dialysis Circuit family
of codes were a series of invoices for a ``ChloraPrep applicator (26
ml)'' supply. We are soliciting comments regarding whether the Betadine
solution has been replaced by a Chloraprep solution in the typical case
for these procedures. We are also soliciting comments regarding whether
the ``ChloraPrep applicator (26 ml)'' detailed on the submitted
invoices is the same supply as the SH098 ``chlorhexidine 4.0%
(Hibiclens)'' applicator currently in the direct PE database.
Finally, we are also interested in soliciting comments about the
use of guidewires for these procedures. We are requesting feedback
about which guidewires would be typically used for these procedures,
and which guidewires are no longer clinically necessary.
(12) Open and Percutaneous Transluminal Angioplasty (CPT Codes 372X1,
372X2, 372X3, and 372X4)
In January 2015, a CPT/RUC workgroup identified the following CPT
codes as being frequently reported together in various combinations:
35475 (Transluminal balloon angioplasty, percutaneous; brachiocephalic
trunk or branches, each vessel), 35476 (Transluminal balloon
angioplasty,
[[Page 46245]]
percutaneous; venous), 36147 (Introduction of needle and/or catheter,
arteriovenous shunt created for dialysis (graft/fistula); initial
access with complete radiological evaluation of dialysis access,
including fluoroscopy, image documentation and report), 36148
(Introduction of needle and/or catheter, arteriovenous shunt created
for dialysis (graft/fistula); additional access for therapeutic
intervention), 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),
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), 75791 (Angiography, arteriovenous shunt (e.g., dialysis patient
fistula/graft), complete evaluation of dialysis access, including
fluoroscopy, image documentation and report (includes injections of
contrast and all necessary imaging from the arterial anastomosis and
adjacent artery through entire venous outflow including the inferior or
superior vena cava), radiological supervision and interpretation),
75962 (Transluminal balloon angioplasty, peripheral artery other than
renal, or other visceral artery, iliac or lower extremity, radiological
supervision and interpretation), and 75968 (Transluminal balloon
angioplasty, each additional visceral artery, radiological supervision
and interpretation). At the October 2015 CPT Editorial Panel meeting,
the panel approved the creation of four new codes and deletion of 13
existing codes used to describe bundled percutaneous transluminal
angioplasty services. The Open and Percutaneous Transluminal
Angioplasty family of codes overlaps with the Dialysis Circuit family
of codes (CPT codes 369X1-369X9), as they are both being constructed
from the same set of frequently reported together codes. We reviewed
these two families of codes concurrently to maintain relativity between
these clinically similar procedures based upon the same collection of
deleted codes. After consideration of these materials, we are proposing
to accept the RUC-recommended work RVU for CPT codes 372X1, 372X2,
372X3, and 372X4.
For the clinical labor direct PE inputs, we are proposing to use
the RUC-recommend inputs with several refinements. Our proposed inputs
refine the recommended clinical labor time for ``Prepare and position
patient/monitor patient/set up IV'' from 5 minutes to 3 minutes for CPT
codes 372X1 and 372X3. The RUC recommendation included a written
justification for additional clinical labor time beyond the standard 2
minutes for this activity, stating that the extra time was needed to
move leads out of X-ray field, check that X-ray is not obstructed and
that there is no risk of collision of X-ray equipment with patient. As
we wrote for the same clinical labor activity in the Dialysis Circuit
family, we agree that extra time may be needed for this activity as
compared to the default standard of 2 minutes; however, we are
assigning 1 extra minute for the additional positioning tasks,
resulting in a total of 3 minutes for this task. We do not believe that
3 extra minutes would be typically needed for preparation of the X-ray.
The equipment times for the angiography room (EL011) and the PACS
workstation (ED050) have been refined to reflect this change in
clinical labor.
We are proposing to remove the ``drape, sterile, femoral'' supply
(SB009) and replace it with a ``drape, sterile, fenestrated 16in x
29in'' supply (SB011) for CPT codes 372X1 and 372X3. The two base codes
out of which these new codes are being constructed, CPT codes 35471 and
35476, both made use of the SB011 fenestrated sterile drape supply, and
there was no rationale provided for the switch to the SB009 femoral
sterile drape in the two new codes. We are seeking comment on the use
of sterile drapes for these procedures, and what rationale there is to
support the use of the SB009 femoral sterile drape as typical for these
new procedures.
(13) Percutaneous Biliary Procedures Bundling (CPT Codes 47531, 47532,
47533, 47534, 47535, 47536, 47537, 47538, 47539, 47540, 47541, 47542,
47543, and 47544)
This group of fourteen codes was reviewed by the RUC at the April
2015 meeting. We established interim final values for this group of
codes during the CY 2016 PFS rulemaking cycle, and subsequently
received updated RUC recommendations from the October 2015 meeting for
the CY 2017 PFS rulemaking cycle. Our proposals for these codes
incorporate both the updated RUC recommendations, as well as public
comments received as part of the interim final status of these
procedures.
We received several comments regarding the CMS refinements to the
work values for this family of codes in the CY 2016 final rule with
comment period. The relevance of many of these comments has been
diminished by the new series of RUC recommendations for work values
that we received as a result of the October 2015 meeting. Given that we
are proposing the updated RUC-recommended work RVUs for CPT codes
47531, 47532, 47533, 47534, 47535, 47536, 47537, 47538, 47539, 47540,
47542, 47543, and 47544, we seek additional comments relative to these
proposed values. We agree that the second round of physician surveys
conducted for the October 2015 RUC meeting more accurately captured the
work and time required to perform these procedures. The one exception
is CPT code 47541; the survey times for this procedure were identical
as conducted for the April and October 2015 RUC meetings, yet the RUC
recommendation increased from a work RVU of 5.61 in April to a work RVU
of 7.00 in October. Given that the time values for the procedure
remained unchanged between the two surveys, we do not understand why
the work RVU would have increased by nearly 1.50 in the intervening
months. Since this code also has an identical intraservice time (60
minutes) and total time (121 minutes) as CPT code 47533, we do not
agree that it should be valued at a substantially higher rate compared
to a medically similar procedure within the same code family. We are
therefore proposing to crosswalk the work value of CPT code 47541 to
the work value of CPT code 47533, and we are proposing a work RVU of
5.63 for both procedures.
We also note that many of the codes in the Percutaneous Biliary
Procedures family were previously included in Appendix G, and were
valued under the assumption that moderate sedation was typically
performed on the patient. As part of the initiative to pay separately
for moderate sedation when it is performed, we are removing a portion
of the work RVU and preservice work time from CPT codes 47532, 47533,
47534, 47535, 47536, 47538, 47539, 47540, and 47541. For example, we
are proposing that CPT code 47541 undergoes a 0.25 reduction in its
work RVU from 5.63 to 5.38, and a 10 minute reduction in its preservice
work time from 33 minutes to 23 minutes, to reflect the work that will
now be reported separately using the new moderate sedation codes. CPT
codes 47542, 47533, and 47544 are also included in the moderate
sedation initiative; however, as add-on codes, they are not subject to
alterations in
[[Page 46246]]
their work RVUs or work times since the moderate sedation code with
work RVUs and work time (991X2) will only be billed once for each base-
code and not additionally with the add-on codes. These changes are
reflected in Appendix B and the work time file posted to the Web; see
section II.D for more details.
For the direct PE inputs, we are proposing to remove the L051A
clinical labor for ``Sedate/apply anesthesia'' and the L037D for
``Assist Physician in Performing Procedure'' for CPT codes 47531 and
47537. As we wrote in last year's final rule with comment period (80 FR
71053), we believe that this clinical labor describes activities
associated with moderate sedation, and moderate sedation is not typical
for these procedures. We are also proposing to refine the L037D
clinical labor for ``Clean room/equipment by physician staff'' from 6
minutes to 3 minutes for all of the codes in this family. Three minutes
is the standard for this clinical labor activity, and we continue to
maintain that the need for additional clinical labor time for this
cleaning activity would not be typical for these procedures.
Comment: One commenter disagreed with our refinement to replace
supply item ``catheter, balloon, PTA'' (SD152) with supply item
``catheter, balloon ureteral (Dowd)'' (SD150). The commenter stated
that a Dowd catheter is designed and FDA approved for use in the
prostatic urethra by retrograde placement through the penile urethra,
and it is not designed for use in an antegrade ureteral dilation
procedure. The commenter stated that this replacement is inappropriate.
The updated RUC recommendations for this family of codes also restored
the balloon PTA catheter.
Response: We are proposing again to replace the recommended supply
item ``catheter, balloon, PTA'' (SD152) with supply item ``catheter,
balloon ureteral (Dowd)'' (SD150). We believe that the use of this
ureteral balloon catheter, which is specifically designed for catheter
and image guidance procedures, would be more typical than the use of a
PTA balloon catheter. While we recognize that the Dowd catheter is not
FDA approved, it is our understanding that the PTA balloon catheter has
also not been FDA approved for use in these procedures. We are
uncertain if the commenter was requesting that we should no longer
include catheters that lack FDA approval in the direct PE database;
this would preclude the use of most of the catheters in our direct PE
database. We welcome additional comment on the use of FDA approved
catheters; in the meantime, we will continue our long-standing practice
of using the catheters in the direct PE database without explicit
regard to FDA approval in particular procedures.
We are also proposing to remove the recommended supply item ``stone
basket'' (SD315) from CPT code 47543 and add it to CPT code 47544.
Based on the code descriptors, we believe that the stone basket was
intended to be included in CPT code 47544 and was erroneously listed
under CPT code 47543. We are soliciting comments from the public to
help clarify this issue.
We note again that many of the codes in the Percutaneous Biliary
Procedures family were previously included in Appendix G, and as part
of the initiative to pay separately for moderate sedation when
performed, we are removing some of the recommended direct PE inputs
related to moderate sedation from CPT codes 47532, 47533, 47534, 47535,
47536, 47538, 47539, 47540, and 47541. We are removing the L051A
clinical labor time for ``Sedate/apply anesthesia'', ``Assist Physician
in Performing Procedure (CS)'', and ``Monitor pt. following moderate
sedation''. We are also removing the conscious sedation pack (SA044)
supply, and some or all of the equipment time for the stretcher
(EF018), the mobile instrument table (EF027), the 3-channel ECG
(EQ011), and the IV infusion pump (EQ032). These changes are reflected
in the public use files posted to the web; see section II.D for more
details.
(14) Flexible Laryngoscopy (CPT Codes 31575, 31576, 31577, 31578,
317X1, 317X2, 317X3, and 31579)
After we identified CPT codes 31575 and 31579 as potentially
misvalued in (80 FR 70912-70914) the RUC referred the entire flexible
laryngoscopy family of codes back to CPT for revision and the addition
of several codes representing new technology within this family of
services. At the May 2015 CPT meeting, the Editorial Panel added three
new codes to describe laryngoscopy with ablation or destruction of
lesion and therapeutic injection. Based on the survey results, the time
resources involved in furnishing the procedures described by this code
family experienced a significant reduction in the intraservice period,
yet the recommended work RVUs were not similarly reduced. Therefore, in
reviewing the recommended values for this family of codes we looked for
a rationale for increased intensity and absent such rationale, propose
to adjust the recommend work RVUs to account for significant changes in
time.
For CPT code 31575, we disagree with the RUC-recommended work RVU
of 1.00, and we are instead proposing a work RVU of 0.94. We looked at
the total time ratio for CPT code 31575, which is decreasing from 28
minutes to 24 minutes, and applied this ratio of 0.86 times the current
work RVU of 1.10 to derive our proposed work RVU of 0.94. We are
supporting this value for CPT code 31575 through a crosswalk to CPT
code 64405 (Injection, anesthetic agent; greater occipital nerve),
which shares 5 minutes of intraservice time and also has a work RVU of
0.94.
We agree with the RUC that CPT code 31575 serves as the base code
for the rest of the Flexible Laryngoscopy family. As a result, we are
proposing to maintain the same RUC-recommended increments for the rest
of the codes in this family, measuring the increments from CPT code
31575's refined work RVU of 0.94 instead of the RUC-recommended work
RVU of 1.00. This means that each of the work RVUs for the codes in the
rest of the family has decreased by 0.06 when compared to the RUC-
recommended value. We are therefore proposing a work RVU of 1.89 for
CPT code 31576, a work RVU of 2.19 for CPT code 31577, a work RVU of
2.43 for CPT code 31578, a work RVU of 3.01 for CPT code 317X1, a work
RVU of 2.43 for CPT code 317X2, a work RVU of 2.43 for CPT code 317X3,
and a work RVU of 1.88 for CPT code 31579.
Amongst the direct PE inputs, we are proposing to refine the
clinical labor time for ``Obtain vital signs'' for CPT codes 31577 and
31579 from 3 minutes to 2 minutes. We believe that this extra clinical
labor time is duplicative, as these codes are typically performed with
a same day E/M service. Each procedure is only allotted a maximum of 5
minutes for obtaining vital signs, and since 3 minutes are already
included in the E/M code, we are proposing to reduce the time to 2
minutes for these services. Similarly, we are proposing to remove the 3
minutes of clinical labor time for ``Clean room/equipment by physician
staff'' from CPT codes 31575, 31577, and 31579. These procedures are
typically reported with a same day E/M service, making the clinical
labor minutes for cleaning the room in these procedure codes
duplicative of the time already included in the E/M codes.
For CPT code 317X1, we are proposing to remove the ``laser tip,
diffuser fiber'' supply (SF030) and replace it with the ``laser tip,
bare (single use)'' supply (SF029) already present in our direct PE
database. We
[[Page 46247]]
believe that the invoice for SF030 submitted with the RUC
recommendation is not current enough to establish a new price for this
supply; as a result, we are substituting the SF029 supply for this
input. We welcome the submission of new invoices to accurately price
the diffuser fiber with laser tip.
We are also proposing to make significant changes to the prices of
several of the supplies and equipment related to Flexible Laryngoscopy,
as well as to the prices of scopes more broadly. We are proposing to
set the price of the disposable biopsy forceps supply (SD318) at
$26.84, based on the submission of an invoice with a price of $536.81
for a unit size of 20. In our search for additional information
regarding scope inputs, we obtained a quote from a vendor listing the
current price for several equipment items related to the use of scopes.
Since we believe that the prices in vendor quotes would typically be
equal to or higher than prices actually paid by practitioners, we are
updating the prices in our direct PE database to reflect this new
information. As part of this process, we are proposing to increase the
price of the ``light source, xenon'' (EQ167) from $6,723.33 to $7,000
to reflect current pricing information. We are also proposing to adjust
the price of the ``fiberscope, flexible, rhinolaryngoscopy'' (ES020)
from $6,301.93 to $4,250.00.
In accordance with the wider proposal that we are making involving
the use of scope equipment, we are proposing to separate the scopes
used in these procedures from the scope video systems. In the course of
researching different kinds of scopes, we obtained vendor pricing for
two different types of scopes used in these procedures. We are
proposing to price the ``rhinolaryngoscope, flexible, video, non-
channeled'' (ES063) at $8,000 and the ``rhinolaryngoscope, flexible,
video, channeled'' (ES064) at $9,000 in accordance with our vendor
quotes. We are proposing to use the non-channeled scope for CPT codes
31575, 31579, and 317X3 and the channeled scope for CPT codes 31576,
31577, 31578, 317X1, and 317X2 in accordance with the RUC-recommended
video systems that stipulated channeled versus non-channeled scope
procedures.
We believe that the ``Video-flexible laryngoscope system'' listed
in the recommendations is not a new form of equipment, but rather
constitutes a version of the existing ``video system, endoscopy''
equipment (ES031). We are not adding a new equipment item to our direct
PE database; instead, we are proposing to use the submitted invoices to
update the price of the ES031 endoscopy video system. As the equipment
code for ES031 indicates, we are proposing to define the endoscopy
video system as containing a processor, digital capture, monitor,
printer, and cart. We are proposing to price ES031 at $15,045.00; this
reflects a price of $2,000.00 for the monitor, $9,000.00 for the
processor, $1,750.00 for the cart, and $2,295.00 for the printer. These
prices were obtained from our vendor invoice, with the exception of the
printer, which is a crosswalk to the ``video printer, color (Sony
medical grade)'' equipment (ED036).
We do not agree that there is a need for multiple different video
systems for this collection of Flexible Laryngoscopy codes based on our
understanding of the clinical differences among the codes. In keeping
with this understanding, we are proposing to use the same existing
``video system, endoscopy'' equipment (ES031) for the remaining codes
in the family that included RUC recommendations for new equipment items
named ``Video-flexible channeled laryngoscope system'' and ``Video-
flexible laryngoscope stroboscopy system.'' For CPT codes 31576, 31577,
31578, 317X1, and 317X2, we are proposing to replace the Video-flexible
channeled laryngoscope system with the existing endoscopy video system
(ES031) along with a channeled flexible video rhinolaryngoscope
(ES064). For CPT code 31579, we are proposing to rename the RUC-
recommended ``Video-flexible laryngoscope stroboscopy system'' to the
shortened ``stroboscopy system'' (ES065) and assign it a price of
$19,100.00. This reflects the price of the StrobeLED Stroboscopy system
included on the submitted invoice. We are proposing to treat the
stroboscopy system as a scope accessory, which will be included along
with the ``video system, endoscopy'' equipment (ES031) and the
``rhinolaryngoscope, flexible, video, non-channeled'' (ES063) for CPT
code 31579. When the price of the scope, the scope video system, and
the stroboscopy system are summed together, the total proposed
equipment price is $42,145.00.
We are proposing to refine the recommended equipment times for
several equipment items to conform to changes in clinical labor time.
These are: The fiberoptic headlight (EQ170), the suction and pressure
cabinet (EQ234), the reclining exam chair with headrest (EF008), and
the basic instrument pack (EQ137). We are proposing to use the standard
equipment time formula for scope accessories for the endoscopy video
system (ES031) and the stroboscopy scope accessory system (ES065). We
are also proposing to refine the equipment time for the channeled and
non-channeled flexible video rhinolaryngoscopes to use the standard
equipment time formula for scopes. For this latter pair of two new
equipment items, this proposal results in small increases to their
respective equipment times.
(15) Laryngoplasty (CPT Codes 31580, 31584, 31587, and 315X1-315X6)
CPT code 31588 (Laryngoplasty, not otherwise specified (e.g., for
burns, reconstruction after partial laryngectomy) was identified as
potentially misvalued based on the RUC's 90-Day Global Post-Operative
Visits screen. When this code family was reviewed by the RUC, it was
determined that some codes in the family required revision to reflect
the typical patient before a survey could be conducted and the code
family was referred to the CPT Editorial Panel for revision. At the
October 2015 CPT Editorial Panel meeting, the CPT Editorial Panel
approved the creation of six new codes, revision of three codes, and
deletion of three codes. For CPT codes 31580, 31587, 315X1, 315X2,
315X3, 315X4, and 315X6, CMS is proposing the RUC-recommended work
RVUs.
For CPT code 31584, the RUC recommended a work RVU of 20.00. We
believe that the 25th percentile of the survey, which is a work RVU of
17.58, better represents the time and intensity involved with
furnishing this service based on a comparison with and assessment of
the overall intensity of other codes with similar instraservice and
total time. This value is also supported by a crosswalk code of CPT
code 42844 (Radical resection of tonsil, tonsillar pillars, and/or
retromolar trigone; closure with local flap (e.g., tongue, buccal)),
which has identical intraservice time and identical total time.
Therefore, we are proposing a work value of 17.58 RVUs for CPT code
31584.
For CPT code 315X5, the RUC recommended a work value of 15.60 RVUs.
We believe that the 25th percentile of the survey, which is a work RVU
of 13.56, better represents the time and intensity involved with
furnishing this service based on a comparison of the overall intensity
of other codes with similar instraservice and total time. The 25th
percentile of the survey is additionally bracketed by two crosswalk
codes that we estimate have slightly lower and slighter higher overall
intensities, CPT code 36819
[[Page 46248]]
(Arteriovenous anastomosis, open; by upper arm basilic vein
transposition), which has a work RVU of 13.29, and CPT code 49654
(Laparoscopy, surgical, repair, incisional hernia (includes mesh
insertion, when performed); reducible), which has a work RVU of 13.76;
both of these codes have identical intraservice time and similar total
time. Therefore, we are proposing a work RVU of 13.56 for CPT code
315X5.
Additionally, the RUC forwarded invoices provided by a medical
specialty society for the video-flexible laryngoscope system used in
these services. As discussed in section II.A of this proposed rule, we
have proposed changes to the items included in equipment item ES031
(video system, endoscopy). Consistent with those proposed changes, we
are proposing to add a Nasolaryngoscope, non-channeled, to the list of
equipment items used for CPT codes 31580, 31584, 31587, and 315X1-
315X6, along with the modified equipment item ES031.
(16) Mechanochemical Vein Ablation (MOCA) (CPT Codes 364X1 and 364X2)
At the October 2015 CPT meeting, the CPT Editorial Panel
established two Category I codes for reporting venous mechanochemical
ablation, CPT codes 364X1 and 364X2. We are proposing the RUC-
recommended work RVU of 3.50 for CPT code 364X1. For CPT code 364X2 we
believe that the RUC-recommended work RVU of 2.25 does not accurately
reflect the typical work involved in furnishing this procedure. The
specialty society survey recommended that this add-on code has half the
work of the base code, CPT code 364X1. This value is supported by the
ratio between work and time in the key reference service, CPT code
36476 (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)). Therefore, we are proposing a
work RVU of 1.75 for CPT code 364X2.
The RUC-recommended direct practice expense inputs for CPT codes
364X1 and 364X2 included inputs for an ultrasound room (EL015). Based
on the clinical nature of these procedures, we do not believe that an
ultrasound room would typically be used to furnish these procedures. We
are proposing to remove inputs for the ultrasound room and put in a
portable ultrasound (EQ250), power table (EF031), and light (EF014).
The RUC also recommended that the ultrasound machine be allocated
clinical staff time based on the PACS workstation formula. We do not
believe that an ultrasound machine would be used like a PACS
workstation, as images are generated and reviewed in real time.
Therefore, we are proposing to remove all inputs associated with the
PACS workstation.
(17) Esophageal Sphincter Augmentation (CPT Codes 432X1 and 432X2)
In October 2015, the CPT Editorial Panel created two new codes to
describe laparoscopic implantation and removal of a magnetic bead
sphincter augmentation device used for treatment of gastroesophageal
reflux disease (GERD). The RUC noted that the specialty societies
conducted a targeted survey of the 145 physicians who have been trained
to furnish these services and who are the only physicians who have
performed these procedures. They noted that only 18 non-conflicted
survey responses were received despite efforts to follow up and that
nine physicians had no experience in the past 12 months with the
procedure. The RUC agreed with the specialty society that the expertise
of those responding was sufficient to consider the survey, however,
neither entity used the survey results as the as the primary basis for
their recommended value.
For CPT code 432X1, the RUC recommended a work RVU of 10.13. We
compared this code to CPT code 43180 (Esophagoscopy, rigid, transoral
with diverticulectomy of hypopharynx or cervical esophagus (e.g.,
Zenker's diverticulum), with cricopharyngeal myotomy, includes use of
telescope or operating microscope and repair, when performed), which
has a work RVU of 9.03 and has identical intraservice time and similar
total time. We believe the overall intensity of these procedures is
similar, therefore, we are proposing a work RVU of 9.03 for CPT code
432X1.
For CPT code 432X2, the RUC recommended a work RVU of 10.47. To
value this code, we used the increment between the RUC-recommended work
RVU for this code and CPT code 432X1 (0.34 RVUs) to develop our
proposed work RVU of 9.37 for CPT code 432X2.
(18) Electromyography Studies (CPT Code 51784)
We identified CPT code 51784 as potentially misvalued through a
screen of high expenditure by specialty. This family also includes CPT
code 51785 (Needle electromyography studies (EMG) of anal or urethral
sphincter, any technique) but was not included in this survey. Both
services have 0-day global periods. The RUC recommended a work RVU of
0.75 for CPT code 51784. We believe that this service is more
accurately valued without a global period, since that is more
consistent with other diagnostic services, and specifically, with all
the other diagnostic electromyography services. We are proposing a
change to the global period from 0-day to no global period, and we are
proposing the RUC-recommended work RVU of 0.75 for CY 2017. We are also
proposing to change the global period for CPT code 51785 from 0-day to
no global period, to be consistent with 51784. Additionally, we are
proposing to add CPT code 51785 to the list of potentially misvalued
codes to update the value of the service considering the change in
global period, and to maintain consistency with 51784.
(19) Cystourethroscopy (CPT Code 52000)
In the CY 2016 PFS final rule with comment period, CMS identified
CPT code 52000 through the screen for high expenditure services by
specialty screen. The RUC-recommended work RVUs of 1.75 for CPT code
52000 is larger than the work RVUs for all 0-day global codes with 10
minutes of intraservice time and we do not believe that the overall
intensity of this service is greater than all of the other codes.
Instead, we believe the overall work compares for this code compares
favorably to CPT code 58100 (Endometrial sampling (biopsy) with or
without endocervical sampling (biopsy), without cervical dilation, any
method (separate procedure)), which has a work RVU of 1.53, and has
identical intraservice time and similar total time. Therefore, we are
using a direct crosswalk to CPT code 58100 and are proposing a work RVU
of 1.53 for CPT code 52000.
(20) Biopsy of Prostate (CPT Code 55700)
In the CY 2016 PFS final rule with comment period, CMS identified
CPT code 55700 as potentially misvalued based on the high expenditure
by specialty screen.
The RUC subsequently reviewed this code for physician work and
practice expense and recommended a work RVU of 2.50 based on the 25th
percentile of the survey. We believe the RUC-recommended work RVU
overestimates the work involved in furnishing this service given the
reduction in total service time; specifically, the reduction in
preservice and postservice times. The RUC recommendation also appears
overvalued when compared to similar 0-day global services with 15
minutes of intraservice time and comparable total
[[Page 46249]]
times. To develop a proposed work RVU, we crosswalked the work RVUs for
this code from CPT code 69801 (Labyrinthotomy, with perfusion of
vestibuloactive drug(s), transcanal), noting similar levels of
intensity, similar total times, and identical intraservice times.
Therefore, we are proposing a work RVU of 2.06 for CPT code 55700.
As part of the recommended direct PE inputs for CPT code 55700, the
RUC recommended inclusion of a new equipment item, Biopsy Guide, but we
have not received any invoices to price this item. Given our
longstanding difficulties in acquiring accurate pricing information for
equipment items, we are seeking invoices and public comment for pricing
this equipment prior to adding this new equipment item code.
(21) Hysteroscopy (CPT Codes 58555-58563)
In the CY 2016 PFS proposed rule, we proposed CPT code 58558 as a
potentially misvalued code based on the screen for high expenditure by
specialty screen. This code was reviewed at the January 2016 RUC
meeting and CPT codes 58559-58563 were included in the review as part
of the family.
For CPT code 58555, the RUC recommended a work RVU of 3.07. We
believe that the 25th percentile of the survey, a work RVU of 2.65,
more accurately reflects the resources involved in furnishing this
service. This value is bracketed by two crosswalk codes, CPT code 43191
(Esophagoscopy, rigid, transoral; diagnostic, including collection of
specimen(s) by brushing or washing when performed (separate
procedure)), which has a work RVU of 2.49, and CPT code 31295 (Nasal/
sinus endoscopy, surgical; with dilation of maxillary sinus ostium
(e.g., balloon dilation), transnasal or via canine fossa), which has a
work RVU of 2.70. Compared with CPT code 58555, CPT codes 43191 and
31295 have identical intraservice times and similar total times.
Therefore, we are proposing a work RVU of 2.65 for CPT code 58555.
For CPT code 58558, the RUC recommended a work RVU of 4.37.
However, we believe that a direct crosswalk from CPT code 36221 (Non-
selective catheter placement, thoracic aorta, with angiography of the
extracranial carotid, vertebral, and/or intracranial vessels,
unilateral or bilateral, and all associated radiological supervision
and interpretation, includes angiography of the cervicocerebral arch,
when performed), which has a work RVU of 4.17, and which has identical
intraservice time and very similar total time, more accurately reflects
the time and intensity of furnishing this service. This value is
additionally supported by using an increment between this code and the
base code for this family, CPT code 58555. The increment between the
RUC-recommended values for these two codes is 1.3. That increment added
to the proposed work RVU of 2.65 for the base code, CPT code 58555,
results in a work RVU of 3.95. Therefore, we are proposing a work value
of 4.17 RVUs for CPT code 58558.
For CPT code 58559, the RUC recommended a work RVU of 5.54.
However, we believe that a direct crosswalk of the work RVUs for CPT
code 52315 (Cystourethroscopy, with removal of foreign body, calculus,
or ureteral stent from urethra or bladder (separate procedure);
complicated), which has a work RVU of 5.20 and which has a similar
(slightly higher) intraservice time and similar total time as compared
with CPT code 58589 more accurately reflects the time and intensity of
furnishing this service. This value is additionally supported by using
an increment between CPT code 58559 and the base code for this family,
CPT code 58555. The increment between the RUC recommended values for
the two codes is 2.47. That increment added to the proposed value for
the base code, CPT code 58555 (2.65), results in a work RVU of 5.12.
Therefore, we are proposing a work RVU of 5.20 for CPT code 58559.
For CPT code 58560, the RUC recommended a work RVU of 6.15.
However, we believe that a direct crosswalk of the work RVUs for CPT
code 52351 (Cystourethroscopy, with ureteroscopy and/or pyeloscopy;
diagnostic), which has a work RVU of 5.75 and which has more
intraservice time and very similar total time, more accurately reflects
the time and intensity of furnishing this service. This value is
additionally supported by using an increment between CPT code 58560 and
the base code for this family, CPT code 58555. The increment between
the RUC recommended values for the two codes is 3.08. That increment
added to the proposed value for the base code, CPT code 58555 (2.65),
results in a work RVU of 5.73. Therefore, we are proposing a work RVU
of 5.75 for CPT code 58560.
For CPT code 58561, the RUC recommended a work RVU of 7.00.
However, we believe that a direct crosswalk of the work RVUs for CPT
code 35475 (Transluminal balloon angioplasty, percutaneous;
brachiocephalic trunk or branches, each vessel), which has a work RVU
of 6.60 and which has similar intraservice and total times, more
accurately reflects the time and intensity of furnishing this service.
This value is additionally supported by using an increment between CPT
code 58561 and the base code for this family, CPT code 58555. The
increment between the RUC recommended values for the two codes is 3.93.
That increment added to the proposed value for the base code, CPT code
58555 (2.65), results in a work RVU of 6.58. Therefore, we are
proposing a work RVU of 6.60 for CPT code 58561.
For CPT code 58562, the RUC recommended a work RVU of 4.17.
However, we believe that a direct crosswalk of the work RVUs for CPT
code 15277 (Application of skin substitute graft to face, scalp,
eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or
multiple digits, total wound surface area greater than or equal to 100
sq cm; first 100 sq cm wound surface area, or 1% of body area of
infants and children), which has a work RVU of 4.00 and which has
identical intraservice time and similar total time, more accurately
reflects the time and intensity of furnishing this service. The RUC
also used this code as one of its supporting codes for its
recommendation. This value is additionally supported by using an
increment between CPT code 58562 and the base code for this family, CPT
code 58555. The increment between the RUC recommended values for the
two codes is 1.10. That increment added to the proposed value for the
base code, CPT code 58555 (2.65), results in a work RVU of 3.75.
Therefore, we are proposing a work RVU of 4.00 for CPT code 58562.
For CPT code 58563, the RUC recommended a work RVU of 4.62.
However, we believe that a direct crosswalk of the work RVUs for CPT
code 33962 (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)), which has a work RVU of 4.47
and which has identical intraservice time and similar total time, more
accurately reflects the resources involved in furnishing this service.
This value is additionally supported by using an increment between CPT
code 58563 and the base code for this family, CPT code 58555. The
increment between the RUC recommended values for the two codes is 1.55.
That increment added to the proposed value for the base code, CPT code
58555 (2.65), results in a work RVU of 4.20. We note that CPT code
58563 has the same instraservice time and the same total time as CPT
code 58558; however, we agree that the
[[Page 46250]]
intensity would be slightly higher for this service. Therefore, we are
proposing a work RVU of 4.47 for CPT code 58562.
The RUC submitted invoices for two new equipment items used in
furnishing CPT code 58558, the Hysteroscopic Fluid Management System
and the Hysteroscopic Resection System. We are proposing to use these
invoice prices for the Hysteroscopic Fluid Management System, which
totaled $14,698.38. The Hysteroscopic Resection System included the
price of the hysteroscope as well as other items necessary for tissue
removal. However, we generally price endoscopes separately and not as a
part of a system. In order to maintain consistency, we are proposing
not to include the hysteroscope from the Resection System. Instead, we
are proposing to update the equipment item ``endoscope, rigid,
hysteroscopy'' (ES009) with the invoice price, $6,207.50. We are not
proposing to include the sterilization tray from the Hysteroscopic
Resection System because we believe this tray has generally been
characterized as an indirect expense. For the Hysteroscopic Resection
System, we are proposing to include the Hysteroscopic tissue remover
($18,375), the sheath ($1,097.25), and the calibration device ($300),
and creating a new equipment item code, priced at $19,857.50 in the
proposed direct PE input database. We did not propose to include the
calibration device since the submitted price was not documented with a
paid invoice.
(22) Epidural Injections (CPT Codes 623X5, 623X6, 623X7, 623X8, 623X9,
62X10, 62X11, and 62X12)
We are proposing the RUC-recommended work RVU for all eight of the
codes in this family.
We are proposing to remove the 10-12ml syringes (SC051) and the RK
epidural needle (SC038) from all eight of the codes in this family.
These supplies are duplicative, as they are included in the epidural
tray (SA064). As an alternative, we could remove the epidural tray and
replace it with the individual supply components used in each
procedure; we are seeking public comment on either the inclusion of the
epidural tray or its individual components for this family of codes.
(23) Endoscopic Decompression of Spinal Cord (CPT code 630X1)
For CY 2016, the CPT Editorial Panel created CPT code 630X1 to
describe the endoscopic decompression of neural elements. The RUC
recommended a work RVU of 10.47 based on a crosswalk to CPT code 47562
(Laparoscopy, surgical; cholecystectomy) with a higher intraservice
time than reflected in the survey data. Since we believe CPT codes
630X1 and 47562 are similar in intensity, we believe using the same
work RVU as the crosswalk code overestimates the work involved in
furnishing CPT code 630X1. Reference CPT code 49507 (Repair initial
inguinal hernia, age 5 years or older; incarcerated or strangulated)
has a work RVU of 9.09 and has similar intensity and an identical
intraservice time compared to CPT code 630X1. Therefore, we are
proposing a work RVU of 9.09 for CPT code 630X1.
(24) Retinal Detachment Repair (CPT Codes 67101 and 67105)
For CY 2015, the CPT Editorial Panel made several changes to CPT
codes 67101 and 67105. These changes include revising the code
descriptors to exclude ``diathermy'' and ``with or without drainage of
subretinal fluid'' and removing the reference to ``1 or more
sessions''. The recommended global period has also changed from 90 days
to 10 days.
For CPT code 67101 we propose the RUC recommendation of 3.50 work
RVUs, which was based on the 25th percentile of the survey. For CPT
code 67105, the RUC recommended a work RVU of 3.84 based on the 25th
percentile of the survey. The RUC also stated that CPT code 67105 was a
more intense procedure, and therefore, should have a higher work RVU
than CPT code 67101. Currently, CPT code 67101 has a higher work RVU
than CPT code 67105 and according to the surveys the intraservice and
total times remain higher for CPT code 67101. It was not clearly
explained and we do not understand why the RUC believes that CPT code
67105 is more work than CPT code 67101. Therefore we are not proposing
the RUC-recommended work value of 3.50 for CPT code 67105. We do not
find evidence that CPT code 67105 is more intense than CPT code 67101
and accordingly propose a new value for CPT code 67105. To value CPT
code 67105 we used the RVU ratio between 67101 and 67105. We divided
the current work RVU of CPT code 67105 (8.53), by the current work RVU
of CPT code 67101 (8.80) and multiplied the quotient by the RUC-
recommended work RVU for CPT code 67101 (3.50) to arrive at a product
of 3.39 work RVUs.
Therefore, for CY 2017 we are proposing a work RVU of 3.39 for CPT
code 67105.
(25) Abdominal Aortic Ultrasound Screening (CPT Code 767X1)
For CY 2017, the CPT Editorial Panel created a new code, CPT 767X1,
to describe abdominal aortic ultrasound screening, currently described
by HCPCS G-code G0389. The specialties that surveyed CPT code 767X1 for
the RUC were vascular surgery and radiology, and the direct practice
expense inputs recommended by the RUC included an ultrasound room.
Based on an analysis of Medicare claims data, the dominant specialties
furnishing the service are family practice and internal medicine. We
believe that these specialties may more typically use a portable
ultrasound device rather than an ultrasound room. Therefore, we are
proposing to accept the RUC-recommended work value of 0.55, and the
RUC-recommended PE inputs for this service, but we are seeking comment
regarding whether or not it would be more accurate to substitute a
portable ultrasound device or possibly a hand-held device for an
ultrasound room for CPT code 767X1. We note that while the phase-in of
significant reductions in RVUs ordinarily would not apply to new codes,
we believe that it would be appropriate to consider this change from a
G-code to a CPT code to be fundamentally similar to an editorial coding
change since the service is not described differently, and therefore,
we propose to apply the phase-in to this service by comparing the
previous value of the G-code to the value for the new CPT code.
(26) Fluoroscopic Guidance (CPT Codes 77001, 77002, and 77003)
In the CY 2015 PFS final rule with comment period, CMS indicated
that while CPT codes 77002 and 77003 had been previously classified as
stand-alone codes without global periods, we believe their vignettes
and CPT Manual parentheticals are consistent with an add-on code as has
been established for CPT code 77001. Therefore, the global periods for
CPT codes 77002 and 77003 now reflect an add-on code global period with
modifications to the vignettes and parentheticals.
For CPT code 77001, we are proposing the RUC-recommended work RVU
of 0.38. The RUC-recommended work RVUs for CPT codes 77002 and 77003 do
not appear to account for the significant decrease in total times for
these codes relative to the current total times. We note that these
three codes describe remarkably similar services and have identical
intraservice and total times. Based on the identical times and
[[Page 46251]]
notable similarity for all three of these codes, we are proposing a
work RVU of 0.38 for all three codes.
(27) Radiation Treatment Devices (CPT Codes 77332, 77333, and 77334)
We identified CPT codes 77332, 77333, and 77334 through the high
expenditures by specialty screen. These services represent an
incremental increase of complexity from the simple to the intermediate
to the complex in design of radiation treatment devices. The RUC
recommended no change from the current work RVUs for these codes, which
are currently 0.54 for CPT code 77332, 0.84 for CPT code 77333 and 1.24
for CPT code 77334. We believe the recommended work RVUs overstate the
work involved in furnishing these services, as they do not sufficiently
reflect the degree to which the RUC concurrently recommended a decrease
in intraservice or total time. For CPT code 77332, we believe the RUC
recommendation to maintain its current value despite a 34 percent
decrease in total time appears to ignore the change in time. Therefore,
we are proposing a value for this code based on a crosswalk from the
value from CPT code 93287 (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)), due to its identical
intraservice time, similar total time, and similar level of intensity.
We are therefore proposing a work RVU of 0.45 for CPT code 77332. We
are further supporting this valuation with HCPAC code 97760
(Orthotic(s) management and training (including assessment and fitting
when not otherwise reported) upper extremity(s), lower extremity(s)
and/or trunk, each 15 minutes), which has similar physician time and
intensity measurements and a work RVU of 0.45. As these codes are
designed to reflect an incremental increase in work value from simple,
to intermediate, and complex device designs, we used an incremental
difference methodology to value CPT codes 77333 and 77334. We are
proposing a work RVU of 0.75 for CPT code 77333, maintaining its
recommended increment from CPT code 77332, For CPT code 77334, we are
proposing a work RVU of 1.15 which maintains its increment from CPT
code 77332.
(28) Special Radiation Treatment (CPT Code 77470)
We identified CPT code 77470 through the high expenditure charges
by specialty. We are proposing the RUC-recommended work RVU of 2.03.
However, we believe the description of service and vignette describe
different and unrelated treatments being performed by the physician and
clinical staff for a typical patient, and this presents a disparity
between the work RVUs and PE RVUs. We seek public comment on
information that would clarify this apparent disparity to help
determine appropriate PE inputs. In addition, we seek comment to
determine if creating two G-codes, one which describes the work portion
of this service, and one which describes the PE portion, may be a
potentially more accurate method of valuing and paying for the service
or services described by this code.
(29) Flow Cytometry Interpretation (CPT Codes 88184, 88185, 88187,
88188, and 88189)
The Flow Cytometry Interpretation family of codes is split into a
pair of codes used to describe the technical component of flow
cytometry (CPT codes 88184 and 88185), which do not have a work
component, and a trio of codes (CPT codes 88187, 88188, and 88189)
which do not have direct practice expense inputs, as they are
professional component only services. CPT codes 88184 and 88185 were
reviewed by the RUC in April 2014, and their CMS refined values were
included in the CY 2016 PFS final rule with comment period. The full
family of codes was reviewed again at the January 2016 RUC meeting, and
new recommendations were submitted to CMS as part of the CY 2017 PFS
rulemaking cycle.
We are proposing the RUC-recommended work RVU of 0.74 for CPT code
88187, and the RUC-recommended work RVU of 1.70 for CPT code 88189. For
CPT code 88188, we are proposing a work RVU of 1.20 instead of the RUC-
recommended work RVU of 1.40. We arrived at this value by noticing that
there were no comparable codes with no global period in the RUC
database with intraservice time and total time of 30 minutes that had a
work RVU higher than 1.20. The RUC-recommended work RVU of 1.40 would
go beyond the current maximum value and establish a new high, which is
not consistent with our estimation of the overall intensity of this
service relative to the others. As a result, we believe it is more
accurate to crosswalk CPT code 88188 to the work value of the code with
the current highest value, which is CPT code 88120 (Cytopathology, in
situ hybridization (for example, FISH), urinary tract specimen with
morphometric analysis, 3-5 molecular probes) at a work RVU of 1.20. We
believe that CPT code 88120 is crosswalk comparable code since it
shares the identical intraservice time and total time of 30 minutes
with CPT code 88188.
We also noted that the survey increment between CPT codes 88187 and
88188 at the RUC-recommended 25th percentile was 0.40 (between work
RVUs of 1.00 and 1.40), and this increment of 0.40 when added to CPT
code 88187's work RVU of 0.74 would arrive at a value of 1.14. In
addition, the total time for CPT code 88188 decreases from 43 minutes
to 30 minutes, which is a ratio of 0.70, and when this time ratio is
multiplied by CPT code 88188's previous work value of 1.69, the result
would be a new work RVU of 1.18. With this information in mind, we are
proposing a work RVU of 1.20 for CPT code 88188 as a result of a direct
crosswalk to CPT code 88120.
For CPT codes 88184 and 88185, which describe the technical
component of flow cytometry, we are proposing to use the RUC-
recommended inputs with a series of refinements. However, we believe
that the coding for these two procedures may inhibit accurate
valuation. CPT code 88184 describes the first marker for flow
cytometry, while CPT code 88185 is an add-on code that describes each
additional marker. We believe that it may be more accurate to have a
single CPT code that describes the technical component of flow
cytometry on a per patient case basis, as these two procedures are
always performed together and it is difficult to determine the clinical
labor, supplies, and equipment used in the typical case under the
current coding structure. We are soliciting comments regarding the
public interest in consolidating these two procedures into a single
code used to describe the technical component of flow cytometry.
Absent such a change in coding, we are proposing to refine the
clinical labor time for ``Instrument start-up, quality control
functions, calibration, centrifugation, maintaining specimen tracking,
logs and labeling'' from 15 minutes to 13 minutes for CPT code 88184.
We maintain that 13 minutes for this activity, which is the current
time value, would be typical for the procedure, as CPT code 88182 also
uses 13 minutes for the identical clinical labor task. We are also
proposing to refine the L054A clinical labor for
[[Page 46252]]
``Load specimen into flow cytometer, run specimen, monitor data
acquisition, and data modeling, and unload flow cytometer'' from 10
minutes to 7 minutes using the same rationale, a comparison to CPT code
88182.
We are proposing to maintain the clinical labor for ``Print out
histograms, assemble materials with paperwork to pathologists Review
histograms and gating with pathologist'' for CPT code 88184 at 2
minutes, as opposed to the RUC-recommended 5 minutes. A clinical labor
time of 2 minutes is standard for this activity; we disagree with the
RUC rationale that reviewing histograms and gating with the pathologist
in this procedure is not similar to other codes. We also note that the
review of histograms with a pathologist is not even described by CPT
code 88184, which again refers to the technical component of flow
cytometry, not the professional component. We are also proposing to
refine the L033A clinical labor time for ``Clean room/equipment
following procedure'' from 2 minutes to 1 minute for CPT code 88184. We
have established 1 minute in previous rulemaking (80 FR 70902) as the
standard time for this clinical labor activity in the laboratory
setting.
We are proposing to maintain our removal of the clinical labor time
for ``Enter data into laboratory information system, multiparameter
analyses and field data entry, complete quality assurance
documentation'' for both CPT code 88182 and CPT code 88184. As we
stated in last year's final rule with comment period (80 FR 70979), we
have not recognized the laboratory information system as an equipment
item that can be allocated to an individual service. We continue to
believe that this is a form of indirect PE, and therefore, we do not
recognize the laboratory information system as a direct PE input, and
we not consider this task as typically performed by clinical labor on a
per-service basis.
We are proposing to maintain the quantity of the ``lysing reagent''
supply (SL089) at 2 ml for CPT code 88185, as opposed to the RUC-
recommended quantity of 3 ml. In our discussions with pathology
specialists who perform flow cytometry, we were informed that the use
of 50-55 ml of the lysing reagent would be typical for an entire
patient case. The RUC recommendation similarly suggested a quantity of
46 ml or 48 ml per patient case. We were also told that the most
typical number of markers used for flow cytometry is 24, consisting of
1 service of CPT code 88184 and 23 services of CPT code 88185. An
investigation of our claims data confirmed this information, indicating
that 24 markers is the most frequent per patient case for flow
cytometry, and the use of more than 20 markers is typical. We believe
that this data supports our refinement of the lysing reagent from a
quantity of 3 ml to a quantity of 2 ml for CPT code 88185, which is
also the current value for the procedure and the RUC-recommended value
from the previous set of recommendations. For the typical case of 24
markers, our value would produce a total lysing reagent quantity of 51
ml (5 ml from the single service of CPT code 88184 and 46 ml from the
23 services of CPT code 88185), which matches with the amount required
for a total per patient case. If we were to adopt the RUC
recommendation, the total lysing reagent quantity would be 74 ml, which
is well in excess of what we believe to be typical for these
procedures.
We are also proposing to refine the quantity of the ``antibody,
flow cytometry'' supply (SL186) from quantity 1.6 to quantity 1, which
is also the current value for the supply and the RUC-recommended value
from the previous set of recommendations. We do not agree that more
than one antibody would be typically used for each marker. We are
reaffirming the previous RUC recommendation, and maintaining the
current quantity of 1 antibody for each marker.
We are not proposing the recommended additional time for the
``printer, dye sublimation (photo, color)'' equipment (ED031). We are
proposing to maintain the equipment time at 2 minutes for CPT code
88184, and at 1 minute for CPT code 88185. As we stated in the CY 2016
PFS final rule with comment period (80 FR 70979), we are proposing to
assign equipment time for the dye sublimation printer to match the
clinical labor time for ``Print out histograms, assemble materials with
paperwork to pathologists.'' We do not believe that it would be typical
for the printer to be in use longer than it takes to accomplish this
clinical labor task.
(30) Mammography--Computer Aided Detection Bundling (CPT Codes 770X1,
770X2 and 770X3)
Section 104 of the Medicare, Medicaid, and SCHIP Benefits
Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554)
required us to create separate codes with higher payment amounts for
digital mammography compared to film mammography, which was the
technology considered to be typical at the time. In addition, the
statute required additional payment to be made when computer-aided
detection (CAD) was used.
In CY 2002, we began valuing digital mammography services using
three G-codes, G0202, G0204, and G0206 to describe screening
mammography, unilateral diagnostic mammography, and bilateral
diagnostic mammography, respectively. CMS implemented the requirements
of BIPA section 104(d)(1), which applied to tests furnished in 2001, by
using the work RVUs of the parallel CPT codes, but establishing a fixed
PE RVU rather than using PE RVUs developed under the standard PE
methodology. The fixed amount of PE RVUs for these codes has generally
remained unchanged since implementation of the G-codes that
specifically described digital imaging.
Most mammography services under Medicare have since been billed
with these G-codes when digital mammography was used, and with CPT
codes 77055, 77056, and 77057 when film mammography was used. The use
of CAD has been reported with CPT codes 77051 and 77052. For CY 2017,
the CPT Editorial Panel deleted CPT codes 77051, 77052, 77055, 77056,
77057 and created three new CPT codes, 770X1, 770X2, and 770X3, to
describe mammography services bundled with CAD. For CY 2017, the RUC
recommended a work RVU of 0.81 for CPT code 770X1, a work RVU of 1.00
for CPT code 770X2, and a work RVU of 0.76 for CPT code 770X3, as well
as new PE inputs for use in developing resource-based PE RVUs based on
our standard methodologies. The RUC has recommended these inputs and
only one medical specialty society has provided us with a set of single
invoices to price the equipment used in furnishing these services.
We have reviewed these coding changes and recommended changes to
valuation for CY 2017. The revised CPT coding mitigates the need for
both separate G-codes and the CAD add-on codes. Based upon these coding
changes and the recommended input values, overall Medicare payment for
mammography services would be drastically reduced. This is especially
the case for the technical component of these services, which could
possibly be reduced up to 50 percent relative to the PE RVUs currently
used for payment for these services.
Based on our initial review of the recommended inputs for the new
codes, we believe that these changes would likely result in values more
closely related to the relative resources involved in furnishing these
services. However, we recognize that these services, particularly the
preventive
[[Page 46253]]
screenings, are of particular importance to the Medicare program and
the health of the Medicare beneficiaries. We are concerned that making
drastic changes in coding and payment for these services could be
disruptive in ways that could affect beneficiary access to necessary
services. We also recognize that unlike almost any other high-volume
PFS service, the RVUs used for payment for many years have not been
developed through the generally applicable PFS methodologies, and
instead reflect the statutory directive under section 104 of the BIPA.
Similarly, we recognize that the changes in both coding and valuation
are significant changes for those who provide these services.
Therefore, instead of proposing to simultaneously adopt the revised CPT
coding and drastic reductions in overall payment rates, we believe it
is advisable to adopt the new coding, including the elimination of
separate billing for CAD, for CY 2017 without proposing immediate
implementation of the recommended resource inputs. We anticipate that
we will consider the recommended inputs, including the pricing of the
required equipment, as carefully as possible prior to proposing revised
PE values through subsequent rulemaking.
Therefore, for CPT codes 770X1, 770X2, and 770X3, we are proposing
to accept the RUC-recommended work RVUs, but to crosswalk the PE RVUs
for the technical component of the current corresponding G-codes, as we
seek further pricing information for these equipment items.
In addition to seeking comment on this proposal, we are also
seeking comment on rates for these services in the commercial market to
help us understand the potential impacts of any future proposed
revisions to PFS payment rates.
Finally, we note that by adopting the new coding for CY 2017, any
subsequent significant reduction in RVUs (greater than 20 percent) for
the codes would be subject to the statutory phase-in under section
1848(c)(7).
To help us examine the resource inputs for these services, we are
seeking public comment on the list of items recommended as equipment
inputs for mammography services. We also invite commenters to provide
any invoices that would help with future pricing of these items.
Table 17--Recommended Equipment Items for Mammography Services
------------------------------------------------------------------------
# Item description Quantity Purpose
------------------------------------------------------------------------
1.............. 2D Selenia 1 Mammography unit and
Dimensions in-room console
Mammography itself.
System.
2.............. Mammo 1 Required for MQSA.
Accreditation The phantom is
Phantom. currently valued
into the existing
mammography room.
3.............. Phantom Case.... 1 Protects expensive
required phantom
from damage.
4.............. Paddle Storage 3 It requires 3 racks
Rack. to hold and prevent
damage to all of the
paddles that are
part of the typical
standard mammography
system.
5.............. Needle 1 Needed for a full
Localization functioning
Kit. mammography room.
Allows for the
performance of
needle
localizations. Input
is not separately in
the PE for the
mammography guided
procedure codes,
19281-19282, as a
fully functioning
mammography room is
needed for those
procedures.
6.............. Advanced 1 Workflow system
Workflow connecting
Manager System. mammography room and
workstations.
7.............. Cenova 2D Tower 1 CAD server, and also
System. used for post-
processing.
8.............. Image Checker 1 License required for
CAD (9.4) using CAD. This is a
License for One one-time fee.
FFDM.
9.............. Film Digitizing 1 Digitizes analog
System. films to digital for
comparison purposes.
10............. Mammography 1 A special chair
Chair. needed for patients
who cannot stand to
safely have their
mammogram performed.
11............. Laser Imager 1 Prints high
Printer. resolution copies of
the mammograms to
send to surgeons and
oncologists, and to
use in the OR.
12............. Barcode Scanner. 1 Allows selection of
individual patient
file for
interpretation.
13............. MRS V7 SQL 1 MQSA requires that
Reporting the facility develop
System. and maintain a
database that tracks
recall rates from
screening, true and
false positive and
true and false
negative rates,
sensitivity,
specificity, and
cancer detection
rate. A reporting
system is required
to build the
required database
and produce the
federally required
quality audit.
Components below
needed for the
reporting system.
The reporting system
is currently valued
into the existing
mammography room.
14............. Worksheet 1 Database reports are
Printing Module. required for federal
tracking purposes.
This is used to
generate reports for
MQSA.
15............. Site License.... 1 License for site to
use the reporting
system. This is a
one-time fee.
16............. Additional 3 Licenses for
Concurrent User radiologists to use
License. the reporting
system. A minimum of
three additional
licenses is typical.
17............. Densitometer.... 1 Required for MQSA.
------------------------------------------------------------------------
We also received specialty society recommendations for a new
Equipment Item, a physician PACS mammography workstation. We note that
we discuss physician PACS workstation in section II.A of this rule. The
items that comprise the physician PACS mammography workstation are
listed in Table 18. We are requesting public comment as to the
appropriateness of this list and if some items are indirect expenses or
belong in other codes. We also invite commenters to provide any
invoices that would help with future pricing of these items.
Table 18--Physician PACS Mammography Workstation
------------------------------------------------------------------------
-------------------------------------------------------------------------
PC Tower.
Monitors 5 MP (mammo) (x2).
3rd & 4th monitor (for speech recognition, etc.).
Admin Monitor (the extra working monitor).
Keyboard & Mouse.
[[Page 46254]]
Powerscribe Microphone.
Software--SV APP SYNC 1.3.0.
Software--R2 Cenova.
------------------------------------------------------------------------
We also note that for CY 2015, the CPT Editorial Panel created CPT
codes 77061, 77062, and 77063 to describe unilateral, bilateral, and
screening digital breast tomosynthesis, respectively. CPT code 77063 is
an add-on code to 77057, the CPT code for screening mammography. To be
consistent with our use of G codes for digital mammography, we did not
implement two of these three CPT codes for Medicare purposes. We only
adopted CPT code 77063 an add-on code to G0202. Instead of adopting
stand-alone codes 77061 and 77062, we created a new code, G0279
Diagnostic digital breast tomosynthesis, as an add-on code to the
diagnostic digital mammography codes G0204 and G0206 and assigned it
values based on CPT code 77063. Pending revaluation of the mammography
codes using direct PE inputs, we propose to maintain the current coding
structure for digital breast tomosynthesis with the technical change
that G0279 be reported with 770X1 or 770X2 as the replacement codes for
G0204 and G0206.
(31) Microslide Consultation (CPT Codes 88321, 88323, and 88325)
CPT codes 88321, 88323, and 88325 were reviewed by the RUC in April
2014 for their direct PE inputs only, and the CMS refined values were
included in the CY 2016 PFS final rule with comment period. The family
of codes was reviewed again at the January 2016 RUC meeting for both
work values and direct PE inputs, and new recommendations were
submitted to CMS as part of the CY 2017 PFS rulemaking cycle.
In the CY 2016 PFS final rule with comment period, we finalized our
proposal to remove many of the inputs for clinical labor, supplies, and
equipment for CPT code 88325. The descriptor for this code did not
state that slide preparation was taking place, and therefore, we
refined the labor, supplies, and equipment inputs to align with the
inputs recommended for CPT code 88321, which also does not include the
preparation of slides. After further discussion with pathologists and
consideration of comments received, we have been persuaded that slide
preparation does take place in conjunction with the service described
by CPT code 88325. In the RUC-recommended direct PE inputs from the
January 2016 meeting, the labor, supplies, and equipment inputs related
to slide preparation were added once again to CPT code 88325. We are
proposing to accept these restorations related to slide preparation
without refinement.
Regarding the clinical labor direct PE inputs, we are proposing to
assign 1 minute of L037B clinical labor for ``Complete workload
recording logs. Collate slides and paperwork. Deliver to pathologist''
for CPT codes 88323 and 88325. We are maintaining this at the current
value for CPT code 88323, and adding this 1 minute to CPT code 88325
based on our new understanding that slide preparation is undertaken as
part of the service described by this code. We are proposing to remove
the clinical labor for ``Assemble and deliver slides with paperwork to
pathologists'' from all three codes, as we believe this clinical labor
is redundant with the labor assigned for ``Complete workload recording
logs.'' We are similarly proposing to remove the clinical labor for
``Clean equipment while performing service'' from CPT codes 88323 and
88325, as we believe it to be redundant with the clinical labor
assigned for ``Clean room/equipment following procedure.''
We are proposing to maintain the quantity of the ``stain,
hematoxylin'' supply (SL135) at 16 ml for CPT codes 88323 and 88325, as
opposed to the RUC-recommended quantity of 32 ml. The RUC
recommendation stated that the hematoxylin supply does not include
eosin and should not be redundant; the stains are not mixed together,
but are instead sequential. The recommendation also made a comparison
to the use of the hematoxylin supply quantity in CPT code 88305.
However, we note that CPT code 88305 does not include 8 ml of eosin
stain (SL201), but instead 8 gm of eosin solution (SL063), and these
are not the same supply. Therefore we do not agree that a direct
comparison of the supply quantities is the most accurate way to value
these procedures. For CPT codes 88323 and 88325, we continue to note
that the prior supply inputs for these procedures had quantity 2.4 of
the eosin solution (SL063) and quantity 4.8 of the hematoxylin stain
(SL135); in other words, a 1:2 ratio between the eosin and hematoxylin.
We are proposing to maintain that 1:2 ratio with 8 ml of the eosin
stain (SL201) and 16 ml of the hematoxylin stain (SL135).
We are also proposing to update the use of the eosin solution
(sometimes listed as ``eosin y'') in our supply database. We believe
that the eosin solution supply (SL063), which is measured in grams,
reflects an older process of creating eosin stains by hand. This is in
contrast to the eosin stain supply (SL201), which is measured in
milliliters, and can be ordered in a state that is ready for staining
immediately. We do not believe that the use of eosin solution would
reflect typical lab practice today, with the readily availability for
purchase of inexpensive eosin staining materials. We also note that in
the CY 2016 PFS final rule with comment period, we removed 8 gm of the
eosin solution and replaced it with 8 ml of the eosin stain, and this
substitution was accepted without further change in the most recent set
of RUC recommendations. As a result, we are proposing to update the
price of the eosin stain supply from $0.044 per ml to $0.068 per ml to
reflect the current cost of the supply. We are also proposing to use
CPT codes 88323 and 88325 as a model, and replace the use of eosin
solution with an equal quantity of eosin stain for the rest of the
codes that make use of this supply. This applies to 15 other CPT codes:
88302 (Level II--Surgical pathology, gross and microscopic
examination), 88304 (Level III--Surgical pathology, gross and
microscopic examination), 88305 (Level IV--Surgical pathology, gross
and microscopic examination), 88307 (Level V--Surgical pathology, gross
and microscopic examination), 88309 (Level VI--Surgical pathology,
gross and microscopic examination), 88364 (In situ hybridization (e.g.,
FISH), per specimen; each additional single probe stain procedure),
88365 (In situ hybridization (e.g., FISH), per specimen; initial single
probe stain procedure), 88366 (In situ hybridization (e.g., FISH), per
specimen; each multiplex probe stain procedure), 88367 (Morphometric
analysis, in situ hybridization (quantitative or semi-quantitative),
using computer-assisted technology, per specimen; initial single probe
stain procedure), 88368 (Morphometric analysis, in situ hybridization
(quantitative or semi-quantitative), manual, per specimen; initial
single probe stain procedure), 88369 (Morphometric analysis, in situ
hybridization (quantitative or semi-quantitative), manual, per
specimen; each additional single probe stain procedure), 88373
(Morphometric analysis, in situ hybridization (quantitative or semi-
quantitative), using computer-assisted technology, per specimen; each
additional single probe stain procedure), 88374 (Morphometric analysis,
in situ hybridization (quantitative or semi-quantitative),
[[Page 46255]]
using computer-assisted technology, per specimen; each multiplex probe
stain procedure), 88377 (Morphometric analysis, in situ hybridization
(quantitative or semi-quantitative), manual, per specimen; each
multiplex probe stain procedure), and G0416 (Surgical pathology, gross
and microscopic examinations, for prostate needle biopsy, any method).
(32) Closure of Paravalvular Leak (CPT Codes 935X1, 935X2, and 935X3)
The CPT Editorial Committee developed three new codes (two base
codes and one add-on code) to describe paravalvular leak closure
procedures that were previously reported using an unlisted code. The
RUC recommended a work RVU of 17.97 for CPT code 935X2. We are
proposing a work RVU of 14.50 for CPT code 935X2, a direct crosswalk
from CPT code 37227. We believe that a direct crosswalk to CPT code
37227 accurately reflects the time and intensity described in CPT code
935X2 since CPT code 37227 also describes a transcatheter procedure
with similar service times.
To maintain relativity among the codes in this family, we are
proposing refinements to the recommended work RVUs for CPT code 935X1.
The RUC noted the additional work associated with CPT code 935X1
compared to CPT code 935X2 was due to the addition of a transseptal
puncture to access the mitral valve. The RUC identified a work RVU of
3.73 for a transseptal puncture. Therefore, for CPT code 935X1, we are
proposing a work RVU of 18.23 arrived at by using our proposed work RVU
for CPT code 935X2 (14.50) and adding the value of a transseptal
puncture (3.73).
CPT code 935X3 is an add-on code used to report placement of
additional occlusion devices for percutaneous transcatheter
paravalvular leak closure, performed in conjunction with either an
initial mitral or aortic paravalvular leak closure. The RUC recommended
a work RVU of 8.00 for this code. We considered applying the relative
increment between CPT codes 935X1 and 935X2, however, we believe that a
direct crosswalk to CPT code 35572, with a work RVU of 6.81, more
accurately reflects the time and intensity of furnishing the service.
Therefore, for CPT code 935X3, we are proposing a work RVU of 6.81.
(33) Electroencephalogram (EEG) (CPT Codes 95812, 95813, and 95957)
In February 2016, the RUC submitted recommendations for work and
direct PE inputs for CPT codes 95812, 95813, and 95957. We are
proposing to use the RUC-recommended physician work and direct PE
inputs for CPT code 95957 and to use the RUC-recommended work RVUs for
CPT codes 95812 and 95813.
In the CY 2016 PFS final rule with comment period (80 FR 70886), we
finalized direct PE input refinements for several clinical labor times
for CPT codes 95812 and 95813. The RUC's February 2016 PE summary of
recommendations indicated that the specialty society expert panel
disagreed with CMS' refinements to clinical labor time for these two
codes. The RUC recommended 62 minutes for clinical labor task ``perform
procedure'' for CPT code 95812 and 96 minutes for the same clinical
labor task for CPT code 95813, similar to the values recommended by the
RUC in April 2014.
We are proposing to maintain the CMS-refined CY 2016 PE inputs for
clinical labor task ``perform procedure'' for CPT codes 95812 (50
minutes) and 95813 (80 minutes). The PE summary of recommendations
state that CPT code 95812 requires 50 minutes of clinical labor time
for EEG recording, and CPT code 95813 requires 80 minutes of clinical
labor time for the same clinical labor task.
(34) Parent, Caregiver-Focused Health Risk Assessment (CPT Code 961X0)
In October 2015, the CPT Editorial Panel created two new PE-only
codes, 961X0 (Administration of patient-focused health risk assessment
instrument (e.g., health hazard appraisal) with scoring and
documentation, per standardized instrument) and 961X1 (Administration
of caregiver-focused health risk assessment instrument (e.g.,
depression inventory) for the benefit of the patient, with scoring and
documentation, per standardized instrument). For CPT code 961X0, we are
proposing the RUC-recommended direct PE inputs. For CPT code 961X1, the
service is furnished to a patient who may not be a Medicare beneficiary
and thus we do not believe would be eligible for Medicare payment. We
are proposing to assign a procedure status of I (Not valid for Medicare
purposes) for CPT code 961X1.
We note that we believe that this code describes a service that is
frequently reasonable and necessary in the treatment of illness or
injury, such as when there has been a change in health status. However,
when the service described by CPT code 961X0 is explicitly included in
another service being furnished, such as the Annual Wellness Visit
(AWV), this code should not be billed separately, much like other codes
that describe services included in codes with broader descriptions. We
also note that this service should not be billed separately if
furnished as a preventive service as it would describe a non-covered
service. However, we are also seeking comment on whether this service
may be better categorized as an add-on code and welcome stakeholder
input regarding whether or not there are circumstances when this
service might be furnished as a stand-alone service.
(35) Reflectance Confocal Microscopy (CPT Codes 96931, 96932, 96933,
96934, 96935, and 96936)
For CY 2015, the CPT Editorial panel established six new Category I
codes to describe reflectance confocal microscopy (RCM) for imaging of
skin. For CPT codes 96931 and 96933, the specialty society and the RUC
agreed that the physician work required for both codes were identical,
and therefore, should be valued the same. The RUC recommended a work
RVU of 0.80 for CPT codes 96931 and 96933 based on the 25th percentile
of the survey. Based on the similarity of the services being performed
in CPT codes 96931 and 96933 and the identical intra-service times of
96931, 96933 and 88305, the key reference code from the survey, we
believe a direct crosswalk from CPT code 88305 to 96931 and 96933 would
more accurately reflect the work involved in furnishing the procedure.
Therefore, for CY 2017 we are proposing a value of 0.75 RVUs for CPT
codes 96931 and 96933. In addition, we are removing 3 minutes of
preservice time in CPT codes 96931 and 96933 since it is not included
in CPT code 88305 and as a result, we do not believe it is appropriate
in CPT codes 96931 and 96933 either.
For CPT codes 96934 and 96936 the specialty society and the RUC
agreed that the physician work required for both codes were identical,
and therefore, should be valued the same. In its recommendation, the
RUC stated that it believed the survey respondents somewhat
overestimated the work for CPT code 96934 with the 25th percentile
yielding a work RVU of 0.79. Consequently, the RUC reviewed the survey
results from CPT code 96936 and agreed that the 25th percentile work
RVU of 0.76 accurately accounted for the work involved for the service.
Therefore, the RUC recommended a work RVU of 0.76 for CPT codes 96934
and 96936.
We believe that the incremental difference between the RUC-
recommended values for the base and add-on codes accurately captures
the difference in work between the code pairs. However, because we
valued the base codes differently than the RUC, we are proposing values
for the add-on
[[Page 46256]]
codes that maintain the RUC's 0.04 increment instead of the RUC-
recommended values. Therefore we are proposing a work RVU of 0.71 for
CPT codes 96934 and 96936.
We are also proposing to reduce the preservice clinical labor for
Patient clinical information and questionnaire reviewed by
technologist, order from physician confirmed and exam protocoled by
physician CPT codes 96934 and 93936 as this work is performed in the
two CPT base codes 93931 and 93933. The service period clinical labor
for ``Prepare and position patient/monitor patient/set up IV'' was
reduced from 2 to 1 minute for CPT codes 93934 and 93936 since we
believe that less positioning time is needed with subsequent lesions.
The service period clinical labor for ``Other Clinical Activity--Review
imaging with interpreting physician'' was refined to zero minutes for
CPT codes 96933 and 96936 as these are interpretation and report only
codes and not image acquisition.
(36) Evaluative Procedures for Physical Therapy and Occupational
Therapy (CPT Codes 97X61, 97X62, 97X63, 97X64, 97X65, 97X66, 97X67,
97X68)
For CY 2017, the CPT Editorial Panel deleted four CPT codes (97001,
97002, 97003, and 97004) and created eight new CPT codes (97X61-97X68)
to describe the evaluative procedures furnished by physical therapists
and occupational therapists. There are three new codes, stratified by
complexity, to replace a single code, 97001, for physical therapy (PT)
evaluation, three new codes, also stratified by complexity, to replace
a single code, 97003, for occupational therapy (OT) evaluation, and one
new code each to replace the reevaluation codes for physical and
occupational therapy--97002 and 97004. Table 19 includes the long
descriptors and the required components of each of the eight new CPT
codes for the PT and OT services.
The CPT Editorial Panel's creation of the new codes for PT and OT
evaluative procedures grew out of a CPT workgroup that was originally
convened in January 2012 when contemplating major revision of the
Physical Medicine and Rehabilitation CPT section of codes in response
to our nomination of therapy codes as potentially misvalued codes,
including CPT code 97001 (and, as a result, all four codes in the
family) in the CY 2012 PFS proposed rule.
In reviewing the eight new CPT codes for evaluative procedures, the
HCPAC forwarded recommendations for work RVUs and direct PE inputs for
each code. Currently, CPT codes 97001 and 97003 both have a work RVU of
1.20, and CPT codes 97002 and 97004 both have a work RVU of 0.60. These
CPT codes have reflected the same work RVUs since CY 1998 when we
accepted the HCPAC values during CY 1998 rulemaking.
i. Valuation of Evaluation Codes
The HCPAC submitted work RVU recommendations for each of the six
new PT and OT evaluation codes. These recommendations are intended to
be work neutral relative to the valuation for the previous single
evaluation code for PT and OT, respectively. However, that assessment
for each family of codes is dependent on the accuracy of the
utilization forecast for the different complexity levels within the PT
or OT family. As used in this section, work neutrality is distinct from
the budget neutrality that is applied broadly in the PFS. Specifically,
work neutrality is intended to reflect that despite changes in coding,
the overall amount of work RVUs for a set of services is held constant
from one year to the next. For example, if a service is reported using
a single code with a work RVU of 2.0 for one year but that same service
would be reported using two codes, one for ``simple'' and another for
``complex'' in the subsequent year valued at 1.0 and 3.0 respectively,
work neutrality could only be attained if exactly half the services
were reported using each of the two new codes. If more than half of the
services were reported using the ``simple'' code, then there would be
fewer overall work RVUs. If more than half of the services were
reported using the ``complex'' code, then there would be more overall
work RVUs. Therefore, work neutrality can only be assessed with an
understanding of the relative frequency of how often particular codes
will be reported.
The HCPAC recommended a work RVU of 0.75 for CPT code 97X61, a work
RVU of 1.18 for CPT code 97X62, and a work RVU of 1.5 for CPT code
97X63. The PT specialty society projected that the moderate complexity
evaluation code would be reported 50 percent of the time because it is
the typical evaluation, and the CPT codes for the low and high
complexity evaluations are each expected to be billed 25 percent of the
time. The HCPAC-recommended work RVU of 1.18 for CPT code 97X62
represents the survey median with 30 minutes of intraservice time, 10
minutes of preservice time, and 15 minutes postservice time. The HCPAC
notes this work value is appropriately ranked between levels 2 and 3 of
the E/M office visit codes for new patients.
The HCPAC recommended a work RVU of 0.88 for CPT code 97X65, a work
RVU of 1.20 for CPT code 97X66, and a work RVU of 1.70 for CPT code
97X67. For the OT codes, work neutrality would be achieved only with a
projected utilization in which the low-complexity evaluation is billed
50 percent of the time; the moderate-complexity evaluation is billed 40
percent of the time, and the high-complexity evaluation only billed 10
percent of the time. For purposes of calculating work neutrality, the
HCPAC recommended assuming that the low-complexity code will be most
frequently reported even though the HCPAC-recommended work RVU of 1.20
and 45 minutes of intraservice time for moderate complexity code is
identical to that of the current OT evaluation code. The HCPAC believes
that the work RVU of 1.20 is appropriately ranked between 99202 and
99203, levels 2 and 3 for E/M office visits for new outpatients.
ii. Valuation of Evaluation Codes and Discussion of PAMA
In our review of the HCPAC recommendations, we noted the work
neutrality and the inherent reliance on the utilization assumptions. We
considered the three complexity levels for the PT evaluations and the
three complexity levels for the OT evaluations; and we also considered
the evaluation services described by the codes as a whole. The varying
work RVUs and the dependence on utilization for each complexity level
to ensure work neutrality in the PT and OT code families make it
difficult for us evaluate the HCPAC's recommended values or to predict
with a high degree of certainty whether physical and occupational
therapists will actually bill for these services at the same rate
forecast by their respective specialty societies.
We are concerned that the coding stratification in the PT and OT
evaluation codes may result in upcoding incentives, especially while
physical and occupational therapists gain familiarity and expertise in
the differential coding of the new PT and OT evaluation codes that now
include the typical face-to-face times and new required components that
are not enumerated in the current codes. We are also concerned that
stratified payment rates may provide, in some cases, a payment
incentive to therapists to upcode to a higher complexity level than was
actually furnished to receive a higher payment.
We understand that there may be multiple reasons for the CPT
Editorial Panel to stratify coding for OT and PT
[[Page 46257]]
evaluation codes based on complexity. We also note that the codes will
be used by payers in addition to Medicare, and other payers may have
direct interest in making such differential payment based on complexity
of OT and PT evaluation. Given our concerns regarding appropriate
valuation, work neutrality, and potential upcoding, however, we do not
believe that making different payment based on the reported complexity
for these services is, at current, advantageous for Medicare or
Medicare beneficiaries.
Given the advantages inherent and public interest in using CPT
codes once they become part of the code set, we are proposing to adopt
the new CPT codes for use in Medicare for CY 2017. However, given our
concerns about appropriate pricing and payment for the stratified
services, we are proposing to price the services described by these
stratified codes as a group instead of individually. To do that, we are
proposing to utilize the authority in section 220(f) of the Protecting
Access to Medicare Act (PAMA), which revised section 1848(c)(2)(C) of
the Act to authorize the Secretary to determine RVUs for groups of
services, rather than determining RVUs at the individual service level.
We believe that using this authority instead of proposing to make
payment based on Medicare G-codes will preserve consistency in the code
set across payers, thus lessening burden on providers, while retaining
flexibilities that are beneficial to Medicare.
We propose a work RVU of 1.20 for both the PT and the OT evaluation
groups of services. We are proposing this work RVU because we believe
it best represents the typical PT and OT evaluation. This is the value
recommended by the HCPAC for the OT moderate-complexity evaluation and
nearly the same work RVU for corresponding PT evaluation (1.18).
Additionally, 1.20 work RVUs is the long-standing value for the current
evaluation codes, 97001 and 97003, and, thus, assures work neutrality
without reliance on particular assumptions about utilization, which we
believe was the intent of the HCPAC recommendation.
Because we are proposing to use the same work RVU for the six
evaluation codes, we are not addressing any additional concerns about
the utilization assumptions recommended to us. By proposing the same
work values for each code in the family, there will be no ratesetting
impact to work neutrality. As such, we are not revising the utilization
crosswalks as projected by the respective therapy specialties to
achieve work neutrality. However, were we to value each code in the PT
or OT evaluation families individually, we would seek objective data
from stakeholders to support the utilization crosswalks, particularly
those for the OT family in which the low-level complexity evaluation is
depicted as typical and the high-complexity is projected to be billed
infrequently at 10 percent of the overall number of OT evaluations.
We are proposing to use the direct PE inputs forwarded by the HCPAC
(with the refinements described below) for the typical PT evaluation
and also for the typical OT evaluation in the development of PE RVUs
for the PT and OT codes as a group of services. For the PT codes, we
are proposing to use the recommended inputs for the moderate-complexity
code for the direct PE inputs of all three codes based on its
assumption as the typical service. Our proposed direct PE inputs
reflect the recommended values minus 2 minutes of physical therapist
assistant (PTA) time in the service period because we believe that PTA
tasks to administer certain assessment tools are appropriately included
as part of the physical therapist's work and the time of the PTA to
explain and/or score self-reported outcome measures is not separately
included in the clinical labor of other codes. We are proposing to
include the recommended four sheets of laser paper without an
association to a specific equipment item, but we are seeking comment
regarding the paper's use.
For the OT evaluation codes, we considered proposing to use the
direct PE inputs for the low-complexity evaluation because the OT
specialty organization believes it represents the typical OT evaluation
service with a projected 50 percent utilization rate. However, we
propose to use the moderate-level direct inputs instead, because the
direct PE for this level is based on a vignette that is valued with the
same intraservice time, 45 minutes, as the current code, CPT code
97003. Consequently, we propose to use the recommended direct PE inputs
for the moderate-complexity code for use in developing PE RVUs for this
group of services.
Our proposed direct PE inputs reflect the recommended values minus
2 minutes of occupational therapist assistant (OTA) time in the service
period because we believe that OTA tasks to administer certain
assessment tools are appropriately included as part of the occupational
therapist's work and the time of the OTA to explain and/or score self-
reported outcome measures is not separately included in the clinical
labor of other codes. We also rounded up the recommended 6.8 minutes to
7 minutes to represent the time the OTA assists the occupational
therapist during the intraservice time period. For the Vision Kit
equipment item, our proposed price reflects the submitted invoice that
clearly defined a kit.
iii. Valuation of Reevaluation Codes
The recommendations the HCPAC sent to us for the PT and OT
reevaluation codes are not work neutral. For the new PT reevaluation
code, CPT code 97X64, the HCPAC recommended a work RVU of 0.75 compared
to the work RVU of 0.60 for CPT code 97002. This recommended work RVU
falls between the 25th percentile of the survey and the survey's median
value and was based on a direct crosswalk to CPT code 95992 for
canalith repositioning with 20 minutes intraservice time and 10 minutes
immediate postservice time. The HCPAC supported this 0.15 work RVU
increase based on an anomalous relationship between PT services and E/M
office visit codes for established patients, noting that physician E/M
codes have historically been used as a relative comparison. The HCPAC
stated its 0.75 work RVU recommendation for code 97X64 appropriately
ranks it between the key reference codes for this service 99212 and
99213, levels 2 and 3 E/M office-visit codes for established patients.
The HCPAC provided a work RVU of 0.80 for the OT reevaluation code,
CPT code 97X68, based on the 25th percentile of the survey, which
represents an increase over the current work RVU of 0.60 for CPT code
97004. This work value includes 30 minutes of intraservice time, 5
minutes preservice time, and 10 minutes immediate postservice time. The
HCPAC noted that the increase in work compared to the PT reevaluation
code (0.75) is because the occupational therapist spends more time
observing and assessing the patient and, in general, the OT patient
typically has more functional and cognitive disabilities. The HCPAC
recommendation notes that the 0.80 work RVU recommendation
appropriately ranks it between the level 1 and 2 E/M office-visit codes
for new patients.
The HCPAC's recommended increases to work RVUs for the PT and OT
reevaluation codes are not work neutral. We are unclear why the HCPAC
did not maintain work neutrality for the OT and PT reevaluation codes
since maintaining work neutrality was important to the establishment of
the six new evaluation codes. We are proposing to maintain the
[[Page 46258]]
overall work RVUs for these services by proposing 0.60 work RVUs for
CPT codes 97X64 and 97X68, consistent with the work RVUs for the
deleted reevaluation codes. We are seeking comments from stakeholders
on whether there are reasons that the reevaluation codes should be
revalued without regard to work neutrality particularly given the
HCPAC's interest in preserving work neutrality for the new evaluation
codes.
We are proposing the HCPAC-recommended direct PE inputs for CPT
code 97X64 with a reduction in time for the PTA by 1 minute (from 5 to
4) in the service period- the line for ``Other Clinical Activity''--
because the time to explain and score the self-reported outcome measure
(for example, Oswestry) is not separately included in the clinical
labor of other codes.
We are proposing the HCPAC-recommended direct PE inputs for CPT
code 97X68 with a reduction in time for the OTA by 1 minute (from 3 to
2) in the service period--the line for ``Other Clinical Activity''--for
the same reason we reduced the corresponding line for PTAs--because the
time to explain and score any patient-self-administered functional and/
or other standardized outcome measure is not separately included in the
clinical labor of other codes.
Because the new CPT code descriptors contain new coding
requirements for each complexity level, we seek comment from the PT and
OT specialty organizations as well as other stakeholders to clarify how
therapists will be educated to distinguish the required complexity
level components and the selection of the number of elements that
impact the plan of care. For example, for the OT codes, we invite
comment on how to define performance deficits, what process the
occupational therapist uses to identify the number of these performance
deficits that result in activity limitations, and performance factors
needed for each complexity level. For the PT codes, we would like more
information about how the physical therapist differentiates the number
of personal factors that actually affect the plan of care. We would
also be interested in understanding more about how the physical
therapist selects the number of elements from any of the body
structures and functions, activity limitations, and/or participation
restrictions to make sure there is no duplication during the physical
therapist's examination of body systems.
iv. Always Therapy Codes
It is also important to note that CMS defines the codes for these
evaluative services as ``always therapy.'' This means that they always
represent therapy services regardless of who performs them and always
require a therapy modifier, GP or GO, to signify that the services are
furnished under a PT or OT plan of care, respectively. These codes will
also be subject to the therapy MPPR and to statutory therapy caps.
Table 19--CPT Long Descriptors for Physical Medicine and Rehabilitation
------------------------------------------------------------------------
CPT long descriptors for physical
New CPT code medicine and rehabilitation
------------------------------------------------------------------------
97X61.............................. Physical therapy evaluation: Low
complexity, requiring these
components:
A history with no personal
factors and/or comorbidities that
impact the plan of care;
An examination of body
system(s) using standardized tests
and measures addressing 1-2
elements from any of the
following: Body structures and
functions, activity limitations,
and/or participation restrictions;
A clinical presentation
with stable and/or uncomplicated
characteristics; and
Clinical decision making
of low complexity using
standardized patient assessment
instrument and/or measurable
assessment of functional outcome.
Typically, 20 minutes are spent
face-to-face with the patient and/
or family.
97X62.............................. Physical therapy evaluation:
Moderate complexity, requiring
these components:
A history of present
problem with 1-2 personal factors
and/or comorbidities that impact
the plan of care;
An examination of body
systems using standardized tests
and measures in addressing a total
of 3 or more elements from any of
the following: Body structures and
functions, activity limitations,
and/or participation restrictions;
An evolving clinical
presentation with changing
characteristics; and
Clinical decision making
of moderate complexity using
standardized patient assessment
instrument and/or measurable
assessment of functional outcome.
Typically, 30 minutes are spent
face-to-face with the patient and/
or family.
97X63.............................. Physical therapy evaluation: High
complexity, requiring these
components:
A history of present
problem with 3 or more personal
factors and/or comorbidities that
impact the plan of care;
An examination of body
systems using standardized tests
and measures addressing a total of
4 or more elements from any of the
following: Body structures and
functions, activity limitations,
and/or participation restrictions;
A clinical presentation
with unstable and unpredictable
characteristics; and
Clinical decision making
of high complexity using
standardized patient assessment
instrument and/or measurable
assessment of functional outcome.
Typically, 45 minutes are spent
face-to-face with the patient and/
or family.
97X64.............................. Reevaluation of physical therapy
established plan of care,
requiring these components:
An examination including a
review of history and use of
standardized tests and measures is
required; and
Revised plan of care using
a standardized patient assessment
instrument and/or measurable
assessment of functional outcome
Typically, 20 minutes are spent
face-to-face with the patient and/
or family.
97X65.............................. Occupational therapy evaluation,
low complexity, requiring these
components:
An occupational profile
and medical and therapy history,
which includes a brief history
including review of medical and/or
therapy records relating to the
presenting problem;
An assessment(s) that
identifies 1-3 performance
deficits (i.e., relating to
physical, cognitive, or
psychosocial skills) that result
in activity limitations and/or
participation restrictions; and
Clinical decision making
of low complexity, which includes
an analysis of the occupational
profile, analysis of data from
problem-focused assessment(s), and
consideration of a limited number
of treatment options. Patient
presents with no comorbidities
that affect occupational
performance. Modification of tasks
or assistance (e.g., physical or
verbal) with assessment(s) is not
necessary to enable completion of
evaluation component.
Typically, 30 minutes are spent
face-to-face with the patient and/
or family.
[[Page 46259]]
97X66.............................. Occupational therapy evaluation,
moderate complexity, requiring
these components:
An occupational profile
and medical and therapy history,
which includes an expanded review
of medical and/or therapy records
and additional review of physical,
cognitive, or psychosocial history
related to current functional
performance;
An assessment(s) that
identifies 3-5 performance
deficits (i.e., relating to
physical, cognitive, or
psychosocial skills) that result
in activity limitations and/or
participation restrictions; and
Clinical decision making
of moderate analytic complexity,
which includes an analysis of the
occupational profile, analysis of
data from detailed assessment(s),
and consideration of several
treatment options. Patient may
present with comorbidities that
affect occupational performance.
Minimal to moderate modification
of tasks or assistance (e.g.,
physical or verbal) with
assessment(s) is necessary to
enable patient to complete
evaluation component.
Typically, 45 minutes are spent
face-to-face with the patient and/
or family.
97X67.............................. Occupational therapy evaluation,
high complexity, requiring these
components:
An occupational profile
and medical and therapy history,
which includes review of medical
and/or therapy records and
extensive additional review of
physical, cognitive, or
psychosocial history related to
current functional performance;
An assessment(s) that
identify 5 or more performance
deficits (i.e., relating to
physical, cognitive, or
psychosocial skills) that result
in activity limitations and/or
participation restrictions; and
A clinical decision-making
is of high analytic complexity,
which includes an analysis of the
patient profile, analysis of data
from comprehensive assessment(s),
and consideration of multiple
treatment options. Patient
presents with comorbidities that
affect occupational performance.
Significant modification of tasks
or assistance (e.g., physical or
verbal) with assessment(s) is
necessary to enable patient to
complete evaluation component.
Typically, 60 minutes are spent
face-to-face with the patient and/
or family.
97X68.............................. Reevaluation of occupational
therapy established plan of care,
requiring these components:
An assessment of changes
in patient functional or medical
status with revised plan of care;
An update to the initial
occupational profile to reflect
changes in condition or
environment that affect future
interventions and/or goals; and
A revised plan of care. A
formal reevaluation is performed
when there is a documented change
in functional status or a
significant change to the plan of
care is required.
Typically, 30 minutes are spent
face-to-face with the patient and/
or family.
------------------------------------------------------------------------
v. Potentially Misvalued Therapy Codes
Since 2010, in addition to the codes for evaluative services, CMS
has periodically added codes that represent therapy services to the
list of potentially misvalued codes. The current list of 10 therapy
codes was based on the statutory category ``codes that account for the
majority of spending under the physician fee schedule,'' as specified
in section 1848(c)(2)(K)(ii)(VII) of the Act. We understand that the
therapy specialty organizations have pursued the development of coding
changes through the CPT process for these modality and procedures
services. While we understand that, in some cases, it may take several
years to develop appropriate coding revisions, we are, in the meantime,
seeking information regarding appropriate valuation for the existing
codes. See Table 20.
Table 20--Potentially Misvalued Codes Identified Through High
Expenditure by Specialty Screen
------------------------------------------------------------------------
HCPCS code Short descriptor
------------------------------------------------------------------------
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.
97535......................... Self care mngment training.
G0283......................... Elec stim other than wound.
------------------------------------------------------------------------
(37) Proposed Valuation of Services Where Moderate Sedation Is an
Inherent Part of the Procedure and Proposed Valuation of Moderate
Sedation Services (CPT Codes 991X1, 991X2, 991X3, 991X4, 991X5, and
991X6; and HCPCS Code GMMM1)
In the CY 2015 PFS proposed rule (79 FR 40349), we noted that it
appeared that practice patterns for endoscopic procedures were
changing. Anesthesia services are increasingly being separately
reported for endoscopic procedures, meaning that resource costs
associated with sedation were no longer incurred by the practitioner
reporting the procedure. Subsequently, in the CY 2016 PFS proposed rule
(80 FR 41707), we sought public comment and recommendations on
approaches to address the appropriate valuation of moderate sedation
related to the approximately 400 diagnostic and therapeutic procedures
for which the CPT Editorial Committee has determined that moderate
sedation is an inherent part of furnishing the service. The CPT
Editorial Committee created separate codes for reporting of moderate
sedation services.
Table 21--Moderate Sedation Codes and Descriptors
------------------------------------------------------------------------
CPT/HCPCS code Descriptor
------------------------------------------------------------------------
991X1.............................. Moderate sedation services provided
by the same physician or other
qualified health care professional
performing the diagnostic or
therapeutic service that the
sedation supports, requiring the
presence of an independent trained
observer to assist in the
monitoring of the patient's level
of consciousness and physiological
status; initial 15 minutes of
intra-service time, patient
younger than 5 years of age.
[[Page 46260]]
991X2.............................. Moderate sedation services provided
by the same physician or other
qualified health care professional
performing the diagnostic or
therapeutic service that the
sedation supports, requiring the
presence of an independent trained
observer to assist in the
monitoring of the patient's level
of consciousness and physiological
status; initial 15 minutes of
intra-service time, patient age 5
years or older.
991X3.............................. Moderate sedation services provided
by a physician or other qualified
health care professional other
than the physician or other
qualified health care professional
performing the diagnostic or
therapeutic service that the
sedation supports; initial 15
minutes of intra-service time,
patient younger than 5 years of
age.
991X4.............................. Moderate sedation services provided
by a physician or other qualified
health care professional other
than the physician or other
qualified health care professional
performing the diagnostic or
therapeutic service that the
sedation supports; initial 15
minutes of intra-service time,
patient age 5 years or older.
991X5.............................. Moderate sedation services provided
by the same physician or other
qualified health care professional
performing the diagnostic or
therapeutic service that the
sedation supports, requiring the
presence of an independent trained
observer to assist in the
monitoring of the patient's level
of consciousness and physiological
status; each additional 15 minutes
of intra-service time (List
separately in addition to code for
primary service).
991X6.............................. Moderate sedation services provided
by a physician or other qualified
health care professional other
than the physician or other
qualified health care professional
performing the diagnostic or
therapeutic service that the
sedation supports; each additional
15 minutes intra-service time
(List separately in addition to
code for primary service).
------------------------------------------------------------------------
For the newly created moderate sedation CPT codes, we are proposing
to use the RUC-recommended work RVUs for CPT codes 991X1, 991X2, 991X3,
and 991X6. CPT codes 991X1 and 991X2 make a distinction between
moderate sedation services furnished to patients younger than 5 years
of age and patients 5 years or older, with CPT codes 991X3 and 991X4
making a similar distinction. The RUC recommendations include a work
RVU increment of 0.25 between CPT code 991X1 and 991X2. For CPT code
991X4, we are proposing a work RVU of 1.65 to maintain the 0.25
increment relative to CPT code 991X3 (a RUC-recommended work RVU of
1.90) and maintain relativity among the CPT codes in this family. We
are proposing to use the RUC-recommended direct PE inputs for all six
codes.
When moderate sedation is reported for Medicare beneficiaries, we
expect that it would most frequently reported using the code that
describes moderate sedation furnished by the same person who also
performs the primary procedure for patients 5 years of age or older.
Under the new coding structure, these services would be reported using
CPT code 991X2. Stakeholders have presented information that
illustrates that the specialty group survey data regarding the work
involved in furnishing the moderate sedation described by CPT code
991X2 showed a significant bimodal distribution between procedural
services furnished by gastroenterologists (GI) and those services
furnished by other specialties. The GI societies' survey data reported
a median valuation of 0.10 work RVUs for moderate sedation furnished by
the same person furnishing the base procedure; all other specialty
groups (combined) reported a median valuation of 0.25 work RVUs. Given
the significant volume of moderate sedation furnished by GI
practitioners and the significant difference in RVUs reported in the
survey data, we are proposing to make payment using a gastrointestinal
(GI) endoscopy-specific moderate sedation code GMMM1 that would be used
in lieu of the new CPT moderate sedation coding used more broadly:
GMMM1: Moderate sedation services provided by the same physician or
other qualified health care professional performing a gastrointestinal
endoscopic service (excluding biliary procedures) that sedation
supports, requiring the presence of an independent trained observer to
assist in the monitoring of the patient's level of consciousness and
physiological status; initial 15 minutes of intra-service time; patient
age 5 years or older.
We are proposing to value GMMM1 at 0.10 work RVUs based on the
median survey result for GI respondents in the survey data. We are
proposing that when moderate sedation services are furnished by the
same practitioner reporting the GI endoscopy procedure, practitioners
would report the sedation services using GMMM1 instead of 991X2. In all
other cases, we propose that practitioners would report moderate
sedation using one of the new moderate sedation CPT codes consistent
with CPT guidance. This would include the full range of codes for those
furnishing moderate sedation with the remaining (non-GI endoscopy) base
procedures as well as for the other circumstances during which moderate
sedation is furnished along with a GI endoscopy (for example, to a
patient under 5 years of age or for a biliary procedure, the
endoscopist furnishing moderate sedation should not use GMMM1, but
instead use the appropriate CPT code; see Table 22 for more information
about when GMMM1 should be used in lieu of the newly created moderate
sedation CPT codes).
In addition to providing recommended values for the new codes used
to separately report moderate sedation, the RUC has provided
recommendations that value the procedural services without moderate
sedation. However, the RUC recommends removing fewer RVUs from the
procedures than it recommends for valuing the sedation services. In
other words, the RUC is recommending that overall payments for these
procedures should be increased now that practitioners will be required
to report the sedation services that were previously included as
inherent parts of the procedures. We believe that if we were to use the
RUC recommendations for re-valuation of the procedural services without
refinement, the RVUs currently attributable to the redundant payment
for sedation services when anesthesia is separately reported would be
used exclusively to increase overall payment for these services. We
refer readers to Section II.D.5. of this proposed rule, which includes
a more extensive discussion of our general principle that overall
resource costs for the procedures including moderate sedation do not
inherently change based solely on changes in coding.
To account for the separate billing of moderate sedation services,
we are proposing to maintain current values for the procedure codes
less the work RVUs associated with the most frequently reported
corresponding moderate sedation code so that practitioners furnishing
the moderate sedation
[[Page 46261]]
services previously considered to be inherent in the procedure will
have no change in overall work RVUs. Since we are proposing 0.10 work
RVUs for moderate sedation for the GI endoscopy procedures, this means
we are proposing a corresponding .10 reduction in work RVUs for these
procedures. For all other Appendix G procedures that currently include
moderate sedation as an inherent part of the procedure, we are
proposing to remove 0.25 work RVUs from the current values.
Table 22 lists the existing work RVUs for each applicable service
and our proposed refined work RVU using the proposed revaluation
methodology described above. Additionally, the table identifies the GI
endoscopic services for which we are proposing that GMMM1 would be used
to report moderate sedation services. This information will be made
available and maintained in the ``downloads'' section of the PFS Web
site at https://www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Table 22--Proposed Valuations for Endoscopy Services Minus Moderate
Sedation
------------------------------------------------------------------------
Use GMMM1
CY 2017 to report
HCPCS CY 2016 proposed moderate
work RVU work RVU sedation
(Y/N)
------------------------------------------------------------------------
10030.................................. 3.00 2.75 N
19298.................................. 6.00 5.75 N
20982.................................. 7.27 7.02 N
20983.................................. 7.13 6.88 N
22510.................................. 8.15 7.90 N
22511.................................. 7.58 7.33 N
22512.................................. 4.00 4.00 N
22513.................................. 8.90 8.65 N
22514.................................. 8.24 7.99 N
22515.................................. 4.00 4.00 N
22526.................................. 6.10 5.85 N
22527.................................. 3.03 3.03 N
31615.................................. 2.09 1.84 N
31622.................................. 2.78 2.53 N
31623.................................. 2.88 2.63 N
31624.................................. 2.88 2.63 N
31625.................................. 3.36 3.11 N
31626.................................. 4.16 3.91 N
31627.................................. 2.00 2.00 N
31628.................................. 3.80 3.55 N
31629.................................. 4.00 3.75 N
31632.................................. 1.03 1.03 N
31633.................................. 1.32 1.32 N
31634.................................. 4.00 3.75 N
31635.................................. 3.67 3.42 N
31645.................................. 3.16 2.91 N
31646.................................. 2.72 2.47 N
31647.................................. 4.40 4.15 N
31648.................................. 4.20 3.95 N
31649.................................. 1.44 1.44 N
31651.................................. 1.58 1.58 N
31652.................................. 4.71 4.46 N
31653.................................. 5.21 4.96 N
31654.................................. 1.40 1.40 N
31660.................................. 4.25 4.00 N
31661.................................. 4.50 4.25 N
31725.................................. 1.96 1.71 N
32405.................................. 1.93 1.68 N
32550.................................. 4.17 3.92 N
32551.................................. 3.29 3.04 N
32553.................................. 3.80 3.55 N
33010.................................. 2.24 1.99 N
33011.................................. 2.24 1.99 N
33206.................................. 7.39 7.14 N
33207.................................. 8.05 7.80 N
33208.................................. 8.77 8.52 N
33210.................................. 3.30 3.05 N
33211.................................. 3.39 3.14 N
33212.................................. 5.26 5.01 N
33213.................................. 5.53 5.28 N
33214.................................. 7.84 7.59 N
33216.................................. 5.87 5.62 N
33217.................................. 5.84 5.59 N
33218.................................. 6.07 5.82 N
33220.................................. 6.15 5.90 N
33221.................................. 5.80 5.55 N
33222.................................. 5.10 4.85 N
33223.................................. 6.55 6.30 N
33227.................................. 5.50 5.25 N
33228.................................. 5.77 5.52 N
33229.................................. 6.04 5.79 N
33230.................................. 6.32 6.07 N
33231.................................. 6.59 6.34 N
33233.................................. 3.39 3.14 N
33234.................................. 7.91 7.66 N
33235.................................. 10.15 9.90 N
33240.................................. 6.05 5.80 N
33241.................................. 3.29 3.04 N
33244.................................. 13.99 13.74 N
33249.................................. 15.17 14.92 N
33262.................................. 6.06 5.81 N
33263.................................. 6.33 6.08 N
33264.................................. 6.60 6.35 N
33282.................................. 3.50 3.25 N
33284.................................. 3.00 2.75 N
33990.................................. 8.15 7.90 N
33991.................................. 11.88 11.63 N
33992.................................. 4.00 3.75 N
33993.................................. 3.51 3.26 N
35471.................................. 10.05 9.80 N
35472.................................. 6.90 6.65 N
35475.................................. 6.60 6.35 N
35476.................................. 5.10 4.85 N
36010.................................. 2.43 2.18 N
36140.................................. 2.01 1.76 N
36147.................................. 3.72 3.47 N
36148.................................. 1.00 1.00 N
36200.................................. 3.02 2.77 N
36221.................................. 4.17 3.92 N
36222.................................. 5.53 5.28 N
36223.................................. 6.00 5.75 N
36224.................................. 6.50 6.25 N
36225.................................. 6.00 5.75 N
36226.................................. 6.50 6.25 N
36227.................................. 2.09 2.09 N
36228.................................. 4.25 4.25 N
36245.................................. 4.90 4.65 N
36246.................................. 5.27 5.02 N
36247.................................. 6.29 6.04 N
36248.................................. 1.01 1.01 N
36251.................................. 5.35 5.10 N
36252.................................. 6.99 6.74 N
36253.................................. 7.55 7.30 N
36254.................................. 8.15 7.90 N
36481.................................. 6.98 6.73 N
36555.................................. 2.68 2.43 N
36557.................................. 5.14 4.89 N
36558.................................. 4.84 4.59 N
36560.................................. 6.29 6.04 N
36561.................................. 6.04 5.79 N
36563.................................. 6.24 5.99 N
36565.................................. 6.04 5.79 N
36566.................................. 6.54 6.29 N
36568.................................. 1.92 1.67 N
36570.................................. 5.36 5.11 N
36571.................................. 5.34 5.09 N
36576.................................. 3.24 2.99 N
36578.................................. 3.54 3.29 N
36581.................................. 3.48 3.23 N
36582.................................. 5.24 4.99 N
36583.................................. 5.29 5.04 N
36585.................................. 4.84 4.59 N
36590.................................. 3.35 3.10 N
36870.................................. 5.20 4.95 N
37183.................................. 7.99 7.74 N
37184.................................. 8.66 8.41 N
37185.................................. 3.28 3.28 N
37186.................................. 4.92 4.92 N
37187.................................. 8.03 7.78 N
37188.................................. 5.71 5.46 N
37191.................................. 4.71 4.46 N
37192.................................. 7.35 7.10 N
37193.................................. 7.35 7.10 N
37197.................................. 6.29 6.04 N
37211.................................. 8.00 7.75 N
37212.................................. 7.06 6.81 N
37213.................................. 5.00 4.75 N
37214.................................. 2.74 2.49 N
37215.................................. 18.00 17.75 N
37216.................................. 0.00 0.00 N
37218.................................. 15.00 14.75 N
37220.................................. 8.15 7.90 N
37221.................................. 10.00 9.75 N
37222.................................. 3.73 3.73 N
37223.................................. 4.25 4.25 N
37224.................................. 9.00 8.75 N
37225.................................. 12.00 11.75 N
37226.................................. 10.49 10.24 N
37227.................................. 14.50 14.25 N
37228.................................. 11.00 10.75 N
37229.................................. 14.05 13.80 N
37230.................................. 13.80 13.55 N
37231.................................. 15.00 14.75 N
37232.................................. 4.00 4.00 N
37233.................................. 6.50 6.50 N
37234.................................. 5.50 5.50 N
37235.................................. 7.80 7.80 N
37236.................................. 9.00 8.75 N
37237.................................. 4.25 4.25 N
37238.................................. 6.29 6.04 N
37239.................................. 2.97 2.97 N
37241.................................. 9.00 8.75 N
37242.................................. 10.05 9.80 N
[[Page 46262]]
37243.................................. 11.99 11.74 N
37244.................................. 14.00 13.75 N
37252.................................. 1.80 1.80 N
37253.................................. 1.44 1.44 N
43200.................................. 1.52 1.42 Y
43201.................................. 1.82 1.72 Y
43202.................................. 1.82 1.72 Y
43204.................................. 2.43 2.33 Y
43205.................................. 2.54 2.44 Y
43206.................................. 2.39 2.29 Y
43211.................................. 4.30 4.20 Y
43212.................................. 3.50 3.40 Y
43213.................................. 4.73 4.63 Y
43214.................................. 3.50 3.40 Y
43215.................................. 2.54 2.44 Y
43216.................................. 2.40 2.30 Y
43217.................................. 2.90 2.80 Y
43220.................................. 2.10 2.00 Y
43226.................................. 2.34 2.24 Y
43227.................................. 2.99 2.89 Y
43229.................................. 3.59 3.49 Y
43231.................................. 2.90 2.80 Y
43232.................................. 3.69 3.59 Y
43233.................................. 4.17 4.07 Y
43235.................................. 2.19 2.09 Y
43236.................................. 2.49 2.39 Y
43237.................................. 3.57 3.47 Y
43238.................................. 4.26 4.16 Y
43239.................................. 2.49 2.39 Y
43240.................................. 7.25 7.15 Y
43241.................................. 2.59 2.49 Y
43242.................................. 4.83 4.73 Y
43243.................................. 4.37 4.27 Y
43244.................................. 4.50 4.40 Y
43245.................................. 3.18 3.08 Y
43246.................................. 3.66 3.56 Y
43247.................................. 3.21 3.11 Y
43248.................................. 3.01 2.91 Y
43249.................................. 2.77 2.67 Y
43250.................................. 3.07 2.97 Y
43251.................................. 3.57 3.47 Y
43252.................................. 3.06 2.96 Y
43253.................................. 4.83 4.73 Y
43254.................................. 4.97 4.87 Y
43255.................................. 3.66 3.56 Y
43257.................................. 4.25 4.15 Y
43259.................................. 4.14 4.04 Y
43260.................................. 5.95 5.70 N
43261.................................. 6.25 6.00 N
43262.................................. 6.60 6.35 N
43263.................................. 6.60 6.35 N
43264.................................. 6.73 6.48 N
43265.................................. 8.03 7.78 N
43266.................................. 4.17 3.92 N
43270.................................. 4.26 4.01 N
43273.................................. 2.24 2.24 N
43274.................................. 8.58 8.33 N
43275.................................. 6.96 6.71 N
43276.................................. 8.94 8.69 N
43277.................................. 7.00 6.75 N
43278.................................. 8.02 7.77 N
43450.................................. 1.38 1.13 N
43453.................................. 1.51 1.26 N
44360.................................. 2.59 2.49 Y
44361.................................. 2.87 2.77 Y
44363.................................. 3.49 3.39 Y
44364.................................. 3.73 3.63 Y
44365.................................. 3.31 3.21 Y
44366.................................. 4.40 4.30 Y
44369.................................. 4.51 4.41 Y
44370.................................. 4.79 4.69 Y
44372.................................. 4.40 4.30 Y
44373.................................. 3.49 3.39 Y
44376.................................. 5.25 5.15 Y
44377.................................. 5.52 5.42 Y
44378.................................. 7.12 7.02 Y
44379.................................. 7.46 7.36 Y
44380.................................. 0.97 0.87 Y
44381.................................. 1.48 1.38 Y
44382.................................. 1.27 1.17 Y
44384.................................. 2.95 2.85 Y
44385.................................. 1.30 1.20 Y
44386.................................. 1.60 1.50 Y
44388.................................. 2.82 2.72 Y
44388-53............................... 1.41 1.36 Y
44389.................................. 3.12 3.02 Y
44390.................................. 3.84 3.74 Y
44391.................................. 4.22 4.12 Y
44392.................................. 3.63 3.53 Y
44394.................................. 4.13 4.03 Y
44401.................................. 4.44 4.34 Y
44402.................................. 4.80 4.70 Y
44403.................................. 5.60 5.50 Y
44404.................................. 3.12 3.02 Y
44405.................................. 3.33 3.23 Y
44406.................................. 4.20 4.10 Y
44407.................................. 5.06 4.96 Y
44408.................................. 4.24 4.14 Y
44500.................................. 0.49 0.39 Y
45303.................................. 1.50 1.40 Y
45305.................................. 1.25 1.15 Y
45307.................................. 1.70 1.60 Y
45308.................................. 1.40 1.30 Y
45309.................................. 1.50 1.40 Y
45315.................................. 1.80 1.70 Y
45317.................................. 2.00 1.90 Y
45320.................................. 1.78 1.68 Y
45321.................................. 1.75 1.65 Y
45327.................................. 2.00 1.90 Y
45332.................................. 1.86 1.76 Y
45333.................................. 1.65 1.55 Y
45334.................................. 2.10 2.00 Y
45335.................................. 1.14 1.04 Y
45337.................................. 2.20 2.10 Y
45338.................................. 2.15 2.05 Y
45340.................................. 1.35 1.25 Y
45341.................................. 2.22 2.12 Y
45342.................................. 3.08 2.98 Y
45346.................................. 2.91 2.81 Y
45347.................................. 2.82 2.72 Y
45349.................................. 3.62 3.52 Y
45350.................................. 1.78 1.68 Y
45378.................................. 3.36 3.26 Y
45378-53............................... 1.68 1.63 Y
45379.................................. 4.38 4.28 Y
45380.................................. 3.66 3.56 Y
45381.................................. 3.66 3.56 Y
45382.................................. 4.76 4.66 Y
45384.................................. 4.17 4.07 Y
45385.................................. 4.67 4.57 Y
45386.................................. 3.87 3.77 Y
45388.................................. 4.98 4.88 Y
45389.................................. 5.34 5.24 Y
45390.................................. 6.14 6.04 Y
45391.................................. 4.74 4.64 Y
45392.................................. 5.60 5.50 Y
45393.................................. 4.78 4.68 Y
45398.................................. 4.30 4.20 Y
47000.................................. 1.90 1.65 N
47382.................................. 15.22 14.97 N
47383.................................. 9.13 8.88 N
47532.................................. 4.25 4.25 N
47533.................................. 6.00 5.38 N
47534.................................. 8.03 7.60 N
47535.................................. 4.50 3.95 N
47536.................................. 2.88 2.61 N
47538.................................. 6.60 4.75 N
47539.................................. 9.00 8.75 N
47540.................................. 10.75 9.03 N
47541.................................. 5.61 5.38 N
47542.................................. 2.50 2.85 N
47543.................................. 3.07 3.00 N
47544.................................. 4.29 3.28 N
49405.................................. 4.25 4.00 N
49406.................................. 4.25 4.00 N
49407.................................. 4.50 4.25 N
49411.................................. 3.82 3.57 N
49418.................................. 4.21 3.96 N
49440.................................. 4.18 3.93 N
49441.................................. 4.77 4.52 N
49442.................................. 4.00 3.75 N
49446.................................. 3.31 3.06 N
50200.................................. 2.63 2.38 N
50382.................................. 5.50 5.25 N
50384.................................. 5.00 4.75 N
50385.................................. 4.44 4.19 N
50386.................................. 3.30 3.05 N
50387.................................. 2.00 1.75 N
50430.................................. 3.15 2.90 N
50432.................................. 4.25 4.00 N
50433.................................. 5.30 5.05 N
50434.................................. 4.00 3.75 N
50592.................................. 6.80 6.55 N
50593.................................. 9.13 8.88 N
50606.................................. 3.16 3.16 N
50693.................................. 4.21 3.96 N
50694.................................. 5.50 5.25 N
50695.................................. 7.05 6.80 N
50705.................................. 4.03 4.03 N
50706.................................. 3.80 3.80 N
57155.................................. 5.40 5.15 N
66720.................................. 5.00 4.75 N
69300.................................. 6.69 6.44 N
77371.................................. 0.00 0.00 N
77600.................................. 1.56 1.31 N
77605.................................. 2.09 1.84 N
77610.................................. 1.56 1.31 N
77615.................................. 2.09 1.84 N
92920.................................. 10.10 9.85 N
92921.................................. 0.00 0.00 N
92924.................................. 11.99 11.74 N
92925.................................. 0.00 0.00 N
92928.................................. 11.21 10.96 N
92929.................................. 0.00 0.00 N
92933.................................. 12.54 12.29 N
[[Page 46263]]
92934.................................. 0.00 0.00 N
92937.................................. 11.20 10.95 N
92938.................................. 0.00 0.00 N
92941.................................. 12.56 12.31 N
92943.................................. 12.56 12.31 N
92944.................................. 0.00 0.00 N
92953.................................. 0.23 0.01 N
92960.................................. 2.25 2.00 N
92961.................................. 4.59 4.34 N
92973.................................. 3.28 3.28 N
92974.................................. 3.00 3.00 N
92975.................................. 7.24 6.99 N
92978.................................. 0.00 0.00 N
92979.................................. 0.00 0.00 N
92986.................................. 22.85 22.60 N
92987.................................. 23.63 23.38 N
93312.................................. 2.55 2.30 N
93313.................................. 0.51 0.26 N
93314.................................. 2.10 1.85 N
93315.................................. 2.94 2.69 N
93316.................................. 0.85 0.60 N
93317.................................. 2.09 1.84 N
93318.................................. 2.40 2.15 N
93451.................................. 2.72 2.47 N
93452.................................. 4.75 4.50 N
93453.................................. 6.24 5.99 N
93454.................................. 4.79 4.54 N
93455.................................. 5.54 5.29 N
93456.................................. 6.15 5.90 N
93457.................................. 6.89 6.64 N
93458.................................. 5.85 5.60 N
93459.................................. 6.60 6.35 N
93460.................................. 7.35 7.10 N
93461.................................. 8.10 7.85 N
93462.................................. 3.73 3.73 N
93463.................................. 2.00 2.00 N
93464.................................. 1.80 1.80 N
93505.................................. 4.37 4.12 N
93530.................................. 4.22 3.97 N
93561.................................. 0.50 0.25 N
93562.................................. 0.16 0.01 N
93563.................................. 1.11 1.11 N
93564.................................. 1.13 1.13 N
93565.................................. 0.86 0.86 N
93566.................................. 0.86 0.86 N
93567.................................. 0.97 0.97 N
93568.................................. 0.88 0.88 N
93571.................................. 0.00 0.00 N
93572.................................. 0.00 0.00 N
93582.................................. 12.56 12.31 N
93583.................................. 14.00 13.75 N
93609.................................. 0.00 0.00 N
93613.................................. 6.99 6.99 N
93615.................................. 0.99 0.74 N
93616.................................. 1.49 1.24 N
93618.................................. 4.25 4.00 N
93619.................................. 7.31 7.06 N
93620.................................. 11.57 11.32 N
93621.................................. 0.00 0.00 N
93622.................................. 0.00 0.00 N
93624.................................. 4.80 4.55 N
93640.................................. 3.51 3.26 N
93641.................................. 5.92 5.67 N
93642.................................. 4.88 4.63 N
93644.................................. 3.29 3.04 N
93650.................................. 10.49 10.24 N
93653.................................. 15.00 14.75 N
93654.................................. 20.00 19.75 N
93655.................................. 7.50 7.50 N
93656.................................. 20.02 19.77 N
93657.................................. 7.50 7.50 N
94011.................................. 2.00 1.75 N
94012.................................. 3.10 2.85 N
94013.................................. 0.66 0.41 N
96440.................................. 2.37 2.12 N
G0105.................................. 3.36 3.26 Y
G0105-53............................... 1.68 1.63 Y
G0121.................................. 3.36 3.26 Y
G0121-53............................... 1.68 1.63 Y
G0341.................................. 6.98 6.98 N
------------------------------------------------------------------------
(38) Prolonged Evaluation and Management Services (CPT Codes 99354,
99358, and 99359)
We previously received RUC recommendations for face-to-face and
non-face-to-face prolonged E/M services. In response to the CY 2016 PFS
proposed rule, in which we sought comment about improving payment
accuracy for cognitive services, commenters suggested that we consider
making separate payment for CPT codes 99358 and 99359. As reflected in
section II.E, we are proposing to make separate payment for these
services.
We are also proposing values for services in this family of codes
based on the RUC-recommended values, including for CPT code 99354,
which would increase the current work RVU to 2.33. Likewise, we are
proposing to adopt the RUC-recommended work values of 2.10 for CPT code
99358 and of 1.00 for CPT code 99359.
(39) Complex Chronic Care Management Services (CPT Codes 99487 and
99489)
We received RUC recommendations for CPT codes 99487 and 99489
following the October 2012 RUC meeting. For CY 2017, we are proposing
to change the procedure status for CPT codes 99487 and 99489 from B
(bundled) to A (active), see II.E, and are proposing to adopt the RUC-
recommended values for work, 1.00 work RVUs for CPT code 99487 and 0.50
work RVUs for CPT code 99489, as well as direct PE inputs consistent
with the RUC recommendations.
(40) Prostate Biopsy, Any Method (HCPCS Code G0416)
The College of American Pathologists and the American Society of
Cytopathology formed an expert panel to make recommendations at the
October 2015 RUC meeting to determine an appropriate work RVU for HCPCS
code G0416, as they felt that the survey results were invalid. The
panel made several arguments to the RUC in recommending for a higher
work RVU under the RUC's ``compelling evidence'' standard. These
arguments were: (1) That incorrect assumptions were made in previous
valuations; (2) the value of HCPCS code G0416 remained constant while
the code descriptors changed over the years; and (3) the ``anomalous
relationship'' between HCPCS code G0416 and CPT code 88305 (Level IV--
Surgical pathology, gross and microscopic examination). The expert
panel recommended a work RVU of 4.00 based on a crosswalk from CPT code
38240 (Hematopoietic progenitor cell (HPC); allogeneic transplantation
per donor). The RUC agreed.
We believe HCPCS code G0416 should not be valued as a direct
crosswalk from CPT code 38240. Instead we believe CPT code 88305 is the
basis for HCPCS code G0416, and therefore, HCPCS code G0416 should be
valued as such. To value HCPCS code G0416, we used the intra-service
time ratio between HCPCS code G0416 and CPT code 88305 to arrive at a
work RVU of 3.60. To further support this method, we note that the
IWPUT for HCPCS code G0416 with a work RVU of 3.60 is the same as CPT
code 88305. Using the RUC recommended RVU of 4.00 results in a higher
IWPUT, and we do not believe there is a difference in work intensity
between these codes. Therefore for CY 2017, we are proposing a work RVU
of 3.60 for HCPCS code G0416.
(41) Behavioral Health Integration: Psychiatric Collaborative Care
Model (HCPCS Codes GPPP1, GPPP2, and GPPP3) and General Behavioral
Health Integration (HCPCS Code GPPPX)
For CY 2017, we are proposing to establish and make separate
Medicare payment using four new HCPCS G-codes, GPPP1 (Initial
psychiatric collaborative care management, first 70 minutes in the
first calendar month of behavioral health care manager activities, in
consultation with a psychiatric consultant, and directed by the
treating physician or other qualified health care professional), GPPP2
(Subsequent psychiatric collaborative care management, first 60 minutes
in a subsequent month of behavioral health
[[Page 46264]]
care manager activities, in consultation with a psychiatric consultant,
and directed by the treating physician or other qualified health care
professional), GPPP3 (Initial or subsequent psychiatric collaborative
care management, each additional 30 minutes in a calendar month of
behavioral health care manager activities, in consultation with a
psychiatric consultant, and directed by the treating physician or other
qualified health care professional), and GPPPX (Care management
services for behavioral health conditions, at least 20 minutes of
clinical staff time, directed by a physician or other qualified health
care professional time, per calendar month) for collaborative care and
care management for beneficiaries with behavioral health conditions, as
detailed in section II.E of this proposed rule. To value HCPCS codes
GPPP1, GPPP2, and GPPP3, we are proposing to base the portion of the
work RVU that accounts for the work of the treating physician or other
qualified health care professional on a direct crosswalk to the
proposed work values for the complex CCM codes, CPT codes 99487 and
99489. To value the portion of the work RVU that accounts for the
psychiatric consultant, we are estimating ten minutes of psychiatric
consultant time per patient per month and a value of 0.42 work RVUs,
based on the per minute work RVUs for the highest volume codes
typically billed by psychiatrists. Since the behavioral health care
manager in the services described by HCPCS codes GPPP1, GPPP2, and
GPPP3 should have academic with specialized training in behavioral
health, we are proposing a new clinical labor type for the behavioral
health care manager, L057B, at $0.57 per minute, based on the rates for
genetic counselors in the direct PE input database. We are seeking
comment on all aspects of these proposed valuations.
To value HCPCS code GPPPX, we are proposing a work value based on a
direct crosswalk from CPT code 99490 (Chronic care management
services), a work value of 0.61 RVUs. We recognize that the services
described by CPT code 99490 are distinct from those furnished under the
CoCM and we believe that these alsovary based on different kinds of BHI
care. We note that there are relatively few existing codes that
describe these kinds of services over a calendar month. We also believe
that the resources associated with 99490 may vary based on the ways
different practitioners implement the service. Until we have more
information about how these services are typically furnished, we
believe valuation based on the minimum resources would be most
appropriate. To account for the care manager minutes in the direct PE
inputs for HCPCS code GPPPX, we are proposing to use clinical labor
type L045C, which is the labor type for social workers/psychologists
and has a rate of $0.45 per minute.
(42) Resource-Intensive Services (HCPCS Code GDDD1)
As discussed in section II.E, we are proposing to establish payment
for services furnished to patients with mobility-related disabilities,
through a new add-on G-code, to be billable with office/outpatient E/M
and TCM codes. Based on our analysis of the resources typically
involved in furnishing office visits to patients with these needs
(especially including the typical additional practitioner and staff
time), we believe that the physician work and time for HCPCS code GDDD1
is most accurately valued through a direct crosswalk from CPT code
99212 (Level 2 office or other outpatient visit for the evaluation and
management of an established patient). Therefore, we are proposing a
work RVU of 0.48 and a physician time of 16 minutes for HCPCS code
GDDD1. We are seeking comment on whether these work and time values
accurately capture the additional physician work typically involved in
furnishing services to patients with mobility impairments.
We believe that a direct crosswalk to the clinical staff-time
associated with CPT code 99212, which is 27 minutes of LN/LPN/MTA
(L037D) accurately represents the additional clinical staff time
required to furnish an outpatient office visit or TCM to a patient with
a mobility-related disability. We are also proposing to include as
direct practice expense inputs 27 minutes for a stretcher (EF018) and a
high/low table (EF028), and 27 minutes for new equipment inputs
associated with the following: A patient lift system, wheelchair
accessible scale, and padded leg support positioning system. These
items are included in the CY 2017 proposed direct PE input database. We
are seeking comments on whether these inputs are appropriate, and
whether any additional inputs are typically used in treating patients
with mobility-impairments.
(43) Comprehensive Assessment and Care Planning for Patients With
Cognitive Impairment (HCPCS Code GPPP6)
For CY 2017, we are proposing to create and pay separately for new
HCPCS code GPPP6 (Cognition and functional assessment using
standardized instruments with development of recorded care plan for the
patient with cognitive impairment, history face-to-face obtained from
patient and/or caregiver, in office or other outpatient setting or home
or domiciliary or rest home), see II.E for further discussion. Based on
similarities between work intensity and time, we believe that the
physician work and time for this code would be accurately valued by
combining the work RVUs from CPT code 99204 (Level 4 office or other
outpatient visit for the evaluation and management of a new patient)
and half the work RVUs for HCPCS code G0181 (Physician supervision of a
patient receiving Medicare-covered services furnished by a
participating home health agency (patient not present) requiring
complex and multidisciplinary care modalities involving regular
physician development and/or revision of care plans, review of
subsequent reports of patient status, review of laboratory and other
studies, communication (including telephone calls) with other health
care professionals involved in the patient's care, integration of new
information into the medical treatment plan and/or adjustment of
medical therapy, within a calendar month, 30 minutes or more).
Therefore, we are proposing a work RVU of 3.30. For direct practice
expense inputs we are proposing 70 total minutes of time for RN/LPN/MTA
(L037D). We believe this is typical based on information from several
specialty societies representing practitioners who typically furnish
this service and report, it, when appropriate, using E/M codes. We are
seeking comment on these valuation assumptions and would welcome
additional information on the work and direct practice expense
associated with furnishing this service.
(44) Comprehensive Assessment and Care Planning for Patients Requiring
Chronic Care Management (HCPCS Code GPPP7)
For CY 2017 we are proposing to make payment for the resource costs
of comprehensive assessment and care planning for patients requiring
CCM services through HCPCS code GPPP7 as an add-on code to be billed
with the initiating visit for CCM for patients that require extensive
assessment and care planning (see section II.E). In valuing this code,
we believe that a crosswalk to half the work and time values of HCPCS
code G0181 (Physician supervision of a patient receiving Medicare-
covered services provided by a participating home health agency
(patient not present) requiring complex and
[[Page 46265]]
multidisciplinary care modalities involving regular physician
development and/or revision of care plans, review of subsequent reports
of patient status, review of laboratory and other studies,
communication (including telephone calls) with other health care
professionals involved in the patient's care, integration of new
information into the medical treatment plan and/or adjustment of
medical therapy, within a calendar month, 30 minutes or more)
accurately accounts for the time and intensity of the work associated
with furnishing this service over and above the work accounted for as
part of the separately billed initiating visit. Therefore, we are
proposing a work RVU of 0.87 and 29 minutes of physician time. We are
also proposing 36 minutes for a RN/LPN/MTA (L037D) as the only direct
PE input for this service.
(45) Telehealth Consultation for a Patient Requiring Critical Care
Services (HCPCS Codes GTTT1 and GTTT2)
As discussed in section II.C, we are proposing use of HCPCS G-
codes, GTTT1 (Telehealth consultation, critical care, physicians
typically spend 60 minutes communicating with the patient via
telehealth (initial) and GTTT2 (Telehealth consultation, critical care,
physicians typically spend 50 minutes communicating with the patient
via telehealth (subsequent)), to report telehealth consultations for a
patient requiring critical care services. We note that due to limited
coding granularity for high-intensity cognitive services, in the PFS,
we do not believe there is an intuitive crosswalk code for ideal
estimation of the work and time values for GTTT1. In general, we
believe that the overall work for GTTT1 is not as much as 99291
(Critical care, evaluation and management of the critically ill or
critically injured patient; first 30-74 minutes) but that the service
involves more work than G0427 (Telehealth consultation, emergency
department or initial inpatient, typically 70 minutes or more
communicating with the patient via telehealth). We believe that GTTT1
is most accurately valued by a crosswalk to the work RVU and physician
intra-service time of 38240 (Hematopoietic progenitor cell (HPC);
allogeneic transplantation per donor) can therefore serve as an
appropriate crosswalk. Therefore we are proposing a work RVU of 4.0 and
are seeking comment on the accuracy of these assumptions. We do not
believe that direct PE inputs would typically be involved with
furnishing this service from the distant site. For GTTT2 we are
proposing a work RVU of 3.86 based on a crosswalk from G0427. We
believe that G0427 has similar overall work intensity to GTTT2 and has
a similar intraservice time. We also believe that no direct PE inputs
would typically be associated with furnishing this service from the
distant site.
Table 23--Proposed CY 2017 Work RVUs for New, Revised and Potentially Misvalued Codes
----------------------------------------------------------------------------------------------------------------
CMS time
HCPCS Descriptor Current work RVU RUC work RVU CMS work RVU refinement
----------------------------------------------------------------------------------------------------------------
00740............ Anesthesia for upper 0.00.............. 0.00 0.00 No.
gastrointestinal
endoscopic
procedures,
endoscope introduced
proximal to duodenum.
00810............ Anesthesia for lower 0.00.............. 0.00 0.00 No.
intestinal
endoscopic
procedures,
endoscope introduced
distal to duodenum.
10035............ Placement of soft 1.70.............. .............. 1.70 No.
tissue localization
device(s) (e.g.,
clip, metallic
pellet, wire/needle,
radioactive seeds),
percutaneous,
including imaging
guidance; first
lesion.
10036............ Placement of soft 0.85.............. .............. 0.85 No.
tissue localization
device(s) (e.g.,
clip, metallic
pellet, wire/needle,
radioactive seeds),
percutaneous,
including imaging
guidance; each
additional lesion.
11730............ Avulsion of nail 1.10.............. 1.10 1.05 No.
plate, partial or
complete, simple;
single.
11732............ Avulsion of nail 0.44.............. 0.44 0.38 Yes.
plate, partial or
complete, simple;
each additional nail
plate.
20245............ Biopsy, bone, open; 8.95.............. 6.50 6.00 No.
deep (e.g., humerus,
ischium, femur).
20550............ Injection(s); single 0.75.............. 0.75 0.75 No.
tendon sheath, or
ligament,
aponeurosis (e.g.,
plantar ``fascia'').
20552............ Injection(s); single 0.66.............. 0.66 0.66 No.
or multiple trigger
point(s), 1 or 2
muscle(s).
20553............ Injection(s); single 0.75.............. 0.75 0.75 No.
or multiple trigger
point(s), 3 or more
muscles.
228X1............ Insertion of NEW............... 15.00 13.50 No.
interlaminar/
interspinous process
stabilization/
distraction device,
without fusion,
including image
guidance when
performed, with open
decompression,
lumbar; single level.
228X2............ Insertion of NEW............... 4.00 4.00 No.
interlaminar/
interspinous process
stabilization/
distraction device,
without fusion,
including image
guidance when
performed, with open
decompression,
lumbar; second level.
228X4............ Insertion of NEW............... 7.39 7.03 No.
interlaminar/
interspinous process
stabilization/
distraction device,
without open
decompression or
fusion, including
image guidance when
performed, lumbar;
single level.
228X5............ Insertion of NEW............... 2.34 2.34 No.
interlaminar/
interspinous process
stabilization/
distraction device,
without open
decompression or
fusion, including
image guidance when
performed, lumbar;
second level.
[[Page 46266]]
22X81............ Insertion of NEW............... 4.88 4.25 No.
interbody
biomechanical
device(s) (e.g.,
synthetic cage,
mesh) with integral
anterior
instrumentation for
device anchoring
(e.g., screws,
flanges) when
performed to
intervertebral disc
space in conjunction
with interbody
arthrodesis, each
interspace.
22X82............ Insertion of NEW............... 5.50 5.50 No.
intervertebral
biomechanical
device(s) (e.g.,
synthetic cage,
mesh) with integral
anterior
instrumentation for
device anchoring
(e.g., screws,
flanges) when
performed to
vertebral
corpectomy(ies)
(vertebral body
resection, partial
or complete) defect,
in conjunction with
interbody
arthrodesis, each
contiguous defect.
22X83............ Insertion of NEW............... 6.00 5.50 No.
intervertebral
biomechanical
device(s) (e.g.,
synthetic cage,
mesh,
methylmethacrylate)
to intervertebral
disc space or
vertebral body
defect without
interbody
arthrodesis, each
contiguous defect.
26356............ Repair or 9.56.............. .............. 9.56 No.
advancement, flexor
tendon, in zone 2
digital flexor
tendon sheath (e.g.,
no man's land);
primary, without
free graft, each
tendon.
26357............ Repair or 10.53............. .............. 11.00 No.
advancement, flexor
tendon, in zone 2
digital flexor
tendon sheath (e.g.,
no man's land);
secondary, without
free graft, each
tendon.
26358............ Repair or 12.13............. .............. 12.60 No.
advancement, flexor
tendon, in zone 2
digital flexor
tendon sheath (e.g.,
no man's land);
secondary, with free
graft (includes
obtaining graft),
each tendon.
271X1............ Closed treatment of NEW............... 5.50 1.53 Yes.
posterior pelvic
ring fracture(s),
dislocation(s),
diastasis or
subluxation of the
ilium, sacroiliac
joint, and/or
sacrum, with or
without anterior
pelvic ring
fracture(s) and/or
dislocation(s) of
the pubic symphysis
and/or superior/
inferior rami,
unilateral or
bilateral; without
manipulation.
271X2............ Closed treatment of NEW............... 9.00 4.75 Yes.
posterior pelvic
ring fracture(s),
dislocation(s),
diastasis or
subluxation of the
ilium, sacroiliac
joint, and/or
sacrum, with or
without anterior
pelvic ring
fracture(s) and/or
dislocation(s) of
the pubic symphysis
and/or superior/
inferior rami,
unilateral or
bilateral; with
manipulation,
requiring more than
local anesthesia
(i.e., general
anesthesia, moderate
sedation, spinal/
epidural).
28289............ Hallux rigidus 8.31.............. 6.90 6.90 No.
correction with
cheilectomy,
debridement and
capsular release of
the first
metatarsophalangeal
joint.
28292............ Correction, hallux 9.05.............. 7.44 7.44 No.
valgus (bunion),
with or without
sesamoidectomy;
Keller, McBride, or
Mayo type procedure.
28296............ Correction, hallux 8.35.............. 8.25 8.25 No.
valgus (bunion),
with or without
sesamoidectomy; with
metatarsal osteotomy
(e.g., Mitchell,
Chevron, or
concentric type
procedures).
28297............ Correction, hallux 9.43.............. 9.29 9.29 No.
valgus (bunion),
with or without
sesamoidectomy;
Lapidus-type
procedure.
28298............ Correction, hallux 8.13.............. 7.75 7.75 No.
valgus (bunion),
with or without
sesamoidectomy; by
phalanx osteotomy.
28299............ Correction, hallux 11.57............. 9.29 9.29 No.
valgus (bunion),
with or without
sesamoidectomy; by
double osteotomy.
282X1............ Hallux rigidus NEW............... 8.01 7.81 No.
correction with
cheilectomy,
debridement and
capsular release of
the first
metatarsophalangeal
joint; with implant.
282X2............ Correction, hallux NEW............... 8.57 8.25 No.
valgus
(bunionectomy), with
sesamoidectomy, when
performed; with
proximal metatarsal
osteotomy, any
method.
31500............ Intubation, 2.33.............. 3.00 2.66 No.
endotracheal,
emergency procedure.
31575............ Laryngoscopy, 1.10.............. 1.00 0.94 No.
flexible fiberoptic;
diagnostic.
31576............ Laryngoscopy, 1.97.............. 1.95 1.89 No.
flexible fiberoptic;
with biopsy.
31577............ Laryngoscopy, 2.47.............. 2.25 2.19 No.
flexible fiberoptic;
with removal of
foreign body.
31578............ Laryngoscopy, 2.84.............. 2.49 2.43 No.
flexible fiberoptic;
with removal of
lesion.
31579............ Laryngoscopy, 2.26.............. 1.94 1.88 No.
flexible or rigid
fiberoptic, with
stroboscopy.
317X1............ Laryngoscopy, NEW............... 3.07 3.01 No.
flexible; with
ablation or
destruction of
lesion(s) with
laser, unilateral.
[[Page 46267]]
317X2............ Laryngoscopy, NEW............... 2.49 2.43 No.
flexible; with
therapeutic
injection(s) (e.g.,
chemodenervation
agent or
corticosteroid,
injected
percutaneous,
transoral, or via
endoscope channel),
unilateral.
317X3............ Laryngoscopy, NEW............... 2.49 2.43 No.
flexible; with
injection(s) for
augmentation (e.g.,
percutaneous,
transoral),
unilateral.
31580............ Laryngoplasty; for 14.66............. 14.60 14.60 No.
laryngeal web, 2-
stage, with keel
insertion and
removal.
31584............ Laryngoplasty; with 20.47............. 20.00 17.58 No.
open reduction of
fracture.
31587............ Laryngoplasty, 15.27............. 15.27 15.27 No.
cricoid split.
315X1............ Laryngoplasty; for NEW............... 21.50 21.50 No.
laryngeal stenosis,
with graft, without
indwelling stent
placement, younger
than 12 years of age.
315X2............ Laryngoplasty; for NEW............... 20.50 20.50 No.
laryngeal stenosis,
with graft, without
indwelling stent
placement, age 12
years or older.
315X3............ Laryngoplasty; for NEW............... 22.00 22.00 No.
laryngeal stenosis,
with graft, with
indwelling stent
placement, younger
than 12 years of age.
315X4............ Laryngoplasty; for NEW............... 22.00 22.00 No.
laryngeal stenosis,
with graft, with
indwelling stent
placement, age 12
years or older.
315X5............ Laryngoplasty, NEW............... 15.60 13.56 No.
medialization;
unilateral.
315X6............ Cricotracheal NEW............... 25.00 25.00 No.
resection.
333X3............ Percutaneous NEW............... 14.00 13.00 No.
transcatheter
closure of the left
atrial appendage
with endocardial
implant, including
fluoroscopy,
transseptal
puncture, catheter
placement(s), left
atrial angiography,
left atrial
appendage
angiography, when
performed, and
radiological
supervision and
interpretation.
334X1............ Valvuloplasty, aortic NEW............... 35.00 35.00 No.
valve, open, with
cardiopulmonary
bypass; simple
(i.e., valvotomy,
debridement,
debulking and/or
simple commissural
resuspension).
334X2............ Valvuloplasty, aortic NEW............... 44.00 41.50 No.
valve, open, with
cardiopulmonary
bypass; complex
(e.g., leaflet
extension, leaflet
resection, leaflet
reconstruction or
annuloplasty).
364X1............ Partial exchange NEW............... 2.00 2.00 No.
transfusion, blood,
plasma or
crystalloid
necessitating the
skill of a physician
or other qualified
health care
professional,
newborn.
36440............ Push transfusion, 1.03.............. 1.03 1.03 No.
blood, 2 years or
younger.
36450............ Exchange transfusion, 2.23.............. 3.50 3.50 No.
blood; newborn.
36455............ Exchange transfusion, 2.43.............. 2.43 2.43 No.
blood; other than
newborn.
36X41............ Endovenous ablation NEW............... 3.50 3.50 No.
therapy of
incompetent vein,
extremity, inclusive
of all imaging
guidance and
monitoring,
percutaneous,
mechanochemical;
first vein treated.
364X2............ Endovenous ablation NEW............... 2.25 1.75 No.
therapy of
incompetent vein,
extremity, inclusive
of all imaging
guidance and
monitoring,
percutaneous,
mechanochemical;
subsequent vein(s)
treated in a single
extremity, each
through separate
access sites.
369X1............ Introduction of NEW............... 3.36 2.82 No.
needle(s) and/or
catheter(s),
dialysis circuit,
with diagnostic
angiography of the
dialysis circuit,
including all direct
puncture(s) and
catheter
placement(s),
injection(s) of
contrast, all
necessary imaging
from the arterial
anastomosis and
adjacent artery
through entire
venous outflow
including the
inferior or superior
vena cava,
fluoroscopic
guidance, radiologic
supervision and
interpretation and
image documentation
and report.
369X2............ Introduction of NEW............... 4.83 4.24 No.
needle(s) and/or
catheter(s),
dialysis circuit,
with diagnostic
angiography of the
dialysis circuit,
including all direct
puncture(s) and
catheter
placement(s),
injection(s) of
contrast, all
necessary imaging
from the arterial
anastomosis and
adjacent artery
through entire
venous outflow
including the
inferior or superior
vena cava,
fluoroscopic
guidance, radiologic
supervision and
interpretation and
image documentation
and report; with
transluminal balloon
angioplasty,
peripheral dialysis
segment, including
all imaging and
radiological
supervision and
interpretation
necessary to perform
the angioplasty.
[[Page 46268]]
369X3............ Introduction of NEW............... 6.39 5.85 No.
needle(s) and/or
catheter(s),
dialysis circuit,
with diagnostic
angiography of the
dialysis circuit,
including all direct
puncture(s) and
catheter
placement(s),
injection(s) of
contrast, all
necessary imaging
from the arterial
anastomosis and
adjacent artery
through entire
venous outflow
including the
inferior or superior
vena cava,
fluoroscopic
guidance, radiologic
supervision and
interpretation and
image documentation
and report; with
transcatheter
placement of
intravascular
stent(s) peripheral
dialysis segment,
including all
imaging and
radiological
supervision and
interpretation
necessary to perform
the stenting, and
all angioplasty
within the
peripheral dialysis
segment.
369X4............ Percutaneous NEW............... 7.50 6.73 No.
transluminal
mechanical
thrombectomy and/or
infusion for
thrombolysis,
dialysis circuit,
any method,
including all
imaging and
radiological
supervision and
interpretation,
diagnostic
angiography,
fluoroscopic
guidance, catheter
placement(s), and
intraprocedural
pharmacological
thrombolytic
injection(s).
369X5............ Percutaneous NEW............... 9.00 8.46 No.
transluminal
mechanical
thrombectomy and/or
infusion for
thrombolysis,
dialysis circuit,
any method,
including all
imaging and
radiological
supervision and
interpretation,
diagnostic
angiography,
fluoroscopic
guidance, catheter
placement(s), and
intraprocedural
pharmacological
thrombolytic
injection(s); with
transluminal balloon
angioplasty,
peripheral dialysis
segment, including
all imaging and
radiological
supervision and
interpretation
necessary to perform
the angioplasty.
369X6............ Percutaneous NEW............... 10.42 9.88 No.
transluminal
mechanical
thrombectomy and/or
infusion for
thrombolysis,
dialysis circuit,
any method,
including all
imaging and
radiological
supervision and
interpretation,
diagnostic
angiography,
fluoroscopic
guidance, catheter
placement(s), and
intraprocedural
pharmacological
thrombolytic
injection(s); with
transcatheter
placement of an
intravascular
stent(s), peripheral
dialysis segment,
including all
imaging and
radiological
supervision and
interpretation to
perform the stenting
and all angioplasty
within the
peripheral dialysis
circuit.
369X7............ Transluminal balloon NEW............... 3.00 2.48 No.
angioplasty, central
dialysis segment,
performed through
dialysis circuit,
including all
imaging and
radiological
supervision and
interpretation
required to perform
the angioplasty.
369X8............ Transcatheter NEW............... 4.25 3.73 No.
placement of an
intravascular
stent(s), central
dialysis segment,
performed through
dialysis circuit,
including all
imaging and
radiological
supervision and
interpretation
required to perform
the stenting, and
all angioplasty in
the central dialysis
segment.
369X9............ Dialysis circuit NEW............... 4.12 3.48 No.
permanent vascular
embolization or
occlusion (including
main circuit or any
accessory veins),
endovascular,
including all
imaging and
radiological
supervision and
interpretation
necessary to
complete the
intervention.
372X1............ Transluminal balloon NEW............... 7.00 7.00 No.
angioplasty (except
lower extremity
artery(s) for
occlusive disease,
intracranial,
coronary, pulmonary,
or dialysis
circuit), open or
percutaneous,
including all
imaging and
radiological
supervision and
interpretation
necessary to perform
the angioplasty
within the same
artery; initial
artery.
372X2............ Transluminal balloon NEW............... 3.50 3.50 No.
angioplasty (except
lower extremity
artery(s) for
occlusive disease,
intracranial,
coronary, pulmonary,
or dialysis
circuit), open or
percutaneous,
including all
imaging and
radiological
supervision and
interpretation
necessary to perform
the angioplasty
within the same
artery; each
additional artery.
372X3............ Transluminal balloon NEW............... 6.00 6.00 No.
angioplasty (except
dialysis circuit),
open or
percutaneous,
including all
imaging and
radiological
supervision and
interpretation
necessary to perform
the angioplasty
within the same
vein; initial vein.
[[Page 46269]]
372X4............ Transluminal balloon NEW............... 2.97 2.97 No.
angioplasty (except
dialysis circuit),
open or
percutaneous,
including all
imaging and
radiological
supervision and
interpretation
necessary to perform
the angioplasty
within the same
vein; each
additional vein.
41530............ Submucosal ablation 3.50.............. .............. 3.50 No.
of the tongue base,
radiofrequency, 1 or
more sites, per
session.
43210............ Esophagogastroduodeno 7.75.............. .............. 7.75 No.
scopy, flexible,
transoral; with
esophagogastric
fundoplasty, partial
or complete,
includes
duodenoscopy when
performed.
432X1............ Laparoscopy, NEW............... 10.13 9.03 No.
surgical, esophageal
sphincter
augmentation
procedure, placement
of sphincter
augmentation device
(i.e., magnetic
band), including
cruroplasty when
performed.
432X2............ Removal of esophageal NEW............... 10.47 9.37 No.
sphincter
augmentation device.
47531............ Injection procedure 1.80.............. 1.30 1.30 No.
for cholangiography,
percutaneous,
complete diagnostic
procedure including
imaging guidance
(e.g., ultrasound
and/or fluoroscopy)
and all associated
radiological
supervision and
interpretation;
existing access.
47532............ Injection procedure 4.25.............. 4.32 4.25 No.
for cholangiography,
percutaneous,
complete diagnostic
procedure including
imaging guidance
(e.g., ultrasound
and/or fluoroscopy)
and all associated
radiological
supervision and
interpretation; new
access (e.g.,
percutaneous
transhepatic
cholangiogram).
47533............ Placement of biliary 6.00.............. 5.45 5.38 No.
drainage catheter,
percutaneous,
including diagnostic
cholangiography when
performed, imaging
guidance (e.g.,
ultrasound and/or
fluoroscopy), and
all associated
radiological
supervision and
interpretation;
external.
47534............ Placement of biliary 8.03.............. 7.67 7.60 No.
drainage catheter,
percutaneous,
including diagnostic
cholangiography when
performed, imaging
guidance (e.g.,
ultrasound and/or
fluoroscopy), and
all associated
radiological
supervision and
interpretation;
internal-external.
47535............ Conversion of 4.50.............. 4.02 3.95 No.
external biliary
drainage catheter to
internal-external
biliary drainage
catheter,
percutaneous,
including diagnostic
cholangiography when
performed, imaging
guidance (e.g.,
fluoroscopy), and
all associated
radiological
supervision and
interpretation.
47536............ Exchange of biliary 2.88.............. 2.68 2.61 No.
drainage catheter
(e.g., external,
internal-external,
or conversion of
internal-external to
external only),
percutaneous,
including diagnostic
cholangiography when
performed, imaging
guidance (e.g.,
fluoroscopy), and
all associated
radiological
supervision and
interpretation.
47537............ Removal of biliary 1.83.............. 1.84 1.84 No.
drainage catheter,
percutaneous,
requiring
fluoroscopic
guidance (e.g., with
concurrent
indwelling biliary
stents), including
diagnostic
cholangiography when
performed, imaging
guidance (e.g.,
fluoroscopy), and
all associated
radiological
supervision and
interpretation.
47538............ Placement of stent(s) 6.60.............. 4.82 4.75 No.
into a bile duct,
percutaneous,
including diagnostic
cholangiography,
imaging guidance
(e.g., fluoroscopy
and/or ultrasound),
balloon dilation,
catheter exchange(s)
and catheter
removal(s) when
performed, and all
associated
radiological
supervision and
interpretation, each
stent; existing
access.
47539............ Placement of stent(s) 9.00.............. 8.82 8.75 No.
into a bile duct,
percutaneous,
including diagnostic
cholangiography,
imaging guidance
(e.g., fluoroscopy
and/or ultrasound),
balloon dilation,
catheter exchange(s)
and catheter
removal(s) when
performed, and all
associated
radiological
supervision and
interpretation, each
stent; new access,
without placement of
separate biliary
drainage catheter.
[[Page 46270]]
47540............ Placement of stent(s) 10.75............. 9.10 9.03 No.
into a bile duct,
percutaneous,
including diagnostic
cholangiography,
imaging guidance
(e.g., fluoroscopy
and/or ultrasound),
balloon dilation,
catheter exchange(s)
and catheter
removal(s) when
performed, and all
associated
radiological
supervision and
interpretation, each
stent; new access,
with placement of
separate biliary
drainage catheter
(e.g., external or
internal-external).
47541............ Placement of access 5.61.............. 6.82 5.38 No.
through the biliary
tree and into small
bowel to assist with
an endoscopic
biliary procedure
(e.g., rendezvous
procedure),
percutaneous,
including diagnostic
cholangiography when
performed, imaging
guidance (e.g.,
ultrasound and/or
fluoroscopy), and
all associated
radiological
supervision and
interpretation, new
access.
47542............ Balloon dilation of 2.50.............. 2.85 2.85 No.
biliary duct(s) or
of ampulla
(sphincteroplasty),
percutaneous,
including imaging
guidance (e.g.,
fluoroscopy), and
all associated
radiological
supervision and
interpretation, each
duct.
47543............ Endoluminal 3.07.............. 3.00 3.00 No.
biopsy(ies) of
biliary tree,
percutaneous, any
method(s) (e.g.,
brush, forceps, and/
or needle),
including imaging
guidance (e.g.,
fluoroscopy), and
all associated
radiological
supervision and
interpretation,
single or multiple.
47544............ Removal of calculi/ 4.29.............. 3.28 3.28 No.
debris from biliary
duct(s) and/or
gallbladder,
percutaneous,
including
destruction of
calculi by any
method (e.g.,
mechanical,
electrohydraulic,
lithotripsy) when
performed, imaging
guidance (e.g.,
fluoroscopy), and
all associated
radiological
supervision and
interpretation.
49185............ Sclerotherapy of a 2.35.............. .............. 2.35 No.
fluid collection
(e.g., lymphocele,
cyst, or seroma),
percutaneous,
including contrast
injection(s),
sclerosant
injection(s),
diagnostic study,
imaging guidance
(e.g., ultrasound,
fluoroscopy) and
radiological
supervision and
interpretation when
performed.
50606............ Endoluminal biopsy of 3.16.............. .............. 3.16 No.
ureter and/or renal
pelvis, non-
endoscopic,
including imaging
guidance (e.g.,
ultrasound and/or
fluoroscopy) and all
associated
radiological
supervision and
interpretation.
50705............ Ureteral embolization 4.03.............. .............. 4.03 No.
or occlusion,
including imaging
guidance (e.g.,
ultrasound and/or
fluoroscopy) and all
associated
radiological
supervision and
interpretation.
50706............ Balloon dilation, 3.80.............. .............. 3.80 No.
ureteral stricture,
including imaging
guidance (e.g.,
ultrasound and/or
fluoroscopy) and all
associated
radiological
supervision and
interpretation.
51700............ Bladder irrigation, 0.88.............. 0.60 0.60 No.
simple, lavage and/
or instillation.
51701............ Insertion of non- 0.50.............. 0.50 0.50 No.
indwelling bladder
catheter (e.g.,
straight
catheterization for
residual urine).
51702............ Insertion of 0.50.............. 0.50 0.50 No.
temporary indwelling
bladder catheter;
simple (e.g., Foley).
51703............ Insertion of 1.47.............. 1.47 1.47 No.
temporary indwelling
bladder catheter;
complicated (e.g.,
altered anatomy,
fractured catheter/
balloon).
51720............ Bladder instillation 1.50.............. 0.87 0.87 No.
of anticarcinogenic
agent (including
retention time).
51784............ Electromyography 1.53.............. 0.75 0.75 No.
studies (EMG) of
anal or urethral
sphincter, other
than needle, any
technique.
52000............ Cystourethroscopy 2.23.............. 1.75 1.53 No.
(separate procedure).
55700............ Biopsy, prostate; 2.58.............. 2.50 2.06 No.
needle or punch,
single or multiple,
any approach.
55866............ Laparoscopy, surgical 21.36............. .............. 21.36 No.
prostatectomy,
retropubic radical,
including nerve
sparing, includes
robotic assistance,
when performed.
58555............ Hysteroscopy, 3.33.............. 3.07 2.65 No.
diagnostic (separate
procedure).
58558............ Hysteroscopy, 4.74.............. 4.37 4.17 No.
surgical; with
sampling (biopsy) of
endometrium and/or
polypectomy, with or
without D & C.
58559............ Hysteroscopy, 6.16.............. 5.54 5.20 No.
surgical; with lysis
of intrauterine
adhesions (any
method).
58560............ Hysteroscopy, 6.99.............. 6.15 5.75 No.
surgical; with
division or
resection of
intrauterine septum
(any method).
58561............ Hysteroscopy, 9.99.............. 7.00 6.60 No.
surgical; with
removal of
leiomyomata.
[[Page 46271]]
58562............ Hysteroscopy, 5.20.............. 4.17 4.00 No.
surgical; with
removal of impacted
foreign body.
58563............ Hysteroscopy, 6.16.............. 4.62 4.47 No.
surgical; with
endometrial ablation
(e.g., endometrial
resection,
electrosurgical
ablation,
thermoablation).
585X1............ Laparoscopy, NEW............... 14.08 14.08 No.
surgical, ablation
of uterine
fibroid(s) including
intraoperative
ultrasound guidance
and monitoring,
radiofrequency.
61640............ Balloon dilatation of N................. N N No.
intracranial
vasospasm,
percutaneous;
initial vessel.
61641............ Balloon dilatation of N................. N N No.
intracranial
vasospasm,
percutaneous; each
additional vessel in
same vascular family.
61642............ Balloon dilatation of N................. N N No.
intracranial
vasospasm,
percutaneous; each
additional vessel in
different vascular
family.
61645............ Percutaneous arterial 15.00............. .............. 15.00 No.
transluminal
mechanical
thrombectomy and/or
infusion for
thrombolysis,
intracranial, any
method, including
diagnostic
angiography,
fluoroscopic
guidance, catheter
placement, and
intraprocedural
pharmacological
thrombolytic
injection(s).
61650............ Endovascular 10.00............. .............. 10.00 No.
intracranial
prolonged
administration of
pharmacologic
agent(s) other than
for thrombolysis,
arterial, including
catheter placement,
diagnostic
angiography, and
imaging guidance;
initial vascular
territory.
61651............ Endovascular 4.25.............. .............. 4.25 No.
intracranial
prolonged
administration of
pharmacologic
agent(s) other than
for thrombolysis,
arterial, including
catheter placement,
diagnostic
angiography, and
imaging guidance;
each additional
vascular territory.
623X5............ Injection(s), of NEW............... 1.80 1.80 No.
diagnostic or
therapeutic
substance(s) (e.g.,
anesthetic,
antispasmodic,
opioid, steroid,
other solution), not
including neurolytic
substances,
including needle or
catheter placement,
interlaminar
epidural or
subarachnoid,
cervical or
thoracic; without
imaging guidance.
623X6............ Injection(s), of NEW............... 1.95 1.95 No.
diagnostic or
therapeutic
substance(s) (e.g.,
anesthetic,
antispasmodic,
opioid, steroid,
other solution), not
including neurolytic
substances,
including needle or
catheter placement,
interlaminar
epidural or
subarachnoid,
cervical or
thoracic; with
imaging guidance
(i.e., fluoroscopy
or CT).
623X7............ Injection(s), of NEW............... 1.55 1.55 No.
diagnostic or
therapeutic
substance(s) (e.g.,
anesthetic,
antispasmodic,
opioid, steroid,
other solution), not
including neurolytic
substances,
including needle or
catheter placement,
interlaminar
epidural or
subarachnoid, lumbar
or sacral (caudal);
without imaging
guidance.
623X8............ Injection(s), of NEW............... 1.80 1.80 No.
diagnostic or
therapeutic
substance(s) (e.g.,
anesthetic,
antispasmodic,
opioid, steroid,
other solution), not
including neurolytic
substances,
including needle or
catheter placement,
interlaminar
epidural or
subarachnoid, lumbar
or sacral (caudal);
with imaging
guidance (ie,
fluoroscopy or CT).
623X9............ Injection(s), NEW............... 1.89 1.89 No.
including indwelling
catheter placement,
continuous infusion
or intermittent
bolus, of diagnostic
or therapeutic
substance(s) (e.g.,
anesthetic,
antispasmodic,
opioid, steroid,
other solution), not
including neurolytic
substances,
interlaminar
epidural or
subarachnoid,
cervical or
thoracic; without
imaging guidance.
62X10............ Injection(s), NEW............... 2.20 2.20 No.
including indwelling
catheter placement,
continuous infusion
or intermittent
bolus, of diagnostic
or therapeutic
substance(s) (e.g.,
anesthetic,
antispasmodic,
opioid, steroid,
other solution), not
including neurolytic
substances,
interlaminar
epidural or
subarachnoid,
cervical or
thoracic; with
imaging guidance
(ie, fluoroscopy or
CT).
[[Page 46272]]
62X11............ Injection(s), NEW............... 1.78 1.78 No.
including indwelling
catheter placement,
continuous infusion
or intermittent
bolus, of diagnostic
or therapeutic
substance(s) (e.g.,
anesthetic,
antispasmodic,
opioid, steroid,
other solution), not
including neurolytic
substances,
interlaminar
epidural or
subarachnoid, lumbar
or sacral (caudal);
without imaging
guidance.
62X12............ Injection(s), NEW............... 1.90 1.90 No.
including indwelling
catheter placement,
continuous infusion
or intermittent
bolus, of diagnostic
or therapeutic
substance(s) (e.g.,
anesthetic,
antispasmodic,
opioid, steroid,
other solution), not
including neurolytic
substances,
interlaminar
epidural or
subarachnoid, lumbar
or sacral (caudal);
with imaging
guidance (ie,
fluoroscopy or CT).
630X1............ Endoscopic NEW............... 10.47 9.09 No.
decompression of
spinal cord, nerve
root(s), including
laminotomy, partial
facetectomy,
foraminotomy,
discectomy and/or
excision of
herniated
intervertebral disc;
1 interspace, lumbar.
64461............ Paravertebral block 1.75.............. .............. 1.75 No.
(PVB) (paraspinous
block), thoracic;
single injection
site (includes
imaging guidance,
when performed).
64462............ Paravertebral block 1.10.............. .............. 1.10 No.
(PVB) (paraspinous
block), thoracic;
second and any
additional injection
site(s) (includes
imaging guidance,
when performed).
64463............ Paravertebral block 1.81.............. .............. 1.81 No.
(PVB) (paraspinous
block), thoracic;
continuous infusion
by catheter
(includes imaging
guidance, when
performed).
64553............ Percutaneous 2.36.............. .............. 2.36 Yes.
implantation of
neurostimulator
electrode array;
cranial nerve.
64555............ Percutaneous 2.32.............. .............. 2.32 Yes.
implantation of
neurostimulator
electrode array;
peripheral nerve
(excludes sacral
nerve).
64566............ Posterior tibial 0.60.............. .............. 0.60 No.
neurostimulation,
percutaneous needle
electrode, single
treatment, includes
programming.
65778............ Placement of amniotic 1.00.............. .............. 1.00 No.
membrane on the
ocular surface;
without sutures.
65779............ Placement of amniotic 2.50.............. .............. 2.50 No.
membrane on the
ocular surface;
single layer,
sutured.
65780............ Ocular surface 7.81.............. .............. 7.81 No.
reconstruction;
amniotic membrane
transplantation,
multiple layers.
65855............ Trabeculoplasty by 2.66.............. .............. 2.77 No.
laser surgery.
66170............ Fistulization of 11.27............. .............. 11.27 No.
sclera for glaucoma;
trabeculectomy ab
externo in absence
of previous surgery.
66172............ Fistulization of 12.57............. .............. 12.57 No.
sclera for glaucoma;
trabeculectomy ab
externo with
scarring from
previous ocular
surgery or trauma
(includes injection
of antifibrotic
agents).
67101............ Repair of retinal 8.80.............. 3.50 3.50 No.
detachment, 1 or
more sessions;
cryotherapy or
diathermy, including
drainage of
subretinal fluid,
when performed.
67105............ Repair of retinal 8.53.............. 3.84 3.39 No.
detachment, 1 or
more sessions;
photocoagulation,
including drainage
of subretinal fluid,
when performed.
67107............ Repair of retinal 14.06............. .............. 14.06 No.
detachment; scleral
buckling (such as
lamellar scleral
dissection,
imbrication or
encircling
procedure),
including, when
performed, implant,
cryotherapy,
photocoagulation,
and drainage of
subretinal fluid.
67108............ Repair of retinal 15.19............. .............. 15.19 No.
detachment; with
vitrectomy, any
method, including,
when performed, air
or gas tamponade,
focal endolaser
photocoagulation,
cryotherapy,
drainage of
subretinal fluid,
scleral buckling,
and/or removal of
lens by same
technique.
67110............ Repair of retinal 8.31.............. .............. 8.31 No.
detachment; by
injection of air or
other gas (e.g.,
pneumatic
retinopexy).
67113............ Repair of complex 19.00............. .............. 19.00 No.
retinal detachment
(e.g., proliferative
vitreoretinopathy,
stage C-1 or
greater, diabetic
traction retinal
detachment,
retinopathy of
prematurity, retinal
tear of greater than
90 degrees), with
vitrectomy and
membrane peeling,
including, when
performed, air, gas,
or silicone oil
tamponade,
cryotherapy,
endolaser
photocoagulation,
drainage of
subretinal fluid,
scleral buckling,
and/or removal of
lens.
[[Page 46273]]
67227............ Destruction of 3.50.............. .............. 3.50 No.
extensive or
progressive
retinopathy (e.g.,
diabetic
retinopathy),
cryotherapy,
diathermy.
67228............ Treatment of 4.39.............. .............. 4.39 No.
extensive or
progressive
retinopathy (e.g.,
diabetic
retinopathy),
photocoagulation.
70540............ Magnetic resonance 1.35.............. 1.35 1.35 No.
(e.g., proton)
imaging, orbit,
face, and/or neck;
without contrast
material(s).
70542............ Magnetic resonance 1.62.............. 1.62 1.62 No.
(e.g., proton)
imaging, orbit,
face, and/or neck;
with contrast
material(s).
70543............ Magnetic resonance 2.15.............. 2.15 2.15 No.
(e.g., proton)
imaging, orbit,
face, and/or neck;
without contrast
material(s),
followed by contrast
material(s) and
further sequences.
72170............ Radiologic 0.17.............. .............. 0.17 No.
examination, pelvis;
1 or 2 views.
73501............ Radiologic 0.18.............. .............. 0.18 No.
examination, hip,
unilateral, with
pelvis when
performed; 1 view.
73502............ Radiologic 0.22.............. .............. 0.22 No.
examination, hip,
unilateral, with
pelvis when
performed; 2-3 views.
73503............ Radiologic 0.27.............. .............. 0.27 No.
examination, hip,
unilateral, with
pelvis when
performed; minimum
of 4 views.
73521............ Radiologic 0.22.............. .............. 0.22 No.
examination, hips,
bilateral, with
pelvis when
performed; 2 views.
73522............ Radiologic 0.29.............. .............. 0.29 No.
examination, hips,
bilateral, with
pelvis when
performed; 3-4 views.
73523............ Radiologic 0.31.............. .............. 0.31 No.
examination, hips,
bilateral, with
pelvis when
performed; minimum
of 5 views.
73551............ Radiologic 0.16.............. .............. 0.16 No.
examination, femur;
1 view.
73552............ Radiologic 0.18.............. .............. 0.18 No.
examination, femur;
minimum 2 views.
74712............ Magnetic resonance 3.00.............. .............. 3.00 No.
(e.g., proton)
imaging, fetal,
including placental
and maternal pelvic
imaging when
performed; single or
first gestation.
74713............ Magnetic resonance 1.78.............. .............. 1.85 No.
(e.g., proton)
imaging, fetal,
including placental
and maternal pelvic
imaging when
performed; each
additional gestation.
767X1............ Ultrasound, abdominal NEW............... 0.55 0.55 No.
aorta, real time
with image
documentation,
screening study for
abdominal aortic
aneurysm.
77001............ Fluoroscopic guidance 0.38.............. 0.38 0.38 No.
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).
77002............ Fluoroscopic guidance 0.54.............. 0.54 0.38 No.
for needle placement
(e.g., biopsy,
aspiration,
injection,
localization device).
77003............ Fluoroscopic guidance 0.60.............. 0.60 0.38 No.
and localization of
needle or catheter
tip for spine or
paraspinous
diagnostic or
therapeutic
injection procedures
(epidural or
subarachnoid).
770X1............ Fluoroscopic guidance NEW............... 0.81 0.81 No.
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).
770X2............ Fluoroscopic guidance NEW............... 1.00 1.00 No.
for needle placement
(e.g., biopsy,
aspiration,
injection,
localization device).
770X3............ Fluoroscopic guidance NEW............... 0.76 0.76 No.
and localization of
needle or catheter
tip for spine or
paraspinous
diagnostic or
therapeutic
injection procedures
(epidural or
subarachnoid).
77332............ Treatment devices, 0.54.............. 0.54 0.45 No.
design and
construction; simple
(simple block,
simple bolus).
77333............ Treatment devices, 0.84.............. 0.84 0.75 No.
design and
construction;
intermediate
(multiple blocks,
stents, bite blocks,
special bolus).
77334............ Treatment devices, 1.24.............. 1.24 1.15 No.
design and
construction;
complex (irregular
blocks, special
shields,
compensators,
wedges, molds or
casts).
77470............ Special treatment 2.09.............. 2.03 2.03 No.
procedure (e.g.,
total body
irradiation,
hemibody radiation,
per oral or
endocavitary
irradiation).
[[Page 46274]]
77778............ Interstitial 8.00.............. .............. 8.00 No.
radiation source
application,
complex, includes
supervision,
handling, loading of
radiation source,
when performed.
77790............ Supervision, 0.00.............. .............. 0.00 No.
handling, loading of
radiation source.
78264............ Gastric emptying 0.74.............. .............. 0.74 No.
imaging study (e.g.,
solid, liquid, or
both).
78265............ Gastric emptying 0.98.............. .............. 0.98 No.
imaging study (e.g.,
solid, liquid, or
both); with small
bowel transit.
78266............ Gastric emptying 1.08.............. .............. 1.08 No.
imaging study (e.g.,
solid, liquid, or
both); with small
bowel and colon
transit, multiple
days.
88104............ Cytopathology, 0.56.............. .............. 0.56 No.
fluids, washings or
brushings, except
cervical or vaginal;
smears with
interpretation.
88106............ Cytopathology, 0.37.............. .............. 0.37 No.
fluids, washings or
brushings, except
cervical or vaginal;
simple filter method
with interpretation.
88108............ Cytopathology, 0.44.............. .............. 0.44 No.
concentration
technique, smears
and interpretation
(e.g., Saccomanno
technique).
88112............ Cytopathology, 0.56.............. .............. 0.56 No.
selective cellular
enhancement
technique with
interpretation
(e.g., liquid based
slide preparation
method), except
cervical or vaginal.
88160............ Cytopathology, 0.50.............. .............. 0.50 No.
smears, any other
source; screening
and interpretation.
88161............ Cytopathology, 0.50.............. .............. 0.50 No.
smears, any other
source; preparation,
screening and
interpretation.
88162............ Cytopathology, 0.76.............. .............. 0.76 No.
smears, any other
source; extended
study involving over
5 slides and/or
multiple stains.
88184............ Flow cytometry, cell 0.00.............. 0.00 0.00 No.
surface,
cytoplasmic, or
nuclear marker,
technical component
only; first marker.
88185............ Flow cytometry, cell 0.00.............. 0.00 0.00 No.
surface,
cytoplasmic, or
nuclear marker,
technical component
only; each
additional marker.
88187............ Flow cytometry, 1.36.............. 0.74 0.74 No.
interpretation; 2 to
8 markers.
88188............ Flow cytometry, 1.69.............. 1.40 1.20 No.
interpretation; 9 to
15 markers.
88189............ Flow cytometry, 2.23.............. 1.70 1.70 No.
interpretation; 16
or more markers.
88321............ Consultation and 1.63.............. 1.63 1.63 No.
report on referred
slides prepared
elsewhere.
88323............ Consultation and 1.83.............. 1.83 1.83 No.
report on referred
material requiring
preparation of
slides.
88325............ Consultation, 2.50.............. 2.85 2.85 No.
comprehensive, with
review of records
and specimens, with
report on referred
material.
88341............ Immunohistochemistry 0.53.............. .............. 0.56 No.
or
immunocytochemistry,
per specimen; each
additional single
antibody stain
procedure (List
separately in
addition to code for
primary procedure).
88364............ In situ hybridization 0.67.............. .............. 0.70 No.
(e.g., FISH), per
specimen; each
additional single
probe stain
procedure.
88369............ Morphometric 0.67.............. .............. 0.67 No.
analysis, in situ
hybridization
(quantitative or
semi-quantitative),
manual, per
specimen; each
additional single
probe stain
procedure.
91110............ Gastrointestinal 3.64.............. 2.49 2.49 No.
tract imaging,
intraluminal (e.g.,
capsule endoscopy),
esophagus through
ileum, with
interpretation and
report.
91111............ Gastrointestinal 1.00.............. 1.00 1.00 No.
tract imaging,
intraluminal (e.g.,
capsule endoscopy),
esophagus with
interpretation and
report.
91200............ Liver elastography, 0.27.............. .............. 0.27 No.
mechanically induced
shear wave (e.g.,
vibration), without
imaging, with
interpretation and
report.
92132............ Scanning computerized 0.35.............. 0.30 0.30 No.
ophthalmic
diagnostic imaging,
anterior segment,
with interpretation
and report,
unilateral or
bilateral.
92133............ Scanning computerized 0.50.............. 0.40 0.40 No.
ophthalmic
diagnostic imaging,
posterior segment,
with interpretation
and report,
unilateral or
bilateral; optic
nerve.
92134............ Scanning computerized 0.50.............. 0.45 0.45 No.
ophthalmic
diagnostic imaging,
posterior segment,
with interpretation
and report,
unilateral or
bilateral; retina.
92235............ Fluorescein 0.81.............. 0.75 0.75 No.
angiography
(includes multiframe
imaging) with
interpretation and
report.
92240............ Indocyanine-green 1.10.............. 0.80 0.80 No.
angiography
(includes multiframe
imaging) with
interpretation and
report.
92250............ Fundus photography 0.44.............. 0.40 0.40 No.
with interpretation
and report.
922X4............ Fluorescein NEW............... 0.95 0.95 No.
angiography and
indocyanine-green
angiography
(includes multiframe
imaging) performed
at the same patient
encounter with
interpretation and
report, unilateral
or bilateral.
[[Page 46275]]
93050............ Arterial pressure 0.17.............. .............. 0.17 No.
waveform analysis
for assessment of
central arterial
pressures, includes
obtaining
waveform(s),
digitization and
application of
nonlinear
mathematical
transformations to
determine central
arterial pressures
and augmentation
index, with
interpretation and
report, upper
extremity artery,
non-invasive.
935X1............ Percutaneous NEW............... 21.70 18.23 No.
transcatheter
closure of
paravalvular leak;
initial occlusion
device, mitral valve.
935X2............ Percutaneous NEW............... 17.97 14.50 No.
transcatheter
closure of
paravalvular leak;
initial occlusion
device, aortic valve.
935X3............ Percutaneous NEW............... 8.00 6.81 No.
transcatheter
closure of
paravalvular leak;
each additional
occlusion device
(list separately in
addition to code for
primary service).
95144............ Professional services 0.06.............. 0.06 0.06 No.
for the supervision
of preparation and
provision of
antigens for
allergen
immunotherapy,
single dose vial(s)
(specify number of
vials).
95165............ Professional services 0.06.............. 0.06 0.06 No.
for the supervision
of preparation and
provision of
antigens for
allergen
immunotherapy;
single or multiple
antigens (specify
number of doses).
95812............ Electroencephalogram 1.08.............. 1.08 1.08 No.
(EEG) extended
monitoring; 41-60
minutes.
95813............ Electroencephalogram 1.73.............. 1.63 1.63 No.
(EEG) extended
monitoring; greater
than 1 hour.
95957............ Digital analysis of 1.98.............. 1.98 1.98 No.
electroencephalogram
(EEG) (e.g., for
epileptic spike
analysis).
95971............ Electronic analysis 0.78.............. .............. 0.78 No.
of implanted
neurostimulator
pulse generator
system (e.g., 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 (i.e.,
peripheral nerve,
sacral nerve,
neuromuscular)
neurostimulator
pulse generator/
transmitter, with
intraoperative or
subsequent
programming.
95972............ Electronic analysis 0.80.............. .............. 0.80 No.
of implanted
neurostimulator
pulse generator
system (e.g., 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 (i.e,
peripheral nerve,
sacral nerve,
neuromuscular)
(except cranial
nerve)
neurostimulator
pulse generator/
transmitter, with
intraoperative or
subsequent
programming.
961X0............ Administration of NEW............... 0.00 0.00 No.
patient-focused
health risk
assessment
instrument (e.g.,
health hazard
appraisal) with
scoring and
documentation, per
standardized
instrument.
961X1............ Administration of NEW............... 0.00 0.00 No.
caregiver-focused
health risk
assessment
instrument (e.g.,
depression
inventory) for the
benefit of the
patient, with
scoring and
documentation, per
standardized
instrument.
96931............ Reflectance confocal 0.00.............. 0.80 0.75 No.
microscopy (RCM) for
cellular and sub-
cellular imaging of
skin; image
acquisition and
interpretation and
report, first lesion.
96932............ Reflectance confocal 0.00.............. 0.00 0.00 No.
microscopy (RCM) for
cellular and sub-
cellular imaging of
skin; image
acquisition only,
first lesion.
96933............ Reflectance confocal 0.00.............. 0.80 0.75 No.
microscopy (RCM) for
cellular and sub-
cellular imaging of
skin; interpretation
and report only,
first lesion.
96934............ Reflectance confocal 0.00.............. 0.76 0.71 No.
microscopy (RCM) for
cellular and sub-
cellular imaging of
skin; image
acquisition and
interpretation and
report, each
additional lesion.
96935............ Reflectance confocal 0.00.............. 0.00 0.00 No.
microscopy (RCM) for
cellular and sub-
cellular imaging of
skin; image
acquisition only,
each additional
lesion.
96936............ Reflectance confocal 0.00.............. 0.76 0.71 No.
microscopy (RCM) for
cellular and sub-
cellular imaging of
skin; interpretation
and report only,
each additional
lesion.
97X61............ Physical therapy NEW............... 0.75 1.20 Yes.
evaluation; low
complexity.
97X62............ Physical therapy NEW............... 1.18 1.20 No.
evaluation; moderate
complexity.
97X63............ Physical therapy NEW............... 1.50 1.20 Yes.
evaluation; high
complexity.
97X64............ Reevaluation of NEW............... 0.75 0.60 No.
physical therapy
established plan of
care.
[[Page 46276]]
97X65............ Occupational therapy NEW............... 0.88 1.20 Yes.
evaluation; low
complexity.
97X66............ Occupational therapy NEW............... 1.20 1.20 No.
evaluation; moderate
complexity.
97X67............ Occupational therapy NEW............... 1.70 1.20 Yes.
evaluation; high
complexity.
97X68............ Reevaluation of NEW............... 0.80 0.60 No.
occupational therapy
care/established
plan of care.
991X1............ Moderate sedation NEW............... 0.50 0.50 No.
services provided by
the same physician
or other qualified
health care
professional
performing the
diagnostic or
therapeutic service
that the sedation
supports, requiring
the presence of an
independent trained
observer to assist
in the monitoring of
the patient's level
of consciousness and
physiological
status; initial 15
minutes of intra-
service time,
patient younger than
5 years of age.
991X2............ Moderate sedation NEW............... 0.25 0.25 No.
services provided by
the same physician
or other qualified
health care
professional
performing the
diagnostic or
therapeutic service
that the sedation
supports, requiring
the presence of an
independent trained
observer to assist
in the monitoring of
the patient's level
of consciousness and
physiological
status; initial 15
minutes of intra-
service time,
patient age 5 years
or older.
991X3............ Moderate sedation NEW............... 1.90 1.90 No.
services provided by
a physician or other
qualified health
care professional
other than the
physician or other
qualified health
care professional
performing the
diagnostic or
therapeutic service
that the sedation
supports; initial 15
minutes of intra-
service time,
patient younger than
5 years of age.
991X4............ Moderate sedation NEW............... 1.84 1.65 No.
services provided by
a physician or other
qualified health
care professional
other than the
physician or other
qualified health
care professional
performing the
diagnostic or
therapeutic service
that the sedation
supports; initial 15
minutes of intra-
service time,
patient age 5 years
or older.
991X5............ Moderate sedation NEW............... 0.00 0.00 No.
services provided by
the same physician
or other qualified
health care
professional
performing the
diagnostic or
therapeutic service
that the sedation
supports, requiring
the presence of an
independent trained
observer to assist
in the monitoring of
the patient's level
of consciousness and
physiological
status; each
additional 15
minutes of intra-
service time.
991X6............ Moderate sedation NEW............... 1.25 1.25 No.
services provided by
a physician or other
qualified health
care professional
other than the
physician or other
qualified health
care professional
performing the
diagnostic or
therapeutic service
that the sedation
supports; each
additional 15
minutes intra-
service time.
99354............ Prolonged evaluation 1.77.............. .............. 2.33 No.
and management or
psychotherapy
service(s) (beyond
the typical service
time of the primary
procedure) in the
office or other
outpatient setting
requiring direct
patient contact
beyond the usual
service; first hour.
99358............ Prolonged evaluation 2.10.............. .............. 2.10 No.
and management
service before and/
or after direct
patient care; first
hour.
99359............ Prolonged evaluation 1.00.............. .............. 1.00 No.
and management
service before and/
or after direct
patient care; each
additional 30
minutes.
99487............ Complex chronic care 0.00.............. .............. 1.00 No.
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.
[[Page 46277]]
99489............ Complex chronic care 0.00.............. .............. 0.50 No.
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;
each additional 30
minutes of clinical
staff time directed
by a physician or
other qualified
health care
professional, per
calendar month.
G0416............ Surgical pathology, 3.09.............. 4.00 3.60 No.
gross and
microscopic
examinations, for
prostate needle
biopsy, any method.
GDDD1............ Resource-intensive NEW............... .............. 0.48 No.
services for
patients for whom
the use of
specialized mobility-
assistive technology
(such as adjustable
height chairs or
tables, patient
lift, and adjustable
padded leg supports)
is medically
necessary and used
during the provision
of an office/
outpatient E/M visit
(Add-on code, list
separately in
addition to primary
procedure).
GMMM1............ Moderate sedation NEW............... .............. 0.10 No.
services provided by
the same physician
or other qualified
health care
professional
performing a
gastrointestinal
endoscopic service
(excluding biliary
procedures) that the
sedation supports,
requiring the
presence of an
independent trained
observer to assist
in the monitoring of
the patient's level
of consciousness and
physiological
status; initial 15
minutes of intra-
service time.
GPPP1............ Initial psychiatric NEW............... .............. 1.59 No.
collaborative care
management, first 70
minutes in the first
calendar month of
behavioral health
care manager
activities, in
consultation with a
psychiatric
consultant, and
directed by the
treating physician
or other qualified
health care
professional.
GPPP2............ Subsequent NEW............... .............. 1.42 No.
psychiatric
collaborative care
management, first 60
minutes in a
subsequent month of
behavioral health
care manager
activities, in
consultation with a
psychiatric
consultant, and
directed by the
treating physician
or other qualified
health care
professional.
GPPP3............ Initial or subsequent NEW............... .............. 0.71 No.
psychiatric
collaborative care
management, each
additional 30
minutes in a
calendar month of
behavioral health
care manager
activities, in
consultation with a
psychiatric
consultant, and
directed by the
treating physician
or other qualified
health care
professional.
GPPP6............ Cognition and NEW............... .............. 3.30 No.
functional
assessment using
standardized
instruments with
development of
recorded care plan
for the patient with
cognitive
impairment, history
obtained from
patient and/or
caregiver, in office
or other outpatient
setting or home or
domiciliary or rest
home.
GPPP7............ Comprehensive NEW............... .............. 0.87 No.
assessment of and
care planning for
patients requiring
chronic care
management services
(billed separately
from monthly care
management services).
GPPPX............ Care management NEW............... .............. 0.61 No.
services for
behavioral health
conditions, at least
20 minutes of
clinical staff time,
directed by a
physician or other
qualified health
care professional
time, per calendar
month.
GTTT1............ Telehealth NEW............... .............. 4.00 No.
consultation,
critical care,
physicians typically
spend 60 minutes
communicating with
the patient via
telehealth (initial).
GTTT2............ Telehealth NEW............... .............. 3.86 No.
consultation,
critical care,
physicians typically
spend 50 minutes
communicating with
the patient via
telehealth
(subsequent).
----------------------------------------------------------------------------------------------------------------
[[Page 46278]]
Table 24--CY 2016 Proposed Codes With Direct PE Input Recommendations
Accepted Without Refinement
------------------------------------------------------------------------
HCPCS code Description
------------------------------------------------------------------------
00740............................... Anesth upper gi visualize.
00810............................... Anesth low intestine scope.
10030............................... Guide cathet fluid drainage.
11730............................... Removal of nail plate.
19298............................... Place breast rad tube/caths.
20245............................... Bone biopsy excisional.
20550............................... Inj tendon sheath/ligament.
20552............................... Inj trigger point 1/2 muscl.
20553............................... Inject trigger points 3/>.
20982............................... Ablate bone tumor(s) perq.
20983............................... Ablate bone tumor(s) perq.
22510............................... Perq cervicothoracic inject.
22511............................... Perq lumbosacral injection.
22512............................... Vertebroplasty addl inject.
22513............................... Perq vertebral augmentation.
22514............................... Perq vertebral augmentation.
22515............................... Perq vertebral augmentation.
22526............................... Idet single level.
22527............................... Idet 1 or more levels.
228X1............................... Insj stablj dev w/dcmprn.
228X4............................... Insj stablj dev w/o dcmprn.
28289............................... Repair hallux rigidus.
28292............................... Correction of bunion.
28296............................... Correction of bunion.
28297............................... Correction of bunion.
28298............................... Correction of bunion.
28299............................... Correction of bunion.
282X1............................... Corrj halux rigdus w/implt.
31615............................... Visualization of windpipe.
31622............................... Dx bronchoscope/wash.
31623............................... Dx bronchoscope/brush.
31624............................... Dx bronchoscope/lavage.
31625............................... Bronchoscopy w/biopsy(s).
31626............................... Bronchoscopy w/markers.
31627............................... Navigational bronchoscopy.
31628............................... Bronchoscopy/lung bx each.
31629............................... Bronchoscopy/needle bx each.
31632............................... Bronchoscopy/lung bx addl.
31633............................... Bronchoscopy/needle bx addl.
31634............................... Bronch w/balloon occlusion.
31635............................... Bronchoscopy w/fb removal.
31645............................... Bronchoscopy clear airways.
31646............................... Bronchoscopy reclear airway.
31652............................... Bronch ebus samplng 1/2 node.
31653............................... Bronch ebus samplng 3/> node.
31654............................... Bronch ebus ivntj perph les.
32405............................... Percut bx lung/mediastinum.
32550............................... Insert pleural cath.
32553............................... Ins mark thor for rt perq.
333X3............................... Perq clsr tcat l atr apndge.
334X1............................... Valvuloplasty aortic valve.
334X2............................... Valvuloplasty aortic valve.
35471............................... Repair arterial blockage.
35472............................... Repair arterial blockage.
35475............................... Repair arterial blockage.
35476............................... Repair venous blockage.
36010............................... Place catheter in vein.
36140............................... Establish access to artery.
36147............................... Access av dial grft for eval.
36148............................... Access av dial grft for proc.
36200............................... Place catheter in aorta.
36221............................... Place cath thoracic aorta.
36222............................... Place cath carotid/inom art.
36223............................... Place cath carotid/inom art.
36224............................... Place cath carotid art.
36225............................... Place cath subclavian art.
36226............................... Place cath vertebral art.
36227............................... Place cath xtrnl carotid.
36228............................... Place cath intracranial art.
36245............................... Ins cath abd/l-ext art 1st.
36246............................... Ins cath abd/l-ext art 2nd.
36247............................... Ins cath abd/l-ext art 3rd.
36248............................... Ins cath abd/l-ext art addl.
36251............................... Ins cath ren art 1st unilat.
36252............................... Ins cath ren art 1st bilat.
36253............................... Ins cath ren art 2nd+ unilat.
36254............................... Ins cath ren art 2nd+ bilat.
36481............................... Insertion of catheter vein.
36555............................... Insert non-tunnel cv cath.
36557............................... Insert tunneled cv cath.
36558............................... Insert tunneled cv cath.
36560............................... Insert tunneled cv cath.
36561............................... Insert tunneled cv cath.
36563............................... Insert tunneled cv cath.
36565............................... Insert tunneled cv cath.
36566............................... Insert tunneled cv cath.
36568............................... Insert picc cath.
36570............................... Insert picvad cath.
36571............................... Insert picvad cath.
36576............................... Repair tunneled cv cath.
36578............................... Replace tunneled cv cath.
36581............................... Replace tunneled cv cath.
36582............................... Replace tunneled cv cath.
36583............................... Replace tunneled cv cath.
36585............................... Replace picvad cath.
36590............................... Removal tunneled cv cath.
36870............................... Percut thrombect av fistula.
369X7............................... Balo angiop ctr dialysis seg.
369X8............................... Stent plmt ctr dialysis seg.
369X9............................... Dialysis circuit embolj.
37183............................... Remove hepatic shunt (tips).
37184............................... Prim art m-thrmbc 1st vsl.
37185............................... Prim art m-thrmbc sbsq vsl.
37186............................... Sec art thrombectomy add-on.
37187............................... Venous mech thrombectomy.
37188............................... Venous m-thrombectomy add-on.
37191............................... Ins endovas vena cava filtr.
37192............................... Redo endovas vena cava filtr.
37193............................... Rem endovas vena cava filter.
37197............................... Remove intrvas foreign body.
37220............................... Iliac revasc.
37221............................... Iliac revasc w/stent.
37222............................... Iliac revasc add-on.
37223............................... Iliac revasc w/stent add-on.
37224............................... Fem/popl revas w/tla.
37225............................... Fem/popl revas w/ather.
37226............................... Fem/popl revasc w/stent.
37227............................... Fem/popl revasc stnt & ather.
37228............................... Tib/per revasc w/tla.
37229............................... Tib/per revasc w/ather.
37230............................... Tib/per revasc w/stent.
37231............................... Tib/per revasc stent & ather.
37232............................... Tib/per revasc add-on.
37233............................... Tibper revasc w/ather add-on.
37234............................... Revsc opn/prq tib/pero stent.
37235............................... Tib/per revasc stnt & ather.
37236............................... Open/perq place stent 1st.
37237............................... Open/perq place stent ea add.
37238............................... Open/perq place stent same.
37239............................... Open/perq place stent ea add.
37241............................... Vasc embolize/occlude venous.
37242............................... Vasc embolize/occlude artery.
37243............................... Vasc embolize/occlude organ.
37244............................... Vasc embolize/occlude bleed.
37252............................... Intrvasc us noncoronary 1st.
37253............................... Intrvasc us noncoronary addl.
372X2............................... Trluml balo angiop addl art.
372X4............................... Trluml balo angiop addl vein.
43200............................... Esophagoscopy flexible brush.
43201............................... Esoph scope w/submucous inj.
43202............................... Esophagoscopy flex biopsy.
43206............................... Esoph optical endomicroscopy.
43213............................... Esophagoscopy retro balloon.
43215............................... Esophagoscopy flex remove fb.
43216............................... Esophagoscopy lesion removal.
43217............................... Esophagoscopy snare les remv.
43220............................... Esophagoscopy balloon <30 mm.
43226............................... Esoph endoscopy dilation.
43227............................... Esophagoscopy control bleed.
43229............................... Esophagoscopy lesion ablate.
43231............................... Esophagoscop ultrasound exam.
43232............................... Esophagoscopy w/us needle bx.
43235............................... Egd diagnostic brush wash.
43236............................... Uppr gi scope w/submuc inj.
43239............................... Egd biopsy single/multiple.
43245............................... Egd dilate stricture.
43247............................... Egd remove foreign body.
43248............................... Egd guide wire insertion.
43249............................... Esoph egd dilation <30 mm.
43250............................... Egd cautery tumor polyp.
43251............................... Egd remove lesion snare.
43252............................... Egd optical endomicroscopy.
43255............................... Egd control bleeding any.
43270............................... Egd lesion ablation.
432X1............................... Laps esophgl sphnctr agmnt.
432X2............................... Rmvl esophgl sphnctr dev.
43450............................... Dilate esophagus 1/mult pass.
43453............................... Dilate esophagus.
44380............................... Small bowel endoscopy br/wa.
44381............................... Small bowel endoscopy br/wa.
44382............................... Small bowel endoscopy.
44385............................... Endoscopy of bowel pouch.
44386............................... Endoscopy bowel pouch/biop.
44388............................... Colonoscopy thru stoma spx.
44389............................... Colonoscopy with biopsy.
44390............................... Colonoscopy for foreign body.
44391............................... Colonoscopy for bleeding.
44392............................... Colonoscopy & polypectomy.
44394............................... Colonoscopy w/snare.
44401............................... Colonoscopy with ablation.
44404............................... Colonoscopy w/injection.
44405............................... Colonoscopy w/dilation.
45303............................... Proctosigmoidoscopy dilate.
45305............................... Proctosigmoidoscopy w/bx.
[[Page 46279]]
45307............................... Proctosigmoidoscopy fb.
45308............................... Proctosigmoidoscopy removal.
45309............................... Proctosigmoidoscopy removal.
45315............................... Proctosigmoidoscopy removal.
45317............................... Proctosigmoidoscopy bleed.
45320............................... Proctosigmoidoscopy ablate.
45332............................... Sigmoidoscopy w/fb removal.
45333............................... Sigmoidoscopy & polypectomy.
45334............................... Sigmoidoscopy for bleeding.
45335............................... Sigmoidoscopy w/submuc inj.
45338............................... Sigmoidoscopy w/tumr remove.
45340............................... Sig w/tndsc balloon dilation.
45346............................... Sigmoidoscopy w/ablation.
45350............................... Sgmdsc w/band ligation.
45378............................... Diagnostic colonoscopy.
45379............................... Colonoscopy w/fb removal.
45380............................... Colonoscopy and biopsy.
45381............................... Colonoscopy submucous njx.
45382............................... Colonoscopy w/control bleed.
45384............................... Colonoscopy w/lesion removal.
45385............................... Colonoscopy w/lesion removal.
45386............................... Colonoscopy w/balloon dilat.
45388............................... Colonoscopy w/ablation.
45398............................... Colonoscopy w/band ligation.
47000............................... Needle biopsy of liver.
47382............................... Percut ablate liver rf.
47383............................... Perq abltj lvr cryoablation.
49405............................... Image cath fluid colxn visc.
49406............................... Image cath fluid peri/retro.
49407............................... Image cath fluid trns/vgnl.
49411............................... Ins mark abd/pel for rt perq.
49418............................... Insert tun ip cath perc.
49440............................... Place gastrostomy tube perc.
49441............................... Place duod/jej tube perc.
49442............................... Place cecostomy tube perc.
49446............................... Change g-tube to g-j perc.
50200............................... Renal biopsy perq.
50382............................... Change ureter stent percut.
50384............................... Remove ureter stent percut.
50385............................... Change stent via transureth.
50386............................... Remove stent via transureth.
50387............................... Change nephroureteral cath.
50430............................... Njx px nfrosgrm &/urtrgrm.
50432............................... Plmt nephrostomy catheter.
50433............................... Plmt nephroureteral catheter.
50434............................... Convert nephrostomy catheter.
50592............................... Perc rf ablate renal tumor.
50593............................... Perc cryo ablate renal tum.
50693............................... Plmt ureteral stent prq.
50694............................... Plmt ureteral stent prq.
50695............................... Plmt ureteral stent prq.
51702............................... Insert temp bladder cath.
51703............................... Insert bladder cath complex.
51720............................... Treatment of bladder lesion.
51784............................... Anal/urinary muscle study.
55700............................... Biopsy of prostate.
57155............................... Insert uteri tandem/ovoids.
58558............................... Hysteroscopy biopsy.
58559............................... Hysteroscopy lysis.
58560............................... Hysteroscopy resect septum.
58561............................... Hysteroscopy remove myoma.
58563............................... Hysteroscopy ablation.
585X1............................... Laps abltj uterine fibroids.
630X1............................... Ndsc dcmprn 1 ntrspc lumbar.
66720............................... Destruction ciliary body.
67101............................... Repair detached retina.
67105............................... Repair detached retina.
69300............................... Revise external ear.
767X1............................... Us abdl aorta screen aaa.
77332............................... Radiation treatment aid(s).
77333............................... Radiation treatment aid(s).
77334............................... Radiation treatment aid(s).
77470............................... Special radiation treatment.
77600............................... Hyperthermia treatment.
77605............................... Hyperthermia treatment.
77610............................... Hyperthermia treatment.
77615............................... Hyperthermia treatment.
91110............................... Gi tract capsule endoscopy.
91111............................... Esophageal capsule endoscopy.
92132............................... Cmptr ophth dx img ant segmt.
92133............................... Cmptr ophth img optic nerve.
92134............................... Cptr ophth dx img post segmt.
92235............................... Eye exam with photos.
92240............................... Icg angiography.
92250............................... Eye exam with photos.
922X4............................... Fluorescein icg angiography.
92960............................... Cardioversion electric ext.
93312............................... Echo transesophageal.
93314............................... Echo transesophageal.
93451............................... Right heart cath.
93452............................... Left hrt cath w/ventrclgrphy.
93453............................... R&l hrt cath w/ventriclgrphy.
93454............................... Coronary artery angio s&i.
93455............................... Coronary art/grft angio s&i.
93456............................... R hrt coronary artery angio.
93457............................... R hrt art/grft angio.
93458............................... L hrt artery/ventricle angio.
93459............................... L hrt art/grft angio.
93460............................... R&l hrt art/ventricle angio.
93461............................... R&l hrt art/ventricle angio.
93464............................... Exercise w/hemodynamic meas.
93505............................... Biopsy of heart lining.
93566............................... Inject r ventr/atrial angio.
93567............................... Inject suprvlv aortography.
93568............................... Inject pulm art hrt cath.
935X1............................... Perq transcath cls mitral.
935X2............................... Perq transcath cls aortic.
93642............................... Electrophysiology evaluation.
93644............................... Electrophysiology evaluation.
95144............................... Antigen therapy services.
95165............................... Antigen therapy services.
95957............................... Eeg digital analysis.
961X0............................... Pt-focused hlth risk assmt.
961X1............................... Caregiver health risk assmt.
96440............................... Chemotherapy intracavitary.
96931............................... Rcm celulr subcelulr img skn.
96932............................... Rcm celulr subcelulr img skn.
97X64............................... Pt re-eval est plan care.
97X68............................... Ot re-eval est plan care.
991X1............................... Mod sed same phys/qhp <5 yrs.
991X2............................... Mod sed same phys/qhp 5/>yrs.
991X5............................... Mod sed oth phys/qhp 5/>yrs.
G0341............................... Percutaneous islet celltrans.
GMMM1
------------------------------------------------------------------------
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Table 26--Invoices Received for Existing Direct PE Inputs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated non-
facility
allowed
CPT/HCPCS codes Item name CMS code Current price Updated price Percent Number of services for
change invoices HCPCS codes
using this
item
--------------------------------------------------------------------------------------------------------------------------------------------------------
19030, 19081, 19082, 19281, 19282, room, digital EL013 168,214.00 362,935.00 116 10 2,294,862
19283, 19284, 77053, 77054, 770X1, mammography.
770X2, 770X3.
31575, 31576, 31577, 31578, 31579, video system, ES031 33,232.50 15,045.00 -55 1 1,497,130
317X1, 317X2, 317X3, 31580, 31584, endoscopy (processor,
31587, 315X1, 315X2, 315X3, 315X4, digital capture,
315X5, 315X6, 190+ other codes. monitor, printer,
cart).
58555, 58562, 58563, 58565......... endoscope, rigid, ES009 4,990.50 6,207.50 24 1 672
hysteroscopy.
88323, 88355, 88380, 88381......... stain, eosin.......... SL201 0.04 0.07 55 5 45,393
88360, 88361....................... Antibody Estrogen SL493 3.19 14.00 339 4 216,208
Receptor monoclonal.
91110.............................. kit, capsule endoscopy SA005 450.00 520.00 16 1 30,464
w-application
supplies (M2A).
91110, 91111....................... video system, capsule ES029 17,000.00 12,450.00 -27 1 30,586
endoscopy (software,
computer, monitor,
printer).
91111.............................. kit, capsule, ESO, SA094 450.00 472.80 5 1 122
endoscopy w-
application supplies
(ESO).
95145, 95146, 95148, 95149......... antigen, venom........ SH009 16.67 20.14 21 4 50,772
95147, 95148, 95149................ antigen, venom, tri- SH010 30.22 44.05 46 3 37,955
vespid.
122 codes.......................... light source, xenon... EQ167 6,723.33 7,000.00 4 1 2,149,616
59 codes........................... fiberscope, flexible, ES020 6,301.93 4,250.00 -33 1 581,924
rhinolaryngoscopy.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 27--Invoices Received For New Direct PE Inputs
----------------------------------------------------------------------------------------------------------------
Estimated non-
facility
allowed
CPT/HCPCS codes Item name CMS code Average price Number of services for
invoices HCPCS codes
using this
item
----------------------------------------------------------------------------------------------------------------
31575, 31579, 317X3, 31580, rhinolaryngoscope ES063 8,000.00 1 541,537
31584, 31587, 315X1, 315X2, , flexible,
315X3, 315X4, 315X5, 315X6. video, non-
channeled.
31576, 31577, 31578, 317X1, rhinolaryngoscope ES064 9,000.00 1 756
317X2. , flexible,
video, channeled.
31576, 31577, 31578........... Disposable biopsy SD318 26.84 1 574
forceps.
31579......................... stroboscopy ES065 19,100.00 1 54,466
system.
317X3......................... Voice SJ090 575.00 1 99
Augmentation Gel.
36X41......................... Claravein Kit.... SA122 890.00 1 264
36X41, 364X2.................. Sotradecol SH108 110.20 1 528
Sclerosing Agent.
55700......................... Biopsy Guide..... EQ375 7,000.00 0 85,731
58558......................... BLADE INCSR 2.9MM SF059 599.00 1 2,677
58558......................... Hysteroscopic EQ378 14,698.38 1 2,677
fluid management
system.
58558......................... Hysteroscopic EQ379 19,857.50 1 2,677
Resection System.
770X1, 770X2, 770X3........... PACS Mammography ED054 103,616.47 8 2,274,249
Workstation.
70540, 70542, 70543; over 400 Professional PACS ED053 14,616.93 9 32,571,650
additional codes. Workstation.
[[Page 46377]]
77332......................... knee wedge/foot EQ376 3,290.00 1 48,831
block system.
77333......................... Thermoplastic SD321 23.90 1 3,493
tissue bolus
30X30X0.3cm.
77333......................... water bath, EP120 2,350.00 1 3,493
digital control.
77333, 77334.................. Supine Breast/ EQ377 5,773.15 1 290,969
Lung Board.
77334......................... Urethane Foaming SL519 53.50 1 287,476
Agent.
88184, 88185.................. flow cytometry EQ380 14,000.00 1 1,680,252
analytics
software.
95144, 95165.................. antigen vial SK127 1.50 2 6,464,311
transport
envelope.
961X1......................... Beck Depression SK128 2.26 1 1
Inventory,
Second Edition
(BDI-II).
96416......................... IV infusion pump, EQ381 2384.45 1 117,248
ambulatory.
96931, 96932.................. Imaging Tray..... SA121 34.75 1 5
96931, 96932.................. adhesive ruler... SK125 9.95 1 5
96931, 96932, 96934, 96935.... reflectance ES056 98,500.00 1 9
confocal imaging
system.
97X66, 97X67, 97X68........... environmental ES057 25,000.00 1 115,107
module--bathroom.
97X66, 97X67.................. kit, vision...... ES058 410.00 1 86,912
GDDD1......................... patient lift EF045 2,824.33 3 15,115,789
system.
GDDD1......................... wheelchair EF046 875.92 3 15,115,789
accessible scale.
GDDD1......................... leg positioning EF047 1,076.50 3 15,115,789
system.
----------------------------------------------------------------------------------------------------------------
III. Other Provisions of the Proposed Rule for PFS
A. Chronic Care Management (CCM) and Transitional Care Management (TCM)
Supervision Requirements in Rural Health Clinics (RHCs) and Federally
Qualified Health Centers (FQHCs)
In the CY 2016 PFS final rule with comment period (80 FR 71080
through 71088), we finalized policies for payment of CCM services in
RHCs and FQHCs. Payment for CCM services in RHCs and FQHCs was
effective beginning on January 1, 2016, for RHCs and FQHCs that furnish
a minimum of 20 minutes of qualifying CCM services during a calendar
month to patients with multiple (two or more) chronic conditions that
are expected to last at least 12 months or until the death of the
patient, and that would place the patient at significant risk of death,
acute exacerbation/decompensation, or functional decline. Payment is
made when CPT code 99490 is billed alone or with other payable services
on a RHC or FQHC claim, and the rate is based on the PFS national
average non-facility payment rate. The requirement that RHC or FQHC
services be furnished face-to-face was waived for CCM services
furnished to a RHC or FQHC patient because CCM services are not
required to be furnished face-to-face.
Medicare payment for TCM services furnished by a RHC or FQHC
practitioner was effective January 1, 2013, consistent with the
effective date of payment for TCM services under the PFS (77 FR 68978
through 68994; also, see CMS-Pub. 100-02, Medicare Benefit Policy
Manual, chapter 13, section 110.4).
TCM services are billable only when furnished within 30 days of the
date of the patient's discharge from a hospital (including outpatient
observation or partial hospitalization), skilled nursing facility, or
community mental health center. Communication (direct contact,
telephone, or electronic) with the patient or caregiver must commence
within 2 business days of discharge, and a face-to-face visit must
occur within 14 days of discharge for moderate complexity decision
making (CPT code 99495), or within 7 days of discharge for high
complexity decision making (CPT code 99496). The TCM visit is billed on
the day that the TCM visit takes place, and only one TCM visit may be
paid per beneficiary for services furnished during that 30 day post-
discharge period. If the TCM visit occurs on the same day as another
billable visit, only one visit may be billed. TCM and CCM cannot be
billed during the same time period for the same patient.
In the CY 2016 PFS final rule with comment period (80 FR 71087), we
responded to comments requesting that we make an exception to the
supervision requirements for auxiliary staff furnishing CCM and TCM
services incident to physician services in RHCs and FQHCs (80 FR
71087). Auxiliary staff in RHCs and FQHCs furnish services incident to
a RHC or FQHC visit and include nurses, medical assistants, and other
clinical staff who work under the direct supervision of a RHC or FQHC
practitioner. The commenters suggested that the regulatory language be
amended to be consistent with the provision in Sec. 410.26(b)(5) for
CCM and TCM services under the PFS, which states that services and
supplies furnished incident to CCM and TCM services can be furnished
under general supervision of the physician (or other practitioner) when
they are provided by clinical staff. It further specifies that 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, but only the
supervising physician (or other practitioner) may bill Medicare for
incident to services. We responded that due to the differences between
physician offices and RHCs and FQHCs in their models of care and
payment structures, we believe that the direct supervision requirement
for services furnished by auxiliary staff is appropriate for RHCs and
FQHCs, but that we would consider changing this in future rulemaking if
RHCs and FQHCs find that requiring direct supervision presents a
barrier to furnishing CCM services.
Since payment for CCM in RHCs and FQHCs began on January 1, 2016,
some RHCs and FQHCs have informed us that, in their view, the direct
supervision requirement for auxiliary
[[Page 46378]]
staff has limited their ability to furnish CCM services. Specifically,
these RHCs and FQHCs have stated that the direct supervision
requirement has prevented them from entering into contracts with third
party companies to provide CCM services, especially during hours that
they are not open, and that they are unable to meet the CCM
requirements within their current staffing and budget constraints.
To bill for CCM services, RHCs and FQHCs must ensure that there is
access to care management services on a 24 hour a day, 7 day a week
basis. This includes providing the patient with a means to make timely
contact with RHC or FQHC practitioners who have access to the patient's
electronic care plan to address his or her urgent chronic care needs.
The RHC or FQHC must ensure the care plan is available electronically
at all times to anyone within the RHC or FQHC who is providing CCM
services.
Once the RHC or FQHC practitioner has initiated CCM services and
the patient has consented to receiving this service, CCM services can
be furnished by a RHC or FQHC practitioner, or by auxiliary personnel,
as defined in Sec. 410.26(a)(1), which includes nurses, medical
assistants, and other staff working under physician supervision who
meet the requirements to provide incident to services. Auxiliary
personnel in RHCs and FQHCs must furnish services under direct
supervision, which requires that a RHC or FQHC practitioner be present
in the RHC or FQHC and immediately available to furnish assistance and
direction. The RHC or FQHC practitioner does not need to be present in
the room when the service is furnished.
Although many RHCs and FQHCs prefer to furnish CCM and TCM services
utilizing existing staff, some RHCs and FQHCs would like to contract
with a third party to furnish aspects of their CCM and TCM services,
but cannot do so because of the direct supervision requirement. Without
the ability to contract with a third party, these RHCs and FQHCs have
stated that they find it difficult to meet the CCM requirements for 24
hours a day, 7 days a week access to services.
To enable RHCs and FQHCs to effectively contract with third parties
to furnish aspects of CCM and TCM services, we propose to revise Sec.
405.2413(a)(5) and Sec. 405.2415(a)(5) to state that services and
supplies furnished incident to TCM and CCM services can be furnished
under general supervision of a RHC or FQHC practitioner. The proposed
exception to the direct supervision requirement would apply only to
auxiliary personnel furnishing TCM or CCM incident to services, and
would not apply to any other RHC or FQHC services. The proposed
revisions for CCM and TCM services and supplies furnished by RHCs and
FQHCs are consistent with Sec. 410.26(b)(5), which allows CCM and TCM
services and supplies to be furnished by clinical staff under general
supervision when billed under the PFS.
B. FQHC-Specific Market Basket
1. Background
Section 10501(i)(3)(A) of the Affordable Care Act (Pub. L. 111-148
and Pub. L. 111-152) added section 1834(o) of the Act to establish a
payment system for the costs of FQHC services under Medicare Part B
based on prospectively set rates. In the Prospective Payment System
(PPS) for FQHC Final Rule published in the May 2, 2014 Federal Register
(79 FR 25436), we implemented a methodology and payment rates for the
FQHC PPS. The FQHC PPS base payment rate was determined using FQHC cost
report and claims data and was effective for FQHC payments from October
1, 2014, through December 31, 2015 (implementation year). The adjusted
base payment rate for the implementation year was $158.85 (79 FR
25455). When calculating the FQHC PPS payment, the base payment rate is
multiplied by the FQHC geographic adjustment factor (GAF) based on the
location of the FQHC, and adjusted for new patients or when an initial
preventive physical examination or annual wellness visit are furnished.
Beginning on October 1, 2014, FQHCs began to transition to the FQHC PPS
based on their cost reporting periods. As of January 1, 2016, all FQHCs
are paid under the FQHC PPS.
Section 1834(o)(2)(B)(ii) of the Act requires that the payment for
the first year after the implementation year be increased by the
percentage increase in the MEI. Therefore, in CY 2016, the FQHC PPS
base payment rate was increased by the MEI. The MEI was based on 2006
data from the American Medical Association (AMA) for self-employed
physicians and was used in the PFS Sustainable Growth Rate (SGR)
formula to determine the conversion factor for physician service
payments. (See the CY 2014 PFS final rule (78 FR 74264) for a complete
discussion of the 2006-based MEI). Section 1834(o)(2)(B)(ii) of the Act
also requires that beginning in CY 2017, the FQHC PPS base payment rate
will be increased by the percentage increase in a market basket of FQHC
goods and services, or if such an index is not available, by the
percentage increase in the MEI.
For CY 2017, we are proposing to create a 2013-based FQHC market
basket. The proposed market basket uses Medicare cost report (MCR) data
submitted by freestanding FQHCs. In the following discussion, we
provide an overview of the proposed market basket and describe the
methodologies used to determine the cost categories, cost weights, and
price proxies. In addition, we compare the growth rates of the proposed
FQHC market basket to the growth rates of the MEI.
2. Overview of the FQHC Market Basket
The 2013-based FQHC market basket is a fixed-weight, Laspeyres-type
price index. A Laspeyres price index measures the change in price, over
time, of the same mix of goods and services purchased in the base
period. Any changes in the quantity or mix of goods and services (that
is, intensity) purchased over time relative to a base period are not
measured.
The index itself is constructed in three steps. First, a base
period is selected (in this proposed rule, the base period is CY 2013),
total base period costs are estimated for a set of mutually exclusive
and exhaustive cost categories, and the proportion of total costs that
each cost category represents is calculated. These proportions are
called cost weights. Second, each cost category is matched to an
appropriate price or wage variable, referred to as a price proxy. These
price proxies are derived from publicly available statistical series
that are published on a consistent schedule (preferably at least on a
quarterly basis). Finally, the cost weight for each cost category is
multiplied by the established price proxy index level. The sum of these
products (that is, the cost weights multiplied by their price levels)
for all cost categories yields the composite index level of the market
basket for the given time period. Repeating this step for other periods
produces a series of market basket levels over time. Dividing the
composite index level of one period by the composite index level for an
earlier period produces a rate of growth in the input price index over
that timeframe.
As previously noted, the market basket is described as a fixed-
weight index because it represents the change in price over time of a
constant mix (quantity and intensity) of goods and services needed to
furnish FQHC services. The effects on total costs resulting from
changes in the mix of goods and services purchased subsequent to the
base period are not
[[Page 46379]]
measured. For example, a FQHC hiring more nurses to accommodate the
needs of patients would increase the volume of goods and services
purchased by the FQHC, but would not be factored into the price change
measured by a fixed-weight FQHC market basket. Only when the index is
rebased would changes in the quantity and intensity be captured, with
those changes being reflected in the cost weights. Therefore, we rebase
the market baskets periodically so that the cost weights reflect a
current mix of goods and services purchased (FQHC inputs) to furnish
FQHC services.
3. Creating a FQHC Market Basket
In 2015, we began researching the possibility of creating a FQHC
market basket that would be used in place of the MEI to update the FQHC
PPS base payment rate annually. An FQHC market basket should reflect
the cost structures of FQHCs while the MEI reflects the cost structures
of self-employed physician offices. At the time of implementation of
the FQHC PPS, a FQHC market basket had not been developed, and
therefore, the law stipulated that the FQHC PPS base payment rate be
updated by the MEI for the first year after implementation (CY 2016).
In subsequent years, the FQHC PPS base payment rate should be annually
updated by a FQHC market basket, if available.
The MEI cost weights were derived from data collected by the AMA on
the Physician Practice Expense Information Survey (PPIS), since
physicians, unlike other Medicare providers, are not required to
complete and submit a Medicare Cost Report. FQHCs submit expense data
annually on the Medicare Cost Report form CMS-222-92 (OMB No: 0938-
0107), ``Independent Rural Health Clinic and Freestanding Federally
Qualified Health Center Cost Report''; therefore, we were able to
estimate relative cost weights specific to FQHCs. We define a ``major
cost weight'' as one calculated using the Medicare cost reports (for
example, FQHC practitioner compensation). However, the Medicare cost
report data allows multiple methods for reporting detailed expenses,
either in detailed cost center lines or more broadly reported in
general categories of expenses. An alternative data source is used to
disaggregate further residual costs that could not be classified into a
major cost category directly using only the Medicare Cost Report data.
We estimated the cost weights for each year 2009 through 2013 and found
the cost weights from each year to be similar, which provided
confidence in the derived cost weights.
In summary, our research over the past year allowed us to evaluate
the appropriateness of using freestanding FQHC Medicare cost report
data to calculate the major cost weights for a FQHC market basket. We
believe that the proposed methodologies described below create a FQHC
market basket that reflects the cost structure of FQHCs. Therefore, we
believe that the use of this proposed 2013-based FQHC market basket to
update FQHC PPS base payment rate would more accurately reflect the
actual costs and scope of services that FQHCs furnish compared to the
2006-based MEI.
4. Development of Cost Categories and Cost Weights for the Proposed
2013-Based FQHC Market Basket
a. Use of Medicare Cost Report Data
The proposed 2013-based FQHC market basket consists of eight major
cost categories, which were derived from the CY 2013 Medicare cost
reports for freestanding FQHCs. These categories are FQHC-Practitioner
Compensation, Other Clinical Compensation, Non-Health Compensation,
Fringe Benefits, Pharmaceuticals, Fixed Capital, Moveable Capital, and
an All Other (Residual) cost category. The All Other (Residual) cost
category reflects the costs not captured in the other seven cost
categories. The CY 2013 Medicare cost reports include all FQHCs whose
cost reporting period began on or after January 1, 2013, and prior to
or on December 31, 2013. We selected CY 2013 as the base year because
the Medicare cost reports for that year were the most recent, complete
set of Medicare cost report data available for FQHCs at the time of
development of the cost share weights and proposed 2013-based FQHC
market basket. As stated above, we compared the cost share weights from
the MCR for CY 2009 through CY 2013 and the CY 2013 weights were
consistent with the weights from prior years.
We began with all FQHCs with reporting periods in CY 2013 (that is,
between and including January 1, 2013, and December 31, 2013). We then
excluded FQHCs missing ``total costs'' (that is, any FQHC that did not
report expenses on Worksheet A, Column 7, Line 62). This edit removed
83 providers from our analysis. Next, we compared the total Medicare
allowable costs (that is, total costs eligible for reimbursement under
the FQHC PPS) to total costs reported on the Medicare cost report. We
kept FQHCs whose Medicare-allowable costs accounted for 60 percent or
more of total costs to remove FQHCs whose costs were primarily driven
by services not covered under the FQHC benefit. For example, FQHCs that
reported a majority of costs for dental services were excluded from the
sample. This edit removed 33 FQHCs from our analysis. We used the
remaining Medicare cost reports to calculate the costs for the eight
major cost categories (FQHC Practitioner Compensation, Other Clinical
Compensation, Non-Health Compensation, Fringe Benefits,
Pharmaceuticals, Fixed Capital, Moveable Capital, and All Other
(Residual) costs).
The resulting 2013-based FQHC market basket cost weights reflect
Medicare allowable costs. We propose to define Medicare allowable costs
for freestanding FQHC facilities as: Worksheet A, Columns 1 and 2, cost
centers lines 1 through 51 but excluding line 20, which is professional
liability insurance (PLI). We exclude PLI costs from the total Medicare
allowable costs because FQHCs that receive section 330 grant funds also
are eligible to apply for medical malpractice coverage under Federally
Supported Health Centers Assistance Act (FSHCAA) of 1992 (Pub. L. 102-
501) and FSHCAA of 1995 (Pub. L. 104-73 amending section 224 of the
Public Health Service Act). Below we derive the eight major cost
categories.
(1) FQHC Practitioner Compensation: A FQHC practitioner is defined
as one of the following occupations: Physicians, NPs, PAs, CNMs,
Clinical Psychologist (CPs), and Clinical Social Worker (CSWs). Under
certain conditions, a FQHC visit also may be provided by qualified
practitioners of outpatient DSMT and MNT when the FQHC meets the
relevant program requirements for provision of these services. FQHC
Practitioner Compensation costs are derived as the sum of compensation
and other costs as reported on Worksheet A; columns 1 and 2; lines 1,
2, 3, 6, 7, 13, 14. The Medicare cost reports also captures ``Other''
compensation costs (the sum of costs reported on Worksheet A; columns 1
and 2; lines 9, 10, 11, and 15). We allocate a portion of these
compensation costs to FQHC Practitioner compensation by multiplying
this amount by the ratio of FQHC Practitioner compensation costs to the
sum of FQHC Practitioner compensation costs and Other Clinical
compensation costs. We believe that the assumption of distributing the
costs proportionally is reasonable since there is no additional detail
on the specific occupations these compensation costs represent. We also
include a proportion of Fringe Benefit
[[Page 46380]]
costs as described in section III.B.1.a.iv of this proposed rule.
(2) Other Clinical Compensation: Other Clinical Compensation
includes any health-related clinical staff who does not fall under the
definition of a FQHC practitioner from paragraph (1) (FQHC Practitioner
Compensation). Other Clinical Compensation costs are derived as the sum
of compensation and other costs as reported on Worksheet A; columns 1
and 2; lines 4, 5, and 8. Similar to the FQHC Practitioner
compensation, we also allocate a proportion of the ``Other'' Clinical
compensation costs by multiplying this amount by the ratio of Other
Clinical Compensation costs to the sum of FQHC Practitioner
Compensation costs and Other Clinical compensation costs. Given the
ambiguity in the costs reported on these lines, we believe that the
assumption of distributing the costs proportionally is reasonable since
there is no additional detail on the specific occupations these
compensation costs represent. We also include a proportion of Fringe
Benefit costs as described in section III.B.1.a.iv of this proposed
rule.
(3) Non-Health Compensation: Non-Health Compensation includes
compensation costs for Office Staff, Housekeeping & Maintenance, and
Pharmacy. Non-Health Compensation costs are derived as the sum of
compensation costs as reported on Worksheet A; column 1 only for lines
32 and 51; and Worksheet A; both columns 1 and 2 for line 38. We only
use the costs from column 1 for housekeeping and maintenance and
pharmacy since we believe that there are considerable costs other than
compensation that could be reported for these categories. We use the
costs from both column 1 and column 2 for office salaries (line 38)
since only salaries or compensation should be reported on this line. We
also include a proportion of Fringe Benefit costs as described in
section III.B.1.a.iv of this proposed rule.
(4) Fringe Benefits: Worksheet A; columns 1 and 2; line 45 of the
Medicare cost report captures fringe benefits and payroll tax expenses.
We proposed to estimate the fringe benefit cost weight as the fringe
benefits costs divided by total Medicare allowable costs. We propose to
allocate the Fringe Benefits cost weight to the three compensation cost
categories (FQHC practitioner compensation, other clinical
compensation, and non-health compensation) based on their relative
proportions. The fringe benefits ratio is equal to the compensation
cost weight as a percent of the sum of the compensation cost weights
for all three types of workers. These allocation ratios are 46 percent,
14 percent, and 40 percent, respectively. Therefore, we propose to
allocate 46 percent of the fringe benefits cost weight to the FQHC
practitioner cost weight, 14 percent of the fringe benefits cost weight
to the clinical compensation cost weight, and 40 percent of the fringe
benefits cost weight to the non-health compensation cost weight. Table
28 shows the three compensation category cost weights after the fringe
benefit cost weight is allocated for the proposed 2013-based FQHC
market basket.
Table 28--Compensation Category Cost Weights After Fringe Benefits
Allocation
------------------------------------------------------------------------
Before fringe After fringe
Cost category benefits benefits
allocation (%) allocation (%)
------------------------------------------------------------------------
FQHC Practitioner Compensation.......... 26.8 31.8
Other Clinical Compensation............. 8.1 9.5
Non-Health Compensation................. 23.1 27.4
Fringe Benefits (distribute to comp).... 10.7 0.0
------------------------------------------------------------------------
We believe that distributing the fringe benefit expenses reported
on line 45 using the provider-specific compensation ratios is
reasonable.
(5) Pharmaceuticals: Drugs and biologicals that are not usually
self-administered, and certain Medicare-covered preventive injectable
drugs are paid incident to a FQHC visit. Therefore, pharmaceutical
costs include the non-compensation costs reported on Worksheet A,
column 2, for the pharmacy cost center (line 51). We note that
pharmaceutical costs are not included in the MEI since pharmaceutical
costs are paid outside of the PFS.
(6) Fixed Capital: Fixed capital costs are equal to the sum of
costs for rent, interest on mortgage loans, depreciation on buildings
and fixtures, and property tax as reported on Worksheet A; columns 1
and 2; lines 26, 28, 30, and 33.
(7) Moveable Capital: Moveable capital costs are equal to the sum
of costs for depreciation of medical equipment, office equipment, and
other equipment as reported on Worksheet A; column 1 and 2; lines 19,
31, and 39.
(8) All Other (Residual): After estimating the expenses for the
seven cost categories listed above, we summed all remaining costs
together for each FQHC to come up with All Other (Residual) costs. The
costs included in the All Other (Residual) category include all costs
reported for medical supplies, transportation, allowable GME pass
through costs, facility insurance, utilities, office supplies, legal,
accounting, administrative insurance, telephone, housekeeping &
maintenance, nondescript healthcare costs, nondescript facility costs,
and nondescript administrative costs.
Although a cost weight for these categories could be obtained
directly from the costs reported in that cost center's respective line
on the cost report form, some FQHCs reported significant costs in other
(specify), or ``free form,'' lines which made it difficult to determine
the accuracy of these costs. For example, some FQHCs reported costs
only in the free form lines and not in the cost center specific lines,
while other FQHCs reported costs in both the cost center specific lines
and the free form lines. Since a majority of FQHCs used the free form
lines, relying solely on the costs reported in the cost center specific
lines for costs could lead to an inaccurate cost weights in the market
basket. For example, if a FQHC reported all other healthcare costs in
line 21 rather than breaking the healthcare costs into the detailed
cost centers (lines 17 through 20.50), then the cost weight for medical
supplies could be lower than it should be if we did not allocate the
costs reported in the free form lines to medical supplies.
Section III.B.1.b explains the method used to allocate the residual
costs to more detailed cost categories.
After we derived costs for the eight major cost categories for each
FQHC using the Medicare cost report data as previously described, we
addressed data outliers using the following steps. First,
[[Page 46381]]
we divided the costs for each of the eight categories by total Medicare
allowable costs for each FQHC. We then removed those FQHCs whose
derived cost weights fell in the top and bottom 5 percent of provider
specific derived cost weights. Five percent is the standard trim
applied for all CMS market basket cost weights. After these outliers
were removed, we summed the costs for each category across all
remaining FQHCs. We then divided this by the sum of total Medicare
allowable costs across all remaining FQHCs to obtain a cost weight for
the proposed 2013-based FQHC market basket for the given category. See
Table 29 for the resulting cost weights for these major cost categories
that we obtained from the Medicare cost reports.
Table 29--Major Cost Categories as Derived From Medicare Cost Reports
------------------------------------------------------------------------
2013 FQHC
Cost category weight (%)
------------------------------------------------------------------------
FQHC Practitioner Compensation.......................... 26.8
Other Clinical Compensation............................. 8.1
Non-Health Compensation................................. 23.1
Fringe Benefits (distribute to compensation)............ 10.7
Fixed Capital........................................... 4.5
Moveable Capital........................................ 1.7
Non Salary Pharmaceuticals.............................. 5.1
All Other (Residual).................................... 20.1
------------------------------------------------------------------------
Totals may not sum to 100.0% due to rounding.
b. Derivation of Detailed Cost Categories From the All Other (Residual)
Cost Weight
The All Other Residual cost weight was derived from summing all
expenses reported on the Medicare cost report Worksheet A, columns 1
and 2 for medical supplies (line 17), transportation (line 18),
allowable GME pass through costs (line 20.50), facility insurance (line
27), utilities (line 29), office supplies (line 40), legal (line 41),
accounting (line 42), administrative insurance (line 43), telephone
(line 44), non-compensation housekeeping & maintenance (line 32, column
2 only), nondescript healthcare costs (lines 21-23), nondescript
facility costs (lines 34-36), and nondescript administrative costs
(lines 54-56).
To further divide the ``All Other'' residual cost weight (20.1
percent) estimated from the CY 2013 Medicare cost report data into more
detailed cost categories, we propose to use the relative cost shares
from the 2006-based MEI for nine detailed cost categories: Utilities;
Miscellaneous Office Expenses; Telephone; Postage; Medical Equipment;
Medical Supplies; Professional, Scientific, & Technical Services;
Administrative & Facility Services; and Other Services. For example,
the Utilities cost represents 7 percent of the sum of the 2006-based
MEI ``All Other'' cost category weights; therefore, the Utilities cost
weight would represent 7 percent of the proposed 2013-based FQHC market
basket's ``All Other'' cost category (20.066 percent), yielding a
``final'' Utilities proposed cost weight of 1.4 percent in the proposed
2013-based LTCH market basket (7 percent * 20.1 percent = 1.4 percent).
Table 30 shows the cost weight for each matching category from the
2006-based MEI, the percent each cost category represents of the 2006-
based MEI ``All Other'' cost weight, and the resulting proposed 2013-
based FQHC market basket cost weights for detailed cost categories.
Table 30--Proposed Detailed FQHC Cost Category Weights
----------------------------------------------------------------------------------------------------------------
Percent of the
2006-based MEI 2006-based MEI Proposed 2013-
Proposed FQHC detailed cost categories cost weights ``All Other'' based FQHC
(%) cost weight detailed cost
(%) weights (%)
----------------------------------------------------------------------------------------------------------------
Total All Other (Residual)...................................... 17.976 100.000 20.1
Utilities....................................................... 1.266 7.0 1.4
Miscellaneous Office Expenses................................... 2.478 13.8 2.8
Telephone....................................................... 1.501 8.4 1.7
Postage......................................................... 0.898 5.0 1.0
Medical Equipment............................................... 1.978 11.0 2.2
Medical supplies................................................ 1.760 9.8 2.0
Professional, Scientific, & Tech. Services...................... 2.592 14.4 2.9
Administrative & Facility Services.............................. 3.052 17.0 3.4
Other Services.................................................. 2.451 13.6 2.7
----------------------------------------------------------------------------------------------------------------
FQHCs have liberty in how and where certain costs are reported on
the Medicare cost report form. We believe that, given the ambiguity in
how the data are reported for these overhead cost centers on the FQHC
cost report form, relying on the relative shares determined from the
MEI is reasonable. We hope that future cost data from the upcoming
revised FQHC cost report form will allow us to better estimate the
detailed cost weights for these categories directly. All FQHCs will
report costs on the new forms for cost report periods for CY 2016
expenses. For details regarding how the 2006-based MEI cost categories
were derived, see the CY 2011 PFS final rule with comment period (75 FR
73262 through 73267). The following is a description of the types of
expenses included in detailed cost categories derived from the All
Other (Residual) cost category:
Utilities: Includes expenses classified in the fuel, oil
and gas, water and sewage, and electricity industries. These types of
industries are classified in NAICS and include NAICS 2211 (Electric
power generation, transmission, and distribution), 2212 (Natural gas
distribution), and 2213 (Water, sewage, and other systems).
Miscellaneous Office Expense: Includes expenses for office
expenses not reported in other categories, miscellaneous expenses,
included but not limited to, paper (such as paper towels), printing
(such as toner for printers), miscellaneous chemicals (such as soap and
hand sanitizer).
Telephone: Includes expenses classified in NAICS 517
[[Page 46382]]
(Telecommunications) and NAICS 518 (Internet service providers), and
NAICS 515 (Cable and other subscription programming). Telephone
service, which is one component of the Telecommunications expenses,
accounts for the majority of the expenditures in this cost category.
Postage: Includes expenses classified in NAICS 491 (Postal
services) and NAICS 492 (Courier services).
Medical Equipment Expenses: Includes the expenses related
to maintenance contracts, and the leases or rental of medical equipment
used in diagnosis or treatment of patients. It would also include the
expenses for any medical equipment that was purchased in a single year
and not financed.
Medical Supplies Expenses: Includes the expenses related
to medical supplies such as sterile gloves, needles, bandages, specimen
containers, and catheters. We note that the Medical Supply cost
category does not include expenses related to pharmaceuticals (drugs
and biologicals).
Professional, Scientific, & Technical Services: Includes
the expenses for any professional services purchased from an outside
agency or party and could include fees including but not limited to,
legal, marketing, professional association memberships, licensure fees,
journal fees, continuing education.
Administrative & Facility Services: Includes the expenses
for any administrative and facility services purchased from an outside
agency or party and could include fees including but not limited to,
accounting, billing, office management services, security services,
transportation services, landscaping, or professional car upkeep.
Other Services: Includes other service expenses including,
but not limited to, nonresidential maintenance and repair, machinery
repair, janitorial, and security services.
Table 31 shows the proposed cost categories and weights for the
2013-based FQHC market basket. The resulting cost weights include
combining the cost weights derived from the Medicare Cost Report Data
(shown in Table 29), distributing the fringe benefits weight across the
three compensation cost categories (shown in Table 28), and
disaggregating the residual cost weight into detailed cost categories
(shown in Table 30). Additionally, we compare the cost weights of the
proposed 2013-based FQHC market basket to the cost weights in the 2006-
based MEI, where we have grouped the cost weights from the MEI to align
with the FQHC proposed cost categories.
Table 31--Proposed FQHC Market Basket and MEI, Cost Categories, Cost Weights
----------------------------------------------------------------------------------------------------------------
2013 FQHC 2006 MEI
FQHC cost category weight weight MEI cost category
(percent) (percent)
----------------------------------------------------------------------------------------------------------------
FQHC Market Basket............................ 100.0 100.000 MEI.
Total Compensation........................ 68.7 67.419 Total Compensation.
FQHC Practitioner Compensation........ 31.7 50.866 Physician Compensation.
Other Clinical Compensation........... 9.5 6.503 Other Clinical
Compensation.
Non-health Compensation............... 27.4 10.050 Non-health Compensation.
All Other Products........................ 16.1 14.176 All Other Products.
Utilities............................. 1.4 1.266 Utilities.
Miscellaneous Office Expenses......... 2.8 2.478 Miscellaneous Office
Expenses.
Telephone............................. 1.7 1.501 Telephone.
Postage............................... 1.0 0.898 Postage.
Medical Equipment..................... 2.2 1.978 Medical Equipment.
Medical Supplies...................... 2.0 1.760 Medical Supplies.
Professional Liability Insurance...... .............. 4.295 Professional Liability
Insurance.
Pharmaceuticals....................... 5.1 .............. Pharmaceuticals.
All Other Services..................... 9.0 8.095 All Other Services.
Professional, Scientific & Technical 2.9 2.592 Professional, Scientific &
Services. Technical Services.
Administrative & Facility Services.... 3.4 3.052 Administrative & Facility
Services.
Other Services........................ 2.7 2.451 Other Services.
Capital................................... 6.1 10.310 Capital.
Fixed Capital......................... 4.5 8.957 Fixed Capital.
Moveable Capital...................... 1.7 1.353 Moveable Capital.
----------------------------------------------------------------------------------------------------------------
Although the overall cost structure of the MEI, the index currently
used to update the FQHC PPS base payment, is similar to the proposed
FQHC cost structure, there are a few key differences.
First, though total compensation costs in the proposed FQHC market
basket and the MEI are each approximately 67-68 percent of total costs,
non-health compensation accounts for a larger share of compensation
costs in the FQHC setting than in the self-employed physician office.
Likewise, physician compensation accounts for a larger percentage of
costs in the MEI than FQHC practitioner compensation accounts for in
the proposed FQHC market basket.
Second, the proposed FQHC market basket includes a cost category
for pharmaceuticals, while drug costs are excluded from the MEI. Drug
costs are an expense in the FQHC PPS base payment rate since drugs and
biologicals that are not usually self-administered, and certain
Medicare-covered preventive injectable drugs are paid incident to a
visit while drug costs are reimbursed separately under the PFS.
Third, as mentioned previously, PLI expenditures are excluded from
the proposed FQHC market basket since most FQHCs PLI costs are covered
under the Federal Tort Claims Act, while in the MEI the PLI costs are a
significant expense for self-employed physicians. Finally, fixed
capital expenses, which include costs such as office rent and
depreciation, are about half of the share in the FQHC market basket as
they are in the MEI.
c. Selection of Price Proxies for the Proposed 2013-Based FQHC Market
Basket
After establishing the 2013 cost weights for the proposed FQHC
market basket, an appropriate price proxy was selected for each cost
category. The proposed price proxies are chosen from a set of publicly
available price indexes
[[Page 46383]]
that best reflect the rate of price change for each cost category in
the FQHC market basket. All of the proxies for the proposed 2013-based
FQHC market basket are based on indexes published by the Bureau of
Labor Statistics (BLS) and are grouped into one of the following BLS
categories:
Producer Price Indexes: Producer Price Indexes (PPIs)
measure price changes for goods sold in markets other than the retail
market. PPIs are preferable price proxies for goods and services that
businesses purchase as inputs. For example, we are proposing to use a
PPI for prescription drugs, rather than the Consumer Price Index (CPI)
for prescription drugs, because healthcare providers generally purchase
drugs directly from a wholesaler. The PPIs that we are proposing to use
measure price changes at the final stage of production.
Consumer Price Indexes: CPIs measure change in the prices
of final goods and services bought by the typical consumer. Because
they may not represent the price encountered by a producer, we are
proposing to use CPIs only if an appropriate PPI is not available, or
if the expenditures are more like those faced by retail consumers in
general rather than by purchasers of goods at the wholesale level.
Employment Cost Indexes: Employment Cost Indexes (ECIs)
measure the rate of change in employee wage rates and employer costs
for employee benefits per hour worked. These indexes are fixed-weight
indexes and strictly measure the change in wage rates and employee
benefits per hour. Appropriately, they are not affected by shifts in
employment mix.
We evaluate the price proxies using the criteria of reliability,
timeliness, availability, and relevance. Reliability indicates that the
index is based on valid statistical methods and has low sampling
variability. Timeliness implies that the proxy is published regularly,
preferably at least once a quarter. Availability means that the proxy
is publicly available. Finally, relevance means that the proxy is
applicable and representative of the cost category weight to which it
is applied. We believe the proposed PPIs, CPIs, and ECIs selected meet
these criteria.
Table 32 lists all price proxies that we are proposing to use for
the 2013-based FQHC market basket. Below is a detailed explanation of
the price proxies that we are proposing for each cost category weight.
We note that many of the proxies that we are proposing for the 2013-
based FQHC market basket are the same as those used for the 2006-based
MEI.
(1) FQHC Practitioner Compensation: We are proposing to use the ECI
for Total Compensation for Private Industry Workers in Professional and
Related) (BLS series code CIU2010000120000I) to measure price growth of
this category. There is no specific ECI for physicians and, therefore,
similar to the MEI, we are proposing to use an index that is based on
professionals that receive advanced training. We note that the 2006-
based MEI has a separate cost category for Physician Wages and Salaries
and Physician Benefits. For these cost categories, the MEI uses the ECI
for Wages and Salaries and ECI for Benefits for Professional and
Related Occupations.
(2) Other Clinical Compensation: We are proposing to use the ECI
for Total Compensation for all Civilian Workers in Health Care and
Social Assistance (BLS series code CIU1016200000000I) to measure the
price growth of this cost category. This cost category consists of
compensation costs for Nurses, Laboratory Technicians, and all other
health staff not included in the FQHC practitioner compensation
category. Based on the clinical composition of these workers, we
believe that the ECI for health-related workers is an appropriate proxy
to measure compensation price pressures for these workers. The MEI uses
the ECI for Wages and Salaries and benefits for Hospitals.
(3) Non-Health Compensation: We are proposing to use the ECI for
Total Compensation for Private Industry Workers in Office and
Administrative Support (BLS series code CIU2010000220000I) to measure
the price growth of this cost category. The Non-health compensation
cost weight is predominately attributable to administrative and
facility type occupations, as reported in the data from the Medicare
cost reports. We note the MEI has a composite index of four price
proxies, with the majority of the composite index accounted for by
administrative occupations, proxied by the ECI for Wages & Salaries of
Office and Administrative Support (Private).
(4) Utilities: We are proposing to use the CPI for Fuel and
Utilities (BLS series code CUUR0000SAH2) to measure the price growth of
this cost category. This is the same proxy used in the 2006-based MEI.
(5) Miscellaneous Office Expenses: We are proposing to use the CPI
for All Items Less Food and Energy (BLS series code CUUR0000SA0L1E) to
measure the price growth of this cost category. We believe that using
the CPI for All Items Less Food and Energy avoids double counting of
changes in food and energy prices already captured elsewhere in the
market basket. We note the MEI does not have a separate cost category
for miscellaneous office expenses.
(6) Telephone Services: We are proposing to use the CPI for
Telephone Services (BLS series code CUUR0000SEED) to measure the price
growth of this cost category. This is the same price proxy used in the
2006-based MEI.
(7) Postage: We are proposing to use the CPI for Postage (BLS
series code CUUR0000SEEC01) to measure the price growth of this cost
category. This is the same proxy used in the 2006-based MEI.
(8) Medical Equipment: We are proposing to use the PPI Commodities
for Surgical and Medical Instruments (BLS series code WPU1562) as the
price proxy for this category. This is the same proxy used in the
current 2006-based MEI.
(9) Medical Supplies: We are proposing to use a 50/50 blended index
comprised of the PPI Commodities for Medical and Surgical Appliances
and Supplies (BLS series code WPU156301) and the CPI-U for Medical
Equipment and Supplies (BLS series code CUUR0000SEMG). The 50/50 blend
is used in all market baskets where we do not have an accurate split
available. We believe FQHCs purchase the types of supplies contained
within these proxies, including such items as bandages, dressings,
catheters, intravenous equipment, syringes, and other general
disposable medical supplies, via wholesale purchase, as well as at the
retail level. Consequently, we are proposing to combine the two
aforementioned indexes to reflect those modes of purchase. This is the
same proxy used in the 2006-based MEI.
(10) Pharmaceuticals: We are proposing to use the PPI Commodities
for Pharmaceuticals for Human Use, Prescription (BLS series code
WPUSI07003) to measure the price growth of this cost category. We note
the MEI does not have a separate cost category for Pharmaceuticals.
This price proxy is used to measure prices of Pharmaceuticals in other
CMS market baskets, such as 2010-based Inpatient Prospective Payment
System and 2010-based Skilled Nursing Facility market baskets.
(11) Professional, Scientific, & Technical Services: We are
proposing to use the ECI for Total Compensation for Private Industry
Workers in Professional, Scientific, and Technical Services (BLS series
code CIU2015400000000I) to measure the price growth of this cost
category. This
[[Page 46384]]
is the same proxy used in the 2006-based MEI.
(12) Administrative & Facility Services: We are proposing to use
the ECI Total Compensation for Private Industry Workers in Office and
Administrative Support (BLS series code CIU2010000220000I) to measure
the price growth of this cost category. This is the same price proxy
used in the 2006-based MEI.
(13) Other Services: We are proposing to use the ECI for Total
Compensation for Private Industry Workers in Service Occupations (BLS
series code CIU2010000300000I) to measure the price growth of this cost
category. This is the same price proxy used in the 2006-based MEI.
(14) Fixed Capital: We are proposing to use the PPI Industry for
Lessors of Nonresidential Buildings (BLS series code PCU531120531120)
to measure the price growth of this cost category. This is the same
price proxy used in the 2006-based MEI. We believe this is an
appropriate proxy since fixed capital expenses in FQHCs should reflect
inflation for the rental and purchase of business office space.
(15) Moveable Capital: We are proposing to use the PPI Commodities
for Machinery and Equipment (series code WPU11) to measure the price
growth of this cost category as this cost category represents
nonmedical moveable equipment. This is the same proxy used in the 2006-
based MEI.
Table 32 lists the proposed price proxies for each cost category in
the proposed FQHC market basket.
Table 32--Proposed Cost Categories and Price Proxies for the FQHC Market
Basket
------------------------------------------------------------------------
Cost category FQHC price proxies
------------------------------------------------------------------------
FQHC Practitioner Compensation......... ECI--for Total Compensation for
Private Industry Workers in
Professional and Related.
Other Clinical Compensation............ ECI--for Total Compensation for
all Civilian Workers in Health
Care and Social Assistance.
Non-health Compensation................ ECI--for Total Compensation for
Private Industry Workers in
Office and Administrative
Support.
Utilities.............................. CPI-U for Fuels and Utilities.
Miscellaneous Office Expense........... CPI-U for All Items Less Food
And Energy.
Telephone.............................. CPI-U for Telephone.
Postage................................ CP-U for Postage.
Medical Equipment...................... PPI Commodities for Surgical
and Medical Instruments.
Medical supplies....................... Blend: PPI Commodities for
Medical and Surgical
Appliances and Supplies and
CPI for Medical Equipment and
Supplies.
Pharmaceuticals........................ PPI Commodities for
Pharmaceuticals for Human Use,
Prescription.
Professional, Scientific, and Technical ECI--for Total Compensation for
Services. Private Industry Workers in
Professional, Scientific, and
Technical Services.
Administrative & Facility Services..... ECI--for Total Compensation for
Private Industry Workers in
Office and Administrative
Support.
Other Services......................... ECI--for Total compensation for
Private industry workers in
Service Occupations.
Fixed Capital.......................... PPI Industry--for Lessors of
nonresidential buildings.
Moveable Capital....................... PPI Commodities--for Machinery
and Equipment.
------------------------------------------------------------------------
d. Inclusion of Multi-Factor Productivity in the Proposed FQHC Market
Basket
Section 1834(o)(2)(B)(ii) of the Act describes the methods for
determining updates to FQHC PPS payment. After the first year of
implementation, the FQHC PPS base payment rate must be increased by the
percentage increase in the MEI. In subsequent years, the FQHC PPS base
payment rate shall be increased by the percentage increase in a market
basket of FQHC goods and services as established through regulations
or, if not available, the MEI published in the PFS final rule.
The MEI published in the PFS final rule has a productivity
adjustment. The MEI has been adjusted for changes in productivity since
its inception. In the CY 2003 PFS final rule with comment period (67 FR
80019), we implemented a change in the way the MEI was adjusted to
account for changes in productivity. The MEI used for the 2003
physician payment update incorporated changes in the 10-year moving
average of private nonfarm business (economy-wide) multifactor
productivity. Previously, the index incorporated changes in
productivity by adjusting the labor portions of the index by the 10-
year moving average of private nonfarm business (economy-wide) labor
productivity.
In 2012, we convened the MEI Technical Panel to review all aspects
of the MEI including inputs, input weights, price-measurement proxies,
and productivity adjustment. For more information regarding the MEI
Technical Panel, see the CY 2014 PFS final rule with comment period (78
FR 74264). The MEI Technical Panel was asked to review the approach of
adjusting the MEI by the 10-year moving average of private nonfarm
business productivity. As described in the CY 2014 PFS final rule with
comment period (78 FR 74271), the MEI Technical Panel concluded in
Finding 5.1 that ``such an adjustment continues to be appropriate. This
adjustment prevents `double counting' of the effects of productivity
improvements, which would otherwise be reflected in both (i) the
increase in compensation and other input price proxies underlying the
MEI, and (ii) the growth in the number of physician services performed
per unit of input resources, which results from advances in
productivity by individual physician practices.''
We are proposing to include a productivity adjustment similar to
the MEI in the proposed FQHC market basket. We believe that applying a
productivity adjustment is appropriate because this would be consistent
with the MEI, which has an embedded productivity adjustment. We note
that the MEI Technical Panel concluded that a productivity adjustment
is appropriate for the MEI given the type of services performed in
physician's offices. Specifically, the MEI Technical Panel report
states that ``The input price increases within the MEI are reflected in
the price proxies, such as changes in wages and benefits. Wages
increase, in part, due to the ability of workers to increase the amount
of output per unit of input. Absent a productivity
[[Page 46385]]
adjustment in the MEI, physicians would be receiving increased payments
resulting both from their ability to increase their individual outputs
and from the productivity gains already reflected in the wage proxies
used in the index. The productivity adjustment used in the MEI ensures
the productivity gains reflected in increased outputs are not double
counted, or paid for twice. Currently, the productivity adjustment in
the MEI is based on changes in economy-wide productivity based on the
rationale that the price proxy for physician income reflects changes in
economy-wide wages. Implicitly, this assumes physicians can achieve the
same level of productivity as the average general wage earner.'' We
believe that the services performed in FQHC facilities are similar to
those covered by the MEI, and therefore, a productivity adjustment is
appropriate to avoid double counting of the effects of productivity
improvements.
We propose to use the most recent estimate of the 10-year moving
average of changes in annual private nonfarm business (economy-wide)
multifactor productivity (MFP), which is the same measure of MFP used
in the MEI. The BLS publishes the official measure of private nonfarm
business MFP. (See https://www.bls.gov/mfp for the published BLS
historical MFP data). For the final FQHC market basket update, we
propose to use the most recent historical estimate of annual MFP as
published by the BLS. Generally, the most recent historical MFP
estimate is lagged two years from the payment year. Therefore, we
propose to use the 2015 MFP as published by BLS in the CY2017 FQHC
market basket update.
We note that MFP is derived by subtracting the contribution of
labor and capital input growth from output growth. Since at the time of
the proposed rule the 2015 MFP has not been published by BLS, we rely
on a projection of MFP. The projection of MFP is currently produced by
IHS Global Insight (IGI), a national economic forecasting firm with
which CMS contracts to forecast the components of the market basket and
MFP. A complete description of the MFP projection methodology is
available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MedicareProgramRatesStats/MarketBasketResearch.html.
Using IGI's first quarter 2016 forecast, the productivity
adjustment for CY 2017 (the 10-year moving average of MFP for the
period ending CY 2015) is projected to be 0.4 percent. If more recent
data are subsequently available (for example, a more recent estimate of
the market basket and MFP adjustment), we would use such data to
determine the CY 2017 increase in the proposed FQHC market basket in
the final rule.
5. CY 2017 Proposed Market Basket Update: Proposed CY 2017 FQHC Market
Basket Update Compared to the MEI Update for CY 2017
For CY 2017, we are proposing to use the proposed 2013-based FQHC
market basket increase factor to update the FQHC PPS base payment rate.
Consistent with CMS practice, we estimated the market basket update for
the FQHC PPS based on the most recent forecast from IGI. Identical to
the MEI, we are proposing to use the update based on the most recent
historical data available at the time of publication of the final rule.
For example, the final CY 2017 FQHC update would be based on the four-
quarter moving-average percent change of the FQHC market basket through
the second quarter of 2016 (based on the final rule's statutory
publication schedule). For the proposed rule, we do not have the second
quarter of 2016 historical data and, therefore, we will use the most
recent projection available.
Based on IGI's first quarter 2016 forecast with historical data
through the fourth quarter of 2015, the projected proposed FQHC market
basket increase factor for CY 2017 would be 1.7 percent. This reflects
a 2.1-percent increase of FQHC input prices and a 0.4-percent
adjustment for productivity. We are also proposing that if more recent
data are subsequently available (for example, a more recent estimate of
the market basket or MFP) we would use such data, to determine the CY
2017 update in the final rule.
For comparison, the 2006-based MEI is projected to be 1.3 percent
in CY 2017; this estimate is based on IGI's first quarter 2016 forecast
(with historical data through the fourth quarter of 2015). Table 33
compares the proposed 2013-based FQHC market basket updates and the
2006-based MEI market basket updates for CY 2017.
Table 33--FQHC Market Basket and MEI, Cost Categories, Cost Weights, MFP, and CY 2017 Update
----------------------------------------------------------------------------------------------------------------
CY 2017 Update
FQHC cost category -------------------------------- MEI cost category
(percent) (percent)
----------------------------------------------------------------------------------------------------------------
FQHC Market Basket............................ 1.7 1.3 MEI.
Productivity adjustment....................... 0.4 0.4 Productivity adjustment.
FQHC Market Basket (unadjusted)............... 2.1 1.7 MEI (unadjusted).
Total Compensation........................ 2.1 2.0 Total Compensation.
FQHC Practitioner Comp................ 1.9 2.0 Physician Compensation.
Other Clinical Compensation........... 1.9 2.0 Other Clinical
Compensation.
Non-health Compensation............... 2.4 2.4 Non-health Compensation.
All Other Products........................ 2.6 -0.6 All Other Products.
Utilities............................. -3.9 -3.9 Utilities.
Miscellaneous Office Expenses......... 2.0 -1.7 Miscellaneous Office
Expenses.
Telephone............................. 0.4 0.4 Telephone.
Postage............................... 0.3 0.3 Postage.
Medical Equipment..................... 1.2 1.2 Medical Equipment.
Medical Supplies...................... -0.4 -0.4 Medical Supplies.
Professional Liability Insurance...... .............. -0.4 Professional Liability
Insurance.
Pharmaceuticals....................... 7.8 .............. Pharmaceuticals.
All Other Services........................ 2.0 2.0 All Other Services.
Professional, Scientific & Technical 1.5 1.5 Professional, Scientific &
Services. Technical Services.
Administrative & Facility Services.... 2.4 2.4 Administrative & Facility
Services.
Other Services........................ 1.9 1.9 Other Services.
Capital................................... 1.6 1.9 Capital.
Fixed Capital......................... 2.1 2.1 Fixed Capital.
Moveable Capital...................... 0.1 0.1 Moveable Capital.
----------------------------------------------------------------------------------------------------------------
[[Page 46386]]
For CY 2017, the proposed 2013-based FQHC market basket update (1.7
percent) is 0.4 percent higher than the 2006-based MEI (1.3 percent).
The 0.4 percentage point difference stems mostly from the inclusion of
pharmaceuticals in the proposed FQHC market basket. Prices for
pharmaceuticals are projected to grow 7.8 percent, faster than the
other components in the market basket. This cost category and
associated price pressures are not included in the MEI.
We propose to update the FQHC PPS base payment rate by 1.7 percent
for CY 2017 based on the proposed 2013-based FQHC market basket. The
proposed FQHC market basket would more accurately reflect the actual
costs and scope of services that FQHCs furnish compared to the 2006-
based MEI. We invite public comment on all aspects of the FQHC market
basket proposals.
C. Appropriate Use Criteria for Advanced Diagnostic Imaging Services
Section 218(b) of the PAMA amended Title XVIII of the Act to add
section 1834(q) of the Act directing us to establish a program to
promote the use of appropriate use criteria (AUC) for advanced
diagnostic imaging services. The CY 2016 PFS final rule with comment
period addressed the initial component of the new Medicare AUC program,
specifying applicable AUC. In that rule we established evidence-based
process and transparency requirements for the development of AUC,
defined provider-led entities (PLEs) and established the process by
which PLEs may become qualified to develop, modify or endorse AUC. The
first list of qualified PLEs are expected to be posted on the CMS Web
site by the end of June 2016 at which time their AUC libraries will be
considered to be specified AUC for purposes of section 1834(q)(2)(A) of
the Act.
This rule proposes requirements and processes for specification of
qualified clinical decision support mechanisms (CDSMs) under the
Medicare AUC program; the initial list of priority clinical areas; and
exceptions to the requirement that ordering professionals consult
specified applicable AUC when ordering applicable imaging services.
1. Background
AUC present information in a manner that links: A specific clinical
condition or presentation; one or more services; and, an assessment of
the appropriateness of the service(s). For purposes of this program,
AUC are a set or library of individual appropriate use criteria. Each
individual criterion is an evidence-based guideline for a particular
clinical scenario. Each scenario in turn starts with a patient's
presenting symptoms and/or condition. Evidence-based AUC for imaging
can assist clinicians in selecting the imaging study that is most
likely to improve health outcomes for patients based on their
individual clinical presentation.
AUC need to be integrated as seamlessly as possible into the
clinical workflow. CDSMs are the electronic portals through which
clinicians would access the AUC during the patient workup. While CDSMs
can be standalone applications that require direct entry of patient
information, they may be more effective when they automatically
incorporate information such as specific patient characteristics,
laboratory results, and lists of co-morbid diseases from Electronic
Health Records (EHRs) and other sources. Ideally, practitioners would
interact directly with the CDSM through their primary user interface,
thus minimizing interruption to the clinical workflow.
Consistent with definitions of CDSM by the Agency for Healthcare
Research and Quality (AHRQ) (https://www.ahrq.gov/professionals/prevention-chronic-care/decision/clinical/), and the Office
of the National Coordinator for Health Information Technology (ONC)
(https://www.healthit.gov/policy-researchers-implementers/clinical-decision-support-cds), within Health IT applications, a CDSM is a
functionality that provides persons involved in care processes with
general and person-specific information, intelligently filtered and
organized, at appropriate times, to enhance health and health care.
2. Previous CDSM Experience
In the CY 2016 PFS final rule with comment period, we included a
discussion of the Medicare Imaging Demonstration (MID), which was
required by section 135(b) of the MIPPA, in addition to independent
experiences of implementing AUC by several healthcare systems and
academic medical centers. Two key aspects of that discussion remain
relevant to the CDSM component of this program. First, AUC, and the
CDSMs through which clinicians access AUC, must be integrated into the
clinical workflow and facilitate, not obstruct, evidence-based care
delivery. For instance, a CDSM external to a provider's primary user
interface could utilize an application program interface (API), a set
of protocols and tools specifying how software components should
interact, to pull relevant information into the decision support
application. By adhering to common interoperability standards, such as
the national standards advanced through certified health IT (see 2015
edition of criteria available in the Federal Register (80 FR 62601) and
described in the Interoperability Standards Advisory at https://www.healthit.gov/standards-advisory), CDSMs could both ensure
integration of patient-specific data from EHRs, and allow clinicians to
optimize the time spent using the tool.
Second, the ideal AUC is an evidence-based guide that starts with a
patient's specific clinical condition or presentation (symptoms) and
assists the clinician in the overall patient workup, treatment, and
follow-up. Imaging would appear as key nodes within the clinical
management decision tree.
Other options outside of certified EHR technology exist to access
AUC through CDSMs. Stand-alone, internet-based CDSMs are available and,
although they will not interact with EHR data, can nonetheless search
for and present AUC relevant to a patient's presenting symptoms or
condition.
In communicating an appropriateness rating to the ordering
practitioner, some CDSMs provide a scale with numeric ratings, some
output a red, yellow, or green light while others provide a dichotomous
yes or no. At this time, we do not believe there is one correct
approach to communicating the level of appropriateness to the ordering
professional. However, section 1834(q)(4)(B) of the Act requires that
information be reported on the claim form as to whether the service
would or would not adhere to the specified AUC consulted through a
particular CDSM, or whether the AUC was not applicable to the service.
We are requesting feedback from commenters regarding how
appropriateness ratings provided by CDSMs could be interpreted and
recorded for the purposes of this program.
There are different views about the comprehensiveness of AUC that
should be accessible within CDSMs. Some stakeholders believe that the
CDSM should contain as comprehensive a collection of AUC as possible,
incorporating individual criteria from across all specified AUC
libraries. The intent would be for ordering professionals to avoid the
frustration, experienced and voiced by many clinicians participating in
the MID, of spending time navigating the CDSM only to find that no
criterion for their patient's specific clinical condition exists.
Other stakeholders believe, based on decades of experience rolling
out AUC in the context of robust quality improvement programs that it
is best to
[[Page 46387]]
start with a CDSM that contains AUC for a few clinical areas where
impact is large and evidence is strong. This would ensure that quality
AUC are developed, and that clinicians and entire care teams could
fully understand the AUC they are using, including when they do not
apply to a particular patient.
As we stated in the CY 2016 PFS final rule with comment period, we
believe there is merit to both approaches, and it has been suggested to
us that the best approach may depend on the particular care setting.
The second, ``focused'' approach may work better for a large health
system that produces and uses its own AUC. The first, ``comprehensive''
approach may in turn work better for a smaller practice with broad
image ordering patterns and fewer resources that wants to simply adopt
and start using a complete AUC system developed elsewhere. We believe a
successful program would allow flexibility, and under section 1834(q)
of the Act, we foresee a number of sets of AUC developed by different
PLEs, and an array of CDSMs from which clinicians may choose.
3. Priority Clinical Areas
We established in the CY 2016 PFS final rule with comment period
that we would identify priority clinical areas through rulemaking, and
that these may be used in the determination of outlier ordering
professionals (a future phase of the Medicare AUC program). The concept
of priority clinical areas allows us to implement an AUC program that
combines the focused and comprehensive approaches to implementation
discussed above. Although potentially large volumes of AUC (as some
PLEs have large libraries of AUC) would become specified across
clinical conditions and advanced imaging technologies, we believe this
rapid and comprehensive roll out of specified AUC should be balanced
with a more focused approach when identifying outlier ordering
professionals. We believe this will provide an opportunity for
physicians and practitioners to become familiar with AUC in identified
priority clinical areas prior to Medicare claims for those services
being part of the input for calculating outlier ordering professionals.
As we describe earlier, CDSMs are the access point for ordering
professionals to consult AUC. We believe the combination of the
comprehensive and focused approaches should be applied to CDSM
requirements as we consider a minimum floor of AUC that must be made
available to ordering professionals through qualified CDSMs. AUC that
reasonably address the entire clinical scope of priority clinical areas
could establish a minimum floor of AUC to be included in qualified
CDSMs, and the number of priority clinical areas could be expanded
through annual rulemaking and in consultation with physicians and other
stakeholders. This allows priority clinical areas to roll out
judiciously, and build over time.
4. Statutory Authority
Section 218(b) of the PAMA added a new section 1834(q) of the Act
entitled, ``Recognizing Appropriate Use Criteria for Certain Imaging
Services,'' which directs the Secretary to establish a new program to
promote the use of AUC. Section 1834(q)(3)(A) of the Act requires the
Secretary to specify qualified CDSMs that could be used by ordering
professionals to consult with specified applicable AUC for applicable
imaging services.
5. Discussion of Statutory Requirements
There are four major components of the AUC program under section
1834(q) of the Act, each with its own implementation date: (1)
Establishment of AUC by November 15, 2015 (section 1834(q)(2)); (2)
identification of mechanisms for consultation with AUC by April 1, 2016
(section 1834(q)(3)); (3) AUC consultation by ordering professionals
and reporting on AUC consultation by furnishing professionals by
January 1, 2017 (section 1834(q)(4)); and (4) annual identification of
outlier ordering professionals for services furnished after January 1,
2017 (section 1834(q)(5)). As we will discuss later in this preamble,
we did not identify mechanisms for consultation by April 1, 2016 and
will not have specified or published the list of qualified CDSMs by
January 1, 2017; therefore, ordering professionals will not be required
to consult CDSMs, and furnishing professionals will not be able to
report information on the consultation, by this date.
a. Establishment of AUC
In the CY 2016 PFS final rule with comment period, we addressed the
first component under section 1834(q)(2) of the Act--the requirements
and process for establishment and specification of applicable AUC,
along with relevant aspects of the definitions under section 1834(q)(1)
of the Act. This included defining the term PLE and finalizing
requirements for the rigorous, evidence-based process by which a PLE
would develop AUC, upon which qualification is based, as provided in
section 1834(q)(2)(B) of the Act and in the CY 2016 PFS final rule with
comment period. Using this process, once a PLE is qualified by CMS, the
AUC that are developed, modified or endorsed by the qualified PLE are
considered to be specified applicable AUC under section 1834(q)(2)(A)
of the Act. We defined the term PLE to include national professional
medical societies, health systems, hospitals, clinical practices and
collaborations of such entities such as the High Value Healthcare
Collaborative or the National Comprehensive Cancer Network. Qualified
PLEs may collaborate with third parties that they believe add value to
their development of AUC, provided such collaboration is transparent.
We expect qualified PLEs to have sufficient infrastructure, resources,
and the relevant experience to develop and maintain AUC according to
the rigorous, transparent, and evidence-based processes detailed in the
CY 2016 PFS final rule with comment period.
A timeline and process was established for PLEs to apply to become
qualified with the first list of qualified PLEs expected to be
published at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/ by
June 30, 2016.
b. Mechanism for AUC Consultation
The second major component of the Medicare AUC program is the
specification of qualified CDSMs that could be used by ordering
professionals for consultation with specified applicable AUC under
section 1834(q)(3) of the Act. We envision a CDSM as an interactive
tool that communicates AUC information to the user. Information
regarding the clinical presentation of the patient would be
incorporated into the CDSM from another health IT system or through
data entry by the ordering professional. At a minimum, the tool would
provide immediate feedback to the ordering professional on the
appropriateness of one or more imaging services. Ideally, CDSMs would
be integrated within or seamlessly interoperable with existing health
IT systems and would automatically receive patient data from the EHR or
through an API or other connection. Such integration would minimize
burden on practitioners and avoid duplicate documentation. Also useful
to clinicians would be the ability to switch between CDSMs that can
interoperate based on common standards.
Section 1834(q)(3)(A) of the Act states that the Secretary must
specify qualified CDSMs in consultation with physicians, practitioners,
health care technology experts, and other stakeholders. This
[[Page 46388]]
paragraph authorizes the Secretary to specify mechanisms that could
include: CDS modules within certified EHR technology; private sector
CDSMs that are independent of certified EHR technology; and a CDSM
established by the Secretary. The Secretary does not propose to
establish a CDSM at this time.
All CDSMs must meet the requirements under section 1834(q)(3)(B) of
the Act, which specifies that a mechanism must: Make available to the
ordering professional applicable AUC and the documentation supporting
the appropriateness of the applicable imaging service that is ordered;
where there is more than one applicable appropriate use criterion
specified for an applicable imaging service, indicate the criteria it
uses for the service; determine the extent to which an applicable
imaging service that is ordered is consistent with the applicable AUC;
generate and provide to the ordering professional documentation to
demonstrate that the qualified CDSM was consulted by the ordering
professional; be updated on a timely basis to reflect revisions to the
specification of applicable AUC; meet applicable privacy and security
standards; and perform such other functions as specified by the
Secretary (which may include a requirement to provide aggregate
feedback to the ordering professional). Section 1834(q)(3)(C) of the
Act specifies that the Secretary must publish an initial list of
specified mechanisms no later than April 1, 2016, and that the
Secretary must identify on an annual basis the list of specified
qualified CDSMs.
As we explained in the CY 2016 PFS proposed and final rules with
comment period, implementation of many aspects of the amendments made
by section 218(b) of the PAMA requires consultation with physicians,
practitioners, and other stakeholders, and notice and comment
rulemaking. We continue to believe the PFS calendar year rulemaking
process is the most appropriate and administratively feasible
implementation vehicle. Given the timing of the PFS rulemaking process,
we were not able to include proposals in the PFS proposed rule to begin
implementation in the same year the PAMA was enacted, as we would have
had to interpret and analyze the new statutory language, and develop
proposed plans for implementation in under one month. As we did prior
to the CY 2016 PFS proposed rule when we met extensively with
stakeholders to gain insight and hear their comments and concerns about
the AUC program, we have used the time prior to the CY 2017 PFS
proposed rule to meet with many of the same stakeholders but also a new
group of stakeholders specifically related to CDSMs. In addition, we
are continuing our stepwise approach to implementing this AUC program.
The first phase of the AUC program (specifying AUC including defining
what AUC are and specifying the process for developing them) was
accomplished through last year's CY 2016 PFS final rule with comment
period. For this second phase, we will use this CY 2017 PFS rulemaking
process as the vehicle to establish requirements for CDSMs, and the
process to specify qualified CDSMs, in a transparent manner that allows
for stakeholder and public involvement. Therefore, the final CDSM
requirements and process for CDSMs to become qualified would be
published in the CY 2017 PFS final rule with comment period on or about
November 1, 2016.
c. AUC Consultation and Reporting
The third major component of the AUC program is in section
1834(q)(4) of the Act, Consultation with Applicable Appropriate Use
Criteria. This section establishes, beginning January 1, 2017, the
requirement for an ordering professional to consult with a qualified
CDSM when ordering an applicable imaging service that would be
furnished in an applicable setting and paid for under an applicable
payment system; and for the furnishing professional to include on the
Medicare claim information about the ordering professional's
consultation with a qualified CDSM. The statute distinguishes between
the ordering and furnishing professional, recognizing that the
professional who orders an applicable imaging service is usually not
the same professional who bills Medicare for that service when
furnished. Section 1834(q)(4)(C) of the Act provides for certain
exceptions to the AUC consultation and reporting requirements including
in the case of certain emergency services, inpatient services paid
under Medicare Part A, and ordering professionals who obtain an
exception due to a significant hardship. Section 1834(q)(4)(D) of the
Act specifies that the applicable payment systems for the AUC
consultation and reporting requirements are the PFS, hospital
outpatient prospective payment system, and the ambulatory surgical
center payment systems.
Since a list of qualified CDSMs is not yet available and will not
be available by January 1, 2017, we will not require ordering
professionals to meet this requirement by that date.
d. Identification of Outliers
The fourth component of the AUC program is in section 1834(q)(5) of
the Act, Identification of Outlier Ordering Professionals. The
identification of outlier ordering professionals under this paragraph
facilitates a prior authorization requirement for outlier professionals
beginning January 1, 2020, as specified under section 1834(q)(6) of the
Act. Although we are not proposing to implement these sections in the
CY 2017 PFS proposed rule, we propose below a list of priority clinical
areas which may serve as part of the basis for identifying outlier
ordering professionals.
6. Proposals for Implementation
We propose to amend our regulations at Sec. 414.94, ``Appropriate
Use Criteria for Certain Imaging Services.''
a. Definitions
In Sec. 414.94(b), we propose to codify and add language to
clarify some of the definitions provided in section 1834(q) of the Act,
as well as define terms that were not defined in statute but for which
a definition would be helpful for program implementation. In this
section, we provide a description of the terms we propose to codify to
facilitate understanding and encourage public comment on the AUC
program.
We propose to define CDSM under Sec. 414.94(b) as an interactive,
electronic tool for use by clinicians that communicates AUC information
to the user and assists them in making the most appropriate treatment
decision for a patient's specific clinical condition. A CDSM would
incorporate specified applicable AUC sets from which an ordering
professional could select. A CDSM may be a module within or available
through certified EHR technology (as defined in section 1848(o)(4) of
the Act) or private sector mechanisms independent from certified EHR
technology. If within or available through certified EHR technology, a
qualified CDSM would incorporate relevant patient-specific information
into the assessment of the appropriateness of an applicable imaging
service.
As prescribed in section 1834(q) of the Act and Sec. 414.94(b) of
our regulations, the Medicare AUC program imposes requirements only for
applicable imaging services furnished in applicable settings. Further,
as specified in section 1834(q)(4)(D) of the Act, we propose to amend
our regulation at Sec. 414.94(b) to state that the applicable payment
systems for the Medicare AUC program are the PFS under section
[[Page 46389]]
1848(b) of the Act, the prospective payment system for hospital
outpatient department services under section 1833(t) of the Act, and
the ambulatory surgical center payment systems under section 1833(i) of
the Act. Applicable payment systems are relevant to implementation of
section 1834(q)(4)(B) of the Act, entitled ``Reporting by Furnishing
Professionals.''
We remind readers that in PFS rulemaking for CY 2016 we defined
applicable imaging service in Sec. 414.94(b) as an advanced diagnostic
imaging service as defined in 1834(e)(1)(B) of the Act for which the
Secretary determines (i) One or more applicable appropriate use
criteria apply; (ii) There are one or more qualified clinical decision
support mechanisms listed; and (iii) One or more of such mechanisms is
available free of charge.
b. Priority Clinical Areas
We propose to establish a new Sec. 414.94(e)(5) to set forth the
initial list of priority clinical areas.
To compile this proposed list we performed an analysis of Medicare
claims data using the CMS Chronic Conditions Data Warehouse (CCW) as
the primary data source. The CCW contains 100 percent of Medicare
claims for beneficiaries who are enrolled in the fee-for-service (FFS)
program. Data were derived from the CCW's 2014 Part B non-institutional
claim line file, which includes Part B services furnished during CY
2014. This is the main file containing final action claims data for
non-institutional health care providers, including physicians,
physician assistants, clinical social workers, nurse practitioners,
independent clinical laboratories, and freestanding ambulatory surgical
centers. The Part B non-institutional claim line file contains the
individual line level information from the claim and includes
Healthcare Common Procedure Coding System (HCPCS) code(s), diagnosis
code(s) using the International Classification of Diseases, Ninth
Revision (ICD-9), service dates, and Medicare payment amount. A
publicly available version of this dataset can be downloaded from the
CMS Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/. We encourage stakeholders to review this dataset as a
source that may help inform public comments related to the proposed
priority clinical areas.
In the CY 2016 PFS final rule with comment period, we stated that
when identifying priority clinical areas we may consider factors such
as incidence and prevalence of disease, the volume and variability of
utilization of imaging services, the strength of evidence for their
use, and applicability of the clinical area to the Medicare population
and to a variety of care settings.
Using the 2014 Medicare claims data referenced above, we ranked
ICD-9 codes by the frequency with which they were used as the primary
indication for specific imaging procedures, which in turn were
identified by the volume of individual Current Procedural Terminology
(CPT) codes for which payments were made in 2014. We extracted the top
135 ICD-9 codes from this list and formed clinically-related
categories. Next, we searched manually through an electronic list of
all ICD-9 codes to find others that would plausibly fit into each
clinical grouping. This process required subjective clinical judgment
on whether a particular ICD-9 code should be included in a given
clinical group. The top eight clinical groupings (by volume of
procedures) are what we are proposing as the initial list of priority
clinical areas. The eight clinical areas account for roughly 40 percent
of part B advanced diagnostic imaging services paid for by Medicare in
2014. We are aware that some stakeholders have suggested beginning the
AUC program with no more than five priority clinical areas while others
have suggested a far greater number. We believe the proposed eight
priority clinical areas strike a reasonable balance that allows us to
focus on a significant range and volume of advanced diagnostic imaging
services.
We also considered extracting pulmonary embolism as a separate
priority clinical area from the chest pain grouping based on
stakeholder consultation and feedback. However, we decided not to
identify pulmonary embolism separately, but are asking for public
comment on whether pulmonary embolism should be included as a stand-
alone priority clinical area. Based on our consultations with
physicians, practitioners and other stakeholders, as required by
section 218(b) of the PAMA, we attempted to be inclusive when grouping
ICD-9 codes into cohesive clinical areas. As an example of how we
derived the priority clinical area for low back pain, we grouped
together 10 ICD-9 codes, incorporating six from the top 135 and four
from the manual search of all ICD-9 codes. Included in this grouping
are the ICD-9 codes for displacement of lumbar intervertebral disc
without myelopathy (722.10), degeneration of lumbar of lumbosacral
intervertebral disc (722.52), intervertebral disc disorder with
myelopathy lumbar region (722.73), post-laminectomy syndrome of lumbar
region (722.83), lumbago (724.2), sciatica (724.3), thoracic or
lumbosacral neuritis or radiculitis unspecified (724.4), spinal
stenosis, lumbar region, without neurogenic claudication (724.02),
lumbosacral spondylosis without myelopathy (721.3), and spondylosis
with myelopathy lumbar region (721.42) which resulted in 1,883,617
services. To see all of the priority clinical area groupings of
diagnosis codes, a table is available on the CMS Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/.
Using the above methodology, we developed and are proposing eight
priority clinical areas. These reflect both the significance and the
high prevalence of some of the most disruptive diseases in the Medicare
population.
Table 34--Proposed Priority Clinical Areas With Corresponding Claims Data
----------------------------------------------------------------------------------------------------------------
% Total Total % Total
Proposed priority clinical area Total services services \1\ payments payments/1
----------------------------------------------------------------------------------------------------------------
Chest Pain (includes angina, suspected 4,435,240.00 12 $ 470,395,545 14
myocardial infarction, and suspected pulmonary
embolism)......................................
Abdominal Pain (any locations and flank pain)... 2,973,331.00 8 235,424,592 7
Headache, traumatic and non-traumatic........... 2,107,868.00 6 89,382,087 3
Low back pain................................... 1,883,617.00 5 180,063,352 5
Suspected stroke................................ 1,810,514.00 5 119,574,141 4
Altered mental status........................... 1,782,794.00 5 83,296,007 3
Cancer of the lung (primary or metastatic, 1,114,303.00 3 154,872,814 5
suspected or diagnosed)........................
[[Page 46390]]
Cervical or neck pain........................... 1,045,381.00 3 83,899,299 3
----------------------------------------------------------------------------------------------------------------
\1\ Percentage of 2014 Part B non-institutional claim line file for advanced imaging services from Medicare
claims for beneficiaries who are enrolled in the fee-for-service (FFS) program (source: CMS Chronic Conditions
Data Warehouse).
CMS also engaged the CMS Alliance to Modernize Healthcare (CAMH)
Federally Funded Research and Development Center (FFRDC), the MITRE
Corporation (MITRE), to begin developing efficient and effective
processes for managing current and future health technology
assessments. MITRE generated an independent report that presents a
summary of findings from claims data from the Medicare population and
their utilization of advanced imaging procedures. Coupled with our
internal analysis, this report has assisted in identification of
proposed priority clinical areas for the Medicare AUC program for
advanced diagnostic imaging services. Analysis and methods for this
report are available at https://www.mitre.org/publications/technical-papers/claims-data-analysis-to-define-priority-clinical-areas-for-advanced.
While this year we are proposing priority clinical areas based on
an analysis of claims data alone, we may use a different approach in
future rulemaking cycles. As we provided in Sec. 414.94(e) of our
regulations, we may consider factors other than volume when proposing
priority clinical areas including incidence and prevalence of disease,
variability of use of particular imaging services, strength of evidence
supporting particular imaging services and the applicability of a
clinical area to a variety of care settings and to the Medicare
population.
We encourage public comments on this proposed initial list of
priority clinical areas, including recommendations for other clinical
areas that we should include among our list of priority clinical areas.
In particular, we are interested in comments on the above methodology
or alternate options; whether the proposed priority clinical areas are
appropriate including information on the extent to which these proposed
priority clinical areas may be represented by clinical guidelines or
AUC in the future. Furthermore, we are interested in public comments,
supported by published information, with respect to varying levels of
evidence that exist across as well as within priority clinical areas.
c. CDSM Qualifications and Requirements
We are proposing to add a new Sec. 414.94(g)(1) to our regulations
to establish requirements for qualified CDSMs. Section
1834(q)(3)(A)(iii) of the Act provides relative flexibility for
qualified CDSMs, and states that they may include mechanisms that are
within certified EHR technology, private sector mechanisms that are
independent from certified EHR technology or mechanisms that are
established by the Secretary.
We believe that, at least initially, it is in the best interest of
the program to establish CDSM requirements that are not prescriptive
about specific IT standards. Rather, we are proposing an approach that
focuses on the functionality and capabilities of qualified CDSMs. The
CDSM, EHR and health IT environments are constantly changing and
improving and we want to allow room for growth and innovation. However,
in the future, as more stakeholders and other entities including the
ONC, AHRQ, and relevant standards development organizations come to
consensus regarding standards for CDSMs, then we may consider pointing
to such standards as a requirement for qualified CDSMs under this
program. We believe standards would make it possible to achieve
interoperability, allowing any CDSM to incorporate any standardized AUC
and for sets of AUC to be easily interchangeable among various CDSMs.
We will continue to work with the ONC and AHRQ to facilitate movement
in this direction.
Recent work under the federally-sponsored Clinical Quality
Framework (CQF) initiative has successfully developed an integrated
approach that harmonizes standards for electronic clinical quality
measurement with those that enable shareable clinical decision support
artifacts (for example, AUC). The CQF initiative is working to support
semantically interoperable data exchange for (1) sending patient data
to a service for clinical decision support guidance and receiving
clinical decision support guidance or quality measurement results in
return, and (2) enabling a system to consume and internally execute
decision support artifacts. As this standard is considered sufficiently
mature for widespread adoption, the ONC may consider it for use in
future editions of certification criteria for health IT. While the
current regulation requires no specific standard, the CMS and ONC are
supportive of this approach and additional information can be found at
https://hl7-fhir.github.io/cqif/cqif.html.
Under Sec. 414.94(g)(1), we propose to codify in regulations the
seven requirements for qualified CDSMs set forth in section
1834(q)(3)(B)(ii) of the Act. The Act requires qualified CDSMs to make
available to the ordering professional specified applicable AUC and the
supporting documentation for the applicable imaging service ordered. We
do not interpret this requirement to mean that every qualified CDSM
must make available every specified applicable AUC. In the CY 2016 PFS
final rule with comment period we allowed for the approval of massive
libraries of AUC (resulting from approvals for qualified PLEs with
comprehensive and extensive libraries), yet we expressed our intention
to establish priority clinical areas. While there is a statutory
requirement to consult AUC for each applicable imaging service, we
recognize that ordering professionals may choose to thoroughly improve
their understanding of, and focus their internal quality improvement
(QI) programs on, those priority clinical areas; and these areas will
in turn serve as the basis for future outlier calculations.
Consistent with that approach, we propose to add a requirement in
Sec. 414.94(g)(1)(iii) that qualified CDSMs must make available to
ordering professionals, at a minimum, specified applicable AUC that
reasonably encompass the entire clinical scope of all priority clinical
areas. We encourage and expect some CDSMs, based on the needs of the
professionals they serve, will choose to include a far more
comprehensive set of AUC going above and beyond the minimum set as we
understand many ordering professionals want such comprehensive access
to AUC. When this Medicare AUC program is fully implemented, all
ordering professionals must consult specified applicable AUC through a
qualified
[[Page 46391]]
CDSM for every applicable imaging service that would be furnished in an
applicable setting and paid for under an applicable payment system in
order for payment to be made for the service. However, when identifying
the outlier ordering professionals who will be subject to prior
authorization beginning in 2020, we anticipate focusing on consultation
with specified applicable AUC within priority clinical areas rather
than the universe of specified applicable AUC. The concept of priority
clinical areas will allow us to implement an AUC program that combines
two approaches to implementation allowing clinicians flexibility to
either engage with a rapid rollout of comprehensive specified
applicable AUC or adopt a focused approach to consulting AUC. Thus,
they can choose their approach and select a CDSM and AUC set(s) that
fit their needs and preferences, while being sure that each qualified
CDSM will include AUC that address all priority clinical areas.
We further propose to add a requirement in Sec. 414.94(g)(1)(iv)
of our regulations that qualified CDSMs must be able to incorporate
specified applicable AUC from more than one qualified PLE. We believe
this approach ensures that CDSMs can expand the AUC libraries they can
provide access to in order to represent AUC across all priority
clinical areas (consistent with the requirements under proposed Sec.
414.94(g)(1)(iii)). We do not necessarily expect that a single
qualified PLE will develop AUC addressing every priority clinical area
domain, especially since we believe that over time and through future
rulemaking, the list of priority clinical areas will expand and cross
additional clinical domains. Ensuring that qualified CDSMs are not
limited in their technology to incorporating AUC from only one
qualified PLE will help to ensure that ordering professionals will not
be in a position of consulting a CDSM that cannot offer them access to
AUC that address all priority clinical areas. As stakeholders continue
to advance CDSM technology, we look forward to standards being
developed and widely accepted so that AUC are incorporated in a
standardized format across CDSM platforms. Increasing standardization
in this area will move the industry closer to the goal of
interoperability across CDSMs and EHRs.
We also propose to add a requirement in Sec. 414.94(g)(1)(i) that
specified applicable AUC and related documentation supporting the
appropriateness of the applicable imaging service ordered must be made
available within the qualified CDSM. For example, the ordering
professional would have immediate access to the full appropriate use
criterion, citations supporting the criterion and a summary of key
evidence supporting the criterion.
We propose to add a requirement in Sec. 414.94(g)(1)(ii),
consistent with section 1834(q)(3)(B)(ii)(II) of the Act, that the
qualified CDSM must clearly identify the appropriate use criterion
consulted if the tool makes available more than one criterion relevant
to a consultation for a patient's specific clinical scenario. We
believe this is important since CDSMs that choose to incorporate a
comprehensive AUC library may be offering the ordering professional
access to AUC from multiple qualified PLEs. In such scenarios, it is
important that the ordering professional knows which appropriate use
criterion is being consulted and have the option to choose one over the
other if more than one criterion applies to the scenario.
We propose to add a requirement in Sec. 414.94(g)(1)(v),
consistent with section 1834(q)(3)(B)(ii)(III) of the Act, that the
qualified CDSM must provide to the ordering professional a
determination, for each consultation, of the extent to which an
applicable imaging service is consistent with specified applicable AUC
or a determination of ``not applicable'' when the mechanism does not
contain a criterion that would apply to the consultation. This
determination would communicate the appropriateness of the applicable
imaging service to the ordering professional. In addition to this
determination, we also propose that the CDSM provide the ordering
professional with a determination of ``not applicable'' when the
mechanism does not contain an appropriate use criterion applicable to
that patient's specific clinical scenario.
We propose to add a requirement in Sec. 414.94(g)(1)(vi),
consistent with section 1834(q)(3)(B)(ii)(IV) of the Act, that the
qualified CDSM must generate and provide to the ordering professional
certification or documentation that documents which qualified CDSM was
consulted, the name and NPI of the ordering professional that consulted
the CDSM and whether the service ordered would adhere to applicable
AUC, whether the service ordered would not adhere to such criteria, or
whether such criteria was not applicable for the service ordered. We
propose to require under Sec. 414.94(g)(1)(vi)(A) that this
certification or documentation must be issued each time an ordering
professional consults the qualified CDSM. Since Medicare claims will be
filed only for services that are rendered to beneficiaries, we will not
see CDSM consultation information on the claim form specific to imaging
services that are not ordered. We believe that for the CDSM to be able
to provide meaningful feedback to ordering professionals, information
regarding consultations that do not result in imaging is just as
important as information on consultations that do result in an order
for advanced imaging.
Thus, we propose to require under Sec. 414.94(g)(1)(vi)(B) that
the documentation or certification provided by the qualified CDSM must
include a unique consultation identifier. This would be a unique code
issued by the CDSM that is specific to each consultation by an ordering
professional. This type of unique code may serve as a platform for
future collaboration and aggregation of consultation data across CDSMs.
In addition, at some point in the future, this unique code may assist
in more seamlessly bringing Medicare data together with CDSM clinical
data to maximize quality improvement in clinical practices and to
iteratively improve the AUC itself.
We propose in Sec. 414.94(g)(1)(vii), consistent with section
1834(q)(3)(B)(ii)(V) of the Act, that the specified applicable AUC
content within qualified CDSMs be updated at least every 12 months to
reflect revisions or updates made by qualified PLEs to their AUC sets
or to an individual appropriate use criterion. We propose 12 months as
the maximum acceptable delay for updating content. We believe that in
most cases it will be possible to update AUC content more frequently
than every 12 months, particularly for cloud-based CDSMs. We further
propose in Sec. 414.94(g)(1)(vii)(A) that qualified CDSMs have a
protocol in place to more expeditiously remove AUC that are determined
by the qualified PLE to be potentially dangerous to patients and/or
harmful if followed.
In addition, we propose in Sec. 414.94(g)(1)(vii)(B) that
qualified CDSMs must make available for consultation specified
applicable AUC that address any new priority clinical areas within 12
months of the priority clinical area being finalized by CMS. We believe
this would allow the CDSM sufficient time to incorporate the AUC into
the CDSM. Thus, any new priority clinical areas finalized, for example,
in the CY 2018 PFS final rule with comment period that would be
effective January 1, 2018, would need to be incorporated into a
qualified CDSM by January 1, 2019. To accommodate this time frame, we
would accept a not applicable determination from a CDSM
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for a consultation on a priority clinical area for dates of service
through the 12-month period that ends, in this example, on January 1,
2019. We note that all qualified CDSMs that are approved by June 30,
2017 should be capable of supporting AUC for all priority clinical
areas that are finalized in the CY 2017 PFS final rule with comment
period.
We propose to add a requirement in Sec. 414.94(g)(1)(viii),
consistent with section 1834(q)(3)(B)(ii)(VI) of the Act, that the
qualified mechanism must meet privacy and security standards under
applicable provisions of law. Potentially applicable laws may include
the HIPAA Privacy and Security rules.
We propose to add a requirement in Sec. 414.94(g)(1)(ix),
consistent with section 1834(q)(3)(B)(ii)(VII) of the Act, that
qualified CDSMs must provide ordering professionals aggregate feedback
in the form of an electronic report on an annual basis (at minimum)
regarding their consultations with specified applicable AUC. Our intent
is to require records to be retained in a manner consistent with the
HIPAA Security Rule. To provide such feedback, and to make detailed
consultation information available to ordering professionals,
furnishing professionals (when they have authorized access to the
CDSM), auditors and CMS, we propose in Sec. 414.94(g)(1)(x) that a
qualified CDSM must maintain electronic storage of clinical,
administrative and demographic information of each unique consult for a
minimum of 6 years. We believe CDSMs could fulfill this requirement in
a number of ways, including involving a third party in the storage of
information as well as for providing feedback to ordering
professionals. We recognize that these requirements represent a minimum
floor that clinicians may choose to expand upon in their local QI
programs.
In the event requirements under Sec. 414.94(g)(1) are modified
through rulemaking during the course of a qualified CDSM's 5-year
approval cycle, we propose in Sec. 414.94(g)(1)(xi) that the CDSM
would be required to comply with the modification(s) within 12 months
of the effective date of the modification.
d. Process for CDSMs To Become Qualified and Determination of Non-
Adherence
We propose that CDSMs must apply to CMS to be specified as a
qualified CDSM. We propose that CDSM developers who believe their
mechanisms meet the regulatory requirements must submit an application
to us that documents adherence to each of the requirements to be a
qualified CDSM.
We propose to require in Sec. 414.94(g)(2) that CDSM developers
must submit applications to CMS for review that document adherence to
each of the CDSM requirements. Applications to be specified as a
qualified CDSM must be submitted by January 1 of a year in order to be
reviewed within that year's review cycle. For example, the first
applications would be accepted from the date of publication of the PFS
final rule until January 1, 2017. A determination on whether the
applicants are qualified would be made by June 30, 2017. Applications
must be submitted electronically to ImagingAUC@cms.hhs.gov. This
process and timeline mirror the qualified PLE application and approval
process and timeline. As we did for qualified PLEs, we will post a list
of all applicants that we determine to be qualified CDSMs to our Web
site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/ by
June 30. We propose that all qualified CDSMs must reapply every 5 years
and their applications must be received by January 1 during the 5th
year that they are qualified CDSMs. It is important to note that, as
with PLE applications, the application for qualified CDSMs is not a CMS
form; rather it is created by the applicant. A CDSM that is specified
as qualified for the first 5-year cycle beginning on July 1, 2017 would
be required to submit an application for requalification by January 1,
2022. A determination would be made by June 30, 2022, and, if approved,
the second 5-year cycle would begin on July 1, 2022.
An example of our proposed timeline for applications and the
approval cycle is as follows:
Year 1 = July 2017 to June 2018.
Year 2 = July 2018 to June 2019.
Year 3 = July 2019 to June 2020.
Year 4 = July 2020 to June 2021.
Year 5 = July 2021 to June 2022 (reapplication is due by
January 1, 2022).
We believe it is important for us to have the ability to remove
from the list of specified qualified CDSMs a CDSM that we determine
fails to adhere to any of the qualification requirements, including
removal outside of the proposed 5-year cycle. We propose to state under
Sec. 414.94(h) that, at any time, we may remove from the list of
qualified CDSMs a CDSM that fails to meet the criteria to be a
qualified CDSM or consider this information during the requalification
process. Such determinations may be based on public comment or our own
review and we may consult with the National Coordinator for Health
Information Technology or her designee to assess whether a qualified
CDSM continues to adhere to requirements.
We invite comments on how we could streamline and strengthen the
approval process for CDSMs in future program years. For instance, CMS
may consider a testing framework for CDSMs that would validate
adherence to specific standards that enable seamless incorporation of
AUC across CDSMs.
e. Consultation by Ordering Professional and Reporting by Furnishing
Professional
Although we continue to aggressively move forward to implement this
AUC program, ordering professionals will not be expected to consult
qualified CDSMs by January 1, 2017. At the earliest, under this
proposal, the first qualified CDSM(s) will be specified on June 30,
2017. We anticipate that some ordering professionals could be able to
begin consulting AUC through qualified CDSMs very quickly as some may
already be aligned with a qualified CDSM.
We anticipate that furnishing professionals may begin reporting as
early as January 1, 2018. This reporting delay is necessary to allow
time for ordering practitioners who are not already aligned with a
qualified CDSM to research and evaluate the qualified CDSMs so they may
make an informed decision. While there will be further rulemaking next
year, we are announcing this date because the agency expects physicians
and other stakeholders/regulated parties to begin preparing themselves
to begin reporting on that date. We will adopt procedures for capturing
this information on claims forms and the timing of the reporting
requirement through PFS rulemaking for CY 2018.
As we expect to implement the AUC consultation and reporting
requirements under section 1834(q)(4)(A) and (B) of the Act on January
1, 2018, we are interested in receiving feedback from the public to
include a discussion of specific operational considerations that we
should take into account and include in such rulemaking. For example,
commenters could consider alternatives for reporting data on claims and
for seeking exceptions, as discussed below. We also seek information on
the barriers to implementation along this timeline that allows ordering
and furnishing professionals to be prepared to consult AUC and report
consultation information on the claims and whether
[[Page 46393]]
separate rulemaking outside of the payment rule cycle would be
preferred.
Under section 1834(q)(4)(B) of the Act, Medicare claims for
applicable imaging services furnished in applicable settings can only
be paid under the applicable payment systems if certain information is
included on the claim including: Which qualified CDSM was consulted by
the ordering professional for the service; whether the service, based
on the CDSM consultation, adheres to specified applicable AUC, does not
adhere to specified applicable AUC or whether no criteria in the CDSM
were applicable to the patient's clinical scenario; and, the national
provider identifier (NPI) of the ordering professional. This section
further allows payment for these services only if the claim contains
such information beginning January 1, 2017. To develop and
operationalize a meaningful solution to collecting new AUC
consultation-related information on the claims, we must diligently
evaluate our options taking into account the vast number of claims
impacted and the limitations of the legacy claims processing system.
While we could have moved more quickly to establish some sort of AUC
consultation indicator for Medicare claims, any such indicator would
have been a relatively meaningless token. Additionally, in the case of
advanced imaging services, related claims are already required to
append certain HCPCS modifiers and G codes for purposes of proper
payments. In the recent implementation of section 218(a) of the PAMA,
we established a HCPCS modifier for CT services rendered on machines
that do not meet an equipment standard. It is important that we
understand and evaluate how the additional requirements for AUC
reporting would impact the information that is already required for
advanced imaging services. Moving too quickly to satisfy the reporting
requirement could inadvertently result in technical and operational
problems that could cause delays in payments.
Section 1834(q)(4)(C) of the Act includes exceptions that allow
claims to be paid even though they do not include the information about
AUC consultation by the ordering professional. We believe that, unless
a statutory exception applies, an AUC consultation must take place for
every order for an applicable imaging service furnished in an
applicable setting and under an applicable payment system. We further
believe that section 1834(q)(4)(B) of the Act accounts for the
possibility that AUC may not be available in a particular qualified
CDSM to address every applicable imaging service that might be ordered;
and thus, the furnishing professional can meet the requirement to
report information on the ordering professional's AUC consultation by
indicating that AUC is not applicable to the service ordered.
We are considering the mechanisms for appending the AUC
consultation information to various types of Medicare claims and expect
to develop requirements for appending such information in the CY 2018
PFS rulemaking process. Stakeholders interested in sharing feedback
related to reporting and claims processing are welcome to do so as part
of the comment period for this proposed rule. We are particularly
interested in receiving feedback on, for example, whether the
information should be collected using HCPCS level II G codes or HCPCS
modifiers. We will use this feedback to inform CY 2018 rulemaking.
f. Exceptions To Consulting and Reporting Requirements
Section 1834(q)(4)(C) of the Act provides for certain exceptions to
the AUC consultation and reporting requirements under section
1834(q)(4)(B) of the Act. First, the statute provides for an exception
under section 1834(q)(4)(C)(i) of the Act where an applicable imaging
service is ordered for an individual with an emergency medical
condition as defined in section 1867(e)(1) of the Act. We believe this
exception is warranted because there can be situations in which a delay
in action would jeopardize the health or safety of individuals. Though
we believe they occur primarily in the emergency department, these
emergent situations could potentially arise in other settings.
Furthermore, we recognize that most encounters in an emergency
department are not for an emergency medical condition as defined in
section 1867(e)(1) of the Act.
We propose to provide for an exception to the AUC consultation and
reporting requirements under Sec. 414.94(i)(1) for an applicable
imaging service ordered for an individual with an emergency medical
condition as defined in section 1867(e)(1) of the Act. For example, if
a patient, originally determined by the clinician to have an emergency
medical condition prior to ordering an applicable imaging service, is
later determined not to have had an emergency medical condition at that
time, the relevant claims for applicable imaging services would still
qualify for an exception. To meet the exception for an emergency
medical condition as defined in section 1867(e)(1) of the Act, the
clinician only needs to determine that the medical condition manifests
itself by acute symptoms of sufficient severity (including severe pain)
such that the absence of immediate medical attention could reasonably
be expected to result in: Placing the health of the individual (or a
woman's unborn child) in serious jeopardy; serious impairment to bodily
functions; or serious dysfunction of any bodily organ or part. Orders
for advanced imaging services for beneficiaries with an emergency
medical condition as defined under section 1867(e)(1) of the Act are
excepted from the requirement to consult AUC. We intend through the CY
2018 PFS proposed rule to propose more details around how this
exception will be identified on the Medicare claim.
The second exception is under section 1834(q)(4)(ii) of the Act for
applicable imaging services ordered for an inpatient and for which
payment is made under Medicare Part A. We propose to codify this
exception in new Sec. 414.94(i)(2). While we are including this
exception consistent with statute, we note that if payment is made
under Medicare Part A, the service would not be paid under an
applicable payment system, such that the AUC consultation and reporting
requirements under Sec. 414.94 would never apply.
The third exception is under section 1834(q)(4)(iii) of the Act for
applicable imaging services ordered by an ordering professional who the
Secretary determines, on a case-by-case basis and subject to annual
renewal, that consultation with applicable AUC would result in a
significant hardship, such as in the case of a professional practicing
in a rural area without sufficient Internet access. We propose to
codify this exception in new Sec. 414.94(i)(3) by specifying that
ordering professionals who are granted a significant hardship exception
for purposes of the Medicare EHR Incentive Program payment adjustment
under Sec. 495.102(d)(4)(i), (ii), or (iii)(A)(B) of our regulations
would also be granted a significant hardship exception for purposes of
the AUC consultation requirement. We are proposing, to the extent
technically feasible, that the year for which the eligible professional
is excepted from the EHR Incentive Program payment adjustment is the
same year that the ordering professional is excepted from the
requirement to consult AUC through a qualified CDSM. We propose not to
adopt the Meaningful Use significant hardship exception under Sec.
495.102(d)(4)(iv)(C) as an exception for purposes of the AUC
consultation requirement. Therefore, ordering professionals with a
primary specialty of anesthesiology, radiology or
[[Page 46394]]
pathology will not be categorically excepted from AUC consultation
requirements.
We believe there is substantial overlap between the eligible
professionals that would seek a hardship exception under the EHR
Incentive Program and those ordering professionals that would seek a
hardship exception under the AUC program and, as such, this proposal
would be administratively efficient. Using an existing program is the
most efficient and expeditious manner to implement the significant
hardship exception under the Medicare AUC program. We also believe it
is the only administratively feasible option for a national significant
hardship identification process that can be implemented by January 1,
2018, though we intend to revisit this option for years after 2018 as
the current EHR Incentive Program payment adjustment is set to expire
after the 2018 payment year as the Merit-Based Incentive Payment System
takes effect. In addition, below we discuss considerations for a
supplemental process to account for hardships for ordering
professionals that are not eligible to apply for a significant hardship
under the EHR Incentive Program (for example, non-physician
practitioners) and ordering professionals that incur a significant
hardship outside of the EHR Incentive Program application deadline.
The criteria for significant hardships under the EHR Incentive
Program relate to insufficient internet connectivity, practicing for
less than 2 years, practicing at multiple locations with the inability
to control the availability of Certified EHR Technology, lack of face-
to-face interaction with patients or a primary specialty designation of
anesthesiology, radiology or pathology. We believe that most of these
criteria would be relevant to demonstrate a significant hardship for
ordering professionals to consult AUC. Regarding hardship exceptions
for certain specialty designations, based on Medicare claims data for
advanced imaging services from the first 6 months of 2014,
approximately 1.2 percent of those claims were for advanced imaging
services that had been ordered by a professional with one of the three
primary specialty designations. While their combined ordering volume is
small, we do not believe that categorical exclusion of certain
specialties of which the practitioner selected as their primary
specialty designation for Medicare enrollment would necessarily be
appropriate under the AUC program. Since eligible professionals in
these three specialties are categorically excepted from the EHR
Incentive Program payment adjustment, few of them would have applied
for an exception on the other grounds. Therefore, we must consider
another mechanism to evaluate whether ordering practitioners with these
medical specialties experience a significant hardship for purposes of
the AUC program.
We understand that there are differences between the purpose and
timing of significant hardship exceptions for the EHR Incentive Program
and the Medicare AUC program. Foremost, a significant hardship under
the EHR Incentive Program is generally based on a hardship that
occurred in a prior period, impacting meaningful EHR use that would
affect payments in a subsequent calendar year. For example, a
professional that submits an application in March 2017 and qualifies
for the hardship exception under the EHR Incentive Program would be
exempt from the EHR payment adjustment for calendar year 2018. Although
significant hardship exceptions for the EHR payment adjustment year
generally are based on the existence of a hardship in a prior period,
we believe it would be appropriate for these professionals to also
qualify for a significant hardship exception for purposes of the AUC
consultation requirement during calendar year 2018. It is also our
best, most efficient, administratively feasible means of determining
significant hardships for ordering professionals for CY 2018.
We also recognize the possibility that an ordering professional
could suffer a significant hardship during the AUC program year, and
therefore, is immediately unable to consult AUC. In addition, while
again we believe there is significant overlap, there may be
circumstances where an ordering professional is not considered to be an
eligible professional under the EHR Incentive Program (for example, an
ordering professional that is not a physician). We are seeking feedback
from commenters regarding processes that could be put in place to
accommodate ordering professionals with primary specialties that
categorically receive significant hardship exceptions under the EHR
Incentive Program, real-time hardships that arise during a year, and
ordering professionals that are not eligible to apply using the EHR
Incentive Program significant hardship exception process and need to
seek a significant hardship exception for the purposes of the AUC
program. We believe this would involve only a small number of ordering
professionals. To the extent technically feasible, some possibilities
for implementing such hardship exceptions may include Medicare
Administrative Contractors granting hardships on a case-by-case basis
or establishing another mechanism to allow for self-attestation of a
significant hardship for a defined period of time (for example, a
calendar quarter or a calendar year). We intend to propose a process in
the CY 2018 PFS proposed rule.
We invite the public to comment on our proposal for ordering
professionals granted a hardship exception for the EHR Incentive
Program for payment year 2018 to also be granted a hardship exception
to the Medicare AUC program for those years. We propose that the year
the practitioner is excepted from the EHR Incentive Program payment
adjustment is the same year that the practitioner would be excepted
from consulting AUC.
6. Summary
Section 1834(q) of the Act includes rapid timelines for
establishing a Medicare AUC program for advanced diagnostic imaging
services. The number of clinicians impacted by the scope of this
program is massive as it will apply to every physician or other
practitioner who orders or furnishes applicable imaging services. This
crosses almost every medical specialty and could have a particular
impact on primary care physicians since their scope of practice can be
quite broad.
We continue to believe the best implementation approach is one that
is diligent, maximizes the opportunity for public comment and
stakeholder engagement, and allows for adequate advance notice to
physicians and practitioners, beneficiaries, AUC developers, and CDSM
developers. It is for these reasons we are proposing to continue a
stepwise approach, adopted through notice and comment rulemaking. We
propose this second component to the program to specify qualified
CDSMs, identify the initial list of priority clinical areas, and
establish requirements related to CDSMs, as well as consulting and
reporting exceptions. However, we also recognize the importance of
moving expeditiously to accomplish a fully implemented program. Under
this proposal, the first list of qualified CDSMs will be posted no
later than June 30, 2017, allowing ordering professionals to begin
aligning themselves with a qualified CDSM. We anticipate that
furnishing professionals could begin reporting AUC information starting
as early as January 1, 2018, but will provide details in CY 2018 PFS
[[Page 46395]]
rulemaking for how to report that information on claims.
In summary, we propose definitions of terms and processes necessary
to implement the second component of the AUC program. We invite the
public to submit comments on these proposals. We are particularly
seeking comment on the proposed priority clinical areas and the
requirements that must be met by CDSMs to become qualified. We believe
the proposed requirements for qualified CDSMs will allow for
flexibility so mechanisms can continue to reflect innovative concepts
in decision support and develop customer-driven products to ultimately
provide information to the ordering professional in such a manner that
will maximize appropriate ordering of advanced diagnostic imaging while
seamlessly integrating into workflow. As the stakeholders continue to
move to a place of consensus-based standards deemed ready for
deployment, we may become more prescriptive in future requirements for
CDSMs. We also seek comment on the exceptions to the requirements to
consult applicable AUC using CDSMs.
D. Reports of Payments or Other Transfers of Value to Covered
Recipients: Solicitation of Public Comments
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 (Open Payments Final Rule) which
implemented section 1128G of the 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 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 are at 42 CFR part 402,
subpart A, and part 403, subpart I.
In addition to the Open Payments final rule, we issued final
regulations in the CY 2015 PFS final rule with comment period (79 FR
67758) that revised the Open Payments regulations. Specifically, we:
(1) Deleted of the definition of ``covered device''; (2) removed the
continuous medical education (CME) exclusion; (3) expanded the marketed
name reporting requirements to biologicals and medical supplies; and
(4) required stock, stock options, and any other ownership interests to
be reported as distinct forms of payment.
Since the publication and implementation of the Open Payments Final
Rule and the CY 2015 PFS, various stakeholders have provided feedback
to us regarding aspects of the Open Payment program. We have identified
areas in the rule that might benefit from revision. In order to
consider the views of all stakeholders, we are soliciting comments to
inform future rulemaking. We do not intend to finalize any requirements
related to Open Payments directly as a result of this proposed rule;
rather, we expect to conduct future rulemaking. We are particularly
interested in receiving comments on the following:
We would like to know if the nature of payment categories
as listed at Sec. 403.904(e)(2) are inclusive enough to facilitate
reporting of all payments or transfers of value to covered recipient
physicians and teaching hospitals. We also seek feedback on further
categorization of reported research payments.
Although there is a 5-year record retention requirement at
Sec. 403.912(e), our regulations are currently silent on how long
applicable manufacturers and applicable GPOs remain obligated to report
on past years of payments or ownership or investment interests. We are
soliciting feedback on how many years an applicable manufacturer or
applicable GPO should continue to monitor and report on past program
years for Open Payments reporting purposes.
We are continuing to refresh all years of program data in
addition to newly submitted payment records. We are interested in
receiving feedback on how many years of Open Payments data is relevant
to our stakeholders to help us determine how many years to continue to
publish and refresh annually on our Web site. In addition, we are
looking for feedback on how many years may be useful or relevant to
Open Payments data users as archive files available for download on our
Web site.
We are seeking feedback on a requirement for all
applicable manufacturers and applicable GPOs as defined in Sec.
403.902 to register each year, regardless of whether the entity will be
reporting payments or other transfers of value, or ownership or
investment interests for the program year. We also seek comment on
requiring applicable manufacturers and applicable GPOs to include the
reason for not reporting any payments or other transfers of value, or
ownership or investment interests.
We are constantly striving to ensure that all published
Open Payments data is valid and reliable. As part of this effort we are
seeking comment on a requirement for applicable manufacturers and
applicable GPOs to pre-vet payment information with covered recipients
and physicians owners or investors before reporting to the Open
Payments system, which we understand is an increasingly common
practice. Specifically, we would like feedback on pre-vetting based on
threshold payment values or random samplings of covered recipients. We
are also interested in hearing how applicable manufacturers and
applicable GPOs are successfully pre-vetting payment or transfer of
value records.
We continue to receive feedback that the current
definition of a covered recipient teaching hospital, as defined at
Sec. 403.902, makes reporting payments or transfers of value difficult
for applicable manufacturers. Section 1128G of the Act is silent on the
definition of a covered recipient teaching hospital. We are soliciting
feedback on the specific hurdles that the current definition presents.
Additionally we would like to receive proposed alternative
operationally feasible definitions or definitional elements of a
covered recipient teaching hospital.
We have heard from stakeholders that verifying receipt of
payments or transfers of value to teaching hospitals is a difficult
process on the recipient end for a various number of reasons (such as
size of hospitals, number of departments, etc.). Without context around
a payment record, teaching hospitals have reported difficulties
verifying payments attributed to them. This leads to payment disputes.
We are seeking feedback on adding a new non-public data element to
assist in review and affirmation of payment records. Some examples
might be hospital contact name or department etc. Would a free form
text field be preferable?
[[Page 46396]]
Should this field be mandatory to facilitate review of any attributed
payments to a teaching hospital?
Some reporting entities have expressed interest to upload
data into the Open Payments system before the end of the calendar year
for which the data is collected. We believe this may increase data
validity and minimize disputes. We solicit feedback on the benefit for
applicable manufacturers and applicable GPOs to report data to CMS
early or ongoing throughout the year.
We recognize that some entities may experience mergers,
acquisitions, corporate organizations and reorganizations, and other
structural corporate changes. We seek feedback on how we might change
our reporting requirements to ensure that industry can properly, and
easily, represent these changes while still monitoring for compliance
with reporting requirements.
We have received feedback from industry that there is
confusion surrounding requirements for reporting ownership and
investment interests. Keeping in mind that these reporting requirements
are statutorily mandated, we solicit feedback on operationally feasible
definitions regarding ownership or investment interests. Specifically,
we would like feedback on the terms ``value or interest'' and ``dollar
amount invested.'' We also solicit comments on additional terms that
may require further clarification to facilitate compliance with
reporting requirements.
We solicit ideas on how to define physician-owned
distributors (PODs) for data reporting purposes, as well as what data
elements PODs should be required to report. We also seek feedback on
what portion of the reported data we should share on our Web site.
From a data collection perspective, we welcome suggestions
on ways to streamline or make the process more efficient, while
facilitating our role in oversight, compliance, and enforcement.
With respect to all solicitations, we are requesting an
estimate of the time and cost burden associated with reporting for
purposes of compliance with the Paperwork Reduction Act.
E. Release of Part C Medicare Advantage Bid Pricing Data and Part C and
Part D Medical Loss Ratio (MLR) Data
1. Background
As part of the annual bidding process required under section
1854(a) of the Act, Medicare Advantage organizations (MAOs) submit bids
for each plan they wish to offer in the upcoming contract year
(calendar year). We refer to each of these bids as a Medicare Advantage
(MA) plan bid. As required by sections 1857(e)(4) and 1860D-12(b)(3)(D)
of the Act, data supporting medical loss ratios (MLR) are submitted
annually to us by MAOs and Part D sponsors, respectively. Using this
authority, we codified the MLR submission requirement in the MLR final
rule for Part C and Part D published in the Federal Register (78 FR
31284) on May 23, 2013.
We are proposing to release to the public MA bid pricing data and
Part C and Part D MLR data on a specific schedule and subject to
specified exclusions. We propose to add contract terms and expand the
basis and scope of our regulations on MA bidding and Part C and Part D
MLR submission to incorporate section 1106(a) of the Act (42 U.S.C.
1306(a)), which authorizes disclosure of information filed with this
agency in accordance with regulations adopted by the agency. (See
Parkridge Hospital, Inc. v. Califano, 625 F.2d 719, 724-25 (6th Cir.
1980). A substantive regulation issued following rulemaking provides
the legal authorization for government officials to disclose commercial
information that would otherwise be required to be kept confidential in
accordance with 18 U.S.C. 1905. See Chrysler Corp. v. Brown, 441 U.S.
281, 306-08 (1979). We note as well that under 45 CFR 401.105(a),\6\ we
have adopted a regulation that permits publication and release of data
that would not be exempt from disclosure under FOIA or prohibited from
disclosure under other law, even if a request has not been submitted.
We further note that because we collect Part D MLR information under
section 1860D-12(b)(3)(D) of the Act, we have the authority to use such
information for purposes of improving public health through research on
the utilization, safety, effectiveness, quality and efficiency of
health care services. We propose to adopt a regulation that clearly
identifies the categories of data from submitted bids and reports of
medical loss ratios that will be released so as to avoid repeating FOIA
analyses and reviews of each request, to standardize the disclosure and
the procedures for disclosure, and in the interest of furthering goals
related to the MA and Part D programs.
---------------------------------------------------------------------------
\6\ The regulation, which implements 42 U.S.C. 1306(a), provides
that the Freedom of Information Act rules shall be applied to every
proposed disclosure of information. If, considering the
circumstances of the disclosure, the information would be made
available in accordance with the Freedom of Information Act rules,
then the information may be disclosed regardless of whether the
requester or beneficiary of the information has a statutory right to
request the information under the Freedom of Information Act, 5
U.S.C. 552, or whether a request has been made.
---------------------------------------------------------------------------
The purposes underlying these proposed data releases include
allowing public evaluation of the MA and Part D programs encouraging
research into these programs and better ways to provide health care,
and reporting to the public regarding federal expenditures and other
statistics involving these programs. In particular, we believe that
facilitating public research using this bid pricing data could lead to
better understanding of the costs and utilization trends in MA and
support future policymaking for the MA program. For example, MA bid
pricing data (which contains actual and projected cost figures) could
be used to understand patterns of health care utilization such as how
projected and actual costs may differ across geographic areas and
different beneficiary populations. Release of MLR data from the MA and
Part D programs could lead to research into how managed care in the
Medicare population differs from and is similar to managed care in
other populations (such as the individual and group markets) where MLR
data is also released publicly; such research could inform future
administration of these programs. Further, we believe that making
certain MA bid pricing data and Part C and Part D MLR data available
publicly aligns with Presidential initiatives to improve management and
transparency of federal information. The President's January 21, 2009,
Memorandum on Transparency and Open Government (74 FR 4685) instructed
federal agencies to take specific actions to implement increased data
transparency and access to federal datasets. Subsequent Presidential
memoranda (including the May 23, 2012 memorandum Building a 21st
Century Digital Government and May 9, 2013 memorandum Making Open and
Machine Readable the New Default for Government Information) further
stated the policy initiative to increase open access to and
interoperability among such government data sets. These memoranda
demonstrate a commitment to making information about government
activities and government spending available to the public and using
the internet as a means of public disclosure in order to eliminate as
many barriers as possible to public access to such information. Our
proposal would promote accountability in the MA and Part D programs, by
making MLR information publicly available for use by beneficiaries who
are making enrollment choices and by allowing the
[[Page 46397]]
public to see whether and how privately-operated MA and Part D plans
administer Medicare--and supplemental--benefits in an effective and
efficient manner. Disclosing MA pricing data would provide the public
with insight as to how public dollars are spent in this aspect of the
Medicare program. Further, we have received requests under FOIA for
data of the type of the pricing data we propose to release here and we
anticipate that, as the MLR Reports from MA and Part D plans are
submitted, we will receive requests for those reports and that data.
These interests, however, must also be balanced with the need to
protect the privacy of individuals, the confidentiality of information
about Medicare beneficiaries, and the proprietary interests of the MA
and Part D plans that submit the information. While transparency in
governmental activities and spending is important, we recognize that
some of the information we collect in the form of MA bid pricing
submissions and Part C and Part D MLR reports should not be publicly
disclosed. We believe that our proposal balances these various
interests and goals, both in carving out from the planned and
authorized releases certain specific data, and (in the case of the MA
bid pricing data) in delaying the release past the point of the
commercial usefulness of the data.
We are seeking to balance protection of the proprietary interests
of MAOs and Part D sponsors with the need to effectively and
transparently administer federal health care programs and to encourage
research into better ways to provide health care. Further, we believe
that adopting a fixed schedule for release of this information and
standardizing releases of this data through this rule, will reduce the
burdens on the public, CMS, and the submitters of the data that are
associated with individual requests for information. Proposing a rule
for these releases provides the opportunity for a fulsome and public
dialogue that is not always the case with individual requests for
information. We encourage commenters to identify and explain additional
uses of the information we propose here to release and to suggest
additional protections from release if commenters disagree with how we
have balanced the competing interests. We hope to receive comments from
all viewpoints to ensure that the lines for releasing and protecting
information are appropriately drawn.
2. MA Bid Submission and Pricing Data
We make monthly prospective payments to MAOs for providing Part C
coverage to Medicare beneficiaries enrolled in their MA plans. As
mandated in section 1854 of the Act, amended by Title II of the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA) (Pub. L. 108-173), our payments to MAOs for their MA plan
enrollees are based on bids that MAOs must submit to us no later than
the first Monday in June for the upcoming contract year. Each MA plan
bid is an estimate of the plan's revenue requirement to cover plan
benefits for a projected population. The monthly aggregate bid amount
for an MA plan is composed of estimated benefit expenses (direct
medical expenses), non-benefit expenses (administrative expenses), and
a gain/loss margin (profit) for coverage of original Medicare benefits,
Part C supplemental benefits (if any), and Part D benefits (if any). We
are not proposing to release Part D bid pricing data in this rule.
Also, cost plans operated under section 1876 and section 1833 of the
Act, Program for All Inclusive Care for the Elderly (PACE)
organizations, and Medicare-Medicaid demonstration plans operated under
the Financial Alignment Initiative (https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/FinancialAlignmentInitiative/FinancialModelstoSupportStatesEffortsinCareCoordination.html) do not
submit Part C bids to us so pricing data relating to those plans is not
part of this proposed rule.
Section 1854(a) of the Act requires that MA bid submissions,
including coverage, cost-sharing, and pricing, be in a form and manner
specified by the Secretary. The statute, as specified in paragraphs
(a)(1), (a)(3), and (a)(6), requires that bids include the plan type,
the plan's geographic service area, projected enrollment under the
plan, bid amounts for the provision of Part C benefits, bid amounts for
Part D benefits (if offered by the MA plan), descriptions of
beneficiary cost-sharing liability for each type of benefit, the plan's
use of the beneficiary rebate (if any), and the actuarial basis for
determining the bid pricing amounts. Part C benefits include basic
benefits (that is, the benefits available under Original Medicare Parts
A and B) and non-Medicare supplemental benefits (both mandatory and
optional); supplemental benefits may include benefits not available
under Original Medicare (for example, vision and dental benefits) or
the reduction in cost-sharing obligations of enrollees compared to
Original Medicare.
The regulation at Sec. 422.254 addresses the content of the bid
submission as well but does not specify the form or manner of the
submission. We developed standardized templates for MAOs to populate
and upload to our Health Plan Management System (HPMS) as the bid
submission described in the statute and regulation. These standardized
MA bid submission templates collect the information required under
Sec. 422.254, and organize the information as follows:
Plan Benefit Package (PBP) information (describing the
Part C benefits and cost-sharing for each MA plan);
Service Area information (identifying geographic areas
where an MA plan is to be offered by the MAO);
Plan Crosswalk information (identifying plan
consolidations, terminations, and/or service area changes from one year
to the next); and
The MA bid pricing data for each PBP (that is, each MA
plan). MA bid pricing data is uploaded to HPMS in a template referred
to as the MA Bid Pricing Tool (MA BPT).
Currently, we publicly release information on the Plan Benefit
Package, service area, and plan crosswalks each year. These data sets
can be found on our Web site at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/, under the subpages Benefits-Data, MA-
Contract-Service-Area-by-State-County, and Plan-Crosswalks,
respectively.
In this rule, we propose to release MA bid pricing data, as defined
at proposed Sec. 422.272, which would be implemented as a release of
data housed in the MA BPT for each MA plan subject to specified
exclusions from release (noted in this section of the proposed rule).
The MA BPT is a standardized Excel workbook with multiple worksheets
and special functions built-in (for example, validation features).
There are also separate BPTs used to price two types of MA plans:
Medicare Medical Savings Account plans (the MSA BPT); and End-Stage
Renal Disease-only special needs plans (the ESRD-SNP BPT). The MSA BPT
was first released for calendar year (CY) 2009 bidding, and the ESRD-
SNP BPT was first released for CY 2014 bidding. We maintain and update
these three MA BPT formats under OMB #0938-0944, and release annual
versions every April.
The MA BPT templates can be found on our Web site at https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Bid-Forms-Instructions.html, accompanied
[[Page 46398]]
by instructions on how to populate the tool and a data dictionary for
all data elements. Information pertaining to the MSA BPT and the ESRD-
SNP BPT can be found in the Appendices within the general MA BPT
instructions, which can be found on the Bid-Forms Web site.
Below we describe the general categories of MA bid pricing data
contained in the MA BPT templates, indicating the associated BPT
worksheet. Worksheets 1 through 6 of the MA BPT template collect
information for the development and identification of the revenue
requirements for basic benefits and mandatory supplemental benefits.
Optional supplemental benefits, which enrollees may opt to purchase
separately, are addressed in a separate worksheet. The BPT as a whole
collects the information described in Sec. 422.254(b), (c) and (d) for
coordinated care and private fee-for-service plans and in Sec.
422.254(b) and (e) for MA-MSA plans. The regulation describes the
required bid elements in general terms, which we implemented and
operationalized at a detailed level in the BPT.
a. MA Base Period Experience and Projection Assumptions (MA BPT
Worksheet 1)
MAOs must report base period experience data, which is defined as
claims incurred in the calendar year 2 years prior to the contract year
for which the bid is being submitted, for basic benefits and mandatory
supplemental benefits. For example, for CY 2017 bids (which must be
submitted June 6, 2016), the base period data is for CY 2015. For the
historical period, MAOs report the plan's actual allowed per member per
month (PMPM) cost, unit cost and utilization by service type (for
example, inpatient, outpatient, etc.); cost sharing and net costs are
also reported. MAOs must also report actual enrollment and revenue, as
well as expenses for claims, administration, and gain/loss margin, for
this base period. Finally, MAOs must report the assumptions they use to
project (that is, trend) the base period claims experience to the
contract year for which they are bidding.
b. MA Projected Allowed Costs (MA BPT Worksheet 2)
MAOs provide the projected allowed PMPM costs, unit costs, and
utilization by service type for the contract year, using the claims
experience and projection assumptions described previously; such
information demonstrates the actuarial bases of the bid. Allowed costs
are ``gross'' costs, that is, before the application of any beneficiary
cost sharing. Total projected allowed costs are reported separately for
dual eligible beneficiaries without full Medicare cost-sharing
liability versus other beneficiaries. MAOs may also enter manual rates
and the credibility assumptions used to blend together manual rates
with projected experience.
c. MA Projected Cost Sharing (MA BPT Worksheet 3)
MAOs present the effective value of a plan's level of cost-sharing
by service type, which must include both in-network and out-of-network
cost sharing (copays and coinsurance) and other amounts such as plan
deductibles and the plan's out-of-pocket maximum cost-sharing amount.
d. MA Projected Revenue Requirement (MA BPT Worksheet 4)
MAOs then combine their allowed cost data and cost sharing
information (described in sections III.E.2.b. and c. of this proposed
rule) to calculate the plan's projected revenue requirement, which
consists of benefit costs (direct medical costs) net of cost-sharing,
non-benefit expenses (administrative costs), and gain/loss margin. The
plan's projected revenue requirement is allocated to the following:
Medicare-covered A/B services, prescription drug coverage (if the plan
is an MA-PD plan), and non-Medicare covered services (mandatory
supplemental benefits under the plan).\7\ MAOs report the revenue
requirement separately for dual eligible beneficiaries without full
Medicare cost-sharing liability versus other enrolled beneficiaries.
They also report administrative expenses by category (for example,
direct versus indirect administration) and information related to the
plan's gain/loss (profit) margin.
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\7\ We are not proposing to release any Part D bid pricing data
as part of this proposed rule. Therefore, for any MA-PD bid, the
Part D information underlying the pricing of Part D benefits would
be redacted from any data release under this rule. However, the
amount of beneficiary rebate applied to buy-down the Part D premiums
if any, is included at Sec. 422.264(b)(2) as a use of Part C
dollars, so will be included in the MA bid pricing data release. See
section III.E.3.a.1.
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MAOs have the option of reporting enrollment, revenue and expense
information related to their plan enrollees with End Stage Renal
Disease (ESRD) on worksheet 4; these costs are otherwise excluded from
bid development. (We have the authority to determine whether and when
it is appropriate to apply the bidding methodology to ESRD MA
enrollees, as set forth at Sec. 422.254(a)(2).) MAOs also have the
option of reporting information related to Medicaid revenue and
expenses for dual eligible beneficiaries.
The plan's expected risk profile (average risk score) is reflected
in the projected revenue requirements (costs) for both A/B and
supplemental bid amounts. That is, the projected costs will reflect the
expected risk profile of that plan's population because the utilization
projections built into the costs projected in the bid reflect the
underlying risk and need for services of the expected enrollees for
that plan. When these projected costs are divided by the plan's
projected risk score for a projected enrollment, the costs become
``standardized.'' Standardized costs have a risk score equal to one,
which means that they reflect the risk profile of the average Medicare
beneficiary.
e. MA BPT Benchmark (Worksheet 5)
The MA BPT illustrates development of the plan-specific A/B
benchmark, based on the service area of the plan and the county rates
(or MA regional rates) applicable to the plan; the benchmark is
identified and calculated using information provided by the plan and
county rate information announced by CMS. See Sec. 422.254 and Sec.
422.258. The service-area level benchmark represents the upper limit
that the federal government will pay PMPM for coverage of A/B benefits
in the defined service area, given the plan's quality rating, prior to
risk adjusting payments. The service-area level benchmark for (non-
regional) plans that cover multiple counties is a weighted average of
the projected plan enrollment and the applicable county ratebook
amounts.
For benchmark development, the MAO reports the following: Projected
enrollment in member months per county; projected average risk score
for the projected enrollment in each county in the plan's service area;
and a plan-level factor for the proportion of beneficiaries with
Medicare as Secondary Payer. Plan-level projected member months and
risk scores are reported separately for dual eligible beneficiaries
without full Medicare cost-sharing liability versus other
beneficiaries.
The MA BPT is programmed to compare the A/B bid amount from the MAO
to the benchmark to determine whether the plan has a beneficiary rebate
(defined at Sec. 422.266) and must submit information required by
Sec. 422.254(d). If the plan A/B bid amount is lower than the plan
benchmark, a percentage of the difference determines the beneficiary
rebate amount (where the percentage is based on the plan's quality
rating). If the bid is greater than benchmark, the plan must charge a
[[Page 46399]]
member premium for coverage of A/B benefits.
f. MA Bid Summary (MA BPT Worksheet 6)
The MA BPT presents a summary of key figures developed in the tool,
including the bid, benchmark, projected risk score, and rebate amount,
to support the final step of bid pricing--development of the
beneficiary premium (if any) for the plan. To determine the premium,
MAOs indicate how the rebate amount will be allocated. Under Sec.
422.266(b), the rebate must be allocated to some combination of MA
mandatory supplemental benefits (defined at Sec. 422.2), which can
include buy down of original Medicare A/B cost-sharing and offering
additional benefits not covered by original Medicare; and buy down of
the Part D basic premium, the Part D supplemental premium, and/or the
Part B premium.
g. Optional Supplemental Benefits (MA BPT Worksheet 7)
MAOs may offer optional supplemental benefits, which plan enrollees
may opt to purchase for a separate, additional premium. MAOs present
the actuarial pricing elements for any optional supplemental benefit
packages to be offered during the contract year, up to a maximum of 5
packages. Not all MA plans offer optional supplemental benefits. MAOs
report projected member months, allowed costs PMPM, cost sharing,
administrative costs and gain/loss margin for each optional
supplemental benefit package. MAOs also report base period experience
for optional supplemental benefits, including revenue, enrollment,
claim expenses, administrative expenses, and gain/loss margin. The
information is reported separately as enrollees must make a separate
election to purchase these benefits, and for coordinated care plans and
private fee-for-service plans they cannot be funded by beneficiary
rebates.
h. MSA BPT and ESRD-SNP BPT
Regarding the MSA BPT and ESRD-SNP BPT, the same general
requirements apply: Submission of base period experience data;
projected allowed costs by service type; projected enrollee cost-
sharing payments; projected revenue requirements (medical,
administrative, and margin); and development of the plan benchmark
against which the bid is compared. Unique to the MSA BPT is development
of the beneficiary deposit amount for the high-deductible plan. Unique
to the ESRD-SNP BPT are service categories such as dialysis and
nephrologist.
i. Additional Documentation
In addition to the categories of data noted in this section of the
proposed rule, MAOs must also submit supporting documentation to
substantiate the actuarial basis of pricing and an actuarial
certification of the bid for their MA BPTs, MSA BPTs, and ESRD-SNP
BPTs, as required at Sec. Sec. 422.254(b)(5) and 422.256(c)(5).
3. Proposed Regulatory Changes for Release of MA Bid Pricing Data
We are proposing to amend our MA regulations to provide for the
release of certain MA bid pricing data. We propose to release to the
public each year, after the first Monday in October, MA bid pricing
data that we accepted or approved for a contract year at least 5 years
prior to the upcoming calendar year, subject to specific exclusions
described in proposed Sec. 422.272(c). We believe this disclosure is
consistent with Presidential directives to make information available
to the public, and with our goals of allowing public evaluation of the
MA program, encouraging research into better ways to provide health
care, and reporting to the public regarding federal expenditures and
other statistics involving this program. For example, MA bid pricing
data (which contains actual and projected cost figures) could be used
to understand patterns of health care utilization such as how projected
and actual costs may differ across geographic areas and different
beneficiary populations, which could inform future bidding and payment
policies. Further, releasing pricing data, particularly in conjunction
with information already released under Sec. 422.504(n), will provide
insight into the use of public funds for the MA program, providing
appropriate transparency about the administration of the program.
We propose to codify the requirements for release of MA bid pricing
data for MA plan bids accepted or approved by us by adding a new Sec.
422.272 to subpart F of part 422. First, we discuss the definition of
MA bid pricing data, then our proposal to release MA bid pricing data
for MA plan bids accepted or approved by us, and the types of
information we propose be excluded from these data releases. Next, we
discuss the specific proposal for the timing of the public data
release. Finally, we solicit public comment on approaches to releasing
more recent MA bid pricing data. We also solicit comment on our goals
and purposes stated above for the release of MA bid pricing data.
(a) Terminology
At Sec. 422.272(a), we propose a definition of MA bid pricing data
to mean the information that MAOs must submit for the annual bid
submission for each MA plan, in a form and manner specified by us.
Specifically, we propose that MA bid pricing data includes the
information described at Sec. 422.254(a)(1) and the information
required for MSA plans at Sec. 422.254(e). We use Sec. 422.254(a)(1)
in our proposed definition because it provides an overview of the
submission requirements in our MA bidding regulations. Specifically,
Sec. 422.254(a)(1) references Sec. 422.254(b), (c), and (d), which
address, respectively, general bid requirements, information required
for coordinated care plans and private fee-for-service plans, and
information on beneficiary rebates. At Sec. 422.272(a)(2), we propose
to include in the definition the information required for bids for MSA
plans, set forth at Sec. 422.254(e), which includes the amount of plan
deductible for the high-deductible plan.
By proposing to define MA bid pricing data at Sec. 422.272(a)
using cross-references to existing regulation at Sec. 422.254(a)(1)
and (e), we are proposing in operational terms that the term encompass
all plan-specific data fields in the MA BPT, the MSA BPT, and the ESRD-
SNP BPT, that is, the figures that MAOs input and those that are
calculated within the BPT. The BPTs also include data that are not
plan-specific, which consist of look-up tables built-in to facilitate
calculations. We do not propose to include these look-up tables as part
of the proposed definition of MA bid pricing data, as they are not
submitted by the MAO. These look-up tables are hidden Excel worksheets
(which can be ``unhidden'' within Excel), and are currently available
to the public in the BPT templates on the CMS Web site at https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Bid-Forms-Instructions.html. Selected data from the look-up tables are reflected
in each MA plan's BPT. For example, there is a look-up table in the
BPTs with the county rates for the contract year and when the MAO
enters a state-county code, the BPT extracts the appropriate rate
amount for the county from the look-up table and populates the
appropriate data field.
Our proposed definition of MA bid pricing data references elements
required at Sec. 422.254(b) and includes information described in
section III.E.2. (MA Bid Pricing Data) of this proposed rule: The
estimated revenue required by an MA plan for providing original
[[Page 46400]]
Medicare benefits and mandatory supplemental health care benefits, if
any (composed of direct medical costs by service type, administrative
costs and return on investment); and the plan pricing of enrollee cost-
sharing for original Medicare benefits and mandatory supplemental
benefits. In addition, the definition references the MA bid pricing
data elements required at Sec. 422.254(c), which include more detail
about the Medicare-covered and supplemental bid amounts such as the
actuarial bases for the bid amounts, projected enrollment, and data
specific to regional MA plans.
Finally, we propose to define MA bid pricing data to include
elements required at Sec. 422.254(d), thus incorporating a reference
to the forms of beneficiary rebate at Sec. 422.266(b). That is, for
plans that bid below the benchmark for their service areas, the term
would include the beneficiary rebate amounts that are allocated in the
BPTs to the uses allowed in law: Reduction of cost-sharing below
original Medicare levels, offering additional benefits not covered by
original Medicare, and reduction of the Part D basic premium, the Part
D supplemental premium, and/or the Part B premium. Unlike the
underlying components of the Part D pricing (that is, pricing
information related to the Part D benefit analogous to the information
included in the MA BPT), we consider beneficiary rebate amounts that
are applied to reduce the Part D basic and supplemental premiums to be
Part C amounts that are part of the MA bid pricing submission, not the
Part D bid pricing submission.
(b) Release of Accepted or Approved MA Bid Pricing Data With a 5 Year
Lag
In Sec. 422.272(b), we propose to authorize the public release of
MA bid pricing data for the MA plan bids that were accepted or approved
by us for a contract year under Sec. 422.256. We propose that the
annual release will contain MA bid pricing data from the final list of
MA plan bids accepted or approved by us for a contract year that is at
least 5 years prior to the upcoming calendar year.
We use the phrase ``accepted or approved'' in the proposed
regulation text because both terms are used in existing regulation when
referring to MA bids. We consider these words to mean the same thing in
the context of MA bid pricing submissions, and we use both words in
proposed Sec. 422.272(b) to mirror existing regulation. For example,
existing Sec. 422.256(b) states that CMS can only accept bids that
meet the standards in that paragraph. However, Sec. 422.256(b)(4)(i)
and (ii) use the phrase ``CMS approves a bid. . . .'' The phrases
``decline to accept'' and ``decline to approve'' are used at Sec.
422.254(a)(5) and Sec. 422.256(a), respectively. In the remainder of
this preamble, we will use the term ``accepted'' to represent the
phrase ``accepted or approved.''
During our annual bid review process, we determine which MAOs must
submit one or more updated versions of the initial MA BPT for one or
more of their MA plans, in response to questions from our bid
reviewers. In addition, as part of the bid pricing submission process,
an MAO may have to adjust its allocation of beneficiary rebate dollars
for some or all of its MA plans that offer Part D and for their
regional PPOs, after we publicly release the Part D national average
bid amount and the final MA regional plan benchmarks. Any reallocation
of rebate dollars results in a revised MA bid, which must be submitted
to us as an updated version of the original submission. Finally, on
occasion an MAO will withdraw an MA plan after we have accepted the
plan bid. For these reasons, we propose that the MA bid pricing data to
be released will only be the data found in the final list of accepted
bids; for operational purposes, this means the final accepted MA BPTs,
MSA BPTs, and ESRD-SNP BPTs, subject to exclusions noted in proposed
paragraph (c).
Finally, in Sec. 422.272(b), we propose to authorize the annual
release of MA bid pricing data for a contract year that is at least 5
years prior to the upcoming calendar year. We believe that 5 years is
an appropriate length of time for the MA bid pricing data to no longer
be competitively sensitive. (The base period data on actual expenses in
the MA BPT, MSA BPT, and ESRD-SNP BPT is 2 years older than the data
for the bidding year--see the description of the MA BPT category MA
Base Period Experience and Projection Assumptions in section III.E.2.
of this proposed rule.) Since this will be an annual release, over time
the public would have the ability to trend bid cost projections across
years, to compare actual costs from the MA BPT with projections from
prior years, and to observe bidding patterns over ever-longer periods
of time.
We are seeking to balance the protection of commercially sensitive
information with our goals to effectively administer federal health
care programs, increase data transparency regarding federal
expenditures, and encourage research into better ways to provide health
care. We propose that a 5-year delay renders multi-year comparisons of
pricing trends less relevant to the current year of MA plan pricing.
The time lag represents a buffer between the development and
implementation of pricing strategies that can be distilled from data
multiple years for and the observed relationship and trend from one
year to the next, thus mitigating possible competitive disadvantage
from the proposed data disclosure. For example, an MAO looking to enter
a new MA market is significantly less likely to gain an unfair
commercial advantage from being able to examine and trend 5-year-old
bid pricing data than if the MAO were able to examine and trend more
recent bid pricing data.
We solicit comment on the proposed 5 year delay for reducing
competitive disadvantages to MAOs. We solicit comments explaining
whether a shorter period would suffice to protect MAOs from competitive
harm associated from the disclosure of confidential commercial
information or if a longer period is necessary to adequately protect
the information and assure the continued submission of accurate data.
(c) Exclusions From Release
In Sec. 422.272(c), we propose that several types of MA bid
pricing information be excluded from the data releases under paragraph
(b). First, we note that we are not proposing to release Part D bid
pricing data in this rule. For this reason, the exclusion from release
at proposed Sec. 422.272(c)(1) is information pertaining to the Part D
prescription drug bid amount for an MA plan offering Part D benefits,
specifically the information required for Part D bid submission at
Sec. 422.254(b)(1)(ii), (c)(3)(ii), and (c)(7). We consider this
exclusion at proposed Sec. 422.272(c)(1) to include the following
amounts in the MA BPT that pertain to the Part D premiums: The Part D
basic premium before and after application of beneficiary rebate
amounts; the Part D supplemental premium before and after application
of beneficiary rebate amounts; the combined MA plus Part D total plan
premium; and the target Part D basic premium.
Regarding Part D bid pricing data, section 1860D-15(f) of the Act
contains protections for data submitted by Part D Sponsors in
accordance with section 1860D-15; these protections would generally
prohibit public release of such data. We propose that the Part D bid
pricing elements listed in this section of the proposed rule, which
appear in the MA bid pricing tools, would be excluded from release.
However, we note that the Part C statute does not establish similar
protections for MA bid pricing data, and we believe that MA
[[Page 46401]]
bid pricing data is not subject to the protections imposed by section
1860D-15 of the Act.
Second, at Sec. 422.272(c)(2), we propose to exclude from release
two categories of additional information that we require to verify the
actuarial bases of the MA plan bids. At paragraph (c)(2)(i), we propose
to exclude from release any narrative information in the MA BPT, MSA
BPT, and ESRD SNP BPT regarding base period factors, manual rates,
cost-sharing methodology, optional supplemental benefits, or other
topics for which narratives are required by us under Sec. 422.254.
These narrative fields provide additional information to allow us to
verify the actuarial bases of the bid, as described at Sec.
422.256(c)(5). For the base period narratives, MAOs are asked to
describe the source of the base period experience data, and any other
utilization adjustment factors, unit cost adjustment factors, and
additive adjustment factors that the MAO applied. For projected allowed
costs, the narrative field captures descriptions of manual rates
including trending assumptions in the manual rates. For projected cost
sharing, the narrative fields contains a description of the methodology
for reflecting the impact of maximum cost-sharing. Finally, for
optional supplemental benefits, there is a general comments field. The
proposed regulation text would also exclude from release any other
narrative fields in the BPT that we may require as the bid submission
process changes over time. We propose to exclude these text fields in
the BPTs. MAOs may populate them with information pertinent to more
than the individual MA plan bid in which the narrative is included,
such as regional or national-level information on an MAO's approach to
cost-sharing methodology or projection factors. For example, MAOs may
provide information on provider contracting, such as the fee schedules.
Further, these explanations and additional information provide insight
into the exercise of actuarial judgment in developing the bids. We
believe that it is reasonable to treat such summary statements of MAO
methodology or strategy as information proprietary to the MAO that
should remain protected from public disclosure. The release of such
information (for example, fee schedules or national pricing strategy)
may provide an unfair commercial advantage to certain entities, such as
new market entrants, and likely would impair the government's ability
to obtain such information in the future, since MAOs have greater
discretion in deciding what written information to share with us and
would likely attempt to avoid sharing fee schedule and pricing strategy
information.
Another category of information that we propose to exclude from
release, at Sec. 422.272(c)(2)(ii), is the supporting documentation
that MAOs submit to us to support the actuarial bases of each MA plan
bid; these materials are collected outside of the BPT templates so this
proposed exclusion would be operationalized by withholding from release
any materials submitted as part of an MA bid that were not part of the
BPT worksheet submission. Supporting documentation for each MA plan bid
can consist of multiple text, spreadsheet, and email files. MAOs submit
the first round of supporting documentation with the initial bid
submission. Subsequently, during the bid review process, our reviewers
may communicate requests for additional supporting documentation, and
in response, MAOs may submit multiple updated versions of an MA plan's
BPT and additional supporting documentation. There are no standard
formats for supporting documentation. A range of files (Word, Adobe,
Excel, and email formats) may be uploaded for each of the MA plan bids,
and there is no way to identify clearly which data elements in any of
the supporting documentation for an MA plan bid applies to the final
accepted version of the bid. Supporting documentation often links a
particular plan bid to an MAO's broader pricing approaches, such as
financial arrangements with providers, and we believe that such
analytical information at a regional or national level could be
commercially sensitive information in a way that the cost and
enrollment estimates in the BPT are not, since such strategic pricing
and contracting information could provide an unfair commercial
advantage to certain entities, such as new market entrants, who would
not need to release such strategic information. We also are concerned
whether release of supporting documentation could have a chilling
effect on the scope of information provided by MAOs for future bidding
and our ability to accurately evaluate bids. We rely on MAOs to provide
detailed explanations of the bids in order for CMS to fully understand
the judgment calls underlying the assumptions reflected in the bids. If
MAOs believe that the explanations and additional information are not
protected from disclosure, they may provide less information and less
explanation. In order to preserve the access we have, we are proposing
to protect this information.
Third, at Sec. 422.272(c)(3), we propose to exclude from release
any information identifying Medicare beneficiaries and other
individuals. We believe that this identifying information should be
excluded from a public data release to protect the privacy of
individuals, including but not limited to protecting the
confidentiality of information about Medicare beneficiaries. Regarding
Medicare beneficiaries, we propose to exclude from release any MA bid
pricing data element that is based on fewer than 11 Medicare
beneficiaries as we believe that this threshold establishes the point
at which individual-level data can be discerned. Following our
longstanding data release policy for protecting individually
identifiable information, in the event that data fields in an MA BPT,
MSA BPT, or ESRD SNP BPT are populated with fewer than 11 MA plan
members (or 132 member months, assuming each individual is counted for
12 months), we would suppress all of those data fields in the public
release file for that MA plan bid under our proposed rule. We are not
proposing to build this threshold into the regulation text, however, as
we believe that technology and the ability to reverse-engineer data to
identify beneficiaries may change over time. We may revisit this
threshold as we administer the data releases proposed here (and in
other Medicare contexts) and will make adjustments as necessary to
ensure that we do not disclose data that could be used to identify
beneficiaries. For example, data fields with member months, utilizers,
and utilization per 1,000 could be populated based on fewer than 11 MA
plan members and would be suppressed from the release under this
proposed rule. Protection of information that could identify Medicare
beneficiaries, particularly in the context of their receipt of health
care services, is a long-standing principle of ours in the context of
the Medicare program. Incorporating this principle and the necessary
protection of this data into this proposal to disclose information is
appropriate.
Regarding other individuals, we require the names and contact
information of certifying actuaries and MA plan contacts in the MA bid
submission, that is, in certain fields in the MA BPT, MSA BPT, and
ESRD-SNP BPT, and we also require the names and contact information in
the actuarial certifications submitted by actuaries who prepared the
bids. We propose to exclude this information from the release that we
propose to implement. The actuarial certification consists of
standardized language that we
[[Page 46402]]
developed for the purpose of bidding; for example, the language notes
that the actuary is a member of the American Academy of Actuaries,
federal law and CMS guidance regarding MA bids were followed, the data
and assumptions used in the development of the bid are reasonable, and
Actuarial Standards of Practice were applied. (Certifying actuaries may
choose whether to append additional language.) We do not believe that
these bid certification paragraphs represent information that serves
the goals for this proposed release of MA bid pricing data (for
example, to inform research and public evaluation of the MA program and
to be transparent about spending). In addition, identifying specific
individuals who have worked on a bid for an MAO appears an unnecessary
intrusion into the personal privacy of these individuals. In sum, we
propose to not release any information identifying individual actuaries
or their associated certification paragraphs, to protect individual
names and to not expend resources separating names from each of the
hundreds of identical or similar paragraphs of attestation language.
Finally, at Sec. 422.272(c)(4), we propose to exclude from release
bid review correspondence between us (including our contractors) and
the MAO, and internal bid review reports (for example, bid desk review
documentation housed in the HPMS Bid Desk Review module, which supports
the automated aspects of bid review). First, bid review correspondence
(emails) often involves follow-up questions requesting clarification of
supporting documentation, so our concerns described above regarding the
release of supporting documentation apply to bid review correspondence.
Second, it would not be operationally feasible to determine which set
of bid review emails between our reviewers and MAOs and which internal
bid review reports pertain to the final accepted/approved bid for an MA
plan, which is the data we propose to release.
(d) Timing of MA Bid Pricing Data Release
At Sec. 422.272(d), we propose the timing of the release of MA bid
pricing data as provided in paragraph (b) and limited by the exclusions
in paragraph (c). We propose that the annual release would occur after
the first Monday in October. We selected the first Monday in October as
the date after which the release could occur each year because the
annual bidding cycle has come to a close at this point and we have
completed the approval of MA plan bids for the upcoming contract year
(calendar year). For example, after the first Monday in October 2016,
the bids for contract year 2017 have been accepted; thus, a public
release in December 2016 or January 2017 would be a release of the
final accepted MA bid pricing data for a contract year not more recent
than 2012.
Under this example, our December 2016 release of MA bid pricing
data under this proposed rule may include the following: (1) The
accepted MA BPT worksheets for 2012 in their entirety, subject to the
exceptions Sec. 422.272(c); (2) the accepted MSA BPT worksheets for
2012 in their entirety, subject to the same exceptions; (3) accepted MA
BPTs for 2006 through 2011, subject to the same exceptions; and (4) MSA
BPTs for 2009 through 2011 (as 2009 was the first year this BPT was
used), subject to the same exceptions, because these years are more
than 5 years prior to 2017. However, under the example of a December
2016 release, we would not release any Part C pricing data for ESRD-
SNPs because the ESRD-SNP BPT was used for the first time for contract
year 2014; the first time that data from accepted ESRD-SNP BPTs could
be released under this proposal is after the first Monday in October
2018.
While we propose to authorize release of this data after the first
Monday in October each year, we are not committing to a specific date
for each annual release. We will provide details on each year's release
schedule through sub-regulatory communications. We anticipate that as
the release process becomes more standardized over the years, we will
be able to release these files closer to the proposed regulatory
timeline. In addition, we intend that the first time we implement a
public release MA bid submission data, we may release data for multiple
contract years that meet the criterion of at least 5 years prior to the
upcoming calendar year.
As mentioned in the Background (section III.E.1), in crafting this
proposal to release MA bid pricing data, we are seeking to balance
proprietary interests with our mission to effectively administer
federal health care programs and increase data transparency. We are
soliciting comments on the approach we are proposing for the public
release of MA bid pricing data based on a 5-year lag in the data, and
whether that is the appropriate timeframe to apply to this data
release. We also seek comment on the scope of the proposed release of
BPT worksheets and data elements. We are particularly interested in
whether of the MA bid pricing data we are proposing to release contains
proprietary information, and if so, are requesting detailed
explanations of good cause for its redaction from public availability
and suggestions for what safeguards might be implemented to
appropriately protect those portions of the data. Detailed explanations
should contain specific examples which show how this information
disclosure could cause substantial competitive harm to MAOs. Specific
examples should (1) cite the particular information proposed to be
released and explain how that information differs from publicly
available data; (2) point to the particular entity or entity type that
could gain an unfair competitive advantage from the information
release; and (3) fully explain the mechanism by which the release of
that particular information would create an unfair competitive
advantage for that particular entity. Similarly, we are interested in
comments that our proposed scope for release is too narrow and
unnecessarily protects data that is not confidential and should not be
protected. We are soliciting comments and explanations that show how
the data is not confidential, could not be used to create unfair
competitive disadvantage, and that its release would not have a
chilling effect on the nature and scope of the data that we currently
receive from MAOs in the bid submissions. As noted above, we view this
rulemaking as the opportunity to solicit wide ranging comments on this
issue in order to chart the wisest course for release of pricing data
in support of our goals.
4. Proposed Technical Change
We propose to amend Sec. 422.250 on the basis and scope of the MA
program to add a reference to section 1106 of the Act. As discussed in
the Background (section E.1.), section 1106(a) of the Act (42 U.S.C.
1306(a)) provides us the authority to enact regulations that would
enable the agency to release information filed with this agency.
5. Other Approaches To Release of MA Bid Pricing Data
We are also considering whether to release MA bid pricing data for
years more recent than the 5-year data lag proposal. In 2011, an
academic researcher submitted a request to CMS for certain data
elements regarding the 2009 MA Base Period Experience in the 2011 MA
bid pricing submissions. We rejected the request under Exemption 4 to
the FOIA, 5 U.S.C. 552(b)(4), which exempts from disclosure trade
secrets and confidential or privileged commercial or financial
information that is obtained from a person. In a 2013 opinion, Biles v.
Dep't of Health and Human Services, 931 F. Supp. 2d 211 (D.D.C. 2013),
the U.S. District Court for
[[Page 46403]]
the District of Columbia ordered the release of the requested bid
information, rejecting HHS's argument that release would cause
substantial competitive harm to the private companies that submit bid
data to CMS. The court remarked that the HHS statements about
substantial competitive harm were conclusory. As a result of this
ruling, we released the requested data to the academic researcher (and
the public) at https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/DataRequests.html. In light of this
litigation, as well as anticipated additional requests for more recent
MA bid pricing data, we are soliciting public comments on a range of
approaches we could implement to release data more recent than the
proposal we are currently setting forth for consideration.
For example, we are considering whether to release MA bid pricing
data on a shorter timeframe than the proposed 5-year lagged timeframe,
which could be as recent as MA bid pricing data from the previously-
concluded MA contract year. We are also seeking comment as to whether
the relationship between the passage of time and commercial sensitivity
of the bid data changes more rapidly for some MA bid pricing data
elements than others. If commenters believe this to be the case, we are
seeking the submission of detailed analysis that sets forth which data
elements meet this standard and why.
If unfair competitive harm is included as a rationale for us to
consider in withholding some or all elements of more recent MA bid
pricing data from release, either to external researchers subject to
some limitations in redisclosure of the data or the public at large, we
seek evidence of this competitive harm linked to particular bid data
elements, and a fulsome discussion as to how each of the elements
identified could be used by a competitor to directly harm a competing
MAO. See section III.E.3.d above for detail on what a fulsome
discussion would include, in our explanation of ``specific examples.''
If there are commercially sensitive data elements in the MA bids, we
also seek comment as to whether there are safeguards that might be
appropriately implemented to protect those identified data elements,
while still allowing releases of more recent data.
Finally, we are seeking comment regarding to whom we should release
more recent MA bid pricing data. Specifically, should such a release be
made fully available to the public at large, or only to researchers who
have studies approved through an application process and who are
subject to our long-standing data sharing procedures. If we were to
release MA bid pricing data for years more recent than the 5 year
lagged data we propose here, we also seek comment on whether to use the
existing policies for the release of Part D prescription drug event
(PDE) data at Sec. 423.505(m) and Part C encounter data at Sec.
422.310(f)(2). We also seek comment on whether research results from
the analysis of MA bid pricing data should be subject to additional
restrictions, such as a prohibition of publication of MA bid pricing
data at the plan level or prohibitions on the identification of the
applicable MAO that submitted the data. We seek comment on whether
external researchers should be able to use MA bid pricing data for
commercial purposes rather than to produce research that could be
useful to us in our administration of the Medicare program generally.
We are considering limiting conditions of this type as means to release
as much data while protecting what should be protected.
As discussed in section III.E.3.d above, we are seeking comment on
our proposal that 5 years is an appropriate length of time for the MA
bid pricing data we are proposing to release to no longer be
competitively sensitive. In addition, in setting forth this section
III.E.5 discussion, we are also soliciting comments on how we can best
serve the needs of the public through the sharing of MA bid pricing
data that is less than 5 years old while at the same time addressing
the concerns of MAOs that we appropriately guard against the potential
misuse of data in ways that would undermine protections put in place to
ensure nondisclosure of proprietary data. The purpose of this
solicitation is to both inform our decision-making process about the 5-
year threshold proposed above, as well as to inform future policy
development.
6. Background on Part C and Part D Medical Loss Ratio Data
Section 1103 of Title I, Subpart B of the Health Care and Education
Reconciliation Act (Pub. L. 111-152) amends section 1857(e) of the Act
to add medical loss ratio (MLR) requirements to Medicare Part C. An MLR
is expressed as a percentage, generally representing the percentage of
revenue used for patient care rather than for such other items as
administrative expenses or profit. Because section 1860D-12(b)(3)(D) of
the Act incorporates by reference the requirements of section 1857(e)
of the Act, these MLR requirements also apply to the Part D program. In
the May 23, 2013 final rule (78 FR 31284), we codified the MLR
requirements for MAOs and Part D sponsors in the regulations at part
422, subpart X, and part 423, subpart X.
For contracts beginning in 2014 or later, MAOs, cost plans, and
Part D sponsors are required to report their MLRs and are subject to
financial and other penalties for a failure to meet the statutory
requirement that they have an MLR of at least 85 percent (see Sec.
422.2410 and Sec. 423.2410). The statute imposes several levels of
sanctions for failure to meet the 85 percent minimum MLR requirement,
including remittance of funds to CMS, a prohibition on enrolling new
members, and ultimately contract termination. The minimum MLR
requirement in section 1857(e)(4) of the Act creates incentives for
MAOs and Part D sponsors to reduce administrative costs, such as
marketing costs, profits, and other uses of the funds earned by plan
sponsors, and helps to ensure that taxpayers and enrolled beneficiaries
receive value from Medicare health plans.
Under the regulations at Sec. 422.2410 and Sec. 422.2460, with
respect to MAOs, and Sec. 423.2410 and Sec. 423.2460, with respect to
Part D sponsors, for each contract year, each MAO and Part D sponsor is
required to submit a report to us, in a timeframe and manner that we
specify, which includes the data needed to calculate and verify the MLR
and remittance amount, if any, for each contract. The information that
MAOs and Part D sponsors report to us includes incurred claims for
medical services and prescription drug costs, expenditures on
activities that improve health care quality, taxes, licensing and
regulatory fees, non-claims costs, and revenue.
We have developed a standardized MLR Report template, called the
MLR Report, for MAOs and Part D sponsors to populate with the data used
to calculate the MLR and remittance amount owed to us under Sec.
422.2410 and Sec. 423.2410, if any. The MLR Report is a standardized
Excel workbook with three worksheets and special functions built in
(for example, validation features). We maintain and update the MLR
Report data collection format under OMB #0938-1232.
For each contract year beginning in 2014 or later, MAOs and Part D
sponsors are required to enter their MLR data and upload their MLR
Reports to our Health Plan Management System (HPMS). Based on the data
entered by the MAO or Part D sponsor, the Report calculates the MLR for
the contract. An MA or Part D contract's MLR is increased by a
credibility factor if the contract's experience for the contract
[[Page 46404]]
year is partially credible in actuarial terms, as provided at Sec.
422.2440 and Sec. 423.2440. Finally, we also require MAOs and Part D
sponsors to include in their MLR Reports a detailed description of the
methods used to allocate expenses, including how each specific expense
meets the criteria for the expense category to which it was assigned.
The MLR Report is on our Web site at https://www.cms.gov/Medicare/Medicare-Advantage/Plan-Payment/medicallossratio.html, accompanied by
instructions on how to populate the Report.
Below we describe the categories of Part C and Part D MLR data
submitted in the MLR Reports:
Revenue. MAOs and Part D sponsors must report revenue
received under the contract. The MLR Report includes separate lines for
MAOs and Part D sponsors to report the amounts of revenue received,
such as beneficiary premiums; MA plan payments (based on A/B bids); MA
rebates; Part D direct subsidies; federal reinsurance subsidies; Low
Income Premium Subsidy Amounts; risk corridor payments; and MSA
enrollee deposits (see Sec. 422.2420(c)(1) and Sec. 423.2420(c)(1)).
Claims. MAOs and Part D sponsors must report incurred
claims for clinical services and prescription drug costs, including
categories such as the following: Direct claims paid to providers
(including under capitation contracts with physicians) for covered
services; for an MA contract that includes MA-PD plans, or a Part D
contract, the MLR Report must include drug costs provided to all
enrollees under the contract; liability and reserves for claims
incurred during the contract year; paid and accrued medical incentive
pools and bonuses; reserves for contingent benefits and the medical or
Part D claim portion of lawsuits; MA rebate amounts that are used to
reduce enrollees' Part B premiums; total fraud reduction expenses and
total claim payment recoveries as a result of fraud reduction efforts;
MSA enrollee deposits; and direct and indirect remuneration (see Sec.
422.2420(b) and Sec. 423.2420(b)).
Federal and State Taxes and Licensing or Regulatory Fees.
The MLR Report includes MAOs and Part D sponsors' outlays for taxes and
fees, such as federal income taxes and other federal taxes; state
income, excise, business, and other taxes; state premium taxes;
allowable community benefit expenditures; and licensing and regulatory
fees (see Sec. 422.2420(c)(2) and Sec. 423.2420(c)(2)).
Health Care Quality Improvement Expenses Incurred. MAOs
and Part D sponsors must enter their expenditures for health care
quality improvement. Expenditures are categorized separately depending
on the primary purpose of the activity. Quality improvement expenses
are reported in categories such as: (1) Expenses for improving health
outcomes through the implementation of activities such as quality
reporting, effective case management, care coordination, chronic
disease management, and medication and care compliance initiatives; (2)
expenses for implementing activities to prevent hospital readmissions;
(3) expenses for activities primarily designed to improve patient
safety, reduce medical errors, and lower infection and mortality rates;
(4) expenses for activities primarily designed to implement, promote,
and increase wellness and health activities; (5) expenditures to
enhance the use of health care data to improve quality, transparency,
and outcomes and support meaningful use of health information
technology; or (6) allowable ICD-10 implementation costs (see Sec.
422.2430(a)(1) and Sec. 423.2430(a)(1)).
Non-Claims Costs. MAOs and Part D sponsors must report
expenditures for non-claims costs, such as administrative fees, direct
sales salaries and benefits, brokerage fees and commissions, regulatory
fines and penalties, cost containment expenses not included as quality
improvement expenses, all other claims adjustment expenses, non-
allowable community benefit expenditures, and non-allowable ICD-10
implementation costs (see Sec. 422.2430(b) and Sec. 423.2430(b)).
Employer Group Waiver Plan (EGWP) Reporting Methodology.
We only apply the MLR requirement to the Medicare-funded portion of
EGWPs. MLR Reports submitted for MA or Part D contracts that include
EGWPs must specify the percentage of the contract's total revenue that
was funded by Medicare. The MLR Report must also identify the
methodology that the MAO or Part D sponsor used to determine the
Medicare-funded portion of the EGWP (see Sec. 422.2420 and Sec.
423.2420).
Total Member Months. MAOs and Part D sponsors must report
all member months across all plans under the contract (see Sec.
422.2440 and Sec. 423.2440).
Plan-Specific Data. MAOs and Part D sponsors enter a list
of all of the plans offered under the contract, and the member months
associated with each plan entered. They must provide additional details
about each plan that is listed, including whether the plan is a Special
Needs Plan for beneficiaries who are dually eligible for both Medicare
and Medicaid (D-SNP); whether the plan's defined service area includes
counties in one of the territories; and plan-level cost and revenue
information for D-SNPs in territories (see Sec. 422.2420(a) and Sec.
423.2420(a)).
Medical Loss Ratio Numerator. This is a calculated field
that is the sum of all amounts reported as claims or as health care
quality improvement expenses in the MLR Report (see Sec. 422.2420(b)
and Sec. 423.2420(b)).
Medical Loss Ratio Denominator. This field is calculated
by taking the contract's total revenue and deducting the sum of the
reported licensing or regulatory fees, federal and state taxes, and
allowable community benefit expenditures (see Sec. 422.2420(c) and
Sec. 423.2420(c)).
Credibility Adjustment. An MAO or Part D sponsor may add a
credibility adjustment to a contract's MLR if the contract's experience
is partially credible, as determined by us (see Sec. 422.2440(d) and
Sec. 423.2440(d)). If a contract receives a credibility adjustment
(determined by the number of total member months under the contract),
this field is populated by a percentage that represents the credibility
adjustment factor (see Sec. 422.2440(a) and Sec. 423.2440(a)).
Unadjusted MLR. This is a calculated field that reflects
the MLR for an MA or Part D contract before application of the
credibility adjustment (see Sec. 422.2440 and Sec. 423.2440).
Adjusted MLR. This is a calculated field that represents
the MLR after the application of the credibility adjustment factor (see
Sec. 422.2440(a) and Sec. 423.2440(a)).
Remittance Amount Due to CMS for the Contract Year. The
MLR Report includes any amounts that the MAO or Part D sponsor must
remit to us. The MLR Report identifies the amount of the remittance
that is allocated to Parts A and B, and the amount allocated to Part D
(see Sec. 422.2410(c) and Sec. 423.2410(c)).
7. Proposed Regulatory Changes for Release of MLR Data
a. Proposed Addition of Sec. 422.2490 and Sec. 423.2490 Authorizing
Release of Part C and Part D Medical Loss Ratio Data
We are proposing to add new contract requirements, codified in new
regulations at Sec. Sec. 422.504 and 422.2490 of part 422, with
respect to Part C MLR data, and Sec. Sec. 423.505 and 423.2490 of part
423, with respect to Part D MLR data, to authorize release to the
public by CMS of certain MLR data submitted by MAOs and Part D
sponsors. We propose to define Part C MLR data at Sec. 422.2490(a),
and Part D MLR data at
[[Page 46405]]
Sec. 423.2490(a), as the data the MAOs and Part D sponsors submit to
us in their annual MLR Reports, as required under existing Sec.
422.2460 and Sec. 423.2460. At Sec. 422.2490(b) and Sec.
423.2490(b), we propose certain exclusions to the definitions of Part C
MLR data and Part D MLR data, respectively. Finally, we propose at
Sec. 422.2490(c) and Sec. 423.2490(c) to release the Part C MLR data
and Part D MLR data, respectively, for each contract for each contract
year, no earlier than 18 months after the end of the applicable
contract year.
Generally, the MLR for each MA and Part D contract reflects the
ratio of costs (numerator) to revenues (denominator) for all enrollees
under the contract. For an MA contract, the MLR reflects the percentage
of revenue received under the contract spent on incurred claims for all
enrollees, prescription drug costs for those enrollees in MA plans
under the contract offering the Part D benefit, quality initiatives
that meet the requirements at Sec. 422.2430, and amounts spent to
reduce Part B premiums. The MLR for a Part D contract reflects the
percentage of revenue received under the contract spent on incurred
claims for all enrollees for Part D prescription drugs, and on quality
initiatives that meet the requirements at Sec. 423.2430. The
percentage of revenue that is used for other items such as
administration, marketing, and profit is excluded from the numerator of
the MLR (see Sec. 422.2401 and Sec. 423.2401; Sec. 422.2420(b)(4)
and Sec. 423.2420(b)(4); Sec. 422.2430(b) and Sec. 423.2430(b)).
As discussed in section III.F.1. of this proposed rule, our
proposed release of Part C and Part D MLR data is in keeping with
Presidential initiatives to improve federal management of information
resources by increasing data transparency and access to federal
datasets. In proposing this release, we are also seeking to align with
current disclosures of MLR data that issuers of commercial health plans
submit each year as required by section 2718 of the Public Health
Service Act. We have published similar commercial MLR data on our Web
site at https://www.cms.gov/CCIIO/Resources/Data-Resources/mlr.html.
The MLR data that we propose to release will enable enrollees,
consumers, regulators, and others to see how much of plan sponsors'
revenue is used to pay for services, quality improving activities, and
Part B premium rebates versus how much is used to pay for ``non-
claims,'' or administrative expenses, incurred by the plan sponsor. We
believe that the release of this data will facilitate public evaluation
of the MA and Part D programs by providing insight into the efficiency
of health insurers' operations. In addition, we believe that our
proposed policy for the release of certain MLR data will provide
beneficiaries with information that can be used to assess the relative
value of Medicare health and drug plans.
b. Exclusions From the Release of Part C and Part D MLR Data
For the purpose of this data release under proposed Sec. 422.2490
and Sec. 423.2490, we would exclude four categories of information
from the release of Part C and Part D MLR data, as described at
proposed Sec. 422.2490(b) and Sec. 423.2490(b), respectively. First,
at Sec. 422.2490(b)(1) and Sec. 423.2490(b)(1), we propose to exclude
from release any narrative information that MAOs and Part D sponsors
submit to support the amounts that they include in their MLR Reports,
such as descriptions of the methods used to allocate expenses. MAOs and
Part D sponsors are required to describe the methods they used to
allocate expenses, including incurred claims, quality improvement
expenses, federal and state taxes and licensing or regulatory fees, and
other non-claims costs. A detailed description of each expense element
should be provided, including how each specific expense meets the
criteria for the type of expense in which it is categorized. We believe
that descriptions of expense allocation methods should be excluded
because MAOs and Part D sponsors may be required to provide information
that is pertinent to more than the individual MA or Part D contract for
which the MLR Report is being submitted (see, for example, Sec.
422.2420(d)(1)(ii) and Sec. 423.2420(d)(1)(ii), which requires that
expenditures that benefit multiple contracts, or contracts other than
those being reported, be reported on a pro rata share), such as an
MAO's or Part D sponsor's proprietary approach to setting payment rates
in contracts with providers, or its strategies for investing in
activities that improve health quality. We are concerned that MAOs and
Part D sponsors would be reluctant to submit narrative descriptions
that include information that they regard as proprietary if they know
that it will be disclosed to the public, which could impair our ability
to assess the accuracy of their allocation methods.
Second, at Sec. 422.2490(b)(2) and Sec. 423.2490(b)(2), we
propose to exclude from release any plan-level information that MAOs
and Part D sponsors submit in their MLR Reports. Some of the plan-level
data in MAO's and Part D sponsors' MLR Reports is also included in
their plan bids as base period experience data, such as plan IDs, plan
member months, and Medicaid per member per month gain/loss. As
discussed in our proposal to release certain MA bid pricing data, we
believe bid data would no longer be competitively sensitive after 5
years; however, we do not believe that bid data becomes no longer
competitively sensitive within the 18-month timeframe for our proposed
release of MLR data. Therefore, we will exclude from our proposed
release plan-level data that is included as base period experience data
in plan bids. We also propose to exclude the plan-level information
submitted in MLR Reports because we do not regard it as relevant to the
purposes of our proposed release of Part C and Part D MLR data, which
include giving the public access to data that can be used to evaluate
the efficiency of MAOs and Part D sponsors and providing enrollees with
information that can be used to compare the relative value of health
plans. For example, our proposed release would exclude MAOs' and Part D
sponsors' responses to questions in the MLR Report that ask whether
each plan under a contract is a Special Needs Plan for beneficiaries
who are dually eligible for both Medicare and Medicaid (D-SNP), or
whether the plan's defined service area includes counties in one of the
territories.
Third, at Sec. 422.2490(b)(3) and Sec. 423.2490(b)(3), we propose
to exclude from release any information identifying Medicare
beneficiaries or other individuals. This exclusion is proposed for the
same reason we propose to exclude similar information from MA bid
submission data that will be released; we believe that it is important
to protect the privacy of individuals identified in these submissions,
particularly Medicare beneficiaries. Protection of information that
could identify Medicare beneficiaries, particularly in the context of
their receipt of health care services, is a long-standing principle of
ours in the context of the Medicare program. Incorporating this
principle and the necessary protection of this data into this proposal
to disclose information is appropriate. With respect to Medicare
beneficiaries, we propose to exclude from release any information (that
is, data elements) in an MLR Report for a contract if the total number
of beneficiaries under the contract is fewer than 11, as we believe
that this threshold establishes the point at which individual-level
data can be discerned. Following our longstanding data release policy
for protecting
[[Page 46406]]
individually identifiable information, if a data field in the MLR
Report for an MA or Part D contract is calculated based on figures
associated with fewer than 11 enrollees (or 132 member months, assuming
each individual is counted for 12 months), we would suppress all the
data from such fields in the public release file for that contract. We
are not proposing to build this threshold into the regulation text,
however, as we believe that as technology changes and the ability to
reverse-engineer data to identify beneficiaries may change over time.
We may revisit this threshold as we administer the data releases
proposed here (and in other Medicare contexts) and will make
adjustments as necessary to ensure that we do not disclose data that
could be used to identify beneficiaries.
Regarding other individuals, we require that MAOs and Part D
sponsors provide in their MLR Reports the names and contact information
of individuals who can answer questions about the data submitted in an
MLR Report. We propose to exclude this information from release. We do
not believe that the release of this information serves the purposes of
our proposed release of certain MLR data, which are to provide the
public with data that can be used to evaluate MA and Part D contracts'
efficiency, and to provide beneficiaries with information that can be
used to compare the relative value of Medicare plans. Further, release
of this identifying and contact information appears to be an
unnecessary intrusion into information about private individuals.
Fourth, at Sec. 422.2490(b)(4) and Sec. 423.2490(b)(4), we
propose to exclude from release any MLR review correspondence. In the
course of the MLR review process, our reviewers may engage in
correspondence with MAOs and Part D sponsors in order to validate
amounts included in their MLR Reports. Such correspondence may include
requests for evidence of amounts reported to us. Responses to these
requests could include competitively-sensitive information, such as
MAOs' and Part D sponsors' negotiated rates of reimbursement. Release
of this correspondence could cause MAOs to be less forthcoming in the
information provided to CMS, which would impede the ability of the
agency to verify the information submitted by MAOs and Part D sponsors.
c. Timing of Release of Part C and Part D MLR Data
We are proposing to release the MLR data specified in this rule for
each MA and Part D contract on an annual basis no earlier than 18
months after the end of the contract year to which the MLR data
applies. We are proposing to follow the commercial MLR approach in
making the data we receive in MLR Reports available to the public. For
Part C and Part D MLR reporting, the data is due about 12 months after
the end of the contract year. After we receive MAOs' and Part D
sponsors' MLR Reports, we anticipate that it will take up to six months
for us to review and finalize the data submitted by MAOs and Part D
sponsors.
We believe that our proposed release of contract-level MLR data
strikes the appropriate balance between safeguarding information that
could be commercially sensitive or proprietary and providing enrollees
of health plans, consumers, regulators, and others with a measure that
can be used to evaluate health insurers' efficiency. The Part C MLR
data and Part D MLR data that we propose to release is aggregated at
the contract level. Costs in the MLR numerator are aggregated across
providers, beneficiaries, and sites of service. Costs and revenues are
further aggregated across all plans under the contract. We do not
believe that there is a realistic possibility that the MLR data that we
propose to release could be disaggregated or reverse engineered to
reveal commercially sensitive or proprietary information. We seek
comment on this point and on our analysis of the commercial sensitivity
of this information.
We believe the availability of the Part C MLR data and Part D MLR
data we are proposing to release will provide beneficiaries a measure
by which they can compare the relative value of Medicare products. Our
proposed release of MLR data will permit enrollees of health plans,
consumers, regulators, and others to take into consideration MLRs when
evaluating health insurers' efficiency.
We also believe the availability of MLR data will enhance the
competitive nature of the MA and Part D programs. The proposed access
to data will support potential plan sponsors in evaluating their
participation in the Part C and D programs and will facilitate the
entry into new markets of existing plan sponsors. In knowing historical
MLR data, new business partners might emerge, and better business
decisions might be made by existing partners. As a result, we believe
that releasing Part C and Part D MLR data as proposed is both necessary
and appropriate for the effective operation of these programs.
We seek comment on the release of Part C MLR data and Part D MLR
data as outlined above. We solicit comment on whether the Part C MLR
data and Part D MLR data we propose to release contain proprietary
information, and if so, what safeguards might be appropriate to protect
those data, such as recommended fields to be redacted, the minimum
length of time that such data remains commercially sensitive, and any
suggestions for publishing aggregations of Part C MLR data and Part D
MLR data in lieu of publishing the MLR data as submitted by MAOs and
Part D sponsors. We invite commenters to provide analysis and
explanations to support comments that information should be protected
for a longer--or shorter--period of time so that we may properly
evaluate our proposal in adopting a final rule. Analysis and
explanations should (1) cite the particular information proposed to be
released and explain how that information differs from publicly
available data; (2) point to the particular entity or entity type that
could gain an unfair competitive advantage from the information
release; and (3) fully explain the mechanism by which the release of
that particular information would create an unfair competitive
advantage for that particular entity.
We also solicit comment on whether MLR data that is associated
single-plan contracts is more commercially sensitive than MLR data that
is associated with contracts that include multiple plans, and if so,
whether we should take any protective measures when releasing the MLR
data for single-plan contracts, such as redacting data fields that
could be used to identify the contract, withholding the MLR data for
all single-plan contracts and instead publishing a data set consisting
of figures that have been averaged across all single-plan contracts, or
by releasing a more limited data set for single-plan contracts.
8. Proposed Technical Changes
We are proposing to amend Sec. 422.2400, which identifies the
basis and scope of the MLR regulations for MAOs, and Sec. 423.2400,
which identifies the basis and scope of the MLR regulations for Part D
sponsors, to add a reference to section 1106 of the Act, which governs
the release of information gathered in the course of administering our
programs under the Act.
F. Prohibition on Billing Qualified Medicare Beneficiary Individuals
for Medicare Cost-Sharing
We remind all Medicare providers (including providers of services
defined in section 1861 of the Act and
[[Page 46407]]
physicians) that federal law prohibits them from collecting Medicare
Part A and Medicare Part B deductibles, coinsurance, or copayments,
from beneficiaries enrolled in the Qualified Medicare Beneficiaries
(QMB) program (a Medicaid program which helps certain low-income
individuals with Medicare cost-sharing liability). In July 2015, we
released a study finding that confusion and inappropriate balance
billing persist notwithstanding laws prohibiting Medicare cost-sharing
charges for QMB individuals, Access to Care Issues Among Qualified
Medicare Beneficiaries (QMB) (``Access to Care'') https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/Downloads/Access_to_Care_Issues_Among_Qualified_Medicare_Beneficiaries.pdf.
These findings underscore the need to re-educate providers about
proper billing practices for QMB enrollees.
In 2013, approximately 7 million Medicare beneficiaries were
enrolled in the QMB program. State Medicaid programs are liable to pay
Medicare providers who serve QMB individuals for the Medicare cost-
sharing. However, as permitted by federal law, states can limit
provider payment for Medicare cost-sharing to the lesser of the
Medicare cost-sharing amount, or the difference between the Medicare
payment and the Medicaid rate for the service. Regardless, Medicare
providers must accept the Medicare payment and Medicaid payment (if
any, and including any permissible Medicaid cost sharing from the
beneficiary) as payment in full for services rendered to a QMB
individual. Medicare providers who violate these billing prohibitions
are violating their Medicare Provider Agreement and may be subject to
sanctions. (See sections 1902(n)(3); 1905(p); 1866(a)(1)(A); 1848(g)(3)
of the Act.)
Providers should take steps to educate themselves and their staff
about QMB billing prohibitions and to exempt QMB individuals from
impermissible Medicare cost-sharing billing and related collection
efforts. For more information about these requirements, steps to
identify QMB patients and ways to promote compliance, see https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/se1128.pdf.
Given that original Medicare providers may also serve Medicare
Advantage enrollees, we note that the CY 2017 Medicare Advantage Call
Letter reiterates the billing prohibitions applicable to dual eligible
beneficiaries (including QMBs) enrolled in Medicare Advantage plans and
the responsibility of plans to adopt certain measures to protect dual
eligible beneficiaries from unauthorized charges under Sec.
422.504(g). (See pages 181-183 at https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2017.pdf).
G. Recoupment or Offset of Payments to Providers Sharing the Same
Taxpayer Identification Number
1. Overview and Background
Medicare payments to providers and suppliers may be offset or
recouped, in whole or in part, by a Medicare contractor if the Medicare
contractor or CMS has determined that a provider or supplier has been
overpaid. Historically, we have used the Medicare provider billing
number or National Provider Identifier (NPI) to recoup overpayments
from Medicare providers and suppliers until these debts were paid in
full or eligible for referral to the Department of Treasury (Treasury)
for further collection action under the Debt Collection Improvement Act
of 1996 and the Digital Accountability and Transparency Act of 2014.
Once an overpayment is referred to Treasury, the Treasury's Debt
Management Services uses various tools to collect the debt, including
offset of federal payments against entities that share the same
provider Taxpayer Identification Number (TIN). Hence, Treasury has the
ability to collect our overpayments using the provider TIN and we pay a
fee for every collection made.
On March 23, 2010, the Affordable Care Act (ACA) was enacted.
Section 6401(a)(6) of the Affordable Care Act established a new section
1866(j)(6) of the Act. Section 1866j(6) of the Act allows the Secretary
to make any necessary adjustments to the payments to an applicable
provider of services or supplier to satisfy any amount due from an
obligated provider of services or supplier. The statute defines an
applicable provider of services or supplier (applicable provider) as a
provider of services or supplier that has the same taxpayer
identification number as the one assigned to the obligated provider of
services or supplier. The statute defines the obligated provider of
services or supplier (obligated provider) as a provider of services or
supplier that owes a past-due overpayment to the Medicare program. For
purposes of this provision, the applicable and obligated providers must
share a TIN, but may possess a different billing number or National
Provider Identifier (NPI) number than one another.
For example, a health care system may own a number of hospital
providers and these providers may share the same TIN while having
different NPI or Medicare billing numbers. If one of the hospitals in
this system receives a demand letter for a Medicare overpayment, then
that hospital (Hospital A) will be considered the obligated provider
while its sister hospitals (Hospitals B and C) will be considered the
applicable providers. This authority allows us to recoup the
overpayment of the obligated provider, Hospital A, against any or all
of the applicable providers, Hospitals B and C, with which it, Hospital
A, shares a TIN.
2. Provisions of the Proposed Regulations
If CMS or a Medicare contractor has decided to put into effect an
offset or recoupment, then Sec. 405.373(a) requires the Medicare
contractor to notify the provider or supplier in writing of its
intention to fully or partially offset or recoup payment and the
reasons for the offset or recoupment. Currently, the written demand
letter sent by the Medicare contractor to a provider or supplier serves
as notification of the overpayment and intention to recoup or offset if
the obligated provider, Hospital A, fails to repay the overpayment in a
timely manner.
With the passage of section 1866(j)(6) of the Act, the requirements
in Sec. 405.373(a) could be interpreted to require the Medicare
contractor to provide notification to both the obligated provider,
Hospital A, and the applicable provider, Hospital B, of its intention
to recoup or offset payment. Because we don't think it is necessary to
provide separate notice to both the obligated provider and the
applicable provider, we propose to amend the notice requirement in
Sec. 405.373. Specifically, we propose to create a new paragraph (f)
in Sec. 405.373 to state that Sec. 405.373(a) does not apply in
instances where the Medicare Administrative Contractor intends to
offset or recoup payments to the applicable provider of services or
supplier to satisfy an amount due from an obligated provider of
services or supplier when the applicable and obligated provider of
services or supplier share the same Taxpayer Identification Number.
Before the effective date of this rule, we intend to notify all
potentially affected Medicare providers of the implementation of
section 1866j(6) of the Act through Medicare Learning Network (MLN) or
MLN Connects Provider eNews article(s), an update to
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the current Internet Only Manual instructions including, the Medicare
Financial Management Manual, and the addition of clarifying language in
the demand letters issued to obligated providers. We believe these
actions would provide adequate notice to providers and suppliers
sharing a TIN, if they choose, provide the opportunity to implement a
tracking system of Medicare overpayments on the corporate level for the
affected providers. We also believe these actions are sufficient
because of Treasury's analogous practice of offsetting using a TIN
without furnishing notice to all potentially affected providers and
suppliers. It has been a long standing practice for Treasury to offset
federal payments using the TIN and Treasury currently does not issue a
notice of intent to recoup or offset to applicable providers and
suppliers when Treasury recoups CMS overpayments.
Additionally, in our review of Sec. 405.373(a) and (b), we propose
to replace the terms intermediary and carrier with the term Medicare
Administrative Contractor as intermediaries and carriers no longer
exist.
H. Accountable Care Organization (ACO) Participants Who Report
Physician Quality Reporting System (PQRS) Quality Measures Separately
The Affordable Care Act gives the Secretary authority to
incorporate reporting requirements and incentive payments from certain
Medicare programs into the Shared Savings Program, and to use
alternative criteria to determine if payments are warranted.
Specifically, section 1899(b)(3)(D) of the Act affords the Secretary
discretion to incorporate reporting requirements and incentive payments
related to the physician quality reporting initiative (PQRI), under
section 1848 of the Act, including such requirements and such payments
related to electronic prescribing, electronic health records, and other
similar initiatives under section 1848, and permits the Secretary to
use alternative criteria than would otherwise apply (under section 1848
of the Act) for determining whether to make such payments.
Current Shared Savings Program regulations at Sec. 425.504(c) do
not allow eligible professionals (EPs) billing through the Taxpayer
Identification Number (TIN) of an Accountable Care Organization (ACO)
participant to participate in PQRS outside of the Shared Savings
Program, and these EPs and the ACO participants through which they bill
may not independently report for purposes of the PQRS apart from the
ACO. This policy was designed to ease reporting burden for individual
EPs and group practices and promote integration of providers and
suppliers within the ACO in order to help achieve the Shared Savings
Program goals of improving quality and coordination of care. While over
98 percent of ACOs satisfactorily report their quality data annually,
if an ACO fails to satisfy the PQRS reporting requirements, the
individual EPs and group practices participating in that ACO will
receive the PQRS payment adjustment along with the automatic VM
downward payment adjustment.
We are proposing to amend the regulation at Sec. 425.504 to permit
EPs that bill under the TIN of an ACO participant to report separately
for purposes of the 2018 PQRS payment adjustment when the ACO fails to
report on behalf of the EPs who bill under the TIN of an ACO
participant. Specifically, we are proposing to remove the requirement
at Sec. 425.504(c)(2) so that, for purposes of the reporting period
for the 2018 PQRS payment adjustment (that is, January 1, 2016, through
December 31, 2016), EPs who bill under the TIN of an ACO participant
have the option of reporting separately as individual EPs or group
practices. If the ACO fails to satisfactorily report on behalf of such
EPs or group practices, we are proposing to consider this separately
reported data for purposes of determining whether the EPs or group
practices are subject to the 2018 PQRS payment adjustment. We are also
proposing to amend Sec. 425.504(c)(2) to apply only for purposes of
the 2016 payment adjustment. We propose at Sec. 425.504(d) the revised
requirements for the 2017 and 2018 PQRS payment adjustment under the
Shared Savings Program. We discuss the proposed changes for the 2017
PQRS payment adjustment under the Shared Savings Program in more detail
later in this section.
We note that the registration deadline for participating in the
PQRS Group Practice Reporting Option (GPRO) is June 30 of the
applicable reporting period. Since affected EPs are not able to
register for the PQRS GPRO by the applicable deadline for the 2018 PQRS
payment adjustment, we propose that such EPs would not need to register
for the PQRS GPRO for the 2018 PQRS payment adjustment, but rather mark
the data as group data in their submission. Thus, we are proposing to
eliminate a registration process for groups submitting data using third
party entities. When groups submit data utilizing third party entities,
such as a qualified registry, QCDR, direct EHR product, or EHR data
submission vendor, we are able to obtain group information from the
third party entity and discern whether the data submitted represents
group submission or individual submission once the data is submitted.
In addition, we propose that an affected EP may utilize the secondary
reporting period either as an individual EP using one of the registry,
qualified clinical data registry (QCDR), direct Electronic Health
Record (EHR) product, or EHR data submission vendor reporting options
or as a group practice using one of the registry, QCDR, direct EHR
product, or EHR data submission vendor reporting options. We note that
this would exclude, for individual EPs, the claims reporting option
and, for group practices, the Web Interface and certified survey vendor
reporting options.
Furthermore, we recognize that certain EPs are similarly situated
with regard to the 2017 PQRS payment adjustment, which will be applied
beginning on January 1, 2017. We believe it is appropriate and
consistent with our stated policy goals to afford these EPs the benefit
of this proposed policy change. Accordingly, as noted above,we are
proposing to permit EPs that bill through the TIN of an ACO participant
to report separately for purposes of the 2017 PQRS payment adjustment
if the ACO failed to report on behalf of the EPs who bill under the TIN
of an ACO participant. Specifically, we are proposing to remove the
requirements at Sec. 425.504(c)(2) so that, for purposes of the
reporting period for the 2017 PQRS payment adjustment, EPs who bill
under the TIN of an ACO participant have the option of reporting
separately as individual EPs or group practices. As noted above, we are
proposing to amend Sec. 425.504(c)(2) to apply only for purposes of
the 2016 payment adjustment. We propose at Sec. 425.504(d) the revised
requirements for the 2017 and 2018 PQRS payment adjustment under the
Shared Savings Program.
The previously established reporting period for the 2017 PQRS
payment adjustment is January 1, 2015, through December 31, 2015. To
allow affected EPs that participate in an ACO to report separately for
purposes of the 2017 PQRS payment adjustment, we are proposing at Sec.
414.90(j)(1)(ii) to establish a secondary PQRS reporting period for the
2017 PQRS payment adjustment for individual EPs or group practices who
bill under the TIN of an ACO participant if the ACO failed to report on
behalf of such individual EPs or group practices during the previously
established reporting period for the
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2017 PQRS payment adjustment. This option is limited to EPs that bill
through the TIN of an ACO participant in an ACO that failed to
satisfactorily report on behalf of its EPs and would not be available
to EPs that failed to report for purposes of PQRS outside the Shared
Savings Program.
In addition, we propose that these affected EPs may utilize the
secondary reporting period either as an individual EP using the
registry, QCDR, direct EHR product, or EHR data submission vendor
reporting options or as a group practice using one of the registry,
QCDR, direct EHR product, or EHR data submission vendor reporting
options. We note that this would exclude, for individual EPs, the
claims reporting option and, for group practices, the Web Interface and
certified survey vendor reporting options.
We note that the registration deadline for the participating in the
PQRS GPRO is June 30 of the applicable reporting period. Since the
applicable deadline for the 2017 PQRS payment adjustment has passed, we
propose that such EPs would not need to register for the PQRS GPRO for
the 2017 PQRS payment adjustment, but rather would be able to report as
a group practice via the registry, QCDR, direct EHR product, or EHR
data submission vendor reporting options. Therefore, we propose at
Sec. 414.90(j)(4)(v) that sections Sec. 414.90(j)(8)(ii), (iii), and
(iv) would apply to affected EPs reporting as individuals using this
secondary reporting period for the 2017 PQRS payment adjustment. In
addition, we propose at Sec. 414.90(j)(7)(viii) that sections Sec.
414.90(j)(9)(ii), (iii), and (iv) would apply to affected EPs reporting
as group practices using this secondary reporting period for the 2017
PQRS payment adjustment. Further, we propose at Sec. 414.90(k)(4)(ii)
that Sec. 414.90(k)(5) would apply to affected EPs reporting as
individuals or group practices using this secondary reporting period
for the 2017 PQRS payment adjustment.
We are also proposing that the secondary reporting period for the
2017 PQRS payment adjustment would coincide with the reporting period
for the 2018 PQRS payment adjustment (that is, January 1, 2016 through
December 31, 2016). In addition, for operational reasons and to
minimize any additional burden on affected EPs (who are already
required to report for CY 2016 for purposes of the 2018 PQRS payment
adjustment), we propose to assess the individual EP or group practice's
2016 data using the applicable satisfactory reporting requirements for
the 2018 PQRS payment adjustment (including, but not limited to, the
applicable PQRS measure set). We invite comment on any 2018
requirements that may need to be modified when applied for purposes of
the 2017 PQRS payment adjustment,
As a result, individual EP or group practice 2016 data could be
used with respect to the secondary reporting period for the 2017
payment adjustment or for the 2018 payment adjustment or for both
payment adjustments if the ACO in which the affected EPs participate
failed to report for purposes of the applicable payment adjustment. We
believe this change to our program rules is necessary for affected
individual EPs and group practices to be able to take advantage of the
additional flexibility proposed at section III.K.1.e. for the Shared
Savings Program. If an affected individual EP or group practice decides
to use the secondary reporting period for the 2017 payment adjustment,
it is important to note that this EP or group practice should expect to
receive a PQRS payment adjustment for services furnished in 2017 until
CMS is able to determine that the EP or group practice satisfactorily
reported for purposes of the 2017 PQRS payment adjustment. First, we
would need to process the data submitted for 2016. Second, we would
need to determine whether or not the individual EP or group practice
met the applicable satisfactory reporting requirements for the 2018
PQRS payment adjustment. Third, we would need to update the individual
EP or group practice's status so that the EP or group practice stops
receiving a negative payment adjustment on claims for services
furnished in 2017 and reprocess all claims that were previously paid.
In addition, as discussed further in section III.L. of this proposed
rule, the EP or group practice would also avoid the automatic downward
VM adjustment, but would not qualify for an upward adjustment since the
ACO failed to report.
Since EPs and group practices taking advantage of this secondary
reporting period for the 2017 PQRS payment adjustment will have missed
the deadline for submitting an informal review request for the 2017
PQRS payment adjustment, we propose the informal review submission
periods for these EPs or group practices would occur during the 60 days
following the release of the PQRS feedback reports for the 2018 PQRS
payment adjustment.
We request comments on these proposals.
I. Medicare Advantage Provider Enrollment
1. Background
a. General Overview
The Medicare program is the primary payer of health care for
approximately 54 million beneficiaries and enrollees. Section 1802(a)
of the Act permits beneficiaries to obtain health services from any
individual or organization qualified to participate in the Medicare
program. Providers and suppliers furnishing items or services must
comply with all applicable Medicare requirements stipulated in the Act
and codified in the regulations. These requirements are meant to
promote quality care while protecting the integrity of the program. As
a major component of our fraud prevention activities, we have increased
our efforts to prevent unqualified individuals or organizations from
enrolling in Medicare.
The term ``provider of services'' is defined in section 1861 of the
Act as a hospital, a critical access hospital (CAH), a skilled nursing
facility (SNF), a comprehensive outpatient rehabilitation facility
(CORF), a home health agency (HHA), or a hospice. The term ``supplier''
is defined in section 1861(d) of the Act as, unless context otherwise
requires, a physician or other practitioner, facility or other entity
(other than a provider of services) that furnishes items or services
under title XVIII of the Act. Other supplier categories may include,
for example, physicians, nurse practitioners, and physical therapists.
Providers and suppliers that fit into these statutorily defined
categories may enroll in Medicare if they meet the proper screening and
enrollment requirements. This proposed rule would require MA
organization providers and suppliers to be enrolled in Medicare in an
approved status. We generally refer to an ``approved status'' as a
status whereby a provider or supplier is enrolled in, and is not
revoked from, the Medicare program. For example, a provider or supplier
that has submitted an application, but has not completed the enrollment
process with their respective Medicare Administrative Contractor (MAC),
is not enrolled in an approved status. The submission of an enrollment
application does not deem a provider or supplier enrolled in an
approved status. A provider or supplier that is currently revoked from
Medicare is not in an approved status. Out-of network or non-contract
providers and suppliers are not required to enroll in
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Medicare to meet the requirements of this proposed rule.
b. Background
To receive payment for a furnished Medicare Part A or Part B
service or item, or to order, certify, or prescribe certain Medicare
services, items, and drugs, a provider or supplier must enroll in
Medicare. The enrollment process requires the provider or supplier to
complete, sign, and submit to its assigned Medicare contractor the
appropriate Form CMS-855 enrollment application. The CMS-855
application form captures information about the provider or supplier
that is needed for CMS or its contractors to screen the provider or
supplier and determine whether the provider or supplier meets all
Medicare requirements. This screening prior to enrollment helps to
ensure that unqualified individuals and entities do not bill Medicare
and that the Medicare Trust Funds are accordingly protected. Data
collected and verified during the enrollment process generally
includes, but is not limited to: (1) Basic identifying information (for
example, legal business name, tax identification number); (2) state
licensure information; (3) practice locations; and (4) information
regarding ownership and management control.
We strive to further strengthen its provider and supplier
enrollment process to prevent and deter problematic providers and
suppliers from entering the Medicare program. This includes, but is not
limited to, enhancing its program integrity monitoring systems and
revising its provider and supplier enrollment regulations in 42 CFR
424, subpart P, and elsewhere as needed. With authority granted by the
Act, including provisions in the Affordable Care Act and Medicare
Access and CHIP Reauthorization Act, we have revised our provider and
supplier enrollment regulations by issuing the following:
In the February 2, 2011 Federal Register (76 FR 5861), we
published a final rule with comment period titled, ``Medicare,
Medicaid, and Children's Health Insurance Programs; Additional
Screening Requirements, Application Fees, Temporary Enrollment
Moratoria, Payment Suspensions and Compliance Plans for Providers and
Suppliers.'' This final rule with comment period implemented major
Affordable Care Act provisions, including the following:
++ A requirement that institutional providers and suppliers must
submit application fees as part of the Medicare, Medicaid, and CHIP
provider and supplier enrollment processes.
++ Establishment of Medicare, Medicaid, and CHIP provider and
supplier risk-based enrollment screening categories and corresponding
screening requirements.
++ Authority that enabled imposition of temporary moratoria on the
enrollment of new Medicare, Medicaid, and CHIP providers and suppliers
of a particular type (or the establishment of new practice locations of
a particular type) in a geographic area.
